CHAI ANNUAL MEETING 1984 - TOWARDS A PEOPLE' ORIENTED DRUG POLICY
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- Title
- CHAI ANNUAL MEETING 1984 - TOWARDS A PEOPLE' ORIENTED DRUG POLICY
- extracted text
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Voluntary Healm Association of India
C*K Community Centre
Sefdarjung Development Area,
New Delhi-110016
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Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652006
D-^0->343,.<R,II:a)
as 4.11.82
Pear Friend,
~
The summary of the Prug Workshop (ll) - an MFC-VHAI collaboration is being sent to you. It is mainly to remind ourselves of our specific
responsibilities.
An up-to-date review of Bangladesh drug ban is also being sent- We are
grateful to Pr-Zafrullah Chowdhury for keeping us infonned. Claude Alvares
is busy building support for the ban in various non-medical circles like the
IIT’s and has started a signature campaign- Pr-Anant Phadke, on behalf of
the National Executive Committee of the Medico Friends Circle has issued a
press release to ’condemn the pressure techniques of the multinationals’The sale of amidopyrine foimulations was to have been stopped from
31st October 1982. Their sale henceforth is ILLEGAL. Please bring cases of
default to our notice. Pr- Kabra as well as the Consumer Education and Research
Centre of Ahmedabad will provide guidance and advise on matters regarding
legal action.
Attempts to get the ban on Estrogen-Progesterone combination and Paediatric Tetracyclin are underway- Dr« Sathya is preparing a detailed review
which will be sent to you soonCiba Geigy has decided to withdraw its popular anabolic steroid prepar*
ation PIANABOL because of its hazardous effects. This action speaks a lot for
the usage of other anabolic steroidj preparations-
We need case histories, documented evidence, field studies about the
hazardous effects of hormonal pregnancy tests, amidopyrines and dipyrones,
anabolic steroids, paediatric tetracyclines, anti-diarrhoeals like Lomotil.
These efforts can only come from concerned individuals and those health
personnel believing in rational therapy.
Pr. Ran© writes that drugs like Unienzyme, which contain iodochlor
hydroxyquinoline, should be included in our list and so also ALL ENZTMES
containing dioquinol in any form.
All we have is our profound concern and commitment to counteract the
biased information given by the drug industry and the mass media which they
can afford- The Prug Controller’s stand on the issue of the hazardous drugs
is amply clean "Someone in the West takes up an issue, and our people promptly
take it up here- More people die in India from unsterilised needles than from
dangerous drugs".
When our people cannot have basic health care, nor essential drugs
for basic health care and life-saving drugs, they can very well do without
hazardous and non-essential drugs having little therapeutic value - and that
too at costs they can ill afford.
c0WlM^n'‘
VV3Of)St
b fcAark5
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p_;iO-343 (B.IT: a)
a: 4.11.82
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The drugs issuft is a health issue. If we do not feel responsible
enough to demand drugs according to our national priorities and people’s
needs, the drug industry will decide all that for us. For them profits
will always come before people, and as one drug representative has so
eloquently put it some years ago - ”we are businessmen not bishops”.
ln.a+ . We appeai
our f^nds to BOYCOTT all hazardous drugs - the black
otho/hf
° tnese/fugs has been prepared by VHAI - and to influence
other health groups and individuals to do the same.
o
’7e appeal for help in compilation of documented <case 'histories,
*
review
recent medical literature regarding various hazardous drugs.
becomes bigger we need to keep each other informed
about our efforts as individuals and groups.
Locking forward, to hearing from you and reminding you that our
next year a priorities are anti-diarrhoealB and shortage of anti-TB (and
anti-leprosy) drugs and the misuse of anti-diarrhoeals.
With sinjperG- regards^
-y
(Mira sAiva)
Co-Ordinator
Low Cost Drugs & Rational
Therapeutics
Z -
•
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area,
New Delhi-110016
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Telegrams : VOLHEALTH
New Delhi-110016
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Phone : 652007, 652008
February 23/ 1982
MS:k:D-10.343:
Dear friend.
This letter is to thank sincerely all those of you who
contributed in the Drug Workshop held in Pune on January 8-10/
1982.
This letter is accompanied by the summary of the Workshop#
the most important part being the Action Plans
kindly
take note of your specific areas of committment.
If you know of other like minded individuals who could or
would like to contribute in any specific areas, it's up
to you to get them in touch witfc us and others.
The Drug related work is going on here includes
writing up the report being sent to you
visits to the Drug Controller by Chandra %
compilation of material
on harmonal pregnancy tests for which we had planned to
launch a campaign. Various women’s groups have been contacted
by Sathya, Anant and Dr. Mathur have contributed significantly
in collection of data.
Visits to various chemists and doctors have been made — to
i —- We find Hormonal Preparation,
collect fir^t hand information,
tests
can
be
obtained over the counter even wj.thfor pregnancy •------- ------- --prescription
after
without
any accompanying literature.
out y
- - - ’by doctors
---- nowith
accompanying
They are prescribed- widely
warning to the pregnant mother.
Some
you.
• The first draft of Book of Tens has been made,
material available with us which may be of interest to
(International Organisation
- 44 misused drugs by IOCU unternauondi
of Consumer Union, Penang)
- Drugs found to be less than effective (FDA of USA)
- Some of the papers presented at Transfer of Technology
Conference at Gonosasthya Kendra, Bangladesh
- Reprints of articles written on Drugs issues by
Dr. Yudkin.
The above can be photostated at cost and sent to you.
• your• comments and what you have done and
If you could send■’ in
could
are doing, we <-----12 inform the others in the group.
With sincere regards and best wishes to you, from your friends
in VHAI.
Looking forward to hearing from you.
S inc e rely,
Mira Shiva
Torr?'"
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r
Voluntary Health Association of India
%
C-14, Community Centre
Safdarjung Development AreaNew Delhi-110016
D-lO/343'
MS:a/16.2.82
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2) VHA1 \
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Telegrams : VOLHEALTH
New Delhi-110016
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Phone : 652007, 652008
REPORT OF WORKSHOP ON
’’DRUGS ISSUES AND SEEKING FEASIBLE ALTERNATIVES"
PUNE, JANUARY 8 - 10,1982
This report is divided, into three partsPart I is a list of participants- Part
II is an enumeration of specific action
plans emerging out of the workshop.
Part III is a brief description of each
session of the workshop with a program
outline-
The appendices follow Part III-
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MS:a:16.2.82
PART I - LIST OF PARTICIPANTS
1.
13.
Dr. D. A. Joseph,
105, Nibbana,
Pali Hill Road,Bandra,
Bombay 400 050
14.
Dr. H- N. Antia,
Foundation for Research in
Community Health,
84-A,R.G.Thadam Marg,
Sea Face Corner, Worli,
Bombay 400 018,Maharashtra
15.
Mr* Rajiv Tiwari,
Centre for Education and
D o cumen t at i on,
3 Suleman Chambers,
4 Battery Street,
Behind Regal Cinema,
Bombay 400 039
16.
Dr- Anant Phadke,
Medico Friends Circle,
50 L.I-C. Quarters,
University Road, Pune 411016
17.
Dr- Wishwas V. Rane,
2117 Sadashiv Peth,
Pune 411 030
18.
Dr. A. R. Patwardhan,
Arogya Dakshata Mandal,
1913 Sadashiv Peth,
Pune 411 030
19.
Sr. Pratiti
Sr. Angella
C/o Bishop’s House,
P.O.Kunkuri,Raigarh Dt.
LIP - 496 225
Dr- U. N. Jajoo,
Reader, Department of Medicire
Sewagram Medical College,
Wardha, Maharashtra.
20.
Dr. Binayak Sen
CMSS Office,
P.O.Rajhara Kondy,
Dist.Durg - 491 228 , MP.
Dr. P. K. John,
Christian Hospital 5
Bissam Cuttack,
Orissa - 765 019
21.
Mr* D. P. Poddar,
Organizing Secretary,
West Bengal VHA,
41-1, Palm Avenue,
Calcutta - 700 019
22.
Dr- V. S. Mathur,
Prof.of Pharmacology,
PGI of Medical Education
and Research,
Chandigarh - 160 012,
Dr•D.B*I.Victor
and
2-
3-
Dr-Vasundara Victor
Star of Hope Hospital,
Akividu, W.Godavari DtA.P. 534 235
Dr- Mishra,
Gram Nirman Mandal,
Sarvodaya Ashram,
Sokhodeora,Bihar 805 106
4.
Mr.Claude Alvares,
Rustic, Thane,
Valpai, Goa 403 506
5.
Mr. D. P. Pandey,
Q-16/8 Rajouri Garden,
New Delhi 110 027
6.
7.
8.
9.
10.
Mr- Pramod Kulkarni,
Consumer Education and
Research Centre,
Thakorebhai Desai Smarak
Bhavan,
Ellis Bridge,
Ahmedabad 380 006
Ur* Alan Crammer,
Mary Calvert Holdsworth
Memorail Hospital,
Mysore - 570 021,
Karnataka.
OR
Kishore Bhartij
Bankhedi - 461, 001,
Dist.Hoshangabad, M.P.
11.
Ms Padma Prakash?
Blossom Society,
60-A, Pali Road,
Bandra,Bombay 400 050
12.
Dr. A. C. Jessani,
K-8 Nensey Colony,
Borivli (e),400 006,
Bombay.
J
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2^.
Mr. Jean Louis Bato,
Overseas Director^
SOLIDARITE,
Associationho 1901,
90 Chemin des Capelies,
31300 Toulouse,
CCP Toulouse 2760 42M, France.
24.
Dr. Satthyamala
25.
Mr. Augustine Veliath
26.
Mrs Chandra Kannapiran
27.
Mr. S. Srinivasan
28.
Dr- Mira Shiva.
)
)
)
)
)
)
)
Voluntary Health Association of India,
C-14, Community Centre ,•
Safdarjung Development Area,*
New Delhi 110 016
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PART - III - SESSION REPORT
Janugzry 8,1982
Objectives and Purpose
The objective of the meeting was to identify and discuss those
problems for which we could pool our efforts in finding solutions and
working towards solving them*
The strategies worked out for VHAI’s involvement in. the Health For
the Millions drugs issue ('April - June 1981) still forms the broad basis
-of our work, but this workshop was to get together a yCOre
.core group
group- of .
concerned individuals and to focus our future activities on concrete
action plans emerging out of- the workshop*
Session Is, (9.00-11.30 am) : Intgoduction
There were totally Co participants representing various interest
groups in drugs and pharmaceuticals. Their expressed interests in the
workshop included rational drug therapeutics; low cost Ofoxaulation
production, bulk purchase and distribution? training; documentation and
information, dissemination, and alternatives in training, action and
therapeutics. The professional backgrounds of the participants included
practising pharmacologists, doctors,academics, consumer education,
journalism, management and practice of herbal, other- pathy alternatives.
For more details of participants’ backgrounds see Appendix
The fact that drugs issue was an important aspect in the politics
of health was recognised. So also was the fact that individuals in
various walks of life - besides doctors and policy makers had an important
role to play.
Session 2: (11.30 - 1 pm) : Drug Situation in India
There was an introductory presentation by Dr. V* S. Mathur- His
paper attempted to identify the major trends in the Indian drug industry
with possible solutions.
Dr*Mathur stated that small scale units had no role in the
production of drugs as their products tended to be sub-standard- Other
participants disagreed with him specially Drx Anant Phadke.
Dr* Mathur highlighted the need for the removal of government
taxation on essential drugs, which is apparently up to 25%, and also
the need to educate doctors by way of informing then about comparative
costs of total therapy (through relevant refresher courses and information
on current therapies and costs) (A~NEED FELT BY MANY IN THE FIELD).
After the ensuing discussion one point came across very clearly the need to draw up a list of those drug firms which produce reliable low
cost generic drugs.
Rajiv Tiwari shared some of his findings and experiences about the
multinational drug companies in Bombay*
Session 3 & 4 (2*30 - 5*50 pm) sOngoing Education & Dissemination of
Information
The participants split into three discussion groups to discuss the
above agenda* The groups were? (a) doctors, pharmacists and pharmacologists.
The Pharmacy and Therapeutics group which would take on the primary
responsibility of obtaining and screening relevant information: (b)
individuals more involved v/ith grass-roots/rural' health work; who would
simplify the drug information, implement rational drug therapy, and give
feedback: (c) individuals interested in consumer education and action,
who would help in building up a healthy, enlightened public to break free
from the injection-tonic culture.
5 .-10/^43
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Group (a) decided to reformulate an essential drugs list in keeping
with the WHO essential drug list, Based on further discussion, the group
hoped to be able to draw up simple 7 broad guidelines for hospitals of
various sizes, fulfilling various needs.
Session 1:
January 9,1982
(8.30 - 9.go am): Pharmacy Management
Since drugs formed an important part of all health care institut
ions, whether they are hospitals, dispensaries or community health
programmes, a session was held to deal with the application of management
techniques and principles in the management of a pharmacy. The subjects
discussed included ABC analysis concepts of buffer stock, load time and
recording level.
Alan Crammer highlighted how 70^ of the costs in terms .of annual investment were due to 10% of the drugs which came’in Category A. He
emphaoized the need to exercise stock control measures for these and
stock the minimum required. He talked about the need to know the lead
—iff6 ^0;r obtaining various important drugs,i.e. the. time between placing
orders and receiving the stocks. He also mentioned the need to maintain ’
buffer stocks. Dr. John talked of other important concepts like VED
I Vital Essential Desirable ) Analysis, the need for smaller voluntary
hospitals to come together and produce or* bulk compound certain drugs in
a cooperative, framework.
Later, in the same session (9.30 - 10 am) there was a discussion on
the cost effectiveness and legality of manufacturing/compounding intra
venous solutions. There was unanimous agreement on the cost effectiveness
of manufacturing intra-venous solutions
There was a sharing in the group
of difficulties experienced by health care institutions (by way’of harass
ment,.etc) in the matter of intra-venous solutions manufactured despite
compliance with all legal and technical requirements. It was suggested
that in case of such events, Dr- P. Dasgupta, Deputy Drugs Controller
INirman Bhavan, New Delhi) could be contacted for help and clarification.
Session 2s (10.30 - l.OO)
3
There were three subjects for discussion in this sessions (a) lop
cost drug manufacture: (b) non-availability of essential drugs, and:(c)
compounding simple mixtures and medicines at the periphrral level.
Srinivasan summarised VHAI’s involvement in making low cost drugs available.
The group discussed the non-availability of essential drugs especially
for TB and Leprosy - Isoniazid and Dapsone. U.N.Jajoo and Mira led the
discussion of the preparation of simple mixtures at the peripheral level.
The conclusions that seemed to emerge from this session were:
(a) One.of the ways of facilitating low cost, good quality medicines
availability is some arrangement between manufacturers of
tablets and medicines.and buying individuals/groups•
Dr. Pane who has worked with UNICHEM for 20 years shared his
views. He felt getting a loan licence by a group representing
concerned and interested health-institutions would probably be
the best thing. He emphasized the need to identify sources and
alternative sources from where reliable raw materials for
formulation could be obtained.
Life saving drugs could be bought from the ’’reliable bigger drug
houses”, while other drugs could be from smaller -reliable
------—j units •
the quality control being done periodically and independently.
Dr. P. K-.John gave his suggestions on how bulk purchases and
distribution in the voluntary health sector could be done*Dr» Antia mentioned Dr. Gaitonde’s recommendations for village,
communes and shared the concept of ’’hand tabletting unit". When
the question of sterile mode of production was raised, he
responded by saying that a sterile tablet of, say, aspirin,
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prcuuced in Bombay is anyway thrown around so much that by the
time it is consumed, its not all that sterile. If a man is
eating salmonella .and drinking salmonella, giving him a sterile
tablet of aspirin produced in Bombay in a fancy drug unit instead
of a village won’t make too much of a difference.
(b) It was suggested that there was a need to put pressure regarding
non-availability of essential drugs - as an initial measure one
essential drug would be selected. Details about the production,
distribution of this drug would be studied. Scientific data will
be shared with othe^s^especially the consumer pressure groups.
It was decided that/further action a detailed dossier on the
production and availability of Isoniazed in India would be
prepared.
The need to explore availability of essential drugs from other
sources, e.g*, charitable institutions - Indian and foreign was expressed*
rf(c) There will be a collation of information on simple preparations
and mixtures by specific members of this group.
Session 3: (g.OO - 3-45 pm): Consumer Education
Augustine coordinated this session’ The discussion centred around
generating consumer pressure on various issues and disseminating consumer
information as widely as possible-
The role of consumer groups according to Dramod Kulkarni of CERCyras seen as an Information Group as well as a pressure ;grpup-
The need for documentation centres for relevant drug related
information was recognized and four of the organizations represented at
the workshop who are already involved in such work, were delegated the
responsibility, and they accepted the same- They were:
- C-E.R.C. Ahmedabad.
- Pune Journal,Punef
- C.E.D. Bombay
- VHAI, Delhi
The need for linkages with other groups involved in similar work
was again emphasized.
The other areas discussed were the need to focus on over-thecounter drugs; the need to bring to the notice of the Government and the
public the irrational advertisements of irrational drugs, The need to
release an advertisement against the OPPI ad fjasfelt. This needed tobe
done by various individual organizational heads.
The need for compiling information on the following drugs was felt:
- drugs most misused.
- drugs with maximum adverse effects
- drugs with severe price differences as compared to other
alternatives available- those essential drugs often unavailable and in shsrrtageThe need to seek legal aid, where malpractices and false advertise
ments were concerned, was recognized. This would be done by getting in
touch with socially concerned legal aid societies and individual lawyers.
CEPlC took on the responsibility of pursuing legal action after the
rest of the group furnished it with relevant data.
The need to get in touch with civil liberty groups was also
recognized, for support and follow-up action.
p-lO/343_____
llkl©:a:16«2^2 .
4 -
- -j demonstrative
Claude Alvares strongly felt there has to be more
undesirable drugs from chemist shops.
social action like throwing°out
‘
It was decided to get information on injectable pregnancy tests
preparations like depo provera, etc., of
E.P.Forte and other hormonal
]
1
s
groujs
by 8th March the Women’s Day.
special concern to women’
(After a discussion later in the evening)
The group finalised the steps given under the section on Action
Plans.
Section 4g (4.15 - 5.45 pm): Rational Drug Therapeutics
Mira led the discussion- Rational drug therapy was defined as
using the right drugs at the right time and in the right dosages. Phadke
and Ulhas Jajoo shared briefly their papers on OTC drugs and misuBe of
antibiotics respectivelyUlhas said that making it compulsory for the
doctors to write their diagnosis and the reasons for prescribing.an
antibiotic had shown marked decrease in prescription of antibiotics.
Among the outcome of this session were:
1) Preparation of drug information sheets and standardisation of
prescription procedures.
2) Preparation of diagnostic flow infoimation charts relevant for
the Indian context which can be used by a doctor as well as a
medical auxiliary3) Working on an Indianised version of the AMREF’s Therapeutic
Guidelines”.
4) Wide dissemination of scientific information on widely misused
drugs/banned drugg, etc.
5)’Compilation of lists of drugs not to be used during pregnancy
or during lactation«
January 10,1982
Session Is(8.30-0.50 am) : Role of Non-Doctors and Health Personnel in
Rational Therapeutics.
Sathya initiated the discussion- ■ There were two broad issues
discussed! (a) The role of Non-Doctor, Health Personnel and their training
and ongoing education? and, (b) the need for some formal training in
compoundry? dispensing skills at the village level. This would be
necessary (1) in view of the need for enhancing overall skills with
respect to the goal of Health for All, etc., and, (ii) in view of the
requirement of the Pharmacy Act (to take effect from August 1984) which
stipulates only registered pharmacists can dispense. The majority of
health workers in the voluntary sector who are working in rural areas
cannot hope to meet the requirement of a diploma in pharmacy. However,
there is a need for providing at least some need-based formal training
to them so as to ensure at least the spirit of the Pharmacy Act (i.e.
quality dispensing and compounding) if not the actual letter of the Act
ki.e., registering all rural health workers in a formal Diploma in
Pharmacy or B.Pharm. course).
Dr- Mathur felt that one could easily provide a one-two month
course which could meet the above situation- Such a course would discuss
at the most 25 drugs only. Mr. Crammer felt that the legality of such a
venture needs to be explored before further action is taken- He agreed
to help VHAI in the designing of such a course. Mira and Chinu agreed
that maintenance of a high quality in such a course was essential, and
if a limited number of drugs were to be dealt with and intense need-based
practical training was ensured, it was definitely not an impossible task.
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Session 2s (10.15 - 12*30 pm)s Alternatives in Health Drugs
1) Sr* Pratiti and Sr* Angella; Shared withthegroup their work in
Raigarh-Ambikapur Health Association, -and the specific ways in
which they have been able to keep their costs low* These are:
a) Use of bulk pruchase together for the 26 dispensaries.
b) Training of Village Health Promoters.
o') No use of a doctor in the programme - only for referrals of
the complicated cases to hospitals.
d) Use of non-drug therapies especially herbal medicines.
e) Health insurance schemes.
They explained the training and education work in RAHA. They presented
samples of herbal plants used by them to treat people in their area.
ii) Louis Batos Explained to thd group the work done by SOLIDARITE
and WHO in Mozambique (Africa) in integration of herbal and allopathic
medicines. It was found that 80% of the diseases in Mozambique could be
treated by herbal medicines. Other features of the work in Mozambique wore
involvement and training of traditional healers, use of modern tcchinques
in the manufacture of traditional medicines; provision for chemical and
laboratory trials; detailed studies in ethro-phsrinacology of the area
and development of herbal gardens with the help of trained agronomists.
The health care costs in this system worked out to approximately
Rs.3-60 per person per year.
iii) Dr*Mishra of Gram Nirman Mandal, Bihar, explained to the group
the efforts of his organization in training village health workers in more
than one system of medicine. He also mentioned the work in an anti
fertility herbal extract.
iv) Mr* Pandey: Outlined in briaf various remedies (home remedies
and those used in non-allopathic systems). Some of them were based on his
desk research and some on his personal experience. Healso shared with the
group his writing projects on homoeopathy and other non-allopathic
systems of modicino.
v) Dr.D.B.I.Victor: Spoke of his interest in alternative systems of
healing and the work in his hospital on a herbal garden, reflexology and
music therapy for stress managemeht- Ho recognized the need for psycholog
ical support since the majority of illnesses have a psychosomatic component
as is being conclusively proved by the latest scientific research in stress
and stress related diseases.
vi) Dr*Vasundhara: Plans to use eye exercises for better eyesight
instead of encouraging unquestioning dependence on spectacles which are
used like crutches, often unnecessarily.
In the last session individual Action Plans were dealt with? the
group members took on responsibility for certain specific areas of interest
and their work. Some of them were representing ilhoir organizations and
institutions but some were present and willing to undertake responsibility
in their individual capacity.
The group would get together later in the year to report back to
each other* Claude suggested that it be in June in Bombay. However, it
would probably be a little later*
B~10/345_
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ACTION PLANS
i
Action plans proposed by the three sub-groups and individual
participants, have been compiled under various headings- This has been
done to avoid repetition and over-lapping- Names of the individuals are
in brackets at the end of each relevant paragraph.
Most of the responsibilities taken by the individuals are in.their
individual capacity, and in a few cases on behalf of their organisations
they representedThe credit for the down to earth, need based action pla^s goes to
for the outcome of these pMiOn
the members of this core group •- the
—credit
---- --plans also will go to them.
It was VHAl’s privilege to coordinate their getting together.
Action Plans according to4ur Strategy*
Information
1.
Compilation, screening and documentation of relevant information
from abroad and at the national level as well as from the field.
- Low cost drug cell
- VHAI - Grassroot needs:Government Acts.
- Pune Journal of Continuous
Medical Education
- Arogya Pakshata Mandal.
- Drug Industry
- Centre for Education &
Development (CED).
- Legal Actions organise
C.E.R.C.
campaign
(This would be in collaboration with other groups actively
involved in the drug issue, e.g., Centre for Science and
Environment and Delhi Science Forum).
- Periodic letter for sharing of
-(Dr. V. S. Mathur)
information? monthly
- Identification of sources
selling generic drugs with
quality control or effective
brand drugs at reasonable prices*
- Setting up of an experimental
basic drug store for consumers
(Dr-V.S.Mathur? Dr. T* John,
Chinu, Poddar)
-(Claude, Augustine, Padma)
Compilation of essential drug list
based on prevailing disease pattern , size of health institution and level
of training of health personnel.
- Responsibility taken by participants of Pharmacy and Therapeutics
groups.
- (Dr-Mathur, Mira, Ulhas, Binayak, Dr.Joseph,Dr.Victor,
Alan Crammer)•
Compilation of relevant drug information on drug information sheets
of the commonly used drugs.
a) initially for those used in 10 commonest diseases
b) later for all the drugs in the essential drug list.
- (Pharmacy and Therapeutics Groups)
Preparation of material for simple effective management techniques for
pharmacy in small health institutions.
- (Alan Crammer)
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Assessment of drug requirement (kinds of drugs and their amount)
based on the disease patterns as found by doing OPD analysis of Health
Institutions of various sizes- (Sathya)
Preparation for Indianized material on Rational Drug Therapy.
- ( Ulhas, Mira)
Formulation of ’’Dear Doctor” series as part of attempt at unbiased ongoing
education for doctors.
- (Augustine, Mira)
Compiling information for certain specific areas
Anti-diarrhoeal preparations and role of oral rehydration therapy.
- (Anant Phadke and Dr» Mathur)
Depo provera•*
- (Sathya, Padma)
Tonics
- (Anant Phadke and Patwardhan)
E.P.Forte
- (Padma, Anant, CERC, Claude, Rajiv, Sathya)
Anti-biotics
- (Ulhas)
Analgesics
- (Anant, Dr.Mathur, Mira, Rane and Patwardhan)
Misbranded drugs
- (Ulhas)
Dissemination of information related to misused drugs.
- (Claude, Kulkarni, CERC)
Preparation of simple, readable comprehensive material/manual for field
workers.
.
- (Joseph, Ulhas, Mathur, Victor, Mishra;
Hand-outs for paramedicals-
- (patwardhan)
Evolving simple methods for communicating with literate/non-literate
Book of Tens.
- (Augustine, Phadke, Raj.iv;
Preparation of posters, wall newspapers
- (Augustine, Rane, Patwardhan, Phadke)
Compiling and preparing material on simple need based compounding
preparation of certain ointments and mixtures
- (Ulhas, Alan Crammer, Mira)
Prenaration of diagnostic flow charts and Management schedules for common
diseases - as an attempt to standardizing diagnostic and prescription
procedures.
- (Ulhas, Mira)
Field Trials
Obtaining information and undertaking comparative studies to assess
cost effectiveness oftieating patients with aliopathic medrcrnes/other
systems of medicine including herbal medicines.
- (Bate, Mishra, Mira)
i
,p-10/343'
MS:as 16•2« 82
3
Undertaking pield trials of herbal medicines
- (Joseph, Pandey, Mathur, Victor, Ulhas, Mishra)
Legal Action
Preparation of a leaflet band-out on drug related laws which
concern the consumers.
Streamlining legal action in case of serious drug induced
complications, death, etc»
- (CERC, Claude, Chinu)
Compiling information on laws related to dispensing of drugs by nurses
and paramedicals.
- (CERC, Chinu, Chandra)
Formation of pressure group, lobbying in Parliament
- (CERC, VHAI, Pandey)
Activity of^&^most priority
- Launching of campaign against E.p.Forte on March 8,Women’s Day.
-(Padma, Sathya, Mira, Phadke)
- Action against depo provera trials.
-(Claude, Sathya, Mira, Augustine)
- Counter Ads.
-(CERC, CDC, VHfkl, Phadke)
D-10/343
MS:’a:16.^.82
APPENDIX - A
BACKGROUND INFORMATION ON PARTICIPANTS, DRUGS WORKSHOP,PUNE5
J anuayy
1.
2.
3.
4.
5.
6.
8-10, 1982
ALAN CRAMMER, Mr.- Pharmacist. Works in Holdsworth Hospital,Mysore,
and Christian Medical Association of India (CMAl). Conducts
training programmes and pharmacists courses for administrators.
Consultant to voluntary hospitals.
BATO, JEAN LOUIS, Mr.Works in a non-profit organization,
SOLIDARITE, based in France. He worked in Mozambique in
establishing low cost production units for drugs and tradition
al medicines. Has come to India with the aim of exploring
possibilities of comparative studies in traditional medicines
in India.
MISHRA, Dr.- Works in Gram Nirman Mandal, a community health
project in Bihar* The project covers whole block. The aim is
to provide low cost; health care in the training of paramedicals,
training of Integrated Rural Medical practitioners,etc. Aims to
integrate various systems of medicines - allopathic, ayurvedic,
unani, etc.
ANGELLA, Sr.- One of the Coordinators of the Raigarh-Ambikapur
Health Association (RAHA). In charge for ^aigarh area. A
staff nurse with 13 years experience in rttral areas. Involved
in supervising the small health centres, training programmes,
health insurance; and interested in collecting information about
the efficacy of.herbal medicines.
PRATITI, Sr>- One of the coordinators of RAHA. In charge of
AmBikapur area. Involved in similar activities as Sr-Angella.
PODDAR, D. ____
P. Mr. - Organizing Secretary, West Bengal VHA since
1979. Involved in low cost health care. Interested in
marketing cheaper drugs and starting a cooperative for distrib
ution of low cost, good quality medicines.
7.
MATHUR, V.S-Dr.- Head, Department of Pharmacology, Postgraduate
Institute of Medical Education- and Research, Chandigarh.
Involved in teaching and research. Editor of Drugs Bulletin.
Consultant to the Government of India on drug reforms-
8.
VICTOR, D.B.I.Dr.- Medical Superintendent, Star of Hope Hospital
in Akkevidu, Andhra Pradesh. Interested in low cost health
care and non-drug therapies..
9,
VASUNDARA, Dr.- Ophthalmologist. Works with Dr.Victor. In charge of
pharmacy in the hospital. Interested in cutting down drug costs.
10.
JAJOO, U.N.Dr.- Reader in Department of Medicine of Sewagram
Medical College, Wardha. Also working in a small community
project attached to the hospital in the nearby area. Interested
in training doctors and paramedicals in rational drug therapies,
low cost health care and rural health insurance.
11.
KULKARNI, Pramod,Mr .- Manager at Consumer Education & Research
Centre, Alimedabad. The centre can help in collecting informat
ion, educating the consumer, filing cases for any action to be
taken up on unethical practices in drugs.
PHADKE, Anant, Dr.- Convenor, Medico Friends Circle (MFC), Pune.
Interested in the role of UNCs in India. Has written articles
on this issue- Writes for the Marathi press on health and
development.
JOHN? P.K. Dr
.Surgeon at Christian Hospital at Bissamcuttack?
Dr.Orissa. Interested in reducing costs for small hospitals. In
the process of organising 12 small hospitals in Orissa to make
12.
13.
If-10/343 ___
.3;a: 16.2.82
2
bulk purchase of drugs.
Wants to explore the possibilities of
drugs
setting up a small manufacturing unit for drugs. Extremely
interested in applications of modern management principles.
14-
15.
16.
17.
BINAYAK SEN, Dr.- Works in Chhatisgarh with a miners’ trade union
in developing health facilities for the mine workers of
Chhatisgarh. Is interested in rational drug therapy and low
cost drugs. Special area of concern- Tuberculosis. Post
Graduate in paediatrics.
TIV/ARI,. Rajiv Mr.- Journalist. Works with Times of India - Sunday
Review Edition- Also with Centre for Education and
Documentation, Bombay- Interested in the role of MNCs in India.
PRAKASH, Padma Ms.- A sociologist, has worked with the Foundation
for Research in Community Health, Bombay. Was involved in the
research for the book "Health for All: An Alternative Strategy if
by ICMR-ICSSR. Interested in the rolq of drugs as related to
,
women and health• '
Parliament• Interested in integ
integ-
PANDEY, D.P.’Mr.Interpreter in Parliamentrating the different systems of medicines. Involved in 3 major
projects in writing about the different systems of medicine-
18.
JESSANI, -A.C.Dr." Doing Ph-D in Sociology. Has a medical background.
• Worked with Foundation for Research in Community HealthInterested in the role of MNCs• He contributed to the Drug
Chapter in "Health for All: An Alternative Strategy".
19
ALVARES, Claude
Clause Mr.Mr*- Journalist. Founder of RUSTIC, a voluntary
organisation in Goa. Member of Lokayan- Author of "Homo-Faber" '
(a comparative study of technologies in India, Vietnam and
China). A frequent contributor to various national newspapers.
20.
• RANE, VISHWAS V. Dr.- Worked with UNICHEM for 25 years. Currently
associate Editor of Pune Journal of Continuing Education.
Works for Arogya Dakshata Mandal, Pune.
21.
JOSEPH, D-A- Dr.- Works in Nair Hospital, Bombay,.as Associate
Professor in Pharmacy- Also involved in consumer movement in
Bombay,
22.
PATWARDHjIN, A.R-Dr,- Editor, Pune Journal of Medical Education and
actively involved in Arogya Dakshata Mandal, Interested in
educating doctors in rational drug therapy.
23.
ANTIA, M- H. Dr.- Director, Foundation for Research in Community
Health. Member of the ICSSR-ICMR Committee which produced the
report: Health for All- An Alternative Strategy.
24.
VELIATH, Augustine Mr.- Coordinates publications in VHAI.Interested
in creative ways of simplifying health education. Has worked as
a journalist for newspapers and periodicals. Interested in
consumer action for drugs.
25.
SATHYAMALA, Dr.- Involved in training for Community Health, small
dispensaries and projects. Interested in social action in
health and development- Revised Werner’s Where There Is No
Doctor for the Indianised edition of VHAI. Coordinator >
Community Health Team Training Programme. Member of MFC-
26-
CHANDRA KANNAPIRAN, Mrs
Officer in Charge Information andLibrary
services at VHAI. Has a background in documentation science.
Collected much of the information for the-Drugs Workshop.
SRINIVASAN, Chinu S. Mr.- Involved in low cost ’drug production*
27.
F
*
p-10/545
3
tr"ining in health care and health care equipment maintenance
and health care management training.rJ^terested in wri
g-ditor of Health for the Millions in VHAI• Has edited VHAI s
Management Process in Health Care (which will he out soon).
28.
HIM SHIVA, Dr- Coordinating low cost drugs and rational drug
------- thprPnv activities. Other areas of involvement - aiternaiiive
S Slnlns for hwlth 1» r«™l ar»s, oebool health, oommity
ioalS oM hJlLtlo health • Also a »eBher of MFC %or<11„ator
Workshop•
************
D-10/343 ._
MS:a:16.1.82
APPENDIX - B
LIST OF HAND-OUTS GIVEN IN THE DRUGS WORKSHOP
%
1.
2.
VHAI
The Drug Situation in India
International Federation of Pharmaceutical Manufacturers
Association (iFPMA).Code of Pharmaceutical Marketing
Practices.
VHAI
3.
Sectorwise production of bulk drugs and formulations-App.4-
4.
Statement showing the categories of fixed dose combinations
recommended by the sub committee of the Drugs Consultative
Committee for being weeded out.
- Government of India.
5.
Method of Pricing -All India Mission Tablet Industry.
6.
Scientific Scrutiny of some over-the-counter drugs. - Dr.A.R.Phadke.
Home Remedies and their role in reducing dependence on institution
alised medicine.
- D.P- Pandey.
7.
8.
VHAI.
9.
VHAI’s role in drug issue.
Rational Therapeutics.
Dr- U. U. Jajoo
10.
Misuse of antibiotics.
Dr- U. N. Jajoo
11.
The Voluntary Health Association of India - Its activities and
its role in Low Cost Drugs.
12.
13-
Some instances of ’Drug Dumping’
- VHAI
Information on some of the unwanted drugs ’Banned Abroad’
- VHAI
(Dumped in the Third World)
14.
16.
Pricing.
Alphabetical list of essential and
complementary drugs.
List of Essential Drugs.
17.
List of Essential Drugs.
18.
19.
Pharmacy»
Our Concern About Drugs.
20.
Ten Commandments of the Drug companies - VHAI
21.
22-
Antidotes to the Drug Industry
Homoeopathic treatment for common
ailments of Infants and Children.
15.
*********
VHAI
WHO
WEIO
- Government of India.
VHAI
VHAI
-
VHAI
Government of India.
VOLUNTARY HEALTH ASSOCIATION OF INDIA
C-14, COMMUNITY CENTRE
SAFDARJUNG DEVELOPMENT AREA
NEW DELHI-110016 INDIA
Telephones :
652007
652008
Gram : "VOLHEALTH" NEW DELHI-110016
24th February,1982
MS-cb/HCA-18/
The Drug Controller
Ministry of Health
Nirman Bhavan
New Delhi - 110 011
Dear Sir,
We appreciate very much the attempts that have been made to
- weed out certain combination drugs|
- ban the use of LCMOTIL for infants;
- banning liquid forms of Tetracycline}
- regarding use <of generic names for certain drugs-
We would like to know about your stand regarding
- use of hormonal pregnancy tests;
- about banning of B complex Forte;
• about use of Analgin Ehenacitin.
We also would liket to be informed whether WARNINGS eg*
- regarding use of
c. Lomotil for infants ;
- hormonal preparations for pregnancy testa, etc
would have to be put on the LABELS besides merely in the enclosed •literature’?
We are
fully supportive of your attempts being made against certain malpractices.
the health activities of approximately 5,000 health institutions
VHAI coordinates
in the voluntary sector all over the country.
in cutting down drug costs and making therapeutics more rational.
We are “Tol”a
“ iXt.«...
At present we are
generic drugs or even
expenses on drugs have to be curtailed.
could you help US locate them or could you help us get in touch with someone who
still have some SOCIAL CONCIBK and can help.
Hoping for an early reply.
With sincere regards,
j
■
CLus—
Dr Mira Shivi,MD
Coordinator, Low Cost Drugs
and Bational Therapeutics
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area
New Delhi-110016
/
A\
J-nt
Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652008
D;.10/343- (r-II)
MS« as 7. 10.82
REPORT ON THE DRUG WORKSHOP (ll) HELD AT JAIPUR
ON AUGUST 30-31,1984''2
This Report comprises five parts.
Part I contains our acknowledgements of
the assistance and encouragement we
received in our work.
Part IT has the
names of and short background notes on
participants.
Part III is an.Introduction
and in Part IV follows the Proceedings of
the Workshop.
In the Annexure there is a
list of hand-outs given at the workshop
as well as a mention of some of the earlier
hand-outs relating to the drugs issue*
oOss;1.&6O001
]).10/345-(R-Il)
M»«.m 1.10.62
PART - I
a nxrtxnyj.pfl) CTJtmmq
*
■
?
'
We of^» •
pincer# thanks ani appreciation, for the
neip, encouragement and information.
----- - roooived fjjomi
- Dr. Yudkin
J
for valuable information and help regarding
amidopyrines, anabolic steroid, etc#
- I.O.C.U
about Clioquinol, Bangladesh Ban.
- Air.Charles Medawar of Social Audit, London, for
the Lomotil Pamphlets: Drug Diplomacy.
- Dr.Zofruilah Chowdhury, Projects Co-Ordinator, People's
Health
Health Centre
Centre, Bangladesh, and
- Diana Melrose of OXFAM
for their contributions on the Bangladesh Drug
Ban situation. - Dr. Rano of Pune Journal of Ongoing Education for his "
articles on Anabolic Steroids.
- Cynthia Browne for her generous assistance in the arduous
task of typing from MIMS and CIMS
- Mr.John Agacy for helping in preparing the drug handouts,
this report and the correspondence involved with
the drug work.
- Mr.P.T.Thomas for preparing some of the handouts.
- Dr. Tunnie Martin who did such a wonderful job on the
•m.ge.ent .M. to .ak. th. .oriatoj, a „0“«»
D.1O.343~(R-II)
MS:a?7.10.82
2 -
1.
Dr. J. S. Bapna. - Assistant Professor, Pharmacology Department,
University College of Medical Sciences, Ring Road,
Hew Dahi, 110 029 (Tel: Off • 666 137: Res. 69s 036)
2.
Dr. S. G. Kabra. - Medical journalist and lawyer.
College, Ajmer 305 001
3.
Dr- Anant PhaZLke. - Convenor, Medico Friends Circle (MFC) j Pune.
Interested in the role of MNCs in India- Has written articles
on this issue, Writes for the Marathi press on health and
development.
4.
Dr- Abhay Bang. - MFC. Co-ordinator, Che tana Vikas Development
Programme,96/78 P.O.Gopuri, Wardha, Maharashtra 442 114
5.
Dr. Ashwin Patel - Founder-Member, Me di co Friends Circle. Commun i ty
Health Programme, Mangrol, Rajpipla, Gujarat 393 145.
6.
Dr. Arti Sawhney - Has been working with Social Work and Research
Centre? Tilonia, health team for the past five years.
B-4/110 Safdarjung Enclave, New Delhi 110 029.
7.
Dr. Binayak Sen- - Worked; with Friends Rural Centre, Hoshangabad.
Now works in Chhatisgarh with a miners1 trade union in
developing health facilities for the mine workers of Chhatis
garh. Is interested in rational drug therapy and low cost
drugs. Special area of concern - Tuberculosis. Post Graduate
in paediatrics.
8.
Dr. Dhruv Mankad - Project Incharge, Self Reliant Alternatives to
Western Medicines Project, 1877 Joshi Galli. Nipani, Karnataka 9
591 237-
9.
Dr* Mohan Rao. - Has worked in Thirumalai Social Service Society,
with training of health workers. Mitraniketan Vagamon P.O.,
Kottayam,Kerala 685 503
"
10.
Mr. Mats Nilsson. - Medical journalist.. Did evaluation of the
Ciba-Geigy boycott in Sweden. Kavlinge Vagev 3A, S-22240 Lund,
Sweden*
T.L.N.Medical
11.
Dr. Mira Sadgopal-- Working with Kishore Bharti. P.O.Kishore Bharti 9
District Hoshangabad, 461 99o, M.P.
12.
Dr* Narendra Gupta - Co-ordinator, Prayas. Village Devgarh (Deolia),
via Partabgarh, Chittorgaract, 312 605, Rajasthan.
13.
Mr. Pramod Kulkami.- Manager, Consumer Education & Research Centre,
Thakorebhai Desai Smarak Bhavan, Ellis Bridge,Ahmedabad,
Gujarat 380 006-
14.
Ms Padma Prakash. - A sociologist. Has worked with the Foundation for
Research in Community Health,Bombay. Was involved in the
research for the book ’’Health for All: An Alternative Strategy”
by ICMR-ICSSR. Interested in the role of drugs as related to
women and health. Blossom Society, 60 A, Pali Road, Bandra,
Bombay 400 050
15.
Dr. Ullhas Jajod. - Reader, Department of Medicine, SeVagran
Medical College, Wardha. Also works in a small community
project attached to the hospital, in a nearby area. Interest
ed in training doctors and paramedicals in rational drug
therapies, low cost health care and rural health insurance.
16.
Ms Sevanti Ninan. - Journalist, Formerly worked with Centre for
S-crion-co cmd
Now with Indian Express.
I
3
D.1O.343-(R-II)
jfSsas 12. 10.82
17.
Dr. S. Srinivasan - Worked as a medical officer, Social Work and
He search Centje in Tiionia. 53, Sector 12, R.K.Puram,
VNew Delhi 110 022.
18.
Mr- J. S. Majumdar - General Secretaiy, redera
Federation of Medical
Representatives Association" of India
------ 1, 1-E, Hajendra
Hagar, Patna 800 016.
19.
Ms Susmita Banerji - B-4/110 Safdarjung Enclave, New Delhi 110 029
20.
Dr. Shehla Ahmad, CHTT Trainee, VHAI.
21.
Mrs Purabi Pandey, Executive Assistant, VHAI.
22.
Dr. Tunnie Martin > Coordinator, Northwestern Region, VHAI.
23.
Mr. Augustine Veliath, Publications Officer, VHAI.
24.
Ms Christine De Sa, VHAI invitee-
25.
Dr- Sathyamala, Co-Ordinator
C_
, Community Health and Training Team,
(chtt‘
),, VHAI.
26.
Dr. Mira Shiva, Co-Ordinator , Low Cost Drugs and Rational Therapeutics, VHAI.
/
B.10/343-(R-Il)
MS;a: 7.10.82
4 -
REPORT ON THE DRUG WORKSHOP HELD AT JAIPUR
ON AUGUST 30-31,1984
INTRODUCTION
PART +■ III
Some of us in VHAI for quite some time have "been quite concerned
about the misuse of drugs, the prescription (in a routine manner) of
certain hazardous and non-essential drugs and the heavy promotion and
marketing of drugs by the industry. Additionally, the shortages
frequently felt of essential and life-saving drugs in the rural areas as well as in towns and cities at times - makes the whole issue of drugs
a problem not only for the socially concerned health personnel but also
for all groups and individuals dealing with PEOPLE.
The problem is growing in proportion with increasing medical care
costs, growing dependence on drugs and doctors, and the consequential
systematic erosion of people’s self reliance in handling common and even
trivial ailments.
We know that in the absence of basic health care requirements,e •e*
availability of clean drinking water, adequate food, sanitary living
conditions, drugs have a vory limited role« The creation and maintenance
of the myth of the omnipotence of drugs for each and everything requires
to be seriously looked into, and, in some cases, seriously challenged in order to explode the myth.
Just as the avallability of drugs alone (some useful, others
mostly useless ones) cannot be equated with the provision of medical care,
so also neither can the mere availability of medical "care (drugs + immunization and a fow othor foatuarco) be equated with good health care.
All of us know that the drugs industry representatives dictate
the prescribing practices of a majority of doctors under the guise of
education about the products in the market (by giving out free samples
besides offering other gifts and often kick-backs). When health personnel
continue to prescribe drugs which are known to be hazardous or irrational
and drugs which have been recommended for withdrawal - it indicates either
inadequate information-sharing by those producing and marketing these
drugs, or, it could mean indifference to this information by thos presc
ribing.
We also know that shortages of life-saving drugs often occur
because their sale is not all that profitable to the drug companies. On
the other hand, over-prescription of vitamins, tonics, etc.,takes place
and there is never any shortage here!
Health education of the people does not mean merely their knowing
what to do when medical problems arise, but also what they should do to
keep healthy, what their rights are from the present health care delivery
system. It is an awareness of the conflict in their own priorities with
that of the drug industry. It is the recognition of essential and life
saving drugs on the one hand and the hazardous and unessential drugs on
the other. It is the beginning of a process of questioning by moie and
more people about the existing drug and health situation and about the
relevance of our present health care delivery system. It is recognition
of the fact that a more rational,more,socially just, more humane health
strategy is requi^p^ which the majority (who happen to be at or below the
proverty line) can/afford.'
’
Our involvement with the ’Drugs Issue’ has emerged out of this
questioning process, our efforts like bringing out the Special Drugs
number of Health for the Millions, the holding of our Drugs Workshop in
\
J.10/543-(b-II)
MBsas 7.10;S2
5
Pune and Jaipur? iand our inclusion of low cost drugs and rational
in
„therapeutics
. .
x
, all
?■- our training programmes. All this is an attempt in
working towards feasible solutions.
P
with
—4Of-,b0th thP work8h°Pa has teen to share information
with concerned individuals and tc draw up action plans.
The issues selected for the Jaipur Drugs Workshop were those which
we felt needed urgent consideration j viz.
follow-up of EP Forte'Campaign
misuse of anti-diarrhoeals
ft
i»
amidopyrines
t!
_
ii
anabolic~steroids
II
ii
clioquinol
ii
" paediatric tetracycline
- Banning of drugs
- The need for an ethical marketing code by the drug
companies.
-
our support of the Bangladesh ban on hazardous and
irrational drugs.
r \krief summary of the discussion at Jaipur is being shared
here for those desirous of joining our alternative, unbiased and
responsible mformation-ghthdrin^-and-sharing network.
i
6
D.10/343-(R.Il)
MSsas12.10.82
PART - IV
August 30, 1982
PROCEEDINGS
1st* Session
The se<cic-'’ •commenced................
.
with the
introduction of participants, their
backgrounds and reasons for their involvement*
Dr* Pramod Kulkami of the Consumer Education Research Centre s
Ahmedabad, shared his experiences with participants.
The objections raised by us in VHAI regarding certain claims made by
mr^ ceters of V_. JoE had been taken up by CERC* They had accumulated evidence
from various sources to disprove some of the exaggerated claims* The
important thing was that a consumer organization had commenced questioning
the authenticity of the claims of marketers of drugs* The fact that a
similar process could be repeated in respect of other inaccurate advertise
ments regarding other drugs was missed by a few participants who felt
7it*E was anyway a low priority item*
(Efforts made by the CERC concerning the Baby Food campaign could not be shared by the group. The relationship of artificial
Baby Food and childhood diarrhoea is well recognized, and the
marketing practices of the milk industry are being more vehemently
questioned, and the practice of breast feeding being advocated by
medical authorities- We hope that something similar will be done
vis-a-vis the marketing practices of the drug industry)*
2nd Session
Among the- topics discussed were anti-diarrhoeals and their misuse.
The mai- treatment of diarrho
is Oral Rehydration Therapy (ORT).
With the simplicity of its preparation, the ready availability of its
constituent^ and its low cost, ORT should have revolutionized diarrhoea
management everywhere.
The nee.
.mfom people about ORT and the dangers associated with
anti-diarrhoeals ad been decided to be taken on a campaign basis at the
MFC General Body meeting and earlier at Pune*
The Medico iriends Circle and VHAI have prepared material on
diarrhoea and anti-diarrhoeals to be used by journalists, health educators
and others-as background material*
Amongst tne anti—diarrhoeals it was decided to focus on the
Chloromycetin-streptomycin combination. Various reasons were given as to
why it should be removed from the market1* Chloramphenical toxicity which is a hypersensitive reactiqi as
well as dose-dependent, cannot be overlooked*
2* ^merging strains of salmonella resistant to chloramphenicol
can cause a major calamity in the future (2000 deaths in
Mexico with typhoid in 1975 due to resistance of
salmonella Typhi to Chloramphenicol was not too long ago numerous reports of resistance strains are being reported
in our own country)*
3. There is no rationale in combining a bacteriocidal and
bacteriostatic drug*
4* .iris combination is banned in developed countries and now
even in Bangladesh*'
There was a consensus on a fdemand being made for banning the
chloramphenicol-streptomycin combinatx
— _on» This demand apart from having an
educational value it would jhelp shift the focus from drugs to ORT in diarrhoea
management,whicl ic as much oof a problem as protein-calorie malnutrition-
I
D.10/345-(fi.II)
MSias 12.10.82
7
The responsibility for making ORT and its preparation aommon
knowledge
rests upon us.
CT andJ skill
"ii ---L-J
LOMOTIL
It was unanimously agreed that thia drug should not be used for
children below two years* Two colourful booklets brought out by Searles
India, are being circulated amongst doctors by them to convince doctors that the
Lomotil controversy is baseless. These were shown by Dr. Ulhas Jajoo who
will be responding to them.
The
me advertisement issued by Dr. H. M. Lal
Lal,- Director, Medical Research
SSearles
_ 1 _ I__
..................
India
in the March issue of the Monthly Index of Medical Specialit
ies
ies (MIMS)
(MIMS) was brought to the notice of participants. Mr. Charles Medawar
(author
which concerns Social Audit's interaction with
(author of
of Drug
Drug Diplomacy
Diplomacy which
Searles over Lomotil) has been requested to respond to the Lal advertisement.
An attempt to collate information on deaths of infants due to Lomotil
will be made.
HJRTHER W0RK_ATO RESPONSIBILITIES UNDERTAKEN BY VARIOUS PARTICIPANTS
To find:
-
-
1) how, much doos streptomycin add to the spectrum of
chloramphenicol in its use in diarrhoea?
2) Fllpj—Iir6 case fatalities due "to chloramphenicol and,
possible? the role of chloramphenicol-streptomycin
combination in this?
3) What alternatives are preferable?
(Dr. Bapna will find out)
collation of drug representatives ^pamphlets
^nowadays these are merely shown and taken back).
4
5
±aking photostats of advertising folders in such cases.
Finding out the uinual* drug sale of Chloromycetin and
stropt; mycin cu./.•.nation and Lomotil.
(Mr*, J.!S. Majumdar will/collate and send)
6) Reviewing the available medical literature end other
Enter i al c a chi o ramp hen i co 1 •
’ ~ ~~
(Dr. Kabra will make the review)’.
Dr.Srinivasan and Mira would review these and compile the
information for the group.
7) VHAI will obtain the reasons for including certain
potentially hazardous drugs in the approved list form
ulated by the Drug Advisory Committee and Drug Controller.
VHAI will screen all information and data, forwarding it
to those concerned, and will function as a clearing house.
A mandatory recommendation was formulated which, the group felt,
should be compulsorily written on all anti-diarrhoeal drugs and their
advertising literatures
- MEDICINES ARE NOT ENOUGH TO TREAT DIARRHOEA! ORAL
REHYDRATION IS MOST IMPORTANT.
- Recommendation of ORT should be in the leaflet. It should
include the WHO formula and how to prepare it, pictorially
or in the regional language for consumers and-BMPs.
It was felt that the Drug Controller and the Drug Advisory Committee
could work out Row best this could be done.
The group placed a lot of emphasis on alternatives. The criteria
',0 e ^orne in mind in_the, selection of any alternative drug, was recommended
an 1 o 1 lows:
-- - —"
D.10/343-(R-II)
MSiai13.10.82
- 8
!• Efficacy
2. Cost
3• Safety
kasy availability (the availability of some drugs depends
•
on their demand. Increased demand
generated increased production. This,
in turn, may lead.to readier
availability of a product- But, this is
not always the case.
5. Chances of Misuse:
It was generally accepted that there was scope
for the misuse of all drugs, but, there was greater scope
for the misuse of certain drugs, e.g., steroids to be
misused more than other drugs.
6. Indigenous production;
It was felt that of two equally comparable drugs,
if one was indigenously produced and the other was imported,
it was preferable to use the former (and avoiding brand
where generic named drugs of equal quality are available).
RESPONSIBILITY
For write-up and mass education was to be shared by the group*
The Clioquinol Controversy
The background paper prepared was shared by Mira with the group
and discussed.
The majority were of the view that Clioquinol and other hydroxy
quinoline derivatives should not be used. The question was of a low cost
alternative* However, in the absence of one at present, and in view of the
high prevalence of amoeHasi’s - a demand for a less hazardous alternative had
to be made. Priority, of course, had to be given to the provision of
uncontaminated drinking water.
Mr. Mats Nilsson, a Swedish medical journalist, shared with the group
the impact of the boycott of CIBA-GEIGY products by over 2000 Swedish
doctors and veterinarians. The reason of the boycott was CIBA-GEIGY’s
continued sale of clioquinol in the third world countries, in spite of
unequivocal evidence to show it is potentially hazardous by causing SMON
kblindness, lose of the use of the lower limbs, incontinence, etc).
According to CIBA-GEIGY, Hydroxyquinolines were not absorbed. This
was untrue. It was also untrue to say that SMON was a problem only in Japan
for there were 43 cases in Sweden itself and numerous other countries have
reported SMON. CIBA-GEIGY was sued but arranged an out-of-court settlement.
The four-year boycott in Sweden was reported to have caused a significant
drop m sales of CtBA-GEIGY products. The company explained away the loss
to a decrease in TB in Sweden. But the fact that the number of cases of
TB in Sweden is negligible made the explanation really ridiculous,
as,
<>
But,^the manufacturers admit that they manufacture and sell what
others want to prescribe, it seems to be as much the responsibility of
bhe^health^personnel prescribing such drugs as of the~d?ug houses "nV^du ci ng
and marketing themp
ACTION
PLANS
We will collate information about reported cases of SMON in India.
Padma will follow-up,the SMON cases reported by Dr-Wadia in gombay.
C.E.R.Q. will take up, the cases to sue, I>rug manufacturers for
comp en s at ion^f_ adequate evi den ex? is available.
1
P.10/343-(R-Il)
itSsas 13.10.82
- 9 -
Dr* Bapna felt that information was needed about the dose and
duration of medication which can give rise to SMON. (Does the premise that
usually these drugs are not taken in full dose really decrease the potential
of the drug toxicity, even/amoebiasls and other diarrhoeal problems are so
common and require repeated medication? This was apparently the reason
given by the Drug Advisory Committee when discussing the hazardous aspect
of the drug)*
3rd.s Session
Use of Hormonal Preparatioiis for Pregnancy Tests
Dr. Sathyamala gave an account of the EP Forte campaign which she
had organized and supervised, The campaign had very successfully brought
together many women’s <groups and other concerned people. (Educational
posters warning pregnant women against
the inherent
dangers
of
- ---o-- hormonal
diagnostic tests, brought out by SAHELI - a women’s group - and Sathya..
are available from VHAl).
