REPORT OF THE COMMITTEE ON DRUGS AND PHARMACEUTICAL INDUSTRY
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CONTENTS
Pages
Chapter
I
Chapter
Introduction
1 — 15
Progress made and status achieved by the Pharmaceutical Industry .
16—53
Public Sector
54—83
Chapter
III
Chapter
IV National Drug Authority
84—85
CHAPTER
V Development of the Drug Industry and the Indian Sector
86—145
Chapter
VI
Raw materials for bulk drug manufacture
146—161
Chapter VII Development and Flow of Technology .
162—172
Chapter VIII Pricing of drugs and Pharmaceuticals
.
173—188
‘-e*. ' -
’ Chapter
Chapter
Chapter
M •
I'< Quality Control of drugs
X
Measures for providing essential drugs and common household remedies to ffae general public especially
rural areas and abolition of brand names for drugs
.
.
...
XI Conclusion and acknowledgement
4
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1 MofP&C/75
189—250
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CHAPTER 1
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c* r/ain, I Block
i'Oramcr.gala
bangalore-560034 '
India
INTRODUCTION
The functioning and growth of the Drugs and Pharmaceutical Industry in India over the past few years were
engaging the attention of Government for quite sometime, particularly with a view to finding out ways and means to
meet the growing requirements and broad social-objectives before the country. Questions about the performance
of the public sector units, multi-national firms' gaining stronghold in this field, prices of locally produced medicines,
etc. were'raised in the Parliament. Following a suggestion made in the Parliament, the Government of India in the
Ministry of Petroleum and Chemicals, set up a Committee by a Resolution No. 3 (26)/73-Ch. Ill dated the Sth Feb
ruary, 1974, consisting of the following members :—
'J
Chairman
2. Shri Yashpal Kapur, M.P.
Member
3. Shri Vasant Sathe, M.P.
u
’
1. Shri Jaisukhlal Hathi
J
4. Dr. Ranen Sen, M.P.
5. Shri K.S. Chavda, M.P.
6. Shri C.M. Stephen. M.P.
7. Dr. M.L. Dhar, Director, Central Drugs Research Institute, Lucknow.
8. Dr. B.D. Tilak, Director, National Chemical Laboratory, Poona.
9. Shri S.S. Marathe, Chairman, Bureau of Industrial Costs & Prices.
10. Shri Vinod Kumar, Joint Secretary, .Ministry of Petroleum & Chemicals.
5»
5J
11. Shri P.S. Ramachandran, Drugs Controller, D.G.H.S.
12. Dr. B. Shah, Dy. Director General, D.G.T.D.
»
13. Dr. B.V. Ranga Rao, Centre for Studies in Science Policy, Jawaharlal Nehru
University.
14. Shri M.K. Rangnekar, Commissioner. Food and Drug Administration, Govern
ment of Maharashtra, Bombay.
15. Dr. P.R. Gupta, Adviser (Drugs), Ministry of Petroleum & Chemicals.
Membir-Sicretary.
2. The Government of India appointed the above Committee to go into tlit various facets of the Drug Industry
in India with a view to promoting growth of the Drug Industry particularly of the Indian and small scale sectors,
improve technological development, take effective Quality Control measures on drugs, reduce the prices of medicines,
as well as to rationalise the prices tructure, provide essential drugs throughout the country, and make available raw
materials to the industry particularly to the small-scale sector, etc. Appointment of such a Committee was also
felt necessary in the context of the large-scale expansion of the drug and pharmaceutical industry envisaged during
the Fifth Five Year Plan period, with a view to ensuring the regulated and rapid growth of drug manufacture. The
terms of reference were as under :—
(i) To enquire into the progress made by the industry and the status achieved by it.
(ii) To recommend measures necessary for ensuring that the public sector attains a leadership role in the
manufacture of basic drugs and formulations, and in research and development.
1
I
(iii) To make recommendations for promoting the rapid growth of the drugs industry and. particularly, of the
Indian and Small Scale Industries Sector. In making its recommendations the Committee will keep in
view the need for a balanced regional dispersal of the industry.
(iv) To examine the present arrangements for the flow of new technology into the industry, and make recommen
dations therefor.
(v) To recommend measures for effective quality control of drugs, and for rendering assistance to small-scale
units in this regard.
2
(vi) To examine the measures taken so far to reduce the prices of drugs for the consumer, and to recommend
such further measures as may be necessary to rationalise the prices of basic drugs and formulations.
(vii) To recommend measures for providing essential drugs and common house-hold remedies to the general
public, especially in the rural areas.
(viii) To recommend institutional and other arrangements to ensure equitable distribution of basic drugs and
raw materials especially to the Small Scale Sector.
A copy of the Government Resob.itioi sotting up the Committee is at Annexurc I.
3. At the meeting held on 21st March, 1974, the Committee coopted Dr. B.B. Gaitonde. Director, Haffkine
Institute, Bombay. Shri P.S. Ramachandran, Drugs Controller (India) retired from Government service but con
tinued as a Member of the Committee. On the advice of the Minister of Health and Family Planning Dr. S.S.
Gothoskar. who succeeded as Drugs Controller (India) was coopted as a member in the meeting held on the 5th
January. 1975.
4. Tne fi 'st meeting of the Comnittee was held on the 6th March, 1974 wherein during the course of discussion
a Sub-Committee consisting of the following members, was set up to examine the question of issue of Permission
No objection Letters and C.O.B Licences by Government :
1. Shri K.S. Chavda, M.P.
2. Dr.
Ranen Sen, M.P.
3. Dr. B. V. Ranga Rao
4 Shri P. S. Ramachandran
Convenor
Shri Jaisukhlal Hathi as Chairman attended the meetings.
5. At the second meeting held on the 21st March, 1974 the Committee finalised the various questionnaires
for issue to the various Organisations etc. A copy of each of the Questionnaires prepared and issed to the units
in the Organized Sector. Associations representing the Drug Industry. Indian Medical Associations and other
Specialists’ Organisations in the medical field is at Annexures II—IV. Subsequently, another Questionnaire was
also issued to the State Governments to elicit their views/suggestions (Annexure V).
6. While the work of the Committee was in progress an unfortunate and tragic incident took place in Kanpur
following administration of a Transfusion solution to some patients in a Hospital resulting in the death of some
persons. As the question of quality of the medicine used was involved in this incident, both the Government and
the Committee felt that the question of quality control should be examined on a priority basis. Following the advice
of the Ministers of Health & Family Planning and Petroleum &, Chemicals, the Committee took up the term of
reference, namely, “to recommend measures for effective quality control of drugs and rendering assistance to the
' small-scale units'in this regard”, for immediate examination and to report to Government. A Sub-Committee
consisting of the following~members was appointed on 2nd May 1974 to go into this question thoroughly and ex
peditiously :—
1. Dr. Ranen Sen
2. Dr M. L. Dhar
3. Shri M. K. Rangnekar
4. Dr. B B. Gaitonde
5. Dr. B. V. Ranga Rao
6. Shri P S. Ramachandran
Convenor
_____report
__ _J
7 : was considered by the Committee on Drugs and Pharmaceutical Industry on
The
of the Sub-Committee
the" 16th May, 1974 and the report was submitted to Government on 25th May, 1974. The report is incorporated
as Chapter IX of this report.
7. With a view to obtaining first hand knowledge of the operations undertaken’ by the various sectors of the
Drug Industry and particularly to assess the problems faced by the Indian sector in expanding their drugs manue
facturing activity and also to obtain the views of the manufactururs and Associations/Organizations of drug manu
facturing units, the Committee undertook a tour to, Maharashtra & Gujarat in June-July, 1974 and visited
some drugs and pharmaceutical manufacturing units both in the organised as well as the small-scale sector of the
industry. ~ The Committee also held discussions with the Local Associations/Organizations of the drugs manu
facturers. to obtain their views on the various aspects involved and particularly as to how this industry could grow
to meet the requirements of the country and also to assess the possibilities/potentiality of the Indian sector to develop
at a faster pace.
I
8. The Committee made similar visits to Rishikesh in August. 1974. Hyderabad and Madras in September
1974. Calcutta in September, October 1974 and Durgapurin November 1974. In Pimpri, Rishikesh and Hyderabad
the Committee visited the public sector units namely Hindustan Antibiotics Limited, Antibiotics Plants and Synthetic
Drugs Plants of the Indian Drugs and Pharmaceuticals Limited.
9. Besides visiting the drug manufacturing, large and small scale units, situated at the various places the
Committee met the representatives of the Associations at Bombay. Baroda, Ahmedabad, Calcutta. Madras ? and
Hyderabad. It also visited the Research centres of Ciba-Geigy, Sarabhais and Bengal Immunity separatetly The
Committee also met the representatives of Organisation of Pharmaceutical Producers of India, Development Council
of Drugs and Pharmaceuticals. Indian Drugs and Pharmaceuticals Limited. State Trading’Corporation and the
Indian Medical Association. The names of the manufacturing units visited by the Committee\ind those of the various
Associations with whom discussions were held along with the dates, are shown in Annexure VI.
10. The Committee during the course of discussions, particularly on the question of making the eseential medi
cines available in adequate quantities to the wider section of the people including those in the rural areas felt that a
list should first be drawn up to identify the essential medicines which are required to be produced in Iar4 Quantities
for mass consumption. It considered that although the question of substitution of brand narrrs bv generic names
in respect of the medicines marketed by the Industry was not specifically mentioned in the terms of reference for this
Committee, the subject followed clearly from the other terms of reference such as reduction/rationalisation of prices
of formulations for the consumers, making essential drugs available in larger quantities to the aenerai nuhlir
The Committee, therefore, appointed a panel consisting of some of the members of the Committee and Sn-i«lists ;
the medical held, from all over the country. The panel consisted of the following members
p^idiisis m
1. Dr. Ranen Sen, Member of Parliament.
2. Dr. A. B. Chowdhury, M.B.. PH.D. F.A.M.S., F.N.A., Director, Calcutta School
of Tropical Medicines,
Chittranjan Avenue. Calcutta-12.
3. Dr. S. Padmavati, Director-Principal, Maulana Azad Medical College, New Delhi.
4. Dr. B. Ray Chaudhury, M.D. (Cal.) FRCP, Ph.D. (Edin), Associate Professor of Medicine Institute nf d +
Graduate Medical Education and Research, 22-Lower Circular Road. Calcutta-17.
’
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1
6. Shri P.S. Ramachandran, Drugs Controller (India), D.G.H.S., New Delhi.
7. Dr. K.G. Nair. MD (Bombay) Ph.D. (Chicago) FACC (U.S.A.) FICA (U.S.A.), of Director
r
CoeneaeneBmnbtvDePartment °f Cardiology and Radio-IsotoPe Unit. REM Hospital and Seth G.S. Medical
8. Dr. B.J. Vakil, Hony. Professor, Gastroenterology. Grant Medical College. Hospital, Bombay.
9. Dr. B.B. Gaitonde, M.D.M.Sc. (Med.), F.A.Sc. Director Haffkine Institute,
Bombay..
Convener
Dr. P.R. Gupta and Shri M.K. Rangnckar assisted the panel in its work.
11. The terms of refee nee for this panel were as follows :—
(i) To recommend measures for providing essential drugs and common house-hold remedices to the
public especially in the rural areas, and
cenerai
(ii) whether it would be in the national interest to substitute brand
manner and extent to which it should be done.
names bv generic names and if
th.
' ~
ana it so, the
The Panel submitted its report on the 29th June, 1974. which was considered bv the Committee on 25th Julv 1Q74 nnd
21st and -2nd January. 1975. The report as modified and adopted bv theCommittee was sent to Governmpnt- d
the 21st February, 1975. This constitutes Chapter X uf the Report. '
° Government on
12. The schedule of the programme of the Committee including its sittings on the Sub-committees meetinn
with the representatives of the Associations at Delhi are also shown in Annexure VI.
umiuees, meeting
13. The time for submission of the report was-extended up to 7th February 1975 and later unrr.
a
-i
lectivX00^01^^ ReSOlUti°nS N°- 3W3-Ch. Ill dated the23rd August, 1974 and 5 th Febru^y? 1975^
14 The Committee has tried to collect the data and statistics of production, capital invested turnover etc
from authentic sources and wherever possible, based on replies given in the Parliament. These may be taken as
indicative and not exhaustive.
y DC taKen as
ANNEXURE I
(Chapter I-Para 2)
TO BE PUBLISHED IN PART II—SEC. 3—SUB-SEC. (ii) OF THE GAZETTE OF
1N DI A—EXTR AO RD I NA RY
No. 3(26)/73-Ch. Ill
MINISTRY OF PETROLEUM & CHEMICALS
New Delhi, the Sth February, 1974
Resolution
Subjects—Constitution of Committee on the drugs and pharmaceuticals industry.
In the context of rhe large-scale expansion of the drugs and pharmaceuticals indutsry envisaged during the Fifth
Five Year Plan, with a view to ensuring the regulated and rapid growth of drugs manufacture, and further with a view
to ensuring that all essential durgs are made available to the consumers at reasonable prices, Government have decided
to constitute a Committee with the following membership
Chairman
1. Shri Jaisukhlal Hathi, M.P.
Member
2. Shri Yashpal Kapur, M.P.
3. Shri Vasant Sathe, M.P.
4. Dr. Ranen Sen, M.P.
.
5. Shri K.S. Chavda, M.P.
.
6. Shri C.M. Stephen, M.P.
.........
7. Dr. M.L. Dhar, Director, Central Drugs Research Institute, Lucknow.
8. Dr. B.D. Tilak, Director, National Chemical Laboratory, Poona.
9. Shri S.S. Mararhe, Chairman, Bureau of Industrial Costs & Prices.
10. Shri Vinod Kumar, Joint Secretary, Ministry of Petroleum &, Chemicals.
11. Shri P.S. Ramachandran. Drugs Controller, DGHS. .
.
...
12. Dr. B. Shah, Dy. Director General, D.G.T.D
13. Dr. B.V. Ranga Rao, Centre for Studies in Science Policy, Jawaharlal Nehru Uni
versity ...
.... z
■
14. Shri M.K. Rangnekar, Commissioner, Food and Drug Administration, Government
of Maharashtra, Bombay.
.........
15. Dr. P.R. Gupta, Adviser (Drugs), Ministry of Petroleum & Chemicals.
55
59
95
Member-Secretary.
2. The Committee will examine and report upon the following matters
(i) To enquire into the progress made by the industry and the status achieved by it.
(ii) To recommend measures necessary for ensuring that the public sector attains a leadership role in the
manufacture of basic drugs and formulations, and in research and development.
(iii) To make recommendations for promoting the rapid growth of the drugs industry and, particularly, of the
Indian and small scale industries sector. In making its recommendations the Committee will keep in view
the need for a balanced regional dispersal of the industry.
(iv) To examine the present arrangements for the flow of new technology into the industry, and make reco
mmendation therefor.
(v) To recommend measures for effective quality control of drugs, and for rendering assistance to small scale
units in this regard.
(vi) To examine the measures taken so far to reduce the prices of drugs for the consumer, and to recommend
such further measures as may be necessary to rationalise the prices of basic drugs and formulations.
(vii) To recommend measures for providing essential drugs and common house-hold remedies to the general
public, specially in the rural areas.
4
F
5
(vm) To recommend institutional and other arrangements to ensure equitable distribution of basic drugs and
raw materials especially to the Small Scale Sector.
b
3. The Committee will ascertain and take into consideration the views of the State Governments and other
interests concenred, as may be found necessary.
uincr
4. The Committee’s headquarters will be at New Delhi.
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Secretariat assistance required by the Committee will be provided by the Ministry of Petroleum and
liC ill ICdl S»
6. The Committee will meet as often as may be considered necessary by the Chairman and shall submit its
final report to Government within six months, The Committee may also, at its discretion, submit interim reports
on specific matters from time to time.
SdZ(P.K. DAVE)
Secretaiy to the Govt, of India
<
ORDER
Ordered that this Resolution be communicated to all the Ministries of Government of India all State Govern
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Ordered also that the Resolution be published in the Gazette of India for general information.
Sd/P.K. DEVE,
Secretary of Govt, of India.
IT
ANNEXURE II
Questionnaire I
(Chapter I-Para 5)
1. Please give a complete list of drugs manufactured by you dividing them into (a) pharmacopoeia! products
(b) ‘New drussr(as defined in the Drugs and Cosmetics Rules) within the last five years and (c) other non-pharmacopoeial products and the value (cost to the wholesaler) of each of these drugs in (a) (b) and (c) produced by
you during your last financial year.
2. Please list out separately the drugs which you manufactured in 1952 and those manufactured subsequently
quoting the Government authority against which the expansion in manufacture has undertaken.
3. Have you any products licensed to be manufactured under the Industries (Development and Regulation)
Act 1951 and whose manufacture has not been commenced by you ? If so. please list those products with capacities.
4. What is the range of products other than drugs which are manufactured by you ? Please specify such products
and their turnover for your last financial year under the following heads :—
(a) Laboratory chemicals
(b) Cosmetics
(c) Insecticides and Pesticides
(d) Nutritional products
(e) Confectionary items
(f) Other items
5. What is the amount of money spent by you separately on the following during your last financial year?
(a) Office establishment (b)) Finance and Accounts Department (c) Planning and Development (d) Sales
Promotion (excluding expenditure covered under 6 and 7 below) (e) Product development (f) Production
of Drugs (g) Quality control (h) Research (i) other heads.
6. What is the strength of the field force of medical representatives employed by you on 1-1-74 and the annual
rpenditure
thereon ?
ex-
7. What is the strength of the field force of sales promotion representatives employed by you on 1-1-74 for
non-drug items and your annual expenditure thereon ?
8 Have you any research organisation ? If so. please give a brief resume of the nature of the research activities
and the money spent on research during your last financial year. As a result of your research in this country, what
baisc durg'chemical is being manufactured by you in this country ?
9 Have you been assisting the medium and small-scale firms by getting intermediate raw-materials
iharmaceutical aids or pharmaceutical formulations manufactured by them ? If so, please supply details with the
pi
names and addresses of firms so assisted.
10 What is the value of your import licence under the ITC regulations for raw materials (1973-74) and what is
h value of your export earnings during the same period ? Also specify the quantities of items imported and the
value of each under the ITC regulations^
11 What is the extent of foreign exchange remittances made by you during 1973-74 towards (a) profit for the
foreign equity holders (b) patent royalties (c) know-how fee (d) scientific contribution and (e) other heads.
19 Please state whether you have opted for compliance with para 7 of the Drugs (Prices Control) Order 1970
a"14
14. In the latter case, what has been your progressive sales turnover during each of your last three company
yearsTnd tlie dividends declared by you for those years.
13 Have you any suggestions to offer to make the Patents Act more useful to the drug industry in this country ?
M Are you satisfied with the quality control measures over drugs taken by the Central and State Drug Control
■ •ctmtinns
Have vou any suesestions to make for improvement in this connection ?
Is there adequate
rlppo^rbeX the Drug Control Administration and the Industry ?
6
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t
7
15. In what way does the industry cooperate with the Drug Control Administration in tackling spurious drugs
ana in what manner can Government’s efforts in this direction be tightened ?
16. Drugs marketed under brand names are generally expensive. Brand names influence the prescribing
practices of physicians and arc used as a lever to boost the sales of products. In the face of these facts, what are
your views on the abolition of brand names of drugs ? If total abolition is not considered advisable, to what extent
can the use of brand names be restricted ?
17. Sampling of drugs by manufacturers to the medical profession it is reported.leads to malpractices of differ
ent-types. What will be your reaction to stopping the distribution of such samples ?
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18. What are your views on (a) the need to avoid multiplicity of drug formulations of the same composition :
(b) combinations of drugs and the need to prohibit irrational and ineffective combinations (c) the desirability of
reducing the number of vitamin preparations to the absolute mihimum and (d) prohibition of advertisement of drugs
in the lay press, in the public and through other audio-visual media ?
19. What role do you expect the public sector concerns to play in the development of the drus industry over
the next 10 years ?
20. Are you satisfied with the performances of the STC and IDPL as canalising agencies for distribution of
raw-materials ? In what way can the working of these organisations be improved ?
21. Are the Government departments at the Centre, namely, the Ministry of Petroleum & Chemicals, the
GTD and the Central Drug Control Organisation
Organisati
helpful and prompt in their dealing with the industry ?
I
I
I
22. Do you own any other company ?
manufactured by each of them.
1 so. give particulars of the names of such companies and the products
If
/
23. Have you any associated companies ?
products manufactured by each of them.
If so, give particulars of the names of such companies and the
24. Do you think that in any particular case the country’s resources are being wasted in obtaining technical
know-how from abroad when it could have been developed indigenously with proper planning and guidance ?
25. The Drugs (Prices Control) Order 1970 has been welcomed by the general public. Without detractingfrom the essential features of this order, have you any suggestions to make for simplifying the implementation proce
dure under this Order ?
26. What measures do you suggest for providing essential durgs and common household remedies to the general
public, especially in the rural areas and to the weaker sections of the community, at reasonably cheap prices ?
27. What measures do you suggest to increase the production of drugs and pharmaceutical products so as to
meet the quantitative requirement of the country at the end of the Fifth Five Year Plan.
28. In case your company has more than 26% foreign equity, please furnish the information also for the ques
tions covered by the enclosed statement separately.
Statement referred to in Question No.
28
1. Kindly supply photostat copies of :—
(a) Industrial Licences for drugs secured under the Industries (Development and Regulation) Act 1951.
(b) Permission/No objection letters granted by the concerned authorities.
i
(c)
Applications for diversification and replies received from Government.
(d) Applications made for COB licences and the licences issued by Government.
2. Please supply information as to the dates on which manufacturing licences under the Drugs and Cosmetics
Act were granted for the items covered by COB licences granted to you.
3. Please supply details about the foreign personnel employed by you during the last five years together with
particulars of the salaries/honorarium and perquisites paid to them.
4. Please supply copies of your Balance Sheets for the last five years.
5. How many products are marketed by you under brand names ?
6. How many drug patents have been sealed/are under registration by your principals in this couutrywo and
how many of these patens are being operated by you in this country ?
1 M of Pet. & Chem./75—2
\
ANNEXURE III
QUESTIONNAIRE II
(Chapter 1—Para 5)
1. What are your Association views on the role so far played by the medium and small-scale sectors of the drug
industry for its development ? What role do you envisage for these sectors in the future development of the industry?
There is a common impression that big firms, particularly the foreign ones, have so far made the major contribution
to the development of the industry. Do you agree with this view ? Give reasons.
2. What arc the handicaps that hamper the development of the medium and small-scale sectors, especially in
attaining the rated capacities of production ? Please specify in terms of:—
(a) Raw material supplies, (b) Packaging materials, (c) Import of Machine^, laboratory' chemicals and
equipment, (d) the Patents Act (e) New Drug clearance, (f) Manufacture of basic drugs, (g) Import subs
titution, (h) Export, (i) Financial resources, (j) ITC Regulations and procedures, and (k) any other aspects.
3. Do you suffer from the disability of obtaining sufficiently qualified technical personnel for manufacturing
your products ?
4. Testing facilities, product development, sales promotion techniques, dissemination of technical information
about drugs to doctors, professional management, planning for future development-these aspects, it is said are not
given sufficient importance by the small and medium scale sectors of the industry. What are your views on these
observations and your suggestions to improve the performance of your member firms in this regard ? In what way can
Government assist the industry in these fields ?
5. In the context of the development profiles that have been prepared for the drug industry over the next 10
years, what contributions can the medium and small-scale sectors of the industry make ?
6. What measures to do you suggest to increase the production of drugs and pharmaceutical products so as to
meet the quantitative requirements of the country'' at the end of the Fifth Five Year Plan ?
7. Big firms, as they expand production of bulk drugs, can encourage small and medium scale firms by assis
ting them with the know-how for development of intermediate raw materials, pharmaceutical aids, etc. Have you any
views on this point, particularly as to how big firms can be persuaded to help the small-scale and medium-scale firms ?
8. The Price Control Order in respect of drugs has been welcomed by the general public. What is the impact
of this Order on the medium and small-scale sectors of the industry ? Without detracting from the essential features oft'
the Price Control Order, have you any suggestions to make for simplifying the implementation procedures under this
order ?
9. It is said that the prices of drugs could be maintained and even lowered if drug firms can diversify into areas
such as nutritional products, laboratory chemicals, cosmetics, veterinary preparations, insecticides, etc. Has your
Association specific idea on these aspects particularly in regard to the potentiality of the firms in the small and medium
scale sectors ? Can the Government (Central & State) assist in any way ?
10. In what manner can tte medium and small-scale firms promote drug research ? Do you think that the facili
ties for research and development in the fields of Fine Organic Chemicals and Microbiology are adequate for the re
quirements of the small and medium scale sector of the industry And what assistance do these firms expect from
Government in this regard ? What are your view on having regional research laboratories with government subs’d:ary ?
11. Are you satisfied with the quality control measures over drugs taken by the Central and State Drug Control
Administrations ? Have you any suggestions to make for improvement in this connection? Is there adequate
rapport between the Drug Control Administration and the industry?
12. In what way does the industry cooperate with the Drug Control Administration in tackling spurious drugs
and in what manner can Government’s efforts in this direction be tightened?
13. The medical profession in India, it is generally reported is not favourably disposed towards drugs manu
factured by the medium and small-scale sectors of the industry vis-a-vis those marketed by big companies and foreign
companies. What steps do members of your Association propose to take to win the confidence of the medical pro
fession and to convince them of the quality of drugs marketed by your member firms?
8
9
14. Drugs marketed under brand names are generally expensive. Brand names influence the prescribing prac
tices of physicians and are used as a lever to boost the sales of their products by big firms, particularly the
foreign ones. In the face of these facts, what are the views of your Association on the abolition of brand names of
drugs? If total abolition is not considered advisable, to what extent can the use of brand names be restricted?
15. What are the views of your Association on (a) the need to avoid multiplicity of drug formulations of tlie
same composition.
(b) Combinations of drugs and the need to prohibit irrational and ineffective combinations (c) the desirability
of reducing the number of vitamin preparations to the absolute minimum and (d) prohibition of advertisement of
drugs in the lay press, in the public and through other audiovisual media.
16. Distribution of samples of drugs by manufacturers to the medical profession it is reported, lead to mal
practices of different types. Want will be the reaction of your Association to stopping the distribution of such samples?
17. What role does your Association expect the public sector concerns to play ?
18. Are you satisfied with the performance of the STC and 1DPL as canalising agencies for distribution of raw
materials 9 Do you think that the system of allotment of canalised raw-materials and indigenously manufactured bulk
dru^s requires any modification to augment the supply of these items to the puerly Indian sector of the industry,
particularly the small and medium sector ? In what way can the working of these organisations be improved ?
19 Are the Government departments at the Centre, namely, the Ministry of Petroleum and Chemicals, the
DGTD and the Central Drug Control Organisation helpful and prompt in their dealing with the industry ?
90 What measures do you suggest for providing essential drugs and common household remedies to the
general public, especially in the rural areas and to the weaker sections of the community, at reasonably cheap prices ?
/
\
ANNEXURE IV
QUESTIONNAIRE✓
III
(Chapter 1—Para 5)
1. What is your general impression about the drug industry in India and its performance ?
2. Has the industry satisfied your expectations in regard to the range of drugs offered by it ? Jn cenerrJ. arc the
drugs marketed by the industry useful to the medical profession or of the type which could be considered as “monev
spinners” ?
3. Has your Association any observations to make on the quality control aspects of the drug industry in this
country in general and with special reference to :—
(a) the multi-national firms operating in this country (such as C1BA-GEIGY, Glaxo, Boots. Sandoz. Cyanamid
Pfizer, etc.);
(b) the big firms of the Indian sector (such as Alembics, Bengal Immunity, Unichem, Sarabhai etc.); and
(c) the small-scale sector in the drug industry ?
4. In the opinion of your Association, are drug prices beyond the reach of the common man ? Does any sector
of the drug industry or do any categories of drugs deserve special mention in this connection ?
5. Is the medical profession "bafiled ' by the multiplicity of the same type of preparations ? If so can vour
Association suggest any solution for this problem ?
’
’
' r
6. One way of minimising the multiplicity of drug formulations could be through wide-spread use by the medical
profession of the National Formulary of India published by the Ministry of Health, in the Government of India
and with which representatives from various medical associations have been associated. Docs your Association
feel that the National Formulary of India has been put loproperuse by the Medical profession ? One of the criticisms
voiced is that this Formulary is biased towards use by doctors in Government hospitals and that the prescribina
practices of the physicians outside hospitals haxe not been given adequate consideration. Has your Association any
suggestions for the improvement of the National Formulary ?
7. What is your Association's view on combination of drugs ? Would you like any specific category of combi
nations to be prohibited ?
8. What is the view of your Association on the usefulness of the vitamin products marketed by drug manu
facturers ? Is there any scope for restricting or regulating their number ?
9. Drugs marketed under brand names are generally expensive. Promotions of brand names, it is stated, in
terferes with the prescribing practices of physicians. Further, brand names are used as a lever to boost the sale of
products. In the face of these arguments, what is your Association's views on abolition of brand names of drugs ?
If total abolition is not considered advisable at this stage, what steps would you suggest for progressive abolition of
such names ?
10. There is criticism about the drugs being advertised :—
(a) through the AU India Radio.
(b) in the lay press, and
(c) in streets, cinema houses, etc.
should advertisement of drugs through these media be prohibited or regulated in any specific manner ?
11. Scripts relating to advertisement of drugs broadcast through the All India Radio are at present screened by
a Committee which includes a representative of the Indian Medical Association. Has your Association any sugges
tions to make for more stringent screening of advertisement so as to prevent false, exaggerated or misleading claims
being made ?
v
10
11
12. What is the Association’s view on the usefulness of advertisements that are mailed by drug manufacturers
to the medical profession ? Since manufacturers include package inserts about the drug is there any need for mailing
of literature on drugs to doctors, especially as doctors are busy and seldom find time to go through them ?
13. Distribution of samples of drugs to the medical profession by drug manufacturers, it is reported, leads to
malpractices of different types. Would your Association support this practice being stopped ? If total stoppage is
not considered advisable, please indicate the manner in which distribution of drugs samples could be regulated.
14. What are your Associations' views on the quality control measures over drugs taken by Government ?
Is there any rapport between your Association and the Drug Control Organisation at the Centre "and the States ?
Has your Association any views on the improvement of quality control measures ? Would it not be useful if Medical
Associations also arrange for study of drug manufacturing and convey their views to the Drug Control Organisations ?
15. In the opinion of your Association, what is the extent of prevalence of adulterated and counterfiet drugs in
the country ? What remedial measures would you suggest for tackling the problem ?
16. It has been represented that the dispensaries run by medical practitioners are deficient in the adequacy of
arrangements for dispensing operations, the qualifications and experience of the dispensing personnel at the con
ditions of storage of drugs. What are the views of your Association on the dispensaries of medical practitioners
being licensed under the Drugs and Co'smetics Rules and subjected to the same regulatory measures as licensed drug
establishments?
17. Does your Association have specific “Drug Panels” to study the problems relating to drugs and the drug
industry? Does the journal of your Association devote itself, among other things, to subjects, such as the
development of the drug industry; the profits made by drug firms, particularly, the foreign ones; the economics of
prescribing drugs and the quality control measures observed by drug manufacturing firms?
18. There is an impression that the medical profession generally tilts towards the products of foreign firms
and that this is partly due to the high pressure sales promotional methods employed by such firms and the massive
scale of sampling of drugs resorted to by them. What is your Association’s reaction to this?
19. What measures do you suggest for providing essential drugs and common household remedies to the general
public, especially in the rural areas and to the weaker sections of the community, at reasonably cheap prices?
20. What measures do you suggest for increasing the production of drugs and pharmaceutical products so
as to nuet the quantitative requiremmts of the country at the end of the Fifth Five Year Plan?
21. Djos your Association have any specific view on drug research in this country? Do you think the facilities
for research and development in the fields of Fine Organic Chemicals and Microbiology adequate to meet the country’s
requirements9 What are your views on having Regional Research Laboratories with Government subsidy?
22. Does your Association have any observations to make on “New Drugs”, their screening and their clinical
trials in this country?
v
- -
ANNEXURE V
Questionnaire For The State Governments
(Chapter I—Para 5)
are your views on the quality and availability of medicines produced by :
1. What
’
(a)i Small-Scale units;
(b) Large wholly—owned Indian units;
(c) Large foreign collaborating units; and
(d) Public-sector units viz. 1DPL and HAL.
2. Please indicate in terms of value and quantity the purchases made for State Government hospitals/Dispensanes etc. from the above four categories of drugs manufacturers, during the last 3 years, separately.
3. What are your purchase policies? Do you insist on procuring the medicines produced by the well-known
foreign collaborating firms only? Or, have you been switching over from the well-established foreign collaborating
firms°to Indian firms’ products, particularly those produced by the public sector units and small-scale firms ? It not,
indicate your reasons.
4. What are your views about the availability of medicines in general? What measures you would like to sug
gest t j improve the supply/availability position of drugs and medicines particularly in the rural areas?
5. What measures do you consider necessary for improving the status of the public sector units, both in the
manufacture of bulk drugs and formulations, and other areas like propaganda, distribution of medicines, research
and development etc.?
6. What steps, in your opinion, should be taken, for the following
(a) to produce all the bulk drugs in the quantities as required in the country;
(b) to prom)te rapid growth of this industry, particularly the Indian and small-scale sectors, keeping in view
the need for balanced regional dispersal of the indstury;
(c) to ensure the availability of essential drugs and common house-hold remedies to the general public, es
pecially those in the rural areas;
(d) to ensure equitable distribution of basic drugs and raw materials, particularly for the small-scale sector
units.
7. Do you think the present quality control on drugs is effective? If not, what measures would you suggest
for effective quality control on drugs and for rendering assistance to the small-scale units, in particular, in this regard ?
8. Whether any efforts have so far been made for setting up of any drug manufacturing unit under the State
control? If so, the nami of such unit along with their detailed activity and sales turnover may be indicated.
9. What measures would you recommend for adoption by the industry to reduce the price of medicines in
the country to the minimum possible level, keeping in view the requirements of funds for its further growth, Research
and Development etc. ?
10. What are your views about the multi-drug formulations as are presently marketed by some of the manu
facturers? Do you consider that the production of fonnukations should be limited to those only as given in the
National Formulary of India?
11. What are your views on the use of Brand Names?
12. Any other point to suggest?
'
12
j
ANNEXURE
VI
Details of sittings of the Committee on Drugs and Pharmaceutical Industry and its Sub-Committees; visits to
various drug manufacturing units, etc., and discussions held with officials of Government and representatives of
Associations/Organisations.
(Chapter—I—Paras 9 & 12)
6th March, 1974
.
First meeting of Committee on Drugs and Pharmaceutical Industry.
18th March, 1974
.
Meeting of the Sub-Committee for drafting questionnaires.
Second meeting of the Committee.
21st March. 1974
8th April, 1974^
17th April. 1974 [>
29th April, 1974J
.
Meeting of the Sub-Committee on Permission/No Objection Letters and C.O.B.
Licences.
Third meeting of the Committee on Drugs and Pharmaceutical Industry.
.
2nd May. 1974
Meeting of the Sub-Committee on quality Cont rol of drugs and related matters.
14th May, 1974
15th May. 1974
16th May, 1974
.
.
Fourth meeting of the Committee on Drugs and Pharmaceutical Industry.
17th May, 1974
.
.
Meeting of the Sub-Committee on Permission Letters.
Meetings of the Medical
(Bombay).
Sth Juie, 1974\
9th June, 1974/
28th June, 1974 Bombay
.
Panel on essential drugs and abolition of brand names,
Visits to :
M/s. Chemical, Industrial & Pharmaceutical Laboratories Limited. Bombay.
M/s. Abbott Laboratories, Bombay.
M/s. Hoechst Pharmaceuticals, Bombay.
M/s. Unique Pharmaceutical Lab., Bombay.
M/s. Nitson Laboratories, Bombay.
M/s. Sandoz (India) Limited, Bombay.
29th June, 1974 Bombay
.
Ciba Research Centre, Bombay.
Visits to :
M/s. Haffkine Institute, Parel, Bombay.
i
I
i
M/s. Labs. Vifor, Bombay.
M/s. Unichem Labs., Bombay.
13
14
Meetings with :
(i) All India Manufacturers Organisation, Bombay.
(ii) Indian Drugs Manufacturers Assn., Bombay.
(iii) Indian Pharmaceutical Assn., Bombay.
30th June, 1974 Bombay
.
Visit to :
M s. Themis Chemicals, Vapi.
M/s. Themis Orgasyn Chemicals, Vapi.
M/S. MAC Labs., Vapi.
1st July, 1974 Pimpri
Visit to :
Hindustan Antibiotics Limited. Pimpri.
2nd July, 1974 Ahmedabad
Visits to :
M/s. Cadila Laboratories, Ahmedabad.
M/s. Gujarat Pharmaceutical and Chemical Works, Ahmedabad.
Meeting with :
Pharmaceutical Manufacturers Association, Ahmedabad.
3rd July, 1974 Baroda
Visits to :
M/s. Alembic Chemicals Works. Baroda.
M/s. Vaccine Institute, Baroda.
Drug Control Labs., Gujarat. Baroda.
4th July, 1974 Baroda
Visits to :
Operations Research Centre. Baroda.
M/s. Sarabhai Chemicals, Baroda.
Sarabhai Research Centre, Baroda.
25th July, 1974
Fifth Meeting of the Committee on Drugs and Pharmaceutical Industry.
31st August, 1974 Rishikesh
Visit to :
Antibiotics Plant. Rishikesh.
16th Septembei,1974
Madras.
Visits to .
17th September, 1974
Madras.
Visits to :
M/s. Medo Pharma.
M/s. Citadel Fine Pharmaceuticals Limited.
Meetings with :
Pharmaceuticals Chemical & Allied Manufacturers Association of South India.
Joint Council of Indian Pharmaceutical Trade.
18th September, 1974
Hyderabad.
Visits to :
Synthetic Drugs Plant, Hyderabad.
M/s. Bio-Chemical & Synthetic Products Limited.
M/s. Warner Hindustan Limited.
Meetings with :
All India Manufacturers’ Organisation A.P. State Board, Hyderabad, Andhra Pradesh.
Pharmaceutical & Chemical Manufacturers’ Associations.
19th September. 1974
Hyderabad
Visits to :
M/s. Biological Evans Limited, Hyderabad.
M/s. Uni Sankyo Limited, Hyderabad.
Discussions with :
Minister of Health—A.P. and other Officers.
M/s. Orient Pharma Private Limited.
M/s. Mount Mettur Pharmaceuticals Limited.
M/s. Tamil Nadu Dadha Pharmaceuticals Ltd.
f
15
f
I
4
30th September, 1974
Calcutta.
Visits to :
M/s. Dolphin Laboratories, Calcutta.
M/s. Organon Laboratories, Calcutta.
M/s. Bengal Immunity Co., Calcutta.
Bengal Immunity Research Institute, Calcutta.
Discussions with—Hon’ble Minister of Health & Family Planning West Bengal
Courtesy call on Hon’ble Chief Minister, West Bengal.
“
&
Meeting with :
All India Manufacturers Organisation, (West Bengal State Board).
1st October, 1974 Calcutta
Visits to :
M/s. Smith Stanistreet, Calcutta.
M/s. Bengal Chemical & Pharmaceutical Works, Calcutta.
Central Drugs Laboratory, Calcutta.
M/s. Dey’s Medical Stores, Calcutta.
M/s. Dcy-Se-Chem, Calcutta.
M/s. Calcutta Chemicals Limited, Calcutta.
Meeting with :
Indian Drugs Manufacturers Association.
2nd October, 1974 Calcutta
Discussions with :
(i) Director of Drugs Control, West Bengal.
(ii) Specialists in the field of medical research.
3rd October, 1974 Calcutta
Visits to :
M/s. Aceto Chemicals, Calcutta.
M/s. East India Pharmaceuticals Limited, Calcutta.
M/s. Standard Pharmaceuticals Limited, Calcutta.
19th October, 1974
20th October, 1974
21st October, 1974
16th November, 1974
Durgapur.
4th January,
5th January,
1975 ?
1975 j
Sixth Meeting of the Committee on Drugs and Pharmaceutcial Industry,
Visits to :
M/s. Durgapur Projects Limited, Durgapur.
M/s. Durgapur Chemicals Limited, Durgapur.
Discussions with the Senior Officials of the Undertakings.
Seventh Meeting of the Committee on Drugs and Pharmaceutical Industry.
20th January, 1975?.
21st January, 1975 J
Eighth Meeting of the Committee on Drugs and Pharmaceutical Industry.
22nd January, 1975
Meeting of the Sub-Committee on Permission/No Objection Letters etc.
7th February, 1975
Meeting of the Sub-Committee on. Permission Letter/No Objection Letter/COB
Licences with the Secretaries of Ministry of I.D., DGTD and P & C.
Sth February, 1975
Meeting of the Sub-Committee on Permission/No Objection Letters.
9th February, 1975
----- !
10th February, 1975
11th Februan
February 1975 [>
12th February, 1975 J
Ninth Meeting of the Committee on Drugs and Pharmaceutical Industry.
25th February, 1975 H
26th February, 1975
Tenth Meeting of the Committee on Drugs and Pharmaceutical Industry.
4th March, 1975
5th March, 1975
6th March, 1975
1
J
5fh April, 1975
1—M of Pet. & Chem^TJ—3
Eleventh Meeting of the Committee on Drugs and Pharmaceutical Industry.
Twelfth Meeting of the Committee on Drugs and Pharmaceutical Industry.
CHAPTER
II
PROGRESS MADE AND STATUS ACHIEVED
by
THE PHARMACEUTICAL INDUSTRY
The dru^s and Pharmaceutical industrv in India is well established today. It now produces a wide range of
dru^s includin'^ the sophisticated ones like antibiotics, hormones, vitamins in addition to a large number of other
synthetic chemo-therapeuticais. This industrv has an important role to play m maintaining the health of the nation
and has the responsibility of meeting the expanding needs of the country.
The task before this industry, there
fore is not only to produce more medicines and provide them in the required quantities but also to ensure that the
medicines produced are of the right quality and would relieve the suffering patients of their illness at low cost. -
2 The dru^ needs of the country are diverse and the industry has to meet all such demands. Because of the
diverse*nature of the requirements, the industry has to adopt widely different and varied techniques for the pro
duction of the medicaments. These cover fermentation technology, synthetic operations, extraction and purifi
cation of the active principles available in the plant and animal kingdom etc., besides converting these active ingre
dients into the finished formulated dosage form of the right type. Basically, this is a highly research-oriented chemi
cal-based industry.
3 It would be worthwhile to trace the history of development of the drugs and pharmaceutical industrys
in India and the stages it has trekked in achieving the present status. It has a long way to go to achieve the objective
placed before this industry, and indeed, it has to strive hard to make the country self-sufficient.
4 Modern system of medicine embraces a large variety of products ranging from phyto-chemicals to
identifiable hishly complex chemical substances like antibiotics, hormones etc. A beginning was made in the pro
duction of medicines required under the modern system by starting cinchona plantation in the States of Bengal and
Madras, presently known as West Bengal and Tamil Nadu respectively. Factories we' set up in the vicinity of the
plantation areas for the extraction and purification of quinine. -Even a brief resume of this chemical-based industry
would be incomplete if no reference is made to the pioneering work done by late Acharya P.C. Ray followed by
similar efforts of late Messrs T.K. Gajjar, B.D. Amin and Koti-bhaskar. Their efforts resulted in the establishment
of units for local manufacture of galenicals and some other simple drugs. Cessation of imports during the first world
war vears save impetus to the industry to produce the medicines locally. A new compound, urea-Stibamine, was
developed through local R & D activity, which was found to be highly effective against Kala-azar. a soourge which was
affliciins people^ much those days. The most remarkable success was achieved in the manufacture of Sera and
Vaccines in the period that followed thereafter. • Pioneering work in the field of phyto-chemicals was done by late
Col R N. Chopra. Manufacture of Caffeine from tea-waste, anaesthetics like other form alcohol and a few simple
dru^s based on coal-tar distillation products were also taken up in the country. In spite of such developments, the
progress was far from being satisfactory. During the second world-war, the local industry made further progress
by producing a number of other products indigenously out of the locally available raw materials. These were mainly
in the category of phyto-chemicals, although some progress was also made in the fields of synthetic drugs and biolomcal products'. The country, by then, produced substantial quantities of Sera and Vaccines. Some industrial units
also took up the manufacture of synthetic ami-dysentery drugs, anti-leprosy drugs and arsenicals. Side by side,
formulating activities were also increasing considerably based on imported bulk drugs and several new formulations
were also developed locally. Here again, the bulk of the activity was confined only to the processing of imported
bulk dru^s except for a few items which were produced from late intermediates. The slow progress of the local chemical
ip dust rv "also affected the growth of the pharmaceutical industry. Besides, the appearance of number of synthetic
drugs and antibiotics, which were developed abroad and imported into the country, also tended to change the pattern
of drug use in India. The medicines that were available out of indigenous production, failed to keep pace with the
competition offered by the products of imported origin.
5. In the year 1953, the Government of India set up the Pharmaceutical Enquiry Committee with the following
terms of reference :—
16
17
(i) To study the working ofthe existing pharmaceutical manufacturing concerns in India with particular
(a) the demand for the drugs produced and their essentiality;
(b) the quality of the drugs;
(c) the cost of production;
(d) the efficiency of the process employed; and
r>w rameHals rn^dch^ doll^ ^h1 impOrted in£ernisdiates and penultimate products, or from basic
(11) To study the operations of foreign and/or Indian concerns, who import drugs and pack them in the
companies71S CXtent
tie’UP betWeSn the whoIly or partly owned Indian concerns, with foreign
(u*) 7ounTryOmmend St6PS ^°r enc0LIraSlno the manufacture of important drugs, which are imported into the
(iv) To enquire into the scheme of distribution of pharmaceutical products, whether imported or m-nufactured or packed in the country, the profit margin to trade or industry and the part plaved in this bv'nurelv
Indian as well as other concerns.
} 1
y
(v) All ancillary matters connected with the above.
6. The above Committee, after a detailed enquiry, made certain recommendations as to how the various n pect and problems concerning this industry should be examined and handled for its growth in the country "ft'
also observed that the then existing pharmaceutical industry in India when compared with the industrv in UK -.n i
USA could be considered to be almost non-existent. It also noted that even after the end of the hostilities the world
shortage of pharmaceuticals and drugs continued and the tempo of development of the pharmaceutical industrv
was maintained in the country, and export markets for glandular products, alkaloids etc. were also de\eloped But
this happy position did not continue for long. Competition from the better established and well-known pharma
ceutical producers, in other countries soon replaced the Indian products from the export markets. " Even within
the country, the Indian industry faced severe competition from foreign products/producers.
7. In spite of the gorwth and progress made so far, the Indian sector still faces competition from the foreign
units and the reasons are not far to seek. It has been so because of the deeply entrenched impression created In
the minds of the medical profession by the well-established multi-national manufacturing concerns of their products
These multi-national units entered the Indian market with their vast resources with the result, that the Indian sector
of the industry now finds it difficult to compete with the former.
8. The Pharmaceutical Enquiry Committee also suggested to make the production of the basic drugs econo
mical, each manufacturer of pharmaceuticals should endeavour to produce as many of the basic drugs as practical
from intermediates and basic raw materials in quantities sufficient not only to meet his own requirements, but also
to dovetail the production programme with the requirements of others in the country. While some of the firms
did tend to undertake the manufacture of bulk drugs, they came across several difficulties due to lack of technology,
basic chemicals etc.
"’
9. The drugs industry presently comprises of 116 units in the organised sector (units registered/licenced under
the Industries (Development and Regulation) Act, 1951 and more than 2500 units in the small scale sector. The
organised sector has 25 units with foreign equity exceeding 5o% and 26 units with foreign equity of 50% or less. In
the small scale sector, 9 units have foreign equity exceeding 50%, while 6 units have 50% or less of foreign equity.
10. According to the Industrial Policy Resolution of 1956, the pharmaceutical industry can be developed both
in the public and private sectors. The Government of India set up in 1954 the Hindustan Antibiotics Limited,
at Pimpri for the manufacture of antibiotics, and Indian Drugs and Pharmaceuticals Limited in 1961 with two drugs
, manufacturing units, one at Hyderabad for the production of synthetic drugs and the other at Rishikesh for the pro
duction of antibiotics, with the folio wing objectives :—
(i) to make the country self-sufficient in drugs and pharmaceuticals;
(ii) to free the country from foreign exploitation; and
(iii) to provide cheaper medicines in adequate quantity to the people.
I
18
11. Out of 116 units borne on the books of the Directorate General of Technical Development (DGTD) 64
units produce bulk drugs and formulation^. While 15 manufacturer bulk drugs only, 18 others manufacture only
"ormulations and 5 have been recently issued industrial licences or have been registered for manufacture of bux
drugs and formulations. There are 14 units which are engaged in the production of gelatine capsules, plasma
volumes expanders, sutures, etc., with or without other drug formulations.
12. The industry has been expanding its manufacturing activity, and the total turnover of this industry in
respect of bulk drugs during the year 1973, has been estimated at about Rs. 75 crores, and that oi formulations at
Rs. 370 crores.
13. The statement (Annexure—I) shows the names of the various antibiotics and other major bulk drugs pre
sently produced in the country. The statement also shows the production of individual units during the years 19/0
197f 1972 and 1973 along with their licensed capacities, as well as the further capacities which have beenappro\ed
under the Letters of Intent issued. The targets for the years 1978-79 and_ 1983-84 estimated by the Task Force set
up by the Planning Commission have also been shown in columns 4 and 5 of the statement. This statement, now
ever, does not cover the data in respect of small-scale sector.
14 While the industrial units in the small-scale sector are mostly engaged in the production of formulations,
some of the units are also producing bulk drugs, which are either formulated by themselves or offered for sale to
other formulating units, both in the small-scale and organised sectors including the foreign units The data furnished
by the small-scale sector units, in response to a query made by the Ministry of Petroleum & Chemicals, has been
compiled in Annexure II. It will be seen therefrom, that a number of bulk drugs like Nicotinic acid/amide I.N.h.
Paracetamol, Lisnocaine, Phenyl butazone, Diazepam, Diphenhydramine, Diethyl Carbarn cizine Citrate, imioramine, Meprobamate, Tolbutamide etc. are produced by this sector. These drugs are also produced by the orga
nised sector of the industry. According to the data available, it is noted that in a number of cases the starting materials
utilised bv the small-scale sector arc the same as 'hose used by the organised sector units while in some other cases,
they differ. Examples of the first category i.e. where both the small-scale sector and the organised sector units
utilise the same raw materials in the manufacture of tile concerned drugs, are as under .
Paracetamol
Diazepam
Di-iodo-oxy-Quinoline .
Thiacetazone
Methanamine mandalate
Imipramine hydrochloride
Nicotinic acid/amide
Chlorpromazine Hydrochloride
.
Meprobamate
Isonicotinic acid Hydrazide
Names of th^W^drugTwhere the small-scale sector use later stage raw materials as compared with those used by
the organised sector are :—
•
Diethyl Carbamazine Citrate .
.
Sulphamethiazole
Sulphadiazine
.
Aspirin
Piperazine salts
.
Tolbutamide
. Phenyl butazone
Riboflavine 5-Phos. Sodium
- Phenacetin
15 The quantum of production during 1973 of bulk drugs, which are produced both by the small-scale as
well as the organised sector units has been shown separately in Annexure III. It will be seen that the production ot
such drills which are already undertaken in the small-scale sector alongwith tne capacities licensed or covered by
letters oUntent issued in favour of the organised sectotunits if utilised fully would take care of the estimated .equirements of such drugs for the 5th Plan period in many cases,.
16. The quantities of synthetic drugs and antibiotics produced by the different sectors of the industry in 197a
are shown below :—
Unit
Item
1
I. Antibiotics
Penicillin
Streptomycin
Tetracyclines
Chloramphenicol .
Others
2
Wholly Indian
Units having
foreign equity
owned units
Public Sector and units with
of more than
equity partici
50%
pation upto 50%
5
4
3
MMU
T
T
T
T
136.88
95.73
24.21
0.27
110.64
84.12
7.04
15.82
3.54
Sulphas
T
670.13
453.81
136.75
Anti T.B.
T
144.61
315.64
159.64
28.70
58.02
31.37
II. Synthe. ic Drugs
Anti Dysentery
T
85.62
Anti-leprotic
T
1.07
Anti-diabetics-Insulin
MMU
T
Synthetics
7.09
898.03
29.02
58.02
9.08
6.01
20.21
6.61
Anti-malai ials
T
Anti-filarials
T
1.04
Anaesthetics
T
417.98
Anti-py reties
Analgesics and Anti-gout
Anthelmintics
Barbiturates
Corticosteroids/hormones
Phyto-chemicals
.
Vitamin A .
B 1
B 2
B 12
C
Folic Acid .
Nicotinic acid/amide
Vitamin D2..'D3
E
K
Panthenoi
Anti-histamiuics .
Diuretics
Vasodilators
Anti-depressants .
Anti-hypertensive and CVS Drugs .
Immunological agents .
Others
T
T
276.43
66.53
T
9.18
Kgs.
T
MMU
T
T
Kgs.
T
5.95
1487.79
0.87
314.14
2262.65
42.15
0.13
47.38
27.39
1.21
T
2.12
T
Kgs.
T
Kgs.
14.92
55.08
261.58
86.18
75.99
123.60
5.52
366.40
0.60
T
T
4.86
1.51
T
0.67
0.63
4.47
T
T
6.85
T
1.00
T
T
Producedfby
Govt and Indian
units.
115.60
4.78
117.16
10
1OAA 1iLTh1eQ7n0dU?t!o^0^VarJ0US b1U,-k tlrugs by the organised sector of .he industry during the year 1952, 1957,
1960, 196d, 1970 and 1973 is indicated in Annexure jV. This shows the extent to which the industry has been able
to take up the production of the bulk drugs and the growth attained bv it during this period. Whatever laudable
progress may have been achieved by this industry so far, it is still far from meeting the requirements of the country.
The progress attained so far is not commensurate with the increasing needs of the country particularlv in respect
of the bulk drugs. Even for a number of items which are currently produced within the country substantial imports
are being made. The quantum ot imports during the last 3 years in respect of the bulk drugs produced indi
genously, is shown in Annexure V. This would give an idea of the extent to which the industry would need to ^ear
itself to meet the country’s requirements. It would also be seen when compared with Annexure I, that in respect
of a number of items, while capacities have been covered by industrial licences issued, there has been no production
in 1973 m respect of certain items, while in respect of a number of other, the production achieved is much b-low
the approved capacities. The reasons for such non-implementation or under-implementation of proposals capacities
are many, such as delay in the proebremmt of equipment/raw materials, poor technology, management problems
uneconomic production, etc.
'
1
’
18. It has been mentioned earlier that more than 2500 units are there in the sm ill-scale sector Although
authentic data are not available, their production is estimated to be about 20% of the over-all turnover of the indus
try. Some of these small-scale units are run by technologists and they are playing an imoortant role in the production cf bul.c diugs from basic, stages as well as intermsdiates and pharmaceutical chemicals required by th;s
industry. Such units would be able to play a vital role in the future growth of this industry bv taking up the manu
facture of additional new bulk drugs as well as m expanding the production of the existing item, to heh m-t the
future requirements of the country. The pharmaceutical industry provides a wide opportunity to this" class of
entrepreneurs, particularly in respect of items which involve relatively less capital investment and where techology
would pose no serious problem for their manufacture. The small-scale sector could then be expected to make a
major break-through and contribute substantially to the nation’s efforts towards self-reliance. Annexure II shows
the quantum of bulk drugs and pharmaceutical chemicals presently produced in this sector. The Committee dtiritm
its visits to the various parts of the country, noted with satisfaction that a number of small-scale units are con
fining their manufacturing activities only to the manufacture of bulk drugs, without the support of formulations
It is necessary to provide adequate incentives and assistance to this sector for its growth, particularly in the field
of basic manufacture.
19. In spite of the considerable growth attained so far by this industry, a large number of bulk dru^s still require
to be imported to meet the present deminds. Annexure VI shows the names of the bulk drugs imported into the
country during the year 1973-74. The items have been identified in the statements (a) those whose individual imports
were more than Rs. 10 lakhs ea;h and (b) those whose imports were valued between Rs. 5 lakhs and Rs 10 lakhs
It will be seen therefrom that the following 6 antibiotics alone accounted for a total import of about Rs 5 crores '
(Rs. in lakhs)
160.69
1. Ampicillin
2. Erythromycin
3. Gentamycirv .
4. Stroptomycin
5. Tetracycline
6. Chloramphenicol
66.39
42.23
63.14
73.59
86.54
Total
492.58
20. The number of items whose individual imports were valued at more than Rs. 10 lakhs is 38 while 26 items
were imported whose individual values ranged between Rs. 5 and Rs. 10 lakhs. To summarise, the followino- number
of bulk drugs were imported during 1973-74; having individual value range as indicated against each ■— °
Above Rs. 50 lakhs
Between Rs. 25 lakhs and Rs. 50 lakhs each .
Between Rs. 10 lakhs and Rs. 25 lakhs^each .
Between Rs. 5 lakhs and Rs. 10 lakhs each .
(Rs. in Lakhs)
9
10
19
26
21
In respect of a number of items where the imports during 1973-74 were more than Rs. 10 lakhs each, expansion in
their local production has been taken on hand and the imports during the next year are expected to come down
substantially with increased local output. The items covered under this category would be Analgin. Tetracycline,
Streptomycin, Chloramphenicol. Chloroquin, Sulpha-guanidine, Sulphamethoxypridazine, Vitamin C. and Ampi
cillin. In respect of number of ether products, additional capacities have been approved for their manufact ure
and with the increased production their imports would also come down in course of time. Examoles under this
group are, Procaine, Dilaxonide, Panthenol, Vitamin E, Vitamin P, Metronidazole, Diazepam and Frusemide.
In the case of the following bulk drugs, the projected requirements for the Fifth Plan period have been covered by
industrial licences and Letters of Intent issued.
Kanamycin
Chloroquin/salts
Sulphaguanidine
Analgin
B-2
Sulphadimidine
Indomethacin
B-6
Sulphadimethoxine
Probenecid
Ethambutol
Diazepam
Ethionamide
Chlofibrate
Metronidazole
Folic acid
Vitamin B-l
Xanthinol Nicothate
Diloxanide/Furoate
It is expected that the quantum of imports would come down after the units go into production.
21. Total imports of major bulk drugs during the last 3 years have been summarised as under, group-wise :—
• Rs. in lakh
SI.
No.
Group of drugs
1971-72
1972--J
1973-74
1. Antibiotics
884.16
61? 97
571.82
2. Anaesthetics/analgesics
90.66
95 23
113.09
3. Antiamoebic (dysentery)
40.55
'23.76
35.28
4. Anti-cancer
4.77
S.I1
8.47
5. Ami-diabetics : Insulin
Orals
32.41
7.02
'.06
' 79
7.37
5.29
6. Anti-epileptics .
2.70
7. Ami-leprosy
Nil
Nil
Nil
8. Anti-malarials
77.21
129.64
64.37
18.38
6.23
9; Anti-histaminics
15.76
24 3 5
10. Anti-T.B. .
25.64
4.64
10.18
11. Cardiac
4.70
7.54
10.06
12. Diuretics
2.76
23.13
12.17
13. Hormones/Steroids
86.43
7S.58
98.17 '
14. Imniunologicals
12.41
12.25
5.98
15. Sulphas
211.81
111 77
110.06
16. Tranquillizers
16.06
14.18
58.70
17. Vitainins
199.87
184.85
246.37
18. Barbiturates
10.57
6.49
7.82
19. X-Ray/Diognostic agents
8.31
2.26
20. Catguts
21. Others
0.15
400.33
0.63
310.63
Nil
306.46
2109.17
1752.44
1711 03
Total .
9.50
—.
..
22
Exports vs Imports :
22. Drugs and pharmaceutical industry is included in the list of priority industries which carry an export obli
gation. The individual units in this industry are liable to a cut in their import requirements/entitlements whose
export performance is less than 5% of their production during the previous year. The cuts imposed are on a slab
system as indicated below :—
Export performance
1. No exports or export less than 1 °/0 ..............
2. Export 1 °/o or above, but less than 2% .............
3. Export 2% or above, but less than 3 % .............
4. Export j % or above, but less than 4% .
.
.
.
.
.
.
.
.
.
.
.
.
5. Export 4% or above, but less than 5 %
6. Export 5% or above
................
Cut imposed
20/o
15%
10%
^.5?.,
5%
No cut.
23. The above cuts apply to the entitlements for imported raw materials required for the manufacture of
the products listed below :—
1. Antibiotics Preparations.
2. Emetine preparations.
3. Quinine sulphate.
4. Quinine preparations—others
5. Strychnine preparations.
6. Brucine preparations.
7. Ayurvedic and Unani Medicines.
8. Antacid and Digestive preparations.
9. Cold, Cough and Bronchial preparations.
10. Asthama, Catarrah and Hay Fever preparations.
11. Gripe water.
12. Headache, Neuralgia and Pain Remeli;s.
13. Disinfectants.
14. Salves. Ointments for Burns, Cuts etc.
15. Tonics, Blood Purifiers and Emulsions.
16. Proprietary and Patent Medicines n.o.s.
17. Botanical drugs and derivatives.
18. Beta Ionone.
24. The cut as mentioned above would not apply to the raw material requirements in respect of otner end
products of this industry. The export obligation, however, does not apply to
(i) small-scale units; and
(ii) other units which have not completed 5 years of production.
25. Depending upon the export performance of the individual units this industry also enjoys a preferential
treatment in respect of their imports of raw materials. In order to help production for exports, units which export
10% or more of their production are entitled to the following facilities :— .
(i) expansion of their export production; and
(ii) import of their requirements from preferred sources of supply.
Industrial units exporting 25% or more of their production are eligible to import a higher quantum of their require
ments against free foreign exchange. Normally, DGTD now allows imports of raw materials etc. in equal pro
portions from both the General Currency Area (GCA) and Rupee Payment Area (RPA), i.e. the Actual Users’
import licence values are divided equally, as 50% from the former and the balance of 50% from the latter. In case
of units exporting more than 10% of their production, the G.C.A. value is increased to 75% and correspondingly
the R.P.A. portion is reduced to 25%, depending upon the availability of the required raw materials from the res
pective sources. In case of essential raw materials, additional ad-hoc imports are also allowed in deserving
cases.
V
23
l
26. According to the statistics compiled by the Basic Chemicals, Pharmaceuticals and Cosmetics Export
Promotion Council, the exports of drugs, pharmaceuticals and fine chemicals during the last 3 years have been
under :—
Year
1971- 72
1972- 73
1973- 74
Rs. crores
10.33
13.53
37.54
The details of the exports of drugs, pharmaceuticals and fine chemicals during these 3 years, have been given in
Annexure VII. It will be seen therefrom that a number of products viz. Streptomycin, Chloramphenicol, Oxy
tetracycline, Anti-diabetic drugs other than Insulin, Chloroquin and its salts, some of the sulpha drugs, Salicylic
acid, Salicylamide and phyto-chemicals like Emetine, Quinine and its salts, Strychnine and Brucine alkaloids, Ber
berine Hcl. etc. along with their preparations have also been exported besides a number of other drugs'formulations.
The above figures include the exports of medicinal castor oil during these years as under :—
Year
1971- 72
1972- 73
1973- 74
(Rs. crores)
0.23
2.03
21.13
27. Drugs and pharmaceuticals produced in India are now being exported to 80 countrie, including the developed countries like UK, USA, West Germany, USSR, Japan and others, who buy mostly the basic drugs and
fine chemicals. Total exports of drugs and pharmaceuticals, excluding medicinal castor oil, accounted for about
5% of the indigenous production.
j
28. There was a remarkable increase in the export of Quinine salts. Exports in 1973-74 were of the value of
Rs. 1.18 crores, as compared to Rs. 0.70 crores during 1972-73, the main buyers being West Germany, Hungary,
USSR and Bulgaria.
29. There has also been a substantial increase in the export of crude drugs, exports having gone upto
Rs. 7.70 crores in 1973-74, as against Rs. 4.29 crores in 1972-73. Major items were Psyllium husk/seeds and
Senna leaves and pods.
30. Annexure VIII would give the details of exports of drugs, pharmaceuticals and fine chemicals effected
during the 6 monthly period April/Sept. 1974, as compared to the corresponding periods in the earlier two years
i.e. April—September, 1973 and April—September, 1972. The total exports, including medicinal castor oil, during
the half yearly periods of 1974, 1973 and 1972, have been as under :—
April—September, 1974
(estimated)
April—September, 1973
April—September, 1972
Rs. 25.3 crores
/
'
..............
Rs. 17.64 crores
Rs. 5.07 crores
An analysis of exports during this half yearly period of the three years would bring out the following data
which would show that there has been a considerable increase in the export of these items over the year :—
(Rs./Lakhs)
Item
April—
Sept. ’74
April—
Sept. '73
139.47
25.21
55.71
13.50
31.36
13.88
1.12
18.02
1569.89
4.13
12.37
0.23
0.14
1229.08
6.47
0.02
0.09
37.68
Quinine salts/alkaloids
...........
Antibiotics and their preparations other than Streptomycin, Penicillin, Oxytetracycline and
Chloramphenicol
......
Nux Vomica alkaloids
...........
Certain sulpha drugs
...........
Salicylic Acid
.............
Medicinal Castor oil
Salicylamidc
.............
April—
Sept. ’72
9.83
31. Besides the general export obligation under the Trade Control Policy, certain specific export conditions
are of late being imposed now while approving proposals under the Industries (Development & Regulation) Act,
for the manufacture of new drugs as well as for expansion, particularly in the case of firms having majority foreign
equity participation. The quantum of export stipulation imposed varies between 10% and 60% depending upon
the nature of the product and its possible demand in the export market.
1—M of Pet. & Chem./75—4
...
. .
1
-5
24
32. The data furnished below would show the growing imbalance between import requirements of the industry
and the export earnings :—
(Rs.'crores)
Exports of drugs, pharmaceuticals and fine chemicals
1963-64
1965-66
1967-68
1969-70
1971-72
1973-74
2.00
4.80 f
I
4.63 | inch Med. castor oil
7.31
S
„
10.33
„
37.54 I
„
J
Import of drugs and pharmaceuticals etc.
(Rs./crores)
1963-64 .
1965-66 .
1967-68 .
1969-70 .
1971-72 .
1973-74 .
13.17
13.90
26.51
26.19
35.04
37.50
It may be seen that while exports have gone up from Rs. 2.00 crores in 1963-64 to Rs. 37.54 (Rs. 16.41 crores.
excluding medicinal castor oil) in 1973-74. imports have gone up from Rs. 13.17 crores in 1963-64 to Rs. 37.50
crores in 1973-74. The production of finished formulations during this period increased from Rs. 120.0 crores in
1963 to Rs. 370 crores in 1973. This would indicate that the industry has to strive hard to reduce the import bill
through increased production.
33. Distribution pattern of drug*
It would be interesting to review the shares of the various drugs, according to the different therapeutic
groups, in their sales through the trade channel. A study of the market survey undertaken by a commercial re
search group would reveal the following interesting data. The study made by this research group is based on the
sales of finished medicinal preparations of about 120 companies effected through the trade channel. These data
were worked out on purchase records maintained by 532 chemists spread out all over India. These, however, do
not cover the off-take by the non-chemisls i.e. the doctors, hospitals, Government agencies etc. The following
percentages against the various categories of products during the years 1969, 1971 and 1973 have been worked out :
Category of products
1969
1971
1973
1
2
3
4
20.7
12.7
5.7
5.1
4.7
5.1
3 .5
3.5
2.9
3.2
3.4
19.3
12.1
6.0
5.5
5.0
4.8
19.9
11.7
5.5
5.3
5.2
4.8
4.1
3.8
1. Antibiotics
2. Vitamins .
3. Cough & Cold preparations
4. Haematinics
• 5. Tonics & Health restorers
6. Hormones
7. Dermatological preparations
8. Analgesics
9. Anti-rheumatics
10. Anti-diarrhoeals
11. Dietetics
12. Enzymes and digestants
13. Cardio-vascular drugs
14. Anti-spasmodics
15. Psyohotherapeutics
16. Opthalmologicals
17 Anti asthmatics
18. Amoebicides
19. Anti-T.B. preparations
'20.‘Antacids .
’21. Anti-histaminies
22. Sulphonomides
3.9
1.9
1.4
3.7
3.1
2.7
3.1
2.7
1.8
1.5
1.8
1.6
1.6
1.9
1.7
1.7
1.4
0.9
1.2
' 1.2
1.2
1.7
1.6
1.3
1.6
1.5
1.5
1.4
1.4
1.4
1.4
1.5
1.4
3.1
3.1
2.6
2.5
1.8
1.8
1.3
25
34. As mentioned earlier, in the computation of the above figures, only the sales effected through the retail
trade channel have been taken into account. Significant purchases are also made by the Government agencies,
hospitals and doctors, which have not been reflected in those estimates. The low percentage in respect of Sulphonomides and Anti-T.B. preparations could be due to the fact that such preparations are made available in large
quantities to the consumers through the hospitals and other Governmental agencies.
35. It would be seen from the above that about 22% of the market share is enjoyed by Vitamins, Tonics and
health restorers and haematinics, while about 20% was shared by the antibiotics. There has been a decline in the
sales of Sulphas through the trade and an increase in the amoebicidals. In the case of other categories of medicines,
the market share has been more or less the same over the years, with minor changes.
Research and Development
36. It is well-known that the drugs and pharmaceutical industry is highly research-oriented and the key role
that R&D plays in this industry cannot be over-emphasized. The need for intensive research and development
work in any field of industrial activity is of utmost importance, but this is more so in the field of drugs and phar
maceuticals.
37. According to the present estimate, the expenditure on research and development activity incurred by the
industry in India, is about Rs. 4.5 crores per annum, about 1.1 % of the total turnover by the industry in 1973.
The expenditure is woefully inadequate when looked at from the-angle of total turnover by this industry, vis-a-vis
the expenditure incurred on R&D in the developed countries and the turnover attained. While the expenditure
by any individual unit here does not exceed 5% of its turnover, except for Haffkines (14%), the R&D expenses in
curred by a number of units in the developed countries range between 12—15% of their turnover. Although some
of the foreign units operating here enjoy the benefits of research undertaken by their parent organisations or asso
ciated laboratories abroad, it is absolutely essential that these units also take up R&D activity in right earnest.
38. An analysis of the data from 71 pharmaceutical companies in the organised sector revealed that while 54
companies have research and development departments, the remaining 17 companies have made no investments so
far in research and development programme.
i
b
1
I
4
ANNEXURE-I
Statement showing names of major drugs including Antibiotics, Capacities licenced, Production targets etc.
(Chapter II—Para 13)
T
SI.
No.
(1)
Item
Unit Target of require
ments
1978-79 1983-84
(2)
(3)
(4)
Name of units
Regis
tered/
Licen
ced Ca
pacity
1970
1971
(7)
(8)
(9)
(10)
(H)
29.94
65.82
55.47
48.13
53.47
54.21
84.56
43.43
47.95
56.23
80.65
57.71
52.93
(6)
(5)
Production
Letter
Intent
Total
of
7& 12
(12)
(13)
of
1972
1973
Antibiotics.
1. Penicillin
MMU
780
1560 I.D.P.L.
H.A.L.
Alembic
Standard
140
84
100
40
60.97
49.18
41.44
45
364 181.53 220.89 230.15 247.52
2. Streptomycin
T
3. Chloramphenicol & its
Esters
T
825
390
1650
780
I.D.P.L.
H.A.L.
Synbiotics
Alembic
T
5. Oxytetracycline
T
88
160
6. Dimethyl-Chlortetracyc- T
line
23
46 Cyanamid
7. Chlortetracycline
200
T
350 I.D.P.H.
H.A.L.
Synbiotics
♦Cyanamid
Pfizer
Pfizer
I.D.P.L.
9. Neomycin Sulphate
10. Nystatin
.
.
257
30.89
71.90
94.92
1.40
24.50
71.23
82.46
157.68
178.65
199.11
179.85
20
30
53
0.8
5
Nil
25.25
12.37
0.29
9.51
34.23
2.81
0.49
9.70
11.79
28.66 19.58
Nil 15.35
2.70
0.47
New Unit
108.8
37.91
47.04
41.06
47.19
25
1.5
3
10
5
7.88
11.73
Nil
Nil
0.214
1.31
4.31
8.64
Nil
Nil
14.52
Nil
3.72
7.03
Nil
14.58
Nil
7.04
8.63
Nil
9
25
25.35
6.05
29.46
11.95
36.59
3.08
39.72
10.63
6.82
4.62
7.71
8.78
70
Nil
0.63
*1.40
Nil
1.59
Nil
0.75
Nil
0.89
0.44*
148.5
52.65
69.30
73.30 9071
I.D.P.L.
Cyanamid
♦Veterinary Quality
8. Amphotericin
15.67
65.57
76.44
22.00
63.10
92.80
0.75
Parke Davis
Boehringer Knoll
Dey-Se-Chem
Mac Labs.
Themis
4. Tetracycline Hcl.
♦Includes Chlortetra
cycline & DimethylChlortetracycline
85
90
62
20
3
6 Synbiotics
1
1.54
0.25
0.55
0.39
T
10
16 Svnbiotics
H.A.L.
0.3
2.0
0.742
0.57
Nil
0.66
Nil
0.31
Nil
4.8 I.D.P.L.
10
0.62
0.74
0.27
3
26
108
1.66
T
T
409
365
24.2
133.0
27
178.5
I
2.7
5.00
JO
=
(1)
(2)
(3)
11. Ampicillin & other
T
Semi Synthetic Penicillins
(4)
(5)
(6).
35
100
Panbaxy
Cipla
H.A.L.
Alembic
Uni-chem
(7)
BU
23
46
13. Cycloserine
T
8
1 6
14. Erythromycin Base &
Esters
T
30
60 Alembic
Themis
H.A.L.
Abbott
6
4
T
20
40
I.D.P.L.
6
16. Hamycin
Kgs.
150
240
H.A.L.
250
17. Kanamycin
T
0.8
1.6
Alembic
1
18. Oleandomycin
Kgs.
19. Doxycycline
T
Kgs.
(10)
(ID
(12)
(13)
15.75
0.02
0.16
1.05
2.84
6
4
15. Griseofulvin
.
(9)
0.75
5
5
No ca
pacity
fixed
12. Bacitracin .
20. Polymyxin
(8)
20
6
15.21
nil
nil
nil
250
1
2400
1500
Ranbazy
I.D.P.L.
130
2.5
5.0
7.5
260
21. Cephaloridinc
22. Gentamycin
23. Rifampicin
24. Framycetin
25. Lincomycln
H.A.L.
0.5
Nil
Nil
Nil
Nil
460 Atul
May & Baker
Cibatul
183
Nil
55.75
Nil
0.79
53.95
Nil
4.33
51 .04
4.35
21.89
42.47
30.09
55.75
54.74
59.72
94.45
7.37
13.69
0.01
Nil
19.35
10.75
Nil
Nil
32.22
11.42
0.06
Nil
0.8
5.70
Nil
Nil
21.10
30.10
43.70
6.50
26. Aureofungin
Sulpha Drugs.
1. Sulphadiazine .
T
230
2. Sulphacetamidc & dcri- T
vatives
3. Phthalyl Sulphathiazole T
4. Succinyl Sulphathiazole
5. Suiphamerazine
T
T
80
150
8
34
160
280
19
35
I.D.P.L.
50
East India
18
Bengal Immunity
Albert David
M.S.D. I.D.P.L.
Ciba
May & Baker
May & Baker
Merck Sharp &
Dohme
39
3.5
3.5
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
100
50
28
(1)
(3)
(2)
6. Sulphathiazole/Sodium
(4)
(6)
(5)
May & Baker
Atul Products,
Cibatul
Ciba
T
6
7. Sulphafurazole
T
8. Sulphamethizole
T
12
9. Sulphasomidine Sodium T
260
(7)
240
(9)
(10)
(ID
Nil
21.72
127.58
Nil
63.17
55.07
Nil
98.05
120.13
Nil
159.97
156.59
1.26
149.30
118.24 218.18 317.82
1.09
1.26
54.74
46.43
68.95
21.39
80.93
97.02
61.79
21.66
Nil
Nil
Nil
Nil
101.17
103.34
177.95
83.45
40.15
36.11
46.89
54.55
43.72
40.80
18.28
7.73
10.91
15.52
(8)
180
13 I.D.P.L.
465 Ciba
Cibatul
German Reme
dies
5
21.6*
350 Cibatul
Ciba
I.D.P.L.
70 German Reme
dies
11. Sulphamoxole
T
45
12. Sulphaguanidine
T
135
145 I.D.P.L.
13. SulphamethoxyP> ridazine
T
17
19
14. Sulphadimethoxine
T
30
55
15. Sulphamethaxozole
16. Sulphanilamide .
T
17. Sulphadiinidine/
Sodium .
T
18. Sulphapyridine .
T
19. Sulphacetamide .
Phthalyl .
I.D.P.L.
30
Roche
Cipla
I.D.P.L.
18
5.5
2020 I.D.P.L.
May & Baker
Cibatul
150
500
May & Baker
T
East India
Albert David
B.L
I.D.P.L.
19.89
50
38.02
156.54 210.40 208.64 265.97
250
I.D.P.L.
1010
(13)
7
t(including Sulpliamoxole)
10. Sulphaphenazole/Sodium T
(12)
84.48 136.90
71.88
150
126.37 225.79 318.88 328.81
0.12
nil
nil
0.04
nil
nil
nil
nil
500
131.69
17.44
20.12
8.13
11.30
0.35
1.76
nil
0.07
2.58
nil
nil
0.85
0.03
1.44
nil
1.35
0.26
1.41
15
(Combined Capacities for Sulpha Drugs)
320 Ciba Geigy
Cibatul
May & Baker
95T
Sulphadizine
Sulphathiazole
Sulphaphenazole
Sulphathiazole
Sulphasomidine
Sulphasomidine
Sulphaphenazole
Sulphamethazine
Sulpha methyl Phcnazole
210T
Sulphadiazinj
Phthalyl Sulpha
thiazole
Succinyl
Sulphathiazole
Sulphamerazine
Sulphapyridine
Sulphathizole
Anti T.B. Drugs.
1. Pas &. its Sal|S .
T
1000
400
80
1200 Haryana Chemicals
A.M. Raja
I.D.P.L.
Pfizer
Bio Evans
Bio Synth
Wander
150
110
120
100
300
nil
95.26
92.60
95.50
182.76
36.25
84.54
109.51
104.40
150.84
98.69 135.90
93.94 119.33
70.10 56.06
67.70 51.16
153.94 135.82
780 466.12 485.54 484.37 498.27
250
1510
'29
(2)
(3)
2. Isoniazid (INH)
T
(i)
(4)
265
(5)
(6)
(7)
530
Cal Chemicals
Bengal Immunity
Chemo Pharma
Ciph
Bio EvansSynbiotics
LD.P.L.
B.C.P.W.
Pfizer
Suneeta
Albert David
Warner Hindustan
Dev. Corporation
of Konkan
(8)
0.05
nil
5.32
4.98
9.18
20.66
0.71
10
1.17
9.96 9.96
12.64
27
3.40
3.96
20
nil
nil
0.04
1.6 0.105
80
16.62
nil
40
22.92
nil
50
nil
nil
20
35
T
70
140
Bengal Immunity
Bio Evans
Chemo Pharma
Unichem
Albert David
Suneeta
I.D.P.L.
25
30
25
12
0.6
30
122.6
4. Ethambutol
T
20
25
(10) (11)
nil
3.07
23.99
0.28
15.31
4.60
nil
0.05
49.00
25.14
nil
nil
nil
1.47
26.55
0.13
11.72
nil
nil
0.06
50.31
6.24
ml
nil
83.00
121.44
96.48
nil
nil
2.31
2.65
0.05
nil
0.09
0.59
8.16
0.04
8.12
0.95
nil
nil
0.40
15.00
0.07
12.39
1.08
nil
nil
1.30
14.98
0.06
10.11
8.71
5.01
17.96
28.94
35.16
15
Themis
LD.P.L.
Cyanamid
T
12
24
6 Morphazinaniide
T
1.22
1.75
7 Ethionamide
T
12
25
8 Prothionamide
Anti Dysentry Drugs.
T
1 Halogenated Oxyquino
lines
lodochloro—
T
Hydoxyquinolines
2 Dilodo Hydoxyquino
lines
(Capacities shown against
each unit cover both Di
iodo and iodo-Oxyquinolines)
450
600
Uni Sankyo
65
458.56
5
127.6
I
12
5
53
3
3
Suneeta
Themis
12
8
20
Themis
2
2
1.12
80
6
30.85
29.40
0.35
33.42
42.0.1
0.45
38.24
30.65
0.30
25.77
38.88
0.29
Albert David
Syn biotics
7.2
Hind Chemicals 7.2
Unichem
25
0.13
1.54
Nil
Nil
2.16
0.13
Nil
0.73
0.02
3.08
0.38
0.64
0.15
6.68
62.27
78.17
73.02
72.79
1.72
0.86
4.32
2.59
0.19
1.57
0.29
2.22
0.01
0.21
4.10
0.20
1.19
Nil
5J5
0.73
2*20
0.02
2.55
0.73
1.63
Nil
4.57
1.70
1.47
0.07
Nil
4.40
3.56
11.38
12.77
17.40
11.17
10.26
East India
Atul
B.C.P.W.
Albert David
East India
May & Baker
Synbiotics
Bio Evans
B.C.P.W.
B.I.
Therapeutic
I.P.C.L.
4.2
‘ 2.94
2.9
Sandoz
2.93
0.03
0.17
120
8
398.6
3. Di-Brome Hydoxyqui
nolinc
(13)
15
Sarabhai
Suneeta
P.C. Sharma
5 Pyrazinamide
(12)
100
293.56 28.715
3. Thiacctazone
(9)
28.8
12.97
14.35
14.63
393.6
11.2
40
30
(D
(3)
(2)
(4)
(5)
(6)
(7)
Sandoz
4. Brobenzoxaldine
(8)
(9)
(10)
(ID
6.46
0.44
3.15
6.18
5. Emetine &. Dchydroemet inc
Kgs.
SX)O
1470
Burroughs Well- 250
come
Whiffens
500
164 4132.204- 16.694- 23.83
Nil 1.10
6. Meironidazole
T
50
100
May & Baker
Indo Pharma
I.D.B.L.
Suneeta
Unichem
Cipla
K.A. Reddy
0.602
4
0.80
Boots
Ranbaxy
Cipla
12
B.W.
B.C.P.W.
Albert David
B.T.
10.8
6.9
7. Diloxamide/furoate
T
55
35
5.30
6 92
7.67
(12)
(13)
750
0.602
30
10
6
12
10
73.204
24
2.5
38.5
Anti Leprotics Drug.
1. Diamino-diphenyl Sul
fone (DDS and deriva
tives)
T
30
50
2. Clofazimine
Anti Diabetics.
T
1. Insulin
MU
3000
6000
2. Tolbutamide
T
75
100
3. Chlorpropamide
4. Phenformin
5. Glybenclamide
T
T
T
40
15
70
30
7.07
1.16
Nil
Nil
1.23
1.08
Nil
7.64
Nil
Nil
7.09
1.07
Nil
Nil
8.23
2.31
7.64
8.16
17.7
1500
Boots
1500
807.04 733.01
631.79 898.03
Hoechst
B.C.P.W.
72
1.2
40.93
Nil
28.99
Nil
58.07
Nil
57.62
0.05
Albert David
Bio Evans
3
0.96
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Pfizer
Albert David
B.C.P.W.
Bengal Immunity
I.D.P.L.
6.5
6.22
Nil
0.13
11.97
Nil
0.08
12.93
Nil
0.45
9.08
Nil
0.35
B.I.
Hoechst
I.D.P.L.
1
1.0
1.2
0.6
0.30
0.0^
Nil -
77.16
15
24.3
0.2
5.0
7.2
Nil
Anti Malarials.
Govt. Factory
Madras
West Bengal
Cipla
1. Quinine Salts
2. Amodiaquin
3. Chloroquin & its Salts
T
T
55
150
1.16
225
21.19
27.34
0.22
11.69
24.52
0.04
12.73
16.91
0.11
8.71
20.31
0.18
16.98
25.74
0.05
0.50
9.89
Nil
0.95
22.72
1.11
0.75
10:32
2.63
2.25
Parke Davis
Albert David
Suneeta
36
1
6
24.06
Nil
Bayer
Bengal Immunity
Saneeta
12
10
18
13.89
1.88
Nil
22.20
Nil
15.79
T
1.5
24
80
48
I.D.P.L.
Themis
4. Prlmaquin
43
22.70
24.58
15.20
192
2.5
I
I
.
6
31
i
(i)
(2)
(4)
(3)
(5)
(6)
(7)
(S)
(9)
(10)
(11)
95
Burroughs Well
come
I.D.P.L.
Lni UCB
2
30
24
4.38
3.12
3.72
6.57
8.10
2.59
7.63
0.61
2.99
6.61
Nil
1.04
11.22
17.26
1.1.23
7.65
24.41
Nil
Nil
39.74
67.39
42.74
Nil
0.03
(12)
(13)
Anti Fliarials
1. Diethylcarbam azine
Citrate
T
45
56
Anaesthetics:
«
1. Procaine HCL
T
209
300
2. Xylocaine/Lignocaine
T
14
30
3. Ether BP/Anaesthetic .
4. Ethyl Chloride
T
T
530
850
Hoechst
Hico Products
I.P.C.L.
Ammar G.
AZIZ
100
150
50
Suhrid Geigy
Unichem
1
2
75
1.95
0.24
3.20
0.95
3.23
0.73
3.05
1.1.7
2.24
4.14
3.90
4.22
266.83
12.78
2.70
108.80
104.00
2.70
348.40 347.00
N.A.
Nil
3.65
1.69
282.31
215.50
352.05
348.69
1.44
45.01
27.50
25.20
22.30
Alta
960
Martin & Harris 300
Indosal
100
G.M. Swamy
Haryana Chemi
cals
696.09
46.55
19.02
Alembic
435
Hvd. Chemicals
B.C.P.W.
150
250
Alembic
1.900
3800
Andhra Sugars
375
3
435
5. Halothane
6. Carbocaine
7. Marcaine .
8. Ketamine Hcl. .
Analgesics. Antipyretics &
Anti Gout.
1. Aspirin
2. Sodium Salicylate
T
T
600
1200
500
744.90
76.92
Nil
90
500
926.73 1001.86
821.82
Alta Labs..
420
Indosa I
80
Calcutta Chemi
cals
Nila Products
G.M. Swamy
214.87
Nil
29.95
204.01
. 1.94
0.97
0.55
0.2
104.08
185.83
48
85
15
10.33
Nil
Nil
1.12
9.50
0.33
Nil
Nil
2.39
10.66
1.92
Nil
3
120
10
23.47
1.70
1.15
5.51
Nil
0.54
4.00
7.22
Nil
0.97
5.19
0.28
7.56
37.77
19.88
28.31
18.62
T
500
800
I.D.P.L.
350
East India
50
Calcutta Chemi
cals
12,18
4. Paracetamol
T
400
800
Mohta
Chemo Pharma
I.D.P.Y.
I.P.C.L. z
Cipla
Burroughs
Wellcome
Themis
Duphar
Therapeutic
East India
381.96
2450
50
136.69 136.85
50
331
p
788.68
184.96
28.22
761.66
3. Phenacetin.
1—M of Pet. & Chem.775—5
755.70
122.27
48.76
50
100
0.83
9.08
Nil
0.87
470
1
32
(2)
(1)
(3)
5. Salicylamidc
T
6. Salicylic Acid
T
7. Methyl Salicylate
T
9. Amidopprine
T
.
11. Phnylbutazone
800
400
J
(8)
(9)
(10)
(ID
Alta
Albert David
120
15.00
16.00
26.00
21.00
Aka Labs.,
600
Indosal
Calcutta
Chemicals
Haryana
Chemicals
G.M. Swamy
175
437.90 1019.98 1615.24 1324.32
219.00 227.00 TP
\
Grade
2.64 39.53
Nil
Nil
Alta
Calcutta
Chemicals
G.M. Swamy
250
I.D.P.L.
0.15
Nil
Nil
t
■
Nil
600
350
1725
155.89
195.00
Nil
0.15
Nil
Nil
50
300
460
26.87
67.8
77.63
136.72 240
400
I.D.P.L.
40
3.45
5.89
3.82
2.86
40
198
216
310
240
750
21,1.8'
11.07
8.93
11.70
159
8.59
7.23
12
Kgs.
1200
2400
Gluconate
750
T
200
300
Themis
50
Jim
Suhrid Geigy
Indo Pharma
P.C. Sharma
50
30
4
25
50
100
Suhrid Geigy
12
13. Indomethacin
T
12
24
8
Kgs.
1200
2100
Themis
I.D.P.L.
Suneeta
15. Allopurional
T
I.D.P.L.
16. Dextropropoxyphene .
T
Uni Chem
17. Trichlorophos Sodium
T
Abbott
18. Ibuprofen
2.20
103.98
T
.
(12)
87.85
12. Oxyphenyl Butazone .
14. Probenecid
(13)
(7)
(6)
(5)
T
8. Analgin
10. Pethidine .
(4)
■
5
I
13
12T
12000
2
6
6
Boots
Gipla
6
2
8
A/il'iebneHtics
1. Piperazine & its salts.
T
118
230 I.D.P.L.
50
2. Bephanium HydoxyN apt boat e
T
15
30 B.W.
5'
21.90
28.58
43.73
66.53
0.12
1.45
nil
nil
3.76
8.97
9.76
9.18
65
115
15
15
3. Treibendazole
4. Niclosamide
5. Tetramizole
6. Pyrantal
Tartarte
Pamoate/
7. Mesulphen
Rarbiturates
T
1. Phenobarbitone
Bayer
T
34
70 I.D.P.L.
. 2. Anylobarbitone
T
10
20
3. Secobarbitone
T
10
20 I.D.P.L.
10
10
4. Diallylbarbitone
T
I.D.P.L.
0
10
5. Thiopentone
T
3
5
900
1800
15
Anti-Depressants
1. Tmipramine
Kgs.
=
I
33 ■
(6)
(3)
(4)
(5)
Kgs.
400
800
T
20
40
4. Chlordiazcpoxidc
T
6
12
Ranbaxy
Roche
5. Diazepam
T
0.5
1
I.D.P.L.
Cipla
Ranbaxy
Roche
(2)
(1)
2. Amitryptiline
.
3. Methaqualcne
(7)
(8)
(9)
(10)
(ID
Themis
200
200
1
0.7
1
4.00
5.7
6. Chlorpromazine
T
12
24
May & Baker
2.5
1.11
7. Phenoth-azines & its
Derivatives
T
2
4
May & Baker
0.5
1.29
2.05
T
50
60
Suneeta
Geoffrey
Manners
30
23.75
4.72
1.42
2.13
.
(13)
8
0.19
2.73
8. Meprobamate
(12)
13.6
1.8
2.5
0.5
31.8
9. Haloperidol
10. Dexebin
.
11. Thiothixene
12. Sintamil
.
Kgs.
Ciba
310
310
13. Nitrazepam
.
Kgs.
Cipla
250
250
12
10
12
34
14. Trifluoperazine Hcl.
.
Anti-Hypertensives and CVC drugs
1. Methyl-Dopa
.
.
.
2. Guanthidine
T
Kgs.
50
35
100
70
Suneeta
I.D.P.L.
Themis
Ciba
3. Prenylamine Lactate .
Kgs.
1600
3200
Hoechst
4. Isoxopurinc
.
Kgs.
1000
2000
Duphcr
5. Clofibrate
.
T
2
4
Themis
Ranbaxy
Cipla
Bio Evans
ACCI
6. Mephentermine
.
- Kgs.
200
252
1
155
nil
4
1
4
Kgs.
Glaxo
9. Practolol
.
T
Cipla
Themis
10
21
6
6.5
13
Hoechst
4
2. Chlorpheniramine
T
16
32
Uni-Sankyo
Indo Pharma
4
3. Diphenhydramine
T
16
32
Unichem
Parke Davis
6
1.92
2.06
0.82
2.55
Vitamins.
80
100
150
200
3.87
2.45
1.60
0.46
1.74
1.42
0.82
9
0.74
0.69
2
Roche
15
19.88
23.52
27.81
26.79
Glaxo
30
17.09
18.66
21.72
20.59
36.97
42.18
49.53
47.38
19.47
27.39
I.D.P. L.
4
3.44
6
May & Baker
4. Mepyramine Maleate .
1
1
. T
. T
500
1
Anti'Histamines.
2. Vitamin Bl Hcl. &
Mononitrate
500
100
.
MMU
800
400
8. Salbutamol .
1. Vitamin A
800
1.0
7. Propanalol .
1. Pheniramine
252
nil
60
5.39
15.74
15
60
60
120
I
f
34
(i)
(2)
(3)
(4)
(5)
(6)
3. Vitamin B2 & derivati
ves .... T
24
48
I. D. P. L.
4. Vitamin B6
50
100
I. D. P. L.
Themis
Sarabhai
T
5. Vitamin Bl2
(Cyano & Hydroxo) .
Kgs.
300
600
MSD
Themis
Alembic
Glaxo
Synbiotics
J
(7)
(8)
(9)
(10)
15
1.45
2.25
1.63
144 98.70
50 29.98
20
6.44
6
0.59
13.2 5.15
233.2
140.84
0.40
6. Folic Acid
T
7.5
15
l.D.P. L.
3.5
7. Panthenol &
Pantothenates
T
60
90
Searle
I. D. P. L.
5.0
8. Vitamin C & Salts
T
900
1800 Sarabhai
H. A. L.
Suneeta
D. R. Gandhi
120
115.13
8.90
9.17
nil
5.35
(11)
1.21
142.37
56.84
11.05
nil
8.03
123.60
42.45
3.17
nil
9.46
138.55 218.29
178.68
1.04
(12)
1 .57
2.12
0.34
0.60
■
(13)
9
24
50
20
12
82
253.2
4
40
45
194.6241.87 254.56 261.58
125
125
150
370
194.06 241.87 254.56 261.58
1030
91.87
520
3
9. Vitamin D2 D3
Kgs.
10. Vitamin E
T
11. Vitamin K
.
Kgs.
1030
2000 Duphsr
9
1140
12. Vitamin P
T
5
13. Nicotinic Acid
T
600
IS
2280
1200
14. Nicotinamide
(Capacities
shown
against each individual
Unit are combined for
both Nicotinic Acid
and Amide)
Roche
E. Merck
71.07
141.4
75.99
5.52
4
Atul Products
Glaxo
450
Ciba
E. Merck
50
4
Chemo Pharma
Cipla
Synbiotics
B.C.P.W.
I.P.C.L.
Therapeutic
Chemo Pharma
Cipla
Synbiotics
B.C.P.W.
I.D.P.L.
I.P.C.L
Bio Evan
Wai ner Hind ustan
Suneeta
East India
H.C. Shah
Dev. Corpa. of
Konkan
1000
386
432
442
366.04
nil
nil
nil
65
19.41
12
6.39
6.16 .
nil
1.2
0.20
15
11.89
22.73
nil
nil
6.46
3.86
1.80
13.54
nil
0.33
0.24
0.19
9.52
5.46
nil
nil
0 25
nil
6.6’
6.90
nil
0.03
nil
5.76
5.02
nil
0.01
8.56
0.15
41.23
49.48
16.34
29.84
16.75
20
0.02
1.26
20
25
48
10
36.08
3.47
nil
0.01
14.92
nil
0.27
54
75
&0
30.55
100
600
Diuretics
Hydrochlorthiazide
T
40
80
East India
Ciba
M.S.D.
2. Hydroflumethiazide
T
40
80
3. Polythiazdie
T
16
23
4. Fruscmide
T
3.5
7
5. Acetazolamide .
6. Spiranolactone .
7. Bendrofluazide .
.
0.5
2
3
0-36 0.43 0.60
0.86 0.02
*
0.04
0.58
0.05
(♦Includes Chlorthiazide also)
Hoechst
I.D.P.L.
1.2
T
I.D.P.L.
25
Kgs.
Searle
28
■
0.173
10
11.2
25
36.55
41.07
!
I
35
(2)
(i)
(3)
(4)
(5)
(6)
T
1
2
Ranbaxy
2
T
45
90
Boehringer
Knoll
B.C.P.W.
Mehta Pharm
18
(7)
(8)
(10)
(9)
(II)
(12)
(13)
A nti-park insonions
1. L-Dopa
2
2. Amantadine
Vasodilators
1. Ephedrine .
2. Theo phyl line/Aminophylline
T
60
120
Khandclwal
31.4
3. Xanthinol Nicotinate .
T
6
12 German Remedies
Cipla
12
3
Kgs.
480
1000 Wyeth
0.23
nil
0.29
0.09
nil
0.02
4.47
nil
nil
4.45
nil
nil
6.52
Hormones & Steroids
1. Ethisterone
2. Nor-Ethisterone
.
Kgs.
192
400
3. Progestrone & Salt
.
Kgs.
192
400
4. Norgestrel
.
Kgs.
48
100
288
580
5.
Mestrenol/Ethinyl Es
tradiol
.
. Kgs.
6. Testosterone Esters
nil
nil
102
16.70
305.05
522.05
19.38
27.50
Ciba
Wyeth
6
3.16
1.61
0.66
2.35
0.20
6.62
0.69
0.67
Ciba
Wyeth
Cipla
Searle
1400
7. Methyl Testosterone .
192
400 Searle
8. Lynestranol
150
300
6700
13000
4500
9000
Kgs.
1.70
Ciba
Cipla
Wyeth
680
.
2.38
Ciba
11.44 22.49
67.02 299.87
17.40 246.50 527.60
30
54.80 24.30
12.80 18.64
283.71 108.88 404.55 363.67
51.20 175.00
4.36 14.27
50
nil
7.50
nil
nil
15 41.95
199.2
72.53
57.36
41.92
61.99
Glaxo
M.S.D.
5.29
nil
8.66
nil
12.61
nil
7.14
nil
Glaxo
Wyeth
m's.d.
37.56
nil
nil
13.53
41.38
757.36 294.58
nil
nil
52.01
183.89
nil
Glaxo
M.S.D.
Wyeth
11.47
nil
516.55
2.68
nil
58.38
3.49
nil
8.95
3.40
nil
10.75
nil
836.90
nil
Cortico Steroids
1. Cortisone .
Kgs.
2. Hydrocortisone .
3. Prednisone
100
200
4. Prednisolene
1500
3000 Glaxo
Wveth
M.S.D.
nil
nil
nil
nil
nil
nil
nil
594.97
nil
Kgs.
Kgs.
90
150
80
180
300 M.S.D.
90 Glaxo
7.52
64.36
13.94
78.26
3.94
18.25
93.09 133.80
Kgs.
96
190 Burroughs
Wellcome
30.08
(197071)
37.61
37.61 15.00
(1971- (J97272)
73)
5. Triamcinboae/Acetonide .
6. Dexamothasone
7. Betamethasone .
Others
1. Adrenaline Salts
2. Nor Adrenaline .
Kgs.
12
20
3. Oxytocin .
MU
240
480
4. Isoprenaline
48
36
3
4
5
6
Kgs.
75
120
Mehta Pharma
Kgs.
Kgs.
75
120
150
240 Sandoz
B & W.
Hind
2
1
8
9
10
10
0.87
Nil
,Nil
Nil
Nil
8.28
0.01
Nil
9.82
Nil
23.15
6.52
Nil
8.71
4.60
Nil
60
15.78
0.07
10.59
0.016
18.41
0.03
22.30
Nil
4
1.25
1.05
0.10
0.30
Nil.
7
12
13
Drugs of Vegetable Origin
1. Atropine
2. Homatropine
3. Hycscine
4. Hyosyamine
•
f
J
5. Butyl Hyoscine Hydrobremide .
•
6. Digoxin
7. Erogotamine
T
8. Caffeine & Saits
75
120
160
350
B.C.P.W.
Mehta Pharma
Smith Stanistreet
Hind Chemicals
T
1600
3200 Govt. Factory
Ghazipur
1.00
0.56
0.75
0.66
9. Morphine & Salts
10. Codeine & Salts
T
20
40 Govt. Factory
Ghazipur
5.58
3.25
7.25
5.17
T
6
12
Kgs.
20
40 Mehta Pharma
Nil
Nil
Nil
Nil
T
60
100 Smith Staninstreet
Mehta
Bio Evans
B.C.P.W.
4,54
1.33
1.65
1.75
9.20
1.82
8.54
0.84
Nil
11.41
4.64
Nil
13.63
4.02
Nil
0.25
0.24
0.16
0.15
0.13
0.05
0.07
0.12
11. Narcotine & Salts
12. Papawerines
.
13. Reserpine
14. Strychnine & Brucine
15. Quinidine Sulphate
T
15
30 Cipla
Govt. Factory
Tamil Nadu./
West Bengal
15
Sera & Vaccines
1. Tetanuc Antitoxin
MU
30000
60000 Bengal Immunity
Bio Evans
Devs
B.C.P.W.
Haffkine
Chowgale
3046.2 4445.4 8223.2 6201.53
4686.00
4487 889.10
3152
Nil The data in res
Nil
Nil
31.68
97.43 187.64 pect of Bio
80.07 80.11
1876.20 1687.00 logical product
480.98 1068
are not com
Nil
Nil
plete.
6791.63 10080.51 16090.91 12745.17
2. Diplheria AT
.
Bengal
Immunity
Haff Line
Bio Evans
(Toxoid) Kgs.
B.C.P.W.
MU
584.61 497.22 562.69 438.08
331.44 355.00
68.55 149
302
0.80
200
Nil
340
0.20
Lit
Lit
617.16 949.02
3. D.T.P.(Triple Vaccine)
4. B.C.G. Vaccine
5. Polio Vaccine
6. Tetanus Toxoid
.
M
Doses
20
40
66
130
20
40
32
70 Bio Evans
B.C.P.W.
Glaxo
Bengal Immunity
Lit
3465
8192.8
2123
243.44
5145.00
6465
5853
17.39
13.92
17.47
Nil
1021
— 1497.00
437.99
f..LJ
Anncxure HI
Chapter-V. Para 5.
*
LIST OF COB LICENCES
S. No.
NiiTie of the Company
i
2
Items of manufacture p.a. and capacity.
Licence No. and Date
4
3
I.
I. M/s Merck Sharp & Dohmc of L/22/422,71-Ch. Ill
dt. 9-9-1971
India Ltd.
3.
4.
6.
2. M’s Abbott Labs (India) Ltd.
1.
L/22/423.'71-Ch. Ill
dt. 20-9-71
Mintezol Tablets
Tri-redisol Tabs
Tri-relisol Drops
Perideca Elixir
Hydro met tabs
Thibendoie
hijectables
(a) Bejectal
(b) Bejectal C Liner
(c) Bejectal T
(d) Revodox
Liquids
(a) Calcidrinc
(b) Cecon drops
(c) Iberoi liquid
(d) Kalteri-C-Neomycin
(e) Selsun Suspension
(f) Surbex Syrup
(g) Torfin
(h) Vidaylin
(i) Vidaylin M
(j) Vidaylin M Drops
(k) Vidaylin Drops
(l) Iberet C
3.
4.
5.
u
2.5 million Nos
10 mill on
1500 litres
2500 litres
2 million
500 bgs
J
,
j
2.36000 Lts.
J
Tablets
(a) Bev id ox
fb) Cecon '500’
(c) Erythrocin 100 mg
(d) Erythrecin 250 mg
(e) Iberoi
(f) Optilels
(g) Optilets M
(h) Pramilets
(i) Sucaryl
(j) Surbex Sugar coated
(k) Surbex T.
Capsules
(a) Nembutal
(b) Tridine
Granules
(a) Erythrocin
(b) Pentothal
18.79 lakhs
100 million
J
'l
y
J
3 lakh Nos.
5737 Kg
2.4 million
3. M/s Glaxo Labs. (India) Ltd.
L/22/430/71-Ch. Ill
dt. 2-12-1971
Bctncton Tabs.
L M/s Wyeth Labs. Ltd.