Some strongly felt that there was no indication for fixed combination
drugs k except as oral contraceptives), not even for secondary amenhorrea.*
According to Binayek the commonest causes of secondary amenhorrea were iron
deficiency, anaemia and genito-urinary tuberculosis. Routine prescription
of hoimones was not indicated. In recent medical literature the use of
high doses of progesterone followed by small doses of estrogens is
recommended and combination drugs have NO ROLEPLAN OF ACTION
- Write to the Drug Controller on behalf of the workshop
participants pledging full support for an immediate ban
on hormonal preparations like E-P.Forte-
- Contact a gynaecologist to present our case before the
Obe.Gyne-Association Conference in Pune scheduled for
December 1982. Also send an appeal to the Conference.
- Contact other doctors and maintain the pressure.
- If necessary, organize a Morcha by women’s groups,
paediatricians, obstetricians and gynaecologists.
.■
->■
-
Use of Hormones- in Threatened Abortions
Sathya presented her paper briefly (see Annexure.)lhe paper was not discussed as it was felt by many in the group
that this was not a priority problem in community
health.
It was decided that a C
—Caution should be u.mcmuca
Consumer
demanded to be
inserted by manufacturers warning women about the risk of foetal
malformations occurring through- the use of female hormones in pregnancy*
Infoimation would need to be collated from medical colleges
concerning the incidence of foetal malformations and their relationship to
- hormonal pregnancy tests
- use of progestronal preparations for threatened abortion
- diagnostic X-rays
VHAI will try to obtain:
- incidence of progesterone deficiency.
- annual sales md marketing figures of progesterone
- advertising literature used
- incidence of teratogenicity in Indian context
/
D>10/343-(r-II)
MSra:14.10.82
- 10
4tht Session
Amidopyrines, Aminopyrines and Dipyipnes
The opinion in medical literature condemning the use of amidopyrines,
aminopyrines, dipyrones was shared by Mira.
The group agreed that the use of the drug was not warranted when
cheaper and safer drugs were available.
Regarding injectable preparations - injectable paracetamol is now
™lable in some places (as Acknil - the cost and ready availibility in the
field have to be ascertained).
The role of anti-pyretics is very limited in hyperpyrexia,and
vigorous cold sponging is much more beneficial in such a stage.
ACTION PLANS
Literature regarding the use l
-____
r
of
antipyretics
in hyperpyrexia would
be reviewed and made available (Dr. Bapna) •
Ulhas shared from his paper the choice of analgesics.and antiinflammatory agents.
Aspirin was regarded as ■the drug
o of
_ choice because of its low cost,
easy availability, efficacy and comparative safety.
I
aoT,a- + .Par®’cetam?1 is preferable for children. It is indicated in patients
sensitive to aspirin. Prolonged doses should, however, be avoided as
Hepatotoxicity may occur, rarely.
(i3-SCUSSine anti-inflammatory drugs, Ulhas mentioned that
of^^+S^R20116 "aS tW1Ce aS costly a-11* “ore toxic (having a longer duration
of action hence a cumulative- effect? than Phenylbutazone. Many of these
lredsnnSn^dC+mbtnatl0A ^lth Steroids are available in the market (the latter
supposed to be weeded out according to the Drug Controller's list).
Non-availability of plain Aspirin
carnations like Aspro, Saridon, Anacin are readily available
everywhere, there was difficulty in obtaining plain aspirin. Burins the
education^o11
SUbJect’ a consensus emerged about the need for consumer
1cation.concerning sensible selection and use of analgesics, as well as,
2
thelr availahility because they are cheap, e.g. Aspirin costs
2 parse but is rarely available.
F
Sth; Session
Prugs and Magic Remedies Act
Dr. Kabra, who is also u
a lawyer and medical journalist, explained that
the Act dealt with
objectionable
j
v ----------- ■*'3 a&vertisements in the Press. It listed
<’ *
diseases and advertising remedies and cures which are prohibited from being
advertised.
7 according to the Supreme Court an advertisement
7T'
yd ^at
for getting abortion (let
alone> amniocentesis) is illegal.
----- ---------Complaints can be filed
Mth the pciice through an F.I.R. (nobody is prosecuted)
in a Magistrate's Court
with the State Drug Controller
to the Indian Medical Council (but only after an affadavit
is sworn in the Court).
It is an accepted fact
even by the Drug Controller that one-fifth
of all drugs are sub-standard or spurious (between 1968-79). pr. Kumud
Joshi also openly admitted in Parliament that ”17%* of
1- xi
. , ------- --- *•/*
the drugs are substandard®
1 ougi the punishment for selling such products is 10 years
imprisonment, so far nobody has been
----- 1 prosecuted adeouately according to the
D.10/343-(R-II)
MS:a:14.10,82
11 -
law.
inefficient drug
; country
th^ ,+
opinion towards demanding better quality control, and
e tablishment of free legal aid colls for social litigation on behalf
Dr Fabra woul’d
r°le °f C’E-R-Cversons like
Dr- Kabra would be invaluable in respect of legal guidance.
According to Dr. Kabra, matters which can be critically examined
under the Drugs & Cosmetics Act are:
1. Advertisements giving misleading information
2. Objectionable equipments, aids and tests.
ACTION TO BE TAKEN
Based on CoE.R.C’'s information •about the Drug & Magic Remedies
Act,
a handout is being prepared by VHAI.
assis+nnoZ
WiU
have more information on this matter. _
6
Legal
assistance from persons like Usha Hingorani could be sought, if required!
Post-dinner Session
Mr- Majundar
^ajumuar shared
snarea with the Lgroup his experiences as General
Secretary of the Federation
of the
the Drug
Drug Representatives
Representatives Union.
Union. He recalled
----------- 1 of
nracticel'ofT
becaUSe he had exP°sed 3^e unethical
some unethical
practices of the company. He was firmly of the view that C
—j drug
were being used to exploit their own people - by compelling
themrepresentatives
to me’et
Z ^reetS’ °r faCG 10Sin« their jobs. They1 are given inadequate
and biased drug information which they in turn very effectively pass on to
the medical professionals and consumer.
7 P
including dot+^T1
^served that an increasing number of individuals
n ludmg doctore - mostly among the younger age group - are evincing
greater concern about the drugs issue. His Federation had foxmulaSd a
His Federation had toimulated
foittiulated a
3-pomt programme in that connection:
1*
dnt?rest
the intelligentsia, particularly
individuals in a position to influence public opinion
to treat health and the drugs issue as a complete question-
2. Mobilising signature campaigns.
3- Taking appropriate action.
government iriuftified^n0?
aOme Participants was whether
government is justified m levying taxes and excise duty on essential and
fit'is ^timte^th-t Goklng ^r6 S° mUCh mOre e^en3ive
the common man. "
o
estrraated that Government gets about 100 crore rupees from annuel druzr
ntLsR*
f°W a^allabllity of these drugs in the PHCs makes it all the more 8
necessary for them to be put outside the scope of tax and excise dutv
(^.ccording to the Drug Controller, excise duty has already been removed from
about 15 categories of drugs. The extent to which this his lowered Iheir
O-UCOfLUU
hip J •
August 31, 1982
Support, of the Bangladesh Ban on certain Drugs
f..--I- ban on hazardous and ineffective drugs imposed by
supports the
the Bangladesh
Government,
information concerning the detailed criteria and
reasons for
ffor banning the-----products was sent to VHAI by Dr. Zafrullah Chowdhury,
Project Coordinator? People* s Health Centre, Bangladesh. Because of
B. 10/345-(S-II)
MS:a:14.10.82
12 -
pressures by the multinational drug companies, support had been sought for
the ban from socially concerned groups and organizations. VHAI feels that
success of the ban would have far reaching consequences in the third world,
and, more specifically, in India, where, it is felt, a similar ban ought to
be imposed.
Some members of the group did not share the above view, They felt
that our support of the ban may be misconstrued a,s support to a.
regime. .In vi w of: tho. diff- ronco in stand by different '
participators , it was decided that individuals and organizations may write
separately to the Bangladesh Government supporting the ban. It was also
decided that articles would be written to gear public opinion in India to
the relevance of a ban on hazardous and useless drugs and the negative role
which multinationals are playing in the Bangladesh ban.
Meanwhile, VHAI will keep others in touch with what is happening in
Bangladesh on the ban imposed and continue building support for the ban.
Shortage of anti-TB drugs
We have repeatedly been told by health personnel in the field that
they are often faced with shortages and erratic supplies of anti-TB drugs,
ihis has been denied by the Central Health Ministry, the Madras Chemotherapy
Centre, and by Dr. Pamra, Director TB Association of India and Dr. Bailey of
the NTI with whom personal interviews were held.
Mr. J.. S. Majumdar presented a paper to focus on inadequate production
of anti-TB drugs as one of the causes of the drug shortage*►
According
According to
to
this
this paper, over 10 million patients are suffering from active TB and only
about 6.12 lakhs (excluding West Bengal, Bihar,J.& K, Manipur and Nagaland)
have been brought under treatment.
In its Report for 1978-79 the BGTI) gave the following figures:
1976
INH
INH
1977
InstallQap.~
:Prod
ucticn
Install
ed Capaci ty
374.56
tonnes
98
473.56
Actual production*
April-September 1980
69.18 tonnes
1978
Prod
uct
ion
56-5
Install
ed Cap
acity
Prod
uct
ion
473.56
95.6
April-Sept.1981
53.70 tonnes
On the 15th December 1981, the Minister of Petroleum, Chemicals and
Fertilizers admitted in the Lok Sabha that there was a declining trend in the x
production of essential drugs, including first-line anti-TB drugs.“
Conversely, imports of 2nd line drugs showed an in
increase
crease.. The
Tl import
1
L, of
essential life saving drugs which are also produced indigenously were
reported as under*
Estimated
Production
Quantity
imported
Value:Rs.
in Lakhs
Streptomycin
(tonnes)238
44.1
123.69
(Sources
HGHS quoted in OPPI Bulletin,Nov-Dec 1981)
On the doth
20th April 1982, speaking in the Lok Sabha,
Sabha Dr. Balbir Singh,
on
attributed the trend of declining production of essential drugs to:
1. demand constraints or demand shifts.
2. - industrial unrest.
3. availability of cheaper imported drugs.
D.10/343-(R-Il)
MS:as 14.10.82
13 -
This, Jhowever, was not true in at least the case of anti-TB drugs,
as is evidenced below:»
Actua„ production and .requirements of anti-TB drugs in India
Actual
production
1977-78
IM
R
E
78
79 tonnes
U
79
175
I
R
E
M
E
N
82 - 83
83 - 84
375
450
T
S
The position of imports of Rifampicin was as follows *.
1979-80
1980-81
1981-82
5413.5 fe
8948.5Kg
15785.5 Kg
Cif (Cost including freight)
per unit in 1981-82 was Rs.4130/Kg.
Therefore, to allege that demand has decrease^ or shifted is incorrect.
,46-19 i'omleS of Elthambutal were imported in 1979-80 while onlv
23.53 tonnes were produced in the country from imported intermediaries.
TB is a poor man's disease and a shift to expensive, second line
drugs makes
them out rof ---his1 reach. Production of INH and PAS by Pfizer
(like other
< ,,'
companies); has been about half the licensed capacity in 1978-79,
while the production of Protignex
— - -—has been more than double.
i
attributin^the^Zcr^s^6
‘u?it by Pfizer management was unwarranted
and attributing the decreased production to labour unrest is another untruth.
'SiaiS4
o^rF'^'W^
n.1T, oaJhin/?plt? °f a11 tho Actors and medical technology at our disposal
the loasYweT^r' diis1^ & hop°less 30^» giving such a high default rate,
rn. least
do is to ensure a regular and adequate supply to those who
”a
meth8? i™ ’h0
availability of the drugs is due to mal-distribution or low production the
problem has to be sorted out by the health authorities.
ProdUctlon’ th®
Under the national TB Programme only the sputum positive TB cases
are
.
to be put on treatment and that too for onlv a year
TB ™ p
+
improved significantly in spite of this. The pLvaCnZe rate Zf TB^a^ot
come down. Cnnwrqoiv
4-~4- u
vextucu rd,-De 01 ib nas not
increase in total popSaMon
TB CaSeS
incl-eased with the
fn-n on
irrational combinations like Streptomycin and Penicill in
S pa“s“&
“ (1 “U3“e S,“lrta»se
=‘«pt«Zeln ?»“
;;
S’
f°r emerging primary resistance to streptomycin, or,(3)
transient conversion of sputum fTOm AFB positive to AFB negative thus
for the past iVa
”ot *rail“ls 'ln1
14 -
D. 10/343-(R-II)
MS:ai14.10.82
PLAN OF ACTION
1* Prepare documentation on anti-TB drug shortages from different
areas - PHCs, the open market, District TB officers and TB
organizations (indenting is done according to availability and
not on the needs and demands). Data accumulation has been
entrusted to the following persons who will cover zones
indicated against their names:
Dr. Abhay Bang
*••
Wardha district
Dr. Mira Sadgopal
Dr* Arti ^awhney
•*•
Hoshangabad
Mrs Purabi Pandey
»•
Ahmednagar
Dr. Dhruv Mankad
• i •
Nipani (only the open
market)
Bihar and Orissa
Rajasthan & Himachal
Pradesh
Mr. J - SoMajumdar
2. Send out more TB questionnaires like the ones sent earlier in order
to obtain the required information about anti-TB drug’’ shortages.
3. Review the ICMR Reports on the incidence of TB regionwise and also
drug shortages.
4. Review medical reports regarding primary drug resistance to
streptomycin with the use of combinations like streptomycin
penicillin. Assessment of alternatives.
5. Verify the newspaper reports in the Times of India about export
of anti-TB drugs.
6. Demand by voluntary health institutions that adequate utilization
be made of the government diagnostic and therapeutic facilities.
7. Verify the impression of many health personnel that TB is on the
increase in their respective areas.
8. Establish closer collaboration between the TB Association of India,
the National TB Institute and the voluntary health institutions
for better feedback, sharing of resources and responsibilities in
TB care.
9. Contact and involve GF’s and RMP’s in our respective areas for
sharing information on better TB care (as {52% of all TB patients
seek medical help, but, for various reasonsJ? only about 10%
receive the proper medical attention).
10. After obtaining documentary evidence relating to drug shortages,
the matter should be taken up with the Central Health Ministiy and,
if need be, even in Parliament*
3rd> Session
!»
Anabolic Steroids
The role of anabolic steroids, based on a review of medical
literature, was presented by Mira. The drug is known to have harmful effects
on women and childrens it is present in many tonics. Consequently, these
facts are ignored by some of the medical practitioners whenever they over
over-
prescribe these products for all typos of irrational indications.. Most of
the indications mentioned in the promotional literature by the producers
15 D.10/343-(R-Il)
MSsas14.10.82
and sellers of these drugs are incorrect and objectionable.
(For details - road VHAI’s. handout No. D-9/334: i and
Pune Journal of Continuing Education’s issue on
Anabolic ^teroids: Issue No*48 of June 1982)
Following the discussions, the group agreed that anabolic steroids
are being misused, and the advertising and associated drug information was
incorrect. Except for a few accepted conditions like aplastic anaemia,
osteporosis, etc-, anabolic steroids have no role and SHOULD NOT BE
PRESCRIBED.
CIBA-GEIGY have notified their decision to withdraw their product Dianabol. This is a step in the right direction and has come not a moment
too soon!
Paediatric Tetracycline
The usage of tetracycline for children and pregnant women can be
associated with brown staining of teeth, interference with bone growth hence stunting; with increased catabolic activity in the undernourished.
The material reviewing current medical literature was prepared
and shared, by Mira. (For details - see VHAI’s handout No.D-9/334:h
regarding this).
The production of this has apparently been banned from January 1982*
Yet, the paediatric dosages are still mentioned in the Monthly Index of
Monthly Specialities (MIMS) and the Current Index of Monthly Specialities
(CIMS)* The product is also freely available without caution* According
to a communication received from Raj Anand of the Consumer Guidance Society,
there is a move by the drug companies to put pressure on the Drug Controller
to withdraw the ban.
The group agreed that paediatric tetracylcine definitely had harmful
effects.
♦
Here again, the question that arose was : which low cost easily
available, effective alternative drug ought to be used?
PLAN OF ACTION
1. Disseminating information on the harmful aspects of paediatric
tetracycline so that it is not misused for trivial problems
and not for prolonged periods.
2. A serious search for an alternative low cost drug for common
childhood infections and whose availability is and can be ensured,
has to be made.
BANNING DRUGS
This handout (No• D/10-340) was prepared by Chandra, based on her
visits to the Drug Controller and' after reviewing the material available
in the office. It answers some of the questions as to how the drug
controlling mechanism is supposed to be working and what is the present
situation regarding the different drug bans.
The IFPMA Code, Low Cost Drugs: International Code and You*
The former tells about the Code,as prepared by the International
Federation of Pharmaceutical Manufacturers Association, and what it implies.
The latter focuses on the need for an international code to ensure ethical
marketing practices by the drug companies*
16
D.10/343-(R-Il)
MStas14.10.82
The above issues could, not be discussed in detail. Health Action
International has been trying to push WHO to formulate or accept an
International code.
We had discussed this earlier at our Organizational Development
Seminar in Pune in February 1982. V/e continue to gather supporters'tc
demand an ethical code and build a network of concerned health personnel
and individuals to ensure its implementation.
Some Suggestions for the Future
- We njjed' to meet again - there is substantial gain by way of
information-sharing and building networks.
- We need..to involve women’s groups? youth organizations and those
associated with mass movements.
- Hold the next meeting in a Medical College - where there is access
to books and medical journals.
- Deal with a few specific issues.
- Tape the sessions for better record purposes.
- Continue to hold in-depth discussions on technical details prior
to reaching any decision? in spite of knowing that we have non
medical friends among us as happened on this occasion.
- Prepare simplified briefing documents for non-medical friends.
- Add key words and their meaning at the end of the handouts.
- Plan the .next workshop well in advance and make background
material available early with everyone assuming more responsibility
in their preparation.
- Keep participants informed, about major developments.
Dr- Mira Shiva? MD
Co-Ordinator of the Workshop
And
Co-Ordinator? Low Cost Drugs .
and Rational Therapeutics
>
D. 10/343-(r-II)
MS:a:14.10.82
ANNEXERE
I
LIST OF HANDOUTS GIVEN TM THE DRUG WORKSHOP (ll)
/
1. Are Hormonal Pregnancy Tests Safe?: Dr.Sathyamala
D-9/331:a
Dr-Mira Shiva
2. References on Oestrogen-Progesterone Tests
for Pregnancyc
Dr-Sathyamala
D-10.341-(b)
3- Controversies in contraception:
^r.Sathyamala
D-10.341:a
4. Review of supportive hormone therapy in
Obstetries:
Dr.Sathyamala
D-9/331:c
5. Low Cost Drugs: Managing Diarrhoea:
D-9/334--U)
Dr .Mira Shiva
6. The Clioquinol Controversy:
D-9/334-(a.1)
Dr.Mira Shiva
7. Management of Acute Diarrhoea:
D-9/334-(b)
Dr .Mira Shiva
8. Drugs in the Treatment of'Diarrhoea:
0-9/334-(c)
Dp.Mira Shiva
9. Diarrhoea - Significance of the Problem:Dr .Mira Shiva
0-9/334-(dj
10. Diarrhoea and Malnutrition:
0-9/334-(e)
Dr-Mira Shiva
11. Causes of Diarrhoea:
0-9/334-(f)
Dr «Mira Shiva
12. Why Amidopyrines Must Go:
0-9/334-(g)
Dr-Mira Shiva
13. Using Tetracyclines for Children and
Pregnant Women:
I>-9/334-(h)
Dr .Mira Shiva
14. Why Not to Prescribe Anabolic Steroids: Dr .Mira Shiva
D-9/334-(i)
15- Drugs containing Irrational Combinations From MIMS
of Steroids and anti-inflammatory agents.
and CTMS
D-10/340
D-9/334-(j)
16-. In Support of Bangla Desh1s Drug Policy5Dr. Mira Shiva
17. IFPMA Code of Pharmaceutical Marketing
Practices:
From HAT
D-10.341
18. Low Cost Drugs and National Drug
Therapy - International Codes and You: Dr.Miija Shiva
D.19/343
19. A Choice of Analgesics:
Dr.Ulhas Jajoo
20. Banning of Drugs:
Ms Chandra Kannapiran
21- Categories of Fixed Dose Combinations
A. 4/119
recommended to be weeded out by the
Drugs Technical Advisory Board
if
ft
22. List of Foreign Drug Firms in India
A.4/119
23. Reasons for Weeding out Fixed Dose
Combinations.
24. A Study of Prevalent Diseases in India) J.S.Majumdar, L•N.Chakravo rty,
and Production of some Essential Drugs) Santanu Chatterjee
25. CI BA GEIGY withdraws Di an ah ol
Dr.Rane for Pune Journal of
Continuing .Education.
OLDER HANDOUTS
1.
2.
3.
4.
5.
6.
7.
Our Concern For DrugsVHAI and its Role in Low Cost Drugs.
What Consumers Can Do.
The Drug Situation in IndiaSpecial Drugs Issue of Health For The Millions
The Ten Commandments and the antidotes to the Drug Industry
Pune Workshop Report & Seeking Feasible Alternatives.
<
Sf
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area,
New Delhi-110016
MS:k:D-10.344
Az
^7
c
£L\
M
Io.
Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652008
February 4Z 1983
Drug Workshop followup - Information
Sharing
1
Dear friend/
High dose
OestrogenProgesterone
Combination
Drug Ban
We are aware of the hazardous nature of high dose
Oestrogen-Progesterone drugs and its wide spread
misuse. The Drug Controller had issued a ban on
their production and salesz applicable from
December 1982 and June 1983- respectively.
Vigorous attempts by the Drug Industry to get this
ban withdrawn have been made.
The news, that 4 drug companies have managed to get
a stay order on this ban from Bombay High Court was
to be expected. Depending upon which is greater the
public pressure and the controllers decision or the
pressure exerted by the Drug industry/ these products
will be BANNEDz or allowed to be misused for pregnancy
testing and attempts at inducing abortions etc.
Dr, Sathyamala of Voluntary Health Association of
India/ Dr. Rane of Arogya Dakshata Mandal/
Dr. Anant Phadke/ Convenor/ Medico-Friends Circlez
Dr. Dhruv Mankadz Medico-Friends Circle/ Vimal
Subramanianz journalist/ Dr. Kabraz Medical Journalist/
Lawyer from Ajmerz the C.E.D. Bombay/ Rajiv Gupta of
C.S.E./ Geeta Hariharanz journalist and Mr. Majumdar/
General Secretary/ U.F.M.R.A.T. all made very signifi
cant contributions towards highlighting the need for
the ban on high dose Oestrogen-Progesterone drugs.
Our friends in Saheli played fth important role in
obtaining first hand evidence from doctors and
chemists about how the drug is misused/ also in the
production of a relevant poster. Dr. Mathur..of the....
Postgraduate Institute/ Chandigarh had helped with : _
valuable information in the initial stages of the
campaign.
.......
_
TS
05.
O
lx!
Dr.„ .Palaniappan-/ Profess orz Obstetries & Gynaecologyz
who had undertaken the much quoted Kilpauls: Study in
Madras is appreciative of the group's sincere efforts
r’ and involvement in this very important issuez which
should have been resolved much- earlier. (Copy of his
original article is available with us in VHAI)
O
_
X
o
<5 °
h 2
<
t .1
UJ
D cc
£ .2° 9
22
✓ A handout reviewing the Oestrogen-Progesterone (EP)
ban situation had been sent to some of you on realis
ing that OPPI was putting heavy pressure to get the
ban on Oestrogen-Progesterone drugs withdrawn. (If
you haven't received and would want to get a copy just drop a line).
Bangladesh
i. -Drug
Ban
- —
I
'/ A handout giving the summary of the review of the
Bangladesh Drug Ban situation had been sent by us
earlier.
. . 2/-~
£
! i.L ca
.2.
MS:k:D-10.344
February- 4, 1983
Our latest issue of Health for the Millions is devoted
exclusively to it.
. . T.._
Hazardous Drug - You must be aware that President Reagan on resuming
policies
—fS-- Presidentship of USA had reversed President Carter's
affecting our ' earlier decision to ban the export of hazardous and
oxic
ic chemic
chemicaaIs
Is (drugs
(drugs && Pesticides)
Pesticides)-- which
which were
were
people
ttox
banned for sales in States.
Allowing export of these hazardous products after in
the absence of adequate and honest ---- information
was bad enough. The passage by the U_.S. Congress of
the Clayton Amendment Act which protects American
Multinationals from being sued by third world Govern
ments (under the earlier U.S. Anti Trust Act) — is a
cause of grave concern. Under this the multinationals
will be provided protection by their Government which
magnanimously allows them to export hazardous and
irrational drugs,f rem any action/ beeause of the
consequences.
If we continue to import these drugst with a poor drug
control at our own end — who is to be blamed? Inform
ed opinion and action by socially conscious health
personnel about our own health policies and drug
policies is needed. Would appreciate to hear your
views and suggestions for action.
c ode f or
Ethical
Marketing
Practices HAI
Health Action International (HAI) has drawn up a Code
Generic Drugs
and
Drug Control
The pressure being exerted by drug industry to get the
government to withdraw its earlier decision on allow
ing sales of 5 single ingredient drugs under generic
names is mounting/ and the government may be forced to
withdraw its decision.’ 'There is an obvious' heed to
demand good drug control mechanism with adeguate number
and guality of drug inspectors, to ensure that no
drug "brand’1 or "generic1^ old in the market is sub
standard.
Zis
FUTURE FOCUS shortages of
aritVTB drugs
and Rational
TB Care
for Ethical Marketing Practices for drug companies
which they are trying to get WHO to enact. A copy of
this code can be sent to those who are interested/ on
a nominal charge (to cover paper and postage) .
We had undertaken some specific responsibilities while
drawing up the action plans for the first and second
drug workshops. In the last workshop in Jaipur (A
Medico-Friends Cirele-Voluntary Health Association of
India collaborative effort) in which we dealt with
hazardous drugs - we had decided to deal with short
ages of essential and life saving drugs. To. facilitate
an in-depth examination of the matter it was felt that
attention ought first to be focussed on anti-TB drug
shortages . A brief hand-out to give an idea of the TJ3
problem and why it is important to take it up on a
priority basis is being sent to you.
- When we meet next, it will be to discuss the efforts
we have made and the progress achieved and not/the
earlier occasions to draw up action plans for the
•future. This work f course will be coupled with other
commitments made earlier. An effort has been made to
draw up an outline of responsibilities that we could
undertake. It would be worthwhile to exchange ideas .oh
our own specific roles as individuals and groups in the
sphere of’’anti-TB drugs shortages and.rational TB Care."
..3/-
•z
I
.3.
MS :k:D-10.344
Your
c orrEribut ion
With regard to spoeitic
February 4, 1983
-d topics
lite to handle or see
J
information we
I will be waiting to hear iron Y
focus on the
need to pool tn to be
you could contribute slgnl?lca„tl? tJ”SnSlng oui the following In your area.
1.
2.
3.
' 4.
•0- anti-TB drug shortage in your area?
Is there are.,
bad is the shortage? And for which
if so, how
For how long has the shortage lasted.
drugs?
of anti-TB drugs
What
What. is the pattern of usage ;z. irrational comin your area? eg. how often are.
treatment started with
binations given?
Or treat?
potent second line drugs.
What is the understanding of the TB patients
about the usage of drugs and their own disease?
Do they know how long to take and if they are
irregular, what will happen?
What is the incidence of TB in your area?n Is it
inc reas ing? If so, what do ~you feel are the
probable"" reasons?
5.
Is poor response to treatment a problem in your
area? If so, do you feel it is because of high
default, i.e. irregularity in drug intake or
probable emerging drug resistance? (check with
medical people in your area) .
6.
Are there health and non-he a 1th groups in your
area equally concerned about the TB problem or
even some aspects of it?
7,
Since active participation by a TB patient in his
own treatment
crucial for the success of his
cure, and since various important issues are in
volved in the TB* problem, how could we involve
health, non-health groups as well as the patients
themselves in looking at the TB problem and BEYOND
the TB problem<
7
VHAI plans to bring out a special TB issue most pro
bably in June. If you wish to contribute something
from which others could benefit - please do so, it
would be deeply appreciated.
Recommended reading list for TB care is being prepared.
One book highly recommeded: ’ Cafee Finding & Treatment
in T.B.by Toman, WHO and also 2)
Blue Print for
National TB Program by TB Association of India.
Self Educa
tion and
Recommended
Reading
To^keep ourselves abreast about the drugs issue the
following areJ some of the books recommended for reading:
a)
Bitter Pills by Diana Melrose of CXFAM.
(Deals
(Deals
with the various drug related issues well**
it
It is
is
based on field research in India, Bangladesh,
the Phi 1lippines.
It is well thought out, convinc
ing, very relevant and de ils with initiatives taken
and that could be undertaken).
<4.
MS:k:D-10.344:
b)
Drug Diplomacy by Charles Medawar (deals with
the battle between Social Audit and Searle's over
Lomotil.
It demonstrates the persistence, convic
tion and courage required to combat drug misuse,
especially when a multi-national drug company is
involved.
c)
Social Audit - Insult or Injury (available in
VHAI)/very relevant for health personnel, activit.ists -»n.l development workers, gives signifi
cant insights into the drug problems, those who
create them and those who get a dose of them.
Cost Rs. 19/-.
d)
Aspects of Drug Industry by Mukarram Bhagat.
February 1982, Cost Rs.18/-, CED.
(Deals with
the drug situation in India, the brand-generic
controversy, quality control) drug pricing,
marketing drug information, etc. Very useful for
understanding of our drug scene, Well documented
and informative.
Zis
The network
naming of
our stared
concern
February 4, 1983
Some persons have raised the question about the need
for our loose, informal network assuming a name.
Others feel that this would interfere with the spirit
of sharing.
Leadership roles have been taken up by
various individuals and groups in different regions
as and when the need has been felt or whenever the
situation has arisen. This is something which is very
much required and appreciated by everybody.
It
indicates healthy decentralized functioning emerging
spontaneously from a shared and common concern. If
you come across others who you feel would like to be
involved or who? jshould
'
be contacted, please take a
a little time to write - so that we too can welcome
them into the network.
We will let you know if anything of importance
crops up.
Looking forward to hearing from you about your
activities .
Wishing you a happy, meaningful 1983 on behalf of my
colleagues in VHAI,
Sincere ly.
/l
(Dr. Mira
Coordinator
Low Cost Drug & Rational Therapeutics
SIG NAT W qWAldH
A note to demand for a People uriented* Drug Policy.
Lear Friend,
This signature
campaign
is against
misuse _of drugs. It is
■> M*. J
*1 _
_<•»
t
.
coxrfcipue<^ sales of hasardous, irrational and banned
<*rugs, against allowing sales of substandard
- - — "and
—i spurious drugs.
rs rv f-. I V>
It is a demand for streamlining production, distribution
of drugs that are needed for the health problems of the
majority. More than that.,it is a c
demand‘ for dealing with those
conditions that ensure ill health.
Please go through the text of the memorandum which summa
rizes the basic demands of the organizations mentioned below'
"'Ka£^
~Address
F ^our Oigahizail6ns j 'four Job| Name
II ~If possible ]
I please give j
the capacity
in which you
are working ■
there
1
I
i
I
I
1
!
I
J
f®el stro”§iy about the injustice in the healthand
dzuts scene, circulate this to others and obtain signature of
others supporting the demands.
n
you w^s^be involved in the Drug Campaign join the
?jf^f+hCM10n ne^y01^ whiGh is Part of an emerging ’People’s
Health Movement'. If you would like the name of your oignniza"+°n inc7u^f<i ln.uiie iis't of organizations who are taking a
strong stand against the drug misuse, let me know. Please also
f?sP°nsibilities you would be willing to take
aftu contributions you would liko to make in Drug Action.
m^nths the ^ew Drug Policy would have been
passed, ihv time to express our concerns, to make our ctepinnda
of th^SeaomeSt is rto* bf°bab^ WJat the m0£;t important "need
Eent is to bo- aoie to organize ourselves around
I
Ii
. ..2. ..
this issue, whether we are health groups, Consumer groups
legal aid groups or involved in Community Organization or
■^e0PTe s Science movement. Public pressure is crucial to
proven.; vested interest from getting away unchecked with anti
people, policies-stands.
The signature campaign is to
- urge you for your support
- it is to build a network of groups
,
to act as the watch
dogs on behalf of the people
- it is to build
pressure to demand public accountabi—
lity from our <drug industry •.
health personnel and
ana
policy makers.
Oj?-y
ve:fy small minority feels concerned about issues
oi social justice. To demand any People Oriented polio/
whether it is related to human rights, enviornmental issues
or health we have to support each other. Since health and
survival are everybody's concern and not the pregorutive'of
tixose involved in health work alone, we hope you will join
nahds wxth us.
■
Looking forward to your support, and solidarity.
Dr^Mira Shiva
Coordinator
Low Cost Drugs & Rational Therapeutics.
V. H A I
COMMUN.JV
ad
. MmORAlWUI
We, the health personnel and citizens of India recognize health as a
fundamental right of the people in this , our welfare state. We recognize
and strongly believe that the health status of our people is more dependent
on their access to adequate food^ safe and adequate water, proper sanitation
and clean environment.~
“ integral Part rf a goM National
1.
We therefore, demand the following:
t0 ^aft7 essentiai, quality drugs which arc in keeping
afford h lth nGedS °f the Pe°Ple> at costs which the majority can
We urge our.government to accept and implement the Hath! Caimittee
Recommendations which arc also in keeping with the WHO Guidelines for
a Rational Drug Policy.
3. Further the national drug formulary should be revised and canpiled by
an expert multi d±iciplinGry committee keeping the following criteria in
mind;
Essentiality
Efficacy
Safety
Cost
Ease of administration
Availability
Potential for misuse.
Such evaluation of the drugs in the market and revision of the lists
should be done periodically.
4. The Essential Drugs Policy should be adopted for all health services,
government and private, and priority, in production, distribution and
dispensing should be given to these essential drugs.
5. The public sector should produce essential and life’saving drugs on a
priority basis at the national level.
6. Drug production by multinationals and private manufacturers in India
should also bo aligned with national health priorities.
7. Bulk procurement of essential and needed drugs should be through world
wide competitive tenders and rationalization of drug purchases should
govern both the public sector as well as private'health sector.
8. Imports and production of non essential, specially hazardous drugs,
should be strictly curtailed.
9. Drugs which have been banned from sale after being marketed for some
time in one country may not be submitted for clinical trial or marketing
in incia. The- onus of proving why a non-essential drug should be intro
duced or allowed to continue on the market should be with the manufact
urer and such introduction should be preceded by adequate trials and
evaluation by Drug Control Authorities.
10, Canprehcnsivo drug legislation which covers areas such as price control
at different levels, patents, and marketing practices should be incor
porated to serve the objectives of the national drug policy and there
should be no levies, sales tax or excise duty on any pharmaceutical pro11 nx
the essential druSf5 iist by the Central or State governments.
11. No technology transfer agreement shall be legal; and binding which cont
ains restrictive practices, disproportionate and unnecessary use of
Intermediaries or obsolete technologies or unfair arrangements
with respect to prices, payments or repatriation of profits.
12. The National Drug Policy should state clearly the steps towards'a
complete abolition of brand names and as a first step use of generic
names should be made compulsory in medical education, prescribing and
abelling of drugs. Generic names should appear more preminently on all
packagings
•„ ..
2.
-.2.,
13. It shall be the primary responsibility of the manufacturer to ensure the
quality of drug products. However, it shall be the statutory responsibi
lity of the Drug Control Authorities to monitor the standards and ensure
a minimum uniform level of government control. Consequently, the govern
ment shall take all necessary measures to .enable the Drug Control Autho
rities to function in an effective manner and discharge the statutory
duties cast upon them.
14. It. shall bo the statutory duty of the drug control authorities to inform
health personnel and ^consumers of the essential drugs lists, policies,
categories or brandsordrugs banned for manufacture or sale, through pub
lication in the national newspapers, magazines, medical journals with
adequate explanations and details.
15. Availability of drugs required in the Governments National Programmes
should be ensured on a priority basis to the government as well as
voluntary and private health institutions. Quotas for anti TB, anti
leprosy, anti malarial drugs, iodized salt etc should be made easily
available with regularity of supply to the voluntary health institutions
whereever possible, specially when their performance, in health care
delivery is known to be effective.
16. In all review committees, statutory bodies and other such bodies, there
should be adequate representation of consumer groups and voluntary health
sector.
17. Drug companies should follow ethical marketing practices, and this should
be ensured by their own organizations like OPPI,1EMA, IFFMA. We deplore
the tendency of those companies and associations to get around every
progressive measure of the government through recoursetQtechnicalities of
the law and through the courts.
18. The marketing code drawn ’up by HAI(Health Action International) should
form the basis for a National Code for Marketing Practices. This should
be accepted by our government and should be suitable implemented through
legislation.
.19. The government of India should take a lead and endeavour to influence
the WA and WHO to adopt the Code in the interests of the other develo
ping countries and their peoples.
(IFPMA and HAI Cede attached) ,
I
- Voluntary Health Association of India
- Centre for Science and.Environment
- Centre of Social Medicine and Canmunity Health-Jaw<akrarlal Nehru Univer- Kerala Sahitya Shastra Parishad
sity.
- Medico Friends Circle
- Arogya Dakshata Mandal
- Lok Vigyan Sanghatana
- Consumer Guidance Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of India.
/
/
/
<D-10/541(e)
MSsa.7.12.85
Meeting of the Drug Action Network held on December 5, 1983
at VHAI gifice premises.
Present s
Sunita Narayan -Centre for Science and Environment
Krishna Kumar - Kerala Sastra Sahitya Parishad
Dr Ekbal
it
P D Wthews
- Indian Social Institute
11
Ms Maria
VQna Daswani
- Foundation for Research in Community Health
Padma Prakash - •Lok- Vi'gyan Sangatna
Dr Pane
- Arogya Dakshata Mandal
■ iVlira Shiva
- Voluntary Health Association of India
Chandra Kannapiran»»
Aspi Mistry
The following decisions were arrived ats
^c.ent Panikulangara13 writ petition in the Supreme Court.discSsionr^SVes
various groups present would go back and have
uiocussions within their organizations1 as to the possibility of being
impleaded as parties in the petition. Vincent
_
and P D Mathews will
prepare and send a short note to the various
---- j groups* The note will contain
the legal and other implications
._11
,.x
as_we11 as a summary of the situation
sofarto help the groups in their deliberations. AxL.
• Arogya Dakshata Mandal
and KSSP stated that they would quite probably decide
-.._j to intervene in
the case. P D Mathews would also send to the VHAI office 50 copies each
of the original writ petition ,as well as the .amended writ petition and
these will also be distributed to the groups.
1‘
2.
tSrt^KcusZiL^auZS^ £XdsvXs
osues. The following were the suggestions accepted for the campaigns
U; A nation-wide signature campaign, signatures to be obtained on a short
one/ wo paragraph statement which can be easily understood by citizens.
&ach organization, to obtain signatures under their own banner, but for
a common statement, the presentation to the authorities being coordinated
during the.campaign week. 1 set of signatures to go to Parliament and
set in each state, in the regional language to the respective state
legislatures.
(b) The "memorandum" which was drafted in Delhi during Dr Zafrullah Chowdhury's
t0 be circulated to other activists, consumers, citizens, civil
liberties groups and associations for their signatures. The memorandum
be be presented in the same manner as above.
(c) Some other suggestions for the week long campaign depending on local
situation:
(i) Exhibition on drug issues- posters, display of drugs, drugs company
inducements, visualisers etc.
cY1‘tural action programmes such as organized currently by KSSP.
(iii)Film shows, especially the films produced by NOVIB on drug and
health issues. Aspi to arrange for this with NOVTB. Mira to try and
.
make film prints and video copies of the tape with her.
, (iv) Publication of brand names list of banned drugs.
(d) Campaign in the media as was done during the E P Forte campaign.
(e) The entire programme
for the all-India campaign to be finalised
j
_
------------- L during
Drug Workshop III.
5.
Drug Workshop III?
To be held at Pune De Nobili College, last week
February, preferably 24, 25, 26 Februaiy , depending on availability of
boarding and lodging at De Nobili.
Tentative agendas
plan for one week all India campaign.
(ii) pricing^of Drugs- j)r Pane will prepare background material.
■—
11 I
II
-------
, Jr
V.
KZ
CX U
1 IaIaC
.0 n
j
7 c
1
5
D-10/341(e)
MSsa.7.12.85
...2...
(iii) Graded Essential Drug List - Dr Ullhas Jajoo, Dr Mathur, Dr Dane,
Dr Mira Shiva will prepare the materials, present h fully completed
draft. „
...
(iv) Banning of drugs- Clarification to be sought from Drugs Controller
of India on his various notifications. Aspi to prepare this letter.
A list of brand names for 22 categories already banned to be pre
pared, even if the list is limited due to the vagueness of the Drug
Controller’s orders. Dr Babu Paul Jacob’s (CMC, Vellore) offer to
help would be taken up by Dr Mira Shiva. The drugs excluded from the
present banned list to be listed and campaign material prepared
for these.
Criteria for a Rational Drug Policys Individuals, groups will send
(v)
their drafts, ideas and suggestions to Aspi by 7th January 1984the basis of these and ether already available material and draft.
4-
• Drug Action Network Newsletter: The objective of having the newsletter
was explained. Padma Prakash suggested that whenever possible a serious
in depth article could also be included. It was decided to include repo
rts of Dr Zafrullah Chowdhury’s meetings in various cities, in the next
newsletter. Representatives from Bombay, Trivandrum, Pune, Bangalore,
Baroda to send in their reports (just one page if possible) to Aspi
within the next 15 days. Campaign plans to the extent they are finalised
in point (20 above to.be also included in the next newsletter.
5.
Other matters discussed:
(1) There was a suggostion from Dr Ekbal that we should collect and
publish material (extracts) from the established medical journals
such as JAI'AA, BMJ, Lancet which often contains articles which support
our stand on many drug issues. This would be useful background mater
ial during campaigns and legal proccdings.
(2) Similarly it was suggested that there should be systematic document
ation of misinformation put out by drug companies.
(5) Virginia Beardshaw’s ’’Prescription for change” was introduced and some
copies distributed. VHAI will attempt to get more copies.
(4) Similarly VH/1I will attempt to get more copies of a picture postcard
entitled ’’Passing the Back”- games for ^Multinationals” from War on
Want. These cards be used as Christmas or New Year cards
dramas at
(5) KSSP invited all present to a performance of one cf the
the FICCI auditorium on the 9th December 1985-
For clarifications which you seek or wish to make, regarding
the above report, please get in touch with
Mira Shiva or Aspi Mistry
at VHAI, C-14 C^nmiunity Centre
S D A, Opp IIT gate
New Delhi 110016.
Tel: 668071/668072.
' D-10(M4)._.
MS:a/16.2.84
COMMUNITY HTALTH CEU.
[>AW0AL03E • 560 0
Drug Action Network Meeting, CINI, Calcutta, 50th January 1984*
Agenda of the meeting was
1. To update each other about our drug related work
2. To focus on drug related issues demanding urgent attention
3. Plan out Drug V/ork’shop III
About JO individuals met to discuss the drugs issue, with special
emphasis on - the changes in the drug policy
- the drug situation
- priority areas of work
- our work and
- future action.
Majority were from MFC but representatives of Junior Doctors Association
FMRAI, Sales Representatives Association, Health Services Association, West
Bengal VHA were also present. Since some of the individuals were coming in
contact with us for the fir^t time, review of our work, the drug workshops,
KSSP meet was given. Introduction of the various organizations who have been
involved in this work and their role in the past was shared. These being
VHAI (Voluntary Health Association of India)
MFC Medico Friends Circle)
Arogya Dakshata Mandal
CERC ( Consumers Education and Research Centre)
FMRAI (Federation of Medical Representatives AssociaCGSI (Consumers Guidance Society cf’t
‘ii°n
India
tit’f
x
India.
Lok Vigyan Sangatna
KSSP (Kerala Sastra Sahitya Parishad)
Social Medicine Department JNU
CED. (Centre for Education and Documentation)
Dr Sujit Das cf Health Services Association said that the Junior Doctors
strike and their demands for a rational drug policy had highlighted the
’Lack of Essential Drugs, availability of .drugs of doubtful efficacy, rela
tionship of the state sector with Multinationals’• He stated that the HSA
and other drug; action groups in West Bengal would translate information into
“slogans and convert theni interactions? He expressed the need of developing
a coordinating cell to coordinate with health and /action groups in the area
and for their own education’ and development.
Amar Singh nzad of Peoples Health Action group from Patiala said that
they had been circulating health and drug material in vernacular press. This
was done specially during Dr Zafrullah’s visit. They had not made much link
ages with outside groups 4n the past, but were planning to do so. They
needed drug information which they were keen to disseminate.
/
/
Calicut group indicated their plans to share information with other
groups as did the representative from Guntur.
Anil Patel mentioned that the ARCH would translate relevant drug mater
ial in Gujarati,
Atul and Mira Sadgopaj .would try forming a drug action group in Indore.
Medico Medical Association Baroda group would plan out an exhibition
“ fef
~ building drug awareness. They also planned to be more involved in
drug action.
Ropresentafi^u^df NOrty.,hal/ 8^1 co fepro&entativg Associfiticn' shared
about the bfforts uadex
r?. ’ "
1- ’ L
.
_r*v\,
*
j
j
r
-•
.J
- ..
.
(*
D-10/544
MS:a/16.2.84
..2..
Ashish Thakore would translate some of the information into Bengali and
circulate it.
Avitabh Guha Zonal Secretaiy of IMRAI, said FMRAI sees itself focussing
on the issues related to essential drugs, dangerous drugs, Indianizing of .
drug industry. Three levels of action indicated by him were
1) aimed at policy makers
2) at mobilizing opinion of research workers, scientists and health
and 5) popularization with lay public.
personnel
Certain issues requiring urgent action were discussed. First one raised
by Mira was the IMPLICATION OF DILUTION OF FORIEGN EQUITY SHAPES OF THE
FERA COMPANIES TO 40%. This would mean that these companies will be treated
as -wholly Indian companies. This would lift various restrictions applicable
to FERA companies eg. .Bulk Formulation ratio to 1?5 instead. Is10 (as appli
cable to India), restriction of production diversification.
Since the National•Drug’ Development Council report will be submitted
in March, urgent action is required.
In principle the group agreed that we supported the dilution of the
FERA companies, but not their concessions as it is obvious that this would
lead to flooding of the market with irrational drug formulations, specially
with the plans tc decontrol 75% of the drugs. Dr Rane in recent communicat
ion has also expressed his fear.
Since technicalities- were involved it was decided that a paper would bo
prepared giving the details and suggestion for a stand that would be desira
ble, for members to give their comments and feedback.
Second issue discussed was the NOTIFICATION OF THE BAN issued by the
Plug Controller of India which has been published in the gazette. Detailed
list of the Banned Brands, nor clarification regarding the banned list has
been obtainable from the Drug Controller.of India. Requests to get clarifi
cation have failed. Members of the group were requested to approach the
State Drug Controllers for this list and use this as a tool for building pub
lic awareness. Availability of this list was one of the demands made by
Vincent Panikulangara. Due to lack of time unfortunately this could not be
discussed and Anani" strongly felt that only these specific areas which needed
urgent handling should be discussed. This issue had been ;any way earlier dis' cussed at MFC general -body meeting, and it was decided that Dr Satyamala
from Delhi and Anil Patel from Gujarat, on behalj of MFC would look into this
Public Litigation case and report to-the rest whether MFC’s legal intervent
ion was indicated or not. Permission fr.bm the VHAI Bot-.rd for similar
intervention being made by those in VHAI had not been granted.
Video movie from IOCU- ’Healthy Business’ was screened for the partici
pants and appreciated. Due to shortage of time we could not have detailed
discussion.
Summary of the Delhi meet as well as a gist of the meeting with
Mr Mazumdar of FIvilUI held earlier were shared. Priority a^uas identified based
on the above were communicated - Banned-Hazardous drugs, essential drugs,
over the counter drugs, pricing, criteria of the Rational Drug Policy.
Responsibilities to prepare background material for tlie above specific
areas for the Drug Workshop III were at-; follows a
- Over the counter drugs -Lok Vigyan S^ngatna, Kerala Sast??a Sahitya Parish- Pricing -FMRAI; (Dr Rane) of Arogya Dakshata Mandal
a'd
- Criteria of Rational Drug Policy-Dr Si^jit Das(of Health Cervices Associa>
tian), I
i
(Even though in Delhi responsibility for this had been te.ken, it was felt
r
■B-10/344
MS:a/16.2.84
..3..
’’
by the group that different view points would be presented by different
groups, Mr Cuba Zonal Secretary MRAI would present FIvIRAI’s views.
- Essential Drug List- Dr Ullhas, Dr Mathur, Mira
”
~
nn ‘
-
<1'^1'
”n
J
-■ r
■3
- J-
” ’ *
'
‘
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3
-
Banned and Hazardous drugs - Mira(responsibility delegated)
With various organizations joining in, An.ant Hiadke felt that Organiza
tional Structure cf Drug Action Network should be discussed at the Coordina
ting Committee *s meeting. At this meeting the ideological stand of tho orga
nization in relation to DAN and Drug work, its strategy and future committ
ment would be shared. Whether there is a need to formalize this organization
was also to be considered. I aired my fears that any kind of formalization
may interfere with the spirit of the work . All this would be discussed at
the Coordinating Committee ’s meeting to be held at Sevagram on jO-^lst July
to finalize the plans for the Drug Workshop III and to discuss Organizational
matters. Representatives of the active organizations would be expected to
attend this. Detailed plans will be sent later.
•> Since many of the groups were busy in March-April and it was decided
the Drug Workshop III after the monsoons in October end or November beginn
ings. It wil^J -fog hela
Calcutta. Pune as a venue was rejected due to diffi
cult access by train.
1
In the mean time Drug Information material would be sent to the various
individuals interested in drug work. The common complaint by Dr Sujit Das,
the Patiala group, as well as the Calicut group were lack of information.
Drug action network newsletter would be sent to these groups* Drug material
prepared earlier over the last couple of years would also be sent from Low
Cost Drugs and Rational Therapeutics cell in VHaI#
It was felt by some members that even though urgent issues needed, our
attention, long term plans were important for individual organizations invol
ved as well as the network on the whole. It was sincerity of our effort to
reach out to other groups, and the credibility of our motives and our work
that would ensure a slow yet lasting emergence of a dynamic group.
Dr Mira Shiva
Coordinator
Low Cost Drugs & Rational Therapeutics.
I
I*
$
,b
Voluntary Health Association of India
C-14, Community Centre
New Delhi-110016
Telegrams : VOLHEALTH
/7\o\
Safdarjung Development Area
ai 5
7 |z
New,Delhi-110016
%
/V
Telephones :
668072
g~4/37S(d) LCD &. RT
SOl-jE DISTINGUISfflIIG ORG^ilZATION/iL FEATURES
OF COWJTTEE FOR WIOKAL DRUG POLICY
- Prepared by Anant Phadke
to help in the discussion on
Structure of Drug Action Network
Ajjns and Objectives:
To work towards a. Rational Drug Policy in India consistent with
the aim of a rational and socially appropriate Health Policy in India.
The Committee would oppose the irrationalities in the production,
distribution and use of drugs in India. In furtherance of this aim,
the Committee would work on the following fronts related to Rational
Drug Policy:Conducting and participating in Seminars, workshops,
discussions °
Conducting and participatiijg in public educational
compaign;
*
Publishing, circulating theoretical, educational
material;
•J
O Jd
■jj-
Conducting relevant research;
o
< /.
Cooperating with and helping like-minded groups^
organizations3 institutions;
u m U.I
£o3
O
-K-
Conducting any other activity consistent with the
aim of the Committee•
.J
§e-
J
M embers bip;
8=
Any individual or group/organization/institution which agrees
with the aim, perspective (as outlined in ’’Essentials of a Rational
Drug Policy” and "Towards a Rational Drug Policy in India”), rules
and regulations of the Committee can become a member on payment of
Annual Membership fee.
Annual!. Membership fee:
i)
q
(ii)
IWVIDU^
ORGANIZATION
5
Rs. 2J/~ for those earning
less than Rs. 750/- p.m. (j
0
Rs. 250/- per year.
Rs. 50/- for those earning
0
more than Rs. 750/- p.m. ()
Individual members cannot become office-bearers of this
Committoe. Only representatives of organizations can. become officebearers.
2/
§
^-4/373(d) LCD & RT
2
The Committee would not be responsible for the views
and actions of its members other than on the drugs-issue.
Termination of Membership;
i) Resignation
ii)
Non-payment of membership foe for one year
iii) Expulsion by the Executive Committoe; if the
individual or organization conducts or parti
cipates in any activity contrary to the aims
and objectives of this Committee.
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area
New Delhi-110016
E-4/373(c) LCDm
VH/kr;pt:17,7J^
TOW/WS A
/<
Telegrams : VOLHEALTH
w
tn M
eV \z’
w
/■nj
New Delhi-110016
T . ,
668071
Telephones : 668Q72
&
COMMUNITY HEALTH CELL
_______________ V Main, I Block__________
Koiamong^la
C'OiOw
Bangalore-560034 )
j
DRUG POLICY IN. imiA
India
Anant Phadko.
Sven a cursory glance ifct the existing ^rug-situation in India would
reveal that the production, distribution, use and monitoring of drugs in
India is today a far cry from a Rational Drug Policy. /XL the aspects
of existing drug-policy need to be completely overhauled in order to
effect' a Rational Drug Policy. Such a change would involve amongst other
things, nationalization of all. the major drug companies along with a
social control over tho nationalized sector.
But such a step cannot
be expected in immediate future because of the low level of awareness
about the necessity of a Rational Drug Policy amongst medical personnel 9
politicians, government officials and the common people; and because
of tho weakness of the people’s Movement in general. Hence only the
following intermediate measures are to be demanded from the Government.
These measures do not constitute a full-fledged Rational Drug Policy
in India but are stops in the right direction. We demand from the
Government the following:-
1.
Setting up of a Drug Roviow Gommittco to assist the Drug Controller
of Indiae It would scrutinize all the drugs currently marketed in
India, on the basis of principles outlined in the ’'Essentials of a
Rational Drug Policy”. The recommendation of this committee to bo
implemented without delay.
The Committee would be a permanent body and would review the
drug policy every year in tho light of now information on older drugs
and invention of new drugs. No drug in India can be produced or
marketed in India unless approved by this committee. Similar,
scrutiny of non—allopathic drugs to be carried out on the basis of
proven efficacy and safety in research.
2.
The Drug Review Committee to prepare a Graded Essential Drug List
as outlined earlier and the Government should make it mandatory on
all drug companies to produce drugs amongst this list only. All
other drugs recommended in standard text—books would be considered,
as non—priority drugs in India. A. separate list of such non-prioriuy
drugs shall be prepared by tho Drug Review Committee and ’drug
companies would be" required to take’ permission to produce or market
any drug from this list.
*I
Only those non-allopathic drugs which have been proved to be
effective and safe in research arc to be allowed to be produced for
general use.
The Public Sector should play a leading role in the manufacture
of life-saving drugs and drugs used in the National Health Programmes
(for example - Tuberculosis Control Programme). It is the respon
sibility of tho Government to ensure; adequate supply of drugs through
increased production and imports. Those private companies which
refuse to continue tho existing level .of production of drugs listed
in tho Graded Essential Drugs List, should be nationalized by tho
Government to prevent fall in the production of these drugs and the
consequent s hort ages.
2/
I
S-4/373(c)LCP
va^;pt:l7\7J84
:
2
:
3»
No technology transfer agreement shall be legal and binding which
contains restrictive practices, disproportionate and unnecessary use
•of imported intermediatories or obsolete technologies or unfair
arrangements with respect to. prices, payments or repatfetion
ropatfetion of
profits.
' ■•
4.
Imports of drugs to bo governed by the same Graded Essential Drug
List andz conducted only through the public sector agencies in a
rational, planned manner and through competitive v^rld-wido tenders
to reduce cost.
5. The Drug Price Control Order of 1979 should be extended to all drugs.
However, the existing categories in the DPCO to bo abolished and a
uniform mark up to bo allowed on all typos of drugs so that pre-tax
profit rate of a maximum 15$ is assured. The packaging, advertising
and other overhead expenses should be standardized.
6.
Abolition of excise duty and salos-tax on drugs commonly required
mairijy by the poor people - antibiotics, antimicrobials, anti-helmi
nthic drugs, drugs used in the treatment of scabies, ringworm
infestation. Exemption to bo granted also to vaccines of all typos,
and drugs used in the National Health Programmes.