L/22/428/71-Ch. Ill
dt. 26-10-1971
(i) Testosterone Pure
25 Kgs
(ii) Testoserene Enanthate
45 Kgs
(iii) 17-A1pha Hydro Progesterone cap270 Kgs.
reate
(iv) Testosterone Hexa Hydrc-Pensoatc 5 Kes
121
1
122
i
2
3
5. M s Roche Products Ltd.
4
L/22/438/72-Ch. Ill
dr. IM-1972
fi) Supradyn Tabs
liiii vJ*yd™enietine tabs
!
CidroTaT^andanlf’ou,«
I
(viu) Rovisol
pVithi;in tbe overall
■y preparations ' licensee
J capacity.
J
Bylk Drugs
6. Burroughs Wellcome
& Co.
(tndia) Ltd
C/22.,440.72-Ch. Ill
dt. 1-5-1972
1-
h)-hydrocnicniine ] Id
3-
Chlordiazepoxide
Vitamin E
Kgs
624 KgS
Diazepam
Gapacity to be Jlxcd
—•
23.
24.
.
25.
26.
7. M s Searle (India) Ltd.
L/22/443/72-Ch.
HI
dt. 26-6-1972
T. Wellcome Seltzer
(i) Lamotil Tablets
(11) Lamotil liquid
L/22/454/72-Ch
III
7-11-72
1.
?•
6.
9. Ms Bocliringcr Knoll Ltd.
*)
I
I
I
^ithin the overall
licensed
capacity.
Baxocid Bm'd'sX'
Alconar
8- M s Gia.™ Labs. (India) Ltd.
df/2K4o3/73'C,L 111
dt. 12-2-1973
a,tcr one year of
operation.
Tablets
H T. Banocidc
joo ml
J’ -}-•
-T’ irones
PaPhones 5 inl
T. Tanoxm Pediatric
4. ’
l- Non—
5. T. Komadrin
6. T. Oxoxine
r 6a.
.
' ’ *Actefcd
“-IV1I. J
T.
injections
Inj. Actid il
8. ’
Inj. Banocide Plus
9. Inj. Lanoxin
10. Inj. Suphentrene
JL -..-pax
Antepar Liquid
Liquid Wormcr
W<
-•
epar Worm POwdcr
AntenarTuko
r
Antepar
Tabs.
15. ’ Banocide 400 m<r
Burmidinsg tabs .
16. Burmtdm 30% rnj.
17. branocide Inj
18. Burmidin Oral
19. Fasool Drench.
Carbachol Inj.
Tablets*
Liquids
Ointments
Sterile inj
Antibiotics Vials
Sohds & POwders
(Details as in Appendix)
I
1
I
J
S-I lakhs tabs
^00 litres
(within the
capacity)
overall
pl rnillio,n
247740K^IreS
■'4.120 litres
lakhs
32-^5 Kgs
(in £?.Ici,uv'n Syrup
. ) Mittavin Capsules
v CM Cnt01 ExPectorant
v) Ch °ramphycin eardroos
M) Strep[o&!n ^ointment
capacities
ly hold a licence.
fegtdansed under cob'^^^"06- but higher
t- AmpoulerNor
l-arised
i
-•
'3.
4.
5.
6.
7.
Grannules
Capsules
Liquid (Oral)
oSS-S,;;-1 “
Powder
-0 lakhs
25,000 Kes
J34 lakh litres
-SjLnkh h’tres
-oOO Kgs
6200 Kgs
1700 Kgs
123
i
2
2
10. M.'s Smith Kline &
(India) Ltd.
4
French L/22/484/73-Ch. Ill
dt. 29-9-1973
3.
4.
5.
6.
7.
Tablets
Liquids
Ointments
Capsules
Powders
Inhalers
Injectables
918 lakhs
34.000 litres
1.55.300 Kgs
145 lakhs
43,310 Kgs
21.600 Nos
3 lakh Nos.
1.
2.
3.
4.
5.
6.
7..
Tablets & Caps
Liquids
Ointments
Solutions
Granules
Injectables (amp)
Injections (Lit)
361.03 lakhs
3.72 lakh litres
2900 Kgs
1900 litres
16500 litres
4.80 lakhs
36 litres
1.
2.
p
11. M/s Laboratories
Ltd.
Grimault L/24/74
dt. 24-1-1974
(Details as in Anncxure ’A')
12.
M/s Uni-Sankyo Lid.
L ’22 407/71 -Ch. Ill
dt. 15-3-197!
1.
3.
4.
13. M/s Ciba of India Ltd
Fungal Diastase
Chloroheniraminc Maleate
Pyrizanamide
Specialities incorporating the above
products)
18 tonnes
2 tonnes
3 tonnes
Capacity to be fixed.
Dexamethasone Triinethyl Acetate
Calcium Coraminc
3 Kgs p.a.
1.5 tonnes p.a.
L/22/413/71-Ch. Ill
dt. 16-6-1971
1.
14. M/s Sandoz India Ltd. Bombay L. 22 ,'416/71-Ch. Ill
dt. 16-7-1971
I.
Intestopan Vaginal Tablets
Intestopan suspension
Intestopan Forte Capsules
Hematrine Liquid
Intestopan Q Capsules
Sandocycline Capsules
Phenipan Sandoz (Dry Syrup)
Folestine tablets
Torecan ampules
Torecan tablets
11. Santevini
(These items will be manufactured within the overall canacities of
the \arious types ot formulations already approved in their
t0 covcr the additional capacity for the aforesaid items.)
15. M/s May & Baker Ltd
I.(a) Conray 280
b. Con ray 420
n Embacetin
L Osbil
4. Surmontil
5. Tegeron Cream (Veterniary)
L.22.417/71 -Ch. Ill
dt. 6-7-1971
3*
4.
5.
6.
7.
8.
9.
10.
6.
1.
-»
16. M.'s. Pfizer Ltd. Bombay
L/22/418/7l-Ch. Ill
dt. 6-7-1971
17. M/s Tata Fision Industries Ltd. L/22/421/71-Ch. Ill
Bombay
Bombay
dated 30-7-71
IS. M/s Gluconate Ltd.
19.
—do—
20 M/s Atul Products Ltd.
These items
will
be manufactured
within the overall
capacity of formu
lations
already
licensed in the’ir
favour.
Vallergan
BASIC MANUFACTURE
Chloramphenicol Ointment
Metronidazole
65 Kgs
602 Kgs
1.
Prenex Capsules Vistaril Svrup, Mirax
Capsules Heptuna Capsules. Diadin
Liquid. Anorexon tablets Distodin
(Hexachlorophene)
(To be manufactured within the overall
capacity).
Infivit Injection etc.
Infivit Inj. 95,000 x 5ml. vial
Emetine Inj. 360,000 Ampoules
L/22/402/70-Ch. Ill
dt. 16-12-1970
Pethidine Hydrochloride
250 Kgs.
L/22/403/70.-Ch. Ill
dt. 16-12-1970
1.
2.
. 1000 Kgs
3000 Kgs
L/22/430/7I-Ch. Ill
dt. 10-12-1974
Para Chlono
Benzone
Sulphanomide
Acriflavine
Proflavine
20 tonnes
.J-
124
1
4
3
2
21. M/s Repatakos Brett & Co.
Ltd.
L/22/485/73-Ch. Ill
dt.
22. M's Orient Pharma (P) Ltd.
CIL. 273(74)
dt. 21-6-74
Aminouly Elixin (300 ml Bottle)
Eupcpline Elixir
Hovita Syrup
Kantamesim Tablets
Dizitonin R.B. Tabs.
Katemesim Injs. (1ml amp.)
A. R. Tablets
1. Ossopan
Binisec
Pankreo
4. Aminoplyllinc
5. Sulphadimidine
6. Ephedrine Hcl.
7. Vitamin B Complex
8. Sulphaguanidinc
9. A.P.C.
10. Robdden
11. Epedosin
12. Ripason
13. Premenolysin
14. Recosen
B. Capsules
1. Oricetin
2 Yeilamycin
C. Injections
Epidosin
1. J "
2. Robudon UD
3. Robudon UV
4. Ravexen
5. Recosen
6. Ripason
7. Dextrose
1. Supramide V Tablets
o Tricobal H
Alvite Injections
56.770
85.290
87,461
4,18.360
5,00.000
15,528
T.
23.
M/s Alembic Chemical Works
Co.. Baroda
LLS No. 586 74
dt. 30-11-74
? -
53.38 lakhs
5.9 lakhs
1
6.7 lakhs
180 lakhs Nos.
1850 litres
u
/
1 . I
’ 5^
••
37
2
1
3
6
5
4
7
8
9
10
11
12
7. Diphtheria Toxiod
8. Gas Gangrene
Anti-Epileptics
I
Phenyl Hydantxoin &
derivatives
T
12
24
Miscellaneous Drugs
1. Calcium Gluconate
T
400
800 Albert David
Sandox
Alembic
Calcutta Chem
Anil Starch
Baropharm
Nila Products
150
240 Baropharm
Nila Products
Sandoz
Albert David
2. Ferrous Gluconate
T
3. Ferrous Succinate
T
25
50
4. Ferrous Fumarate
T
50
100 Rallis
Sandoz
Unichem
Chemo Pharma
5. Ferrous Sulphate
T
240
400
6. Nikethamide & Salts .
T
25
30
120
60
East India
B.C.P.W.
Atul Products
Standard
Ciba
30
60 Indo Pharma
I.P.C.L.
Power Cable
4
9
8. Nitrofurantoin .
T
45
90 Indo Pharma
I.P.C.L.
S.K.F.
I.D.P.L.
Sarabhai
Day-Se-Chem
Power Cables
3
9
Indo Pharma
I.D.P.L.
4
10. Nalidixic Acid .
2.06
7.75
17.20
Nil
0.34
8.97
31 .84
Nil
4.19
2.13
4.50
0.22
1.35
0.26
6.62
Nil
0.09
0.06
3.05
Nil
Nil’
0.12
2.70
Nil
Nil
0.18
4.25
Nil
1.2
20
12
N.A.
T
T
6.20
15.83
Nil
1.84
7. Furazolidine
9. Nitrofurazone .
1.48
1.64
1 .48
1.50
71 .91 111.81 120.63 112.66
24.17
14.92
19.30
17.30
Nil
Nil
Nil
Nil
48.60 43.40 60.70 72.60
11.45
5.38
0.03
8.36
Nil
Nil
Nil
Nil
12
31
10
4
24
5
1
Ranbaxy
P.J. Menezes
10
2.5
11. Azothioprine
12. Iron Chaline Citrate .
B.W.
Cipla
I.D.P.L.
13. Trimethoprin
14. Sod. Cromoglycate
.
T
1. Methotrexate
.
Kgs.
200
400
2. Cyclophesphamide
.
Kgs.
200
400
Cipla
Anti-Micotics
3. Hydroxy Urea
4. 6-Mercaptopurine
5. Testolactone
6. Thiotepa
7. Mustlne Hel
3.6
1.1
2
0.2
13
38
i
2
3
4
6
5
8. Chlorambucil
9. Melphalan
Radio <1 X-Ray Contrast Media'.
1. lodipamide
2. Di & Triazine Salts
:
Kgs.
100
200
1. Cellulase
T
9
15
2. Papain
T
75
120
3. Pancreatin
T
30
50
4. Diastase .
T
45
80
5. Lipase
T
6
10
M. Lts.
1
1.6
T
38
60
3. Sodium Meglumine
Tlothalomate
'
4. lodoxyl
|
J
Enzymes'.
Plasma Substitutes :
1. Dextran
2. Polivinyl Pyrolidone .
7
8
9
10
11
12
13
ANNEXURF. IT
(Chapter II—Para 14)
Bulk Drug production in the Small Scale Sector
S.Nx
Name of the bulk drug
Na tic of firms
1. Paracetamol
1. Poona Pharm. Chem. Industries
2. Mujherat Chemicals
3. Eagle Pharmaceutical Works
4. Trichem Laboratories
5. Unique Pharmaceutical Labs.
6. British Pharmaceutical Works Labs.
7. Suly Chemicals
8. Chandra Bhagat Chemicals
9. Fa^mson Pharmaceuticals Pvt. Ltd.
10. Liger Chemicals
11. Pharma Synth Chemicals
1.2. Suchem Laboratories
13. Atomplant Industries
14. Aceto Chemicals
2. Diethyl Charbamazine Citrate
Production
2640 Kgs.
N.A.
2916 Kgs.
1388 Kgs.
714.30 Kgs.
806 Kgs.
21000 Kss.
2200 Kgs.
40000 Kgs.
8000 Kgs.
5921 Kgs.
2800 Kgs.
NA
13900 Kgs.
Total
(1972-73)
(1973-74)
(1973-74)
(1972-73)
(1.972)
(1973)
i(1972-73)
(1973-74)
(1973-74)
(1973)
(1973)
(1973)
102285.30
1. Chemipharm
2. Trichem Laboratories
31.35 Kgs. (1973-74)
348 Kgs. (1972-73)
3483
1. Chemipharm
2. Mujherat Chemicals
3. Heni Chemical Industries
4. Eagle Pharmaceutical Works
5 Mulraj G. Dungarsey and Co.
5.
6. British Pharmaceutical Labs.
7. Universal Chemicals
8. Chandra Bhagat Chemicals
9. Suchem Laboratories
10. Sunny Industries Pvt. Ltd.
IL Neogy Laboratories
12. Hooghly Chemical Industries Pvt. Ltd
5364 Kgs.
N.A.
N.A.
4819 Kgs,
3000 Kgs.
880 Kgs.
1225 Kgs.
2790 Kgs.
2411 Kgs.
504 Kgs.
6700 Kgs.
1200 Kgs.
28S93
1. Chemipharm
2. Trichem Laboratories
3. Mulraj G. Dungarsey & Co. Pvt. Ltd.
4. British Pharmaceutical Labs.
5. Universal Chemicals
6. Chandra Bhagat Chemicals
7. Suchem Laboratories
3273 Kgs. (1973-74)
3555 Kgs. (1973-74)
5000 Kgs. (1974)
1577.5 Kgs (1973)
50 Kg-. (1971-72)
439 Kgs. (1973-74)
150 Kgs. (1973)
1. Nivedita Chemicals Pvt. Ltd.
558 Kgs.
(1973-74)
558
1. Nivedita Chemicals Pvt. Ltd.
2. Trichem Laboratories
3. British Pharmaceutical Labs.
4. Pharmasynth Chemicals
5. Suchem Laboratories
6. Aceto Chemicals Pvt. Ltd.
918 Kgs.
8370 Kgs.
1775 Kgs.
4932 Kgs.
2080 Kgs.
22600 Kgs.
(1972-73)
(1972-73)
(1973)
(1973)
(1973)
(1973)
40675
1. Chemipharm
2. Crystal Chemicals
195 Kgs.
980 Kgs.
(1973-74)
(1973-74)
1175
8. Chlorpheniramine Maleate
1. Chemipharm
54 Kgs.
(1973-74)
54
9. Diphenhydramine Hydrochloride
1. Chemipharm
1137 Kgs.
(1973-74)
1137
3. Diiodohydroxyquinoline
4. Piperazine and its Salts
5. Vitamin B 2-5 Phosphate Sodium
6. Phenaceiin
7. Calcium Lactate
.
(1973-74)
(1973-74)
(1974)
(1973)
(1973)
(1973-74)
(1973)
(1973-74)
(1973)
(1972-73)
14044.5
.
1. Chemipharm
65 Kgs.
(1972-73)
65
11. Methaqualone
1. Chemipharm
310 Kgs. (1973-74)
310
12. Me'.hanamine Mandelate
1. Chemipharn.
2. Pharmasynth Chemicals
3605 Kgs. (1973-74)
811 Kgs. (1973)
4416
1. Chemipharm
2. Trichem Laboratories
750 Kgs. (1973-74)
837 Kg-. (1973-74)
1587
(1973-74)
195
10. Menadione
13. Sulphadiazine
14. Suocinyl Sulphathiazote .
15. Papain
195 Kgs.
1. Chemipharm
1. True Food Corporation
2. Enzo Chem. Labs. Pvt. Ltd.
39
1—M of Pet. & Chem./75—6
30000 Kgs. (1973-74) *
18000 Kgs. (1972-73)
-----
48000
I
40
1
3
2
1. Eagle Pharmaceutical Works
2. Mulraj G. Dungarsay Pvt. Ltd.
3. Sulphara Pharmaceuticals & Chemicals
4. British Pharmaceutical Labs.
16. Nicotinic Acid/amide
17. Chloramphenicol .
18. Isoniazid
19. Berberine Hcl.
4
6
5
725 Kgs. (1973-74)
1573 Kes. (1972-73)
9448 Kgs. (1972-73)
160 Kgs. (1973)
5. Dekka Chem. India
6. Atomplant Industries
7. Inter Chem.
8. Pharmasynth Chemicals
9. Pharma Indiana Laboratories
10. Suchem Laboratories
11 Shroffs Industrial Chemicals Ltd.
12. Basichem
13. Biochem Agencies
800 Kgs.
454 Kes.
3894.3 Kgs.
31.13.7 Kgs.
7860 4 Kgs.
394 Kes.
382 Kes.
684 Kgs.
N.A.
(1973)
(1973)
(1973)
(1973)
(1973-74)
(1973)
(1972-73)
(1973-74)
1. Trichem Laboratories
2. Unique Pharmaceutical Labs.
3. British Pharmaceutical Works
4. Pharmasynth Chemicals
520 Kgs.
62.6 Kes
1175.8 Kes
7917 Kgs.
(1973-74)
(1.973--4)
(1973)
(1973)
1. Eagle Pharmaceutical Works
2. Mulraj G. Dungarsey & Co. Pvt. Ltd.
3. Pharmasynth Chemicals
4. Bio Chem
5. Dr. Karanths Pharma Chemical Industry
6. Syntho Chem.
7. Katha & Allied Industries Pvt. Ltd.
661 Kgs.
1950 Kgs.
626 Kes.
N.A.
7370 Kgs.
N.A.
71.50 Kgs.
(1973-74)
(1973)
1972
1. Mulraj G. Dungarsey and Co. Pvt. Ltd.
25 Kgs.
29488.5
9675.4
(1973)
(1973)
17757
('973)
25
20. Oxyphenbutazone .
1. Unique Pharmaceutical Labs.
408.80 Kgs.
(1973-74)
408.80
21. Phthalyl Sulphathiazole .
1. British Pharmaceutical Labs.
1360 Kgs.
(1972)
1360
22. Diazepam
1. Nitsan Laboratories
45 Kgs.
(1973)
(Feb. to
March 1974)
45
1600
.
1. Nitson Laboratories
1600 Kgs.
24. Ferrous Fumerate .
■ 1. Universal Chemicals
2. Basi Chem.
1088 Kgs. (1973)
42870 Kgs. (1973-“’4)
43958
25. Aspirin
26. Magnesium Trisilicate I.P.
1. Gujarat Chemical Industries
Hansa Chemicals
N.A.
50000 Kgs.
50000
23. Sulphamethizole
27. Imipramine Hydrochloride
Inter Chem.
28. Thiacetazone.
1. Pharmasynth Chemicals
2. Basichem Industries
29. Phenyl Butazone
.
.
32. Dried Aluminium Hydroxide Gel.
.
35. Tolbutamide
....
.
.
14330
(1973)
1. Pharmasynth Chemicals
13.5 Kgs.
(1973)
13.5
.
1.. Pharmasynth Chemicals
86 Kgs.
(1972)
86
.
1. Sovin Chemicals
2. India Alkalies Ltd.
39240 Kgs. (1973)
350 Kgs. (1973)
39590
1. Unsar Pharmaceuticals
51300 Kgs.
(1973-74)
51300
1. Basichem Industries
886 Kgs.
(1973-74)
886
310 Kgs.
(1973)
310
33. Glycero Phosphates (Sodium, Potas
sium, Calcium etc.)
34. Meprobamate
7020 Kgs. (1973)
7310 Kgs. (1973-74)
17
1752.5 Kgs.
N.A.
.
.
(1973)
1.. Pharmasynth Chemicals
2. Syntho Chem.
.
30. Chlorpromazine Hcl.
31. Salicylamide .
17 Kgs.
(1973-74)
.
1. Dr. Karan ths Pharma
36. Caffeine
1. Associated Drug Co. Pvt. Ltd.
37. Iodo Chlorophydroxyquin
1. Sunny Industries Pvt. Ltd.
2. Neogy Laboratories
25400 Kgs.
1752.5
(1973-74)
25400
271 Kgs. (1.973-74)
16780 Kgs. (1973)
17051
ANNEXURE—III
Production of some bulk drugs in the Organised and Small-scale Sectors vis-a-vis Fifth Plan Target.
(Chapter— II— Para— 15)
Unit
Item
Total
produc
tion in
smallscale
sector
2
I
Total
Total*
produc indige
nous
tion in
the orga- producnised secsec tion
tor
Capacity Fifth
approved Plan
in the
targets
organised
sector
3
4
5
6
1. Paracetamol
T
102.28
18.62
120.90
431
400
2. DCC
T
3.48
7.65
11.13
56
45
3. Halogenated-8-hydroxyquinoline.
T
45.94
100.5
146.44
427.4
450
4. Piperazine & salts.
T
14.04
66.53
80.57
115
118
5. Vitamin B2
T
0-558
1.21
1.768
24
24
...
6. Phenacetin
T
40.67
136.85
177.52
462.18
500
7. N'-trotinic Acid/amide .
T
29.48
101.40
130.88
1799
600
8. INH/Isoniazid
T
17.75
96.48
114.23
458.56
265
9. Oxyphenbutazone
T
0.409
7.25
7.659
12
50
10. Phthalyl Sulphathiazole
T
1.360
Nil.
1.360
153.5
150
500
Kgs.
45
235—
5700
12. Ferrous Fumerate
T
43.95
43.95
33.2
50
13. Aspirin
T
N.A.
821.82
2450
1900
14. Phenyl Butazone .
I
1.75
11.70
13.45
159
200
15. Thiacetazone
T
14.33
35.16
49.49
127.5
70
16. Salicylamide
T
0.086
21.62
21.70
120
17. PAS & its salts
T
bl.A.
498.27
498.27
1510
18. Tolbutamide
T
0.310
57.67
57.98
11. Diazepam .
41
821.82
77.16
1000
75
77
ANNEXURE IV
Production of Bulk Drugs during 1952, 1957, 1960, 1965, 1970 & 1973
(Chapter II Para 17)
SI.
No.
Item
Unit
2
3
1
1952
4
1957
1960
6
5
1965
1970
1973
7
8
9
I. Antibiotics :
. MMU
. T
. T
. T
. Kgs.
. Kgs.
. Kgs.
1. Penicillin
_2. Streptomycin
3. Tetracyclin
4. Chloramphenicol
5. Amphotericin
6. Erythromycin
7. Neomycin Sulphate
17.5
39.70
1.93
1.5
20.19
2.220
3.819
103
100.7
21.79
29.38
182
158
53
38
1542
24
742
247.52
179.85
90.71
47.19
390
2840
310
21.619
70.07
90
100.45
16.76
1.79
513.75
41
6
807
57.62
9.43
898
7.413
3.55
8
8.2
76.312
16.558
413.40
3.52
762
104
38
27
N.A.
198
821.82
136.85
18.62
136.72
204.01
240
If. Anti Dysentry Drugs.
4.84
T
1. Halogenated Oxyquinolines .
III. Anti Diabetic Drugs:
T
T
MMU
1 ..Tolbutamide
2. Chlorpropamide .
3. Insulin
I V. Anti-Leprosy Drugs :
0.83
T
1. DDS and its derivaties .
2.49
V. Anti Pyretics & Anagesics :
1. Acetyl Salicylic Acid
2. Phenacetin .
3. Paracetamol
4. Analgin
5. SjJ. Salicycate .
6. Pethidine Hcl.
VI. Anti
.
.
.
.
.
.
T
T
T
T
T
Kgs.
3.12
118.05
319.46
N.A.
1.08
14.82
42.89
29.047
82.988
56.32
338.90
29
466
5
96\48
498.27
35.16
49.17
0.448
24 •
1.72
51.77
4.22
813
1997
25.60
13
40
26.04
15.23
278
3228
47.79
17.11
165
519
49.02
22.60
T.B. Drugs :
T
T
T
1. INH .
.
.
2. PAS & its Salts .
3. Thiacetazone
VII. Anaesthetics :
1. Procaine Hcl.
2. Xylocaine/Lignocaine .
T
T
VI1I. Synthetic Hormones: .
Kgs.
IX. Anti Malarials:
1. Chloroquin & Amodiquin
T
X. Alkloids & Allied Drugs:
1. Caffeine
...
2. Emetine Hcl.
3. Ephedrine .
.
.
4. Quinine
.
.
.
.
.
.
163
0.06
2.780
T
Kgs.
Kgs.
T
1.18
42
5.28
72
17
12.668
188
23
9.291
4475
29.20
■
■■■'
■ - i
;'W1
I
43
■o-.i
3
2
5. Strychnine & Brucine
6. Reserpine .
.
.
T
Kgs.
5
4
8.48
4.64
0.27
6
7
8
14.324
9.03
21.30
N.A.
15.57
19. 40
14.008
13.134
107.71
19.06
75.236
45.27
27.816
62.56
56
17
126
149
84
101
157
76
20
94.45
11.30
328.81
317.82
71.88
83.45
265.97
37
141
82
1.451
5.39
92
47.38
173.68
261.58
101.40
1.21
27.39
75.99
0.40
2.12
155
23
8
11
Nil.
3
4
198
3.374
217.49
11.04
5.08
7.65
2.13
2.86
9.18
2 40
2.25
9
XI. Sulpha Drugs :
T
T
T
T
T
T
T
1. Sulphadiazine
2. Sulphapyrdidine .
3. Sulphadimidirie .
4. Sulphathiazole
5. Sulphanilamide .
6. Sulphasomidine .
7. Sulphaguanidine .
8. Sulphaphenazole .
9. Other Sulpha Drugs
41.87
114.32
T
T
38.1
XII. Vitamins:
1. Vitamin A .
2. Vitamin B-12
3. Vitamin C .
4. Nicetinic acid/amide
5. Vitamin B-2
6. Vitamin B-l
7. Vitamin D-2 and D-3
8. Vitamin B-6
9. Folic Acid .
.
.
.
.
.
.
.
.
.
MMU
Kgs.
T
T
T
3
T
Kgs.
Kg?.
T
14.5
5.22
0.94
0.18
0.213
23.5
43.7
93.79
57.47
194 ’
1351
XIII. Other Drugs:
1. Calcium gluconate/Lactobionate .
2. Ferrous gluconate
3. Nikethamide
4. Diethyl carbamazine citrate .
5. Meprobamate
6. Amidopyrin
7. Phenobarbitone .
8. Pethidine Hcl.
9. Diphenyl Hydramine He.
T
T
T
. T
. T
. T
. T
. Kgs.
T
1351
.
0.35
3.24
61.415
18.142
3.108
130.14
25.651
8.690
4.88
3.74
r
L
Annexure V
STATEMENT SHOWING THE IMPORTS OF BULK DRUGS DURING 1971-72 TO 1973-74 WHICH ARE ALSO
MANUFACTURED INDIGENOUSLY
(Chapter II—Para 17)
SI.
No.
1
Name of the Drug
2
Acounting
Unit
3
Kgs.
1. Pethidine Hcl. .
2. Procaine Hcl.
3. Analgin (metamizol)
4. Phenyl Butazone
5. Oxy Phenbutazone .
6. Emetine .
7. Phenacetin
8. Chloramphenicol
9. Chloramphenicol Palmitate
10. Chloramphenicol Succinate
11. Chlor-tetracycline
12. Oxy-tetracycline
13. Tetracycline Hcl.
M.U.
14. Penicillin G Sodium
15. Penicillin G Potassium
Kgs.
z 16. Streptomycin Sulphate
17. Neomycin
18. Erythromycin (Bulk)
19. Ampicillin (Bulk)
M.U.
20. Insulin Crystallin Plain
. Kgs.
21. Tolbutamide
22. Chlorprepamide
23. Phenformin Hcl.
24. Chloroquin’s Salts (Bulk) .
25. Mepyramine Maleate
26. Diphenydramine Hcl.
27. Promethazine (Base & Hcl)
28. Promethazine B. ChloroTheophylinate .
29. Isoniazid (INH)
(A) PAS & Its salts
Gms.
30. Digoxin .
31. Caffeine .... Kgs.
32. Hydrochlorthiazide
33. Spironolactone
34. Prednisone
35. Prednisolone .
36. Dexamethasone
J,
37. Ethisterone
38. Hydrocortisone
39. A drenaline & its Salts
40. Diptheria Antitoxin (Bulk)
41. Tetanus Antitoxin (Bulk) .
42. Phthalyl Sulphacetamide .
• 971-72
Quantity
4
323.784
23,781
x 1,30,966
22,209.2
2,366.3
13,650
65,635
19,048
400
55
54,190
44,365.5
1,00,00.000
3,00,00.000
83,703.4
2,554.61
2,577.82
2,776J388
471.14
12,884
2,444,5
1,554.06
52,648.53
697.5
1,718
174.3
95
3.100
71,000
3,453
57,150
25
18.5
Nil .
Nil
99.45
188.672
89.48
20.83
281
3,529.5
1,925
1972-73
Value
in Rs.
Quantity
1973-74
Value
in Rs.
Quantity
Value
in Rs.
7
8
9
280,918
12,680
1,42,670
24,776.01
5,919.2
67,847
4,54,015
54,89,223
9,83,577
15,48,082
183.39
15,633
2,19,094
1,180.26
9,845.6
800
8,76,277
5,53,851
64.78,675
65,209
28,67,153
4,424
1,70,556
64,470.5
1,68,78,618
45,79,718
35,652
1,80,860
400
30,992
447.6
1,07,57,567
1,517.3
20,126
1,16,41,190
19,96,986
Nil
3919,674 99,90,030
1,70,09,884
99,205.74
7,79,524
2,616-7
1,18,61,613
14,421
21,03,551
6,837.5
20,75,640
152.004
.2,93,694
6,201
1,948
1 42,156
2,12,728
29,55.29
76,83,309
99,335.64
87,198
361
1,535.642
95,647
26,159
585
91,11,847
49,09,112
81,295
1,23,316
2,83,453
86,15,109
Nil
11,71,851
16,96,496
778,007
1,14,10,128
47,18,379
705,0411
155,662
1,27.612
4,48,689
1,27,06,977
54,606
73,830
88,028
41,000
20,890
3,100
180
54,025
Nil
5,18,149
51,946
4,458.025
9,007
24,592.81
15.0026
1,648
756
2,584.05
48,062.17
556
1,401
125
49,24,126
26.82,694
10,46,004
66,196
ixil
73.59,803
Nil
70,845
63,41,19[
15,13,919
66,39,081
1,60,69,030
7,36,556
55,196
50,66
26.28
1,300
6,600
32,500
23.85
Nil
9^03
Ni
2,201
25,000
63.81
1
9.68
20,918
47.598
238.43
'100.6
22
1,177.46
3,677.4
1,03,797
8,00,493
3,510
10,634
44,095
86,733
20,22,947
422,143
3,06,155
25,846
4,00,171
7,38,855
3,582
Nil
400
1,53,87 9
Nil
20,000
24,000
5,803
Nil
32,19,410
8,59,111
55,297
35,557
2,33,295
1,93,600
97,379
5
70,101
6,86,794
56,65,850
10,10,878
6,26,843
27,603
93,000
8,89,903
1,53,712
14,38,277
2,029
2,31,492
Nil
Nil
37,99,5(4
3.72,615
, 3,67,561
1,00,264
1,00,112
8,89,633
84,552
44
6
2,300
92,301
Nil
2
l,650x
Nil
9 00,858
246.31
23.8
40
548.540
810
2,000
3,49,349
60,34,201
1,00,030
74,116
26,97
|-i
45
:
-------------------------------------------------------------------------- -■
1
2
43. Sulphathiazole .
44. Succinyl Sulphath:a'.ole
45. Sulphaguinadine
46. Sulphadimidinc
47. Sulphadiazine .
48. Sulphasomidine
49. Sulphaphenazole
50. Sulphamethizole
51. Meprobamate .
52. Pronlorpoazine
Maleate
& Ethane Sulphate .
53. Folic Acid
.
...
54. Penthenol
55. Nicotinamide
56. Vitamin ‘Bl’
57. Vitamin B2
58. Riboflavin 5 Phos-Sodium
59. Vitamin B 12 .
60. Vitamin C
61. Vitamin D
62. Vitamin E
63. Vitamin K
64. Vitamin P
65. Phenobarbitone
66. Phenobarbitone Sodium
67. Ephedrine
68. Metronidazole
69. Nikethamide (ceramine)
70. Piperazine ELxahydrate
71. Diazepam
72. Fursemide
73. Calcium Lactabionate
74. Calcium Lactate
75. Chloro promazine Hcl.
76. Guanithidine Sulphate
77. Clofibrate
3
4
5
6
7
8
9
Kgs.
25,267'
8221,386
2,975
74,375
Nil
Nil •
2.000
50,000
1:48,500
43,410
13,120
14,545
3,525
81,356
12,75.000
86,02,990
28,25,633
6,16,047
12,77,347
3,19,473
Nil
1,00,850
1,24,900
1,035
54,949
8,687
12,357
Nil
1.500
16,16,764
60.000
29,68,111
43,500
55,545
Nil
22,37,980 18,137.55
1,879
10,10,130
9,71,348
11,293
194.2
32.5
1,612.921
5,541.3
465.7 .
35,718.88
2,169.7
1,172.9
448
1.33,633.2
52,92,280.43
5,121
83
5,038.2
236.5
331.3
2,694.2
7,152.4
, 32
12,020
94.5
1,183.95 .
82
4,525
2,207.’7
10
668.38
14,479
9,36,666
7,15,406
22,567
56,98,913
4,70,023
7,77.033
1,07.379
33,93,950
77,173
7,98,760
6.809
7,52.847
16,075
24,915
21,28,449
8.31.183
1,280
88,083
26,785
29,13,859
5,441
20.537
4,13,542
11.160
3,06,052
55.4
Nil
6,758
22,160
14,216
5,189
Nil
Nil
2,80,625
11,76,555
30,90,760
48
3,770.5
130
5,750
9,687.40
16,255.3
187.5
6.800
638.05
1,293.2
31.75
3,975
1.836.50
25,958
Nil
6,42,116
10,12,137
16,19,012
11,01,399
Nil
Nil
1,04,64,494
53,371
4,45,791
12,311
4,61,889
9,987
1,75,812
16,66,161
21,65,815
13,137
58.G22
1,51,598
18,52.577
2,321
20,366
3,09,835
3,782
5,02,653
Gms.
Kgs.
MV
Kgs.
1,319
126.5
500
7,195
Nil
26,626.5
11,250
625
15.77
3,C 6.000
1,88,100
5,629.008
19
5,265
Nil
Nil
12,967.425
25,583.78
2,388
1.06,950
3,110.31
1.406.63
Nil
Nil
2,455.51
10
5,210.3
60,550
10,08,000
10,74,359
Nil
9,63,452
2,01,974
6,99,961
4,273
71,748
2,18,384
7,93,013
Nil
24,95,213
24,15,822
3,70,633
2,34,973
1,12,64,591
37,299
8,60,683
2,149
7,51,890
Nil
Nil
27,14,882
31,97,012
1,13,311
8,37,684
7,69,351
7,95,795
Nil
Nil
3,93,834
18,201
4,14,244
■
>
I'
■
•“5
ANNEXURE VI
(Chapter II—Para 19)
Imports exceeding Rs. 10 lacs During 1973-74
S. No.
A
Quantity
Item
1. Analgin
2. Oxy-phanyl-butazone .
3. Chloramphenicol & estes
4. Tetracycline/Hcl. .
5. Streptamycine Sulphate
6. Griseofulvin
7. Neomycin .
8. Framycetin .
9. Erythromycin
10. Chloroquin/Salts .
11. Ergot alkaloids .
12. Dexamethasone .
13. Triaminolore
14. Nor-ethysterone .
15. Phthalyl Sulphathiazole
16. Sulphaguanidine .
17. Sulphadimidine .
18. Sulphamethoxy Pyridazine
19. Thioridazine (Melleril) .
20. Pentothenates, Na/ca .
21. Vitamin Bl
22. Vitamin B2 .
23. Vitamin B6
24. Vitamin C .
25. Polyvinyl Pynolidone .
26. Ephedrine .
x27. Ethionamide
28. Glucose anhydrous
29. Isoxuprine .
30. Methyl Dopa
31. Metronidazole
32. Amitriptyline
33. Ampicillin .
34.1soptine
35. Gentamycin Sulphate .
36: Nogestrol .
^37. Pyrazinamide
38. Piirinethol .
Value
Rs. lacs
Ton
64.78
219.09
28.67
9.85
86.54
65
73.59
54
63.14
51.95
4.82
17.20
15.14
4.46
0.694
12.28
9
66.39
60.34
48.06
11.63
27.01
32.91
90.08kg.
17.44
39.83
25.32
89.85kg.
40.02
121.99
69
10.08
43.5
10.74
18.82
17.08
11.7
53.88
25.99
14.93
26.62
24.95
11.25
24.16
23.82
32.96
306
112.64
34.72
12.88
12.97
27.14
3.56
10.18
717.56
25.59
10.61
210.32kg.
3.6
18.99
25.58
31.97
555
10.45
24.59
160.69
' 549.kg.
12.93
65.63 kg.
42.23
27.64kg.
14.02
4?26
11.28
502
11.23
B
3
Imports between Rs. 5 and Rs. 10 lacs During 1973-74
S. No.
1
Item
Quantity
Value
2
3
4
Ton.
183.39
15.633
4.97
1. Pethidine Hol.
2. Procaine Hcl.
3. Diloxanide/Furoate
46
Rs. lacs
8.76
5.54
7.49
■
■■
■■■
.
<-.
■
.
47
i
2
4. Cyloserine D Tartrate .
5. Cyclophosphamide
6. Insulin, Plain
7. Chlorpheniramine maleate
8. Aminophyltine
9. Ethysterone
10. Diosaganiu .
11. Sulpha-merazine .
12. Sulphasomidine .
13. Sulphamethizole .
14. Penthenol
15. Vitamin E .
16. Vitamin P .
17. Avapyrazine
18. Bisumuth Salts
19. Dydrogesterone .
20. Furazoldone
21. Piperazine Hexahydrate
22. Diazepam .
23. Furosemide
24. Thiabendazole
25. Doxycycline
26. L-Dopa
1—M of Pet. & Chem./75—7
3
4
486kg.
140
150m.u.
1.88
14.65
246.3kg.
4.12
11.43
18.14
11.29
7.19
5.63
5.26
650
3.34
10.75
11.51
107
3.11
1.41
2.8
158kg.
1.38
6.54
7.34
7.36
5.14
6.99
8.59
7.50
5.36
9.63
7.00
7.93
8.61
7.52
5.81
6.65
6.30
6.11
8.37
7.69
7.96
5.44
5.17
5.88
-
W t
<
ANNEXURE VII
(Chapter II Para 26)
I
ITEMWISE EXPORTS OF THE ITEMS FOR THE YEAR 1971-72, 1972-73 A.\rD 1973-74
RITC No.
Exports During
Items
1973-74
1
(In ’000 Rs.)
1971-72
5
4
3
2
1972-73
Drugs, Pharmaceuticals & Fine Chemicals
Folic Acid
.........
541.1002
Nicotinic Acid/Nicotinamide
541.1003
Vitamin A
......
541.1004
Vitamin Bl
541.1005
Vitamin B2
........
541.1006
Vitamin B12
.........
541.1008
Vitamin B Complex
.......
541.1015
Vitamin C
.
.
.
.
541.1011
Provitamin, Vitamin natural or reproduced n.e.s.
541.1019
Chloromphenicol & its prepns.
.....
541.3001
Erythromycin.
........
541.3003
Oxytetracyclin & its prepns
541.3004
Penicillin & its prepns
541.3005
Streptomycin & its prepns.
......
,541.3006
Other Antibiotics & their prepns
541.3019
Cinchona Alkaloids, other than Quinine Alkaloid
541.4003
541.4005 ■ Cocaine Alkaloid, Salts & derivatives
Ephedrine Hydrochloride
......
541.4008
Ergot Aklaloid
541.4011
Salt other derivatives of Ergot
541.4013
Emetine Alkaloid
........
541.4014
Salt other derivatives of Emetine
....
541.4015
Nicotine Alkaloids
541.4016
Salt & other derivatives of Nicotine
541.4017
Quinine Alkaloid
.......
541.4022
Salt & derivatives of Quinine n.e.s.
.....
541.4023
Rauwolfia Alkaloids & prepns.
.....
541.4024
Strychnine Salts & Alkaloids
541.4025
Salt & other derivatives of Nux Vomica, Alkaloid/Brucine .
541.4026
Theophylline
& Theobromine Alkaloids their salts & other derivatives
541.4027
Quinine Sulphate
541.4028
Berberine Hydrochloride (compiled from the Customs List).
541.4039
Vegetable Alkaloids
541.4039
541.5029
Hormones others .
Digoxin
541.6101
Blood Plasma
541.6201
Liquid Extract of Liver .
541.6202
Liver Extract Dry .
541.6203
Organo Therapeutic Glands or other Organs & their Extracts—others .
541.6209
Anti-toxins .
541.6301
Diphtheria Serum .
541.6302
Tetanus Serums
541.6303
Anti Bacterial Serums & Anti Serums n.e.s.
541.6309
Vaccine Cholera
....
541.6311
Vaccine Tuberculin / B.C.G.
54U6316
7.5
102.3
23.7
42.2
63
340
145
19
2768
1008
1961
7903
370
173
70
211
2168.8
2584.1
6983.9
31.2
615.2
2388.9
2278.7
630.4
703.9
134.3
65.2
4.7
12.3
69.9
106.4
1.7
162.9
377.9
1.5
5682.8
193.4
942.5
3519.1
1366.1
17.0
660.3
9.9
63.7
50.3
148.1
324.0
5.0
213.9
79.3
251.9
91.4
4445.1
232.6
2346.8
3064.1
466.7
0.9
193.2
4.7
6.4
55.4
712.3
4770.6
786.8
6.0
16.4
1088.5
345.0
12.4
6.6
11.0
111.5
661.4
1143.3
L
236.6
4822.0
173.8
788.3
1890.9
1.3
2724.3
1307.5
171.8
6.3
216.0
44.8
6.5
2260.2
-
27.0
4.3
2.4
412.7
0.4
408.3
51.1
1.2
0.6
13.0
3.2
48
[
- - CZV .
49
1
541.6318
541.6329
541.6331
541.7001
541.7002
541.7003
541.7004
541.7005
541.7006
541.7007
541.7011
541.7012
541.7015
541.7017
^541.7021
541.7022
541.7023
541.7025
541.7026
541.7028
. 541.7031
541.7034
541.7036
541.7041
541.7042
541.7046
541.7052
541.7055
541.7058
541.7063
541.7064
541.7065
541.7066
541.7067
541.7068
541.7071
541.7072
^541.7073
X541.7076
541.7081
541.7082
541.7083
541.7084
r>
0
2
Vaccine Yellow Fever
.....
Bacterial Vaccine n.e.s. .
.
.
.
Bacteriological Products n.e.s.
......
Ayurvedic & Unani Medicines
Homeopathic Medicines
.......
Acetarsol B.P.C. (Stovarsol) .
Acetyl Salicylic Acid/Aspirin
......
Antacid & Digestive Prepns
Antidiabetic Drugs other than Insulin
....
Anti Histonines
Anti Malerial Chloroquine & Chloroquine Phesphate
Anti Malerial Quinoline derivatives n.e.s. .
Asthma, Cattarh & Hay Fever prepns
Calcium PAS
Chemical, Medicinal Contraceptive Foam Tablets
Chemical & Medicinal Contraceptive Jellies Paste, Crean^etc. .
Cold, Cough, Bronchial prepns. except salves ointments & vaccines
Dehydrocholic Acid
.
.
.
•
.Diethyl Carbamazine Cirtus Acidus
Gripe water
Headache, Neuralgia & Pain Remedies
....
Iron Almonium Citrate
.......
Iodine Tincture
Leptazol B.P.
Magnesium Trisilicate
Milk of Megnesia
Potassium Glycerophosphate
Phthalyl Sulphathiazole
Sulphacitamidc
Sulphanilamide
....••••■
Sulphathiazole
Sulphadiazine
Sulphamerazine/Sulphamethyldiazine
....
Sulpha Drugs n.e.s.
Salicylamide ....■•••••
Salves & Ointment for Burns Cuts etc
Salves & Ointments for Cough, Cold & Bronchial prepns. .
Sodium P.A.S.
Tonics, Blood Purifiers, Emulsion Appetisers etc
Proprietory & Patent Medicines
Botanical Drugs, Derivatives & Synthetic Equivalent prepns.
Drugs, Animal Origin, Synthetic Equivalent prepns. n.e.s. .
Organic Acids & prepns. n.e.s.
3
1.2
45.3
1.0
1536.4
66.8
633.7
34.6
631.2
1.9
17.0
390.9
37.8
44.8
81.8
17.4
4
5
90.1
11.1
56.5
1959.5
298.8
6.5
823.4
17.1
3112.7
9.9
66.1
31.0
30.5
12.1
10.4
1.4
62.0
145.9
319.2
135.6
28.9 '
50.3
10.6
157.7
154.1
9.2
19.6
65.0
1193.1
69.6
692.5
29.8
4162.1
173.4
25.6
7.1
168.9
143.9
1.0
5.0
187.8
170.2
70.2
7.7
6.7
137.6
2.0
31.7
0.7
16.3
214.2
16.0
137.1
17.1
110.3
590.7
16.0
132.8
22175.9
21.5
11.4
34.0
17.9
81.1
924.3
28.1
5985.5
120.5
3.3
0.6
21.2
96.1
734.4
14.7
71.1
6863.4
62.9
6.5
i
50
2
541.7085
541.7099
Drugs, Medicines, Chemicals Containing Spirit n.e.s.
Other Medicaments
541.9101
Adhesive Bandages
541.9102
Adhesive Tape (Medicinal)
541.9103
Poultice of Kaolin
541.9104
Lint Medicated
541.9105
Plaster of Paris
541.9109
Bandages n.e.s.
541.9901
Dental Cement & other Dental Fillings
541.9902
First Aid Boxes Kits
.
4
5
2007.9
69712.6
962.6
55500.0
2326.6
41301.8
872.3
84.9
647.3
247.9
112.7
151.1
4.1
20 .\1
2.2
363.9
469.9
403.4
723.8
265.1
87.7
13916.1
6189.1
2605.4
81.6
105.0
148.3
219.3
541.9905
Sterile Surgical Catgut etc.
658.5601
512.1308
Wadding & Articles of Wadding/Absorbent Cotton
Chloroform
...
512.2304
Menthol
512.3104
Ether Solvent/Ethyl Ether
x 512.4323
3
27.9
38.4
421.3
6365.5
859.6
24.9
321.7
533.3
10.3
1361.8
1.2
Beta Ionone
4031.8
8103.0
9585.9
38.6
4.5
2.9
170.1
242.1
2.5
4.4
512.5106
Beanzl Benzoate
512.5107
Bismuth Compounds of Monoacids
197.5
512.5142
Undecylenic Acid .
639.2
512.5301
Calcium Gluconate
512.5302
Citric Acid
512.5308
Methyl Salicylate
245.9
81.9
12.4
512.5312
Petassium Citrate .
215.6
48.3
202.0
512.5314
Salicylic Acid
197.6
20.8
2.4
512.5316
Sodium Salicylate
322.2
309.6
11.5
512.6301
512.7413
Calcium Glycerophosphate
32.2
£12.8512
Dehydroxy Quinoline
512.8517
Hydroxy Quinoline Salts
512.8527
Alpha Picoline
512.9103
Papain Pure
514.1601
Potassium Iodide .
514.1609
Iodides, Oxyiodies, Iodates, Periodates others
514.9200
Hydrogen Peroxide
899.1801
Emoty Gelatine Capsules
88.4
90.8
599.2100
9.6
Disinfectants
66.1
912.9
422.5000
1289.4
Medicinal Castor Oil (compiled from the customs lists)
211308.3
20364.2
2319.6
44.9
219.5
.
103.0
51.3
250.2
Phenacetin
1.8
29.7
79.1
571.6
34.9
554.6
11.2
9.3
187.4
0.3
0.1
0.1
7.9
.
Re-Export
541.7099
Othw iMedicaments
....
37,54,24.8 13,52,71.2 10,33,37.0
ANNEXURE—VIII
(Chapter 11—Para 30)
Expon During
(In ’000 Rs.)
Apr./
Sept. ’74
(Est.)
Apr./
Apr./
Sept. ’73 Sept. ’72
(Act.)
(Act.)
3
4
640.1
182.7
4.8
42.2
' 3.8
2
1
Drugs, Pharmaceuticals & Fine Chemicals
Salt and other derivatives of nicotine
Vitamin Bl
Vitamin B Complex
........
Vitamin C
........
Provitamin, Vitamin natural or reproduced n.e.s.
14.5
1.7
3.8
Chloramphenicol & its prepns
92.1
91.3
72.4
445.0
1.5
2307.4
4.9
Erythromycin
1566.0
Oxytetracycline & its prepns
Penicillin & its prepns.
63.9
^ Streptomycin & its prepns
488.8
1350.3
2521.4
Other Antibiotics & their prepns.
C Jcaine alkaloid, salt & derivatives
152.2
Ergot Alkaloid
20.0
........
351.5
1.5
Salt other derivatives of ergot
........
83.0
10.8
1661.6
........
Salt and Derivatives of quinine n.e.s.
......
Quinine Sulphate
8.5
33.7
Salt other derivatives of emetine
Quinine alkaloids
983.5
17.0
Ephedrine Hydrochloride
Emetine alkaloids
356.4
3099.4
1986.5
2063.7
10847.6
1922.9
1072.7
14.6
90.2
Rauwolfia alkaloids & prepns
192.0
403.9
373.3
Salt & other derivatives of nux vomica alkaloid.Brucine
1196.7
833.1
274.2
Berberine Hydrochloride
186.6
352.3
286.4
260.9
240.3
Strychnine alkaloids/salts.
........
Vegetable alkaloids
35.4
Hormones—others
261.2
Digoxin ...••••••••
Blood Plasma
45.7
Liquid Extract of Liver
5.5
Organo Therapeutic glands or other organs & their extracts—others
Antitoxins
.
0.7
4.1
5.0
6.6
56. S
........
Ferrous Sulphate
5.9
4.3
•
1.6
Tetanus Serums
51
library
AND
>
documentation
> Q
J r-
DR-MO
HEALTH cell’
\
rkjd,
Oo
52
'i
2
Antibacterial Scrums & Antiserums n.e.s.
Vaccine Cholera
3
4
203.3
232.1
....
0.4
Serra Vaccine other .
71.9
Bacterial Vaccine n.e.s.
34.9
Bacterialogical products n.e.s.
......
Ayrvedic & LTnani medicines
......
613.5
Homeopathic Medicines
......
10.9
Acetyle Salicylic Acid/Aspirin
......
Antacid & Digestive prepns.
......
Antidiabetic drugs other than insulin
.
.
' .
354.5
527.6
........
Anti Histamines
Anti malaria Is chloroquine & chloroquine phosphate .
44.2
1.0
709.7
38.3
135.5
195.8
433.8
6.0
8.9
630.0
515.8
0.7
9.8
17.C
2.8
Asthma, Catarrah & hay fever prepns
30.0
8.8
Chemical, medicinal contraceptive, foam tablets
44."
0.3
35.2
21.4
287.0
Chemical & medicinal contraceptive Jellies, paste, creams etc.
2.4
Cold, cough & pronchial prepns. except salves, ointments & vaccines
Dehydrochyie Acid
17.4
Gripe Water
69.4
42.2
79.2
Headache, neuralgia & pain remedies
475.2
19.3
23.3
1.4
0.4
64.4
43.5
93,9
Iodine Tincture
Magnesium Trisilicate
....
Milk of Magnesia
9.2
Phthalyl Sulphathiazol
....
Sulphadiazine
....
65.0
16.0
Sulpha Drugs n.e.s
112.5
23.7
Salves & Ointments for burns, cuts etc.
45.0
50.-
26.7
365J
702.7
Salves & Ointments for cough, cold & Bronchial prepns.
Tonics, blood purifiers, emulsions, appetisers
....
Proprietory & Patent Medicines
57.9
47.5
14.4
726.2
2663.9
1757.1
B atanical drugs, derivatives & synthetic equivalent prepns.
1.1
1131.4
Drugs, medicines, chemicals containing spirit n.e.s.
....
Adhesive Tape (Medicinal)
....
I
I
Poultice of Kaoline
16847.8
Lint Medicated
Plaster of Paris
Bandages n.e.s.
.
.
.
.
Drugs Intermediates
Other medicaments ....
14.0
94.2
24.0
20.1
434.4
( 352.4
! 4658.5
1210.7
106.2
40256.6
463.8
7194.4
27.4
36.1
9.7
30.8
27919.2
23664.9
J
Sterile Surgical catgut etc.
Harmless medicines ....
69.2
127.5
I
I
Dental Cement & Other dental fillings
Calcium Co.mpounds/prepns.
291.9
231.1
Wadding and Articles of wadding/ Absorbent cotton .
Adhesive Bandages
0.2
•
■ ,.s-
' ■Il
1
2
3
4
4937.5
Menthol .
1113.7
Beta Ionone
2089.5
1554.0
0.7
36.5
Benzyl Benzoate
Bismuth Compounds of Monoacids
1193.9
Undecylenic Acid
269.2
Citric Acid
40.4
241.0
...
MethyJ Salicylate
103.4
39.9
50.6
Sodium Citrate
Potassium Citrate
145.8
152.5
31.8
Salicylic Acid
1802.8
14.2
9.3
44.2
234.2
233.7
Sodium Salicylate
10.0
Calcium Glycerophosphate
12.1
Acriflavin
126.6
Alpha Picoline
133.6
Papain Pure
139.9
Iodides, Oxyiodides, Iodates & Periodates—others
0.1
Hydrogen Peroxides
8.0
Paracetamol
....
430.4
Empty Gelatine Capsules
Disinfectants
Medicinal Castor Oil
31.1
59.2
615.5
156989.2 122908.1
3768.3
5.3
Soluble Sodium Saccharine
1064.1
Cineole .
286.9
Phenolphthalein B.P.
286.0
Salicylamide
413.8
Fine Chemicals
551.7
253056.5
•I
<1
t-
0.7
185.5
Potassium Iodide
*
116.1
176460.9
50732.4
*
■;
<
r
chapter in
PUBLIC SECTOR
1. This chapter is devoted to the second term of reference of this Committee. This term of reference requires
that the Committee recommends the measures necessary for ensuring that the public sector attains a leadership role in
the manufacture of basic drugs and formulations and in research and development.-
2. The public sector has to p’ay an important role in the industrial development of the country. Subject to the
overall consideration of resources, the programme in the public sector envisages further expansion in high priority fields
to fulfil the gap and correct existing imbalances in the industrial structure to meet the social needs of the country.
The Industrial Policy Resolution, 1956, takes into account the need to prevent monopoly and concentration of econo
mic power in the hands of a small number of individuals.
3. The Ccmmittee notes that the public sector has achieved an overall production of substantial capacity,
particularly in the field of synthetic drugs, and has demonstrated the competence of this sector to handle the growing
needs of the country in this highly technology-intensive area of drug production.
4. In order that the public sector may enter the field of manufacture of basic drugs and formulations in a big
way, as is recommended in this chapter, with a view to making essential medicines available to large masses of our
people at reasonable prices, it will be necessary to remove some of the constraints and deficiencies in the public sector
units.
5. The Committee has suggested measures necessary to make the public sector more efficient, in respect of or
ganisational set-up, and management patterns, taking into consideration the deficiencies, difficulties and disabilities
from which the public sector units are suffering at present. The Committee has also suggested die areas in which the
public sector should expand so that it can effectively serve the objectives and attain a commanding height in the manu
facture of bulk drugs and formulations. Measures have been suggested to bring about technological improvements
and for appropriate organisation of research and development in the field of drug industry. The importance of uti
lizing various public sector laboratories and institutions has also been dealt with. In view of the fact that this sector
must grow in magnitude to fulfil national needs, the Committee has suggested the establishment of National Drug
Authority (NDA) a central organisation which will lay down and coordinate the policies of manufacturing programmes,
as well as the sale and distribution systems of the products produced in public sector units. The composition and
functions of the Authority has been discussed in Chapter IV.
6. Pattern of production of the domineering units in the private sector, which consist predominantly of multi
national subsidiaries or their branches or their equity partners in India, indicates that the primary objective of these
units is trade based almost entirely in the economically preferable area of formulations from bulk drugs, largely im
ported from their principals, rather than on the production of the bulk drugs themselves. Government, therefore,
decided that, in the interests of the health and well-being of the people of this country, more units for the production
of drugs be started in the public sector. It was perhaps felt that health care was a national charge and the ethics of
production of drugs should have essentially the character of meeting national needs as distinct from trade and commer
cial an<de. Further, such needs should be met by a determined effort to produce bulk drugs from primary raw mate
rials and intermediates. The Planning Commission, in addition to recommending the development of chemical indus
try in general (drug in their basic form are chemicals) also emphasized that high priority should be given to manufac
ture within the country, of bulk synthetic drugs rather than the formulation of imported drugs.
7 This emohasized the desirability of the setting up of a large drugs and pharma euticals complex in this coun
try and resulted in the establishment of a public sector enter prise, Indian Drugs and Pharmaceuticals Limited (1DPL),
where production started in 1968. Earlier, Hindustan Antibiotics Ltd., Pimpri, started production in 1955. The
Ccmmittee on Public Undertakings said in their 22nd report ;
“The setting up of the drug manufacturing units and surgical imtruments factory in the public sector was intended to serve the triple objectives, namely to bring down the prices by large scale production of high quality life
saving drugs, to provide facilities for medical relief to the people on a mass scale in consonance with the declar
ed objectives of the Government in this regard and finally, not only to achieve self-sufficiency but also to produce
an expoitable surplus and earn foreign exchange.”
54
1
• 55
8. Despite production of about Rs. 370 crores worth of pharmaceuticals during 1973. it is estimated that modern
drugs reach only about 20% of our people.
This would imply that the majority of people, particularly in the rural
areas and economically weaker sections of the society derive little advantage from the modern systems of medicines
and to that extent their sudering remains unabated. This immediately throws into focus the magnitude of inade
quacy of our national effort in this vital area of not only social but also economic consequence to our poeple. It is
thus clear that production of allopathic drugs, in terms of the magnitude of the needs of the country has barely begun
in India and that the field is wide open for enlightened leadership to make bold efforts and take up the challange, *
on a national scale, and meet this vital problem by proper planning.
9. The National Committee on Science and Technology (NCST) and the Task Force appointed by the Planning
Commission, have, during the last two years carried out studies of the existing product pattern in pharmaceutical and
drugs industry. The Committee feels that the basic data used by the NCST and the Task Force conforms to existant
pattern of marker needs rather than the real social needs of the country. The Committee is of the view that there is
urgent need to institutinalize data collection and base the national production targets in terms of the needs indentified by such a system. However, for the present; the Committee accepts the projection of the Task Force for drawing
up the more immediate production plans. The NCST and the Task Force identified the needs of the nation over the
next 5 to 10 years. Both the groups concluded that it is necessary to maintain a sustained growtli rate of at least 15%
in this industry with high emphasis on the production of bulk drugs. They have also suggested the need to fix tar
gets and adjudge the growth rate in quantitative terms and not in terms of rupee value. This Committee wishes
to emphasize the necessity of fixing growth targets and judging the growth rate in terms of individual quantities. This
is necessary because of the changing value of rupee. Presentation of growth in terms of rupee value can, as it has
been done in the past, present a distorted picture and induce an unjustified sense of achievement and complacency.
I
10. The above two Committees have rightly emphasized the need to dove-tail the development progammes of the
-drug industry with those of the chemical industry on which the former is largely dependent. Besides supporting this
plea, the Committee is of the opinion that extensive development in the field of critical plant materials, as will be
indicated later in this report, should be given high priority.
11. In respect of chemicals, needed as raw materials for the production of bulk drugs, Hincustan Organic Chem
icals (H.O.C.), Indian Petrochemicals Corporation Ltd. (1PCL) and such other units in the public sector as may be
concerned now or in the future, with the production of vital solvents like alcohols, organic acids, ester, anhydrides,
etc. basic chemicals like benzene, toluent, xylenes, napthalene and related intermediates, pyridines, etc. ; mineral
acids would need to be materially strenghened in terms of an annual growth rate of at least 15%. This has been
emphasized in the relevant NCST report. It is essential that all these products, arising out of the efiorts of either the
public sector or the private sector units, shoud meet the priority needs of the bulk drugs industry.
12. As has been mentioned elsewhere in this report, formulation activity represents the high pay-off sector of
the pharmaceutical industry and bulk drugs manufa ture given comparatively low profits. Inevitably, therefore, en
trepreneurs who enter the pharmaceutical industry, usually prefer formulation activity. An analysis of the working
of a number of drug manufacturing units in this country has revealed that the ratio of capital invested to sales turn
over .in the formualtion sector averages out at about 1:2.6 with an upper limit of as high as 1: 7.75. It is estimated
that a purely formulation unit recovers the entire invested capital in a 2-4 year period. On the other hand, in bulk
drug production, under the best of cirmcumstances, sales turnover to capital ratio does not usually exceed the 1:1
figure and in many cases, in the early development stages, this ratio is much lower.
13. It is evident, therefore, that a manufacturer whose basic philosophy is materially trade oriented, would usually
tiy to remain in the formulation sector and keep the less paying basic drug manufacture at the lowest level of produc
tion priority.
<1
14. It has been estimated by NCST that in order to register a formulation production growth rate of 15% lead
ing to a total production of Rs. 700 crores from the present production of about Rs. 370 crores,
at the
end of the Fifth Plan period, capital requirements will be of
the
pr?er ,
only Rs. 100 crores. Where as that group has also estimated that for achieving a targetted production of the value
of Rs. 200 crores worth of bulk drugs from the present Rs. 75 crores, additional investment requirements will be au
high as Rs. 150 crores. The conclusions are obvious.
15. It is not, therefore, surprising that for the past many years, foreign or foreign-equity holding companies have,
by and large, resisted the governmental suggestions to enter the basic drug production in a big way. Experience has
shown that even when these units undertake the manufacture of bulk drugs, they tend to linger long at the very initial
phase of manufacture of bulk drugs from penultimate or near-penultimate intermediates imported often at high cost
essentially from their principals abroad.
1—M of Pet. & Chem./75—8
s' i
■
56
16. An analysis of the effort invested in the production of bulk drugs by the different sectors of the industry pro
vides some revealing data. In 1973, the organised sector of the drugs and pharmaceutical industry in India, produced
a total of 5300 tons of bulk drugs. These included natural products, synethetic drugs, steroids, antibiotics, etc. The
total value of this production was about Rs. 70 crores.
17. The figures for bulk drug production in the small scale sector, in terms of tonnage, are not available. How
ever, their total production is rated at about Rs. 5 cror es in terms of money value and could be estimated at about
500 tonnes including a fairly high percentage of synthetic bulk drugs. It is interesting that out of the production of
500 tonnes by the small scale sector, only about 3% was produced by the foreign and foreign majority units in this
sector and about 97% by the Indian units.
18. Analysis of the production figures of 5300* tonnes produced in the organised sector reveals that :
(i) The public sector units produced about 1500 tons of bulk drugs valued at Rs. 24 crores;
(ii) The Indian and the Indian-majority units manufactured 3200 tons of bulk drugs valued at Rs. 27 crores
and.
(iii) The foreign and foreign-majority equity units produced about 600 tons of bulk drugs valued at Rs. 19
crores.
19. The above figures would indicate that whereas the public sector and the purely Indian and Indian majority
sectors produced large tonnage of drugs of relatively lower value, the foreign and foreign-majority units operated,
in general, selectively in the area of low tonnage high rupee-value bulk drugs. They contributed less than 12% of
the total production of bulk drugs in the organised sector and recovered as much as about 27% of the turn-over in
rupee value.
20. In contrast to the efforts of the various units in bulk drugs production, it is interesting that a hundred and
sixteen units comprising 25 totally foreign or foreign-majority equity firms and 91 other units with either relatively
minority foreign equity or totally Indian units, the “organised” sector, accounted in 1973, for about Rs. 296 crores
(80%) of the total turnover. Over half of this was shared by the 25 firms with total foreign or majority foreign equity
and other half was accounted for by the remaining 91 units including about Rs. 20 crores worth of formulations
produced in the public sector. Out of the remaining Rs. 74 crore turnover (20%), 9 fully foreign or foreign-majority
companies in the small scale sector, accounted for over about Rs. 18 crores (24%). and the remaining nearly 2500
units shared between them a turnover of about Rs. 56 crores. Analysis of about 486 units in the small scale sector,
listed in the publication on Indian Pharmaceutical Industry for 1973 compiled and published by Development.
Council for Drugs and Pharmaceuticals, Govt, of India, reveals that 260 companies, constituting over’52 % of
these listed units, had an individual turnover of rupees one to five lakhs. These figures indicate that the large majority
of the remaining over 2000 units operate only as tiny tablet or tincure makers with no showing whatsoever in
the overall economics of the pharmaceuticals and drugs industry.
21. These relative figures, both for bulk drugs production and formulations, lead to the inescapable conclu
sion that the multinationals have not only concentrated their effort in the production of formulations, but even in
their minor effort in bulk drug production, they have limited their activities on!)- to low-tonnage high-rupee-value
bulk drugs. Some of which are, of course, essential and technology intensive such as steroids vitamins A, Bl2,
etc. It is evident that it is the Indian and Indian majority sector, and in particular the two public sector units, that
have made the major contribution in the critical area of bulk drug production, which constitutes the base plank of •
the pharmaceutical industry.
22. There are three broad areas at present under which the various drugs may be considered :
(i) Those derived from higher plants;
" .
(ii) Those derived from micro-organisms, lower plants and animal sources: and
(iii) Synthetics.
23. Drugs derived from plant sources will include in this report, an important insecticide e.g. extract of Pyre
thrum flower heads. The latter has added to its importance recently because of the threat of the spread of mala
ria in this country and because the malarial parasite -carrying mosquito has become resistant to most of the avail
able synthetic insecticides. ■
24. In the order of importance, plants of medicinal value may be listed as follows :
1. Pyrethrum-as source for mosquitecides.
‘'These figures do not include the turnover of immunological agents in Govt, institutions or private sector
units and of Insulin, Non-pharmacopoeial grade salicylic acid and ether.
■
•
-
-■
■■
■:
■
57
2. (a) Dioscorea species e.g. D. <delteides, ~] D. as source of intermediates for the synthetsis of therafloribunda and D. composita.
peutically active steriods including antifertility
j
steroids.
(b) Salanwn khasianuni
3. Cinchona for quinine and quinidine.
4. Poppy for opium alkaloids e.g. morphine, codeine and noscapine.
5. Ergot of Rye, (Claviceps purpurea) for ergot alkaloids, ergotamine, ergometrine, etc.
6. Digitalis species D. lanata and D. purpurea for cardiac glycosides e.g. digoxin, digitalin, etc.
7. Ipecac for the production of emetine.
8. Dubosia and atropa species (A. belladonna and A. accuminate) for atropine and hyoscine.
9. Tea dust and tea waste for caffeine.
10. Nu.xvomica for strychnine and brucine.
.
11. Glycyrrhiza for new anti-inflammatories and a possible anticarcinogenic agent.
12. Vinca rosea for the anti cancer alkaloids vincristin, vinblastin, etc.
13. Lemon grass for carotenoids for the preparation of Vitamin A.
14. Rauvolfia for hypertensive and CNS active total alkaloids and reserpine.
25. Of the above fourteen plant materials, eight, namely, dioscorea species (or solanum species), cinchonaf,
poppy, ergot, digitalis, ipecac, dubosia (or atropa) species and lemon grass are the sources for essential drugs
identified by this Committee.
26. Five of the above plant materials, namely, pyrethrum, cinchona, poppy, ergot of rye and ipecac have been
and continue to be cultivated entirely by the various State agencies. Three groups of plant materials, namely, dio
scorea species and solanum khasianum, digital is and atropa species arc under various stages of cultivation (experi
mental-commercial) partly under State auspices and partly by the private sector industry.
27. Tea waste and lea dust arc obtained from privately owned tea plantations and rauvolfia, nuxvomica and
vinca are collected almost entirely from the areas where these grow naturally. Only marginal effort has been made
in the State sector for the experimental cultivation of glycyrrhiza. Lemon grass is wholly cultivated in the private
sector.
28. The relative importance of these plant materials needs hardly to be emphasized. These have been taken
note of by the NCST : the magnitude of needs of most of these for the future have been estimated and the area of
land and other facilities required for their economic cultivation have also been worked out and due recommendations
made by NCST.
29. This Committee is of the view that the biologically valuable materials derived from the above plant sources
are not likely to be replaced by any cheaper or less toxic substitutes in the foreseeable future. The Committee
therefore, strongly endorses the recommendations of the NCST in this matter. The NCST’s recommendations
(Annexure I) indicate a large layout of cultivable land for these plant materials. It is estimated that about 4400
hectares will need to be brought under cultivation, in stages, for pyrethrum, dioscorea, ipecac, ergot, atropa species,
glycyrrhiz, etc. It is necessary that acquiring land for this purpose, at the State level, should be appropriately in
corporated in the afforestation policies and land reforms by the State Governments.
30. The Committee feels that the existing area of 8,000 hectares available for cinchona plantation needs urgent
attention for improvement in the variety of the cultivated cinchona species (Java variety is reported to produce 16-17%
total alkaoids whereas the Indian variety produces an average of only 3.5-4% alkaloids), as also in the production
technology by the Governments of West Bengal and Tamil Nadu. It is necessary to expand this plantation to a
larger area. There is need for doubling the area for ipecac (productivity has gone down from 30,000 kg. of ipecac
and is reported to be 18,000 kg. at present) in West Bengal and of consolidating the existing areas under poppy in
the poppy growing States of U.P., Bihar and Madhya Pradesh and the processing of opium at the Ghazipur factory.
31. Technologies for the processing of the above plant materials for their respective end-products (except for
ergot and vinca for which active work is already a foot under the auspices of the CSIR) are all available though
there is need to streamline these processes for better economic productivity. The Committee notes that appropriate
technological skill for all these is already available in the country. While attributing the present shortfalls of pro
duction of the various products outlined above to inadequacy of effort in cultivation, the Committee feels that
if updating of production technologies had gone apace for the items already under production, and this was per
fectly possible within the country) the present production should have been much better.
58
r f tb2; In view of the vital and growing importance of the products derived from the above plant materials and the
sector entrepreneurs, m respect of cultivation, only for such plant materials as may produce the high activity
low bulk and high money value intermediates of final bulk drugs e.g. dioscorea species for the expensive steads’
items aref71so%^
eniOn
f°r Vltamm A’ Inc,dentalIy’ Iand requirements for these specific
.
3/‘-PrU?lS derj.ved froni 1?wer P,ants/micro-organisms and animal sources may be sub-divided into (i) anti
biotics (ii) products from animal tissues such as insulin, pancreatin, trypsin, chymotrypsin, etc. and (iii) immunologi
cal agents, namely, sera, vaccine, antitoxins and toxoids.
immunoiogi
34. Antibiotics account for the m>st imoortant products of this class. Licensed capacities as also production
of the more important antibiotics in 1972 and 1973 arc given in Annexures II and Ill. which also reflect the e£te
participated in the production of this antibiotic.
6 ^ajunty units naxe not
35. Licensed capacity for streptomycin (257 tonnes), in 1973 was shared between the public s-dor units (175
>
f •
o)anuthe
,lldian mojority units(82 tonnes, equivalent to 32%) - Foreign maio itv
umtb did not participate in the production of this antibiotic either.
7
s majority
f r 7n3t6‘ Llcensed caPacity for tetracyclines in 1973, which stood at a total of 149 tonnes, included licensed canacitv
for 70 tonnes of chlorotetracychne which was originally programmed for production in the public sector and
un-utihsed til! 197o. In effect, the total capacity for marketable tetracyclines stood at 79 tonnes of which capa^v
for 52 tonnes was in the public sector and 27 tonnes largely in the foreign majority units.
capacity
private7sectorI1Sed Capacity m 1973 for the Production of* chloramphenicol was 109 tonnes and lay entirely in the
>8' Tliepul’111; sectorP'‘oa'uced ab.out 137 MMU ofpenicillin accounting for about 61 % utilization of the licensed
XEld capanciSn
maJOnty Se°tOr PrOdUCed ab0Ut 111 MMU’ SCIuivalcn‘t0 about 79°o utilization
39. Production of streptomycin in the public sector amounted to about 96 tonnes equivalent to about 55O/
SKSSS’*' ”*ri “
. 'o
84re‘,rc”‘-
40. Public sector produced about 25.0 tonnes of tetracyclines and accounted for the utilization of about 48<’/
of its installed capacity for saleable tetracylcines (Its licensed capacity of 70 tonnes for the non-marketable chlorte’tracychne is not included in this calculation). The private sector, consisting very largely of foreign maioritv units
produced about 65 tonnes of tetracyclines representing 240% utilization of their licensed capacity.
’
41. Production... of chloramphenicol
.
.
,.
was entirely in the private sector and was of the order of 47 tonnes, representing about 43% utilization of the licensed capacity.
r
o
42. Annexure II shows that import for penicillin was negligible whereas there were substantial imports for the
other three antibiotics. These figures indicate that with near 100% utilization of licensed capacities, we should have
been able to meet and even exceed our present national needs for all these antibiotics.
43 Recent production figures of l.D.P.L. are indicative of the realization by this unit that with appropriate
care, utilization of the installed capacities can be materially improved. Over the 12 month period ending October.
1974. streptomv vbi production registered an increase of about 18% and that of tetracycline an increase of about 80%
compared with the corresponding production figures for the 12 month period ending October, 1973 (Annexure IV)
It is necessary that this unit should immediately utilize the 70 tonnes capacity, originally created for the production of
chlortetracycline, for the production of tetracycline and oxytetracycline.
■
59
44. In respect of other mijor antibiotics, namely erythromycin and ampicillin which were imported to the extent
h
of Rs. 1.6 crores in 1972-73 and more than Rs. 2.2 crores in 1973-74, the Committee is of the opinion that the public -sector units must undertake their production also. In respect of erythromycin, against a licensed capcity of 10 tonnes
in 1973, production amounted to about 3.0 tonnes, and for ampicillin, against a licensed capacity of 16 tonnes, a
beginning has now been made for its production by H.A.L. It is relevant to note that the public sector unit (HAL)
has been granted a capacity of six tonnes for erythromycin and 5 tonnes of semi-synthetic pencilfins including ampici
llin. It is understood that ID?L have included the production of erythromycin, ampicillin and deoxy-oxytetracycline
to the extents of 10, 10 and 5 tonnes, respectively, in their production programm-. Projections for erythromycin
and ampicillin requirements are 30 and 35 tonnes respectively for 1978-79 and 60 tonnes and 100 tonnes respectively
for 1983-84.
45. While reviewing the production programme of the public sector units producing antibiotics, the Committee
felt that there was considerable overlap in their spectrum of products and that this contributed to some extent to
their inability to concentrate and specialise on a given line of products. The Committee, therefore, feels that the
public sector units should divide, between themselves, the responsibilities for the production of individual items so
that they may attain the required level of specialisation and sophistication in the'T respective lines of effort. The
Committee hopes that this would lead to better economic working for the production of antibiotics in the public
sector units whereby each of the public sector units does not duplicate the production pattern of another unit, te-y
general, the narrow spectrum antibiotics such as penicillin, streptomycin, and pen'cillin derivatives, could be assigned
to HAL while broad spectrum antibiotics such as tetracycline, derivatives of tetracycline and other newer antibiotics
should be allocated to 1DPL.
46. The Committee notes that the present licensed capacity for the production of penicillin, streptomycin and
' tetracycline is about 660 tonnes (each MMU of penicillin is calculated to be equivalent io 0.7 tonne) and estima
ted requirements for 1978-79 amout to 1675 tonnes.
47. In view of the growing importance of erythromycin, semi-synthetic penicillin and deoxy-oxtetracycline
and the fact that the public sector units are already engaged in the production of penicillin and oxy tetracycline, tlie
starting materials for the two latter antibiotics, the Committee feels that even though these drugs do not
figure in the essential drugs list, the public sector must carry the major responsibility for the production of these
and other useful antibiotics as may appear in therapeutics from time to time.
4b. Drugs from natural sources include such important items as Vitamin Bl2, products derived from slaughter
house waste like insulin, pancieatin, trypsin, pepsin, etc., and immunological agents including sera, vaccines, antitoxins
and toxoids.
49. Vitamin B12 and some of the enzymes like diastase, amylase, lipase, cellulase, etc. belong strictly to the
class of essential materials that lend themselves to production involving fermentation processes. Of these, only
Vitamin Bl2 is listed in the essential drugs list and this is the major therapeutically useful item in this group. Vitamin
B12 is being produced indigenously and some capacity is at the moment available for diastase also Against a
total licensed capacity for Vitamin B12 of233 kg., production in 1973 was of the order of 179 kg Estimated require
ments for Vitamin B12 have been placed at 300 kg. in the year 1978-79 and 600 kg. in 1983-84. Considering the low
figure lor pi esent imports, it would seem that the installed capacity could, with appropriate planned expansion, meet
the national requirements.
50. Enzyme production has heavy economic implications outside the field of drugs and pharmaceuticals. The
Committee would like to stress the need for the creation of active centres for enzyme production to be preceded by
the setting up of a strong centre for R & D in enzymology and enzyme technology as recommended by the NCST.
The Committee does not, however, consider it necessary to make any specific recommendations in this regard because
the use of enzymes as drugs is only marginal.
ol. In respect ot slaughter house products e.g. insulin, pancreatin, trypsin, heparin, etc. effort at their production
is only m.trginal at present. Insulin is manufactured from imported pancreas in quantities of about 900 M.U.
against a licensed capacity of 1500 M.U. Estimated requirements are 3000 M.U. in 1978-79 and 6000 M.U in 1983
84. A joint team of scientists working under the auspices of CS1R and ICAR at the Vallabh Bhai Patel Chest Diseases
Research Institute, Delhi the Haftkine institute, Bombay and the Central Drug.Research Institute, Lucknow are
rigi now engaged in working out the production details and ecomonics of a process for the production of insulin
from sheep, hog and ox pancreas, ft is felt that since production of insulin and other slaughter-house waste products
is boun up with upgrading of abattoirs in the larger cities and because of the need to set up the primary extraction
units tor such products in the immediate vicinity of slaughter houses (the tissue degenerates rapidlv with time and must
becollectedand fiozenand preferably processed immediately afteran animal is slaughtered;' thisentire work of
development of these sensitLve products may be allocated to the Biochemicals units at S.V.P. Institute, Delhi
in collaboration with the Hafifkine Institute and other institutions where adequate scaling up facilities exist.
I
f
60
52. Sera, vaccines, antitoxins and toxoids are produced in this country in governmental institutions and in
the private sector (Annexure V). These include vaccines against samll pox, cholera, antitetanus serum and toxoid
antidiphtheria serum and toxoid and antirabic vaccine and triple antigen and oral polio vaccine etc. This Committee
feels that the institutional centres such as Haffkine Institute, Bombay, Central Research Institute, Kasauli, Pasteur
Institute, Shillong. King Institute, Guindy, Pasteur Institute, Connoor, Vaccine Institutes at Bangalore. Calcutta,
Shillong. Namkum. (Bihar), etc., and the private Indian units should be sterngthened to meet the domestic needs
and even for export in terms of the projections for the Fifth and Sixth Five Year Plan.
53. Synthetic Drugs represent today the king-pin of the entire drugs and pharmaceutical industry. Earliest
attempts to copy and then improve on nature launched the era of modern chemotherapy quite early in the history
of modern drug development. As distinct from products drawn from natural sources, the area of synthetics
provides the premise of possibilities of molecular design to combat the diverse variety of pathological conditions
with logic. Such possibilities of design can of course only follow, with a degree of certainty, the resolution of phy
siological and the corresponding pathological processes in specific molecular terms. Even though possibilities of
such molecular resolution lie right now in a twilight area because of inadequacies in the presently available experi
mental methods of molecular biology, some progress on correlation between molecular structure and physiological
acitivity, does permit a fair degree of logical approaches in chemotherapy. The spectacular array of synthetic drugs,
now available for the treatment of disease, dominate the entire spectrum of the means of treatment in modern therapy.
54. The simpler synthetic analgesics, hypnotics, antipyretics, antiprotozoal agents, etc., were followed by the
powerful antibacterial sulfa drugs and then came the whole variety of drugs effective on the diseases of. or closely
related to cardiovascular system, the central nervous system, hormonal imbalances, etc. And, today synthetic drugs
dominate the entire field of therapeutics and their role is bound to grow with advances in methods of experimental
molecular biology and chemistry.
55. Because of their vary nature, synthetic drugs are directly derived from fine chemicals industry
and depend for their production on a variety of chemicals, which arise in most cases, from down-stream
products of the chemical industry itself.
It is for this reason primarily that all
„.. over the world,
.
synthetic
drugs industry forms, in a high percentage of cases, a subsidiary of the organic chemical industrv.
56. In India, chemical industry is still at the stage of development.
postponed and production of synthetic drugs has to go on.
The need for drugs cannot, however, be
57. The Committee noted with satisfaction that in addition to HOC and IPCL, the recovery of chemicals from
coal tar at Durgapur had been undertaken on a fairly large scale. The Committee is of the opinion that appropriate
units for preparing basic intermediates from the down-stream products of the Durgapur Plant would help substan
tially in the setting up of a bulk drug manufacturing unit in the Eastern region. In the context that new units should
be established mainly on considerations of economic viability, Durgapur holds good promise.
' 58. The multi-national units of the drugs and pharmaceutical industry have dominated, in this country, in
the field of synthetic drugs and by far the largest component of their formulation activities lies in this area. Most
of these multinational units, both in the small and large sectors, have concentrated their activities on the products
marketed by their overseas parent organisations and have almost completely cornered the Indian market for their
respective products. They have also built up enormous markets on the sale of a large variety of other formulations
e.g. tonics, combinations of vitamins etc. Even where purely Indian units in the medium and' the small scale sector
produce equivalent formulations, they face the greatest difficulty in obtaining the relevant bulk drugs from the mul
tinationals, but more particularly in facing high pressure and costly sales practices of the latter.
59. In the last few years, there has been a further tendency in multinational units to introduce newer products
of similar activities with marginal differences. Since such products arc patented, they arc usually priced high and
allowed to be formulated for a period of 2 years by importing the basic bulk drug from their principals at a high
price. The Committee is of the opinion that while considering the licensing of the manufacture of new drugs, deve
loped abroad the main consideration should be that the proposed new drugs has distinct advantages over the exist
ing range of drugs. The Committee further recommends that the therapeutic character of such new drugs should
be scrutinised by a Committee of experts.
60. From the early days of our independence, the Government of India have been endeavouring io persuade
the multinational units to produce bulk synthetic drugs in this country and share these with other formulaters. Res
ponse of the multinationals during the earlier years wa$ negative, or, poor. However, in recent years some of the
multinational units did enter the field of bulk drug production obviously because of the emergence of the public
sector. Even so, they were usually, highly selective and chose low-tonnage, high money-value bulk items and started
to manufacture these, frequently from penultimate or near-penultimate intermediates imported, usuallv. from their
corresponding principals, at high costs. This position is only slightly better today.
61
61. As against the poor performance of multinational units in the field of bulk drugs, the effort of the private
Indian and Indian majority sector has been a great deal more impressive and satisfying. Some of these units sell
their entire production of bulk drugs to formulators or share these with other formulators. There are of course
several units in this sector also whose entire bulk drug production activity is limited for their captive use.
62. The Committee noted that when public sector entered the field of production of synthetic bulk drugs 1968, there was need to modify production technologies to conform to economic compulsions of a competing eco
nomy. The public sector has met this chellange effectively. They have revised the technology for their production
of almost all the products and worked out the technology for several other products. Their mitial licensed capacity
was rated to produce 851 tonnes covering 16 items. The revised licensed capacity for the production of 20 bulk
drugs stood at 1988 tonnes. In 1973. they produced 1212 tonnes of 17 bulk drugs (Annexure VI). Out of this pro
duction, the public sector distributed about 600 tonnes in 1973, to other formulators. This represent about 50%
of their total production of bulk drugs. This commendable performance of the public sector technologists is re
assuring. It is clear that technological competence has developed to an appropriate level in the public sector to
permit entrusting this sector with heavier responsibilities with confidence.
63. Formulation activity of synthetic bulk drugs production in the public sector has, however, been at a low
ebb. There is need clearly for the public sector to upscale this activity materially by increasing the range of
products to include injectibles, storile ointments etc.
f
64. This Committee has identified 44 drugs derived purely from synthetic sources, as essential drugs,
quirements of these essential drugs for the Fifth & Sixth Five Year Plan periods are given in Annexure VII.
Re-
65. Out of these 44 synthetic drugs, 7 are produced exclusively in the public sector and 6 others are produced
both in the public and private sector. Out of the remaining 31 drugs, 20 drugs are produced in varving quantities
in the private sector only. Licensed capacity and production figures for 1973 are also given in Annexure VII. These
figures reveal big gaps in the production of our present requirements of synthetic bulk drugs even though the licensed
capacities are substantially high. Furthermore, production of a fair number of these drugs is carried out at pre
sent from imported intermediates.
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66. As has been indicated earlier in this chapter, the public sector manufacture 13 out of 44 essential synthetic
drugs. These thirteen drugs formed the bulk of their production of 17 items which the public sector unit at Hyde
rabad produced in 1973. Quantities so produced are given in Annexure VI. The annexure also lists the projected
requirements of these drugs for 1978-79 and 1983-84 as estimated by the Task Force. Out of these 13 items, 7 items,
namely, Sulfadimidine, Vitamin Bl. Vitamin B2. Folic acid, Phenobarbitone/sodium, Analgin and Piperazines are’
being manufactured exclusively in the public sector and 6 items namely Nicotinamide, Thiacetazone, PAS, Parace
tamol, Sulfacetamide and Diethyl carbamazine citrate are also manufactured in the private sector.
67. Licensed capacity for the 7 essential items producted in the public sector is about 803 tonnes and total
production of these amounted to about 572 tonnes in 1973. Imports for these 7 items of 1972-73 stood at about
305 tonnes.
68. Projected requirement for 1978-79 for the production of these 7 items add up to 1683 tonnes and proposed
expansion programmes in the public sector for the production of these items is of the order of 1696 tonnes for 1978-
69. It would thus be clear that with full utilization of the existing and projected capacities, the public sector
would meet the entire projected needs, for these items of the country by 1978-79. Projected figures of the Task
Force, for these seven items for 1983-84 stand at 3383 tonnes.
70. The Committee recommends that the public sector must take the responsibility of expanding the produc
tion of these seven important drugs to meet the increasing requirements of the nation and free the country from
import of these drugs. It is clearly understood that this additional production representing over four-fold increase
over the present capacity during the next ten years, will need to be achieved by judicious expansion of the present
capacities and by setting up of new production units where necessary.
71. The Committee notes that out of the remaining six items, projected requirements for 1978-79 for Thiacetazone and Diethyl carbamazine citrate would be adquately met by the capacities already licensed for these two
drugs if the licensed capacities are fully utilized. The Committee recommend that first option for the production
of the remaining 3 items namely, Nicotinamide. Paracetamol and PAS, should be given to the purely Indian sector
and, if, however, it is found necessary, this may be shared between the public sector and the private'Indian sector;
the exact quantum of production of the individual items being determined by mutural consultation between the con
cerned public sector unit/units and the private Indian sector units. In respect of sulfacetamide, the Committee
feels that this drug should be produced in the public sector to meet the projected requirements.
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72. The Committee recommends that in addition to the above, the following eight drugs, appearing in the
essential drugs list and which are currently largely imported (Annexure VIII) should also be produced in the public
sector in quantities projected for the V & VI plan periods taking into account the quantities for which capacities
have already been licensed.
1. Nitrofurantoin, 2. Nitrofurazone, 3. Fursemide, 4. Pyridoxine
6. Phthalyl sulfathiazole, 7. Aminophylline, 8. Calcium pantothenate.
Hydrochloride,
5. Theophylline,
73. Public sector already holds letters of intent for the production of Nitrofurantoin, Nitrofurazone. Furse
mide, Pyridoxine hydrochloride. Calcium pantothenate, Phthalyl sulfathiazole, Aminophylline and theophylline
in quantities given in Annexure VIII.
74. The Committee understands that the public sector manufacturing units and national research laboratories
have already developed laboratory scale technology for the production of nitrofurantoin, nitrofurazone. fursemide
and pyridoxine hydrochloride and some of these technologies are in the test operation stage at the pilot plant level.
The Committee further understands that the public sector and a national laboratory (NCL) have the necessary
technology for the production of Phthalyl sulfathiazole, Aminophylline and Theophylline and a national laboratory
(RRL, Jorhat) had developed a laboratory scale technology for Calcium pantothenate. The Committee recom mends
that immediate steps be taken to coordinate the work already done on these drugs in the above mentioned /aboratories to upscale these processes through pilot plant and prototype large scale production within the next 24 months.
Should it be found necessary, for reasons of time, or if any of above technology is found not to conform to economic
working, the Committee recommends that such technology be imported by the concerned public sector unit on a
priority basis. The Committee also recommends that licences should be immediately given on a priority basis to
the public sector for import of raw materials for these drugs wherever import is necessary. In respect of Pyridoxine,
the Committee notes that the country is spending substantial foreign exchange. The Committee feels that it is neces
sary that the production of this important item should be expedited, particularly because of its short supply in the
international market. The Committee recommends that the available indigenous technology should be assessed
within the next six months by the concerned Ministry/NDA and necessary decision in respect of import, or other
wise, of the technology, should be taken as early as possible.
75. Metronidazole is being produced in a quantity of 7.7 tonnes against a licensed capacity of 0.6 tonnes from
the pentultimate imported 2-methyl 1-4-nitroimidazoIe in the private sector by a wholly foreian company against a
requirement of 33 tonnes as judged from the import figures of 25.5 tonnes in the year 1973-74. One Indian unit
holds a licence for the production of 4 tonnes but it does not appear to have started production so far. Projected
requirements of this drug stand at 50 tonnes for 1978-79 and 100 tonnes for 1983-84. The Committee'understands
that a public sector unit has completed the laboratory scale studies for its production starting from the basic sta^e
of glyoxal. The Committee recommends that the production of this important drug should be undertaken in the
public sector and high priority should be given to immediate upscaling of the laboratory process, and. if necessary
the relevant technology may be imported.
’
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76. Chloroquin is at present produced in the private sector in some quantity (about 15 tonnes in 1973) A
foreign unit and one Indian unit prepare it from the late imported intermediates’ wz.-7chIoro-4-hydroxvquinoline
and novaldiamine. Another Indian producer of this drug, however, produces it from the basic stage vi~ m-chloroaniline. The import figure of 99 tonnes in 1972-73 for this important drug emphasize the need of producing it
in the country from basic indigenous materials. Against a total licenced capacity of 40 tonnes available today
projected needs for 1978-79 are estimated at 150 tonnes and for 1983-84 this figure stands at 225 tonnes The Com
mittee is strongly of the opinion that while facilities should be provided to purely Indian units to reach their licensed
capacity for chloroquin, public sector must undertake its production in a big way and fulfil the targets for 1978-79
and 1983-84.
°
77. Against a licensed capacity of 294 tonnes for INH, production was of the order of 96 tonnes in the private
organised sector for 1973 and there were practically no imports. The rest Of the need was met by the small scale
sector. As at present, there would appear to be no need to create any additional capacity for the production of
INH.
78. Licensed capacities, actual production figures and imports, as in 1972-73, in respect of the 20 items produced
only in the private sector, at present, are shown in Annexure VII. Corresponding projected figures, in respect of these
items for 1978-79 and 1983-84 are also given therein.
79. Out of these 20 items, licensed and/or installed capacities of Methyl salicylate, Lignocaine, Dapsone
Vitamin D2. D3, Tolbutamide and Mephentermine sulfate approximate to the projected requirements for the year
1978-79, though actual production in several cases does not reach anywhere near the licensed capacity. There is
need that the licensees be required to work upto the licensed capacities. No additional capacities for these items
would be necessary at present.
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80. Halogenated-8-oxy-quinoIines, Acetyl salicylic acid, Pethidine and Vitamin C are also largely under-pro
duced at present (compared to the licensed/installed capacities—Annexure VII). Projected- requirements of these
drugs for 1978-79 and particularly 1983-84 are of the order of 200—300% of the presently licensed capacity. The
Committee recommends that expansion of production of these items, to conform to national requirements for 1978-79
and 1983-84 should be handled entirely in the public sector and the Indian-private sector.
81. There appear to be no, or in a few cases, small installed capacities for the production of the relatively
low-tonnage essential drugs, namely, Primaquin, Chloropromazine, Succinyl choline chloride. Thiopental, Adre
naline, Nor-adrenaline, Oxytocin, Chlorpheniramine maleate and hydrochlorthiazide. The Committee recom
mends that the items (some of these are highly technology intensive) should be produced in the public sector to meet
the national requirements. The Committee notes that ephedrine is being manufactured at present by a foreign unit
from imported phenyl acetyl carbinol in a quantity far short of their licensed capacity of 18 tonnes. The Committee
understands that a national laboratory (CORI) has evolved a fermentation process for the production of this inter
mediate and its conversion by synthetic methods into ephedrine. The Committee further understands that up
scaling of this work is being carried out in collaboration with an Indian unit in the private sector. The Committee
iecommends that in order to meet the estimated needs for 1978-79 of 49 tonnes, ephedrine hydrochloride may be
manufactured in the private Indian sector, who may also expand, if necessary.
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82. There are a number of other drugs, not included in the essential drugs list, that are either imported into
the country in fairly large quantities or are high sales items. These include sulpha-methoxazole, indomethacin,
ethamutol, diazepam,, chlordiazapoxide, secobarbitone, trimethoprim, methyl dopa, etc. The Committee is of the
opinion that whereas it is desirable that public sector units may participate in the production and formulation of this
class of drugs, production of each such item should however by examined on merits by N.D.A.
83. Raw materials and intermediates required for the production of essential synthetic drugs are dealt with in
Chapter VI. Recommendations of the Committee in respect of their production in various sectors of the industry
and also for their distribution are also given therein.
84. Existing and recommended capacites for the production of the essential synthetic drugs, identified by
the Committee for production in the public sector, are shown in Annexure IX.
85. The Committee recommends that at least 60% of bulk drugs produced by the public sector units should
be formulated by the public sector industry itself. In the disposal of the remaining 40%, first preference should be
given to meet the needs of the Indian sector particularly small -scale units.
86. In termsxjf the above recommendations, the public sector will be required to manufacture 34 items of bulk
drugs in quantities indicated against these for the Fifth Five Year Plan. It would be necessarv, of course, to make
allowance for setting up additional capacities.
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87. Seven items (Annexure IX—items I—7) which are produced only in the public sector at present and for
which the total licensed capacity is about 800 tonnes, will be required in quantity of about 1680 tonnes in 1978-79.
Production capacity for about 880 tonnes should be set up for these seven drugs.
88. For three drugs (Annexure IX—items 8—10) namely, Nicotinamide, Paracetamol and PAS, the present
licensed capacity in the public and the private sector, is 1335 tonnes and estimated requirement for the year 1978-79
is 2000 tonnes. As has already been recommended, the remaining about 665 tonnes of these three drugs may be
produced in the private Indian sector, or, shared between the private Indian sector and the public sectors. For the
purpose of the present calculations, it is assumed that 60% of the required additional about 665 tonnes, which is
equivalent to about 400 tonnes will have to be produced in the public sector. Requirements of the additional quan
tity of sulphacetamide (Annexure X—item 11) will be produced in the public sector.
89. Eight drugs (Annexure IX, items 12—19) for which the total licensed capacity in the country as on date
is of the order of about 57 tonnes are expected to be required in a total quantity of about 380 tonnes in 1978-79.
No figures have been estimated by the Task Force for nitrofurazone. Considering, however, that this drug is re
quired in small quantities, its requirement for 1978-79 is mostly estimated at 10 tonnes. The capacity to be set
up in the public sector, in terms of the recommendations made above, would add upto about 320 tonnes.
90. Annexure IX (items 20—34) lists the remaining 15 drugs for which the present total licensed capacity is
about 2210 tonnes. These are expected to be required in 1978-79 in a quantity of about 3520 tonnes. In terms of
the above recommendations, the balance of about 1310 tonnes should be met by the public sector.
91. This would mean that public sector will have to raise its capacity by about 3000 tonnes. It is estimated
that the public sector will require an additional outlay .of about Rs. 51.0 crores, in terms of the 1973 prices, to en
sure the production of the above 34 bulk drugs.
1—M of Pet. & Chem./75—9
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92. It has also been recommended above that the public sector should formulate 60% of its total production
of bulk drugs and this amounts to about 1800 tonnes. In terms of the 1973 prices, it is expected that to formulate
these 1800 tonnes of bulk drugs, the capital required for this formulation activity will be about Rs. 18 crores.
Problems of Public Sector and Recommendations
93. During the course of its visits to‘the public sector units, the Committee found that whereas one of the
unit (the Svnthetic Drugs Plant of IDPL) had made commendable progress, working of the two antibiotic-producing
units at Pimpri and Rishikesh needed immediate attention. The performance of HAL at Pimpn has been satis
factory except for a decline during the years 1972 and 1973, and their productivity had gone down inspite of the better
yielding strains and even, in many respects, better technology available to them. The"Rishikesh plant has yet to
make the srade—allowing even for the low yielding strains available to them. The Committee felt that there was
urgent need to bring home to the management and the technologists at both these plants that they could not be
allowed to function at their present low-level of productivity. The fact that the employees of public sector units
enjoy certain privileges, should make the employees more responsible in their work and behaviour. A spirit and
system of accountability to the industry and therefore to the nation must develop- from top to bottom. Moreover,
the management should see that the workers are increasingly involved in the functions and operations of the Public
Sector so that they feel that they are a part and parcel of the industry and management. Bureaucratic behaviour
at the top and irresponsible attitude at the lower level should be deprecated. This would generate a healthy indus
trial relationship which is the best way of increasing production.
94. The management should have a degree of freedom to act in every respect, subject to the overall super
vision by the Government/NDA and to the general guide-lines laid down from time to time in respect of Public Sector
Parliament being the supreme body has the right and duty to check up the activities of Public Sector.
95. In general, the Committee feels that the present structure need substantial changes so as to achieve the
objectives set for the public sector in terms of our socio-economic goals.
96. The Committee noted that even though the public sector had served to an extent to safeguard against
irrational pricing by the private sector, the existing system had not made material difterence in the pattern of either
the production or distribution of drugs which are at the moment governed largely by marketing mechanics. There
is need to revise these to conform to our social needs.
97. The Committee recommends that working of the public sector plants at all levels should be carefully
reorganised in respect of every step whether it involves purchase and standardization of raw materials, processing
of raw materials and production of bulk drugs or formulations, their storage and distribution, etc. The Committee
feels that there is need to attend immediately to removing all deficiencies in the plants. The Committee is also of
the view that with intelligent and devoted attention to detail, these deficiencies could be overcome without involving
heavy financial commitments. The Committee feels that each unit should operate strictly on economic basis.
98. The public sector units are facing difficulties in procurement of raw materials required for the production of
essential drugs. The Committee recommends that the raw materials and intermediates produced or manufactured
indhenouslv essentially those manufactured in other public sector units, e.g. H.O.C. and I.P.C.L., and such other
units as may come into existence hereafter, must be made available to the public sector engaged in drug production
on the basis of the highest priority. Auxiliary items such as rubber caps, glass ware and packaging materials should
also be available to these units on highest priority to make them more effective and efficient.
99 The Committee notes that both the units (IDPL & HAL) have fair sized R&D laboratories and that they
need to be strengthened. It is well known that for all R&D efforts, there is a lower critical minimum in men and
materials necessary to produce meaningful results. Whereas all the three laboratories at Pimpn. Rishikesh and
Hyderabad have some every competent scientists/technologists for their R&D effort, there is need to bring this num
ber up to a level of meaningful productivity. The Committee recommends that each one of these units should take
immediate steps to strengthen their R&D effort by reasonably liberal allocations in men, equipment and materials.
The Committee recognize that modern R&D. in this sophisticated field, is expensive in terms of investments. The
Committee, is however, convinced that a sound R&D base is the best insurance for the growth of the drugs and
pharmaceutical industry.
100. Besides recommending the strengthening-of R&D laboratories at each plant, the Committee is strongly
of the view that as between these three units, avoidable duplication of effort must be discouraged and the results
(even the raw research data) of each unit must be available to the related unit in other R&Dl^°ratones. This
recommendation is based on the philosophy that as between the two units in the public sector (IDPL & HAL) there
should be no secrets. Indeed, any improvements, in a strain, a process or a plant developed in the R&D laboratory
of one unit, should be freely available for the use to the other unit.
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101. The Committee further recommends that both the public sector units must establish the closest liaison
with the other R&D laboratories such as the CSIR, ICMR, ICAR, etc., and the State institutions like the Haffkine
Institute, the IITs, Universities, etc. The Committee feels that such coordination is vital for development. The
Committee cannot but emphasise the need for such coordination by NDA. The Committee recommends that appro
priate facilities should be created in the identified institutions, wherever necessary, to permit time-bound completion
of individual projects.
102. The Committee wishes to emphasise that the primary task of the R&D laboratories of the public sector
units and their associates should be to constantly upgrade technologies for achieving greater economics in the pro
duction of on-stream products and innovate technologies for products proposed to be manufactured in the imme
diate future.
103. The Committee recommends strongly that the Public Sector should set an example in respect of R&D
in this area and must, to begin with, set aside at least 5% of their net turn-over for this purpose.
104. To enable the pharmaceutical industry in general, and the public sector in particular, to fulfil its objectives,
it is essential that equipment, instruments and appliances of high precision should be made available to them expedi
tiously. The Committee notes that there has been commendable progress made in the manufacture of such equip
ment by private sector, particularly in Gujarat, Maharashtra and West Bengal. A number of firms are manu
facturing sophisticated equipment of desired specifications. The engineering and designing units deserve encourage
ment from the public sector units.
105. In respect of such essential technologies, or the high yielding strain > of antibiotics producing micro
organisms as may not await indigenous development, for economic reasons, the best available technology, or anti
biotic producing microbial strains, mus. b; purchased on the following terms :
(i) The technology or an antibiotic producing microbial strain should as far as possible, be the best available
in the world market.
(ii) The technology, or an antibiotic producing microbial strain, should be purchased centrally so that it is
available to all the concerned units in the public and to such other units in the private sector, as the Go
vernment/NDA may identify in national interests.
(iii) Import of technology must not be linked up with import of machinery.
(iv) The technology or an antibiotic producing microbial strain may be1 purchased on the basis of one-time
lumpsum payment or, where necessary, on the foliowig terms.
(a) Royalty payment for a period not exceeding 5 years which may vary between 2—5% of the net sale
value of the bulk drug, the quantum being dependent upon the essentiality of the drug and the intri
cacies involved in the manufacturing technology.
(b) Lumpsum payment, to be made in instalments; the final payment to be made only after successful
implementation of commercial production in India.
The public sector is today poised to absorb any imported technology and then improve it through R&D.
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106. Under Section 100 of the Patents Act, 1970, it is stated that the Central Government and any person
authorised in writing by it, may use a patented invention for the purposes of the Government. Use for the purpose
of the Government has been defined in Section 99 of the said Act to include the making, using, exercising or vending
for the purposes of the Central Government, a State Government or a Government undertaking. Government
should, therefore, under the powers vested in it, permit the public sector undertakings to use the inventions for the
purposes of the Government. The effect of this will be that the mere fact that a patent has been filed or—a patent
has been granted will not debar public sector undertakings from manufacturing and distributing the products so
patented. The Committee feels strongly that allowing the freedom to the public sector units to use desirable patents
would not only constitute an exciting"challenge to the scientists and technologists, to innovate and establish, pro
duction technologies, ordinarily forbidden to them by patent laws, but also would obviate payment of high royalties
for really worthwhile patents.
107. The Committee recommends that early steps may be taken, with a time bound programme to expand
capacities where possible and instal new capacities when necessary for enabling the public sector to fulfil the produc
tion obligations incorporated in the recommendations of this Committee. The Committee is of the opinion that
while planning these additional tasks due care should be taken that location of sites for new units for bulk drug pro
duction is dictated by reasons of economy. This must of course be done in the overall context that within the desired
constraints of economic functioning, there is, as far as possible, reasonable dispersal of the new units in different
regions of the country. As an example, it has been suggested elsewhere in this chapter, that a unit for bulk drugs—
production requiring large bulk volumes of chemicals arising from products of coal tar distillation may be set up
around the Durgapur complex.
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108. The Committee also recommends that wherever possible public sector units for drugs and pharmaceuticals
should also produce bulk intermediates which may not either be produced indigenously or may be produced in
insufficient quantity. The Committee notes that ordinarily it is not feasible for any country to produce all the bulk?
drugs and intermediates that it may need. It is however necessary and wise that such dependence is reduced to the
£/
minimum.
109. The Committee recommends that additional formulation units be set up in the country immediately.
One such unit is recommended to be set up in the Eastern Zone by developing M/s. Smith Stanistreet and Co. Ltd.,
which is at present being managed by IDPL. The Committee recommends that this unit be now taken over by
IDPL. While making this recommendation, the Committee recognizes the limitations of Smith Stanistreet in the
shape of old and outdated plant. These limitations will need to be met by preferably transferring the availableassets to a new site and starting a modern formulation plant. The Committee feels that the proposed and the exist
ing formulation units should feed groups of neighbouring states. Eventually, there will be need to set up a formu
lation unit preferably in each State.
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110. The Committee recommends that distribution systems in the public sector should make use of uncon- ,
ventional agencies such as primary health centres, panchayats, dispensaries, post offices, petrol and kerosene~salesdepots, etc., for the distribution of household remedies. The Committee recognized that logistics of a wide distri
bution system of this nature will have to be worked out carefully by NDA. The Committee feels that there is need
to evolve a wide distribution system suited to our own socio-economic ecological conditions. Marketing arrange- /
ment of the products of public sector is week. They should pay greater attention to the maintainance of close liaison )
with the medical profession.
J11- The Committee feels that all the pharmaceutical public sector units now in existence should have strong
boaids of directors consisting of more non-otneial membersincluding academicians, technologists, management ex
perts and representatives ot workers employees. This board should supervise a functional whole-rime internal
board consisting of the Managing Director, (ii) a Finance Director, (iii) a Technical Director, (iv) a Commercial
Du ecto i, (v) a R.&D Director, (vi) a Planning and Public Relations Director. The Committee also recommends
that each individual unit should have a similar functional board, headed by the general manager of the unit for
conducting the affairs of the unit.
SUMMARY OF RECOMMENDATIONS
(1) With a view to streamlining the operations and achieving the basic objectives of producing and distribu
ting essential drugs to the largest number of people as economically as may be possible, the Committee recommends
the establishment of a National Drug Authority (NDA) which will also lay down and co-ordinate the policies.
(Chapter—111. Para. 5)
(2)^ in appreciation ot the fact mat ill-health has major socio-economic implications, the Committee feels that
in a welfare state, availability of prophylactics and curatives should receive the highest priority on par with food and
s.ielter. Production and distribution ot drug^ shculd, therefore, constitute an important social resposibility of the
state.
The Committee is of the opinion that trade aspects of this vital industry should be divorced from the ordinarily
accepted^principles of trade tor profit. Indeed, the Committee feels that trade aspects in this field should be limited
only to the extent that the industry generates resources for its own growth and expansion through R & D, where
necessary., to meet the increasing needs of the nation.
In order to achieve the above objectives, the Committee feels that leading role for production and distribution
of drugs and pharmaceutiGals should vest with the State. The Committee makes the following recommendations
tor providing to the public sector a leading role in the production and distribution of essential drugs and pharmaceutiCHIS.
The public sector should be given the major role for the production of capital and technology intensive bulk
drugs such as are needed in high tonnage quantities and where large scale production would be economically ore.ferable.
(Chapter—111. Para. 6).
i
67
h
Q) The Committee feels that the basic data used by the NCST and the Task force appointed by the Planning
Commission conforms to the existing pattern of market needs rather than the social needs of the country. There is
urgent need to institutionalise data collection and base the national production targets in terms of the needs identified
by such a system. The Committee also emphasise the necessity of fixing growth target and judging the growth rate
in terms of individual quantities.
(Chapter Ill. Para
9)
(4) It is essential that raw miterials for the production of bulk drugs arising out of the effort of either the public
sector or the private sector units should meet the priority needs of the bulk drug industry.
(Chapter 111. Para 11)
(5) In the order of importance, the Committee has identified 14 plants having medicinal value, out of which 8,
namely, dioscorea species, cinchona, poppy, ergot, digitalis, ipecac, dubesia (or atropa), and lemon grass are
the sources for essential drugs identified by this Committee.
(Chapter III. Para 24 & 25)
(6) The Committee strongly endorses the recommendations of the NCST for increased cultivation of the 14
plant materials and also production of active Principles obtainable therefrom with updated technology.
(Chapter 111. Para 29 & 30)
(7) In view of the vital and growing importance of the drugs derived from the identified plant materials, cul
tivation of these plants, which is technology, finance, and labour intensive, should be taken up in a determined and
business like m inner under the public seotor/joint sector.
(Chapter 111. Para
32)
(8) 1DPL should utilize the capacity that was originally created for the production of chlor-tctracycline, for
the production of tetracycline and oxy-tetracycline.
(Chapter Ill. Para 43)
(9) Although such antibiotics as Erythromycin. Ampicillin etc. have not been identified as essential drugs,
the Committee feels that it may be desirable to produce these in the public sector because of their heavy imports.
Ampicillin in Deoxy-oxytetracycline may be produced in the Public sector particulary because the starting material
for ampicillin and deoxy-oxytetracycline are already being produced in the public sector.
(Chapter Ill. Para 44 & 47)
(10) Public sector units should between themselves’ divide the responsibilities for the production of in
dividual items so that they may attain the required level of specialisation and sophistication in their respective lines
of effort.
(Chapter ill. Para 45)
(11) The Committee stresses the needs for the creation of active centres for enzyme production to be preceded
by the setting up of a strong centre for R & D in enzymology and enzyme technology.
(Chapter III. Para 50)
(12) Considering the importance of insulin production and utilization of the products available from the slaughter
houses, the work of development of the sensitive items may be allocated to the bio-chemical units at S. V. P.
Chest Institute, Delhi, Haffkine institute Bombay and other institutions like CDR1 where facilities for such work exist.
(Chapter 111. Para 51)
68
(13) The production of immunological agents at the State-owned institutions and in the private Indian Sector
should be upsexled and streamlined to miet the needs of the country and also for exports.
(Chapter 111. Para 52)
(14) The Committee noted that recovery of chemicals from coal-tar distilation prod ucts has been undertaken
at Durgapur on a fairly large scale. New units should be established for the manufacture of bulk drugs at Durgapur
to utilize the available downstream products.
(Chapter 111. Para 57)
(15) While considering the licensing of new drugs manufactured abroad, the main consideration should be
that the proposed new drugs have distinct advantages over the existing range of drugs, for which therapeutical charac
ter should be scrutinized by a Committee of experts.
(Chapter 111. Para
59)
(16) Public sector has developed technological competence in the field of synthetic drugs and can be entrusted
with the heavier responsibilities with confidence.
(Chapter 111. Para 62)
(16A) The Committee has identified 44 drugs derived purely from synthetic sources as essential drugs.
(Chapter Ill. Para 64)
(17) The public sector should take the responsibility of expanding the production of analgin, piperzine, pheno
barbitone, sulphadimidine, folic acid, vitamin Bl. and vitaman B2, upto the quantities envisaged for the Fifth and
Sixth Plan periods.
(Chapter 111. Para 70 & 87)
(18) The Committee recommends that the first option for the production of nicotinamide, paracetamol,
and PAS salts should be given purely to the Indian sector and if necessary, their production may be shared with
public sector, la respect of sulphacetamide. the increased requirements should be met by the public sector.
(Chapter 111. Paras 71 & 88)
(19) The following-eight drugs, appearing in_.th£.Lejise.niial.drttgs_listmnd which are currently largely imported,
should be produced in the public sector in quantities projected for the Fifth and Sixth Plan periods, taking into account
the quantities for which capacities have already been licened :—
1. Nitrofurantoin
2. Nitrofurazone
3. Fursemide.
4. Pyridoxine Hydrochloride
5. Theophylline
6. Phthalyl sulfathiazole
7. Aminophylline
8. Calcium pantothenate
(Chapter 111. Paras 72 & 89)
(20) Immediate steps should be taken to co-ordinate the work already done in respect of developing production
technologies of the eight drugs mentioned in 19 above, in the National laboratories and the Public sector, to upscale
their processes through pilot plant and proto-type large soale production within the next 24 months. If technology
for any of the above drugs is found not to conform to economic working, such technology should be imported by the
concerned public sector unit on priority basis. Licences for import of raw materials for thes: drugs, wherever
necessary should also be given on a priority basis.The Committee feels that the production of Vitamin B6 in particular
should be expedited and recommends that the available indigenous technology should be assessed within next six
-
*■>***’
.
■
69
months by the concerned Ministry/NDA and necessary decision to import or otherwise of the technology should be
taken as early as possible.
(Chapter-Ill. Para 74)
(21) Production of Metron-dazole should be undertaken in the public sector and high priority should be given
to upscale the laboratory process and, if necessary, the relevant technology may also be imported.
(Chapter-Ill. Para 75)
(22) While facilities should be provided to purely Indian units to reach the licenced capacity for the production
of Chloroquin, public sector should also undertake its production in a big way and fulfil the targets for 1978-79 and
1983-84.
(Chapter-Ill. Para 76)
(23) No additional capacities for the manufacture of Methyl salicylate, Lignocaine, Dapsone Vitamin D2/D3,
Tolbutamide and Mephentermine sulfate would be necessary at present and the existing licence-holder should be
asked to work up to the licensed capacities.
(Chaptci-III. Para 79)
(24) Expansion in the capacities for Halogenated-8-oxyquinolines, Acetyl Salicylic acid. pethidine,
aspirin, and vitamin C should be handled entirely between the public sector and Indian units to meet the national
requirements.
(Chapter-Ill. Para 80)
(24) Public sector should also take up the manufacture of Primaquin, Chlorpromazine, Succinyl choline chloride
Thiopental. Adrenaline, Noradrenaline, Oxytocin. Chlorpheniramine moleateand Hydrochlorthiazide. The Committee
also recommends that Ephedrine should be manufacture in the Indian sector and the Indian sector should be given
the necessary licence to produce such quantity as may be required for the V & VI Plan Period.
(Chapter HI. Para 81)
(26) The Public Sector miy produce sulphaemetheoxazole, indomethacin, ethambutol, diazepam, chlordiaze
poxide, secobarbitone, trimethoprim and methyl dopa etc., which are currently
ntly largely imported.
(Chapter-111. Para 82)
(27) At least 60% of the bulk drugs produced by the public sector should be formulated by the Public Sector
Industry itself. In the disposal of the remaining 40%, first preference should be given to the Indian sector, particularly
the small scale sector units.
(Chapter-111. Para 85)
(27A) The public sector should be required to manufacture 34 items of bulk drugs in quantities indicated against
these for the Fifth Five Year Plan by setting up additional capacities.
(Chapter-111. Para 86)
(28) To ensure the production of 34 bulk drugs in quantities indicated in these two paras, the public sector will
require an outlay of Rs. 51 crores in 1973 value of the rupee. For formulating, 60% of their total production of
bulk drugs, they will require another about Rs. 18 crores at the 1973 value of rupee.
(Cpahter-lII. Para 91-92)
(29) Healthy industrial relation at all points in the production and management of the public sector should be
developed to achieve the desired results.
(Chapter-111. Para 93)
(30) The management should have a degree of freedom to act in every respect subject to the overall supervision
by Government/NDA.
(Chapter-Hl. Para 94)
(31) The present system of production and distribution of drugs needs revision to conform to our social needs.
(Chapter-Ill. Paras 95-96)
7Q
(32) Working of the public sector plants at all levels should be carefully reorganized in respect of every step
including purchase and standardization, production of bulk drugs and formulations, their storage and distribution
etc. Each unit should operate strictly on economic basis.
(Chapter-Ill. Para 97)
(33) Raw materials and intermediates produced or manufactured indigenously in the Public Sector and such
other units which may come into existence hereafter should be made available to the Public Sector units engaged in
drug production on the basis of highest priority.
(Chapter-Ill. Para 98)
(34) The R & D Laboratories of all the Public Sector drug manufacturing units should be strengthened im
mediately by reasonably liberal allocations in men. equipment and materials. A sound R & D base is the best in
surance for the growth of the drugs and pharmaceutical industry.
(Chapter-Ill. Para 99)
(35) Avoidable duplication of R & D efforts must be discouraged and the results available at each unit must
be made available to the other related unit. There should be no secrets between the Public Sector units. Any im
provement in a strain or a process or a plant developed in the R & D laboratory of one unit should be freely
available for use by the other units.
(Chapter-111. Para 100)
(36) Public Sector units must establish the closest liaison with the other R. & D laboratories of the Natioaal
Laboratories, State Institutions and other Educational Institutions under the supervision of NDA. Appropirate
faclities should be created in the identified institutions wherever necessary, to permit time-bound completion of
individual projects.
(Chapter-Ill. Para 101)
(37) Public Sector should set an example in respect of R & D activity in the drugsfield and to begin with should
set aside at least 5 % of their net turn-over for this purpose.
(Chapter-Ill. Para 103)
(38) Public Sector should engage the indigenous engineering and designing units to meet their requirements
of equipments, instruments and appliances of high precision.
(Chapter-Ill. Para 104)
(39) To achieve increased production of Antibiotics expeditiously high yielding strains of micro organism and
the associated balancing technology should be allowed to be purchased as per conditions mentioned in para 105.
(Chapter-Ill. Para 105)
(40) Public sector units should be allowed to use the Patents/invention as permissible under Section 99 and
100 of the Patents Act 1970.
(Chapter-Ill. Para 106)
(41) Early steps should be taken, with a time-bound programme to expand capacities and also instal new capa
cities, wherever necessary, to enable the Public Sector to fulfil the production obligations as recommended by this
Committee.
(Chapter-Ill.
Para 107)
(42) Wherever possible Public Sector units should also produce bulk intermediates.
(Chapter-Ill, Para 108)
71
1
(43) Additional formulation units should be set up in the country immediately. M/s. Smith Sanistreet, which
is presently managed by IDPL should be taken over by IDPL and strengthened and converted into a modern pharma
ceutical unit.
(Chapter-Ill. Para 109)
1I
(44) Distribution systems in the Public Sector should make use of unconventional agencies such as Primary
Health Centres, Panchayats-Dispensaries, Post Offices, Petrol and Kerosene Sales Depots, etc. for the distribution
of house-hold remedies. There is need to evolve a wide distribution system suited to our own socio-economic, eco
logical conditions.
(Chapter-Ill. Para 110)
(45^ All pharmaceutical units in the Public Sector should have strong Boards of Directors as indicated in para
111.
(Chapter-Ill. Para Hl)
I
J
ADDITIONAL RECOMMENDATIONS AND SUGGESTIONS
(1) Items which are part of the approved production programme of public sector units or items in respect of
which public sector has the capacity to produce should ordinarily not be licensed to private sector units. How
ever, in order to ensure that such a reservation of items does not result in shortages, or increased need for imports,
an annual implementation programme should be drawn up in the first quarter of the calender year. This programme
will have to be kept under review; and on the basis of such a review twice a year, appropriate adjustments should be
made in the items to be licenced to units outside the public sector.
(2) Capital requirement for achieving the targetted figures for 1978-79 both for bulk and formulation (60 % of
bulk) production of antibiotics is estimated at Rs. 15 crores in terms of 1973 prices.
(3) The Public sector may farm out to the purely Indian sector, particularly the units run by technocrat entre
preneurs, its needs for relatively low-cost tonnage intermediates. And, for this public sector should accept the res
ponsibility to provide the basic technology to the entrepreneurs.
i
J
■
(4) The public'sector should be so planned that its constituent units for bulk production of basic drugs and
their intermediates are set up in different parts of the country' subject to the desirability of centralizing single-raw
material or single/similar technology fine products at one place for reasons of economy; the choice oflhe site for a
unit being dictated only by economic compatibilities.
(5) The State Governments and the Government of India should obtain all the governmental and corporation
needs of such of the drugs as are produced in rhe public sector from this sector at prices that may be fixed by a body
of cost accountants, in consultation with the concerned public sector unit and the BICP. The ruling principle for
determination of prices should be that the drugs must reach the largest number of people and profitability should be
limited only to ensure progressive growth of the industry for meeting the increasing needs of the nation, with its own
resources.
(6) The existing public sector units should consolidate their technological gains and give first priority to the
expansion of production of the items for which they have the necessary know-how skills. The magnitude of this
expansion should be limited only by the magnitude of the estimated national needs in the next ten years. Simultane
ously efforts must be made to improve, by innovation, the technologic or such other products as may already be within
the production programmes of the public sector units and for which the present technologies need improvement.
(7) Urgent steps should be taken to ensure employment of competent technologist and management experts
and provide necessary in-job training facilities for different cadres.
Constant appraisal and updating of the economics of in-plant operations as also of management procedures
and practices and speedy implementation of improvements, as and when these occur, should be assured at both the
plant and management levels.
(8) In respect of the import of technologies concurrent purchase of equipment should be avoided. In every
case of import of technology, the R & D units of the industry, and their collaborators should be associated from the
very beginning. This would ensure that sophistication from the stage of import upwards may be brought about
indigenously. Each imported technology should be freely available to all the relevant public and'lndian sector units.
1—M of Pet. & Chem./75—10
V
I
ANNEXUREI
RECOMMENDATIONS OF NATIONAL COMMITTEE ON SCIENCE AND TECHNOLOGY ON CULTIVATION
OF MEDICINAL/INSECTICIDAL PLANTS
(Chapter III—Para 29)
Name
Estimated demand
Present production
Present imports
Plant part Product
(tonnes)
Total
Plant
(tonnes)
Active
material
(tonnes)
Quantity
(tonnes)
Cost
Land
needed
(lakhs)
for cul
tivation
(ha.)
2
3
4
5
6
7
1. Chrysanthamum (Cinararifolium) .
300
3T
25
20
NA
1000
2. Dioscorea species .
3. Atropa belladone & A. acuminate .
4. Claviceps purpurea
500
70
25
25T
800 Kg.
500 Kg.
250
10
Experi
mental
8
0
NA
7
3.5
(1965)
0
NA
15.1
5. Glycyrrhiza
6. Cephaelis epecacuanha .
7. Papaver somniferum .
1000
8-10
3500
5
600 Kg.
3000 Kg.
14
1200
NA
1000
1
2.0
8
7.17
400
200
600
4400
72
ANNEXURE II
LICENCED CAPACITY, PRODUCTION AND IMPORT OF ESSENTIAL AxNTIBIOTICS
(Chapter III - Para 34)
1972
1973 1972-73 Value
Qty.
in Rs.
lakhs
SI. Name of the antibiotics
No
Unit
Licenced
capacity
as on
1-12-74
1. Penicillin .
2. Streptomycin .
3. Tetracyclines .
4. Chloramphenicol
MMU
Tonnes
364.0 230.15 274.52
257.0 199.11 179.85
148.5 73.30 90.27
108.8 41.06 47.19
I
73
Estimated De
mand
Imports
Production
9.9
99.2
22.0
102.0
12.0
137.0
90.1
141.0
1973-74 Value
In Rs.
Qty.
lakhs
0.5
51.9
54.2
64,9
0.7
63.4
74.2
86.5
1978-79 1983-84
780.0
825.0
303.0
390.0
1560.0
1650.0
556.0
780.0
h
ANNEXURE III
Licensed Capacity and Production of essential antibiotics by individual units
(Chapter III - Para 34)
Production
SI Product
No
1. Penicillins
2. Streptomycin
3. Tetracyclines
4. Chlorainohinicol
Manufacturer
1. I.D.P.L.
2. H.A.L.
3. Alembic Chemicals
4. Standard Pharm.
1. I.D.P.L.
2. H.A.L.
• 3. Alembic Chemicals
4. Synbiotics
1. I.D.P.L.
2. Cyanamid
3. Pfizer
4. Svnbiotics
5. H.A.L.
1. Dey Se-Chem
2. Boehinger Knoll
3. Parke Davis
4. Mac Labs
5. Themis
Unit
Licenced
capacity
as on
1-12-1974
1972
1973
M.M.U.
140.0
84.0
100.0
40.0
54.21
84.56
43.43
47.96
56.23
80.65
57.71
52.93
Total
364.0
230.15
247.52
Tonne
85.0
90.0
20.0
30.89
24.50
71.90
71.23
1.66
62.0
1.40
94.92
Total
257.0
199.11
179.85
Tonne
120.0*
10.0
14.0
3.0
17.50
15.49
36.59
3.72
25.21
18.30
39.72
7.04
94.27
1.5
82 46
Total
148.5
73.30
Tonne
53.0
30.0
20.0
0.8
5.0
28.66
9.70
2.70
11.79
108.8
41.06
47 19
Total
15.35
19.58
0.47
‘lae'.i les 73 T of Chlor tetracycline which is not biing produced.
o
cP
74
3!C’
-lth CELL
V
Kor a^ng3/a
-
ngalcfQ-56QQ^ .
/ndia
ANNEXURE IV
Comparative Production of I.D.P.L. during the year October 1973 and October 1974.
(Chapter III— Para 43)
Production of IDPL
SI.
Product
Unit
No.
1
Nov. ‘72
Oct. '73
2
3
1. Penicillin
2. Streptomycin
3. Tetracyclins.
MMU
Tonnes
Tonnes
xNov. ’73
Oct. ’74
I
5
65.22
63.65
46.23
39.60
38.69
22.11
r
75
I
ANNEXURE V
Manufacture of Sera Vaccines
(Chapter III—Para 52)
Manufacturing Units—
(a) Government Units
(b) Private Sector Units.
(2)
(1)
1. Central Research Institute, Kasauli.
1. Biological Evans.
2. Haffkin Institute, Bombay.
2. Glaxo Laboratories.
3. Pasteur Institute, Shillong
3. Bengal Immunity.
4. Bovincial Hygiene Institute, Lucknow (U.P )
4. Curewell.
5. Vaccine Institute, Belgaum.
5. B.C.P.W.
6. Vaccine Depot, Shillong.
6. Chowgule.
7. Duphar-Interfran.
7. Govt. Vaccine Depot, U.P.
8. South India Research Instiute Pvt. Ltd.
8. M.P. Institute, Nagpur.
9. Public Health Lab.
Travancore-Cochin.
♦9. Vaccine Institute, Baroda (S.S.).
10. Vaccine Institute and Lab. Calcutta.
♦10. Serum Institute of India, Poona.
11. King Institute, Guindy.
.11. Vaccine Institute, Nagpur.
♦12. West Bengal Vaccine Institute, Calcutta.
12. Vaccine Institute, Bangalore.
13. Vaccine Institute, Namkarim*
14. Public Health Central Labs.,* Hyderabad.
♦to be added to Govt. Sector.
15. Public Health Institute, Bangalore.
16. Lymph Depot, Gwalior.
17. Pasteur Institute. Coonoor.
18. Drug Research Lab., Jammu.
Actual Production (1972)
Types
(2)
(3)
894 Mega Units.
16091 Mega Units.
N.A.
. N.A.
. N.A.
. N.A.
4000 Mega Units
30000 Mega Units.
20 M. doses
66 M. doses
20 M. doses
32 M. doses
(1)
Diptheria AT
Tetanus AT
DTP (Triple Antigen)
BCG. Vaccine .
Polio Vaccine .
Tetanus Toxiod
Targets (fifth Plan) (1978-79)
.
.
76
*
ANNEXURE VI
Details regarding the Licence capacities, Production in 1973 in Public Sector and the targets suggested by the Task Force.
(Chapter III—Para 62)
(In Tonnes)
Demand Target by
SI.
No.
Name of the Product
Original
Licenced
capacity
(1)
(2)
(3)
(4)
40
40
1. Amidopyrine
Present Letter of Production 1978-79 1983-84
Licenced Intent for
in
capacity addition
1973
capacity/
as on
31-3-74 Expansion
(5)
(6)
(7)
(8)
2.86
20
40
400
800
2. Analgin
10
160
240
186.72
3. Phenacetin .
100
350
50
85
500
800
50
50
65
66.53
118
230
5. Diethyl Carbamazine Citrate
30
30
45
95
6. Isoniazid
20
20
265
530
7. Acetazolamide
25
25
34
70
.4. Piperazine salts
.
8. Phenobarbitone and Sodium salt
10
15
15
9. Sulphacetamide and Sodium salt .
50
50
30
0.80
80
160
10. Sulphadimidine and Soidum salt
280
500
500
328.81
1010
2020
133
145
11. Sulphaguanidine .
12. Sulphanilamide
.
.
.
.
.
.
.
9.18
130
250
265.97
50
150
71.88
13. Folic acid ....
1
3.5
14. Nicotinamide
20
20
15. Vitamin Bl and derivative
30
16. Vitamin B2 and derivative
5
4
2.12
7.5
15
14.92
600
1200
60
60
27.39
103
200
15
9
1.21
24
48
17. Paracetamol
85
403
833
18. PAS and its salts .
150
250
135.93
1333
1233
19. Sulphamethizole . '
5
7
1.26
12
23
20. Sulphacetamide Phthalyl
1
21. Allopurinol
10
1.41
2
77
r
78
i
3
2
4
r
5
6
7
8
5
8.71
70
140
22 Thiacetazonc.
23 Deallyl barbitone
10
24 Secobaroitone
10
20
40
25 Sulphadimethoxine
30
30
55
26 Sulphaphenazole .
50
180
350
50
50
100
28 Nitrofurantoin
10
45
90
29 Nitrofitrazone
1
5143.5
9151
27 Pyridoxine Hel
.
Total
-tfaa—
■ - 'TmtirTiiirrri-*'-—"i——nnr-rr-~A“' ■■
851
1988.5
1398
1212.52
/
ANNEXURE VII
Licensed Capacity, Prcduction, Impartsand Targets of essential Synthetic Drugs
(Chapter III—Para 65)
(Qty. in Tonnes)
■-y
SINo-
1
Estimated Targets
Production Total
Licenced
Total
capacity Production in Public Imports
Sector
1972-73 1978-79 1983-84
as on
in 1973
Nov ’74
Item
4
2
3
1. Acetyl Salicylic Acid ....
2. Analgin
.....
3- Adrenaline
.....
4- Halogenate j-8-Hydroxy Quinoline .
5- Chlorpheniramine
....
6. Chlorpromazine
....
7. Calcium-pentothenate* ....
8. Chloroquin saltes
....
9- Dapsone
10, Ephedrine Hydrochloride
11- Fursemide
.....
12. Hydrochlorthiazidet
....
13- Isoniazid
14- Lignocaine Hcl
....
15. Methyl salicyate
....
16- Mephcnteramine Sulphate .
17. Metronidazole
....
18. Nitrofurantoin
....
19. Nitrofurazone
....
20. Nicotinamide
21. Oxytocin
22. Pethidine .
.
....
23. Par
....
24. Phthalyl S-ilphathiazole
25. Piperazme & Salts
....
26. Para-amino-salicylic acid (Sodiu m)(PAS) .
27. Primaquin Diphosphate
28. Phenobarbitone & its Sodium Salt
29. Pyridoxine Hydrochlorid e
30. Sulphadimidine & Sodium Salt
31. Sulphacetamide & its Salt
32. Succinyl Choline Chloride .
33. Tolbutamide
34. Thiacetazone
35. Theophylline
1360
160
0.048
427.4
2.5
5.0
40
17.7
18
1.2
5.50
293.5
3.0
250
3.6
4.6
12.0
4
224.3@
136.72
142.69
0.021
4.81
0.05
19.20
2.73
0.60
15.20
8.16
4.47
0.17
99.33
.63
14.92
0.24
18.62
3.5
50
780
66.53
498.27
66.53
135.90
15
9.18
9.18
500**
68
0.005
77.1
122.6
328.85
6.50
0.053
57.67
35.16
328.81
0.80
8.71
31 .4
60.00
27.39
1900
400
0.096
450
16
12
60
150
30
96.51
4.22
195.0
1.7
7.67
85.31
8
7
27.39
3800
800
0.190
600
32
24
90
225
50
90
7.0
80
530
30
N.A
0.4
49
3.5
1.29
40
0.064
264
1.3
14
Nil
N.A
N.A
0.2
100
50
16.25
90
45
N.A
NA
NA
NA
1200@
22.16
600*
N.A. 240MMU 48OMMU
2.4
1.2
0.28
800
400
280
150
83.21
230
118
12.10
2000
1000
2.5
1.5
0.12
70
34
5.88
100
50
14.25
2020
1010
124.00
1600
80
N.A.
N.A.
N.A.
100
75
6.20
140
JO
3.69
331.0
0.75
79
1—m of Pet. & Cbem./75—11
6
6.0
36. Aminophylmine J
37. Thiopontal Sodium
38. Vitamin Bl & derivatives
I
821 .82
136.72
0.015
10.50
5
15.00
60
120
1.10
14.21
5
100
10
200
L
1
80
r
i
2
3
39. VitaminB2&Derivatives
40. Vitamin C
.
41. Vitamin D2/D3 (Calciferol)
42. Folic Acid .
.
.
4
15.00
1 .21
370.00
1.0
.
.
6
5
1 .21
7
8
5.19
24
48
261.58
218.00
900
1800
0.076
1.17
1.0
2.0
7.5
15.0
2.12
3.5
2.12
43. Diethyl Carbamazine Citrate
56.0
7.65
45
90
44. Nor-adrenaline
N.A.
N.A.
0.012
0.024
•Includes capacity and production of Panthenol and Pantothenates,
t Includes capacity of Chlorthiazide also.
©This includes Capacity of Nicotinic Acid also.
••Some non-specificcapacity with private companies.
*
ANNEXURE VIII
J
Essential Synthetic Drugs not yet produced in the country
I
(Chapter IH—Para 72)
SI.
No.
Name of the Product
Unit
(Tonnes)
1. Nitrofurantoin
Tonnes
Imports
Estimated Targets
1972-73
1973-74
1978-79
Letter of
Intent
1983-84 withLD.
P.L.
N.A.
N.A.
45.0
90.0
10.0
2. Nitrofurazone
N.A.
N.A.
N.A.
N.A.
1.0
3. Fursemide .
1.3
1.4
3.5
4. Pyridoxine Hcl. .
14.3
23.8
50.0
10.0
50.0*
I
I
10.0
5. Theophylline
15.0
N.A.
60.0**
120.0** 250.0**
6. Phthalyl Sulphathiazole
82.3
122.0
150.0
290.0
7. Aminophylline
18.9
14.6
♦*
♦♦
8. Calcium Pantothenate .
19.2*
26.0*
60.0
90.0
100.Of
40.0
♦Incluies both calcium and sodium-pantothenates.
♦♦Includes Aminophylline also.
tlnclules Calfoine and Aminophylline also.
4^
81
J
I
4
1 -i, K-'
ANNEXUREIX
Additional Capacity proposed, in respect ofessential drugs for Public Sector
Total
licensed
capacity
1973 '
Product
1
Production Target
Proposed
1973
require additional
ment for
capacity
1978-79 in public '
sector
2
3
4
5
1. Analgin
2. Sulfadimidine
160
500
137
329
400
1000
240
500
3. Vitamin Bl
4. Vitamin B2 .
5. Folic Acid
60
15
3.5
27
1.2
2.12
100
24
7.5
40
9
4.0
6. Phenobarditone
15.0
9.2
34
19
7. Piperazine
50.0
67
118
68
803.5
572.52
1683.5
880.0
85.3
600
226
8. Nicotinamide
224
9. Paracetamool
331
18.66
400
41
10. PAS .
780
498.3
1000
132
11. Sulfacetamide
68
6.5
80
7
1403.0
608.7
2080
406
12. Nitrofurantoin
12
45
33
13. Nitrofurazone
4
10
6
14. FursemiJe .
1.2
3.5
2.3
0.17
15. Pyridoxine HC1.
16. Theophylline
60
0
31.4
17. Aminophylline J
18. Phthalyl Sulphathiazolc
19. Calcium Pantothenate .
60
28.6
0.60
150
146.5
5.0
0.60
60.0
55.0
57.1
0.77
378.5
321.4
4.6
7.7
50
45.4
/
20. Metronidazole
21. Chloroquin
40.0
15.2
150
110.0
22. IIaIogenated-8-oxyquinolincs
427.4
100.5
450
22.6
23. Acetyl salicylic acid
1360
822
1900
540
-•*-. 24. Pethidine
0.75
0.24
1.2
0.45
25. Vitamin C
370
262
900
53 0
1.5
1.5
26. Primaquin .,
82
2
1
27. Chlorpromazine
28. Succinylcholine chloride
2.5
3
4
5
2.75
12
9.5
3
3
0.96
0.048
0.012
0.012
0.005
29. Thiopental .
30. Adrenaline .
0.048
0.015
31. Nor-adrenal inc
32. Oxytocin
33. Chloropheneraminc maleate .
34. Hydrochlorthiazide
*Includes capacity of Chlorthiazide also.
O
240 mu 240 mu
....
16
10
5.5*
0.63
40
34.5
2216.8
1211.0
3524.6
+240mu
of
Oxytocin
1307.0
-7-240mu
of
Oxytocin
6.0
I
CHAPTER IV
NATIONAL DRUG AUTHORITY OF INDIA
The Committee believes that health care has direct relationship with the socio-economic growth of the country
and a welfare slate should treat production, procurement, and distribution of essential drugs, as a social responsibility
just as important as ensuring supply of food and shelter.
With a view to tackling the problem of large scale production and distribution of drugs, the Committee re
commends the creation of a statutory body which may be called the National Drug Authority of India (N.D.A.).
The N.D.A. should perform the following functions :—
(1) Continuously assess national needs for essential drugs in the context of diseases prevalent in the country;
(2) Plan, programme, co-ordinate and monitor the production of all essential bulk drugs and their formulations
and lay down the relevant priorities ;
(3) Plan, co-ordinate and allocate production responsibilities to identified individual units in respect of bulk
drug production and formulations;
(4) Plan, procure and allocate all raw materials, intermediates and accessories either through indigenous
production or by local purchase or by import, where necessary. N.D.A. should evolve a workable procedure for
purchase/import of drugs in consultation with concerned agencies.
(5) Allocate production responsibilities to identified individual units for all raw materials, intermediates and
accessories including equipment required for drug production.
(6) Centrally import, where necessary, bulk drugs, intermediates, raw materials, equipment and accessories and
distribute these to the concerned units of the industry.
(7) Evolve and implement economic distribution system for all essential drugs and formulations produced in
the country or imported, making use of workers in primary health centres, post offices and after public distribution
agencies particularly for identified household remedies.
(8) Recommend price maxima in consultation with the Bureau of Industrial Costs and Prices (B.I.C.P.).
(9) Plan, allocate priorities and co-ordinate R & D activities by integrating all R & D facilities in men and
materials that may be available at State units, State sponsored autonomous laboratories, the relevant laboratories
of research agencies supported by public funds e.g. Council of Scientific and Industrial Research (CSIR), Indian
Council of Medical Research (ICMR), Indian Council of Agricultural Research (ICAR) ; etc., Universities, Indian
Institutes of Technology and other institutions, and encourage all these units and laboratories in all possible ways by
providing additional facilities, where necessary, to carry out time-bound R & D programmes, giving highest priority
to process innovation and upgrading of technology.
(10) Pool all available resources, facilities in men and materials by mobilising the industrial scientists and
technical experts, the national institutions and other laboratories by statute, if necessary.
(11) Any new drugs, or process innovations evolved, in any one of the institutions mentioned above shall be
the property of N.D.A. and should be made available to the identified units of the industry for their exploitation.
(12) Establish an upto-date data bank for technologies, Patents, R & D information etc., and act as a docu
mentation centre and provide all relevant information to the different units of the industry.
-(13) Act as sole importer of any technology, that may need to be imported, and ensure its distribution to the
participating unit/units.
(14) Ensure horizontal transfer of technology already available within the country and such technologies as
may be developed/imported in future.
84
a
■
85
15) Carry out continuous and systematic analysis of the relevant data to formulate policies necessary for im
plementing the above recommendations.
In order to discharge the above and such other functions as may be relevant to the implementation of the basic
philosophy of socialising drug production and distribution, the N.D.A. should be free from day-to-day governmental
interference and should have the powers to function without operational constraints.
Composition : The N.D.A. should have a Governing Board consisting of two Members of Parliament, one
expert each on commercial finance and business managements, two eminent technoIocists, a scientist, a social scien
tist, a marketing expert, a labour leader and 3-5 representatives of the public and Indian private sector industry.'1 It
should have a full time Chairman who should be of the rank of Secretary to the Government of India with such
powers as may be necessary to ensure economic and efficient functioning of the organisation. He should be of
proven ability as an eminent technologist or a technologist-cum-management expert with wide operational experience
and social commitment.
Finances .- TheN.D.A. should be funded by a cess of 2% levy on total value of sales of all units of the industry.
This 2 /0 cess will be on par with excise duty, except for the fact that it will be earmarked for N.D.A. only. The
sum of money so collected should take care of (i) the legitimate expenditure of the organisation excluding expenditure
involved m business, transactions such as distribution of raw materials, intermediates, bulk drugs and formulations
etc , which will be self-financing, (u) R & D expenditure barring that incurred in individual units of the industrv
“d w
“d
CHAPTER—V
DEVELOPMENT OF THE DRUG INDUSTRY AND THE INDIAN SECTOR
The Committee has discussed in this chapter the third term of reference which calls for recommendations for
promoting the rapid growth of the drugs industry particularly of the Indian and small scale sectors of the industry
taking into account the need for a balanced dispersal of the industry. Examination of this term of reference in correct
perspective would be greatly facilited if the historical developmentof the drug industry in the country is studied and
the current status of the various sectors of the industry, namely, the foreign sector (unit with any measure of foreign
equity) and the Indian sector including the small-scale sector indentified. It also requires to be considered what the
expectations of government were in the context of its various Policy Resolutions on the development of the drug
industry, the extent to which achievements in this field conform to the expectations of Government and the imbalan
ces or distortions that have crept into the growth of the industry either because of loopholes in the policies or their
defective implementation.
2. Two decades ago, a limited number of Indian companies were manufacturing conventional drugs such as
tinctures and other spirituous preparations, sera and vaccines etc. Synthetic drugs, antibiotics and steroids were
introduced into this country after the Second World War. It is worth recalling how within a few years after the
country became independent, foreign companies built up substantial business in this country.
3. Shortly after India became independent, most of the leading multi-national drug companies established
themselves as trading concerns. Their initial investments were insignificant compared to their turnover. They
started by importing the finished drug formulations and marketing them. Subsequently, they imported the for
mulations in bulk and got them repacked in this country. Under pressure from Government, as a next stage, they
imported the formulations in bulk drugs and got them processed into formulations on a “job-work” basis by Indian
companies. All these activities were carried on without investing in factories or employing technical personnel.
Thus, foreign companies could remit substantial profits and build up large reserves and assets within the country for
subsequent use or investment. Annexure I indicates the initial investment of foreign companies in this country and
how these investments, within a comparatively short period, multiplied several fold.
4. Between 1952 and 1965 and even up to 1968, well-known multinational units and a few Indian units operating
in this country received a big impetus to boost their turnover in the shape of “Permission Letters” 364 items were
permitted to be manufactured by 15 leading foreign units. Four of these items were bulk drugs and the remaining
360 items were formulations, many of which could have been easily manufactured by the Indian sector. These
formulations included house-hold remedies such as formulations containing vitamins and minerals, many of which
did not require a doctor's prescription, cough mixtures, ring worm ointments, ‘health salts’, ‘gripe mixtures’, laxative
tablets, eye drops, malted tonics, digestive tablets, ointments for burns and piles, tonics containing calcium, alcohol
based tonics, etc. Annexure II makes interesting reading in this connection.
5. In 1965, the Government of India announced certain liberalisation of its licensing policies in respect of all
industries, including drugs and pharmaceuticals, in order to overcome the shortages which were developing. Subse
quently. after ‘devaluation of the rupee and the liberlisation of import policy, two further notifications were issued—
one in 1966 and the other in 1967—Permitting manufacturers to diversify production into the manufacture of‘new
articles’, and to expand production of licensed or registered capacities up to 25% without any amendment to the
licences’under the Industries (Development and Regulation) Act. This was, however, subject to the condition that no
additional plant and machinery, other than balancing equipment procured indigenously, was installed. The applica?
tion of this policy in respect of all the industries including the drugs and pharmaceuticals, was, however, reviewed in
1970. because it was felt that under the policy permitting diversification, foreign units and these belonging to large
houses were likely to expand their activities in contravention of Government’s policies. The concession of permitting
diversification had. therefore, to be withdrawn, and such diversification as had taken place prior to that date, was
required to be regularised by specific applications for “Carrying-on-business” licences (COB Licences), in the
context of this new procedure, 12 foreign companies and 5 Indian companies obtained COB licences’which cover 215
formulations and 20 bulk drugs. Some of the tonics and house-hold remedies which command a wide sale and which
were marketed as a result of C.O.B. licences are : Santevini, Vidayalin, Surbex Becadc Trox, etc. ‘Valium5 and
‘Librium’, the two largest-selling tranquillizers in the world, marketed by Roche were also included in the C.O.B.
licences. The details are given in Annexure III.
86
87
6. The advent of the public sector undertakings marked an important milestone in the development of the drug
industry. Hindustan Antibiotics Limited and the Indian Drugs and Pharmaceuticals Limited together had an inves
tment outlay of about Rs. 56 crores. The fields they ventured into were antibiotics and bulk synthetic drugs whic"
are essential and required in large quantities. Yet, the growth of the influence of the foreign sector on drugs an
pharmaceuticals market could not be deterred.
7. Thus, within a period of twenty years, multi-national Companies attained a position of dominance in the
drug industry. Their success could be partly attributed to the antibiotics and synthetic drugs which they introduced
in the market. The Patent law concerning drugs prevented Indian Companies from entering into the field of synthetic
drugs. Multi-national companies had an extremely favourable climate in this country when they commenced opera-,
tions. They managed for a good length of time with a meagre capital investment, pushed up the sales of their products
remitted profits to their principals abroad and built up substantial reserves. Governments' policy permitted payment
of royalty even on drug formulations. Whatever basic drugs they manufactured were mostly utilised for captive
consumption. High prices were maintained for their drugs for several years. Added to this, money-spinning tonics
and household remedies which they could market on the basis of’'Permission Letters” and "COB Licences” swelled
their profits. By the time, Indian companies, particularly those in the western region, braced themselves up to the
situation and introduced competitive products, the sales promotion machinery of foreign companies was stream
lined and perfected. High pressure sales techniques coupled with distribution of medical samples on a liberal scale to
the medical profession was their forte. Attractively got-up medical literature and international brand names of
drugs appearing in advertisements in foreign medical journals with which top consultants in the medical profession
were acquainted, played their part in popularising the drugs of foreign companies. Large sums of money were
spent by foreign companies in systematically training their "medical detailers” and the general tone of detailing
resorted to by them was that their products contained "something plus” over products with identical composition
marketed by Indian units and that the edge in their quality was the outcome of their superior expertise and inter
national standing.
8. In contrast. Indian companies were swept off their feet by the new range of drugs introduced by foreign
companies. When the medical profession fell in for such drugs and discarded the coventional drugs which were
in use till then, the Indian sector of the industry took time to gear itself to the changed pattern. M/s. Standard
Pharmaceuticals in Calcutta and M/s. Alembic Chemical Works Ltd. were the only two Indian companies, outside
the public-sector units which evinced interest in production of penicilline and other antibiotics. A few units in
West Bengal embarked on manufacture of synthetic drugs for treatment of tuberculosis, leprosy, malaria, diabetics
etc. These products which were manufactured from basic or near-basic stage, did not make much headway in the
market compared to the same products marketed by foreign companies, partly because the latter were produced
from late-stage intermediates but mainly because the rapport between the Indian companies and the medical profes
sion was tenuous and ineffective. Besides, the medical services were not geared to serve the sections affected by^
these diseases and suitable distribution mechanics were not evolved.
9. In so far as technology was concerned, it was only available with -he multi-national companies operating in
India and it was difficult for Indian companies to obtain the technology. Also, in general, multi-national companies
operating in different countries tended to make it difficult for Indian manufacturers to obtain the technology of the
products developed ty them. The resource position of Indian companies in terms of finance and other facilities was
no match for that of foreign units. But more than resources and products, it was the management policy, the high
streamlined recruitment and "raining procedures for medical detailers. the aura of super-expertise that was created,
the techniques employed by foreign companies to persuade doctors to prescribe their drugs and the meticulous cost
and economic studies of al! operations carried out by them that beat th-* Indian companies completely and left them
far behind in the race. While a limited number of Indian companies in some parts of the country succeeded incopyiny
the methods of foreign companies and establishing themsleves fairly successfully, by and large, Indiar manufacturers
still lag behind considerably in the fields of professional management systems and methods marketing and finance.
On an all-lndia basis, Indian companies have not been able to make an organised effort to win the sustained support
of the medical profession for their products.
10. Government’s Industrial Policy Resoultion which was announced on April SO, 1956 includes “Antibiotics
and other essential drugs" in Schedule B attached to it. In regard tc the Industries covered by this Schedule, the
policy made it clear that with a view to accelerating their future development, the State will increasingly establish new
undertakings in these industries and that at the same time private enterprise will also have the opportunity to develop
in this field, either on its own or with State participation. Subsequent policy changes announced in July, 1965 and
27th October, 1966 permitted drug units to diversify up to 25% of their licensed/registered capacity (by value) subject
to certain conditions. In February 1970 Government made certain changes in the licensing Policy on the basis of
the recommendations made by the Industrial licensing Policy Inquiry Committee, the Administrative Reforms
Commission and the Planning Commission. Measures to regulate tiie licensing of foreign firms and larger Industrial
Houses were taken. A Press Note issued on 18th February, 1970 states :—
“In the middle sector, involving investments ranging from Rs. I crore to Rs. 5 crores, licence applications
of parties other than undertakings belonging to the larger Industrial Houses shall be given special consideration
and shall be issued liberally, except where foreign exchange implications necessitate careful scrutiny. Licence
1—M of Pct. Chem./75—12
88
applications from undertakings belonging to or controlled by the Larger Industrial Groups and foreign branches/
subsidiaries, shall be considered for normal expansion, where such expansion is necessary to develop to a
minimum economic level which would ensure greater cost efficiency. The provisions of the Monopolies and
Restrictive Trade Practices Act will be taken into account”.
11. The Government also revised the diversification policy cf 1966 in July, 1970. This ploicy prohibited
foreign firms from effecting diversification without an Industrial Licence and also stipulated that C.O.B. licences
should be obtained in cases where diversification was effected earlier on the basis of 1966 policy.
12. A Press Note issued by Government on July, 21. 1971 explained that the “Liberalised Industrial Licensing
Policy" announced by Government sought to strike a balance bet'.veen the requirement of accelarated industrial
growth and encouragement of small and medium entrepreneurs on the one hand and the need to prevent concen
tration of economic power in the hands of few large business groups on the other. In January, 1972, Indian firms
were permitted by Government to increase their licensed capacities on the basis of maximum utilisation of plant and
machinery and diversify up to 1000/0. The Press Note issued on February 2, 1973 sums up Central Government's
basic philosphy on the development of the drugs industry (and other industries), taking into account the growth
priorities envisaged under the Fifth Five Year Plan. We reproduce below the relevant portions from the Press Note
which need to be highlighted for the purpose of our discussions in this Chapter :—
“Government have carefully reviewed their policies relating to industrial development in the light of the
experience gained in the implementation of the Industrial Licensing Policy of 18 February 1970 and in the
context of the approach to the Fifth Five Year Plan. The Industrial Policy Resolution of 1956 has laid down
the basic principles that govern Government’s approach towards industrial development. These principles
have been derived from the Directive Principles of State Policy contained in the Constitution and from the
adoption by Parliament in December 1954 of the socialist pattern of society as the objective of social and econo
mic policy.’ The Industrial Policy Resolution of 1956 will continue to govern Government’s policies for achie
ving die objectives of growth, social justice and self-reliance in the industrial sphere.
Role of Public Sector
2. As pointed out in the Industrial Policy Resolution the adoption of the socialist pattern of society as the
national objective, as well as the need for planned and rapid development, requires that all industries of basic and
strategic importance, or in the nature of public utility services, should be in the public sector. Other industries which
are essential and require investment on a scale which only the State, in the present circumstances could provide, have
also to be in the public sector, in the context of die approach to the Fifth Five Year Plan, the State will have to
take direct responsibility for the future development of industries over a wide field in order to promote the cardinal
objectives of growth, social justice, self-reliance and satisfaction of basic minimum needs.
Licensing Policy
3
**
**
5. Government consider it desirable to consolidate the list of industries which are opened, along with other
applicants, for die participation of larger industrial houses (as defined in the MRTP Act). In the context of the
approach to the Fifth Plan, the core industries of importance to the national economy in the future, industries having
direct linkages with such core industries, and industries with long term export potential are all of basic, critical and
strategic importance for the growth of the conomy. A consolidated list of such industries is attached in Appendix I.
Such of the industries included in Scheduled A of the Industrial Policy Resolution 1956 will be reserved for the public
sector. Larger houses will be eligible to participate in and contribute to the establishment of industries in the fist
included in Appendix I along with other applicants, provided that the item of manufacture is not one that is reserve
for production in the public sector or in the sin ill-scale sector. They will ordinarily be excluded from the industries
not included in this list except where, as is permitted under existing arrangements, production is predominantly for
exports.
6. Foreign concerns and subsidiaries and branches of foreign companies will be eligible to participate in the
industries specified in Appendix I along with other applicants but will ordinarily be excluded from the industries not
included in this list. They will also be e.ititled as at present to invest in industries where production is predominantly
for exports. Their investments will be subject as higtherto to the “guidelines on the dilution of foreign equity” and
will be examined with special reference to technological aspects, export possibilities and the over-all effect on the
balance of payments.
Small-scale and Cooperative
Sectors
7. In the implementation of the licensing policy. Government will ensure that licensing decisions conform to the
growth profile of the Plan and that techno-economic and social considerations such as economics of scale appropriate
tech’iology. balanced regional development and development of backward areas arc fully reflected, Government’s
89
policy will continue to be to encourage competent small and medium entreprenurs in all industries including those
listed in Appendix 1. Such entrepreneurs will be preferred vis-a-vis the larger industrial houses and foreign com
panies, in the setting up of new capacity. Licensing policy will seek to promote production of anoilaries, wherever
feasible and appropriate, in the medium or small-scale sector, cooperatives and small and medium entrepreneurs
will be encouraged ’o participate in the production of mass consumption goods with the public sector also taking an
increasing role. Other investors will be allowed to participate in the production of mass consumption goods only
if there are special factors such as sizable economies of scale resulting in reduced prices, technological improvements,
large investment requirements, substaintial export possibilities or as part of modernisation. Government also
intend to enalarge and intensify a vareity of positive measures deisgned to promote the growth of small and medium
entrepreneurs.
**
8.
**
9. The existing policy of reservation for rhe small-scale sector involving investment in machinery, and equipment
up to Rs. 7.5 lakhs, and in the case of anacillary industries up to Rs. 10 lakhs will be continued. The area of such
reservation will be extended consistent with potentialities and performance of the small-scale sector. The policy of
encouragement to the cooperative sector will receive special emphasis in industries which process -gricuhural raw
materials such as sugarcane, jute cotton or produce agricultural inputs such as fertilisers. The cooperative sector is
also ideally suited for the manufacture and distribution of mass consumption goods.
Joint Sector
10. Government’s policy regarding the joint sector is derived from the Industrial Policy Resolotion 1956 and
the objective of reducing the concentration of economic power. In appropriate cases, the Central anc State Govern
ments have taken equity participation either directly or through their Corporations with private parties. Some joint
sector units have come up in any way. This type of joint sector unit is a device which may be resorted to in specific
cases having regard to the production targets of the Plan. Each proposal for establishing a joint sector unit of this
nature will have to be judged and decided on its merits in the light of Government’s social and ecor. 'mic objectives.
The Joint sector will also be a promotional instrument, as for instance, in cases where State Governments
Goverrjnents go into,
into.
partnership with new and medium entrepreneurs in order to guide them in developing a priority ind-stry.’’
13. It is now worth considering whether the drug industry, as it has now emerged, is in conformity with the
requirements of the country. The fact that the drug industry has mvde phenomenal progress within the last two
decades cannot be gainsaid, in 1947, drug production was of the value of Rs. 10 crores. In 1973. the gross output
is estimated to be of the order of Rs. 370 crores. The indigenous output of bulk drugs is estimated a: Rs. 75 crores.
The publication of the Development Council for Drugs and Pharmiceuticals entitled “Indian Pharmaceuticals In
dustry 1973” sets out the range of bulk drugs a that is produced in the country together with their production capacity.
The list of drugs set out in the publication is sufficiently imposing in the context of the development caking place in
other countries. However, a critical appraisal of our achievements reveals many interesting facts. These facts,
together with our observations, are set out below :—
(a) About 70% of the total sales turnover of drug; in the country, namely. Rs. 370 crores bel.c.gs to foreign
sector. (Annexure-lV)
(b) Out of the total turnover of Rs. 3 70 crores, the value of tonics, house-hold remedies, vitamins and minerals
etc. comes to about Rs. 70 crores.
(c) 27 years after independence, 10 firms with 100% foreign equity are operating in the country. Six of these
are engaged solely in the manufacture of drug formulations. There are six branches of forergn companies
operating in India and are engaged in the manufacture of bulk drugs and/or formulations- Their total
turnover in 1973 was about Rs. 22 crores and their indivdual turnover ranged from Rs. 0.13 crores to
Rs. 9.7 crores. According to a reply given in the Parliament, another firm M/s. C.E?F ulford has been opera
ting without securing an industrial or C.O.B. licence and importing raw materials worth Rs. 42 lakhs for
processing a single item, namely, gentamyccin injection.
An analysis of the drug companies holding
foreign equity in issued capital is given below :—
Category
100%
50-99%
40-50%
Below 26%
10
24
15
11
6
Total :
66
26-40%
90
(d) The value of imports of bulk drugs, penultimates, intermediates and chemicals was about Rs. 35 crores
during 1973-74.
(e) The total outflow of foreign exchange towards payment of royalty, technical fees and dividends during
1969 to 1973 is about Rs. 26 crores (Annexure V). This figure does not reflect the additional foreign
exchange remittance that is implicit in purchases of bulk drugs, intermediates etc. by foreign companies
in India at prices dictated by their foreign principals. These prices bear no relation to either the cost of
manufacture of the final products or international prices. In order to check these malpractices. Govern
ment are now progressively canalizing the items wherever such cases are brought to light. Likewise, exp
orts, a substantial portion of which is made by foreign companies in India to their principals abroad, are
often made at prices which are not quite favourable to the country. An interesting feature about remitt
ances made by foreign companies to their principals is that even today remittances towards ’Head Office’
expenses have to be permitted because of the operation of trading companies with 100°/ foreign interests.
(f) Only 19 foreign Companies manufacture bulk drugs.. The rest have built up their turn-over
on formulations, many of which are common-house-hold preparations which are advertised in the
lay press. Annexure VI shows the stages from which manufacture of bulk synthetic drugs is car
ried out by foregin companies. A reply (Annexure VII) recently given by the Minister of Petro
leum and Chemicals to a question raised in the Lok Sabha of the Parliament (Question No.
2919 answered on 3-12-1974) indicated that few companies have made available any portion of their
bulk drug production to others.
(g) Foreign companies manufactured in 1973 bulk drugs worth about Rs. 19 crores. The two public
sector units together produced bulk drugs of value of about Rs. 24 crores, while the Indian
Sector of the industry including the small-scale sector was responsible for about Rs. 32 crores.
Manufacture of bulk synthetic drugs from late-stage intermediates imported by foreign companies
from their principals at prices dictated by the latter would put the country to double loss once
when the country imports late intermediates and secondly, when the profits accruing from the
sale of the finished formulations are remitted abroad. Every rupee worth of bulk drugs would produce
about Rs. 3 worth of formulations.
(h) Some multi-national units hold an almost mono-polistic position in this country in regard to the supply of
life-saving drug formulations such as Methyldopa. Indomethacin, Furosemide, Prenylamine lactate,
gentamycin sulphate, diphenylhydantoin sodium etc. The Committee understands that the Ministry o^'
Petroleum and Chemicals, perhaps with the intention of increaing production of bulk drugs in the countrY
have hid down a working principle that no company (including its sister concerns) with a turnover in
excess of Rupees two crores would be allowed to manufacture drug formulations unless it manufactures
the related bulk drugs. Such a restriction, in the view of this Committee, has not only worked to the de
triment of the Indian sector of the drug industry but also created shortages. Even today many foreign
companies are importing mostly bulk drugs and processing them into formulations, though firms applying
today for formulation activity only are denied this facility. Manufacture of bulk drugs requires subs
tantial financial outlay and takes time. If this condition continues to be imposed, the Indian companies
which have the technological base and the know-how for the manufacture of formulations will suffer se
rious set backs. The Committee recommends that this restriction should be removed and forign companies
which process formulations from imported bulk drugs should be made to manufacture the bulk drugs
within a specified period. As regards the Indian sector of the industry, the Committee has recommended
later on in this Chapter that a more liberal policy is necessary in order to encourgage the Indian compa
nies to make their contribution to the production of bulk drugs and formulations.
(i) The initial investment made by foreign companies is insignificant compared to the volume of the turn-over
built up by them. The early part of this Chapter recounts how most of the foregin companies started as
trading concerns, later imported drugs in bulk and processed them into formulations through other firms
on a Job work’ basis, remitted profits to their principals and concomitantly built up reserved from which
they subsequently established processing facilities of their own. Annexure I reveals that the capital issued
on account of considerations other than cash and bonus shares consititutes a substantial proportion of
the toal capital
(j) We had mentioned earlier that foreign companies built up their financial sinews and achieved the present
dominant position mainly through sale of formulations which were allowed to be manufactured by them
through the issue of “Permission Letters” which continued up to 1968 and COB licences. The legal
backing for “Permission Letters” under the Industries (Development & Regulations) Act, and the manner
in which COB licences were secured by foreign companies were examined by this Committee through a
specially constituted Sub-Committee. The latter discussed with the officials in the Ministries connected
with the processing and issue of “Permission Letters” and "COB Licences” and also obtained clarifications
from the Secretaries of the Ministry of Petroleum and Chemicals, the Directorate General of Technical
J
iiiiiii imiiL
91
The
Committee’s
view
Development and the Ministry of Industrial Development.
legal
backing in terms of
the
is that
“Permission
Letters” do not have any
.
i
provisions
of the Industries (Development
and1 Regulations) Act vide Annexure VIII. Likewise,
most of the companies which were granted C.O.B. licences did not inform the Directorate General of
Technical Development of the particulars of their diversification activities, “including their revised manu
facturing programmes and the new articles proposed to be manufactured and the value of the minor
balancing plant, if any added by them” as required by governments' Press Note of October 27, 1966. The
authorities concerned did not verify whether effective steps had been taken by the companies for the
items covered by their C.O.B. applications. Permission Letters and C.O.B. licences have given undue ad
vantage to foreign companies to the detriment of the Indian sector.
Shri S. S. Marathe. Dr. B. Shah, Dr. S. S. Gothoskar and Dr. P. R. Gupta have expressed their reservations
on the interpretation and conclusions regarding COB Licences, Permission Letters. (Para j)
(k) On February 19, 1970 the policy permitting diversification and the exemptions granted under the Industries
(Development &. Regulations) Act were revoked by govenment. Foreign companies were specifically
prevented from augmenting their production capacities. Annexure IX shows the extent to which these
firms have contravened government notification. This fact is known to the Directorate General of Tech
nical Development who receive production statistics from the companies and the Ministry of Petroleum
and Chemicals. On directions from the Economic Sub-Committee of the Cabinet, it is understood that
the contravening firms were disallowed raw materials needed for normal annual expansion. Foreign
interests are compaigning for regularization of the excess capacities of production. Their views are that
shortages of drugs would result otherwise and that the country’s requirements are so enormous as to acco
mmodate any prod iction that Indian companies may achieve. The Indian sector of the industry has re
presented to this Committee that the public sector unit and the Indian firms which^are in a position to
take up the manufacture of most of the bulk drugs involved have not been approached by Government
and that drugs such as Metronidazole have all along been manufactured from the penultimate stage inter
mediates. What the foregin firms are keen about is the processing of all the bulk drugs produced by them
into formulations which they feel they are entitled to in terms of Ministry of Petroleum and Chemicals
Notification No. 3(3)/65-Ch. Ill of 27th May, 1969. Lastly, the Indian sector argues that regularization
of excess capacities will induce foreign undertakings to produce more in contravention of Government’s
policies in the hope that exess production will continue to be regularized so long as the country’s reqirements of drugs remain unfulfilled. The Committee's view is that the long term objective of buliding up a
self-reliant Indian sector of the drug industry should not b3 lost, sight of,
while at the same time any
solution which is arrived at should be such as not to result in shortages of drugs. With this object in mind,
the Committee has spelt out its views on how best the excess production capacities of foreign companies
should be regularized later on in this chapter.
(l) Indian drugs manufacturers could be broadly classified into four categories; namely :—
(i) Those who have a small turn-over and are engaged only in the manufacture of simple house-hold
remedies, such as, cough-syrups, fever tablets, “gripe-mixtures” for infants, ointments for colds
or wounds etc. The number of manufactures under this class might exceed a thousand and their
activities are confined to the district round about their locations or the States in which they operate.
(ii) Companies winch concentrate exclusively on catering to government hospitals and other medical
institutions against rate contracts.
(iii) A more progressively inclined category of manufacturers—about a couple of hundred in number—run .
by technically—competent enterepreneurs who manufacture a good range of pharmacopecial pre
parations used by hospitals and other medical institutions, supplemented by a range of good quality
proprietary medicines. They may also be interested in the manufacture of basic drugs.
(iv) Companies whicn market newer drugs, operate a research establishment albeit*on a moderate scale,
manufacture bulk drugs and are ..engaged
in export to limited
falling
— extent.
-------- Units
------ -----c in this category
have been able to develop sufficient financial resources and marketing organisation to withstand
competition from multi-national concerns.
It is obvious that the categories at (i) and (ii) cannot survive long in the face of the aggressive and well-organised
marketing techiniques enployed by units falling within categores (iii) and (iv) and by the multi-national
companies which market drugs under internationally—known brand names. Unit^ under (ii) operate
on bare margins of profits and are therefore compelled to cut on product development research and even
on employment of adequately qualified technical personnel to supervise manufacturing and technical
operations. These self-defeating practices will not sustain these companies for long unless they diversify
their product-mix, adopt “Good manufacturing Practices”, complete in tthe
’ open’ market
' ’and develop the
will and strength to survive and progress.
1
92
Companies falling under (iii) and (iv) consititute the backnone of the future drug industry in the country. If
government takes special interest in these Units and helps them they can play a useful role in the develop
ment of the drug industry.
Quite a number of small-scale drug units have been receiving raw material licences for values which have no
relation to their turnover or status and are reported to have sold off the raw materials. Such malpractices
have tarnished the image of the Indian sector of the industry.
(m) In a separate chapter in our Report, the Committee has pointed out how remiss most of the State Govern
ments. barring a few States such as Maharashtra, Gujarat. Karnataka, Kerala and to a lesser extent West
Bengal and Tamil Nadu, have been in enforcing stringently the quality control measures over drug manu
facturers. In particular, pre-licensing inspections and ispection of manufacturing process have not been
rigid in some States. This will have the effect of increasing the incidence of sub-standard drugs., Likewise
in the absence of concertaed efforts between the police and the Drug Control Departments and without
the co-operation of the general public, the menace of adulterated drugs cannot be effectively tackeled.
General laxity in enforcement of qulity control measure have adversely affected the interests of the Indian
sector of the drug industry. The Committee also understands that the leaders of the foreign sector of the
drug industry have been making statements that quality control over drugs can be maintained only by
those firms which have organised research in a big way, thereby hinting "obliquely that Indian firms
which lag behind in financial resources may not be able to market quality drugs.
(n) In the field of drugs, it may not be so difficult to make a good formulation as it is to sell it. Neither
the dealer nor the patient has any choice of his own while supplying or purchasing drugs. There may be
several good products of the same drug available in the market but the patient will perforce have to buy
the drug prescribed by the doctor. In the course of our visit, members have had occasion to see several
well-organised Indian units, including some in the small-scale sector which have technical competence
to produce high quality drugs. The representation of these firms was that adequate Government support
would enable them to fulfil the needs of the country. While Government’s support for such undertakings
is important, more vital is the need for the units themselves to maintain an effective “dialogue’’ with the
medical profession regarding their products, which is absent today.
(o) A feature which the Committee specially noted was that Indian units, particularly the small and medi”.m
scale sectors have yet to appreciate more and more the importance of professional management, system
and procedures, cost accounts and carefully worked out pricing policies. Many of them” are ownd by
persons who have had no bakground of drug manufacture and drug testing and who have not been conversant with the ethics of the profession. The prices of drugs produced are adjusted well below those
of similar products produced by well-organised firms, without any consideration for the economics of
operations. Ill-paid staff and ill-organised manufacturing facilities result in the lowering of quality control
measures. The stolest for improvement and progress is totally absent.
(pj In regard to Patent provisions relating to drugs, the Committee was keen on ascertaining the impact of the
Patent Act on the drug industry. Quite a number of the principals of multi-national units operatingin this
country, we were informed, asserted their patent rights over life-saving or essential drugs such as Chlo
ramphenicol, Tolbutamide, Oxytetracycline, Metronidazole, etc., and proceeded legally against Indian and
other concerns which tried to import the bulk drugs and process them itito formulations. The Patent Act
was amended in 1970 with the specific object of helping the Indian sector of the drug industry. The
Committee was glad to know that young scientists in the country have now bestirred themselves and
started producing bulk drugs. However, all applications for drug patents remain “frozen” in this country
from 1963. This has created certain anomalies in the implementation of the 1970 Act according to
which a “Licence of right” can be given only after three years of the sealing of patents. This means
that unless a patent is sealed, no “Licence of right”can be given. The task of examining the “frozen”
patent applications and sealing the patents covered by them it is understood, would take a long time.
In the"matter of imports of drugs, indigenous manufacturers had represented to us that bulk drugs
which are available from overseas countries at competitive prices cannot in many cases, be imported
because of the anomaly that obtain in this country in regard to drug patents.
(q) While Government has been pressing drug manufacturers, with a trun-over of Rs. 2 crores to take-up
the manufacture of bulk drugs. Indian manufacturers had a different story to tell the Committee. There
have been instances where Indian companies have accomplished the manufacture of bulk drugs before
the foreign companies who were the researchers of such drugs could do so in this country.
Glybenclamid,
an anti-diaba’ic drug, has been reported to be manufactured by an Indian Company, whereas two com
panies with foregin equity participation have still to commence production of the drug. Similarly, another
Indian unit is manufacturing bulk Propranolol andPractolol and making their formulations. The plea
' of rhe Indian units that the multi-national units in India should be compelled to buy the bulk drugs from
the Indian manufacturers, so long as their quality is accepted by the Drugs Controller (India) is still under
r.
I
93
Government's consideration. In the past, Indian units were compelled to buy bulk Tolbutamide, Vitamin
B12 etc. from units with foregin interests even when there was only one source of-apply. A small-scale
unit Kerala which reportedly is manufacturing a number of anti-cancer drugs has .vporoached Government
suggesting that formulators of the anti-cancer drugs should be compelled to buy *he drugs from them.
Expeditious decisions in all such cases to ban the import of the bulk drugs concerned should be taken and
implemented quickly. Unless this encouragement is given, there would be no incen-ive for Indian compa
nies to take up the manufacture of bulk drugs.
(r) Till about 10 years ago. foreign companies were averse to reduce their foreign equitv participation. Govern
ment's attitude in this regard stiffened progressively. In consequence, foreign units .-.ere compelled to re
duce their foreign equity. West Bengal drug firms, possibly because of the strong mtionalistic background
prevalent in that region, have been generally stronly opposed to the idea of corporation with foreign
undertakings. The rapid progress made by several Indian firms which enjoyed :r.e benefit of foreign
participation and know-how had little effect on the drug industry in West Bengal.
(s) The drug industry is concentrated in three States, namely, Maharashtra, Gujarat and West Bengal. Quite
a few drug units and the synthetic drug unit of l.D.P.L. are operating in Andhra Pradesh.
Karnataka lias also, of late, been attracting a few drug manufacturing units.
(t) In regard to Research, barring a few, ether multi-national companies have been taking the line that basic
innovational research for “new drugs'* involving co-ordination between multi-discirTiary teams of scien
tific workers requires giant outlays and top-grade research scientists. According to them, research should be
concentrated in the parent organisation functioning abroad rather than be dissipated in many countries
Eight Indian institutions, including the public-sector companies and the National Laboratories maintain
fairly well-organised research facilities and specialize in different classes of durgs. Six Indian firms can
also be considered to have made reasonable efforts towards developing basic research activities.
On an overall basis, however, Indian comapnies, by and large, have yet to initiate research efforts. From the
therapeutic angle, the diseases that are endemic in Indian and which need to be controlled or eradicated
are malaria, tuberculosis, filaria, leprosy, amoebiasis. helminthiasis, malnutrition, iron-deficiency anaemin,
trachoma, scabies and various types of infections. The current rage of drugs available for he treatment
of these diseases cannot be said to be entirely satisfactory. The highest priority has therefore to be accor
ded for centrally-directed research aimed at discovering newer drugs in these fields. Besides, the dis
covery' of new and more efficacious contraceptives also need to be given on equally high degree of priority.
Fore-igns firms arc not interested in research on drugs for tropical diseases as ihe global demand for such
drugs, in their view, will not be sufficiently economic. Side by side, research for new drugs for the treat
ment of diseases of the cardio-vascular system, metabolic disorders, diseases or disorders of the digestive
and endocrine systems, venerel diseases, allergic diseases, diserders of the skin etc. cannot be .gnored if the
pace of growth of the drug industry is to be accelerated and the country is to be ;; the manstream of
scientific progress.
(u) The Drugs Prices Control Order, also had its impact on the growth of the industry’ wit- in the li>- few years.
In general, while foregin drug companies managed to diversify into areas where price c qi-.ru is not ope
rative e.g. laboratory chemicals, foods and nutritional products, insecticides, etc.
Indian units had to
face its full blast. There profitability progressively declined and thir capacity to maricet new formulations
of drugs, particularly in competition with foreign undertakings, has been seriously impaired. The Commit
tee has dealt with this aspect in chatper VI11.
14. Having studed the evolution of the drug industry in this country and identified the imbalances that have
developed in it. the Committee would like to set forth the challanges that face the industry. Tie report of the Task
Force on Drugs and Pharmaceuticals set up by the Planning Commission (Annexure I of Chapter II) indicates the
drugs that would be needed by the country over the next ten years and the quantities in wheih they would be required.
The Task Force also provided information as to whether indigenous technology is avialable for their production or
the technology will have to be imported. The Task Force has also listed the raw materials utd the intermediates
which would be required for the manufacture of important durgs and the areas of research v.hich could usefully
be pursued by different sectors of the drug industry. Besides making the country self-sufficient in regard to drugs,
this Committee feels that another eqully important objective, should be introduction of medical senicc of a rudimen
tary' nature in the remote villages where at least common house-hold remedies for cough, cold, fever, antacid pre
parations for the elderly sections of the population, drugs for skin infections, preparations for treatment of acidity
in children etc. should be made avialable in pilfer-proof packings and in quantities which would be yjfficicnl foj
3 to 4 days’ treatment.
!
94
15. The question that poses itself before the Committee— and indeed before the country— is : What changes
in the drug policies are necessary to fulfil the task that lie ahead of us? A multipronged effort is c .lied for to achieve
a number of targets sumultancoulsy. We should reduce the import bill of the country in respect of the drugs required
over the next ten years, develop as far as possible the technologies required for bulk drugs and intermediates through
co-ordinated research carried out at the-National Laboratories and the academic institution, try t^ achieve a balance
between foreign exchagne inflow and outflow by boosting exports in a judicious manner without affecting the domestic
demand adversely and lastly foster the developm.-nt of sound and ethical small-scale sector which would not only
serve as feeder units for the' large-scale sector but also produce all drug formulation which are essential or which have
remained the m/nopoly of foreign companies so far. All these exercises should be done keeping in mind the twin
objectives of rdeucing the dominant position now enjoyed by the foreign sector of the industry and rapidly buildng
up the Indian sector.
policies of Government
16. Before answering the question whether any change is required in the current drug
<
to help ichieve th: challenges ahead, a more relevant point to be considered is : Is the drug industry that has developed "in______________________________________
conformity with the national requirements ?"'The
T'' profile of
-ruthe
-- drug industry, as has been elaborated by us
-- in
para 13 of this chapter, would indicate that the basic objective have been far from achieved. A beginning has no
■ - •been made
’ with production
’
'
r .drugs in the public
-----t(> sector
continue
doubt
of
sector but if the public
units are *
the manufacture of bulk drugs after investing heavily and distributing the raw materials to other manufacturers
for bens processed into finished formulaHons, the maximum benefit put of this policy will accrue to the
subsidiaries of multi-national companies in this country who heve the capcity to out-do the public sector units in
sales even after maintaining higher prices. Government's policy is against concentration of the industry in the
hands of foreign branches/subsidiaries and larger Industrial group but the result achieved is just the contrary.
17. Government’s policy assures all support for the medium and small-scale sector of the industry but our
I discussions with the Indian Drug Manufacturers* Association and other associations representing the interests
of small and medium scale drug manufacturers give us the impression that there is little rapport between Government
and these sectors of the industry. The latter feel that if they ask for protection for the bulk drugs manufactured by
them. Government does not appear to be confident about their ability and technical competence. The Indian
manufacturers, including the small-scale units managed on ethical lines by technically competent en:repreneurs.
desire that thev should^be given encouragement. They suggest stringent punishment for these companies which
indulse in malpractices such' as sale of raw materials etc., or which are deficient in quality control measures. To
judse&all the medium and small-scale units by the same yardstick, the Indian manufacturers represent, would be less
than fair to the Indian sector of the industry. The Committee feels that in our anxiety to produce more drugs,
we should not adopt a policy which places Indian manufacturers at a disadvantage. On the contrary if the choice
were between a foreign company and an Indian company, encouragement should be given to Indian companies which
are technically competent. Somehow or the other, there seem to be exaggerated notions about the capabilities of
foreign companies vis-a-vis Indian units.
18. It was represented to us by the Indian sector of the drug industry that the general preference showed by the
medical profession to the products of foreign manufacturers, the real or exaggerated shortages of drugs marketed
by such manufacturers and the subtle propaganda that any shortage would lead to prevalence of spurious drugs
would weigh heavily with the authorities in their actions. The Joint Secretary of the Ministry of Petroleum and
Chemicals assured the Committee that such propaganda had not influenced Government. The Committee is fully
aware of the fact that foreign companies in India with the commanding position they have attained in the drug
industry today and with the'technological and other resources which they can command from their principals abroad,
may produce all the bulk drugs that are needed b\ the country well within the time schedule envisaged by the Task
Force. But the bis question That we should ask is : What would it cost the country if the future development of the
. drug industry is entrusted primarily to the foreign sector of the industry? In response to a querry raised by the
Committee as to why the member firms of the Organisation of Pharmaceutical producers of India (an organisation
which is dominated by foreign companies and firms with foreign interests), have not shown adequate interest in the
manufacture of bulk drugs, "the reply received from the Organisation stated that its members “arc in a position to
further expand their production of bulk drugs provided such expansion is immediately sanctioned by governmen
without attaching any condition". This proviso pithily sums up the attitude of multifnational companies. It
implies that Government should not ask them to bring down progressively their foreign equity, that no condition
should be imposed to the effect that a portion of the bulk drugs manufactured by them should be distributed to other
manufacturers for beins processed into formulations, that no export obligations should be stipulated and, lastlyj
that the cost of the bulk drues and the prices of the formulations produced by them should not be investigated by j
government agencies and fixed. It must not be forgotten that- the multi-national undertakings which are operating <
in India are the very firms which also -control the industry in whatever countries they operate. The techniques
emplovtd by these firms all over the world arc the same and are lucidly dealt with in the report of the United Nations
i
95
I
a lavish scale and rig up prices to levels which h’ave no relatio^to ffiTcost'of mlnJfacture o^produc^H
pnees. They are interested in carrying out research only on products which will have a global demand such as
tranquillisers, anti-histaminics, anti-hypertensives etc. and not on drugs for treatment of tropical diseases or even
cancer. If in the course of their scheduled research the drugs synthetised by them show activityPagainst tuberculosis
helminths etc. they are marketed as such. In short, the already dominant foreign sector would become a mighty
force to reckon with in the country s economy unless certain further steps are taken to curb the dominance' of
multinational-companies.
uuimnance oi
C-
19. Having regard to the socio-economic objectives embodied in Government’s policies and the specific direction
contained in the erms of reference of the Committee under this Chapter, this Committee has no hesitation to suXt
that the potentiality of foreign companies to exploit their names and smother the development of the Indian sector
of the industp' should be blunted. A more purposeful and positive policy of helping the Indian sector should be
simultaneously implemented. The scientists and technologists in the country are bubbling with a new sen e of con
fidence and feel that they can maximize their research effort. If purchase of technolog;is necessitated it should
mu?atinngaskills.Orarae
Y
C“ttee ln ChaPter IIL The Indian sector has developed high grade dmg foj-
k m
P°e? the dru? industry> as„ h has developed, fulfil the socio-economic needs of the country’ If not how
should its development be oriented? —These questions were debated by the Committee. Nationalisation of the
drug industry was discussed at length as one of the alternate solutions. Different views were expressed One of the
views was as follows :—
k7ne oi me
“In India inspite of the efforts to plan socio-economic growth, the drugs and phramaceuticals industry
like several others, operates on the principles of free market economics. The Drugs industry is dominated
by the foreign units which set the pattern in this industry. The drug needs of anv country are characteristic
of the climatic conditions, social behaviour and economic conditions in each society. The foreign units which
evolve their policies for the rich countries in temperate climates, with redically different socio-economic
conditions, operating in free market systems, promote the same systems in India, which are adv-rselv detri
mental to our national interests. Even in the Western European and North American countries^ is widely
realised that the diug firms exploit the socio-psychological factors to reap high profit. It is said that the firms
have reduced life to a disease to be cured in those countries by their sales propagation techniques.
The experience of the last one quarter of a century in India, in the operation of the multi-national dnw
also re‘nf0rCeS heS® fearS' Thls has bsen confirmed by the studies conducted by various international agencies
Throughout the world, foreign firms are given facilities to operate with the hope that capital flow and
technological development are facilitated. In our country however the flow of capital through the foreign
units is almost nil and, the accumulation of assets, through their trade operations in this country is very raoTd
as can be seen from the data provided elsewhere in this report.
y’
y p d’
1
The claim that flow, of technology from parent foreign firms on a continuing basis is ensured because of
foreign equity holdings is not valid. Firstly, such flow is usually restricted only to the technolog avaflaX
with the overseas parent Co. and not from other competitive overseas venders of technology even if they may
be cheaper. Other points to remember in this connection are (1) introduction of technology of basic drucs
newly into the Indian subsidy does not occur free since for most such introductions additional payments have
nevertheless to be made notwithstanding equity interests, and (2) the overseas firms choose to perSh flow of
such technology to India as will serve the interest of the parent firms. Rarely new and novel technology is
permitted to flow either free or even on payment. Most technologies that flow from parent foreign fi J,
nd IoeTd n
HUnSld,et °r P-artners are in fact weU established all over the world for the last 15-20 vem
and could as well have been imported into the country without taking recourse to equity participation.
Fears that technology flow will dry up if foreign equity is discouraged or stopped is also exaggerated
Countries in which the drug industry is state-owned have not suffered on this account They hive either
bought such drug technologies as they need or have been able to develop them on their own
If indeed technology flow becomes difficult due to take-over of the drug industry it mav be a boon in
d.sguise as it will spur greater national effort in these directions and develop self reliance- “goal to whfch our
country is committed Success of the development of self reliance by our scientists and technolooiS k to
atomic energy and defence field (where possibilities of import of production techndogy are IhnTed) s^ows
that even if overseas technology flow for drugs were to dry up, the country, with its strong scientific and tech
nological capacihty, will not be stranded. Indeed such an eventuality is also remote s^“e
energy and defence areas, drug technology from overseas is not as restricted or difficult.
1—M of Pet. & Chem./75—13
I
96
It is contended that the anti-social role of multi-nationals can be contained by laws of the land and the_
powers that are available with the Government. Whereas this is so, the real point at issue before the Com’
mittee is the manner in which such governmental powers have been used in the past so as to curb the activitie
of these companies which are not in the national interest. The Committee’s findings in this regard, discussed
in the various chapters of this report indicate that progress in these directions has been very slow. If this
process of change is to continue at the existing rate it is doubtful if the desired objective of a truely social bene
fit oriented drug industry will develop in the near future. A quantum change has therefore, to take place
in the rate of change if the desired goals are to be achieved quickly enough.
The contention that technology flow through equity participation by multi-nationals in the drug field is the
most effective and economical because of its higher rate of obsolescence, will have to be supported by cogent
facts and will also have to be examined in the context of alternative methods of technology flow not involving
equity participation. As of now, no such study is available. The assertion that equity participation in several
cases would be the only way by which technology flow can be ensured may be valid only for a very few cases.
In these cases we may import such drugs but we should at the same time launch a crash programme of R & D
to develop self reliance for such drugs. The impediment to development of domestic technology, due to
patents in the drug field, have also now been largely removed. There is little doubt that Indian scientists
and technologists will develop all such technology if a concerted effort is made and if subsequent use of tech
nology use is assured.
The drain of foreign exchange by way of remission of profits by multi-nationals has to be viewed in the context
of their import bill for drugs "and intermediates in relation to their own export of drugs and not in terms of
their total sales inclusive of formulations. It is well known that the value added in formulations is upwards
of 3 times that of bulk drugs. Any comparison of the foreign remittances with the country’s total exports
is not relevant to the issue of social and economic costs resulting from equity participation by multi-national
drug companies.
Another social cost which cannot be quantified when foreign multi-nationals hold dominent equity (i.e.
their equity holdings are more than the largest single holding by Indian individuals or institutions), is in the
matter of self sustaining growth based largely on domestic R & D carried out'either in the company itself
or that which is available from other laboratories in India. It is well known that the management and staff
of Companies with dominent multi-national foreign equity holdings tend only to look overseas tor most of their
technological needs and often even for resolving their day to day plant problems. Even where the R & D
staff is such companies propose to develop technology on their own, such initiatives are usually discouraged
by their foreign collaborators and their Indian partners usually on the ground that such efforts are futile in
view of the possibilities of access of information from parent foreign companies. In such a situation their
is little incentive for such companies to become self reliant for their R & D needs. These social costs which
are non-quantifiable are indeed very serious since they make our industry permanently dependent on overseas
expertise and technology.
It is glaringly obvious that the multi-national units are not interested in producing bulk drugs in countries
like India. In Europe and U.S.A, the multi-national units produce bulk drugs in a spirit of collaborative
relationship. In the developing countries, such production is avoided by them and where this is done, the
host country pays dearly for such drugs.
The multi-national units operating in India produce only a small fraction of bulk durgs. The main thrust
of the multi-national units continues to be towards capitalizing on drug formulations and non drug items like
cosmetics and luxury goods where technology and capital in-puts are much lower and which permits promo
tion of aggressive salesmanship and brings in much higher returns on investments. The Permission Lettersand C.O.B. licences have further helped these units to build enormous assets, which are completely out of proportion to their investments. Besides, they have repatriated over the years large sums of money in the form
of profits.
The selective attitudes of multi-nationals even in the field of Research and Development are dictated
almost entirely by their philosophy of global trade. Indeed, their entire philosophy of building monopolies
which lead inevitably to high prices and excessive profits is completely incompatible with the socio-economic
needs of this country. Their capacity to manipulate is recognised throughout the world and mere
regulatory measures cannot curb these activities.
We are convinced that their continued presence in this country is a powerful damper on the challenge of
our achieving the technological goals of self-sufficiency and self-reliance.
Basic drugs are produced in the Indian sector, including the public sector, to the extent of about 90%
in tonnage terms, and this demonstrates effectively the competence that has already been achieved in indigenous
technical skills.
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Continued presence in this country of the highly profit motivated multi-national sector can but promote
only the business nterests of this sector. Their presence in India, as a part of their global effort to capitalize
on human suffering in an organised manner, must therefore cease as early as possible.
We, therefore, strongly recommend that the multi-national units in the field of drugs and pharmaceuticals
should be taken over by Government and managed by the proposed National Drug Authority. Such take
over will not create any dislocation in production or distribution of drugs. Overwhelming majority of the
technological and managerial personnel in these units are Indians. We are convinced that with appropriate
governmental support they will carry on their respective functions with greater enthusiasm in reaching the goals
set by the nation. Should there be any technical difficulty for such take-over, suitable legislative measures
may be approved by the Parliament to remove it.
Interim measures aimed at facilitating the take-over of the multi-national units are recommended here
under.”
A second view was expressed as under :—
“As against these arguments in favour of taking over of multi-national drugs firms, some of the members
argued that there was no case, at this stage, to justify such drastic measures. The arguments advanced
by this group of members were :
While there is no difference of opinion that the activities of the multi-national corporations have to be
kept under strict surveillance, there is no evidence to suggest that their relative importance has grown-or is
growing or that the existing instrumentalities are inadqeuate to achieve established social objectives.
Under the existing legislative framework, and in particular the Industries (Development and Regulation)
Act, the Foreign Exchange Regulation Act and the Essential Commodities Act, Govt, have adequate powers
to ensure that the Drug Industry, both Indian as well as Foreign conforms to established national objectives.
In fact, over the last 20 years Govt, has in fact, used these powers to encourage the flow of much needed tech
nology and also to progressively reduce the share of the multinational companies in the production of for
mulations. After the recent amendments of the Foreign Exchange Regulation Ac. Govt, has the necessary
powers to further accelerate these processes.
It is true that in the absence of any concerted or purposive policy, there will be a tendency for the multi
national corporations to operate on the basis of self interest which may, in some cases, be in conflict with
national interest. But this type of situation can be dealt with through the exercise of powers already available
to Govt, and does not either require or justify a measure such as taking over all multi-national corporations
operating in this country. It is argued that the multi-nationals have a dominant role in the Drugs and Phar
maceuticals Industry. It has to be recognised, however, that the share of the multi-national in total production
has been steadily coming down and with the growth of the public sector and encouragement as envisaged in
other parts of this Report to Indian private sector, this share will continue to diminish. Incidentally, the
share of multi-national corporations in the Drugs and Pharmaceutical Industry in the country roughly about
40% of total production—is significantly lower than in many other Indian industries in which foreign invest
ment is permitted, and indeed, the relative importance of the multi-national corporations in the Drugs and
Pharmaceuticals Industry in India is much lower than in other developing countries and even as compared
to countries like United Kingdom where nearly 2/3rd of the total production emanates from multi-national
units.
The argument that multi-national companies have not and will not make any significant contribution
to the transfer of technology is not borne out by experience. From the very beginning it has been Govt.’s
policy to develop this industry on the lines of self-sustaining growth. Manufacture of basic drugs was accorded
high priority in the development of the industry. The success of this policy is borne ou t by the fact that while
as in the early 1950’s most of the requirements of Drugs and Pharmaceuticals were imported, th shares of
imports, including imported chemicals, is hardly 10% of the total value of production of the industry. Several
instances can be quoted to show that governmental pressure and pursuation has already succeeded in utilising
the vast resources of the multi-national Corporation to secure for the country, the kind of production and
the type of technology which otherwise would not have been available. For instance as far back as 1959-61
the manufacture of Vitamin ‘A’ was established within the country using indigenously available Lemongrass
oil. From 1963 Vit. ‘C’ and B, 12 had been produced from the basic stages. The same is true to the case
of many other drugs such as Chloramphenicol, Insulin, wide range of corticosteroids, Erythromycin, Penthonal, ampicillin etc. Many other products such as PAS, INH, Oral anti-diabetic, calcium Gluconate and
other calcium salts, and other iron salts also come into commercial production as a result of the activities of
multi-national Corporation in this country.
An important reason why the continued presence of multi-nationals Corportions under appropriate
surveillance is desirable, is because it provides the most effective and economical method for the transfer of
technology in a field in which technological and product obsolescence is quite significant. It is often argued
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that instead of permitting foreign firms to operate in this country, technology can be purchased outright. This
is claimed to be cheaper and would also assist the development of domestic Research and Development. While
in appropriate cases outright purchase of technology may be the most suitable method for the transfer of tech
nology, this mode of transfer of technology cannot be generalised.
In highly specialised fields or where the new technology is confined to one or two sources, it may not always
be possible to purchase the know-how. Moreover, it is one thing to buy know-how and quite another to have
continuing access to improvement in technology which are taking place all the time.
Purchase of technical know-how either by making a lump-sum payment, or by way of a royalty to be
paid for a fixed period provides access to an existing technology. On the other hand, when the foreign party
which has provided the technology has an equity participation, the Indian company can have access to the
continuing improvements in technology. There would be instances, therefore, where continuing association
in the form of equity participation is the only way of securing access of new technology. It may also be the
best way of ensuring that the country derives benefit from improved technology and updates it. If the objective
is to provide for the masses in this country drugs and pharmaceuticals at reasonable prices, this can only be
done by constant improvement in product-technology based on researches which are continuing elsewhere.
The argument that existence of foreign firms in the field of drugs and pharmaceuticals results in a drain
on foreign exchange, also needs to be viewed in proper perspective. The remittance of profits by multi
nationals has been of the order of a little over Rs. 5 crores annually in the last 5 years. This constitutes
0.16% of the country’s total exports. Indeed, the total annual remittance is today less than the actual exports
by firms having foreign equity of more than 50%. The foreign exchange costs of the multi-national corpora
tions, therefore, can be easily exaggarated.
While, as pointed out earlier,, there is a clear case for appropriate administrative action and constant
surveillance of the performance of the multi-national corporation, there is no case for the take over of foreign
companies in the field of drugs and formulations. The multi-national character of some of the units in this
industry can be—and indeed, should be—used for subserving national interest. In particular, the internationl
character of their operations can be utilised to increase the exports of formulations to a much greater extent
than at present. It would be our national advantage to utilise the resources and technology of multi-national
corporations, provided these fimrs are made to operate in conformity with established national objectives and
priorities.
The question of takeover of multinational units clearly has political overtones. The economic case for
takeover of drugs and pharmaceuticals units, however, has to be based on the advantages accruing to the
community from such a step ; and in this, it is difficult to make a distinction between foreign and I ndian com
panies. If there is a case for nationalisation of drugs and pharmaceuticals firms, the agrument would be equally
applicable to units in the Indian sector, above a certain size. There is no case for limiting the take over to a
segment of the industry namely the multi-national units and no persuasive case has been made out in favour of
nationalisation of the whole industry.”
A third view endorsed the second view but added that the size of the wholly Indian units to be nationalised be
atleast with an annual turnover of Rs.2 crores and above and those which are determined as sick units need not be
nationalised and paid unnecessary compensation.
The Committee could not come to any unanimous decision though the majority of the members were of the
view that foreign firms should be taken over as set out in the first view. However, the Committee was unanimous
that the measures set out in the succeeding paragraph should be taken forthwith.
21. Under the Guide Lines issued for administering Section 29 of the Foreign Exchange Regulation Act, 1973,
(FERA) Indian Companies having more than 40% foreign shareholding and branches of foreign companies engaged
in the production of items specified in Appendix I of the Industrial Licensing Policy of February 1973 of which ‘Drugs
and Pharmaceuticals’ is one are required within a specified period to associate Indian participation to not less than 26%
of the equity of the Company. The Committee recommends that having regard to the present stage of development
of the drug industry, for the purpose of FERA Guidelines, this industry should not be eligible for the preferential
treatement given to items specified in Appendix I of the Industrial Licensing Policy of 1973. In the view of the
Committee, foreign undertakings operating in this country should be directed to bring down their equity to 40%
forthwith and further reduce it progressively to 26%. This', however, is without prejudice to other concessions to
which they are eligible as a result of the industry being in Appendix I of the Industrial Licensing Policy of 1973.
The Committee would further recommend that the dilution of foreign equity as suggested above, should not take the
form of dispersed holding of the shares by large number of Indian nationals. This is because such widely dispersed
holdings will not, in any way, reduce the effective control of the foreign equity holders. In order to serve national
objectives, it would be desirable for Government to purchase these shares either by public sector undertakings which
are directly or indirectly connected with the manufacture of drugs/chemicals or by public financial institutions or by
Government itself.
22. Bulk drugs manufactured by companies fall under 3 categories, namely (i) against Permission Letters and
COB Licences, (ii) in excess of the licensed capacities, and (iii) in accordance with the capacities specified in the IDR
Act.
Regarding (i), the manner in which the production should be regularised, has been spelt out by us in Annexure
VI11 of the Chapter. As regards (ii), the companies concerned should be made part with 50% of the excess licensed
capacities in addition to the quota of 50% of their authorised production. As regards (iii), the companies should be
made part with 50% of their production to non-associated formulators.
Wherever manufacture of bulk drugs is carried on from penultimate stage, the companies concerned should be
directed to manufacture the drug from basic stages within a period of two years. In regard to “new drugs” which
are developed as a result of research carried out in this country, there is no need for such a condition to be imposed.
23. In respect of bulk drugs for which production capacities have not been fixed (e.g. Diazepam in the case of
M/s. Roche against C.O.B. licence) the capacities should be pegged at the level of production achieved in 1973 so
as
to affect adversely the interests of Indian units which are already engaged in the manufacture of such drugs.
Likewise the capacities of all formulations should be fixed. The Committee understands that in many licences serveral
formulations have been clubbed together and “combined capacities” fixed. This anomaly should be set right and the
capacity of each formulation specified separately. The Committee realises that demands for certain formulations
may sometime spurt up considerably and that rigid adherence to capacities mentioned in licences may occasionally
lead to shortages. We would therefore suggest that units may be permitted to exceed their capacities by 15% if
need in national interest.
24. Where foreign undertakings are producing in Indian drug formulations using imported bulk drugs, they
should be warned that unless they start and complete the manufacture from the basic stage the bulk drugs in question
within a period of three years they will not be permitted to continue marketing'the formulation at the end of the three
vears’ time limit. If however the bulk drugs are such as have been assigned to Public-Sector units, as recommended
by the Committee in chapter 111 of this Report their manufacture should be taken up by the Public Sector units. The
manufacture of essential and life saving drugs such as cardiacdrugs anti-diabetic drugs, anti-epileptic/convulsant
drugs, diuertics. anti-arthritic drugs, etc., must be assigned to the Public Sector units. Government should mobilize
all research telents available in academic institutions and the National Laboratories and start working on the produc
tion of the bulk drugs on a time-bound programme. If for some reasons, the public sector undertakings are not in
a position to take up the manufacture of the bulk drugs, the Indian sector of the industry should be offered the second
choice. The need for working on a time-bound basis should be emphasised on Indian companies also.
25. Indian drug manufacturers who are already engaged in the manufacture of those bulk drugs identified as
essential by tlie Task Force up to 10% of their total turn-over should be freely allowed to make all drug formulations
subject to their therapeutic rationale being accepted by the Drug Control authorities.
26. In no case foreign companies be allowed hereafter to manufacture house hold remedies such as alcoholbased tonics, other types of tonics, vitamin preparations, ointments for cold, burns, sprains, etc., cough mixtures,
gripe mixtures, aspirin tablets, pain releiving tablets etc. beyond the capacity mentioned in the Industrial Licence or
application for registration. Foreign units which are already engaged in the manufacture of these household
remedies, etc. should not be granted any expansion of capacity. The manner in which drug formulations already
permitted’ to be manufactured against Permission Letters/C.O.B. Licences issued to units are to be regularised has
been set forth in Annexure VIII.
27. The Committee is informed that branches of foreign companies or foriegn companies with 100% foreign
equity*have been engaged in unauthorized production of drugs. We are of the view that wherever a company is
found manufacturing drugs without Government’s authority (valid licence), penal action should be taken against
them.
28. Aimexure V indicates that there is scope for tightening repatriation of money by foreign companies under
various heads. The norms for payment of “Research contribution”, “Technical know-how fees”, “Trade Mark
fees”, etc. in the opinion of this Committee, need to be reviewed. We would suggest that tlie NDA should be entrus
ted with this task.
29. Remittances of money outside this country by foreign companies are permitted subject to certain conditions
being fulfilled by them. Certain companies may be required to start manufacture from the basic stage in a phased
manner. Export commitments are imposed in licences. Again, the principals abroad of foreign subsidiaries opera
ting in this country may be required, by a condition in the licence, to invest money in this country. The Committee
recommends that a suitale machinery should be evolved to check that the conditions imposed in industrial and
other licences are fulfilled before remittances abroad arc permitted.
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30. The Committee understands that foreign companies which are unable to secure a foothold in the drug
industry in the country in terms of the Industrial Policy sometimes by pass the regulations by purchasing a company
operating in this country and work through it. Many foreign companies have also grown up in size by operating in
the small-scale sector. As already mentioned by us. rhe small-scale sector should be a prohibited area for foreign
companies.
31. Distribution of samples of drugs by drug manufacturers to the medical profession, in our opinion, is neces
sary, particularly to enable physicians to use them and form their opinion on the basis of the therapeutic effects
achieved. Unfortunately, this practice of distributing samples has degenerated into a rat race among manufacturers,
each one trying to excel the other in the quantity of drug samples distributed to doctors.
The scale of distribution
of samples resorted to is unusually hfcavy in many cases and leads to malpractices. Reports have been received of
physicians’ samples being found on the premises of drug dealers. In order to curb these malpractices, the Committee
would recommend that excise duty should be levied on drug samples distributed by manufacturers. Besides, all
expenditure incurred on samples by drug manufacturers should not be deemed to be business expenditure for purposes
of corporate taxation.
Supply of free samples may however be permitted, as at present, for the first three years from the date of introduc
tion of a product for the first time by an Indian company.
32. Drug manufacturers have cashed in heavily on the sale of their household remedies including vitamin
preparations. Most of these products are advertised in the lay press and through the medium of the radio. Such
indiscriminate advertisements, in our opinion, would lead to self-medication of drugs which is not desirable. The
Committee appreciates the importance of educating the people residing in rural areas about the use of household
remedies, and advertisements of drugs may have to be permitted to serve this limited need.
33. The Committee wishes to point out that drug companies have been processing life-saving and essential
drug formulations from raw materials imported from their principals at very high prices. Examples of such formula
tions are gentamycin injection, corticosteroid preparations, etc. The import of some bulk drugs has been canalize
through the State Trading Corporation. The companies concerned are reported to have been engaged in the import
of such bulk drugs for many years. The prices of bulk drugs, intermediates and raw materials should be screened by
the National Drug Authority and wherever there are reasons to doubt that they are excessive, the prices should be
brought down. Such a check is necessary in the country’s interests. Indeed, we would go to the extent of suggesting
that if the directions issued by Government in this connection are not complied with by companies the latter should be
taken overby Government under the powers vested in the Industries (Development and Regulations) Act.
34. We understand that several drug companies, both Indian and foreign, have secured industrial licences but
have not implemented them. The NDA should be asked to go into those cases and suggest necessary action. NDA
should also look into those units which had committed themselves io go basic in the manufacture of bulk drugs in a
phased manner but have not acted in accordance with the terms of the commitment.
35. Trade Marks registered in India by foreign firms for formulations should not be permitted to be renewed
if similar formulations are processed in India by Indian firms. The provisions of the Trade and Merchandise Mark
Act should be examined in this connection.
36. Turning to the measures of assistance for the Indian sector of the drug industry, the discussions that the
Committee had with the organisations representing the interests of this sector, including the small scale sector, and
with individual manufacturers, emphasised the need for protecting the interests for those Indian manufacturers who
produce basic drugs and for a more liberal allotment of canalised raw materials for essential drug formulations. Other
aspects represented by the Indian sector of the drug industry were
_ Distribution of canalised raw materials should be done on the basis of production capacity. Facilities for
obtaining solvents like alcohol and acetone, ammonium sulphate, acids, etc., should be provided.
—Extending preference and help to Indian companies for manufacture of bulk drugs. For this purpose, the
Patents Act should be amended.
__Encouragement to units which set up manufacturing facilities in the “backward” regions in States.
—Indian firms should be given special consideration in matters relating to exports.
—The working of the Drugs (Price Control) Order should be so rationalised as to ensure that prices of drugs are
fixed without delay and that the Indian Sector gets sufficient incentive to develop.
37. As for allotment of raw materials, the Committee considers that there is force in the representation of
manufacturers regarding inadequate releases of raw materials for essential new formulations or for new units. The
Committee, therefore, recommends that liberal allocations of raw material for essential new formulations and to new
units should be made.
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38. As regards exports, the Committee recommends that (a) wholly Indian companies should be exempted from
the export obligation as applicable presently; and (b) additional incentives like extra foreign exchange for import of
raw materials and components should be provided in case they export their products.
39. The manner in which the Drugs Price Control Order should be rationalised so as to facilitate the working
of the drug industry and the incentives that should be extended to the industry in the matter of drug prices so as to
foster the production of bulk drugs have been dealt with separately in Chapter VI11.
40. Considering the general increase in the cost of machinery, equipment etc. that the small-scale sector of the
drug industry should maintain for ensuring “’Good Manufacturing Practices’’ and for effective quality control
measures, the Committee recommends that the monetary limit for investment in plant and machinery for a small
scale unit in the drug industry should be raised to Rs. 20 lakhs. The general representation from the small units is
that it is very difficult for them to obtain import licences for machinery and equipment. The Screening Committee
that functions under the Chairmanship of the Chief Controller of Imports and Exports for considering applications
for import licence for machinery etc. by small-scale units, it was reported to us, adopts a very rigid attitude in this
respect. This aspect, we would recommend, should be taken up by the National Drug Authority and a satisfactory
solution found. We also with to point out that the recommendations made by a Committee of the Ministry of
Petroleum and Chemicals immediately after the price control measure over drugs was introduced, to help the small
scale sector of the industry should be implemented expeditiously.
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41. Small-scale manufacturers producing bulk drugs should be advised by the State Drug Control authorities
to register their production capacities with the D.G.T.D., the Drug Controller India and the Ministry of Petroleum
and Chemicals. Registration of capacities should be done on the basis of the information supplied by manufacturers
through the State Drug Control authorities regarding their potential capacity of production, die level of production
achiever., the raw materials required for manufacture, the specifications of the drugs and their sale prices. Thecapacities for production, as registered, should be taken into account by Government while granting Industrial
Licences under the 1(DR) Act.
42. The Indian sector of the drug industry, in general, needs considerable information to enable it to plan its
expansion, programmes. In Chapter 111, we have recommended the constitution of N.D.A. This Authority should,
in our opinion, maintain a “Drug Information Service” and make available to drug manufacturers information
reoardin" the items that can be manufactured, the Patent position regarding drugs, the processes and know-how that
are available from indigenous sources, the overseas countries and companies which are in a position to provide know
how. the supply position of raw materials in world markets and the prospects for export.