7. Marketing of drugs only under generic name. The company!s name
can be mentioned on the label in bracket. For example - Ferrous
Sulfate (Glaxo). But the generic name should be at least equally
prominently and clearly printed on the label as the company’s name.
So
It shall be the primary responsibility' of the manufacturer to ensure
the quality of drug products. However, it shall be the statutory
responsibility of the Drug Control Authorities to monitor the
standards and ensure a minimum uniform level of government control.
Consequently, the government shall take nil necessary measures to
enable the Drug Control Authorities to function in an effective
manner and discharge the statutory duties cast upon them.
9.
It shall, bo the statutory duty of the drug control authorities to
iriform health personnel and consumers of the essential drugs lists,
policies, categories or brands of drugs banned for manufacture or
sale, through publication in the national newspapers, magazines,
medical, journals with adequate explanations and details.
10.
The marketing code drawn up by HAL (Health Action International)
should form the basis for a National Code for Marketing Practices.
Tliis should be accepted by our government and should be suitably
implemented through legislation.
11.
Adoption of the marketing code prepared by the Working 'Group
on the Formulation of the National Code on the marketing of Breast
Milk Substitutes.
12.
The Drug Review Committeo should also scrutinize sill the over-thecounter drugs and only those drugs which are fully scientifically
justified to bo sold- as over-the-counter should bo allowed to be
sold in such a maruxur. No vitamin preparation be allowed to bo
advertised in the lay press and all advertisements in the lay press
should be preccriporod to prevent any misleading of lay people.
3/
I
a-4/373(c)LCD & RT
VIlAIspt:17.7.,S4
3
13.
Abolition of wholesale stockists and distributors - the unnecessary
profitmaking middlemen. Establishment of National Corporation for
the distribution of drugs and Pharmaceuticals to the retailers.
Tliis Corporation to work on no loss no profit basis.
14. Making mandatory for doctors to keep propor clinical records•
The records arc open to scrutiny and doctors answer able to a
regional bureau of medical experts which would investigate
allegations of misuse of drugs by doctors.
15.
Punishment to unauthorised persons or to chemists for giving
drugs without a doctor’s prescription.
I6x
Inclusion in medical education a study of Rational Drug Policy
and the current status, measures in India,
17.
Compulsory continuing education of all doctors and medical personnel
through journals and refresher courses.
Education of the lay-people about over-the-counter drugs and about
misuse of drugs.
19.
All the above measures
non-allopathic drugs.
should also be applied in case of all
COMMUNITY HEALTH CiU
326, V Main. I Block
Korambngala
Bangalore-560034
India
CHAPTER 8
„ summary of recommendations/comments
OF THE STEERING COMMITTEE
1.
There should be a smaller span of price control on the
drugs than now.
2.
There was need for an economic study (App.X) to provide
to study
the data base for changes in policy as also
the impact of the present proposals.
3.
A priority list of drugs as amended (Appendix VI) was
approved/ as essential from the Health angle by the
steering Committee.
4.
The Comittee recognised the need to match essentiality
with keeping the price control basket as minimum as
possible and left further consideration to the NDPDC and
Government.
5.
The Committee felt that the priority list would'require
updating periodically# at least once in five years.
6.
The production of these drugs should be monitored and
any shortfall in production be immediately attended to
after assessing the causes therefore.
7.
The minimum economic scale of production should be
permitted.
8.
The drugs in the priority list and the formulations
based* on them are, to be under price control. The
rest of the drugs and their formulations may be price
9.
decontrolled.
The essential formulations based on the priority list
listed in (i) the WHO publication/ "The use of
Essential Drugs:" (ii) Hath! Committee Report
(iii) National Formulary and (iv) Indian Pharmacopoea
will be the leader compositions.
The leaders, among
those who make formulations.
With the listed compositions will be identified and
their price fixed.
The prices will apply to these who
make the same compositions in the same dosages and
packs.
10.
For single ingredient formulations suitable plus minus
formulas for changes in dosage or packs or packing
materials will be worked out to enable the leader price
to be adopted without actual costing to the non-confor
ming multiple or sub-muJtiple dosages and packs of
formulation.
11.
For multi-ingredient formulations individual price fixi
ng will have to be resorted to. There was a majority vi
ew that for multi-ingredient industry should be allowed
to fix and revise the price themselves subject to review
by Government.
The export members contended that this
was not consistant with price control and needed to be
looked into from the point of view of administrative
feasibility.
12.
It was felt that the feasibility of adopting normative •
costing of the leaders deserves examination and
consideration.
13.
(A) There were four views on mark-up on priority list:
A common mark up of 75%,
i.
Two mark-ups (a) 65% for those formulations based on
priority drugs which are listed in the categories
I & II DPCO 79 and (b) 100% for formulations based
on the rest of the priority drugs:
iii. 65% for the cat. I&II list as mentioned above and
125% for the rest of the priority list- and a common
mark up of 80%.
The technical members and the public sector representative
were for a common mark up of 75%.
The private industry
and trade representative were strongly for two mark ups.
One technical member agreed with the private industry
view.
(B)
The mark up on imported formulations should
continue to be 50%.
14.
On trade commission there were two views:
a total commission of 20% for the retailer and
wholesaler together* and
ii.
a total commission of 26% as recommended by the
working Group.
There was no consensus.
15.
A decision may be taken by Govt.
after suitable study.
On over-all profitability limit on the turnover of
for mulatto ns, again therre were two views:
Given the frame work of recommendations the
1.
predominant view was that in view of the insistance
on each producer marking 20% of the priority drutjs
and formulations tbis being a self limiting parameter,
there was no *necesskity for an overall profitability
limit.
2.
There was another view which desired continuance of
the overall profitability limit on formulations/ and
supporting the working Group recommendation of a
limit of 10% on turnover of formulations for whose
companies not engaged in research and development and
3.
16.
17.
12% for those companies engaged in R & D.
All agreed that there should be no overall profitabi-
lity limit on bulk drugs.
The "independent'’ small scale sector should be outside
price control for formulations irrespective of the turnover.
On bulk drugs made by both small and large units/ without
formally pricing the small scale secotr, the price fixed
would operate as a ceiling for the small scale sector.
It was recognised that large units who buy bulk drugs from
the small scale sector and formulate and where the bulk
drugs.is produced only by the small scale sector would be
rare but the large units in such cases would have to be
18.
price controlled.
Many members felt that there should be liberalised licen
sing procedure/ without capacity and demand should projec
tion restrictions for priority bulk drugs# proposed ffom
basic stages and involving no import of technology/ where
technology was available in the country.
Where technology
is not available/ import of technology should also be under
liberalised procedure for priority drugs.
Import however#
needed scrutiny and should be allowed in needed areas only.
19.
The Steering Committee had earlier felt that there should
be no free licensing of formulations.
At the Vlth meeting
four views were expressed.
Formulations can be dealt with throgh ordinary lice
i.
ii.
20.
nsing hence no change in the earlier consensus
free licensing of formulations is necessary to react
20% target insisted^
iii. Having permitted liberalised licensing of bulk drugs
at least related formulations■should he permitted.
One member felt that no compulsion to produce 2 0%
iv.
should be there and no free licensirig*h.
The OPPI representative favoured free licencing, of bulk
•r •
The JOMA ijipresentative
was against free licensing in any area, as beilng harmful
drugs in the non-priooidt^r area.
to National Industry.
21.
20% of the total value of production of each producer
every year should be in the form of priority bulk drugs and
formulations based on priority bulk drugs and combinations
of the priority drugs.
Fuflfilment of these obligations
will be monitored as and when industrial licence application
is received from a manufacturer.
22.
The committee recognised the desirability of all sectors
conistibuting to the production of priority drugs.
23.
There should be incentives to those producing more than
20% of their total value of own legitimate production in
terms of priority bulk drugs only.
The return for such bulk
drug production would be higher than the normal rate.
24.
Duties on intermediates should be much less than those on
25.
bulk drugs.
In the priority list for those bulk drugs under basic
production/ there should be no customs duty on imported
26.
inputs or domestic duties on production.
There should be exemptions from duty on formulations based
on priority drugs.
One member felt that increase of import duties should
(a)
not be resorted to during the middle of the financial
year.
27.
On brand/generic formulations there were two views:
Since gradual removal of brand names was a conscious
1.
decision and the matter is sub-judic, 'it would not
ii.
be proper to promote brand products.
Others supported the view of the working Group for
industrial Approvals which had recommended
permitting brand names.
The predominant view was the
latter.
iii. For encouraging generic production a much lower
corporate (income) tax on profits from generic
production and marketing as compared to normal rate
28.
of corporate
tax was proposed.
Details of imparts should be computerised to errable watch
and scrutiny at senior levels in Government.
2 9.
It was noted that the drugs sector should not be a drag
on foreign exchange and that there were complaints of
transfer pricing, in intended benefits through imports etc.
I
30.
There wore two views on whether individual foreign
exchange balance for each company should be insisted
or not.
on the view was that export production should
be promoted (and made competitive.
The other view was
that the individual producer should justify outgo of
foreign exchange through advantageous import substitu
tion, failing wljich he has submit a scheme to Government
to reach a favourable balance as quickly as possible.
There were again two views' whether individual insi stance
should be made on all sectors or not.
According to one
view view export obligation to correct adverse balance
should be made on all foreign share holding companies.
The other view was that the
suggestion of individual
balance should be applied to all manufacturers who were
There was no consensus.
spending foreign exchange.
At the
Vlth meeting it was felt that application of the concept
of DRC to the drug sector required examination.
31.
If this policy is to be implemented effectively there
have to be a statutory National Body to ensure quality
Control and ethical practices, and all producers and
dealers will have to be registered.
Registration of
all dealers and manufactuers with some National Agency
32.
33.
was considered possible.
A Code of conduct inciliuding CMP (for manufacturers)
can be drawn up to be observed voluntarily by all
manufacturers and dealers.
Any beach of the code of conduct if proved will entail
de-regiistration from the
National Body and the fact
will be given due publicuty.
34.
Consumers associations and voluntarily Health Organis
ation have been active role in informing the public and
35.
educating them.
Adequate funds for strengthening the Drug Control machinery
in the States and the Centre must be ensured.
36.
Special fiscal and other measures such as easy bank loans
at concessional rates of interest, import of equipment
under O.G.L., procurement of equipment under H.P. .
system and exemption of customs duty on imported equip
37.
ment, may be provided to the small scale sector for
installing quality control equipment.
One member was of the view that insisting on each manu
facturers setting up a chemical testing laboratory is
not practicable.
38.
More drug testing laboratories set up jointly by indu
stries themselves in the co-operative sector by the
National Body should be encouraged and recognised as
39,
4 0,
per rules.
The recommendation 2.9 of the working Group on Pricing
& Procedure was accepted deleting the word ’’Permanently".
The recommendations 2.10 of the same Working Group was
accepted deleting the words "along with their formula
tions" .
41.
Regarding DPEAZ there were two views:
DPEA should be abolished.
1.
It should be retained. There was no concensus.
At the VI meeting this was rediscussed.
It was
felt ttjat Govt, should substitute and arrive at a more
dynamic and workable scheme to solve the problems asso
2.
42.
ciated with multiple costs and prices.
All the recommendations of the Working Group on Pricing
Policy & Procedure/ not covered in the list above were
accepted by the Steering Committee.
43.
All the recommendations by the Working Group on
Planning & Development were accepted.
44.
On recommendations 1 and 2 of the Working Grogp on
approvals.
It was agreed in principle that wholly Indian
1.
Companies deserve a more concessional treatment/
concessions to be left to Government.
However,
this does mot mean that the existing facilities
for diluted FERA Companies should be reduced.
2.
According to one view, foreign share holding com
panies should be given restrictive treatment for
licensing/ registration/ ratio parameters and
sectoral reservation as compared to wholly Indian
3.
45.
Companies,
The other views were for following the present
policy or for accepting the Working Group
recommendation^On recommendation No. 3 of the Working Group on Industrial Approvals/ there were two views:
that the Working Group recommendations should apply
1.
only to non-priority Sector.
minant view.
u
This was the predo
2.
46.
One view was for accepting the recommendation with
the IDMA view.
On recommendation No. 4 of the same Working Group, there
were three views:
1.
One view was for drawing up new reservation lists
for both priority and non-priority sectors.
(App.XIIl)
2.
Having reservations in non-priority sector in
addition to insistence of 20% production of the
priority drugs was an undue restriction was a
second view.
3.
The third view was that because of the 20% stip
ulation reservation was not justificable in the
priority sector, Reservation lists might be drawn
up for the non-priority area. This was the predominant view.
47.
Recommendation No.6 of the same working Group was
deleted being redundant.
48.
On recommendation No. 12 of the Working Group on
Industrial Approvals there were three views:
Parties to apply for registration or licences and.
the applications should be disposed of on'a case,
to case basis as per new policy being framed.
This was the predominant view.
2.
The second view was to follow working Grou^.,
recommendations.
3.
The third was to go by decisions of Government‘
on the recommendation of the Task Force Consti
tuted to study this problem.
4 9.
On loan licences there were two views, equally
divided
1.
2.
Loan licensing should continue.
Loan licensing should be progressively stopeed as
suggested by the Task Force on substandard drugs
constituted by the Ministry of Health.
There was no concensus:
5 0.
All other recommendations of the Working Group on
Industrial Approvals not referred to in the list
above were accepted by■the Steering Committee.
51,
The comments of the Steering Committee on the recomm
endations of the three Working Groups are indicated in
Appendix II.
52.
The existing patent law should continue.
53.
The recommendations as per additional note (Appendix IX)
given by Dr. Namjoshi were accepted by the Steering
Committee.
54.
Interim revision in prices based dn increase in prices
of inputs should be considered by Government.
We are grateful to the Hon’ble Minister Shri. Vasant
Sathe and Shri B.B. Singh, Secretary for their guidance
and advice. Thanks are due to the officers of the
Ministry and in particular to Dr. R.V.V. Ayyar, Dr. D.K.
Roy , Shri E.N. Murthy, Shri Mehta, Shri K.C. Kohli,
Shri. B.R. Verma and Shri K.L. Kakkar for constant
assistance.
This report was discussed in the V and the VI meetings
of Steering Committee held on 14th August^ 1984 and on
18.8.84 and appoved a mendments.
1.
Shri Mahendra Prasad, M.P.
2.
Shri Krishna Mohan, M.P.
3.
Dr.
4.
Dr. Nitya Nand
5.
Dr. Gothoskar
6.
Dr. Nam Joshi
7.
Shri Khorakiwala, President, IDMA
Shri Denial, President, OPPI
8.
9.
Chairman
B.B. Gaitonde
11.
Shri J.B. Kochhar, President AISDMA
Shri Gharpure, MD, HAL.
Shri H. Grover, Secretary IMA.
12.
Shri. V. Shah, President AIOCD.
13.
Dr.
(Mrs.) Satyawati, Deputy Director General ICMR,
14.
Dr.
lagh. Chairman BICP
15.
19.
2 0.
Shri S.L. Kapoor, JS Ministry of Ind. Development
STiri Malta, CCIE
Shri Keltar, Economic Adviser.
Representative of M/0 Finance/Rev.
Shri. Chaturvedi, Planning Commission.
Shri, Keayla. A/o Commercd.
21.
Dr. V. Vankitanarayan, Member Secretary.
10.
16.
17.
18.
J
13.
President,
Indian Council of Medical Research
14.
.. Member.
Dr. V. Venkita Narayanan,
Joint Secretary and Development
. . Member
Commissioner (Drugs)
Secretary.
The ■£ Committee would also have the following Special
Invitees to its Meetings:1.
Representative of Department of Industrial
2.
Development.
Controller of Capital Issues (®CCE)
3.
Representative of Ministry of Finance,
4.
Department of Revenue.
Chairman, Bureau of Industrial Costs and Prices.
5.
Representative of Ministry of Planning.
Representative of Ministry of Commerce.
7.
Shri Vijay Kelkar, Economic Adviser,
Ministry of Chemicals and Fertilizers.
3.
The terms of reference of the Committee will be as
follows:
a.
to evolve a consolidated Report based on the recomm
endations of the respective Working Groups;
b.
to formulate a re-conciled perspective between the
different sectors concerned;
to finalise recommendations to the National Drugs
and Pharmaceutical Development Council keeping in view
the main obrg’iectives of the Drug Policy, namely, to produce
medicines for the masses particularly of life saving nature
and those required for the National Health Programme
ensuring quality and fair prices.
The first Meeting of the Committee would be held on 16th
April 1984 at ll.'lO A.M. in Room No. 353 'A* Wing.
4.
(E.N. MURTHY)
DEPUTY SECRETARY TO THE GOVT. OF
INDIA.
Note:- The above is the summary of the recommendations of the
steering committee set up by National . Drugs & Pharmace
utical Development Council Aug. 84 Ministry of Chemic
als & Fertilizers.
Please go through it carefully & give your comments
preferably in writing to me.
Dr. MiFaShiva
Coordinator
All India Drug Action
Net Work.
ffwfc (um © g?
1
NEWSLETTER OF THE LOW COST DRUGS AND RATIONAL THERAPEUTICS CELL
VOLUNTARY HEALTH ASSOCIATION OF INDIA 014 COMMUNITY CENTRE SDA NEW DELHI 110016
HEW DELHI
23
Jan
1984
For most of us in the Drug Action
Network, the last three months
have been fairly hectic.Of course,
the highpoint was Dr Zafrullah
Chowdhury’s whirlwind tour, an
encounter which not only ’galvan
ised ’(to use Dr Raj Anand’s
phrase) everyone into more action,
but also provided a most welcome
and unscheduled opportunity for
network members from different
parts of the country to meet. The
outcome of these meetings is
detailed elsewhere in this issue.
Happily, going by the feedback
received so far, there have been
no serious adverse reactions to
the trial launch of ’The Drug
Action Network Newsletter1.There
have been some positive criticisms
and suggestions.
Dr Anant Phadke has written in
to say that the emphasis should
be on work done by groups and
activists in the field. We cannot
but agree with the suggestion
that there should be more cover
age of news and events emanating
from places other than New Delhi.
But this would have to mean a
much more steady flow of inform
ation from the activist groups,
than there is at present.
Ms Padma Prakash felt that each
issue of the newsletter should
carry at least one in-depth
article. It was decided that we
would try and incorporate this,
though it may not be possible
to make a hard and fast rule
of it.
In terms of future action, two
major activities are Drug Work
shop III in February and the
nationwide campaign on drug
issues in April(see ’Coming
Eve nt s1).
HIGHLIGHTS
• Meet! ng with
Mr Vasant Sathe
• Dr Zafrullah Chowdhury
- Press Clippings
• Estimates Committee
Report
• FERA Companies
- equity dilution
• Drug Utilisation Study
-
S
. sc
4
5S £
S1 '-Ji“ u
i’
6
9
c.
;- o r
h: o 3
•>
4 IL CL
10
12
network news
WDr Zafrullah Chowdhury had a
series of meetings with network
members in various cities. He also
addressed a number of public
meetings and seminars at the
various centres. Press confer
ences were held in Bombay and
Pune, and in Delhi he was inter
viewed by individual journalists
as well as on television.
Some
of the press coverage appears on
Pgs. 6,7,8, in this issue.
please contact Dr. N. N.Mehrotra
at NISTADS, 12, Hillside Road,
New Delhi.
A meeting between the health and
drug policy makers and some of
the individuals and groups involved
in Drug Action was held at the
CSIR Science Centre on 5 Dec.’83.
This was organized by NISTADS to
utilize the opportunity presented
by Dr. Zafrullah’s presence in New
Delhi. The organizations represent
ed were VHAI, Arogya Dakshata
Mandal, Lok Vidnyan Sanghatna,
Centre for Social Medicine and
Community Health,JNU, Child in
Need Institute,Calcutta, CRHP,
Jamkhed.
A meeting was also arranged with
Shri Vasant Sathe, Minister for
Chemicals and Fertilizers.
A
joint memorandum setting out our
stand on a rational drug policy
and raising key demands covering
these issues, which was circul
ated and signed during the public
meetings, was presented to the
Minister.
* On 5 Dec.’83, an informal meet
ing of the Drug Action Network
was held in Delhi. Those present
included Dr. Rane (Arogya Dakshata
Mandal), Dr. Ekbal and Mr. Kumar
(KSSP), Ms. Padma Prakash (Lok
Vidnyan Sanghatana), Ms. Mona
Daswani (FRCH), Fr.P.D. Mathews,
Ms. Maria Mathew (I.S.I.), Dr.
Imrana Quadeer (Centre for Social
Medicine and Community Health JNU), Ms. Sunita Narayan (CSE),
Dr. Mira Shiva, Ms. Chandra
Kannapiran and Aspi Mistry (VHAI).
Unfortunately some of the key
officials involved in Drug Policy
failed to be present. General
feeling after the meeting was that
there was an element of defensive
ness on the part of the policy
makers and a tendency for the main
issues and genuine problems as
felt by the health personnel and
consumers in the field to be side
tracked and ignored.
On behalf of Vincent Panikulangara,
Fr.P.D. Mathews made a strong pie'
for intervention by other groups
in the writ petition pending in
the Supreme Court. He is to pre
pare a short note on the legal and
other implications of this step to .
facilitate the groups in arriving
at this decision.
It is high time organisations in
volved in drug and health issues
demanded representation at various
levels of policy making. Leaving
it to those who have failed to
deliver the- goods so far would,
under the present circumstances,
be an indication of our passivity.
Tentative plans for a campaign on
drug issues in April were drawn up.
So also a rough outline for Drug
Workshop III was planned and the
preparatory work alloted to dif
ferent individuals and groups.
The Drug Action Network Newsletter
was also discussed and various
suggestions made to make it more
effective.
For details about the meeting
2
^ A Workshop on 1’Pharmac euticalg
and
Health Policies
_______________
les’ organised
by IOCU and QIAP was attended by
Dr Mira Shiva.
"emphasis on generic names
for all product information
and labels. For details contact
Mira Shiva at VHAI.
From 22-25 November, 39 particip
ants from 31 consumer and health
action groups from 14 countries
took part in this first regional
workshop held in Penang.
4 1 SOCIAL EVILS ANALYSED THROUGH
FOLK ART
’A sample of how people from all
walks of life can be brought to
gether and helped to scientifically
analyse their social dnd environ
mental problems was presented by a
group of KSSP workers in a memor
able performance on the occasion of
Kerala day, celebrated on Friday,
at the FICCI auditorium, here
(9 Dec. New Delhi)...
Highlights:- The workshop was
aimed at getting individuals and
groups to pool in relevant infor
mation, experiences and efforts
for a coordinated campaign
against irrational and socially
unjust Drug and Health Policies
and Practices.
’The malayalam adaptation of Bertolt
Brecht’s famous poem "Take the book
in your hand - it is a new weapon"
was a forceful exhortation to aban
don blind faith and to question
everything...
- Launching of ASEAN NETWORK FOR
HEALTH ACTION was another histor
ical event. Along with other
networkers of Health Action Inter
national, HAI (U.K.) and HAI
(Sweden), the Asean Network will
join in the campaign ’for safe,
rational and. economic use of
pharmaceuticals and appropriate
health delivery systems world
wide. ’
’A skit composed on the fight the
people of Calicut had put up against
the pollution of Chaliyar river,
showed the workers’ growing aware
ness of causes and consequences of
atmospheric pollution...
- Another major outcome of the
workshop was the signing of the
Penang Declaration of Rational
Stealth Policies. The ten specific
areas of action agreed upon in
clude a call for
"the adoption of essential
drugs lists for both govern
ment and private health care
services
"legislation to prevent dump
ing of hazardous, useless or
substandard drugs
"the encouragement of research
into the use and local pro
duction of traditional
medicines
"the use of the HAI Code on
Pharmaceuticals as a basis
for action
3
’Folk adaptations of Gorky’s
’’Mother” and other pieces by
Brecht touch on many aspects of
education and knowledgejpresented as the only forces that can
liberate the people from oppres
sion' ,(Indian Express, Dec 10)
The charter includes demands for
Rational Drug Policies relevant
to the health needs of the
country, effective drug control,
ban on irrational and hazardous
drugs•
The KSSP has decided to take up
the drugs issue as its major
campaign plan for 1984*
Attempts at involvement of other
trade unions in drugs ani health
issues would be considered a
very significant contribution
of FMRAI.
FMRAI Annual Convention held
^.n 13 Dec 198?.The convention
was held at the Mavalankar Hall
in New Delhi after a demonstra
tion in front of the Parliament
by members of FMRAI and AITUC
to press the government to meet
their 27 point charter of demands.
FMRAI’s role in ‘campaigning for
ethical marketing practices,
rational drug pricing, giving
of unbiased drug information
by the drug industry is well
known to those involved in
drug action.
drug news
WITH MR, VA.SACT SATHE
whether after dilution these com
panies would be treated as Indian
companies he answered in the affir
mative.
On 3 Dec ’83 an informal meeting
took place between Mr. Vasant
Sathe and Dr. Zafrullah along
with some of the representatives
of organizations involved in Drug
Action - Dr. Sameer Choudhry from
CINI Calcutta, Dr. Narendra
Mehrotra-NISTADS, Dr. Imrana
Quadeer-Centre for Social Medicine
a^id Community Health JNU and
Dr. Mira Shiva,VHAI.
He expressed his anguish at the
drug related decisions being struck
down by the High Courts and the
Supreme Court, for example the
switching over to generic names for
five single ingredient drugs, ban
on certain hazardous drugs etc.
Mr. Sathe agreed to accept our
representatives in the National
Drug and Pharmaceutical Development
Council as coopted members in re
cognition of the fact that the
voluntary health sector contributes
over 30% of the health care services
in the country. Based on their indepth knowledge and familiarity with
the drug industry and its functioning
the names of Dr. W.S. Rane,'Dr.
Sameer Choudhry and Mr. J.S. Majumdar
have been sent to Mr. Sathe.
Dr. Za#?ullah related to Mr. Sat he
how the Bangladesh Expert Committee
on Drugs had got inspiration from
the Hathi Committee Report.
Mr. Sathe was incidentally a
member of the Hath! Committee.
With regard to the extent to which
Hath! Committee recommendations
have been implemented, Mr. Sathe
spoke about the 40% dilution of
the FERA companies.
When asked
4
I1
As stated earlier, a joint memo
randum on behalf of all the
organisations was submitted to
Mr. Sathe.
He was also urged on
behalf of the consumers and
socially conscious health person
nel to make public the entire
list of brand names of the banned
drugs.
- to direct the licensing author
ities not to renew the licenses
for any drug except these
v
- to direct the Government tOu’_.
;
streamline the licensing polMcJr,..
administrative acts and statutfW
functions in such a way that‘Use
less, injurious and harmful drugs
are weeded out and essential and
life saving drugs are easily made
available through the nubile sec
tor undertakings.
Further details of this meeting
can be sent to those interested.
In the meantime we are trying to
get more information about other
’working groups’ besides the one
on drug pricing so as to demand
representation on these groups
t oo.
-to ban the import, manufacture
and sale of those drugs not yet
covered by the recent order of the
Government.
- to direct the Government to
appoint an expert committee to
report about the conditions pre
vailing in the drugs industry and
market after the period covered by
the Hathi Committee.
/
IN THE SUPREME COURT
Vincent Panikulangara, who had
filed the earlier writ petition
in the Supreme Court regarding
the ban of the import, manufacture,
sale and distribution of drugs
identified as hazardous and/or
irrational by the Drugs Consult
ative Committee (D.C.C.) has filed
a further petition to amend and
add to the original petition.
This has been done in the wake of
the Government of India’s notifi
cation of 25 July ’85 banning 22
categories of drugs, under the
powers conferred on it by the
recent Drugs and Cosmetics (Amend
ment) Act (see previous newsletter)
In the new petition Vincent has
drawn the attention of the Court
to the fact that certain categories
recommended by the D.C.C. to be
banned are not included in the
present order of the Government.
Moreover certain of these recom
mended categories have been given
specific exemptions (like hydroxy
quinolines for use in diarrhoea).
BANNED DRUGS
LIST OF BRAND NAMES
The Eastern Pharmacist (May 1985)
had reported that the Retail and
Dispensing Chemists Association
had filed a writ petition against
the Union and State Governments
asking them to publish a list of
the brand names of the drugs then
proposed to be banned, (and theo
retically banned since then) so
’that they are not harassed’.
The Bombay High Court had directed
the requisite notification under
Section 26A with the list of for
mulations proposed to be banned be
published in the Gazette.
The
notification has since been pub
lished but it does not include the
list of formulations.
The list of the formulation packs
marketed in the country have to be
obtained from State Drug Control
Authorities by the Drugs Controller
of India since registration of
these drugs has been done by the
State Drug Control Authorities^
many of them being more than 20
years old. It is also learnt that
the drug companies have obtained
Pg 9
In the amended petition the follow
ing orders are prayed for from the
C ourt:
- to direct the licensing authori
ties not to grant new licenses for
the import, manufacture and sale of
any drug except the 116 recommended
by the Hathi Committee.
5
to
Tuesday, December 6, 1983
Big brother
is creating a
problem
for us’
£
Our Staff Reporter
"Noval^in has been banned 1
Pakistan, Sri Lanka. Bangladesh
Malaysia. Unfortunately our big bro4
there has not yet done it. And it is
creating a problem for us”.
This pain-killer was one of many
drugs mentioned in a brief but im
passioned talk on “Drug Misuse &
Drug Misinformation” in Delhi on
Saturday by Dr Zafrullah Chowdhu
ry, Director of the People’s Health
Centre, Bangladesh.
The 42-year-old doctor was among
those on the Drugs Expert Commit
tee whose proposals led to 1,579
dangerous drugs being banned by
Bangladesh.
In the country he calls *blg bro
ther’, India, 43,606 drugs are regis
tered and sold. “Three quarter of
them are non-essential”, says the
dictor. “And the policy taken b;r
your country affects us”.
When Bangladesh declared its
new drug policy on 7 June, 1982 he
said, multinationals
immediately
brought tremendous pressure to
bear, to have the policy amended.
‘First the American. British, Dutch
and German governments started a
campaign with our government.
When that failed, the US Embassy
brought in a 4-member expert sci
entitle committee from pharmaceuti
cal companies.
A report in the Washington Post
on .19 August, 1982 said that the US
goyamment was worried that its
“SO-blllion-donar market in the de
yeloning countries would be at stake
If other countries followed suit”.
The Bangladesh government stuck’
to its guns, lifting the ban from
only a token 128 drugs.
The Bangladesh drug policy weeds
out ‘all unnecessary, useless drugs-
and drugs of doubtful efficacy** kilogram. This
bottle’s basic
from the market. They include li cost is therefore not more
quid vitamin mixtures, multiple com
binations of potent drugs, combina tn?n 90 naise. and cannot be
tions of antibiotics gripe waters, more than Rs 3 or 4 after addcough mixtures, tonics, balms, di ing taxes a«d other charges.
gestive enzymes, addictive drugs
Itiere are other muitmatioand antacids.
“We thought, let us have our nai tricks. “To take the mini
for
own ulcers — instead of getting mum dose of .Ampicilin
them from multinationals**, said five days, which is the pres
Dr Chowdhury.
cribed course, you need 100 ml.
In India, where multinationals con But the bottles that are sold
trdl 78 per cent of the market, ami in developing countries
are
modem drugs reach only about 20 only 60 ml. A poor man is
per cent of the population, he says,
the policy is not firm enough. In* forced to pay for 120 mis—two
to get his
deed, the Indian drug policy, is bottles—in hrder
being quoted by multinationals to dose”. The bottle sold in the
criticise the Bangladesh ban, says ? est is of 100 ml. he said.
a study of the Voluntary Health AsTerramvcin syrup was ban
sneirtipn of India, which organised
ned from the Indian market in
the talk.
July this vear—r“But why has
“Blindness
is
a growing
the comnany been given one
problem in your country”, said year
to
withdraw?’*. He
Dj Ohowdbury. “Yet, the so- asks
"A
lot can
hap
called
anti-diarrhoel
drug pen in a year: governrrilnts
Wexsfom is still in wide use.
—
It has not only been conclu can change, policies can be rev<rsed, there can be second
sively established that it has
serious side-eTects. can cause thoughts”
Bangladesh's
Drug Control
cancer and leads to dimness of
announced
with
vision and blindness, but awo Ordinance.
therapeutic amendments on 6 September last
that it has
no
value whatsoever in treating year, allowed su days for all
stocks of banned drugs to be
diarrhoea”.
In 19?8 he said, the drug destroyed. Within four days
h ovalgin was found to derange the multi-nationals were seek
some people's ability to pro. ing permission to export the
duce white blood cells. A re- drug stocks to other countries
piesentative of
the
pfizer tke Saudi Arabia, West Af.
rompany, which makes the
when ft decides the matter,
drug, claimed at that
times Bangladesh will insist
on a
tiat a pharmaceutical from label saying that the drugs »v.ad !
hitler's country
couldn’t be been recommended for destrucwrong, ’Hitler Is 46ad, but lion by Bangladesh.
your country Is
still selling
The Voluntary Health AssoK ovalgin’, said the doctor.
datiou of India plane to rreMultinationals
sav
their eent the government with a
drugs are cheaper,
isaid
‘J Dr memorandum
demanding
Chowdhury, and withdrew
a among other things, that drugs
bottle of Ampicilin from •bis for India be chosep
u after ex.
pocket **I bought this today, in ^mining their
afff.
your city. It cost me Rs \W. cacy, safety, cost, ease of ad.
The international
wMemde ministration, availabUtty, and
nrice of Ampicilin is Rs 60 a potential for mlsoce.
“It Is the common
body, not the doctor's or the
bureaucrat's, that is affected by
the drug
poMey*, said Dr
Chowdhury.
6
INDIA YET TO EMULATE BANGLADESH
stillailab
BY SUMANTA BANERJEE
;ed from them, were based on the kistan and Malaysia. He suggested forXe'°=
DL
ZAfFRRU1 riAh
I list.
........................ co-operation between India and BanJ..X Chowdhury
During his talks with medical and
eliminate these chinery to check misuse of a drug does
Hiuiy of
ui Bangladesh,
uaiigiauvo.,,
ana giadesh to totally
to
who was instrumental in
not exist, is it not better'to ban it.
in^ the health workers in Delhi recently, , Dr. harmful drugs.
It is sad that a medical expert from a
int^nationany "acSd^Nawho^.g bus.®
r1 small neighbouring country had to
tinnaT DriiP Policv of 'his COun- Bangladesh, was still ceing sowi m rem|nc| us of Our duties. The sub-
Hi1™; 7H Eh. 15S**?>5r4!5s« s™"r.sz.bife“E
’
banning over 1,000 hazardous desh’were being diverted to other
and irrational drugs — mainly Third World countries. How was this weedijng
ng out
0U( of several drugs. But the proposition rather than a^question of
manufacturedby multinationals bejng done?
nQnoin4„k gazette notification of the Ministry of
m n. ir-- rx.iJ:
and r The Drug Controller of Bangladesh, flealth and Family wcifare> lssucd on
following the implementation of the July 23, 1983, prohibited the
Bangladesh Government s drug policy “manufacture and sale” of only 22
drugs banned in Bangladesh banning
the drugs,
drugs, had
had directed
directed that
that categories ooff drug
nine the
drugss and drug comcom- lts im»ted jesources ®n
were still being marketed in stocks
Stocksotofthe
thebanned
bannedarugs
drugswouia
would nave
have5 hinations.
bin^ions. Besides,
Besides,the
thewording
wording/lfof♦*the
”* ^dlcasUcto
were
still
being
India by the multinationals.
to be exported to the home countries of gazette js 80 Vague that it does not pubiic hla b €« bud«t is far
the multinationals which had manu- fCgR||y bind a manufacturer to stop
Dr. Chowdhury, Dma
who was
a member
thoSe-drugs
Bangladesh
Fxnert
Com- factured
ffaclured
a?ured those*
ddrugs
5u.§? ,-in
n Ban
£lac'esh JXducing
introducing inin the
the market,
market, the
the comcom- down in the list of
of the Bangladesh Drug Expert Com- (through their subsidiaries).
bination of certain products.
imperative that the healthbudget is
mittee, recommended^ ^ia,baI” SlJuf The multinational companies com- jn october 1980, the Drugs Tech- spenfo^good
iSh — adequate food, safe water
. ^3, u.h.
.... .... jSS,f«• ‘VhAXS.’JX’..™
B^aS [a
«>, .-a,.- - -j.
s
ssasiflsssxass
a « m&satas awes —Bs-jaras
of essential drugs and rational drug companies shippi them to ports in aand s’teroids wjth tranquillisers.” But not be was^.
irrational and hatherapy which is not merely based on ybird World countries.
later tbe phrase “combination of ste- zardous medicines.
efficacy, safety, ease in administration
and easy availability, but also on rea“
■» WM M
Not irrational
sonable cost — a factor of crucial
Whenever the Drug Controller of
India’s attention is drawn to the con
like India where more th an 50 per&ent banned in Bangladesh, were also bantinuing sale of drugs, which have been
of the ^pljj live below the poverty ned jn tbcse Western countries— the Jntnlication
declared harmful by medical experts,
line, and medicines are a luxury which .
- . multi-national companies
’
only a few can afford.
™ l"c^nufactuHna tdlugs This had a subtle implication. Since the Controller repeats the argument
r .
through thek .ubsidH in Bangla- combination of steroids with t anti- that since such drugs “have been in the
Divernon of drugs
dcs^The rtX from Bangladesh histaminics can, at least technically, be market for a long time it may be
SU?h a nation, deny.ng the
'Xm «he trecent o
d. fwuH „s,?(Rc
people their right to low cotit safe thesei Westernicountnej,
S^ban by thf Drugs Techni- Education and feesearch Centre’s
essential, quality drugs with the right divertedI to thejrhird World countries,
Advjsorv goard _ can escape the memorandum), or “such combinations
s-“S£L';."X,3.h=
h
i'-oSSta.»!«»■’ixya tob,“£i*sv. ,
needs and making them use their h- from Bangladwhhad found th
xs.”":!
«h“js.2’h“si “XS;11’.»™.n§v prGmole<i for ftn types of etable, or enjoying a wide marxet for a
s -se. es ;sis,
...................
DECCAN HERALD
15-12-85
Banned drugs still
in use in India
NSW DELHI, December 3
fPTI).
.ric names introduced. BansJacksh has
already started a campaign' in th a
Ban^adesK Sn L®pk*, Pakistan^ and re;(iucdoni he pointed out.
Malav^a are still being administered
.
, . _
to patients in India, according to a
prmedical expert from Bangladesh.
v^«
Citing th© example of analgin <*ribe 12 drugs for which a list had
(amidopyrine), Dr. Zafarvliah Chow- been circulated.
dhury, director of Gonoshasthya The kendra had started manufacturKendra (people’s health centre), jng 30 /essential drugs to avoid ex
Dhaka regretted that India' emerging plokation by multinationals, he said,
as < leader in th® third world, is still
PaneliaU criticised th® M ot
pens^ttina th® use of this.
availability of an infonnaUfoB' ayatotft
Dr. Chowdhury ewd that brand
?{s f^^jations and uses,
should be aboHshed and gen®consuas^rs acd chemists. They
7
TIMES OF INDIA
4-12-85
suggested that a li«t of banned and
harmful drugs
(with
generic
and
brand names) should be widely cir
culated by government and .-property
advertised.
Dr. Samir Chaudhury, a primary
health worker from West Bengal, ex
pressed concern over the very am ill
number ’ of drugs Inspectors in the
whole country.
He said even, essential dmga and
vaccines to cure tuberculosis’, diar
rhoea, blindnesa are not available in
right quantities to the rural poor.
Voluntary health organisations could
jointly tak® up production of soffit
essential drugs, he auggested.
Political will needed
for drug policy: expert
By A Slaff Reporter
BOMBAY. November 27
TIMES OF INDIA
28-11-83
bf medicine
in rural
vx mvuicine
ana and
work work
in rural
areas.........
. to^nV
2 According to Dr. Chaudhary, pat ho-
who can
colour
A combination of political will ’'Anyone ,"5,®
Cu" distinguish “
lour
A and pressure from the medi- nnd hasbI£d'
he said
tn”^ can
some basic
intelligence
analyse
blood
”, he
said.tub^wmk
In fact, his
S' “mdnn'ni,yii'S
f0™11- staff'
have
doni
7,000
b'
staff have done 7,000 tubectomies in
late a drug policy in this country thc rural
areas,
surpassing
the
govern.l:...! areas, surpassing the govern
to prevent it from being used as ment's family planning record.
j
a dumping ground for banned
The
regions
in
which
the
kendra
drugs, according to Dr. Zafrullah
worked showed no maternal mortality,
Chaudhary.
a low infant mortality, and popularity
Dr. Chaudhary, as a member of of immunisation programmes, hc said,
the Bangladesh drug expert com rhe kendra worked on grans from
mittee, was instrumental in the for charity and *on money that came in
mulation and passing of his country’s from its health programmes, in which
drug policy in June last year. He fought medicines ycre sold at dilierent prices
people /b£ different economic cate
a bitter battle against multinational to
pressure on the Bangladesh government gories.
and even from the medical fraternity
to get drugs including novalgin, mexafor’i. some sterold.s. gripe water, a
combination of antibiotics, micropyre
nes and tctracycling syrup banned.
Dr. Chaudhary told “The Times of
India’, here today, that India with its
large complement of scientists and
qualified people, was in a better posi
tion to formulate its own 'drug'-lolicy
so that the above drugs which .had
shown several harmful side-effects
could be prohibited
HAITH REPORT
It was ironical that the Hathi com-'
mittee report, which had inspired Ban
gladesh’s drug policy, had not been
implemented in India, Dr. Chaudhary
said.
Bangladesh today had managed to
keep the multinationals at bay but was
beginning to face a new problem —
the infiltration of the banned drugs
from across the border with India, Dr.
Chaudhary said.
Dr. Chaudhary recommended the
marketing of drugs under their gc
generic
names, because this would create
.c con-
THE HINDU
5-12-83
‘India has no effective law to curb sale
of multinationals’ harmful drugs’
From Our Staff Reporter
NEW DELHI, Dec. 4.
Dr. Zafrullah Choudhury. a pioneer in the
Bangladesh People's Health Movement, speak
ing at a seminar on 'rational drug policies for
the third world', organised by the Council of
Scientific and Industrial Research here, said he
was surprised to find that India had no effective
law which prevented sale of harmful drugs
manufactured by multinational companies.
He had bought a bottle .of tetracyclin
syrup (banned in the West and in Bangladesh
now) without prescription at a chemists s shop
in the capital on Friday. The literature did not
specify it was dangerous for children under 12.
Another surprising thing he noticed was
when he addressed a meeting at the Indian
Medical Association auditorium on Friday. At
.the foyer of the building was displayed the pro
paganda by multinational companies some of
whose products should be on the banned lists
prepared by institutions like the IMA.
Dr. Choudhury said the rationalisation of
Bangladesh’s drug policy last year was an at
tempt at eliminating from the market all useless
drugs and those of doubtful efficacy and
preparing a list of 150 drugs considered ade
quate for therapeutic purposes.
He said 1.707 drug formulations were con
sidered harmful or useless and pharmacies
were given three months to dispose of their
stocks. But because of pressure from U.S.
based multinationals, ban orders on 60 formula
tions. mainly pertaining to ointments and balms,
were rescinded. The formulations, the manufac
ture and sale of which were banned included II-,
Quid vitamin mixtures, multiple combinations of
potent drugs, alkali mixtures, gripe waters,
cough mixtures, tonics, digestive enzyme
preparations and habit forming drugs.
All health workers and village doctors in
Bangladesh were supplied with 12 basic drugs,.
8
including two antibiotics, which they could pre
scribe simple illness. In addition, 45 essential
drugs had been identified for supply to primary
health centres. These drugs would be manufac
tured and sold under their generic and not
trade names.
Drugs for rural dfcoaeG*; Voluntary health
workers, who participated in the seminar, em
phasised the need for manufacturing drugs to
combat diseases most prevalent In rural India
like diarrhoea, measles, tuberculosis and
whooping cough.
According to a participant voluntary
health groups provided about 30 per cent of
the primary health care service available in'the
countryside. It was suggested that if Govern
ment agencies actively joined such voluntary
groups, monitoring of drug control laws, train
ing of village-based, para-medical sthff and
strengthening of community health services
could be achieved.
Banned drugs stiM in use: Dr. Choudhury.
who runs the people's health centre (Gonosasthya Kendra) in Dhaka, told PTI that certain
harmful drugs banned in Nepal, Bangladesh.
Sri Lanka, Pakistan and Malaysia were still be
ing administered to patients in India. He re
gretted that India, emerging as a leader in third
world, was still permitting use of analgin
(amidopyrine).
Drugs banned in Bangladesh were still be
ing marketed in India by multinationals. These
found their way to Bangladesh, he alleged and
suggested cooperation between the two
countries in totally eliminating these harmful
drugs.
Detailing advantages of abolition of brand
names, Dr. Choudhury said introduction of
t
—i __
generic names would avoid confusion'and
re
duce profit-making by various pharmaceutical
firms. In ,the U.S. and the'UK.,.generic names
had been intoodufied^
",
‘
__________________ T
a stay order against publication
of the names of the brands in
volved and the drug houses pro
ducing them.
o
"AS BETWEEN THE LIVES OF
THE CITIZENS OF THIS COUNTRY
ON THE ONE HAND AND LOSS
THAT MAY RESULT TO THE MANU
FACTURERS AND TRADERS BY THE
IMMEDIATE BAN ON THE MANUFAC
TURE AND SALES ON THE OTHER,
THE GOVERNMENT HAD CHOSEN TO
VIEW THE LATTER AS OF MORE
(COroERNM.
It is the duty of
the state to protect its
citizens from injury and harm
especially when the injury is
not inevitable.
- Acting Chief Justice
P. Subramanian Potti and
Justice Paripuran,
Kerala High Court, in their
directive to the Union
of India to release the list
of brand names of banned drugs.
In view of this it is imperative
that a demand for this list to
be made public by the state and
central drug control authorities
is raised at every forum. Our
attempt to compile this list on
an urgent basis continues and
help from other Drug Action
Network members is sought.
B ST MATES COMMITTEE ON SUBSTANDARD
DRUGS
The 64th report of the Estimates
Committee on the Ministry of
Health and Family Welfare tabled
in the last session of Parliament
has focussed on the unsatisfactory
condition of’Drug Testing and
Standards’. The existing com
placent attitude and laxity of
drug control authorities was a
major factor contributing to this
situation.
The recommendations of the Com
mittee include:
- a 100% centrally sponsored
scheme to create adequate facili
ties for drug testing, should be
drawn up and launched without
delay.
From 1977-78 to 1981-82 the per
centage of substandard drugs was
between 14.5 to 21.6%.
In 1981-82
18 5% of drug samples were found
to be substandard.
- multistage quality control
should be done.
- strict quality testing of
imported drugs too.
The Committee pointed out that no
information regarding percentage
of drugs produced in the country
subjected to testing by either
central or state drug control
authorities is available.
No
statistics related to the number
of cases in which licenses of drug
manufacturers were suspended or
cancelled is available.
- name of manufacturer and batch
number of drug found substandard
by the Drug Control Lab should
be published in the press to
caution the public.
If necessary
the law should be changed in this
regard.
The Health Secretary in his evid
ence had stated that 18% samples
found substandard did not indicate
that 18% of the drugs moving in
the market were all substandard.
He gave reasons for not consider
ing this percentage as unduly high.
There is no machinery to prevent
the entry of spurious and sub
standard imports into the market.
(In 1982-83>60 out of 2540 samples
were found substandard).
A number of licenses of a large
number of manufacturers were
renewed despite their having fail
ed to create testing facilities.
This according to the Committee
’displayed a complacent attitude...
9
’Complacency or laxity in the
maintenance of drug standards can
pose grave danger to the health
of the people*.
DILUTION OF FOREIGN EQUITY FERA COMPANIES - SOME IMPLICATIONS
The decision by most of the
foreign companies to voluntarily
dilute their shares to 40% may
not prove to be greatly beneficial
to the consumers after all.
Had the ’attractive proposition’
of being treated as an Indian
company with freedom to diversify
into trading and other commercial
activities not been there they
would have continued fighting
tooth and nail as in the past.
The sudden decision by Burroughs
Wellcome, a 100% foreign company
which has resisted dilution all
along, to bring down its foreign
share holdings to 40% is there
fore extremely surprising.
Ciba*Geigy's Indian business
-------------------------------- ;------------------------- - ---- —---------------Hindustan Ciba-Geigy has reduced its foreign equity from
65% tch51% with an oversubscribed offering of shares to
Indian investors. The company plans to reduce its foreign
equity to 40% next year in order to become an Indian
company under the Foreign Exchange Regulations Act
(FERA). With this in mind, Hindustan Ciba-Geigy changed
its name from Ciba-Geigy of India on January 1st, 1983.
The company's sales during the past five years (1978-82)
have increased by 60%, from Rs 548.9 million in 1978 to Rs
875.9 million ($86.8 million) in 1982. The first multinational
company to set up a 100% export unit in the Kandla Free
Trade Zone at Gujarat, in 1980, Hindustan Ciba-Geigy's
exports were Rs 121 million in 1982 against Rs 59 million in
1980. R&D expenditure is currently around Rs 30 million
annually, and Rs 180 million will be spent on improvements
at the production centres at Goa, Bombav and Kandla, and
on new projects, in 1983 and 1984.
Of the 13 companies with foreign
equity above 40%, those which have
indicated their decision to volun
tarily bring down the foreign share
holdings to 40% are Hoechst, Parke
Davis (India) Ltd, Warner Hindustan
Ltd, May and Baker (India) Ltd,
Hindustan Ciba Geigy Ltd and
Organon Ltd.
The implications of the drug com
panies having 40% foreign equity
being treated as Indian companies
would be far reaching. Restric
tions placed by the Drug Policy of
1978, that would be removed include:
- obtaining of industrial licence
only for high technology bulk drugs
from basic stage.
- eligibility for registration with
DGTD for manufacture of new pro
ducts only.
- adherence to bulk drug formulation
ratio of 1:5 (instead of 1:10
allowed to Indian companies).
- sales of 50% of the bulk drugs pro
duced to unrelated small sector
companies.
The Indian Drug Manufacturers'
Association (IDMA) strongly feels
that companies with 40% foreign
equity cannot be treated as 100%
Indian companies.
IDMA has sug
gested creation of another category
of companies with more than 25%
foreign equity. The four cate
gories of companies would then be public sector, wholly Indian com
panies, more than 25% foreign
equity companies and FERA companies.-
The company's performance during the past five years is
summarised in the following table:
{rupees millions)
1X2
19811
1978
1980}
1979
637.2
875.9
610.9
BA8.9
715.0
Sales.
34.2
86.9
32.5
73.3
61.3
Pre-tax profits*
49.3
32.2
31.0
36.8
Net profits
280.4
317.1
380.0
230.7
Gross fixed assets 195.0
12
12
102
12
Dividend/share(%)
12
action at the Bombay factory was affected by industrialaction;
'.reased capital after a bonus issue.
IDMA is strongly against DGTD re
gistration for 40% foreign drug
companies and permission to con
tinue with international brand
names,, as this would negate the
efforts put in by the wholly
Indian companies in introducing
newer drugs such as ampicillin,
ethambutal, mebendazole.
Since the New Drug Policy is in
the offing it is crucial for those
involved in Drug Action to make
SCRIP No. 827 Sopwflbor ffti 1^83
10
biotics and has reduced the
leader prices of rifampicin
formulations, a widely used
anti-TB drug. The prices of
ampicillin trihydrate have been
raised from Rs. 1475/Kg to
Rs. 1677/Kg and that of amoxycillin
from Rs. 1910/Kg to Rs. 2229.
Rifampicin formulation prices
have been brought down by 22% on’
an average.
their contribution and interven
tion now.
|
With the decontrol of Category III
drugs from Price Control, 75% of
the drugs in the market will be
decontrolled. With FERA companies
being allowed to produce propor
tionately more formulations than
before( i.e. 1:10 instead of 1:5 )
we can guess that these formula tions will be those which are
most profitable to the drug comp
anies and will consist more of
inessential and irrational comb
inations. The poor performance
of the FERA companies ( and some
of the Indian companies) with
regard to low priority in prod
uction given to essential and life
saving drugs is well known.
• The Union Ministry of Chemicals
has slashed the prices of various
antacids, analgesics and a number
of other drugs falling under
category III
These were ear
lier allowed a mark-up of 100%.
It has evolved the concept of
"non-standard” drugs to reduce
the mark-up under category III
from 100% to 60%.
If there is no legislation ensur
ing production and supply of ess
ential life saving drugs of good
quality,the market will be flooded
with inessential drugs, with drug
companies producing more of shampoos
and cosmetics and the consumers
paying through their noses for
so called R&D in these areas.
The Shore Committee in 1945 had
recommended an increase in the
number of medical colleges
together with a parallel decen
tralisation of health care. While
the first part of the recommend
ation was unhesitatingly imple
mented ( we now have 106 medical
colleges ) the
efforts made in
the direction of decentralisation,
resulted in no significant change
in the health care delivery
system. A similar lopsided imple
mentation of the Hathi Committee
recommendation to gradually decrease
foreign equity to 40 and then
26%, without ensuring production
and supply of essential life sav
ing drugs to the people will be
a big farce and a meaningless
exercise where consumers are
concerned:.,
P&ICI1S
• The government has raised the
price of bulk ampicillin and
amoxycillin, two popular anti11
• The Bombay High Court has grant
ed an ad interim stay of the
operation of the Union Government’s
order revising the prices of multi
vitamin preparations of Pfizer Ltd4
During the year ended Nov. 1982,
Pfizers’ sales turnover was Rs. 54
crores and its profit before tax
Rs. 6.19 crores (about 11%). The
popular multi-vitamin preparations
account for about a fourth of the
sales turnover of Pfizers.
• In a similar order, the Bombay
High Court set aside the Union
Government's order fixing the
prices of multi-vitamin products
of Abbot Laboratories. The com
pany has been asked to file de
tailed cost data and the Government
would have to disclose its reasons
and submit material to the company
which form the basis for its
decision.
• The Ministry of Chemicals and
Fertilizers has raised steeply the
prices of bulk drug Vitamin C
with immediate effect. The Govern
ment had refixed the prices of
Vitamin C only in August ’85, after
a protracted battle with the
Sarabhais to reduce the price.
This sudden upward revision has come
scarcely a month after the lower
prices were accepted by Sarabhais.
DRUG UTILISATION SURVEY REPORT
- amongst self administered drugs
analgesics, nutritional products
and antibiotics topped the list.
This survey was conducted by the
National Institute of Nutrition
(NIN) in cooperation with the
Directorate of Drug Control Ad
ministration and A.P. Chemists
and Druggists Association,
Hyderabad in the twin cities of
Hyderabad and Secunderabad cover
ing 10% of the 330 retail pharma
ceutical shops.
Analgesics, Antipyretics and Anti
inflammatory drugs:
- 30.2% of the self prescribed
analgesics, antipyretics and antiinflammatory agents were scheduled
drugs. These were mainly analgin,
phenylbutazone (with or without
corticosteroids?and ibuprofen.
Some of the findings of the
survey are as follows:
- an earlier survey by the CERC
(Consumer Education and Research
Centre, Ahmedabad) had shown that
of 13 over-the-counter brands of
these drugs, 11 did not provide
any information. The 44 doctors
interviewed reported seeing on
an average 8 to 10 cases of drug
poisoning per month.
- self medication rate was an
alarming 46%.
- 27% of the doctors’ prescrip
tions were for 3 to 4 drugs.
Only 4.3% of prescriptions were
for more than 4 drugs.
- the maximum number of prescrip
tions were for Nutritional Pro
ducts (tonics, enzymatic prepara
tions and vitamins), then antiinfectives (antibiotics and sulfas)
and tnen analgesics.y
- 58% of the self medicated drugs
were schedule *L’ and *H’ drugs
which cannot be sold without
prescription,nor should be con
sumed without medical supervision
because of the associated major
side effects and toxicity.
Vitamins and Tonics:
- only 31% persons surveyed had a
correct concept regarding nutri
tional supplements. The majority
held the erroneous view that daily
consumption of tonics was essential
for health.The credit for this
false belief goes to advertising
pressure as well as doctors’
prescription practices.
- 16% of the doctors had prescribed
simultaneously more than one vitamin
preparation having the same ingred
ients in various dosage forms.
- iron deficiency anaemia, B2
deficiency, were the commonest
deficiencies in the population but
sales of B-Complex(B1,B2,B6,B12)
combinations and other vitamins
topped the list of sales figures.
CHEMICAUS ‘
.EXPLOSIVES
Antibiotics:
- over 30% of the doctors’ pres
criptions contained antibiotics.