43. During the course of the visits undertaken by this Committee to the Different regions of this country, some
member's of thelndustry mentioned about the apprehensions and diffculties faced by them m taking up the manufacture of new bulk drugs with the meagre resources at their disposal. It was mentioned that m 196o, applications for
natents in respect of drugs and medicines were frozen and even with the enactment of the new patents Act, 1970,
which came into force in April, 1972, this freeze continues till today. It was mentioned that about 7,000 applications
were still pending with the Patent Authorities and though the inventions claimed in these applicat.ons d:d not enjoy
any protection until these are accepted or sealed, entrepreneurs, not being aware of the inventions claimed in the
frozen applications, find it very difficult to adoct any process/technology and set up any manufacturing facilities for
their production. They also apprehend that if any of the units starts manufacturing and marketing the drugs, which
mi"ht have been covered by such frozen applications, with the sealing of such applications and consequently the
patents, the patentees would have secured rights in respect of the inventions claimed whereby they would be entitled
to take legal action for infringement against the entrepreneurs who would have gone ahead in the manufacture of
such dru^s and thereby would face the prospect of closing down their activities, which would adversely affect the
industry and the public besides the members of the public would also be deprived of the drugs so produced indigenously,
U is under these circumstances that the local entrepreneurs found it very difficult to decide whether or not to
embark on such activities. On the other hand, it was also gathered from the Controller of Patents that no party has
so far approached him for any compulsory licence, a provision under which an intending entrepreneur could take up
such manufacturing activities. It was also pointed out by some that even today it is not possible for anyone who
intends to manufacture and market a new drug, to ascertain whether the item is covered by any of the pending/frozen
applications. It was suggested that to remove all such difficulties, the Patents Office should maintain an Information
Centre to snide the entrepreneurs as to whether there are any applications pending covering the drugs sought to be
produced, and that this could be done even without divulging the specifications contained in the applications.
44. The Committee recommends that a subject index should be prepared immediately and maintained by the
Patent Controller’s Office regarding the pending applications to guide the intending entrepreneurs, who after inspec
ting the same could decide the course of action themselves. It would also be helpful if the Patents Office brings out a
lisfof patents applications which are rejected after examination by that office. The Committee agrees that so long
as anxiety persists in the minds of the industry who have introduced or are in the process of introducing new drugs
about the outcome of the pending applications, many of the units would shy and shun any fresh venture on production
of new bulk drugs. The Committee would also recommend that wherever an Indian entrepreneur has set up any
basic production within a certain specified period which might infringe on the coverage claimed in the pending applica
tions, a suitable solution should be found out whereby the concerned entrepreneurs could continue with their manu
facturing operations.
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45. Whenever foreign companies apply for manufacture of bulk drugs, Government should issue a notice about
the application and its terms and ask, within a period of two months, whether Indian companies and the public
sector units can take up the manufacture of such drugs. The applications should be considered in the light of the
replies received from Indian Companies and th-, public sector units. This however will not apply to applications
received foi bulk drugs manufactured in accordance with the recommendations made in para 24 of this Chapter.
46. Drug companies all over the country had represented to us about the difficulties experienced by them in
obtaining supplies of solvents and other items such as alcohol, acetone, nitric acid, ammonium sulphate, glass vials,
rubber closures, aluminium strips, etc. Most of the items are controlled by public sector agencies or Government’
We are of the view that a special cell should be established in the National Drug Authority to process representations
received from the drug industry in this connection and take them up expeditiously with the various agencies. Some
State Governments, who have supplies of alcohol, we regret to say, have not been able to assist drug manufacturers
with their requirements. In particular, units in Andhra Parades^ manufacturing life-saving drugs" such as P.A.S.
heparin, anaesthetic ether etc. were unable to produce to their full capacity because of shortage of alcohol.
47. Our discussions with the Indian Medical Association and other members of the medical profession lead us
to believe that in matters relating to drugs, which are mainly preserfbed by physicians. Government should keep the
medical profession in touch with its policies and concepts on the development of the drug industry. The proposed
objective of Government for giving special attention to the growth of the Indian sector of the industry should surely
find support from the members of the medical profession if proper rapport is maintained by Government with them.
We would suggest that for this purpose the NDA should have a top-level committee and that representatives from
the medical profession, the Ministry of Health, the various sectors of the drug industry and State Drug Controllers
should find a place in the top level committee.
48. For promoting the rapid growth of the drug industry, this Committee is in general, agreement with the
measures suggested by the Task Force of the Planning Commission subject to the specific orientation in policies rela
ting to foreign and Indian companies advocated by us in this chapter as a result of the term of reference assigned to
us.
49. On the subject of exports, this Committee, while fully agreeing with the view that unless the country steps
up exports, the availability of foreign exchange for import of chemicals, drugs and i ntermediates may not be adequate,
feels that export of basic chemicals, solvents and bulk drugs that we import or are deficient in, should not be allowed.
50. On the subject of drug research, we agree with the recommendations of the Task Force that a centralized
committee should be set up to supervise the overall planning and work in this field. The NDA may be assigned the
supervisory task. In our view, the Indian Council of Medical Research should concentrate its attention particularly
on the discovery of newer drugs for tropical diseases. The Recommendations of the Task Force on the subject of
drug research, is also supported by this Committee.
51. The Committee feels that the necessity for import of technology by the drug industry, wherever it is needed,
should be screened by the “NDA”. The terms of payment for imported technology have been set out in para. 105
of chapter 111. In the case of drugs with low volume turn-over such as anti-cancer drugs etc., which are imported
today, if any Indian unit wishes to study the possibility of their manufacture in this country by assessing their demand
the import of such drugs should be permitted for a period of two years. At the end of two years, if the sales volume
of the drugs exceeds Rs 10 lakhs in value,the company which imports the drugs should be permitted to undertake the
bulk manufacture of the drug on payment of a scale of royalty up to 5% on the net sales realisation of the finished
product (i.e. sales value minus excise duty and trade commission). Export obligations need not be insisted upon in.
such cases.
52. We have been asked to make recommendations for a balanced dispersal of the drug industry in the country
Considering the vastness of the country and the strategic importance of this industry in the maintenance of health
care, the Committee is convinced that dispersal of the industry is essential. Even within States, the industry should
not be allowed to concentrate in or around leading towns and cities. States should provide sufficient incentives to
the industry and help them to develop in the ‘backward’ regions, where basic facilities such as good water supply and
electricity are available and where transport and disposal of effluents will not present problems. At present, the drug
industry is concentrated in Maharashtra, Gujarat and West Bengal. Even in these States the industry is concentra
ted in one or two large metropoliton.cities. Also other States, excepting Andhra Pradesh have practically no industry
worth the name. Andhra Pradesh is developing on right lines and Karnataka has been offering sufficient incentives
to attract pharmaceutical units. Unless the Central and State Governments work in unison, it will be difficult to
achieve any measure of success towards the goal of rational dispersal of the industry in different regions.
53. Unfortunately the industry has very little idea of the raw material and other resources that are available in
various States. Barring a few States, most of the States have not made any survey of the raw material resources
available in their area. We would recommend, as a first step, that States should enlist the support of drug manu
factures, leading organic chemists, botanists etc. and make a survey of the raw materials, plant products, animal
I
I
103
products, solvents etc. that are avilabl in their regions. Taking the drugs and intermediates identified by the Task
Force as essential for the country, the States should publish brochures setting forth the raw material position and the
facilities and concessions that prospective manufacturers can hope to receive. We would specifically recommend to
the State Governments that manufacture of bulk drug being capital intensive, they should form joint sector ventures in
collaboration with well-established companies or technical entrepreneurs. At present only Tamil Nadu Government
is participating in a joint-sector venture which manufactures both drug formulations as well as basic drugs. Our
discussions with the scientists in West Bengal indicate that there is good scope for development of phytochemical
industry in that state, in the Joint Sector. More joint-sector ventures are in our opinion necessary for manufacture
of glass containers, tubings for ampoulesand glass ampoules. Similarly, the aluminium foil industry for manufacture
of strip-pack! ng of tablets is also a suitable field for such joint-sector ventures. In chapter III. this Committee has
elaborated the plant products that can be cultivated in India. The importance of phytogenetic studies and agricultural
botany in the cultivation of medicinal plants needs no emphasis. The scope for manufacture of drugs from animal
glands and tissues is considerable. For this purpose, well-organised slaughter-houses operating under ideal condi
tions and fitted with arrangements for referigeration of animal glands etc. are necessary. This Committee has no
doubt that on the drug industry has before it the picture of the raw materials and facilities available in the States,
new units can be expected to be started in various parts of the country.
54. We wish to make a special mention of the discussit ns we had with the scientists from West Bengal. The
Committee was also specially invited by West Bengal Government to see the chemical and other plants functioning in
Durgapur. The Committee feels that the growth of the drugs industry is largely dependent upon that of the chemi
cal industry, particularly the organic chemical industry, which in turn, is based on coal-carbonisation complexes and
petroleum-based complexes. Prices of petroeum products have today shot up in the world markets. Consequently,
this country may have to manage with inadequate supplies of petroleum products. India, with its abundant supplies
of coal, should therefore develop coal-carbonisation plants which could provide many basic raw-materials for the
drug industry. The Committee notes that the coal-carbonisation complex situated in Durgapur, has already been
developed to a certain stage and would therefore, recommend that its potentialities should be explored fully by the
Central Government.
55. Similarly, there is scope for developing coal-carbonisation complexes in the Western and Southern regions.
We understand that the coal-reserves in Chandrapur District in Maharashtra and Kothagudam in Andhr? Pradesh
can constitute the nucleus round which coal carbonisation complexes can be developed, The Committee would
urge on the State Governments and Central Government to give serious consideration to the development and utilisation of these coal resources.
56. The concept of “industrial estates” is yet to be developed in very many States. The need for ensuring
continuous electric power to drug units should not be lost sight of. Similarly water supply in abundance are needed
by many units. These aspects are not taken care of even now by many States. Unless these aspects are streamlined,
drug manufacturers may not be attracted.
57. Our recommendations for regularising production by foreign units in excess of their licensed capacity is
subject to the overall condition that this should only be allowed if Indian Sector or the public sector is no; manufac
turing this or there is no scope of it being manufactured in the near future.
i
3
■
■
1—M of Pet. & Chem./75—14
j
9
SUMMARY OF RECOMMENDATIO xNS
tHc units having a turnoTerTf
the restrictions stated to have h
<-’) The I,ld,an sector should
... ..................
fChapter_v, para
regarding their
8
° the Ind,an coraPanies which are technS?cCOnipailICS
r L (SA) The Committee
recommended by a majority view that the
iorthwith.
[dapter-V, para
multinational firms should be taken
for the'pu^sforFERA “ends that having regard to the n
19].
over
^apter-V, para 20]_
specified in Appendix-I 5f S'lnduSial’r51'7 Sh°Uid not be eSe Ke°f d7eiopmen' of the drug ,nfj
Country should be directed to hrin^S St
L^cens,n^ Policy of
Preferential treatment aiV5 lndllstry
This however is without nr^ ri^0Wn tl]ejT equitv to 40°/ forth • u
F°reign undertaking or» °Iven to dems
It would be desirable for Government
°f disPe™d holdings oZe t j^ -
ther rccommend th
Lbe'ng
onsorby Government
3
[Chapter-V, para 2?J
104
t
105
(11) Those who are producing in accordance with the specified capacities should be made to part with 50%
of their production to non-associated formulators. In regard to new drugs which are developed as a result of re
search carried out in this country, there is no need to impose such a condition. This will automatically; negate
the Government Notification No. 3(3)/65-Ch. Ill dated the 27th May, 1969.
[Chapter—V, para 22].
(12) Wherever manufacture of bulk drugs is carried on from penultimate stage, the companies concerned
should be directed to manufacture the drug from basic stage within a period of two years.
[Chapter—V, para 22].
(13) In regard to the capacities approved for the manufacture of bulk drugs against permission letters and
c.o.b. licences, the Committee recommends that having regard to the national need for bulk drugs, the permission
letters and c.o.b. licences issued to such firms, may be regularised on the condition that
(a) all bulk drugs are manufactured from the basic stages; and
(b) 50% of the production of basic drugs should be made available to non- ossociated Indian formulators.
[Chapter—V, para 22 Annexure VIII].
(14) So far as formulations covered by Permission letters/C.O.B. Licences are concerned, in order that there
may not be a gap between production and market demand thereby creating a shortage in the market, the Indian
firms applying for the manufacture of such formulations should be given licences liberally forthwith and the foreign
firms should be asked to switch over within one year to the manufacture of bulk drugs and formulations to the extent
of 50% of the production of basic drugs by them, and the balance 50% to be supplied to non-associated formulators.
[Chapter—V. para 22, AnnexureVIII]
(15) In regard to bulk drugs for which no capacities have been fixed in the c.o.b. licences, capacities should
be pegged at the level of production achieved in 1973. Likewise, the capacities of all formulations should be fixed.
In regard to formulations for which combined capacities have been fixed, the capacity for each formulation
should be specified separately. Wherever demand warrants, the firms may be permitted to exceed their capacity
by 15%, if needed in national interest.
[Chapter—V. para 23].
(16) Where foreign undertakings are producing in Indian drug formulations using imported bulk drugs, they
should start and complete manufacture from the basic stage within a period of three years, failing which they should
not be allowed to continue marketing the formulations after the said period. If, however, the manufacture of such
bulk drugs have been assigned to the public sector units, their manufacture should be taken up by the public sector.
All research talents available in the academic institutions and the national laboratories should be mobilized and work
on the production of bulk drugs on a time-bound programme should be undertaken. If for some reason, the public
sector undertakings are not in a position to take up the manufacture of the bulk drugs, the Indian sector of the
Industry should be offered the second choice, who, in turn, should take up this work on a time-bound programme.
[Chapter—V, para 24].
(17) Indian drugs manufacturers who are already engaged in the manufacture of the bulk drugs, identified
by the Task Force, up to 10% of their local turnover should be freely allowed to make all drug formulations, subject
to their therapeutic rationale being accepted by the Drug Control authorities.
[Chapter—V, para 25].
(18) Foreign companies which are already engaged in the manufacture of house-hold remedies such as alcoholbased tonics, vitamin, preparations etc. should not be granted any expension in capacity, nor should they be allowed
to take up such activity as additional items hereafter, nor be allowed to manufacture such items beyond the capacity
mentioned in the Industrial Licence or application for registration.
[Chapter—V, para 26].
(19) The Committee suggests that penal action should be taken against branches of foreign companies or 100%
foreign equity holding units, manufacturing drugs without Government authority (Valid licence).
[Chapter—V, para 27].
(20) The Committee suggests that the NDA should review the norms for payment of research contribution,
technical know-how fees etc., by foreign companies.
(Chapter—V. para 28].
(21) The Committee recommends that a suitable machinery should be evolved to check that the conditions
imposed in industrial and other licences are fulfilled by foreign firms before remittances broad are permitted.
[Chapter—V, para 29].
(22) The small scale sector should be a prohibited area for foreign companies.
[Chapter—V. para 30].
106
(23) The Committee recommends that excise duty should be levied on drugs sample distributed by manufac
tures. All expenditure incurred on samples by drug manufacturers should not be deemed to be business expendi
ture for purposes of corporate taxation. Supply of samples may however be permitted, as at present, for the first
three years from the date of introduction of a product for the first time by an Indian Company.
[Chapter—V, para 31].
(24) The Committee appreciates the importance of educating the people residing in rural are is about the
use of house-hold remedies, and advertisments of drugs may have to be permitted to serve this limited need.
[Chapter—V, para 32].
(25) The prices of imported bulk drugs, intermediates and raw materials should be screened by the NDA and
wherever there are reasons to doubt that they are excessive, the prices should be brought down. If the directions,
issued by Government in this connection are not complied with by the companies, the letter should be taken over
bv-Government.
[Chapter—V, para 33].
(26) The NDA should look into the cases of all unimplemented licences, including those involving basic manu
facture of bulk drugs in a phased manner, and should suggest necessary action.
[Chapter—V, para 34].
(27) Trade Marks registered in India by foreign firms for formulations should not be permitted to be renewed
if similar formulations are processed in India by Indian firms. The provisions of the Trade and Merchandise Marks
Act should be examined in this connection.
[Chapter—V, para 35].
(28) In regard to allotment of raw materials to Indian sector, the Committee recommends that liberal alloca
tions of raw materials for essential new formulations and to new units should be made.
[Chapter—V, para 37]
129) Indian firms should be given special consideration, in matters relating to exports, as follows:—
(a) wholly Indian companies should be exempted from the export obligation as applicable presently; and
(b) additional incentives like extra foreign exchange for import of raw materials and conponents should be
provided in case they export their products.
[Chapter—V, para 38].
(30) The monetary limit for investment in plant and machinery for a small scale unit in the drug industry should
be raised to Rs. 20 lakhs.
[Chapter—V, para 40].
(31) Tire NDA should look into the difficulties experienced by the small scale sector in obtaining import
licences for machinery and equipment and a satisfactory solution be found. The Committee also wishes to point
out that the recommendations made by a Committee appointed by the Ministry of Petroleum & Chemicals, soon
after the Price control measure cover drugs were introduced to help the small scale sector of the industry, should be
implemented expeditiously.
[Chapter—V, para 40]
(3'’) Small scale manufacturers producing bulk drugs should be advised by the State Drug Control Authority
to register their production capacities with the DGTD, Drug Controller (India), and the Ministry of Petroleum &
Chemicals- Registration of capacities should be done on the basis cf the information supplied by manufacturers
through the State Drug Control authorities regarding their potential capacity of production, the level of production
achieved, the raw materials required for manufacture, the specifications of the drug and their sale prices. The capa
cities for production as registered should be taken into account by Government while granting Industrial Licences.
[Chapter—V, para 41]
(33) The NDA should maintain a comprehensive Drug Information Service in respect of the items mentioned
in para 42.
[Chapter—V, para 42].
(34) The Committee recommends that a subject index should be prepared immediately and maintained by the
Patent Controller’s Office, regarding the pending applications to guide the intending entrepreneurs who after inspect
ing the same could decide the course of action themselves. It should also be helpful if the Patents Office brings
out a list of patents applications which are rejected after examination by that office. The Committee would also
recommends that wherever an Indian entrepreneur has set up any basic production within a certain specified period
which might infringe on the coverage claimed in the pending applications, a suitable solution should be found
out whereby the concerned entrepreneurs could continue with their manufacturing operations.
[Chapter —V, para 44].
107
(35) Whenever foreign companies apply for manufacture of bulk drugs. Government should issue a notice
about the application and its terms and ask the Indian companies and the public sector units to inform with a period
of two months, whether they can take up the manufacture of such drugs. The applications should be considered in
the light of the replies received from Indian companies and the public sector units. This, however, will not apply
to applications received for bulk drugs manufactured in accordance with the recommendations made in para 24.
(Chapter—V. para 45)
(36) A special cell should be established in the NDA to process the representations received from the drug
industry in connection with the availability of raw materials, solvents etc. from indigenous sources. NDA should
look into this problem expeditiouslv in consultation with the various agencies involved.
(Chapter—V, para 46)
c
(37) The Government should keep medical profession in touch with the policies and concepts on the develop
ment of drug industry. For this purpose, NDA should have a top-level Committee consisiting of the representa
tives of the medical profession, Ministry of Health, various sectors of the drug industry and State Drug Controller.
(Chapter—V, para 47)
(38) Export of basic chemicals, solvents and bulk drugs which we import or are deficient in, should not be
allowed.
.nx
(Chapter—V, para 49)
(39) Indian Council of Medical Research should concentrate its attention particularly on the discover} of the
newer drugs for tropical diseases. NDA should be assigned the supervisory task in this regard. The Committee
endorses the recommendations of the Task Force on the subject.
(Chapter—V, para 50)
(40) NDA should screen the import of technology required by the drugs industry.
The import of
dru^s having low-volume turnover, like anti-cancer drugs, should be allowed for a period of 2 years. At the
end°of two years, if the sales value exceeds Rs. 10 lakhs, the concerned unit should be permitted to undertake the bulk
manufacture of the drug, on payment of royalty upto 5% of net sales realisation of the finished products i.e.
sale value minus excise duty and trade commission. Export obligations need not be imposed in such cases.
(Chapter—V, para 51)
(41) Considering the vastness of the country, dispersal of the industry is essential. Within states, the industry
should not be allowed to concentrate in or around towns and cities. States should provide sufficient incentives to
the industrv and help them to develop in the backward regions where the basic facilities are .available.
(Chapter—V, para 52)
(42) State Governments should enlist the support of drug manufacturers, leading organic chemists, botanists
etc. and make a survey of the raw materials, plant products, animal products, solvents etc. that are available in their
regions. States should also publish brochures setting forth the raw material position and the facilities and
concessions that prospective manufacturers can hope to receive. They should also form Joint Sector Ventures
in collaboration with well established companies or technical entrepreneurs. West Bengal offers good scope for
development of phyto-chemical industry in that State in the Joint Sector. Joint Sector Ventures should also be set
up for the manufacture of glass containers, tubings for ampoules and other packing materials like aluminium foils
etc*
(Chapter—V, para 53)
(43) In view of the soaring prices and inadequate availability position of petroleum-based chenrcals, greater
attention should be paid on coal-carbonisation, as abundant supplies of coal are available in the country’. The
coal carbonisation Comdex situated in Durgapur has already been developed to a cetrair stage and its potentia
lity should be explored fullv bv the Central Government. Similarly the coal reserves in Maharashtra and Andhra
Pradesh should be utilised and coal carbonisation complexes be developed in those regions. The Committee would
urge on the State Governmentsand Central Government to give serious consideration to the development and utilisa
tion of these coal resources.
'
(Chapter—V, paras 54 & 55)
(44) Uninterrupted supplies of electric power and abundant supply of water should be ensured to the drug
industry.
(Chapter—V, para 56)
(43) Our recommendations for regularising production by foreign units in excess of their licensed capacity
is subject to the overall condition that this should only be allowed if Indian Sector or the public sector is not manufacturine this or there is no scope of it being manufactured in the near future.
(Chapter—V, para 57)
l
AbcNEXURE—I
Growth of Assets <f Important Units Having Foreign Equity
!
(Chapter—V, para 3)
S. No.
Original
Equity
Name of the Firms
Present total paid-up capital of the
Indian firm.
Issued for
Cash
Rs.
(1)
(3)
(2)
1. A.C.C.I. '
2. Anglo-French Drug Co.
3. Bayer (I) Ltd.
4. Beechem .(1) Ltd.
5. Boehringer—Knoll
6. Boots Co. Ltd.
7. Burroughs Wellcome & Co.
8. Ciba of India Ltd.
9. Cyanamid (I) Ltd.
10. Glaxo Labs.
11. Johnson & Johnson
. ’
12. Merck Sharp & Dohme
13. Parke Davis Ltd.
14. Pfizer Ltd.
15. Reckitt &. Colman.
16. Richardson Hindustan Ltd.
17. Roche Product Ltd.
18. Sandoz (I) Ltd.
19. Searle (I) Ltd.
20. Wyeth Labs. Ltd.
21. Abbott Labs. Ltd.
22. C.E. Fulford Ltd.
3. Dental Products of India
I.
Rs.
(4)
35,34,000 310,00,000
10,000
10,000
4,00,000
300.00,000
1,00,000
1,00,000
15.00,000
35,00,000
10,00,000
42,50,050
5,00,000
45,00,070
3,00,000
61,00,000
1.50,200
26,05,300
1,50,000
210,00,000
20,00,000
24,00.000
180,00,000
180,00,000
87,50,000
105,00,000
2,00,000
265,91,550
190.00,000
30,00.000
2,000
50,00,000
100,00,00
100,00,000
10,00,000
140,00,000
60,00.000
60,00,000
33,30,000
75,00,0000
1,00,000
1,00,000
4,00.000
4,00,000
2,00,000
3,40,000
Issued for
considera
tion other
than Cash
Rs.
(5)
Total
7,8&9
Rs./
Lakhs
Rs./
Lakhs
Issued for
Cash
Rs.
Rs.
Issued for
considera
tion other
than Cash
Rs.
(6)
(/)
(<S)
124,00,000
235,00,000
8,000
172,34,500
1.00,000
16,80,000
20,00,050
45,00,070
34,75,000
1,50,200
30,00,000
18,00,000
108.00,000
87,50,000
200.00,000
11 5,00,000
27,50,000
89,00,000
80.00,000
27,00.000
55,50,000
1,00,000
4 00,000
1,66,600
25,00,000
25,00,000
412,50,000
360,00,000
12,00,000
292,36,680
60,00,000
20,00,000
10,00,000
Total
of4-5&6
Issued by
bonus
Shares
5,00,000
9,99,950
4,99,930
14,00,000
44,09,300*
150,00,000
Paid up capital held by the foreign
share-holders
Issued by
bonus
Shares
Turn-over
Year
Rs.
Lakhs
Rs.
(9)
Reserves
(10)
(II)
(12)
328.00 1972-73
0.08 1973
172.345 1973
6.0
5,00 000
1973-74
12.00.000
60 00 28.80 1972-73
77.50 45.00 1973
9,99.950
15,00,000
4,99,930
50.00 50.00 1973
14,09,300
268,12,500 487.50 316.87 1973
44,09,300
70.146 45.595 1973
150,00,000
360,00,000 720.00 540.00 1973-74
9,00,000
36.00 27.00 1973
180.00 108.00 1973
105.00 87.50 1973
220,00,000 558.28 420.00 1973
60,00,000
250.00 175.00 1972-73
11,00,000
70.00 38.50 1972-73
100,00 89.00 1973
10.00,000
150.00
90.00 1973
60.00 27.00
1973
75.00 55.50 1973
1.00
1.00 1973
4 00
4.00 1973
3.40
1.666 1973
93,00,000
534.00
0.10
300.00
6.0
(13)
Rs.
Lakhs
(14)
3316
298
227.69
49
1578
368
127
1
346.86
54
778.43
126
419.10
10 3
3122.00
403
1201.00 485
3639.00
758
489.36
92
1051
93
1062
291
823
2570
144
802.74
546
^3
926
330
1556.42 489
36
185.33
393
63
824.07
159
159.48
11
19.00
8
O
oo
t
■>
24. E. Merck Ltd.
25. Griffon Labs.
26. Indian Schering Ltd.
27. Roussel Pharm
28. Dupher Intcrfran
29. Goeffrcy Manners & Co.
30. Hoechst Pharm
31. Martin & Harris
32. Organon (India) Ltd.
33. Suhrid Geigy Ltd.
34. Synbiotics Ltd.
35. Uni-Sankyo Ltd.
36. Wander Ltd.
37. Warner Hindustan Ltd.
.7
20,00,000
2,00,000
83,500
1,96,000
8,00,000
1,000
20,00,000
N.A.
97,54,900
7,20,000
60,00,000
1,00,000
9,70,000
70,00,000
62,21,800
1,81,740
1,00,000
6,37,000
27,00,000
5,01,000
80,00,000
16,77,090
97,54,900
27.00,000
75,00,000
11,90,000
4,67,500
70,00,000
12,78,200
18,260
5,00,000
17,000
1,50,000
9,00,000
90,99,000
95,52,200
19,00,000
233,00,000
5,22,500*
5,10,000
28,00.000
32,21,800
1,40,20
88,700
2,18.000
13,50,000
3,60,000
40,00,000
1,000
47,79,900
12,82,000
36,00,000
5,81,100
22.000
35,00,000
12,78,200
18,260
4,43,500
1,50,000
4,50,000
39,60,000
47,76,100
17,01,090
110,68,000
3,74,000
2,04,000
14,00,000
34
477.28
45.00 1973
75.00
30
243.00
1.588 1973
2.00
81
5.32 1973.74 414
6.00
49
233.66
6.54
1.18 1973
324.86
64
36.00
18 .00 1973
1536.69
218
96.00
43.20 1973
619
175.52
87.76 1973
2172.48
18.52 1973
122
N.A.
37.27
47.79 1973
25
97.54
316
262
260.00 123.50 1972-73 1500.51
99
75.00
36.00 1972-73 313.80
N.A.
5.83
11.90
17
15.00
1973
127.77
6.00
1973
70.00
35.00
639.00
154
♦Towards Import of Equipment.
i
1
/
O
I
i
’’OB’
A.vskxure n
List of Permission/No Objection Letters Issued
(Chapter V—Para 4)
S.
No.
Permission'No objection
letter No. & date
1
Item of manufacture
4
3
2
1. Hoechst Pharmaceuticals Ltd. Bombay
(i) Hostacycline Drope
1. 3/15/62-Ch.III
(ii) Hostacycline Syrup
dt. 15-10-62
(i) Hostacortin
2. 3/15/62-Ch. HI
(ii) Hostacortin H
dt. 24-9-62
(iii) Pyracortin
(iv) Pyracortin Forte
(v) Novalgin Quinine
*(vi) Fostavital
Afran
3. 3/15/62-Ch. Ill
dt. 11-6-1962
(i) Aspasan
4. 3/14/61-Ch. Ill
(ii) Efosin
dt. 19-8-61
(iii) Polyfen
(iv) Tumoson
(v) Reverin
2. Geoffrey Manners
L 1/56/62-Ch. Ill
dt. 1-11-62
2. 1/56/62-Ch. Ill
dt. 20-8-1962
3. 1/56/62-Ch. Ill
dt. 9-4-1963
4. 3/69/62-Ch. Ill
dt. 22-3-1963
5. 3/20/61-Ch. Ill
dt. 27-5-1961
6. 22/475/A(TD‘60
dt. 19-1-1961
7. 22/438TA(II)/69
dt: 19-1-1961
8. 22/465/IA(ID'60
dt.17-9-1960
9. 22/370/IA(ID/
dt. 26-10-1960
10. 22/240/IA)II)/59
dt. 29-7-1959
11. 22/146.TA(II/58
dt. 6-10-1958
12. HC-1/71/57
dt. 31-7-1957 &
dt. 31-3-1958
13. 22/100-IA(LB)/56
dt. 22-1-1958
14. 22/172-IA/LB/56
dt. 1-2-1957
15. 22/172/IA/II/56
dt. 4-9-1958
16. 22/313/IA/n/59
dt. 16-6-1961
Remarks
Capacity, if any
5
22,222
__of
212
*Within
overall
25,000 2-..'.
bottles
10 ml each rper______
annumi
10,030 bottles of 80 ml each per annum capacity of Postal
approved in Lie.
6 lakh tablets p.a.
No. L 22 No.-164/
35 lakh tablet p.a.
60 dt. 2-7-60
10 lakh tablet p.a.
10 lakh tablets p.a.
5 lakh Dragees p.a.
20 lakh dragees p.a.
6 lakh tablets p.a.
(vi) Baralgan Tabs.
(vij) Baralgan Amps.
12 lakh tablet p.a.
240 litres p.a.
120 lakh tablets p.a.
8000 Kgs. p.a.
10 lakhs vials (350 mg/vial)
2 lakhs vials (275 mg/viaD.
30 lakh tablets p.a.
7.5 lakh amp. p.a.
Benzathino Penicillin
G 360 Kgs. p.a.
Meprobamate
3000 Kgs. p.a.
Antibiotics Vials
34,000 p.m.
Multivitamin Tabs.
60 lakhs p.a.
Prcmarin Tabs.
2.5 lakhs, p.m.
Dristan Tabs.
5 lakhs p.m.
Zactrin Tabs.
1 million p.m.
Equaprin Tabs
12.5 lakhs p.m.
Trisulfose Tabs.
1 million p.m.
Prozine
1 million p.m.
Equanitrate Brand Maprobamate and 2.5 lakhs p.a.
pentnacrythritol Tetran Nitrate T
Tablets.
1 lakh p.m.
(i) Penicillin V. Tablets
1 lakh IU per tab.
2 lakh IU per tab.
2 lakh p.m.
(ii) Penicillin V with Triple sulpha Tabs 2 lakhs p.m.
Quanil Brand Moprobamate Tabs.
(400 mg & 200 mg).
(i) Clutamic Acid B Complex Tabs.
(ii)) Vit. B-12-B.I. Rosperin Tabs.
(iii) Malt Tonic
(iv) Gripe Mixture
(v) Laxative Tabs.
Manners Health Salt.
Manners Health Compound
110
I
|
I
111
1
1
2
17. 22/172/IA/II/57
dt. 22-4-1957
1
18. 22/125/IA/II/58
dt. 31-8-1959
19. 22/172/IAfLA)'56
dt. 3-12-1956
F
C
3. UNI-Laboratories Ltd.
1. 22/487 IA/II 60
dt. 22-1-1960
2. 22/309 IA 11/59
dt. 23-12-1959
4. Boots Co. India Ltd.
1. 22/433/IA/II/60
dt. 31-10-1960
2. 22/430,TA/II/60
dt. 31-10-1960
3. 22/431 /IA/11'60
dt. 31-10-1960
4. 22/429/1A 11/60
dt. 24-1-1961
5. 22/449/IA/II/60
dt; 31-1-1961
6. 22/491 /IA 11/60
dt. 1-2-1961
7. 22/432, IA/II/60
dt. 5-11-1960
8. 3/34/62-Ch. Ill
dt. 27-7-62
9. 3/34/62-Ch. Ill
dt. 28-1-1963
10. 3/38/62-Ch. Ill
dt. 9-3-1964
11. 22/127/IA LA'55
dt. 31-1-1956
12. 40/70/58-M.C.
dt. 18-6-1958
13. 22/196/IA/II/59
dt. 9-4-1959
14. 22/181/IA/II/59
dt. 11-4-1959
15. 22/179/IA/II/59
dt. 18-4-1959
••j
16. 22/212/IA/II/59
dt. 5-1959.
17. 22/435/IA/II/60
dt. 31-10-1960
18. 22/230/IA/II/59
dt. 31-10-1960
19. 22/483/IA/II/6O
dt. 27-1-1961
20. 22/492/IA/II/60
dt. 1-2-1961
1—M of Pet. & Chem(/75—15
4
3
5
(i) Lopvit
(ii) Manavit
(iii) Vitamycetni
(iv) Protisole
(v) Homules
Preparation ‘H’ Ointment
(i) Ointment for ringworm
(ii) Pain balm for head-aches
(iii) Cold Tabs.
(iv) Cough Syrup
Aceto Phona Lisatin
20 Kgs. p.m.
(i) Chlorpromazine Hcl.
(ii) Injections (25 mg. /cc).
5 lakh p.m.
100 litres p.m.
Junivite (Kentitone)
20 gallons p.m.
Strong crcmaffin with Phenolphthaloin
300 gallons p.m.
Otoxpear Drops
30 gallons p.m.
(i) Milk of Magnesia
(ii) Chirana Cherry Cough Syrup
(iii) Screen Travel Sickness Tab.
Supersan
600 gallons p.m.
8000 p.m.
200 gallons p.m.
Opsan Eye Drops
90 litres p.m.
Cobe-tone Elixir
400 gallons p.m.
Furamide Compound Tabs.
12 lakhs/year.
(i) Magmist Tabs.
(ii) Safersol
(i) Sweetex Liquid
(ii) Penicillin V. with Triple
Sulphanomide Tabs.
(i) Jackosin Emulsion
(ii) Triple Sulphanamide Tabs.
120 lakhs, p.a.
200 litres p.a.
6000 litres p.a.
12 lakhs p.a.
Elixir of Figs. (Figine)
(i) Sulphacitaniide Eye Oint. 10%
(ii) Fydal ex Tabs.
(hi) Fydal Tabs.
(iv) Didandin Tabs.
(v) Penicillin V. Tabs.
(vi) Thyroid Tabs.
(vii) Chirana Cough Lozenges
(viii) Calcium Gluconate Tabs.
(ix) Sulpha Citramide Sodium Solution 10 %
Piperli (Piperaz ine Citrate Syrup).
(i) Hydrocorterone Acetate Eye Drops
(ii) Cortesone Acetate Eye Drops.
(iii) Cortesone Acetate Eye Ointment
(iv) Tablets of Cortesone Acetate B.P.
(v) Hydromycin Ointment
(iv) Hydromyoin Eye/Ear Ointment
Delta-Stab Nesal Spray.
Tablets Cobeton
2 lakhs p.m.
Entamidc Feeroate Tabs.
6 tabls. p.m.
Pipre lix Tabs.
1.05 lakhs p.m.
(i) Aprenox Tabs (5mg)
(ii) Aprenox Tabs (2.5 mg).
2 lakhs p.m.
3 lakhs p.m.
Within
over a
Tableting capacity
112
1
2
1=
4
3
21. 3/11/61-Ch. Ill
dt. 15-4-1961
Strepsils Lozenges
8 lakhs p.m.
22. 3/38/62-Ch. Ill
dt. 4-2-1963
(i) Motha Quanlone
(ii) Dexamethasone Tabs.
42 lakhs p.m.
16.80 lakhs p.m.
23. 3/2/63-Ch. Ill
9-3-1964
(i) Ivax
12.009 Kgs p.m.
24. 22/102/IA/LA 55
dt. 24-4-1956
(ii) Ascorlleic Acid Tabs. (50mg &.
100 mg).
Penicillin Lozenges
25. 535/IA/II/57.
dt. 1-4-1957
Sugar Coated Tabs.
26. 22/120TA/II 53
dt. 23-9-1958
Dolfa Stab Tabs.
27. 22/230/IA/II/59
dt. 27-4-1959
Entamide Tabs.
28. 22/21 l/TA/II/59
dt. 7-5-1959
Halazone Tabs.
29. 22/102/IA/II/55
dt. 22-10-1959
Enzo lets
30. 23/311/IA/-1 '59
dt. 19-11-1959
Hydranox 50 mg. Tabs.
31. 8191-IA/II/57
dt. 18-12-1957
Mylol
32. 40/67/58-HC
dt. 31-5-58
Librox
33. 49/(1 l)/52-IA(4)/60
dt. 25-11-60
Chloriside Dust
5
Within
licensed
over all
capacity.s
1.50 million p.a.
5. Mis. May and Baker Ltd.
1. 22/269/IA/11/59
dt. 30-3-60
Chlorpromazine Hcl.
2. 22/434/1 AT 1/60
dt. 16-8-60
‘Anthical’ Cream
3. 22/168/IA/CA/56
dt. 11-10 -56
Anthisan Injection (includes Veterinary)
4. 22/168/IA/CA/46
dt. 11-10-56
Avomine Tabs
5. 22/244/1A/H/59
dt. 16-1-60
Avoprin Tabs
6. 22/137/1A/CA/56
dt. 19-6-56
Acriflavine Powder 5 mg.
7. 22/168/1A/CA/56
dt. 11-10-76
Gardenal Sodium Inj.
8. 22/168/1A/CA/56
dt. 11-10-56
Largactil injection (including veterinary) —
9. 22/46/IA/L/54
dt. 16-9-55
Nivaquine injection
10. 22/158/1A/CA/56
dt. 3-9-56
Plasmosan brand sol
11. 22/244,TA/11/59
dt. 16-1-60 and
dt. 19-10-60
Rovamycin Capsules
6 lakh p.a.
12. 22/93/1A/L/55
dt. 17-5-55
(i) Sulphamerazine tablets
(ii) Sulphadimidene tabs.
Within the overall capacity
B.P.
2508 Kgs.p.a.
1200 Kgs. p.a.
50.40 lakh Tab. p.a.
c
113
4
2
3
13. 22/168/1A/CA/56
dt. 11-10-1956
Anthionaline Sol.
14. 3/8/60-Ch. Ill
dt. 24-2-61
Carbachol injection
15. 22/378/IA/11/60
dt. 13-5-60
Digcstol Tabs.
2.40 lakhs p.a
16. 22/422/1A/l 1/60
dt. 20-7-60
Embazin Sol.
1800 litres p.a.
17. 3/75'62-Ch III
dt. 19-1-63.
Embazin Promix Powder
108 tonnes p.a.
18. 22/409 I A/11/60
dt. 18-1-61
Strinacin tabs
30.000 p.a.
19. 22/137 IA/LA/55
dt. 14-5-56
Sulphanilamide Powder 1 lb.
20. 22/377/IA 11/60
dt. 15-6-60
Trinamide Powder
21. 3/75/52-Ch. Ill
dt. 27-7-63
Peroxy 1 Sol.
22. 22/19/IA/L/55
dt. 28-6-55
Anthicol brand lotion
23. 22/244, IA 11/59
dt. 16-1-60
Rovamycin brand Spyramaycin
Capsules
Avoprin brand promethazine chloroIheopylline with acetyl salicylic acid
1
24. 22/158, IA’LA/56
dt. 3-9-56
Plasmosan brand solution
25. 22(L-22)IA-II/60
dt. 26-7-60
Embazin Brand SulphaQuinozaline Solution
300 litres p.a.
53,000 litres p.a.
6 lakhs
30.4 lakhs
6. M/s Roche Products Ltd.
1. 22/399 IA/U/60
dt. 13-10-60
Rovimix
Consuming Vitamin A 2.4 tonnes
2. 3/53/61-Ch. Ill
dt. 28-2-62
(i) Taractan 15 mg. tabs.
(ii) Taractan vials 50 mg.
(iii) Prostigmin tabs.
(iv) Prostigmin ampoules & vials
4 million p.a.
150 litres p.a.
1 million p.a.
280 litrds p.a.
3. 3/39/62-Ch. Ill
dt. 1.8.62.
Librax tabs
6 million p.a.
4. 3/39/62-Ch. Ill
dt. 25-9-62
Librium Ampoules
150 litres p.a.
5. 3/39/62-Ch. Ill
dt. 6-11-62
Marplan tabs.
4 million p.a.
1. 22/481/1ATI
dt. 18-1-62
Bephan Retard Tabs
60 lakhs p.a.
2. 3/6/61-Ch. Ill
dt. 8-1-61
Mcllaeric Tabs
100 lakhs p.a.
3. 3/6/61-Ch. Ill
dt. 5-4-61
(i) Vitamin C + Ferronicum Tabs
(ii) C.C.F. Sandoz
(iii) Ferintrin Caps.
(iv) Ferintrin Syrup
(v) Calcibronate+Bl
(vi) Ferintrin Sol.
(vii) Calcibronate + Bl.
(viii) Calcibronate+Bl Granules
50 lakhs p.a.
75 lakhs O.a.
100 lakhs p.a.
30,000 litres p.a.
-do10.000
-do1,000
10.000
-do10,000
-do-
7. Sandoz (India') Limited
->
5
r
114
1
2
4
3
4. 3/43/62-Ch. Ill
dt. 6-11-62
Nutrolac Tabs/Caps.
200 lakhs p.a.
5. 3 43 '62-Ch. Ill
dt. 20-12-62
(i) Cd. Sindoz tabs fortified with
200 lakhs p.a.
6. HC/1/23/58
dt. 4-3-58
(i) Cal. Sandoz Chock Tab
(ii) Belladenal Retd.
(iii) Bellargal Rtd.
(iv) Sandosten + G.S. Spray
(v) Sandortin + G.S. Syrup
7. 22T25/IAT1 55
dt. 14-5-57
Ferronicum
18,000 litres p.a.
8. 3/43/62-Ch. Ill
dt. 4-9-62
(i) Cal. Sandoz CVit.B 12
Calcium Sandoz Multi dose with
Vit. D2 and B 12
80.000 litres p.a.
14,250 litres p.a.
9. 22/296/IA 11.60
dt. 11-7-60
(i) Acylanid 2 ml ampl.
(ii) Ballafine 1 ml.
(iii) Godilanid
(iv) Digilanid 2 ml.
(v) Digoxin 1 ml.
(vi) Dihydorgot 1 ml.
(vii) Gynirgon 11 I ml.
(viii) Hydergone 1 ml.
(ix) Laboline 1 ml.
(x) Mothergin 1 ml.
(xi) Noogynergan 1 ml.
(xii) Sciliaron 1 ml.
(xiii) Strophosid 1 ml.
(xiv) Syntocinon l/A/2 ml.
1
Vii. D.
(ii) Calglufor
300 lakhs p.a.
8. Anglo French Drug Co. (Eastern) Ltd.
1. 22. I00 IA L 55
dt. 4-7-55
(i) Maxamottes
(ii) Lypofax Tablets
2. 2008/IA/II 57
dt. 15-4-1957
Sulpha Tablets
3. 22/214/IA/II 59
dt. 14-5-59
Malfax
4. 5/213/IA/II/59
dt. 1-6-59
Afdcr
9. Parke Davis (India) Ltd.
1. 22/239/IA 11/59
dt. 21-8-59
Prednisolone tabs. (5 mg.)
60,000 p.a.
2. 3/22/61-Ch. Ill
dt. 26-7-61
Chemoprim Tabs.
5 lakhs per month
3. 3/61/62-Ch. Ill
dt. 10-12-62
Benadriyl Lozenges
25,000 x 100 p.m.
10. Indo Pharma Pharmaceutical Works (P) Ltd.
1. 3/6/62-Ch. Ill
dt. 6-11-62
(i) Spasmindon Pediatric drops
(ii) Scabin ointment
600 litres p.a.
3000 kg- p.a.
2. 3/6/61-Ch. Ill
dt. 16-8-62
Ferrous Gluconate, B.P.
Sugar coated tabs.
12 million p.a.
3. 3/55/61-Ch. Ill
dt. 28-7-62
Asmacort T. Indon Tabs.
36 lakhs p.a.
4. 3/35/61-Ch. Ill
dt. 24-7-62
Piperazine Indon Tabs.
72 lakhs p.a.
5. 3/6/62-Ch. Ill
dt. 2-3-62
Diuret Indon Tabs.
1 lakhs p.a.
5
115
1
2
3
4
6. 22/450/IA/U/60
dt. 13-9-60
Ncospasmindon Tabs.
7. 22'410 [A/H 60
dt. 13-6-60
Vitamin don ‘C’ 500 mg. tab.
8. 22/279/IA/II 60
dt. 27-5-60
(i) Asmacortindon tabs.
(ii) Gravidindon tabs.
(iii) Lysindon B
(iv) Maprotoneindon Tabs
(v) Salexindon Tabs
50 lakhs p.a.
12 lakhs p.a.
600 litres p.a.
12 /akhs p.a.
12 lakhs p.a.
9. 22'282/IA II 59
dt. 13-1-60
(i) Prcdinsolcn Indon Tabs
(ii) Mcprindon
1 lakh p.m.
2 laks p.m.
10. 22 26S/IA IT5)
dt. 13-1-60
(i) Dexamethafon tabs
(ii) Hydrochloro Thiazide tabs
1 lakh p.m.
1 lakh p.a.
11. 22/85/IA/II/58
dt. 3-11-59
(i) Butazolone Indon
(ii) Gariatindon
(iii) Maprocolonc Indon
(iv) Talbutamide Indon
(v) Asmatriad Indon
5
11. Mis. Glaxo Laboratories India Ltd. Bombay
1. 3/24/62-Ch.IH
dt. 26-7-62
(i) Hydroxocobalamin
(vial of 5 ml.)
(ii) Anacohin B (Vial of 5 ml.)
30,000 p.a.
2. 22/468/IA/II 60
dt. 17-1-61
Aluminium Hydroxide
Magnesium Carbonate Gel. Tabs.
(Almacarb)
5 (five) lakhs tablets p.m.
3. 22/349/IATI 60
st. 16-1-60
Volpar Foaming tabls.
1 (one) million tabs p.m.
4. 22/9/IA/II/57
dt. 25-7-58
Prodasin tablets
5. HC-1/64/57
dt. 11-9-57
Capsulating Vitamins and other pro
ducts
6. 22/203 TA 11.59
dt. 20-4-59
Distivit Vitamin B12 Tabs.
7. 3/1/63-Ch. Ill
dt. 5-8-63
Radio-Malt
8. 22/22/L/R/52
dt. 22-5-54
Complex B tabs
Folic Acid
Vitamin B Complex B2
Macrafolin-Iron Tabs.
Complex B liquid
Complex B Forte Tabs
Complex B Forte Vials
Comycin S Vials
Comycin S Stabs. Solution
Comycin S Syrup
Comycin S Tabs.
Crystamycin Vials
Seolomycin Vials
9. 22/104/1 A./L/55
dt. 15-7-55 &
4-8-55
Helmacid Tabs. Helmacid Liquid
Helmacid with Sonna
30,000 p.a.
500 Kgs. p.m.
12. Merck Sharp & Dohme of India Ltd.
1. 22/346/1A/11/60
dt. 29-1-60
‘Vitmol’ Compound
2. 1/24/60-Ch. Ill
dt. 7-12-62
(i) Tri-redisol H
(ii) Periactin Elixir
(iii) Periactin Tabs
Within the overall licensed capacity
12 lakhs
The party obtained
COB Licence No.
L'22/454/72 Ch.
Ill dt. 7-11-72
L
116
1
2
3
4
5
13. Johnson & Johnson of India Ltd.
1. 3/73-62-Ch. Ill
dt. 16-1-1963
(i) Plaster of Paris B.P.C.
(ii) K.Y. Jelly
(iii) Calamine B.P.
(iv) Calamine I.P.
500 tons
2500 lbs.
50 tons
50 tons
14. Cyanamid Undid) Ltd.
1. A & 1-31(1),'65
dt. 4-5-1965
Ledermycin Dimethyl
Chlortotracycline 300 mg.
2. 3(28)/62-Ch. Ill
dt. 8-1-1963
Diethyl Carbamazine tablets
10 lakhs
3. 3(15)/63-Ch. Ill
dt. 22-6-1963
Vi Magna Multivitamin Drops
2400 litres
4. 3(28)/62-Ch. Ill
dt. 22-10-1962
Strcsscap Capsules
18 lakhs
5. 3(28)/62-Ch. Ill
dt. 4-8-1962
Aurcomycin Chlortetracycline
Soluble oblets
1.50 lakhs
6. 3(39)/61-Ch. Ill
dt. 27-7-1962
Pethibamate tablets
9 lakhs
7. 3(39)/61-Ch. Ill
dt. 4-7-1961
LeJercort Cream with Neomycin
48000 tubes of 5 gm.
8. 3(39)/61-Ch. Ill
dt. 28-9-1971
(i) Incremin with iron Syrup
(ii) Lederkyn Acetyl Pedictric sus
pension
3500 litres
36000 litres
9. A& 1-10(2) '61
dt. 24-1-1961
(i) Aurofac
(ii) Aurofac 2 A
10. 22(362) TX (II)/60
dt. 19-5-1960
Filibon Capsules
11. 22(367) TA(II)'60
dt. 30-3-1960
Ledermycin Capmls
12. 22(366)/[A([I)/60
dt. 14-3-1960
Austrin Capsules
13- 22(222) [A([I)/(lI)/59
dt. 30-5-1959
Vi Magna Granules
14. 22(232)[A(II) 59
dt. 12-5-1959
Varidase Baclal Tablets
15. 22(151) TA(II)/58
dt. 1-10-1958
(i) Liver injection
(ii) Achromycin Soluble tablets
16. 22(180)[A(lD/58
dt. 6-1-1959
Aureomycin Ointment
17. 22(105)lA(II)/58
dt. 16-8-1958
Lcdercort tablets
IS. 22(348) IA(II)'6O
dt. 13-3-60
Ledercort Acetonide Cream
Ointment
Ledercort Diacetate Parenteral
19. 22(105)IA(II)/5S
dt. 5-6-1958
Incremin Lysine Vitamin Drops
20. 22(72)-lA(II)/58
dt. 24-4-1958
(i) Achromycin V. Liquid Pediatric
Drops.
(ii) Achromycin V Syrup
21. 22(72)IA(II)/58
dt. 30-1-1958
Achromycin Hcl Ophthalmic oil sus
pension
22. 22(53)IA(II)/57
dt. 17-10-1957^
Ledcrplex Parenteral
23. 22(18) IA(II)/57
dt. 27-5-1959
(i) Lederkyn tablets & Syrups
(ii) Achromycin V Caps.
24. 22(20)IA/(II)57
dt. 28-5-1957
Protein preparations
14 lakhs
48000 tabs of 5 gms. each
48000 tabs, of 5 gms. each
25,000 amp. of 5 ml. each.
e
117
i
2
3
25. 22(58)IA(L)/54
dt. 1-11-1966
Miltown tablets
26. 22(58)IA(L)/54
dt. 12-7-1956
Achromycin Intramuscular
27. 22(58)IA(LA)/55
dt. 1-3-1956
Delphical Sol.
28. 9422-1A(A)/5 5
dt. 19-12-1955
(i) Pacitane tablets
(ii) Diamox tabs.
29. 22(52)IA/52
dt. 22-9-1955
Aurcomycin Stress Formula Caps.
30. 22(52)IA(R)/54
dt. 1-8-1955
Simple Liver Inj.
31. 22,-52/IA(R)/52
dt. 12-7-54
32. 22/52/IA(R)/52
dt. 30-12-1953
Liver Inj. with Folvite
4
Folvite Solution
Folvite Tablets
Folvron Capsules
Folvron Elixir
Gevral Capsules
Gevrabouse Elixir
Hetraxan tablets
Hetrazan Syrup
Ledercillin Torches, LeJerplex
Liquid
Lederplex Capsules
Normecytin tablets
Normecytin-Fovite tablets
Perfolin capsules
Perihemiz capsules
Ferihemin Liquid
Prenetal Capsules
Sulfaguanidine tablets
Sulfamerazince tablets
Triple Sulfas
Vi-Delta capsules
Vi-Delta Emulsion
Vi-Magna Capsules
Vi-Magna Syrup
15. Alembic Chemicals Works Co. Ltd.
1. 22(262)IA(n)/59
dt. 19-2-1960
I
(i) Multivitamin Preparations
(ii) Ante Ananomia Preparatio ns
1080 litres
Injections
600 litres
Tablets
600,000
Oral
2400 litres
(iii) Antinauseant Preparation
1,44 lakh tabs.
(iv) Anti Hasmerrhagic Preparation
2.40 lakh tabs
(v) Anthe Imintic Preparation
0.60 lakh tabs.
(vi) Enzyme Preparations
(i) Trypsin Injection
6000 ml.
(ii) Chyrmotrypsin Injec 6000 ml.
tion
(iii) Ointment
75.6 kgs.
(vi) Bioflavinoid preparation
2.40 lakhs tabs.
2. 22(110)IA(L)/75
(i) Sylomin tablets
dt. 21-9-1955
(ii) Silo mag tablets
(iii) Alzide PAS tabs.
(iv) Zeet tabs.
(v) Chlorpromazine Hcl tabs.
(vi) Alzide Streptomycin Inj.
16. Deys Medical Stores (Manufacturing) Pvt. Ltd.
1. 4O(124)/58-MC
dt. 15-7-1958
(i) Aralon tablets
(ii) Aralin tablets
(iii) Franol tablets
(iv) Milibis tablets
(v) Monodra 1 tablets
(vi) Philips Milk of Magnesia tablets &
Syrup
(vii) Tolopapue tablets
5
118
1
2
4
3
72 lakhs tablets
2.44) lakhs vials
2. 22(423)-!A(II),60
dt. 14-7-1960
(i; Dexamethasone tablets
(ii) Dexamethasone Eye Drops
3. 22(424)IA(nj 60
dt. 14-7-1960
Chlorpropamide tablets
4. 3(44)/61-Ch. Ill
dt. 25-5-1962
(i) Papsamer tablets
(ii) Synephrical tablets
67 lakhs
30.6lakks
5. 3(44) 61 -Ch. Ill
dt. 1-11-1962
Fenarol tablet
29.20 lakhs
17. Standard Pharmaceuticals Ltd.
1. 3422.TA(LA)56
dt. 14-5-1956
Anthe Imintic and Vermifrge
2. 22(172)IA(II)/58
dt. 1-12-1958
(i) Alliquin Tablets
(ii) Lucitone
(iii) Dectomet
3. 3(21)63-Ch. Ill
dt. 10-10-1963
Phthalyl Sulphathiaz?le
Diode Oxyquinoiine
Ante Tussive Co ugh t Syrup
Contraceptive Tablets
4. l(83)/62-Ch. Ill
dt. 9-1-1963
Tensolysin
Hystalizine
Hypnodyne
24 lakhs Tablets
24 lakhs Tablets
30000 kgs.
24 lakhs Tablets
18. German Remedies Ltd.
1. 22(93)IA/H'5S
dt. 21-1-1961
Sulfune tablets
5 lakhs
2. 3(1)/61-Ch. Ill
dt. 20-1-1962
Selvigon dragees drops
36 lakhs
600 litres
Itridal tablets (20 mg. Protheiphendyl 7.2 lakhs
and Cyclobarbitone sodium 100 mg)
30 lakhs
Sulfuno tablets
1800 kgs.
Thrombophob ointment
Heemocuro ointment
36000 vials
Heparin vials
1.2 lakhs
Itridal ampolles
6000 litres
Sulfuno suspension
19. Reckitt & Colman of India Ltd.
50,000 lbs.
1. 3(19)/6l-Ch. Ill
Loxene
dt. 27-9-61
30.000 kgs.
All purpose ointment
2. 3(46)'60-Ch. Ill
dt. 24-1-61
20. M/s. Martin and Harris Ltd.
Agarol
1. HC-l(2O)/58
Anusol ointment
dt. 19-2-58
Anucol supponsitories
Cal Bis-ma
Gelusil tablets
Sloans liniment
Sloans Balm
Tedral tablets plain
Proloid tablets
Angiers emulsion
3. 3(20) 62-Ch. Ill
dt. 5-11-62
2. 3691-IA'I[)/58
dt. 24-7-58
Magnesia Magma USP
3. 22(283) IA (n)k9
dt. 5-1-60
Strik
4. HC-l(25)/57
dt. 7-3-57
Formulations of Aspirin, ^Sulpha
Diodohy
INH,
drugs,
PAS,
and
rdroxyquinoline Hormones,
r___
. Vitamin prcgladular products,
Malt extract and fish
parations I.kk
ii___ _
liver oil Anti malarial drugs. Anti
histamine drugs Antileprosy drugs.
Barbiturates, Ephedrine Hcl.
384,000 litres
5
119
f
1
2
3
■j
\f 's. Cib.i of India Ltd.
1.22(90)4 A (ii)/55
dt. 13-64957
(i) Nimarol
(ii) Bradex-vioform
2. HC4(24)/56
dt. 30-94957
(i) Serpasil tablets,
drops —
and1 am
. .
poules from locally manufactured
serpasil (Reserpin).
(ii) Adelphane tablets from locally
manufactured serpasil (Reser
pine) and imported 1-4 dibydrazinophthazine.
(iii) Elkosin syrup from locally manu
factured Elkosin (Sulphasomidine).
(iv) Triolandren ampoules from local
ly manufactured perandren (Tes
tosterone propionate) and im
ported Testosterone valerianate
and undecxlenatc.
(v) Remandren from locally manu
factured perandren (Methyl Tes
tosterone) and imported Thinyoestradiol.
HC-1(I49)'57
dt. 24-1-1958
(i) Antrenyl tablets—from
oxyphenonium bromide.
(ii) Neuro-Transentin tablets from
Adiphenine Hcl and Phenobar
bitone BP
(iii) Spasmo labalgin tablets—from
Amidopyrine B.Pc. Allobarbi
tone BPC and Adiphanine Hcl.
(iv) Priscophen tabs—from pheno
barbitone BP tolazoline Hcl.
B.P.C. and Aidphenine Hcl.
(v) Eticyclin li ng—from Ethinvl oes
tradiol B.P.C.
(vi) Pyribenzamine tabs—from Tripelemanamine Hcl. U.S.P.
(vii) Priscol tabs—from tolazoline Hcl
B.P.C.
c
Ampoules
(i) Cibalgin amps—from Amido
pyrine B.P.C. and Allobarbitone
B.P.C.
(ii) Dial amps—from Allobarbitone
B.P.C.
(iii) Percorton amps.—from Deoxy
cortone acetate B.P.C.
(iv) Priscol amps—from Tolazoline
Hcl. B.P.C.
(v) Perandren Micro-crystules—from
testosterone isobutyrate.
Ointments:
(i) Antistine cream—from AntazolineHcl. B.P.C.
(ii) Pyribenzamine Elixir—from Tripelennamine Hcl USP.
(iii) Privine Sol. and Emulsion—from
Naphasoline Nitrate and Sulphathiazole ex-atul.
4; 22(107)IA(U)58
dt. 10/11-4-1958
(i) Antistine Previne Nebulisers
(ii) Retal in tablets.
5. 22(20)IA(n)/59
dt. 28-4-1959
(i) Entobex tablets.
6. 22(229) IA(II);59
(i) Cortisone Eye ointment
(ii) Cortisone Eye Drops.
(iii) Ultra cortenol Eye Ointment
(iv) Ultra cortenol Eye Drops.
7. 22(228) IA(U)/59
dt. 11-9-1959
(i) Esidrex tablets
(ii) Millicorten preparation
(iii) Mcxaform tablets
(iv) Doriden tablets
(v) Apreso line and ecoiid tablets.
dt. 13-5-1959
1—M of Pet. & Chem./75—16
4
5
■
r
<
..
• f■
120
i
2
3
8. 22(228) IA(111 59
dt. 2-1-1960
(i) Adclphinc F.sidrcx tablets.
9. 22(331) IA (lb 59
(i) Antrenyl Drops
dt. 9-1-1960
13. 22(374) U(ii) 5)
dt. 5-11-1960
(i) O.'isul tablets 4 million p.a.
(ii) Orisul syrup
450 kg.
11. 22(460) IA(11) 60
(i) Millicortcn voform Cream
dl, 14-11-1960.
12. 3(13) 61-Ch. Ill
d*. 11-9-1961
< -
Ortrivin drops
Orisul Eye ointment
4
I lakh tubes
1 lakh containers (10 each)
1 lakh tubes (5 gm each)
13. 2(13)/61-Ch. Ill
dt. 14-5-1962
(i) Testosterone (Jndecyciineate
(ii) Testosterone valerinate
15 kgs.
15 kgs.
14. 3(36)/62-Ch. Ill
dt. 6-8-1962
(i) Ismelin tablets (10 mg)
(ii) Ismelin tablets (25 mg)
7.5 million.
one million.
‘5
J
11
February 15, 2002
PHARMACEUTICAL POLICY-2002
INTRODUCTION
I he
basic
objectives
of Government’s
Policy
relating
to
the
drugs
and
pharmaceutical sector were enumerated in the Drug Policy of 1986. These basic
objectives still remain largely valid. However, the drug and pharmaceutical industry
in the country today faces new challenges on account of liberalization of the Indian
economy, the globalization of the world economy and on account of new obligations
undertaken by India under the WTO Agreements. These challenges require a
change in emphasis in the current pharmaceutical policy and the need for new
initiatives beyond those enumerated in the Drug Policy 1986, as modified in 1994, so
that policy inputs are directed more towards promoting accelerated growth of the
pharmaceutical industry and towards making it more internationally competitive. The
need for radically improving the policy framework for knowledge-based industry has
also been acknowledged by the Government. The Prime Minister’s Advisory Council
on Trade and Industry has made important recommendations regarding knowledge
based industry. The pharmaceutical industry has been identified as one of the most
important knowledge based industries in which India has a comparative advantage.
2. The process of liberalization set in motion in 1991, has considerably reduced the
scope of industrial licensing and demolished many non-tariff barriers to imports.
Important steps already taken in this regard are: -
•
Industrial licensing for the manufacture of all drugs and pharmaceuticals has
been abolished except for bulk drugs produced by the use of recombinant
DNA technology, bulk drugs requiring in-vivo use of nucleic acids, and
specific cell/tissue targeted formulations.
•
Reservation of 5 drugs for manufacture by the public sector only was
abolished in Feb.1999, thus opening them up for manufacture by the private
sector also.
•
Foreign investment through automatic route was raised from 51
to 74U/» in
March, 2000 and the same has been raised to 100%.
•
Automatic approval for Foreign Technology Agreements is being given in the
case of all bulk drugs, their intermediates and
formulations except those produced by the use of recombinant DNA
technology, for which the procedure prescribed by the Government would be
followed.
i 1
•
•
Drugs and pharmaceuticals manufacturing units in the public sector are being
allowed to face competition including competition from imports. Wherever
possible, these units are being privatized.
Extending the facility of weighted deductions of 150% of the expenditure on
in-house research and development to cover as eligible expenditure, the expenditure
on filing patents, obtaining regulatory approvals and clinical trials besides R&D in
biotechnology.
•
Introduction of the Patents (Second Amendment) bill in the Parliament. It,
inter-alia, provides for the extension in the life of a patent to 20 years.
3. The impact of the policies enunciated, from time to time, by the Government has
been salutary. It has enabled the pharmaceutical industry to meet almost entirely the
country’s demand for formulations and substantially for bulk drugs. In the process
the pharmaceutical industry in India has achieved global recognition as a low cost
producer and supplier of quality bulk drugs and formulations to the world. In 19992000, drugs and pharmaceutical exports were Rs.6631 crores out of a total
production of Rs. 19,737 crores. However, two major issues have surfaced on
account of globalization and implementation of our obligations under TRIPs which
impact on long-term competitiveness of Indian industry. These have been addressed
in the Pharmaceutical Policy-2002. A reorientation of the objectives of the current
policy has also become necessary on account of these issues:-
a. The essentiality of improving incentives for research and development in the
Indian pharmaceutical industry, to enable the industry to achieve sustainable
growth particularly in view of anticipated changes in the Patent Law; and
b. The need tor reducing further the rigours of price control particularly in view
of the ongoing process of liberalization.
4. It is against this backdrop, that Pharmaceutical Policy-2002 is being enunciated.
OBJECTIVES
5. The main objectives of this policy are:-
a. Ensuring abundant availability at reasonable prices within the country of
good quality essential pharmaceuticals of mass consumption.
b. Strengthening the indigenous capability for cost effective quality production
and exports of pharmaceuticals by reducing barriers to trade in the
pharmaceutical sector.
c. Strengthening the system of quality control over drug and pharmaceutical
production and distribution to make quality an essential attribute of the
Indian
pharmaceutical
pharmaceuticals.
industry
and
promoting
rational
use
of
i i
d. Encouraging R&D in the pharmaceutical sector in a manner compatible with
the country's needs and with particular focus on diseases endemic or rele\ ant
to India by creating an environment conducive to channelising a higher lex el
of investment into R&D in pharmaceuticals in India.
e. Creating an incentive framework for the pharmaceutical industr\' which
promotes new investment into pharmaceutical industrv and encourages the
introduction of new technologies and new drugs.
APPROACH ADOPTED IN THE REVIEW
6. In order to strengthen the pharmaceutical industry’s research and development
capabilities and to identify the support required by Indian pharmaceutical companies
to undertake domestic R&D, a Committee was set up in 1999 by this Department by
the name of Pharmaceutical Research and Development Committee (PRDC) under
the Chairmanship of Director General of CSIR.
7. To qualify as R&D intensive company in India, the PRDC has suggested following
conditions (gold standards)
•
Invest at least 5% of its turnover per annum in R&D,
•
Invest at least Rs.10 Crore per annum in innovative research including new
drug development, new delivery systems etc. in India,
•
Employ at least 100 research scientists in R&D in India,
•
Has been granted at least 10 patents for research done in India,
•
Own and operate manufacturing facilities in India.
8. The recommendations of the PRDC in so far as they relate to the Pharmaceutical
Policy have been taken into account while formulating the proposals on pricing
aspects.
9. The Pharmaceutical Research & Development Committee has recommended in
its report, submitted inter-alia, the setting up of a Drug Development Promotion
Foundation (DDPF) and a Pharmaceutical Research & Development Support Fund
(PRDSF). Necessary action in this regard has been initiated.
10. As far as the question of price control is concerned, the span of control has been
gradually reduced since 1979. Presently, under DPCO, 1995 there are 74 bulk drugs
and their formulations under price control covering approximately 40% of the total
market. The functioning of the Drugs (Price Control) Order, 1995, has brought to light
some problems in the administration of the price control mechanism for drugs and
pharmaceuticals. In order to review the current drug price control mechanism, with
the objective, inter-alia, of reducing the rigours of price control, where they have
become counter-productive, a committee, called the Drugs Price Control Review
Committee (DPCRC), under the Chairmanship of Secretary, Department of
Chemicals & Petrochemicals was set up in 1999, which has given its report. The
Ii
recommendations of DPCRC have been examined and taken into account while
formulating the "Pharmaceutical Policy - 2002".
11. It has emerged that the domestic drugs and pharmaceuticals industry needs
reorientation in order to meet the challenges and harness opportunities arising out of
the liberalisation of the economy and the impending advent of the product patent
regime. It has been decided that the span of price control over drugs and
pharmaceuticals would be reduced substantially. However, keeping in view the
interest of the weaker sections of the society, it is proposed that the Government will
retain the power to intervene comprehensively in cases where prices behave
abnormally.
12. In view of the steps already taken and in the light of the approach indicated in the
foregoing paragraphs, the decisions of the Government are detailed below
I. Industrial Licensing
Industrial licensing for all bulk drugs cleared by Drug Controller General (India), all
their intermediates and formulations will be abolished, subject to stipulations laid
down from time to time in the Industrial Policy, except in the cases of
1.
bulk drugs produced by the use of recombinant DN A technology,
11.
bulk drugs requiring in-vivo use of nucleic acids as the active principles, and
iii.
specific cell/tissue targetted formulations.
II. Foreign Investment
Foreign investment upto 100% will be permitted, subject to stipulations laid down
from time to time in the Industrial Policy, through the automatic route in the case of
all bulk drugs cleared by Drug Controller General (India), all their intermediates and
formulations, except those, referred to in para 12.1 above, kept under industrial
licensing.
III. Foreign Technology Agreements
Automatic approval for Foreign Technology Agreements will be available in the case
of all bulk drugs cleared by Drug Controller General (India), all their intermediates
and formulations, except those, referred to in para 12.1 above, kept under industrial
licensing for which a special procedure prescribed by the Government would be
followed.
IV. Imports
Imports of drugs and pharmaceuticals will be as per EXIM policy in force. A
centralized system of registration will be introduced under the Drugs and Cosmetics
Act and Rules made thereunder. Ministry of Health and Family Welfare will enforce
strict regulatory processes for import of bulk drugs and formulations.
V. ENCOURAGEMENT TO RESEARCH AND DEVELOPMENT (R&D)
(a) In principle approval to the establishment of the Pharmaceutical Research and
Development Support Fund (PRDSF) under the administrative control of the
Department of Science and Technology, which will also constitute a Drug
Development Promotion Board (DDPB) on the lines of the Technology Development
Board to administer the utilization of the PRDSF.
(b) With a view to encouraging generation of intellectual property and facilitating
indigenous endeavours in pharma R&D, appropriate fiscal incentives would be
provided.
VI. PRICING
(a) Span of Price Control
4
IJ
The guiding principle for identification of specific bulk drugs for price regulation
should continue, as per DPCRC’s recommendation, to be: (a) mass consumption
nature of the drug and (b) absence of sufficient competition in such drugs. However,
the DPCRC’s recommendation regarding the new criteria for ascertaining the mass
consumption nature of a bulk drug on the basis of the top selling brand is not
acceptable as it gives rise to anomalies.
In this context, it may be noted that there is no tailor made data available for the
purpose of ascertaining the mass consumption nature and absence of sufficient
competition with reference to a particular bulk drug. There is only one source
namely, "Retail Store Audit for Pharmaceutical Market in India" published by ORGMARG, which lists out all major brands and their sale estimates on All India basis.
This publication contains data for single ingredient as well as multi-ingredient
formulations. However, it does not give complete description of all the ingredients of
the pharmaceutical product listed therein.
Hence, there is need to obtain information in regard to composition of each brand,
dosage form wise and pack wise, from various other publications / sources, viz.,
(a) Indian Pharmaceutical Guide (IPG)
a. Current Index of Medical Specialities (ClMS),
b. Monthly Index of Medical Specialities (MIMS),
c. Drug Today
d. Information provided by some manufacturers
e. Label composition as indicated on market samples.
Though none of these sources can be said to be exhaustive and comprehensive in
regard to market information, yet under the given circumstances, these are the best
available. It has also been noted that the sale value of any combination formulation
is not directly relatable to a single particular bulk drug forming part of the
combination formulation. Combination formulations involve too many variables, viz.,
strength of a particular bulk drug and its proportion with respect to other bulk drugs
used in the combination formulation, price difference between bulk drugs used in
combination formulation, pack sizes, dosage forms etc. In view of these facts, ORGMARG sales data for combination formulations does not yield information in regard
to mass consumption nature and absence of sufficient competition with reference to
a particular bulk drug. Also, it is to be borne in mind that processing of such data,
which requires cross-checking with other publications and sources of information in
regard to composition of each brand, dosage form-wise and pack-wise may involve
instances of omission / commission.
In view of above, it would be logical to conclude that although ORG-MARG sale
estimates available in regard to all single-ingredient formulations of a particular bulk
drug would not yield the sale value of that bulk drug in the form of all its formulations,
yet it would adequately reflect the mass consumption nature of that bulk drug in the
form of single ingredient formulations, which may be used as a practical indicator for
formulating the policy.
The Department through NPPA, with the help of NIPER has developed the desired
database for single ingredient formulations from the retail store audit data as
published by ORG-MARG. On this basis, the Department proposes to undertake the
3
11
exercise of identifying the bulk drugs of mass consumption nature and having
absence of sufficient competition according to the following methodology: 1.
The 279 items appearing in the alphabetical list of Essential Drugs in the
National Essential Drug List (1996) of the Ministry of I lealth and Family
Welfare and the 173 items, which are considered important bv that Ministrv
from the point of view of their use in various Health Programmes, in
emergency care etc., with the exclusion., as in the past, therefrom of sera &
vaccines, blood products, combinations etc. should form the total basket out
of which selection of bulk drugs be made for price regulation.
ii.
The ORG-MARG data of March 2001 would form the basis for determining
the span of price control as suggested by DPCRC.
iii.
The Moving Annual Total (MAT) value for any formulator in respect of anv
bulk drug will be arrived at by adding the MAT values of all his single
ingredient formulations of that bulk drug, its salts, esters, stereo-isomers and
derivatives, covering all the strengths, dosage forms and pack sizes listed
against that formulator in all groups / categories of the ORG-MARG (March
2001).
iv.
The MAT value for all the formulators, as defined in sub-para (iii) above, in
respect of a particular bulk drug will be added to arrive at the total MAT
value in the retail trade.
v.
The MAT value for an individual formulator, in respect of any bulk drug, as
arrived at in sub-para (iii) above, will be the basis for calculating the
percentage share of that formulator in the total MAT value arrived at as in
sub-para (iv) above, in respect of that bulk drug.
vi.
Bulk Drugs will be kept under price regulation if:(a) The total MAT value, arrived at as in sub-para (iv) above, in respect of any
particular bulk drug is more than Rs.2500 lakhs (Rs.25 Crore) and the
percentage share, as defined in sub-para (v) above, of any of the formulators
is 50% or more.
(b) The total MAT value, arrived at as in sub-para (iv) above, in respect of any
particular bulk drug is less than Rs.2500 lakhs (Rs.25 Crore) but more than
Rs.1000 lakhs (Rs.10 Crore) and the percentage share, as defined in sub
para (v) above, of any of the formulators is 90% or more.
vii.
All formulations containing a bulk drug as identified above, either
individually or in combination with other bulk drugs, including those not
identified for price control as bulk drug, will be under price control. The
Government shall, however, retain the following over-riding power
in cases of drugs/formulations listed by the Ministry of Health and Family Welfare,
mentioned in sub-para (i) above, and those presently under price control, having
significant MAT value as per ORG-MARG but not covered under the criteria in sub
para (vi) above, as a result of this proposal, the NPPA would specially monitor
intensively their price movement and consumption pattern. If any unusual movement
I i
of prices is observed or brought to the notice of the NPPA, the Authority would work
out the price in accordance with the relevant provisions of the price control order.
(b) Maximum Allowable Post-manufacturing Expenses (MARE)
Maximum Allowable Post-manufacturing Expenses (MAPE) will be 100% for
indigenously manufactured formulations.
(c) Margin for Imported Formulations
For imported formulations, the margin to cover selling and distribution expenses
including interest and importer’s profit shall not exceed fifty percent of the landed
cost.
(d) Pricing of Formulations
(i) For Scheduled formulations, prices shall be determined as per the present
practice. The time frame for granting price approvals will be two months from the
date of the receipt of the complete prescribed information.
(ii) The present stipulation that a manufacturer, distributor or wholesaler shall sell a
formulation to a retailer, unless otherwise permitted under the provisions of Drugs
(Prices Control) Order or any other order made thereunder, at a price equal to the
retail price, as specified by an order or notified by the Government, (excluding excise
duty, if any) minus sixteen percent thereof in case of Scheduled drugs, will continue.
(iii) The present provision of limiting profitability of pharmaceutical companies, as per
the Third Schedule of the present Drugs (Prices Control) Order, 1995, would be
done away with. However, if necessary so to do in public interest, price of any
formulation including a non-Scheduled formulation would be fixed or revised by the
Government.
(e) Ceiling prices
Ceiling prices may be fixed for any formulation, from time to time, and it would be
obligatory for all, including small scale units or those marketing under generic name,
to follow the price so fixed.
(f) Exemptions
(i) A manufacturer producing a new drug patented under the Indian Patent Act, 1970,
and not produced elsewhere, if developed through indigenous R&D. would be
eligible for exemption from price control in respect of that drug for a period of 15
years from the date of the commencement of its commercial production in the
country.
(ii) A manufacturer producing a drug in the country by a process developed through
indigenous R&D and patented under the Indian Patent Act, 1970, would be eligible
for exemption from price control in respect of that drug till the expiry of the patent
from the date of the commencement of its commercial production in the country by
the new patented process.
(iii) A formulation involving a new delivery system developed through indigenous
R&D and patented under the Indian Patent Act, 1970, for process patent for
formulation involving new delivery system would be eligible for exemption from price
control in favour of the patent holder formulator from the date of the commencement
of its commercial production in the country till the expiry of the patent.
(iv) The DPCRC has suggested that the low cost drugs measured in terms of "cost
per day per medicine" may be taken out of price control. Any formulator can
represent to NPPA with proof of per day cost to consumer-patient. NPPA will be
authorised to exempt such formulation from price control if its cost to consumer
patient does not exceed Rs. 2/- per day, under intimation to the Government. All
orders passed by the NPPA will be prospective in operation. Whenever the
concerned formulator wishes to revise the price, he, before effecting any change in
—
price, would be bound to inform NPPA and seek fresh exemption and in case the
cost to consumer-patient, on the basis of the proposed revised price, exceeds
beyond the limit of Rs. 2/- per day, obtain the necessary price approval.
(g) Pricing of Scheduled Bulk Drugs
1.
11.
For a Scheduled bulk drug, the rate of return in case of basic manufacture
would be higher by 4 per cent over the existing 14 per cent on net worth or 22
per cent on capital employed. The time frame for granting price approvals
will be 4 months from the date of the receipt of the complete prescribed
information.
The Government shall, however, retain the overriding power of fixing the
maximum sale price of any bulk drug, in public interest.
(h) Monitoring
(i) The DPCRC’s recommendations to have effective monitoring and enforcement
system and to move away from the "controlled regime" to a "monitoring regime" is in
the present context an extremely important recommendation as imports will
increasingly compete with local drugs and pharmaceuticals in the domestic market.
A new system based on solely market prices data is required to be evolved and
controls applied selectively only to cases where, either profiteering or monopoly
profit seeking is noticed. The National Pharmaceutical Pricing Authority, set up in
August, 1997, would need to be revamped and reoriented for this purpose. It will
continue to be entrusted with the task of price fixation / price revision and other
related matters, and would be empowered to take final decisions. It would also
monitor the prices of decontrolled drugs and formulations and over-see the
implementation of the drug prices control orders. The Government would have the
power of review of the price fixation/and price revision orders/notifications of NPPA.
(ii) Although the prices of some bulk drugs have been steadily decreasing, yet the
same do not get reflected in the retail price of non-Scheduled formulations. Also,
there is need to check high margin/commission offered to the trade by printing high
prices on the labels of medicines to the detriment of the consumers. It is, therefore,
proposed to strengthen the National Pharmaceutical Pricing Authority by providing
appropriate powers under the DPCO which would make it mandatory for the
manufacturer to furnish all information as called for by NPPA and also to regulate
such prices, wherever, required.
(iii) The other recommendations of DPCRC like giving powers to drug control
authorities to dispose of small and petty offences etc., will require an amendment to
the Essential Commodities Act. This suggestion is considered not practicable.
Monitoring price movement of drugs sold in the country as well as that of imported
formulations will require developing appropriate mechanism in the NPPA.
(i) Drug Price Equalization Account (DPEA)
Provision would be made in the new Drugs (Prices Control) Order (DPCO) to ensure
that amounts which have already accrued to the DPEA and those which are likely to
accrue as a result of action in the past, are protected and used for the purpose
stipulated in the existing DPCO.
VII. QUALITY ASPECTS
The Ministry of Health & Family Welfare would
(i) progressively benchmark the regulatory standards against the international
standards for manufacturing,
(ii) progressively harmonize standards for clinical testing with international practices,
8
ii
f
(iii) streamline the procedures and steps for quick evaluation and clearance of new
drug applications, developed in India through indigenous R&D, and
(iv) set up a world class Central Drug Standard Control Organisation (CDSCO) by
modernizing, restructuring and reforming the existing system and establish an
effective net work of drugs standards enforcement administrations in the States with
the CDSCO as a nodal center, to ensure high standards of quality, safety and
efficacy of drugs and pharmaceuticals.
VIII. PHARMA EDUCATION AND TRAINING
The National Institute of Pharmaceutical Education and Research (NIPER) has been
set up by the Government of India as an institute of "national importance" to achieve
excellence in pharmaceutical sciences and technologies, education and training.
Through this institute, Government’s endeavor will be to upgrade the standards of
pharmacy education and R&D. Besides tackling problems of human resources
development for academia and the indigenous pharmaceutical industry, the institute
will make efforts to maximize collaborative research with the industry and other
technical institutes in the area of drug discovery and pharma technology
development.
9
Appendix
IS.
19.
20.
Vf's Glaxo Laboratories (India) Ltd., Bombay
I. Tablets
1.
3.
4.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
24.
25.
26.
28.
29.
30.
31.
32.
33.
34.
Elixir Myanesin
Kapilin Liquid
Radiostolume Liquid
III. Ointments
Trox
1.
Volpar Foaming tablets
Dilosyn Tablets
Aluminium Hydroxide Magnesium
Carbonate Gel. Tabs (Alnocarb)
Secrodyl Tablets
Secrosterone tablets
Mata lines
Viceolin 6 mg cap. 30 mg., 100 mg
Becadex Forte Caps
Cel in 500 mg
Complex B
Complex B Forte
Folic Acid 5 mg
Vitamin B Complex B2
Peeazid tablets 100 mg.
Maccrafolin Iron tablets
Helmacid tablets
Predasin tablets
Comycin-S tablets
Eltroxin Tabs 0.01 mg+0.05 mg.
Adexolin capsules
Kapilin Tablets
Prepalin Capsules
Vitamin A & D Capsules
Radiostolume Caps.
Laxene
Myanesin 0.5 mg.
Testaform 5 mg
Dyloform 0.01 mg.
Serial 28
Volidan V
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Crystapen H.P.
Mystrepton
Mystrepton H.B.
MyciJ.
Efcorlin Eye Oint.
Betnovate-C Skin Oint.
Betnovate Skin (Greasy) Oint.
Betnovate-N Skin (Greasy) Oint.
Betnovate-CSkin (Greasy) Ointment
Derobin-C
Efcorlin-N Skin Oint.
Efcorlin-N Eye Oint.
Parvel Jelly
MALTS.
Radio Malt.
IV. Sterile Injections
1.
2
3.
4.
5.
6.
7.
8.
9.
10.
11.
Dextrose 5 BP
Dextrose 5 °/o with Sodium
Chloride 0.9%
Dextrose 10% —do—
Sodium Chloride BP
Sodium Chloride and Gum Acacia BP
Anacobin 500 mg. + 1000 mg.
Jectof or Injection
Complex B 139 ml.
Complex B Forte 5 ml.
Baedex 10 ml.
Macrabin-H 500 mg 5 ml.
Macrabin-E 1000 mg 5 ml.
Qaleiosterlin B12
Fan tori n
12.
13.
14.
15. Kapilin
16. Prepalin 1 ml.
17. Prepalin Forte 1 ml.
18. Progestin 10 mg. 1 ml.
19. Progestin 25 mg. 1 ml.
20. Testaform 10 mg.
21. —do— 25 mg.
Efcorlin soluble
23. Mersalyl 1 cc
24. Mersalyl 2 cc
25. Myanesin
Lutofcrin 5 mg+lOmg.
II. Liquids:
1. Multivite Deca Drops
Dilopact Syrup
3. Entacyl Elixir
4. Dilosyn Syrup
5. Complex B Liquid
6. Macrafolin Iron Syrup
7. Complin S. Syrup
8. Becadex Syrup
9. Becadex Drops
10. Helmacid Syrup
11. Maerabin Liquid
12. Ostocalcium B12 Syrup
13. Guanimycin Sus. Forte
14. Adexolin Liquid
15. Prepalin Liquid
16. Efcorlin NE/E Drops
17. Diapec
V. Antibiotic vials
1.
3. ’
4.
5.
6.
7.
8.
125
Comycin—S 1 g.
Comycin S 2 g.
Comycin S Stab. Solution
Seclomycin 5 dose.
Crvstamvcin 1 dose
PAM
Benapen Forte
Solids & Powders
1. Holmacid with Senna
2. Anathanine
3. Crystapen V Granules
126
M/s Laboratories Grintault (India) Limited
Tablets & Capsules
Liquids
1.•
2.
Amicline
Digitaline
3. Meladinine
4. Natisedine
5. Retanitrinc Plain
6. Phenobarbitone
7. Psorline P
8. Tuxyne
9. Alucinol
10. Bcneuron
11. Beneuron Fort.:e
12. Glydphage
13. Hepasulfol
14. Hepasulfol AA
15. Meprophen
16. Plurizyme
17. <Suxifer
Ointments
1. Grimault’s Linctus
-• Grimault’s Syrup
3. Hemopatol
4. Sorbiline
5. Omilcal +F
Solutions
I- Meladinine
2. Psorline
Injectables
(ampoules)
Lactisyn
L Meladinine
-• Paraminei
3. Psorline
4- Relaxyl
Granules
L Evacuol
2. Glutancurol
Injections
(Litres)
1. Be-Douze 500 Mog
2. Be-Douze 1000 Mog
3. Hydroxycobalomino
Chapter-V. Para. 13(a)
Annexure-IV
Turnover of durg Manufacturing firms with foreign Equity Exceeding 50%
Chapter-V. Para 13(a)
(Rs./Lakhs)
S.
No.
Name of the firms
1971/1971-72
Drugs
1. M s. Alkali & Chemical Corp.
of India Ltd.
2. M s. Anglo-French Drug Co
(Eastern) Limited
3. M's. Abbott Laboratories
(I) (P) Limited
4. M/s. Bayor (India) Lmiited .
5. M/s. Becchem (India) (P)
Limited
....
6. M's. Boehringer-Knoll Limi
ted
... .
7. Boots Co. (India) Limited .
8. M’s. Barroughs Wellcome &
Co. (I) (P) Limited
9. Ciba of India Limited .
10. Cyanamid India Limited
11. M/s. B. Merck (I) Private
Limited
12. M/s. Glaxo Laboratories (I)
Limited
13. M s. Johnson & Johnson of
India Limited
14. M's May & Baker Limited
15. M s. Merck Sharp & Dohme
of India Limited .
16. M s. Parke Davis (India) Limited
17. M s. Pfizer Limited (Bombay D
18. M's. Reckitt & Colman of
India Limited
19. M s. Richardson Hindustan
Limited
....
20. Mzs. Roche Products Limited
21. M/s. Sandoz (India) Limited
22. M/s. Searle (India) Limited
23. M/s. Smith Kline & French
(I) Limited ....
24. M/s. Wyeth Laboratories Li
mited
....
25. M/s. Griffon Laboratot ies
26. M/s. C.W. Carnrick Co.
(Asia) Branch
27. M/s. C.E. Fulford Limited .
2. 28. M/s. Cooper Laboratories
29. Ethnor Limited
30. M/s. Nicholas of India Limi
ted
31. Indian Schering Limited .
32. M s. Roussel Pharmaceuticals Limited
Non
Drugs
99
1972/1972-73
Total
Drugs
3
4
5
2378
2477
119
193
223
193
Non
Drugs
6
1973/1973-74
Total
Drugs
Non
Drugs
9
10
7
8
2578
2697
116
223
228
Total
11
3000
3110
228
614
230
821
614
1051
752
289
1031
752
1320
824
311
1267
824
1578
30
96
126
35
73
108
26
101
127
410
521
25
410
546
365
631
29
365
660
406
748
30
400
778
279
1263
788
43
1003
154
322
2266
942
322
1331
892
45
1289
168
367
2620
1050
391
1454
999
29
1668
202
420
3122
1201
302
380
380
469
8
477
302
1995
1250
3245
1901
1195
3096
2331
1207
3538
232
808
174
33
406
841
210
664
147
34
357
698
295
907
194
65
489
972
856
868
868
1051
856
883
1766
318
883
2084
1024
2062
376
1024
2438
1062
2177
144
573
717
135
668
803
N.A.
439
892
623
77
85
524
892
1012
108
508
920
713
105
38
546
920
1226
146
643
928
963
146
359
359
525
525
636
316
173
316
173
339
221
339
221
393
243
7
65
25
173
7
65
25
173
9
120
22
211
9
120
22
211
13
. 160
26
258
128
272
128
272
124
321
124
321
148
148
186
186
389
31
513
41
■1051
393
1062
2"50
N.A.
95
594
39
738
928
1557
185
(
127
1—M of Pct. & Chem./75—17
J
-
%
128
i
2
3
33. M/s. Dental Products
Indkl&tftfrfA .
6
5
4
of
____________ 4~-f~9l 2791_______
15
21
-s
,,
gnilmo/l (Jiup.'I Jggnol Hli/^nil gnhunLlmn.1/
Firms with,ForeignBetween 40 &
L
2. Nl/s^ Cure-Well tbUl5mited
8
9
ttI0T
.
<2IJ1G
51
<-,:a
l.;oT
no’Z
_ _22__
a103
?-y0
"a
.ji/iCl
77
22
C
-286
~23T
'^99
1071
'-1’833
1988'
— 93■. '...J32}/
I
,PJ i.i’ f I ‘Io
<j ) ■ju it 1 i: >
ioJligc' r.l[
m420
0'245
314
014 7
12^6
v^8
'-k
65
20 f.
171
2f2
8.08
290
r'503
J425
0071
104
44!
53
5996
298
^7
rx48
f?4
Q
e
rr
8?2
021
22
1(2
I (2
7
?.O
?.2
C7I
£?.>
414
421
122
421
!2£
82!
272
821
4f.£
081
03!
841
841
••f84';‘'P172,; ,
iZ .f
iif.dd/-.
Luiirni.l ‘jW11
• 117
• 23’4l,n,jl; _
,^44-;,bnl'1067J
LWiJ
z.
-inn?l lion/Lis-nhr’oPI8631/ .0
■
J-'J'
.13&Jirni J (f.ij.j ;
>’> jrriuollo'V ^'inuo’nidl .< 1/ .8
557
In S2-. I <<!} (639,2)
!/j
"!o gr.dO .9
I . :mi
• • • I■ i.d.nl
'
Luf’f. j I tibnl Linn r-r: O 01
oo M .11
'jj.92'q <!'
FZ -tl
InJtfLi.l
( 1) .
"■< .. I (,/LiO > 1/ .21
g •
■ "_______!__j;:r :i. 1
4W-
"io no-’fw •■I. 7j ro^rf'ol. .- 1/ .fl
fn'irni 1 nil;;!
L-jurm ! • ..•.‘4
vG/-b/ .4!
.^.(l ;■
;y,.]/270V P.1
• 1.52 ■
338iirri:J ' *490
-irrii'l (:;ibrl I - i CI a/ '-'/l .' 1Z 01
524
..
•524to!
11 /;drn(.l!) LoiitriiJ
.' 1/ .7!
'.iP3inrnl«O 27jiiJ^l 130 TZ 81
l.oiiniiJ f.'Lrl
r;.42i>Lnill ri • I. irrl-'ll 42 1/ .( !
633 ■
5698
L-jiirniJ
t>rloo5l
1Z .02
L^lrniJ (EiilrlOi .\oLjifid54 1Z .12
baiirniJ (sibnl) shio? .? FZ .££
inrrnl A
fl.’imZ
.f.£
. botirniJ (I)
-kFcoiiolinc'fPJj rllovV/^^ FZ .42
.32
....
. BS.'irn
/oiioJBiGdf J ncTiiiO .< FZ .?£
,o5 ^□i-miE.'i3 W/.O 3.Q I/ ,d£
'3o
02
“
.qi<, ) I u _’rr;
oK
021
.?
.oX
Htnil -r!-: : >
(J.?
CI
001 .
19
19r
2H
1701
?
4
0
3. M's.j pupher Intef/jran Limit#
8
tcd__.._ . -___1-84
_____________
----- 68 - —252
—210
"76
4. M/s. Geoffrey Manners & Co.
"^l
7(837
<349
4’1186
7W8
-OOOf-Oilv 5. M/s. Hoechst PharmaceuticaJsrLJmited , .
..
#375
. .104
M650
'W9
• 183
6. M/s. Martin & Harris (P)
47
Lipped
. _ .
. (.£3 .
2656
.. 40
2f396
H373
!2\
.
7. M^^)rganon-(Jpdia) Liipjted
1^5
ICOJ.
98111
022.H
8. M/s. Suhrid Geigy Limited .
707
609
1316
808
703
0v
^4
?-S04
?-3b4
9. M/%2 SynbiotidOLimited 6£ .
10. M/s. Uni-Sankyo Limited > .
cO^2
Olt-7
11. M^hVander Limited
.
O.-W94
?£ • •
aP5
P,?4
« '
12. M/s'. Warder Hindustan Emiited
<4
70 f
13. Mft£4 Whiffets (India) iMifool
0025g
tedrjf.
. 200!• 4244
Iff. 7
02057
4c!
249
14. M.'^»Carter ^Vallace &.-(Go.
80!
298
000!
Limifed
. " .
40
40
65
20 C
15. M.&jU.S. Vitamins & Phir08f.
08C
maceuticals Limited
132
132
171
'TO 91---------- --------------- OcSi—
0(01
I
7021
^'7
Firms with Foreign Equity Between 26 & 40%
471
----------------------- O4£—
98,.
47*1
'. 72
1. M'^^SioIogical) Evans Lix^iff
148
I
^6
^6
290
2. M/s^£jbatul Limited . ,q1
2S5
^3
.322
458
.181
P.01
3. M's. German Remedies Limitcd£001
’ «
’ ^00-1
742$
4^
4. M '^Me-Gaw-Revindra Labo? If
4802
4 16
^(J
ratuncs (I) Limited
82
22
5. M/'s.
M/s.. aVy-ore Industrial,&
f.7r
rr
''^0
Testihg'Laboratory Ltd// ’ .
53
6. M/^pRallis Indag Limited J A .
4879
H77
5519
54W
7. M/s-rSmith & Nephew (India)
Limited
.
.
V^P
8. M/s7A!lni-UCBe?- (India)r^)
If.
14
^8
Limited
. Of .
. 041.
''tfS
9. M/s. J.L. Morison, Son &
(’i6
<58
Jone£<Limited ...
. 620
326
344
168
10. M/s. Christian Hoden Limited
11. M/s-.^Vard Blenkinsop Limt•11
■ ‘4
rih
£1
001
02
8?2
11
10
(E)fJ .EIB‘1 7-lVJqEfD
15
„
34. Nfi?k.Ioim.T/?tth4E^0h')).
7
----7-------- ;-------- :------ ftlrflDltl (liiffA)
cO
£2
C7I
. baiirniJ biolluH .3.D .2'FZ .7£
i-aiioiciodfiJ loqooD FZ .8£
bolirniJ ionrl)3 .92
-irnid Gtl.nl 1<> ^blod'jiX .?\TZ .02
ba I
. bol'fniJ aniiarla?. nBibn! .12
-i luojnrrnrf!0! Io<hjo>1 .?'FZ .££
balirniJ ?lr/J
V£!
V!__ ?A\.rnori3
<?>
JoM Io M —
130
i
2
11. E. Merck Ltd.
3
4
1969
0.97
1.19
0.97
1.73
1970
1971
1972
12. Glaxo Laboratories Ltd.
1973
2.19
1969- ^0
62.51
62.51
62.1
77.0
1970- '!
1971- 72
1972- 73
1973- "4
13. Johnson & Johnson Ltd.
14. May & Baker Ltd.
1969
1970
1971
1972
1973
I
5
6
7
8
2.19
66.6
42.24
36.57
35.6
29.0
104.75
99.08
97.7
32.1
98.7
106.0
5.10
5.10
5.10
5.10
5.10
5.10
10.38
7.02
10.38
7.02
1969- 70
1970- 71
50.00
44.90
30.00
52.96
(8 months)
1973
Nil
1969
28.54
1970
1971
1972
1973
(13 months')
16. Parke Davis & Co.
1969
1970
1971
1972
1973
17. Pfizer Ftd. .
1969
1970
1971
1972
1973
18. Beekitt & Colman of India Ltd.
19. Richardson Hindustan Ltd.
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
20. Roche Products Ltd.
1969
1970
1971
1972
1973
21. Sandoz India Ltd.
1969
1970
1971
1972
1973
22. Searle India Ltd .
50.00
44.90
30.00
52.90
Nil
28.54
21.20
21.20
21.20
21.20
16.85
10.85
16.85
10.85
67.31
67.31
67.31
67.31
16.51
16.51
26.25
22.75
26.25
22.75
60.40
63.13
68.28
68.21
68.63
60.40
63.13
68.28
68.21
68.23
15.63
9.25
14.30
15.63
9.25
14.30
14.30
14.30
2.75
3.85
3.85
3.85
4.29
2.75
3.85
3.85
3.85
4.29
16.80
16.80
16.80
16.53
16.53
6.79
8.54
9.27
7.35
8.87
10
0.97
1.19
0.97
1.73
1971- 72
1972
15. Merck Sharp & Dohme of India Ltd.
9
16.70
9.47
33.5
26.20
16.87
12.61
29.10
16.534
1.68
2.42
8.47
11.08
9.27
0.12
1.55
1.03
8.90
9.90
1969
1970
1971
1972
1973
23. Smith Kline & French Ltd. .
1969
1970
1971
1972
1973
13.57
18.01
27.46
22.23
27.26
27.46
22.23
27.26
13.57
18.01
0€I
VQ.O
01.1
VO.O
£v I
VI.£
£
i
70.0
060!
. b J J J /iolZ . J . 11
A^.BXURE I 0701
Chapte^.^Para. 13 (e)r^j
C".40l
60r-On-
Name of the firms
0.
I-
c
d
V
8
0(
o.
Ob—r-
Remittand&of Drug Firms
(Firms with Foreigl£E^liity exc
42. £4
£^_x)L.
o.?£
0.02
1.2'.
00. O'
00 4-iOO.OE
00-S'
2. Alkali & Chemical Corpn. of India
4'72
02.12
02 12
ry, ,3.i Anglo French Drug Co
£8.01
.
I? 4>|Bayer.India Ltd...
'2.62
'7-2
04 0)
£ 1. £0
82 5. 'Beechem Ltd.
12.86
£2.86
[Boehringer Knoll Ltd. .
o:i01
0.60
'8 £
.
1969
1970
1971
1972
1973
07 61
-•
ojj.eitirroughs Wellcome & Co. Ltd.21.
.
1969
••1970
1971
1972
• 1973
4£?:.dl
v 4.
80.11
V£ 0
09.' Ciba of India Ltd.
04. V£
fc cr
9
:o
8
Nil
.b’J ioJf.11.^ /L1Z23-.65
22.65
14.45
I4 86
• 07-0001
• -17-0-0 1
•£r-l\0l
•• £701
..
..
••
33.74
'.rr f1' (i Z '-ujY.
..
..
32.’32
svei
wf .•
I 'llmwi £ I)
2.57
0.60
••
0601 ...
0701 ..
I-01
£701 ••
£-01 ••
..
.bkl 0t551
0.08
.'■J
zi/fZl.‘jjix/l QT'^O
0.59
Nil
2.07
2.07
-’(i^i-'22;i3
41.37
0601 ...
0701 ..
1701
£701 ..
£701 ..
6.07
5.89
••07.0601 ••
••17-0-pi ••
••27-1701 ■•
•: .biJ n.sS'<!' rnll
5.72^ '■
6.11- 4
6.12 .
.. ^^.22
.. ^W30
0.22 VoVI ••
6.3 J"' ‘V,
XO. 1
VdP I
07(’l ..
ITCH - ..
2.98
0.09
I.tt ;
1.17. r
Ni”38.6
' I 1.44
)8.dl
7 55z
7 55^^
07VI•’
I\0l • •
2? 01
£701 ••
7.5Kd
0001 ..
0701 . .
24.10
24.10
24.1 '
24.10
35.65
.
7
.GfJ nibnl '16’nBn■'< ') Z’j.izk'-.H
1969
1970
. 1971
. 1972
. 1973
00.0
Total
“o"-PdOI
”l7-0r0l
“ 27-I7QI ■*
£--£‘01
47-£70r'-
1969
• 1970
1971
1972
1973
.'
.
X2.86
6.07s. 06
5.896 XA
6.57
5.4$ .'I
2.67.2.0
0£ 41
2.66>£ M
9.44.? 3
11.14-r v
££.V
£0.1 19.94rx.8
19.94
35.89.
23.54 .
23.54 .
£1 0
6
£-01
Nil
22.531-. 06
41.3^ ;d
1969
1970
1971
1972
■•1973
0£.4
roi
0.60.76
0.49 76
I' .61
72.62
1969
1970
1971
1972
1973
7•; zj Boots Company Ltd.
d£.V£
■V4-4410.81
32.20 87.
32.241 12
02.12
’ 1971-72’
1972- 73
1973- 74
'2.0
5
£701
1969- 70
1970- 71
£6.'I
Profits
plIiHOHI 8)
1969
1970
1971
1972
1973
IE. "A
I £.76
04.V£
22.65
22.65
14.86
14.86
Tech. Fees Head
Office Ex-
ppp I
NoP,r
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
liZ
• • 10. Cyanamid Ltd.
01.'
oi ’
4 01.'.
>.£.() I
1969
1970
1971 ’
1972
1973 ■
00.0'
00.44
00.0£
'^•22
Oc.d£
Dividends Research’-2 Royalty
6.66 £--£701
3
r0 4. Abbott Laboratories
Q/tlO -£l
-------- rrro--------- fij-ivoi------
Year
2
01 >1
Obrr8£ 01
.bJJ
£4.2
2.67
2.66
l-<37
1.71
2.30
5.94
6.42
.b*J /r.uL« Zl 0fLc>16.(396.35
1.44
7.55
’
••
7.55
bi J hi Lc 1 sol. n£^7; 55
9.44
11.14
Ivor..
£701
£\0i..
19.94
bid IJl’Tfl 3ll£3^-.?jf
..
53.07
Wi
OVQt ”
m 12
22.55
0001 • •.
0701 • ‘
1701 *•
£V0I ••
♦.
SVP I
EV 01
23.54
48.21
..
,b:J fl'xwi I
24.10
24/10
24.10
24.10
35.65
■W4------
10 81
129
*
131
i
2
3
4
24. Wyeth Laboratories Ltd.
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
6.28
4.19
4.19
8.24
6.28
4.19
4.19
8.24
25. Griffen Laboratories Ltd.
1969
1970
1.68
2.28
2.85
0.02
1.68
2.28
2.85
0.02
1971
1972
1973
26. C.W. Carmick Lsia
1969
1970
1971
1972
1973
1969
1970
27. Cooper Laboratories
1971
1972
1973
28. Dental Products of India
29. Ethnor Ltd.
30. Roussell Pharmaceuticals Ltd.
31. CE Fulford Ltd.
1969
1970
1971
1972
1973
1969
1970
1971
1972
1973
1969
1970
1971
1972
1973
1969
1970
1971
32. Indian Schering Ltd.
33. Nicholas of India
34. John Wyeth Bros.
.
1972
1973
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
Nil
Nil
5
6
7
8
0.40
Nil
0.80
0.46
Nil
9
10
0.0S
0.48
0.12
0.92
0.46
Nil
Nil
Nil
Nil
0.11
0.15
0.44
0.29
0.11
0. 15
0.44
0.29
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
1.52
0.75
1.33
3.33
8.00
3.90
3.93
Nil
4.70
4.27
7.48
7.09
7.26
21.95
40.74
34.19
1.52
0.75
1.33
3.33
8.00
3.90
3.95
4.70
4.27
7.48
7.09
7.26
Nil
21.95
40.74
34.19
(
IcI
2
01
I
£
♦>
I
d
8
.blj /oilODHC'dcJ fhovV/ .t-2
82.d
..