J
- approximately 12.8% of self
prescribed drugs were antibiotics.
-CuMu£©70/z.N5
THE COMPANY WONT ACCEPF THIS HEPOHT
ON UNSAFE WORKING CONDITIONS.
ITS NOT TYPED DOUBLE SPACED!
- most antibiotic prescriptions
were for sulfa and trimethoprim
(from1Science for the People*)
12
combinations, tetracyclines and
penicillin, in that order.
drugs.
Last year we had demanded that the
following caution be printed on
all anti-diarrhoeal packaging:
- tetracycline,sulfa-trimethoprim
and penicillin were the most pop
ular self-prescribed drugs.
"Anti-diarrhoeals alone are not
enough - the main treatment for
diarrhoea is Oral Re-hydration
Therapy”
- 30% of the antibiotics purchas
ed for self medication were for
less than a day. Only 18% were
purchased for a full course of
five days. Only 40% of prescrip
tions for antibiotics were bought
for five days.
together with a pictorial repre
sentation showing how to make
the ORT.
For hydroxyquinolires
(Mexaform, etc) we had demanded
the following caution if not
a complete ban on these drugs.
’’These drugs are known to cause
blindness, paralysis of the legs,
burning and pain in the limbs and
loss of bladder control”.
We had
demanded that these be given in
regional languages.
The findings of the NIN and CERC
surveys indicate the urgent need
for public education where disease
and drugs are concerned.
Emerging drug resistance to anti
biotics, wastage of scarce resour
ces and potential for iatrogenic
problems are the price that will
have to be paid for irresponsible
advertising, prescribing and con
sumption of drugs.
With financial
constraints, unavailability of
affordable diagnostic and medical
facilities and ignorance of the
people, irresponsible self pres
cription will continue to be a
reality.
In the absence of the basic re
quirements for survival and health,
namely adequate food, water and
sanitation, decreased resistance
and increased susceptability to
infection and disease will force
even the poorest to unrealistically
depend upon the ’pill for every
ill’. Under these circumstances
eit is crucial to realize^ that
safety'and’scientificity of a drug
cannot be assessed in its utiliza
tion in the ivory tower alone or
by experts and specialists.
It
has to be assessed in its true
social context.
In this context, drug information,
specially the hazards, should be
indicated, to safeguard the in
terests of the public. ‘Consumer
Caution*on the packaging is not
merely essential for over-thecounter drugs but is also imper
ative for antibiotics and other
13
The Central Government’s agreement
to consider making obligatory
information regarding dosage,
storage and warnings related to
atleast the over-the-counter drugs
by pharmaceutical firms will make
sense only on its implementation.
Similarly we fully endorse the
Government’s attempt at standard
ising the contents and prices of
vitamin preparations.
After all
15% of total drug production cost
in India is accounted for by sales
of vitamins and tonics.
The findings of the NIN and CERC
surveys underline the urgency of
providing unbiased drug information^
to tilt the balance in favour of
the consumer in the conflict bet
ween his well-being and safety and
the profit interests of the industry.
DRUG- UTILIZATION IS DEFINED
AS THE MARKETING, DISTRIBU
TION, PRESCRIPTION AW USE
OF DRUGS IN A SOCIETY WITH
SPECIAL EMPHASIS ON THE
RESULTING MEDICAL, SOCIAL
AND ECONOMIC CONSEQUENCES.
WHO
coming events
Campaign on Drugs Issues: A
co-ordinated one week nation-wide
campaign has been planned for the
first week of April to focus pub
lic attention on various issues.
Some of the suggestions from net
work members are:
- campaign in the media as was
done during the EP Forte campaign.
- a nation-wide signature campaign,
signatures to be obtained on a
short one or two paragraph state
ment which can be easily under
stood by citizens. Bach organisa
tion would obtain signatures under
its own banner, but for a common
statement, the presentation to the
authorities being coordinated dur
ing the campaign week. One set of
signatures would be sent to Par
liament and one set in the region
al language to the respective state
legislatures.
— the memorandum which, was cir
culated in Delhi Dr-. Zafrullah
Chowdhury’s visit to be sent to
other activists’, consumers’,
citizens’, civil liberties’ groups
and associations for their sig
natures and then presented in the
campaign week, as above.
IN THE BEGINNING-. .
r
- other suggestions included film
shows, cultural action programmes
(like those of KSSP), exhibitions,
posters, depending on the resources 1
of each group.
* Workshop on Producing Low Cost
Health Education Materials through
Screen Printing Process. Co-spon
sored by the Voluntary Health
Association of India and the
British Council, this workshop
will be held at the College of
Home Science, Haryana Agricultural
University, Hissar from Feb 14 to
21, 1984. The workshop will be
conducted by Bob Linney and Ken
Meharg of XJ Posters, London.
Accommodation has been arranged
at the University Faculty House.
For other details please contact
the Voluntary Health Association
of India.(Mr Padam Khanna)
IN THE NEAR. FUTURE-..
ru o
0
• J 7
\
I
from
Social Action
News
u
reading
PUHE JOURNAL OF CONTI HUI EG
' H E A LT H
UC AT I ON, An educational
publication presenting scientific
information and opinion on con
troversial health and drugs
issues for health personnel.
Subscription Rs 10 from:
Arogya Dakshata Mandal,
1913 Sadashiv Peth,Pune 411030.
MEDICO FRIENDS OIRCLB BULLETIN.
Deals with some of the burning
issues related to health care and
its delivery systems and services.
Very relevant for all personnel
involved in health work or con
cerned about health issues.
Subscription Rs 15 from:
Dr Anant Phadke, Convenor,
Medico Friends Circle,
50 LIC Qtrs,University Road,
Pune 411 015.
COMMUNITY HEALTH NEEDS AND INDIA'S
DRUG INDUSTRY.
A brief six page
note prepared by Dr. Debabar
Banerjee, Professor, Centre for
Social Medicine and Community
Health, JNU, New Delhi 110067.
INTERNATIONAL CODES AND YOUThis is a reprint published by the
Voluntary Health Association of
India containing the IFPMA code,
a critique of the IFPMA code by
HAI and the HAI Draft Internation
al Code for Pharmaceuticals.
ANABOLIC STEROIDS.
A report by
the IOCU analysing the dangers of
anabolic steroids, the medical
literature, the marketing prac
tices, etc. For those interested,
copies can be obtained by us from
IOCU.
DRUGS BULLETIN. An informative
monthly giving unbiased technical
information on drugs and thera
peutics. Recommended for health
personnel. The latest issue deals
with 'Drugs for Primary Health
Care*. Annual Subscription Rs 10
from ; Dr V S Mathur, Editor,
Drugs Bulletin, Post Graduate
Institute, Chandigarh.
PRESCRIPTIONS FOR CHANGE, Health
Action International's Guide to
Rational Health Projects by
Virginia Beardshaw, Published by
HAI and IOCU (see detailed des
cription on Pg.16). The original
price is Rs. 68.
A request for a
30% discount for the Drug Action
Network has been very kindly
granted.
HAI NEWS, Bimonthly service of
HAI Clearing House from the
Regional Office for Asia and the
Pacific of IOCU. Subscription
S 10 from IOCU, P.O.Box 1045
Penang, Malaysia.
HEALTH FOR THE MILLIONS - SPECIAL
ISSUE On DIARRHOEA is now available
with VHA~ tfhe articles emphasise
the role of ORT and nutrition in
diarrhoea and include detailed
schemes for the correct management
of diarrhoeal diseases.
THE MEDICAL LETTER on Drugs and
Therapeutics is published from 56
Harrison Street, New Rochelle, New
York 10801. This monthly public
ation, edited by Mark Abramowicz
M.D., is aimed at medical and
health personnel. Founded in 1959
by Arthur Kallet and Herold Aaron
it provides updated Information on
a number of drugs issues.
BETTER DIARRHOEA CARB. Part of
the Better Care series being pub
lished by the Voluntary Health
Association of India, this book
let which was earlier printed in
English is now available in
Marathi and Gujarathi. For orders
please contact VHAI.
t5
TIRED
of wasting money on inessential drugs?
CONTUSED
by irrational prescribing ?
WORRIED
about unethical drug promotion?
For fast, effective relief you need:
Active ingredients:
• More than 40 ideas for action research projects on drugs
• A summary of the main elements of the rational health
issue and suggestions about how to campaign on-it
• Advice on how to talk to drug companies and the
powers-that-be
•A reference section that lists the main materials you
need to research on drugs
Preacription for Change is published by the International Organization of Consumers
Union (IOCU) as a part of its work within Health Action International (HAI). Further
m.ormation available from IOCU Regional office, P.O. Box 1045, Penang, Malaysia.
I
14
5
L p;,'/
I
/
E.N. MURTHY
Deputy Secretary
Tele: 386752
D.O.No.7(77)/84-DII
Government of India
Ministry of Chemicals & Fertilizers
Office of the Development Comm.(Drugs)
Shastri Bhavan
New Delhi-110 001
the 26th Nov.,1984
Dear Shri "K.
Please find enclosed <?. general note concerning
review of drug policy and and consideration of the same by
a group of which you are a member. The note might be of
use to you during the deliberations on 29th Nov.,1934.
With regards,
Yours sincerely
(E.N.MURTHY)
To
1
NEW DRUG P0LICY l I55UE._PAPER
off good quality at
Plentiful availability of medicines
functioning
for the effective
reasonable prices is essential
11 is widely acknowledged that
health
infrastructure.
of the
diversified and
industry is the most
the Indian pharmaceutical
c ount rie s• The country
ertically integrated of all developing
finished
in formulations (the
self-sufficiency
.has acquired near
tablets,
are administered egdosage forms in which medicines
drugs (i.e . the active
and a large number of bulk
capsules etc • )
ing redient s of formulations) •
Ztc
The trade balance in drugs is
increasing exports and decreasing
also improving as a result of
While
in total bulk drug c onsump ti on.
p rop orticn of the imports
aceutical industry are impressive,
the achievements of the phar’
if the health needs of the entire
it has miles and miles to go
to be adequately
and if the export potential
p op u 1 a t i on a re
Accelerated growth of the pharmaceutical
is^/be fully realised,
in view of the
industry acquires a greater sense of urgency,
parliament in 1983. If
National Health policy, approved by the
frame should be c endue ive
be
met
the
policy
a
re
to
the s e ob j ec t iv es
to :
•• j health needs in
(a) Growth of output•; commensurate with
export potential,
the tcountry and the ( ,
technological progressiveness;
(b ) C ost competitiveness and
fair to the consumers as well as
(c ) P ric es wh ich are
p roduc ers.
therefore is how far the
The basic question that arises
2.
aforementioned ob j ec t iv es.
present policy f ra me is conducive to the
C ont d
2/-
2
»
In the pharmaceutical
sector,
the policy frame includes in
FERA and MRTP and import
addition to th e general licensing,
policies,
the specific
provisions of the Drug Policy statement
floor of the Lok
which
was laid
1970.
The 1978 Drug Policy,
on the
Sabha
inter-alia.
on 29th March,
contains a number of
provisions for;
(a)
the growth of the Indian pharmaceutical industry,
with particular preference to containing the
channelising the activity of foreign companiss in
accord with national objectives and priorities;
a nd
(b ) to make drug s available at prices fair to the
consumer ar well as to the industry.
3.
frame for the future grewth
In prescribing the policy
of the pharmaceutical industry,
is
it
only appropriate to •
address the following questions;
. 4.
(a)
Is the
existing policy frame adequate?
(b)
If so,
is
(c )
If not, what are the areas where reform is needed,
in what direction and in what manner?
The basic
there need
for improvement
approach underlying report of the National
Drugs a nd Pharmaceutical Development Council
special attention neec!
’priority drugs’
practice and
are
be
is that
- drugs which are widely used in medical
requi ed for National Programmes for major
report gives the list
re-oriented to ensure
abundant
(NDPDC)
to be paid by the Government to the
diseases like TB, Leprosy, Malaria
NDPDC
g
of implementation?
quantities at
may like to comment
on
etc.
Appendix VI
of priority drugs.
that the
drugs are
fair prices a nd w ith
the approach
of the
Policies should
available
in
good quality. Experts
and its spec ifics„
Contd..., 3/-
\
3
Among
5.
very
engaged a
which
of
operation
attention
high
policy
and
procedure.
The
the
is
summary
of
the
industry,
as
a
a
is
one
the
the NDi’DC,
from
Annexure-I
price controls.
pricing
existing
the Drug Policy,
areas of
various
the
whole, is of the view that:
the procedures for price f ix a t i on/re v isi on
cumbersome and arbitrary;
(a)
(b) the costs allowed ii. fixation
actual
to the
(c )
the
production
is
pattern,
essential Category
the
Then
pricing
which
the
not
related
of price arc
costs,
further made that
point
up •
slow 9
the mark-ups are low
and' the faulty administered
pricing system has eroded the profitability of the
industry and sapped all incentives for investment
in further capacities and R&D .
The
ma rk
are
there is
system is
is
industry
system is
pricing
fermjlatiuns,
the criticism
not properly
implemented
to get sway
able
the
with
the m o re
carry
which
from
distorting
from
away
shifting production
and II
I
the
a
Icwcr
end ,
that
result
of
other
as
a
profit s
unintended
d ue to:
(a ) faulty categorisation of products;
(b) failure to promptly revise the administered price
where the landed c cs ts of inputs or
prices of bulk drugs: decline; and
(c )
6.
the
of
present pricing
the
produ ct by
and their
own
to mop up
the
oneself
system
to the
one can not
given
ba
due to the
the
various
sure whether
the
of
inherent dificiencies
It will be
policy and
has an
characteristics
performance
necessary
procedural alternatives.
Total price decontrol
structural
market
far the lacunae
product price regulation.
implications.
but
are
the
unintended profits.
as to how
is for consideration
It
to address
its
failure
of
of
appeal
the
industry
of un-rogulated
C ont d
of
4/~
a
markets are socially optimal.
Given this value judgement the
question is how to devise a sclective price control system
that is simple, easy to administer and socially optimal in tha r
it strikes a fair balance bwtween the consumer and thu
7.
The matters of det lil which
ind ust ry.
emerge from the NDPDC repcart
a nd need consideration arc:
(i)
Should price control be limited only to those bulk
drugs which figure in the priority list?
(ii) Even, amongst the drugs in the priority list should
there be price control, of bulk drugs '.which are
produced by'a large number of producers and where
there is intense price competition?
(iii) What should be t he ma rk up.f or f or mulati ons of th e
bulk drugs included in the priority list?
(iv) How to improve the pricing procedure so that the
administered price responds quickly and smoothly
to changes in oxosts?
(v) Can there be a system of normative costing and if so,
what are its specifics?
G.
Another area which merits attention is that of industrial
approvals.
Ann exure-11
is
a
policy in the pharmaceutical
summary of the
sector.
existing licensing
The matter of details which
emerge from the NDPDC report end which require consideration arc;
(i) How to ensure 2 0% of the value of production
manufacturer c emprises the priority drugs?
of every
(ii) Should there be free licensing of the priority drugs?
(iii) I s the present sectoral reservation consistent with
the stipulation that the production of every
manufacturer should include priority drugs?
(iv) Should there be any modification in the present
policies in regard to ex-FERA companies?
(v) What are the changes required in lieensing/tariff/
import policies to ensure that production is cost
competitive and the domestic resource cost of
production is not unduly high in relation to the
exchange rate
C ont d.. ..5/-
5
9.
Another important area is that of
quality.
Administration
of the statutory provisions relating to quality control,
under
the Drugs and Cosmetics Act is vested with the State Government.
it
While the State Drug Organisation need to be strengthened,
is also for consideration whether it is possible to devise a
system of self—regulation and promotion of good manufacturing
practices by the indu st ry.
This raises the related issue of
organisation; whether the planning,
regulation and development
of the drug industry calls for institutional changes such
as
setting up of a National Drug Authority with which the industry
is fully associated.
A nncxur9
I
PHICING POLICY A D PROCEDURES
The prices of over 75% of the bulk drugs and
formula
tions are controlled undor tho Drugs (Prices Control)
Order,
19?9
(OPCO) which was issued under
Act.
Tho OPCO lists 347 bulk drugs which aro statutorily
price controlled.
Drugs
Of the 347 bulk drugs,
the Essential Commodities
not listed are
drugs
not price controlled.
albout 225 are
listed,
domestically produced. The DPCO also lists tho therapeutic
groups cf
formulations which arc subject to price control.
As tho classiciation is by therapeutic
possible that
though
Groups,
it is
•^v •? n
formulations are subject to price control,
tho bulk drugs which go into their manufacture are
not
price co nt rolled.
Tho prices of bulk drugs are
fixed on the basis of the
study of tho costs of manufacture by tho BICP.
The prices
recommended by tho BICP take into account tho installed
capacity,
achieved capacity, optimum
raw materials,
norms of consumption of
utilities an! coversion costs.
In determining
the prices for individual manufacturers return on netuorth
(□ juity capital plus
category I
free rosorvos)
and II bulk druns the return is 14% and that
bulk drugs going into category
post
is also built in.
III
formulations it
For
for
is 12%
tax on notworth.
for the purpose of price control, formulations arc
divided into four categories *
(a)
Category I formulations which carry a mark up of 40/?;
(b)
(c)
Category II which carry a mark up of 55/6;
Category III formulations which carry markup upto 100% 4
(d)
Category IV formulations which are outside nrico control*
Mark up includes distribution cost, promotional expenses,
trade commissions
II
and tho manufacturers margin. Category I a nJ
formulations cterry a lower mark up because they are
essential
formulations used in large tolumas.
A nnox u.r.o._LL
I hgUSTR_IA,L A_PPil2v.h.L
iniustrial aporofil
Control to ths existing schamJ of th3
policy in th - drug sector is •
the classicieticn of dug undertakings into five
(a)
c a 13 g or i o s s
i)
small seals enterprises;
ii)
Indian non-pqRTP companies;
iii)
iv)
v)
(b)
India n FIRTP cempa nies
...
public sector companies;
companies (!.□• companies coming within the
for sig n
purview of FERA)
f those catooorias io
if f ar o ntial troatma nt of each c nd pr ocaduros.
regard to the policy pa r a m 21 a r s c
Th'3 ^rug Policy c
i)
ii)
iii)
lassi fi -s bulk iru
those open to lie ansi ng
o nly
those open to licensing for
3
into thr-ao ceto
r igs :
for th 2 p ublic sector;
the Indian sector
(i.e.
FERA companies) and
all undertakings other than
sectors including
those open tn licensing for all
FtRA companies
In addition, under the g«
neral inlusti.al licensing policy, □
reserved for the small scale sector.
numb er of bulk drugs are
an to licensing for all sectors,
Cv□ n in regard to bulk drugs op
additional stipulations that
subject
to
the
FZHA companios are
hinh tochnolony and
nufacturing process must involve
the ma
Tho drug policy also
n must be from the basic stage.
Indian non-^TP companies
productio
•joun that other thims bsim equal, Iman non
The -drug
Lay s
NRTP comnanios and lastly thu FERA compare.
Indian
d0un a r^mber of parameters (a.g. supply t o
policy also lays
formulations, ratio parameters) which va.y fr cm
no n-assneiatod
These dotaila are -ivor in tne
category to category,
■exhibit enclosed.
Approval precoduros 31sd vary from oatooory to category.
sc^le enterprises are
not required to secure -;ith-?r DGTD
registration of an industrial lioonco.
It is sufficient if
th«y got themselves registered with the State Director of
ndustries concerned.
Ncn-FERA 3 nd
non-MRTP comoanies are
/. lgiblQ fOr ^Sistration eith the DGTD instead of qoir,g through
e more elaborate procedure for industrial licensing provided
investment in plant and
a nd machinery doos not exceed fe. 5 crores and
he requiremerts of foreign
foreign exchange
for rau materials and
exchange for
not exceed
the certain
certain limites.
exceed the
limites.
required to secure an industrial licence.
contents does
Othersare
CXH19 IT
□1.
No.
Paramster
--------- Pu'bli“j~ctSF------ TnKaA Co’/CKbn-'FTiT.T, '
Thn-fiRTP Co. other
•
than Public Sector)
'rn'ia'nTrfTT'
Company
’ Foriig'n (FEFTh;' CoTnpany'""’
(5 )‘ .
1.
2.
Sectoral
H-jservatic n
Bulk drug
me nufactors
3j Ra^io
h > r am ators
Can manufacture
all drugs
Can manufacture all
drugs othsr than
those reserved for
the public sector
subject to securing
industrial approval.
No. Spl. para
meters under the
new drug pulley.
:
:
No s-scial parameters
under tho n-j Drue
folicy.
1:10
10
Ct.n manufacture all
drugs other than thosa reserved for the
public sector subject
to securing indust
rial approval.
1
: 1C
exfactory value of
production of bulk
drugs to ox-factory
value of formulations.
O n ma nu factors only
drugs open to licenses
for all sectors inclu
ding foreign companies.
Only high technology
bulk drugs and drug
intermediates from the
basic stage.
-<•
: 5
No foreign company will be
given licence for formula
tion not conr.ectad with
manufacture of bulk drug of
high technology of their own.
b)
additional stipu
lation for foreign
com pa nio s
c)
ratio between value
1 • 2
of importod/canalisod bulk
drugs and value of indigenous
bulk drugs in the total
formulation activity.-
4.
Supply to no n-associn
to d formulators.
5,
Loan licensing
40%
1
: 2
30%
Nd restriction
1
: 2
5 0%
1
: 2
50%
Not eligible for
loan licensing.
fresh
i
1-9/330(c)
LOL;a.24.9.84
Sub: Banned Brand Drug List.
Dear Friends,
COMMUIMSTY HEALTH CELL
47/1#(First i‘i<jor)Ox. iviarksHcsd
- 520 Oul
The banned brand drug list is being sent to you. The list is
divided into 5 classes.
Class I: Drugs banned under gazette Notification of 23rd July 1983Class II: Drugs that should have got banned under the same notifi
cation but were not because of the existing ambiguity of
wording . eg. See Category 4 which is strychnine Yohimbine,
-<•
.
testesterone
and tonics. Any drug containing yohimbine arP
'.SO
—‘strychnine or test esterone in tonics is just as irrational
as a drug containing all the 4(obviously the number of drugs
affected this way are much less.
Class IU : Drugs recommended for withdrawal by the Drug Consultative
Committee(Original list attatched -Appendix A)
Class IV: Drugs that were banned independently ie. drugs which hhd
no relation with Drug Consultative Committee recommendatior..
Class V: Problem drugs that should be severely restricted if not
banned, eg. Anabolic steroids for children,Phenyland
oxyphen butazones.
Class VI: Irrational combination of tonics,cough syrups etc.
To be compiled by friends in the Drug Action network.
The sequence used is that given in the Gazette Notification.
The three, obliques x/x/x indicate DCC/DTAB/Gazette Notification to
facilitate cross checking. If there are any errors they are unint er-1%
You are requested to review the list, add/sub st ract/modify
according to most recent information. T here is notmachinary fur
sharing unbiased drug information crco^as health personnel and con
sumers would not have to spend time on this. If this list makes sonof the drug companies upset, we cannot help it, they had more than
$2 years to compile and disseminate a more accurate,more up-to-date,
more impressive banned brand drug list.
The list is as comprehensive as we can make it.
Note: - It is possible that some brands have been reformuJa ted,
eg. Some APCs may now contain Paracetamol instead of Phenacetin which
drug companies have actually done so and withdrawn their earlier APCs
containing phenacetin. We do not know you can of course'double chec
the contents on the container.
After the Kerala High Court Judgement 1982 a directve^Jiad^bee
given to State and Central health authorities to make the banned A
brand drug list available to the Public. It is end of September ’84.
This list is made in Public Interest.Use it in whatever ways you can,
share the information with others. Information and knowledge are
powerful tools for action.
YOU ARE REQUESTED TO BOYCOTT THESE PRODUCTS?AS THEY ARE DANGER
OUS AND’/OR IRRATIONAL. We have a right to safeguard our health and
that of our people.
Prepared specially for ^rug Action Networkers and VHAI members
with help from Dr Rane and Dr Anil Pilagaonkar of Arogya Dakshata
Mandal. Late Mr Agacy, Cynthia Brown have helped with the earlier
'Black Lists’. For the final version we owe our thanks to Alphonse.
In solidarity,
Dr Mira Shiva
Coordinator
Low Cost Drugs & Rational Therapeu
tics, VHaI.
*
/
ALL INDIA DRU$ ACTION NETWORK
C'“14 Community Centre •
S D A, New Delhi-16
August 22, 1985
PRESS
RELEASE
Mr Veerendra Patil, the Minister of Chemicals
and Fertilizers told the delegation of the All India
Drug Action Network which met him yesterday to submit a
memorandum about the coming of new drug policy and AIDAN’S
alternative Rational Drug Policy«. AIDAN’is a body coordin
ating the drug related work of different organizations
working in the field of health, science policy, consumer
and People’s Science Movement from different parts of the
country.
In its Rational Drug Policy Statement, AIDAN has
drawn attention to the fact thar unless unscientific, use
less drug combinations which constitute the majority of
drugs available in the market ar< withdravm, enough „ ■
resources would not be available for the production of
lifesaving- andother essential drugs. The delegation pointed
out that some of these irrational drugs are even harmful
and the Government is doing hardly anything about it* Out
of a number of bannable drugs. Government had banned 22
categories of drugs in an order on 23rd July, 1983* This
ban order is not properly implemented. The Minister replied
that this implementation is beyond the purview of his
Ministry. To the many of the demands related to the Rational
Drug Policy, his response was that these concerned the
Health Ministry. It thus appears that there is no proper
coordination between differenu ininistries and the existing
drug policy is only concerned with licensing and price
regulations.
In its memorandum, AIDAN has pointed out that the
very approach of the report of the Steering Committee of the
National Drug and Pharmaceutical Development Council (NDPDC)
is mistaken from the point of view of the needs of the
people. It is not based on the disease pattern in our
country but is- meant, to put in dts own words, “to decide
on the selectivity of price regulation”. Instead of
progressing beyond the Hathi Committee report, the Steering
Committee report is regressive in character. This is
because of the very method of the constitution of the NDPDC
(with no representative from the people), its terms of.
reference and method of functioning. The report contains
no reference whatsoever to the o question of essential drugs
as recommended by the WHO, no refernece to the question of
irrational, and hazardous drugs.
deals only with different
demands about profit - margins, pr e regulations coming
from different sections of the i idu try, and.hence is
irrelevant to the needs of the people, the Minister was told.
The list of essential drugs given in the appendix of this
report is grossly inadequate and meant only to reduce
“the basket of price - controlled drugs”.
»
XJ
C5
jsJ r?
CC
LU
O
o
s:
c«
■ e* °
o
• io
U o Hi
X
rC
o o
£2
O
s= t <
Lu ca
o
d;
U
—“D ,5Cfl
't cS
5
J
II
r■L
2
The Minister was unable to respond to all these questions
related to the selection of drugs and suggested that a
joint meeting with the Health Ministry is required to
sort out these issues„
AIDAN has; after indepth analysis and many intense
discussions formulated an outine of a Rational Drug Policy
which was submitted to this Ministry in November 1984.
The Rational Drug Policy Statement which sums up this out
line was submitted to the Minister today« Apart from the
central question of essential drugs and irrational drugs,
this statement emphasizes the need for proper, continuing
education of doctors, other medical personnel and consumers;
stoppage of misleading promotional literature of drug
companies; the necessity to adopt "The; International
Code for Ethical Marketing of Pharmaceuticals“ as.detailed
by the Health Action International; proper drug distribution
to the
poor and the needy, through Governmental channels;
abolition of taxes on priority drugs; plugging the specific
.loopholes identified by AIDAN in the import of technology
drug and in the licensing policy to ensure self reliance;
adoption of the 1975 Helisinki (Mark II) Declaration on
■ ehtical drug trial on human subjects .etc. It points out
t that all these measures cannot be planned unless the Government
' is keen on a Rational Drug Policy and not a drug pricing .policy
•/and unless profit making ceases to be the primary cr_uterion
for the: drug 'industry*
Correspondence, meeting
various officials and even
the Minister has failed to bring about any change in their
concomSn
has therefore decided, to take these issues
to the people and. also show by way of demonstration, how
things can be done. Member organizations or ...IDAN are publis—
hing lists of brands of banned and bannable hazardous drugsw
Two pilot studies to assess ’now many of drugs in different
categories (antidiarrhoeals, analgesics) areirrational have
been completed^ Prioritized essential drug list is being
final?zed and studies are being launched to calculate the
drug needs of certin essential drugs based on the ectual
incidence of diseases. A critical analysis of. the drug
industry-in India is already being circulated in regional
lanjaages and likewise, aspects., of alternative strategy would
also be circulated. Member organizations of AIDAN have
recently launched such-a mass movement and have, received
a good response from the people as well as many doctors*
° 0 ° o
/
° o ° o ° o
Q
DE/FT OF THE RATION/iL DHDG PQLIg
PI&AMBLS :
(WARfflA JOgRW)
DHJG PQLICT 33J THE PBRSPECTIVE OF HEALTH POLICY
The Committee for Raticnal Drug Policy would work toxvards a rational drug policy in
India and would appose the irrationalities in the production, marketing and use of
medicines in India# The CRDP believes that a rational drug policy can be really
meaningful only as a part of rational health policy and hened CROP would work cn the
drug issue within the framework of a broader perspective, of a rational health polio, ,
Majority of the Indians suffer from the diseases of poverty and ignorance i.e#
conmunicable diseases, diseases due to undemutrition, etc. These are preventable
and curable. Industralisation and urbanisation have also led to spread of conse
quential diseases* Lhat ue need then, is adequate nutrition, safe water, univenial
sanitation, environmental protection and a primary medical care service available
to all#
ROLE
UTILITY OF DHJCS IN ; ?DIC/I> CASE
Though proper provision of food, water, shelter, physical and cultural environment
are essential and much more important in inproving health of a people, a rational
drug policy would tremendously help as an adjustment part of this broader social
process.
To the people, doctors and non doctors alike, drugs appear as panacea for all ills.
Health is still regarded as an individual or personal responsibility and it is belie
ved that freedom from diseases could only be obtained ty better and better and more
and more drugs. Such a belief among educated and illiterate alike has led to a uni
versal craze for drugs and the DRUG CULTURE has to come to dominate the society#
On the other hand, another school conprised of obscurantist and progressives point
out the harmful consequences of the drug culture and prescribe a journey back to
nature. Vfe are told to reject this dependence on drugs and concentrate on attackinc
the socio-economic cause of illness.
It is not disputed that without being free from inequality and exploitation, a socle'
cannot achieve freedom from avoidable illness> On the other hand, cne cannot allcvz
people to suffer and die till that real freedom arrives. Hence, in our society, meoical care service has an iimediate, essential and priority role to play and the drugs
occupy a pivotal position in the medical care service# Besides, there arc preventive
drugs too# e.g# vaccines etc.
Criteria ox a rational drug policy should therefore be discussed in this perspective
and with the view that the drug policy should be consistent vrith the rational hoalAh
. o
policy#
Zj
O
OBJECTIVES OF THE RATIQ/'/UL DRUG POLICY
X « o
b; asi
< j
(a) To ensure availability of safe efficacious drugs to all the needy#
I?
(b) To eliminate harmful and irrational drugs#
H
(c) To insure production, distribution and use of all drugs on scientific basis > o 6
k:
£ 2
and in accordance with the need.
(d) National seld reliance on priority drugs.
b
(e) To ensure dissemination of relevant information to the medical profession
f-;-C
and consumers as well.
j
K i
pJilOXUTY (igSENTIAL DRUGS)
It hardly needs emphasis that we have to set up priorities for the production of
drugs accordin ’ to the prevailing disease attorn i.e. drugs to combat coniinunicable
and nutritional diseases should claim priority. The idea behind the term ’essentia'.,
drugs’ may be better served by using the words ’priority drugs’.
e
r
- 2 -
■bile there is paucity of* essential, and life saving drugs, the market is flooded
id.th irrational and even hamful drugs, /here is no effective measure to curb tire
profitcring of the dominatir£ ®?iS, neither there is much awareness ainongst the
medical profession an$i people regarding the unfair practices in tho drug industry.
•(Hef. Iljathi Ccmittee Report)
All the aspects of. existing drug policy need to be completely overhauled in order
to effect a Rational Drug Policy. Such a change ww.Ld invotvea^’Tongst other things,
nationalization, .of all the major drug companies al on . with asocial control over -die
nationalised sector. Rut such a step&annot be • expected in immediate .future because
of the low level of awareness a}.'>out t|ie necessity of a Rational Drug Policy anon st
medical personnel, politicians, government officials aid the common people; and
because of tho weakness of the people/s Novasent in general. Hence cnl^< the folio-r
ing interriediate measures are to be demanded from the governmait. These measures
do’not constitute a full-fledged Latibnal Drug Policy in India but are steos in
the right direction^, he demand from .the wbvernment the follaring:
•^Setting up of an independent machinery, to scrutinize all the drugs currently
marketed in India cn the following principles.
*The committee would be a permanent boefc7 and would review the drug policy
every year in the light of new information on older chugs and inve ition
of new drugs. No drug in India can be produced or marketed in India unless
approved by t’ni-s committee.
Such a cormnittde should be formed at the
state level.
.. • \
^Production aid inport of drugs to be carefully planned according to the
pattern and incidence of diseases in our country and accordin..; to the
requirements of economic, technological sell’-reliance. To pursue this
aim, it would be necessary,
^Importance fromthe;point of view of caanunity medicine, of diseases
ag.;aihst which.the drug is to bp used. For exam le, drugs to be used in,
diseases that cause larger mortality > severe .'morbidity, serious sequelae
(after effects) xvbuld get a priority. Drugs used in the National Pro/raimes
of-prevention and control ef diseases (tuberculosis, gdtre, etc.) to get
priority. Thus vaccines te get priority over multivit/^rdns, antibiotics.
"^Therapeutics rationality which included consideration of both efficacy and
safety (therapeutic index). Cn^" those drugs and. their combinations which
have been recommended by latest edition of stands rd textbooks or by >-HC
to be produced.
• y,:
*Cost and self-reliancc: then there is no qualitative difference between
therapeutic rattohaiity of r two. drugs, priority should be iven to the cliaapte:.
one and/or the one, which is closer to the requirements of national selfreliance.
.
Further the national drug foxyulary should be revised and compiled by an expert;
u Iti di sc in li nary c ora, lit tc e koe ing the follad.n . criteria in mind:
senti aU. ty
-^Safety.
^Cost
*'Sage q f ad:i inis tr at ion -'Availability
^•Potential for nlguge
Such evaluation o£ the drugs in tho market and revision of the lists should be uonc
periodically.
J
- 3 •
Recommendations of the Hathi Committee is to taper down the foreign equity to 26%. In
fact it should be brought down to 10% within a span of 3 years and no company having
any amount of foreign equity should be considered as ’Indian Company’. No company
should be given the status of Indian company unless the plant and mac binaries are
installed on turn key basis and no stipulation is put for import of raw materials,
from the parent company.
Transfer technology should be gul^r uha'er Ui;UO recommendation^. Only latest technc
logy can be imparted on the basis of global tender from all the developed countries.
Preference should be given to the countries whoever accept ■Rupee’ as transfer
currency and indegenous plant and machinery are accepted.
TNGs should not be allowed to manufacture household remedies, cosmetics, food
products and essential drugs (priority) produced in Indian sector. Suitable change
in the Drugs and Cosmetics Act and Rules so that small scale industries do not suffer.
It shall be the primary responsibility of the manufacturer to ensure the quality
of drug products. However, it shall be the statutory responsibility of the Drug
Control Authorities to monitor the standards and ensure a minimum uniform level of
government control. Consequently, the government shall take all necessary measures
to enable the Drug Control Authorities to function in an effective manner and dischar
the statutory duties cast upon them.
No import of mac binaries directly or without the guarantee from the end-users. No
import of machina des, if the similar machines are indegenously available. Import of
the machines for filling, sealing, labelling, caping, packing, etc. should be banned.
Open General Licence system is to be abolished.
There should be raw materials pool
in cash state for inform pricing of raw materials. A Bulletin is to be published
informing availability and prices of the raw materials every month. Prices of raw
materials should be uniform all over the country.
A standard has to be fixed for packing cf fixed dosage forms - unifomity in bottle
size, strips, shippers, etc. No fashionable packs like tonic bottles, bliser pack
etc. should be allowed.
All taxes of priority essential drugs should be abolished. Subsidy should be provided
for transport of essential drugs and raw materials.
’’Leader Price” system is to be changed and. maximum price of each drugs is to be
calculated on the basis of BIGP data. The basis of this calculation and all BICP data
about drugs and pharmaceuticals should become public document. Loan Licence system
is to be totally withdrawn.
Range of products and production capacity has to be det emined by the Committee and
it should be distributed to the manufacturers for essential drugs which should form
the minimum base line for capacity utilisation.
No COB licence or production over the licenced capacity should be allowed.
QUALITY COmOL
Adequate number of Drug testinglaboratories are to be established in different parts
of the country,. AU canplaints regarding harmful effects of drugs are to be
entertained. Analysis should be conducted on the basis of the double check study.
Regular sample survey throughout the nation should be done.
bpecial statute and judicial set-14) should be made to check production and sales
of harmful and substandard drugs . Compendstion should be extracted from the
convicted producers. Food and drug court should establish for expedibeous trial.
In arrangement with the leading institutions in four zones of thlb country trial
and study has to be made for each new drugs before its introduction.
~ 4Information re; arding banning: withdrawal of drugs from the market has to bo publidied in mass media and irailing to the retailers, and medical professions. Dr us
should be innediatelg- replaced to the buyers if any doubt is expressed even if a
part 01 the pack is used. Cosmetics, OiC drugs, household remedies cannot be sold
irom the shop where ph ariaace tti cals are sold in the cities and towns.
SALES PHSuCTIDH
Vhere should be a pcraanent iJatimal Organisation :?or information on cru^s .-ind
therapy. Information’ is to be circulated by the organisation everjr month through
a journal• (updating N.F.I. and I.?.)
L.' sales promotion activity, onl^r scientific information can be circulated by the
mnuxacturers. 711 sales promotion inforrMions/advcrtiso; ents has to be checked
oy the national organisation of information education and co muni cation on medicines.
No physician sauple should be given. /■r^/ forn of literature,
'
,L_
visual
aids etc.
can be published without mentioning full indications, contra-indications,, side effect.- .
druf; inter action and anti-dotes.
tvO gifts of any form shall be allowed to be given to the medical profession and the
- retailers.
ko saiiinar, scientific sessions can be held by the drug companies.
i^onus, incentive j^stcin on sales of the products b^r the distributors or retailors
has to be r.bdished.
fhe nu^*k eting code dr am up h; HAI (Health ction International) should form the
basis for a National Code for Larkcling Practices. This should be accepted by our
government and should be suitably- ir:plar.en.ted through legislation.
abolition of wholesale stockists and distributors - the unnecessary profit-rule in ■;
.middleman •
ibstaoli diraent df National-Corio or ail on for the distribution of drugs rnd Pharneceuticals to the retailers. This corn or rt?. on to work on no loss no profit basis.
M arketing of drugs only under generic nams and abolition of brabd news should
appear.
xhe Drug Price Control Order of 1979 shou3d.be extended to all crugs. However,
the existing categories in the D?CO to be abolished and a uniform mark uo to be
allowed on all types of drugs on sales turnover prices to he reviewed periodically7.
Ensuring proper1 utilisation and prevention of rdsuse, this would involve inclusion
of National Drug Policy in medical education.
Conipulsory continuing education of
doctors and other medical personnel (like paramedics, chemists) in latest trends in
rational, low-cost pharmacotherapeutics. Kedicnl audit astern should be introduced,
mandatory adequate cli.nical roc ord-keeping by doctors and .walking doctors answerable
as regards rational therapeutics to a comittee of experts if a cowplaint, of possible
nisuso of drugs is received from any person. Continuing education through different
aiodia ty Government about the use of over the counter drugs, Kii scone eptions about
eortidn drugs, and hazards of wrong use of drugs. Those drugs which are nore 1 ikely
to give rise to life time atoning or serious side effects, but which may have to be
used in certain conditions, v/ould be allowed to be used only under the supervision
of post;graduates, doctors vrho would be required to keep a close watch on the
possible serious side-effects and keep adequate clinical records of side effects,
for example, drugs like clinido^. cin, oxyphenbutazone, dextropropoxyphene, diphen
oxylate, etc.
5
Setting up a Drug Review Cosset tec entrusted with the task of :
Ixonitoning the changing pattern of diseases.
kew information on old drugs and invention of new drugs.
Ffficacy of the existing policy of production, distribution and the use of drugs
in the light of principles of Rational Drug Policy.
I'his comi the c is to include one representative each fror.7 manufacturing sector,
the Government, medical experts engaged :n primary, secondary r^id tertiary levels
of medical care, chemists, consumer organisations etc.
Fostering research on issues t-identified by the Drug Review Comittee.
Fostering research on non allopathic drugs and production aid use of those which
haw proved to be therapeutically useful in such research.
RA^AKKA’S STORY
Ranakka, wife of Veerabadrappa has two children,
She goes to work in
Periaswamy ’s field for the wage of lOrupee a day.
Her younger son,
Linga, only 11 months old, got diarrhoea which is a common problem
leading to death in the village, With one rupee which she got as that
day’s uajs, she bought 50 paise worth of powder medicine from the
nearby petty shop.
50 paise worth of flowers she offered in the
temple for the cure of her son. As the diarrhoea continued she appro
ached the local Oai Yellamma for help. She gave her some herbal
medicines. But the situation became worse and so Ramakka, with the
money ^Tjhar husband borrowed, took the child to the local doctor,
who has no training but sone knowledge received by watching his uncle
who was a compounder. He gave an injection worth ^•7/-. The child
got temporary relief. Uhen the sedation power of the injection got
over, the diarrhoea started again.
The local Oai, advised Ramakka
to take the child to the district hospital 20 Kms away. She borrowed
18.20/*- from the money lander on tho condition that the amount with the
one third of it as interest will be paid pack in paddy, during the
harvest season.
Thus they reached the hospital, She was ignorant of the proceadUres
of the Govern ent Hospital, She had to give ^s.2/- to the gate keeper
for entry, The hospital personnel were so busy th^t they could attend
to the child only very late,
The scolded Ramakke for the delay in
bringing the child for medical care.
She could not tell the doctor
that their trip cost her three week’s pay which she should pay back
with interest.
The doctor also scolded Ramakka for not bringing the
child early, and furiously wrote a long prescription including four
I.V, fluids. The pharmadist billed her
But Ramakka did not
have that much money. Ghe bought few tablets and returned home.
Uhile on her way back home, the child breathed its last on Ramakka’s
shoulder•
-xxxxxxxxxxxx-
TUI,.- !>1
botanic 1 nemal
cinuw sanctum
Synonyms
.-^ r £ t.
H i ndi
*■ r . li
Kannada
Ral&yalam
T Kffii 1
T elugu
Cngliah
Oescrl: tisn:
Linn
Iul3®i
Tulsl
T ul$i
Tul ssi
Tuleai
TuX i5i
Tulasi
-acrad frasil. Holy Basil
An annual arotBatic hairy herb found throughout
India. It is mostly grown y Hindus in their
Houses f r its s^crednass.
Stow greenish, sometimes ur^lish. Leaves
2.5—5 cr> softly iairy, oblong. Flowers rran gad in s ikes giving a cylln irlcal ®p;?earBnca.
»e®ds ax- r^d br un -nd dightly cr. wpre'-sod.
Parts used:
Leav&s
T a$te:
Astringent and acrid.
Caramon uses:
Loss of apnetit®, cough, hiccough, respiratory
disa.roes, fevers, c^ld*
Prep retion and do^o:
One toaspocnful of leaf juice with powder of
one or two oep -rcorns reli&v’as re© iratory
diseases and fcvor. One taaspoonful of :nwder
of th® dried drug along with honey or uatar
twice daily clears car ? stion of the throat.
A decocti*. r riade using Dhanyaka (i p^rt)f
R richa (1 part), Tulasl (1 p rt) ->nd ^unthi
(Ip rt) is found henefic 1 in i fluenz
’jd
f v«rs asaaciated with chill.
RArtAKKA’S STORY
Ramakka, wife of Veerabadrappa has two children. “.he goes to work in
Periaswamy’s field for ths wage of Wrupee a day. Her younger son,
Linga, only 11 months old, got diarrhoea which is a common problem
leading to death in the village, with one rupee which she got as that
day’s wage, she bought 50 paiso worth of powder medicine from the
nearby petty shop. 50 paise worth of flowers she offered in the
temple for the cure of her son. As the diarrhoea continued she appro*
ached the local Oai Yellamma for help.
medicines.
money .
3
She gave her some herbal
Rut the situation became worse and sc Ramakka, with the
her husband borrowed, took the child to the local doctor,
who has no trlining but some knowledge received by watching his uncle
who was a compounder. He gave an inject! n worth I.7/-. The child
got temporary relief, ’when the sedation power of the injection got
over, the diarrhoea started again. The local ’-al, advised 'amakka
to take the child to the district hospital 20 Kms away. She borrowed
'b.20/- from the money lender on the conditi jo that the amount with the
one third of it as interest will be paid pack in paddy, during the
harvest season.
Thus they reached the hospital, She was ignorant of the proceedUras
She had to give Rs.2/- to the gate keeper
of the Govern ent Hospital,
for entry. The hospital personnel were so busy that they could attend
to the child only very late« The scalded Ramakka for the delay in
bringing the child for medical care. She could not tell the doctor
that their trip cost her three week’s pay which she should pay back
with interest. The doctor also scolded ^areakka for not bringing the
child early, and furiously wrote a long prescription including four
I.V. fluids. The pharmadist billed her &<60/-. Rut Ramakka did not
have that much money. She bought few tablets and returned home.
<hile an her way back homet the child breathed its last on kamakka’s
shoulder•
-KXXXKXXXXXXX-
r
«yA Workshop on ’Pharmaceutical^
and Health Policies’ organised
by IOCU and QIAP was attended by
Dr Mira Shiva*.
"emphasis on generic names
for all product information
and labels. For details contact
Mira Shiva at VHAI.
From 22-25 November, 39 particip
ants from 31 consumer and health
action groups from 14 countries
took part in this first regional
workshop held’ in Penang.
4’SOCIAL EVILS ANALYSED THROUGH
FOLK 'ART
.-a
’A sample of how people from all
walks of life can be brought to
gether and helped to scientifically
analyse their social and environrtiental problems was presented by a
group of KSSP workers in a memor
able performance on the occasion of
Kerala day, celebrated on Friday,
at the FICCI auditorium, here
(9 Dec. New Delhi)...
Highlights:- The workshop was
aimed at getting individuals and
groups to pool in relevant infor
mation, experiences and efforts
for a coordinated campaign
against irrational and socially
unjust Drug and Health Policies
and Practices.
’The malayalam adaptation of Bertolt
Brecht’s famous poem "Take the book
in your hand
it is a new weapon"
was a forceful exhortation to aban
don blind faith and to question
everything. . .
- Launching of ASEAN NETWORK FOR
HEALTH ACTION was another histor
ical event. Along with other
networkers of Health Action Inter
national, HAI (U.K.) and HAI
(Sweden), the Asean Network will
join in the campaign ’for safe,
rational and. economic use of
pharmaceuticals and appropriate•health delivery systems world
wide. ’
’A skit co-mposed on the fight the
people of Calicut had put up against
the pollution of Chaliyar river,
showed the workers’ growing aware
ness of causes and consequences of
atmospheric pollution...
- Another major outcome of the
workshop was the signing of the
Penang Declaration of Rational^
Health policies. The ten specific
areas of action agreed upon in
clude a call for
"the adoption of essential
drugs lists for both govern
ment and private health care
services
"legislation to prevent dump
ing of hazardous, useless or
substandard drugs
"the encouragement of research
into the use and local pro
duction of traditional
medicines
"the use of the HAI Code on
Pharmaceuticals as a basis
for action
A
3
COMMUNITY HEALTH CELL
47/1, (First foor)
M-'- 3
BAWGAlO.SE'-BSOOO'I
1
Folk adaptations of Gorky’s
’’Mother” and other pieces by
Brecht touch on many aspects of
education and knowledgejpresented as the only forces that can
liberate the people from oppres
sion’ .(Indian Express, Dec 10)
The charter includes demands for
Rational Drug Policies relevant
to the health needs of the
country, effective drug control,
ban on irrational and hazardous
drugs.
The KSSP has decided to take up
the drugs issue as its major
campaign plan for 1984.
Attempts at involvement of other
trade unions in drugs and health
issues would be considered a
very significant contribution
of FMRAI.
# FMRAI Annual Convention held
mi 13 Dec 1983.The convention
was held at the Mavalankar Hall
in New Delhi after a demonstra
tion in front of the Parliament
by members of FMRAI and AITUC
to press the government to meet
their 27 point charter of demands.
FMRAI *s role in campaigning for
ethical marketing practices,
rational drug pricing, giving
of unbiased drug information
by the drug industry is well
known to those involved in
drug action.
drug news
MEET I MI WITH MR. VASANT SAT HE
whether after dilution these com
panies would be treated as Indian
companies he answered in the affir
mative.
On 3 Dec '83 an informal meeting
took place between Mr. Vasant
Sathe and Dr. Zafrullah along
with s|piJje of the representatives
of organizations involved in Drug
Act!oit^ 'Dr. Sameer Choudhry from
CINI Calcutta, Dr. Narendra
Mehrotra-NISTADS, Dr. Imrana
Quadeer-Centre for Social Medicine
and Community Health JNU and
Dr. Mira Shiva,VHAI.
He expressed his anguish at the
drug related decisions being struck
down by the High Courts and the
Supreme Court, for example the
switching over to generic names for
five single ingredient drugs, ban
on certain hazardous drugs etc.
Mr. Sathe agreed to accept our
representatives in the National
Drug and Pharmaceutical Development
Council as coopted members in re
cognition of the fact that the
voluntary health sector contributes
over 30% of the health care services
in the country. Based on their indepth knowledge and familiarity with
the drug industry and its functioning
the names of Dr. W. S. Rane, Dr.
Sameer Choudhry and Mr. J.S. Majumdar
have been sent to Mr. Sathe.
Dr. Zafrullah related to Mr. Sat he
hpw the Bangladesh Expert Committee
on Drugs had got inspiration from
the Hathi Committee Report.
Mr. Sathe was incidentally a
member of the Hath! Committee.
With regard to.the extent to which
Hathi Committee recommendations
have been implemented, Mr. Sathe
spoke about th^ 40% dilution of
the FERA compaiiies'.
Whan asked
4
As stated earlier, a joint memo
randum on behalf of all the
organisations was submitted to
Mr. Sathe. He was also urged on
behalf of the consumers and
socially conscious health person
nel to make public the entire
list of brand names of the banned
drugs.
- to direct the licensing author
ities not to renew the licenses
for any drug except these 116.
- to direct the Government to
streamline the licensing policy,
administrative acts and statutory
functions in such a way that use
less, injurious and harmful drugs,
are weeded out and essential and
life saving drugs are easily made
available through the nubile sec
tor undertakings.
Further details of this meeting
can be sent to those interested.
In the meantime we are trying to
get more information about other
’working groups’ besides the one
on drug pricing so as to demand
representation on these groups
t oo.
-to ban the import, manufacture
and sale of those drugs not yet
covered by the recent order of the
Government.
- to direct the Government to
appoint an expert committee to
report about the conditions pre
vailing in the drugs industry and
market after the period covered by
the Hathi Committee.
IN THE SUPREME COURT
Vincent Panikulangara, who had
filed the earlier writ petition
in the Supreme Court regarding
the ban of the import, manufacture,
sale and distribution of drugs
identified as hazardous and/or
irrational by the Drugs Consult
ative Committee (D.C.C.) has filed
a further petition to amend and
add to the original petition.
This has been done in the wake of
the Government of India’s notifi
cation of 23 July ’83 banning 22
categories of drugs, under the
powers conferred on it by the
recent Drugs and Cosmetics (Amend
ment ) Act (see previous newsletter)
In the new petition Vincent has
drawn the attention of the Court
to the fact that certain categories
recommended by the D.C.C. to be
banned are not included in the
present order of the Government.
Moreover certain of these recom
mended categories have been given
specific exemptions (like hydroxy
quinolines for use in diarrhoea).
BANNED DRUGS - LIST OF BRAND NAMES
The Eastern Pharmacist (May 1985)
had reported that the Retail and
Dispensing Chemists Association
had filed a writ petition against
the Union and State Governments
asking them to publish a list of
the brand names of the drugs then
proposed to be banned, (and theo
retically banned since then) so
’that they are not harassed’.
The Bombay High Court had directed
the requisite notification under
Section 26A with the list of for
mulations proposed to be banned be
puW.ished in the Gazette.
The
notification has since been pub
lished but it does not include the
list of formulations.
The list of the formulation packs
marketed in the country have to be
obtained from State Drug Control
Authorities by the Drugs Controller
of India since registration of
these drugs has been done by the
State Drug Control Authorities^
many of them being more than 20
years old. It is also learnt that
the drug companies have obtained
Pg
In the amended petition the follow
ing orders are prayed for from the
Court:
I
- to direct the licensing authori
ties not to grant new licenses for
the import, manufacture and sale of
any drug except the 116 recommended
by the Hathi Committee.
5
10
Tuesday, December 6, 1983
and drugs of doubtful efficacy'' kilogram. This
bottle’s basic
from the market They include li cost is . therefore not more
quid vitamin mixtures, multiple com tn?n 90 nahe. and cannot be
binations of potent drugs, combina
tions of antibiotics gripe waters, more thsn Rs 3 or 4. after addcough mixtures, tonics, balms, di ing taxes a^d other charges,
gestive enzymes, addictive drugs
Ibere are other multiiiaUo*
and antacids.
“We thought, let us have our nai tricks. “To take the mini
for
own ulcers — instead of getting mum dose of«Ampicilin
them from multinationals”, saidi five days, which is the pres
Dr Chowdhury.
cribed course, you need 100 ml.
In India, where multinationals con But the bottles that are sold
trol 78 per cant of the market, and 4|n developing countries
arc
modern
drugs reach only about
“
’ ’ 20 only 60 mL A poor man is
per cent of the population, he says^ forced to pay for 120 mis—two
Our Staff Reporter
“Noval^n has
bottles—ip order
to get his
Pakistan, Sri Lanka, Bangladesh
dose
”
.
The
bottle
sold
in the
Malaysia. Unlortunatel/ our big bro4
?est is of-100 mL he said.
there has not yet done it And it is
a study of the Voluntary Health As
Terramvcin syrup was bancreating a problem for us”.
of India, which organised ned from the Indian market in
This pain-killer was one of manv sociation
the talk.
drugs mentioned in a brief but im
Jv.lv this vear-TTMBut why has
passioned talk on “Drug Misuse &
“Blirdness
is
a growing the comnany been given one
Drug Misinformation” in Delhi on problem in your country”, said
withdraw?**. He
to
Saturday by Dr Zafrullah Chowdhu Dj Chowdhury. “Yet, the so- year
asks
*A
lot can
■ fcPry, Director of the People's Health caHed
anti-dierrhoel
drug pen in a
year: governrrilnts
* Centre, Bangladesh.
The 42-year-cld doctor was among Jiex'lom is still in wide use. can change, policies can be rethose on the Drugs Expert Commit It h-’s not only been conclu- v<rsed. there can be second
tee whose proposals led to 1,579 s-ve’y established that it has
dangerous drugs being banned by Sfriowa s'dn-effects, can cause tboughts”
Bangladesh.
e cancer and leads to dimness of
Bangladesh’s
Drug Control
In the country he calls ‘big bro- i vision and blindness, but two
Ordinance,
announced
with
”
ther’, India, 43,606 drugs are rois
amendments on 6 September last
therapeutic
that
it
has
no
tered and sold. “Three quarter of
value whatsoever in treating year, allowed sue days for all
them are non-essential”, says the
stocks of banned drugs to be
dictor. “And the policy taken bj diarrhoea”.
your country affects us”.
In 19?8 he said, the drug destroyed. Within four days
When Bangladesh declared Its
the multi-nationals were seek
new drug policy on 7 June, 1982 he H ovalgin was found to derange ing permission to export the
some
people
’
s
ability
to
pro.
said, multinationals
immediately
brought tremendous pressure
to duce white blood cells. A re- drug stocks to other countries
bear, to have the policy amended. presentative of
the
pfizer like Saadi Arabia, West Af.
‘First the American, British, Dutch rompany, which makes the nca, when it decides the matter.
and German governments started a
on a
times Bangladesh will- insist
campaign with our government drug, claimed at that
When that failed, the US Embassy tilt a pharmaceutical from label saying that the drugs ’"had •
couldn't be been recommended for destruc
Hitler’s country
brought
a 4-member expert sci
entitle committee from pharmaceuti wrong. *Hitler is dead, but tion by Bangladesh.
cs! companies.
still selling
The Voluntary Health Asso
your country is
A .report in the Washington Post
ciation of India plans to Teon .19 August, 1982 said that the US hovalgin’, said the doctor.