Pi >__
1-2.8
SI.
(Rs. lakhs)
2V-KP1
---------- ------------- --------------------------------------Dividends ReAarclr Royalty Tech. .
Year
Head
P/ofits
Total
Fees .bjJof^eJLicdKd KonnO .cT
8d.i
PdVI .
82.2
0'PI
Expenses
Name of the firms
80. F*0,
82.2
Firms with Foreign^fc^uity3>et4^^^^ and S0%
3
20.0
---------- LS£U
Asso^pd Caq^l^s Ltd.
I«Z
08.0
£1.0
2V.0
At-,0
<4-0
liX
2. Curewell India Ltd.
1969
1970
1971
1972
1973
.
1969
4. Geoffrey Manners & Co.
1969
1970
1971
1972
1973
6.73X
7.34Z
8.15<
S.SiZ
8-^
00.7-. Organon (India) Ltd.
00.'.
cP.E
.. 1969
.. 1970
.. 1971
1972
r2>
Suhri^j^igy Ltd; •
d2.\
02."
liZ
?Q.12
cP.12
^SynbipVc^;Ltd. .
■
1.60
cr.o
ec.r
0“ -
liZ
IPX
liX
liZ
1970 ••
1971
1972
1973
1969
1970
1971
1972
•• 1973
72.1-
liZ
1969
1970
1971
1972
1973
5. Hoechst pharmaceuticals
liZ
6. Martin & Harris (P) Ltd.
liZ
1969- 70
1970- 71
1971- 721972- 73-■
1973- 74
11 .
Duphar Interfran Ltd. .
cl .
I-1- 0
liS.O
0 " . I-
-----
5 2rPi
24.0
.
• ’ 1973
i-ffi
8^
20*7^
21.1IX
IjZ
.00.8
. DP.£
.K.£
2.86'
.•■1969-70 ■
• • 1970-71 •
•• 1971-72
.. 1972-73 .
.. 1973-74 ..
29.08- •
14.7614.54-
.’' 1969-70 ‘
7.92’
’ ’ 1970-71
5.92'
___19JL-Z2_:____
1972- 73
2.67
1973- 74
10. Uni Sankyo Ltd.
1969- 70
1970- 71
1971- 72
1972-73
1973- 74
Nil
11. Wander Ltd.
1969
1970
1971
1972
1973
1.04
0.60
0.30'
0.59
0.94
132
7
6
.. PdPI ...
..-- 07PI..
.. ivvi ..
2791
£7P1
CdQl
•• 0791
..
.
'•
..
••2791 ••
£791 ’•
9601
.. 07910.05
• • 1-911.16
• - 2791 .25
.. £7910.33
.. W|0.39
0791
1791
2791
9691
0791
• 1'91 •*
•• 2791 ••
•’ £791 • •
9691
0791
1791
2791
£791
07-9691 .
17-0791
27-1791
£7-2791 '■
t-7-£791
• • 07-96^1.97
• • r-07^.95
1.30
■X52
°-58 l*7-£7<(£.68
0.59
'. O7.9dQj'.67
17-0791
27-1791
• • £7-2791 ..
• • 47-£7VI ..
10
9
Nil
Nil
Nil
..
Nil
zondH.icch.J
.72
Nil
Nil
Nil
Nil
Nil
jiibnl To z'j-.jjbci’l l/nmXl .k£
..
..
..
..
8
1.39
0.16
1 66
2.40
2.28
0.35
.bidnonrlid
6.73
7.34
8.15
8.82
JjjJ zlnoinjovrimsrPl II.'j/hjOI $^2
Nil
Nil
8.78
21.19
ntibnl
.bid
0.50
0.50
.. niLnl !o
0.76
’
fPjiMQ.^7
3’.81
32.66
16.02
tlioVV/ nrlolgt-^
7.92
5.92
2.67
1.77
1.82
1.04
0.60
2.07
2.41
0.94
lie
133 *£l
1
01
r
2
12. Warner Hindustan Ltd.
c.
13. Carter Wallace & Co. Ltd. .
liZ
14. U.S. Vitamins & Pharmaceuticals Ltd. .
1. Biological Evans Ltd. .
3. German Remedies Ltd.
4. Me-Gaw-Ravindra Laboratories (I) Ltd.
A’
i
J
I
2.80
3.15
3.15
4.41
8.82
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
Nil
Nil
Nil
Nil
Nil
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
1.60
0.25
0.25
0.25
. 4:
iiZ
liZ
IiZ
IiZ
IiZ
eov i
IiZ
IiZ
.
.
1969
1970
1971
1972
1973-
0.38
0.38
0.38
0.37
O-. 3 7
2.55
1.05
.gJ
9d91
"0791
T79I
2791
£791
.bi I hoLgH
A
-
1969
1970
1971
1972_1973
—
0.75
—
—
) J
0.31
0.31
.bj.f (*1) /.qoUil'Ji)
.oO-+toiH
—PM* I
0791
~1791
—2791
”•1791
0.38
0.47
0.66
0.37
^.37.
Nil
.oD slugworlO
.0^-2* J/GlrJO.^p.! .C
__
1 30
.biJ
liZ_
----------------- _2131-----—
2.45
1.75
1.02
1.38
1.75
1.02
1.38
1.66
2.14
1.66
2.14
1969
1970
1971
1972
1973
6.24
6.22
6.22
6.21
6.10
7. Smith & Nepheu Ltd. .
1969
1970
1971
1972
1973
0.91
0.91
0.85
0.84
0.91
0.91
0.85
0.84
8. UNI-UCB Ltd.
1969
1970
1971
1972
1973
0.15
0.15
0.79
0.79
0.79
0J5
0.15
0.79
0.79
0 79
1969
1970
1971
1972
1973
Nil
Nil
Nil
Nil
Nil
Nil
.
9. J. L. Morrison, Son & Jones Ltd. .
-2
Nil
2.45 ”
1969- 70
1970- 71
1971- 72
1972- 73
1973- 74
0.25
-?ji 1 o -i/TS<-nc)i
.vji/ijas gmb io) loZ
1.30
1.30
1.41
-*
—
0.09-nt
0.2^791
9E.0
QITTT
2670
£270
19692
1970_
1971_
1972
1973
3.15
3.15
6.96
9.87
j/JqGUne.l JI
VdP i
0791
1791
2791
r.7Pl
iv/wvTA AVvh
JO J—
__ 8.___ 9 .bl I qorf/niz'nolH
OTCI
IVQI
2791
f.vqi
.liZ
liZ
.7
Nil
ii
II
1969
1970
1971
1972
1973
r 5
1969
1970
1971
1972
1973
6. Rallis India Ltd.
Fi
4
07^691
174)791
42.027=4791
42.tr
£7=479!
02.0"
47-£79l
Firms with Foreign Equity between 26 °/Q and 40
079!
?.4.0
2. CiBatOl Ltd. - .
9£.0
—
2d.O
—
?.2.0
—
5. M.I.T. Laboratories
?
1969- 70 oa<)2
O.’63
1970- 71
197L-72
J0.31
1972-73
JO.31
1973- 74
15. Whiffens (India) Ltd. .
l-S.O
bC.O
02.0
1
Nil
0.32
1.87
1.61
6.24
6.22
6.22
8.08
8.03
134 l >
i
2
10. Wand Blenkinshop Ltd.
11. Leukoplast & Co.
12. Christian Hoden Ltd. .
3
4
1969
1970
1971
1972
1973
1969
1970
1971
1972
1973
1969
1970
1971
1972
1973
Nil
Nil
Nil
Nil
Nil
.5
Nil.
6
7
8
9
10
Nil
Nil
Nil
Nil
Nil
Firms with Foreign Equity below 26 °0
1. Capsukation Service Ltd.
2. Gelikeps (P) Ltd.
3. Raptakos Brett Co.
4. Chowgule Co.
.
1969-70
1970- 71
1971- 72
1972-73
1973- 74
1969
1970
1971
1972
1973
1969
1970
1971
1972
1973
0.24
0.24
0.20
0.24
0.24
0.20
Nil
0.45
0.39
0.39
0.62
0.25
0.45
0.39
0.39
0.62
0.25
Not for drug cctivity.
5. Leukoplast & Co.
Nil
6. Themis Chemical Ltd.
Nil
1
_—i
y
ANNEXURE
VI
Import Content in Bulk Drug Manufacture
Chapter-V. Para. 13(f)
3
SI.
No.
Selling
Name of the Bulk Drug c.i. f.
Price
Price in
rupees per
k.g. of
the Bulk
Drug
Firm
4
5
Chloroquin Phosphate
125.4
260
Sulphadiazine
Metronidazole
53.6
125
2
3
1. Payer India Limited.
1
2.
.
& Biker
. *Forsemide
3. Hoechst
4. Parke Davis
.
5. Boehringer Knoll
6. Pfizer Limited
7. Parke Davis.
565 .
Avil Maleate
Tolbutamide
Chloramphenicol
273
34
1200
Amodiaquin
. Ephedrine'Hcl.
. Chlorpropamide
NA
209
67
Tetracycline
136
Oxytetracycline
187
PAS
Diphenhydramine Hel.
NA
.
.
Imported raw-materials
Import
content
per k.g.
(c.i.f.)
Percentage of
Import content
on
selling
Price
on
c.i.f.
Price
Rs.
8
9
78
37
62
78
32
22
312
59
26
155
15.7
54
56
46
4.5
17
8
100-.7
192
33.22
92
49
31
44.46
32.4
5
30.24
16
3
0.15
40
8
NA
Neg.
7
6
97.88
Hydroxy Chloroquinolinc
Novaldiamine.
2—Aminopyramidine
33.00
2—Methyl 1-1—nitroimidazole 86.10
102.
400
(Approx.)
Lasamide
1200
(STC price)
NA
IBerayl Pyridine Sodamide
91.71 :Maleic acid Butylamine
Banzeldehyde
662
j
Methyl Bromide
Lithium Hydride
4. 7-DichloroquinOiine
232
Ketol
NA
107.72 n-Propyl Isocyanate
Triethylamine
H>flusupercel
Hyflusupercel
850
Ethyl Cellulose
Corn steep liquor
Glass wool
Hyflusupercel
950
Ethyl Cellulose
Triethylaine
Sod. Nitrate
Glass wool
Hyflusupercel
53
Benz Hydro1
Beta Dinethyl
Aminoetanol
43
48
’ 6’""
to0'-5600^
135
l—M of Pet. & Chem./75—18
ANNEXURE VTT
Statement Showing the N'ame of Foreign Company, Bulk Drug Manufactured, Licence No.JPermission!no Objection
Letter j\ro. and Date etc.
(Chapter, V Para 13f)
SI. Name of the Company Item of bulk drug ManuNo.
factured
Lie. No./Permission
Letter No. & date
4
3
1
Licensed/approv- °/Q of bulk drug made available
ed capacity P.A.
to others.
1971
1972
5
6
7
Nil
1973
8
1. M's. Cy?.n',.mid India
Limited
Tetracycline
Lie. No. L/22'N-132.60
dt. 29-1-1960 and amend
ment No. 22(168) IA
(11)58 dt. 31-8-61.
10 tonnes
Nil
2. M/s. Reckitt and Colman of India Limited.
Para Chlore Mera xylenol
Lie. No. L/22/404/71 Ch. Ill dt. 25-1-1971
50 tonnes
This material is required for
their captive consumption in
Dettol.
L/22/99/62-Ch.III
dt. 3-1-1962
4 tonnes
540 Ki’S.
240 „
200 „
400 „
1000 ,,
350 „
10 tonnes
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
12 tonnes
Nil
Nil
Nil
(For captive
consumption)
Nil
Nill
Nil
Nil
Nil
Nill
Nil
Nil
Nil
Nil
Nil
Nil
30 tonnes
Nil
Nil
Nil
12 tonnes
Nil
Nil
Nil
18 tonnes
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nill
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
, Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
1500 MU
Nil
Nil
Nil
12 tonnes
Nil
Nil
Nil
3 tonnes
Nil
Nil
Nil
120 Kgs.
Nil
Nil
Nil
Nil
Nil
N.A.
Nil
Nil
Nil
Nil
Nil
Nil
N.A.
Nil
Nil
Nil
Nil
Nil
Nil
91.5 kgs.
Nil
Nil
Nil
Nil
3. M/s. Bayer India Limit- Chloroquin Phosphate
ed.
Resotren
Cresival
Entodon
Etaine HelPiperazine Hezahydrate
-Piperazine Phosphate
Mesulphen B.P.
L'22/351/67-Ch. Ill
dt. 15-12-1967
Chloroquin Phosphate (S.E.) L'22/477/73-Ch. Ill
dt. 3-8-1973
Badional Substance
No. l(6)/72-Ch. Ill
Detigon Substance
dt. 31-7-1972
Incidal Substance
Diphenyl hydentoin
4. M/s. Boehringer Knoll
Chloramphenicol
Chloramphenicol
Monostearo ylglycolate
Ephedrine B.P.
L 22/N-125/60
dt. 5-1-1960
L 22/26/66-A&I
dt. 7-4-1966
L/22/140/62-Ch. Ill
dt. 1-12-1962
Nil
Carbutamidl
Oc-inum Mucate & D Mucate.
Ocinum D Amidosulpho- Nil
nate
I-Ephedrine
Hydrohoda- Nil
nat \
Chloramphinicol Palmiate
Leptazol B.P.
Multifungin Substance
Priatan Substance
Soventol Hcl. & Salicylate
5. M/s. Boots Company
(India) Limited
Insulin
Diloxamide Furoate
(For captive
consumption)
L/22/N-30/60-Ch. HI
dt. 8-11-1960
L/22/420/71-Ch. Ill
dt. 26-7-1971
6. M/s. Merck Sharp and Chlorthiazide and hydro- L/22/N-57/58
Dohme of India Limited
chlorthiazide
dt. 18-9-1958 and amend
ment.
Cyproheptadine
No. L/22/101(IA)(II)/58
Cortisone, Dexamethasone dt. 25-8-1959
and other Hormones
Phthalyl Sulphathiazole
Succinylsulphathiazole
Vitamin B12
Indomethacin blend
Nil
Methyl Dopa Gran
Benztropine Meaylate
Ethacryinc Acid
136
3.5 tonnes
3.5 tonnes
144 kgs.
(for captive
consumption)
Nil
2
3
7. M/s. Sandoz (India)
Limited
Calcium Gluconate
1
4
6
7
8
Nil
Nil
Nil
20 tonnes
Nil
Nil
Nil
Nil
Nil
Nil
Ni I
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
5 tonnes
Nil
Nil
Nil
54 tonnes
Nil
Nil
Nil
Capacity yet to
be fixed
Capacity yet to
be fixed
28.8 tonnes
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
48 kgs.
Nil
Nil
Nil
5 tonnes
Nil
Nil
Nil
60 kgs.
Nil
Nil
Nil
10.8 tonnes
Nil
Nil
Nil
250 kgs.
Nil
Nil
Nil
2 tonnes
Nil
Nil
Nil
To be fixed
Nil
Nil
Nil
150 kgs.
Nil
Nil
Nil
5 tonnes
Nil
Nil
Nil
100 kgs.
Nil
Nil
Nil
200 kgs.
1.2T
Nil
Nil
Nil
Nil
Nil
Nil
3 tonnes
Nil
Nil
Nil
L/22/N-33/58
dt. 12-2-1958
L/22/297/66-Ch. Ill
dt. 4-3-1966
L/22/308/66-Ch. Ill
dt. 20-7-1966
L/22/348/67-Ch. Ill
dt. 1-12-2967
240 kgs.
Nil
Nil
Nil
5 kgs.
Nil
Nil
Nil
To be fixed.
Nil.
Nil
Nil
200 K^s.
Nil
Nil
Nil
L/22/414/71-Ch. Ill
dt. 16-6-1971
-do-do-do-doL/22/413/71-Ch. Ill
dt. 16-6-1971
-do-
415 Kgs.
Nil
Nil
Nil
2850 Kgs.
60 Kgs.
2150 Kgs.
95 tonnes
1.5 T
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
3 kgs.
2T
Nil
Nil
Nil
Nil
Nil
L/22/322/67-Ch. Ill
dt. 11-9-1970
L/22/293/66-Ch. Ill
dt. 15-1-1966
L/22/163/63-Ch. Ill
dt. 31-5-1963
Nil
Nil
Nil
6 kgs.
Nil
Nil
Nil
252 kgs.
Nil
Kil
Nil
L/22/71/56
dt. 19-11-1956 &
Calcibromate
Calcium Lactobinnate
Calcium Lactate '
Gluconate
Ferrous Gluconate
Galactose
Fructose
Ferrous Fumeratc
L/22/32/60-Ch. Ill
dt. 19-11-1960 &
L/22/383/70-Ch.III
dt. 7-4-1970
L'22/281/65-Ch. Ill
dt. 28-17-1965
Magnesium Gluconate
L'22/288/65-Ch. Ill
dt. 1-10-1965
Active Principles of Podo- L/22/166/63-Ch. Ill
phyllum.
dt. 21-8-1963
amended vide
Active Principles of Senna I/77)/62-Ch. HI
and Belladone
dt. 16-5-1967
Digoxin B.P.
L/22/240/64-Ch. Ill
dt. 26-10-1964
Intcstopan Substance (S.E) L/22/373/69-Ch. Ill
dt. 24-11-1969
8. M/s. Burrougts Well Adrenaline & Adrenaline
Acid & Tartarate
come & Co.
Bephenium Hydroxynaphthoate
Chlorcyclizine Hcl.
Depsone & Solapsonc
Cycline Hcl. & base
DCC
Digoxin
Emetine Hcl.
Ferrous Succinate
Isoprcnalin Sulphate
Methlamphetamine Hcl.
Methyl Stearate
Paracetamol
Primethamine Hcl.
Succinyl Choline
Tubocuracine C12
Zinc Undecylenate
9. M/s. Ciba-Geigy Ltd. .
Antrenyl
Crude Quinone
lianabol
Entobex
Sulphonamides
Calcium Coraminc
Dexamethasone
Trimethyl Acetate
Esidrex
Mestranol
Ismelin
5
L/22/N-33/58
dt. 12-2-1958
L/22/348/67-Ch. Ill
dt. 1-12-1967
L/22/N-33/58
dt. 12-2-1958
L/22/N-33/58
dt. 12-2-1958
L/22/348/67-Ch. HI
dt. 1-12-1967
L/22/224/64-Ch. Ill
dt. 10-8-1964
L/22/211/64-Ch. Ill
dt. 2-5-1964
L/22/N-33/58
dt. 12-2-1958
L/22/328/67-Ch. Ill
dt. 14-3-1967
L/22/348/67-Ch. Ill
dt. 1-12-1967
do.
L,'22/206/64-Ch. Ill
dt. 4-4-1964
L/22/325/67-Ch. Ill
dt. 3-3-1967
160 tonnes
Nil’
■
138
1
3
2
Vitamin E
Rutin
Caloromycetin
Benadryl Hcl.
Camoquin Hcl.
13. M/s. Pfizer Ltd.
.
Tetracyclines1
Chlorpropamide
PAS & its Salts
I.N.H.
Benminth
8
Nil
Nil
5 Kgs.
Nil
Nil
Nil
500 Kgs.
Nil
Nil
Nil
18 Kgs.
Nil
Nil
Nil
50 T
Nil
Nil
Nil
12 Kgs.
18 Kgs.
60 Kgs.
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
102 Kgs.
Nil
Nii
Nil
15 Kgs.
Nil
Nil
Nil
15 Kgs.
Nil
Nil
NJ
4 tonnes
Nil
Nil
Nil
4 tonnes
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
20 tonnes
Nil
Nil
Nil
6T
Nil
Nil
Nil
36 T
Nil
Nil
Nil
14 T
L/22/37/67-A & I
645 T
dt. 13-7-1967
HOT
L/22/329/67-Ch. Ill
dt. 13-7-1967
L/22/36/55 dt. 26-3-55 &
letter No. 1 (39)/61-Ch. Ill SOT
dt. 28-4-62 &
L/22/373/69-Ch. Ill
dt. 4-10-1969
300 Kgs.
L/22/429/71-Ch. HI
dt. 23-11-1971
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
L/22/424/71-Ch. Ill
dt. 27-9-19/1
-do-
210 tonnes
L/22/23/54 dt. 21-9-54
&L/22/N-146/60dt. 21-3-60
& L/22.69 dt. 7-11-52 &
22(6 5) IA(II) 57 dt. 27-4-60
2 tonnes
L/22/N-13 '60-Ch. Ill
dt. 19-7-1960
500 Kgs.
-doPromethazine Hcl & Base
300 Kgs.
L/22/131/62-Ch. Ill
Promethazine 8-Chlorodt. 13-9-1962
theophyllinate
250 Kgs.
L/22/N-13-’60-Ch. HI
Prochlorperazine Maleate
dt. 19-7-1960
2508 Kgs.
22(260) IA (11)59
Chlorpromazine Hcl. B.P.
dt. 30-3-1960
4.2T
L/22/41 55 dt. 3-8-55
Di-Iodochlorohydroxy
& letter 22(85)IA( 11)55
Quinoline
dt. 20-2-1961
602 Kgs.
L/22/417/71-Ch. HI
Metronidazole
dt. 6-7-1971
1800 Kgs.
L/22/23/54 dt. 21-9-54
Acetrasol
& letter 22(61)IA( 11)54
dt. 5-8-1959
136 Kgs.
.
L/22/23:54 dt. 21-9-54
Neptal
65 Kgs.
Chloramphenicol Cinnamate L/22/417 71-Ch. Ill
dt. 6-7-1971
Not specified
R/22/69 dt. 7-11-52
Ephedrine Hel.
-doPsedudo Ephedrine Hcl.
.
7
Nil
11. M/s. May & Baker Ltd. Sulpha Drugs
(Sulphadiazine
Phthalyl Sulphathiazole
Sulphamerazine etc.)
Mepyramine Maleate B.P.
12. M s. Parke Davis
L
6
199.2 Kgs.
L 22/293 66-Ch. HI
dt. 15-1-1966
L/22/163/63-Ch. HI
Navidrcx
dt. 31-5-1963
. L'22/324/67-Ch. HI
Naprcsol
dt. 20-2-1967
L/22/317/66-Ch. Ill
Oestradial, Oestradiol
dt. 15-10-1966
Propionate
L 22/468/73-Ch. HI
Ethinyl Oestradiol
dt. 20-3-1973
Rutin
L/22/38/55
Serpasil
dt. 22-6-1965 &
Perandrcn
22/555/lA(II),61
Lutocycline
dt. 16-8-1961
L/22/100 62-Ch. Ill
Testosterone esters &.
dt. 8-1-1962
.Progesterone
Testosterone Undecylineatc 2(J3)/61-Ch. HI
dt. 14-5-1962
-doTestosterone Valerinatc
Lynestrcno! & derivatives
10. M/s. C. Merck (India)
Pvt. Ltd.
5
4
L/22/9/62-A & I
dt. 5-4-62
L/22/64/56
dt. 22-9-1956
-do-
14. Richardson Hindustan
Ltd.
Menthol
L/29(3)(ii) 62-Ch. Ill
dt. 17-11-1962
Not fixed.
Nil
Nil
Nil
15. Reche Products Ltd.
Vitamin A
L/22/292/65-Ch. Illi
dt. 11-11-65
L/22/438/72-Ch. HI
dt. 11-4-1972
20 m m u
Nil
Nil
Nil
95 Kgs.
Nil
Nil
Nil
D eh}droeinetinc Hcl.
139
1
2
3
Chlordiazepoxide
Vitamin E \
Diazepam
f
Sulphamethoxazole
16. M/s. Searle (India) Ltd. Spironolacetone
Propantheline Bromide
Dimenthydrimate
Methyl Testosterone
Testosterone
Diphenoxy-late Hcl.
6
7
8
Capacity to be
fixed
Nil
Nil
Nil
CIL 119(74)
dt. 23-4-1974
1 8 Tonnes
Nil
Nil
Nil
L/22'336 67-Ch. Ill
dt. 30-6-1967
28 Kgs.
Nil
Nil
Nil
120 Kgs.
190 Kgs.
15 Kgs.
50 Kes.
200 Kgs.
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
5 Tonnes
Nil
Nil
Nil
L 22/N-142 59 dt. 12-2-60 720 Kgs.
L/22 330 67-Ch. Ill
dt. 29-3-1967
Nil
Nil
Nil
L/22 378,70-Ch. Ill
dt. 12-2-1970
DL-Panthenol
17. M's. Wyeth Labo
ratorics Ltd.
Cortis Costeriods(Prednisolone/Acetate
Prednisone & Hydrocor
tisone 1 Acetate)
Methyl Testosterone
5
4
L/22/N-142
dt. 12-2-1960
& L/22 4.28/71-III
dt. 26-10-1961
44.40 Kgs.
Nil
Nil
Nil
25.00 Kas.
180 Kgs.
45 Kgs.
5 Kgs.
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
L/22/N-142
dt. 12-2-60
L/22/428/71-Ch. Ill
dt. 26-10-1971
L/22/330'67-Ch. Ill
dt. 29-3-1967
1(10) 65-Ch. Ill
dt. 27-5-1966
7.50 Kgs.
Nil
Nil
Nil
270 Kgs.
Nil
Nil
Nil
2.4T
Nil
Nil
Nil
As per
requirements
Nil
Nil
Nil
L/22; 54 54
dt. 19-10-1954 &
L/22 394/70-Ch. HI
5005 Kgs.
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nl
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
L/22 N-161 60
dt. 2-5-1960
CIL 61(74)
dt. 5-3-74
L/22/177/63-Ch. Ill
dt. 25-11-1963
L/22/210 64-Ch. Ill
dt. 17-4-1964
L/22 236 64-Ch. Ill
dt. 12-10-1964
3T
1 00 T
Nil
Nil
Nil
3.6 Kgs.
Nil
Nil
Nil
6T
Nil
Nil
Nil
300T
Nil
Nil
Nil
1500 Kgs.
Nil
Nil
Nil
30 m m u
Nil
Nil
Nil
157.5 Kgs.
10.5 Kgs.
180 Kgs.
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
19. Alkali &
Chemicals
Corporation of India.
Nil
Nil
Nil
Nil
20. Anglo French Drug Co.
Nil
Nil
Nil
Nil
21. Beechem (India) Ltd.
Nil
N1
Nil
Nil
Testosterone
Testosterone Propionate
Testosterone Enanathatc
Testosterone Hexahydro
Benzoate
Ethinyl Estradiol
J 7-Alpha Hydroxy
Progesterones Caproate
Progesterone &
intermediates
Ethoheptazine Citrate
18. M's. Glaxo Lab
oratories Ltd.
Methyl Salicylate B.P.
Merselyl B.P.
Vitamin K
Piperazine Adipate
Methyl Testosterone
Ethisterone
Progesterone
Testosterone Propionate
Contramine
Mephesin &
Chlorphensin
Chlorphenesin
Calcium Sannosidcs
Beta Ionone
Ethinyl Oestradiol
Vitamin B 12
Cortisone
Hydrocortisone
Betamethasone
Prednisolone
Predisone
Trichloroethyl Phosphate
Vitamin A
Magestrol Acetate
Dimenthisterone
Methdilasine Hcl.
L/22/279 65-Ch. Ill
dt. 14-7-1965
L/22/408/71-Ch. Ill
dt. 13-4-1971
L/22/447/72-Ch. Ill
dt. 15-12-1972
1
(
140
i
2
22. Johnson & Johnson
India'Ltd.
23. Abbott Laboratories
Ltd.
24. Smith Kline & French
25. Laboratories Grimault
Ltd.
26. Anglo Thai Corporation
27. G.W. Carnrick & Co.
28. Chesborough
Laboratories.
29. Cooper Laboratories 1
30. Dental Products
31. Lthnor Ltd.
32. C.E. Fulford
33. Indian Schering Ltd.
34. John Wyeth Bros.
35. Nicholas of India Ltd.
36. Ronssel Pharmaceuti
cals Ltd.
3
5
6
7
8
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
4
Nil
These Companies are yet to obtain Industrial Licence under the I(D£Rj
Act, 1951.
ANNEXURE-VIII
Chapter V Para 13 (j)
Report of the Sub-committee on Permission Letters, Diversification and COB Licences
During the visit of the Committee to various drugs and pharmaceutical units and also by written representations
it was brought to the notice of the Committee by the Indian sector that the permission letters and C.O.B. licences were
issued to many foreign firms to manufacture mainly formulations with the result that the foreign firms have attained
a dominant position in the Industry to the detriment of the Indian sector. The question of permission letters and
C.O.B. licences was raised on the floor of the Parliament on a number of occasions and the Minister, in reply to the
question, stated that the Committee on Drugs and Pharmaceuticals Industry, appointed by the Government, will
go into this question in detail. The Committee appointed a Sub-committee consisting of the following :
1. Shri K. S. Chavda
2. Dr. Ranen Sen
3. Prof. B. V. Ranga Rao
4. Shri P. S. Ramachandran
J
:i
Convener
Shri Jaisukh Lal Hathi, Chairman also participated in the meetings. This Sub-Committee went into the question of
permission letters and C.O.B. licences in detail. The Ministry of Petroleum & Chemicals had made available to the
sub-committee some files relating to the issue of permission letters and C.O.B. licences. The Sub-Committee had
also the benefit of hearing the views of the Secretary, P & C Ministry, the Secretary, I.D. Ministry and the Secretary
Techinical Development. A questionnaire was also issued to these Ministries and the Department and the replies
received from them have been carefully considered by the Sub-Committee.
2. The general view expressed by the representatives.of the Ministries was that the industrial licences, the per
mission letters and the C.O.B. licences have the same legal sanction. Having regard to the stage of development of
the industry, during the first 16 years from 1952-68 permission letters were issued to the firms and C.O.B. licences
were issued after 1970. According to them the permission letters were a corollary to the registration certificates and
were in the nature of calrification.
3. The Committee has examined the provisions of the Industries (Development & Regulation) Act to ascertain whether the permission letters and the C.O.B. licences issued can stand the test of legal scrutiny.
4. The Industries (D&R) Act, 1951 came into force on Sth May, 1952. Under Section 10, even’ existing un
dertaking had to register the undertaking within a prescribed time. A certificate of registration as prescribed under
the Rules was to be issued to such firms. There were only 10 firms which had been granted registration certificate
under section 10, out of these 10 firms the following 5 firms have been given pemission letters :
1. M/s. Boots Co. India Limited.
2. M/s. May & Baker Limited.
3. M/s. Glaxo Laboratories Limited.
4. M/s. Cyanamid (India) Limited.
5. M/s. Ciba of India Limited.
All the five firms who were given permission letters are foreign firms. All other firms were given licences. In
the case of the firms to whom registration certificate is granted, the item in the column Schedule Industry “22, Drugs
& Pharmaceuticals” is mentioned. The view of the Ministry is that these firms can manufacture any item falling within
the category of Drugs & Pharmaceuticals, and as such they need not apply for a licence so long as the^firm is
manufacturing any item falling within the category of Drugs & Pharmaceuticals.
5. Under Section HA the owner of an industrial undertaking not being the Central Government which
is registered under Section 10 or in respect of which a licence or permission has been issued under Section 11 shall
not produce or manufacture any new article unless :—
(a) in the case of an industrial undertaking registered under section 10, he has obtained a licence for produc
ing or manufacturing such new articles; and -
(b) in the case of an industrial undertaking in respect of which a licence or permission has been issued under
section 11, he has had the existing licence or permission amended in the prescribed manner.
141
/
r
L
i
142
“New article” is defined in section 3(dd) as under :—
(a) any article which falls under an item in the First Schedule other than the item under which articles ordi
narily manufactured or produced in the industrial undertaking at the date of registration or issue of the
licence or permission, as the case may be, fall;
(b) any article which bears a mark as defined in the Trade Marks Act, 1940, or which is the subject of a patent,
if at the date of resistration or issue of the licence or permission, as the case may be. the industrial under
taking was not manufacturing or producing such article bearing the mark or which is the subject of that
patent.
6. The Resistrar of Trade Marks, who was consulted on the interpretation of trade mark has given his opinion
as under :—
“A trade mark is a mark (which includes any device, brand, heading, lable, ticket, name, signature, word,
letters or numerals or any combination thereof), which is used by a trader or manufacturer to identify his goods
from the goods of other traders or manufacturers in the course of trade.
Tye definition of a trade mark as given in Section 2(1 )(v) of the Trade and Merchandise Marks Act, 1958 is
as follows :—
(V) ’‘trade mark” means—
l(i) in relation to Chapter X (other than section 81). a registered trade mark or a mark used in relation
to goods for the purpose of indicating or so as to indicate a connection in the course of trade between
the goods and some person having the right as proprietor to use the mark: and
(ii) in relation to the other provision of this Act. a mark used or proposed to be used in relation to goods
for the purpose of indicating or so as to indicate a connection in the course of trade between the goods
and some persons having the right, either as proprietor or as registered user, to use mark whether
with or without any indication of the identify of that person, and includes a certification trade mark
registered as such under the provisions of Chapter VII.
A trade name is the name under which a person trades or a business is carried e.g.. the name of company, the
name of a firm etc. (e.g. United Trading Co.).
.
■ ; ■ confers
' ; on the grantee for a limited term, the exclusive priviA patent is a grant from the Government
which
and
authorising for the disclosure of an invention.
lege of marking, selling and using an iinvention
----- --------2 also
'
Brand name is another term for a trade mark. Both are the same thing. But in legal parlance the term used
is Trade mark’.”
Thus even if a certificate is granted or a licence is issued, a firm cannot manufacture a new article under a new
brand name without obtaining a fresh licence.
7. The 15 leading foreign firms were given permission letters to manufacture 364 items, of which 360 were
formulations. It is well known that the formulations yield larger profit than bulk drugs.
8 With resard to the C.O.B. licences. 12 foreign firms and 5 Indian firms were given such C.O.B. licences which
included 215 formulations and 20 bulk drugs. Of these, the share of Indian firms was insignificant. The C.O.B.
licences are intended to cover the diversification of products by the firms. The Press Note dated 27th October,
1966 states that the undertakings going in for diversification has to intimate to the Directorate General of Techni
cal Development, the particulars regarding their revised manufacturing programme and the new articles proposed
to be manufactured and also the value and nature of the minor balancing plant, if any added by them.
9. It appears that barring M/s. Merck Sharp & Dohme, Hoechst and East India, no other firm which secured
COB licence, had intimated to the D.G.T.D, the details required under the Press Note. The Sub-Committee
was also told that C.O.B. licences were given to those firms which had taken “effective steps”. Rule 2, (ii) of the
Rules framed under the IDR Act defines “effective steps” as one or more of the following
(a) that 60 per cent or more of the capital issued for an industrial undertaking which is a public company
within the meaning of the Indian Companies Act. 1913 (VII of 1913) has been paid up;
(b) that a substantial part of the factory building has been constructed;
(C) that a firm order has been placed for a substantial part of the plant and mechinery required for the under
taking.
It aooears from the discussions which the Sub-Committee had with the Secretaries of Ministry of Industrial Develooment Ministry of Petroleum and Chemicals and D.G.T.D. on the 7th Feburary, 1975 that no verification was
made whether effective steps had actually been taken by the firms applying for C.O.B. licences. But they were
issued on the strength of information supplied by the applicants in their applications. The Committee feels that it
?
143
is not consistent with the provisions of the IDR Act. Section 14 provides that “before granting any licence or per
mission under section 11, 11 A, 13 of section 29-B the Central Government may require such officer or authority
?k-ltunla^rapP?IIIt f°r
Purpose, to make a full and complete investigation in respect of applications received in
this behalf and report to it the result of such investigation and in making any such procedure as may be prescribed”.
This provision has not been satisfied before or after giving C.O.B. licences.
10. The Sub-Committee has come to the conclusion that :
(1) on a proper interpretation of the IDR Act, permission letters could not be issued for new articles whether
the firm has been given certificate or registration or a licence unless a new licence has been obtained by the
M?rkr thS raanufacture of a new articIe as defined under the Act and clarified by the Controller of Trade
(2) before granting C.O.B. licences and D.G.T.D. or the authority should have verified whether effective
steps have been taken by the firms in accordance with the provisions of Section 14; and
(3) the issuance of permission letters and C.O.B. licences to foreign firms have given undue advantage to these
foreign firms to the detriment of the Indian sector.
'
"
The Sub-Committee, therefore recommends that so far as the bulk drugs are concerned, having regard to the
national need for bulk drugs, the permission letters and C.O.B. licences issued to these companies may be
regularsed on condition that—
(a) all bulk drugs are manufactured from the basic stage; and
(b) 50% of the production of the basic drugs should be made available to non-associated Indian formulators.
11. So far as formulations are concerned, in order that there may not be a gap between production and market
demand and thereby creating a shortage in the market, the Indian companies applying for the manufacture of such
formulations should be given licences liberally forthwith and the foreign companies should be asked to switch over
within one year to the manufacture of bulk drugs and formulations to the extent of 50% of the production of basic
drugs by them and the balance 50% to be supplied to non-associated formulators.
I
I
J
Il
1—M of Pct. & Chcm./75—19
i
Annexure—IX
(Chapter V—Para 13-k)
Excess Production of Bulk Drugs by Drug Manufacturing Firms
S’.
No.
Name of the Foreign
Company equity
Unit
Item
%
1
2
1. Burroughs
Wellcome
2. May & Baker
Limited.
Excess
Permis
sible
Capa
city.
1971
1972
1973
1971
1972
1973
Production
4
5
6
7
8
9
10
11
12
13
Bephenium Hydroxvnapthoate
Cyclizine Hcl.
D.C.C.
Isoprenaline Sulphate .
Paracetamol
Succinyl Gholinechloride
Zine Undccylcwate
T
5
6.25
8.46
11.91
9.99
2.21
5.66
3.74
312
419
2.5
6.3
125
303
3.75
7.6
6.25 89.7
250
302
534
7.4
222
392.30 107
6.612 3.8
4.9
252.42 178
6.95
0.868 3.85
53.70 83.25 65.25
235
259.77 52
80.30^
4.112
127.42
Kgs.
Kgs.
250
2
100
3
5
200
Kgs.
Kgs.
602
500
750.5 5941
625
1028
6922
858
7662
2055
5190.5 6171.5 6911.5
403
233
1430
Kgs.
21
86
668
16
102
3
100
Licen
ced
Capa
city
Kas.
T
Kgs.
114
10.7
71.5
485
47.45
9.77
100 Metronidazole
Promathazine Hcl
Promethazine 8Chlorothcophylline
Di-iodochlore
Hydroxy Quinoline
Neptal
300
375
216
396
461
Kes. 4200
Kgs.
136
5250
170
1572
175
5938
186
4573
272
3. Roche Products
89 Dehydronmetine
Vitamin A
Kgs.
MMU
95
15
118.75
18.75
199
300
23.52 27.81
19.0
26.79
80.25
4.77
181.25
9.06
8.04
4. Pfizer Limited
75
9.10
7.21
22.54
5
Chlorpropamide
Oxytctracycline
T
T
1.5
9
1.87
11.25
11.97
30.82
12.90
39.00
9.08
33.79
19.57
11.03
27.75
5. Glaxo Labs.,
75 Beta Ionone
Calcium Sennosides
T
T
60
3
75
3.75
96
4.73
103
3.28
100.07
2.29
21
0.98
28
25.07
6. Wyeth Lab.
Limited
74
Methyl Testosterone
Kgs.
44.40
55.50
50,70
67.90
73
12.40
17.50
7. Cyanamid Lab.
65 Tetracycline
T
10
12.5
16.7
20.1
18.23
5.73
8. Ciba of India
Limited
65
9. Merck Sharp
& Dohmcd
10. Bayer India
Limited
11. Searle India
Limited.
12. Hoechst
Sulphonnamides
Nepresol
Crude Quinone
Salt Antreryl
60 Vitamin Bl2
57.45
57
Chlorequin Phosphate
Entodoi
Aldaotane
4.2
7.6
T
95
Kgs. 500
Kes. 2850
Kgs. 415
72
Kgs.
136
118.75 146.8
573
625
763
3652
2185
4125
467
503.75 629
90
94
142
81.69 28.05
637
138
4618
369
125.25
123.60
4
17.25
562.4
12
966
52
33.60
T
Kgs.
Kgs.
5
250
35
4
200
28
22.3
126
N.A.
22.8
500
36.55
10.32
Nil
41.9
17.3
17.0
250
1.55
5.32
Nil
6.9
57.99
65.54
50 Tolbutamide
T
36
45
60.47
15.47
12.99
20.54
13. Wander Ltd.
49 PAS & Its Salts
14. Synbiotics
48 Streptomycin
T
T
120
62
150
77.5
146.4 150.7 135.82
92.89 94.73 80
15.39
0.7
17.23
2.5
0.4
23.12
53
43
52.21
N.A.
15. Suhrid Geigy
47.5 Tanderil
T
6
7.5
7.9
7.3
16. Geoffrey
Manners & Co.
45 Al-hydroxide Gel.
T
216
270
251.4
293.2
17. Cibatul Ltd
30 Sulpha drugs
T
160
200
243
252.21
N.A.
Kgs.
150
187.5
232.1
199.3
366.4
44.6
11.0
178.9
T
120
150
242
259
261
92
109
111
Kgs. 2400
Kgs. 1200
Kgs. 120
3000
1500
150
4812
1074
175.1
2200
2369
1618
1300
4.1
18. Atul Products
Limited
Nil
Menadione Bisulphate
19. Sarabhai M.
Chemicals
Nil
Vitamin C
20. Cipla
Nil
Diosgcnin
16-D-hydropregnelone
Testo tcrone
144
7.23
323
1812
118
25.1
Appendix—I
Chapter—V. Para 12
(Note :
The classification of industries follows the First Schedule to the Industries (Development and Regulation) Act 1951.
Items of manufacture reserved for the public sector under Schedule A to the Industrial Policy Resolution 19o6 or
for production in the small-scale sector as may be notified from time to time will be excluded from the application of the
list).
1.
Metallurgical Industries
(1) Ferro alloys
(2) Steel castings and forgings
(3) Special steels
(4) Non-ferrous metals and their alloys.
2.
Boilers and Steam Gen rating Plants
3.
Prime Movers (other than Electrical Generators)
(1) Industrial turbines
(2) Internal combustion-engines
4
Electrical Equipment
(1) Equipment for transmission and distribution of electricity
(2) Electrical motors
(3) Electrical furnaces
(4) X-ray equipment
(5) Electronic components and equipment.
5.
Transportation
(1) Mechanised sailing vessels up to 1000 DWT
(2) Ship ancillaries
(3) Commercial vehicles.
6.
Industrial machinery.
7.
Machine tools.
8.
Agricultural machinery
Tractors and power tillers.
9. Earthmoving machinery.
10. Industrial instruments: indicating, recoding and regulating devices for pressure, temperature, rate of flow, weights, ^esels and
the like
11.
Scientific instruments.
ll
Nitrocenous and phosphatic fertilisers falling under (1) Inorganic fertilisers’ under 18. Fertilisers’ in the First Schedule to
ID&R Act 1951.
13.' Chemicals (other than Fertilisers)
(1) Inorganic heavy chemicals
(2) Organic heavy chemicals
(3) Fine chemicals, including photographic chemicals
(4) Synthetic resins and plastics
(5) Synthetic rubbers
(6) Man -made fibres
(7) Industrial explosives
(8) Insecticides, fungicides, wecdicides and the like
(9) Synthetic detergents
(10) Miscellaneous chemicals (for industria- use only).
14.
Drugs and pharmaceuticals.
15.
Paper and pulp including paper products.
16.
Automobile tyres and tubes
17.
Plate glass.
18.
Ceramics
(1) Refractories
(2) Furance lining bricks—acidic, basic and neutral.
19.
Cement Products
(1) Portland cement
(2) Asbestos cement.
145
I
CHAPTER—VI
RAW MATERIALS FOR BULK DRUG MANUFACTURE
The raw materials required for bulk drug manufacture cover a very wide field. They consist of substances of
.ntaals a tai of organic ehetaak'ljd hXSSeStaiXSVKdteta
houses and facilities for collection and storage of glands and organs to prevent deterioration of the active principles
before they are t ansported to pharmaceutical untts. Action on these lines has been taken in Bombay by seuing
up a modern abattoir tn D-'onar. The Committee understands that several expert bodies have examined in detail!
the posstbthtjes of setting up of facilities in other parts of the country and have made comprehensive recommendations.
The Committee is of the opinion that these valuable raw materials which are being wasted in large quantities, could
be profitably used for biological products, sutures etc.
2. We have dealt in this chapter with some of the important solvents and nutrients for antibiotics and chemical
raw materials for synthetic drugs m the supply of which the industry is experiencing difficuly. The list of nutrients
and other raw materials required by the antibiotics industry is given in Annexure-1. Nutrients are mainly agricultural
products and their supply is dependent on the overall agricultural production. But, even if the availabilit/improve
a lot depends on he standardisation of these products to get optimum yields. The industry has had to change its
source often resulting in different qualities which affect the yields. The list also gives the chemical raw matlrials
and solvent requirements as well for the antibiotics industry. Requirements of important intermediates and chemicals
for antibiotics and syntehtic drugs are shown in Annexure II and requirements of the same for other chemical based
industries along with their total anticipated availability.
3. As regards solvents, chemicals and chemical intermediates excepting the inorganics the problem is Quite
complex. Many of the chemical based industries including drugs were established even before the locally manufactured
organic chemicals and intermediates became available and they still depend on imports to some extent Manv of
these intermediary products are interrelated in diverse ways to those required by the plastics, dyes, pesticides paints
aromatic chemicals and rubber chemical industries. Several of them have common starting raw materials and several
others are those which are obtained in a complex manufacturing chain and hence form co-products. This calls for
an integrated development of all the chemical raw materials for the chemical-based industries. The’large expansion
that is taking place in the manufacture of basic chemicals as also in the chemical based industries are being linked at
the stage of producing intermediary chemicals which are the starting point of chemical-based industries In other
words, the development of production of the chemical intermediates has been a series of exercises on imoort substitu
tion which has been achieved in serveral instances. This is a continuous process and not only the existing production
has to be increased but also new ones will have to be taken up as more and more basic chemicals become available
and the expansion of the chemical-based industries make it possible to set up economic units of production of the other
mtermmiates. A rough idea of the expansions necessary in the filed of organic chemicals and intermediates required
to teed the chemical-based industries cm be visualised by the following approximate break-up of imoorts of these
products that are at present being made :—
Chemicals and intermediates :
for Drugs
Dyes ....
Pesticides .
Plastics, fibres, rubber etc
. Rs. 10 crores
. Rs. 10 crores
. Rs. 5 crores
. Rs. 20 crores
Total
Rs. 45 crores.
Over and above this, the finished products are also being imported and when they are also made in the country the
requirements of the intermediates will go up further thus increasing the scope for indigenous production of inter
mediate chemicals.
4. There are certain areas in this filed where the small-scale industries, especially those set up by the technical
entrepreneurs can play a very important role. Guidance from both the users of such intermediates as well as the
research laboratories in the country are required in setting up units for their production. The State Governments and
146
147
financial institutions who are offering spcieal concessions for these young entrepreneurs need to be also greatly streamli
ned for accelerating this development. There is also a mistaken impression that their efforts should be utilised for
making finished products only, starting from bulk materials made by the larger industries. Such activities need
large marketing abi ities and facilities which the small entrepreneurs hardly possess. Therefore, very often thev comto grief and blam? the larger units who have such facilities in not being able to market their products.
Kln
r?ent past’.IaT developmmts have taken place to increase the supply of basic organic chemicals
which form the starting point for the various chemical intermediates required by the chemical-based industries. In
several instances, these have been linked also within the major producing units, with the production of chemical
intermediates and certain finished products. Several plants have also come up to make the intermediates starting
from these basic chemicals to supply the same to chemical-based industries. Certain captive units have also been
set up by the chemical-based industries themselves to meet their own requirements of intermediate. Still several of
them have yet to be linked with basic chemical production to provide their requirements and those that are already
being made have to be expanded to reduce the imports. To give a general idea of the various basic chemicals produ
ced and where they have been linked with the production of intermediates for chemical-based industries thev are
dealt with under the following groups :—
'
7
A. Chemicals based on alcohol.
B. Chemicals based on coal.
C. Chemicals based on petroleum.
A. Chemicals based on alcohol
6. From the sugar industry, ethyla alcohol to the extent of 4,03,099 tonnes per annum is obtained bv the fer
mentation of milasses. A number ot basic organic chemicals based on alcohol is produced in the country and
they are shown in Annexure 111.
7
7. Unfortunately, several of these units have not been able to produce to capacity because of diversion of alcohol
obtained from fermentation of molasses for potable use. Potable spirits can be made from alcohol obtained from
other alternative raw-materials and there is no justification for diverting low priced molasses-based alcohol for
such purposes. Unfortunately, many States are giving priority for suppfy of molasses based alcohol to potable
spirits mainly from revenue considerations and are starving the alcohol-based chemical plants which have been
set up at considerable cost resulting in under-utilisation of their capacity and shortage of the concerned chemical
products which, in turn, have resulted m shortages of chemicals and intermediates required by the chemical-based
industries. The same is true of ethyl alcohol required as a solvent in the pharmaceutical industry The difficulty
in obtaining alcohol for pharmaceutical and other industrial uses arises presumably because of the
existing system of pricing and distribution control in regard to molasses.
This system which originated in the
treatment of molasses as a waste product, has now becom: out-dated considering the very large demind for molasse
for the production of alcohol needed for industrial use. The Committee understands that this question has received
the attention of government but because it happens to be a State subject, there have been dificulties in evolving a m ore
rational and effective system of pricing distribution controls on mdasses which would protect the supplies for indus
trial use. The Committee recomm :nds that this question should be pursued vigorously, so that the essential require
ments of alcohol, particularly of the chemical-based industries are met with, irrespective of the fluctuations in the
output of sugar and, therefore, of molasses.
8. It has been brought to the notice of this Committee that different States charge different rates of excise dutv
on alcohol with the result that there is disparity in prices and availability. The Committee recomm ends that Govern
ment should examine this question and ensure that this disparity is eliminated.
B. Chemicals based on Coal :
9. Chemicals based on Methane and Methyl alcohol are shown in Annexure IV. Here also, difficuhies are
encountered as, today, there is only one source for methyl alcohol, namely Fertilizer Corporation of’india, Trombay
It is necessary to have an alternate source to ensure regular supplies of methyl alcohol, which forms the starting point
for a number of chemicals required by the chemical-based industries.
10. The present position of coal based chemicals is given in the enclosed statement Anneuxre-V. From the
coke ovens of steel plants, 25,000 tonnes of benzene and corresponding quantity of toluene is obtained buthardlv
15,000 tonnes are made available to the chemical industry. The rest gets burnt in the steel plants themselves.
Alternative substitutes should be used in the steel plants and valuable chemicals like benzene and toluene should be
released for the various intermediate producing plants in the country, which are set up for the purpose. An impor
tant source of organic bases is the acid sludge obtained from the acid wash of coke oven gases as they contain valuable
148
pyridine bases. If these are pooled from all the coke-ovens of Steel plants, valuable by-products like pyndine, pico
lines, and quinolines can be recovered. They will provide sUrting materials for a number of other chemicals required
by the chemical-based industries. At present the acid sludge is a total waste. Steps should also be taken to ensure
that in the coke ovens of the new Bokaro Steel Plant, where 45,000 tonnes of benzene and the corresponding amount
of toluene could be obtained thereform, are recovered and made available to organic chemical industries.
C. Chemicals based on Petroleum :
11 With the discovery of petroleum resources in the country and the installation of large number of refineries,
a very rich source for organic chemicals has become available. Several petro-chemical units have been set up to
produce a lar^e number of organic chemicals. These petro-chemjcal industries have been set up near the refineries
and are clustered around with a number of other chemical based units. This is because certain primary manufacturing
processes such as reforming and cracking give rise to a number of different gaseous fractions which cannot be ^ran^“
ported over long distances and must be converted at adjacent locations and economic uses for others have to be found
by recycling them to petroleum refineries for conversion to petroleum products.
12. The total quantity of crude distilled in the oil refineries amounts to 22 million tonnes, out of which 7
tonnes are obtained locally and 15 million tonnes are imported. When the crude oil is obtained from the oil wells,
* associated "ases largely methane and ethane are also botained which are today largely used as fuel or lor power
veneration/ There are also certain off-gases obtained from petroleum conversion operations at the refinerey and these
are mostly flared and in tom? instances used in the fertilizer plants. Among the light fractions obtained from the
refineries there are again gaseous compounds. The earlier ones which are mostly methane and ethane are used lor
captive heating and steam generation in the refineries. 13. The others which are propane and butane are liquified and used as domestic fuel after filling in cylinders
CLPG). Out of the liquid fractions, those with low boiling points between 25° and 60° C are used as petroleum ether
as a solvent in the extraction of active principles of plant materials and for other purposes. The most important
fractions for the petro-chemical industry are the fractions which have boiling points between 60' and 125 C (mptna),
and are the source of petrol or motor-spirit and also petro-chemical and fertilizer feed stock. The intermediate
fraction between 125* and 180* C is also used as petro-chemical feed stock but progressively more as fertilizer teed
stock. These fractinns comprise 15% of the crude distilled and roughly amount to 3.3 mil. tonnes. The petro
chemical industry uses less than 1 million tonnes, of this today but with the expansions that are taking place, this will
be increased considerably.
14 There are at present two petro-chemical reformers and four petro-chemical crackers, of which the largest
cracker is under construction. Various primary and down-stream products that are obtained and planned for produc
tion are given in Annexure-Vl.
Vi
15. In addition, several drug manufactues produce their own intermediates for their captive requirements and
could if necessarv, increase their production to meet other’s demands. One of the examples is INDIAN DRUGS AND
PHARMACEUTICALS LlMlTED‘s intermediate plant at Synthetic Drugs Plant, Hyderabad. There arc
other firms in the private sector, who make intermediates which are given in Annexur Vll.
16. It is seen from the various statements, which are illustrative and not exhaustive, that a large number of
intermediate chemicals are being made. The main problem is the supply of basic chemicals to increase their pro uction and expansions in their capacities. With more refineries that have been planned and associated reformers and
crackers that will come up, there will be an increasing supply of the petro-chemicals. Similarly, for coal based indus
tries and alcohol based industries, a better rationalisation in the use of the basic raw-materials will result in better
utilisation of their capacities. Linking of basic chemicals with intermediates required by chemical based industries
not yet produced in the country is a continuous process and a challenge that will have to be taken up both by the indus
tries" and the R & D institutions in the country. Wherever technologies are available in this filed, there should be no
hesitation in obtaining the best. Our efforts should be concentrated in improving them further. Harnessing the
potentialities of the technologist^ that are coming out of the educational institutions, is another important factor
in this direction The integrated development of chemical raw materials and intermediates is the main factor that
will increase the technical base of the country and that makes all the difference between a developing and developed
country in so far as chemical industry is concerned. Once this is achieved a two way flow of chemical products
and know-how with developed countries could be established. Processing a large number of imported products
does not build the required base even if it be by mainly Indian owned firms but on the other hand only increases
our dependence on other countries. Hence, whatever facilities are available in this direction m all sectors of the
industry, should be fully utilised to raise the technical base of the country which only can increase our bargaining
power and put us on the map of production of chemical and chemical-based products including drugs-
149
17. As will be seen from Annexure II the demand for intermediates by the chemical based industries including
drugs will be large and indigenous production of more of the intermediates will have to be planned. In many
instances the requirements of drug industry from only a small percentage of the total demand. The two major
raw materials required for making the intermediates are benzene and toluene, especially the former. Even
with the full capacities of the petro-chemicals reformers in operation and complete recovery of these from the coke
Ovens, the production will fall short of country’s requirement by the end of the Fifth Plan period. As all the naptha
produced is not being fully utilised, reformer units should be set up another existing refineries and also those pro
posed to be set up for recovering aromatics like benzene, toluene and xylene. This will enable more intermediates
being produced for the drugs and other chemical-based industries.
18. At present 48 bulk drugs including a few intermediates and chemicals are imported through State Trading
Corporation. This system of canalisation was introduced from April, 1970, with a view to :—
(i) check the possible over-pricing of drugs by some companies ;
(ii) assist the small-scale manufacturers who are large in number in the procurement of raw materials ;
(iii) obtain the drugs at cheaper prices as a result of bulking imports, and
(iv) regulate excessive imports by the actual users direct to protect the growth of the local industry engaged in
the manufacture of such items.
Drugs falling within the production range of Indian Drugs and Pharmaceuticals limited are handed over by State
Trading Corporation to Indian Drugs and Pharmaceuticals Limited for distribution along with the quantum produced
by them. In other cases like Vitamin-C and Chloramphenicol, State Trading Corporation, itself distributes the drugs
imported by them and also issues release orders on the indigenous manufacturers of the concerned drugs taking their
production into account. The remaining canahsed items imported are also distributed by the State Trading Corpora
tion itself.
19. The release orders for canalised items, except for a few chemicals as mentioned in the import Trade Con
trol Policy book, are issued to the various formulators-those registered with the Directrate General of Technical
Development under the industries (Development and Regulation) Act and in the small scale sector, based on the
recommendations made by the concerned State Drug Controllers. In the case of units registered under the Industries
Development and Regulation Act, the raw materials are released on the basis of the best of past two years consump
tion of the individual items. In the case of small scale unit, some incremental allocations are made over the past
consumption on the following pattern :—
(a) Additional 30% to units having a turnover of less than Rs. 1 crore ;
(b) Additional 15 % to units having a turnover of Rs. 1 crore and more per annum, and
(c) Additional 50% to the small scale units situated in the State of West Bengal, irrespective of their turnover.
DGTD units are also entitled to claim more releases if the allocations made to them fall below their requirement as
per
c licensed/approved capacities for the production of the concerned formulations.
'
Additional releases are also
made for meeting Government Orders, subject to their being certified by the Drug Controllers of the States.
20. Besides, some bulk drugs and chemicals are also canalised through State Trading Corporation. In addi
tions to this, the actual users in both the settors-organised and small scale, are given import licence for other drugs
and chemicals on actual users basis.
21. As is well known the number of manufacturing units is more than 2,500 and each one needs different raw
materials and bulk drugs depending upon their production pattern. While it would be ideal to canalise the import of
all the chemicals, solvents and drugs consumed by the entire industry through a centralised agency, it would be practi
cally un-manageable to handle such canalisation effectively.
22. The Committee, however, feels that it is necessary that there should be a central agency for import of all
bulk drugs and intermediates needed for the 117 essential formulations indentified by the Committee. This should be
done by the National Drug Authority sugguested by us separately in this Report. It would be one of the functions of
this Authority to import raw materials and also the ingredients required for these drugs and distribute them to the
manufacturers. The N.D.A. will stipulate the quantities of formulations that should be produced by firms out of
the bulk drugs supplied to them and ensure that the manufacturers utilise the bulk drugs properly. Although, it
would be desirable to regulate the import of raw materials for all formulations, the Committee, feels that a beginning
should be made in regard to 117 formulations indentified as essential by the Committee. It is also hoped that as the
National Drug Authority expands, it would progressively undertake the distribution of all drug formulations manu
factured in the country.
«
150
23. As regards the bulk drugs produced indigenously, the Committee, understands that while many of the firms
are themselves consuming drugs for captive use, some other manufacturers do not find a market for the bulk drugs
produced by them. It would, therefore, be desirable to have a centralised agency which would advise various manu
facturers to regulate their production in accordance with the demand pattern and would also control the distribution
of the drugs so produced among formulators. It has to be appreciated that the task involved in this operation would
be stupendous considering the number of the bulk drugs involved and the formulators requiring them. The bulk
drugs indigenously produced and the chemicals required for the production of 117 items identified by this Committee,
should be pooled by the National Drug Authority and distributed to the manufacturers according to their requirements.
Ultimately the bulk drugs produced in our country, which are necessary for production of drugs other than
those indentified by the Committee should also be pooled and distributed by this Authority.
24. Presently, there is no organised distribution system in respect of the chemicals, solvents or basic raw
materials produced in the country and consumed by this industry. Each drug manufacturer has to arrange for his
requirements and in the case of any difficulty experienced by any manufacturer in obtaining his raw-materials like
nitric acid, glycerine, alcohol etc., assistance of government is sought. Government, in turn, assists such entre
preneurs by asking the concerned manufacturers of chemicals etc., to help. Such efforts, however, have yielded
very little results. In a few cases like alcohol the efforts have failed. Ultimately, however, the National Drug
Authority should take up the responsibility of coordinating the production and distribution of the chemicals which
are exclusively usep for the drugs manufactured in the country. In the case of alcohol, this Authority should
persuade the State Governments to ear-mark the bonafide requirements of the drugs industry.
25. Similarly the same organisation should look after the requirements of packaging materials like glass/plastic
bottles, rubber stoppers, cellophare/aluminium strips and such other essential packing materials required by the
drug industry.
Summary of Recommendations
The Committee understands that several export bodies have examined in detail the possibilities of setting up of
facilities in various part of the country, like modern slaughter houses, facilitises for collection and storage of glands,
extraction of active principles etc. The Committee is of the opinion that these valuable raw materials which are now
being wasted in large quantities could be used profitably for biological products, sutures etc.
(Chapter-VI. Para 1)
2. In regard to manufacture of chemical intermediates, the small scale industries expecially those set up by the
technical entrepreneurs can play a very important role. Guidance from both the users of such intermediates as well
as the Research laboratories in the country are required in setting up uints for their production. The State Govern
ments and financial institutions who are offering special concessions to these young entrepreneurs need to be
streamlined for accelerating this development.
(Chapter-VI. Para 4)
3. The Committee understands that the question of distribution of molasses for the production of alcohol has
received the attention of the Central Government but becuase it happens to be a State subject, there have been diffi
culties in evolving a more rational and effective system of pricing/distribution controls on molasses which would pro
tect the supplies for industrial use. The Committee recommends that this question should be pursued vigorously
so that the essential requirements of alcohol, particularly of the chemical-based industries are met with, irrespective
of the fluctuations in the output of sugar and, therefore, of molasses.
(Chapter-VI. Para. 7)
4. It has been brought to the notice of this Committee that different States charge different rates of excise duty
on alcohol with the result that there is disparity in prices and availability. The Committee recommends that Govern
ment should examine this aspect and ensure that this disparity is eliminated.
(Chapter-VI. Para 8)
5. Presently, there is only one source for Methyl alcohol. It is necessary to have an alternate source to ensure
regular supply of methyl alcohol.
(Chapter-VI. Para. 9)
6. Valuable chemicals like Benzene and Toluene should be made available to the chemical industry and these
should not be used as a fuel as is done in the Steel plants. Steps should also be taken to ensure that in the coke oven
of the new Bokaro Steel Plant where 45,000 tonnes of benzene and the corresponding amount of toluene can be
obtained from the coke ovens should be recovered and made available to organic chemical industries.
(Chapter-VI. Para 10)
&
151
<
7. The acid sludge, obtained from the acid wash of coke oven gases contain valuable pyridine bases and this
should be pooled from all the steel plants, for recovery of valuable items like pyridine, picolines, and quinolines.
(Chapter-VI. Para. 10)
8. Linking of basic chemicals with intermediates required by chemical-based industries not yet produced in
the country is a continous process and a challenge will have to be taken up both by the industries and the R & D
institutions in the country. Wherever technologies are available in this direction, there should be no hesitation in
obtaining the best and our efforts concentrated i:n improving them further. Harnessing the potentialities of the
technologists that are coming out of the Educational Institutions, is another important factor in this direction. The
integrated development of chemical raw materials and intermediates is the main factor that will increase the technical
base of the country. Processing a large number of imported products does not build the required chemical base
even if it be)by mainly Indian owned firms but on the other hand only increases our dependence on other countries.
All available facilities, in this direction, should be fully utilised to raise the techical base of the country.
(Chapter-VI. Para. 16)
9. All the naptha produced should be fully utilised by setting up recovery units near the refineries for recovering
the aromatic chemicals like benzene, toluene and xylene. This will enable more intermediates being produced for
the drugs and other chemical based industries.
(Chapter-VI. Para. 17)
10. Although it would be desirable to regulate the import of raw materials for all formulations, a beginning
should be made, whereby a central agency imports all bulk drugs and intermediates needed for the 117 essential
formulations identified by the Committee. This should be done by the National Drug Authority, who will also
import raw materials and the ingredients required for these drugs and distribute them to the concerned manufacturers.
The NDA will also stipulate the quantities of formulations that should be produced by the firms out of the basic
drugs supplied to them and ensure that the manufacturers utilise them properly. The Committee also hopes that
as the NDA expands, it would progressively improve and expand its activity in this direction.
(Chapter-VI. Para. 22)
11. NDA would advise various manufacturers to regulate their production in accordance with the demand
pattern and would also control the distribution of the drugs so produced among formulators. To begin with, the
bulk drugs indiaenouslv produced and the chemicals required for the production of 117 items as identified by this
Committee, should be pooled by the NDA and distributed to the manufacturers according to their requirements.
(Chapter-VI. Para 23)
12. NDA should take up the responsibility of coordinating the production and distribution of the chemicals
which are required for the manufacture of drugs in the country. In the case of alcohol, this Authority should also
persuade the State Governments to ear-mark the bona-fide requirements of the drugs industry.
(Chapter-VI. Para 24)
13. NDA should also look after the requirements of packaging materials, like glass plastic bottles, rubber
stoppers, colophane/aluminium strips and such other essential packing materials required by the drug industry.
(Chapter-VI. Para 25)
1—M of Pet. & Chem./75—20
A
*
oocv)’
1
1
Annexure I
Requirement of Raw Miterials for the Manufacture of Antibiotics for Achieving Targets for the year 78-79 in respect of the
Antibiotics as Indicated below
(Chapter VI—Para 2)
780 mmu
825 tonnes
280 tonnes
10 tonnes
Penicillin
Streptomycin
Tetracyclines
Neomycin .
Raw Materials :—
Carbohydrates
2500 tonnes
400 tonnes
. 15800 tonnes
. 9600 tonnes
.
Strach .
Dextrin
Dextrose
Cane Sugar .
Protein Sources
6620 tonnes
6750 tonnes
232 tonnes
Soya Flour .
Corn Steep Liquor (50%)
Ground nut meal
Salts
3330 tonnes
990 tonnes
70 tonnes
10 tonnes
2.2 tonnes
. 0.825 tonnes
190 tonnes
190 tonnes
610 tonnes
.
Ammonium Sulphate .
Sodium Sulphate .
Ammonium Chloride
Manganese Sulphate
Zinc Sulphate
Sodium Bi-phosphate .
Sodium Chloride .
Potassium Acetate
Potassium Dihdrophosphate
Acids
9500 tonnes
5S0 tonnes
3400 tonnes
280 tonnes
115 tonnes
Sulphuric Acid (Tech) .
Nitric Acid (Tech)
Hydrochloric Acid (Teeh)
Oxalic Acid (Tech)
E.D.T.A. .
Alkalies
Calcium Carbonate (Tech)
Sodium Hydroxide (Tech)
Potassium Hydroxide (CP)
Calcium Oxide (Tech) .
Gases
Ammonia .
.
.
Chlorine
.
.
.
Nitrogen
.
.
.
Carboxide .
585 tonnes
9900 tonnes
320 tonnes
135 tonnes
.
.
.
.
.
225 tonnes
14.6 tonnes
2150 tonnes
78 tonnes
.
Solvents
.
.
Butanol
Butylacctate
Methanol
Isopropyl Alcohol
Octanol
152
2120 tonnes
2340 tonnes
1275 tonnes
56 tonnes
15 tonnes
153
Queternary Ammonium Compounds
Arquad/Citramide
NLD/Tretolite
750 tonnes
10 tonnes
Filter Aid
Dicalite/Hyflosupercel .
1800 tonnes
Decolorising Agent
Active carbon
1360 tonnes
Resins (Replenishments)
IRC—50
.
IR—1-5 or equivalent
IR—124 or equivalent .
Deacidite FF
Zcocarb—225
Antifoamers
Wax Emulsion
Vegetable oils
82.5 tonnes
25 tonnes
52 tonnes
50 toncns
24 tonnes
1136 tonnes
4300 tonnes
Miscellaneous
Formaldeyde (30%)
.
.
.
.
Potassium Phenyl Acetate
Phenyl acetamide and Phenyl acetic acid .
355 tonnes
940 tonnes
400 tonnes
L
.
Annexure II
REQUIREMENTS OF IMPORTANT INTERMEDIATES AND CHEMICALS
(Chapter VI—Para 2)
Unit—Tonnes
Availability (anticipat
ed)
Ninu of Criemical/Intcrmediate
Estimated
demand
1978-79
Estimated
demand by
1978-79 by
the Drug
Industry
3
4
3 3,200
12,156
9,500
7,230
3.000
(4-10,000 others)
According to demand.
36,000
13,000
10,000
70,000
20.000
20.000
3,650
2,470
2,340
8,000
500
1,90,000
1,20,000
4,000
1,500
1,20,000
75.000
6,000
2,000
5.000
750
125
1,500
1.000
1,125
6.000
1,500
170
1.500
1.000
5,000
2,000
300
2,000
1.000
1,300
1,500
300
1,300
1,000
30.000
3,000
6,000
2,30.000
15,000
30,000
2,170
2,000
3,800
92,000
14,000
31,000
30,000
24,000
600
6,000
(4- 9,000 from alchol)
20,000
3,700
1,500
15,000
(4- 6,000 from coal)
2,30,000
15,000
35,000
40,000
24,000
1,200
2,170
2,000
250
200
80
1,200
2,470
1
A. Alcohol bused
1. Acetic Acid .
2. Acetic anhydride .
3. n-butanol
4. Butyl acetate
5. 2-EthyI hexanol
6. Ethyl acerate
B. Methane & Methanol based
1. Methanol
2. Formaldehyde
3. Methylamine
4. Dimethyl sulphate
5. Methylene dichloride "I
6. Methyl chloride
J ■
C. Other derivatives based on ,alcohol
1. Monochloroacetic acid
2. Aceto acetic ester cyanoacetic ester
3. Methyl dichloro acetate .
4. Aceto acetic ester .
5. Diethyl malonate
7,000
D. Coke-oven products & their derivatives
1. Benzene
....
2. Toluene
....
3. Phenol
....
E. Petro chemicals products
1. Benzene
2. Toluene
3. Orthoxylene
4. Ethylene oxide
5. Acrylo Nitrile
6. Acetonitrile .
7. Butanol
S. Acetone
9. MIBK .
10. Ethyl chloride
11. Phenol
154
36,000
4,000
1,500
30,000
100
1,200
155
1
3
2
4
Products from H .O.C.
12. Nitro Benzene
11,000
30,000
(4- 18,300 others)
13. Meta amino phenol
14. M.C.B..
15. Aniline
16. Acetanilide .....
17. Para-nitro tolene
18. Meta Nitro toluene
19. Ortho Nitro Toluene
Other products based on Toluene & Benzene
20. Acetophenone
....
21. Amino chlorobenzophcnonc .
22. C & P nitro phenol
23. p-Chloro phenol ....
24. p-Chlorobenzene sulfonamide
25. 2-5-dichloro nitrobenzene
26. Methyl benzene sulfonate
27. p-nitro aceto phenone .
28. Benzaldehyde
....
29. Benzoic acid
....
30. Benzyl chloride ....
31. Benzyl cyanide ....
32. p-chloro benzoic acid
33. 2:4-Dichloro benzoic acid
34. p-nitro benzoic acid.
35. m-nitrobenzoic acid
36. p-toluenc sulfonamide .
37. Phenyl acetamide ....
38. Phenyl acetic acid & its salts
Other miscellaneus products
1. Beta Picoline
1
2. Alpha picoline j
3. Pyridine
.
4. Gama picoline |
5. Phosgene
750
4,250
(4- 2,000 others)
6,000
(4-5,000 others)
2,300
1,100
90
1,900
80
160
500
150
800
10,000
800
1,700
15,000
6,000
4,000
1.50)
1,000
2.50)
4,000
300
1,000
15
1,600
10
50
2,000
2,500
1,000
1,200
1,000
2,000
1,000
25
15
250
50
100
400
1,500
700
12
600
500
50
300
350
4,000
40
25
2,400
780
610
10
270
1,000
15
10
200
40
100
400
940
500
15
350
150
Annexure III
ETHYL ALCOHOL BASED CHEMICALS (TONNES)
(Chapter VI—Para 6)
Acetic
Acid
2
1
Acetic
Anhyd
ride
Butyl
Acetate
3
4
5
500
From Butanol obtained from other plants.
Also acetaldehyde supplied for sale.
Indian Organic Chemicals, Khapoli ....
Somaya Organo Chemicals (Godavari Sugars) Kanhegaon, Maharasthra
Sirsilk, Hyderabad
......
3,800
2,900
Mysore Sugars, Mandya Karnatak, Mysore Acetate
3,600
1,800
Andhra Sugars, Tanku, A. P.
A.P.I.D.C. Hyderabad
1,080
750
Major part of acetic anhydride acetic acid
used for conersion to Cellulose Acetate.
Major part of acetic anhydride used by
Mysore Acetate for producing Cellulose
Acetate.
For sale.
For sale.
1,680
Acetalde
hyde
acetic
acid
2-Ethyl
Butyl
Hexanol Alcohol
Butyl
Acetate
Remarks
3,000
2,730 Part of acetaldehyde and acetic acid also
sold.
2,400
2,400
3,000
3,000
1,500
1,000 Also sell acetic acid.
Polyethy- P.V.C.
lene
Styrene
Union Carbide, Bombay
1,363
Somaiya Organics, Barabanki, U.P.
Kolhapur Sugars
Chemplast, Mettur
6,000
1,800
Remarks
3,000
.
Remarks
From ethylene obtained from alcohol through
ethylene dichloride and vinyl chloride.
A.C.C.I., Rishra
13,000
—
From ethylene obtained from alcohol.
Hindustan Polymers, Vizag
10,000 Based on ethylene from alcohol and benzene
from coke ovens.
Four manufacturers made esters like ethyl acetate to the extent of 3,950 tonnes.
12,000
—
OTHER DERIVATIVES BASED ON ALCOHOL CHEMICALS (TONNES)
Monochlore
Acetic
Acid
2,050
1,000
Sardesai .
.
.
.
Cellulose Products, Bombay
Hico Bombay
Acetic
Pyrazolone AcetoAnhydride
Acetic
Ester
Colour Chem. .
200
As
required
1,500
I.D.P.E.
S.B.R.
Rubber
P.V.C.
Styrene
Synthetic & Chemicals, Bareilly .
30,000
Remarks
Pyrazolone is obtained by treating diketene
with phenyl hydrazine. Aceto acetic ester
is obtained by treating diketene with al
cohol.
Remarks
This is based on ethylene from alcohol
which in turn is converted to styrenewith benzene. Butadiene is also ob
tained from alcohol thro’ acetaldehyde
stage and condensed with styrene for
making SBR rubber.
156
I
1
Annexure IV
METHANE AND METHYL ALCOHOL BASED CHEMICALS (TONNES)
(Chapter VI—Para 9)
F.C.I., Bombay has a capacity to produce 37,500 tonnes of methanol.
Formal
dehyde
Standard Chemicals, Bombay
Mettur Chem. Mettur Dam
F.C.I., Bombay
Several Units (HOC, Atul Drug House, Allied
Resins & Chem. Newchem. etc.)
Ganesh Chemicals Industrial Solvents and
Chenicals P. Ltd., Bombay
Chloro Methyl
met ha nes amines
Remarks
5,000
5,000
4,000
85,000
1,500
Penta
Erythri
tol
Atul Drugs, etc.
I
Dimethyl
Sulphate
2,400
157
Hexamine
900
Remarks
Penta-erythritol is made starting from Ace
taldehyde & formaldehyde. Hexamine
is made starting formai’dehyde and am
monia.
I
£
■
u.
Annexure V
COKE OVEN PRODUCTS AND THEIR DERIVATIVES
(Chapter VI—Para 10)
Benzene
Hindustan Steel
25,000
Naphth
alene
Toluene
py ridine
picoline
&
quinoline
6,000 Corres
ponding
qty.
-do
3,000
45,000
Bokaro Steel
....
Pooled resources of Hindustan Steel &
500
Bokaro, Acid sludge .
PRODUCTS BASED ON COAL-BASED PRODUCTS
M.C.B.
Durgapur Chemicals, Durgapur .
Matching
for phe
nol.
Phenol
6,000
Pentach
lorophe
no I
900
Phthalic
anhydride
Remarks
Under planning.
Recovery units to be set up.
Remarks
3,300 (expansion by 6,000 based on Oxylene).
4
158
4
Annexure VI
PETROCHEMICAL REFORMERS (TONNES)
(Chapter VI—Para 14)
t
Udex Plant Baroda Refinery
I.P.C.L. Baroda .
Benzene
Toluene
45,000
14,000
PETROCHEMICAL CRACKERS
Ethylene
P-xylene
21,000
17,000
2,500
Propylene Butadiene
Benzene
7,000
14,000
6,000
24,000
60,000
35.000
5.000
22,000
1,30.000
78,000
12.000
(Ethylene & Acetylene)
NOCIL, Bombay
Union Carbide, Bombay
I.P.C.L., Baroda
Plastics & Resins Tuticorin
DOWNSTREAM
PRODUCTS
MADE
BY
Mixed
Xylenes
O-xylene
PETROCHEMICAL
22,000
UNITS
I.P.C.L.
Ethylene
oxide
Ethylene
Propylene
24,000
Ploybutadine
Butadine .
20,000
.
As per demand.
Propylene
UNION CARBIDE
Ethylene
glycol
Vinyl
Chloride
12,000
10,000
MIBK
3,700
Butanol
Octanal
Acetone
30.000
Aceton
Di
6.000
Styrene
10,003
Polystyrene
11,000
2,800
14.000
10,000
2,000 .
PLASTIC & RESINS
P.V.C.
12,000
Ethylene & acetylene
DOWNSTREAM
UNITS
BY
PETROCHEMICAL
I.P.C.L.
Xylene
159
1—M of Pci- A: Chem,/75—21
30,000
Ethylene
oxide
L.D.P.E.
Ethylene
600
NOCIL
Ethylene
Benzene
20.000
80,000
Poly propylene
Using Alpha paraffin from Superior Kero
sene obtained from the refiner.
Detergent Alkylate
Benzene
L.D.P.E.
5,000
Acetonitrile
Acrylonitrile (HCN by products) Me
thyl Methacralate Sod. Cyanide
Ethylene
Glycol
REFORMERS
DMT
Polyester
24,000
3,500
P.V.C.
20.000
160
DOWNSTREAM
OTHER
THAN PETROCHEMICAL
ETHYLENE BASED
UNITS (TONNES)
H.P.D.E.
P.I.L.
Remarks
30,000
Styrene
Polychem .
14,000
Polyst rene
10,000 Using .‘Iso Benzene.
Ethyl Chloride
Standard Mills .
1,500
PROPYLENE BASED
Acetone
Phenol
Hcrdillia .
.6,000
10,000
Using also benzene via cumene. Aceto
phenone obtained as a by product.
BENZENE BASED
Nitrobenzenes
H.O.C.
MNB
DNB
NBSA
Chloro
M.A.P.
benzenes
11,000 MCB 4,250
350 ODCB 300
600
2.250 PDCB
ONCB
1,500
BNCB 1,500
750
B.H.C.
Aniline
Acetani
lide
Nitrocholrobenzene
3,500
6,000
2,000
2.320
Remarks
S.B.R..
Synthetic & Chemicals
30,000
Using benzene Butadiene.
Styrene Caprolactum
G.S.F.C. .
30,000
20,000 Sytrene using ethylene.
TOLUENE BASED
O.N.T.
H.O.C.
D.C.M. Daurala
1,900
P.N.T.
D.N.T.
M.N.T.
1,100
Benzyl Cyanide
Phenyl acetamide
Mostly capative
80
90
350
Phenyl Acetic Acid
160
ANNExURE VII
DRUG INTERMEDIATES
(Chapter VI—para 15)
x>
Indian Drugs & Pharmaceuticals Ltd.
160—200
Hydrazine hydrate 50%
Phenylhydrazine
Pyrazolone
tonnes
225
Under implementation.
Paraphenetadine
Para Amino phenol
Thiosemicarbazide
Acetyl Sulfanilamide
Cyano Acetic Ester
Acetyl Acetone
Acetobutrolactone
Diethylamine
Triethylamine
Monoethylamine
Malonic ester
Sulfaguanidine
Diethyl Carbamly chloride
Trichloroacetone
1300
10—30
300
75
220
30
500
119—125
875
18
6
Warner Hindustan
(Tonnes)
200—500
50
200—300
50—350
1. Beta Picoline
2. Alpha Picoline
3. Pyridine
4. Gamma Picoline
Atul Products
170—220
100—150
100
50
1. Methyl dichloroacetate
2. Phosgene
3. P. Toluene sulphanamide
4. Ethyl chloroformate
Hico Products
2000
1. Quaternary Ammonium Compounds
161
CHAPTER VH
DEVELOPMENT AND FLOW OF TECHNOLOGY
Technology, economy and social utility are very much dependent upon the scale of production, physical -re
quirement, market capacity and government policies. The present structure of the drug industry being one geared
to the market mechanism from which vast majority of the Indian population is excluded, it cannot serve the broad
social goals envisaged.
2. It is necessary in the Indian drug industry to identify a radically new direction to fulfil the social needs and
enhance its technological efficiency. Technology is closely linked up with its social role, in the Indian drug in
dustry, introduction of a new drug or a new process by a unit is decided on the profitability to an individual entre
preneur. Problems of technology in the drug industry are complex, not only due to the rigorous experiments to
be conducted first in the laboratories, on animals and then on human beings, but also due to the involvement of
various sections in the community and their interlinks in the use of drugs. In a country like India, where the average
technical knowledge of the consumer is rather low and technical guidance for him is scarce, the role of Government
becomes highly important. The drug manufacturing units, in general, are credited with the ingenuity and exper
tise to cozen not only millions of citizens, but also the governments and even the most advanced and technically
powerful societies could not escape this. Unless the very activities through which such influence could be exer
cised are eliminated, it is difficult to bring out any marked change in the prevailing system.
3. Technological development in any industry has to be comprehensive and it has to be aimed at achieving
specific goals. In the present situation in India, acquisition of process know-how is only one aspect, though impor
tant, of the mmy problem; in the technological development in the rug industry. The other aspects of the whole
innovation chain are so characteristic of each society that foreign examples or institutions can play a limited role.
4. Technology for the production of bulk drugs is closely interwoven with that needed for the production
of basic chemicals. Indeed, in the West, drug industry followed the establishment of the basic chemicals industry,
industry.
Europe, led by Germany, had an early start in the establishment of the fine chemicals industry and actually Ehrlich’s
’ was' inspired
’J and
' ’ supported by this industry.
« Later, other countries in Europe entered this arle
pioneering work
of production of fine chemicals and they were followed by U.S.A, and Japan. Long years of concerned effort have
provided all these advanced countries with a tradition of high level sophistication in the field of production of all
chemicals and, all drugs are in essence chemicals. All these countries have, over the decades, worked out refine
ments in each technology to permit bulk production at economic levels. Usually, each country and sometimes,
even an individual complex
production
to feed a diverse
/ within
’’ a country, diversifies its base in bulk chemicals
’
’
’
variety of chemical-based activities such as synthetic polymers, dyestuffs, drugs and pharmaceuticals for human
and animal consumption, etc. Also, many of the large complexes base their drug lines either on their own discoveries or on such critical intermediates, as they m ty produce, and which have application in m>re than one of the
above areas. It must be emphasized, however, that it is unusual for the same complex to produce all the basic
raw materials and intermediates that they may need for their individual lines of production in bulk drugsand phar
maceuticals.
,
5. In India, chemical industry was almost non-existent at the down of our independence and our effort in drug
production am muted really to only large scale preparation of simple extracts, and injectibles and the latter two
groups were often prepared from imported materials.
6. Chemical industry has come a long way during the past 27 years and we have today a reasonable base to
pick up challenges in this technology-intensive industry with confidence. Indeed, working of Hindustan Organic
Chemicals Ltd. (H.O.C.) and Indian Petrochemical Corporation Ltd. (I.P.C.L.), the Durgapur complex and as
number of units in the private sector manufacture today a large variety of chemicals based on down-stream products
of coal-tar distillation, molasses-based alcohol, petroleum, etc. These is, of course, need for increased productivity
in a rationalised manner of all that we produce now and diversification of production to cater to national needs on
a priority basis. Quite apart from working out and establishing large scale technology, there is now in existence
a substantial number of competent chemical engineers, design engineering consultants, other technologists and
plants for m.inufacture of sophisticated chemical equipment. And, barring very high pressure re-action vessels
and related equipment, m)St of the equipment needed for production of drugs is now being fabricated in India.
162
163
7. We have, over the years, imported technologies for the production of important antibiotics and a number
of bulk synthetic drugs both in the public and private sectors. Many of these technologies have been substantially
refined by indigenous effort, for better economy in production. Besides, technology for several products has been
developed within the country. All these challenges have been met with confidence and our base of technological
comoetence as on date is quite substantial. Indeed, the country is now poised not only to absorb technology of
any complexity that may be imported but also to improvise and innovate production technologies with competence
and complete confidence.
8. There are two broad areas where flow of technology is important in the field of pharmaceuticals in our
country. The first is with regard to the existing drugs, to produce the essential items in quantities adequate to meet
our increasing requirements and maximise production from available resources and manufacturing facilities already
established. This, of course, presupposes that it should be of the required quality, i.e. well formulated and
effective in its therapeutic action and is made available at reasonable prices. These drugs should cover specific
areas where both prophylactive and curative action have to be taken to treat common diseases that affect large popu
lation of country.
9. Secondly, there are areas where existing drugs arc not really very effective or where no curative drugs exist
for certain diseases in the country. In this case, technology has to deal with research and introduction of better
and more eftiecacious remedies for treatment.
10. It is natural that the first part, i.e. maximising production for improvement of manufacturing technology
rationalising resources etc. takes comparatively shorter time than the second part i.e. discovery and introduction of
new drugs °to treat diseases which still do not have effective remedies.
11. The pattern of consumption of drugs in this country does not follow the pattern in other advanced coun
tries. This is because of the different climatic conditions, lack of proper supply of potable water in rural areas,
nutritional deficiencies in our diet and lack of hygienic conditions of living resulting from want of proper housing
facilities lack of proper collection and disposal of sewage and other wastes. In Annexure 1 are shown 42 basic
drills which would make roughly 80% of value of the items required by the end of the Fifth Plan period as worked
out°bv the Task Force. They comprise anti-infective agents to a large extent, anti-diarrhoeals, analgesics and
nutrititional supplements like vitamins. Technology for the manufacture of most of these drugs are already avail
able in the country as several commercial units are producing them. 29 of these drugs are covered by the essential
drugs identified by this Committee.
12 Increasing supply of raw materials for increasing production, specially for synthetic drugs is essential.
Larae efforts have been made to increase the production of basic chemicals, both by the expansion of the produc
tion^ of mineral acids and inorganic salts and also in the production of organic chemicals by setting up of recovery
its in the coke ovens attached to Steel Plants, alcohol based chemicals and petrochemicals obtained from refiU?rv operations. These need to be linked in a large way with the production of chemical intermediates required
R t onlv bv the drug industry but by other allied chemical based industries like dyes, pesticides, plastics, synthetic
fibres rubber chemicals etc. We have dealt this in some detail in the chapter on raw materials enumerating the
” rious steps that have been taken on hand in this direction and that have yet to be taken up in the future and the
part the national laboratories and the part the large and small scale entrepreneurs have to play in this connection.
v Stepping up production of the existing units by improvement of technology through R & D activities and
ff rts of the State owned research laboratories are, no doubt, very important. This should not, however, preclude
obtaining from abroad crucial technology for the purpose. Harnessing our limited resources of R & D facilities
’ll definitelv vield better results by concentrating on selected fields and also on improvement of imported processes.
In this wav "we will be able to shorten the period during which we have to depend upon imports of drugs essential
to the community, miximise the effectiveness and development of domestic research and in the long run build up
competence for export of technology developed by us.
14 Some of the advantages in following this procedure are very glaring in the field of antibiotics. With better
strains and improvement of environmental conditions for the growth of the miro-organisms which produce the anti
biotic molecule, much higher production can be attained from the existing plants.
15 The improvement of technology in the field'of synthetic drugs involves the improvement of the different
unit nrocesses and operations and sometimes by reducing the number of steps in the process itself. This again,
requires intensification of R &D activity carried out within the country. With the progressive improvement of the
technical base in the country coupled with any improvement in the processes obtained from abroad, several of the
164
bottlenecks which affect production could be overcome. This along with our own ingenuity can mean a totally
new process which we can even offer to other countries. It should be borne [in mind that bargaining power of our
country for obtaining new technology is entirely dependent on our technical base. The amount of foreign exchange
that can be saved by these efforts is evident from the major imports of drugs, which in many cases, are necessitated
because of inadequate indigenous production (Annexure II).
16. With improved technology' and better utilisation of capacity not only can imports be reduced but also
exports of drugs, which amount to Rs. 16.41 crores in 1973, can be increased several-fold. Even improved tech
nology can be offered to other countries to generate a two-way flow of technology.
17. Another important field where this country can take advantage of the special climate and soil condition
is the Scientific cultivation of plants required for the drug industry. This potential has not been tapped to any
appreciable extent so far. Cinchona, poppy, ipecac, ergot, etc. are mainly cultivated by Governmental agencies
while some other plants like mentha, eucalyptus, citronella, dioscorea. etc., are cultivated largely by the private
sector. This is because large investments have to be made in conditioning the soil, importing the required seeds
and adopting other agronomic practices for commercial viability. This aspect has been dealt with separately in
Chapter III. Today, there is considerable demand for plant products in the world inspite of the advances in chemical
technology and development of cheaper synthetics and antibiotics.
18. The following drugs derived from plant materials have been identified in the essential drugs mentioned
in Chapter X:
Quinine, Morphine, Emetine, Digoxin, Methyl ergomatrine, alkaloids of Ergot. Reserpine, Atropine. Phys
ostigmine, Homatropine, Prednisolone, Noscapine, Vitamin A, Camphor, Menthol, Oils of Clove, Educalyptus, Peppermints, Anethi, Anisi, Caraway and Cajeput and Belladonna.
The Committee notes that most of these products are manufactured at present in the country and therefore
there should ordinarily be no need of importing any technology for any of these. However, vitamin A, predniso
lone and other steroids, digoxin, belladonna alkaloids and emetine are produced largely by the foreign equity hold
ing units. The Committee recommends that the National Drug Authority (NDA) should plan and supervise the
development of indigenous know-how by utilising the relevant CS1R laboratories, namely Central Drug Research
Institute Regional Research Laboratory, Jorhat/Department of Chemistry. Indian Institute of Science, Bangalore,
Department of Chemistry. College of Science, University of Calcutta for developing the indigenous know-how for
thes- products on an economic scale. The NDA should also plan and supervise the streamlining of production
technologies of other natural products listed in this group. The NDA should also take over the responsibility for
the production of an important drug, Quinidine, (which does not appear in the list of identified essential drugs but
is Important) from Cinchona febrifuge or from quinine itself.
19 The Committee feels that it may be necessary to import the technologies for the economic production
of ergot alkaloids and of the therapeutically active steroids if these are not worked out by the above group of labo
ratories within a period of two years.
^0 Belladonna is being processed by a large number of units in the private sector and camphor, menthol, oil
of eucalyptus, etc. are produced by units outside the drugs and pharmaceutical field and, therefore, there is no need
for import of any technology. However, there is need for their cultivation on a large scale.
21. Three steroidal drugs are required for family planning pill e.g. ethinyl estradiol, norethisterone and norsestroh ' Ethinyl estradiol is being produced in this country at present in the private sector both by Indian and fore
ign equity companies and ethisterone and norgestrol are not produced in this country at present. The Committee
is of die opinion that the public sector unit at Hyderabad in collaboration with the Department of Chemistry Indian
Institute of Science, Bangalore, Indian Institute of Experimental Medicine, Calcutta, Central Drug Research Insti
tute Lucknow and other Institutions engaged in phytochemical research, may be asked to develop the technology
for these drugs within the next 3 years. In the meantime, the Committee feels that since there is urgent need for
these sieroins in the country, purchase of technology for these products may be considered. Norgestrel is a synthetic
product add no separate mention of this will be made in the synthetic group of products.
1
.J
165
22. Research and development require large resources. We should, therefore, concentrate on mostly those
drugs which arc essential for diseases prevailing in our country. Some of the essential categories are
(i) Anthelmintics
(ii) Anti-leprotics
(iii) Anti-filarials
(iv) Anti-malarials
23. The situation in respect of the availability of technology for the different classes of drugs and pharmaceu
ticals is outlined hereunder:—
Immunological agents
The Committee has identiried the following immunological
(i) Tatanus antitoxin
Sera
(ii) Diphtheria antitoxin
(iii) Anti-venom serum
Vaccine
(i) D.P.T. (Triple vaccine)
(ii) Polio (Types I, II, III)
(iii) Typhoid-Paratyphoid A & B
(iv) Cholera
(v) Smallpox (freeze dried)
Toxoid
agents among the essentia! drugs, as under:—
(i) Tetanus
(ii) Diphtheria
The Committee notes that the technology for production of sera, vaccines, antitoxins and toxoids including
those identified as essential drugs, in Chapter X, has been evolved and further improved in this country. As at
present, there is therefore, no need to import any technology for this line of endeavour.
24. Out of 117 essential medicines identified by the Committee 44 are synthetic drugs,
notes that the following 13 of these essential drugs are produced in the public sector:—
The
Committee
Piperazine salts. Folic acid, Sulphadimidine, Phenobarbitone. Vitamin BL Vitamin B2, Analgin, Diethyl
Carbamozine Citrate, Para amino Salicylic Acid, Thiacetazone, Nicotinamide, Sulphacetamide and Paraceta
mol.
The last 6 drugs are also produced in several units of the Indian sector and by some foreign equity sector units.
It is obvious that the technology for all these is available in the public sector and the private Indian sector, and
there is no need to import technology for any of these drugs.
25. The Committee is strongly of the opinion that while facilities should be provided to the purely Indian units
to reach their licensed capacity for chloroquin, public sector must undertake production of this drug in a big way
and fulfil the national targets for 1978-79 and 1983-84.
26. Acetyl salicylic acid and methyl salicylate are produced in the country in the indigenous sector in fairly
large- quantities. There is no need, therefore, to import technology for these 2 items.
27. Halogenated 8-Hydroxy quinolines are produced in this country in the private Indian sector from basic
materials and though there is need to materially enlarge the production capacity for this drug, there is no need to
import technology for this item.
28. Succinyl choline chloride, Tolbutamide. Chlorpromazine, Adrenaline, Metronidazole, Furosemide, Hy
drochlorothiazide, Vitamin D2 and Mephentermine are being produced in the country by the foreign equity sector
in some quantities. Lignocaine is produced in the Indian sector. Nor adrenaline is not produced in the country.
There is need for indigenous technology to be developed for same of these items like Metronidazole. Nor-adrenaline etc.
29. The Committee recommends that in addition to R & D laboratories of the public sector, the following
laboratories may be involved in developing these technologies:—
National Chemical Laboratory, Poona.
search Laboratory, Hyderabad.
Qentral Drug Research Institute, Lucknow.
Other institutions interested in this type of work may also be associated in this work.
Regional Rc-
166
30. Considerable amount of work has already been done for developing the technologies for the production
of the above items in the laboratories of a public sector unit and the above mentioned laboratories. Pethidine is
being produced by an Indian unit and, therefore, there is no need for the import of technology for pethidine.
31. (i) The following drugs are not at present manufactured in this country at all or are manufactured in
only small quantitites:—
Nitrofurazone, Nitrofurantoin. Theophyline, Aminophylline, Phthalyl Sulphathiazole, Calcium Pentothenate. Chlorpheniramine maleate, Thipentol. Oxytocin. Primaquin diphosphate and Vitamin B6.
(ii) Laboratory scale know-how for the production of the above drugs except for thiopental, primaquin,
calcium pantothenate and chlorpheniramine maleate are available in the public sector and in the national laboratories.
(iii) It is expected that these processes will be put through the pilot scale trials within the next 24 months. As
at present, the Committee feels that we should await the results of these pilot scale trials. However, as mentioned
in Chapter III. para 74, the Government/N.D.A. should assess the availability of indigenous technology in respect
of Vitamin B6 and take necessary decision on the import or otherwise of technology for the same.
(iv) Technologies for the production of Thiopental, Primaquin, Calcium pantothenate and Chlorpheniamide should, however, be imported because they are not being produced in the country and are imported.
(v) Dapsone is being produced in the private sector by an Indian unit and also by a foreign equity unit.
is no need to import technology for this drug.
Theie
(vi) Isoniazid is being manufactured largely in the private Indian sector and there is no need to import tech
nology for this item also.
(vii) At present ephedrine is being prepared by a foreign equity unit from imported intermediates. Ephe
drine can be manufatured either by purely synthetic or semi-synthetic processes. The Committee understands
that the production of ephedrine by semi-synthetic process is economical. A process for this has been developed
by Central Drug Research Institute (CDRI) and is, at the moment, being scaled up, by an Indian unit. There is
no need, therefore, to import the technology for the production of ephedrine.
(viii) Vitamin C is being produced at present by two Indian units and a plant has been set up for the produc
tion of this item in the public sector also with the assistance of the National Chemical Laboratory, Poona. The
Committee feels that there is no need to import technology for production of Vitamin C. The Committee, however,
wishes to emphasise that the public sector should give the highest priority to the production of Vitamin C to avoid
heavy imports.
32. Diethyl ether, ethyl chloride, salicylic acid, glycerine, glucose, carbolic acid, benzoic acid, trinitrogly
cerine, etc., are'large bulk items which find major application outside the drugs and pharmaceutical industry. These
are produced in the country and. therefore, import of technology is not necessary.
33 Nearly, all the inorganic chemicals (Annexure III), except for iodine in the essential drugs list, are being
produced in the’country and? therefore, it is not necessary to import technology for any of these. In respect of
iodine, the Committee feels that for the present, this chemical has to be imported.
34. The Committee has identified four antibiotics among the essential drugs. These are penicillin, tetracy
cline streptomycin, and chloramphenicol. Penicillin, tetracycline and streptomycin are being produced in the pri' vate sector and public sector and chloramphenicol which is being manufactured synthetically, is produced entirely
in the private sector. Whereas the basic technology for the production of penicillin, tetracycline and streptomycin
is available both in the public sector and Indian units of the private sector, there is urgent need to obtain high yield
ing strains of the micro-organisms. One of the public sector units has obtained a high yielding strain of strepto
mycin and the Committee recommends that urgent steps should be taken to optimise the production at other public
sector units also bv making the new high-yielding strains available to them. It is immediately necessary to acquire
high yielding micro-organisms of Penicillin and Tetracycline along with the associated balancing technology.
35. Chloremphenicol is being produced in the private sector at present and that the productivity in the Indian
unit in the private sector, has been low due to technological difficulties. Chloramphenicol production is fairly comnlicated and the Committee feels that in order to produce the quantity of chloramphenicol required in the country,
steps should be taken to develop this technology indigenously starting from basic raw materials. This work should
be entrusted to the National Chemical Laboratory (NCL) and the Indian Institute of Science. Bangalore and Cen
tral Drug Research Institute. Lucknow.
r
r
i
167
36. Sufficient technological skill is available in the public sector and the indigenous private sector to carry
out formulations of almost any sophistication. The Committee does not, therefore, consider that there is need
to import any formulation technology whatsoever. The Committee, however, recommends that the public sector
units should set up a formulation R & D unit as early as possible.
37. The Committee recommends that in order to reduce dependence on import of technology in general,
urgent steps should be taken to equip the public sector units of the industry as also the laboratories mentioned above,
with such R&D and pilot plant equipment as may be necessary for this work. This would include low-tempera
ture, high pressure and high-temperature equipment including the vapour-phase reaction equipment. The Commit
tee strongly recommends that in consultation with the above laboratories, the specialised equipment may be pro
vided at least at two centres to begin with.
38. The Committee is of opinion that there is urgent need to strengthen the R &D laboratories and pilot plant
units with men and materials. The Committee strongly recommends that early steps should be taken to strengthen
the available facilities in the public sector units, care being taken that there is a strong design and engineering com
ponent established in the R & D structure, so that a chemical process that the developed may be indigenously tested
and upscaled by employment of the necessary component of indigenous and competent design and engineering skill.
It is of course understood that wherever necessary, the public sector units should seek assistance from other public
sector or private design and engineering organisations in respect of unsealing of a given process. The proposed
N.D.A. should co-ordinate all these Research and Development activities.
39. We have identified in this Chapter areas where the technologies are existing and also such areas where
there is need to develop and import technologies. We, however, feel that in general wherever it becomes necessary
for economic reasons or for pressure of time to import a technology or an improvement thereon and/or it is avail
able without onerous conditions attached to it, such technologies might be accepted.
Summary of Recommendations
1. There is need for increased productivity in a rationalised manner of all that we produce now and diversiication of production to cater to national needs on a priority basis.
('Chapter VII, Para 6)
2. There as e two broad areas where flow of technology is important in the field of Pharmaceuticals in our
country. Th? first is with regard to the existing drugs, to produce the essential items in quantities adequate to meet
our increasing requirements and maximise production from available resources and manufacturing facilities already
established. Secondly, there are areas where existing drugs are not really very effective or where no curative drugs
exist for certain diseases in the country. In this case, technology has to deal with research and introduction of better
and more efficacious remedies for treatment.
(Chapter VII. Para 8 & 9)
3. Stepping up of production by the existing units by imporvement of technology through R & D activities
and efforts of the State owned research laboratories are very important. This should not, however, preclude obtai
ning from abroad crucial technology for the purpose. Harnessing our limited resources of R & D facilities will
definitely yield better results by concentrating on selected fields and also on improvement of improted processes.
(Chapter VII—Para 13)
4. Another important field where this country can take advantage of the special climate and soil conditions is
the scientific cultivation of plants required for the drug industry.
(Chapter VII—Para 17)
5. The National Drug Authority should plan and supervise the development of indigenous know-how of natural
products by utilizing the relevant National laboratories. Educational institutions, etc. on an economic scale. It
should also plan and supervise the streamlining of production technologies. The National Drug Authority should also
take over the responsibility for the production of an important drug-Quinidine-from cinchona febrifuge or from
quinine itself.
1 M of Pet. & Chem./75—22
1
168
.
y
I?
s^eU^ICa
necessary to import the technologies for the economic production of ergot alkaloids and of the
actlx c ster°ids if these are not worked out by the above group of labroatories within a period of two
(Chapter VII—Para 19)
7. There is need for the cultivation of menthol,, eucalyputs oil bearing plants on a large scale.
(Chapter VII—Para 20)
8. The Public Sector unit at Hyderabad in collaboration with the Department of Chemistry, Indian Institute of
Science, Bangalore, Indian Institute of Experimental Medicine, Calcutta and Central Drug Research Institute. Luck
now, may develop the technology for ethinyl estradiol, nor ethisterone and norgestrel.
(Chapter VII—Para 21)
9. R & D efforts should be concentrated towards the development of techlology for new drugs required for
treatment ot diseases prevailing in our country, such as (i) Anthelimintics (ii) Anti-kprotics (iii) Anti-~larials (iv)
Anti-malarials.
(Chapter VII—Para 22)
10. Indigenous technology should be worked out for succinyl choline chloride, chlorpromazine, adrenaline,
metronidazole, furesemide, hydrochlorothiazide and nor adrenaline.
(Chapter VII—Para 28)
11. In addition to the R & D laboratories in Public Sector the following laboratories may be involved in deve
loping these technologies :—
National Chemical Laboratory, Poona
Central Drug Research Institute. Lucknow
Regional Research Laboratory, Hyderabad.