Multinationals
sav
their sent the government with a
government was worried* that its
drugs are cheaper,
said Dr memorandum
demanding
•’SO-billion-dollar market in -the de
veloning countries would be at stake thowdhury, and withdrew
among other things, that drugs
If otner countries followed suit”.
bottle of Ampicilin from bis for India be chosen after ex
The Bangladesh government stuck’
to its guns, lifting the ban from po:ket. “I bought this today, in amining their essentiality, effi
your city. It cost me Rs ‘'.90. cacy, safety, cost, ease of ad.
only a token 128 drugs.
The international
wholesale ministration, availsbiyty, and
The Bangladesh drug policy weeds
out “all unnecessary, useless drugs- nrice of Ampicilin is Rs 00 a ^oteAtial for mlsoee.
“It is the common man’s
body, hot the doctor’s or the
bureaucrat’s, that is affected by
the drug
policy**,
said Dr
Chowdhury.
‘Big brother
is creating a
problem
for us’
A;
i
__ a
*
*
•
*-
1
INDIA YET TO EMULATE BANGLADESH
Harmful drugs still available
BY SUMANTA BANERJEE
7 a PR 111 I AH emerged from them, were based on the kistan and Malaysia. He suggested continue 'o recommend the
dr“^
sbSW 111^ ixmis
banning over 1,000 hazatdous dcsh were being diverted to other of Indiai recommended in 1980 the p‘00()sitionhr“ther ?{Tan a question of
and irrational drugs — mainly Third World countries. How was this wecding out of several dru^. But the PfORO Givcn this cornbinalion in lhe
manufactured by multinationals
Controller of Bangladesh,
ann0^X
Son « one W the Go^ment
—* was in Delhi recently, and following
implementation of the Jul
23 l983t prohibited the t0
brought to our notice that the Bangladesh Government’s drug policy .*m^nufacture and sale’’ of only 22 itXited?eXc?s^on ambitious but
drugs banned in Bangladesh banning the drugs had directed that categories of drugs and drug com-
%
s
Dr. Chowdhury, who was a member factured thoSe-drugs in Bangladesh infrcJucin? the market, the com- f°*n'"i'h
‘ ?JeP health budget is
of the Bangladesh Drug Expert Com- ^lhrough tbcjr subsidiaries).
bination of certain products.
cJm sensibly in preventing ill-health,
mittee, recommended tha ban on the Thc multinational companies com- In October 1980, the Drugs Tech- s^nt sens biy, in p
g
drugs on the basis of the World Health piicd with thc request by shipping the ical Advi
Board of the GovernK d adequate tod safe water
Organisation’s (WHO) recommenda- sHtocks to the ports of their respective ment of
prohibited the com“£ Th?money allottion* and concept of Essential Drug coufftries, but instead of taking them binations of “steroids with bronchodi- and good samta . e nr0^
List. The WHO initiated the concept insidc these Western countries, the
steroids with antihistaminics
of essential drugs and rational drug companies shipped them to ports m add steroids with tranquillisers.” But
medicines
therapy which is not merely based on Third World countries.
iatcr thc phrase “combination of ste- zardous medicines,
efficacy, safety ease in administration
.
roids with bronchodilators” was reint- . r
.
.
»
and easy availability, but also on rea- Banned IK rVCSt tOO
erpreted as “combination of steroids Not ITTUtlOndl
sonable cost - a factor °f crucial
Explaining thc rcasOn Dr Chowd- with other drugs (except) for the Whcncvcr thc Drug Controller of
importance to developing
bury said that most of the drugs, treatment of asthma,
India’s attention is drawn to the con-
Diversion of drugs
deshU8hTheC st<S^S trom* BanllXh histaminics can, at least technically be market for a long tim^it may ^be
In such a situation, denying the therefore wirid,not^be•import^ into
preparations’.’ (Reply to the Consumer
people their right to low cost, safe, these Western
mended for ban by the Drugs Techni- Education and Research Centre s
essential, quality drugs with the right diverted to the
ts’ cai Advisory Board — can escape thc memorandum), or “such combinations
amount of information is uneth^d.
J? at guillotine! ?he manufacturers can now arc being marketed in many countries
Hypnotising them into believing that Dr. Chowdhury s informaUon, in at g 1
iU indicale and cannot be consldered as
rn'aSy of the irrational^and hazardous least two Third World onmtn* - c™h%“7nfor
'nIy, dlhough irrational." (Ibid). .
drags are “essential for their health ^sotbonaniIehmheRi fnl,bndthehwav in the pwl such products have been The question is. is anything markneeds and making them use their ii- from
rfuJ?M hk talks ?n vigorously promoted for all type* of etable, or enjoying a wide market for a
,"d F1"“ta
drugs sold in the market. Dr. Zafrallah drugsmany of them in far-flung villages - vertise and sell it, or its real effective-
DECCAN HERALD
15-12-83
Banned drugs still
in use in India
XJ
ci
TIMES OF INDIA
4-12-83
NEW DELHI. December 3 ,ric name* introduced. Bangladesh, has suggested that a list of banned and
already started a campaign in th s harmful drugs (with generic and
(PTD.
. .
, , .
< ■ t. reaard Also, thii will cut down the brand names) should be widely cir
pERTAlN harmful drag*
drug. which
wh>ch
^asideraS)Iy,
the U.K., thl. culated by government and properly
V have beoa
bean banned in Nepal,
resulted in a 42 per cent price advertised.
Dr. Samir Chaudhury, a primary
Ban^adesh, Sri Lanka, Pakistan, and reduction, he pointed out.
health worker from West Bengal, ex
Malaysia are still being administered
rlcordina to
to aa
^r- Chowdhury said in Bangladesh,
concern over the very small
to patient* in India, eccording
village doctors could directly pres- pressed
number ‘ of drugs Inspectors in the
medical expert from Bangladesh.
example of
of analgin
analgin «*e 11 drugs for which a bat Had whole country.
Citing the example
-----He said erven ©ssentlal drug* and
(amidopyrine). Dr. Zafarullah
Chow. been circulated.
The kendra had started manufactur- vaccine* to cure tuberculosis, diar
dhury, director of Gonoshasthya
(peopie’s8 health centre).
centre), ing 30 essential dru®i to avoid ex rhoea, blindncu are not av?liable in
Kendra (people
Dhaka regretted that India' emerging ploitetion by multmatlonaJa, he said, right quantities to the
pooms could
as < leader in the third world, is still
Panelists criticised the lack o! Voluntary
. health organs?,
v
penaitting the use of this.
availability of an information syatexn jointly take up production of soma
essential drags,
drags, he
ho suggested,
suggested.
Dr. Chowdhury said that brand on drugs, ita formulation* and uses, essential
name® should be abolished and 2?tne- to consumer* agd chemists. They
7
1 Cu
u ’ e>
o
O
o
X § o
S
1
<
U CD UJ
X
CT-
s ’t. 0
o O
g U- C3
O <
o c
Political will needed
for drug policy:
. : expert
TIMES OF INDIA
28-11-83
By A Staff Reporter
of medicine and work
BOMBAY. November 27 . 1o*Cne^V%?S
——
.
..
.!??• nvCd noJ be *A doctor
’s forte only.
aovtors
Anyone
colour
A combination of political will n??
y2nc who can distinguish a
'
and pressure from thc medie. —
^asic
< iSon!,..
*’* int«Hi«ence
vn^niu^n^e can
cal community is needed to fonnu- sta^hav?
an^yse Hood”, he said. In fact.
'
hU
caff
donc 7/)00 tubc..tornies .n
late a drug policy in this country thc rural'
to prevent it from being used as moni'c f a-fas’ ,SurPa”ing the govern
a dumping ground for banned ment s family planning record.
drugs according to Dr. Zafrullah
worked showed no maternal mortalih,
Chaudhary.
a low infant mortality, and popularity
ihPu »?ia’i<I,lary j as a mu{"b8r of ThJmvni'ni'sat,On ProPranimes. hc said.
lhe Bangladesh drug cxpcri com JX,k«n«7 worUd on Krnnl.'iron,
mittee, was instrumental in the for- chanty and on money that came in
and ,passi?fi of his country’s from jfs health programmes, in uhich
Pric«
drug policy m June last year. He fought S wnnujyVrr0111 81
a bitter battle against multinational Xries°P^^ Afferent ecoaomic catcpressure on the Bangladesh government
and even from the medical fraternity
to get drugs including novalgin, mexas<?mc steroids, gripe water, a
Combination of antibiotics, micropyre
nes and tetracycling syrup banned.
I Z*
■ fl* * A ff a —
aa _ ,
wJl’L Tg'onV in which thc
r 2rv.9ni,dhary to,d “The Times of
India , here today, that India with its
fomPlcment of scientists and
qualified people, was m a better posi
tion to formulate its own dnig- solicy
so that the above drugs winch had
shown several harmful side-effects
could be prohibited
IIATHI REPORT
Jt was ironical that the Hathi com
mit tec report, which had inspired Bangladcsh’s drup policy, had not been
implemented m India, Dr. Chaudhary
said.
I Bangladesh today had managed to
step the multinationals at bay but was
beginning to face a new problem —
me infiltration of the banned drugs
from across the border with India, Dr.
Chaudhary said.
Dr. Chaudhary recommended the
mart
'* of drugs
l_o. under theirr generic
irketing
nPnnurA this "would
______ i 1
nqmes, because
creaic con-
■
THE HINDU
5-12-83
‘India has no effective law to curb sale
of multinationals* harmful drugs*
From Our Staff Reporter
including two antibiotics, which they could pre
NEW Demi. Dec. 4.
scribe simple Illness. In addition, 45 essential
Dr. Zafrullah Choudhury. a pioneer in the drugs had been identified for supply to primary
Bangladesh People's Health Movement, speak health centres. These drugs would be manufac
ing at a seminar on 'rational drug policies for tured and sold under their generic and not
the third worid'. organised by the Council of trade names.
Scientific and Industrial Research here, said he
Drugs for rural
Voluntary health
was-^urprised to find that India had no effective workers, who participated in the seminar, em
law which prevented sale of harmful drugs phasised the need for manufacturing drugs to
manufactured by multinational companies.
combat diseases most prevalent In rural India '
He had bought a bottle .of tetracyclin like diarrhoea, measles, tuberculosis and
syrup (banned in the West, and in Bangladesh whooping cough.
now) without prescription at a chemists s shop
According to a participant voluntary
in the capital on Friday. The literature did not health groups provided about 30 per cent of
5.
■;
________________________________
specify it was dangerous for children under 12.
the primary health care service available in'the
Another surprising thing he noticed was countryside. It was suggested that if Govern
when he addressed a meeting at the Indian ment agencies actively joined such voluntary
1-...^.^.. .. auunuiiui11 uii rnusy.
Medical Association auditorium on Friday. At groups, monitoring of drug control laws, train
was
d'splayed
pro ing of village-based, para-medical sthff and
- -—y.'— ?f'the
.W
»»uu VliOf^ICZ
vcw the
urc LJfM*
pag anda by multinational companies some of strenothening of community health services
whose products should be on the banned tets
lists could be achieved.
prepared by institutions like the IMA.
Banned drugs still in use: Dr. Choudhury.
Dr. Choudhury said the rationalisation of who runs the people’s health centre (GonosasBangladesh’s drug policy last year was an at thya ^Kendra) in Dhaka, told PTI that certain
tempt at eliminating from the market all useless harmful drugs banned in Nepal. Bangladesh.
drugs and those of doubtful efficacy and Sri Lanka, Pakistan and Malaysia were still be
preparing a list of 150 drugs considered ade
ade- ing administered to patients in India. He re
quate for therapeutic purposes.
gretted that India, emerging as a leader In third
He said 1.707 drug formulations were con world, was still permitting use of analgin
sidered harmful or useless and pharmacies (amidopyrine).
were given three months to dispose of their
Drugs banned in Bangladesh were still be
Stocks? But because of pressure from U.S.
stocks.
ing marketed in India by multinationals. These
based multinationals, ban orders on 60 formula
formula- found their way to Bangladesh, he alleged and
tions. mainly pertaining to ointments and balms,
balms. suggested cooperation between the two
were rescinded. The formulations, the manufac- countries in totally eliminating these harmful
included
Ik,
drugs.
- — wh’ch were banned
w
.■
w.wWW II
”,
quid vitamin mixtures, multiple combinations
of
Detalling^advantages
of abolition ofVIbrand
”
- —— . w —
W VW
..
__'Z
C
potent drugs, alkali mixtures, g.
gripe waters, names. Dr._ XX.
Choudhury
said
Introduction
of
cough mixtures, tonics, digestive enzyme generic
Z-------- --------.‘J avoid confusion' and re
names would
preparations and habit forming drugs.w
duce profit-making by various pharmaceutical
All health workers and village doctors
<
in firms. In the U.S. and the'
1
U.K.., generic narr.as
Bangladesh were supplied with 12 basic dnigs^ had been intaodufiMij
8
a stay order against publication
of the names of the brands in
volved and the drug houses pro
ducing them.
"AS BETWEEN THE LIVES OF
THE CITIZENS OF THIS COUNTRY
ON THE ONE HAND AND LOSS’
THAT MAY RESULT TO THE MANU
FACTURERS AND TRADERS BY THE
IMMEDIATE BAN ON THE MANUFAC
TURE AND SALES ON THE OTHER,
THE GOVERNMENT HAD CHOSEN TO
VIEW THE LATTER AS OF MORE
.CONCERN”.
It is the duty of
the state to protect its
citizens from injury and harm
especially when the injury is
not inevitable.
- Acting Chief Justice
P. Subramanian Potti and
Justice Paripuran,
Kerala High Court, in their
directive to the Union
of India to release the list
of brand names of banned drugs.
In view of this it is imperative
that a demand for this list- to
be made public by the state and
central drug control authorities
is raised at every forum. Our
attempt to compile this list on
an urgent basis continues and
help from other Drug Action
Network members is sought.
ESTIMATES COMMITTEE ON SUBSTANDARD
DRUGS:
:
The 64th report of the Estimates
Committee on the Ministry of
Health and Family Welfare tabled
in the last session of Parliament
has focussed on the unsatisfactory
condition of’Drug Testing and
Standards’. The existing com
placent attitude and laxity of
drug control authorities was a
major factor contributing to this
situation.
The recommendations of the Com
mittee include:
- a 100% centrally sponsored
scheme to create adequate facili
ties for drug testing,should be
drawn up and launched without
delay.
From 1977-78 to 1981-82 the percentage of substandard drugs was
between 14.5 to 21.6%.
.
In 1981-82
18 5% of drug samples were found
to be substandard.
- multistage quality control
should be done.
The Committee pointed out that no
information regarding percentage
of drugs produced in the country
subjected to testing by either
central or state drug control
authorities is available.
No
statistics related to the number
of cases in which licenses of drug
manufacturers were suspended or
cancelled is available.
- strict quality testing, of
imported drugs too.
- name of manufacturer and batch
number of drug found substandard
by the Drug Control Lab should
be published in the press to
•caution the public.
If necessary
the law should be changed in this
regard.
There is no machinery to prevent
the entry of spurious and sub
standard imports into the market.
(In 1982—85>60 out of 2540 samples
were found substandard).
The Health Secretary in his evid
ence had stated that 18% samples .
found substandard did not indicate
that 18% of the drugs moving in
the market were all substandard.
He gave reasons for not consider
ing this percentage as unduly high.
A number of licenses of a large
number of manufacturers were
renewed despite their having fail
ed to create testing facilities.
This according to the Committee
’displayed a complacent attitude...
3
’Complacency or laxity in the
maintenance of drug standards- can
pose grave danger to the health
of the people*.
DILUTION OF FOREIGN EQUITY FERA C CMP ANTES - SOME IMPLICATIONS
The decision by most of the
foreign companies to voluntarily
dilute their shares to 40% may
not prove to be greatly beneficial
to the consumers after all.
Had the 'attractive proposition'
of being treated as an Indian
company with freedom to diversify
into trading and other commercial
activities not been there they
would have continued fighting
tooth and nail aS in the past.
The sudden decision by Burroughs
Wellcome, a 100% foreign company
which has resisted dilution all
along, to bring down its foreign
share holdings to 40% is there
fore extremely surprising.
Ctba-Geigy's Indian business
Hindustan Ciba-Geigy has reduced its foreign equity from
65% toJj1% with an over-subscribed offering of shares to
Indian investors. The company plans to reduce its foreign
equity to 40% next year in order to become an Indian
company under the Foreign Exchange Regulations Act
(FERA). With this in mind, Hindustan Ciba-Geigy changed
its name from Ciba-Geigy of India on January 1st, 1983.
The company's sales during the past five years (1978-82)
have increased by 60%, from Rs 548.9 million in 1978 to Rs
875.9 million ($86.8 million) in 1982. The first multinational
company to set up a 100% export unit in the Kandla Free
Trade Zone at Gujarat, in 1980, Hindustan Ciba-Geigy's
exports were Rs 121 million in 1982 against Rs 59 million in
1980. R&D expenditure is currently around Rs 30 million
ahnually, and Rs 180 million will be spent on improvements
at the production centres at Goa, Bombay and Kandla, and
on new projects, in 1983 and 1984.
Of the 13 companies with foreign
equity above 40%, those which have
indicated their decision to volun
tarily bring down the foreign share
holdings to 40% are Hoechst, Parke
Davis (India) Ltd, Warner Hindustan
Ltd, May and Baker (India) Ltd,
Hindustan Ciba Geigy Ltd and
Organon Ltd.
’The implications of the drug com
panies having 40% foreign equity
being treated as Indian companies
would be far reaching. Restric
tions placed by the Drug Policy of
1978, that would be removed include:
- obtaining of industrial licence
only for high technology bulk drugs
from basic stage.
- eligibility for registration with
DGTD for manufacture of new pro
ducts only.
- adherence to bulk drug formulation
ratio of 1:5 (instead of 1:10
allowed to Indian companies).
- sales of 50% of the bulk drugs pro
duced to unrelated small seer or
companies.
The Indian Drug Manufacturers'
Association (IDMA) strongly feels
that companies with 40% foreign
equity cannot be treated as 100%
Indian companies.
ZDMA has sug
gested creation of another category^
of companies with more than 25%
foreign equity. The four cate
gories of companies would then be public sector, wholly Indian com
panies, more than 25^ foreign
equity companies and FERA companies.
The company's performance during the past five years is
summarised in the following table:
(rupees millions)
1978
1979
1980‘
19811
IDMA is strongly against DGTD re
gistration for 40% foreign drug
companies and permission to con
tinue with international brand
names,, as this would negate the
efforts put in by the wholly
Indian companies in introducing
newer drugs such as ampicillin,
ethambutal, mebendazole.
1982
637.2
875.9
610.9
715.0
548.9
Sales.
34.2
61.3
86.9
32.5
73.3
Pre-tax profits*
49.3
31.0
32.2
36.8
44.4
Net profits
280.4
317.1
380.0
230.7
195.0
Gross fixed assets
12
12
102
12
12
Dividend/share(%)
'Auction at the Bombay factory was affected by tridustrial action;
^on increased capital after a bonus issue.
Since the New Drug Policy is in
the offing it is crucial for those
involved in Drug Action to make
SCRIP No. 827 Septwnbor
10
biotics and has reduced the
leader prices of rifampicin
formulations, a widely used
anti-TB drug. The nrices of
ampicillin trihydrate have been
raised from Rs. 1475/Kg to
Rs. 1677/Kg and that of amoxycillin
from Rs. 1910/Kg to Rs. 2229Rifampicin formulation prices
have been brought down by 22% on’
an average.
' their contribution and interven
tion now.
With the decontrol of Category III
drugs from Price Control, 75% of
the drugs in the market will be
decontrolled. With FERA companies
being allowed to produce propor
tionately more formulations than
before( i.e. 1:10 instead of 1:5 )
we can guess that these formula tions will be those which are
most profitable to the drug comp
anies and will consist more of
inessential and irrational comb
inations. The poor performance
of the FERA companies ( and some
of the Indian companies) with
’•egard to low priority in prod.ction given to essential and life
saving drugs is well known.
• The Union Ministry of Chemicals
has slashed the prices of various
antacids, analgesics arid a number
of other drugs falling under
category III
These were ear
lier allowed a mark-up of 100%.
It has evolved the concept af
"non-standard" drugs to reduce
the mark-up under category III
from 100% to 60%.
If there is no legislation ensur
ing production and supply of ess
ential life saving drugs, of good
quality,the market will be flooded
with inessential drugs, with drug
companies producing more of shampoos
and cosmetics and the consumers
paying through their noses for
so called R&D in these areas.
The Shore Committee in 1945 had
recommended an increase in the
number of medical colleges
together with a parallel decen
tralisation of health care. While
the first part of the recommend
ation was unhesitatingly imple
mented ( we now have 106 medical
colleges ) the
efforts made in
the direction of decentralisation,
resulted in ho significant change
in the health care delivery
system. A similar lopsided imple
mentation of the Hathi Committee
recommendation to gradually decrease ’
foreign equity to 40 and then
26%, without ensuring production
and supply of essential life sav
ing drugs to the people will be
a big farce and a meaningless
exerciss where consumers are
concerned.
DHTO pRICim
e The government has raised the price of bulk ampicillin and
•■oxycillin, two popular antiIt
• The Bombay High Court has grant
ed an ad interim stay of the
operation of the Union Government's
order revising the prices of multi
vitamin preparations of Pfizer Ltd*
During the year ended Nov. 1982,
Pfizers'' sales- turnover was Rs. 54
crores and its profit before tax
Rs. 6.19 crores (about 11%).
The
popular mulji-vitamin ^reparations
account for*about a fourth of the
sales turnover of Pfizers.
• In a similar .order, the Bombay
High Court set aside the Union
Government's order fixing the
prices of multi-vitamin products
of Abbot Laboratories. The com
pany has been asked to file de
tailed cost data and the Government
would have to- disclose its reasons
and submit material* to the company
which form the basis for its
decision.
•The Ministry of Chemicals and
Fertilizers has raised steeply the
prices of bulk drug Vitamin C
with immediate effect. The Govern-,
ment had refixed the prices of
Vitamin C only in August '85, after
a protracted battle with -the
Sarabhais to reduce the price.
This sudden upward revision has come
scarcely a month after the lower
prices were accepted by Sarabhais.
DRUG UTILISATION SURVEY REPORT
- amongst self administered drugs
analgesics, nutritional products
and antibiotics topped the list.
This survey was conducted by the
National Institute of Nutrition
(NIN) in cooperation with the
Directorate of Drug Control Ad
ministration and A.P. Chemists
and Druggists Association,
Hyderabad in the twin cities of
Hyderabad and Secunderabad cover
ing 10% of the 350 retail pharma
ceutical shops.
Analgesics, Antipyretics and Anti
inflammatory drugs:
- 50.2% of the self prescribed
analgesics, antipyretics and anti
inflammatory agents were scheduled
drugs. These were mainly analgin,
phenylbutazone(with or without
c ort i c ost eroid s) a nd ib up r of e n.
Some of the findings of the
survey are as follows:
-an earlier survey, by the CERC
(Consumer Education and Research
Centre, Ahmedabad) had shown that
of 13 over-the-counter brands of
these drugs, 11 did not provide
any information. The 44 doctors
interviewed reported seeing on
an average 8 to 10 cases of drug
poisoning per month.
- self medication rate was an
alarming 46%.
- 27% of the.doctors’ prescrip
tions were for 3 to 4 drugs.
Only 4.5% of prescriptions were
for more than 4 drugs.
- the maximum number of prescrip
tions were for Nutritional Pro
ducts (tonics, enzymatic prepara
tions and vitamins), then antiinf ectives (antibiotics and sulfas)
and tnen analgesics.7
- 58% of the self medicated drugs
were schedule ’L’ and ’H’ drugs,
which cannot be sold without
prescription,nor should be con
sumed without medical supervision
because of the associated major
side effects and toxicity.
Vitamins and Tonics:
- only 51% persons surveyed had a
correct concept regarding nutri
tional supplements. The majority
held the erroneous view that daily
consumption of tonics was essential
for health.The credit for this
false belief goes to advertising
pressure as well as doctors’
prescription practices.
- 16% of the doctors had prescribed
simultaneously more than one vitamin
preparation having the same ingred
ients in various dosage forms.
- iron deficiency anaemia, B2
deficiency, were the commonest
deficiencies in the population but
sales of B-Complex(B1,B2,B6,B12)
combinations and other vitamins
topped the list of sales figures.
'CHEMICALS*
.explosives
Antibiotics:
- over 50% of the doctors* pres
criptions contained antibiotics.
- approximately 12.8% of self
prescribed drugs were antibiotics.
© 7S/Z.N5
7W£ COMPANY WONT ACCEpr THIS REPORT
ON UNSAFE WORKING CONDITIONS.
ITS NOT TYPSD DOUSLE SPACED I
- most antibiotic prescriptions
were for sulfa and trimethoprim
(from1Science for the People’)
12
/
combinations, tetracyclines and
penicillin, in that order.
drugs.
Last year we had demanded that the
following caution be printed on
all anti-diarrhoeal packaging:
- tetracycline,sulfa-trimethoprim
and penicillin were the most pop
ular self-prescribed drugs.
"Anti-diarrhoeals alohe are not
enough - the main treatment ford
diarrhoea is Oral Re-hydration
Therapy"
- 30% of the antibiotics purchas
ed for self medication were for
less than a day. Only 18% were
purchased for a full course of
five days. Only 40% of prescrip
tions for antibiotics were bought
for five days.
together with a pictorial repre
sentation showing how to make
the ORT.
For hydroxyquinolines
(Mexaform, etc) we had demanded
the following caution if not
a complete ban on these drugs.
’’These drugs are known to cause
blindness, paralysis of the legs,
burning and pain in the limbs and
loss of bladder control”.
We had
demanded that these be given in
regional languages.
The findings of the NIN and CERC
surveys indicate the urgent need
for public education where disease
and drugs are concerned.
Emerging drug resistance to anti° biotics, wastage of scarce resour
ces and potential for iatrogenic
problems are the price that will
have to be paid for irresponsible
advertising, prescribing and con
sumption of drugs.
With financial
constraints, unavailability of
affordable diagnostic and medical
facilities and ignorance of the
people, irresponsible self pres
cription will continue to be a
reality.
In the absence of the basic re
quirements for survival and health,
namely adequate food, water and
sanitation, decreased resistance
and increased susceptability to
infection and disease will force
even the poorest to unrealistically
depend upon the ’pill for every
ill’. Under these circumstances
eit is crucial to realize^that
‘safety'and‘scientificity of a drug
cannot be assessed in its utiliza
tion in the ivory tower alone or
by experts and specialists.
It
has to be assessed in its true
social context.
In this context, drug information,
specially the hazards, should be
indicated, to safeguard the in
terests of the public.
Consumer
Caution*on the packaging is not
merely essential for over-thecounter drugs but is also imper
ative for ani/lbiotics and other
13
The Central Government’s agreement
to consider making obligatory
information regarding dosage,
storage and warnings related to
atleast the over-the-counter drugs
by pharmaceutical firms will make
sense only on its implementation.
Similarly we fully endorse the
Government’s attempt at standard
ising the contents and prices of
vitamin preparations.
After all
15% of total drug production cost
in India is accounted for by sales
of vitamins and tonics.
The findings of the NIN and CERC
surveys underline the urgency of
providing unbiased drug information^
to tilt the balance in favour of
the consumer in the conflict bet
ween his well-being and safety and
the profit interests of the industry.
DRUG- UTILIZATION IS DEFINED
AS THE MARKETING, DISTRIBU
TION, PRESCRIPTION AND USE
OF DRUGS IN A SOCIETY WITH
SPECIAL EMPHASIS ON THE
RESULTING MEDICAL, SOCIAL
AND ECONOMIC CONSEQUENCES.
WHO
coming events
•4* Campaign on Drugs Issues:
A
co-ordinated one week nation-wide
campaign has been planned for the
first week of April to focus pub
lic attention on various issues.
Some of the.suggestions from net
work members are:
- campaign in the media as was
done during the EP Forte campaign.
- other suggestions included film
shows, cultural action programmes
(like those of KSSP), exhibitions,
posters, depending on the resources .
of each group.
- a nation-wide signature campaign,
signatures to be obtained on a
short one or two paragraph state
ment which can be easily under
stood by citizens. Each organisa
tion would obtain signatures under
its own banner, but for a common
statement, the presentation to the
authorities being coordinated dur
ing the campaign week.
One set of
signatures would be sent to Par
liament and one set in the region
al language to the respective state
legislatures.
# Workshop on Producing Low Cost
Health Education Materials through
Screen Printing Process. Co-spon
sored by the Voluntary Health
Association of India and the
British Council, this workshop
will be held at the College of
Home Science, Haryana Agricultural
University, Hissar from Feb 14 to
21, 1984. The workshop will be
conducted by Bob Linney and Ken
Meharg of’ X5 Posters, London.
Accommodation has been arranged
at the University Faculty House.
For other details please contact
the Voluntary Health Association
of India.(Mr Padam Khanna)
- the memorandum which was cir
culated in Delhi Dr-. Zafrullah
Chowdhury’s visit to be sent to
other activists’, consumers’,
citizens*', civil liberties’ groups
and associations for their sig
natures and then presented in the
campaign week, as above.
IN THE BEGINNING--.
IN THE NEAR FUTURE...
O
o
O
Sen
pnu
DOO
from
Social Action
News
1 e SEP
;a- )/33u (c)
84.
‘
>ote:
□c.nn .■
1.
2
3.
drug list is b- ing divideo into 6 classes:
orug ; b nnea under the Gazette wotirication
drugs that should have been banned under Gazette ■.'.otidication in
. bs<jnce of the ambiguous wording, gxxx or modification.
□rugs that were reconraenoo 1 for being weeded out by DCC
•.■ere
U .;t
oatiOd OUt.
Ihose drugs that wwre b nnod
rll<r separately, eg.
- irugs.
roller. Drugs that should be severely restricted if no ;. b.< nn .■ .
eg. Butaaolldine U b ril, ;uinoline, Anabolic steroids for
chi 1 ran •
Xrr< tioii il combinations of Stonies.
. vic min J Complex >iver extract and iron.
□ rui': belonging to Class I are being dealt with rirst, the sequence
u :>-'d for the various categories is be-sea on the sequence cin
J Witte it;.w-ic.-' tion.
Category
Banned.
Vos use:, in
Neme of the Drug House
Drugs
jourc©
Content
avcliable
in the
ma rket
or not
j. z .itto i4oti-
.. io. ! ion res/■■ctiV'.dy,
)/82/83__ __
I
2/1/1
^^idooyrine and its
GOLibinations.
c£ty
CoNl^^’^'
r 550 001
q/XLO‘?‘w
iUL
. -one of these brands now contain
Arnidopyrine; some of the brands
h. vo boon •-ithdrr-/n, others reformuleted.
I
uoc u^oo in
C .t^gory
mcrac of the
-the Drug House Content aource c.vcil^
Meme
tejory
□CC/oiVu/
Banned
Drug
able 4n,l
□anned
□rug
Gazette moti—
the
--d.
iicction resh oectively.
_______
______
__________________..................................................
5/2/2
Fixed, dose combinations of Vitamins with anti inflomm^tory
agents and tranquillisers:
Plecidin
iiupin
Joc- sms ^roxyvon-woekhsrdt
Dicyclomine l-iCh, Doxhoproxhphene HCL,/^cot. minophon,
Cloriazephoxide
Sudhinol*M*C coraj;.)and-R h ■
. >oxyherie/ rRpoylct'.-,
P a r axe tamo 1 di a z eph e .m
Tyl ; ;.j1 ■<ith codeine - Ethno r-Ac e t aminoph on , Corel ritcciKJktroprophyhen, Vr. c rtc.nol,
diazephem
^lagesic
Geter Wallace
Corn ill
Citadel
/nalgin,Coedine, >hos
.. s ran al
ffR Vharma
41 ,
Voneta
diazepam
2
5/2/z-:
u
: de- ejiC
)t ■ .
'•
.V otl ■•
•
^iliqen
■
C
.
■
,
... .
Vile >
• '
>
rUAC 1 .in, old. .!■: 2^ oruri.
,
•..liez-j .-•..ra
Cu' 31 ,in
tlicro 1; os
•loo
/
.
.
. lor ,/ronezine
t
.....
. dke.A
. .1
>■
,
i
-3 --
"a
\
'
’
/
....
.
..,; .in
3 i;i
th^l /.icrphinu nec
Jt; o'.c'i
■'
/
/..tro ui,
0
....
.i vLn'/li
:
.-
.
'
i 3i'/ .?b inootTb
»
trp in
1
1
. lioixitr y.
?!
;tendc‘i..
.■•i
-
/
/
.d/i;.- yleb
. mnel
/ 5/ 5
ac ^tconinophyn
'
PuC/ o..’rdt
■
0/4/4
••.? reu ...tc.n-m 1#
■_i< 3 0, < ra
'
.
>< •.
. -.<;2uvon
6/d, '3
i, seocm
z .do
x»oc j cns
j >2 rvon
roc .' . nel,
ic 2 - /•. n
J. .ic.
■ ji-ycj •
Indoco
Cyc1open
Do 1pp.. r
-c.
o.johonitrc io#
of strychninyil
:?i:<ec ojsei,.
.•ttrj .
i
an..!
■
1
. il
$
•• •
^/6/'6
Jil.
10/7/7
Uyno "-x
^--- -r'e
. —
>V . .
/ 3
•
,
..
o—
p l<r C ■~. •. > - t
. JUS .. *
3 13/9/8
NIL
None of these brands now
contain Phenacetln.
1/13/9
Eixed dose combinations of anti histaminics with
anti diarrhoeals.
~
NIL.
2/11/10
Fixed dose combinations of pencillin and
Ju 1 th on aiva d^s .
•a•
None of these brands are now
available*
■ ■• •--•■• In
W <
5/12/11
Go>ribinu-cicns ox vitanans with Anel^osico 3
withdrawn.
0/13/12
NIL.
Fixed dose combinations jf Tati<.eyeline vitb Vitamin C.
/ichromycin I.v> Luderle
2) Miniciiln
Ethico
3} Terramyuin Ji VIT.... pfizur
0/14/13
Fixed dose com01i-.otion.s or :/ roxy.._,uinoline ^rouo
or drugs except oreparationo which are asek Lor the
treatment ..-k diarrhoea and ysentery and ror external
use only.
\ * otedmed iSntxo2;y*ne 3od.cCLoro
Diastase
Bi, 32 niacin
amide.
(Jtcfd;\ocU
i
•>
1/15/14
Fixed ■ xse c<xrbln. Lions o£ oterpids . ji i.^t^nial
use except combination of steroias vith other
for the tree tra..-nt •f A.> th If-a.
Ccrtihist
Xngo
■ :. q. . ■ ill sc 1 an-3, chi orphan® a. iine
Peridjg a
A/..iiv^rn 312
Mxoj en
Xnj .iiixogen
'c sums • strong •
Testiobion oisecron Forte
Lynoral
Ma leate
riorcx Sharpe
)ex« MiG the sone t
v. i)ohrne*
cy prohe/.tv -in^.
Nicholes
Fxee ■„ ::stostcrone,
Vt.312
Ini - .... Ii<
Jtl’sinyl oestradiol,
i _■ d;y x t•.>.-st<j y.tcrone •
'oestrcxllol TOnooenzoate
Methyl
lp?ru. iGZicte,
T□stoj te rone, .xopionate
-nylp£o.?io;i. -.e,
i \cv-j.jivlte.
de rck
Merck
Nicholas.
-
I...................................-
■■■■.,.'
....
Goffjine,recophodrinu,dCL(tob)
Testosterone,Vit.
”
,Vit.E, H6, B12.
r og e j t rone, s tra d i o 1,
benzoate.
»
7/18/1.7
0/0/18
- 5 C^nbinations of Vitamins, ^ith
ea£i IB druus .expert caabinition of Isoni/.aide
d3:Ad^^X^gln.e. J ly ,. roch lor ids (v i t. ls6J. j
WXL
.Cr^-C J,-_ 1,1 in ,.'• ir^/^y -
1 n .ieii-c
.,ix,
0/0/19
■Srl^yi^ypline .liquid ora.l, ^repar^tion^ g
XijtXMX
^•eirsmycin syrup
Tarr^faycia
AlcycLlxi^tj
-
Pfix&r uxytetracycline
drops
Cl>kj
H
- Alembic
-'xyt^tracyclin^ CIM6
lidocaine,anhydrous
oxytetr^cyeline♦
A*
Voluntary Health Association of India
LCD / a/1 6. 7.84C-14, Community Centre
Az
Safdarjung Development Area
c
New Delhi-110016
a.\ M\
Telegrams : VOLHEALTH
Z
New Delhi-110016
/v
nt
668071
Telephones . 66g072
w ^7
Graded Essential Drug List
Explanatory Note;
’V HEALTH CELL
i-i:oor)3
aor)3 c. Marks
-noad
BARIGALOH&-5SOOQ1
These are the guidelines to help Community health progra
mmes and health institutions draw up their own essential drug
list ♦
This is a compilation of various drug lists and it empha
sises the concept of Essential drugs. For those believing in
and for those involved in alternative health care, the concept
of Essential drugs is an integral part of health work.
The format used for this compiled list is based on WHO’s
Essential drugs list 9 Technical Report Series 685. An outline
d£ it is given. It should^be noted that certain drugs are
repeated as they are used more than one disease entity.
The various drug lisiS as they appear in the compiled form
are as follows:
RMRQ(Eastern Mediteranean Regional Office)- WHO
List A - for Sth class passed
List B - for that are class 10 passed and have had training
Bangladesh drug list;
Category I - for village level workers
Category II - for Primary Health Cere.up to Thana complex lev<L
CMC
Christian Medical Council list - Contact Ito..63,August
1981, ’’Getting Essential Drugs to the People”- Stuart
Locost;Low cost standard therapeutics a collective votun^a^V
enterprise for rational therapeutics
C/0 Amr.l, G P 0 Box No.7, Vadodara 390001.
PU:Essential drug list drawn up. by sub-group dealing
this at VHAl’s Pune Workshop ’’The Drugs Issues seeking feasible alternatives”.
Formulary of Post Graduate Institute of Medical
PGI:~
Education and Research.
Sri Lanka graded Drug list included here is list of
SL:d>rugs recommended for doctors incharge of Peripheral
health centre.
Gambia restricted drug list based on their national
Gi
formulary.
An English NGO supply equipment and drugs to Charity
E^ho
Hospitals overseas.
AM:7
Action Medeor.
our humble recommendations
for trained village health worker level
for trained Paramedic or middle level workers
)
for
doctors involved in primary health care
2- )
r~>
Those drugs included in-the Hath! Committee have been
underlined. This drug list is meant fo/be a guideline to help
health care institutions in the voluntary health sector to
select their own essential drug list. It is up to us to show
it to the government a^i Our medical colleagues who believe in
commercialisation of medical care that good health care does
not necessarily depend upon the length and variety of^the
drugs used.
♦
. • .ii.• .
It is extremely difficult to go against thecurrent create.
by the market forces. It is a true test of our conviction
:
our capability o eonvimce others.
* - Alternative substitute from the same therapeutic ..’roup
can be selected based on comparative lost and available ivy
equivalent products, eg. Hydrochlorothiazide: any orhcr thia
zide type diuretic currently in broad clinical use.
Lumbers in the Paren thesis following the drug names indie .
1) Drugs subject to internattonal control under the Single
Convention on Narcotic Drugs(l961) and the Convention on
Psychotropic substances(1971)
2) Specific expertise, diagnostic precision or special equip
ment required for proper use
3) Greater potency
4) In renal insufficiency .contraindicated or dosage adjustments necessary.
5) To improve compliance
6) Special pharmacokinetic properties for purpose
7) Adverse effects diminish benefit/risk ratio
8) Limited indications or narrow spectrum of activity
9) For epidural anaesthesia
Letters in the parentheses following the drug names ind Lo
cated the reasons for the inclusion of comp element ary drug:'
A. When drugs in the main list cannot be made available
B. V/hen drugs in the main list are known to be ineffective or
inappropriate for a given individual
C. For use in rare disorders or in exceptional circumstances.
9
The criteria of selection of essential drugs,
Steps to be taken to implement such a programme^Provision of
information on essential drugs as recommended by WHO have bee;,
dealt with earlier. In the text of the paper the format of the
drug list is as follows:
Refrised model list of Essential Drugs - a WHO "*
Exp ert' C‘ ommit t j; Report - Technical Report SerTes
1.
2.
3.
4.
56.
anaesthetics
1.1 general anaesthetics and oxygen
1.2 Local anaesthetics
Analgesics, antipyretics, nonsteroidal antiinflammatory
drugs and drugs used* to treat Gout.
2.1 non - opioids
2.2 Opioid analgesics and antagonists
Antiallergics
Antidotes and other substances used in poisonings
4.1 general
4<2 specific
Antiepileptics
Antiinfective drugs 6.1 anthelmintic drugs
6.2 a nt iam oeb ic d rug s
6.3 antibacterial drugs
6.5.1 penicillins
6.3.2 other antibacterial drugs
6.3.3 antileprosy drugs
6.3.4 antituberculosis drugs
6.4 antifilarial drugs
6.5 antifungal drugs
6.6 antileishmaniasis drugs
6.7 antimalarial drugs
6.8 antischist osomal drugs
6.9 antitrypanosomal drugs.
Antimigraine drugs
Ant
ine oplast ic and immunosupp ress ive drugs
8.
Ant
ip a rk in s o ni sm d r ug s
9.
10. Blood,drugs affecting the
10.1 ant iana emi a drug s
10.2 anticoagulants and antagonist
11. Blood products and blood substitutes
11.1 plasma substitute
11.2 plasma fractions for specific
11.3 plasma substitute.
12.1 ant ianginal drugs
12. Cardiovascular drugs
12.1 antiarrhythmic drugs
12.3 antihypertensive drugs
12.4 cardiac glycosides
12.5 drugs used in shock or anapbyL. •
13.1 antifungal drugs
axi^ .
13. Dermatological drugs
13.2 antiinfective drugs
13.5 antiinflammatory and ant ip/-. ■
.
tic drug/
13.4 astringent drugs
13.5 keratoplastic and keratol/ - L
13.6 scabicides and pedi- ‘ ' I///.
culicides
14.1
0]>t
halmi
c
d
r
ug
s
14. Diagnostic agents
14.2 radiocontrast media
15. Disinfectants
16. Diuretics
17. Gastrointestinal drugs 17.1 anacids and other antiulc.
17.2 antiemetic drugs
a-"uo17.3 antihaemorrhoidal drugs
17.4 antispasmodic drugs
17.5 c at harti c d rug s
17.6 diarrhoea, drugs used in
17.6.1 antidlarrhoeal(symptomatic
17.6.2 replacement solution, c'ru/.. 18.1 adrenal hormones and synthetic
18. Hormones
18.2 androgens.
substitutes
18.3 estrogens
18.4 insulins and other aatidiabet-.
18.5 oral contraceptives.
agent
18.6 ovulation inducers
1§.7 progestogens
18.8 thyroid hormones and antithphpid
19-1 Sera and immunoglobulins
1 9. Iiamunologicals
19.2 vaccines
1'9.2. 1 for universal immunization
19.2.2 for specific groups o: indi"’±20. Muscle relaxants(peripherally acting) and choline- d uals,
sterase inhibitors.
Ophthalmological
preparations.
21.1 antiinfective agents
21.
21.2 antiinflammatory agents
21.3 local anaesthetics
21.4 mi ot ic s
7.
21.5
22.
23*
24.
25.
myd ri at ic s
Oxytocics
21.6 systemic preparations
Peritoneal dialysis solution
Psychotherapeutic drugs
Respiratory tract,drugs acting on the 25.1 antiasthmatic
25.2 antitussives
uru^s
26. Solutions correcting water electrolyte and acid-base distum26.1 oral
bar/'26.2 parenteral
27. Vitamins and minerals.
„
ite of adminlstration dosage
^ls 1^Afc>^^O'w£,uipG]SL
0 o.f? p 1 erae i ■ alist
riai-'
_____ forms .and .stxe^ths______Em jo " f °sh ...I 1, Anaesthetics
1.1 General anaesthetics and Oxygen
ether,anaesthetic(2)
inhalation
powder for injection,0.5g,1.Og
(Sodium salt) in ampoule
1.2 Local anaesthetics
.5% inj, 1,2(hydrochloride)in vial
•^Lid^ocaine
inj.1%, 2% + epinephrine 1:100000
topical forms 2-4 (hydbrochl oi'id e^q
a
2. Analgesics9antipyretics,Nonst eroidal antiinflammator/
Bnug_s and drugs used to treat Gout,
2A1 Non-opioids
tablet 100-500mg, suppository,
5O-15Omg poed Aspirin
tablet 200mg
* ibuprofen
capsule or tablet 25 mg
ind ometacin
tablet 100-500mg,suppository 100m
paracetamol
+ syp
2..2. Opigid .analgesics jand antagonists
(P h e hy lb ut az on e.) / 0 xyp h enb ut a z on e
inj 10mg(sulfate or hydrochloride)
morphine(1)
in 1 ml ampoule
pet hid the Hcl 5ml/ ml
2..*..4^ iall e rg i c s
*c.hl orph enamine
epin? ep brine
tablet 4mg(maleate)
inj 10mg in 1ml ampoule
inj 1mg(as hydrochloride in 1ml
ampoule
----- ,
__________________________________________ ________
E ; ai l
I II |
0
0
B
. A
s
4
A
A
A
’A
t
'4
Lj -1-
4. A nt id ot e s and
4?T (Tener4.5”
chare oal 9 act ivat ed
b
ao•.nlc. b i at ion d Osage
forms and sJ re ng ths
1
Lisfei-. t
jt ner s ub st anc es^ i u; ed in p ais oning s
A
B
Emtro
>i
pc.'.it
r 3L G L
21 II
e
—T-t—
Powd er
A
4»2 specific
atropine
inj 1mg(sulfate)in 1ml ampoule
diazepam
inj 5mg/ml in 2m1 ampoule
5» .intiepileptics
phenobarb it al (1)
tablet 50mg,100mg,syp 15mg/pml
capsule or tablet 25mg, 100mg(sodi"inj 50mg(sodium salt/ml in Jml via
ig* ’
phenyt .in
• ?
B
I
6, ^Ant;iijifcctive drugs
6.1 Anthelmintic drugs
meLenda.zole
A
B
• I
i
i
I
C
C
A
tablet 100mg
piperazine
tablet 500mg(citrate or adipate)
senna tablet Xlevamisol)II tablet elexir.
Elexir or syp(as citrate)equivalent I
A
B
let r^Morei-iyUnelHathiJ
t o 500mg hyd rat e/5ml
6.2 „ Ant lamp eb ic drugs
chloroquine
tablet 200mg(as phosphate or sulfate)
diloxand.de
tablet 500mg(furoate)
A
B
B
metronidazole . ,
'
tablet 2OO-5OOmg
dehyro emetine(B)j,7) inj 60mg(hydrochioride)in 1ml ampoule
f urazolid ine
inj 60mg
.
B
P tiiaJ.yl gulp hath tag ole
A
I
1
II
------ --- —^4-
Main list
G
p 1 •• i g nt ary I i st
6.5. ..hat it actejriala fjogs
6 s 3•1 Penicillins
*ampicillin-(4)
nout . .■ of administration dosage
forms and st rehgths
fortified benzyl penicillin
phenoxymethyl penicillin
procaine benzyl panicillin(7)
UH-
Capsule or tablet 25Omg,5OOmg
(annydrous)I
powder for oral suspension 125mg
(anhyd rous)/5ml
powder for ini 500mg('as sodium
in
salt) ZI i
— vial
.
inj 1.44mg benzylpencillin
(
b ensathine benzylpenicillin(5)
--
List Mnls-qCIiC’ Lot
A
I n
jPU PQ1SL G- : E ;i /Ml
■p OS'£---nmr^
■
i
\
/ r-
B
. n
procaine benzyl penicillin 30000
u/ml + benzyl
pencillin 10000 u/ml
powder for inj 0»6g
1milion IU) 3.0g(=5millionIU)(as
sodium or potassium salt)in vial
tablet 250mg(as potassium salt)I
powder for oral suspension 250mg
(as potassium salt)/5ml
powder for inj 1g(=1million IU)
B
B
B
)
!
t
B
I
B
3g(^3 million IU)
6. Antiinfective, drugs
2 other
antibacterial
drug’s
6.3.4?
Zl■'
capsule 250mg
^chloramphenicpl (7.)
powder for inj 1g(as sodium succinate)
in vial
capsule ortablet 250mg(as lactoerythromycin
bionate)/5ml
powder for inj 500mg(as lactobionat.e) in vial
inj
10mg
9
40mg(as
sulfate)/ml in
entamjoin(4)
2ml vial
tablet 200-500mg
m e t r on id a z o 1 e
B
i
I
(
I
I
?
. J
I
0
C
B
vlain
C o:.i p J.. G;.. i e nt a ry 1 i st
.^S.iu,£a±imiu ine.l 4) (snip had iazine)
* s ulfarn e t h oxa z ol e-H r in e t h op r im (4)
A
B
SI G E AM C .1
ui
st I ListCMC L ow
AA
___ Cost puki
-Si o
Route of administ rat ion dosage
forms and strengths
inj SOOrng in 100ml
Suppository SOOmg, 1g
tablet 500mg,oral suspension 500mg/
inj 1g(sodium salt)in 3ml ampoule
t ab1et 10Omg+2Omg? 4 0 Omg+8Ong
A
. B
,*Xetra£y^Xine(4) ’
doxycyline(B)(5? 6)
capsule or tablet 25Omg(hydrochlor.de)
capsule or tablet 100mg(as hydrochLloride)
inj 100mg(as hydrochloride)/5ml in
^i£2Xu£8£iojX<A,B)(4>7) tablet lOOmg
ampoule
Hydroxy quinolines
100mg tablet
• 3*3 Antilepr ^sy_f’ rugs
clofazimine
capsule 100mg
dapsone
tablet 50mg9100mg
rifampicin
^capsule or tablet 15Omg,3OOmg
< 6 *_3^£r, Ant it uherc ulps is drugs
ethamj&o-ut ol
t ab 1 et 1 00- 5 OOmg (hyd r oc hl or id e)
i.$pni%zid
tablet 100-300mg
pyrazinamid.e
rifampicin
-
. A
c
t
. k
I
. C
B
I
i
C I
powder for inj 1g(as sulfate)invial
t h i aac et az on e¥is oh iazid
tablet SOmg+lOOingy 15Ong+3OOag
•d
...Ant if il_axis^j?u^s
’
tablet 50ng(citrate)
6.5 Art if urr al C rug s
'
i
. B
o
. B
B
Thiacetazone
50C'( -
«
. c
capsule or tablet 15Oing(3OOmg
‘Gnb?
i
c
tablet 500ijig
alxsaisiizc(4)
ny £• t at I n
II
<o
l
I
I
in
i
O
nxin list •
C'o„..pl
•*»
<2
•
f oi<j s airi st reagt-hsi
6 ? 6 Antilelshnaniasis
s od ium st ib ogl uc onat e
pentanidi’.ie
6.7
^rugs
tcklox'P^Uin-g.
r
■
? xy list
.xstiList OMClc’,
A- ! B
C?
Cosfpl>GI SL G E AM BC I
Enpo
inj 33% equivalent of 10% antinoiy
in 30d1
povjder for inj 200ng in vial
tablet 150ng(as phosphate or
(0
0
*
5) .
syrup 50ng(as phosphate or sulfa se)
/5nl
t ab1et
Qi1<&fe§ph^t e)
s ul I at e)
tablet 300ng(as bhsulfate or
inj 300ng(as di&yifSenioride)/
ini in 2.-11 ampoule
Pri;iaq.'uino
B
B
B
py r^vret ham ine
sulfadoxine+pyrimethamine(B ) tablet 500mg+25iag
7raine drugs
ergotamine(2,7)
tablet 2.3g(as tartrate)
■
B
.Blood-.drugs affecting the blood
10.1 Anuianaenia drugs
ferrous salt A
folic acid(2)
*hydroxocobalanin(2)
*iron dertran(B)(5)
tablet equivalent to 60ng iron
(as sulfate or fumarate)
oral solution equivalent to 15ng
iron(as sulfate)in 0.6ml
tablet 1mg
inj 1ng(as sodium salt)in 1ml ampoule
A
C
inj 1mg in hsl ampoule
inj equivalent to 5Ong iron/ml
in 2ml ampoule
Cardipvs.gscnlar drugs
72Tl /Jru1 d rugs
t cb1et (sub1ingua1)0.5ng
1 t rinitretx
i
r
i
0
11 i
i
.r. diet
*isosorbide dinitrate
*
propranolol
*verap aril 1
Ptont. ox nd. .iniyt.iat ion dosage
f o r::i s and st r g ngt h s
"1st TIsTcmcTo^ .pup I SL G E
A „
B i
Eero
C
c
“”“——-
in j^aepheht eramine sulpli^Xp
i inj noracenalin(Hathi)
W'rv IMV.
■
*WW—I
II I » l-MMZl H-. M «.0 '—W «*•
_______
t ablet(sub1ingual)5ng
tablet 10ngr40ng(hydrochloride)
inj 1:ng(hydrochloride)in 1nl ampoule
tablet 40ngf80ng(hydrochioride)
inj 2.5ng/nl(hydrochloride)in_2^1^ e
Tablet 25Ong 9 500mg(hyd rochlorid c)
inj 100rng(hydrochloride)/nl in
10ral ampoule
12.3 Antihypertens:ve drugs
TStflet 5Ong(hudrochloride)II
*hyaraiazine ’ " ——•
tablet 50ng
*hydroc hlorot hiazine
tablet 40ng?80ng(hydrochioride)
■ *P r °P r 01 °1
t ablet 0.1mg,0.25mg
*reserpine(A)(7)
inj 1ng in 1ml ampoule
2>4. Cardiac .dycosides
.——---- — tablet 0.0625 Dg?O.25cig
cl igaxin(4)
oral solut i on 0.25 ng/ml
inj O.25ng/nl in 1al ampoule
1 2drugs usc^1 in s hock or anaphylaxis
epinephrine
~
j 1 ag (as ’hydrochi or id e) in Imlampoule
*procainanid o
I II
■ .Gosa
C
B
C
B
15mg/ml
Img/ml
C
*'« ***.*■«- .^^••►■■■*••0^ ■
1‘ ke rnat oloA-i cal d rugs
’Benzoic - L ^5-* t .oii-^Lmngal.
; acid + salicylic aodd
Wtfield
) ...............
1p.2 ./ A•; 1 ”; .;.-ct ? ce drugs
-jr.-i’t-oit.. ...c n
ointr ent 5:'';G neonycin sulfate+500lt
bac it ricin ainz/g-
B
I
i
i B
c
Co iplu....ientary list
1 ] ■
. .7. .
LisilCMOlow I '
Route of administration dosage 1 sbst B
SostFPUPGI SI G E JIM
forns and strengths
E..rc
i
i
t
tetracycline dintment
chlorauiphenic ol
13.3. Antiinflacyatcry jind_antiprurItic _drugs
*betanethazohe(3)
*6Tntnent *or-crean d7l%(as
valerite)
*calani;ne lotion
lotion
*hydrocortis one
ointnent or cream 1%(acetate)
1 3.5...Kerat qpla£ t io and kerat olyticuagents
.... '^oIuTioh topical 5%
1 3.6 Sc ab i c id e q „ a nd,., r d. iculicid es
b.eujzy 1. b qri s oat e
lotion 25%
14» .diagnostic agents
14
tub ere ulin ? p
; ur if i ed ” p’f of I eh
’
de r ivat ive (RPR)
injection
fluroescein
14.1 Op ht halroi c d rug s eye drops 1%(sod|un salt)
salicylic acid
*c h 1 o rh e xid in e
1 g^-Di^g^ctant s
solution 5%(gloonate)for dilution.
solution 2.5^
“iodine
B
B
J
B
A
B
0
B
biuret .res
T^X^Tpoohl pr i t_ g iaz id e
tablet 40ng
inj lOng/nl in 1n.l anpoule
tablet 5Ong
. B
. B
C-astroint estinal drugs gt 5
alun.inhu’i, hyd roxide (AT ”
oral suspension 320ng/5nl
n agii *e s i un hyd r oxide-
oral suspension equivalent to
5 5 Ong nagri e s i un o xid e/10r. 1
*p roc vet haziae(a) 17.2 Antieaetic dngs tablet Wag., 2 5 reghydrochloride)!^!.
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— ------- ,--- r-iuti.L—»
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18•8 Thyroid honauneg and antihydroid drugs
lev othyro xine
tablet 0.05-ng?0.1 mg(sodium salt)
tablet 60mg
potassium iodide
*propyIt hieurao il
tablet .5Ong
1
Micals
ant i ven ox sera 19.1 Sera and ai^ooncglQ ulins
2na all plasma fractions should
c oin p 1 y vri t h WH 0 r e q u i r e n e nt e
d iptheria ant it oxin
in J for the collection,processirg
and quality control"of humai"
blood and blood products
inj 10000 IU
i
1
■
i
solution(eye drops) 10% sodium salt
eye ointment 1% (hydrochloride)
21.2 Ans
AniXXuSlXSXy. ugorts
4
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I
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eye ointment 10%(sodium salt)
L
!
i
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sulfacetamide
I
1C
i
1x PpthalmologIcal preparations
silver nitrate.21.1 antiinfectivo agents solution(eye drops) 1%
I
c
I
19.2.2 cholera TABC,small pox
I
i
20000 IU in vial
inj 50000 IU in vial
eta?Ui§...ant itpxin.
19.2 Vaccines
1.9» 2* 1_.'for universal ipnunization
BCG vaccine(dried)
inj )all vaccines should comply vith
fil&U1:J^Eia^P.ja:t]^.S^te.t:anua_p&0$-!.ne.inj) the WHO requirements for
diphtheria-tetanus vaccine
inj) Biological substances.
'measles vaccine
inj)
’^Qlj^iy^itX^y.3.c-c.ine(l.iveat^enuatec )inj/oral solution
tetanus vac c ine (WO, Hat hi)
ip£
II
c
c
c
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9
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H
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i .. Main list
21.1 '
pilocarpine
♦
0 -n -1 er ent ary
crro fllsy
Rout e of adainist rat-1 on d osage
A
forms and strengths.
asA -I
21.4 Jli otic s
21 .• 5_ Myd ruit ic s
Pl^si 9stigmine£^^,)
1 Oi la t r opin eJ L.)
^ergometrine
oxytpej-n
1 i et
22. Oxytocics
‘
-------- ---
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i
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U I PG I S G
cos:tp
...' - ...
~I 11
solution(eye dpops)2%,4%(hydroclcride or nitrate)
s olut i on (eye d rop s) 2?o( hyd r ob r odiid e)
teyswsgfewi’ 1=1
=
imj 10 IU in 1r=l a-spouJ.-'
24 Paychotherapeatic- drugs
t c hl-orp r o.:-a zi n e
i tablet 10^iag (hydrochloride)
syrup 25ng(hydrochloride)/5nl
inj 2Jrag(hydrochiGride)sl in 2 cl
*diazepan
tablet 5 ag
anpoule
^-■■g.gspjL.ra.tory^tract, drugs acting on
* air in op hy11 in e 2 5 <.> 1 ant lastnr-aTic 'dr ugs ’ " '
tablets 200tig
inj 25ng/r?*l in 10nl aripoule
epinephrine
inj 1rag(as hydrochloride)in 1ei1 ,
e.Eip o u 1 e
*salbut anol
; tablet 4ng(sulfate)
oral inhalation(aerosolJo.1ng pci
syrup 2iLg(sulfate)/5nl
does
adrenalin tartafat& naliate in 1000
phenjjbard 5ng, cphidr^ne 10~g?
tnepphyliiie _. 1_252(Hathi)
noscapine(cough suppressant)
epJaed r i n e (A)
tablet 50ng(as hydrochloride)
!
i
!
n
i
(
i
C !
B
I
5
9
I
I
i
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11.00
.’rx**"*»**"*S**4Bl-< W**
Main 11st
-~'**r7r’l‘SW‘t
•'
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-
0o?:p 1 c•o11i;a.ry list
1■
.
—I
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-------- -r
•- -T
JMT-. .
--.Uli
!!!-
Route of administration dosage
f o rm s a nd s t r engtr h s»
.milMJJ.: —II..-
J-
iis-i
stCMC lowi
costj^U
Bn ro
lp
r
C'l SL G B AM I II c
26. _Solut iop.s Gori ecting water, electpolyte and acid-bas<
?r
disturbances_
■ oral rehydratio&%al£sftor ."Iucoe e-salt solution) (for compos it on see
p otassium chiorid e
glucose/ (dextrose) 26. 2 Parent eral
gl^Qs e_with^ s pdiu^„ shlszid k
potassium chloride
sodium bicarbonate
Sodium chloride (cholera fluid)
calcium carbonate gluconate
water for injection
A
17.6.2 replacement solution)
oral solution
B
injectable solution5% isotonic, 50%
hypertonic
injectable solution 4% glucose 0.18
sodium chloride
(Ka+0mrapl/1) (Cl-30 mmol/l)
injectable solution
B
B
B
"
" 1.4% isonic(Na+167 oe ol/D
(HCO3-167 mol/1)
injectable solution 0.9% isotonic(
(Na+154 nmol/1) (01-154 nmol/1)
in 2ml,5ei1,10ml ampoules
rib oflavin
s od i uni f 1 u^ > d e (8)
vitamin . &.D.
VM
B
I
B
i
i
2 7Vitamin s a nd l inerals
~
---------t^ret 5 Ong
ascorbic acid
*ergocalciferol
capsule or tablet 1.25mg(50000 IB)
oral solution .25ng/nl(10000 IU)
*nic o-t inamid e
tablet 50ng
pyridoxine
tablet 25mg(hyd rochloride)
retinol
r
I
capsule or tablet 7<5ng(25000 IB),
60mg( 20000 IU()
oral solution 15ng/ril(5OOO iU)tab.5n
tablet 0«,5ng( as fl ud ride)
oiiAQXhK (Prophylactic KT’I therapeutic NEI with Vit 0+ folic acid)
tablet + injection)
? 12(hathi)
j
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/
Voluntary Health Association of India
%
C-14, Community Centre
Safdarjung Development Area
New Delhi-110016
c
i4.\
D-344
Telegrams : VOLHEALTH
New Delhi-110016
/0
/V
Telephones . 668071
' 668072
”7;72379785
PRIORITY DRUG LIST AS SELECTED BY NATIONAL
DRUGS AND PHARMACEUTICALS DEVELOPMENT COUNCIL
THE STEERING COMMITTEE
MINISTRY OF CHEMICALS AND FERTILIZERS
GOVERNMENT OF INDIA
AUGUST, 1984
ANAESTHETICS
1)
2)
3)
4)
5)
Ether Anaesthetic
Halothane
Thiopental
Lidoc ai ne/Proc ai ne
Nitrous Oxide
ANALGESTICS/ ANTIPYRETICS ETC
6)
71
8)
Aspirin
Ibuprofon *
Paracetamol *
O
ANTI-ALLERGICS
9)
10)
Ch 1 o rph e ne r ami ne
Epinephrine
ANTI-INFECTIVES
11)
12)
13)
AntheImi ntic
(a)
Mebendazole *
Piperazine
Behphenium Hydroxy Naphthoate
(b)
14)
’15)
16)
Antiomoebic
Chloroquine
Metronidazole
Ampicillin
Benzathine Bonzyl PenciIlin
17)
18)
19)
20)
Benzyl Pencillin
Procaine Benzyl Pencillin
Chloramphenicol
21)
22)
Sulphadimidine
Sulphamethoxazole
cont’d .. 2
s
■ 344..,
23.
2
25.
Trims thoprim
Tetracyclines
Oxytetracyline
26.
E ryth romyc i n
24.
s
Anti-Leprosy
27.
28.
29.
Chlof azimino
Dapsone
Rifampicin
ANTI-TB
30.
31.
32.
33.
34.
Ethambutol
Isoniazide
Pyrazinamide
Streptomycin
Thiacetazone
ANTI-FILARIAL
35.
Diethylcarbamazine
ANTI-FUNGAL
36. Griseofulvin
ANTI-MALARIAL
37.
Primaquine
Amodiaquine
38.
IMMUNO-SUPPRESSIVE
39. Busulphan
40.
41.
42.
Ch1orambuc i1
Cyclophoshamide
Flurouracil
ANTIANAEMIC
43.
44.
45.
Ferrous Salts *
Acid
Folic
Hyd roxoc ob a 1 ami ne/Cy anoc ob a 1 ami ne
cont’d .. 3
.*-344
2
3
s
PLASMA SUBSTITUTE
46.
Dextran
CARDIO VASCULAR
47.
48.
49.
50.
Glyceryl trinitrate
Isosorbide dinitrate
Propranolol
Verapanil
51.
52.
Hydrallazine
Hydrochlorothiazide
53.
Methyl dopa
54.
Digozin
DERMATOLOGICAL
55. Neomycin
56. Bacitracin
57.
Bethanethasone
58.
Benzl Benzoato
OPTHALMIC DRUGS
59. Sulphacetamide
60.
Pilocarpine
61.
Homotrophinc
DISINFECTANTS
62. Chlorohexidine
63<
64.
Cetrimide
Dettol (Xylenole)
DIURETICS
65.
Fruesamide
ir.
GASTRO-INTENTINAL
66.
67.
Promethazine
Oral Rehydration Salts (deleted in the
meeting of Steering Committee)
cont’d ..4
%
2
4
2
H0RI40NES
68.
Dex ame th a s o ne
69.
Prednisolone
ORAL CONTRACEPTIVES
70. Ethinyl Oestradrol
71. Leveno grge s tro1
72. Nerethisterone
ANTI-DIABETICS
73. Insulins
74.
Glybene1amide
75.
76.
Chloropropamide
Tolbutamide
MUSCLE
77.
78.
RELAXANTS
Neostigmine
Suxamethomium
OXYTOCICS
79.
80.
Ergometrine/methyl orgomotrino
Oxytocin
PSYCHOTHERAPY DRUGS
81.
Ami trio ty1i ne/lmipyrami ne
82.
Chlorpromazinol (substituted)
83.
Trifluperazine
RESPIRATORY
84. Aminophyllin/theophyIlin
85.
86.
Hydroxy Ethyl Theophyllin
Salbutamol *
87.
Ephedrine
cont’d.. 5
'34
5
s
s
VITAMINS
88.
Vitamin A
89.
Vitamin D
90.
Vitamin C
B Vitamins Nicotinamide
91.
92.
93.
94.
Pyridoxide
Pantothenetes
Riboflavin
95.
Thiamine
★ decided as
requiring special attention
for encouraging production.
* *
*
*
*
*
★
*
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area.
New Delhi-110016
4-
v\
>1
al Vm\
(d.\
A
Telegrams : VOLHEALTH
New Delhi-110016
/o,
Telephones : ooonZl
oboU/z
--7379.85
September 23, 1985
Dear
As you are aware the "NATIONAL DRUG POLICY"
of India is being formulated at present.
Voluntary Health Association of India (VHAI)
has been deeply concerned about the
non-availability of essential and life saving
drugs in the field
- flooding of the market with costly irrational
and hazardous drugs
- non-availability of unbiased drug information
- poor quality control and drug control (so that
one in every five drugs is substandard)
With 30,000 formulation in the market, it
is becoming impossible for the doctors, chemists and
the consumers to differentiate the good from the bad.
In countries like Sweden, with a very efficient drug
control mechanism, adverse drug reaction monitoring
and strict prescription monitoring, merely 2,000
formulations are permitted in the country.
As a nation we can not afford to squander
the scarce resources of the nation and of the
individual consumers on irrational and useless drugs.
.3
'.•j
o w o
o
5
> o a
□
This letter is being sent to you to obtain
your expert views on
tn
2 .t• <3!
■. a
(1)
what should be our essential drug list ?
(2)
if graded according to level of expertise and
size of health institutions, what kind of graded
essential drug list would you recommend ?
(3)
your comments on the essential drug list as
drawn up by National Drugs & Pharmaceutical
Council Steering Committee
cont’d .. 2
s
2
s
Alongwith this letter the following is being sent
to you s
(1)
WHO Essential Drug List as reprinted in CONTACT
(2)
List of 115 drugs selected as essential by the
National Drugs & Pharmaceutical Council Working
Group (NDPDC) (Trying to obtain this list)
(3)
List of 95 drugs selected by the NDPDC Steering
Committee which was compiled with the aim of
"decreasing the number of drugs undej? price
control"
(4)
A cyclostyled Graded Essential Drug List drawn up
by us last year is also being sent, which compares
the essential drug lists recommended by various
Governments and organizations.
Before I end, I wish to quote two statements
From
ICSSR-ICMR Report, "Health For All - An
(1)
Alternative Strategy^’ 1981
"There is always a dangerous turning point at which
the overproduction of drugs and doctors creates a^
vested interest in the continuance or expansion of ill
health. It is not generally recognized that we
are dangerously close to this explosive point’1.
Z) V)
(2) Quoting Dr Halfden Mahler, Director General, W.H.O.
I
c
"I am saddened that by and large the (medical)
profession has not grasped the seriousness of the
world health situation in spite of heroic medical
efforts, nor has it realized how inappropriate
society’s response to this situation is, no
matter at what level of social and economic
development. I can only appeal to it again to
assume its leadership role in health before it is
taken away from it irretrievably1,.
Reference s Eighteen Years to go to Health for All
in’WHO Chronicle 1982 s Code of Practice
for the Pharmaceutical Industry.
We would like to see this selection process
being a part of your medical college or institution's
important activity, you could discuss it in s
a medical conference
journal or club
staff meeting, or whatever you think is best
cont’d •• 3
~ ' 44
s
3
Needless to say that prices of drugs
outside this essential drug list will be decontrolled
and shoot up, while availability of essential and
life saving drugs will still probably not be ensured.
I would very deeply appreciate at least
some response from you at the earliest.
A week ago in Gorakhpur for the first time
one of the Medical Professional bodies deliberated on
drawing up their stand regarding the National Drug
Policy. VHAI and other organizations constituting
the All India Drug Action Network (AIDAN) have been
urging for a Rational Drug Policy for our country for
several years.
An irrational drug policy would not merely be
anti-people and anti-health, it would irrevocably alter
the very concept of health care and wipe out self
reliant low cost effective alternatives that may
exist in the field. A policy made by politicians
and bureaucrats-and with half the members on the
NDPDC being from the drug industry - could do great
harm if allowed to be finalized without a public
debate, at least amongst key health institutions
and medical colleges and the academic bodies.
Your response would be deeply valued.
Kindly consider this a personal as well as
a collective appeal for your help.
With sincere regards.
Yours sincerely.
Dr Mira Bhiva, M.D.
Coordinator
Low Cost Drugs & Rational Therapeutics
ends s as above
^Indian Academy of Paediatrics, Gorakhpur, UP
4
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area.
New Delhi-110016
-10/344..14.10.85
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Telegrams': VOLHEALTH
New Delhi-110016
T . .
668071
Telephones : 668Q72
October 14, 1985
Subjectst US BILL to allow export
from UNITFD STATES, material
not marketed in USA.
Watering Down of UN Consolidated
list of hazardous drugs and
chemicals.
Dear Friend,
I have just received a cable informing
us about the ’HATCH BILL’, being brought into US
Senate. There is a move to get Senate Edward
Kennedy to co-sponsor the BILL, which if he does,
the chances of this BILL becoming law are very
bright.
The BILL will allow export of pharmaceuticals
not APPROVED FOR USE IN USA to countries with
regulatory and drug enforcement procedures considered
adequate by F.D.A. The problem for the Third World
countries will be that re-export of these products
from the above mentioned countries cannot be regulated.
Please send your views by cable or letter
immediately to s
Sen Edward Kennedy
US Senate
113 Russel Senate
Office Buildings
Washington DC 20510,
USA
and if possible a copy to s
I)) Mr Joe Coffman
Public Citizen
•
Congress Watch
215 Pennsylvania Ave
Washington DC 20003
cont’d
W.LTH CELL
(rjru•, w
noad
BANGALOBe - 5uu
2
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20/344
2
s
3) Ms Virginia Beardshaw
■■ H A I, IOCU
Emmastraat 9
2595 EG The Hague
Netherlands
and to me. If you would like your letters to be
posted from here.j I will do so.
In our last ’Drug Action Network' newsletter
7-W?
informed you all about the U.N.
i^.St
hazardous drugs and chemicals which have^een
banned or restricted.
There is a move to EXCLUDE the brand name
and the manufacturing data and also to exclude drugs
that were recommended for being weeded out because
or their therapeutic uselessness.
For countries with poor drug controls
and gross lack of availability of unbiased drug
information any such dilution of information related
to Hazardous chemicals and pharmaceuticals is
unacceptable.
We are aware these changes are being
contemplated because of pressure from certain sources
Please write immediately to the following ?
sources1) Mr Luis Gomes
Asstt. Secretary General
UNITED NATIONS
DIESA - Program Planning & Coordination
Office
DC 2, 18th Floor
New York, NY 10017, U.S.A.
2) Mr Peter Hansen
Executive Director
UNITED NATIONS
Centre on Transnational Corporations
DC 2, 12th Floor
New York, NY 10017, U.S.A.
TTnitoH M
se®ms.that world Health Organization and
united Nation Environment Program (UNEP) will be
playing a major role in compilation of the 1986
consolidated list.
con’d..3
I ,
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s
3
s
It is important that the above
organizations (known to be very susceptible to
pressure) are kept informed of NGO’s concern and
demand for a comprehensive updated consolidated list.
You could communicate your views to s
1)
Mrs Inger Brugemann
Director of External Coordination
WORLD HEALTH ORGANIZATION
20 Avenue Appia
1211 Geneva 10, Switizerland
2)
Mr Jan Huismans
Director
IRPTC/UNEP
Palais des Nations
1211 Geneva 10, Switzerland
I am sending this ’ALERT* to those of you,
who I feel are concerned about drug, science and health
policy issues and if you want any further details
about the HATCH BILL contact me.
Kindly send your letters directly with a copy
to me for follow up action, You could also send your
original letter (along with a copy) which could be
forwarded from here.
Best wishes.
Yours sincerely.
9G
Dr Mira'Shiva
Coordinator, Low Cost Drugs &
Rational Therapeutics
&
All India Drug Action Network
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Telegrams : VOLHEALTH
Safdarjung Development Area
New Delhi-110016
Delhi-110016
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Telephones :
53
E-10/344
MsJs5.11.1985.
The Hatch Bill
It was last year that Senator Orrin Hatch introduced a bill
No.S 2878 in the US Senate. The passing of this bill would allow
export of U.S. FDA unapproved drugs to be exported.
It should be noted that the existing American Law embodied,
in Section 801 of the 1938 Food, Drug & Cosmetics Act prohibits
the export of drugs which have not been approved for use in U.S.
Consumer and Health Groups have been working for similar
legislation in EEC countries.
When the Hatch Bill was introduced last year, protest came
from all over the world against the retrograde amendment. On
3rd December, 1984 hundreds of Thai Pharmacology students
demonstrated outside the American Embassy in Bang Kok against
the ’Inhuman' double standard policy, according to a third world
network feature.
Protest came from several organizations e.g. Satyodya in
"O
C5
Sri Lanka. Following an alert sounded by VHAI it came from
-J °
j
the Consumer Guidance Society of India, Medico Friends Circles, LM y>„ v,
Arogya Dakshata Mandal, Consumer
r
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Education Research Section,
O
-f" fl
Catholic Hospital Association of India,r KSSP and other
_ member
o
organizations of The All India Drug Action Network. Drug
< w ur>’
Action Forum,j West
r ' Bengal
~
one of the coordinating Committee
‘•j
X
members of AIDAN had organizedla ’morcha' in Calcutta in
o
5
protest.
o u
5 s ..
X — <
2t£
2^2
Health Action International played an important role in
keeping the first world grouns informed about the implications
u. CB
O \
of the Bill - and their social responsibilities. Many first
O c
world groups joined hands with the third world f^GOs in
expressing their concern. Public interest groups in U.S. played
a key role. After all the public outcry, the Bill was not voted
upon.
The Bill has been reintroduced with some modifications.
Senator Hatch has developed a 3—tier variation. Under this
scheme drugs not yet approved by FDA could be exported to
countries with ••<adequate
respected“ system where import is legally
allowed, would be the first tier countries.
The 2nd tier countries would consist of countries capable
of ensuring that information provided by physicians,pharmacists
patients is consistent with drugs labelling. Export to the
second tier countries would be allowed if a first tier nation had
approved the drug.
}
The third tier would constitute of all other countries
to which export would not be authorized except of drugs for
tropical diseases.
contd.... 2
E-10/344
2
MsJ s 5.11.1985
The fear of the critics of this Hatch Bill is that export
to any 1st or 2nd tier country does not ensure non re-export
to 3rd tier countries.
Subsidiaries of foreign companies have
been known to manufacture and sell drugs banned in their parent
countries.
There are several examples of what we would consider
unethical marketing. The laws of EEC countries do not prevent
export of hazardous drugs not sold in their own countries.
Support of Senator Edward Kennedy is being sought to Cosponsor
the Bill. The chance of the Bill becoming law are good.
Lars Broch, Director, International Organization of
Consumer Union expressing his concern, about the Bill to
Edward Kennedy writes in his telegram to him:
"Forcing third world consumers to accept less effective
and safe drugs would perpetrate a morally unacceptable daub.'
standard. Developing countries often have unadequate
or non-existant drug laws, and patent prescrintion only
products can be bought freely in corner grocery stores,"
Consumers and health and public interest groups all over
the world are urging that section 801 of the 1938 US Food, drug
and Cosmetic Act be left intact and no retrograde decisions
leading to double standards in health matters be permitted.
While concern has to be drawn for the laws in other
countries which could legally permit dumping of drugs by their
re-export from 1st, 2nd tier countries. The internal dump
that we allow in our own country requires stronger action.
Allowing manufacture and sales of hazardous and irrational
drugs is legalizing exploitation of the people, their money and
their health.
The National Drug Policy of India is round the corner.
We expect it to ensure that all the dru^s in the market are
screened and drugs that a known to be therapeutically hazardous
material, be withdrawn since safer alternatives exist.
Health of the people must take priority over health of the
industry, it is irrespective whether its a multinational,
national or small scale sector.
India as a nation and majority of the Indians cannot
afford the luxury of wasteful expenditure on hazardous
and useless drugs. It requires courage, concern and a sincere
belief in rational health care and rational drug use to take
some tough decisions.
cowtd...3
E-10/344
3
MsJ?5.11.1985.
We expect these decisions to be taken - they are
long overdue. A Rational Drug Policy is not merely owed
to the nation, but to the third world,
world. and to our little
neighbourer Bangladesh which has fought for implementation
of a very courageous people oriented drug policy through an
ordinance in 1382.
(Dr. Mira Shiva)
Coordinator
Low Cost Drugs and Rational Therapeutics
Convenor
All India Drug Action Network
$8
o
0^<
ALL INDIA DRUG ACTION NETWORK
M;J;5.11.85
NEEDED INTERVENTION IN THE NATIONAL DRUG POLICY <»
Dear Friends,
M2SL°f JlOU are alreadV aware of the exploitative functioning
of the pharmaceutical companies in third world countries.
You are also aware that the National Drug Policy is under
formulation. The outcome will be mainly decided by the pressure
nd influence of the drug industry's foreign sector and the
national sector.
The National Drug & Pharmaceutical Development Council (NDPDC)
which was formulated in.1983 to look into'the drugs issue'- has
ooKed into the mere pricing and production aspects of the
drug problem and that too from the point of the drug industry.
There is a strong possibility that the National Drug Policy will
be like the Textile Policy.
It is crucial that the peoples interest is safeguarded. The
drugs are supposed to be produced in their
—.*■ interest after all.
To give you an.idea of our demands, I am sending you our All
India Drug Action Network's Rational Drug Policy Statement.
'Just read our.criticism of the sSteering committee report and
the mam headings - if you are too busy. if you can spare
sometime and concern (not because you lack it, but because
you are already involved with other things) please alert your
-riends, your organisations network and request them to take
whatever action they can take. From writing protest letters
to the
**6 policy
p°licy makers involved, t
to editors in holding meetings.
Since medicines deal with health
health and lives of people and no
matter what area of work you all are involved
-- —in ■ -if you could,
drop a letter concerning your views about a people oriented drug
policy to
Mr. R.K. Jaichandra Singh
Minister of State for Chemicals & Petrochemicals,
Shastri Bhavan
New Delhi
Mrs. Mohsinha Kidwai
Minister
Ministry of Health & Family Welfare
Nirman Bhavan
New Delhi-110011
Dr.D.B. Bisht^.
Director General of Health Services
Ministry of Health
Nirman Bhavan
New Delhi-110011
Dr.Vaidyanathan Ayyar
Development Commissioner (Drugs)
Ministry of Chemicals & Fertilizers,
Shastri Bhavan
New Delhi-110011.
contd.... 2
E-4/3 78
2
MsJ:5.11.85
with a’copy to me. Your contribution would be .deeply apprec.i. ted
and would make a GREAT DIFFERENCE.
Our demands are very rational and fundamental.
°f essential and life _saving drugs (i. e. ade■ r-u
production and streamlined distribution) to the peripheral
areas.
withdrawal of hazardous and irrational drugs.
availability of unbiased drug information to health personnel
and consumers.
(This would include updating of our National Drug Formulary
which has not been done since 1977 and provision of
therapeutic guidelines as in British National Formulary.
Provision of consumer Caution in regional languages - for
problem drugs).
A^-e(?uate Quality Control and Drug Control
(so.that every Sth drug in the market is not substandard as
it is at present according to Government's own figures, an<
hasXtorbXe^surllthe existing dru9 control:mechanism ‘ ‘
Drug legislation
station reform
need to prevent drug companies
from misusing legalistic loopholes against the people.
•1.
Since the National Drug Policy is coming up in the Parliament in
the November session - it would be a pity if inspite of all of us
knowing about it, we let an anti-people drug policy be passed
unchallenged.
In no other country are matters related to drugs dealt by the
Industry Ministry and not Health Ministry - the priorities and
influences are obvious.
Warped growth pattern of the pharmaceuticals flooding of the
market with irrational and hazardous drugs, total confusion
about essential and non-essential drugs is not in the interest
of our people.
The Banned and Bannable Drug list with information about these
drugs being produced by VHAI is in the press. It is another
attempt at focussing attention of the people on what is going
on in the name of health care, and why they must speak up and
safeguard their own interest.
The issue related to withdrawal of hazardous drugs, availability
of drug
information.
j
j-r. .
ensuring drug distribution has been TOTALLY
contd.... 3
r
.?r4/?7£
3
Msj75.11.1985
AND CONVENIENTLY OMITTED from the Drug Policy recommendations
by the NDPDC — inspite of these being the chief problem areas
from the peoples point of view and even according to WHO
criteria of a Rational Drug Policy.
With the involvement in Bhopal issue, the drug policy issue
has received a very low priority from many of the groups
involved in Drug Action itself.
In view of the urgency and in view of the seriousness of the
nature of the Drug Policy - your intervention is needed.
With sincere regards,
Yours sincerely.
Encl; AIDAN
RDP Reoort
(DR. MIRA SHIVA)
Coordinator
Low Cost Drugs & Rational Therapeutics
and convenor
All India Drug Action Network
Note ?
Following my meeting with Mr. Jaichandra Singh, Chemicals
minister on 4.11.1985 it is clear that contribution from the
Health Ministry by way of drawing up a clearly defined
essential drug list for the nation for guidance of both
public and private sector,
- drawing up an updated national formulary with therapeutic
guidelines.
r a list of drugs that are hazardous^ and irrational has notdome.
Failure in monitoring exact mode of drug useThisus^ and
drug shortages will prevent identification of problem areas and
formulation of functional strategies that are required.
E-1Q/344
TBsSM? 8.11.1985
-?r Coordinating Committee Members,
key Networkers,
This is just a brief note to remind you about the
need of your response about the Hatch Bill and the
UN Consolidated list.
Meeting for
Preparation
of drug
Education
material for
patient
The informal WHO meeting on education material
focussed on patient education material only. The
fact that a greater urgency existed for drug
education material training and education of hea.1' personnel, policy makers druggists and chemists an."
consumer groups in rational drug was registered.
I felt and still feel that our energies have to bo
focussed in key intervention areas. Preparing dr y
education material for individual patients in my
mind is neither strategically sound, nor effect!" e
and feasible with the drug education. Communicators
can turning to be indifferent, ignorant or corrupt.5
I was unable to change the agenda and preparation of
drug education material for individual patients to
my mind is an activity we can logically afford to
take up only later - after doing ground work, in oth r
priority areas.
Once the official summary of the discussions is sent
to me I will send a copy to those of your dealing wit"
preparation of drug education material.
Material
Drug
policy
There is a strong possibility of the new Drug Policy
going the Textile Policy way. There isn’t very much
we can do, but strongly feel that, before the Drug
Policy comes up in the Parliament some amount of
noise has to be made. It is CRUCIAL that an anti
people policy does not go unchallenged.
Please send off your views anyway to the new Chemio/l
Minister to the Health Minister etc. etc. (with a
copy to me). They must know that everybody is not
ignorant or indifferent.
We will keep our demands focussed on s
availability of essential and life saving drugs
(Production and Distribution)o
Withdrawal of hazardous and irrational drugs.
COMMUNE Hr4,T„
(First Fl
BAMGAi.oaE
2
availability of unbiased drug information
(updating of national formulary with therapeutic
guidelines).
better drug control to prevent sales of subt
substandard suprious drugs.
Drug legislation reform to prevent exploitation
of the consumers.
CHAI
Convention
10th - 11th is CHAI Convention on People Oriented
Drug Policy. We hope the Banned Brand druglist will
be ready by then, we are dedi catdrug it to Dr. 3Tle
Hansson
CONFIDENTIAL
I have gathered that due to US pressure the 'Cost
Factor' has been excluded from the updated WHO
Essential Drug List by the Croup incharge of EDL
at present. If it is so it is outrageous.
I am
trying to get a copy to check if it is so I shall send
you an alert - to raise your protest.
Since 25% of WHO’s budget comes from U.S., there is
a fear that our demands for international controls and
international code at the WHO meeting on Rational Drug
use in November end at Nairobi -may lead to stoppage
of US funds (as they did for UNESCO) and amongst the
first programmes to go will be the Action Programme
for essential drugs.
Your views would be very valuable - since its an
extremely tricky situation and the strategy has to
be well planned.
I personally feel outrageous violation of ethical
marketing practices of pharmaceuticals by MNC's e.g.
ep case organ, stay order should be given priority.
1260% overpricing by Hoechst of Beralgan Ketone etc.
are the kind of things that need to be highlighted to
prove the need for international controls. At the
AIDAN meeting I had shared the areas being c’nvored at
the Na i rohi ma-o
na.
1. Sources Types and availability of informat.t<m.
2. Drug Control and Distribution.
3. Training and Education, and other information
transfer.
3
The issues that have to be addressed at this forum
have to be different from the issues that we try
to deal with at national level.
You must have received the AIDAN coordinating
Committee Delhi meeting report. It was drafted
within a few days of the meeting - but due to
lack of typing facility it has been unduly delayed.
A demand for Rational Drug Policy has to come from
all over India, from all kinds of groups,
organizations, individuals.
Wishing as always that you all were more accessibleo
With warm regards.
Yours sincerely.
(Dr. Meera Shiva)
Coordinator
Low Cost Drugs & Rational Therapeutics
and Convenor
All India Drug Action Network
P.S. Send me your contact phone numbers, again, in case I have to
contact you urgently.
MADRAS DECLARATION
PHARMACEUTICALS AND THE POOR IN ASIA
THE URGENT NEED EOR A RATIONAL DRUG POL IC Y
The Asian Seminar on "Pharmaceuticals and the Poor" held in Madras
between December 6 to 9, 1985
views with serious concern the deterioration
in the drug supply situation in most countries of the continent, along with a
remarkable improvement in the few countries which have established national
drug policies based on the concept of essential drugs suited to the health needs
of their peoples.
While essential drugs needed to fight the major diseases afflicting
majority of the population remain scarce, there is an overabundance and
use of expensive, irrational and even harmful
the
over-
preparations in most countries
of the region.
This situation has arisen as a result of unethical practices of the private
drug industry, particularly the multinational corporations, and the aggressive
promotion of drugs for profit.
Even as "Health lor All" remains a virtual mirage lor the
majority of
the poor people of the region, drugs have come to play a disproportionately
large role in the health care system.
The workshop notes with distress the alarming decrease in recent years
in the production and supply of vital essential drugs needed to combat diseases
and ailments such as Malaria, TB, some other infectious diseases and nutritional
blindness.
The workshop notes with concern the lack of reliability and quality of a large
proportion of medical preparations on the market.
A concomitant of the
drug companies^ irresponsibility in respect of quality, coupled with an excessive
emphasis on aggressive drug promotion, is the laxity of government regulatory
bodies and lack of quality assurance facilities.
.1
LU
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' ^-8o
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The workshop strongly urges governments to institute a stringent system of
2 -
regulation on the promotion and quality of medicines and augment quality
§ LU Q
C
o
o
2
5
2
control facilities on a high priority basis.
The first step in this direction
must be the total banning of irrational and dangerous drugs.
This has become
an urgent need which cannot be postponed except at the cost of the nation's
health.
This underscores the vital imporance of regulatory measures to impose
production and distribution obligations on the drug industry and trade so as to
increase the supply of therapeutically and socially useful drugs,
Such measures
are lacking or absent in most countries of the region.
J
The most disturbing aspect of this is the growing divorce between considerations
of health on the one hand and of drugs on the other,
Instead of formulating
comprehensive and rational drug policies based on health needs of the people,
many governments are going in for counterfeit substitutes in the nature of
pharmaceutical industry policies.
This can only have the unhealthy effect
of placing the health of the drug industry before the health of the people.
Basing itself primarily on these considerations, the Non-Aligned Movement had
on twe occasions (at Colombo in 1076 and at Havana in
1979) given clear
directions for the. formulation of national drug policies based on essential
drugs and the health needs of the people,
The workshop emphasises the
continuing relevance of the Non-Aligned Movement's position and urges all
governments in the region to evolve a model policy in conformity with that
orientation.
A model policy drafted by the seminar could provide useful
guidelines in formulation of a drug policy by governments.
In the absence of an independent source ok objective information on drugs and
of continuing education of doctors, the medical community in most Asian
countries have become totally dependent on the pharmaceutical industry,
The
situation is further compounded by the absence of emphasis in undergraduate
education on the rational selection and cost-effective use of drugs, which
keeps therapeutic, social and economic dimensions in mind.
The seminar urges the government of the region to move comprehensive
legislation on drugs, pertaining to the registration of products, the supply
of complete unbiased information with packages, and providing for exemplary
3
3
punishment in case of default or breach of norms.
Neither such legislation nor a national drug policy can be effectively
formulated without the asociation of voluntary organizations, consumer
groups and representatives of the public.
i
The ^workshop underlines the need for regional cooperation among the Asian
countries on sharing of information on drugs, their pricing, quality assurances
and undesirable company activities, and on monitoring adverse drug reactions.
The health of the people is too vital a matter to be left to the market forces
or to arbitrary government policies and actions guided by the influence of
vested interests.
The public’s right to information and public accountability
of the drug industry and health professionals are not mere principles; they
have become imperatives.
Madras
10.12.85
!
i
5
Hazardous Drugs
The group was informed that the Banned, Bannable drug
list being brought out by VHAI is in the press. Due to
unfortunate and unforeseen circumstances it has been
delayed (I. have to continue to apologize for it till it
actually comes out)o
There was a flot or‘ discussion
'
about relevance of the
list and mode of its utilization
------- when it comes out.
I was recognised as an educational tool and a campaign
tool to monitor sales of hazardous drugs and make a case
for a Rational
r
“ ' *
-----Drug
Policy.
The need to make written
complaints was emphasised.
A need for an URGENT SURREY to document: the existing
marketing situation regarding banned drugs 1was unanimously
felt.
The NE3D -TO BUY THESE PRODUCTS ALONG WITH CASH MEMOS was
recognised and this will have to be done.
A section at the back giving situation todate i. e. with
photographs of these products giving
name, the content and
-- J name.
manufacture as part.ef the efforts to- assess the
market situation would have to be included in the Banned
Brand Drug List (BBDL).
Specific responsibilities have been taken by the
following to buy these drugs so as to be able to incorporate
these latest findings in the Banned Brand Drug List.
THIS INFORMATION IS CRITICAL FOR JUSTIFYING AND LEGALIZING
THE PUBLICATION OF THE LIST.. IN ABSENCE OF THIS FEEDBACK
THE BANNED, BRAND DRUG LIST (BBDL)) WILL HAVE TO BE HELD BACK
AND NOT DISTRIBUTED. H
We cannot afford to be ill informed
about the present situation
--- n regarding banned drugs, at
least in our own areas. Please take this as a priority
request and respond at the earliest.
If needed, all cexpenses will be reimbursed by VHAI. For
hazardous drugs campaign
4T drugs were selected for future
‘
action :■
- EP drugs
- An'abolic Steroids
- Chloramphenicol
Streptomycin
- Analgin
Dr.Mira Shiva
Dr. Pawan
VHAI
Dr. Sarkar
DAF.WB
Dr.Pane
Cheenu
ADM &
LOCOST
ACASH
Preparation of material for following 2 other drugs would
also be undertaken side by sides
- Streptomycin-Penicillin
- Diadoquin
contd.ooo
6
Regarding Analgin and Boston Study - Dr.Rane would
circulate <-a note
- •
about the problem and the implications of
this particular study.
Mira in the meantime would try to get Dr.John Yudkin’s
reservations regarding the methodology used for the Boston
Study.
Study. Anil Pilgankar would compile information on
alternatives to injectable analgin and compare the costs,
side-effects availability scope for misuse,
misuse. existence of
better substitution etc.
The fact that the book is being brought out in public
interest for health safety and education should be stated
in the book. Amitava on behalf of FMRAI would try to
collate information on double standards and unethical
marketing practices where sales of these hazardous drugs
are concerned.
The material for drug information on the
'
4 hazardous drugs
would be sent to Mira and compiled by her.
On 23rd March AIDAN group would meet in Bimbay to finalize
the draft. The printing would be done by VHAI. The
document would ft)rm part of the Hazardous drug campaign for
23rd May Olle Hansson's day.
Shortages of Essential Drugs
•>
It was felt that AIDAN as a group should give greater priority
to shortages of Essential Drugs. In VHAI a high priority
has been given to this, as reflected in the paper Essential
Drug need for prioritization, documentation of shoftages of
anti-T B. drugs and Vit.•A’,iodized salt and vaccines.
Responsibilities taken for preparing background papers on
shortages of vaccines specially s
1. Polio and measles
pawan
ACASH
2. Data availability
documenting shortages.
Cheenu
LOCOST
3. Vit1 A* t iodized salt
Mira Shiva
VHAI
4. Phenobarbitone
Ashwin
MFC
Since production of such material would require presence of
these communication skills, a workshop bringing together
potentialproducers of drug education material from different
regions with communication skills would need to be held.
Ullhas was requested to coordinate such a Drug Information
Communication workshop in Wardha. Time suitable to drug
activists and others interested in the subject would have to be
selected. ;
" those
'
All
interested in contributing and participating please informs
contd....
7
Dr.Ullhas Jajjoo
Reader - Medicine
Sewa Gram Medical College
Wardha-442102
(with a copy to :
Dr.Mira Shiva, 14-c, C
Community Centre,
Safd^rjung Development- Area, N.Delhi-110016)
Listing of existing materia1
A request was made to all the AIDAN members to give a
11st ot all the drug material, ;articlesposters
’’ *
etc. produced
by them. Compilation of all suchi material
i.^xlll was
we needed to
~eJX1Ch3nge. and £or categorization
--- of the material
according to key subjects3 areas is needed.
e.g. 1. Diarrhea campaign and rational
diarrhea care
2. ORT drugs
3 • Rational Drug Policy etc.
Organizations that have broucjht (
e-g*.Arogya Dakshata Mandal, MFC#
- - _.o so.
such a list as recommended
— 1has
- 'been made by VHAI in the
reading
the Banned Brand Drug List.
The need to keep each (other informed and sending of
complimentary copies of all. material produced to the
Coordinating Committee, if possible
- j was stressed.
The need to promote each others drug and health education
material was also emphasised.
There is ra great
7- - 1 scope to promote Pune Journal, DAF.W’s
Rational Drug Therapy newsletter,/ MFC1s rational analgesic
and anti—diarrhea1 study etc. VHAI's Banned Brand Drug List.
A mention of AIDAN on Cdrug related material being produced
by the members would,. be3 in ^eping with the ethos of
c llective functioning and it cannot be made mandatory.
Dr. Rane pointed out that while giving references - material
anddrPfPr^L°^herS AIDAN members' if 9°°^/ should be quoted
nd referred to increase each others credibility.
Material in the Pipeline
D AF. WB
KSSP
Rational Drug Therapy (Quarterly)
Video in Bengali on drugs
Report on a decade after Hathi Committee
VHAI
Information packs for MPs health personnel
and lay people.
Video on drugs, posters and audio-visuals .
A journal by the workers cooperative to be
distributed amongst doctors as a substitute
for samples.
contd....
8
Suggestions were made regarding modes of reading out to
more people.
1
Obtain address list of doctors those who are socially
conscious from organizations like CERC consumer centre.
. -2.
Reach out to children through school health programs,
deal with drugs used by them e.g. food suppliments,
tonics etc.
3.
Ask various organizations producing their own material
to keep space in their magazine for important drug
related material which should be provided by AIDAN
members.
4.
Interact with academic bodies.
5.
Conferences, national book fairs etc.
Indian Academy of Paediatrics in its national workshop on
protection of Child Consumer had dealt with R.D.P. It
being the first academic body to do so, Copy of IAP
recommendations are available with Dr. Mathur, convenor of the
Workshop (Dr.G.P. Mathur, Prof. & Head of the Dept of
Paediatrics, BRD Medical Colleges, Gorakhpur-273013) . It
was felt that as AIDAN members we must express our appreciation
and compliment to the IAP*s Executive-body for its
initiative and for passing of the recommendations. Write
to : Dr. Ramesh Poddar, Kailash Dasshan, IAP Office,
Kennedy Buildings, Bombay-400007.
Organizational matters
Coordinat Very intense discussions took place regarding structure, long
ed action term action plans of AIDAN and the criteria for letting in
plans.
new coordinating committee members.
I am reporting some of the discussion and this will have to
be taken up in the next meeting. Regarding AIDAN structure
some individuals present felt that AIDAN should be kept
informal and all those interested in joining should be
allowed to join in. Others felt that as AIDAN is an action
group involved in drug issue which had high political
implications and since the work required a certain political
maturity and understanding, opening it to anybody and everybody
could create serious comolications later.
It was pointed out by Cheenu that VHAI had so far borne most
of the inivisible costs, of AIDAN in
its formulation
period.
AIDAN had as such no money and a decision had been taken
that no funds would be taken byAIDAN so as to prevent any
emergence of misunderstanding over mode of obtaining and
spending of this gioney. Various organizations were free to
take the funds directly for their own drug work. Rani pointed
out that it was important for AIDAN to ensure certain amount
of formulation but without any bureaucracy norms of
discretion must be laid down and it would be healthy for the
contd
9
organization in the long run. So far for those contributing
to and part of AIDAN work there has been mainly bearing of
responsibility and contribution in drug work with no financial
or any other gains associated with time dynamics could change spefially if question of funds and come in - these things were
known to lead to mistrust and with misuse.
The mutual trust and respect and the mode of functioning of the
group should not be jeopordised, nor any false restrictions
be imposed.
AIDAN was initiated, to facilitate coordinated drug action.
Drug enthusiasists would continue working, even if at any
stage it was decided to lift the AIDAN banner.
Some of the criteria that could help in ensuring joining by
other organizationi was listed by the groups :
1)
2)
3)
Agreement with AIDAN, RDP statement
Agreement to the mode of group functioning and decision
Long term involvement with drug work
4)
Recommendation by a coordinating committee member
organization
5)
Organizations willing to take responsibility for AIDAN.
6)
Payment of Rs.200/- membership.
Till the decision is taken at next AIDAN meeting people will
be invited as special invitees. The question of long range
plans of AIDAN specially regarding distribution of essential
drugs from fair shops, influencing Rational Drug Use in
medical education etc.
Role of non-allppathic systems of medicine in RDP also needed
to be discussed.
Ashwin had raised the questions in Wardha and be raised it
again about the limitation of the role of unifocal
organization. Ashwin was requested to prepare a note on
organization of structure and role of AIDAN. This would be
circulated well in advance and be discussed at AIDAN Coordinating
Committee Meeting in July - Cheenu of LOCOST has offered to
arrange for it in Baroda, It was felt by some that Calcutta in
rainy season may not be approoriate.. DAF.WB's view would have
to be taken.
To Note in RZAIDAN Diary
By 20th Feb. RDP related material to reach Dr. Rane
21st
- Parliament Budget Session starts.
22nd
- DAF.WB convention
7th Mar - Editorial Committee meets in Bombay to finalize
RDP draft.
8th Mar - Women's Day
15th Mar- Consumer Rights Day
contd o...
10
L^unching of Banned Brand Drug List.
Material regarding
■Anabolic steroids, chloremphenical, analgin, EP to reach.
Mira.
23rd Mar
AIDAN meet in garoda to finalize draft of
information booklet on 4 hazardous drugs.
31st Mar/ 1st Apr
FMRAI meeting on Drugs for World Health Day
to be celebrated as Essential Drugs Day to
focus on essential drug shortages.
2 3 rd May-
Dr. 01le Hansson’s day
Hazardous Drug Campaign launched.
Launching of Drug information book on
4 hazardous drugs.
Anytime in February and March the Drug Policy will come up
in the Pailiament«
Name
Address
Area of interest and
contribution
i) RDP campaign
ii) for long term drug
action 1986.
1. Amitava Guha
177 Criper Road
Konnaga, Hooghly
W„Bengal
Production of RDP
Monitoring the
activities of TNLS.
2. Rani DoAdvani
H.K. House
6th floor.
Ashram Road
Ahmedabad-9
Law
3. T.Vijayendra
B-2Z Marg 2, Saket
New Delhi-110017
Information of
Consumer levelo
4. Sashidharan E^M.
C/o Friends Society.
Fatehganj Main Road
Baroda-390002
ORS (ORT)
5, Ravindra R.P.
C.U.Shah College of
Pharmacy,
Sir Vithaldas
Vidyavihar, Juhu Rd
Santacruz (W)
Bombay-400049.
- Sex pre-determination
test.
- injectable
contraceptives
- Preparation of a.v.
aids for consumer
education.
6. Karunakono
Pattnayak
Comprehensive Health Community
Community Health
and Development
Proj ect,PO’PACHOD,
Aurangabad-432121 «
contd
r
11
7. Meena Dalal
V-305 Sunder Nagar
Maiad (W)
Bombay-400064 .
Drug issue
8. Anil Pilgaokar
34-B Noshir Bharucha
Road,
Bombay-400007
Formulation and
Production of RDP.
9. S.Srinivasan
GPO Box 134
Baroda-390001
Rational Drug
Therapy
lO.Ashvin J.Patil
21 Ninnan Society
Alkapuri,
Vadodara-390005
Rational Therapy and
Community Health.
11.
Mira Shiva
VHAI
Rational Drug Policy
C-14,Community Centre and Rational Drug
S.D.A.
Use
New Delhi-110016.
12. Wishwas V.Rane
2117 Sadashiv Peth
Pune
Health Education
13. Pawan R.Sureka
Vl/505 Sunder Nagar
Maiad (W)
Bombay-400064
Promoting RDP
among Health
Professionals.
I
NATIONAL DRUG POLICY UPDATE
According to recently available information, the
Essential drug list has been further slashed down to 65
drugs from 95
-
meaning virtual price decontrol of the
rest.
<
Inspite of all efforts Health Ministry has failed t
to make any statement regarding the NDP Conflicting reports
are circulating regarding the draft having been finalized
by the Industry’s Minister and it is lying with the PM.
Some say it is still being drafted.
The Economic Advisor to Industry Minister is
coming to discuss about the drug policy to VHAI tomorrow.
Amitava,(FMRAI); Dinesh (DSF); Narendra (NISTADS) and I
are meeting this evening to draw up our economic arguments,
we need much more background work in this area.
I foresee a fairly bad drug policy, with just a few
minor changes being made for its pacifying value.
Our
failure at not being able to get academic bodies, medical
colleges, doctors in hospitals, community health programmes,
social action groups and concerned citizens to demand a
Rational Drug Pol. cy is obvious.
This is a plea for your support.
Efforts towards
ensuring Rational Drug Policy must be made at all levels
within next 15 days to 1 month.
Please send in your
protest letters to the Health and Chemicals Ministry.
I will intimate the contents of the draft once I get hold
of it. An S.O.S. for your views and your presencemay be
sent according to the contents of draft,
Concerted action
is needed now, and later on it will be too late, making
our task much more difficult, probably impossible.
KINDLY CONSIDER THIS AS A MATTER OF URGENCY.
(Dr.Mira Shiva)
Convenor
All India Drug Action Network
> E-4/378
■■M/j/171285
Dear Coordinating Committee Members/
NAIROBI
ME ST
A full report of the WHO’S Nairobi Meeting on Rational
use of drugs held on 26th-29th November, 1985 in Nairobi
will be sent to you soon.
In brief the industry lobby
had come well prepared - their key arguments revolved
around need for "free enterprise", need for R&D and
therefore need for high costing.
The industry lobby repeatedly broughtout the fact that
WHO should not play a 'supra national’ role.A In view
of the lack of effective regulatory mechanism in most
of third world countries - WHO cannot leave everything
to the third world governments. International controls
are needed to ensure that double standards and unethical
marketing practices do not take place.
Any discussion on restricting drugs, created a lot of
discomfort and protest from the industry side, They
stated that while attempts at Rational Drug Policy
implementation could be tolerated in the Public Sector
by them, the private sector should be left untouched.
In view of the fact that over 80% of the drug market
in most countries being in the private sector, we wanted
application of the national policies in private as
well as public sector.
, :lr
On behalf of the doctors, a private practitioner from
Sri Lanka who also has connections with Pfizer and
Chairman of GP Association of Sri Lanka -condemned
strongly any attempt at restricting clinical freedom.
My understanding is that the industry will be increasing
play on this clinical freedom ego booster for doctors.
There was a great debate over the 'medical need clause" Scandanavian countries have this clause in their drug
legislation - no drug is given any registration unless
»t meets a medical need and is comparatively superior to
what exis=ts in the market. The medical need clause which
we all wanted to be incorporated in WHO's statement
tended to upset the industry very much. The fact that
several drug regulatory authorities supported our
stand was very reassuring. The key role in this was
played by representatives from Australia, and Scandanavia..
Madras
Meet
The Asian Seminar on Pharmaceuticals and the Poor
(6th-9th December’85) has just got over. A copy of Madras
declaration is being sent.
It was decided to hold
April 7th as Essential Drug Day and 23rd May as Dr. Olle
Hanssons day to focus on the issue of hazardous drugs.
A national level meeting has been recommended to be called
on one of these days. We will work out the detailso
contd...... 2
.o0,0'
'
,7^
i-
E-4/378
M/j/171285
- 2
International
News
The Hatch Bill has been passed by the Senate Sub
committee. Senator Kennedy did cosponsor the bill
ultimately. The bill is coming in the Senate very
soon. We have to go through the whole exercise of
protesting again.
*
National News
Letter
Dr. Zafrullah, Dr. Qasem and I had a meeting with
some of the parliamentarians. Sometime after 13th
a meeting between Dr. Zafrullah and the Prime Minister
will be arranged.
Dr. Zafrullah has agreed to host our next AIDAN meet
in G.K. We could go by buses to the border and G.K.
will pick us up. Tentative dates are 2nd week of
March.
Dr. Sujit Das and Dr. Sarkar of Drug Action FOrum,
West Bengal wanted the AIDAN meeting to be held in
Calcutta sometime in the 3rd week of February.
I am
awaiting confirmation.
(A telegram has just comez the
meeting is fixed on 23rd February)..
V H A I
The AIDAN newsletter is being posted.
The banned brand drug list is still in the press and
should be out within 1 or 2 weeks.
National Front
The Parliamentary drug consultative committee has
rejected the NDPDC report.
I hope you have written to Mrs. Mohsina Kidwai and
Mr. Jaichandra Singh.
An emergency meeting may be needed and I will contact
those of you involved in drug policy issues.
XLERT
(Co n f i den t i a 1'
I also want to inform you. that Dr. Joseph Daniel of
Jornbay c^me to the Madras meeting self invited and
he told Dr* Pram John, Coordinator, ACHAN and
Organising Coordinator of the Workshops that he wanted
to come as the Chairman of the Pharmaceutical Committee
of CGSI, there is apparently no such committee.
■-Lis hotel bill was paid by Inf ar i.e. Organon.
Dr. Joseph should not be invited to any of the AIDAN
meetings and tht feet that we are aware of all this
should not be known to him. He should be closely
ob^oivcd.
We vzill be intensifying the Nattunnl
caiituuiijn,
hk ■ph t j
how to go about it were discussed, post Madras meeting between
Dr.zafrullah. Dr. Qasem, Amitava Guha, Dr. Ekbal.
Your suggestions in formalizing the plans in planning out Asian region
and national level and locctl level drug action would be very helpful.
With warm regards.
Encl? AIDAN Statement
DAN newsletter
Madras Declaration
(Dr. Mi’fa Shiva)
Convenor
All India Drug Action Network
J) 3
3
.i
MWPJkNDai
We, the health personnel and. citizens of India recognize.health as a
fundamental right of the people in this, our welfare state. We recognize
and strongly believe tliat the health status of our people is more dependent
on their access to adequate food, safe and adequate water, proper sanitation
and clean environment.
While we support the overall perspective and approach of the new
National Health Policy Statement and demand its proper implementation^ we
believe that a !Rational Drug Policyr is an ihtegral part of a good fetional
Health Policy.
1.
2.
3.
We therefore, demand the following:
We have a right to safe, essential, quality drugs which arc in keeping
with the health needs of tho people, at costs which the majority can
afford.
We urge our government to accept and implement the Hath! Canmittce
Recommendations vmich are also in kcopi w wif.h
— -r ..
a Rational Drug Policy.
Further the national drug formulary should be revised and compiled by^
an export multi disciplinar^r committee keeping tho following criteria in
mind;
Essentiality
Safety
Cost
Ease of administration
Availability
Potential for misuse.
Such evaluation of the drugs in the market and revision of the lists
should be done periodically.
4» The Essential Drugs Policy should be adopted for all health services,
government and private, and priority in production, distribution and
dispensing should be given to these essential drugs.
5- The public sector should produce essential and life saving drugs on a
priority basis at tho national level.
6. Drug production by multinationals and private manufacturers in India
should also bo aligned with national health priorities.
7. Bulk procurement of essential and needed drugs should be through world
wide competitive tenders and rationalization of drug purchases should
govern both tho public sector as well as private health sector.
8. Imports and production of non essential, specially hazardous drugs,
should bo strictly curtailed.
9. Drugs which have been banned from so.lo after being marketed for some
time in one country may not bo submitted for clinical trial or marketing
in India. The onus of proving why a non-essential drug should be intro
duced or allowed to continue on the market should be with the manufact
urer and such introduction should be proccdod by adequate trials and
evaluation by Drug Control Authorities.
K-. Ccmprchensivo drug legislation which covers areas such as price control
at different levels, patents, and marketing practices should bo incor
porated to serve the objectives of the national drug policy and there
should bo no levies, sales tax or excise duty on any pharmaceutical pro
duct in the essential drugs list by the Central or State governments.
11. No technology transfer agreement shall be legal, and binding which cont
ains restrictive practices, disproportionate and unnocossaiy use of
imported intermediaries -r cbs 'iete technologies or unfair arrangements
with respect to prices, payments or repatriation of profits.
12. The National Drug Policy should state clearly tho steps towards 'a
complete abolition of brand names and as a first step use of generic
names should be made canpulsory in medical education, prescribing and
labelling of drugs. Generic names should appear more preminently • n all
packagings
■„ .
?*
13. It shall be the primal responsibility of the manufacturer to ensure the
quality of drug products. However, it shall be the statutory responsibi
lity of the Drug 'Control Authorities to monitor the standards and ensure
a minimum uniform level of government control. Consequently, the govern
ment shall take all necessary measures to enable the Drug Control Autho
rities to function in an effective manner and discharge the statutory
duties cast upon them.
14. It shall bo the statutcuy duty of the drug central authorities to inform
health personnel andvccnsumers of the essential drugs lists, policies,
catcgori.es or brands0 drugs banned for manufacture or sale, through pub
lication in the national newspapers, magazines, medical journals with
adequate explanations and details.
' t
1?, A-rra-i Ubn Ii +jr of drugs required in the Govcrnioents National Programmes
should be ensured on a priority basis to the government as well as
voluntary and private health .institutions. Quotas for anti TB, anti
leprosy,’anti malarial drugs, iodized salt etc should be made easily
available with regularity of supply -bo L!:e voluntary health institutions
whercevcr possible, specially when their performance, in health care
delivery is known tc be effective.