(Chapter VII—Para 29)
12. In regard to the drugs mentioned in paragraph 31. laboratory scale technology is available and it j expected
that these processes will be put through pilot plant scale trials within the next 24 months. The results of Liese pilot
plant trials should be awaited. Govt./NDA, should , however, assess the availability of indigenous technology in
respect ot \ it. B and take necessary decision on the import of technology. Technologies for the production of
thiopental, primaquin, calcium pantothenate and chlorpheniramine should be imported.
(Chapter VII—Para 31)
13. There is an urgent need to botain high yielding strains of the micro-organisms. One of the public sector
unit has obtained a high yielding strain of streptomycin and the Committee recommends that urgent steps should be
taken to optimise the production at other public sector unit also by making the new high-yielding strains available to
them. It is immediately necessary to acquire high yielding micro-organisms for Penicillin and Tetracycline along with
the associated balancing technologies.
•
(Chapter VII—Para 34)
14. In order to produce the quantities of chloramphenicol required in the country, steps should be taken to
develop this complex technology indigenously starting from basic raw materials. This work should be erzrusted to
N.C.L. and the Indian Institute of Socience, Bangalore and Central Drug Research Institute, Lucknow.
(Chapter VII—Para 35)
15. The public sector unit should set up a formulation R & D unit as early as possible.
(Chapter VII—Para 36)
..
169
16. In order to reduce dependence on import of technology in general, urgent steps should be taken to equip
the public sector units as also the laboratories already mentioned, with such R & D and pilot plant equipment as may
be necessary for this work. This would include low temperature, high pressure and high-temperature equipment
including the vapour phase reaction equipment. The Committee strongly recommends that in consultation with the
above laboratories, the above specialised equipment should be provided at least at two centres to begin with.
(Chapter VII—Para 37)
17. Early steps should be taken to strengthen the available facilities in the public sector units, care being taken
that there is a strong design and engineering component established in the R & D structure so that a chemical process
that may be developed may be indigenously tested and upscaled by employment of the necessary component of indi
genous and competent design and engineering skill. Wherever necessary, the public sector units should seek assista
nce from other public sector or private design and engineering organisations in respect of upscaling of a given pro
cess. The proposed N.D.A. should coordinate all these Research and Development activities.
(Chapter VII—Para 38)
18. The Committee has indentified areas where the technologies are existing and also such areas where there is
need to develop and import technologies. The Committee, however, feels that, wherever it becomes necessary, at
any point of time, for economic reasons or for pressure of time to import such a technology or an improvement thereon
and/or it is available without onerous conditions attached to it, such technologies might be accepted.
(Chapter VII—Para 39)
1.
1
ANNEXURE I
(Chapter VII, Para 11)
PRODUCTION OF BASIC DRUGS
1978-79
1. Pericillin
2. Streptomycin .
3. Chloramphenicol
4. Tetracycline
5. Nicotinic Acid Amide
6. Sulphadimidine
7. Vitamin C
8. Analgin
9. PAS
10. Ampicillin
11. Oxytetracycline
12. Vitamin Bl
13. Oxy phenyl Butazone
14. Vitamin A
.
<
Units
Rs
Crores
7S0 MMU
825
390
200
600
1010
900
400
1000
35
SO
100
50
80 MMU
39.00
24.34
16.46
13.00
9.00
7.78
7.20
5.04
5.03
4.90
4.80
4.32
' 4.13
3.73
148.73
B ITExMS
1. Chloroquin
2. Isoniazid ....
3. Halogenated Oxyquinolines
4. Vitamin B12 .
5. Aspirin ....
6. Sulfadiazine, Sulphadimidine
7. Vitamin B6
.
8. Phenacetin
9. Panthenol
10. Phenylbutazone
11. Vitamin B12. Insulin ....
150
265
450
300 Kg
1900
1230
50
500
60
200
24
3000 xVIMU
3.53
3.45
3.38
3.00
2.76
12.53
2.50
1.80
1.71
1.68
1.56
1.50
39.40
C ITEMS
1. Paracetamol
2. Metronidazole
3. Folic Acid
4. Phthalyl Sulfathiazole
5. Thiacetazone .
6. Sulfacetamide .
7. Diethylcarbamazine .
8. Tolbutamide
9. Phenobarbitone
10. Neomycin
11. Vitamin E
12. Piperazine
13. Ether
14. Sulfamerazine .
15. Sulfamethozy Pyridazine
16. Amidopyrine .
400
50
75
150
70
SO
45
75
34
10
9
118
530
34
17
20
1.44
1.20
1.02
0.90
0.88
0.64
0.54
0.52
0.51
0.45
0.34
0.33
0.32
0.26
0.26
0.24
197.98
170
ANNEXURE 11
(Chapter VII, Para 15)
MAJOR IMPORTS OF DRUGS MANUFACTURED IN INDIA
1973-74
Product
1. Ampicillin
2. Vitamin C
Quantity Value
(Tonnes) (Rs.'lakhs)
....
24.6
306
3. Chloramphenicol
4. Tetracyclin
....
5. Analgin
6. Streptomycin Sulphate .
7. Chloroquin
....
8. Phthalyl Sulphathiazolc
9. Metronidazole ....
10. Phenyl Butazone/Oxyphenyl Butazone
11. Vitamin B2
....
12. Vitamin Bl
....
13. Pantothenates/Panthenol
14. Sulphamethoxy-Pyridazine
15. Neomycin
65
54
219
161.0
113.0
86.0
74.0
65.0
63.1
-S
60.0
40.0
25.6
II.0
11.8
32.0
29.4
33
18.8
4.5
28.0
25.0
23.0
17.0
15.0
831.5
Total :
171
ANNEXURE III
(Chapter VII, Para 33)
INORGANIC CHE5UCALS
2. Magnesium Hydroxide
4. Sodium Chloride
6. Potassium Iodide
8. Potassium Permanganate
10. Boric Acid
12. Caustic Soda
14. Sodium Sulphate
16. Potassium Sulphate
18. Ferrous Sulphate
1. Aluminium Hydroxide
3. Magnesium Trisilicate
5. Iodine
7. Sodium Bicarbonate
9. Zinc Oxide
11. Chlorinated Lime (Bleaching Powder)
13. Magnesium Sulphate
15. Potassium Chloride
17. Ammonium Mercuric Chloride
172
I
*
»
CHAPTERA’TII
Pricing of Drugs and Pharmaceuticals
One of the terms of refernce of the Committee is “to examine the measures taken so far to reduce prices of drugs
for the consumer and to recommend such further measures as may be necessary to rationalise the prices of basic drugs
and formulations.” In order to assess the impact of the measures taken so far and also to consider what further
steps if any, are needed in public interest, it would be useful to refer briefly to some of the special characteristics of
this industry ; and in the light of these chracteristics to clarify the main objectives of Governmental action affecting
the working of this industry including the pricing of its products.
2. The modern pharmaceutical industry is of relatively recent origin. Essentially, the production of synthetic
drugs and pharmaceuticals based on research is a post-World War-I phenomenon ; but during the half a century since
the modern pharmaceutical industry was born, and particularly after World War-II, it has grown at a phenomenal
rate. According to an Organisation for Economic Cooperation and Development (OECD) Survey in 1969, the total
market for pharmaceutical products in the OECD countries i.e. North American Continent, Western Europe, Japan
etc. was of the order of $ 10 billion. By 1974, it would have increased still further, and currently, it is likely to be
nearer $ 15 billion at current prices. Compared to this huge turnover, the production and consumption of modern
pharmaceuticals in India is still minuscule.
3. Unlike some other modern industries such as automobiles or aluminium, the pharmaceutical industry con
sists of several thousand units ranging from very small establishments which are engaged in manufacturing specialised
chemicals to enormous manufacturing empires with turnover as high as $ 1 billion i.e. roughly about Rs 800 crores.
The wide range in terms of size arises because beyond a certain minimum size which is not very large, the economices
of scale in production are not important in the pharmaceutical industry. Nevertheless, it has been common ex
perience all over the world that in every country a large number of small firms which are locally owned account for
roughly about 20 % of the total sales of drugs and pharmaceuticals. The remainder of the market is controlled by
mostly multi-national units which are much larger in size and resources. The reason why large units generally do
minate this industry is because the pharmaceutical market is extremely heterogenous and really consists of a large
number of products each differentiated from the other and often protected by patents. In the result, the industry
is highly competitive particularly in the matter of formulations; but this competition is not in terms of price but rather
in the form of persuading doctors or in the case of house-hold remedies, consumers, to patronize a particular brand
of drug and formulation. An important characteristic of this industry is a quick product change or product adapt
ion technique which is only partly based on proven imporvements is the effectiveness of production combinations.
In large part, the Product adaptation innovation is essentially a marketing technique with a view to retaining or
augmenting one's share of the market for a particular pharmacopoial product group. Such a marketing technique,
of course, necessarily involves substantial selling costs which in turn have to be added to the costs of the drug. In
advanced industrial countries, the pharmaceutical industry also spends substantial amounts—around 10% of total
turnover—on drug research and product development. But these expenditures are relatively less significant in de
veloping countries, including India, and by and large the multi-national corporations use their research outlays in the
parent company to introduce new drugs/formulations by their subsidiaries in developing countries. The use of brand
names as opposed to generic names also enables the industry to sell essentially similar drug formulations at widely
varying prices. Quite often, it is difficult for the doctor and almost impossible for the patient Io have, at their disposal,
informatio which would enable them to compare prices of drugs which are virtually identical. Advertisements rarely
mention prices and. in general, the medical representatives canvass the superiority of their particular brands of me
dicine with the doctor not on grounds of prices but on other grounds such as therapeutic effectiveness or advantages
of the new or improved drug. In short, the success of the larger units in the modern pharmaceutical industry is
dependent mainly on their ability to develop new products based on research and to create and sustain a demand for
their product; and this is done by effective selling techniques and by product adaptation/innovation with a view to
help the effective marketing.
4. This particular characteristic of the industry implies that in judging the growth or performance of the industry,
reliance merely on the value of output can be misleading. Even if, as in India, prices of drugs have been under con
trol oxer a number ot years, the increase in output could well reflect the introduction of new products at higher
prices and, in any case, in judging the social utility of the industry, what is important is the product composition and
not only the value of output. This is particularly important in a country like India where general poverty and the
173
I
/
174
wide disparities in levels of incomes between different sections exist, special efforts need to be made to ensure that
the pharmaceutical industry devotes adequate attention to producing the drugs and medicines which are most essential
to the large mass of poeple and that these are marketed at prices within the reach of common man. There is some
evidence to suggest that while the growth of the pharmaceutical industry over the last 15 years has been quite
impressive in terms of growth of output, it has been less so, if one takes into account the product composition and
the pricing policies of the industry. It has been brought to the notice of the Committee that according to expert
medical opinion, in a large number of cases the therapeutic usefulness of particular drug combinations is somewhat
doubtful ; and indeed there are cases where the usage of pharmaceutically effective ingredients are irrational or waste
ful in terms of therapeutic value.
5. In the context of the structural charateristics of the drug industry and keeping in view the social objectives
of Government, it is important to clearly define what it is that we want to achieve through governmental action in
the field of drug prices. The per capita consumption of modem drugs and pharmaceuticals in India is currently
estimated to be Rs. 6 per year and according to some estimates, only about 20% of the population use modern drugs.
On a rough estimate it would appear that the total annual expenditure on drug formulations will probably be below
Rs. 30 per family where the family income is Rs. 4200 per year. The pricing of drugs is thus a socially important is
sue not because of its effect on the family budget but for certain other considerations. High prices of drugs, for in
stance, would effect the ability of the public hospitals to cater to the needs of the poor; but even here, it has to be
recognised that the cost of medicines constitutes a relatively small proportion around 12 to 15 per cent of the total
cost of the public health services. The reduction in the price of drugs, by itself, therefore, will not make much differ
ence to the ability of the municipal or state agencies to provide medical facilities. The concern about drug prices,
therefore, really arises from the fact th?-t many of them are essential to the health and welfare of the community;
and that there is no justification for the drug industry charging prices and having a production pattern which is based
not upon the needs of the community but on aggressive marketing tactices and created demand. In other words,
the main objective of policy has to be to secure a better convergence of ommercial considerations * and social
needs and priorities. The emphasis has to be on increasing the social utility of the industry particularly in the con
text of extreme proverty and the urgent need for extending as rapidly as possible certain minimum facilities in terms
of preventive and curative medicines to the large mass of people both urban and rural.
6. It is in this somewhat broader perspective that one needs to view the efforts made so far to reduce the prices
of drugs for the consumer. Prior to 1962, there was no statutory control over prices of drugs and formulations.
Prices were brought under statutory control, for the first time in 1962 in the wake of Chinese aggression and the de
claration of emergency. The Drugs (Display of Prices) Order. 1962 and the Drugs (Control of Prices) Order, 1963
were promulgated under the Defence of India Act. These orders had the effect of freezing prices of medicines as
on 1st April. 1963.
7. The industry was highly critical of the freeze order on the ground that the prices of various raw materials and
inputs were not similarly frozen. It was also claimed that the blanket freeze was adversely affecting the growth of
Indian firms of medium and small size. Government introduced a system of selective increases of prices in 1966;
and further. 17 essential drugs were identified and were referred to the Tariff Commission for investigation of their
cost structure in August, 1966. Drug Prices (Display and Control) Order, 1966 made it obligatory for the manu
facturer to obtain prior approval of Government before increasing the prices of any formulations in their lists as onJune 30. 1966. By an amendment, items with pharmacoppoeial names were exempted from price approval. Ex
emption was also made in the case of new drugs i.e. which had been evolved as a result of original research and were
marketed for the first time. In such cases, the manufacturer could fix the prices after submitting necessary data;
and it was open to Government to fix revised prices, if necessary, within 4 months.
8. As a result of their study of the cost structure of 17 selected essential drugs and their formulations and some
other related matters, the Tariff Commission recommended their fair selling prices and also made certain other
related recommendations (43 in number). The Commission came to the following two broad conclusions :
(a) “The domestic prices of the selected drugs are generally very much lower in most cases in other countries
(24.5).
(b) “By and large the prices in the Indian market of formulations compare favourably with the prices of simi
lar-formulations in the domestic markets of other countries.” (24.7).
The higher prices of essential drugs as compared to those in developed countries were said to be due to the
follow!.is more important factors (i) the high cost of equipment, inter-mediates, and raw materials, a good part of
which was imported ( if) the small size and lower capacities of production as compared to other countries, and (iii)
the Patent Law and related conditions for the transfer of know-how.
J
I
175
9. The Commission took all these aspect into account and adopted generally the principle of weighted aver
age for arriving at fair ex-works price for each essential bulk drug where more than one manufacturer was involved.
The price of each individual costed unit was built up after a careful analysis of the data collected by them in respect
of the years 1965-66 and 1966-67 for the units and after determining the costs on account of materials, manufacturing
expenses, packing, royalty, research and selling expenses incurred by them. Provision was also made for a pre-tax
return of 15 per cent on capital employed.
10. The Commission’s findings in respect of selected forumlations was that the prices can bear some reduction
even after allowing for all costs and a reasonable return on investment. For arriving at the fair retail prices for the
selected formulations of each firm, the Tariff Commission computed the factory cost comprising of costs of materials
and packing materials, conversion cost and packing cost. As regard selling expenses the Commission found that
their incidence varied from company to company and was “rather on the high side”. Accordingly, they restricted
it to 15 per cent of the total factory cost. The outward freight and excise duties were added on the basis of the then
existing rates. They recommended selling prices included in addition to the above items, a ]5% mark-up on the tota
cost of sales, i.e. total factory cost plus freight and the selling expenses corresponding to 15 per cent on capital emp
loyed in the case of essential drugs, the commission of the retailers, the wholesalers and other intermediates a
dfferential rates for ethical drugs and non-ethical drugs (i.e. drugs saleable against a doctor s prescription an
those saleable without such a prescription).
11. The Drugs (Prices Control) Order, 1970 was promulgated on 16th May, 1970. The principal objective of
the order was to effect a measure of rationalisation in the prices of drugs and to build up a rational system o price
control. The order was also designed :
(i) to bring down the prices of those essential drugs where prices generally remained very high,
(ii) to provide sufficient incentives to the industry to maintain/facilitate its growth from the basic stages and
to develop research facilities and expansion in a planned manner,
(iii) to promote diversification of entrepreneurship in the future development of this industry, and thereby
provide better opportunities, for Indian personnel with requisite technical qualifications, and
(iv) to curb excessive profits.
12. Ths Drugs (Prices Control) Order, 1970 was subsequently amended from time to time in the light of the
experience gained in its working and suggestions received from the indsutry and trade. The salient features o t lese
amendments and Order are as follows :—
(i) Selling prices for 17 essential bulk drugs in different forms were fixed by Government taking into account
the recommendations of the Tariff Commission.
(ii) Selling prices of other bulk drugs frozen at the level prevailing immediately before the promulgation of
the order, mo manufacturer, importer etc. were to be permitted to increase the selling prices ot the u
drugs without prior approval of the Government for which details are required to be furnished in the pre
scribed form.
(iii) In regard to formulations, certain norms for conversion charges and packing charges were prescribed for
reworking the costs and a formula was devised for calculating the prices of all formulations having due
regard to products of original research and development.
Under the usual scheme, the formulations were priced with a mark-up of 75% on the total ex-factory cost.
The mark-up includes provision for :
(i) Outward freight,
(ii) Distribution costs and the trade commission,
(iii) Promotional expenses, and
(iv) Manufacturers’ margin.
13. In case of formulations involving original work and research, higher rate of mark-up upto 100/ was per
missible. In respect of formulations involving original research in India on basic drug a maik-up upto nowas
permissible. This order also provided for an alternative scheme of pricing. This alternative scheme provided some
flexibility in the fixation of prices, subject to certain conditions relating to mark-up applicable to essential and
other formulations and overall profitability not exceeding 15 percent on sales turnover.
1—M of Pet. & Chem./75—24
&
( !
u
176
It was provided under alternative scheme that gross profits made by this industry (gross profit before tax)
will not exceed 15% of turnover in any year; and any excess thereof; if earned, shall be funded" separately which can
be utilised, with the prior approval of Government, for following purposes :
(a) Research and development expenditure.
(b) Adjustments against future profits or losses; and
(c) Such other purposes as may be specified by the Central Government from time to time.
'"During four years of operation of the Drugs (Prices Control) Order, 1970, only two companies have funded
Rs. 22.52 lakhs. These two companies have also not come up so far with any proposal in regard to the utilisation
the amount so funded.
14. Incidental provisions, such as issue of price lists, marking of prices on containers of drugs, sales of split
quantities of drugs, proper maintenance of accounts etc., have also been made for the effective implementation of
the Order. Prior approval of Government is necessary for revision of prices of formulations once fixed, as well as
for fixation of prices of new packs and new formulations. However, small units with a sales turnover of Rs. 5 lakhs
or less were exempted from getting prior Government approval. This was provided to help small scale manufac
turers.
Implementation of Drugs {Prices Control) Order, 1970
15. The Order provided certain time limits for submission of revised price lists supported by complete data
for approval by the Government. When it was found that there was rise in the selling prices of certain products
Government issued an order on 18th August, 1970 whereby the prices of such products where increases had been
effected by the industry after 1st of August, 1970, were “frozen” at the level prevailing immediately before the com
mencement of the Order, pending scrutiny of the pricing data by Government.
16. Subsequently, necessary approvals after scrutiny of the detailed cost data, were issued in December 1970
There are over 2,500 drug manufacturing units of various sizes in the country. As. it was obviously not nkssibb.'
for the Government to exanune the detailed price calculations of all these units in respect of the formulations within
the time-limit specified in the Price Control Order, a beginning was made by fixing the prices of the dru^s nror rtd
by the more important units numbering about 110. It was considered that as a result of operation oAhe market
forces, the prices of formulations manufactured by other units would have to move in svmpathv with those nT ti,»
aforesaid leaders in this industry.
'
J
01 ine
17. Details of cost structure of 11,732 packs of formulations as produced by the manufacturers were pyn™;
suss?
estimated that as a result of the above exercise, the community would have benefited to the extent of Rin a total turnover of about Rs. 220 crores.
‘
0
tnei1
crores
18. In September, 1970 a Working Group was set up by the Ministry of Petroleum & Chemicals nnHnr .i.
Chairmanship of the Chairman, Bureau of Industrial Costs & Prices to examine the cost structure of 24 h lu a the
and other allied matters. This Working Group also investigated the cost structure of certain formulations and PgS
loped norms of conversion and packing charges of different packs of these formulations The Work ;™ T- 6’
submitted its report in four volumes, the first three relating to bulk drugs and the fourth to formulations S LjrouP
Reports of the Working Group were submitted to Government between April to October 197'’ t a •>
and May, 1974 Government announced its decisions in respect of the recommendations pertaining to norms r
conversions and packing charges. As costs of production had undergone a significant change sTnre rhJ •. °f
investigation by the Working Group, Government asked the Bureau of Industrial Costs and Prices f
whether and to
what extent, the earlier recommendations needed modification. In the Imht of this A™eXa™lr,e
Government also announced its decisions in regard to the prices of 24 bulk drugs. No decision however h^k01’’
reached on the recommendations of the Working Group in regard to the basis of pricing of formulations hv th r
the Committee on Drugs and Pharmaceuticals was appointed on the 8th of February, 1974.
th lme
19. The price control on the Drugs and Pharmaceutical industry has thus been in force in one form nr rmno
for more than a decade Since 1970, virtually all changes in the prices of drugs and formulations required prior
approval of Government. The operation of the control, however, had less impact on the structure and level of S
of drugs and formulations than one would have expected in view of the very large proportion of items in respect
3
s
177
of which reductions in prices were effected. As pointed out earlier, the Drug Price Review Cell undertook a quick
examination of the cost structure of 11,732 packs and formulations and after discussions with the manufacturers,
certain price adjustments mainly downward were effected. In such an exercise, however, it was only to be expected
that manufacturers agreed to reduce the prices of those items where the sales value was small and/or growth pros
pects were limited. While the price reductions covered nearly 45% of the formulations in terms of numbers, in
terms of total sales of the 110 companies, the proportion was less than 30%. Similarly, in the case of more than
l/3rd of the formulations, prices were allowed to be kept at the earlier levels. In a large number of cases, these items
wliich together constitute about 6% of the sales were also products which carried a much higher mark-up ; and,
therefore, had a significantly higher margin of profit.
20. The review of the trends in profitability on manufacture of formulations since these were brought under
statutory control by the Drugs (Prices Control) Order, 1970, shows certain interesting results. Firstly, there has
been a general decline in the ratio of profitability on sales over the 3 years ending 1972-73. The results are
summarised below :
Table
(i) 31 .i m . .vith more than 50% foreign equity
.
(ii) 11 firms with less than 50 % foreign equity
.
(iii) 16 firms with no foreign equity
(iv) Aggregate of 58 firms
(Percent)
1969-70
1971-72
1972-73
19.15
11.59
9.79
14.62
9.01
8.34
9.11
7.^7
5.70
15.47
10.19
8.53
This general decline in profitability, however, covers a fairly wide variation as between units. For instance,
while the average profitability of companies with majority foreign equity participation has come ^own from
to 9 79 % the analysis shows that even in this sector there was a fair number of units with rates of profitability which
were slnificantlv higher than the average. Thus, in 1969-70, 20 units had a profitability rate which was 12 z and
Tnve on sales and even in 1972-73, there were still 10 units in this category. Similarly, in 1969-70, 4 units had a
’
tabiliry
«hid,
tae, .tan 6%. This number tas gone up.o 7 in 1972.73. Seeonbly, lhe proSmbili.y
o Mon companies wi.b no foreign staMoMng tas generally been lower rtan th.l of oomp.mes Mb fore,go
stare “oldiita. There are se.erul reasons for ihis .rend bn. in large par. .he d.Oereooe arises from .he M .ta, .he
;
1 industry Generally is based on aegressive and competitive selling. Companies and foreign share
SX :i:Xo£"Xter established=and even after the institution of price control in 1970, they have
a product range which continues to have a wide market acceptability and fairly attractive profitability. Newers
entrants-mostly Indian companies-have had to face the handicap of being late comers in the field but even in the
cu e of Indian companies it has to be noticed that in 1972-73, the profitability rates among profit making companies
varied from 1 6% of sales to 10.7%; two units incurred losses. Thirdly, profitability does not seem to be related o
the size of the units except to the extent that generally units with a turnover in excess of Rs
^[es annuaUy
seem to have a somewhat better profitability record. Otherwise, there is no firm trend suggesting that Piofitab11 V
of smaller units or units of intermediate size is any different from profitability of other units both in terms of leve s
of profits as well as the variations as between units. This would suggest that except for very large firms-and these
are also the older established units-the profitability record is more dependent on the productc omposition
and their ability in terms of marketing rather than on scale of production.
178
21. The analysis of profitability in the preceding paragraph is based on returns received from the companies
as required under the Drugs (Prices Control) Order, 1970,
and relate’to pre-tax’profitability in relation to the
sales turnover of formulations only. In order to assess the profitability of the industry, however, it is necessary
to look at the performance of the industry not merely in terms of pre-tax profits as a percentage of sales but also other
indicators such as the rate of profitabifity in relation to capital employed or net profits {i.e. profits after payment
of tax as a proportion of net worth i.e. paid-up capital plus the reserves). The only source of information for this
kind of assessment is the analysis of Balance-sheets periodically published by the Reserve Bank of India; and the
coverage of companies is somewhat different from the companies included in the analysis in the above paragraph.
The following table summarises the results of Reserve Bank of India's analysis of Balance-sheets:
Table
(Rs. lakhs)
39 Companies
42 Companies
1968-69
1969-70
1970-71
1970-71
1971-72
1972-73
1. Net worth .
5956
6677
7422
7618
8477
9063
2. Capital employed
8493
8917
10320
10691
' 12015
12922
3. Net Sales
14278
16450
18414
18315
21422
24183
4. Gross Profit
2708
3394
3289
3347
3564
3831
5. Pre-tax Profit
2448
3164
3023
3070
3203
3388
6. Net Profit .
1069
1358
1222
1250
1363
1411
7. Gross Profit to
(a) Capital employed .
(b) Net Sales
31.9
19.0
38.1
20.6
31.9
17.9
29.7
18.3
31.3
16.61
29.6
15.8
8. Net profit to capital employed
12.59
15.23
11.84
11.69
11.34
10.92
9. Net profit to net worth
17.9
20.3
16.5
16.4
16.1
15.6
10. Net profit to net sales .
7.49
8.26
6.64
6.83
6.36
5.83
It will be seen that the profitability after tax measured as a return on capital employed or as a return to the
shareholders on their own funds i.e. paid-up capital plus reserves, have not dechned as sharply as in the case of pro
fits as a proportion of sales. Of course, in 1973-74 and in 1974-75, there would have been a somewhat more pro
nounced decline in profitability because of the rise in manufacturing and other costs which were off-set only parti
ally by the the revision of prices. But the fact remains that the industry was able to off-set part of the decline in
profitability on sales by the increase in the volume of sales. Between 1968-69 and 1972-73 the total sales of formula
tions by foreign companies with more than 50 per cent foreign equity, increased by 69.2 per cent. The correspond
ing increase in the case of the Indian companies, however, was only 32.9 per cent and this is one of the reasons for
the relatively sharper reduction in the profitability of some of the Indian companies.
There is also another factor which needs to be borne in mind in comparing the profitability as derived from
the analysis of Balance Sheets and profitability on the sale of formulations reported by the companies as required
under the Drugs (Prices Control) Order, 1970. The latter relates only to the formulation activity and the profits
are shown as a percentage of sales turnover including excise duty, but in calculating the profits, payment of interest
and bonus are treated as elements of cost. Thus, the concept of profitability is somewhat different than the one
traditionally used in the analysis of balance sheets. Moreover, in many of the larger compenies, particularly foreign
companies, the non-drug activity constitutes a significant part of the total turnover. In the case of 25 companies,
a
179
19 foreign majority and six with a measure of foreign ownership, which accounted for 48 per cent of total sales of
formulations in 1972, non-drug activity accounted for 24.5 per cent of their total sales and most of the non-drug
products were not covered by any price control. In assessing the impact of price control on the drugs and pharma
ceutical industry, it is necessary, therefore, to take a comprehensive view of their profitability.
22. While the operation of price control so far has certainly helped in preventing the emergence of very large
or excessive profits by the drug and pharmaceutical industry, it does not appear to have contributed materially to
the emergence of a product or price pattern which is more in consonance with social needs or national objectives.
For instance, in spite of the fact that the industry has been under some form of price control for over a decade,
there are still fairly wide variations in the prices charged by different units for same or similar formulations.
Even more disturbing, however, is the fact that the structure of product pricing appears to have a bias in favour of
greater profitability in respect of less essential formulations which are consumed by the more affluent sections. This
is of course, implict in the alternative scheme of pricing referred to in para 13 and the procedure adopted in enforc
ing price reductions when the Drugs (Prices Control) Order came into force in 1970.
23. An important clement of cost which needs particular attention is the cost of packing. It has been brought
to the”notice of the Committee that in many insances. the cost of packing materials constitutes a fairly high
proportion of the costs of pharmaceutical products. It has also been noticed that in respect of the same formula
tion and type of pack, there are fairly wide variations as between units in regard to cost of packing. It is recognised
that in some preparations like eye- drops, eye ointments, transfusion solutions, sterile preparations, the cost of,
packing material could be much higher than the ingredients used because it is necessary to keep the ingredients free
from even a trace of impurity. In certain other cases also, therepeutic properties of the medicines need to be
protected and this can be done only by resorting to somewhat special packing materials which are relatively expen
sive. Nevertheless, the Committee feels that greater attention needs to be paid than at present to standardization
and*economy in the use of packing material consistent with the protection of consumers’ interest.
Economy in packing costs can be achieved through bulk packings which would enable the cost to be reduced
very considerably for large consumers such as hospitals, health centres and institutional users. Special attention
needs to be paid to discouraging non-functional packing which is often resorted to not in order to maintain the quality
of the product but to make the product look more attractive. The Committee feels that it would be desirable to
keep under continuous review the modes of packing and the materials used for packing purposes by the drugs and
pharmaceutical industry with a view to evolving, appropriate packing standards, rationalising material usages and
ensuring that competitive packing is not resorted to as a salespromotion measure. The system of price fixation
which is based on computation of material cost, conversion costs and packing costs, together with the mark-up
thereon, as laid down in paras 6 & 7 of Drugs (Prices Control) Order, 1970 sometimes tended to reduce the incentive
to the manufacturers to keep packing costs to the minimum necessary.
24. Risid control on prices of drugs and formulations had to be modified and selective increase in prices per
mitted on the merits of each case to take account of any substantial variations in costs of materials including packag
ing material. But the extent to which such modifications were required was relatively small, until the Fast quarter
of51973. For instance, the total number of applications received for refixation of prices was 759 in 1971, 2716 in
1972 and 2653 in 1973. With the oil crisis and the subsequent spiralling up of world prices and also the high rate
of domestic inflation, the situation was radically altered by the end of 1973. During the first quarter of 1974, the
number of applications for price revision went up to 1469 and it increased further to 2151 in the quarter ending
June, 1974. It was evident that with the steep rise in production costs, the revision of prices both of bulk drugs
and formulations was necessary if supplies in the market were to be maintained.
25. In July 1974, Government after detailed discussions with representative associations of manufacturers
evolved a system under which manufacturers could apply for price increases but the extent of such increases was to
be limited to the actual increase in costs of materials including packaging materials only. Other cost increases such
as those due to increase in wages, electricity rates, freight charges, distribution costs etc. were not to be taken into
account. The salient features of the guidelines are
1. A basis for calculation of escalatory effect due to rise in the prices of raw and packing materials over the
prices used in the cost data of 1970/the. latest cost data approved for price revision prior to May, 1974.
2. A simplified procedure for adoption and acceptance of prices for drugs and excipients used in the formulations duly certified by Chartered/Cost Accountant in the prescribed proforma.
3. Notified rates besides norms for Conversion Costs, Packaging Costs and process loss for overages for work
ing out current ex-factory costs.
180
4. Provision of an additional mark-up on the escalatory effect to provide for the increased cost of commission,
transport and miscellaneous selling and distribution expenses as under :—
(i) 50% on escalatory effect wherever the existing mark-up is 75% or less.
(ii) 25% on escalatory effect wherever the existing mark-up is between 75% to 100'%.
(iii) Mark up on escalatory effect up to a maximum of 25% wherever the existing mark-up is between
100—150% limited to a maximum mark-up of 100% on the revised ex-factory cost.
(iv) No mark-up on escalatory effect for items where the existing mark-up is more than 150%. In such
cases even the escalatory effect would be so restricted as to limit the revised mark-up to 150%.
Further, in order to assist smaller units which, in any case, would have to price their products in relation to the
prices charged by the larger manufacturers in the industry, Government also decided to raise the exemption limit
from Rs. 5 lakhs to Rs. 50 lakhs.
26. As a result of these measures, it was possible to deal with the large number of applications received for
price revisions much more expeditiously. In general, decisions on applications were taken within 4 to 6 weeks alth
ough the total number of applications was very large. Thus, the monthly receipt of applications which was on an
average of 221 in 1973 went up to 603 in the first half of 1974. As a result of the revised procedures, in the course of
3 months between September and November, 1974, it was possible to deal with as many as 1466 price revision cases.
27. The procedure laid down in the guidelines for price revision, however, is intended to be a stop-gap arrangement
in order to provide interim relief to the industry in an expeditious manner. The main purpose of this revision was
to ensure that there was no serious disruption in supplies on account of the spiralling of production costs and the con
tinuation of an uneconomically low price. This purpose was, by and large, achieved. The more important and
longer term problem of evolving arrangements to ensure that the drug industry operates in a framework which ensures
adequate supplies of essential drugs and pharmaceuticals at prices which are fair an reasonable both to the producers
and to the consumers, however, still remains. It is to this problem we will now turn.
28. In order to evolve a long-term policy, it is necessary to identify, in the first instance, the main objective of
such a policy, taking into account the socio-economic conditions in the country and the declared objectives of pla
nned development in the field of health services. In this backgroungd, it would appear that any scheme of price/
production regulation should be: (i) to ensure that the country's dependence on imports of basic drugs is reduced as
quickly as possible by encouraging, wherever possible, an economically viable domestic production of such bulk
drugs. The primary objective ot policy in this field should be larger production and lower costs so that in the long
run, these may be reflected in adequate availability and lower prices (ii)) In the field of formulations, the main thrust
of policy should be to take measures which will reduce or eliminate the social costs involved in competitive product
adaptation or aggressive selling. The recommendation of the Committee in Chapter X regarding the abolition of
brand names in respect of 13 drugs will be an important initial step in this direction. In addition, the administrative
regulation and licensing should be geared to ensure that greater emphasis is lai don production of the inessential
medicines listed in Annexure-II to chapter X of the report. In this area, the policy objective should be to ensure that
prices are fair and reasonable to the producer and to the consumer. But this will need to be supplemented by appro
priate administrative action to streng then the production base by ensuring adequate supplies of materials, both do
mestic and imported, and adequate arrangements to ensure that extraneous factors such as shortage of power,
allotment of materials such as alcohol etc. do not interfere unduly with production;-and (iii) apart from these, it
would still be necessary to have some arrangements to monitor and regulate where necessary, prices of important drugs
and formulations with a view to ensuring,that the drugs and pharmaceutical industry does not generally act to the
detriment of the consumer.
29. If these are accepted as the primary objectives of the regulatory framework, it seems necessary to have a
certain shift of emphasis in regard to the existing regulatory arrangements including the present basis of price control,
Firstly, in older to encourage the production of bulk drugs which are currently imported in significant quantities,
it would be necessary to list out items which can and should be produced within the country in a specified period
of time. Having identified these items, all necessary assistance should be provided to enable the industry to produce
them. To the extent that the public sector and/or the wholly owned Indian units are able and willing to produce these
bulk drugs, they should receive preference. If. however, for any reason, production plans of these units do not
materialise, other units in the industry including those with foreign equity may be permitted to set up production
capacity. As long as the country is dependent on net imports of a basic drug, the existing unit or a new unit may be
free to determine the selling price provided it is not higher than the selling prices of State Trading Corporation which
are based on average landed costs of imports and handling and other charges.
30. In the case of bulk drugs in which production is already established and in which imports are no longer
necessary, greater attention should be paid to ensure that the cost of production is kept to the minimum. This
involves the use ot efficient technology and process know-how; an adequate scale of production and also special care
181
to ensure that some of the essential ingredients are not excessively high priced as compared to international price
either because of high import duties or other tax measures or because of under-utihsation of productive capacity
or inefficient management. It would also be desirable to exempt from price control items in which there are no im
ports and which in terms of total sales of the basic drug do not exceed Rs. 25 lakhs annually. In respect of other
bulk drugs, a system of price regulation based on detailed cost investigation should continue subject, however,
to the price being so fixed that an efficient manufacturer is able to get a return on his capital employed which is a
little higher than is available on formulations for the industry as a whole.
31. The Committee has given serious consideration to the question of the rate of return on investment required
for production of bulk drugs. The Tariff Commission had come to the following conclusion in their report regarding
the return on capital employed on the basic activity:—
“Considering that the durg industry is oriented to humanitarian services it should not hanker after the high
profits and we have assumed a low rate of dividend and consider that the stability of the companies as well as higher
margins earned their side activities would be conducive to the attraction of the requisite capital. W'e have there
fore, arrived at the figure of 15 per cent of the employed capital as fair return for the industry in respect of its manu
facture of basic drugs.”
This aspect was also examined by the Working Group on Drugs and Pharmaceuticals set up by Ministry of
Petroleum & Chemicals under the Chairmanship of Shri N.N. Wanchoo, the then Chairman of BICP and came to
almost similar conclusion, as follows:
“It seems to us that with a return at 12%, many units of this industry may not even be able to declare a dividend
at 10% on the share capital, let alone find adequate funds from internal sources for the growth of the industry’. The
importance of having a well developed drug industry and the need for self-sufficiency cannot be over-emphasised
from the point of view of the health of the community. In these circumstances, we are of the view that a higher re
turn would be justified in this case and, accordingly in our calculations of fair selling prices, we have allowed return
at 15% on the capital employed.”
It is interesting to note that while the return of 15% was allowed on sales turnover in case of formulation acti
vity, the return on bulk drug activity was calculated at 15 % on capital employed. It is also necessary to note herethat the
ratio of turnover to capital employed is 2.6 : 1 in formulation activity and hardly 1 : 1 in case of bulk drug activitv.
It need therefore be emphasized that in the past the drug manufacturers have put up more stress on the production
of formulations which were more profitable than on the bulk drug activity. In order to set the things right, the return
on capital employed in case of bulk drug activity should now be made as attractive as possible to encourage more
basic production, and to realise the targets laid down in the Task Force Report of the The Planning Commission.
The Committee, therefore, recommends that a return-post tax between 12 to 14% with reservation from Shri K.S.
Chavada who wanted 90% post toxr eturn on capital employed, on equity i.e. paid up capital plus reserves may be
adopted as the basis for price fixation, depending on the importance and complexity of the bulk drug. For the pur
pose of determining the rate of return, on this basis, taxation should be calculated on the basis of statutory- rate of
tax. Otherwise, the benefits on any specific corporate tax concessions will be denied to the units in the industry7.
32. In respect of formulations, it will be seen that the control over prices has evolved over the years in a some
what ad hoc manner. Under the existing arrangements, prices of all formulations in different packs manufactured
by all units in the industry having a total sales turnover of over Rs. 50 lakhs are subject to control. Any change
in the prices has to be with the prior approval of Government. In effects, therefore, the present price regulation
extends to over 6000 packs distributed amongst 2800 products. Though the system of price regulation is compre
hensive, as pointed out earlier, it has not succeeded fully in bringing about equitablility as between units or contri
buted to a socially desirable structure of prices. The present arrangement for price fixation costs an enormous admi
nistrative burden on the agency responsible for fixation/revision of prices. The operation of the alternative scheme
of pricing referred to in para 13 has meant that for the same or similar products, variation in prices between different
producers could be considerable.
33. The general inflationary trend and more particularly the recent steep escalation in some of the costs input
and manufacturing expenses which have been only partially compensated in the form of an adjustment of prices has,
in effect, meant that the ceiling of 15% on sales turn-over prescribed under the alternative scheme has become noti
onal tor most of the units in the industry. At the same time, the way in which the cost increases and price revisions
have affected the units in the industry have not been uniform. In general, units which started with a relatively high
mark-up on growth items in their production structure— and many of these have been foreign dominated units—
been less adversely affected than those units which started with a relatively lower average mark-up. This is true of
many Indian units and also those units which had a high proportion of their output in the form of generic name drugs
or life saving drugs which were deemed essential to the life of the community, and. therefore, the mark-up had been
kept deliberately on the lower side. Altogether, the situation today is that the structure of drug prices has tended
to be distorted both in relation to the original intentions of the Drugs (Prices Control) Order, 1970 and also in terms
ol any objective or rational criteria for evolving a pricing policy in respect of drugs and formulations.
182
34. In this background, the first question to ask oneself is: is it necessary in terms of public interest to have a
price control system which covers each and every formulation; or is it better to introduce some selectivity in regard
the formulations which are to be brought under price control ? Given the characteristics of the industry and keeping
in view the need to have an effective system which is administratively workable, the Committee has come to the con
clusion that more selectivity in the system of price regulation, with a view to ensuring fair prices in respect of drugs
and formulations, would be desirable rather than all drugs and formulations irrespective of their importance. Regula
tion of prices is essentially a device io ensure that public interest is protected. In the drug industry, effective compe
tition is often vitiated by the prevalence of brand names and the strong brand preference which has been created
over the years through aggressive marketing. In respect of formulations based on thirteen drugs, the Committee
has recommended that brand names should be abolished. Provided there are no artificial restrictions placed on in
crease in production in respect of formulation sold under a generic name, there will be adequate competition and the
Committee recommends that these should be free from price regulation. It will be recalled that as pointed out in
para 7, formulations sold under a generic name were originally exempt from price control order. Adequate produc
tion and the abolition of brand names in the case of particular drug formulations would, in the view of the Com
mittee. provide sufficient protection to the consumer in terms of availability and price.
35. In the case of other formulations, selectivity could be (a) in terms of size of the units (b) in terms of selection
of items and (c) in terms of controlling the prices only of market leaders in particular products for which price con
trol is contemplated. An appropriate combination of these criteria is also feasible. The essential point, however,
is that the new system of price control should be one which does not require a prior approval of Government in res
pect of each formulation, irrespective of its importance, nor should it involve having to examine costs and prices ot
each manufacturer of a product, irrespective of whether or not the unit accounts for a significant share ot the market.
36. On this basis, there is a good case for exempting from the purview of price regulation all units with a turn’
over of less than Rs. 1 crore, as against the present exemption limit of Rs. 50 lakhs for this prupose. . There are about
2500 units in the drug and pharmaceutical industry but according to the available information only 42 ot them have
presently a turnover in excess of Rs. 2 crores annually and another 15 have a turnover in excess of Rs. 1 crore. These
57 units between them account for over 3/4ths of the total production of drugs and pharmaceuticals. In order to
ensure that this relaxations not misused, the Committee feel that the exemption should not be applicable in respect
of those units which come within the purview of the Monopolies and Restrictive Trade Practices Act.
37. It is possible that in exceptional cases, units with a total turnover of less than Rs. 1 crore may still be im
portant from the point of view of price regulation, because they account for a substantial proportion ot the total
output of a drug which is essential to the community and which in terms of total sales is significant in volume. In
order to ensure that all formulations (other than those which have to be marketed under generic names only) which
have a substantial volume of sales turnover are within the ambit of price regulation, the Committee suggests that all
formulations which have an annual all-lndia sale in excess of Rs. 15 lakhs (including excise duty) should be within
the ambit of price regulation whether or not the total annual turnover of the unit is in excess of Rs. 1 crore. At
the same time, even large firms may have items of manufacture which are minor elements in their production pro
gramme and have a small turnover. According to the available data, the pharmaceutical industry in 1974 had
2791 products (each with several pack sizes) which it marketed. Of these, only 453 products had an annual sales
turnover, individually, of more than Rs. 15 lakhs. In other words, if price control is limited to products with sales
in excess of Rs. 15 laks annually, it would be possible to minimise the product coverage of control by nearly
80%, and yet the 453 products which will continue to be under control will account for 70% ot the total turnover of
the industry. In this way, the administration of the control can be made more manageable and, therefore, more
effective. If necessary. Government may, in exceptional cases, decide to add any particular product to the list of
price controlled items, in public interest. But, ordinarily, in any product group only those manufactures which
individually have a total sale of their specific formulation in excess of Rs. 15 lakhs will be brought under control. The
ceiling price will be determined taking into account the production costs and a reasonable return for the units which
are the market leaders; and all other units will be free to decide on their own prices provided they are not inexcess
of the ceiling price determined by Government.
38. Another variant of selectivity, which could also be considered, would be to identify product groups which
individually are important and which collectively constitute the bulk of the output of the drugs and pharmaceutical
industry. In respect of each item on this list, it would be possible to identify the leading producer who, between them,
account for. say 60%, of the sales. On the basis of the cost analysis in respect of these units, maximum prices may
be prescribed and all other units may be free to fix their prices. But in practice they will have to adjust their prices
to keep in line with those charged by the market leaders. Under this arrangement, all the major units will find them
selves in a siiutation where a few ’of their products are market leaders and the selling price is based on an exami
nation of their costs. But in respect of other products some other firm would be recognised as a market leader and
although they may have the freedom to price their product, it will be circumscribed by the fact that the leading
producers of that product have to sell it at a price which is based on a claculation of reasonable costs of production
including a margin of profit. Such an arrangement will considerably reduce the volume of detailed cost investiga
tion and'will still ensure that the consumers get the formulations at prices which are fair and reasonable. Such an
I
183
arrangement, however, will work only provided there are no constraints on the market leaders Increasing their out
put so as to meet emergent demand at the controlled price. Otherwise, a situation can arise when in the absence of
adequate volume of production by the market leaders, there is a thriving black market for their products and the
°r k rnaRU^actuI’ers are
ahle to charge prices higher than the ceiling prescribed by Government, to the detriment
of the consumer. On balance, the Committee is of the view that this particular variant of selectivity may be adminis
tratively simpler.
I
I
39. In.any of these variants, however, it is necessary to provide for a reasonable margin of profit which will
provide the industry— both private and public sector— not only to maximise production by utilising existing capacity
but also to incur additional investment for a sustained growth of the industry. Starting from a relatively small base
as we do, it is important to ensure that regulation of prices is not suh as to discourage the planned rate of growth. At
the same time, it has to be recognised that the profitability of the drug industiy and particularly in respect of formula
tions has traditionally been higher than in most other industries; and this is true in most parts of the world. The return
of 15% on sales, including excise duty and exclusive of bonus and interest payments, provided for under the Drugs
(Prices Control) Order, 1970 is, in the view of the Committee, excessively generous. Translated in terms of return
on capital employed, this would mean a grooss return of between 35 to 40% (or even more) on capital employed an
in most cases, this would imply a rate of return in excess of 20% after payment of tax on equity i.e. paid up capital
plus reserves. Of course, in practice, profitability with very few exceptions, has been much lower than this level
partly because of administrative action taken by Government in fixing lower mark-ups on certain essential products
and partly because generally cost increases have been offset only partially by revision of prices. In the last year or
so, the profitability of the industry has been further reduced as a result of the sharp escalation in costs and only
part of the increase has been taken into account in the readjustment of prices. The Committee feels, therefore, that
in determining fair and reasonable return to the industry, the basis should not be the one provided under the DPCO.
Die Committee is inclined to the view that a ceiling on profitability as recommended by the Working Group under
the Chairmanship of Shri N.N. Wanchoo adjusted for the significant increases in longterm interest rates would serve
the purpose and would ensure an adequate return.
40. The main recommendations of working group on Drugs and Pharmaceuticals under the Chairmanship
of Shri N.N. Wanchoo on return on formulation activity under the alternative scheme were as follows
Ceiling on pro
fits
as per
centage of sales
turnover
Type of Unit
1. Large units with sales turnover exceeding Rs. 6 crores per annum and
(a) having
no basic drug manufacturing activity nor any reseacrch activity
6
(b) having basic drug manufacturing activity corresponding to 5% or more of sales turnover, but no research
activity.................................................................................
.
.
7
(c) having basic drug manufacturing aoiv'ty at 5 °/9 or more of the sales turnover and engaged in approved research
and development work relating to new drug
8
I
2. Medium size uivts with sales turnover between Rs. 1 crore to 6 crores per annum and;
(a) having no basic drug manufacturing activity nor any research activity
7
(b) having basic drug manufacturing activity corresponding to 5 */9 (or more) of the sales turnover but no research
activity
..................
9
(c) hiving basic drug manufacturing activity at 5 % or more of sales turnover, and engaged in approved research and
development work relating to new drugs
11
3. Unit with sales less than Rs. 1 crore per annum
1—M of Pet. & Chem./75—23
-
■
10
1
1
J
184
When the sales turnover of a medium size unit exceeds Rs. 6 crores per annum, jt would shift out of the class
and the ceiling on profit would be reduced to the levels applicable to large units indicated above. In order that a
medium size unit having a ceiling at 7%, 9% or 11% as recommended above may not suffer adversely, we would re
commend marginal adjustments. Accordingly, when such units shift out of the class, the rule of ceiling on profit re
commended for large units should be so applied that the profit left with these units would be not Jess than Rs. 42
lakhs, Rs. 54 lakhs or Rs. 66 lakhs as may be appropriate. Similarly, when a small size unit shifts into medium size,
a marginal adjustment should be allowed, so that the ceiling rule would operate when profit exceeds Rs. 10 lakhs.
The above oercentages were suggested on slab basis taking into consideration the size of the units and also
turnover in September, 1972. In the light of the subsequent changes that have taken place since then in the economy
due to oil crisis and unbridled increase in the cost of inputs and the increase in bank rates etc., it is suggested that the
percentage of 6-11 % may be amended to 8-13% by adding 2% to each of the percentages suggested against the cate
gory of each activity listed under the large, medium and small groups. In order to ensure that the profitability ceilings
as above, do not work to the disadvantage of manufacturing units particularly those in the Indian sector, the Commi
ttee would further suggest that as an alternative critcrian the ceiling on profitability may also be specified in terms of
the rate of return, after taxes on equity i.e. paid-up capital and reserves. Depending on the type of unit, this ceiling,
in present circumstances, may be kept between 10 to 12.5 per cent post-tax on net worth.
In para 21, the general profitability of the industry was discussed. It may be observed therefrom that the
industry on an average was making a profit of 15% on the net worth alter taxes. It was also stated that the decline
in profitability would have been more pronounced in 1973-74 and 1974-75. In order to promote a healthy growth
of the industry, it has been suggested that the rate of return permissible may be between 10 and 12|% post tax on
net worth. In view of the flexibility allowed in adjusting the price structure of the products in line with those of market
leaders, the range of products that come under direct price control, will be limited, and the manufacturer will therefore,
have much more freedom to adjust the prices of other products according to market conditions. In some cases, the
manufacturers may even be in a position to earn profits in excess of the ceilings suggested above. There should,
therefore, be a nrovision, as at present, for funding the excess profits and these should be utilised for the purposes
to be specified by the Central Government. However, the provision for ajdjusting the funded amount in the future
profits or losses should be deleted as suggested by the Working Group.
41. The above suggestion, it needs to be emphasised, would involve a radical departure from the existing system
of price regulation in this industry. Instead of the present comprehensive control on all products of each firm above
certain size, the proposed system will be a much more selective and will be confined to the determination of fair prices
in respect of important pharmaceutical product groups. Even in respect of these products, the basis for determina
tion of fair prices would be an investigation in the costs of production of two or three leading manufacturers which
between them, account for say 60 % or more of the total sales of that product. Similarly, the basis of price determina
tion will also undergo a change. According to the Drugs (Price Control) Order, 1970, retail prices of products are
based on a calculation of material costs, conversion costs and packing costs. In addition to these costs, a mark
up to a maximum of 75 % on essential drugs and 150% on others is allowed.
The quantum of the mark-up
has varied even more widely for reasons explained in para 19. Under the new system, fixation of ceiling prices tor
leader products will be on the basis of a more detailed cost examination. There will be no mark-up on costs but all
costs including legitimate selling expenses, trade commission, freight etc. will be taken into account. In addition,
a return on sales on the lines suggested in para 40 will be permitted in arriving at the fair retail selling price, i nis
price, as pointed out earlier, will be in the nature of a ceiling and all producers will be free to change their prices
without prior approval of Government provided the retail price does not exceed the ceiling notified for that product.
Such an approach to the fixation of prices will enable the price fixing authority to examine carefully the cost elements
and also judge whether or not it is possible to reduce some elements of costs such as fancy packaging or exhorbitant
expenditure on sales promotion. Such a uniform approach to the price fixation of major phramaceutical groups
would also remove the disincentives for the production of essential drugs which have sometimes arisen in the past
because mark-up on essential drugs was kept at a very low level. In additionl to the control of prices, the systeni will
also have an overall limit in terms of profitability as pointed out in para 40. The Committee feels that the above
proposals would be fair to the consumer and at the same time provide adequate incentive to the industry to minimise
costs and increase production.
42. The preceding discussion has been specifically in the context of appropriate price regulation for this indus
try.
try. Given the characteristics of the industry, however, the Committee firmly believes that in order to achieve na lona
objectives and orotect the consumer, price control, by itself, is not enough. What is needed is a multi-pronged appro
ach. In order to ensure that the drug and pharmaceutical industry acquires adequate social content, the extension
of the public sector, so that it acquires a dominant role in this industry is very important. In addition, now^er, tne
Committee feels that it is essential to evolve an effective and continuing system of monitoring, in respect oi this in
dustry, if social objectives are to be achieved. For instance, it is not merely enough to fix what are deemed to be lair
and reasonable nrices and revise them as and when manufacturers approach Government for an uPw,ar^.r?v^sl0I}t7_
prices on account of escalation in costs. In this way, prices tend to be revised only in the upward directton. It is
185
equally necessary for Government to have a suitable organisation which would be in a position to take suo-moto action
to bring about a reduction in prices whenever circumstances so warrant. As a result of improved technology or larger
scale of production or because of lower input prices, production costs of drugs and pharmaceuticals go down; and
in all such cases, the consumer should benefit in the form of reduced prices.
43. The main objective is to make essential drugs and pharmaceuticals available to an increasing number of
people at prices which they can afford. This objective cannot be secured merely by price regulation or even by
giving the public sector a more dominant role. What should cause concern is not merely the high prices but even
more importantly high costs. The drug industry in this country, like many other industries, suffers from a high cost
structure which is attributable to several reasons. In some cases, the teachnology is poor or obsolete. In others,
the scale of output is too small to be economically viable. Some of the essential materials which go into the production
of drugs and pharmaceuticals are available at twice or thrice the prices prevailing abroad. High rate of duties inclu
ding heavy customs duty on items which are not planned to be produced in the country in the near future also have
contributed to the high cost structure.
44. The Committee understands that the Bureau of Industrial Costs and Prices to which the work relating to
the revision of prices under the Drugs (Prices Control) Order was transferred since January, 1974, is presently engaged
in evolving a computer programme which will maintain complete and up-to-date information on raw’ material and
packaging costs; and which will also enable Government to build up, on a continuing basis, a detailed profile of the
activities of all large units and of the industry as a whole. We recommend that high priority should be given to the
building up of such an information/monitoring system. The primary purpose of the information system should be
to provide, on a continuing basis and with minimum time lags, all the relevant information regarding production and
stocks, costs, sales, profitability, raw material availability and the emerging shortages etc. This type of information
will enable Government to act effectively and quickly. For this purpose the Committee feels chat it would be desirable
to have in Government a Central Co-ordinating Committee at an appropriately high level which will keep under
review the trends and developments in this industry. This aspect has been dealt with in details in the chapter dealing
with National Drug Authority (Chapter IV).
Summary of Recommendations
1. It has been common experience all over the world that in most countries a large number of small firms which
tre locally owned account for roughly about 20% of the total sales of drugs and pharmaceuticals. The remainder
of the market is controlled by mostly multi-national units which are much larger in size and resources.
(Chapter-Vlll. Para 3)
2. An important characteristic of this industry is a quick product change or product adaptation technique which
is only partly based on proven improvements in the effectiveness of production combinations. In large part, the pro
duct adaptation/innovation is essentially a marketing technique with a view to retaining or augmenting one’s share
of the market for a particular pharmacopoeial product group. Such a marketing technique, of course, necessarily
involves substantial selling costs which in turn have to be added to the cost of the drug. In advanced industrial coun
tries, the pharmaceutical industry also spends substantial amounts—around 10% of total turnover—on drug research
and product development. But these expenditures are relatively less significant in developig countries, including India,
and by and large, the multi-national corporations use their research outlays in the parent company to introduce
new drugs/formulations by their subsidiaries in developing countries. The use of branch names as opposed to generic
names also enables the industry to sell essentially similar drug formulations at widely varying prices. Quite often,
it is difficult for the doctor and almost impossible for the patient to have, at their disposal, information which would
enable them to compare prices of drugt which are virtually identical. Advertisements rarely mentioned prices and,
in general, the medical representatives canvass the superiority of their particular brands of medicines with the doctor
not on grounds of prices but on other grounds such as therapeutic effectiveness or advantages of the new or improved
drug. In short, the success of the larger units in the modern pharmaceutical industry is dependent mainly on their
ability to develop new products based on research and to create and sustain a demand for their product; and this is
done by effective selling techniques and by product adaptation/innovation with a view to help the effective marketing.
(Chapter-Vlll. Para 3)
3. There is some evidence to suggest that while the growth of the pharmaceutical industry over th e last 15 years
has been quite impressive in terms of growth of output, it has been less so, if one takes into account the product com
position and the pricing policies of the industry.
(Chapter-Vlll. Para 4)
4. The per capita consumption of modern medicine in India is currently estimated to be Rs. 6 per year and accor
ding to some estimates, it would appear probably below Rs. 30 per family where the family income is Rs. 4200
per year. The Committee feels that the main objective of policy has to be to secure a better convergence of commer
cial considerations and social needs and priorities. The emphasis has to be on increasing the social utility of the
industry’ particularly in the context of extreme poverty and the urgent need for extending as rapidly as possible certain
minimum facilities in terms of preventive and curative medicines to the large mass of people both urban and rural.
(Chapter-Vlll. Para 5)
5. While the operation of price control so far has certainly helped in preventing the emergence of very large
or excessive profits by the drug and pharmaceutical industry, it does not appear to have contributed materially to the
emergence of a product or price pattern which is more in consonance with social needs or national objectives.
(Chapter-Vlll. Para 22)
6. An important element of cost which needs particular attention is the cost of packing. In some of the prepa
rations like eye-drops, eye ointments, Transfusion solutions, sterile preparations, the cost of packing material could
be much higher than the ingredients used because it is necessary to keep the ingredients free from even a trace of im
purity. The Committee feels that greater attention should be paid, than at present, to standardization and economy
in the use of packing materials consistent with the protection of consumers’ interest.
(Chapter-Vlll. Para 23)
7. It would be desirable to keep under continuous review the modes of packing and the materials used for packing
purposes with a view to evolving appropriate packing standards, rationalising material usages and ensuring that com
petitive packing is not resorted to as a sales promotion measure.
(Chapter-Vlll. Para 23)
186
187
8. The administrative regulation and licensing should be geared to ensure that greater emphasis is laid on the
production of the 117 essential medicines identified by the Committee. In this area, the policy objective should be
to ensure that prices are fair and reasonable to the producer and to the consumer. But this will need to be supple
mented by appropriate administrative action to strengthen the production base by ensuring adequate supplies of mate
rials, both domestic and imported, and adequate arrangements to ensure that extraneous factors such as shortage of
power, allotment of materials such as alcohol etc. do not intefere unduly wdth production.
(Chapter-Vlll. Para 28)
9. If these are accepted as the primary objectives of the regulatory framework, it seems necessary’ to have a
certain shift of emphasis in regard to the existing regulatory arrnagements including the present basis of price control.
Firstly, in order to encourage the production of bulk drugs which are currently imported in significant quantities, it
would be necessary to list out items which can and should be produced within the country in a specified period’of
time. Having identified these items, all necessary assistance should be provided to enable the industry to produce
them. To the extent that the public sector and/or the wholly owned Indian units are able and willing to produce these
bulk drugs, they should receive preference. If, however, for any reason, production plans of these units do not mate
rialise, other units in the industry including those with foreign equity may be permitted to set up production capacity.
As long as the country is dependent on net imports of a basic drug, the existing unit or a new unit may be free to de
termine the selling price provided it is not higher than the selling prices of STC which are based on average landed
costs of imports and handling and other charges.
(Chapter-Vlll. Para 27)
10. In the case of bulk drugs in which production is already established and in which imports are no longer nece
ssary, greater attention should be paid to ensure that the cost of production is kept to the minimum. It would also be
desirable to exempt from Price Control items in which there are no imports and which in terms of total sales of the
basic drug do not exceed Rs. 25 lakhs annually.
(Chapter-Vlll. Para. 30)
11. In respect of other bulk drugs, a system of price regulation based on detailed cost investigation should con
tinue, subject, however, to the price being so fixed that an efficient manufacturer is able to get a return on his capital
employed which is a little higher than is available on formulations for the industry' as a whole.
(Chapter-Vlll. Para. 30)
12. The Committee after taking into consideration the question of the rate of return on investment required for
production of bulk drugs, made by the Tariff Commission and also the Working Group headed by Shri N.N. Wanchoo
recommends that a return post-tax between 12 to 14% on equity i.e. paid up capital plus reserves may be
adopted as the basis for price fixation, depending on the importance and complexity of the bulk drug. For the pur
pose of determining the rate of return, on this basis, taxation should be calculated on the basis of statutory rate of tax.
Otherwise, the benefits of any specific corporate tax concessions will be denied to the units in the industry.
(Chapter-Vlll. Para 31)
13. The Committee has come to the conclusion that more selectivity in the system of price regulation with a
view to ensuring fair prices in respect of drugs and formulations would be desirable rather than on all drugs and for
mulations irrespective of their importance. As a first step, Committee recommends that the formulations based
on 13 drugs, as identified by the Committee for the purpose of generic name usage should be free from price
Regulation.
(Chapter-VI11. Para 34)
14. In the case of other formulations, selectivity could be (a) in terms of size of the units (b) in terms of selection
of items ard (c) in terms of controlling the prices only of market leaders, in particular products, for which price control
is contemplated. The Committee considers:—
(i) Units having annual turnover of less than Rs. 1 crore, may be exempted from the purview of Price Regu
lation. This however should not be applicable in respect of the units which come under the purview of
MRTP Act.
(ii) Alternatively all formulations, other than those marketed under generic names which have an annual all
India sale in excess of Rs. 15 lakhs (including excise duty) should be within the ambit of price regulation,
whether or not the total annual turnover of the unit is in excess of Rs. 1 crore. If necessary, Government
may in exceptional cases decide to add any particular product to the list of price controlled items in public
interest.
The ceiling price will be determined taking into account the production costs and a reasonable
return for the units which are the market leaders.
188
(iii) Another variant of selectivity, which could also be considered would be to identify product groups which
individually are important and which collectively constitute the bulk of the out-put of the drugs and pharmaceu’icals industry. In respect of each item on this list, it would be possible to identify the leading pro
ducers who, between them, account for, say, 60% of the sales. On the basis of the cost analysis in respect
of those units, maximum prices may be prescribed and all other units may be free to fix their prices. On
balance the Committee is of the view'that this particular variant of selectivity may be administratively
simpler.
(Chapter-Vlll. Paras 35 to 38)
15. The Committee feels that the recommendation of the Working Group on Drugs and Pharmaceuticals under
the Chairmanship of Shri N.N. Wanchoo, on forumulation activity, under the altcrnath-e scheme of pricing, may be
adopted with the revised rates of ceiling on profits, as 8% to 13% on sales turnover, by adding 2% to 6 to 11%,
to cover the recent increase in the cost of inputs, bank rates etc. following the category of firms having the activities
listed under the large, medium and small groups. Marginal adjustments would need to be made when an unit shifts
from one class to another. In order to ensure that the profitability ceilings as above do not work to the disadvantage
of manufacturing units, particularly the Indian Sector, she Committee would further suggest that, as an alternative cri
terion, the ceiling of profit may also be specified as between 10 to 12.5% , post tax, on net worth i.e. paid up capital
and reserves.
(Chapter-VIll. Para 40)
16. In view of the flexibility allowed in adjusting the price structure of the products in line with those of marke,
leaders, the range of products that come under direct price control, will be limited, and the manufacturer will therefore
have much more freedom to adjust the prices of other products according to market conditions. In some cases, the
manufacturers may even be in a position to earn profits in excess of the ceilings suggested above. There should,
therefore, be a provision, as at present, for funding the excess profits and these should be utilised for the purposes to
be specified by the Government. However, the provision for adjusting the funded amount in the future profits o
losses should be deleted as suggested by the Working Group.
(Chater-Vlll. Para 40)
17. Instead of the present comprehensive control on all products ot each firm above certain size, the proposed
wstem will be a much more selective and will be confined to the determination of fair prices in respect oi important
nharmac-utical product groups. Even in respect of these products, the basis for determination ot fair prices would
he an investigation in the costs of production of two or three leading manufacturers which between them, account for
sav 60o/ or more of the total sales of that product. Under the new system, fixation of ceiling prices for leader product
will be on the basis of a more detailed cost examination. There will be no mark-up on costs but all costs including legitimate selling exnenses, trade Commission, freight etc. will be taken to into account. In addition, a return on sales
on the lines“su^ested in para 40 will be permitted in arriving at the fair retail selling price. This price, as pointed
out earlier, will be in the nature of a ceiling and all producers will be free to change their prices without prior approval
of Government provided the retail price does not exceed the ceiling notified for that product.
(Chapter-VIII. Para 41)
18. In order to ensure that the Drug and Pharmaceutical Industry acquires adequate social content, the extension
of the public sector to acquire a dominant role in this industry is very important. . In addition, however, the Commi
ttee feels that it is essential to evolve an effective and continuing^system of monitoring in respect of this industry if
social objectives are to be achieved.
(Chapter-VIII. Para 42)
19 The Committee recommends that high priority should be given to the building up of an information, monitor-
This type of information will enable Government to act effectively and quickly.
(Chapter-VIII. Para 44)
})
CHAPTER IX
QUALITY CONTROL OF DRUGS
The Committee on Drags and Pharmaceuticals Industry was constituted by the Ministry of Petroleum and Che
micals by their Resolution dated the Sth February, 1974 to examine various aspects of the drag industry. One of the
terms of reference was also to recommended measures for effective quality control drugs and rendering assistance to
the small scale units in this regard. While the work of the Committee was in progress, certain unfortunate and tragic
incidents connected with the quality of drugs took place in the country which created a sense of urgency on the part
of the Committee to look into the specific terms of reference. The Minister for Health was also concerned over this
unfortunate incident. He had discussions with the Chairman and requested him to go into the problem on a priority
basis. He also wrote a letter dated the 30th April. 1974 to the Minister for Petroleum and Chemicals to that effect.
The Ministry of P&C desired that the Committee should examine this problem thoroughly and submit an interim
report. Accordingly, the Committee which had already discussed this subject on the 29th March, 1974, met on 2nd
of May, 1974 and appointed a Sub-Committee consisting of:—
J
1. Dr. Ranen Sen, M.P.
2. Dr. M. L. Dhar, Director, Central Drug Research Institute, Lucknow.
3. Shri M. K. Rangnekar, Commissioner, Food & Drag Administration, Maharashtra, Bombay.
4. Dr. B .B. Gaitonde, Director, Haffkine Institute, Bombay.
5. Dr. B. V. Ranga Rao, Jawaharlal Nehru Universit}’, New Delhi.
6. Shri P. S. Ramachandran, Drug Controller (India)—Convener.
2. The Sub-Committee held two meetings on the 14th and 15th May, 1974. The Report of the Sub-Committee
as approved by the Committee on Drugs and Pharmaceuticals Industry, is appended (Appendix A). This was sub
mitted to Government on 25th May, 1974 as an interim report.
3. We cannot conclude without expressing our warm appreciation for the full cooperation and assistance the
Committee has received from the Directorate of Drug Control. Ministry of Health and Family Planning, Government
of India and from Mr. P. S. Ramachandran and Mr. M. K. Rangnekar. The Directorate made available to the Com
mittee all the previous reports, literature and important information. But for this valuable assistance, the Committee's
task would have been difficult, especially when the Committee had to submit its interim report within a short time,
looking to the urgency of the problem.
4. We sincerely hope that the Government will give due consideration to our recommendations made in this
interim report and will take immediate steps to implement them so that the quality of drugs may be improved, stan
dard-quality drugs may be made available to the community and the menance of sub-standard and spurious drags
may be combated effectively.
(This was submitted on 25th May, 1974 as an interim report)
3
APPENDIX A
CH/XPTER IX
Report
The Sub-committee on Quality Control of Drugs and Related Matter (as approved by the
Committee on Drugs and Pharmaceuticals Industry)
Term of Reference:
To recommend measures for effective quality control of drugs and for rendering assistance to the small scale
units in this regard.
This term of reference, in the opinion of the Committee, is the most vital for consideration at present. Deve
lopment of the drug industry, the patronage that is extended to it by the medical profession and the recognition thatother countries give to the quality of drugs made in India are dependant on the image of the drug industry that is
projected to the consumers of drugs in this country and abroad. The drug industry has undoubtedly made pheno
menal progress over the last 25 years during which period its turnover has risen from Rs. 10 crores to Rs. 350 crores.
However, while quality control measures are being enforced fairly rigidly by certain States, enforcement of these mea
sures in many States is not satisfactory. This must, in our view affect the tempo of progress by the industry and what
is more, the progress made in this important field by some States would be nullified. While the development of the
industry in certain States has been carefully nurtured by experts who are fully competent to handle problems of drug
manufacture and testing, other States have adopted the attitude that mere increase in the number of drug manufactur
ing units constitutes development of the industry. It is noteworthy that in the States where drug control is fairly
rigid, the industry has received a great impetus and the products manufetured in those States command good support
from’ the medical profession and consumers. On the other hand, in the States in which drug control has been lax,
there has not been sufficient appreciation of the educative and developmental aspects of the drugs industry. Drug
control, we would wish to reiterate, is not merely enforcement of the quality control measures but is intimately connected
with the development of the ethical sector of the drug industry. Haphazared multiplication of drug units only,
benefit, the unscrupulous elements who are inclined to get-rich-quick rather than help developing a real industry.
Associated malpractices, such as unauthorised sale of raw materials, cannot be ignored. An aspect which is parti
cularly deplorable is the tendency on the part of many States to extent special concessions to firms located in their
States in making purchases of drugs without regard to the quality control measures observed by tendering firms.
Such a course of action is .obviously ill-advised and it is likely to endanger the health of the people.
2. The overall aim of the drug control organisation in the country should be to infuse a sense of confidence in the
quality of drugs that are manufactured by firms, notwithstanding the size of operations of the unit. Today, a section
of the industry feels that medical practitioners are not inclined to encourage products of firms which are wholly Indian
in structure. This attitude of the medical profession is understandable as the interests of patients are of paramount
importance to it and as its aim is to cure the patients quickly by administering those drugs in whose quality the pro
fession has confidence. It is the responsibility of the drug control administration, both at the Central and State
levels, to ensure that the quality of drugs manufactured by all firms is uniformally satisfactory. In the case of drugs,
a little latitude shown to a manufacturer may spell all the difference between life and death. Unless concerted efforts
are made by the Centre and the State Governments to improve the standards of inspection, licensing of drug firms and
the weeding out of firms which are technically or otherwise incompetent to manufacture drugs, the medical profession
cannot be expected to have full confidence in the quality of all the drugs that are available in the country.
3. Quality control of drugs assumes considerable importance when we have to compare the same drug made by
different manufacturers. Some units in the industry have a built-in system for quality control right from the raw
materials to the finished stage and also the requisite organisation to frequently the stability of the drug when it moves
in the market and for recalling any drug from the market from different parts of the country whenever neces
sary. Others, however, lack these essential facilities without any built in quality control and without any regard to
the keeping quality of the drug. The difference is obvious. It is not enough if a drug complies with the standards
when it is made but it is equally important that its potency is guaranteed when it is consumed in any part of the
country and under various climatic conditions. Such a quality control check can be enforced only if the officer in
overall charge of the organisation and the Drugs Inspectors have the necessary background knowledge and are pro
perly trained. Frequent inspections of manufacturing establishments and stability studies of products and enforcing
stringent precautions at the first and subsequent inspections must constitute the most important duties of such officers.
190
v
♦
191
f
,
4. The technique of manufacturing drugs is becoming more and more highly specialised and complex and newer
techniques in manufacture and testing of drugs are being introduced continuously. Organised manufacture of drugs
of high potency has greatly increased the social responsibility of the Drug Control Organisation and compels it to
exercise rigid control over the practices of drug manufacturers and also act as an adviser to the industry to strive for
constant improvement of its performance. All these need an expert in the field of drugs and the responsibility cannot
be assigned to personnel whose competence in this complex field is questionable.
Scope of the Drugs and Cosmetics Act
5. “Drugs Control” is a social measure intended to ensure that the community at large obtains drug of standard
quality. With this object in view the Drugs Act was enacted in 1940, the Rules under it were framed in 1945 and en
forcement of the legislation was started in 1947. The Act regulates the import into and manufacture, distribution and
sale of drugs in the country.
Control Mechanism and Division of Responsibility :
6. Central :
Under this Act, the Central Drugs Standard Control Organisation, headed by the Drugs Controller (India),
is responsible for :
(i) Controlling the quality of imported drugs, and drugs moving in inter-State Commerce;
(ii) Co-ordinating the activities of the States advising them on matters relating to the uniform administration o f
the Act in the country.
(iii) Laying down regulatory measures and standards of drugs, and
(iv) Granting approval to ‘New Drugs’ proposed to be imported into or manufactured in the country.
7. States :
The State Drug Control authorities are responsible for controlling the quality of drugs manufactured, sold or
distributed in the country. This control is exercised through a system of licensing of manufacturing and sale premises
through Drugs Inspectors.
8. Drugs Control Organisation in the States :
Although the Drugs and Cosmetics Act has been in force for nearly 26 years, the level of enforcement in most
of the States is far from satisfactory. The main reasons for this unsatisfactory state are the varying standards of ins
pection and licensing of drugs firms and the lack of qualified officers in most of the States to supervise drug control
operations. With a view to identifying the short comings in the Drugs Control Administration on an all-Tndia basis,
three Committees studied all aspects of enforcement of Drug Control in the States and recommended the nature of
re-organisation that was necessary. The salient features of their recommendations were that for the Drugs Control
Organisation to be effective the following pre-requisites are necessary (a) a full-time Drugs Controller with necessary
qualifications and experience (b) adequate number of duly qualified Inspectors on attractive pay scales, (c) a fulfledged testing laboratory for testing all categories of drugs, (d) a legal-cum-Intelligence Cell for carrying on a campaign
against spurious drugs and for processing legal cases, and (e) a machinery for maintaining “public Relations”
which is vital in a field like drugs.
9. This Committee agrees that the Drug Control Organisation should be streamlined in the manner set out above.
The position that obtains today in the various States is set out below together with our recommendations.
A full time Drugs Controller with necessary qualifications and experience :
At present the States of Maharashtra, Karnataka, Gujarat and Kerala have a full-time State Drugs Controller
with necessary qualifications and experience in the field of drug manufacture and drug testing. West Bengal has a
whole-time Officer but this officer belongs to Provincial Medical Service Cadre.
The Director of Medical or Health Services is incharge of the Drugs Control Organisations in Andhra Pradesh
Assam, Bihar, Haryana, Madhya Pradesh, Orissa, Punjab, Rajasthan, Tamil Nadu, Uttar Pradesh, Himachal Pradesh
and the Union Territories of Delhi, Chandigarh, Pondicherry. In some of the States he is assisted by an Assistant
Drugs Contr oiler who is a full-time Officer.
Recommendations:
10. The officer in over-all charge of Drug Control in a State constitutes the king-pin of the Organisation. He
should be responsible not only for enforcing the quality control measures over drugs but also for the development
of the drug industry, having regard to the raw materials and natural resources available in the country. Lack of
adequate technical knowledge on the part of the top officer will result in ill-equipped and ill-organised firms being
1—M of Pet. & Chenu/75—25
\
192
licenced to manufacture drugs. The check that is experienced over the first licensing or the renewal of licences deter
mines the quality of products that are turned out by rhe firm though frequent inspections of the manufacturing firms
are also necessary to ensure that the quality control discipline is ingrained in all the personnel working in the firms.
Considering these aspects, the need for laying down the qualifications for the ‘Licensing Authority' needs no emphasis.
We understand that the Drugs Technical Advisory Board, constituted under the Drugs and Cosmetics Act, had
recommended that the qualifications of the licensing authority in each State should be laid down in the Drugs and
Cosmetics Rules and if necessary an enabling provision should be introduced in the Drugs and Cosmetics Act for
this purpose. The qualifications should be the same as that required for Drugs Inspector under the Drugs and Cos
metics Rules, the idea being that experienced Inspector should be made eligible for appointment as the Drugs Control
Authority. The overall authority in the State should also be the ‘Controlling Authority tor Drugs Inspectors and.
no Drugs Inspector should be permitted to institute a prosecution without the express order in writing from the ‘Con
trolling Authority'.
11. Apart from laying down the qualifications for the Licensing Authority, it is felt that in licensing firms, the
Licensing Authority should be guided by a small technical committee which among others should include a senior
officer from the Central Drugs Control Organisation. Indeed, the Committee would go a step further and recom
mend that licensing of drug manufacturers in each state should be decided by a Board. This licensing Board should
consist of (i) Drug Control Authorities of the State concerned; (ii) Drug Control authorities of the State in the region;
(iii) a senior representative of Drugs Control Authority of India; and (iv) if possible, one of the Drug Control Autho
rity from Maharashtra, Gujarai or Karnataka. This procedure of screening applicants for manufacturing licences
would greatly help in weeding out firms which are incompetent or ill-equipped to manufacture drugs and also obviate
inter-state complaints. This Committee recommends that the Drugs and Consmetics Rules should be suitably
amended for this purpose. The Committee also feels that manufacturers of injectibles including glucose solutions,
anti-biotics etc. (Schedule C items) should not be licensed to manufacture unless they have their own arrangements
for testing them. The present provision which permits such firms to get their finished products tested by a private
laboratory lends scope for abuse and should be amended in the manner recommended by us. Other items—non
schedule C items may, for the present, be permitted to be got tested by manufacturers through commercial labora
tories, even though, in our opinion this provision should also be withdrawn when the restrictions on imports of an
alytical equipment get eased. Such commercial laboratories should be required to maintain efficient standards with
regard to technical staff, equipment and environments and should be approved by the Drug Control Organisation at
the Centre.
12. Last and this aspect in the opinion of the Committee is of vital importance—the Drug Control Organisa
tion should be divorced from the Directorate of Medical and/or Health Services and constituted into a separate depart
ment functioning directly under the control of the Ministry/Department of Health. Such a realignment of the Drug
Control Organisation will be conducive to greater coordination between the Government and the Drug Control
Organisation, eliminate delays that are inevitable in an arrangement where the Drugs Controller functions under
someone else’s control and help in answering the criticism that the power to license drug manufacturing firms is
vested in the authority that also purchases drugs.
Adequate number of duly qualified Inspectors on attractive pay scales
13. Earlier, the Committee on Drugs Control, which was appointed by the Government to study the existing
conditions of drug control organisation in the States and make recommendations for making the control measures
more effective had recommended that there should be one Inspector for 200 selling premises. According to his
recommendation, the minimum number of Inspectors that the States Drugs Control Organisations should have is
about 480, against which the actual number of Drugs Inspectors in the States is 369. The States of Gujarat, Kerala
Maharashtra and Tamil Nadu have now the full complement of Drugs Inspectors. However, more appointment of
Drugs Inspectors without concomitant efforts to bring their technical knowledge up-to-date will not help in toning
up quality control measures. “Drugs” is a field where innovations in the techniques of manufacture and testing
drugs are a daily feature and if the inspectors are not conversant with them they will cease to command the respect
of the industry which engages top-grade technical personnel. A programme for training Insp motors,'it is learnt, has
been organised by the Central Drugs Control Organisation though many States have not availed themselves of this
facility.
Recommendations:
14. The States which do not have an adequate number of Drugs Inspectors, as per the scale recommended by
the Committee on Drug Control should be helped to expand their Drugs Inspectorate. The Salary scale offered to
Drugs Inspectors should be reasonable and sufficient to attract good talents to the profession. This is particularly
necessary as the industry is prepared to pay very attractive salaries to technically competent personnel. In our opinion
each State should have at least one Chief Inspector on a salary scale of Rs. 1100-1600 who should be well-conversant
with the manufacture of antibiotics preparations, injectibles including transfussion solutions, sera, vaccines etc.
This officer should carry out the inspection of firms which apply for the manufacture of these drugs. We also
193
strongly recommend that an Inspector from the Central Government should also be associated with the first inspection
of firms. It is at the time of granting first licence for manufacture that utmost care should be exercised by the Drugs
Control Authority. Once the manufacturing licence is granted, it would be difficult to make the manufacturer im
prove his quality control measures to the extent that is desirable. No Inspector should be posted by a State Govern
ment unless he has been trained. The training facilities for Inspectors should be augmented by the Central Govern
ment and the Committee recommend that for the benefit of the States in the northern and eastern regions, a second
training course should be organised in Calcutta.
A Full-fledged testing laboratory for testing of all categories of drugs
15. At present, onlv three States namely Maharashtra, Gujarat and Tamil tfadu have facilities for testing ail
categories of druzs. Other States have limited facilities for testing of non-biological drugs, while some States and
Union Territories' have no testing facilities at all. The position in respect of various States is set out below
I. States having facilities for testing all categories of drugs :
1. Maharashtra
2. Gujarat
3. Tamil Nadu
II. States having facilities for testing norMological drugs:
1. Andhra Pradesh
2. Bihar
3. Kerala
4. Madhya Pradesh
5. Punjab
6. Karnataka
7. West Bengal
8. Assam
9. Rajasthan
10. Haryana
11. Uttar Pradesh
12. Jammu & Kashmir
111. States which do not have facilities for~testing many drugs:
1. Orissa
2. Chandigarh
3. Delhi
4. Goa
5. Himachal Pradesh
6. Manipur
7. Pondicherry
8. Tripura
The Centre has three laboratories, namely the Central Drugs Laboratory Calcutta, the Central Indian Phatna1 T
Crh-iziabad and the Central Research Institute, Kasauli for testing samples of drugs. A well
copoeia Labota o y
ub
constructed lo housc the Central Drugs Laboratory and the Ghaziabad
the vfew “anhe Zk-Z in the
tory reports get delayed.
Central Drugs Laboratory. Calcutta has increased to sucn an extent that labora-
194
Recommendations:
16. Mere exhortation to the States advising them to build up testing facilities will not have the desired effect.
The Centre, in our opinion, should assist the States in developing combined food and drugs laboratory by extending
financial assistance to them- A scheme for this purpose, it is understood, has been accepted under the" Fifth Five
year Plan and that the intention is to build eight laboratories during this period. There may be States which may
not have the resources to employ competent persons on adequate salary scales in the laboratory and to meet the re
curring expenditure for running the laboratory. If such States ask for financial aid from the Centre for expending
some of their departments, the Central Government should consider such requests favourably.
17. The Central Government have done well in providing a new building for the Central Drugs Laboratory
Tne Laboratory at Ghaziabad, in our opinion, will be pre-occupied with Pharmaceutical and National Formulary
work. The Centre should have three more regional laboratories one in the South, one in the East and one in the
West. In addition, to this, a laboratory for testing sera, vaccines and immunological products should also be set
up by the Centre. A scheme for the establishment of a Central Biological Standardisation Laboratory, it is under
stood, is being examined. This scheme should be given high priority during the Fifth Five Year Plan/
Legal-cum-Intelligence Cell for carrying on campaign against spurious drugs and for processing legal cases.
18. The State Governments of Maharashtra, Karnataka, Gujarat and West Bengal have a ‘Legal-cum-Intelli
gence Cell’ for carrying on the campaign against spurious drugs and for processing legal cases. Other States have
not so far created such ‘Cells’.
Recommendations:
19. The States should constitute a legal-cum-intelligence Cell for carrying on the campaign against snurioiis
drugs. Our recommendations setting forth the manner in which the compaign against spurious dru-s should he
organised are given separately. The Central Government should assist the States in organising this comnaion hv
extending financial assistance to them.
F
y
20. There is need for maintaining close contact with the medical profession, consumer croups etc Unless
this contact is established, the public may not be aware of the governmental efforts that are being made in this directions.
Most of the States are remiss in this direction,
commendable strides in this connection.
Recommendations:
Maharashtra, Gujarat and Karnataka have, however, made
21. Enlistment of the co-operation of the public, the members of the medical profession and other social harliAc
such as Consumer Councils etc. in tightening drug control measures and in combating spurious druss should enonl
the attention oi the Central and State Governments. Today, there is little awareness among the public and the mem
bers of the medical profession about the working of the drug control agencies. While some of the States like MahT
rashtra, Gujarat. Karnataka and others have constituted State Drug Advisory Boards where representatives from
the medical profession, the police department, social workers, the industry and the trade are represented other State?
despite repeated requests, have not been able to constitute such Boards. It is not enough that Dru0, Control Oro■lni,
sations function efficiently in States, The public must also be aware of the functioning of such organisations. °The
Committee would go to the extent of recommending that the constitution of Drug Advisory Boards should be
provided for statutorily in the Drugs and Cosmetics Act so that it becomes mandatory on the part of the deficient
States to constitute such Boards.
Spurious drugs and problems connected with the compaign against them
22. The term "Spurious Drugs” does not specifically occur in the Drugs and Cosmetics Act. IK.,
wrwi the
ll4V
However,
term ‘misbranded drugs’ defined in Section 17, covers what is commonly intended by the term ‘Spurious^Druc^
In brief, spurious drugs would include :—
b’
(a)
(b)
(c)
(d)
A drug whose label shows it to be manufactured by a firm which is non-existent.
A drug which is found to be different from what is claimed on the label.
A drug which is manufactured by a party other than the manufacturer shown on the label.
A drug which is a close colourable imitation of a well established drug or brand of drug and which is likely
to deceive the consumer into the belief that he is buying the established drug or brand of drug.
(e) Defective drugs which are treated in such a manner as to conceal the damage or defects of drugs which arc
are
made to appear of better or greater therapeutic value than they really are (Penicillin adulterated with other
material and labelled as pure penicillin of certain potency is a case in point).
7
195
mAt.wH’ . SU^nduard Dru?s” are those whlch do not conform to the standards laid down in the Drugs and CosminnfaAtC£’ Whl a
manu£acture of spunous drugs is essentially a clandestine operation indulged in by8 unlicensed
bl hw
dea
’ sub'stai.ldard dru8s may be manufactured by licensed manufacturers8 “Spurious drags”
bamed articles d ThPe0D en1’ t
°ther .llleSa> activi.ly> such as counterfeiting of currency or smusglina of
faemrers
gS ,InJ?.ectOr whose prlmary duty ,s t0 educate and assist llonest and ethical drue manutacturers operating against valid licences to improve their quality and performance, is illequinped to tackle the nrobco”e? aSrandUtCt°f ” t
‘hiS ,S
—“-e of spurious dra|s is moXan ulderend If deZ lk whnhn
d2W" r® hlde'°uts.uwhere dru«s are faked- the operations should start from the
'contLl’ of s,7ph HJ 1 SUSp5cted
b.e se,hng or distributing such spurious drags. The activities and the external
the‘leads’
ale oht
kept U?der suurv?,Ianfee throuSh Plain cIotfled watchers or policemen. From
Carried hv the noliorh'dt;’oui ^lere the drug-faking activity is carried on should be traced and raids
hnnph d-th P
or the ^rug
Organisation with the help of the police. Prosecutions may have to be
h r It-’ d maily-cases* simultaneously under the provisions of the Drugs and Cosmetics Act, the Trade Marks Act
t
r nai. C?df; e£C” 30 a? t0 enSHrc that the accused does not escape clutches of a sintrle legislation on technical
hAtna 1 ii In Sh° ’ ?e camPai8.n aga'nst spurious drugs will be effective only if the Drugs Inspectors, apart from
being fully conversant with the ms and outs of drugs manufacture and testing, are also well-acquainted with the
provtsions of other legislations such as the I.P.C., the Evidence Act, the Criminal Procedure Code etc. and also know
p® P J3 *Sf la Posing prosecutions. The secret of success of the campaign against spurious drues lies in the mainin nce of close liaison with the police authorities. This implies that an ‘Intelligence-cum-legal’ unit must operate
in each Mate, ihis organisation should consist of‘watchers’ who would be well-conversant with the drua trade and
us practices. Barring a few States such as Maharashtra, Gujarat and Delhi, other States have not been able to
rganise l. ese ce s to counteract drug fakers. As already stated above, reports of movement of spurious drugs
are more frequent in the State where drug control has been lax. The most disconcerting feature has been the lack of
response on the part of several States to the information given to them about the positive clues relating to spurious
drugs, such as the names of parties dealing with spurious drugs or the areas where they move. The Centre has to
rest content watching this helpless state of affairs and can do very little with out the active support from the States.
The value of maintaining a close liaison with the police officials at high levels has not been appreciated bv most of the
Mates. A few cases of spurious drugs were investigated and proceeded against by the Central Drues Inspectors,
surate^esult^ Proce^uies necessitated icpeated visits to the State by the Central Drugs Inspectors with no conimen-
‘Spurious Drug” problem assessed by Planning Commission’s Task Force
■ f i4’ ll? Task Force on Pru£S and Food Adulteration appointed by the Planning Commission which had gone
into the problem of spurious drugs m great detail recommended that special mobile squads for tracking down spurious
drugs and rood, must be constituted. Each squad was recommended to comprise a Drugs Inspector assisted by suit
able police personnel. The Task Force had further recommended the establishment of 25 squads in the States with
4 squads at the Centre for coordinating the activities of the States mobile squads. As past experience has shown
that Lhe States may not be willing to establish such squads because of financial difficulties, the Task Force had speci
fically recommended that the scheme for setting up those anti-spurious drug squads should be centrally sponsored
scheme with 100% central assistance.
H
OlOWSSSlgi
as otherwise drug-faktng activities may reach alarming proportions and pose a grave danger to the health of the nation’
mole,' the confidence of the medical profession about the drugs which their patients secure will be shattered
and the people at large will also develop a psychological distrust about the quality of medical relief available in the
country. Lastly, our export prospects will suffer a serious set-back if wide-spread reports on the movement of spurious
drugs continue to be published m the newspapers or are discussed in the Central and State legislatures.
inadequate11651'011 alS° needS t0 be considered wIlether the penalties laid down in the Drugs and Cosmetics Act are
Penal provisions of the Drugs and Cosmetics Act whether these are
adequate or not
26 Under the existing provisions of Section 27 of the Drugs and Cosmetics Act, the punishment prescribed for
manufac ure, sale or distribution of certain categories of'Misbranded Drugs’ and ‘Adulterated drugs’and also for
manufacture of sale of drugs without valid licence is imprisonment for a term which shall not be less than one year
but which may extend to 10 years and also liable to fine. The Court may, however, for special reasons to be recoMed
‘n writing, impose a sentence of less than one year. This is the enhanced penalty decided upon by the Parliament
when the Act was last amended m 1964.
?
106
27. During the discussions of the Joint Committee in 1963. The punishments provided in the Act were thorou
ghly discussed. °The Joint Select Committee enhanced the maximum punishment from three years imprisonment to
ten vears The minimum punishment of one year's imprisonment and also the provision that the Court, for any
soccific reasons to be recorded in writing could impose a sentence of imprisonment of less than one year were retained
bv the Committee. Three members of the Joint Committee (Shri H.V. Kamath and Shn R.S. Khandekar and Shri
P.C. Mitra) in two different minutes of dissent had expressed their views that the penal provisions
(I) should be such as life term if not capital sentence, confiscation of property, deprivation of civil rights and
even flogging (views of Shri H.V. Kamath and Shri R.S. Khandekar).
(2) should not give any discretion to the Court to award punishments less than one year as no sympathy should
be shown to person found guilty for misbranding or adulteration of drugs (views of Shri P.C. Mitra).
28. The Joint Committee, however, did not agree to these views of three members.
accepted into to the recommendations of the Joint Select Committee.
The Parliament also had
29. The Joint Committee had also made a new provision in the Drugs and Cosmetics (Amendment) Act of
1964 by which the implements and machinery used in the manufacture of misbranded and adulterated drug, also the
animal’s and vehicles used in carrying these drugs would be liable to confiscation.
30. The Law Commission had aHo recently examined the penal provisions of the Drugs and Cosmetics Act
and have found them adequate. The Commission however recommended that the existing provision in the Drugs
and Cosmetics Act by which the Court may for any special reasons to be recorded in writing impose a sentence of
imprisonment of less than 1 year should be modified’ so that for trifling reasons the court may not give lesser sentence
of imprisonment.
31. Recently, the West Bengal Assembly passed a Bill recommending life imprisonment for persons found guilty
of food and drug oifences. The Courts have, however, been given discretionary powers to award a less severe penalty.
This Committee^ view is that merely amending the Act without streamlining the organisation to track down spurious
drugs will not have the desired effects. It is recommended that a distinction should be made between offences relat
ing w the manufacture and sale of spurious drugs and those offences relating to standards of drugs and that life im
prisonment may be provided for the manufacture, sale stocking or exhibiting any drug which is deemed to be mis
branded under clauses (a), (b), (c), (d). (f) and (g) of Section 17 of any drug that is adulterated under Section 17-B
or for manufacture of a drug without a valid manufacturing licence. Elsewhere, in this report, we have indicated
what amendments, in our opinion, are necessary in the existing Drugs and Cosmetics Act.
32. Summing up what is required is the establishment of an Uintelligence-cum-legal wing’ in each State which
can made use of the local police authorities in the campaign against spurious drugs and also process prosecutions
quickly and efficiently. The constitution of 'State Advisory Committees' which should include representatives from
the medical profession, consumer groups, the industiw and the trade, should be considered so that the type of publicity
measures that are needed to enlist the cooperation and goodwill of the public could be considered. Close liaison
with non-official organisations such as the Citizens' Central Council and Consumer Councils are being maintained
by the Drugs Control Organisation at the Centre and in the States. The main objective behind such liaison is to
create a sense of awareness among the public as to the measures that the man in the street could protect himself
from spurious drugs. A note (Annexure I) setting forth the manner in which the public can cooperate and assist
the Drug Control Organisation in the compaign against spurious drugs is also attached.
The role of the Central Drug Control Organisation
33. The Committee of Economic Secretaries of the Government of India had considered the existing conditions
in drug control in India in a meeting held in January 1970 and it was agreed that quality control of products manu
factured anywhere in India was not solely the responsibility of the State in which the manufacturing unit is located
since the product is sold all over the country. If a unit in one State was allowed to manufacture and market a pro
duct of substandard quality, this would nullify the measures taken by other States. It was essential that the Central
Government should assume responsibility for ensuring statutory enforcement and control over the manufacture of
drugs all over the country and also supervise their whole-sale distribution among the various States. Unfortunately
these decisions have not been given effect to with the vigour that was necessary mainly because of financial and ad
ministrative reasons. Augmentation of the staff and testing facilities in the Central Drugs Standard Control Organi
sation, it must be admitted, has been slow.
34. Considering the overall coordinating role that the Central Drug Control Organisation has to play, this
Committee would recommend that the following steps should be taken immediately to streem line the Central Organi
sation :—
(a) The complement of the Central Drug Inspectors should be augmented to at least 50 immediately and the
Zonal Officers in Madras and Ghaziabad should be senior enough in status to enable them to discuss with
the State Drug Control Authorities and Health Secretaries the problems relating to drug control.
F
197
(b) The facilities of screening ‘New Drugs’ should be reinfordeed by' the inclusion of a medical officer with
postgraduate qualification who should be able to advise on the Conduct of clinical trials with ‘New Drugs’.
(c) The Central Drug Control Organisation is at present depending entirely on the veracity of the toxicity data
on ‘New Drugs’ presented to it by firms, mainly the foreign ones. There are no facilities for counter
checking the toxicity data. Besides, Indian drug manufacturers are now taking an increasing interest in
drug research and it is reasonable to expect that within the next five years there will be many new
drugs developed by this sector of the industry. Carrying o,ut toxicological studies on such new drugs will
be beyond the resources of most of the Indian firms. The Central Government should therefore have a
fully equipped toxicological laboratory for carrying out toxicity as well as teratology studies with new Drugs
in particular. The Committee understands that the Bureau of Industrial Costs and Prices had recommended
the establishment of such a laboratory for the Central Drug Control Organisation and had further
suggested that a cess of 1 % on the tunrover of drug firms should be levied on the drug industry for this
purpose.
(d) The library facilities should be augmented at the Zonal Offices and these facilities should be made available
to drug manufacturers and State Drug Control Authorities.
(e) The facilities for training Drugs Inspectors (two such courses are recommended in Bombay and Calcutta)
and Drug Analysts should be made permanent and whole-time senior officers should be appointed to con
duct them.
(0 The ‘Drug Standard Cell’ for the publication of Pharmacopoeia and National Formulary is seriously
handicapped for want of staff. This deficiency should be rectified immediately, as otherwise the Indian
Pharmacopoeia and the National Formulary cannot be kept up-to-date.
(g) The Central Drug Standard Control Organisation should have its own library of books and journals.
Likewise, the provision for travelling allowance for this organisation, including the Zonal Organisation,
should be adequate. This is necessary as frequent discussions with the State Authorities at high levels
will help improve the tone of Drug Control measures in the country.
(h) The Central Government should have its own 'Publicity Wing’ so that suitable guidance could be given to
the States/general public.
(i)
Four mobile squads equipped with fast transport radio communication, police assistance and plain clothed
watching staff should be attached to the four Zonal Officers to help the States in the campaign against spuious drugs.
J)
Lastly, the Central Drug Control Organisation should be separated from the Directorate General of Health
Services and brought under the direct control of the Ministry of Health, Unless this is done, and the
Centre sets an example, it will be futile to expect the States to create a separate department for drug con
trol administration.
Financial aid to the States
35. Our salient recommendations covering the State Drug Control Organisations include :—
(i) The constitution of a separate drug control department and the appointment of a technically competent
officer to head the State Drug Control Organisation.
(ii) The augmentation of the Drugs Inspectorate in the States and arrangements for keeping their technical
competence upto-date such as provision of journals, pharmacopoeias, technical books etc.
(iii) Assistance to States for providing transport to at least Senior Inspectors.
(iv) The establishment of 25 mobile squads all over the country to tackle spurious food and drugs: and
(v) Financial assistance for the States in establishing a top-grade combined food and drug laboratory at the
State level.
36. A statement showing the present status of the Drug Control Organisation in the States and the manner in
which they should be streamlined if the organisations are to function effectively is attached (Annexure II). A proposal
for extending financial assistance to the States for strengt hening the Drug Control Administration with a view to ena
bling them to tackle the problem of sub-standard and spurious drugs more effectively is also attached (Annexure III).
The scheme aims at extending financial assistance to the States on two counts, namely, (i) for reorganising the Drug
Control Administration by appointment of a full time competnet Drugs Controller with adequate number of quali
fied inspectors and providing transport facilities; (ii) establishing anti-spurious squads with adequate facilities for
quick investigation of the movement of spurious drugs. We have proposed financial assistance only for the additional
staff that would be required to be recruited in the States to bring the Administration to uniform level throughout
the country. The extent to which each state should be assisted has also been indicated.
198
37. Unless the Centre extends financial help for augmentation of the States Inspectorate and for the constitution
of 25 mobile squads, States cannot be expected to make any headway in this direction. The Committee wishes to
point out in this connection that while the States are being assisted financially in a liberal manner by the Centre to
imolemcnt th? Family Planning programme, ‘Drug Control’ has not been accorded even that degree of importance,
although this activity is vital for maintenance of public health. This Committee would also support the recommenda
tion made by the Bureau of Industrial Costs and Prices that a cess of 1% should be levied on the pharmaceutical
industry and that the funds so collected, which are expected to be of the order of Rs. 3.5 crores per annum, should
be utilised primarily for the construction of the Toxicological Laboratory' where ‘New Drugs’ could be got screened
by the Drugs Controller at the Centre. The balance of funds should be utilised for strengthening Drug Control
Administration in the States, as well as for financing approved Research Schemes.
Coordination between the Centre and State Drug Control Organisation
38. Once the State Drug Control Organisation is streamlined in the manner recommended by us, the tone ef
drug control can be expected to improve. The standards of first inspection of manu facturing firms and inspection
at the time of renewal of manufacturing licences must be stringent. The Committee would particularly recommend
to the States that manufacturers of drugs which require special precautions namely the drugs, covered by Schedule
C of the Drugs and Cosmetics Rules should be jointly inspected by Central and State Drugs Inspectors before licences
are granted or renewed. Thereafter, States should draw up priorities for frequent inspection of drug manufacturing
units, and firms which execute orders for goverment departments, and those which manufacture Schedule C drugs,
including ’Blood Banks’, should figure high in the priority list. Inspection of hospital stores and pharmacies through
out the states would not only have a salutary effect on their working but also raise the confidence of the common man
in the quality of drugs made avialable by hospitals.
39. The Centre, in our view, should concentrate its attention on repeated inspections of firms manufacturing
Schedule C drugs and also take for test samples, of life saving drugs on a planned basis. Test reports on drugs which
are not of standard quality should be quickly pursued by the Central Drugs Standards Control Organisation with
the concerned State Drug Control Authorities. Wherever the Central Drug Control Organisation feels that drug
manufacturers who have been licensed are unfit to carry on the manufacture, it should be incombent on the Central
Government to take up with the State Authorities (at a high levd) and get the licences cancelled.
40. The Committee debated at great length on the advisability of the Central Organisation prosecuting firms
located in the States if they are found to be marketing sub-standard drugs. Here again, we feel that such prosecustions if considered necessary should be resorted to by the State Authorities. The Central Organisation, in our op
inion, will find itself hopelessly dependant on the police and prosecution facilities available with the State,
the experience of a few prosecutions launched by the Centre, in some States makes us feel that the Centre should
not waste its efforts in such activities single handed. Needless to say that close liaison between the Central and
State Government Officers at the top level is called for to settle prosecution cases quickly and effectively.
Amendment of the Drugs and Cosmetics Act
41. The Committee has had close look at the existing provisions of the Drugs and Cosmetics Act. The ex
perience gained by the Central and State and State Drug Control Administration over so many years of enforcement
activity makes us recommend that amendments to many sections in the Act are called for. The penal provisions have
been carefully examined, particularly in the context of life-imprisonment for drug, offences that has been provided
by the West Bengal Government in its amendment Act. We are of the opinion that life-imprisonment should be
made applicable only to offences relating to manufacture and sale of misbranded drugs which fall under clauses (a),
(b), (c), (d), (f) and (g) of Section 17, to drugs which are adulterated under Section 17 (B) or for manufacture of drugs
without a valid manufacturing licence. The present proviso to Section 27 (a) which permits the Court to award im
prisonment for a period not less than one year have been amended and imprisonment for a minimum period of five
years has been recommended. A list of the amendments recommended by us is enclosed (Annexur? IV).
42. The Committee considered whether a separate definition for the term ‘Spurious drugs’ should be included
in the Drugs and Cosmetics Act. Section 17 defines misbranded drugs. Section 17 (b) defines adulterated drugs.
Hence the committee feel that it is not necessary to add a separate definition for spurious drugs as the existing
definition covers all aspects of spurious drugs.
Hospital purchases of drugs
43. Government purchases of drugs are made against tender enquiries and from firms which quote the lowest
prices. The quality of drugs manufactured by a firm depends upon the manufacturing facilities and conditions of
manufacture, the competence of the personnel that supervise the production and testing of raw materials and finish
ed products, product development research, the improcess checks and counter checks exercised by the firm, the moni
toring arrangement maintained by the firm for following up the performance of their products when they move in
the marekt and the extent to which they are able to recall a product from the market whenever necessary. These
199
Good Manufacturing Practices cost money and any firm which observes them meticulously cannot be expected to
quote unduly low prices for their drugs. Besides, several States extend special preferences to drugs manufactured
by the firms located in their states, ignoring the status of sucn firms or the nature of the quality control discipline exer
cised by them. We have reasons to believe that in some States firms were allowed to be floated specially for exe
cuting order from hospitals. Such parochial tendencies in matters relating to purchases of drugs are fraught
with dangerous consequences to the health of the people. All these factors tend to make the public believe—and
rightly so in many cases—that the quality of drugs purchased and used by hospitals is poor.