16. In all review committees, statutory bodies and other such bodies, there
should be adequate representation of consumer groups and voluntary healt?
sector.
17. Drug companies should follow ethical marketing practices, and this should
be ensured by their <wn organizations like OPPI,IEMA, IFB1A, We deplore
the tendency of those companies and associations to got- around every
progressive measure of the government through re c ours e^echni call ties of
the law and through the courts.
18. The marketing code drawn up by HAI(Health Action International) should
form the basis for a National Code for Marketing Practices. This shculd
be accepted by our government and should be suitable implemented through
legislation.
19. Tiie government cf India should take a lead and endeavour tc influence
the WHA and WHO to adopt tee Code in the interests of . the other develo
ping countries and their peoples.
(IFPMA and HA1 Cede attached).
/■
/
- Voluntary Health Association of India
- Centi’e for Science and Environment
- Centre of Social Medicine and Canmunity Health-Jaw airaria,! Nehru Univer
sity.
- Kerala Sahitya Shastra Parishad
- Medico Friends Circle
- Arogya Dakshata Mandal
- Lok Vigynn Sanghatana
- Consumer Guidance Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of India*
E-4/377
MS7jb7T.2.86
ALL INDIA DRUG ACTION NETWORK (AIDAN)
WESTERN REGION MEETING
KHANDALA 30th-31st JANUARY 1986
********
Dated s 5.2.1986
MAJOR DECISIONS, KEY ISSUES DISCUSSED
Since MFC meeting was Joeing held in Khandala
and since the drug action groups old and new from Bombay,
Pune etc. not met together, a western region AIDAN meeting
was contemplated. The agenda items had been circulated
earlier to the AIDAN members (please see communication-1
and communication-II dated 22nd Dec’85 and 15th Jan'86
respectively).
The final agenda constituted of the following items s
1. National Drug Policy
2. Legal action
3. Drug Action
- EP Drugs
- Hazardous Irrational Drugs ?
Banned Brand Drug List
(BBDL)
- 4 campaign drugs
- Shortages of Essential Drugs
4. Preparation of Drug Education Material - for lay people,
& MPs.
5. Dissemination of drug information.
6. Incorporation of new groups into the coordinating
committee, xAIDAN1 s role and structure.
7a Time schedule for all activities.
le National Drug Policy
In- view of the new drug policy being formulated, efforts
towards rationalizing it had to be undoubtedly given the
highest priority.
It was felt that irrespective of the nature of the new drug
policy draft, the need to ensure its rationalization would
still remain. The NDPDC recommendations have been rejected
by the Parliamentary Drug Consultative Committee as stated
by a member of D.C.c. in a personal communication.
The Rational Drug Policy (RDP) campaign would require good
coordination and concerted action/
Elaboration of the AIDAN, RDP statement so as to provide
details, statistics would be needed.
Responsibility was taken for. different sections of the
AIDAN, RDP statement. These are listed below.
contd.... 2
2
Some of the AIDAN members not present at the Khandala
meeting, are requested to prepare notes in their area of
expertise as noted below (See page 4 onwards of AIDAN
Statement for details).
Subject
Name of person
responsible
Organization
Al
Essential Drugs
Dr. Mira Shiva
VHAI
A2
81
Irrational Drugs
Dr.Sujit Das
Srinivasan
DAF, W*
Dinesh Abrol
DSF*
Amitava
(Fr.John)
Dr.Mira
Dr. Ekbal
FMRA
(CHAI)*
VHAI
KSSP*
82
Production & Price
Control
Registration and
Monitoring.
C
Drug Distribution
DI
Drug Information
D2 (i-v) Unethical marketing
LOCOST
Pawan
D2(v-ix)Conventions and Codes Anant
OTC (Over the counter
drugs)
D3
Drug Nomenclature
Srinivasan
Brand Generic
Quality Control.
El
Self Reliance
Dinesh Abrol
DSF
F
Research &
Develooment
Narendra
Mehrotra
sys/ntstads
G1
Drug Legislation
labelling
Magic remedies.
Rani Advani
CERC
G2
National Drug &
Therapeutics
Authority.
Dr.Mira Shiva
VHAI
H
Human Power Deve
lopment.
Dr.Mira Shiva
i
ACASH
MFC
LOCOST
VHAI
(can work, if
need be)
A- note on Decontrol and Delicensing and Patent Act would
need be prepared by Dinesh and Amitava. All the relevant
materials should be kindly sent at the earliest to
Dr.Rane W.V., 2117, Sadashiv, Pune-411030.
If it“is not
possible to prepare the note on its edited form, relevant
material must be sent to him by 20th February, 1986.
On 7th March, 1986 the Editorial team consisting of Dr.Rane, Arogya Dakshata Mandal, AnantPhadke, MFC; Cheenu
Srinivasan, LOCOST - will get together in Pune.
The printing of this AIDAN document will be undertaken by
LOCOST
Please note the document represents tfte collective
thinking of AIDAN as it has. evolved over past few years <.
It is an AIDAN document being printed by LOCOST, credit to
LOCOST and Sahej {or bearing the printing cost and undertaking-
3
the printin'. :responsibility
---would be given.,
Effort at
recovering of the expenses through sales of the
material
would be made.
Lobbying with Policy Makers
WhiJ»e not all organizations felt much inclined
to undertake
this role. VHAI has given it high priority.
*
hidWrL33 PaLhamentary Drug ..Consultative Committee that
LniSS^iS? TDC r:PSrt‘ In Pres^ce of shuffle
the
being put under the ^ndSstry SnX^-^he^onstftSfSn'of '
Conaul,i8t1^
Is yet to be
The need to select tsocially conscious Parliamentarians
for
raising Questions in the Parliament, dealing with inadequate
replies was expressed. Publicity
__
to(wrong replies and
challenging them should also
-l~o be builtin.
in the process of compiling a list of Parli ament
past^and tb1Sed ^uestions related to drugs and health in'the
past and those who are doctors. A note on using Parliament-rv
procedures by Sarhjit of the Liaison Division of VHAI has
for d?ugPlc5on? W±11
available to those needing it
I would try to get the draft of the new proposed policy and
circulate it, as soon as I get it.
There is an apprehension
-u
th'et the drug policy
in and
passed
like the 4 bills passed in the may be brought
.
Oc,od.lrke
last Parliament
Session ALL within 15 minutes, iwithout
' ''
any discussion with
routine30 5°% MP'S
eVSn attending the*Sessions
Legal Action on Drug Front
-estiS^r1 ass°c^ted with CERC (Consumer Education and
druos
Centre) bussed the role of legal action where
drugs iss.ue was concerned.
She stated that the judiciary could not touch any
Parliamentary Procedure
- - unless
--- —a the harmful effect of the
policies is shown.
The EP case ((high^dose^Estrogen Progesterone combination)
was discussed in detail, The Governments and our own failure
at not having taken legal action to challenge the stay order
against the ban was admitted with profoundI concern.
it: was decided that Rani would file a
ln GuJarat H19h Court. ACASH in Bombay,
ln Calcutta coulo intervene in the cases filed by
UNICHEM, NICHOLAS and ORGANON (Infar) respectively.
Y
4
Rani said till the time judgement was given, intervention
could be made. rRegarding filing of Public
‘ ’
litigation suits
straight at the Supreme Court as being planned by DSF.
Rani stated that the case would, in such circumstances, be
referred to Bombay and Calcutta High Courts where judgement
is pending.
Secondly - the choice of lawyer and the judges bench
would be a matter being decided by computer at present.
In case we landed up with an unsympathetic lawyer and judge
this would be a problem.
Thirdly
- with the number of writ petitions in the
Supreme Court it would take about 2 years for the writ to
come up for hearing.
The Diethyl Stilbaestrol case in USA was cited where
daughters born to women who were prescribed DES developed
vaginal cancer when they reached maturity. Rani informed
us that since it was not possible for women to remember the
brand names of the DES drugs the compensation liability was
fixed according to the market shere of the different
companies who were producing and selling the drugs.
Responsibilities taken for legal action are as follows;
DSF, Delhi
ACASH/ Bombay
CERC, Ahmedabad
DAF.WB, Calcutta
Dr.Kabra, Rajasthan
- for technical support.
Voluntary Health Association of India (VHAI) would try;
1.
to get views of Drug Regulatory Authorities from
other countries, which have banned the product/
products;
2O
3.
4.
Summary of Dr. zahena Abbas study;
Comments from experts •utside;
ICMR expert committee report.
ACASH, ADM, MFC would obtain the opinion of Indian
Gynaecologists. Dr. Rane who feels strongly about EP drugs
would try to get a statement from Ex-Drug Controllers of
India. 7
---- and other Gujarat
* •
LOCOST
based drug activists from
MFC would provide the technical support to Rani (CERC)
drug the process.
It was reaffirmed that the perusal of the EP case at the
legal front was very important not merely because a
hazardous drug was being sold with double standards, but
in view ofc the flouting of the loopholes indicating a
need for drug, legislative reforms with Rational
Policy formulation round the corner, It is crucial that
the first maj>r Drug action oom-prai’gr*
brought to its
logical conclusion.
For those interested in drug acts and legal action, a
section on drug acts in Pharmaceutical Index and Drug
Laws 1985 are available for self education.
contd..o
33-
™yTsT™TTE,R
cp THE LOW G0ST DRUGS AND
AND rational therapeutics cell z/1’
VOLUNTARY HEALTH ASSOCIATION OF INDIA C14 COMMUNITY CENTRE SDA NEW DELHI 110016
NEW DELHI
23
Jan
1984
For most of us in the Drug Action
Network, the last three months
have been fairly hectic.Of course,
the highpoint was Dr Zafrullah
Chowdhury’s whirlwind tour, an
encounter which not only ’galvan
ised-’ (to use Dr Raj Anand’s
phrase) everyone iitto more action,
but also provided a most welcome
and unscheduled opportunity for
network members from different
parts of the country to meet. The
outcome of these meetings is
detailed elsewhere in this issue.
Happily, going by the feedback
received so far, there have been
no serious adverse reactions to
the trial launch of ’The Drug
Action Network Newsletter1.There
have been some positive criticisms
and suggestions.
Dr Ana nt Phadke has written in
to say that the emphasis should
be on work done by groups and
activists in the field. We cannot
but agree with the suggestion
that there should be more cover
age of news and events emanating
from places other than New Delhi.
But this .would have to mean a
much more steady flow of inform
ation from the activist groups,
than there is at present,
Ms Padma Prakash felt that each
issue of the newsletter should
carry at least one in-depth
article. It was decided that we
would try and incorporate this,
though it may not be possible
to make a hard and fast rule
of it.
In terms of future action, two
major activities are Drug Work
shop III in February and the
nationwide camoaign on drug
issues in April(see ’Coming
Eve nt s1).
HIGHLIGHTS
• Meeting with
'
Mr Vacant Sat he
•Dr Zafrullah Chowdhury
- Press Clippings
• Estimates Committee
w
Report
• FERA Companies
- equity dilution
• Drug Utilisation Study
4
6
9
10
12
netujork news
* Dr Zafrullah Chowdhury had a
series of meetings with network
members in various cities. He also
addressed a number of public
meetings and seminars at the
various centres. Press confer
ences were held in Bombay and
Pune, and in Belhi he was inter
viewed by individual journalists
as well as on television.
Some
of the press coverage appears on
Pgs. 6,7,8, in this issue.
please contact Dr. N. N.Mehrotra
at NISTADS, 12, Hillside Road,
New Delhi.
A meeting between the health and
drug policy makers and some of
the individuals and groups involved
in Drug Action was held at the
CSjIR Science Centre on 3 Dec.’83.
This was organized by NIST ADS to
utilize the opportunity presented
by Dr. Zafrullah’s presence in New
Delhi. The organizations represent
ed were VHAI, Arogya Dakshata
Mandal, Lok Vidnyan Sanghatna,
Centre for Social Medicine and
Community Health,JNU, Child in
Need Institute,Calcutta, CRHP,
Jamkhed.
A meeting was also arranged with
Shri Vasant Sathe, Minister for
Chemicals and Fertilizers.
A
joint memorandum setting out our
stand on a rational drug policy
and raising key demands covering
these issues, which was circul
ated and signed during the public
meetings, was presented to the
Minister.
* On 5 Dec.’S?, an informal meet
ing of the Drug Action Network
was held in Delhi. Those present
included Dr. Rane (Arogya Dakshata
Mandal), Dr. Ekbal and Mr. Kumar
(KSSP), Ms. Padma Prakash (Lok
Vidnyan Sanghatana), Ms. Mona
Daswani (FRCH), Fr.P.D. Mathews,
Ms. Maria Mathew (I.S.I.), Dr.
Imrana Quadeer (Centre for Social
Medicine and Community Health JNU), Ms. Sunita Narayan (CSE),
Dr. Mira Shiva, Ms. Chandra
Kannapiran and Aspi Mistry (VHAI).
Unfortunately some of the key
officials involved in Drug Policy
failed to be present. General
feeling after the meeting was that
there was an element of defensive
ness on the part of the policy
makers and a tendency for the main
issues and genuine problems as
felt by the health personnel and
consumers in the field to be side
tracked and ignored.
On behalf of Vincent Panikulangara,
Fr.P.D. Mathews made a strong plea
for intervention by other groups
in the writ petition pending in
the Supreme Court. He is to pre
pare a short note on the legal and
other implications of this step to
facilitate the groups in arriving
at this decision.
It is high time organisations in
volved in drug and health issues
demanded representation at various
levels of policy making. Leaving
it to those who have failed to
deliver the goods so far would,
under the present circumstances,
be an indication of uur passivity.
Tentative plans for a campaign on
drug issues in April were drawn up.
So also a rough outline for Drug
Workshop III was planned and the
preparatory work alloted to dif
ferent individuals and groups.
The Drug Action Network Newsletter
was also discussed and various
suggestions made to make it more
effective.
For det ils about the meeting
2
I
to ban forthwith the import,
manufacture, sale and distribution
of all the drugs which had been
identified by the Drugs Consult
ative Committee in 1981 as hazard
ous and irrational.
individuals, launched Health
Action International (HAI),
Sweden. This is the group which
had spearheaded the campaign to
boycott Ciba-Geigy products as ;a
protest against the company’s
policies in the third world.
With the recent notification (See
DRUG NEWS below) some of these
have been already banned. It is
not clear therefore how he is
planning to proceed in the matter
as we have had no detailed news
from him.
^Health Action International(HAI)
-U.K, was set up at a meeting in
London in April. Participants
from the Catholic Institute for
International Relations, the
International Contraception,
Abortion and Sterilisation Camp
aign, Third World First, Voluntary\
Service Overseas, War on Want and
World Development Movement agreed
to meet every two months to
update each other on strategy
and action.
It will be recalled that in 1982
he had filed a similar writ peti
tion in the Kerala High Court.At
that time the Central Government
had no powers to ban any drug
directly. It had to be done thro
ugh the State Drug Controllers.
The High Court had therefore
merely directed the government to
publish the list of the trade
names and manufacturers of the
injurious drugs.
>^As part of the Jaipur workshop
it was decided that there should
be a survey of anti-TB drugs
shortage in different areas. Based
on her experiences Mira Sadgopal
from Hoshangabad has written an
article in the latest MFC bulletin.
Purabi Pandey has been twice to
Ahmednagar district and is tabu
lating the results. We have yet
to hear from the other partici
pants who were to do a similar
survey in other areas. Besides
the questionnaires sent out by
post to various institutions and
projects, we feel that there
should be a more in depth field
study in vulnerable areas.
"We live in a world in which
violence,waste and manipulation
have not only become central ele
ments in our lives but which have
become profitable for the merch
ants of death,the rapists of the
earth and those who manipulate
our behaviour, our fears and
desires..." - Anwar Fazal ,IOCU
CONSUMER INTERPOL was formed in
1982 by IOCU members who linked
up with the European Bureau of
Consumers Unions to hasten the
exchange of information,focus at
tention on generic safety probl
ems, help build up capability of
consumer groups and support nat
ional and international efforts
to control the trade in hazard
ous products, technologies and
wastes. In recognition of IOCU’s
work in setting up the Interpol
system,Anwar Fazal received the
1982 Alternative Nobel Prize.
i
^Dr Pile Hanson (who was the
first to report the link between
clioquinol and optic neuritis and
had successfully challenged CibaGreigy’s claim that the drug is
not absorbed systemically) and
Mats Nillgon, medical journalist
who attended the Jaipur workshop,
have together with other concerned
3
I
•
drug news
drugs that the sub-committee of
the Drugs Consultative Committee
(in 1980) had recommended for
weeding out. The most glaring
ommissions are combinations of
- chloramphenicol with strepto
mycin
- penicillin with streptomycin
- fixed dose combinations of
analgin.
Moreover the notification has
been carelessly worded and in
some instances deliberate loop
holes seem to have been left that
will definately be taken advant
age of by the drug companies.
22 CATEGORIES OF DRUGS BANNED
The Ministry of Health and Family
Welfare finally issued a Gazette
notification on July 25 "to pro
hibit the manufacture and sale”
of 22 categories of drugs ana
drug combinations.
The list of banned products
includes amidopyrine, phenacetin,
penicillin ointments, nialamide,
practolol, methapyrilene along
with its salts and tetracycline
liquid oral preparations.In addi
tion the following fixed dose
combinations have been banned:
The editorial in the September
1985 issue of MIMS titled ’’Hanged
Drugs Remain Alive” has summed up
the situation very well indeed
and we reproduce below a slightly
lengthy extract with which we
quite agree :
1
Vitamins with anti-inflamma
tory agents and tranquillisers
2
Atropine in analgesics and
antipyretics
5
Strychnine and caffeine in
tonics
4*
Yohimbine and strychnine with
testosterone and vitamins
55
Iron with strychnine, arsenic
and yohimbine
Sodium bromide/chloral hydrate
6
ith
other drugs
w:
Antihistaminics
with anti7
dj-arrhoeals
Penicillin with sulfonamides
8
Vitamins with analgesics
9
10 Tetracycline with vitamin C
Hydroxyquinolines with other
11
drugs except for the treatment of
diarrhoea and dysentry and for
external use
12 Steroids for internal use
except combinations of steroids
with other drugs for the treat
ment of asthma
15 Chloramphenicol for internal
use except combination with
streptomycin
14 Ergot with other agents
15 Vitamins with anti TB drugs
except combination of isoniazide.
The notification does not even
now cover all the combination
”(a) Ban on the combination of
’atropine with analgesics and
antipyretics’ does not legally
bind a manufacturer to stop- or
not to introduce - the combina
tion products of other belladonna
alkaloids or substitutes such as
homatropine with analgesics and
antipyretics.
(b) Ban on combinations of ’Tetra
cycline with vitamin C’ is mean
ingless if one can market combin
ation of doxycycline with Vit.C.
(c) What is the ’legal’ meaning of
the words ’combinations of strych
nine and caffeine in tonics’?
Does it mean that a tonic should
not have both the agents together,
i.e. strychnine and caffeine ? Or
should it not have them even
separately,!.e. strychnine or
caffeine? Can a tonic have strych
nine alone?
''While most of the orders listed in
the notification can have more
than one interpretation in a court
4-
i
f
to ’combination of steroids with
other drugs (except) for the
treatment of asthma’. The impli
cations of this subtle change are
obvious enough. Since combination
of steroids with antihistaminics
can, at least technically, be used
in the treatment of asthma, they
would escape the guillotine.
Legally the manufacturers can
claim that in future they will
indicate such products for asthma
only, though in the past such
products have been vigorously
promoted for all types of allerg
ies, food poisoning, insect bites
and what not. Who will go to the
nation’s 206,000 doctors and tell
them to forget all past detailings
on, say, a branded formulation of
dexamethasone with cyproheptadine,
and use it in future for asthma
only? No one.”
of law, nothing is more sinister
than the back-door re-entry of
s t eroi d/a nt ihi st aminic combina
tions.
In October 1980, the Drugs Tech
nical Advisory Board prohibited
the combinations of ’steroids
with bronchodilators, steroids
with antihistaminics and steroids
with tranquillisers’. While for
some unknown reasons, the imple
mentation of the decision was
delayed, intense lobbying led to
partial reversal of the decision.
By late 1981 it was decided that
after all steroids/bronchodilators
combinations may have some utility
a nd hence ’wider medical opinion’
should be sought before scrapping
this combination. This meant that
combinations of steroids with
antihistaminics or tranquillisers
shall remain banned. But this was
not to be. Someone, somewhere,
sometime in the meetings changed
the phraseology from ’combination
of steroids with bronchodilators’
We would only add that what MIMS
says regarding the use of steroids
with antihistaminics, would equal
ly apply to any drug whose use is
sought to be restricted after
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r’
years of misuse. For instance
who will go to the nation's
206,000 doctors and tell them to
forget all past detailings on
high dosage estrogen-progesterone
combinations as HPT and use it in
future for secondary amenorrhoea
only?
Though MIMS does not say it in so
many words, we will : When the
machinery to check misuse of a
drug (for which there are alter
natives) does not exist, the only
solution is to ban it.
DRUGS & COSMETICS ACT & RULES
amended
The Drugs and Cosmetics (Amend
ment) Act was passed by Parliament
in October 1982 and it came into
force from February 1, 1983oThis
Act was first enacted in 1940 and
has now gone through six amend
ments since then.
it would now enable government to
exercise control over products
such as transfusion sets, sterile
needles, orthopaedic implants and
curtail the production of spurious
products.
3. A new definition of the term
’spurious drugs’ has been induded
in the Act. Formerly the Act dealt
with ’misbranded drugs’ and ’adul
terated drugs’.
4. The powers of Drugs Inspectors
have been enhanced (Sec 22).
Inspectors are now empowered to
stop ani search any vehicle,vessel
or any other conveyance which
they have reason to believe is
being used for carrying a drug or
cosmetic in respect of which they
have reason to believe that an
offence under the Act is being
committed.
I
5. Penalties for most offences
under the Act have been enhanced®
Considering that the recent banning
of 22 combination drugs will affect
nearly 1000 brand names under which
they are sold, it will be the task
of socially conscious people in
different areas to monitor whether
these drugs in fact are withdrawn
from the market. Now that the
government has armed itself with
such sweeping powers, it would be
in the public interest to pressur
ise the State and Central Drugs
Controllers and Inspectors to use
these powers and actually imple
ment the ban.
The most important changes
effected by this latest amendment
are as follows:
1. Two new sections have been
added to the Act namely Sec. 10 A
and Sec. 26a empowering the Centri.1 Government to prohibit the
import manufacture and sale of
drugs and cosmetics if such drugs
and cosmetics are likely to involve
any risk to human beings or if the
drug does not have the therapeutic
value claimed for it or contains
ingredients and in such quantity
for which there is no therapeutic
justification. This is an import
ant provision since hitherto the
Central Government had no such
powers under this Act.
MEET IBB WITH THE MUGS COBTROLLER
On July 6, 1983, Mira Shiva, Purabi
Pandey and Aspi Mistry had a meet
ing with Dr S S Gothoskar, the
Drugs Controller of India in his
office at Nirman B havan, New Delhi.
We had earlier written to him
asking for information on a number
of topics. This personal meeting
was to elicit some answers as he
had declined to give any detailed
or written response.
2. The definition of the term
’drug’ has been revised which now
covers mosquito repellant, sub
stances intended for use as comp
onent of a drug, empty gelatin
capsules and devices. The inclu
sion of devices in the definition
is of particular significance as
6
I
t
The following were some of the
highlights of the meeting:
1
♦ On clioquinol - the DCI stated
that in his opinion this was a
safe drug - he took it himself
ani found it effective. When
reminded that during his meeting
with Dr Olle Hanson in April he
had shown willingness to look
into the matter and reevaluate
the product,he said he did not
feel the need to do thiSo
Regarding the lack of efficacy
of clioquinol, he said he would
be willing to accept such a
conclusion only if expert medical
opinion was given on the mattersince in 1978 an ICMR committee
had considered the matter and
decided not to ban clioquinol.
* Screening of medical literature/
handouts given to doctors The DCI said it was the State
Drugs controllers who were res
ponsible for this work, but he
doubted if anyone was really
doing the screening.
♦ We informed him that on the
question of generic names and
the banning of BP drugs we were
supporting the stand of the
government. Since the matter was
now in the courts we would like
to help the government with info
rmation and arguments obtained
through our contacts in the fields
especially in the voluntary
sector. With this explanation we
requested to be given a copy of
the petitions filed by the comp
anies against the government.
The Drugs Controller indicated his
absolute inability to do this.
He refused to give us even an out
line of the companies’ arguments
orally or to inform us who were
the advocates for the State hand
ling the matter so we could
approach them.
B0ILIN5 DOES NOT DETOXIFY KHESAKI
DAP - BANNING ONLY ALTERNATIVE
There are over one lakh persons in
the Indian sub-continent who are
crippled with Lathyrism - spastic
paralysis of the lower limbs caused by the consumption of khesari
dal,Lathyrus sativus. Unlike other
states, W. Bengal, M.P. and Bihar
have not banned the cultivation of
this crop. InM.P., in two districts
Rewa ani Satna alone there are over
25000 and 52000 lathyrism cases,
respectively. The majority of those
afflicted are labourers many of whom
are bonded labourers and who receive
khesari dal as wageso
Studies by Dr Kamal Ahmad from the
Institute of Nutrition and Food
Sciences, University of Dhaka,show
that boiling the seeds with water
five times,discarding each time the
aqueous filtrate,D ID NOT DETOXIFY
THE SEEDS even after 2/2 hours of
boiling.
♦ We pointed out that in the
latest issue of CIMS a high dose
EP drug (Lut-Estron Porte) was
still being indicated for preg
nancy testing. We discussed the
The government and health authori
ties have till now maintained that
boiling the dal, soaking it cfi
u
7
i
CERC REPORT ON DAHrEROUS
ANALGESICS
need for the drugs control autho
rities to communicate their
decisions and information to health
personnel in the field. We felt
that at least the editors of MIMS
and CIMS should be informed of
banned drugs,etc. We also suggested
that organisations like VHAI who
were in contact with institutions
in the voluntary sector could be
kept informed so that decisions
of the drug control office reach
the field. The DC I said that he
informed the IMA regularly but
"I cannot inform everyone".
The Consumer Education and Research
Centre (CERC) prepared a welldocumented report on analgesics
and submitted it to the Drugs
Controller of India for his action
a nd comments. The report in two
parts deals with both hazardous
as well as irrational combinations.
This was part of the reply from
the Drugs Controller with respect
to "Irrelevant Analgesic Combin
ations" :
* Anti-diarrhoeals - We suggested
that the following caution should
be included in the packaging of
anti-diarrhoeals: " Anti-diarrhoel
drugs are not enough, oral rehy
dration is the main treatment for
diarrhoea", pictorially showing
how ORT can be prepared. The Drugs
Controller informed us that this
was not within his jurisdiction.
In the context of the national
Diarrhoeal Disease Control Pro
gram, we feel that this is some
thing that can be immediately
implemented. We already have the
example of "Breast milk is Best"
on baby food tins and a good
and effective illustration of
pictorial instructions can be seen
on Nespray tins (Nestltf).__________
REMEMBER - NOVEMBER IS
CAMPAIGN MONTH
Various individuals and groupspart of the Drug Action Network
and others-will be launching a
concerted campaign in November.
Contact the group in your area
for more information - VHAI.CSE
(DeIhi)CE RC(Ahmedabad)M FC, A rogya Dakshta Mandal(Pune)CED,Lok
Vidnyan Sanghatna(Bombay)FMRAI
(Gen Sec,Patna)KSSP(Trivandrum)
"These preparations have been
marketed worldwide for several
decades and have been accepted
by the medical profession and the
public. As these preparations
have been in the market for a
long time it may be difficult to
withdraw these preparations unless
adequate clinical evidence is
available that these preparations
are irrational and harmful".
One of the hazardous combinations
referred to in the CERC report
is dextropropoxyphene with
paracetamol. This is what the 28th
Edition of Martindale has to say
about this drug(Pg 1006):
"There are a disturbing number of
fatalities from either accidental
or intentional overdosage with
dextropropoxyphene. Many reports
emphasize the rapidity with which
death ensues; death within an hour
of overdosage is considered by
some not to be uncommon. Over
dosage is often complicated by
patients also taking alcohol and
using mixed preparations such as
WHO has updated its model list of essential drugs by adding
22 preparations and deleting 7 from the main list. It has
also published a list of 22 drugs for primary health care
which can be used effectively and safely by responsible
individuals with little formal medical knowledge.Also being
compiled is a list of 'banned products’....
3CRIP No. 811
July 13 1983 and SCRIP No. 803,UK, June 15 1983.
k
------------------------------------ - ---------- ------------—--------------- -
8
*
< <
dextropropoxyphene with paracet
amol or aspirin.”
A FORMULARY BASED ON RATIONAL
And this is the Drugs Controller’s
reply:
The Kurji Holy Family Hospital in
Patna has prepared a ’Formulary and
Therapeutic Guide’ based on the
principles of rational drug therapy
and the essential drugs list con
cept. The avowed aim of the Hospital
Administration is to "build the
image of the Hospital as a centre
for health education, leadership
training, conscientisation and
social reform rather than that of
merely being a centre for curing
diseases.”
therapeutics"
••Regarding the combination of
dextropropoxyphene with paracet
amol, such combinations are being
marketed in many countries and
cannot be considered as irrational”
1
There seems to be some inescapable
connection between "marketing" and
’’rationality” that does not quite
convince. Even when there has been
more than ample ’’clinical evidence”
(for instance clioquinol), the
Drugs Controller has consistently
refused to take action.
We definitely feel that such
detailed studies as done by CERC
and other consumer groups deserve
an equally studied response from
all of us. It is neccessary to
build up counter - documentation
on medical and scientific issues
to challenge established "expert'1
opinion.
CHANGES IN THE DPCO
The formulary is the result of the
accumulated experience of the Senior
Medical Staff of over 10 years. It
has been prepared to deal with 9698 % of the conditions admitted
to the hospital. The hospital policy
is to prescribe the drugs by generic
names and the formulary contains
drugs which are said to have passed
the criteria of being efficient,
safe, low cost and easy to adminis
ter. The formulary also contains
diagrammatic representations of
relative costs of various drugs
for different types of conditions.
The recent changes in the DPCO
have affected most of the pharma
ceutical industry. Whilst the
merits and demerits of these chan
ges are being debated, the drug
companies have already started
making threatening noises regarding
the availability of life saving
and essential drugs. The existing
shortages are likely to be accent
uated and most of us feel that
shortage of essential drugs and a
rational drug policy will be the
main issue in the future over
shadowing even the question of
hazardous and irrational drugs.
We would like the individuals and
groups in the network to give
serious thought to this subject so
that we can jointly prepare a plan
of action.
!
I
We feel this formulary is a good
model for future work along the
same lines.
COMMERCIAL ORT PACKETS
Some time back we had received a
report from the Head of the Paed
iatrics Dept at CMC Vellore,
Dr Sheila Pereira, of serious
complications like hypernatraemia,
caused by the use of unstandard
ised commercial ORT packets.
The problem occurs due to the
different sizes of packs which are
required to be mixed with differ
ent quantities of water( ranging
from 250 ml to 2 lit.) which are
difficult for people to measure
(and for illiterate persons to even
read on the packet).The formula
used is also not a standard one.
Incidentally, the NCAER has prep
ared a document on the same issue
(Drug Policy) which will be rel
eased to the public shortly.
9
•»
The quantity of water in which
it is to be mixed viz. one glass
can be shown pictorially on the
packet. Larger sized packets
should be divided into compart
ments in the packet, each comp
artment containing the mix for
1 glaa© of water.
One possible solution would be
to standardise ORT packets for
1 glass of water (200 ml) as
this is the measure most commonly
available.Moreover preparing a
glass at a time would save both
wastage and the risk of the ORT
becoming stale.
coming events
Pune
support from drug firms. The step
has become neccessary because of
high pressure tactics of pharma
ceutical firms. Senior physicians
and surgeons say that unless they
act now, drug companies will infl
uence doctors unfairly and unduly
in an even bigger way. ’’Doctors
need to have stronger ethical
standards and observe them strictly
because violations hurt the ord
inary public”, Dr R K Anand, of
Nair Hospital in Bombay said.
( The Times of India, Bombay,
June 25, 1985 )
This program is subject to change
as we have not heard definitely
from Dr Zafrullah. The various
persons listed above are in touch
with each other and with Dr Zaf
rullah to finalise the itenerary.
j^The next meeting of the MFC will
be held in Calcutta at the Child
In Need Institute (CINI) at the
end of January. The theme of the
meeting will be Alternative Medical
Education.
Or Zafrullah Choudhary will be
in India from 25 Nov to 4 Dec.
His schedule roughly is as
f ollows^ and programs in the
various cities are being organised
by the persons mentioned:
25 - 26 Dr Anant Phadke
Dr Rane
Bombay
27 - 28 Dr Raj Anand
Dr Antia
Trivandrum 29 - 50 Dr Ekbal,KSSP
Bangalore
1
Dr Ravi Narayan
Delhi
2-5 Dr Mira Shiva
Dr Narendra
Mehrotra.
Calcutta (?) 4
Mr. Poddar,
WBVHA.
We hope you will contact the person
closest to you and participate
actively in the program and help
strengthen the drug action network
in your area.
* The Pune branch of the Indian
Academy of Paediatricians hosting
the next academy conference in
November has turned down financial
★ lOCU is organising a workshop on
Pharmaceuticals and Health Policies
22-25 Nov 1985 at Penang,Malaysia.
Some of the important topics for
discussion include: Developing a
National Health Policy, A Code for
Marketing Practice, Representation
of National Groups’ Work Plans.
Mira Shiva has been invited for
this meeting.
io
> *
*
J
I
I
11
1®1ORAIWIF1
We3 the health personnel and citizens of India recognize health as a
fundamental right of the people in this, onr welfare state, WTe recognize
and strongly believe that the health status of our* people is more dependent
on their access to adequate food, safe and adequate water, proper sanitation
and clean environment.
While we support the ovcre.ll perspective and approach of the new
National Health Policy Statement and demand its proper implementation, we
believe that a 1 Rational Drug Policy1 is an integral part of a good National
Health Policy.
1.
2.
3.
We therefore, demand the following:
'We have a right to safe, essential, quality drugs which are in keeping
with the health needs of tho people, at costs which the majority can
afford.
We urge our government to accept and implement the Hathi Caimittee
Rec ammo ndations which are also in koopin^ with tt^
a Rational Drug Policy.
.
Further the national drug formulary should be revised and c.cmpi e . y
an export multi disciplinary committee keeping the following cri -eraa m
mind;
Essentiality
■n'p pj
Safety
Cost
Ease of administration
Availabi li ty
Potential for misuse.
Such evaluation of the drugs in the market and revision of the lists
should be done periodically.
4. The Essential Drugs Policy should be adopted for all health services,
government and private, and priority in production, distribution and
dispensing should be given to these essential drugs.
5. The public sector should produce essential and life saving drugs on a
priority basis at the national level.
6. Drug production by multinationals and private manufacturers in India
should also be aligned with national health priorities.
7. Bulk procurement of essential and needed drugs should be through world
wide competitive tenders and rationalization of drug purchases should
govern both the public sector as well as private health sector.
8. Imports and production of non essential, specially hazardous drugs,
should be strictly curtailed.
9. Drugs which have been banned from sale alter being marketed for some
time in one country may not bo submitted for clinical trial or marketing
in India. The onus of proving why a non-essential drug should be intro
duced or allowed to continue on the market should be with the manufact
urer and such introduction should be preceded by adequate trials and
evaluation by Drug Control Authorities.
10. Ccmprchensivo drug legislation which covers areas such as price control
at different levels, patents, and marketing practices should bo incor
porated to serve the objectives of the nati -nal drug policy and there
should be n"' levies, sales tax or excise duty on any pharmaceutical pro
duct in the essential drugs list by the Central or State governments.
11e No technology transfer agreement shall be legal and binding which cont
ains restrictive practices, disproportionate and unnecessary use of
imported intermediaries or obsolete techn-•logics or unfair arrangements
with respect to prices, ■ payments or repatriation of profits.
12. The National Drug Policy should state clearly tho steps towards
cfjnplctc abolition of brand names and as a first step use of generic
names should bo made compulsory in medical education, prescribing and
labelling of drugs. Generic names should, appear more preminently ...n all
packagings
.
z
•r
..2..
I
13. It shall be the- primal^ responsibility of the manufacturer to ensure t.e
duality of drug products. However, it shall be the statute respensa -xlit-v of the Drug Control Authorities to monitor the standards an^ cnsur-c
a minimum uniform level of government control. Consequently, the government shall take all necessary measures to enable the Drug Control Au., urities to function in an effective manner and discharge the statutory
duties cast upon them.
>
. , .
14. It shall bo the statutory duty of the drug control authorities to iriiorm
health personnel and consumers of the essential drugs list», po c^,^,
catcgGri.es or brandsordrugs banned for manufacture or sale, through pub
lication in the national newspapers, magazines, medical journals witn
adequate explanations and-details.
, ;
3?. Anra-m'ir.'hn in fy of drugs required in the Governments National Programme
should be ensured on a priority basis to the government as well as^
voluntary and private health institutions. Quotas tor anti IB, anti
loprosy, anti malarial drugs, iodized salt etc should be made easily
- available with, regularity of supply to the voluntary health institutions
whereevor possible, specially when their performance, in health carx
delivery is knovin tc be effective.
16. In all review committees, statutory bodies and other such bodies, there
should be adequate representation of consumer groups and voluntary heaita
sector.
-| 17. Drug companies should follow ethical marketing practices, and this shcuK.
be ensured by their own organizations like OPPI,1IMA, IFPNA. We deplore
the tendency of those companies and associations to get around every
progressive measure of the government through recourse ‘technicalities oi
the law and through the courts.
.
18. The marketing code drawn up by HAI(Health Action International) should
form the basis for a National Code for Marketing Practices. This should
bo accepted by our government and should be suitably implemented through
legislation.
19- The government of India should take a lead and endeavour tc iniluenc^
the WHA and WHO to adopt ti.o Code in the interests .of the other develo
ping countlies and their peoples.
(IFPMA and HAL Code attached).
- Voluntary Health Association of India
- Centre for Science and Environment
- Centre of Social Medicine and Community Health-Jawaharlal Nehru Univer
sity.
- Kerala Sahitya Shastra Parishad
- Medico Friends Circle
- Arogya Daks h ata. Mandal
- Lok Vigynn Sanghatana
- Consumer Giidanco Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of India#
i
*
AIDAN
All India Drug Action
Network (AIDAN)
Adi India Drug Action Network
(AIDAN) is a coordinating body of
Voluntary Health, Consumer, Science
ganizations and individuals actively
involved in this field, from different
parts of India; set up to :
i Work towards a Rational, Propeople Drug Policy in India and to
ii Exchange ideas, experiences about
different aspects of alternative
practices at grass root level
pertaining to the production,
distribution, use etc. of Rational
Drugs.
PERSPECTIVE
AIDAN realizes that the health of
people depends primarily on nutrition,
sanitation, living and working
conditions, social culture..etc and that
availability of health services especially
of drugs, has only a secondary role to
play. But at the same time, in India,
where infectious diseases predominate,
drugs can save large-number of lives
and remarkably reduce sufferings. The
Rational Drug Policy, can therefore,
play an important role as part of a
Rational Health Policy. However,
during the last thirty years, along with
a rapid increase in the range and
volume of drug-production, there has
been a more rapid rise in the
irrationalities at all levels of the drug
policy (i.e. Research, Production,
Distribution, Marketing, Education
and Use) due to a lack of scientific
approach coupled with the profiteer
ing by the drug industry. Secondly
even 39 years after independence, the
multinational drug companies con
tinue to dominate the drug scene in
India; self-reliance continues to be a
dream. As a result, essential drugs are
in short supply, out of the reach of the
majority of the people who need them;
whereas there has been a plethora of
high-cost, useless, hazardous drugs in
the market.
There is, therefore, a dire need to
work for a Rational Drug Policy
which should have the following
objectives:
A Assessing the real drug-needs
1 To identify the real drug needs in
consonance with the health need of
the people, particularly those
required for primary health-care; to
prepare a graded essential and
priority list of drugs for different
levels of health-expertise in keeping
with actual health needs of the
people.
2 To eliminate irrational, useless and
hazardous drugs. (This has become
one of the most important problems
today).
B Production, Price and Quality
control
1 To produce and make rational
drugs available at low prices to the
people, particularly the essential
and priority drugs. Adequate
supply of free drugs to the poor
people through the state health
system.
2 To ensure strict quality control of
all drugs.
C Drug Distribution
To establish a national corporation
for the distribution of drugs;
retailing of drugs through appro
priate channels and government’s
health infrastructures.
D Drug Information & Ethical
Marketing
1 To ensure a drug information
system for health personnel and
consumers.
2 To ensure ethical marketing
3 To abolish brand names and
introduce generic names of all
(drugs)
E Self-reliance
1 To develop self-reliance in drug
technology.
2 To foster and encourage the growth
of the Indian Sector and to provide
a leadership role to the public
sector.
3 To aim at quick self-sufficiency in
the output of drugs with a view to
reducing the quantum of imports.
F Research and Development
1 To promote research and develop
ment for self-reliance and to meet
the real health needs of the Indian
people.
2 To evolve strictly ethical mode of
medical research.
G Legislation and Administration
1 To provide comprehensive drug
legislation and administrative
support to deal effectively with and
implement all the above aims and
objectives.
2 To ensure smooth Centre-State
relations and inter-departmental
coordinations for effective drug
production, drug control and drug
supply.
H Human Power Development
To fulfill the needs for the above
Rational Drug Policy, different
types of technical personnel (e.g.druggists, paramedics technicians
etc) need to be adequately and
appropriately trained in adequate
numbers.
Some elaboration of these
objectives ( A to H) has been
published in the form of a 16 page
pamphlet “Rational Drug State
ment” of AIDAN and is available
for Rs. 1-50 from Dr. Mira Shiva,
Coordinator, AIDAN. A substantial document “A Rational Di
Policy” (see at the end) gives a
much more detailed account.
EVOLUTION & ACTIVITIES
Some groups and individuals
concerned with misuse of drugs came
together in 1981 and launched a
campaign against the high dose
combination of estrogen and proges
terone. The campaign proved to be
effective and the Government had to
ban this combination. Encouraged by
this success, attempts were made to
rouse public opinion against irrational
and hazardous drugs. Through the
interaction during these campaign, it
was felt that there was a need for a
regular network to co-ordinate this
work; to lobby for a rational drug
policy as a whole and not only about
hazardous drugs. A loose co
ordinating network was formed in
1983. A series of prolonged and
intense discussions were held amongst
those who had been consistently active
in this collective work during those
couple of years and a Rational Drug
Policy Statement (RDP Statement)
was prepared outlining our basic
common
understanding
briefly
elaborating the points enumerated
above.
Within the perspective of this RDP
Statement, member organisations &
individuals have tried to create public
awareness through various means
“ (articles in periodicals, pamphlets,
meetings..etc.) On different aspects of
the drug policy, particularly the
relationship between plethora of
irrational drug combinations and the
paucity of essential drugs and that
between high prices of drugs and the
domination of multinational drug
companies. (At the end, a list of
publications in English on the drugs
issue by member organisations has
been given.)
From 1984, a new drug policy by
the Government was quite in the air
and hence AIDAN as a collective
focussed its attention on this new
policy. A detailed critique of the report
of the steering committee of the new
National Drugs and Pharmaceutical
Development Council (NDPDC) was
submitted to the Government; a spate
of newspaper articles were written,
concerned parliamentarians were
appraised of our perspective and
demands by providing substantial
material. A signature campaign
amongst doctors enlisting medical
demands about new drug policy was
carried out in different parts of the
country.
After the announcement of the New
Drug Policy on 18-12-86, its anti
people, pro-industry, irrational charac
ter is being exposed in the eyes of the
public.
Apart from lobbying about the
policy issues at the National level,
some member organizations of
AIDAN have been active in educating
doctors, paramedics and the lay people
about Rational drug use in their
practice. For example:
★ “Drugs Diseases Doctors” by Drug
Action Forum, West Bengal, is a
periodical for doctors which is
almost exclusively devoted to
rational use of drugs and to
highlight misuse of drugs.
★ Voluntary Health Association of
India has been training their
paramedics in rational drug use and
has published health related
booklets.
★ LOCOST has been trying to evolve
a method of supplying good quality
generic name drugs at cheaper rates,
to the voluntary sector and
promoting rational use of drugs.
WHAT YOU CAN DO FOR
AIDAN
1 To become an active member of
AIDAN please write to the cooridnator on the following address.
Dr. Mira Shiva C-4/14, S.D.A.
New Delhi 110 016.
2 To study the substantial material
published during last few years by
AIDAN members or by other
fraternal groups; and to write in
various periodicals with the help of
this material.
Please do not forget to send a
copy of the cuttings of published
material to the AIDAN Co
ordinator.
A list of such publications is
given at the end of this brochure.
3 To sell this material to appropriate
groups, socially conscious doctors,
activists, Journalists...etc.
4 To foster Rational Drug Policy
Cells in your area or within already
existing appropriate organizations
to carry out the above work of
lobbying as well as to promote
rational knowledge and use of
drugs in your area. For example, a
local group can launch a campaign
amongst doctors as to why they
should not accept any drug samples
from any drug company, or why
they should not use hazardous
drugs like E.P. forte, Analgin,
Butazones, Anabolic Steroids,
Clioquinol, Combination of strepto-
>
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ii
F
i
ii
iii
G
i
ii
iii
v
H
i
700 089. Annual Subscription
Rs. 12-00.
Poster: Drugs for the people or
People for the Drugs, Rs. 3/Kerala Shashtra Sahitya Parishad (KSSP) Parishad Bhavan,
Marvencheri Lane, Trichur 680
002.
A decade after Health Committee,
Ed. Dr. B. Ekbal, Rs. 35/Drug Alert-Hazardous Drugs
(AIDAN) pp. 52, Rs. 6/National pplicy for Universal salt
lodization-A critique, Dr. K.P.
Arvindan, Rs. 3/Medico Friend Circle
Rational DrugPolicy Cell,50, LIC
quarters, University Road, Pune411 016.
“Tonics how much an economic
waste ?” by Dr. Kamala Jaya Rao,
xeroxed 6 page article from MFC
Bulletin: Rs. 5-00 (available free
of charge with V.H.A.I)
“Scientific Scrutiny of some overthe-counter-drugs” by Dr. A.R.
Phadke, xeroxed copy of the
reprinted article in “Medical
service” Oct-Nov. 1985, 7 pages:
Rs. 6-00
“Multinationals in the Indian
Drug Industry” by Dr. A.R.
Phadke, xeroxed copy of the 5
page article from MFC bulletin,
Rs. 4-00 iv) Dipyrone, Hoechst
and the Boston Study, Wilbert
Bannenberg, reprint from MFC
Bulletin No 123, December 1986,
4 pp. Rs. 2-00
Drug Alert-Hazardous Drugs,
pp 52, Rs. 6/Pondicherry Science Forum
Issues involved in drug policy. (A
brief account of some of the issues
discussed in I,II and Di published
by Chennai Books; 6, Thayar
Sahib Street, II Lane, Madras 600
012, pp 56; revised edition,
Februrary 1987 Rs. 10-00
I Voluntary Health Association
of India (VHAI) 40, Institutional
Area, south of IIT, New Delhi110016
i Banned and Bannable Drugs, pp.
67, Rs. 15-00
ii Drug Information pack; Rs. 15-00
iii The use of Essential Drugn
(reprint from WHO) Rs. 10-C
(for other books, see T in the
beginning)
iv “Do you really need all these”, a
leaflet, Rs. 2-00
v Reprints from: “Where there is no
Doctor”, Right and wrong uses of
modern medicine: Re. 1/Instructions and precautions for
Injections: Re. 1/-. The uses,
dosage and precautions of
common medicines, Rs. 2-50
vi Leaflets of Rs. 0-50 each: The
declaration of Alma Ata,
Drugging of Asia, WHO essential
drugs, Bangladesh drug policy,
Hazardous bannable and dumped
drugs, Our concern about drugs,
Essential drugs, The Courageous
Bangladesh.
vii Posters: Murder in the name of
medicine, profits before the people
Rs. 5-00 each ‘Can you
understand the small print’, Ban
Bannable drugs, Drugs can be
dangerous too. Don’t judge a
medicine by its packaging, Rs.
3-00 each.
For a list of other publisher’s books
on drugs available at VHAI, please
write to the publication officer, VHAI.
For mode of payment, postage., etc,
please write to individual publishers
listed above.
40, Institutional Area, South of
I.I.T. New Delhi-110 016.
iii Critique of the New Drug Policy,
April 1987 (under preparation)
available at VHAI and CED).
iv Drug Alert-Hazardous Drugs, pp
52, Rs. 6/II Material Published by AIDAN
Members:
A Arogya Mitra Mandal 2117,
Sadashiv Peth, Pune 411 030 —
Our Health, Our Medicines,
Rs. 10/B Catholic Hospital Association
of India (CHAI) PB 2126,
157/26 Staff Road, Secunderabad
500 003
1 Health Action — a monthly
published by Health Accessories
for All (HAFA) propagates
Rational Drug Therapy and
Critical approach on Health Care
delivery.
Subscription Rate:
Life Membership
: Rs. 1000/Annual — Individual
: Rs. 60/Annual — Institutional : Rs. 80/Foreign-Annual
:US$ 50/Foreign-Life
: USS 500/Single copy
: Rs.
7/Themes covered by past issues in
1988 include Immunization, Infec
tious diseases, Tuberculosis, Nutri
tional Anaemia, Diarrhoea, Acute
Respiratory Infections, Antenatal
Care, Rational Drug Therapy,
Nutrition, Leprosy, Addictions and
Blindness.
1989 — Sports and Health,
Growing Child, Hypertension,
Mental Health, Accidents and
Poisoning, Diabetes, Community
Health, Allergies, Dental Health,
Universal Immunization Pro
gramme, Cancer and Shelter
(Housing).
2 Buyer’s Guide — '
A purchase guide to Health Care
products and services — useful for
Hospitals and Dispensaries.
Price Rs. 175/3 Herbal and Home Remedies —
Loose Leaf format. Photographs
and sketches of herbs used
commonly as home remedies.
Price Rs: 40/4 Mini-manuals in Hindi (set of 10
titles) — Illustrated guide to deal
with common health problems in a
simple and rational way, giving
both allopathic and home remedies.
Topics covered are Scabies,
Pneumonia, Tuberculosis, Polio,
Care of Eyes, Ears and Teeth.
Price: Rs. 15/- for whole set.
C Centre for Education &
Documentation, 3 Suleman
Chambers, 4 Battery Street,
Behind Regal Cinema, Bombay400 039
i Aspects of Drug Industry in India,
M Bhagat, pp. 130, 1982. Rs. 19
ii Brief List of the Literature on
Drugs and Drug-related issues
available at C.E.D. with facility
for xeroxing and sending by post.
Most of the literature in this list is
available for sale with C.E.D. and
V.H.A.I.
iii Injecting NET-EN into India,
Mira Savara, June 86 Rs. 5.
D Delhi Science Forum, B-l, Ilnd
floor, ‘J’ Block, Saket, New Delhi110017
i Drug Industry and the Indian
people, Dr. Amit Sen Gupta,
(ED.) co-publisher-F.M.R.A.I.
Patna, pp 333, 1986, Rs. 40-00,
Harbdound Rs. 100-00
E Drug Action Forum West
Bengal
i Drug Disease Doctor (Quarterly);
Ed. Dr. P.K. Sarkar, P. 254,
Block-B, Lake Town, Calcutta-
mycin with chloramphenicol or
with penicillin...etc.
Campaign amongst the people
about primary importance of oral
Rehydration in diarrhoea; and try
to start “diarrhoea-treatment cent
res” by paramedics under the
guidance of a doctor and about the
wastage of money involved in the
use of most of the highly advertised
over-the-counter drugs and the
alternative to these brands.
Lobby with the Government on
the basis of awareness amongst the
people about★ The urgent need to make
available measles vaccine on a
priority basis in the Government
centres or to shelve the plans to
give NET-EN injections to
women.
Lobby with the professional
bodies like in Indian Academy of
Paediatrics, IMA to
★ promote rational use of medi
cines amongst its members; to
conduct seminar on the new
drug policy;
★ to pressurize the Government to
immediately make available the
measles vaccine in its pro
gramme.
★ to prepare and distribute healtheducational material for parents
on child-health and about do’s
and don’ts about drugs.
Only a couple of illustrative
examples have been given above
about some of the types of activities
that you can take up. Many such
instances and also other types of
activities are possible depending
upon resources.
5 If you are interested and are in a
position to do academic work; this
will also be helpful. If you are a
doctor, you can contribute to the*
above mentioned periodicals or you
can prepare a study of various
formulations belonging to any one
of the groups of drugs (cough
mixtures, haematinics, antacids., etc)
that are available in the market to
assess their rationality. Studies
conducted by the Medico Friend
Circle (see at the end) offer such
examples and have proved to be
very useful in re-education of
doctors.
If you are an economist or
sociologist, you may study from that
angle, various aspects of a rational
drug policy-for example, the real needs
of the Indian people about different
drugs for example, how much of
isonex-the antitubercular drug-would
be required to treat all the TB-patients
in India? How much money is
wasted, concretely speaking, on
irrational drugs? What is the impact of
the new drug policy on the ex-FERA
companies, Indian monopoly drug
companies, medium size companies?...
etc. If you are an artist, you can draw
posters, cartoons, prepare songs, make
a slide show...!
This is a movement and different
types of people with different skills can *
make valuable contributions. Let us all
together work towards a ‘Rational
Drug Policy”.
LITERATURE ON DRUGS IN
ENGLISH PUBLISHED BY
AIDAN MEMBERS
I AIDAN Materials:
i Rational Drug Policy statement:
pp 16, Rs. 1.50, VHAI (see below)
ii A Rational Drug Policy; pp.162,
2nd edition 1986, Rs. 20.00 (This
book and C1 - see below-are very
substantial resource books on
different aspects of Drug Policy)
Published by Voluntary Health
Association of India for AIDAN
3)3
Voluntary
Health
Association
C - 1 4» Community
Safderju ng
New
9 f
India
c e n t r e
development
Delhi-110016
Area
July 17, I934e
4
ESSENTIAL DRUGS
A DEM.AI^D FOR PRIORITIZATION
Prepared for
V H A I members.
Drug Action Netvprkors
and all those who believe
in the concept
and implementation
of Rational Drug and Health Policy
Background pap or
for
Drug Action Network
Core Group Meeting
Wardha
30 - 31st JULY 19^4.
Dr. Mira Shiva
Coordinator
Low Cost Drugs
and Rational Therapeutics
V.H.A.I.
I
*
B-4/37#(c) LCD & RT
7HAI: pt: 19.7.! S4
bssenti AL, DRUGS - A DEMAND FOR prioritization
Dr. Mira Shiva, VHZI.
Content Outline
I • Essential Drugs ~ An Introduction
II.
Courageous Efforts - Brief Review
Chile
Srilanka
Pakistan
Mozambique
Bangladesh
WHO
India
III.
Our efforts in the area of essential drugs
IV.- Ihe Selection of essential drugs and the essential drug programme
- W H 0 Rec omm end at ions.
~
V.
The Rationale of Essential Drugs or Winy do wo need an Essential
Drug List?
---- ----A. Existing low, priority to essential drugs (needed for the
priority health needs) and the deteriorating trends in output.
B. DPCO The Drug Price Control Order and its negative impact on
Production of Essential and life saving drugs i.e. Category I
and II drugs.
C.
Poor performance of multinationals in production of essential drugs
D.
Dilution of EBRA companies - an invitation to more formulations.
E.
The need for rational use of scarce resources: Controlling Cost
by:
1. preventing .wastage of scarce foreign exchange by net
importing excess inessentials.
2.
ensuring preventive health measures before promoting
inessential drugs.
3.
ensuring placing essential drugs before inessential drugs
4.
increasing -production of essential drugs, decreasing
drug costs through economy of scale.
5.
ensuring bulk, purchase of selected essential drugs and
thus cutting costs.
....2/
4
3-4/37S(o). LCD & RT
VIL'I:ptj9.7.’a4
2
:
F.
Subsidizing costs of essential drugs-
G.
Need for i^luoncing market demand and thus the drug
production pattern in favour of ess ent n ad driigs
H.
Need to decrease drug misuse ard overuse.
I.
Need for efforts in preventing Iatrogenesis
J.
Need for
*
‘ ‘
personnel and consumers.
K.
Need for ensuring better quality control
L.
Need for Ensuring generic prescribing
drug information for health
VI. Graded Essential Drug List
I.