44. While it is the responsibility of Central and State Drug Control Administrations to ensure that all drugs
that move in the market are quality products, this cannot be achieved only by s^ingent inspection and licensing of
firms by the Drug Control authorities. It is possible for firms to produce drugs which, when freshly made, will ans
wer all the pharmacopoeial specifications. But if stability studies on the products were not properly carried out or
if the conditions of manufacture were defective, deficiencies whould manifest themselves in the product sometime
after the drugs afe manufactured. This underscores the need for every manufacturing firm to develop the quality
control discipline and to safeguard the quality of their products.
45. The Committee would therefore recommend that States should have their own centralised arrangement for
purchase of drugs and that manufacturers of drugs who tend for supplies should be screened with reference to the
good manufacturing practices observed by them and controlled as potential suppliers. The procedure followed by
the Maharashtra Government (Annexure V) and the D.G.S. & D. could be usefully adopted by other States.
Deliveries against orders should be phased into convenient instalments so that hospitals are not saddled with large
stocks of drugs or with drugs with limited life-periods. The Drugs should be
subjected to thorough visual exami
nation at the time of receipt in hospitals and whenever there are reasons to suspect their quality, samples should be
got examined. The quality of drugs distributed to patients in hospital is not only dependent on the precautions
that are taken when drugs are purchased but also by the care with which the drugs arc stored, issued and acc minted
for. We attach a note (Annexure VI) setting forth the manner in which Hospital Pharmacy Services should be
organised. While the Committee note with satisfaction that inspection of hospital drug stores in being carried out
in metropolitan centres, such inspections are all the more necessary in smaller towns in the rural areas and public
health centres. The Central and State Drug Control Organisations would do well to concentrate on this aspect.
Likewise, the Drug Control authorities should subject firms which supply the drugs to hospitals to frequent
inspections.
Quality Control and Small-Scale Units
46. The Committee has been specifically asked to examine, vide the terms of reference, as to what assistance
can be rendered to small-scale units in the drug industry for maintenance of quality control measures. We have
given careful thought to this aspect and are of the view that in respect of drugs, where a slight carelessenss on the part
of a manufacturer of a minor defect overlooked by a manufacturing unit might make all the differences between
life and death, there should be no special favour shown to any drug unit in regard to quality control measures, regard
less of the size of the unit. Though statements have been made by certain sectors of the drug industry boasting
that their quality is above questioning, the Committee feels that even well-organised firms have to be eter nally vigi
lant about the quality of their products. The number of products recalled by the drug manufacturers in the U.S.A,
and other advanced countries and the action taken recently against manufacturers of great repats in the U.K. and
U.S-A. lend support to this view, indeed, the practice of recall from the market of drugs whose performance is not
in accordance with the expectations of manufacturers is itself sufficient proof, that despite all the precautions taken
by manufacturers things could go wrong.
47. Most of small scale firms find it difficult to get their drugs tested. Setting up of analytical laboratories
by the units themselves, on a cooperative basis, seems to be one of the solutions. The small scale sector of the indus
try, we understand, is aware of this suggestion but apparently, it has not found favour with the industry. We would
also recommend that the state Governments should place the testing facilities available with their analytical labora
tories at the disposal of small scale firms on payment of prescribed fees.
48. The Committee, however, wishes to point out that in order to improve the performance of small scale
manufacturing firms which are already operating in this country, the Central and State Government Drug Control
Organisations should conduct special seminers, technical lectures etc. and issue bulletins emphasising on manufac
turers the various aspects that have to be taken into cousiderations in maintaining quality control measures. In
particulars, we feel that talks on subjects, such as. ‘The maintenance of sterile areas in drug manufacturing units’,
Sterilization procedures for durgs’, “Maintenance and house-keeping hints for manufacturers of sterile products.
‘Problems relating to the production and quality control of opthalmic preparations” etc. should be arranged. Some
of the Zonal Organisations attached to the Central Drug'Control Organisations have been circularising pamphlets
which should benefit drug manufacturers. This practice should be followed by the other Zonal Officers and State
Drug Control Organisations also.
1— M of Pet. & Chem. '75—26
1
■' ’ J
200
49. We are also given to understand that the Ministry of Industrial Development may be in a position to star
an organisations where prospective manufacturers of drugs particularly those whose financial resources arc
could be initialed into the subtleties of quality cDntrol measures inregard to durgs. Such an organisation shou c
started every soon.
Some general observations
The Drug and Equipment Standards Committee appointed by the Ministry of Health and Family Planning
in 1965 had made valuable recommendations but unfortunately they have reminded unimplemen’cd. Two specific
rccommenda’ions namely the oie suggesting that the Drug Control should administratively function independent!)
under the Government concerned and not as an organisation attached to other departments and the other that off
ences under the Drugs and Comsciics Act and related legislation should be tried in specified Courts so that the latter
might be fully conversant with the objectives of the legislation and technical aspects of the cases deserve special men
tion. As alreadv mentioned by us earlier, we reiterate tha1 the Central and State Drug Control Organisations should
be independent of the Directorate of Medical and Health Services specially as the latter organisation and responsible
for purchases of drugs. States will be reductant to carry out this separation unless the Centre sets an example. The
seond recommendation should also be pu.sued vigorously.
51. Most of the States have been extending all help to the drug industry. Special incentives for the industry
are also offered by some States. We find however that in some States the industry has been suffering from certain
handicaps, particularly because of water-shortage non-availability of alcohol and electricity etc. Units which are
engaged in the production of drugs which are thcrmolabile and are sensitive to.heat such as sera, vaccines, other
immunological products and antibiotics should not be subjected to power cut as their production would be seriously
hampered. The lack of power would effect refrigeration facilities and result in loss of valuable drugs. The Committee
would particularly wish to bring this point to the notice of the Central and State Governments.
52. A Joint inspection by the local and Central Drug Controllers should be undertaken and completed with
in a period of two months for all units in the small scale sector in respect of Schedule C items. This work should
start immediately.
53. The general public in their own interest should also be aware of the precautions to be taken while purchas
ing drugs. They should also bring to the notice of the Drug Control authorities whenever the existence of any spur
ious drug comes to their notice.
Jaisukhlal Hath!
Sd/
Sd/ Yashpal Kapur
Sd/ Vasant Sathe
Sd
Ranen Sen
Sd; K.S. Chavda
Sd/ C.M. Stephen
Sd/ M.L. Dhar
Ma rat he
S.S.
Sd/
Vinod Kumar
Sd/
Sd/ P.S. Ramachandran
Sd/ B. Shah
Sd/ B.V. Ranga Rao
Sd/
M.K. Ranganekar
Sd/ B.B. Gaitande
Sd/
P.R. Gupta.
New Delhi
Recommendations
1. The officer in charge of the Drug Control in a State Constitutes the king-pin of the Organisation, He
should be responsible not only for enforcing the quality control measures over drugs, but also for the development
of the drug industry, having regard to the raw materials and natural resources available in the country. Lack of
adequate technical knowledge on the part of the top officer will result in ill-equipped and ill-organised firms being
licensed to manufacture drugs.
. [Chapter-lX Para 10.]
2. The check that is exercised over the first licensing or the renewal of licence determines the quality of products
that are turned out by the firm, though frequent inspections of the manufacturing firms are also necessary to ensure
that the quality control discipline has become ingrained in all the personnel working in the firms.
[Chapter-IX para 10.]
3. As recommended by the Drugs Technical Advisory Board, the qualifications of the Licensing Authority
in each State should be laid down in the Drugs and Cosmetics Rules and if necessary an enabling provision should
be in trod need in the Drugs and Cosmetics Act for this purpose.
[Chapter-lX para 10.]
■»
/
201
4. The overall authority in the State should also be the '-Controlling Authority” for Drugs Inspectors and no
Drugs Inspector should be permitted to institute a prosecution without the express order in writing from the "Con
trolling Authority”.
[Chapter-]X Para 10.]
5. The Licensing of firms in each State should be done through a Licensing Board consisting of (i) Drug Con
trol authority of the State concerned, (ii) Drug Control authorities of the States in the Region, (iii) a senior represen
tative of the Drug Control authority of India; and (iv) if possible, one of the Drug Control authority from Maharashtra
Gujarat or Karnataka. The Drugs and Comsetics Act and Rules should be amended accordingly.
[Chapter-IX para I I.]
6. The manufacturers of injectables including glucose solutions, antibiotics (Schedule C) items should not
be licensed to manufacturer unless they have their own arrangements for testing them.
[Chapter-IX para 11.]
7. The present provisions permitting such firms to-get their finished products tested by private laboratory
should be withdrawn when the restrictions imposed on import of analytical equipments gets eased. Meanwhile
commercial laboratories should be required to maintain efficient standards with regard to technical staff, equipment
and environments and should be approved by the Drugs Control Organisation at the centre.
[Chapter-IX Para 12.]
should
be divorced from the Directorate of Medical and/or Health Ser8. The Drug Control Organisation
-...
vices and Constituted into a separate department functioning directly under the Dcpartmcnt/Ministry of Health.
[Chapter-l.X Para 12.]
9. The State which do not have an adequate number of Drug Inspectors as per the scale recommended by the
Committee on Drugs Control, should be helped to expand their drug Inspectorate.
[Chapter-IX Para 14.]
10 The salary offered to Drug Inspectors should be reasonable and sufficient to attract good talents from
the profession.
IV.
. .,
[Chapter-IX Para 14.]
11. Each State should have alteast one Chief Inspector in the scale ot Rs 1100-1600 who whould be well
including transfusion
conversant with the manufacture of antibiotic preparations, injectable and vaccines, etc.
solutions. He should carry out the inspection of firms which apply for the manufacture of drugs also associating an
inspector from the Central Government with the first inspection.
[Chapter-IX Para 14.J
12. At the time of granting first licence for manufacture, utmost care should be exercised by the Drug Licens
ing Board/Drug Control authority.
[Chapter-IX Para 14.]
13. No inspector should be posted by a State Government unless he has been trained,'. Training facilities for
Calcutta for Northern and
inspectors should be augmented and a second training course should be organised in Calc:
Eastern Regions.
[Chapter-lX Para 14.]
14. The Central should assist the States in developing and /or expanding combined food and drug control
laboratorien bv extending financial assistance to them.
[Chapter-IX rara lo.j
15. In addition to the existing Central Drug Laboratory at Ghaziabad, the Central should have three moie
regional laboratories, one in the South, one in the East and one in the West.
[Chapter-lX Para 17.]
16. In addition, the Central should also set up a control laboratory for testing Sera, Vaccines and immunolo
gical products. The scheme of establishment of a Central Regional Standardisation Laboratory, should be given
high priority on the Fifth Five Year Plan.
[Chapter-IX Para 17.]
17. The Slates should constitute legal-dum-intelligence Cells for carrying on the compaign against spurious
drugs, The Central Government should assist the States in organising this compaign by extending nnancxai assistance to them.
[Chapter-lX Pare 19.]
-
202
j 18. Enlistment of the co-operation of the public, members of the.medcial profession, social organisations like
Consmeers’ Councils etc. ,in tightening Drug Control measures and in combating the menance of spurious drugs
should be considered both by Central Government and State Governments.
>:
/.I • .
ji'
[Chapter-JX Para 21J
? 19. Setting up of State Drug Advisory Boards consisting of medical profession, Police Department, Social
workers, the Industry and the trade should be provided for statutorily in the Drugs and Cosmetics Act and that this
should become mandatory on the part of deficient States to constitute such Boards. Public should also be made
aware of such organisations/Boards.
' ■ ■ 1
’ /i ■ .
>•
[Chapter-IX Para 21.]
20. As recommended by the Task Force on Drugs and Food Adulteration, 25 special Mobile squads in the
States should be organised for tracking down spurious drugs and food with 100 % financial assistance from the Centre.
[Chapter-IX Para 24.]
21. Four special Mobile Squads should be established at the Centre for coordinating the activities pf mobile
squads in States.
[Chapter-IX Para 24.]
22. A distinction should be made between offences relating to the manufacture and sale of spurious drugs
and those offences relating to standards of drugs. Punishment of life irnprios nment may be provided for the manu
facture, sale, stocking or exhibiting any drug which is deemed to be misbranded under clause (a), (b), (c), (d), (f) and
(g) of Section 17 of any drug that is adulterated under Section 17 or for manufacture of a drug without a valid licence.
[Chapter-IX Para 31.]
s
23 The compl ement of the Central Drug Inspectors should be augmented to at least 50 immediately, and the
Zonal Officers in Madras and Ghaziabad should be senior enough in status to enable them to discuss with the State
Drug Control Authorities and Health Secretaries the problems relating to drug control.
[Chapter-IX Para 34 (a)]
24. The facilities for screening ‘New Drugs’ should be reinforced by the inclusion of a medical officer with
post-graduate qualifications who should be able to advise on the conduct of clinical trials with ‘New Drugs’.
[Chapter-IX Para 34 (b)]
25. The Central Government should have a fully equipped toxicological laboratory for carrying out toxicity
as well as teratology studies with new drugs in particular.
°
[Chapter-IX Para 34 (c)]
26. The library facilities should be augmented at the Zonal offices and these facilities should be made available
to drug manufacturers and State Drug Control authorities.
[Chapter-IX Para 34 (d)]
27. The facilities for training Drug Inspectors (two such courses are recommended in Bombay and Calcutta)
and Drug Analysts should be made permanent and whole-time senior officers should be appointed to conduct them
[Chapter-IX Para 34 (e)j
28. The Drug Standard Cell for publication purposes like the publication of Pharmacopoeia and National
Formulary should be strengthened immediately to keep them up to date.
-b m /-.Ji.:/ . ; ■ kpi'E
[Chapter-IX Para 34 (f)]
29. The Central Drug Standard Control Organisation should have its own library of books and journals
Adequate provision should also be r made for this organisation towards travelling allowances and to improve the
.^tone of drug contrpL measures in the country. ,
§(
;
O
■
vfio Inc • ->;J □nj ni ono .dwoB-od; m
[Chapter-IX gara,34 (g)]
30.
, States.
The Central Government should have its own publicity wing to enable it to give suitable guidance to the
.':i bf': ■
_
■ -zl ■
'' ‘ 7
:
1 n‘ J •
'■;
'•
.........
’
In sm'j.t-.
FChinter-lX Pnra 3 1 fkvi
31. Four mobile squads equipped with fast transport radio communication, police assistance and plain clothed
watching staff should be attached to the four Zonal offices to help the States in the compaign against spurious drugs
[Chapter-IX Para 34 (i)j
I-
32. Drugs Inspectorate in the States and arrangements for keeping their technical competence upto date such
as provision of journals, pharmacopoeias, technical books, etc. should be augmented. Transport facilities at least
to the senior Inspector should be provided.
■■ oi
[Chapter-IX Para 35(H)]
r'fni
*
203
33. Financial assistance should be provided to the States in establishing top grade combined Food and Drug
control laboratory.
[Chapter-IX Para 35(v)]
34. As recommended by the BICP, a cess of 1 % should be levied on the pharmaceutical industry and the funsso collected which are estimated to be of the order of Rs. 3.5 crores should be utilised primarily for the construed
tion of the Toxicological Laboratory at the Centre and the balance of funds should be utilised for strengthening the
Drug Control measures at the Central and State levels, as well as for financing approved schemes of research/
[Chapter-IX Para 37.]
35. The standards of first inspection of manufacturing firms and inspection at the time of renewal of manu
facturing licences must be stringent. Joint inspections by the Central and State Drugs Inspectors should be
carried out before licences are granted or renewed.
[Chapter-IX Para 38.]
36. States should draw up priorities for frequent inspection of drug manufacturing units and firms which ex
ecute orders of Government departments and those which manufacture Schedule ‘C’ drugs including ‘blood banks’.
[Chapter-IX Para 38.]
37. Inspection of hospital stores and pharmacies throughout the States should be frequently done.
[Chapter-IX Para 38.]
38. The Centre should concentrate on repeated inspections of firms manufacturing Schedule C’ drugs, and also
take out for test samples of life-saving drugs on a planned basis.
[Chapter-IX Para 39.]
39. The
'
licences of the drug manufacturers who have been given licences and who are unlit to carry on the
manufacture in the opinion of the Central Drug Control authorities should be cancelled in consultation with* the
State Drug Control authorities.
[Chapter-IX
Para 39.]
40. The prosecution for offences under Drugs & Cosmetics Act should be initiated by States. There should be
a close liaison between the States and the Centre to ensure quick effective prosecution.
[Chapter-IX Para 40.]
41. The present proviso to Section 27(a) which permits the court to award imprisonment for a period not less
than one year has been amended and imprisonment for a minimum period of five years has been recommended. Fur
ther amendments as recommended vide Annexure V are suggested for implementation.
[Chapter-IX
Para 41.]
42. The States should have their own centralised arrangements for purchase of drugs. The tenderers should
be screened with reference to good manufacturing practices observed by them and enrolled'as prospective suppliers.
[Chapter-IX Para 45.]
43. The procedure adopted by Maharashtra (Annexure V) should be followed for purchases of druss by other
States. Hospital pharmacy services should be re-organised as per the manner set forth in Annexure VI
[Chapter-IX Para 45.]
44. The drugs should be subjected to a thorough visual examination at the time of receipt in hospitals and where
there are reasons to suspect their quality, samples should be got examined.
[Chapter-IX Para 45.]
45. In smaller towns and rural areas and Public Health Centres, frequent inspection of drugs is all the more
necessary.
[Chapter-IX Para 45.]
46.
The Drug Control authorities should frequently inspect the firms which supply drugs to hospital;.
[Chapter-IX Para 45.]
204
47. Most of the small scale firms find it difficult to get their drugs tested. The State Government should place
the testing facilities available wi,th their analytical laboratories at the disposal of the small scale firms on payment of
prescribed fees.
[Chapter-IX Para 47.]
48. The Central and the State Drug Organisations should conduct special seminars, technical lectures and issue
bulletins emphasising on manufacturers the various aspects that have to be taken into consideration in maintaining
quality control measures.
[Chaptcr-IX
Para 4i<.]
49. Talks on subjects such as maintenance of sterile areas in drug manufacturing units, sterilization procedures
for drugs etc. should be held.
[Chapter-IX
Para 48.]
50. An organisation where prospective manufacturers of drugs particularly those whose financial resources are
limited could be initiated into the subtcleties of quality control measures in regard to drugs should be started.
[Chapter-IX Para 49.]
51. As recommended by the Drugs and Equipment Standards Committee, the Central and Slate Drug Control
Organisations should be independent of the Directorate of Medical and Health Services. The Centre should adopt
this immediately to act as an example for the State to follow.
[Chapter-IX Para 50.]
52. Industrial units which arc engaged in the production of drugs which arc thermo labile and are sensitive
to heat such as sera, vaccines, other immunological products and antibiotics should not be subjected to power cuts
as their production would be seriously hampered.
[Chapter-lX Para 51.]
53. A joint inspection by the local and central Drug Control authorities should be undertaken immediately and
completed within a period of two months for all units in the small scale sector in respect of Schedule ‘C’ items.
[Chapter-] X
Para 52.]
54. The general public in their own interest should also be aware of the precautions to be taken while purcha
sing drugs. They should also bring to the notice of the Drug Control authorities whenever the existence of any
spurious drug comes to their notice.
[Chapter-IX Para 53.]
ANNEXURE I
Note on the Manner in which the Public can Co-opcrate and Assist the Drug Control Organisation.
(Chapter IX—Para 32 (APP. I)
The Drugs and Cosmetics Act which regulate the quality of drugs imported into, manufactured and sold in the
country is a social legislation, its objective being to ensure that drugs arc being manufactured under proper condi
tions and that the drug reaching the consumer is of standared quality.
The Drug Control Organisation at the Centre and in the States are responsible for enforcing the provisions of
this Act. This law affords protection not only to consumers but also to law abiding manufacturers and dealers
as it guards them against unfair competition by inferior or dishonestly-labelled products. It is, therefore, in the
interests of the consumer, law-abiding manufacturers and dealers to co-operate and assist the Drug Control Organisa
tion in the strict enforcement of this Act.
The gullible consumer is the main victim of an unscrupulous dealer dealing in spurious drugs. It is not
possible for a consumer to have every drug purchased by him tested to ensure its quality. In some cases spurious
durgs are made up so competently to resemble closely the genuine product that it is difficult for a layman to notice
any difference between the genuine and the spurious product.
The racket of spurious drugs thrives mainly because of the greed of the manufacturer, dealer, and even the con
sumer. The desire to save money by purchasing drugs at a lower price without a cash memo, is in many cases the
root cause for the prevalence of spurious drugs.
Generally, reputed manufacturers and dealers do not engage in the manufacture and sale of spurious drugs,
is generally the small chemist working on low margin of profits which deals in sale of spurious drugs.
It
The question that naturally arises is how should a consumer protect himself from this menace of spurious drugs.
While there can be no fool-proof protection, nevertheless there are certain precautions which if taken by consumers
could not only ensure their protection but also assist the Drug Control Organisation in their investigational activities.
These precautions are: —
1.
Buy drugs only from a reputed chemist preferably one known to you.
Insist on a cash-memo while purchasing the drug. The Drugs and Cosmetics Act requires a chemist to
give a cash-memo and it is an oficnce for a chemist to refuse to grant a cash-memo.
3.
Compare the price charged by the Chemist with that indicated on the lable. If the price charged is consi
derably lower than that indicated on the lable then there is a possibility that the drug supplied^may not be
genuine.
4.
Beware of any shop which sells drugs at prices considerably lower than other competitors.
5.
Examine the labels of the drugs purchased and do not buy drugs which have crossed the expiry date.
6.
If the package of the medicine purchased appears different from that purchased earlier, forward the package
to the nearest Drug Inspector for investigations. Similarly, if a medicine purchased tastes differently then
report along with a sample of the medicine all to the nearest Drug Inspector.
7.
Destroy all used containers of medicines particularly those where the name of the medicine or the manufac
turer is indelibly marked on the container.
8.
Associate the Drug Control Organisation in meetings of the Citizen Committee where quality control of
drugs is being discussed.
9.
Inform the State Drugs Controller of any cases of spurious drugs that have come to your notice. While
furnishing this information please ascertain the facts correctly so that the time of the Drug Control Officer
is not unduly wasted in fruitless investigations.
The steps set out above if followed by consumers would ensure not only protection but also assist the Drug Con
trol Organisation in investigating cases of spurious drugs.
205
",
ANNEXURE II
SET UP OF THE DRUGS CONTROL ORGANISATION IN THE STATES AS ON 1-1-1974
(Chapter IX'—Para 3C (App. I)
SI.
Name of State
No.
Whether whole time No. of Inspectors
independent officer- and scale of pay
in-charge of the
Department
No. of manu- No. of Intelligencc-cww-Iegal
wing for tracking
facturing pre- sale
mises as on premises down spurious
1-1-74
as on
drugs
1-1-74
Independent test
ing facilities
available
2
3
4
5
1. Andhra Pradesh
No, Director Health
Services is the
Drugs Controller
& Licensing Au
thority.
16—Rs. 350—650
Rs. 250—500
(Gaz.).
Drugs—189
Cosmt.—13
Homeo.—8
2. Assam
Drugs—10
No. Director Health 5—Rs. 350—950
Services is the
(Gaz.)
+35 part-time civil
Drugs Controller.
Surgeons of States
Sub-Divn.. Health
Officer & Officer
& Asstt. Sur
geon as Ex-Officio
Drugs Inspectors.
1.987
No. The drugs test
ing Lab. have not
yet been establish
ed and the samples
are tested by
C.D.L.. Calcutta
or Pasteur Instt..
Shillong.
3. Bihar
No. Director Health 4—Full time Drugs Drugs—79
Cosmt.—4
Inspectors.
& Medl, Services
Homeo.—1
is the Drugs Con
troller.
6.100
(Approx.)
(a) Yes, for nonbiological ropducts
(Bihar
Drugs Control
Lab., Patna).
1
6
7
8
12325, A police wing con (а) Yes. for nonsisting of one cir
biolcgical pro
cle Inspector and
ducts only (Irslione Sub-Inspector
tute preventive
one head constable
medicine, Hyder
and two constables
abad).
was done as an (б) Biologicals pro
experimental mea
ducts tested at
sure and was in
C.D.L., Ghazieffective and was
bad.
withdrawn by the
Police Deptt. in
1969. A proper
pattern of police
Wing has to be
evolved where the
police functions
under the dirccttions of Drugs
Controller.
(b) Biological product tested at
C.D.L., Calcutta.
4. Gujarat
Yes. Director Drugs 50—Rs. 375—695
Control Admn.
Rs. 245—515
(Gaz.)
5. Haryana .
Drugs—225
Cosmt.—131
Homeo.—2
Ayur.—10
Drugs—68
No, Dy. Director of 6—Rs. 200—400
H.S. is the Drugs
7C, M.O.’s work Cosmt.—7
ing as ex-officio Homeo.—1
Controller.
D.I.
206
3.691
Intelligence Yes, (Drugs Lab.,
Yes.
Baroda), Sample
Branch Connecting
sent for test to
of I Asstt. Direc
tor, 4 Drugs Ins
Haffkine
Instt.,
pectors and 10
Bombay.
Watchers.
1.031
No, samples sent
for test to C.D.L.,
Cal., and Public
Analyst, Chandi
garh.
IM
4
2
3
6. Himachal Pradesh
No. Dy. Director
of
H.S. is the
Drugs Controller.
2—Rs. 210-400
Drugs—8
(Non-Gaz.)
4-4 M.O.’s appointed Dy. Insp.
7. Kerala
Yes, Drugs Control
ler.
17—Rs. 225—500
(Gaz.)
8. Madhya Pradesh
1
5
6
7
8
531
No. samples sent to
C.D.L.. Calcutta.
Drugs—57
Cosmt.—10
Homeo—15
2.378
The State D.C. Orgn. (a) \'es.
for nonhas got an intel
Biological
pro
ligence
Branch
ducts (Drugs test
under the charge
ing Lab., Trivan
of a Drugs Inspect.
drum).
and a‘Legal Wing* (A) Biological
pro
in charge of a
ducts at C.D.L.
legal Asstt.
Calcutta.
Yes, Drugs Control 32—Rs. 190—315
ler under the Dir.
(Non-Gazj
of H.S.
Drugs—154
Cosmt.—13
Homeo.—8
4.582
The
Government («) Yes. for nonhave created four
Biological proposts of Police
ducts
<
(Drugs
Prosecutors in the
Testing
Lab.,
State for conduc
Indore).
tion of Drugs Act (h') Biological procase. Steps arc
duct tested at
also being taken
C.D.L.. Calcutta.
to start an Tntclligence-ctz/n-Legal
Wing.
9. Maharashtra
Yes, Commissioner,
Food & Drugs
Admn.
107—Rs. 250—715
(Gaz.)
Drugs—909
Cosmt.—602
Homeo.—23
12.969
Yes.
Intelligence
Branch consists of
1 Sr. Drug Insp..
2 Drugs Insp. and
17 Watchers. This
Branch is assisted
by the Police staff
consisting of 1
Inspector, 2 S.I.,
and 14 Constables.
10. Manipur .
No. DHS is the
Drugs Controller.
One full time Drugs
Insp.
Nil
11. Mysore
Yes. Drugs Control
ler.
13—Rs. 250—500
(Gaz.)
Drugs—71
Cosmt.—40
Homeo.—
Yes. Drug Control
Lab..
Bombay.
Samples also test
ed at Haffkine
Institute.
Parel,
Bombay.
159
No, samples tested
to C.D.L., Cal
cutta.
5.036
Yes, Legal Intelli- (a) Yes. for nongence and prose
Biological procution
branch
ducts
(Drugs
formed.
Testing
Lab.,
Bangalore.
(/)} Biological pro
duct tested at
C.D.L., Calcutta.
12. Orissa
No. Dir. H.S. is the
Drugs Controller.
9—Rs. 300—100
(Gaz.)
Drugs—60
Cosmt.—27
Homeo.—12
5,004
No. samples sent to
Central
Drugs
Lab.. Calcutta &
C.I.P.L.,
Ghaziabad.
13. Punjab
No. Dv. Director
of H.S. (Food &
Drugs)
is
the
Drugs Controller.
12—Rs. 200—400
(Gaz.)
Drugs—49
Cosmt.—52
Homeo—6.
2,198
(a) Yes. for nonBiological products
ifPublic
Analysis, Chandi
garh).
(Z>) Biological
product tested
at
C.D.L., Calcutta.
14. Rajasthan
No, Addl. Dir. of 5 full time drugs Drugs—89
Med. and H.S. is
Insp.
appointed Cosmt.—13
the Drugs Con
19 Medl. Officer
troller.
appointed as Ex-'
officio Drugs Insp.
1— M of Pet. & Chem./75—27
3.176
(a) No. Prof.
of
Pharmacology
S.M.S. Medl.
College, Jaipur
appointed
as
part-time Govt.
Anah'sts.
(A) Samples also sent
for test to the
DDL, Calcutta.
208
2
i
3
15. Tamil Nadu
16. Tripura
.
.
17. L'ttar Pradesh .
4
7
8
5
.6
No, Dir. of Medl. & 10—Rs. 525—900
Health Services is 59—Rs. 400—650
the Drugs Control
ler.
Drugs—303
Cosmt.—77
Homoeo.—6
13,044
Yes. King Institute,
Guindy, Madras.
No, D.H.S. is the No, Drugs Insp.
Drugs Controller.
Drugs—5
49
Samples sent
to
C.D.L., Calcutta.
Yes, a Drug Con 16—Rs. 300—900
troller in the Dir.
Rs. 255—550
of Medl. and
Health Services-
Drugs—154
Cosmt.—2
16,000
(a) Yes, Samples test
ed by the Public
Analyst, Luck
now
to
the
Govt, of L.P.
(b) Samples also test
ed at the Central
Research Insti
tute. Lucknow.
(c) Samples also sent
to the C.D.L..
Calcutta.
18. West Bengal
.
Yes, Director of 6—Rs. 325—1000
Drugs Controller 17—Rs. 275—650
Admn.
(Gaz.)
Drugs—367
12,900 An Intelligence Cell Yes. Drugs.
Cal
Cosmt.—101
has been set up
cutta. Samples also
Homoeo.—200
under the State
sent for test to
Drugs
Control
the C.D.L., Cal
Orgn.. in collabo
cutta.
ration with the
Enforcement
Branch of the
State Police.
19. Chandigarh
.
No, Dy. Secy.,-c///n- One Inspector
Dir. of HES.
Drugs—4
20. Delhi
.
No, D. H.S. is the
Drugs Controller.
Drugs—97
16—Rs. 350—900
Cosmt.—136
(Gaz.)
Homoeo.—3
21. Dadra & Nagar No, Chief Medl. N.A.
Haveli.
Officer is the
Drugs Controller.
.
22. Goa
23. Pondicherry
Drugs—4
No. D.H.S. is the No full time Drugs Drugs—12
Drugs Controller.
Insp.
Consmt.—5
5—Asstt. Drugs Homoeo.—1
Controller
appointed as Exofficio Drugs Ins
pectors.
Do.
Total No. of Inspectors—405
N.A.—Not Available.
C.D.L.—Central Drugs Laboratory. Calcutta.
C.I.P.L.—Central Indian Pharmacopoeia
Laboratory,Ghaziabad.
C. R.I.—Central Research Institute, Kasauli.
D. H.S.—Director of Health Services.
Gne full time Drugs Drugs—21
Inspector.
Cosmt.—8
135
No. samples sent for
test C.D.L., Cal
cutta.
4,042
Two watchers have No._samples sent to
been appointed.
C.D.L., Calcutta
Govt, has agreed
and
C.LP.L..
for appointment of
Ghaziabad.
Police personnel
to assist the Drugs
Control Admn.
N.A.
Samples sent for test
to C.D.L.. Cal
cutta. C.LP.L..
Ghaziabad.
163
Yes. Public Health
Lab.. Goa, CIPL.
Ghaziabad.
376
No. samples sent to
King
Institute,
Guindy, Madras.
Total No. of Manufacturing Premises :
(as on 1-1-1974)
Total No. of wels premises : 1,07,876
(As on 1-1-1974)
r
Drugs— 2,935
Cosmetics—1.271
Homoeo. — 292
PRESENT POSITION REGARDING DREGS INSPECTORS
(STATES)
Name of the State
S.
No.
No. of Drug Ins
pectors as per the
staffing pattern
recommended by
Committee on
Drugs Control
Present strength
of Inspectors
1
2
3
4
1.
Andhra Pradesh
31
16
2.
Assam
7
5
3.
Bihar
27
4
4. Gujarat
27
50
5.
Haryana
9
6
6.
Himachal Pradesh
3
2
7.
Kerala
17
17
8.
Madhya Pradesh
30
32
78
107
19
13
9.
Maharashtra
10. Mysore
1
1
12. Orissa
14
9
13.
Punjab
15
12
14.
Rajasthan .
29
5
15. Tamil Nadu
38
69
49
16
11.
Manipur
16. Uttar Pradesh
.
17. Tripura
11
18.
63
West Bengal
23
1
19. Chandigarh
20. Delhi
17
21. Goa .
2
22. Pondicherry
1
16
1
478
405
CENTRAL DRUGS STANDARD CONTROL ORGANISATION
Number of Drug Inspectors....................................................................................
50
(Expected strength
at end of Fifth Five
Year Plan)
209
0^' ■’!;
;
Ko n: i
17
v health cell
"in, I Sleek
ANNEXURE-1II
BROAD DETAILS OF THE SCHEME TO BE IMPLEMENTED IN THE STH PLAN
(Chapter IX-Para. 36-App. I)
I. Title of the Scheme :
Financial Assistance to the States for strengthening the Drug Control Administration for combating the preva*
lence of sub-standard and spurious drugs.
II. Objective of the Scheme :
The objective of this scheme is to extend financial assistance to the States for strengthening the Drugs Control
Administration with a view to enabling them to tackle the problem of sub-standard and spurious drugs more effec
tively. The Drugs and Cosmetics Act has been in force for nearly 25 years. However, it cannot be said that the prevalancc of sub-standard and spurious drugs has been reduced considerably. The main reason why drugs standard
control has not been able to make considerable headway is that the pre-requisites which are essential for effective
enforcement ot drug control measures in the States have been lacking. These pre-requisites are :
(1) Appointment of a whole-time officer with adquate background knowledge of drug manufacturing and dru"
testing as an overall officer in-charge of Drug Control in the State.
(2) Appointment of adequate number of Drug Inspectors with sufficient practical experience in drua manufacture
and drug testing.
(3) Establishment of an “Intelligence-cum-Legal” Wing operating under the supervision of Drug Inspectors/
Control Officer possessing legal knowledge and commanding the support of the necessary police staff for
tracking down spurious drug;.
The officer, who is in overall charge of Drug Control in each State and the Drugs Inspectors appointed under
the Drugs and Cosmetics Act, constitutes the King-pin of the enforcement machinery. At present, only 5 States
namely, Maharashtra, Gujarat, Kerala. Mysore and West Bengal have full-time and adequately qualified Drugs Con
trollers with a well-organised administrative set-up. In most of the other States the controlling authority is the State
Director of Health Services who functions as a Drugs Controller, in addition to his other multifarious duties as
Director of Health Services. It has been observed that in States where there is a full-time Drug Controller, the standdards of enforcement are more stringent than in States where the Director of Health Services functions as a Drugs
Controller. It is an administrative fact that unless an organisation is headed by a well-qualified and knowledgeable
officer on a full-time basis the administration cannot function effectively. Although the Drugs and Cosmetics Act
and the Rules require that manufacturing and sale premises are inspected only at the time of granting or renewal of
licences. This state of affairs is mainly due to the fact that in most states the total number of Drug Inspectors
appointed are inadequate as compared to the number of licensed manufacturer and sale premises in the States. The
Committee on Drug Control has recommended that there should be one full-time Drug Inspector for every 25 manu
facturing premises and one full-time Drug Inspector for every 200 sale premises. On the basis of this yardstick, the
total number ot inspectors that should be in position in the countrv would number 575. Against this, the total number
of Drug Inspectors appointed in the States are today 305.
It is proposed under this scheme to extend financial assistance to the States to enable them to reorganise their
Drugs Conti ol Administration so that the Administration is headed by a full-time competent officer assisted by ade
quate number of Drugs Inspectors.
Whde strengthening of the Inspectorate staff would help in combating the problem of sub-standard drugs,
the problem of spurious drug has to be tackled on entirely a different footing. The manufacture of spurious drugs,
by its very nature, is essentially a clandestine affair indulged in by unlicensed manufacturers or dealers. Antisocial
elements generally engage themselves in the manufacture of spurious drugs and try to cash in on the reputation of
established products. As these drugs are not manufactured by licensed manufacturers but manufactured clandes
tinely. the pioblem of spurious drugs becomes essentially a law and order problem just like other illegal activities
such as coumerieiting of currency or smuggling of imported goods. The Drug Inspector does not normally have the
necessary training that is required lor tracking the manufacture and sale of spurious drugs which can be organised
only with police assistance. The problem of suprious drugs can, therefore, be effectively tackled, by the joint efforts
210
211
of a Drug Control Organisation and the Police. In certain States such as Maharashtra and Gujarat where the Drug
Control Administration is very well organised “Intelligence” Cells have been constituted in the Drug Control Organi
sation and Police Stall attached to these Cells.
Although State Governments have repeatedly been advised to constitute Special Squads for investigating
offences relating to the manufacture and movement of spurious drugs, except in the States of Maharashtra and
Gujarat no such squads have been constituted in any other State. Experience has shown that reports of movements
of spurious drugs are more frequent in States where Drug Control has been lax. The object of this scheme is also to
extend financial assistance to the States for setting up Anti-spurious Squads so that complaints regarding spurious
drugs are speedily investigated and persons dealing in this activity apprehended.
II. Agency for execution review and evolution :
The State Government will be primarily responsible for executing these schemes. The Central Government
would in addition to extending financial assistance, co-ordinate the activities of the Anti-Spurious Squads and also the
activities of the Drug Control Administration
IV.
Control Jot'Centrally sponsored scheme :
It would be a Centrally Sponsored Scheme.
V. Justification for its being taken up as a Central or Centrally sponsored scheme during the Fifth Plan :
As already pointed out under (II) above, though the Drugs and Cosmetics Act has now been in force for nearly
25 years, the standards of enforcement are far from stisfactory. Barring Maharashtra, Gujarat. West Bengal
Mysore, Tamil Nadu and Kerala and to a limited extent Orissa, other States did not have any well-defined and pro
perly phased schemes under the 4th Five-Year Plan for development of Drug Control. This lends room for the im
pression that either the States have not been able to appreciate the importance of this programme notwithstanding the
repeated recommendations and exhortations of the Central Council of Health Ministers or thev have not been able
to accord the degree of priority that this vital sector of health activity deserves.
The Prime Minister and the Chairman of the Planning Commission had also written a letter to the Chief
Ministers emphasising the importance of strengthening Drug Control with a view to eradicating spurious drugs. The
Planning Commission made bulk allocations for the Health Sector of the State Plan Schemes and in manv States
the funds were mostly utilised for schemes other than Drugs and Food Control.
As for spurious drugs, experience shows that reports of their movement are more frequent from the States
where Diug Control has been lax. The most disconcerting feature has been the lack of response on the part of several
Sates to the information given to them about the positive clues of the names of parties dealing in sourious drugs.
The Centie had to rest content watching the helpless state of affairs and could do very little without active police
support from the States. A few cases of spurious drugs were investigated and proceeded against bv the Central
Drugi Inspector. Protracted legal proceedings necessitate repeated visits to States bv the Drugs Inspector with no
commensurate results.
'
Complaints have repeatedly been in the Press as well as in Parliament about Government’s inabilitv to eradi
cate manufacture and sale of spurious drugs. Our experience over the past 25 years shows that if this matter is left
solely to the States, tins sorry state ol aliairs is likely to continue. Although the State Governments realise the need
loi streamlining the Drug Control Administration and for establishing Anti-Spurious squads, thev have not been
able to take necessary action mainly because of lack of financial resources. The Task Force appointed bv the Plann
ing Commission has also recommended that Central Assistance should be provided to the States for reorganising
the Diug Control Administrations in the States and for establishing Anti-Spurious Squads.
VI. Details oj Advance Action already taken for introduction of the scheme in the Sth Plan {Pilot studies, surveys etc
completed experimental scheme already in operation and so on).
The Task Force appointed by the Planning Commission has, made aa detailed study of the subject and has recommended among other things, that finnacial assistance should be giveni to the States for strengthening the Drug
Control Administration.
VII. Broad details of the scheme to be implemented in the Sth Plan :
The financial assistance would have to be granted to the States on two counts :
(i) For ieorganising the Drug Control Administration by appointment of a full-time competent Dru»s
Conti oiler with adequate number of qualified inspectors, and providing transport facilities.^
°
^^pudous^ruos^1111 SpUli°US S^uads with ^equate facilities for quick investigation of the movements of
212
So far as the reorganisation of the Drug Control Administration is concerned, it may be stated that an effective
Drug Control Administration should have a Drugs Controller at the top, assisted by an Assistant Drugs Controller
at headquarters and adequate number of Drugs Inspectors. Each zone should be incharge of an Assistant Drugs
Controller with adequate number of Drugs Inspectors. The number of Drugs Inspectors that should be stationed
at headquarters and in the zones would depend upon the number of manufacturing and sale premises located in the
States. For the purpose of this scheme, w'e have adopted a yardstick of one Drugs Inspector for 25 manufacturing
premises and one Drugs Inspector for 200 sale premises. On the basis of guidelines indicated above, the Adminis
trative set up that would be required has been worked out in respect of each State and the relevant information is
given at Appendix I. In addition to assisting the States for increasing the Inspectorate Staff, it is also proposed
under this scheme to provide transport facilities to the Drug Control Administration by way of one mobile van
lor each zone in the States and one mobile van for the work of the headquarters. Under this scheme, assistance
is also proposed to be given to the Slates for purchase of technical books required by the Drug Control Staff.
The Central Assistance that would be required to be extended to the Stales to enable them to bring up the
Drug Control Administration to the desired level has been worked out in respect of each State and this information
is given at Appendix II. For the purpose of this scheme, ire have proposed financial assistance only for the additional
staff that would be required to be recruited in the Stares to bring the Administration to uniform level throughout the
country. It is realised that this pattern of assistance would adversely affect States which have well-organised Drug
Control Administration and where the number of inspectors appointed are adequate in that the share of central
assistance for them would be less. However, the object of this scheme is primarily to bring up States which have
not given sufficient importance to Drug Control Administration and where the Drug Control Administration has
been lax.
It may be relevant to mention that drug is a commodity which moves across State borders and as such unless
the Drug Control enforcement is uniform and effective throughout the country, no State would be free from the
menace ot sub-standard or spurious drugs irrespective of the fact that any particular state may have an efficient drug
control administration.
While strengthening of the Drug Control Administration by appointment of a fully qualified Drugs Controller
and adequate number of Drugs Inspectors would enable the States to combat effectively the problem of sub-standard
drugs, the problem of spurious drugs as pointed earlier, has to be combated on a different footing. Manufacture
of spurious drugs is essentially an under cover activity indulged in mostly by unlicensed parties. Tackling such
an unlawful activity would require the help of Police and “Watchers” in plain clothes who should move in leading
wholesale markets in the States, or in areas where spurious drugs are reported to be moving and monitor “’leading”
information. The Police staff and Watchers should be under the control of Senior Drugs Inspectors who have
had comprehensive training in legal procedures for carrying out raids, searches, seizures, institution of prosecutions
and for conducting such cases. The Squads constituted for tracking down spurious drugs must be equipped to
be mobile and therefore be provided with fast transport and ancillary equipment such as facilities for transmitting
wireless messages etc. There should be close liaison between Senior Police Officers at the district levels and the
officers commanding the Anti-Spurious Drugs Squad'. Incentives should be gixen to ’informers’ who provide clues
to the hideouts ot drugs and the connecting links in the trade. Rewards may also have to be given to those who
manage to effect substantial hauls of spurious drugs. All these would indicate that a parallel police force has to
be run direct by the Drug Control authorities or by their working in concert with the Senior Police Officers. In
many Slates such as U.P., Madhya Pradesh, Bihar and Rajasthan, more than one Squad would have to be organised
and in some cases as many as four, to operate in different parts of the States. It is estimated that about 25 Squads
may be required to be organised in the States as under :—
Name of the State
No. of squads
to be organised
1. Punjab
2
2. Harvana .
1
3. Delhi
1
4. U.P.
4
2
5. Bihar
7
6. West Bengal .
2
7. Rajasthan
8. Madhya Pradesh
3
9. Assam
1
10. Orissa
1
11. Andhra Pradesh
3
12. Tamil Nadu
1
13. Mysore .
1
1
14. Kerala
25
Central Cell—1 Squad for each zonex4 .
Total
.
.
.
.
4
29
213
These squads may, in many cases, be required to cross inter-state territories in their pursuit of offenders. The
Centre, on its own, may find it difficult to organise a police force for this purpose and make it operate in all the
Stales. Each Squad, with its ramification of watchers and informers may cost about Rs. 2.00 lakhs (Appendix-C).
There should be a central Co-ordinating Cell at the Centre for this purpose complete with its complement
of watchers and other legal staff. There are four zonal offices under the Central Drugs Standard Control Organisa
tion at the centre. Considering that one Squad should be stationed in each zone, it will be necessary to provide for
4 Anti-spurious squads at the centre. Thus the net work of 25 Squads in states and 4 Squads at the Centre would
comprise 29 Squads in all. Considering that each Squad should have 2 Drug Inspectors. 2 Police Officers. 1 field
Assistant, 1 Driver and 3 Watchers, the cost for 29 squads on staff equipment and other charges would work out
of Rs. 1.65 lakhs during 5th Plan period.
VI11. Pattern of assistance indicating in respect of liabilities of Centre and States and other institutions for recurring
and non-recurring expenditure .
The cost involved in reorganising the Drug Control Administration in the States which would be of a recurring
nature, will be met 100% by the Centre. The cost involved in providing travel facilities to the Drug-. Inspector such
as mobile vans etc., would be of a non-recurring nature and would also be met 100% by the Centre.
IX. Outlay envisaged for the Sth Plan and Year-wise Phasing :
(a) Reorganisation of Drugs Control Administration in States :—
Year
Staff
Equip
ment
1974- 75
1975- 76
1976- 77
1977- 78
1978- 79
20.05
26.38
32.72
39.05
45.38
Total for 5 years
163.58
Other
items
Total
in lakh
12.25
10.150
7.00
3.00
2.80
1.10
1.10
1.10
1.10
1.10
33.40
37.98
40.82
43.65
49.28
36.05
5.50
205.13
Other
items
Total
5.60
6.00
6.00
6.00
6.00
36.87
37.31
29.46
30.19
30.64
Cons
truction
(b) Setting up of Anti-Spurious Squads
Year
Staff
Equip
ment
1974- 75
1975- 76
1976- 77
1977- 78
1978- 79
13.87
14.31
14.76
15.49
15.94
17.40
17.40
8.70
8.70
8.70
Cons
truction
164.87
Lakh
i.e. 165 lakh
X. Physical targets envisaged and yearwise Phasing :
The main objective of this Scheme is to assist the State Governments financially in streamlining their Drug
Control Administration so as to make it effective in tackling the problem of sub-standard and spurious drugs.
The implementation of this scheme would be done primarily by the State Governments and as such the laying down
of specific targets would have to be considered by the States.
XL Any other details, remarks etc.
Appendix—A
1. ANDHRA PRADESH
Existing set up
Proposed set up
.Additional statT req.
Estimated Expenditure during 5th Plan
Emoluments
in 5 yrs.
(including
incr.)
No. of
Posts
Rs.
I. Personnel
1. Dy. Drugs Controller-1
I. Drugs Controllcr-1
(1300-1600)
1. Drugs controller-1
(1300-1600)
1,02.090
3
1.94.58
59
23.59.764
2. Asstt. Drugs Contro- 2. Asstt. Drugs Contro
ller-3
ller Rs. (700-1250)
Rs. (700-1250)
2. Asstt. Drugs Controller-3 2. Dy. Drugs Controller
one
3. Asstt. Drugs Cont- 3. Drugs Inspectors-59
roller-6
4. Drugs Tnsps.
(i) Manufacturc-9
(ii) Sales-62
3. Drugs Inspectors
Rs. C*50-900)
TI. District : 20
Zones-5
II.
III. Premises :
Equipment :
1. Manufacturing premi
ses : 232
Six Mobile Vans
35,000 per van
3. Drugs Inspcctors-22
1
I.
1. Drugs Controller
(1300-1600)
Equipment :
Six vans @ 35,000
III.
Books. Journals Sl
Periodicals
Rs.
Total
26.56,434
6x35 000
2,10,000
5000 x 5
25.000
28,91,434
2. Sales premises: 12,323
Total Central Assistance
involved.
Books, Journals & Perio
dicals (a- Rs. 5000 per
vr.
2. ASSAM
Existing set up
Proposed set up
Additional staff req.
Estimated expenditure during 5th Plan
Emolu
ments in
5 yrs.
Rs.
Uo- of
posts
I. Personnel
1. Asstt. Drugs Controller-1 1. Drugs Controller one
1300-1609
2. Drugs Inspector-5
II District-\\
III. Premises :
(i) Manufacturing—14
(ii) Sales
Premises 252
1. Drugs Controller-l
(1300-1600)
1. Drugs Controller1300-1600
2. Asstt. Drugs Cont- 2. Asstt. Drugs Cont 2. Asstt. Drugs Cont
roller 700-1250,
roller-2 (700-1250)
rollers-3 (700-1250)
3. Drugs Inspectors:—' 3. Nil
(i) Manf.-l
(ii) Sales-2
II. Equipment :
II. Equipment
Zones-2
M. Vans
M. Vans
3 x35000
III. Books periodicals &
III. Books. Periodicals
Journals
& Journals Rs. 5000x5
214
1,02,090
2
1,29,720
3x35,000-
1,05,000
25,000
Total
Total Central Assistance
involved :
1
3,61,810
3,61,810
215
3. BIHAR
Existing set up
setjip
Prop ds
Additional staff required
Estimated Expenditure for 5th Plan peri o d
Posts
I. Drugs Inspectors-4
Emoluments
for 5 yrs.
Rs.
1. Drugs Controller-1
(1300-1600)
I. Drugs Controlier-1
1. Drugs
Controller
(1300-1600)
1
1,02,090
2. Assit.
Drugs Controllcr-5 (700-1250)
2. Asstt. Drugs
roller-5
2. Asstt. Drugs Cont
roller (700-1250)
5
3,24,300
3. Drugs Inspectors
29
Cont-
3. Inspectors :
(i) Manf.—3
(ii) Sale;
II. District - 17
No.
11.60,000
(350-900)
15.86,390
II. Equipment :
5 Vans x 35,000
II. Equipment
1,75,000
III. Books Periodicals &
Journals.
Rs. 25,000
III. Books Periodicals &
Journals
25,000
■30
Zones-4
III. Premises :
(i) Manufacturing-72
(ii) Sales-6100
17.86.390
Total Central Assistance
involved
17,86,390
4. GUJARAT
Existing set up
Proposed set up
1
2
I. Personnel
Personnel
1. Director. D.C.A.
Gujarat-1
2. Dy. Director Admn.-l
3. Asstt. Directors-5
4. Drugs Inspectors-35
5. Law Officer-1
II. Districts : 19
Zones ; 5
III. Premises :
(i) Manufacturing-170
(ii) Sales—3288
Additional staff
Estimated Exoenditure for 5th Plan Period
(Rs.)
3
4
The existing set up of the I. Personnel
State Drugs Control
Department in Gujarat
is adequate to exercise
a stringent control over
rhe quality of drugs
manufactured & mar
keted in the State.
II. Equipment
II. Equipment 6x35, 000 .
Six Vans x 35,000
III. Books .Periodicals
and Journals.
Nil.
2.10.CC0
III. Books, Periodicals & Journals,
25.0CO
25.CC0
2,35,000
Total Central Assistance
2,35.000
5. KERALA
Existing set up
Proposed set up
Additional staff
required
Estimated E-.penditure during the 5th Plan
Period.
No. of
Posts
Emolu
ments
(Rs.)
I. Personnel
I. Personnel :
1. Drugs Controller-1
1. Drugs Controller -1
1. Asstt. Drugs Contro
ller-3 Rs.700-1250
Asstt. Drugs Controller-3
700-1250
3
1.94,580
2. Asstt. Drugs Contro
ller-!
2. Asstt. Drugs Controller-4
3. Drugs Inspectors-1
Drugs Inspector
1
40.CC0
3. Drugs Inspectors-12
Manuf.-2 \
Sales-10
f 12
1—m of Pet. & Chem./75—28
3. Drugs Inspectors-11
I. Personnel
s
.-
216
IL Districts-10
Rs.
1,40.000
II. Zones -3
III. Premises :
1. Manufacturing-67
2. Sales 2031
II. Equipment
II. Equipment .
Rs. 1,40,000
(Purchase of mobile vans)
III. Equipment Vans : 4x III. Books. Periodicals & III. Books, Periodicals &
35,000
Journals 25,000
Journals
25,0(0
3,99.580
3.99.580
Total Central Assistance :
6. MADHYA PRADESH
Existing set up
Proposed set up
Additional staff
Estimated Expenditure for Fifth
No. of
Posts
I. Personnel :
1. Drugs Controller-1
2. Drugs Inspectors-16
Personnel
1. Drugs Controller-1
1. Asstt. Drugs Contro
ller-12
2. Asstt. Drugs Control- 2. Drugs Inspectors-11
ler-12
3. Drugs Inspectors :
(i) Manf.
7
(ii) Sales
20
I. Personnel
1. Asstt. Drugs Con
trollers (700-1250)
2. Drugs Inspectors
(350-900)
Plan period.
Emolu
ments.
(Rs.)
7,78,320
12
11
4,40.000
12.18,320
27
Zones : 11
II. Districts 43
Equipment
12 Mobile vans X
III. Premises
1. Mimfacturing 169
II. Equipment
II. Equipment
12 Mobile Vans x
12 Mobile vans x
35.000
35,000
III. Books, Periodicals &. III. Books, Periodicals &.
Journals 25,000
Journals
4,20.000
25,0-00
35.000
2. Sales 4029
16,63.320
Total Central Assistance
involved :
1. MAHARASHTRA STATE
Existing set up
Proposed set up
1
Additional staff required
3
I. Personnel:
1. Commissioner I
2. Joint Director 1
3. Asstt. Dir. 9
4. Drugs Inspectors 70
I. Personnel
1. Commissioner 1
2. Joint Director 1
Drugs Inspectors 34 *
3. Asstt. Dir.9
(350-900)
4. Drugs Inspectors- 104
5. Tech. OfIi:er-2
6. Law Officer- 1
7. Piarnicjutical
Chemist-1
8. Analytical Chemist-2
9. Lab. Asstt.-1
II. District
(ii) Sales —68 j 104
5. Tech. Officer- 2
6. Law Officer-1
7. Pharmaceutical
Chemist-1
8. Analytical Chemist-2
9. Lab Asstt.-1
Zones : 7
Equipment
IL 8 Mobile Vans X
35,000
(i) Mfr.
III. Premises
16,63.320
Estimated Expenditure during 5th Plan peried
No. of
EmoluPosts
ments
4
5
6
Rs.
I. Personnel
34
1,36,000
Drugs Inspectors 3
(350-900)
=36\
11. Equipment
8 Mobile vans
x 35,000
III. Books. Periodicals &
Journals Rs. 25,000
II. 8 Mobile Vans x
35,000
III. Books. Periodicals &
Journals
2,80,000
25.000
■
217
1. Manufacturing-888
2. Sales-13,586
II. Books, Periodicals &
Journals 25,000
4,41,000
4,41,000
Total Central Assistance involved :
8. .MYSORE STATE
Existing set up
Propoied set up
Additional staff
Estimated Expenditure during 5th Plan Period
No. of
Posts
I. Personnel
1. Asstt. Drugs Controlers (700-125O)-3
2.
Dy.
Drugs
Controller1
2.
Drugs Inspectors-3
2. Dy. Drugs Controller-1
3.
Asstt.
Drugs
Control3. Asstt. Drugs Controllerlers-6
4.
Drugs
Inspectors :
4. D ags lnspectors-22
I. Personnel :
1. Drugs Controller-1
I. Personnel:
1. Drugs Controller-1
(i) Mfg..-
(ii) SalesII. District : 20
III. Premises
I. Personnel
1. Asstt. Drugs Control
lers (700-1250)
2. Drugs Inspectors
3
1,94,580
1,20,000
3
3.14,580
3
22
25
II. Zones : 5----III. Equipment
6 Mobile Vans x
35,000
II. Equipment
6M. Vans x 35,000
2,10,000
II. Equipment
6x35,000
25,000
III. Books, Periodicals & III. Books, Periodicals &
Journals
Journals 25,000
1. Manufacturing-65
2. Siles-4,448
Emolu
ments
5,49,580
IV. Books, Periodicals &
Journals 25,000
Total Central Assistance invohed :
5,49,580
9. ORISSA
Existing set up
Proposed set up
Additional staff required
I. Personnel
1. Joint Drugs Controller-1 1. Drugs Controller-1
2. D ugs lnspectors-7
5
4
3
1
I. Personnel
Estimated Expenditure for the 5th Plan Period
I. Personnel
I. Personnel
No. of
Posts
1. Drugs Controller-1
1300-1600
1. Drugs Controller
1300-1600
1
2. Joint Drugs Controller 2. Asstt. Drugs Control- 2. Asstt. Drugs Controller 4
(700-1250)
ler-4 (700-1250)
-1
1
3. Drugs Inspectors
3. Asstt. Drugs Control 3. Drugs Inspcctros-1
(350-900)
(350-800)
lers^
4. Drugs Inspectors :
2
(i) Mfr.6
Ci)- Sales8
II. District : 13
II. Zones : 3
II. Equipment
Rs. 1,40,000
II. Equipment
4 Mobile vans
III. Premises :
III. Equipment
4 M. Vans x 35,000
III. Books & Journals
25,000
III. Books, Periodicals
& Journals
6
Emoluments
for 5
years.
1,02,090
2,59,440
40,000
4,01,530
1,40,000
25,000
5,66,530
1. Minufacturing-49
2. Sales-1,123
IV. Books, Periodicals
and Journals Rs.
25,000
Total Central Assistance :
5,66,530
218
10. PUNJ.4B
Existing set up
Proposed set up
Additional staff Required Estimated Expenditure during 5th
Plan Period.
No. of
Posts.
I. Personnel
I. Personnel
1. Drugs Inspectors-] 2
1. Drugs Controller-1
Emoluments
I. Personnel
2. Asstt.
Drugs Controller-6
3. Drugs Inspectors :—
i. Mfr.;
3
ii. Sales :
12
1. Drugs
Controller-1 1. Drugs
Controller.
(1300-1600)
(1300-1600)
2. Asstt. Drugs Con- 2. Asstt. Drugs Con
troller-6 (700-1250)
troller. (700-1250)
3. Drugs Inspector-3
3. Drugs Inspectors (350(350-990)
900)
1
Rs.
1,02,090
6
3,89.160
3
1,20,000
15
II. Districts: 20
III. Premises:
1. Manufacturing : 63
2. Sales :2410
6,11,250
Zones : 5
II. Equipment
6 mobile vans
x35,000
II. Equipment
6 Mobile Vans
2,10,000
III. Books, Periodicals &
Journals 25,000
III. Books &
25,000
II. Equipment
6 Mobile vans
x35,OOO
2,10,000
Journals III. Books, Periodicals
& Journals
25.000
8,46.250
Total Central Assistance involved :
8,46,250
11. RAJASTHAN
Existing set up
Proposed set up •
I. Personnel
1. Drugs Inspectors-6
I. Personnel
1. Drugs Controller-1
Additional staff required
Estimated Expenditure during 5th Plan
I. Personnel
/. Personnel
1. Drugs Controller-!
1. Drugs Controller.
(1300-1600)
(1300-1600)
2. Asstt. Drugs Con- 2. Asstt. Drugs
Con- 2. Asstt. Drugs Con
t roller-7
troller-7
troller-7
3. Drugs Inspectors :—
3. Drugs Inspectors-12
3. Drugs Inspectors-12
i. Manufacture-2
(350-900)
(350-900)
ii. Sales :
16
No. of
Posts.
1
Emoluments
Rs.
1,02,090
7
4,54,020
12
4,80,000
10,36,110
18
II. Districts : 23
II. Zones : 6
III. Premises :
1. Manufacturing 50
2. Sales : 3176
III. Equipment
7 Mobile vans
x35,OOO
II. Equipment
7 Mobile vans
2,45.000
III. Books & Journals :
25,000
II. Equipment
7 Mobile Vans
x35,OOO
III. Books & Journals
2,45,000
25,000
13,06,110
IV. Books, Periodicals &
Journals 25,000
Total Central Assistance
Involved:
12. UTTAR
Existing set up
Proposed set up
PRADESH
Additional staff required
Estimated Expenditure during 5th Plan
I. Personnel
I. Personnel
I. Personnel
I. Personnel
1. Asstt. Drugs Contro- I. Drugs Controller-1
1. Drugs Controller-]
1. Drugs Controller-1
ller-1
(1300-1600)
2. Drugs Inspectors-15
2. Asstt. Drugs Con 2. Asstt. Drugs Con 2. Asstt. Drugs
Con
troller-14
troller-13
troller (700-1250)
3. Drugs Inspectors :—
3. Drugs InSpectors-79
3. Drugs Inspectors-79
14
i. Manuf.
(350-900)
ii. Sales :
80
94
13,06,110
No. of
Posts.
1
Emoluments
Rs.
1,02,090
13
8,43,180
79
31,60,000
41,05,270
<•
I
II. Districts :54
III. Premises
1. Manufacturing : 340
2. Sales : 16,000
'219 •
II. Equipment
14 x 35,000
—4,90,000
Zones : 13
III. Books, Periodicals & III. Books & Journals,
Journals 25,000
25,000
II. Equipment
14 Mobile Vans
4,9 ,
III. Books, Periodicals &
Journals
25, 0
Rs. 46,20,270
Total Central Assistance
Involved :
13. WEST
Existing set up
BENGAL
Additional staff required
Proposed set up
Rs. 46,20,270
Estimated
Expenditure during 5th Plan.
i\ro. of
Posts.
I. Personnel
I. Personnel
D.C.A., W. 1. Director, D.C.A.-l.
1. Director,
Bengal-1.
2. Asstt. Directors-7
2. Asstt. Directors-2
3. Drugs Inspectors-23
1. Personnel
I. Personnel
1. Asstt. Directors-(700- 1. Asstt. Directors.
1250)-5
(700-1250)
2. Drugs Inspectors-28, 2. Drugs Inspectors
(350-900)
(350-900)
Emoluments
Rs.
5
3,24,300
28
11,20,000
3. Drugs Inspectors :—
i. Mfr. :
20
ii. Sales
31
51
4. Administrative Officer-1
5. Law Officer-1
II. Districts : 16
III. Premises
1. Manufacturing : 508
2. Sales : 6,379
4. Administrative Officer-1
5. Law Officer-1
Zones : 4
II. Equipment
5 Mobile Vans
1,75,000
I IL Equipment
III. Books, Periodicasl &
5 Mobile
Journals 25,000
Vans x 35,000
II. Equipment
5 Mobile Vans
1,75,000
III. Books, Periodicals &
Journals
25,000
Rs. 16,44,300
Total Central Assistance
Involved :
Rs. 16,44,300
14. DELHI
Existing set up
I. Personnel
1. Asstt. Drugs Con
troller-2
2. Drugs Inspectors-8
Proposed set up
I. Personnel
1. Drugs Controller-1
2. Asstt. Drugs Controller-2
3. Drugs Inspectors :—
i. Manf.
4
ii. Sales
19
Additional staff required
Estimated
I. Personnel
1. Drugs Controller-1
(1300-1600)
2. Drugs Inspectors-15
(350-900)
I. Personnel
1. Drugs Controller.
(1300-1600)
2. Drugs Inspectors :—
(350-900)
Expenditure for 5 years
No. of
Posts.
Emoluments
Rs.
1
1,02,090
15
6,00;000
7,02,090
23
II. District : 1
III. Premises
Zones : I
III. Equipment
2 Mobile
vans x 35,000
II. Equipments
2 Mobile Vans
70,000
II. Equipment
2 Mobile Vans
III. Books & Journals III. Books & Journals
25,000
70,000
25,000
Rs. 7,97,090
1. Manufacturing-91
2. Sales-3,806
IV. Books & Journals :
25,000
Total Central Assistance
Involved :
Rs. 7,97,090
220
15. HIMACHAL PRADESH
Additional staff required Estimated Expenditure during 5th Plan period
Existing set up
Proposed set up
I. Personnel
1. Drugs Inspectors^
I. Personnel
I. Personnel
I. Personnel
1. Drugs Controller-1
1. Drugs
Controller-1
1. Durgs Controller-1
(1300-1600)
2. Asstt. Drugs Control- 2. Asstt. Drugs Con
troller-2
ler-2
2. Assistance Drugs
controller-2
(700-1250)
3. Drugs
Inspectorsj :— 3. Drugs Inspcctors-2
3. Drugs Inspectors-2
....
(350-900)
i. Manf.
3
ii. Sales
No. of Emoluments
Posts.
Rs.
1
1,02,090
2
1,29,720
80,000
4
fl. Districts : 6
III. Premises :
1. Manufacturing : 6
2. Sales-531
3,11,810
II. Equipment
II. Equipment
2 Mobile Vans
2 Mobile vans
70,000
III. Books, Perodicals A III. Books A Journals
Journals 25,000
II. Zones : 1
III. Equipment
2 Mobile vans
70,000
25,000
35,000
4,16,810
IV. Books, Periodicals A
Journals Rs. 25,000
Total Central Assistance
Involved :
4J6,810
16. HARYANA
Existing set up
Proposed set up
Additional staff required
I. Personnel
I. Personnel
1. Asstt. Drugs Con- 1. Drugs Controller-1
troller-1
2. Asstt. Drugs Con2. Drugs Inspectors-6
troller-2
3. Drugs Inspectors :—
n
i. Manf.
5
ii. Sales
Estimated
Expenditure during 5th Plan Period
I. Personnel
1. Drugs Controller-1
I. Personnel
1. Drugs Controller
(1300-1600)
2. Asstt. Drugs Con- 2. Asstt. Drugs Con
troller-1
troller-1
3. Drugs Inspectors-1
3. Drugs Inspectors-1
No. of
Posts.
1
Emoluments
Rs.
1,02,090
1
64,840
1
40,CIO
7
II. District 6
III. Premises :
1. Manufacturing-67
2,06,930
II. Equipment
2 Mobile vans
x 35,000
III. BooksA Journals :
II. Zones - 1
III. Equipment
2 Mobile vans
x 35.000
II. Equipment
2 Mobile Vans
70,000
III. Books & Journals :
25,000
25,000
3,01,930
2. Sales-1031
IV. Books A Journals :
25,000
Total Central Assistance
Involved :
3,01,930
17. PONDICHERRY
Additional staff required
Estimated Expenditure during 5th Plan
Existing set up
Proposed set up
I. Personnel
1. Drugs Inspector-1
I. Personnel
1. Drugs Controller.
(1300-1600)
2. Asstt. Drugs Con- 2. Asstt. Drugs Con- 2. Asstt. Drugs Controllcr-2
troller-2
troller.
3. Drugs Inspcctors-3
3. Drugs Inspectors :
3. Drugs Inspectors.
i. Manf.
1
3
ii. Sales :
I. Personnel
1. Drugs Controller-1
4
I. Personnel
1. Drugs Controller-1
No. of
posts
1
Emoluments
Rs.
1,02,900
2
1,29,720
3
1,20,000
3,52,620
221
II. Territory-
II. Zones: 1
III. Premises
III. Equipment
1. Manufacturing-22
2. Sales-603
2 Mobile vans
x 35,000
II. Equipment
2 Mobile vans
II. Equipment
2 mobile vans
Rs.
70,000
III. Books & Journals-
III. Books & Journals
25,000
Rs.25.000
IV. Books &. Journals
25.030
4,47,620
Total Financial Assistance
involved :
4.47,620
18. CHANDIGARH
Estimated emoluments for 5 years of 5:h Plan
Period
Additional staff required
Existing set up
Proposed set up
I. Personnel
1. Drugs Inspectors-1
I. Personnel
I. Drugs Controller-1
/. Personnel
1. Drugs Controller.
(1300-1600)
2. Asstt. Drugs Con- 2. Asstt. Drugs Con- 2. Asstt. Drugs Controller-1
troller-1
troller
(700-1250)
3. Drugs Inspector-2
3. Drugs Inspcctors-1
3. Drugs Inspectors
(350-900)
I. Personnel
1. Drugs Controller-1
No. ef Emoluments
Posts.
Rs.
1.02,090
1
1
64,860
I
40,000
2.06.950
II. Territory : 1
III. Premises
Zone -1
HI. Equipment
1 Mobile van :
35,000
II. Equipment
I Mobile van
35,000
III. Books & Journals
25,000
II. Equipment
1 Mobile Van
35.000
III. Books & Journals
25.000
1. Manufacturing : 63
2.66,950
2. Sales :—
Books &
25.000
Journals
Total Central Assistance
involved :
19. TAMIL
Existing set up
Proposed set up
2,66,950
NADU
Additional staff required
Estimated expenditure during 5 yrs. of 5th Plan
Period.
/. Personnel
I. Personnel
T. Personnel
I. Personnel
1. Deputy Drugs Con- 1. Drugs Controller-1
I. Drugs Controller-1
I. Drugs Controllertroller-1
Ci 300-1600)
2. Asstt.
Drugs
Con- 2. Dy. Drugs Con
2. Asstt. Drugs
Con- 2. Asstt. Drugs Controller-1
troller-1
trollcr
troller-3
3. Asstt. Drugs Con- 3. Drugs Inspectors-3
3. Drugs [nsoectors-69
3. Drugs Inspectors.
troller-4
4. Drugs Inspectors :
i. Manf.
11
ii. Sales
61
No. of
Posts
1
Emoluments.
Rs.
1.02,090
3
1,94,580
3
1,20,000
4,16,670
72
II. District: 13
II. Zones : 3
III. Premises :
III. Equipment
4 Mobile Vans
x 35,000
1. Manufacturing : 275
2. Sales 12291
/V. Books. Periodicals &
Journals Rs.25.000
II. Equipment
4 Mobile vans
x 35,000
III. Books &. Journals
Rs.25,000
II. Equipment
4 Mobile Vans
1.40.000
III. Books & Journal
25,000
5,81,670
Total Central Assistance
involved
:
5,81,670
222
20. GOA,
Existing set up
I. Personnel
Propsed set up
DIU
&
DAMAN
Additional staff required.
Estimated
Expenditure for 5 years, of 5th Plan
Period
Rs.
Personnel
1. Drugs Controller-1
1. Drugs Controller-1
2. Asstt. Drugs Con
troller-5
2. Asstt. Drugs Controller-cum-Drugs
Inspector-5
Nil
Staff :
Nil
70.000
25.000
Equipment :
Books & Journals :
or
Territory :3
II. Zone : 1
Premises :
III. Equipment
2 Mobile vans
x 35,000
HI. Equipment
70,000
IV. Books & Journals
25,000
IV. Books &
Rs. 25,000.
1. Manufacturing 14
95,000
1,00.000
Nil
Total
Central
Assis1,00.000
TANCE REQUIRED :
2. Sales-75
Journals
21. .MANIPUR
Existing set up
Proposed set up
Additional staff required
Personnal
I. Personnel
1. Drugs Inspector-1
Estimated
1. Asstt. Drugs
troller-1
Con-
1. Asstt. Drugs
trolier-l
(700-1250)
Expenditure
for 5 yrs. of 5th Plan
Personnel
Con-
1. Asstt. Drugs
troller
(700-1250)
No. of
Post
Emoluments
Rs.
1
64,860
Con-
2. Drugs Inspector-1
2. Territory-1
3. Premises :
Equipment
1 Mobile van
x 35,000
Equipment
1 Mobile \ an
35,000
Books & Journals 25,099
Books & Journals, 25,099 3. Books & Joarntls
2. Equipment
1 Mobile van
35,000
25,090
1. Manufacturing
2. Sales-142
1,24,860
Total Central Assistance :
22.
Existing
set up
I. Personnel
There is no exclusive staff
for Drugs Control in the
Territory.
Proposed
set
up
Additional staff required
Estimated Expenditure for 5 yrs.of Plan
No. of
Posts.
I. Personnel
I. Personnel
1. Asstt. Drugs
troller-1
Con-
1,24,860
TRIPURA
Same as in Column-II
1. Asstt. Drugs
troller
(700-1250)
Period.
Emoluments
Rs.
Con-
I
64,860
2. Drugs Inspector-1
2. Drugs Inspector.
(350-900)
II. Equipment
1 Mobile van
x 35,000
II. Equipment
1 Mobile van
35,000
III. Books & Journals
25,000
III. Books & Journals
25,000
1
40,000
1,04,860
II. Territory-l
///. Premises
1,64,860
1. Manufacturing-5
2. Sales-49
Total Central Assistance
INVOLVED
1.64,860
t
I
Appendix—II
SUMMARY : Strengthenging of Drugs Control and Enforcement Wing in States
SI.
No.
Name of the State/Territory
1
2
Additional Establishment proposed to be provided
3
Total Central Assis
tance involved for
shouldering expendi
ture @100% for 5
years of 5th Plan
period
4
Rs.
28,91,434
1. Andhra Pradesh .
•
Staff
1. Drugs Controller-one
2. Assitt Drug Controller-3
3. Drugs Inspectors-59
Equipment
4. Mobile Vans-6
5. Books and Periodicals-25,000
2. Assam
.
Staff
1. Drugs Control let-1
2. Asstt. Drugs Controller-2
Equipment
3. Mobile Vans-3
4. Books & Periodicals-25,000
3. Bihar .
<
Staff
1 Drugs Controller-1
2. Asstt. Drugs Controller-5
3. Drugs Inspector-29
Equipment
4. Mobile Vans-5
5. Books & Journals -25,000
17,86,390
4, Gujarat
.
S7<-Nil
Equipment
1. Mobile Vans-6
2. Books & Joumals-25,000
2 »35,OOO
5. Kerala
.
Staff
1. Asstt. Drugs Controller-3
2. Drugs Inspector-1
Equipment
3. Mobile Vans-4
4. Books & Journals—25 000
3,99,580
.
6. Madhya Pradesh .
Staff
1. Asstt. Drugs Controller-12
2. Drugs Inspectors-11
Equipment
3. Mobile Van-12
4. Books & Journals—25,000
7. Maharashtra State
.
Staff
1. Drugs Inspectors-34
Equipment
2. Mobile Van-8
3. Books & Journals-25,000
8. Mysore State
•
Staff"
1. Asstt. Drugs Controller-3
2. Drugs Inspectors-3^
Equipment
3. Mobile Vans-6
4. Books & Joumals-25.000
9. Orissa.
.
Staff
1. Drugs Controller-1
2. Asstt. Drugs Controller-4
3. Drugs Inspector-1
Equipment
4. Mobile Vans-4
Books and Joumals-25,000
3,61,810
16,63,320
4,41,000
5,49,580
5,66,530
223
1 M of Pet & Chem/75—29
I
1
224
1
3
2
11. Rajasthan
Staff
.
10. Punjab
.
12. Uttar Pradesh
4
Rs.
8,46,250
1. Drugs Controllcr-1
2. Asstt. Drugs Controller-6
3. Drugs Inspetors-6
Equipment
4. Mobile Vans-6
5. Books & Journals-25,000
• Staff
1. Drugs Controller-1
2. Asstt. Drugs Controller-7
3. Drugs Inspectors-!2
Equipment
4. Mobile Vans-7
5. Books & Journals-25,000
• Staff
1. Drugs Controller-!
2. Asstt. Drugs Controller-13
3. Drugs Inspectors-79
Equipment
4. Mobile Vans-14
5. Books & Journals-25,000
13. West Bengal
13,06,110
46.20,280
Staff
1. Asstt. Director-5
2. Drugs Inspectors-28
Equipment
3. Mobile Vans-5
4. Books & Journals-25,000
16,44,300
14. Delhi
•
Staff
1. Drugs Controller-1
2. Drugs Inspectors-15
Equipment
3. Mobile Vans-2
4. Books & Journals-25,000
7,97,090
15. Himachal Pradesh
■
Staff
1. Drugs Controller-]
2. Asstt. Drugs Controller-2
3. Drugs Inspectors-2
Equipment
4. Mobile Vans-2
5. Books & Journals-25,000
4.16,810
16. Haryana
.
Staff
1. Drugs Controller-1
2. Asstt. Drugs Controller-1
3. Drugs Inspectors-1
Equipment
4. Mobile Van-2
5. Books & Journals-25,000
3,01,930
17. Pondicherry
■
Staff
1. Drugs Controller-1
2. Asstt. Drugs Controller-2
3. Drugs Inspectors-3
Equipment
4. Mobile Vans-2
5. Books & Journals-25,000
4,47,620
18. Chandigarh .
•
Staff
2,66,95°
19. Tamil Nadu
.
Staff
5,81,670
20. Goa, Daman & Diu
.
Staff—Nil
Equipment
1. Mobile Vans-2
2. Books & Journals-25,000
1,00,000
1. Drugs Controller-1
2. Asstt. Drugs Controller-1
3. Drugs Inspector-1
Equipment
4. Mobile Van-1
5. Books & Journals-25,000
1. Drugs Controller-1
2. Asstt. Drugs Controller-3
3. Dnigs Inspectors-3
Equipment
4. Mobile Vans-4
5. Books & Jorunals-25,000
-
1
2
4
3
’
21. Manipur
.
Staff
1. Asstt. Drugs Controller-!
Equipment
2. Mobile Van-1
3. Books & Journals-25,000
22. Tripura
.
Staff
1. Asstt. Drugs Controller-1
2. Drugs Inspector-1
Equipment
3. Mobile Van-1
4. Books & Journals-25,000
Rs.
1,24,860
1,64,860
Grand Total
I. Total Additional Staff for 5th Five Year Plan :
(1) Drugs Controller :
(2) Asstt. Drugs Controllers :
(3) Drugs Inspectors :
13
74
286
II Mobile Vans :
103
III. Books & Periodicals :
Q
5.50 Lakh.
250,13,374
7.7
•RF
Appendix—C
EMOLUMENTS OF EACH SQUAD
No.
Emolu
ments
1974-75
Emolu
ments
1975-76
2
3
4
1. Drugs Inspectors (350-900) .
2
2. Police Officer (325-575)
Staff
Total
Emolu
ments
1976-77
Emolu
ments
1977-78
Emolu
ments
1978-79
5
6
7
8
9
15,400
15,900
16,400
17,900
18,400
84,000
2
14,655
15,155
15,655
16,155
16,655
78,275
3. Field Asstt. (150-300) .
1
4,322
4,466
4,610
4,754
4,900
23,052
4. Watchers (110-180)
3
9,131
9,395
9,619
9,863
10,107
38,905
5. Driver (150-300)
1
4,322
4,466
4,610
4,754
4,900
23,052
47,830
49,362
50,894
53,426
54,962
2,56,474
1st Yr.
13.87
Hnd Year
14.31
3rd Yr.
14.76
4th Yr.
15.49
5th Yr.
15.94 74.37 iakh
or say 75 lakhs
1
Cost of 29 Squads :
Cost per Squad : 75:29-2.60 lakhs
226
■
■
.
Annexure—IV
A STATEMENT OF PROPOSED AMENDMENTS TO THE DRUGS AND COSMETICS ACT
(Chapter IX—Para 41—App. I)
SI. No.
Section of the Act
(A)
(B)
1. Section 3(b) dehnition
term “drug”
Existing provision in the Drugs and Cosme
tics Act, 1940
(C)
of the
2. Section 3(f)
Proposed amendment
(D)
After caluse (ii) the following shall be added :
“drug” includes :—
(i) all medicines for internal or external use
(iii) All substances intended for ujc as
of human beings or animals,and all subcomponents of a drug including empty
gelatin capsules.
tances intended to be used for or in the
diagnosis, treatment, mitigation or pre
(iv) Such devices intended for internal or
vention of disesase in human beings or
external use in the diagonisis, treatment,
animals;
or mitigation of disease or disorder in
human beings or animals as may be
(ii) such substances (other than
food)
specified from time to time by ' the
intended to affect the structuie or any
Central Government by notification
function of the human body or intended
in the Official Gazette in consultation
to be used for the destruction of vermin
with the Board.
or insects which cause disease in human
beings or animals, as may be specified
from time to time by the Central Govern
ment by Notification in the Official
Gazette;
(f)
manufacture in relation to any drung or Delete the words '‘with a view to its sale and
cosmetic includes any process or part of a
distribution.”
process formaking, altering, ornamenting
finishing, packing, labelling, breaking
up or otherwise treating or adopting
any drug or cosmetic with a view to its
sale and distribution but does not include
the compounding or dispensing of any
drug or cosmetic in the ordinary course
of retail business; and to manufacture’
shall be construed accordingly;
3. Section5—The Drugs Technical 5. The drugs Technical Advisory Board. (1) The In sub-section (2) after clause (xvi) the follow
Central Government shall, as soon as may be, ing shall be added :
Advisory Board
constitute a Board (to be called the Drugs
Technical .Advisory Board) to advise the
Central Government and the State Govern
ments on technical matters arising out of the “(XVII) two persons to be nominated by the
administration of this Act and to carry out
Central Government representing con
the other functions assigned to it by this Act.
sumer’s interests.
(2) The Board shall consist of the following
members, namely;
4. Section
metics
9—Misbranded cos-x
Ini clause (f) after the word “container” the
Misbanded cosmetics—
For the purpose of this Chapter, a cosmetic
following words shall be introduces :
shall be deemed to be misbranded—
(f) if its label or container bears the name
“or anything accompanying the cosmetics”.
of an individual or company purporting
to be the manufacturer or producer of
the cosmetic which
individual
or
company is fictitious or does not exist,
or
5. Section 9 B Adulterated drugs 9B. Adulterated drugs—For the purposes, of
this chapter, a drug shall be deemed to be
adulterated.
6. Section 10
After clause (b) the following clause shall be
added:
“(bb) if it contains any harmful or toxic
material which renders it injurious to.
health.
10. Prohibition of import of certain drugs & After (a) the following shall be added :
(aa) any drug which is not generally recog
cosmetics—From such date as may be fixed
by the Central Government by notifica
nised among experts as safe or efficacious
tion in the Official Gazette in this behalf, no
for use under conditions recommended
person shall import—
or suggested on the label thereof unless
(a) any drug or cosmetic which is not of stan
it is approved by such authorities and
dard quality;
in a manner as may be prescribed.”
227
228
(A)
7. Section 10
S. Section 10
(B)
(C)
J
(D)
10. Prohibition of import of certain drugs and For sub-section (d) the following shall be
cosmetics—From such date as may be fixed
substituted:
by the Central Government by Notification in “(d) Any patent or proprietary medicine
the Official Gazette in this behalf, no person
unless there is displayed in the prescrib
shall import—
ed manner on the label of the container
(a) any drug or cosmetic which is not standthereof the true formula or list of in
dard quality;
gredients together with quantities there
of”.
(d) any patent or proprietary medicine, un
less there is displayed in the prescribed
manner on the label or container thereof
the true formula or list of ingredients
contained in it, in a manner readily intell
igible to the members of the medical pro
fession.
Explanation—The formula or list of ingredients For the existing Explanation the following
shall be substituted :—
mentioned in clause (d) shall be deemed to be
“Explanation—The formula or list of
true and sufficient compliance with that sub
ingredients rr.enticr.ed in clause (d) shall
clause if without disclosing a full and detailed
be deemed to be true and sufficient ccir.precioe of the ingredients, it indicates correctly
liancc with that sub-clause if it indi
all potent or poisonous substances contained
cated correctly all the active ingredients
therein together with an approximate statement
contained therein together with the
of the composition of the medicine.
quantities thereof.
9. Section 12-Power of Central 12. Power of Central Government to make In sub-section (1). after the words “after
Rules—
consultation with the Board” the following
Government to make Rules.
(10)The Central Government may. after conswords shall be inserted :
sultation with the Board and after pre“or on the recommendation of the Board”.
- vious publication by notification in the
official Gazette, make Rules for the pur
pose of giving effect to the provisions of
this Chapter;
10. Section 12—Power of Central 12. Power of Central Government to make Rules—In sub-section (2), after clause (c) the
following shall be added :
Government to make Rules.
(1) ......................
(2) Without prejudice to the generality of
the foregoing power, such Rules may—
“(cc) prescribe under clause (aa) of Section
(a) .....................
10, the authority who will approve the
(b) .....................
drugs specified in it, the information to
(c) prescribe the conditions subject to which
be called for in this connection and
small quantities of drugs the import of
the manner in which such drugs
should be investigated before approx al
which is otherwise prohibited under this
is granted.”
Chapter, may be imported for the pur
pose of examining, tost or analysis or
for personal use;
13. Offences—(1) Whoever contravenes any of For the existing Section 13, the following
11. Section 13 Offences
shall be substituted :—
the provisions of this Chapter or of any Rule
(1) Whoever imports
made thereunder shall, in addition to any pen
deemed
to be misbranded under
alty to which he may be liable under the pro (a) any drug
•
'
clause (a), clause (b), clause (c), clause
visions of Section 11, be punishable with im
(d), clause (f), and clause (g) of Section
prisonment which may extend to one year, or
or adulterated under Section 9B or any
with fine which may extend to five hundred
cosmetic contravening clause (ee) Sec
rupees or with both.
tion 10shall be punishable with impri
(2) Whoever, having been convicted under
sonment which may extend to three
sub-section (1), is again convicted under
years or with fine which may extend
that sub-section shall, in addition to any
to rupees one thousand or with both.
penalty as aforesaid be punishable with
imprisonment which may extend to two
years or with fine which may extend to
(b) Any drug other than a drug or cosme
one thousand rupees, or with both.
tic referred to in clause (a) in contraven
tion of Section 10 or any rule there
under shall be punishable w ith imprison
ment which may extend to one year
or with fine which may extend to five
hundred rupees or with both.
(2) Whoever having been convicted under
sub-section (1) is again convicted under
that sub-section shall, in addition to any
penalty aforesaid be punishable with
imprisonment which may extend to five
years or with fine which may extend
two thousand rupees or with both.
I
L
I
229
(A)
(B)
(Q
(D)
12. Section 17B Adulterated drugs. 17B. Adulterated drugs—For the purpose of this After clause (b), the following clause shall
■
’ ”'be deemed’ •to ’be adulterat
’ ’•
be added :—
Chapter drug
shall
'(bb) if it contains any harmful or toxic
ed—
material which renders it injurious
to health”.
18 Prohibition of manufacture and sale of cer For Section 18, the following shall be substi13. Section 18 Prohibition of
_______
______________
tuted :—
tain
drugs
and cosmetics—_______________
From such date as
manufacture and sale of certain
may be fixed by the State Government by not 1- “18. Prohibition , of manufacture and sale of
drugs and cosmetics.
certain drugs and cosmetics
fication in the official Gazettee in this behalf,
From such date as may be fxed t> the
no person shall himself or by any other person
State Govenrment by notification in
on his behalf :—
the official Gazette in this behalf, no
(a) manufacture for sale or sell, or stock or
person shall himself or by any other
exhibit for sale, or distribute—
person on his behalf : —
(a) manufacture, or sell, or stock or exhibit
(i) any drug or cosmetic which is not of
for sale or offer for sale or distribute
standard quality;
r.
(ii) any misbranded drug or misbranded cos
metic ;
(iii) any adulterated drug;
(iv) any patent or proprietary medicine unless
there is displayed in the prescribed man
ner on the label or container thereof the
true formula or list of ingredients con
tained in it in a manner readily intelligi
ble to the members of the medical pro
fession.
(i) any drug or cosmetic which is not
of standard quality;
(ii) any misbranded drug or misbranded
cosmetic:
(iii) any adulterated drug;
(iv) any patent or proprietary medicine
unless there is displayed in the
ner on the label or presciihct••irrncontainer thereof the true formula
or list of ingredients contained in it
together with the quantitiesthereof;
(v) any drug which by means of any
statement, design or device accompanying it or by any other means
purports or claims to prevent, cure
or mitigate any such disease or ailment. or to have any such other
effect as may be prescribed:
(vi) any cosmetic containing any ingre
dient which may render it unsafe or
harmful
for
use
under the
directions indicated or recommended;
(v) any cosmetic containing any in
gredient which may render it unsafe
or harmful for use under the direction
indicated or recommended.
(vi) Any drug which is not generally
recognised by experts as sate or
efficacious for use under the condi
tions recommended or suggested
in the label thereof unless'it is
approved by such authority and
in such manner as may be pres
cribed.
(vii) any drug or cosmetic in contravention of any of the provisions of
this Chapter or any Rule made
thereunder :
(b) sell, or stock or exhibit for sale, or distri
bute any drug or cosmetic which has
been imported or manufactured in contra
vention of any of the provisions of this
Act or any Rule made thereunder ;
(c) manufacture for sale, or sell, or stock
or exhibit for sale, or distribute any
drug or cosmetic, except under and in
accordance with the conditions of, a
licence issued for such purpose under
this Chapter:
Provided that nothing in this Section
shall apply to the manufacture, subject
to prescribed conditions, of small quan
tities of any drug for the purpose of
examination, test or analysis.
Provided further that the Central Go
vernment may, after consultation with
the Board by notification in the official
Gazette, permit, subject to any conditions
specified in the notification, the manu
facture for sale, sale or distribution of
any drug or class of drugs not being of
standard quality
Explanation—The Formula or list of
ingredients mentioned in sub-clause (iii)
of clause (a) shall be deemed to be true
and a sufficient compliance with that
sub-clause if whithout disclosing a full
(vii) any drug which by means of any
statement, design or device accom
panying it or by any other means
purports or claims to prevent cure
or mitigate any such disease or
ailment or to have any such other
effect as may be prescribed ;
(viii) any cosmetic containing any ingre
dient which may render it unsafe
and harmful under the directions
indicated;
(ix) any drug or cosmetic in contra
vention of any of the provisions
of this Chapter or any Rules made
thereunder;
(b) Sell or stock or exhibit for sale, offer
for sale or distribute any drug or. cos
metic which has been imported or
manufactured in contravention of any
of the provisions of this Act or any
Rules made thereunder;
(c) manufacture, or sell, or stock or exhibit
for sale, or distribute any drug or cos
metic except, under and in accordance
with the conditions of licence issued for
such purpose under this Chapter.
Provided that nothing in this Section
shall apply to the manufacture, subject
to the prescribed conditions, of small
quantities of any drugs for the purpose
of examination test or analysis.
230
(A)
(B)
(C)
and detailed recipe of the ingredients
it indicates correctly all the potent or
poisonous substances contained therein
together with an approximate statement
of the composition of the medicine.
(D)
Provided further that the Central Go
vernment may, after consultation with
the Board,
by notification in the
official Gazette, permit subject to any
conditions specified in the notification,
the manufacture, sale or distribution of
any drug or class of drugs not being of
standard quality.
Explanation : The formula or list of
ingredients mentioned in sub-clause
(iv) of clause (a) shall be deemed to be
true and a sufficient compliance with
the sub-clause if. it indicates correctly
all the active ingredients contained
therein together with the quantities
thereof.”
14. Secrion 19(3) Pleas
Under Section 19(3) the words “duly licensed”
19. Pleas.CS) A person, not being the manufacturer
shall be added after the word “person.”
of a drug or cosmetic or his agent for
distribution thereof, shall not be liable
for a contravention of Section 18 if he
proves—
15. New Seci ion 19 A
After Section 19 the following shall be added
“19A. Burden of Proof: When any drug or cos
metic is seized from any person in the reason
able belief the drug or cosmetic is mis
branded or adulterated, the burden of prov
ing that such drug or cosmetic is not
misbranded or adulterated shall be on the
person from whose possession such drug or
cosmetic seized.”
16. Section 22. Powers of Inspectors
22. Powers of Inspectors.—
(1) Subject to the provision of Section 28
and of any rules made by the Central
Government in this behalf an Inspector
may, within the local limits of the area
for which he is appninted;
(a) inspect any premises wherein any
drug or cosmetic is being manu
factured and in the case of sera,
vaccines and any other drugs
or
cosmetics prescribed in this behalf,
the plant and process of manufacture
and means employed for standrdizing
and testing the drugs.
17. Section 22 Powers of Inspectors
22. Powers of Inspectors :
G) .......................
“(a) inspect any premises wherein
(i) any drug or cosmetic is manufactured
and the plant and process of manu
facture and the means employed
for standardizing and testing the
drugs or cosmetics; and
(ii) any drug or cosmetic is sold or
stocked or exhibited for sale or
offered for sale or distributed.
After—sub-clause (cc) the following sub
22. Powers of Inspectors.—
clauses shall be added :—
(i) Subject to the provision of Section 23
(d) seize and detain for such time as may
and of any rules made by the Central
be necessary any articles by mean
Government in this behalf, an Inspector
of or in relation to which he reasonably
may, within the local limits of the area
believes that any provision of this
for which he is appointed
Act or Rules have been contravened.
(cc) examine any record, register docu
ment or any other material object
found in any place mentioned in
clause (c) and seize the same if he
has reason to believe .that it may
furnish evidence of the commission
of an offence punishable under this
Act or the Rules made thereunder;
(e) stop and detain for such time as may
be necessary any vehicle suspected
to contain any drug or cosmetic which
he has reason to believe contravenes
any of the provisions of the Act or
the Rules made thereunder ;
(f) seize in any place or any person any
drug or cosmetic in respect of which
he has reason to believe an offence pu
nishable under this Act or Rules made
thereunder, has been committed and
alongwith the drug or cosmetic, other
articles or documents which he has
reason to believe may furnish evidence
of the commission of any offence pu
nishable under this Act.
...
....
--7.-4- -
f
.
231
I
(0
(B)
(C)
(D)
(g) require the production of any register or
other documents relating to manufacture
or sale of such drug or cosmetic and take
on the spot or otherwise, statements of
any peison which he may consider
necessary for carrying out the purposes
of the Act.
Clause (d) shall be renumbered (h)
18, New Section 22A
After Section 22 of the Act, the following
new Section shall be added : —
“Section 22A:—POWER to summon persons
to give evidence and produce documents
for enquiries under the Act.
(i) An Inspector shall have the power
to summon any person whose
attendance he considers necessary
cither to give evidence or to produce
a document or any other thing in
any enquiry or investigations which
such Inspector is making for any of
the purposes of this Act.
r
(ii) The summons to produce documments or other things under sub
section (i) may be for the produc
tion of certain specified documents
or things or for the production of
all documents or things of a certain
descritpion in the possession of or
under the control of the persons
concerned.
(iii) All persons so summoned shall be
bound to attend either in person
or by an authorised agent as the
Inspector may direct and all persons
so summoned shall be bound to state
the truth of any subject, respecting
which he is examined or make
statements and produce such docu
ments and other things as may be
required.
19. New Section 25a
(iv) Every such enquiry as aforesaid shall
be deemed to be a judicial proceed
ing within the meaning of» Section
193 and 228 of the Indian Penal Code.
After Section 25, the following Section shall
be added :—
“25 A—Presumption in certain cases
(1) When it is proved that a package con
taining any drug or cosmetic bears the
name and address purporting to be the
name and address of the person by
whom it was manufactured, the Court
may presume in a prosecution for con
travention of this Act. or Rules that the
drug or cosmetic was manufactured or
sold as the case may be, by the person
whose name and address appear on the
label thereof.
I
(2) Tn a prosecution for contravention of
this Act, or Rules, it is sufficient proof of
the offence to establish that it was commited by an employee or agent of the
accused.
(3) Tn trials under this Chapter it may be
presumed unless and until the contrary
is proved that the accused has committed
an offence under this Chapter in respect of
b M of Pet. & CheA.. '75—30
■
C "U.
232
(A)
(B)
(Q
(D)
any drug or cosmetic if he fails to account
satisfactorily for the possession of any
apparatus of device designed for the
manufacture of such drug or cosmetic of
any material which has undergone any
process towards the manufacture of any
drug or cosmetic or of any raw material
for such drug or cosmetic or of any
packing or lebelling materials.
20. Section 27 Penalty for manu 27. Penalty for manufacture, sale, etc., of drugs For the existing Section 27, the following may
facture. sale etc., of drugs in con
in contravention of this Chapter—Whoever be substitued :—
travention of this Chapter.
himself or by any other person on his behalf (i) Whoever himself or by any other person
manufactures for sale, sells, stocks or exhibits
on his behalf manufactures, sells, stocks
for sale or distributes—
or exhibits for sale or offers for sale or
(a) any drug—
distributes—
(i) deemed to be misbranded under
(a) any drug—
clause (a), clause (b), clause (c), clause
(i) deemed to be misbranded under
(d), clause (f), or clause (g) of Section
clause (a), Clause (b), clause (c),
17 or adulterated under section 17B;
clause (d). clause (f) or clause (g)
or
of Section 17 or adulterated under
(ii) without a valid licence as required
section 17B; or
under clause (c) of Section 18, shall
(ii) manufactures a drug without a
be punishable with imprisonment for
valid licence as required under
a term which shall not be less than
clause (c) of the seciion 18 shall be
one year but which may extend
punishable with imporisonment for
to ten years and shall also be liable
life and shall also be liable to fine:
to fine.
Provided that the Court may for any special Provided that the court may for any special
reasons to be recorded in writing, impose a
reasons to be recorded in writing impose a
sentence of imprisonment of less than one
sentence of imprisonment which shall not
year;
be less than five years.
(b) any drug other than a drug referred to
in clause (a) in contravention of any of
the provisions of this Chapter or any
rule made thereunder shall be punishable
with imprisonment for a term which
may extend to three years, or with fine,
or with both :
(b) any drug other than a drug referred to
in clause (a) in contravention of any of
the provisions of this Chapter or any
rule made thereunder shall be punishable
with imprisonment for a term which
may extend to three years, or with fine
or with both.
Provided that where the drug has caused grie
vous personal injury the punishment shall be
imprisonment for life.
21. Section 27A Penalty for manu 27A. Penalty for manufacture, sale, etc. of For the words “one year*’ the words “three
facture, sale, etc. of cosmetics
cosmetics in contravention of this Chapter—
years” shall be substituted.
in contravention of this Chapter.
Whoever himself or by any other person
on his behalf manufactures for sale, sells,
stocks or exhibits for sale, or distributes any
cosmetic in contravention of any of the pro
visions of this Chapter or any rule made
thereunder, shall be punishable with imp
risonment for a term which may extend to
one year, or with fine which may extend to
five hundred rupees, or with both.
22. New Section 27B
After Section 27-A, a new section 27-B, may
be added:
“27-B—whoever himself or by any other
person on his behalf maintains any
record or submits any information which
is false or misleading in any particular
material under this Chapter or any rule
made thereunder shall be punishable with
imprisonment, which may extend to
three years or with fine or with both.
23. Section 28
Penalty for non-disclosure of the name c.
of‘ the For the existing Section 28 the following may
manutacturer etc.—Whoever contravenes the
be substituted:
provisions of section 18-A shall be punish
“28—Penalty for non-disclosure of the name
able with imprisonment for a term which
of the manufacturer, etc.
c
2M
(A)
(B)
(O
may extend to one year, or with fine which
may extend to five hundred rupees, or with
both.
(D)
(i) Whoever contravenes the provisions of
Section 18-A and Section 24 shall be
punishable with imprisonment for a
term which may extend to three years
or with fine which may extend up to
five hundred rupees or with both.
24. Section 30 Penalty for subse 30. Penalty for subsequent offences—(1) Who For the existing Section 30, the following ’shall
be substituted:
ever, having been convicted of an offence—
quent offences.
“30. Penalty for subsequent offences:
(a) under clause (a) of Section 27 is again
convicted of an offence under that
(i) whoever, having been convicted of
any offence—
clause, shall be punishable with imp
risonment for a term which shall not
be less than two years but which may
(a) under clause (a) of Section 27,
extend to ten years and shall also be
is again convicted of an offence
liable to fine:
under that clause, shall be
Provided that the Court may, for any
punishable with death. While
special reasons to be recorded in
this is the recommendation of
writing, impose a sentence of less
the Committee of Drugs Con
than two years;
trollers, Citizens Central Council
has recommended life impri
sonment for repeated offences:
Provided that the Court
may, for any special reasons to
be recorded in writing, impose
a sentence of imprisonment for
a term which shall not be less
than ten years.
25. Section 30 Penalty for subse (I A) Whoever, having been convicted of an In clause 1-A of Section 30, the words “two
offence under section 27-A is again convic
years” shall be substituted by the words
quent offences.
“six years”.
ted under that section shall be punishable
with imprisonment for a term which may
extend to two years, or with fine which may
extend to one thousand rupees, or with both.
26. Section 32 Cognizance of offences 32. Cognisance of offences (1) No prosecution Under Section 32, for sub-section (1) the follow
ing shall be substituted:
under this Chapter shall be instituted except
by an Inspector.
(I) “No prosecution under this Chapter or
the Rules made thereunder shall be
instituted except by an Inspector with
the consent of the authority specified
under sub-section 4 of Section 21”.
27, Section 32
offences.
Cognizance
After sub-section 1 of Section 32. the following
' this
'' Chapter‘ shall‘-be
J instituted
proviso shall be added;—
tion under
“Provided that in respect of the offence
except by an Inspector.
under Section 27(a), any police officer not
below the rank of an Inspector of Police
may also institute prosecution”.
of 32. Cognizance of offences (1) No prosecu-
28. Section 32-A power of Court to 32-A. Power of Court to Implead the manufac- In section 32-A, the words “within seven days
turer etc.—Where at any time during the
of its so being satisfied” may be added bet
implead the manufacturer etc.
trial of any offence under this Chapter alleged
ween the words “Code of Criminal Procedure,
1898” and “proceed against................. ”
to have been committed by any person, not
being the manufacturer of a drug or cosmetic
or his agent for the distribution thereof, the
Court is satisfied, on the evidence adduced
before it, that such manufacturer or agent
is also concerned in that offence, then the
Court may, notwithstanding anything con
tained in sub-section (1) of section 351 of
the Code of Criminal Procedure, 1898, pro
ceed against him as though a prosecution had
been instituted against him under section 32.
29. Section 33 Power of Central 33. Power of Central Government to make In sub-section (1) after the words “after consultation with the Board” the following words
Rules (1) The Central Government may
Government to make Rules.
shall be inserted;—
after consultation with the Board and after
“or on the recommendation of the Board”.
previous publication by notification in the
Official Gazette, make rules for the purpose
of giving effect to the provisions of this
Chapter.
234
(A)
<B)
(C)
(D)
30. Section 33(2) Power of Central (2) Without prejudice to the generality of the Clause (e) of sub-section (2) of section 33 may
Government to make Rules.
foregoing power, such rules may—
be substituted by the following:—
(c) prescribed the forms of licences for the
(e) Prescribe the various forms of licence
manufacture for sale, for the sale and
for manufacture, for the sale and for
for the distribution of drugs or any
the distribution of drugs or any specified
specified drug or class of drugs or of
drug or class of drugs or of cosmetics
cosmetics or any specified cosmetic or
or any specified cosmetic or class of
class of cosmetics the form of applica
cosmetics, the form of application for
tion for such licences, the conditions
such licences, the conditions subject to
subject to which such licences may be
which such licences may be issued, the
issued, the authority empowered to issue
authority empowered to issue the same
the same and the fees payable therefor.
and the qualifications of the authority
and the fees payable thereof including
the fee for inspection of manufacturing
premises;”
31. Section 33(2) Power of Central (2) Without prejudice to the generality of the Clause (n) of sub-section (2) of Section 33
Government to make rules.
foregoing power, such rules may—
may be substituted by the following:—
(n) prescribe the powers and duties of
Inspectors and specify the drugs or
classes of drugs or cosmetics or
classes of cosmetics in relation to which
and the conditions, limitations or res
trictions subject to which, such powers
and duties may be exercised or perfor
med.
32. Section 34
“(n) prescribe the powers and duties of
Inspectors and specify drugs or class
of drugs or cosmetics in relation to
which and the conditions, limitations or
restrictions subject to which, such powers
and duties may be exercised or perfor
med, the qualifications of the authority
specified in sub-section (4) of Section 21.
34(1) Where an offence under this Act has been After explanation the following explanation
committed by a company every person who
■’
'
shall
be added:
—
at the time the offence was committed, was Explanation 2
incharge of, and was responsible to the com Where a person, being the Chairman or Manag
pany for the conduct of the business of the
ing Director of a Company has, on behalf of
company, as well as the company shall be
the company, signed an application for licence
deemed to be guilty of the offence and shall
under this Act, any contravention of the
be liable to be proceeded against and punished
conditions of that licence shall, so long as
accordingly:
such person holds an office in the company,
be conclusively presumed to have been com
Provided that nothing contained in this sub
mitted with his consent or connivance.
section shall render any such person liable to
any punishment provided in* this Act if he Explanation 3
proves that the offence was committed with Where an application for licence under this
out his knowledge or that he exercised all
Act is signed by an officer of a company other
due diligence to prevent the commission of
than the Chairman or .Managing Director, it
such offence.
shall, for the purposes of this section, be
deemed to have been signed also by the
(2) Notwithstanding anything contained in
Chairman and the Managing Director of the
sub-section (1) where an offence under this
Company.
Act has been committed by a company and
it is proved that the offence has been com
mitted with the consent or connivance of,
or is attributable to any neglect on the part
of, any director, manager, secretary or other
officer of the company, such director, manager,
secretary or other officer shall also be deemed
to be guilty of that offence and shall be liable
to be proceeded against and punished accor
dingly.
Explanation—For the purpose of this Section—
(a) ‘company’ means a body corporate, and
includes a firm or other association of
individuals; and
(b) ‘director’ in relation to a firm means a
partner in the firm.
33. New Section 34-B .
c?
After Section 34-A, the following shall be
introduced as Section 34-B namely—
34-B. Prohibition of import manufacture, sale,
etc. of drugs or cosmetics etc., for reasons
of public safety.
235
(A)
(B)
34. Section 35(1) .
35. New Section 37-A .
(D)
(Q
.
Sub-Section (1) of Section 35 shall be substi
Publication of offender's name—
tuted by the following:—
(1) If any person is convicted of an offence
“35(1) If any person is convicted of an offence
under this Act, it shall be lawful for the
under this Act, the Court before which
court before which the conviction takes
the conviction takes place shall, on an
place to cause the offender’s name, place of
application made to it, cause the offen
residence, the offence of which he has been
der name, place of residence, the offence
convicted and the penalty which has been
of which he has been convicted and the
inflicted upon him. to be published at the
penalty which has been inflicted upon
expense of such person in such newspapers
him, to be published at the expense of
or in such other manner as the court may
such person in such newspapers or in
direct.
such other manner as the court may
direct.
After Section 37, the following Section shall
be added as Section 37-A:—
■‘37-J—Penalty for vexatious search or seizure—
Any Inspector exercising powers under this
Act, or under the Rules made thereunder
who vexatiously or without any reasonable
ground of suspicion—
(a) searches any premises where drugs or
cosmetics or components thereof are
manufactured, sold, stocked or distri
buted; or
(b) seizes any stocks of any drug, cosmetic
or component thereof, or
(1) Notwithstanding the fact that any
provisions contained herein before
it shall be lawful for any authority,
conferred with powers in this behalf
under this Act, by the Central or
State Government to prohibit im
port, manufacture, sale or distribu
tion of any drug or cosmetic or
component thereof, and order re
call of the issues already made
thereof, if he has reason to believe
that the use of such drug or cos
metic or the component thereof is
likely to involve such risk to human
being or animal as to render it
expedient or necessary to take
immediate action’’.
(2)
o
the authority may, in such cases>
by an order in writing or notifica
tion in the Official Gazette, prohi
bit, import, manufacture, sale or
distribution of any drug or cos
metic or component thereof for
such period not exceeding sixty
days as may be specified in the
’
order or notification,
pending
investigation in the matter in Con
sultation with the Board.
(3) if as a result of investigation or on
receipt of opinion of the Board,
the authority is satisfied that the
use of the drug or cosmetic or com
ponent thereof is or is not likely to
cause any such risk, he may pass
such order as he deems fit.
(c) commits any other act. to injure any
person without having reason to believe
that such act is necessary for the execu
tion of his duty—
shall be guilty of an offence under this
Act. and shall be punishable for
such an offence with tine which may
extend to one thousand rupees.
236
(A)
(B)
36. Section 38 Rules to be laid
before Parliament.
(O
j
(D)
38. Rules to be laid before Parliament—
Section 38 may be substituted by the following:—
Every rule made under this Act shall be laid
“Every rule made by the Central Govern
down as soon as may be after it is made
ment under this Act shall be laid, as
before each House of Parliament while it
soon as may be after it is made, before
is in session for a total period of thirty days
each House of Parliament, while it is in
which may be comprised in one session or
session, for a total period of thirty days
in two or more successive sessions, and if
which may be comprised in one session
before the expiry' of the session in which it
or in two or more successive sessions,
is so laid or the successive sessions aforesaid,
and if, before the expiry of the session
both Houses agree in making any modifica
immediately following the session or the
tion in the rule or both Houses agree that
successive sessions aforesaid, both House
the rule should not be made, the rule shall
agree in making any modification to the
thereafter have effect only in such modified
rule or both Houses agree that the rule
form or be of no effect, as the case may be;
should not be made, the rule shall there
so, however, that any such modification or
after have effect only in such modified
annulment shall be without prejudice to the
form or be of no effect, as the case may
validity of anything previously done under
be; so, however, that any such modi
that rule.
fication or annulment shall be without
prejudice to the Validity of anything
previously done under that rule.”
c
*
ANNEXURE V
[CHAPTER IX PARA 45-App. I]
«nrrkT^ ?™gS — r Gov®rnment hospitals, and Semi-Government Institutions in the Maharashtra State are heina
5h’ ""
««1 Ceo,<.l S.„IS purohZXeTo'f“S
The Government of Maharashtra have constituted a C
Committee consisting of the following members to advise
the Central Stores purchasing Officer with regard to the items
of drugs and medicines to be purchased :
Members
...
G3
- -
1. Director of Haffkine Institute. .
- ------------------------------------------- 1UV1UU1.13 I
.
2. Commissioner, Food and Drug Administration (Maharashtra State)
3. Jt. Director of Medical Education and Research (Maharashtra State)
Member.
.
4. Professor of Medicines, Grant Medical College, Bombay.
Member.
Member.
5. Professor of Surgery, Grant Medical College, Bombay
.
6. Professor of Obstetrien and Gynaecology. Grant Medical College, Bombay
7. Dy. Dirctor of Health Services (HQ). Maharashtra State
Chairman.
Member.
Member.
Member.
8. Professor of Pharmacology, Grant Medical College, Bombay
Convenor.
Cornmitt.ee after makmg deliberations recommends to the Central Stores Purchasina
u
■
certificate is then either issued or refused depending upon the merits of each case 'sim l
' The p?rformance
ficates are being issued to the applicants if their firm is not convicted for
iLT’ Sinlllarl> - non-conviction certicertificates issued by this Administration are endosej’as AppendS ‘C’and 5’The Profo™ae of these
Government of Maharashtra has also constituted
a Drugs Selection Committee consisting of the following
members :—
1. Commissioner of Industries (Maharashtra State).
2. Commissioner of Food and Drug Administration (M.S.),
3. Professor of Pharmacology, Grant Medical College, Bombay,
237
representing the Medical Department.
•■if-
I
238
The tenders so invited are being opened by Central Stores Purchasing Officer in presence of the representatives
of the tenderers and then quotations are tabulated by the Central Stores Purchasing Officer. These tabulated quota
tions are finallv checked and senrinised by the aforesaid drugs Selection Committee. This Committee then makes
the recommendations regarding the drugs and the manufacturer from whom these should be purchased by the Cent
ral Stores Purchasing Officer. While making their recommendation the Committee gives preference to
to the
-i.e basic
and original manufacturer of the drugs so as to ensure uninterrupted supply of the drugs to the institutions, This
policy is adopted in case of life saving drugs and drugs which are consumed comparatively in large quantities, While
to make
scrutinizing and selecting these drugs this Committee also checks the samples of these drug^ visually so
so as
as tc
sure that the drug to be supplied is of acceptable quality.
The recommendations so made are then forwarded to Central Stores Purchasing Officer, who in turn fix the
rate contract with the manufacturers for supply of drugs to the Government Hospitals and Semi-Gov eminent
institutions.
Regular samples are drawn by Food and Drug Administration from the institutions to check their quality
* - - •
■ has
- shown
’ ■ that sub-standard
----3 are notdrugs
supplied to Government or Semiduring the tender period.
Experience
Government institutions.
enclosed)
(Not
A copy of the forms also enclosed at Appendix ‘E’.
APPENDIX ‘A’
Information to be supplied by the Applicant for issue of Certificate in respect of performance Certificate.
(1) Items quoted in the Tender.
(2) When first permitted by this Directorate to manufacture these items. (Quote No. and date of the letter)
(3) How many batches of these items have been and quantity manufactured during the last two years, state also
the quantities of each batch size.
(4) Whether any samples of these products have any time been reported to be not of standard quality by any
Government Analyst, if so, give details.
(5) Whether permission to manufacture these products was ever withdrawn or suspended
Directorate. If so. give reasons and when such permission was withdrawn or suspended.
by this
(6) Whether these products were accepted on any tender previously. If so, give details regarding when, it
was accepted, quantity supplied, whether supplied regularly and whether there was any complaint.
(7) If the items to be supplied are thermolabile substances, state whether stability study is carried out.
(8) Whether the production in any of the departments was stopped by this Directora- -during the last two years.
If so, give details and reasons.
(9) Whether any of licences were suspended partly or wholly during the last five : irs. If so. give details.
(10) Whether you are manufacturing
manufacturing drugs
drugs qaoiea
quoted at
at your
your own premises or under a an licence.
(11) Whether your firm has got own testing arrangments or whether tests are prrTbrmed by an approved
laboratory ?
(12) Whether you are manfacturer of the basic drug for which you have quoted.
(13) Whether any of the , roduct previously accepted on Rate Contract were rep z «d to be not of standard
aualitv
quality ? If so, give details.
T declare that the information given above is true and I am aware that any certific:,± issued on the basis of
the above information is liable to be withdrawn if any particular given in the information a .^not true.
APPENDIX ‘B’
Report regarding issue of perfomance/reliability and bona fide Certificates to fim .^r Rate Contract. E.S.l.S.
and Govt,
endeis.
A°rt’
renort should be based on the observations and General workings of the m- ifacturers during the last
r months, k'ou may visit the plant if you feel this would help in giving the information . ou are required to submit
your report within 15 days of the receipt.
239
Mis.
J. Whether raw materials used in the manufacture are tested for Pharmacopoeial tests
Yes
No.
2. Whether all therapeutically active ingredients present in the finished products are tested for quality,
purity and strength (Excluding those which are not normally possible).
Yes
No
3. Whether control samples of the finished products are retained
Yes
No
4. Whether good manufacturing practices are followed as intimated in circulars issued earlier
Yes
No
5. Whether licences are suspended during the last 12 months
Yes
No
Yes
No
Yes
No
Yes
No.
.......
6. Whether stability studies are adequately conducted on the products which deteriorate on storage
Whether the production of an> categories of drugs was suspended or stopped.
If so. which categories.
8. If any samples of any categories of drug manufactured by the firm are reported to be not of
standard quality do you think that this is the result of a laxity in quality control and or failure to
adopt good manufacturing practice and technique. If no products are drawn for test please state
so. (Base your answer on the products tested and general observation during the last 12 months).
9. Whether product development studies arc carried out (Excluding stability studies).
In my opinion the firm can/cannot be relied upon to supply quality drugs to Maharashtra State,
or Employees State Insurance Scheme and any other tender.
APPENDIX
C'
Hopsitals
/°f
No. A./CERT/
/of 72.
Food and Drugs Administration.
Maharashtra
State.
Griha Nirman Bhavan. Bandra (E)
Bombay-51.
CERTIFICATE
This is to certify that M s
......................................................................................
have not been convicted in this State for adulteration or for manufacturing selling drugs below standards laid down
in the Drugs and Consmetics Act. 1940. during last five years.
(
for
)
Commissioner.
Food and Drugs Administration.
APPENDIX D*
No. A/CERT/
. /of 73.
Food and Drug Administration.
Maharashtra
State,
Griha Nirman Bhavan. Bandra (E)
Bombay-51-AS.
PERFORMANCE CERTIFICATE
This is to certify that up to the time of wiriting this certificate the performance of M/s
in complying with the provisions of Drugs and Cosmetics Act. 1940 and the Rules thereunder is generally
satisfactory.
This Certificate is given in accordance with condition of Tender of the .. .
and is given on the express condition that it will not be quotedI or used for any other purpose except for the purpose
of the said condition for the said tender.
(
)
for
Commissioner.
Food and Drug Administration.
IMof Pet. & Chem./75—31
l‘ J
CHAPTER—IX
Annexure ‘VI’
(Para. 45—App. f)
A MANUAL ON THE WORKING OF HOSPITAL STORES
Introduction :—1. The activities of the Hospital Pharmacy where drugs are processed by the hospital for the
use of patients and the hospital stores where the drugs are stored, checked and issued contribute a great deal to the
overall quality of medical service rendered by hospitals. The importance of these two institutions in an hospital
has been rightly emphasized by the Union Health Minister in a letter addressed to State Health Ministers (Appendix I).
The role, the State Drugs Control Authorities can play in toning up the functions of a Hospital Pharmacy and hospi
tal stores were discussed at a meeting of the Drug Standard Control Officers from the Centre and the States and
it was agreed that the conditions under which drugs formulations are processed by hospitals for the use of their pati
ents, the functioning of stores etc. needed close surveillance with a view to ensuring that patients in hospitals receive
drugs of quality.
2. The following recommendations were made at the meeting :—
(a) If drugs are manufactured for use of patients by hospitals in hospital pharmacies, the conditions of manu
facture should be stringently controlled in the same manner as private manufacturer/manufacturers of
similar items are controlled.
(b) Facilities for sterilisation services in hospitals should be frequently inspected by the Central and State Drugs
Inspectors.
(c) The manner in which drugs are ordered, stored and issued by the hospitals should also be subjected to fre
quent checks so as to ensure :—
(i) that purchases are made in phased instalments to obviate financial loss to hospitals;
(ii) that drugs which require special storage conditions are stored properly; and
(iii) that dtugs which bear a date of expiry are issued or turned over by arrangement with manufacturers
in such a manner that hospitals are not saddled with any time expired stocks.
(d) The responsibility for ensuring “good manufacturing practices” including sterlisation facilities in hospitals
and management of hospital stores should be fixed on specific members of the staff in hospitals who should
also be made to maintain the necessary registers and records.
(e) In hospitals with 200 beds and above, a Chief Pharmacist who should be at least a graduate in pharmacy
should be appointed and given gazetted status with an appropriate status with an appropriate salary scale.
The Chief Pharmacist should have a thorough background knowledge of drugs, their substitute, storage
conditions etc., and should be able to assist the hospital administration in maintaining the qualitv of druss
supplied to patients.
The Committee also recommended that similar facilities should be made available in smaller hospitals.
The General impression is that medical stores where drugs are stored for issue to the wards, patients etc. do not
function satisfactorily. The object of this manual is to lay down guide-line or organising the medical stores in a
hospital with particular reference to the location, personnel, conditions of storage of drugs, manner of distribution of
drugs etc. Necessary modifications to suit any particular institution may be carried out by the Medical Superinten
dent wherever considered necessary, so long as the basic objectives are fulfilled.
3. Under the provisions of Drugs and Cosmetics Act & Rules a medical store run by a hospital is exempted
from the requirements of taking a sales licence under the Act, subject to the following conditions
(i) the dispensing and supply of drugs shall be carried out by or under the supervision of a qualified person;
(ii) the piemises where drugs are supplied or stocked under drugs shall be open to inspection bv an Inspector
appointed under drugs & Cosmetics Act who can, if necessary, take samples for test; and
(iii) the drugs shall be stored under proper storage conditions.
240
i'
241
A drug Inspector is thus fully authorised to inspect the premises of medical stores of an hospital and ensure compliance
with the conditions mentioned above
Location : 4.1 The medical stores should preferably be located in the basement of ground floor in a multi
storeyed building well removed from the autoclaves, heating apparatus, laundry etc. It should be well lighted and
ventilated. AH measures should be taken to maintain the place dust-free, neat and tidy.
4.2 The area provided for the stores should be such as to prevent undue congestion and disorderly storage
of drugs.
Personnel :—4.3 The Staffing pattern of the stores will depend on its function. Thus the staff of the Medical
Stores in a hospital which has manufacturing Pharmacy will vary from that of an ordinary stores. In the former
case the following staff pattern is recommended.
4.4 A Chief Pharmacist, possessing adequate education qualifications, preferably a post-graduate degree in
Pharmacy and having adequate practical experience (about 3 years) should be in overall charge of the following
sections in the Hospital :
(i) Medical Stores.
(ii) Dispensary.
(iii) Hospital Pharmacy (Transfusion Solutions) and Central Sterlisation.
(iv) Quality Control.
He must also have a thorough background knowledge of drugs, their substitutes, storage conditions, drug
market, and manufacture and testing of Transfusion Solutions etc. Considering the workload, the duties, responsi
bilities etc. to be shouldered by him the Chief Pharmacist should be treated on par with the senior cadre officers in
the Hospitals and offered a salary scale of Rs. 700-1200 so that he may command respect not only from the staff
members working under him but also from the medical staff in the hospital. This salary scale will also attract
suitable-candidates having the requisite qualifications and experience from the industry.
4.5 In case of hospitals maintaining hospital stores only a Chief Pharmacist possessing adequate educational
qualifications say a graduate degree in Pharmacy and having adequate practical experience (about 3 years) should
be in overall charge of the following Sections in the Hospitals;
(a) Medical Stores
(b) Dispensary
(c) Quality Control.
He must also have a thorough background knowledge of drugs their substitutes, storage conditions, drug market
etc. The Chief Pharmacist in this case may be offered a salary scale of Rs. 400.950.
4.6 The chief Pharmacist should be associated with a Hospital Committee which should be entrusted with
the responsibility for making purchases of medical stores either on rate contract or direct from the
manufacturers. The Committee should consist of Heads of the department of Medicine and Pharmaco
logy. The Chief Pharmacist should be the convener of the same and should furnish to the Committee competitive
paces of products of identical composition. As far as possible, the products purchases should confirm to the
requirements given in the latest edition of the National Formulary of India. Only those firms which in the opinion
of the State Drugs Control Authorities adopt Good Manufacturing Practices and against whom there are no com
plaints for quality of drugs or other eithical practices should be enlisted for local purchases.
4.7 The Chief Pharmacist should be directly under the administrative control of the Medical Superintendent
of the Hospital and all the different Section Heads of the Stores, Hospital Pharmacy (mentioned under 4.4 or 4.5
above) should function under his supervision & control.
Supervision
5. The medical Stores of a hospital should be under the suprvision of a person who is a registered pharmacist
and has adequate experience in operating a Drug Store. He should be assisted by suitable number of other regis
tered pharmacists.
Facilities for storage of drugs :
6.1 Storage of General drugs : The section should be well equipped with storage facilities i.e.,
242
(a) raised wooden platforms for storage of drugs and gunny bags, and
(b) steel racks, shelves etc., for storage of general drugs.
Storage of Narcotic drugs :
6.2 All narcotic drugs, barbiturates and other habit forming drugs should be stored in separate almirahs
and the key for these almirahs should be kept with the supervisor mentioned at 5 above.
The stocks of these drugs should be physically verified by the Chief Pharmacist (mentioned in 4.4 or 4.5J at
least once a month and signed by him.
Storage of drugs at low temperature :
6.3 Special attention should be given to storage of certain categories of drugs which are required to be kept
at low temperature for retaining their potency. Some of these drugs'shoud be stored between 2 to IO C and others
between 15 to 20'C.
Cold Storage :
6.4 Drugs which are required to be stored between 2 to IO:C will include (a) Sera (b) Vaccine (c) Galandular
preparations and other lhermolabile products. It is not possible to give an exhaustive list of these druss which
require cold storage but an illustrative list is given at Appendix -II. A list of such drugs indicating the brand names
in the brackets should be exhibited prominently in the stores. Several products with brand names will fail within the
purview of this list. Storage conditions are invariably shown on the outer packings of such drugs and these should
be checked and compared by Supervisor mentioned in 5 above.
6.5 For storage of drugs covered by 6.4 it would be advisable to have separate room or a portion maintained
at this temperature range. A recording thermometer should be provided and the temperature should be noted
at least twice a day by the supervisor mentioned at 5 above singed by him. In case such room is not available adequate number of refrigerators should be provided for the purpose. The maintenance of these refrigerators in working
order is the responsiblity of the Supervisor mentioned at 5 above.
6.6 Drugs such as Insulin, certain Vaccines etc. should not be allowed to freeze. Care should be taken to see
that such drugs are not kept in the freezing compartment of the refrigerators. The Chief Pharmacist referred at 4 4
or 4.5 should oersonally check and ensure that such drugs are not kept outside the refrigerators. A list of such druas
should be exhibited in the stores.
Storage at cool temperature (15
to 20c C)
6.7 Drugs such as antibiotics. Vitamins, hormones. Liver, preparations etc. arc required to be stored at a cool
temperature. An illustrative list is given at Appendix III. Storage conditions are invariably shown on the"outer
packing of drugs and these should be checked and compared by the Supervisor mentioned in 5 above. Air-Condi
tioned storage accommodation should be provided for the purpose and a record of the maximum and minimum
temperature by a recording thermometer should be maintained.'checked and signed by the supervisor referred at 5
above at least twice a day. The space of this room should be adequate considering the maximum stock of drugs
likely to be purchased by the hospital during any time of the year.
6.8 The Chief Pharmacist referred at 4.4 and 4.5 should ensure that no drug falling in this category is stocked
away from this room. An inspection register for recording the observations of the Chief Pharmacist during the
cheek should be maintained.
43
Storage of drugs with life-period :
7.1 It is advisable to store such drugs in a separate area in the Medical Stores to facilitate regular checking of
these drugs with respect to their ‘dates of expiry’ of potency. Such products with expiry dates should be arranged
on the racks or the shelves in the medical stores in such a manner that drugs having a shorter life period are kept
in the front while those with a comparatively longer life-period are stored in the rear. A card system should be adopt
ed for indicating the upto date stock position of such dated products together with their ‘dates of expiry’. In addi
tion to thk. a separate ‘Date Expiry Register’ for such products should also be maintained for ready reference by the
stores in charge. Both the cards as wells the Expiry Date Register should be reviewed regularly at least once a’fort
night by the Chief Pharmacist referred to at 4.4 or 4.5 above to ensure proper distribution of such drugs in the various
wards.
7.2 Stocks of drugs nearing their dates of expiry should also be physically inspected by the Chief Pharmacist
referred to at 4.4 or 4.5 and examined for any visible signs of deterioration of the content of such drugs, for example,
change of colour of the products or change in the physical conditions, such as caking of pencillin or tetracyline in
243
vials. In.the event of any such deteriorated goods, the Chief Pharmacist referred at 4.4 or 4 5 shou’d indicate the
action taken in respect of the goods in the register which should be dated and signed by him and he shou’d nersonallv
ensure that action as suggested is actually taken in the matter.
1
11
7.3 11 scrutiny of the stocks reveals that certain drugs will be crossing the dates of expiry within a ncriorl of
3 months or so and if the Chief Pharmacist referred at 4.4 or 4.5 feels that the balance stocks of such dru-s cannot
normally be consumed by the hospital within that period, then steps should be taken bv tlr Chief Pharmacis f
replacement of the stock from the manufacturer, or in alternative he may consider the feasibility of offering s H
stocks to other Govt. Hospitals in consultation with the Medical Superintendent of the Hosni-al To p I
t
contingencies it would be better tf the requirements of the drugs are assessed by the Chi -f Phir n-i’-is- o , -i r “,li ri
basis and orders placed in such a manner as lo ensure phased delivery to the Hospital.
' 1
Pending final action from the ma lufacturers the stocks of drugs which become data-expired. shoidd b- ren-rmd
to a separate area specially earmarked for the purpose with the notice i i red >‘0 VTE EXPIRED nnr-rt x-rA r
TO BE ISSUED” in bold letters.
v
<.S—AO 1
Complaint Register :
8.1 A complaint Register should be maintained by the Chief Pharmacist wherein all tlm comnhinu
regarding adverse reactions of any drug on patients from different wards should be incornom 2
)
the details ot action taken on such complaints both by the Hospital authorities as well as th- Dru« Contr I ™
may be indicated agamst each Whenever any complaint (such as side reactions)^dinXSo
£a%hT
reported further issue ot the batch should be suspended forthwith till such lime as the- causer the sid- rea-dons
is identified. Side reactions wluch are frequently encountered with the treatment of penicillin and th- instructions
as to the line of ac ion io be fo lowed in such cases are indicated in a letter issued bv the Director G-n -n of Hea h
Services. New Delhi (copy enclosed Appendix -IV). Such complaint Register may be maintained'in the folkwin"
(1) SI. No. (2) Date ol Complaint (?) Ward No. from which complaint rccAived ( I) N-imt* nf
Manufacturer's name (6) Batch Number (7) Nature of the complaint (8 ) Action taken bv tb- Ho mini - n
n
^US
Au,to..,les (J FMCIO. Wfc.hcoh, d™any untoward reaction has been reported.
1
b d Q ''ntlher
8.2 If drugs stored by the hospitals have deteriorated before the date/expiry, such cases should also be entered
in the Complaint Register.
Receipt of Drugs :
9 1 There should be a system in the Stores Section whereby the supply of all the druas received in th-’ M’di.-nl
Stores from the manufacturers are properly checked by a person specially desifinated for 3he pu^ose r eferabl the
sion about the nature of drugs received.
' challans. invoices to avoid any subsequent confu-
9.2 Random samples should be checked visually to make sure th..
,1^ products
,„uuuuls confirm to the tendered spethat the
cifications particularly with the products having Date of Expirv and the products do
- _j not show any visible sign of
deterioration such as change of colour, caking up etc.
and
manufacturer should also be apprised of the positbn
on
the Hcipital SpTes"^^
Medical Superintendent
S Inspector s permission is received. The
’'riting
b^nuX’
etc. by putting his signature and date.
Distribution of Drugs to the Wards :
howexS‘iHsnot
Fo d“o!hev'should^£V'wpSi'm de5>rigin4t1
rt,;«i.I1eptop„ic,„r,he.rW„a1iusS
—ificturer. If.
244
It is advisable that proper precautions are taken in disposing of the ‘original’ empty containers of drugs so as to
prevent their misuse by unscruplulous persons. The containers should be destroyed in the presence of a responsible
officer and a written statement must be signed and maintained.
10.2 The Chief Pharmacist should visit wards to check that drugs requiring special storage conditions such as
cold storage are properly stored and stocks of drugs which are not normally required are not kept in the wards.
General
11.1 In case of failure of the electric supply or airconditioning Unit the necessary authorities should be imediately contacted and telephone number of such authorities should be readily available on the desk of the Chief
Pharmacist. Failure of the electric supply or airconditioning Unit for a longer period should be at once reported
to the Medical Superintendent. The Chief Pharmacist should be empowered with the authority for repair of ait’
conditioning Units, by the Medical Superintendent.
Import of Drugs :
12.1 Druss can be imported from abroad upto Rs. 1000/- C.I.F. value (This is exclusive of postal and air
charges), at a time for the use of the hospital. The benefit of this provision can be made use of by the hospital stores
in case of newer life-saving drugs. A list of such newer life-saving drugs which can be imported is enclosed at Appen
dix V. These drugs are exempted from the custom duty by the Ministry of Finance Notification No. 9/21/70-Customs V dated 22-6-1971.
1
I
Appendix-I
Copy of D.O. No. F. 3-13/70-D dated the 17th June, 1971, sent to all State/Union Territories. Health Ministers
by the Deputy Minister for Health and Family Planning.
Dear
At a recent meeting of the Drugs Standard Control Officers from the Centre and the States, the question of
excercising stringent control over the quality of drugs used by the hospitals was considered. It was felt that the
conditions under which the drugs formulations are processed by hospitals for the use of their patients, the function
ing of Hospital stores and the operation of sterile service in hospitals needed close surveillance and a number of
measures were suggested which are contained in the attached note.
May I therefore suggest that the Superintendents of Hospitals in your State be advised to avail themselves of
the assistance of the State Drugs Control authorities in organising Hospitals Stores, Hospital Pharmacy and dis
pensing and sterile service establishments on the lines recommended by the Drug Control authorities. In particular,
the hospital authority should invite more frequent inspection of their hospitals by the officers/Inspectors of the
State and Central Government and extend to them all assistance. Mutual co-operation between Drugs Control
authorities and hospital authorities would contribute a great deal towards improvements of hospital services in the
country.
I shall be glad to know in due course the action taken in the matter.
Yours sincerely,
Sd/- A. K. K1SKU.
245
Appendix— 11
Illustrative list of Drugs Requiring storage at cold temperature (2 C to 10 C) but which arc not to be frozen.
This is not an exhaustive list and the Pharmacists should check the labels on the Drugs to know about the proper
storage.
(1) Sera in general.
(2) Vaccines in general.
(3) Whole human blood.
(4) Concentrated Human Red Blood corpuscles—4'C to 6’C.
(5) Normal H man plasma.
(6) Frozen plasma—at a temperature not above—18 C (Minus—IS'C).
(7) Thrombin (Bovine orgin).
(8) Thromboplastin.
(9) Cobra Venom in Solution.
(10) Viper Venom in Solution.
(11) Posterior Pituitary Injection.
(12) Oxytocin Injection.
(13) Vassopressin Injection.
(14) Corticotropin Gelatin Injection.
(15) Corticotrin Zinc Oxide Injection.
(16) Cholistin Sulphamethate Injection.
(17) Suxemethonium Chloride Injection.
(18) Insulin Preparations.
(19) Human Gamma Globulin Injection.
(20) Normal Liquid Human Serum Albumin.
(2D Schick Test Toxin.
MS
246
Appendix—11!
Illustrative List of Drugs Requiring storage at a Cool Temperature (15C to 25 C). This is not an exhaustive
list and the Pharmacists should check the labels on the Drugs to know about the proper storage.
1
Antibiotics :
1. Crystalline Pencillin Preparations.
2. Potassium Phenoxymethyl Penicillin preparations.
3. Benzethine Pencillin preparations.
4. Cloxicillin preparations.
5. Methicillin preparations.
6. Ampicillin preparations.
7. Streptomycin Sulphate & Chloride preparations.
8. Dihydrostreptomycin sulphate and Chloride preparations.
9. Chloramphenicol & its salts preparations.
10. Tetracycline. Oxytetracycline, Chlortetracycline and demythyl chloretetracycline
11. Bacitracin & Zinc Bacitracin preparations.
12. Cephaloridino preparations.
13. Neomycin preparations.
14. Neobiocin preparations.
15. Nystatin preparations.
16. Viomycin preparations.
17. Cycloserin preparations.
Arsenicals :
18. Neoarasphenaminc Injection.
19. Suipharasphenamine Injection.
20. Tryprsamide Injection
Blood Preparations :
21. Dried Plasma—below 20cC.
22. Human Fibrim Foan—below 20"C.
23. Human Fibrinogen—below 20 C.
24. Human Serum dried—below 20' C.
25. Human Thombin—below 20° C.
Hormone Preparations
26. Corticotropin.
27. Betamethasone Sodium Phosphate Injection.
28. Chorionic Gonadotropin
29. Prednisolene Sodium Phosphate Injection.
30. Thyried Tablets.
31. Oxytocin Tablets.
<!
Vitamin Preparations :
32. Preparations containing Vitamin A.
33. Preparation containing Vitamin Bl
34. Preparation containing Vitamin B2
247
1 M of P<SC,75—32.
preparations.
248
35. Preparation containing Vitamin B6
36. Preparation containing Vitamin C
37. Preparation containing Vitamin D.
38. Vitamin B-Complex Elixir & Injection.
39. Vitamin K Injection.
40. Vitamin KI preparations.
Others :
41. Dextran Injection.
42. Dextran Sulphate Injection.
ion.
43. Destrose Injection.
44. Dextrose & Sodium Injection.
45. Frogenevine Maleate Injection.
46. Heparin Injection.
47. Hyaluronidase Injection.
48. Chlorambucin preparations.
49. Chlorahexidine.
50. Choline Theophyllinatc preparationcs.
51. Dihydrotachysterol.
52. Dimercaprol Injection.
53. lodone Injection.
54. Glyceryl Trinitrate tablets.
55. Domiphane Bromide.
56. Nitrofurantoin tablets.
57. Pentaenithratol tablets.
58. Phenetzine tablets.
59. Prophyliodine Injection.
60. Tetrachloranhylene Capsules.
61. Trichlorethylene.
62. Vinyl Ether.
63. Anesthetic Ether.
64. Paradehyde.
65. Halothane.
66. Pancreatin.
67. Penicillamine Hydrochloride Capsules
68. Liver Injection Crude.
69. Protein Hydrolysate Inj.
70. Ergot Liquid Extract
I IU
111
Appendix -IV
Prevention and Treatment of Penicillin Reactions
An Expert Committee of the World Health Organisation recommended in 1959 that individual and public health
measures should be taken to prevent or treat penicillin reactions (WHO Expert Committee on Veneral Infections and
Treponematoses, 1960); particular reference was made to anaphylactic reactions. These measures for prevention'and
treatment are still valid, and are summarized below with appropriate modification according to recent experience
and knowledge (Guthe et al. 1958; Epstein 1966; Brandrisee et al. 1964; Calnan, 1964: Danbold, 1960; King & Nicol,
1964: American Public Health Association, 1960; A. perdrup, personal communication).
Prevention of penicillin reactions at the patient level:
1. Always have emergency kit for treatment of allergic reactions readily available.
2. Always have an exact past history of the patient’s previous content with penicillin, previous penicillin rea
ctions, and allergic diatheses. In infants less than 3 months old, inquire about penicillin allergy in the mother.
3. No penicillin treatment should be given to patients with a previous history of reactions; indications for ad
ministration of penicillin are severly restricted in patients with an allergic diatheses (e. g., bronchial asthma).
4. If possible .refer patientsVvith suspected penicillin allergy (preferably within 3 months of the alleged reaction)
to a specialist trained in mordern Amunological techniques (skin testing with penicillin and penicillin derivatives
serological tests) in order to provide the patient with an objective diagnosis and a permanent record.
5. Always tell the patient that he is going to receive penicillin treatment.
6. No penicillin should be employed for external treatment or on mucous membranes, particularly not on mace
rated or eczematized skin, especially likely to cause sensitization. Other antibiotics, not likely to be given systemi
cally later, can be employed for local treatment (e. g., neomycin, bacitracin, gramicidin). Due to cross sensitivity
of the semisynthetic penicillins all have the 6-aminopenicillanic acid nuclues reactions, although less frequent, may
also be expected to occur eventually with cephalosperin.
7. Avoid the use of penicillinase-resistant penicillins (meticillin, closacillin, nafcillin, ancillin and quinacillin)
which should be reserved for infections caused by penicillanase -producing staphylococci.
8. Ensure the through washing and adequate sterilization of all purpose syringes which have been used in peni
cillin treatments, when using them to inject other drugs. If possible, use disposable syringes and needles.
9. If possible, retain all patients for half-an-hour in the clinic after an injection of penicillin (most anaphylactic
reactions occur shortly after Injection).
Most investigators hold the view that antihistamines have an insignificant effect both in the propylaxis and in
the treatment of immediate reactions (Calnan. 1964; Seipel et al. as also is the case with prophylactic ephedrine and the
ephylline (Horkheimer & Stresseman, 1960). They are, on the other hand, recommended in late penicillin reactions
(Willcox, 1964). The “antinflammatery” effect of corticosteriods, however, should be used also in the treatment of
penicillin anaphylaxis after the emergency drugs have been administered (Calanan, 1964 ;Will-eox, 1964). However,
corticosteriods should not be trusted for prophylactic purposes except in cases where penicillin treatment is abso
lutely indicated despite the potential risk of the patient being penicillin -sensitive (Calnan, 1964).
$
Pencillinase has been found to be rapidly effective in breaking down circulating benzylpenicillin ,at least as
measures by the circulating blood (Greaves, 1961) but its effect on already formed antibody-antigen complexes is
not known (Westerman et al. 1966) and is likely to be minimal. Experence has shown, though, that it may be of some
use in treatment of anaphylatic reactions if given very soon after symptoms have been observed (Wasterman et.
al.. 1966) Greaves, 1961; Trinca and Keen, 1960; Backer, 1960). In late reactions, particularly, the breaking -down
effect on circulating penicillin and tissue penicillin may prevent further proteing-binding and formation of antigenic
conjugates. However, penicillinase itself has in turn been reported to induce anti-penicillinase antibodies (Weiss,
Grepea, 1959) and to provoke senitivity reactions (Becker, 1960) mostly of minor significane but also in some few
cases of analpylactie character (Gaputi, 1959, Hyman 1959; Reisch, 1959 Thornes, 1959) a fact which calls for caution
(Becker, 1960).
Desensitization can be achieved by the use of graded doses (Reiseman et. al. 1962) but the procedure is not
without considerable danger and should be reserved for patients who are and when there is no effective alternative
antibiotics (Valery et. al. 1960).
249
j
Appendix -V
Life Saving Drugs :
1. Amylobarbitone Sodium Injection.
2. Phentcin Sodium Injection (Dilantin).
3. Isoprenaline Injection.
4. Edrephonium Chlorise Injection (Tensilon).
5. Amino Caproic Acid Injection (Amicar).
6. Trasylol Injection.
7. Diazepam Injection.
g. Streptokinase Injection.
9. Polymyxin^B Sulphate Injection.
10. Colistin Sulphate Tablets & Injection.
11. Colistin Sulphomethate Injection.
12. Methicillin Sodium Injection.
13. Gloxacillin Sodium Injection & Capsules.
14. Getaniicin Sulphate Injection (Garamycin).
15. Carbemicillin Injection (Pyopen)
16. Trimetheprin /Sulphamethazazole Tablets (Septrin).
17. Elyorouracil Injection.
18. Methotrexate Injection and Tablets.
19. Lincomycin Hydrochloride Injection & Capsules.
20. Thiotepa Injection.
21. Actinomycin D Injection.
22. Tinblastino Sulphate Injection.
23. Tincristine Sulphate Injection.
24. Mitomycin C Injection.
25. Dopa and its Capsules.
26. Rifamycin Capsules.
27. Chorionic Gondadotrophin Injection (Antintrons).
28. Allopurinol Tablets (Zytone).
29. Blecomycin Injections.
250
■ w
CHAPTER X
Measures for providing essential drugs and common household remedies to the general public, especially in rural areas.
The Committee on Drugs and Pharmaceuticals Industry was consTruled by the Ministry of Petroleum & Chemi
cals by the Resolution dated the Sth February. 1974 to examine the various aspects of the drug industry. One of
the terms of reference was ”to recommend measures for providing essential drugs and common household remedies
to the general public especially in rural areas.”
2. The Committee during the course of their discussions, particularly on the availability of essential medicines
in larger quantities, felt that although the question of substitution of brand names of the medicines marketed by the
Industry by generic names was not a specific term of reference for this Committee, the subject follows c’.early from
the other terms of references, such as reduction rationalisation of prices of formulations for the consumers, making
the essential drugs available to the general public, attainment of leadership role by the public sector, promoting the
growth of the Indian sector etc. Besides, the question was also'directly linked with many important facets of the
industry such as drug patents, irrational practice of medicines, excessive use of ingredients in multi-drug formula
tions. proliferation of such preparations and baneful influence on the medical profession etc. of medicines marketed
under brand names. Keeping the above aspects in view, the Committee decided that this question should also be
looked into by the Committee. The Committee also felt that the views of eminent medical personnel from the diffe
rent parts of the country should be obtained in this regard. Accordingly, a panel was set up with the following
members:—
1. Dr. Ranen Sen, Member of Parliament.
2. Shri P.S. Rimachi idran, Drugs Controller (India) DGHS, New Delhi.
3. Dr. B. Shah. Deputy Director General (DGTD). New Delhi.
4. Dr. A.B. Chowdhury, M.B.. Ph. D.. F.A.M.S. F.N.A.. Director, Calcutta School of Tropical Medicine,
Chitteranjan Avenue. Calcutta-12.
5. Dr. B. Ray Chaudhury. M.D.. (Cal.) F.R.C.P.. Pn.D (Edin.). Associate Professor of Medicine,
of Post Graduate Medical Education and Research. 22-Lower Circular Road. Calcutta-17.
Institute
(This report was submitted to the Govt, on 21st Feb.. 1975.)
6. Dr. K.L. Wig. M.B.B.S. (Pun.) F.R.C.P. (London) M.R.C.S. (England) D.T.M. & H. (London) F.A.M.S79, Sundar Nagar. New Delhi.
Dr. S. Padmavati. Director, Principal. Maulana Azad Medicai College. New Delhi.
8. Dr. K.G. Nair. MD (Bombay) Ph. D. (Chicago ) F.A.C.C. (L'.S.A.) F. I.C.A. (U.S.A.). Director-Profes
sor of Medicine. Head Deptt. of Cardiology and Radio-Isotope Unit KEM Hospital and Seth G.S. Medical
College. Bombay.
9. Dr. B.J. Vakil, Hony. Professor Gastroenterology. Grant Medical College. Hospital, Bombay.
10. Dr. K.V. Thiruvengadam, B.Sc. MD. F.A.M.S. Professor of Medicine and Vice Principal, Stanley Medical
College. Physician. Government Stanley Hospital. Madras.
11. Dr. B.B. Gaitonde. M.D. M.S.C. (Med).. F.A.Sc. Director. Haffkine
Convenor.
Institute,
Bombay. ..
Dr. P.R. Gupta, Adviser (Drugs) in the Ministry of Petroleum & Chemicals was also associated with this
Panel.
3. The terms of reference for this Panel were as follows : —
(i) To recommend measures for providing essential drugs and common household remedies to the general
public especially in the rural areas, and
(it) Whether it would be in the national interest to substitute brand names by generic names and if so. the
manner and extent to which it should be done.
251
..
4. Dr. K..L. Wig, regretted his inability to work on this Panel, because of his preoccupation with other assign
ments. Dr. B. Shah also informed his inability to join this Panel as he was proceeding on leave.
5. The Panel met in Bombay on Sth and 9th June, 1974 at the Haffkine Institute, and submitted its report on
the 29th June. 1974 to the Chairman of the Committee. A copy of the Panel’s report is attached (Annexure 1).
6. The Committee on Drugs and Pharmaceuticals Industry at its meetings on 25th July, 1974 and 21st and
22nd January. 1975 considered the Report of the Medical Panel and adopted the same with some modifications.
Supply of essential drugs &. Common House Hold Remedies.
7. Keeping in view the essentiality of the medicines their need and the availability of the concerned bulk drugs/
active ingredients, the Committee, after due consideration, drew up a revised list (Annexure 11) of medicines which
in its opinion are extensively used in medical practice, both in urban and rural areas. In order to make these essen
tial drugs available at a reasonably low price throughout the country, the Committee recommends the following
measures :—
(i) Production of the drugs/medicines as identified in Annexure 11, should be given top priority for the manu
facture of the relevant bulk drugs/active ingredients.
(ii) The Ministry of Petroleum & Chemicals should take all such measures, which will increase the production
of these drugs expeditiously. Special assistance, priority for power supply, other incentive schemes etc.
may be given to entrepreneurs, preferably Indian, who come forward to undertake production of these
essential drugs. In short, if there arc any impediments, these should be immediately looked into and
removed.
(iii) In case of some drugs, the technical know-how is already available, but there is a production short-fall.
More entrepreneurs should be encouraged to take to production of such drugs. In case of those drugs,
for which technical know-how is not available in the country, special incentives maybe given to National
Laboratories to develop the know-how on a time-bound basis. If necessary, the foreign technical know
how may also be obtained immediately.
(iv) Distribution : To make these drugs available in rural areas, the distribution system must be rationalised
and decentralised, in regard to household remedies and commonly used medicines whch do not require
the prescription of doctors. For this, assistance should be sought from the postal department, Indian
Oil Company Depots, kerosene depots. Co-operative Societies should be encouraged for the distribu
tion of drug in rural areas. Packing details should be looked into. Tablets should be supplied in strip
packings. Liquid preparations should be supplied in bottles fitted with pilfer proof closures. Export
of the bulk drugs required for the production of medicines mentioned at (Annexure 11), as well as their
formulations should be so regulated that there is no shortage of these essential drugs in the country at
any time.
(v) Dispensing : At present, there are a number of difficulties, especially in small towns and rural areas, to
establish pharmacies for dispensing of drugs. One of the major difficulties is the non-availability of train
ed pharmacists. According to the Drugs Act. those who possess a Diploma in Pharmacy can only be
lincensed as dispensers. The Diploma Course is quite lengthy and the remuneration paid to the dispen
ser is not attractive. It was considered that a short-term need oriented course, after matriculation,
may be instituted for young people, who could take up the job of distribution of these medicines in the
rural areas and other remoter parts of the country. The Committee recommends that steps should be
taken to revise the present syllabus of training of the pharmacists. The Pharmacy Council should be
approached to tailor the course to suit the needs of the country. An intensive, need-oriented course of
a sh?rt duration should bi instituted for training of dispensers, who then could be licensed to establish
pharmacies and drug stores in smaller towns and rural areas.
(vi) Primary Health Centres should be given adequate financial assistance for purchase of drugs,
rural population also gets the same quality of drugs in adequate amounts as in urban areas.
So that
Substitution of brand names of drugs by generic names :—
8. The question of substitution of brand names by generic names was extensively discussed. All(facets of the
problem, such as Indianisation of brand names, impact on drug prices, bio-availability, quality of drugs, enforcement
of drug control, multiple ingredient preparations, expo \ of drugs, labelling difficulties, impact on small-scale industry,
patent rights, distribution system, acceptance by the medical profession, role of distributors and pharmacists, effect
on the growth of pharmaceutical industry, difficulties and inconvenience in the use of tongue twisting generic names
i
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253
efc., were discussed in detail. The Committee also met the representatives of various organisations such as Indian
Medical Association (IMA), Organisation of Pharmaceutical Producers of India (OPP1), Indian Drug Manufacturers
Association (1DMA), All India Manufacturer’s Organisation (A I MO), members of the Development Council for
Drugs and Pharmaceuticals, etc., to elicit opinion on this very important question of far reaching significance. The
Committee also considered the memoranda submitted by tarious State Governments. Public Sector and others in
cluding Small scale sector undertakings and different associations mentioned above.
9. The Committee had before it the report of the medical panel recommending the abolition of brand names
in a phased manner starting with specific drugs identified by the panel.
10. Throughout the world, and in our country as well, a medical student receives his training on drugs under
generic names. In fact, in all text books of therapeutics as well as pharmacology, drugs are mentioned by generic
names always. In the interest of rational practice of medicine, therefore, it is in the fitness of things that medical
practitioners should continue to use prescribe a drug under generic name, so that they are fully conscious of the type
of therapy prescribed for their patients. More often, the practising physician is likely to be unaware of the active
ingredients of a drug prescribed under brand name. Two branded products containing the same or similar active
ingredients may be prescribed to patients resulting in overdosage and consequent toxicity/damage to the patient’s
health.
11. Further, many brand names are phonetically similar creating confusion, which can be seen from the follo
wing examples:—
Cornil and Corlin, ; Codogin and Codopin ; Detazone and Deltazyne ; Diaginol and Dianabol ; Dicazine and Dicarzen: Etadryl and Metagyl ; Methicol. Methiscol. Methiolin. Methionine etc.
12. To bring about uniformity in names, the W.H.O. issues periodically a list of non-proprietary names with
the recommendation that these be adopted by national organizations. The intention here is to prevent confusion
and chaos in the field of prescribing medicines. It is also necessary to point out that all national formularies includ
ing the Indian National Formulary, prepared by the most eminent leaders of medical profession in this country,
list all drugs and formulations under generic names or pharmacopoeial names. Further a large number of very im
portant and potent drugs such as insulin, sera, vaccines, antibiotics, digitalis glycosides are mostly marketed under
generic names without any difficulty or disaster.
13. It has often been alleged that, the branded products containing the same ingredients differ to a very great
extent in their prices, and the products bearing generic names are decidedly cheaper. Several examples have been
cited such as Aspirin and Aspro. Paracetamol and Metacin etc. It is reasonable to accept that promotional efforts
and expenses incurred by the manufacturers to establish their brand names are commensurate with higher prices.
In fact, in the larger context this is not in the best interest either of the manufacturer or the patient. If the same
money is spent on better standardization, quality control and Research and Development, the national gains will
be substantial.
14. The drugs which are sold under brand names fall under two categories :—
(1) Those which contain a single ingredient,
(2) Those which contain multiple ingredients.
A larger number of single ingredient drugs are pharmacopoeial but are still being marketed under brand names.
Since there is no control over the number of brand names that can be given to a single drug formulation, we have a
state of confusion with respect to brand names. Thus, a single drug, such as aspirin, paracetamol or nikethamide,
is being marketed separately in this country under several brand names. This is not in the best interest of either the
medical profession or of the patient, who is often led to believe that one branded drug isd ifferent from the other and
possess superior values. In effect, this is not the case and the patient is unwillingly made to pay higher prices for
his treatment.
15. In the case of multi-ingredient preparations, the situation is still worse. Brand names have been responsi
ble for putting up a large number of unnecessary and often irrational formulations in the market. In fact the orga
nised sector has maintained dominance over the drug market principally through their branded products contain
ing multiple ingredients. Many examples can be given to illustrate this point. This has resulted in excessive use
of drugs particularly under the names ‘tonics’ containing vitamins in excessive quantities. Multiple drug com
binations in amounts far in excess of what is required result in colossal national wastage of drugs. This could be
substantially reduced if the brand names are eliminated. In this respect, it is to be emphasised that the entire British
Health Service runs on the British National Formulary preparations, which are by and large, single ingredient drugs,
rather than multiple ingredient preparations. The Food and Drug Administration of the United States (F.D.A.)
appointed a Committee of Experts drawn from National Research Council (N.R.C.) and National Academy of
?
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Sciences (N.A.S.) to evaluate the efficiency of over 3.000 preparations marketed in the United States. It was proved
that a majority of these do not possess therapeutic eificiency and were directed to be either withdrawn or to provide
further evidence of their effectiveness. There is thus a case for controlling multiple ingredient branded products,
marketed in this country, particularly by the organised sector, and promoted rigorously. This, in itself, will serve
to loosen the hold of the organised sector on the pharmaceutical industry to a great extent.
16. The medical profession has acquired the habit of prescribing branded products. This has unfortunately
come out of tradition of several years and not by virtue of training in medical colleges. At no stage brand names
are introduced in the medical curriculum. The brand names have a corrupting influence on the profession. A
doctor more often patronises branded product and. unwittingly therefore, makes his patient pay more than necessary. This is a matter which the medical profession should think over very seriously.
17. A number of new drugs are being introduced in this country under brand names. This has a two-fold
effect. A company with aggressive sales promotion establishes its new product under a brand name and reaps the
benefits during the period the patent is valid.
t
After the patent period is over, having established the brand names, it continues to reap this harvest much to
the disadvantage of other entrepreneurs. Thus, inspite of the modification of the Patents Act, the disadvantage to
the Indian entrepreneur continues in a large measure. Many examples of this can be given. Chloramphenicol
is marketed under the brand name of Chloromycetin and nikethamide is marketed under the brand name of Coramine. In both these cases, the process patents have expired. However, the concerned pharmaceutical firms manu
facturing these drugs continue to derive benefits by virtue of their established brand names.
18. It is often argued that the quality of a product is assured because of its brand name and substitution of
brand name by generic name will result in lowering of standards. Maintenance of quality is the responsibility of
the manufacturer and it does not go with the brand name. Scrutiny of the total number of substandard, misbrand
ed and spurious products reported by various drug control organisations and the drug testing laboratory of the Go
vernment of India at Calcutta will reveal that there are more instances of branded products being misbranded or,
therefore, spurious. There have been no instances where a product marketed under generic name has ever been re
ported to be spurious. Thus, branding of products promotes a tendency to prepare misbranded or spurious products.
19. Quality must be maintained and every effort must be made to see that all drugs introduced in the market
conform to pharmacopoeial or prescribed standards. Very often, it is stated that the branded products of certain
firms have standards higher than those prescribed by the pharmacopoeia. Pharmacopoeia standards are adequate
enough to protect the interests of the patient. If higher standards are going to result in higher pricing, which is
said to be the case with respect to some branded products marketed by a few firms in the organised sector, there is
no advantage to be gained. However, as long as the quality control organisation is properly strengthened, there
is no reason to fear that a substandard product will be marketed. It is. therefore, absolutely essential to achieve
high standards of quality control throughout the length and breadth of the country, irrespective of whether the drugs
are going to be marketed under generic or brand names.
20. It is often argued that bioavailability is an important factor in the efficiency of a drug. The W.H.O.
Technical Series Report on bioavailability has highlighted differernt facets of this problem, particularly, the fact
that as yet there are no established and accepted methods for evaluation of bioavailability of different brands of
drugs. A drug manufactured by a firm, may differ from batch to batch in its bioavailability. Bioavailability is parti
cularly important in the case of oral preparations and that too with respect to only a very few drugs. It cannot be
denied, that in case of drugs like digoxin, phenytoin etc. bioavailability is important, but this has nothing to do with
brand or generic names. The Drug Control authorities will have to exericse effective control over the standards
of such drugs which will need bioavailability studies as per recommendations of the W.H.O., whether these
drugs are introduced under generic or brand names.
21. In view of all the above considerations, it is clear that there is a strong case for substitution of brand names
by generic names. In the considered opinion of the Committee it may not. however, be advisable to accomplish
this change immediately. The medical profession has been traditionally used to prescribing drugs under brand
names and a sudden shift may result in considerable confusion and difficulties for prescribing doctors. A sudden
change may also affect the present distribution system. The manufacturers will also be faced with some difficulties
with respect of labelling etc., if a sudden change is brought about. Steps will have to be taken to strengthen Drug
Control organisations in various states in order to enable them to exercise very rigorous control over the quality of
drugs.
22. The Committee, therefore, is of the view that .this change over from brand names to generic names should
brought about in a phased manner as recommended by the medical panel. In view of all the above considerations
and taking into accounts and taking into account the intricate facets of the problem, the following recommendations
are being made.
(a) Brand names should be abolished in a phased manner.
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255
(b) A beginning should be made for a change over to generic names starting with the drugs mentioned in
Annexure III. Mostly these drugs are already being marketed under generic names and heir generic
names are quite elegant.
(c) Drugs which are exported may be allowed to bear brand names.
(d) All supplies of single ingredient drugs and drugs included in Indian Pharmacopoeia for Central and State
Government Institutions and local bodies should be tendered and supplies made under generic names. At
present, drugs, though tendered under generic names, are supplied under brand names, and this should
be discouraged.
(e) All drugs other than those listed in the Annexure III should bear labels displaying prominently the generic
names. Brand names may be shown on lables in a less conspicuous manner.
(f) The Drug Controller should, while granting permissions, be requested not to give recognition to brand
names of New drugs, new drugs should not be allowed to be marketed under brand names, when first
introduced into this country.
(g) Multiple drugs combinations often containing drugs, particularly vitamins, in amounts far in excess of what
is required are presently marketed in India. The majority of such combinations are irrational. There is a
colossal national wastage of drugs because of such combinations. The Drug Control Administration
should immediately go into the various drug combinations and take prompt measures to eliminate irrational
drug combinations. No firm should be allowed to incorporate excessive quantities of any drug over and
above what is required to go into the formulations for therapeutic and prophylactic purposes. Pharma
copoeia! Committee should be requested to give new/generic names for multiple ingredient preparations.
New types of multi-ingredient preparations should not be allowed to be marketed hereafter unless they
are mentioned in the National Formulary or Pharmacopoeia and approved by the Drug Controller
of India. If any amendment of the Drugs and Cosmetics Act and Rules is considered necessary for this
purpose, this should be carried out.
(h) Non-proprietory names as recommended by W.H.O. from time to time should be adopted.
(i) Bioavailability studies are important in cases of a few drugs, although this factor has recently been over
played not always on rational basis. Facilities should be created in different parts of the country, so that
the'industry, both large and small scale, can take advantage of such facilities to plan and conduct bioavai
lability and pharmacokinetic studies.
(j) In order to keep the medical profession, particularly the general practitioners, well-informed about New
Drugs and also to popularise the generic names, it is essential to take steps immediately.
(i) To revise the Indian National
Formulary
and make it up-to-date.
(ii) To publish journals on the lines of Prescriber’s Journals, U.K., Medical Letter, U.S.A., or Formulary
Notes of Sri Lanka. Such publications will have to be under the control of an Editorial Board
Comprising leaders of the medical profession in the country constituted by the Ministry of Health,
Government of India.
23. The Committee is of the view that from legal point of view there should be no difficulty in abolishing the
brand names. Abolishing of brand names will entail first the amendment of the Trade and Merchandise Marks
Act, 1958 and subsequently the Drugs and Cosmetic Rules.
24. A periodic review of the impact of this step on the drug industry price and availablity of medicines is nece
ssary etc. So as to take suitable corrective measures, if required.
25. Apart from emphasising the needs for ensuring more rigid and uniform quality control throughout
the country, the Committee also recommends to the Government for early implementation of the recommenda
tions made ’with regard to measures for providing essential drugs and common household remedies especially in
the rural areas.
26. While making the above recommendations, the Committee would emphasise that the recommendations
regarding the change over from brand names to generic names has to be implemented cautionally and on a phased
manner ensuring simultaneously the necessity of enforcing quality control on drugs and in particular the concerned
recommendations made in the Interim Report of the Committee on ‘Quality Control’ of drugs.
27. The Committee in concluding this report would like to place on record its deep and w’arm appreciation of
the quick and excellent work done by the eminent doctors of the panel and in particular by Dr. B. B. Gaitonde, Direc
tor, Haffkine Institute, Bombay, who took special interest in this complex problem and finalised the Report in a very
short time.
IMofPet. &Chem./75—33
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(Out of the 117 essential medicines, the items which in the opinion of the Committee could be concerned
as household remedies are shown at Annexure IV).
SUMMARY OF RECOMMENDATIONS
Essential drugs and common household remedies-SuppIy thereof
In order to make the essential drugs as indentified by the Committee, available in large quantities and at a
reasonably low price throughout the country, the Committee recommends following measures: —
Production:
(i) Production of those medicines should be expanded or taken up in adequate quantities giving top priority
for the manufacture of the relevant bulk drugs/active ingredients.
[Chapter X—Para 7(i)]
(ii) The Ministry of Petroleum & Chemicals should take all such measures, which will increase the production
of those drugs expeditiously. Special assistance, prioritv for power supply, other incentive schemes
etc. may be given to entrepreneurs, preferably the National Sector, who come forward to undertake pro
duction of these essential drugs. In short, if there are any impediments, these should be immediately
looked into and removed.
[Chapter X—Para 7(ii)]
Technology'.
(iii) In cases of some drugs, the technical know-how is already available, but there is a production shortfall.
More entrepreneurs should be encouraged to take up the production of such drugs. In case of these drugs
for which technical know-how is not available in the country, special incentives may be given to national
Laboratories to develop the know-how on a time-bound basis. If necessary, the foreign technical know
how may also be obtained immediately.
[Chapter X—Para 7(iii)]
Distribution:
(iv) To make these drugs available in rural areas, the distribution system must be rationalised and decentralised,
in regard to household remedies and commonly used medicines which do not require the prescription of
doctors. Assistance should also be sought from the postal department, Indian Oil Company Depots,
kerosene depots. Cooperative Socties should be encouraged for the distribution of drugs in rural areas’
[Chapter X—Para 7(iv)]
Packing :
(v) Packaging details should be looked into. Tablets should be supplied in strip packings, liquid prepara
tions should be in bottles fietted with pilfer proof closures.
[Chapter X—Para 7 (iv)]
Exports :
(vi) Export of the bulk drugs required for the production of medicines identified by the committee, as well
as their formulations should be so regulated that there is no shortage of these essential drugs in the country
at any time[Chapter X—Para 7 (iv)]
Dispensing :
(vii) At present, there are a number of difficulties, especially in small towns and rural areas, to establish phar
macies for dispensing of drugs. To obviate these problems, immediate steps should be taken to ievise
the present syllabus of training of the pharmacists. The Pharmacy Council should be approached to
tailor the course to suit the needs of the country. An intensive, need-oriented course of a short duiation
after matriculation should be instituted for training of dispensers, who then could be licensed to establish
pharmacies and drug stores for distribution of these medicines in smaller towns, rural areas and remote
parts of tbe country.
[Chapter X—Para 7 (v)]
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257
(viii) Primary Health Centres should be given adequate financial assistance for purchase of drugs, so that the
rural population also gets the same quality drugs in adequate amounts as in urban areas.
[Chapter X—Para 7 (vi)]
2. Substitution of brand names by generic names :
(i) Brand names should be abolished in a phased manner.
[Chapter X—-Para 22(a)]
(ii) A beginning should be made for a change-over to generic names starting with the drugs as identified by
the Committee. These drugs are mostly being marketed under genric names and their generic names are
quite elegant.
[Chapter X—Para 22(b)]
(iii) Drugs which are to be exported may be allowed to bear brand names.
[Chapter X—Para 22(c)]
(iv) All supplies of single ingredient drugs and drugs included in Indian Pharmacopoeia for Central and State
Government Institutions and local bodies should be tendered and supplies made under generic names.
At present, drugs, though tendered under generic names, are supplied under brand names, and this should
be discouraged.
[Chapter X—Para 22(d)]
(v) All drugs other than these listed in the Annexure III should bear labels displying prominently
the generic names. Brand names may be shown on labels in a less conspicious manner.
[Chapter X—Para 22(e)]
(vi) The drug Controller should, while granting permissions, be requested not to give recognition to brand
names of new drugs. New drugs should not be allowed to be marketed under brand names, when first
introduced into this country.
[Chapter X—Para 22(f)]
(vii) Multiple drugs combinations often containing drugs, particularly vitamins, in amounts far in excess of
what is required are presently marketed in India. The majority of such combinations are irrational.
There is a colossal national wastage of drugs because of such combinations. The Drug Control Adminis
tration should immediately go into the various drug combinations and take prompt measures to eliminate
irrational drug combinations. No firm should be allowed to incorporate excessive quantities of any drug
over and above what it required to go into the formulations for therapeutic and prophylactic purposes.
Pharmacopoeial Committee should be requested to give new/generic names for multiple-ingredient pre
parations. New types of multi-ingredient preparations should not be allowed to be markted hereafter
unless they are mentioned in the National Formulary or Pharmacopoeia and approved by the Drugs
Controller of India. If any amendment of the Drugs and Cosmetics Act and Rules is considered necessary,
this should be carried out.
[Chapter X—Para 22(g)]
(viii) Non-proprietory names as recommended by W.H.O. from time to time should be adopted.
[Chapter X—Para 22(h)]
(ix) Bioavailability studies are important in cases of a few drugs, although this factor has recently been over
played not always on rational basis. Facilities should be created in different parts of the country, so
that the industry, both large and small-scale, can take advantage of such facilities to plan and conduct
bioavailability and pharmaco-kinetic studies.
[Chapter X—Para 22(i)]
(x) In order to keep the medical profession, particularly the general practitioners, well-informed about new
drugs and also to popularise the generic names it is essential to take the following steps immediately :
(a) To revise the Indian National Formulary and make it up-to-date.
(b) To publish journals on the lines of the Prescriber's Journals, U.K., Medical Letter, U.S.A., or For- z
mulary Notes of Sri Lanka. Such publications will have to be under the control of an Editorial
Board comprising leaders of the medical profession in the country constituted by the Ministry of
Health, Government of India.
[Chapter X—Para 22(i)]
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258
3. Periodic Review :
A periodic review of the impact of this step on the drug industry, prices and availability of medicines is necessary
so as to take suitable corrective measures, if required.
[Chapter X—Para 24]
4. Availability of Medicines :
Government should take steps for early implementation of the recommendations made above with regard to
measures for providing essential drugs and common household remedies especially in the rural areas.
[Chapter X—Para 25]
5. Quality Control :
The Committee emphasises that the recommendation regarding the change over from brand names to generic
names has to be implemented cautiously and on a phased basis ensuring. Simultaneously the necessity of enforcing
quality control on drugs and in particular the concerned recommendations made in the Interim Reports of Com
mittee on ‘Quality Control of Drugs*.
[Chapter X—Para 26.]
I
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Annexure I
(Chapter X—Para 5)
Report of the Panel constituted by the Committee on Drugs and Pharmaceuticals, Ministry of Petroleum and Chemicals,
Government of India, New Delhi
The Panel met on Sth and 9th June, 1974, at the Haffkine Institute Bombay. The following were present :
1. Dr. Ranen Sen
2. Dr. A. B. Chowdhury
3. Dr. S. Padmavati
4. Dr. B. Ray Chaudhari
5. Dr. K. V. Thiruvengadam
6. Shri P. S. Ramachandran
7. Dr. K. G. Nair
8. Dr. B. J. Vakil
9. Dr. P. R. Gupta
10. Dr. B. B. Gaitonde
Convener.
Sliri M. K. Ranganekar attended by special invitation.
The Committee discussed in detail the following :
(1) Measures for providing essential drugs and common house-hold remedies, especially in rural areas.
(2) Whether it would in the national interest to substitute brand names by generic* names and, if so, the
manner and the extent to which it should be done.
I. With regard to the first term of reference, it was felt that a list of essential drugs, particularly those, which
are used extensively in medical practice in both urban and rural areas, will have to be prepared. Accordingly,
the lists of the essential drugs prepared by the Committee on Essential Drugs, 1967,
as well as those prepar
ed by Prof. Padmavati and the Drugs Controller (India), were scrutinised and a new list (Appendix 1) was pre
pared. In the opinion of the Committee, drugs mentioned in the attached list are extensively used and are essen
tial for medical practice. In order to make these essential drugs available at a reasonably low price throughout
the country, the Committee recommends the following measures :
(i) Production of these drugs should be stepped up immediately giving top priority for the manufacture of the
relevant basic drugs.
(ii) The Ministry of Petroleum & Chemicals should take all such measures, which will increase the production
of these drugs expeditiously. Special assistance, priority for power supply, other incentive schemes etc.,
may be given to entrepreneurs, preferably Indian, who come forward to undertake production of these
essential drugs. In short, if there are any impediments, these should be immediately looked into and
removed.
(iii) In case of some drugs, the technical know-how is already available, but there is a production short-fall.
More entrepreneurs should be encouraged to take to production of such drugs. In case of those drugs
for which technical know-how is not available in the country, special incentives may be given to National
Laboratories to develop the know-how on a time-bound basis. It necessary, the foreign technical know
how may also be obtained immediately.
The term “generic” denotes “non-proprietary”
259
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4.
260
Distribution :
(iv) To make these drugs available in rural areas, the distribution system must be rationalised and decentralised.
For this, assistance should be sought from the postal department,
Indian Oil Company Depots, Kero
sene depots. Cooperative Societies should be encouraged for the distribution of drugs in rural area.
Packaging details should be looked into. Tablets should be supplied in strip packings. Liquid prepa
rations should be supplied in bottles fitted with pilfered proof closures. Exports of the basic drugs
(Appendix I) as well as their formulations should be so regulated that there is no shortage of essential
drugs in the country at any time.
Dispensing :
(v) At present, there are a number of difficulties, especially in small towns and rural areas, to establish phar
macies for dispensing of drugs. One of the major difficulties is non-availability of trained pharmacists.
According to the Drug Act, those who possess a Diploma in Pharmacy can only be licensed as Dispensers.
The diploma Course is quite lengthy and the remuneration paid to the dispenser is not attractive. The
Pane! recommends that steps should be taken to revise the present syllabus of training of the pharmacists.
The Pharmacy Council should be approached to tailor the courses to suit the needs of the country. An
intensive, need-oriented course of a short duration should be instituted for training of dispensers, who
then could be licensed to establish pharmacies and drug stores in smaller towns and rural areas. Primary
Health Centres should be given adequate financial assistance for purchase of drugs, so that rural
population gets the same quality of drugs in adequate amounts as in urban areas.
II. Substitution of brand names of drugs by generic names
The question of generic names and brand names was extensively discussed. All facets of the problem, such
as impact on drug prices bioavailability, quality, of drugs, enforcement of drug control, multiple ingredient pre
parations, export of drugs, labelling, difficulties, impact on small-scale industry, patent rights, distribution, system,
acceptance by the medical profession, role of distributions and pharmacists, effect on the growth of pharmaceutical
industry, difficulties and inconvenience in the use of tongue-twisting generic names etc., were discussed in detail.
After taking into account all these very intricate problems, the Panel makes the following recommendations :
(a) Brand names should be abolished in a phased manner. This step is in the right direction both for rational
practice of medicine and general national interest. Drugs which are exported may be allowed to bear
brand names.
(b) A beginning should be made for a change over to generic names for the drugs, mentioned in Appendix
II. These drugs are used very extensively and their generic names are as elegant as brand names. These
drugs should, therefore, not be allowed to be marketed under brand names with immediate effect.
(c) The change over from brand names :o generic names may result in the increase of spurious and sub
standard drugs. It is, therefore, strongly recommended that steps should be taken to ensure more rigid
and uniform quality control throughout the country.
(d) All supplies of single ingredient drugs and drugs included in Indian Pharmacopoeia for Central and State
Government Institutions and Local Bodies should be tendered and supplies made under generic names.
At present, drugs, though tendered under generic names, are supplied under brand names, and this should
be discouraged.
(e) All drugs other than those listed in Appendix II, should bear labels displaying prominently generic names.
Brand names may be mentioned in brackets.
(f) The Drugs Controller (India) be requested not to give recognition to the brand names of new drugs when
first introduced in this country.
(g) Multiple drug combinations often containing drugs, particularly vitamins, in amounts far in excess of what
is required are presently marketed in India. The majority of such combinations are irrational. There
is a colossal national wastage of drugs because of such combinations. The Panel, therefore, strongly
recommends that the Drug Control Administration should immediately go into the various drug combi
nations and take prompt measures to eliminate irrational drug combinations. No firm should be allowed
to import excessive quantities of any drug over and above what is required to go into the formulations
for therapeutic and prophylactic purposes.
(h) The Indian Pharmacopoeia Committee be approached to devise simple, short and suitable non-proprietary names for drugs, which have not long and difficult generic names.
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(i) Bio-availability studies are important in cases of a few drugs, although this factor has recently been over
played not always on rational basis. The Panel recommends that facilities should be created in different
parts of the country, so that the industry, both large and small-scale, can take advantage of such facilities
plan and conduct bioavailability and pharmacokinetic studies.
(j) In order to keep the medical profession, particularly the general practitioners, well-informed about New
Drugs and also to popularise the generic names, it is essential to take steps immediately to :
(i) revise the Indian National Formulary,
(ii) to publish journals on the lines of the Prescriber’s Journals, UK, Medical Letter, USA or Formulary
Notes of Sri Lanka.
Saeh publications will have to be under the control of an Editorial Board comprising leaders of the medical
profession in the country constituted by the Ministry of Health, Government of India.
Sd/- Dr. Ranen Sen
Sd/- Shri P. S. Ramachandran
Sd/- Dr. A. B. Chowdhury
Sd/- Dr. K. G. Nair and Dr. B. J. Vakil
Sd/- Dr. S. Padmavati
Sd/- Dr. P. R. Gupta & Dr. B. B. Gaitonde
Sd/- Dr. B. Ray Chaudhury
Sd/- Dr. K. V. Thiruvangadam.
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Appendix I
Tablets and Capsules (Granules included)
1. Cap. Chloramphenicol 250 mg.
2. Cap. Tetracycline Hydrochloride 250 mg.
3. Tab. lodochlorhydroxy Quinoline 0.5 gm.
4. Tab. Nitrofurantoin
5. Tab. Chlorpheniramine
6. Tab. Ferrous Sulphate
7. Tab. Folic Acid
8. Tab. Digoxine
9. Tab. Aspirin
10. Tab. Phenobarbitone
11. Tab. Chlorpromazine
12. Tab. Predinisolone
13. Tab. Hexa Vitamin (N.F.I.)
14. Tab. Vitamin B. Complex
15. Tab. Vitamin C
16. Tab. Sulphadimidine
17. Tab. Metronidazole
18. Tab. Hydrochlorothiazide
19. Tab. Reserpine
20. Tab. Glyceryltrinitrate
21. Tab. Analgin
22. Tab. Antacid (B.N.F.)
23. Tab. Piperazine (Syrup Piperazine)
24. Tab. Tetrachlorethylene
25. Tab. Tolbutamide
26. Tab. Thiacetazone & Isoniazid (each tablet to contain Thiacetazone 37.5 mg. BPC & Isoniazid 75 mg. IP)
27. PAS granules
28. Tab. I.N.H.
29. Tab. Dapsone (50 mg)
30. Tab. Chloroquine Sulphate 0.2 gm (or Tab. Chloroquine Phosphate 0.25 gm IP)
31. Tab. Primaquine Diphosphate (2.5 gm. of Primaquine base)
32. Tab. Diethylcarbamazine Citrate (50 mg)
33. Tab. Anti-asthmatic (containing ephedrine Hcl. 50 mg. Theophylline 65 mg. and Phenobarbitone 30 mg)
34. Tablets containing alkaloids of Ergot equivalent to 0.4 mg of total alkaloids ergotoxin.
35. Capsules of Vitamin A 6000 units and Calciferol 1000 Units.
36. Tab. Vitamin A
37. Tab. Vitamin D
38. Tab. Milk of Magnesia
39. Oral Contraceptive (approved by Family Planning Department).
Injections
1. Injection Penicillin
2. Inj. Streptomycin
3. Inj. Emetine Hydrochloride
262
263
4. Inj. Atropine
5. Inj. Adrenaline
6. Inj. Nor-Adrenaline
7. Inj. Dextrose Saline
8. Inj. Furosemide
9. Inj. Morphine Sulphatic
10. Inj. Pethidine
11. Inj. Paraldehyde
12. Inj. Predinisolone
13. Inj. Anti-Tetanus Serum
14. Inj. Methyl Ergometrin
15. Inj. Chlorpheniramine Meleate
16. Inj. Fortified Benzyl Penicillin PP (Procaine Benzyl Penicillin 3,00,000 units. Benzyl Penicillin 1,00,000 units).
17. Inj. Aminophylline /0.5 gm/2ml)
18. Inj. Oxytocin (Oxytocin 5 i.u./ml)
19. Inj. Chlorpromazine
20. Antivenom Serum (Polyvalent)
21. Rehydration fluid (for treatment of cholera cases)
22. Glucose Ampoule (containing dextross 25%)
23. Distilled Water (25cc ampoule)
24. Inj. Phenobarbitone Sodium (200mg/ml)
25. Inj. Mepheteramine
26. Diphtheria-Pertussis-Tetanus Vaccine
27. Inj. Totanus Toxoid
28. Inj. Diphtheria Toxoid
29. Inj. Anti-Diphtheria Serum
30. Oral Polio Vaccine
31. Inj. Insulin Plain (40 units per ml)
32. Inj. Sodium Pentathol
33. Inj. Succinyl Choline
34. Inj. Xylocaine.
Miscellaneous (Syrup, Ointments, mixtures, eye drops, ear drops, etc.)
1. Sulphacetamide Eye Drops
2. Homatropine Eye Drops
3. Esserine sulfate eye drops
4. Benzyl Benzoate Emulsion
5. Acid Carbolic
6. Lysol
7. Tr. Iodine
8. Syrup Piperazine
9. Ext. Belladonna (Combination of Phenobarb & Belladonna)
10. Chloramphenical suspension (125 mg/ml)
11. Syrup Paracetamol (125 mg in 5 ml)
12. Tetracycline Hydrochloride Ointment 1 % in sterile ointment base
13. Gripe Mixture for infants (5 ml contains Dill oil BPC 0.005 ml; sodium bicarbonate I.P.O.
0.005 gm dehydrated
alcohol I.P. 0.0248 ml (Syrup & Preservative).
14. Syrup Noscapine
Whitefields Ointment Benzoic acid 6 g; salicylic acid 32g; alcohol 70% upto 100g)
16. Nitrofurazone ointment (0.2% in non-greasy ointment base)
17. Petroleum Jelly
1 M of Pet & Chcm/75—34
> t
264
18. Potassium, Permanganate 5g packets
19. Diethyl Ether (Anaesthetic)
20. Cetrimide Lotion
21. Iodine Solution (Claudium Solution) for sterilizing raw catgut, loops and loop introducers (lodinel 1g, Pot
Iodide 1.5 g. Distilled Water to produce 100 ml)
22. Plaster of Paris Bandages.
23. Adhesive Plaster
24. Ethyl Chloride (100 ml spray)
25. Boric Acid-Alcohol-Glycerol drops (Boric Acid 1.5 % Glycerol 3.3% in alcohol 95%, 10 ml)
26. Bleaching Powder
27. Phenyle
28. Epsom Salt
29. Krushen’s Salt (Each gram contains Sod. Sulphate Exsic 20 mg., Sod. chloride 10 mg., Pot. chloride lOmg,
Potassium Sulphate 55 mg., Citric Acid 45 mg., Magnesium sulphate excis).
30. Ointment containing : Resublimed Iodine 4%, Mehyl Salicylate 5%
31. Ointment containing : Oil Eucalyptus 8%, Oil clove 1%, Camphor 5%, Menthol 3%, Thymol 2%, Methyl
Salicylate 5 %.
1 St
Appendix n
1. Chloramphenicol
2. Tetracycline
3. Ferrous Sulphate
4. Aspirin
5. Chlorpromazine
6. Reserpine
7. Tolbutamide
8. Analgin
9. Piperazine
10. Crystalline Pencillin G
11. Streptomycin
12. INH Tablets
13. Tablets INH—Thiacetazone.
(All dosage forms of above drugs be marketed uader generic names.)
I
*
I
265
■
■ ■
f
i
I
9
Awbxure—II
Chapter X—Para 7)
Tablets and Capsules (Granules included)
SI. No.
1
Name of the Product
Bulk drug involved
2
3
1. Capsule Chloramphenicol—250 mg.
Chloramphenicol.
.
2. Capsule Tetracycline Hydrochloride—250 mg.
.
Tetracycline.
Hyderochloride
3. Tablet lodochlorhydroxy Quinoline—250 mg.
.
lodochlorhydro.xy Quinoline.
4. Tab. Nitrofurantoin—50 mg.
.
Nitrofurantoin
,
Chlorpheniramine
.
Ferrous Sulphate
5. Tablet Chlorpheniramine—4 mg.
.
6. Tablet Ferrous Sulphate—200 nig.
7. Tablet Folic Acid—5 mg.
.
Folic Acid
8. Tablet Dixogin—0.25 mg.
.
Digoxin
9. Tablet Aspirin—300 mg.
.
Acetyl Salicylic Acid
10. Tablet phonobarbitone—30 mg., 60 mg.
.
Phenobarbitone
11. Tablet Chlorpromazine—10 mg.
.
Chlorpromazine
12. Tablet Prednisolone—5 mg. .
.
Prednisolone
13. Hexa Vitamin Capsules and Tablets. (Each tablet or Capsule contains) :
Vit. A—5000 I.U.
.
.
Vit. D—100 I.U. .
Vit. Bl—2 mg. ...
Vit. B2—3 mg
Nicotinamide—20 mg. .
Vit. C—75 mg
. Vitamin A, calciferol. —vitamin D2/Vit. D.3
. Thiamine hvdrochloride
. (Vit. Bl), Riboflaving
. (Vit. B2), Nicotinamide
. Ascorbic Acid (Vit. C)
.
14. Tablet Vitamin B-complex, Prophylactic N.F.I. :
Vit. B. 1—2 mg. .
Vit. B.2—2 mg
Vit. B.6—0.5 mg.
.....
Nicotinamide—25 mg. ......
Calcium Pantothanate—1 mg.
....
Yeast—100 mg.
15. Tab. Vitamin B-Complex with Folic Acid and
For therapeutic use :
Vitamin B-l—10 mg. .
Vitamin B-2—10 mg. .
Vitamin B-6—2.5 mg. .
Cal. Pantothenate—5 mg.
Niacinamide—100 mg.
Folic Acid —1.5 mg.
Vit. C—150 mg.
.
.
.
.
Vit. B.l Vit. B.2.
Vit. B.6—(Pyridoxine
hydrochloride)
Nicotinamide, Calcium—
Pant othenate, Yeast.
Vitamin-C, therapeutic N.F.I.
.
.
.
16. Tab. Vitamin C—50 mg., 100 mg. and 500 mg.
Vit. Bl, Vit. B2, Vit. B6,
Cal. Pantothenate, Nia-cinamide
Acid, Vitamin-C.
Folic-
Ascorbic Acid
17. Tab. Sulphadimidine—500 mg.
.
18. Tablet Metronidazole—200 mg.
Sulphadimidine (Synonym)—Sulphamcthazine.
Metronidazole
19. Tablet Hydrochlorthiazide —25 mg., 50 mg. .
.
Hydrochlorthiazide.
20. Tablet Reserpine—0.25 mg. .
.
Reserpine
21. Tablet Glyceryl Trinitrate—0.5 mg.
.
Glyccryltrinitrate
22. Tablet Analgin—500 mg.
Analgin.
26.6
261
i
I
2
3
23. Tablet Antacid
Dried Al. hydroxide—120 mg. gel..
Peppermint oil 0.003 ml
Mg. Trisilicate—250 mg.
.
.
.
.
Al. hydroxide
mint bil.
24. Tab. Piperazine citrate—300 mg. .
25. Cap. Tetrachloroethylene 1 cap. contain 1 ml. of the drug
26. Tablet Tolbutamide —500 mg.
.
.
Tolbutamide
Thiacetazone and INH
28. PAS/Sodium PAS'Granules/Tablets—500 mg..
Para-amine salicylic acid/sodium para
aminosalicylate
......
30. Tablet Dapsone—100 mg. tab.
I
.
Piperazine citrate.
Tetrachloroethylene
27. Tablet Thiacetazone (50 mg.) and Isoniazid (100 mg.)
29. Tablet INH—100 mg. tab.
i.
.
.
Mag. Trisilicate. Pepper
Iscnicetinic Acid hydrazide
.....
Dapsone
31. Tab. Chloroquine Phosphate 250 mg. tablet .
Chloroquine-Phosphate
32. Tab. Primaquine phosphate 2.5 mg of base and 7.5 mg. of base
Primaquine phosphate
33. Tab. Diethylcarbamazine citrate—50 mg tablet
Diethylcarbamazine citrate
34. Tablet Anti-asthmatic :
Ephedrine Hcl.—-10 mg.
......
Phenobarbitone—7.5 mg.
......
Theophylline—125 mg.
......
35. Tablet Alkaloids of Ergot—150 mg.
....
36. Tablet of Vitamine A (6000 LU.) and Vitamin D (1000 LU.)
37. Tablet Vitamin A 50,000 LU.
.....
38. Tablet Vitamin D 50,000 LU
39. Tablet Milk of Magnesia—300 mg.
....
40. Tablet Paracetamol—500 mg.
.....
41. Tablet Quinine Sulphate—0.3 mg..
....
42. Tablet Pathalyl Sulphathiazole—500 mg.
....
43. Oral Contraceptive :—
(a) Norethisterone—1.0 mg
......
Ethinyl Estradiol—30 mg.
.....
(b) Dl-norgestrel—0.5 mg Ethinyl Estradiol—30 mg.
.
.
.
.
.
.
.
.
.
.
Ephedrine Hcl.
Phenobarbitone
Theophylline
Prepared Ergot
Vitamin A and Vitamin D
Vitamin A
Vitamin D (calciferol)
Magnesium Hydroxide
Paracetamol
Quinine Bisulphate
Phythalyl Sulphathiazole
Norethisterone
Ethinyl Estradiol
dl-norgestrel
Injections
1. Inj. Pencillin :
(a) Benzyl Penicillin Injection—5,00,000 units
(b) Procaine Benzyl Penicillin Injection—2,50,000 units/ml.
|
(c) Fortified Benzyl Penicillin Injection—Procaine Benzyl Penicillin—3,00,000 Units S- Peni cillin G
+ Benzyl Penicillin 1,00,000 units/ml.
J
2. Inj. Streptomycin Sulfate—1 mg.
.......
Streptomycin
1
3. Inj. Emetine hydrochloride—60 mg. of Emetine hydro-chloride/ml.
.
4. Inj. Atropine Sulphate—0.5 mg./ml
.
Atropine Sulphate
-f
5. Inj. Adrenaline Tartrate/Maleate Contains equivalent of adrenaline 1 in 1000
.
Adrenaline Tartrate
Adrenaline Maleate
6. Inj. Nor-Adrenaline Acid Tartrate Img./ml.
.
Noradrenaline Acid—Tartrate
I
-
i
......
.
Emetine Hcl.
7. Inj. Dextrose Saline')
—5°/ow/v
I
—10%w/v
J—25%w/v
—50 % w/v
J
8. Inj. Fruscmide 20 mg. of Frusemide/2 ml. of water .
9. Inj. Morphine Sulphate—10 mg. ml. . .
10. Inj. Pethidine Hydrochloride—50 mg./ml.
11. Inj. Paraldehyde .......'
12. Inj. Prednisolone Sodium Phosphate 20 mg./ml.
13. Inj. Tetanus Antitoxin 1500 I.U., 10,000 I.U., 50,000 LU..
14. Inj. Methyl Ergometrine maleate 0.2 mg./ml. .
1 M of P&C/75
Dextrose
.
.
.
.
.
.
.
Fruscmide
Morphine Sulphate
Pethidine Hydrochloride
Paraldehyde
Prednisolone Sodium Phosphate
Tetanus Antitoxin
Methyl Ergometrine Maleate.
268
i
2
3
15. Inj. Chlorpheniramine Maleate 10 mg./ml.
.
.
.
.
.
16. Inj. A-minophylline 250 mg./lO ml. ampoule ...
Chlorpheniramine Maleate.
.
Aminophylline
.
Oxytocin
.
Chlorpromazine Hcl.
20. Rehydration Fluid Dextrose in Sod. Chloride injection 25% w/v
.
Dextrose and Sod. Chloride
21. Injection Glucose containing 5% w/v
.
Glucose
.
Phenobarbitone Sodium
.
Mephentcramine Sulphate
17. Inj. Oxytocin 5 units/ml..............................................
18. Inj. Chlorpromazine Hcl. 25 mg./ml.............................................
19. Antivenom Serum (Polyvalent Crotaline Antivenine)
22. Water for injection
23. Inj. Phenobarbitone 200 mg./ml.
....
24. Inj. Mephentcramine Sulphate 15 mg./ml.
25. Diphtheria-Pertussis-Tetanus Vaccine I.P.
26. Inj. Tetanus Toxoid I.P.
.
27. Inj. Diphtheria Toxoid I.P.
.
.
.
Diphtheria Toxoid Tetanus toxoid Pertussis-vaccine.
.
.
Tetanus Toxoid
.
Diphtheria Toxoid
.
Diphtheria Antitoxin
.
Aqueous suspension sutiable live-attenuated
strains of Poliomyelitis virus-tvpe I,
H and III.
.
Insulin
28. Inj Diphtheria A-ntitoxin 10,000—20.000 Units
29. Oral Polio Vaccine
...
30. Inj. Insulin Plaini
20, 40 or 80 units/ml.
.
31. Inj. Thiopentone Sodium 500 mg. 1 gm.
Thiopentoll
32. Inj. Succinyl Choline Chloride 50 mg./ml.
33. Inj. Lignocaine 0.5 %, I % and 2%
34. Inj. Vitamiae B-Complex N.F.I. Each ml.
Vit. BI
Vit. B2
Vit. B6
Mitacinamide
Vit. B.12
Penthenol
.
Succinyl Choline Chloride
.
Lignocaine Hydrochloride
.
Bl, B2, B6, Niacinamide,
nate, B12
—10 mg.
— 2 mg.
— 2 mg.
— 2 mg.
—10 mg.
— 2 mg.
35. Inj. Thiamine Hydrochloride 5 mg. ml. .
36. Inj. Cyanocobalamin 100 mcg and 500 mcg/mL
37. Typhoid-paratyphoid A and B Vaccine I.P.
Cal Pantothe
.
Vit. Bl (Thiamine hydrochloride)
.
Cyanocobalamin
38. Cholera Vaccine
Each ml. contains not less than 8,000 million of Vibric Cholerae.
39. Small Pox Vaccine (Freeze dried) (Vaccine Lymph)
Missellaneous
1. Sulphacetamide Eye drops 10%, 20%, 30%
2. Homatropine Eye drops :—
Homatropine Hydrobremide
Sodium Chloride
Solution for Eye drops
Sulphacetamide Sodium
Homatropine Hydrobromi de
0.1 G
28.0 mg.
5.0 ml.
3. Esserine
J
Sulfate Eye drops Physostigmine Salicylate
Physostigmine Salcylate
25.0 mg.
Sodium Chloride
40.0 mg.
Sodium Metabisulohite
2.0 mg.
Solution for Eye Drops
5.0 ml.
4. Benzyl Benzoate Emulsion 25 % .
5. Acid Carbolic Lotion (25%)
.
6. Lysol :
50 % Cresol V/V in a Saponaceous Solvent
Physostigmine Salicylate
.
Benzyl Benzoate.
.
Phenol
269
3
2
1
7. Tr. Iodine Solution (Aqueous)
Iodine
—1.25 g.
Potassium Iodine —2.5 g.
7(a) Tincture Iodine :
Iodine
—2.5 g. .
Potassium Iodine -1.5 g.
Purified Water
—2.5 ml.
Alcohol
—90% up to 25 ml.
8. Tr. Benzoin
Benzoin Crushed
Alcohol
up to 1000 ml.
Iodine
Benzoin
-100 g.
-90%
9. Syrup Piperazine ....
(500 mg. of Piperazine Citrate/5ml.)
Piperazine Citrate
10. Extract Bellodonna I.P.
Belladonna Root Powder
Chloramphenicol Palmitate
.
11. Chloramphenicol Suspension
125 mg./5ml.
Paracetamol
12. Syrup Paracetamol 125 mg./5ml
14. Gripe mixture :
Oil Anethi—0.0016 ml.........................................................
Oil Anisi—0.0016 ml
Oil Caraway—0.0062 ml.
......
Sod. Bicarbonate—290 mg.
Alcohol 90 %—3 ml.
Distilled Water—30 ml.
Tetracycline Hydrochloride
.
13. Tetracycline Hydrocholride Eye Ointment 1 % W/W Tetracycline
. Oil Anethik, Oil Anisi,
. Oil Caraway, Dod. Bicarbonate,
. 90% Alcohol, Distilled Water.
15. Noscapine Linctus B.P.C. 15mg./5inl.
.
Noscapine
16. Whitfields Ointment
Benzoic Acid—60 %
Salicylic acid—3 %
.
.
.
N
Benzoic Acid
Salicylic Acid
Nitrofurazone
17. Nitrofurazone Ointment
Nitrofurazone—0.5 %
18. Petroleum Jelly
19. Potassium Permanganate Solution : (0.1 per cent) .
Potassium Permanganate
.
20. Anesthetic Ether.
Cetrimide.
21. Cetrimide Lotion (1 %)
22. Plaster of Paris Bandage
.
Zinc Oxide
23. Adhesive Plaster .
24. Ethyl Chloride Spray
.
Ethylchloride
.
25. Boroglycerme Eye Drops (1 %)
.
Cresol
Caustic Soda
Magnesium Suplphate,
.
.
.
.
Sod. Chloride, Sod. Sulphate
Pot. Chloride, Pot. Sulphate,
Citric Acid, Pot. Iodide,
Mag. Sulphate
28. Epsom Slats
29. Health Slats—0
Sod. Chloride—10% .
Sod. Sulphate—2%
Pot. Chloride—1 %
Pot. Sulphate—5.5 % .
Citric Acid—1.5 %
Pot. Iodide—0.001%
Mag. Sulphate to—100 %
IMof Pct. &, Chem./75—36
1
Boric Acid Glycerine
Calciumhypochlorite
26. Bleaching Powder
27. Phenyl
Calcium Sulphate-hemihydrate
■■
270
2
i
3
30. Iodine Ointment
Iodine
Methyl Salicylate—5 %
Iodine—
5 °/o
31. Sprain Ointment
Methyl Salicylate
Ointment : .
Methyl Salicylate—500 g.
White Bees wax—200 g.
Wool Fat—105 g.
Menthol—100 g.
Water—45 g.
Cajuput Oil—25 g.
Eucalyptol—25 g.
Methyl Salicylate
White Bees Wax.
Wool Fat, Menthol
. Cajeput Oil.
. Eucalyptol
32. Cough Syrup
33. Ammoniated Mercury Ointment
Ammoniated Mercury —5 g.
Liquid Paraffin—3 g. .
White Ointment—92 g.
34. Pain Balm
Clove Oil 1 70
Oil of Eucalyptus 8 °/o
Camphor 5
Menthol 3 °/o
Thymol 2
Methyl Salicylate 5 7O
.
Ammoniated Mercruy.
Liquid Paraffin—
—White
Annexure III
J
[Chapter X—Para 22(b)]
1. Chloramphenicol and its esters such as palmitate, monostearoyl glycollate, succinate and stearate.
2. Tetracycline, Oxytertracycline, Chlortetracycline, Demethyl-chlor-tetracycliness, 5 Deoxy-Oxytetracycline.
3. Ferrous sulphate
4. Aspirin (Acetyl Salicylic acid)
5. Chlorpromazine
6. Roserpine
7. Tolbutamide
8. Analgin
9. Piperazine and all its salts such as adipate, citrate and phosphate.
10. Crystalline Penicillin G such as procaine, long-acting benzathine penicillin, including semisynthetic penicillins.
11. Streptomycin
12. INH
13. Combination of INH-Thiacetazone.
i
(All single ingredient dosage forms of the above drugs shall be marketed under generic names.)
271
Annexure IV
(Chapter X—Para 27)
Household Remedies
SI. No.
Name of the Product
1. Tablet lodochlorhydroxy Quinoline—250 mg.
2. Tablet Ferrous Sulphate—200 mg.
3. Tablet Aspirin 300 mg.
4. Hexa Vitamin Capsules and Tablets
(Each tablet or Capsule contains) :
Vit. A—5000 I.U.
Vit. D—100 I.U.
Vit. Bl 2 mg.
Vit. B2 3 mg.
Nicotinamide—20 mg.
Vit. C—75 mg.
5. Tablet Vitamin B-Complex, Prophylactic N.F.I.,
(Vit. B.l
—2 mg.
Vit. B.2
—2 mg.
Vit. B.6
—0.5 mg.
Nicotinamida
—25 mg.
Calcium Pantothenate
—1 mg.
Yeast
—100 rng.)
5.a. Tab. Vitamin B-Complex with Folic Acid and Vitamin C, therapeutic N.F. II.
’ For therapeutic use :—
—10 mg.
Vitamin B-l
—10 mg.
Vitamin B-2
—2.5 mg.
Vitamin B-6
Cal. Pantothenate — 5mg.
—100 mg.
Niacinamidg
—1.5 mg.
Folic Acid
—150 mg.
Vit. C
6. Tab. Vitamin C-50 mg.
100 mg. and 500 mg.
7. Tab. Antacid
Dried Al-hydroxide—120 mg.
gel.
Peppermintoil—0.003 ml.
Mg. trisilicate—250 mg.
8. Tabl. Milk of Magnesia 300 mg.
9> Tab. Quinine Sulphate 0.3 g.
10. Sulphacetamide Eye Drops
10% 20% 30%
11. Benzxl Benzoate Emulsion 25%
12. Acid Carbolic Lotion (25 %)
13. Lysol
50% Cresol V/V in a Saponaceous Solvent
14. Tr. Iodine Solution (Aqueous)
Iodine—1.25 g.
Potassium lodida —2.5 g.
14. a. Tincture Iodine
Iodine—2.5 g. Potassium Iodide—1.5 g.
Purified Water—2.5 ml.
Alcohol—90 % up to 25 ml.
272
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173
15. T. Bonzoin.
Bonzoin Crushed—100 g.
Alcohol 100 ml.—90%
upto 90 ml.
16. Gripe mixture
Oil Anethi—0.0016 ml.
Oil Anisi—0.0016 ml.
I
Oil Caraway —0.0062 ml.
Sod. Bioarbonate—290 mg.
Alcohol 90/o —3ml.
Distilled Water—30 ml.
17. Noseapine Linctus B.P.C. 15 mg./5ml.
18. Whiuiclds Citntment
Benzoic Acid—60 %
Salicylic Acid —3 %
19. Nitrofurazone Ointment Nitrofurazone—0.5 %
20. Potassium Permanganate
Solution—(0.1 per cent)
21. Cetrimide Lotion (1 %)
22. Adhesive Plaster
23. Boroglycerine Eye-Drops (1 %)
24. Bleaching Powder.
25. B Phenyl*
26. Fpsom Salts.
27. Health Salts.
Sod. Chloride—10%
Sod. Sulphate—2%
Pot. Chloride—1 %
Pot. Sulphate—5.5 %
Citric Acid —1.5%
Pot. Iodide—0.001 %
Mag. Sulphate to—100 %
28. Iodine Ointment :—
Methyl Salicylate—5 %
Iodine —5%
29. Sprain Ointment :—
Methyl Salicylate
Ointment :—
Methyl Salicylata—500 g.
White Bleeswax—200 g.
Wool Fat—105 g.
Menthol—100g.
Water—45 g.
Gajuput Oil —25 g.
Euclyptol—25 g.
30. Cough Syrup
31. Pain Balm
Clove Oil 1%
Oil of Eucalyptus 3 %
Camphor 5 %, Menthol 3 %
Thymol 2%, Methyl Salisylate 5%.
1
*
CHAPTER XI
CONCLUSION AND ACKNOWLEDGEMENT
In conclusion, we may state that it has been constant endeavour of Government to see that the majority o
our people particularly in the rural areas and the weaker sections of the society get drugs and medicines at cheap
and reasonable cost. The pharmaceutical industry in India, we are convinced, has a great potential, and given propc
support, encouragement and guidance, it can meet the social needs and achieve the objectives set before it.
2. At the outset, we wish to place on record our gratitude to Shri D.K. Borroah and Shri Shah Nawaz Khan,
the former Ministers in the Ministry of Petroleum and Chemicals, Dr. Karan Singh. Minister of Health an-' Familv
Planning, Shri K.D. Malaviya and Shri K.R. Ganesh, the present Ministers in the Ministry of Petroleum l d Che
micals for the interest evinced by them and the encouragement and assistance we received from them.
3. We gratefully acknowledge with thanks the assistance and support received from the Government of India.
We also wish to thank the State Governments of Maharashtra. Gujarat, Andhra Pradesh, Tamil Nadu and Wes
Bengal for the assistance and hospitality rendered by them during our visits to the respective places, to study the
status and problems of the industry. In particular, we convey our deep gratitude and acknowledgement of the in
terest shown by Shri Siddharta Shankar Roy, Chief Minister.- West Bengal and Health Ministers"of West Bengal.
Maharashtra, Andhra Pradesh and Tamil Nadu. The Governments of Maharashtra and West Bengal were gooc
enough to arrange for special trips for the members of the Committee to Pimpri and Durgapur Chemical Complex,
respectively.
4. During our visits to various manufacturing units and the research and development institutions, we were
greatly impressed by the enthusiasm of Indian scientists, research scholars and technologists. We had also occasion
to discuss problems relating to the Pharmaceutical Industry with various manufacturers, their associations/organizations, the Indian Medical Association, scientists and research scholars, many of them submitted detailed- me
moranda in reply to the questionnaire issued by the Committee. We would like to express our thanks to all those
individuals and associations for their assistance and co-operation.
5. The question of substituting generic names for brand names was a complex one. We, therefore, sought the
assistance of eminent doctors to advise the Committee on this vexed question, as well as on the identification of
essential drugs. The Committee had the benefit of having in a very short time their report which formed the basis
for our conclusions on these issues. We acknowledge with thanks the valuable assistance given by Dr. A.B. Chow
dhury and Dr. B. Ray Chaudhury of Calcutta, Dr. S. Padmavati of New Delhi, Dr. K.G."Nair and Dr. B.J. Vakil
of Bombay and Dr. K.V. Thiruvengadam of Madras.
6. We also thank the two public Sector Units, viz., the Indian Drugs and Pharmaceuticals Limited and the
Hindustan Antibiotics Limited as well as the Drug Control Organization of various States we visited for the assistance
rendered by them to the Committee.
7. During the short time that was available to us we have tried to analyse the problems of Pharmaceutical
Industry, and have made recommendations which would enable the Public Sector to attain a commanding height
in the Industry. We have also recommended steps to be taken to encourage Indian large and small scale"sectors.
S. We have recommended in our report the establishment of a National Drug Authority which should be
entrusted with the responsibility of planning, procuring and producing drugs, supplying of raw materials, obtaining
technology from abroad, co-ordinating the work of various research and development institutions, and distributing
essential drugs.
9. This and various other recommendations made by us, we believe,-will go a long way in developing the Phar
maceutical Industry in India, through indigenous efforts. Strengthening of Drug Control Organization at the Centre .
and the States will ensure quality and standard of drugs manufactured. Encouragement to and co-ordination of
various R & D institutions will help the Industry to equip itself with modern technology and know-how. These
recommendations when implemented, we hope, will in a large measure satisfy the social needs of the country'. The
fulfilment of these needs is imperative and we cherish the hope that Government will implement the recommenda
tions made in this report expeditiously.
\A--.
10. We cannot conclude without expressing our warm and sincere appreciation for the full co-operation and’
assistance received from the Ministry of Petroleum and Chemicals and Ministry of Health and Family Planning. We wish to place on record our high appreciation of the work done by Dr. P.R. Gupta, our Member Secretary for
the assistance rendered during the tenure of the Committee, in addition to his normal duties, and in the preparation
of this report. We also thank the officers and staff of the Committee including Dr. O.P. Madan of I.D.P.L., Shri
V. Rajagopalan, Under Secretary and Shri O.P. Grover, Section Officer for the assistance rendered by them.
274
I< •
A
I
4
■
Abbreviations used
A.U.
BTCP
CSIR
CDRI
COB
DGTD .
DPCO
.
E.I.
FERA
.
G. C.A.
H. A.L. .
H.O.C. .
IDPL
IPCL
ICMR
.
ICAR
I1T .
IDR Act .
L.P.G.
.
MRTP
NCL
N.C.S.T.
N.D.A. .
“Organised” Sector
OCED .
R&D
RRL
RPA
S.T.C.
.
Actual Users (refers to the manufacturers)
Bureau of Industrial Costs and Prices
Council of Scientific and Industrial Research
Central Drug Research Institute, Lucknow.
Carrying on Business
Directorate General of Technical Development
Drugs (Prices Control) Order, 1970
Established Import
Foreign Exchange Regulation Act, 1973
General Currency Area
Hindustan Antibiotics Ltd.
Hindustan Organic Chemicals Ltd.
Indian Drugs and Pharmaceuticals Ltd.
Indian Petrochemical Corporation Ltd.
Indian Council of Medical Research
Indian Council of Agricultural Research
Indian Institute of Technology
Industries (Development & Regulation) Act, 1951
Liquified Petroleum Gas
Monopolies and Restrictive Trade Practice? Act 1969
National Chemical Laboratory, Poona
National Committee on Science and Technology
National Drug Authority of India
Units registered/licensed under the I (DR) Act, 1951, and borne on the books of DGTD
. Organisation for Economic and Co-operative Developn'ent
. Research and Development
. Regional Research Laboratory'
. Rupee Payment Area
. State Trading Corporation of India
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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275
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