ES.SSNTIAL DRUGS
INTRODUCTION
I he concept of essential drugs is the focal point of the drugs
issue and of the rational drug policy.
Our focussing on essential drugs does not mean that by ensuring
production and supply of essential drugs5 the health care status of
our people -will dramatically improve. Wo are focussing on it to high
light the fact that majority of our people are not merely deprived of
health care facilities, but whatever they are given by way of health
care does not necessarily have their interest in mind. The Irind of
health care facilities, medical technologies and drugs being promoted
under the garb of "sciontificity" and "modern advances" and as "latest
break through" usually servo the interest of the "m0G_uCal industry" i.e.
the drug industry and the medical establishment. Some of those modern
n^ths and superstitions have to bo demolished. Eg. Myth I - medicine
is a noble profession brimming with selflessness, putting patients
interest and welfare, above self interest.
Myth II - The drug industry
produces Tpills for every ill1 and is fighting an unselfish battle
against death and disease. If it wasn’t for them, lots of us would be
sick and suffering if not dead. Myth III - India ist a welfare state,
signatory of the Alma Ata Charter giving priority to Primary Health Care,
and that our health policies arc people oriented, and are guided by reco
mmendations of Committees like the B^ore Committee, 1946, Hat hi Committee
1975- Alternative strategy Health for ;111 "ICMR-ICSSR Report 19^1’’and
oven the last years the’National Health Policy Statement "all of which
emphazise that the health needs of the majority, have to take priority
over sophisticated, centralised, costly, high technology medical services
meant for the minority with the purchasing power.
rc.'.
a-4/37^(c) LCD & RT
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:
3
The concept of essential drugs^ questions the health personnel
who are supposed to safeguard the health of tho people; it questions why
thoir prescriptions include irrational, inessential, costly combinations
and often hazardous drugs. It questions tho medical establishment for
not demanding bans on bannablo drugs, nor attempting to ensure and
implement such bans. It focusses tho attention on tho prosont day medical,
services- private and government; tho proscription'patterns; the grots
lack of accountability to tho public or to any medical council. The
doctors bask in the prostigo that comes, with tho practice of 1 white
man’s’ modicinc.
It is tho public that potst hem on'a podostal (not
far bolow the ono meant for tho Almighty). In reality, thoy, like tho
drug Eianufacturcrs and their representatives aro no better than salesman;
and medical care is debased into a ’commercial sarvi^o’and it son a,
oven if tho people neoding it have to bog, borrow, or steal.
If tho proscription patterns have to bo based unmodifiodblindly, unchallenged on the medical text book vritton by and for tto
West - then wo should also ensure that their control^ go with thorn.
There should bo registration with tho nodical council, need to pass
board exams after certain years of practice, medical audit and withdrawal
of medical liconee for unethical medical practice. If our state mechanism
is meant to ensure anything, it is to ensure total safeguard against
those who in the name of medicine, beliovo in making quick money, and
usd their medical license, to exploit tho people. Not merely are such
medical practitioners whoso number is fast increasing an insult to
medical practice, but they sot examples for others, so that medicine
has become a ’’Dhanda” (business) for many. Youngsters bribe, fudge
mark sheets, pay lakhs of capitation fees to get admission in medical
colleges to join their ranks - while Primary Health Centres lie ..unstaffed,
unequipped and disfunctional. Rarely do tho prestigious medical establish
ments raise a huo and cry over tho ever incroasirig nodical swindles;
against tho decreasing health budget of tho 5/jroar plans; against
tho drug bans that novor cono or are never isiplemonted; against health
and drug policies that aro not in tho interest of the people.
hju
~ The drug industry is there not to serve, but safeguard its
own interests. The performance of multinationals in decreasing product ion of essential and life saving drugs, and the double dealing in giving
biased drug inferaation; thoir ensuring the punchasc of drug prescript
ions for ones company by gratifying doctors with samples, gifts and
sponsored medical conferences. With loan licensing, products of many
of the big name companies arc produced by small scale drug outfits
■with as much quality control as most other small scale drug ccmpanias.
All coiumorcial enterprises serve a purpose, but a few like
drug industry start sharing the role of a healer, server, educator,
benefactor, tiaving touched the dizzy heights of highly toihnical
uystified science.
Myth III - The third myth of course is that our health pol icy is
geared to fulfil the health needs of the majority.
The ^health budget has steadily decreased. It may have been
broken up under different heads but with increasing population and
increased need for health services, health budget should bo going up
much more rapidly.
V
/ h
E-4/378(o) LCD RT
VliU;pt:19.7.’S4
How has the money boon spent? What are the disparities existing?
Wliat has been the role of the policy makers? What has happened to the
various recommendations mentioned earlier? The perspective should have
been set when we attdined independence. The direction being pursued now
■ hashrt changed very fnuch from the pre-independence period.
The public
/has had no say ip deciding the kind of doctors it-wants trained with its
money'-'and. what-kind :of health facilities and-drugs it needs. Such an
? . iritervdriticnyby the consumers -remained impossible inspite of the numbers
because sc ^‘p^they- havp remained unorganized and fragmented.
10'^
;y
vi'..-■'-Focussing ..publid' attention;;on thd- issue of essential drugs provides
r r 1-a.pl^tfdrfi for prga^zihg: 'thp consumers for. focussing attention on our
... healtW'carp^ ^a^gipcs', on\bur...lOgislatlc)ns, 'policies, education and
.^■
-vAi
is to fopus?, on the‘role the exports, the committees and policy
“ -r mdkers^hSVd. played..in.:th6 past (many of whom- arc known to have been
bought and’sold). It focusses,on the ‘role of consumers and on their
demand for .p^iftipM’-ion in decision mailing as a majority, for the benefit
.
^iorityy.
. :-.'V
.
Demand-'for ops-ent ial’- and life saving drugs as a priority is an
‘ exercise.in■■•db^tMi^^^mcdlcinef’it-iSi.-an-oxcrbise in public education.
•. .?gn exercise’ in - ensuing thaV public’needs guide and influence decision
iiaking;. -’This demand is also an exorcise in learning to boycott drug
docisipns arid'policies whichlare thrust down peoples throats against
' their- will and.’against the interest of the majority.
■y
,l : W. '•
< 16^
• *yi ’
...
.'At
’•
.
..
•;
' "
c.;It -is part of ’• a slowly emerging >. consumer movement, peoples science
movement and’.,.also peoples ■ health movement. It is an integral part of a
-l^gcr process and not ?a piece-meal demand of a minor rectification.
oj/ The politics of health at the concrete level can only be based on
‘ .... popples action.; As Fritjbf Capra points out in the Schumacher Lectures
W '.^Refusal to take, even a single pill is such'a political act’. On this
political, philosophy is .based tho mobilization for. essential-and life
.. saving drugs as a priority.
Just as manufacture, sale and prescriptions of hazardous and irrational
drugs is a oppressive political act, refusal to become victims of this
oppression is a political response.
II.
COURAGEOUS EFFORTS - A Brief Review
. •The concept of essential drugs list is nothing.new nor did it have
its origins in WJD’s Technical Report Derive No. 615 (1977) as many believe.
Many efforts had been made prior to this. Wo just mention few.
CHILE:
As far back as 1973, the Chilian Medical Coinmission comprising of
Dr. Salvador Allende had believed in -limiting the drugs to those that had
dompnstrablo therapeutic value and thus 1 scale dovzn the pharmacopea’.
All ends during his short tenure as President quite successfully compelled
the medical profession to serve ’'basic” rather than profitable needs *
He proposed to ban drugs not prescribed for clients in North America.
or Europe.
B-4/37£(o) LCD & RT
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:
5
Within one week alter the talcing over of the military junta on
11th September 1973 the Chilian doctors who participated in this
revolutionization of medicine, these outspoken proponents of Chilian
medicine based on community action rather than on drug imports and
drug consumption wore assassinated. Men with much'courageous ideas
even though they are for the benefit of the people, arc seldom
appreciated.
SRI L«A;
!
In 1971 under the guidance of Sencka Bibile, Sri Lanka had formed
the State Pharmaceutical Committee to launch its people oriented new
Drug Policy. The number of drugs in the market were slashed down from
2100 to 600 and made available mostly under generic names and obtained
by cal ling international tenders. Within 6 months there were savings^
of about AQC in relation to expenditure incurred earlier.
It is absolutely essential for those of us involved in drug work,
to know tow the resistance from multinationals, their governments^ with
support from Sri Lanka’s own medical establishment forced the.Sri Lahk^
government, to give into vested interests and revert some of it sown
bravo and correct decisions.
PAKISTAN:
Pakistan’s attempts at restricting the drug list to essentials,
vith rejection of unessentials met with similar resistance from uhe
2 most powerful lobbies in the medical industry ’the drug industry
and the medical establishment 1.
INDIA:
In 1975
the Hathi Coimittco in India rcconmonded a rostrictod
today for interested health and consumer groups no copies oi the
Hathi Committee recommendations are.available
These recommendations are shrouded in cob rfob.
n+hors is that
the Indian experience with essential drugs and that of obhsrs is that
S tto aid not onorgo
ionnls and has W r-oohtly
St iSkThr ^TrnSah
not from people iikc
B^ladclh3 Dr. Salvador Allondo of
Chowdhry and Dr. Nurul Islam of tsangiaac^n,
Chile.
MOZAMBIQL^?
mcr its liberation from Portuguese rule in ^76 ^ Mozambique
ono ““nth °f ind^peg^co.
198O aS SntSe^W^Sugs. .ONLY
was r^sed
COUW BE
PRESCRIBED.
........... 6/
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6
The result of streamlined contracts was that the drug prices of many
essential drugs camo down to 1/3 of their original prices» The essential,
drugs became available, to more people in remote areas, not just to the
privileged few. This could be dene with the drug import costs the same
as they were 10 years ago because the selection was more sensible.
I
VI H 0:
>
r
€
The VIED Expert Connnittee on essential drugs in Technical Report Seri.?
615 gave the criteria for selection of essential drugs and a model of
such a list. Another report in 1979 was followed by the Technical RopcrJ’
Series 63$ which dealt with the ’use of Essential Drugs1 and gave the
essential drug list for emergency situations and primary health care.
BANGLADESH:
In June 19&2 Bangladesh’s Military regime under General Er shad,
prnrnijlgated a Drug Policy based on iVH) ’recommendations. 1742 drugs
were banned because of their hazardous and irrational nature. Tliis
of course had been preceded by educational campaigns abouh rational
drug use by some of the individuals involved in pushing the National
Drug Policy. The January 19#2 international conference on Health and
Pharmaceutical Policies was one such attempt organized by Gonoshasthya
Kendra. Through its monthly magazinonGonoshasthya Patrika” dealt
with this and other issues systematically. Dr. Zafrullah Chowdhury
admits that the Hath! Committee and its recommendations hold great
inspiration for evolving and for implementation of the Bangladesh drug
policy. In Bangladesh the resected drug list constitutes of 150
drugs. The grading of 150 selected essential drugs has also oeon done
based on location of utilization and level of potential users.
I
II
Ill
12 Essential drugs have been selected for village level health
workers.
Additional 33 essential drugs for Primary Health Care up to
Thana Health complex level.
Additional 105 essential drugs for use up to tertiary level.
There is also a list of ?6 supplementary drugs for restricted use which
after discussion will be compiled to 100.
The heavy pressure being applied to dilute or just scrap this
courageous pro people drug policy, which is ironically very much based
on the VIHO
VIH) guidelines
guidolirxos for Rational Drug use - has come from the mullnational dr^g lobby ani tto medical lobby. The loudest voice being
from the US based multinationals and from B M A (Bangladesh Medical
Association). It is openly stated by the latter tnat if India can
allow unrestricted sales of drugs banned in Bangladesh, .the drugs must
be safe and wonderful. After all Indian Medical Sstablisment with
all its brains and advanced technology can’t be wrong - (any way wo
allow continued manufacture and sales of drugs banned by our Drug
Controller of India and recommended for withdrawal by our expert
committees.)
Efforts to gathor support for Bangladesh's ’oravc drug policy had
boon made by us right fron the beginning and our
of
since survival of Bangladesh drug policy is crucial foi tus people of
Bangladesh and other third world countries including India.
. .7/
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:
7
Zimbabwe’s Government has selected 376 essential drugs to bo
used in the public health system. Government will not make foreign
e^hange available for- importing drugs outside this list,
•a^y^is tiis concept oi essential drugs seen as. such a big threat bjr
medical establishment and the drug lobby? The reason is very obvious.
It interferes with the drug companies profit making oven though in
reality it benefits more- people.
.
III.
/J, 1
1 •
.d '
OTJH imiATIVlgS IN PROMOTING AWARENESS OF
^SSEmAtTWlGS
~
“
By the end of 1930, the drug issue,tho rational use of drugs and
the role of non-drug therapy and of systems of medicine etc. had become
an important component of our training programmes; whether it was up
grading'of diagnostic and therapeutic skills of middle level health
workers, holistic health workshops, community health or health care
management training programmes.
By ^January 1930 a clearly defined strategy of drug wrk ■was drawn
up.. Tliis was later presented to VHAITs general body for ensuring organi
zational support. This work strategy figures in the special issue of
Health for oho Millions — April-^June 1931 and indicates the various
levels at which it was felt that intervention was required. (Right from
village hospital to health personnel and their trainersj ped 5 cy makers,
drug companies, multinationals and international drug and health action
groups).
In April-Juno 19&1 issue of our bi-monthly wo informed our VHAL
members and Wi readers of the concept of essential drugs and gave the
essential drug list meant for Primary Health Caro. The list of irra
tional and'hazardous drugs wliich was at that time, recommended for being
wooded out, was also disseminated to warn the health personnel and
health institutions about them.
-■■v'f-
By 19&1 ond a serious, attempt to draw up an essential drug list
of 50 drugs and recommended riianagomcnt of 10 commonest health problems
was made, based on the invited views and opinions of selected academi
cians, health personnel in the field or hospitals and pharmacologists
etc. (There xvere too many disparities in the responses and effort
to compile a very unanimous and coherent result based on these responses
was abandoned. It was found that most health personnel were not
familiar with the concept of essential drugs and WID’s essential drug list.
In January 19^2, tho first drugs workshop ’Drugs Issues and
Feasible Alternatives-1 was' organized in Pune to bring socially
conscious health personnel, consumer group activists for drug action
together. The- Hath! Committee and WIO essential drug lists word
made available to the participants ,of the first Drug Workshop in Pune
as well to the participants of various training workshops and organi
zation Dcvoloprnont (OD) seminars etc. conducted by VIliC and dissemina
ted amongst various levels 'of health and non-health personnel.
A sub group constituted of doctors and pharmacologists mot during
the course of the workshop to compile a mutually acceptable essential
drug list* (The‘Pune workshop list - in the comparative drug list
was an outcome of this effort). Sec Annexuro I.
S/
g-4/378(e) LCD & RT
Vll'lrpt; 19.7J84
By August W it was fully realised
------- that
—j an essential, drug list
drawn up by us> r
even as a group would not necessarily be acceptable
- to
-J
hoalth personnel
—
----- . jind if while
while attoripts
attonpts to
to influence
influence government
govornmont aut.'X)
authoritios wont on
< side by side in the voluntary health sector, the acceptancc and unplumcntatuon of this had to be ensured*
The exercise to draw up a comparative essential dr^ list was
undertaken for 3 reasons:
1.
xc dewnstrate that’ any rational drug policy fornul.nted
had a lot in coiwai,no matter from which country.
2.
That.at was not a handful of concerned persons but expert
committees that had drawn up these lists. The fact that
these experts believed in the concept of essential drugs,
we felt would have greater convincing and educational value.
3.
The rationale in malcing the comparative drug list available
to the.individuals, in the field and solicit a response from
cause xiuormc-d individuals was to give a better guideline,
as well as to involve them in the evolution of a process.
The comparative essential drug list prepared incorporated the
following drug lists:
, -
WHO
Rathi Committee
?GI (Post Graduate Institute list) Dr. V.S. Matahur
Pune Workshop list
Sri Lanka list
Restricted lists used by ECHD UK and Action Kodcor (both
agencies are involved in bulk purchase of essential dru^s
'drugs for
third, world countries).
obvious that theso essential drug lists would provide guideLkWJ selo^lon fcr larger medical institutions. But forAiviaUor
hoc^uh.programmes with which I was mainly involved in the course of w
workj.thero was a neod.for a graded essential drug list, based on the
experience, Qualifications «£)£ the health personnel
1,-nJp
rhe availability or non availability of other health facilities
specially referrals
availability of supervision, consultation and on going education
- the gamut of health problems dealt with and the workload
- resources available in terms of finances, manpower, diagnostic
facilities, transport etc.
. J,^£or^
obtain graded essential -drug lists from Bangladesh,
ori LanBh, Mozambique and EMRO have been made.
Bealing with Resistanccn
The most vocal argunont against the concept of essential druc- li-t
by the drug lobby and its supporters is that it is relevant on^ V
t-x extremely poor countries and not for developed countries nor a ’
tkc inost' dQTC1°Pcd Pharmacoutical industry in
the ttard world, ihis is far from true sin.ee drug lists of many dcveloned
countries are ^ghly rationalised and liiited. Prolification of noneosential drugs is no indicator of development.
• -5/
jM/373(o) LCD & RT
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9
In 19&2 a request to the Editor MIMS was made to:
1) delete the drugs that wore recommended forbeing wooded out by
the Drug Consultative Committee
2) indicate clearly the drugs included in WHO essential drug list,
so as to give a guideline for the readers to help them, in their
selection process - by underlining or writing these drugs in capitals
or italics.
This evoked besides a personal response, an editorial in MIMS
where the relevance of the essential drug list only for the strhg/-ling
poor- countries was emphasised. Dr. Halfdon Mahler, Secretary General
WHO was quoted as saying ’’that a consignment of antimalarials was
received in a certain country with as much celebration and gaity as
demonstrated at that country’s independence'1. This was an attempt to
show that the concept of essential drug list is meant only for extremoly
poverty stricken and not countries like ours.
This is totally untrue.
Developed countries have mado more serious efforts to restrict drugs.
In UK, the- 6500 preparations is considered too many by the Rational
Health Campaigners and^Charlos Medawar of Social Audit in his latest
book ’The Wrong Kind of Medicine’. Norway has about 1900 preparations.
The Norwegian authorities have licensed a total of 730 active ingredients.
An attempt to have less of irrational and non-sensical 'drugs is not
limited to the third, world countries but developed countries t houseIves.
How long in the name of ’frac enterprise’ and so called ’clinical freedom.*
will irrational and hazardous drugs continue to be inflicted upon the
people specially when they arc ill affordable by them cat the cost of
their actual health care needs being mat?
Today the question is not whether to include or delete a particular
drug, but for health personnel and people alike to bo exposed to and
to irtcrn&lizo the concept of Qssontial drugs, so that they can“mkc. an
informod choice about usserAial and unessential drugs.
“The benefits of our huge drugs list are essentially to do with
trade, not health. The advantages of a restricted drug list include
having fewer bad drugs and a reduction in drug induced disease, and
better information about drug use and less confusion about which drugs
to use”. (Charles Medawar ’The Wrong Kind of Medicine’ page 1$).
Dr. John Yudkin who has long been concerned about third world
drug policios says ’the drug companies must not bo permitted to become
a hazard to health in the underdeveloped world by failing to provide
information or by drawing scarce resources, away from more effective
projects’.
10/
A
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10
IV •
selection of essential drugs and steps for
IMPmWTI^an essential drugs programme
JIONS •
In order to ensure that an essential drugs programme is adequately
instituted at the National level, sever al. stops aro advised:
• Establishment of a list of essential drugs, based on recommend’
tions of a local committee constituted of individuals competent in the
fields of medicine, pharmacology, and pharmacy as well as peripheral
health workers.
2. The international non-proprictary (generic) names for drugs
or pharmaceutical substances should be used whenever possible and
proscribers should bo used whenever possible and prescribers should be
provided with a cross index on noproprietary and proprietary names.
3. Concise, accurate, and comprehensive drug information should
be prepared to accompany the list of essential drugs.
4. Quality, including stability and bio-availability should
be assured through testing or regulation.
5. The success of the programme is dependent on .efficient
administration of supplyf storage and, distribution at every porbnt from
the manufacturer to the end user.
Government intervention may be
necessary to ensure the availability of some drugs in the- formulations
listed,and special arrangements may need to be instituted for the
storage and distribution of drugs that have a short sholf life o^
require refrigeration.
Efficient management of stocks is• necessary. To eliminate
waste and to ensure continuity of supplies9 ,a Procurament Policy should
be based upon detailed records of turnover, In Some instances drug
utilization studies may contribute to a better understanding of true
r e quir ement s.
7. Need for both clinical and pharmaceutical research under
local conditions.
for selection of essential, dr-u^s:
ESSENTIAL DRUGS ARE TIOSE THAT SATISFY TIE
ffiAlTH GARS NEEDS OF TIE MAJORITY OF TIE
PEOHEB. THEY S®ULD THEREFORE, BE AVATLjSBLE
AT j'iLL TIMES IN ADEQUATE AK0UNTS-, AND IN THE
APPROPRIATE DOS A® FORMS. .
£gj£„t.^Q.s.Q drugs should be selected for which sound and adequate
data on efficacy and safety arc
aro availablo.
available; And from adequate clinical
studies and for which evidence of performanco in general use in a variety
of medical settings has been obtained.
11/
S~4/373( o) LCD & RT
VHAI:pt.:19.7.'84
11
, The choice between 2.or moso drugs which are similar in all the
±ypL':Sp0Chh should be-based on careful, evaluation of their relative.
h'’
quality, price (of the cost of taking a full course
and not merely tho unit cost; .and'availability.
t? bQ kepb 1x1
aro pharmacokinetic properties
and availability of facilities for manufacture or storage.
formulations should be single ingredient drugs, Fixed dose
combinations should be acceptable only when a combination provides a
proven advantage over single compounds administered
L----- 1 separately in
therapeutic effectsafety or comp!iaren.
-Selection of Do5^0 forms;
+ 1^
Tablets are usually loss expensive than capsules, but wliile
e cost factor should be taken into account, oho selection should also
be based on a consideration of pharmacokinetics, bioavailability,
2d SablSS i t
C?aatiC conditions> availability of excipients
cJiu Coraoiishod local profa? arico.
— The use of scored tablets is rocommendcd as a simple method
of making dosage more flexible.
d x z»
Txiere is a need to periodically revise and unrtatA
- - — Updat° vij
But frequent .and extensive, changes ,
vhU° list*
are clearly undesirable since they
result in. disruption of channels of
and distribution and may
have implications for the training ofprocurement
health personnel.
Provision ot'_information on essential drugs:
10?0130’ acc™’a$e and comprchensivo information on the US'-' of
is appropriate'^‘thear^ejSSmtiQ^i?’:SairS^
on the selection of essential drugs
1<
substance
i and recommended dosage form.
■J
-
*
J
of
wCbVXX
“tiTO
UVvlVU
, 2» Pharmacological information: brief description of •Dbarrn^cological effects and mechanism of action.
3.
Clinical information:
3.1
o 9
Indications: whenever, it is thought appropriate, s-Hr.^
di^nostic criteria should bo provided.
Dosage regimen and relevant pharmacokinetic data.;
12/
W
c
12
:
3.2.1 ^voragc dosage and range for adults
and children
3.2.2 Dosmg interval
3.2.3 Average duration of treatment
3.2.4 Specialsituations, eg. renal, hepatic,
cardiac
upward or
j ■.
1. winch require either
upward.or downward dosage adjustments.
3.3
Contraindications
3.4
Adversi^?? (rsf9renc'3 to F^egnancy, lactation etc/
3.5
Anvorso affects (quantitate by category, if
3.6
1
in^er2101ions (to bo mentioned only if
drUgS USed for syndication
oncuiu. oo included)
3.7
Overdosage:
3.7.1 Brief clinical
_______
description of symptom
3.7.2 Non drug treatment
x and supportive thcrapj’3.7.3 Specific antidotes
4.
Pharmaceutical information.
V.
QF SSSENTI/L DRUGS
Drug Filicr.nCTho -SpScuSions^t13
drugs list based on
backbonc of W Rational
health^ of
- ensuring thoir production
- ensuring their efficient distribution
- ensuring appropriate stocking of pharmacies with th^so dru^
bS^
tS^l^UiPreSCrlpti°n
udoua. on unoso accepted drugs.
to £ "
Since 4-6% of the drugs marketed •rr’r* r/w-n*
a prescription (according to NIN Drug Util•Synt^10 a+V?rlbQ coun'tcr without
altered or improved 'prescription oXti^^ -i
11 is obvious tint,
consumption patterns. With th',
r
alone cannot alter the drug
selection of esse^
unesseXi^
^es^iPtion of drugs, ''
Specially if this is associat'd w4+b±<J- dfuSs can have, a great impact,
and health personnel, of
b°?'coU by thG consumers
Neurologist In tho intormtlFF-/iF/<°2 ™-°
Paodlstrio
related drugs vras later iolnod bv n
ugoanst clioquinol, mexaform
by over 3000 doctors and vet£an=
^ons_ 01 Norway, Denmark - totally
drugs list needs to be done urgently and ^1Gmentat;Lon of essential
arc given below*
^oOntly and the reason why it is so crucial
AsjLgcjprating trend ?
issues bei^doSb ap^oSatlly7
th9 roal tealth
are unessential and iSt based on’th' hr 1,aori“y of Drugs manufactured
1260 crores worth of^urs
t''!rn??ds.of
P^plo. Of the
crores worth of drugs wJo essential'/r
“ 1979-'80,only Rs. 350
mainlyr non-essontial drugs.
saving drugs^ the rost -wuro
13/
^-4/378(0) LCD & RT
VHAl:pt:l9.7J84
13
The following figures speak for themselves:
Table
Category
WL
1920
I
4.5^
3.6^
II
16.7%
13.2$
III
6?.1%
68.6%
IV
11.7%
14.6%
Source:
MAE News
July 1984.
The production of category I drugs i.e. essential and life
saving drugs and Category II drugs (essential drugs) is showing a
declining trend according to Ministry of Petroleum and Chemicals and
Fertilizers.
Production of antimalarial, anti-TB, antifilarial and anti
leprosy drugs have been trailing far behind the estimated demand and
while demand h^s increased the actual production has been falling.
In fact, production of the antimalarial Ghloroquin, and the anti tuber
culosis PAS, INH and thiacetazono fell short of estimated demand by
about 84, 50>
and 7C% respectively in 1979-'80, except for a small
increase in INH. production for all these drugs decreased further in
1980-181.
Estimated demand Production in tonns MT Estimated Production
1979-80
“
79-80
80-81
81-82
82-83
Antimalarial
Chloro quin
Amodiaquin
250
40
35.16
38.49
34.62
23.15
58.96
26.02
70.00
33.00
600
481.78
112.43
405.46
129.20
261.97
110.40
290.00
12.55
220.16
8.44
227.33
13.98
255.45
25.00
266.00
Ant it ub er c ular
PAS & Salts
INH
Thiacet azone
Streptomycin
200
40
300
Antifilarial
DEC
30
21.57
18.99
16.43
13.00
Antileprosy
DDS
28.
16,20
21.05
25.61
•■30.00
Ref:
128.00
Dr. W.Y. Rano - Why don’t our drugs match our diseases Science Today - October 1982.
....14/
g-4/378(c) LCD & RT
VHAI:pt:19.7.’84
14
:
Remand Projection for Bulk drugs for tl^ period 1979-80 tq^384~185
Base year
Estimated Rcgidrcmcrib
79-30
80-51
81-82
82-83
83-84
8Z;~85
2>0
40
275
46
300
53
335
61
365
70
400
80
630
240
330
660
290
44
363
700
360
Streptomycin
600
200
40
300
400
730
415
48
W
770
500
50
485
Antifilarial
DEC
30
33
36
40
45
50
Anti leprosy
DBS
28
32
37
45
50
56
CntiMlarial
Chloroquin
Amdiaquin
Anti Tubercular
PAS
INH
Thiacet azone
1^2
The Indian rharmacoutical Industry Problems and Prospecta£
P.L. Narayanj NCAER Study National Council of j^pplied BcorLoimtc
Research - January 1984.
Rof:
ICMR and IGSSR study on Alternative Strategy had indicated the
grossly inadequate drug production for IB and. leprosy which happen
to bo our priority health pfoblwis.
With half of the TB patients
of the world in India our production of IN® was less than 1 /3 of the
minimum requiremont ,.,
Tha Malaria deaths in Rajasthan-waro net mcroly duo to drug
resistance and cerebral malaria, but due to non-availability of
ch^rcquiri even at certain government PHCs. The estimated require
ment and the actual'production are getting further apart and reliance
on imports is resulting for drugs that are so routinely noodod.
Chloro quin imports in tons
1979-’80
^ ^80 - <81
1981 - ’82
Production
Imports
Production
Imports
Production
Imports.
35.2
52.8 •
34.6
71.8
59
166.3
Ref s* ®}® Roport - The
Indian Pharmacoutical Industry.
• --
1
tfiomic Research.
/
15/
S-4/378(c) LCD & RT
Va'il:pt:19.7.'84 "
—
15
there are an estimated 60 million iodine deficiency cases
of goitre .in India. It is known that children of- iodine
deficient mothers are known to bo born as cretins, deaf,
mutes and mental subnormality.
Tho simple technology of production of iodized salt is known.
Merely 50 paisa worth of iodized salt can make all the <Hfferry
between a child being normal and subnormal.
Wo still produce only 20/ of the iodized salt required.
Rcquirod amount of iodized salt is - 7 lakh tons
Amount produced
- 2 lakh tons
Amount sent to Nepal
- 1 lakh tons
Amount left for utilization for
the 60 million goitre cases
- 1 lakh tons
When adequate production of an essential low cost item' like
iodized salt for a National Goitre Programme cannot be assured,what
happens to production of the essential drugs for non priority national
programmes can very well be imagined.
1:1 5^^ in a pilot project funded by D/IHDA and. SID A, svppli;n
of drug kits containing 39 drugs in 1.5 rural districts has increased tho
accessibility of essential medicines for the rural population from
W to w.
B.
DPCO and its negative impact on Production of Category I and II dr-ys:
Under DPCO (Drug Price Control Order) tho mark up on Category I
drugs is limited to 4C^ and that on. Category II is 6C/. Producing category
IV drugs because of the high mark up allowed are therefore definitely most
profitable.
For the decreasing, priority being given to essential and life savirv
drugs DPCO is therefore blamed. ..With.the decontrol of prices of 75/ of
the drugs as is being reconEiended by the drug lobby and its supports, a
further switch ©to production of more profitable unessential drugs is
imminent. If government is serious about ensuring that essential drugs
are sold at a reasonable price - this can bo done by doing away with taxes
C.
Poor performance of unltinationals in production of essentia], dry,;
Thc^outright, calculated neglect of the priority drug needs of
tho majcrity is woll
---•’1 known, The following table speaks volumes. (See
.jincxuro II - Production of Essential Drugs by Multinat ionals and Orgari.., .1
Sector)
Dilution of FORA Companies - an invitation to more formulations:
kith the dilution of foreign’equity shares to AQi, various
concessions arc being granted to the FERA companies so that bulk to
formulations ratio will bo increased from 1:5 to 1:10. With the drug
production pattern as it is, we can look forward to more formulations
and more unessential drugs irrelevant to our ^^pcoplos health need.
Bulk production by foreign sector for 1982-'83 was Hs, 55 crores worth:
the formulation turnover according to 1:5 ratio should not have exceeded
Rs. 275 crores, however, Rs. 515 croies worth of formulations were
produced i.e. more than 1:10 ratio when only 1:5 was allowed.
16/
g-4/378(o) LCD & itT
19.7.'84
:
16
Ck j '■
r*. •''.'..■•J,.!.
•E.
Eatioi^al use of scarce resourceS£
scarce foroign exchange: India with its level of
indobtodness to IMF World Bank, IDA etc., caii hardly afford to sqandor
■its scarce fordign exchange for inserting inessential drugs.
ii) Inessential vs basic health needs: Worse still is the
enforced wastage of scarce resources of the poor on useless nonsensical
when they can hardly afford adequate food and clothing and bare
essentials. When the percentage of people, below or around the poverty
line nappen to be around 60 •* 7^ of a country's population — the very
production and heavy promotional of costly irrational and hazardous drugs
is criminal. . A strong public opinion alone can ensure withdrawal of
such drugs, with priority being given to essential and life saving drugs.
,
Lpossontial vs essential drugs: Often inessential drugs
are bought at the cost of specifically needed essential drugs. For "tho
ignorant majority, the difference between the therapeutic value of a
costly tonic, vitamin, digestive ensymes, antipyretic and much needed
specific drug eg. antiasthmatic, antibiotics etc.- Ill written in the
same proscription — does not exist. This was shown by Vocna Shatrughapa.1 ?S
stiidy.of Prescription writing and'drug consumption. By ensuring
priority availability and prescription of essential drugs, wo would be
contributing to preventing the wastage.
j’-v\ Economics of scale increased; 7'*
If essential drugs wore given
priority in production, through sheer econornics of scale, the production
cost would decrease for the manufacturer and
thus the
and thus
the consumer^
n-p
Purchaso-.
essential drug list can ensure bulk nurchaso
of selected essential drugs, which can cut down drug costs.
market demand and thus the Drug Production patterrx in
favour of essential drugs:
.
‘
—
by chDicC
list
propagated, accented
y choice^c.x ->y legislation, ulus would necessarily influence the
honc!
This would
deiuuto^ air or the drug production pattern towards essential drugs.
•
p£fZQaGQ tb/ug misuse and over use;
dOTiB 7th iuunfcificatioh of-drugs which arc - therapouticolly effective, safe, easy to administer, and of appropriate cost
prefcrabl^r single ingredient well tried drugs. The use of drugs which
are.of douKiul value, costly, irrational and hazardous drugs should be
avoidou. Majority of the drugs available are combinationtdrugs. This
increqpes costs as these drugs'are often in subtherapeutic and irrational
dosages. According to. Halfden Mahler, 9C^ of drugs in the developing
countries are non essential.
ih
I^Qycntzing Iatrogenesis (Drugs induced health hazard):
J r •
'
'
'
-•
•
'As long as potentially hazardous drugs with very high risk
(compared to ^benefits ratio are. misused and overused, unwarranted high
incidence of iatrogenesis is bound-to occur.
17/
I
gr4/378(o) LCD & RT
VHM:pt: 19.7.'84“
17
In US/k where the drug control and the prescription practices
bettor controlled, the incidence of iatrogenesis is very high.
t
9 Aspite! admissions are known to be due Vo iatrogenesis. In
ndia ,w have such a high degree of self’prescription, prescription
wrxricg. by .unqualified health .personnel and by qualified personnel who
are made highly biased by drug representatives. Tins along with poor
drug controls ensures drug misuse, overuse and iatrogenesis. Most
cases oi is&roganesis are not diagnosed in India. This of course doos
not imply t hat t hey doxi11 exist.
are
combination drugs -have 2 or wre ingredients. It is
aaown.that with consumption of over 6-drugs compared to 2, chances of
drug interaxrtion increase bjr
compared to 5^ .
i
I.
Pi At Information for he alth personnel and-consumers -possible:
Mth 30,000 drugs in the market it’is impossible net to be
confused about them. A doctor-may bo- familiar, with tha drugs he or she
uses routinely. Unfortunately he or she cannot be so with the various
brands used by others. Their prescriptions are often taken from one doctor
to another by <iritdrally '<r ctrcrically. sick patient.
Confusion abounds, since majority of the health personnel have no
access vo pharmaceutical index to figure out what drug has been given.
Majority.of the drugs in the market, are combination drugs. Lack of
familiarity with the contents and their dosages makes matt cars worse.
If prescription practices- for the majority of the. health problems could
be based on essential drugs? Relevant drug information about; their
relative cost, dosages, indications, contraindications, side effects and
toxicity could be made available to health personnel and consumer
caution, be-ensurM? - x
Studies also indicate that it is impossible to .remember det an 1 s
of even- 100 drugs in routine practice. Ensuring that these prescribed
drugs are the ones that people need and not what are'most heavily pushed
by the. drug -companies because of their profitability., i$ our responsibility.
Focussing on all.aspects of essential drugs and rational drug use in
medical education wojld ensure their better us© which, would be better
foi* -the nation and the. patients.
J.
Ensuring better quality control:
There are 30,000 for-mlations. in the market. Most of them arc
combination drugs and one in 5 drugs in. the market is substandard. With
a lesser number of. drugs in the .market which are single ingredient drugs
quality control can be better •streamlined.
Making profits by promoting
unessential drugs is crazy, but to make inadequate number of essential
drugs available, xith even-these being-substandard, is really unacceptable.
K.
/
Ensuring generic proscribing:
Goneric prescribing is reconEondsd by WHO ifcselX as it cuts down
drug costs.
m Pharmacology input during medical education^ nomenclature used
in medical liter at uro and medical journals is based entirely on generic
names.
18/
1
4
LCD & RT
VIRJjpt: 19.7J^4
IS
:
With a restricted essential drug list generic prescribing can
definitely be ensured. The pharmaceutical industry and government drug
control authorities would have to take greater responsibility to ensure
quality control AT ALL IUVELS. Brand name prescribing is no solution
for substandard drugs. Brand names do not prevent spurious drugs enter
ing the market as most spurious drugs
imitations of well known
brands. Name of the specific drug house can bo written if it is felt
absolutely necessary. Gonorlc proscribing is possible with single- ingre
dient essential drugs which arc quality controlled.
L.
f'
Subsidizing costs of essential drugs:
.With restricted list of drugs meant for the health needs of
the majority, subsidizing is possible by removing sales tax, excise duty
and octroi for these. /liXiy "loss in
- the
• - taxes
"
can be compensated by
increasing taxes on cigarette-,. alcohol
and . other
(
~
or «uch
anti-health
products or more so on luxury items meant for the rich,* In conclusion
demanding an <essential
■• - drug
programs© is aimed at focussing attention '
and giving priority to health, needs of the majority.
■>
CONCLUSION /SUL^/RY
Demanding priority production and distribution for essential
drugs is accompanied by demand for a just health care delivery system.
Wo know that a just health care delivery system cannot exist in isolat
ion in^a socially unjust system.
Demand for essential"drugs before un
essential drugs is accompanied by demand for employment, fair wages,
fpodj water, sanitation and all that goes to ensure good health. Our
fight for essential drugs and health care as a fundamon&al right of
every Indian, specially the deprived sections is a fight against the
unjustico of the present socio-political system, which in reality
accepts this, ^deprivation of health .and basic health care as a normal
phenomenon.
•*
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DRUGS BANNED IN INDIz^
c_cw>!■ ---IT -m «w 11^1.■
innniii
' -T
'"
Under section 26(a) of the drugs and Cosmetic Act-GaS.R.
578(e) dated 23.7.1983.
1.
2.
3.
4.
5.
Amidopyrine c
Fixed-dose combinations of Vitamins with anti-inflammatory
agents and transguilisers.
Fixed-dose combinations of Atropine in analgesics and
antipyretics.
Fixed dose c -nbinations of strychnine and caffeine in tonics.
10.
Fixed'-dose bombinations of strychnine and yohimbine with
testosterone and Vitamins.
Fixed-dose combinations of sodium bromide. Chloral hydrate
with other drugs.
Fixed- dose combinations of iron with strychnine, arsenic
and. yohimbine.
PLenasetin.
Fixed-dose combinations of anti-histaminics with antidiarrhoeals.
Fixed-dose combinations of pencillih with sulphanamides.
1.
Fixed-dose combinations of vitamins with analgesics.
12.
Fixed-dose combinations of tetracycline and Vitamin C.
Fixed-dose combinations of Hydroxyguincline group of drugs,
except preparations which are used in the treatment of
diarrhoea and dysentry and for external use only.
Fixed-dose combinations of corticosteroids with any other
drug for internal use.
6 o
7O
8.
9.
13.
14.
15.
Fixed-dose combinations of enloramphenicol with any other
drug for internal use.
Fixed-dose combinations of Ergot.
Fixed-dose combinations of vitamins with anti-TB drugs,
except combinations of isonizid with pyridoxine
hydrochloride (B6).
. - la. Pencil1in skin eye ointment.
'\9. ' Tetracycline liquid (oral) preparations.
16.
17
20.
21.
22.
23.
24.
25.
26.
27.
28.
Nialamide.
Practolol.
Methapyritene as .salts. (G .8.R . 49 (e) 31.1.84).
Metriaqualone (G.S.R.322(e) 3.5.84).
Oxytetracycline liquid (oral) preparations.
Demoelocycline liquid (oral) preparations (G.3.R.863(e)
22.11,85).
Combination of anabolic steriod with other drugs (G.3.R.700(e)
15.6.88) .
Fixed-dos^ combinations of oestrogen and progestin (other than
oral contraceptives) containing per tablet estrogen content of
more than 50mcg and of progestin of more than 3 mg.
Fixed dose combination of Sedatives/hypnotics/anxiolytics
with analgesic-antopyreties.
_ _ _^2
J
• 29 e
' I
Pixed dose' combination or pyra^xn^.<rd'~ ~ - n o-ther an-ta
.a Inainide witn
tubercular drugs except combination ox
Rifampicin and 1NH as per rucomftiens.ed c.ai.x\ dose given belows?-'aximu.r
4.-. w.-r ■ .% -<•*..r
30 n
31.
3 2.
33.
34.
35.
y
600mg.
Rif ample in
45 () mg.
400mg.
INH
30 9 mg.
1500mg.
Pyrazinamide
lOOOmg.L__„
-receptor antagonistsFixed dose combination of histamine
combinations
approved by the
with antacids except for those, <—2drugs controller, India.
The natent and proprietary' medicines ci fixed dose combinations
of essential oils' with alcohol having percentage hrgner thon
20%JroSf except preparations given in the Indian pharmacopoeia.
zvil pharmaceutical prepations containing chloroform exceeding
0.5%-w/w or v/v whichever is appropriate.
Fixed dose cobination of ethambutol with 11® other thair the
following;IWH 200mg„ and ethambutol 600mg., and
ana INH
INH 300mg.
300mg.
and (ethambutol 800mg.
Fixed dose combination containing mor^ than one antihistamine.
Fixed dose combination of antmelmintic,
©athetric/purgatives.except for piperazine®
dose combination of salbutamol or any other bronchodilator
36. Fixed
with centrally acting' anti-tussive, and/or anti histamine.
37. Fixed dose combination of laxatives and/or anti-spasmodic
drugs in enzyme prepations.
38. Fixed dose combination of metoclopramide with other drugs
except for preparations containing' metoclopramide and
aspirin/paracetamol.
39 • Fixed dose combination df centrally acting, anti-tussive with
antihistamine having high .atropine like activity in
expectorants.
40. Preparation claiming- to ooir\at cough associated with asthma
containing centrally acting anti-tussive and/or antihistamine.
41. Liquid oral tonic prorations containing glycerophosphates and/
ocher phosphates ui?d/or central nervous system stimulant
and such prepations contiruing alcohol more than 20 percent
proof.
42. . Fixed dose combination containing pectin and/or_kaolin with
any drug which is systemically absorbed from Gx tract except
for combinations of pectin and/or kaolin with drugs no<.
systemically absorbed.
1
Page 1 of 2
PHM Secretariat
From:
To:
Sent:
Subject:
sahajbrc, renu and chinu <sahajbrc@icenet.net>
Dr Dabaae <drdauade@sanchamet.in>: Sudarshan H <vgkk@vsnl.com>, Shyamala
Bhaskaran <vani3@hotmail.com>: <shyamanarang@hotmail.com>;
<esparun@bgl.vsn!.net.in>; Community Health Cell <sochara@vsnl.com>; <van@vsnl com>’
2prasanna_aid@yahoo.com>: Prasanna. PHM Secretariat <phmsec@touchtelindia.net>
Tuesday, August 19, 2003 9:06 AM
News
WCCAH fe. HERALD
Wednesday, November 13, 2002
i
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Directive to Centre
on pharma policy
DH News Service BANGALORE, Nov 1
“hie implementation of Centre's 'Pharmaceutical Policy-2002' received a
setback today with the Karnataka High Court directing the Centre not to
implement the policy till a list of essential and lifes-aving drugs is prepared
and such essentia! drugs are brought into the basket of essential drugs
under price control mechanism.
i he High Court also directed the Ministry of Health and Family Welfare to
'eview essential and lifesaving, drugs while also taking into consideration
such new drugs, before implementing the policy.
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A division bench consisting of Chief Justice N K Jain and Jus-tice V G
Sabhahit passed the above order on a public interest writ petition filed by Lt
Col (Retd) K S Gopinath and B V Bhaskar-of Bangalore questioning the
constitutional validity of the policy.
The petitioners had contended that the new policy was framed like a
'business policy and if allowed to be enforced, it would take away life-saving
and essential drugs out of the limit of Drugs Price Control Order (DPCO)
which was highly detrimental to the public interest. The petitioners furtherargued that the basis for DPCO which was mentioned in the new policy was
clearly arbitrary and takes into account the sales turn over of a particular
drug and not the volume of the sale.
I heir argument was that if the DPCO was promulgated on the basis of the
impugned policy, then the price control would be left to the whims and
fancies ot the pharmaceutical manufacturers and hence the policy was
violative of Article 14, 19 and 21- of the Constitution and Sec 3 of the
Essential Commodities Act.
Appearmg for the Centre, additional solicitor .general, V T Gopalan had
c
J'
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8/19/03
Page 2 of 2
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Contact Us
argu&d that the policy was framed keeping in mind the W lO agreements
and globalisation of economy.
He contended ft was not open for the petitioner to question the very policy
of the Centre. He had also submitted that the government was yet to come
out with the DPCO while stating that the Government would not give away
its power on drug pricing.
Writing the judgement for the bench, Chief Justice Jain ruled: "the price
control mechanism adopted in the policy to deter-mine drugs under price
control was arbitrary as it defeats the entire purpose of equitable
distribution and availability of essential drugs at a fair price."
Copyright, 1999 The Printers (Mysore) Private Ltd., 75, M.G. Road, Post Box No 5331, Bangalore - 560001
Tel: +91 (80) 5588999 (16 Lines), Fax No. +91 (80) 5586443
8.19.03
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MEDICAL ETHICS
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MARATHA MANDIR
CINEMA
“i- RESERVE BANK
YMCA
INTERNATIONAL HOUSE
BELASSIS ROAD
(Only on Invitation)
Please note: There is NO CLASH OF DATES WITH 11IEJSA MEETING
The JSA meeting on “Right to health care” is to be held on 5'1' and h'1' September, 2003, at the
Retreat House, Bandra (West). The Drug action revival-FME meeting has been planned for the
7'1’ of September, 2003, so that senior health advocates attending the JSA meeting in Mumbai,
can participate in the FME meet, over the same weekend.
Drug enthusiasts not attending the JSA meeting on the 611’ arc welcome to the discussions on the
study completed by the FME on “Promotional practices of Pharmaceutical firms in India” and
the Peter Mansfield session for students on the 6,h of September at the YMCA. (Separate
program sheet — please ask for it)
Contact persons:
Nobhojit Roy (098212-91225 or nobsroy@yahoo.cofn)
Murlidhar V. (inurlidharv@vsnl.coin)
A.
MEETING SCHEDULE, STRUCTURE AND AGENDA
Background:
'Phc genesis of this meeting was an appeal sent out on the MFC e-forum by Chinu
Srinivasan (LOCOST) and Anant Phadke (CEI lAT-Pune), which sums up the mood of
drug action in India today:
“The Drug Actionfont has been dormant for a long time. The increasingly regressive drug policy of the
government despite our lobbying in the eighties dampened our spirits. There is not much enthusiasmfor
advocacy about the dr'ug-policy, as the government has adopted the "Pharmaceutical Policy 2001" and it
is unlikely that ive can make any dent at the policy level, but we can and definitely need to oppose anti
people, irrational actions by the drug-companies. ”
FME offered to organize this meeting with the overall agenda of rejuvenating drug
action on a list of issues, discuss the organizational aspects and have participants pledge
commitments. Another important agenda is to foster a new generation of drug-advocates
to take up the new drug issues. It is acknowledged that the seniors are over committed
already.
Structure of the meeting:
'Fhc target group of this meeting arc the young people who are likely to be the future
drug enthusiasts. There will be 15 Senior Drug advocates discussing drug issues and
more importantly the 25-30 young Observers, who have been nominated by their
teachers and professors. Total Participants: 40-50 people (listed below)
Moderator : Gopal Dabadc, Karnataka Drug Action Forum
First Session: 10 AM -12:30 PM
Introductions
Welcome by Moderator
Discussion plan and topics
-—Ljinch and informal interaction-—
Second Session: 2:00 PM — 5:30 PM
Action plan formulation
Pledging of commitments
Organizational aspects
Suggested topics and chairpersons:
1.
2.
3.
4.
5.
6.
Rational Drug Policy - Mira Shiva/Anant Phadke
Essential Drug Production - Chinu Srinivasan
Patent GA IT issues/TRIPs - Amit Sengupta
Pricing and Promotion - Amitava Guha
Essential Drug List - Shantanu Tripathi
Banned and Bannable Drugs: P.K. Sarkar
Outcome:
All participants would hhve responded positively to the issues raised and identified a few
more action-areas. A table (Road map) would be prepared to categorize these points
(policy issues, local issues, urgent issues, non-drug-issues like screening tests, further
meetings’to understand in-depth the new drug situation) based on comments on these
points and define time and energy commitments (graded to a scale of I t'o III) of the
various groups attending. Action points, which seem to attract the most commitment,
can be taken up for a trial for the coming months.
I
Limitations: Since people from different organizational backgrounds, will be meeting
after a long time-lapse, it is expected that within a short span of a few hours; we may not
be able to conclude all the issues.
About FME:
The Forum for Medical Ethics is a not-for-profit, voluntary organization. FME has
produced an academic quarterly called ''Issues in Medical Ethic?' for the last 10 years.
Besides the print issues, the journal is available on the Internet
(www.issucsinmedicalcthics.org). It is an effort by a group of concerned doctors and
health activists, to focus attention on the need for ethical norms and practices in the
health profession.
PARTICIPANTS (40 confirmed)
Gopal Dabade
Karnataka Drug action forum
Karnataka
Amar Jesani
CEIIAT
Mumbai
Kanamma Raman
ACASII
Mumbai
R K Anand
ACASII
Mumbai
Dr.T.Sundararaman
State Health Resource Center
Chhattisgarh
Dr.Inamdar I.F.
P.S.M. deptt., G.M.C.
Aurangabad
Sattar Patel
P.S.M. deptt., G.M.C.
Aurangabad
Ila Shah
Worker, SEWA
Ahmedabad
Khyati Shah
Worker, SEWA
Ahmedabad
Third SEWA worker
Worker, SEWA
Ahmedabad
Kamaxi Bhate
PSM KEM
Mumbai
Peter R Mansfield
Healthy Skepticism Australia
Amit Scngupta
I )elhi Science Porum
Delhi
Anant Phadke
CEIIA'I' Pune
Pune
Meenal/Bashir Mamdani
PMI*
Pune
Atiya R. Pamiqui
M.D. student in Pharmacology
CMC, Vellore
S. Jacob Prabhu
faculty in Pharmacy CMC, Vellore
J.S. Raja Thomas
Facult y in Pharmacy CMC, Vellore
Natasha Catherine Edwin
Medical Student
CMC, Vellore
SujithJ Chandy
Sr. Lecturer, Pharmacology Unit
CMC, Vellore
Dinkar (Gujarat)
MPII student
Trivandrum
Prasanth (Kerala)
MPH student
Trivandrum
Aravind (Kerala)
MPH student
Trivandrum
Senthil Arasi (Tamil Nadu)
MPH student
Trivandrum
Srec I lari ( Karnataka)
MPH student
Trivandrum
Cho (Myanmar)
MPH student
Trivandrum
Chinu Srinivasan
LOCOST
Baroda
P.K. Sarkar
BODIII
Kolkata
Santanu Tripat hi
CDMU
Kolkata
Amitava Guha
FMRAI
Kolkata
Saumya Panda
BODIII
Kolkata
Prasanna
CHC
Bangalore
Mathew Abraham
CHC
Bangalore
Murlidhar V.
Organiser
Mumbai
Nobhojit Roy
()rganiser
Mumbai
Sandhya Srinivasan
FME
Mumbai
Neha Madhiwala
CEIIAT
Mumbai
Anil Pilgaokar
FME
Mumbai
Sanjay Nagral
FME
Mumbai
Amita Mukhopadhayay
Researcher
Mumbai
Not confirmed as yet:
Mira Shiva
Zafarullah Chowdhury
Joe Vcrghese
Slot 2
Slot 3
?Ulhas Jajoo
?S.P. Kalantri
Slot 3
VIIAI
Gonoshasthya Kendra
Christian Medical Association India
Christian Medical Association India
Christian Medical Association India
MGIMS
MGIMS
Student
Delhi
Bangladesh
Waiklha
Wardha
Wardha
DRUG ISSUES FOR DISCUSSION
This write up is aimed at introducing issues concerning drugs in India the uninitiated
students, who will be attending the meeting as participants on Sept 7, 2003.
Rational Drug Policy
(Moderators: Mira Shiva /Anant Phadke)
Changes in the Drug Policy:
rhe first drug policy declared by the Government in 1978, which gave priority to the Indian
sector (particularly to the Public sector) resulting in India becoming almost self reliant in the
production of essential drugs. However, there have been drastic changes in the Drug Policy
since then and in this era of globalization, it is viewed that regulatory control of the Govt, in
pharmaceutical industry would deter growth. The policy is skewed towards the interests of
the Multinational companies. The Ministry of Chemicals and Fertilisers, Government of
India, recently released the new Drug Policy of the country under the name the
'Pharmaceutical Policy - 2002". The first few lines of the new Policy clearly spelt out the
following two main guiding forces in its formulation.
. The WfO obligations
. fhe policy of economic liberalisation set in motion in 1991.
Abolition of industrial licensing.
No industrial licensing would be required for bulk drugs, their intermediates and
formulations if cleared by the I )rug Controller General. This decision has allecled ding
industry adversely. Withdrawing of industrial licence has forced the country to import more.
Reservation of certain drugs for production in the public sector has been withdrawn and its
consequences arc already felt. Now any one, multinational or Indian sector would be allowed
to manufacture
Suggested reading: Mira ’r background paper commenting on Drug Policy 2002.
The Essential Drugs List- Santanu Tripathi
WHO had promoted the concept of Essential Drugs, and the WHO’s Drug Action
Programme was one of its most progressive programmes. However, the fact that WHO in its
Health Strategy for 21st century docs not even mention Essential Drugs reflects
the changing priorities at national and global levels. The entire concept of Essential Drugs is
based on the concept of Primary I Icalth Care and right to 'basic health care'. Twenty-two
years after Alma Ata Charter the very concept of primary health care is being replaced by top
down, technology centric, capital intensive, vertical health programmes where principles and
concept of comprehensiveness, integration, and holistic health have little or no value and
meaning. There is a replacement with pharmaceuticaliscd, commercialised, curative carcoriented technological fixes, which are adequately remunerative, in terms of trade,
irrespective of the question of affordability acceptability and sustainability. With increasing
globalisation of'Health Policy', making globalised solutions are recommended irrespective of
the health needs and health priorities of different countries.
Essential Drug Production - Chinu Srinivasan
In spite of the formulation of two drug policies in 1986 and in 1994, there was no
formulation of an Essential Drug List. After several decades of requests, recommendation,
demands and pressure, in 1996, the formulation of a National Essential Drug List by Health
Ministry took place and was presented in the Supreme Court where a public interest litigation
was filed by DAFK (Drug Action Forum Karnataka), AIDAN (All India Drug Action
Network), NCCDP (National Campaign Committee on Drug Policy) for banning of
hazardous and irrational drugs. Yet, in the absence of an Essential Drug Policy for the
manufacturers there is absolutely no mandate given to ensure adequate production of
essential drugs, the drug policy being under the Department of Chemicals under the Industry
Ministry. In reality it is basically a drug pricing and production policy as many of the
components of what should constitute a drug policy are under the Health Ministry.
Patent GATT issucs/TRIPs - Amit Sengupta
Patent is a right conferred by the government to an inventor for a certain lime period for a
product or process to produce it, for commercial utilisation of the invention. It is argued that
patent is given to the inventors for his investment of his talent and cost for his invention.
Indian Patents Act, 1970: This act is well known for helping the development of Indian
Pharmaceutical industry and considered as a model Act for the developing countries. This
act The Associations of multinational drug companies in the USA, Europe and Japan have
strongly lobbied to include patent in the GAIT system. GATT was a platform to negotiate
trade among the countries. There was no basis to include the monopolistic right like pateht
in the trading system. Only objective of this was monopolistic capture of the market in the
vital area like drugs. The WTO Agreement compels all the member national to enforce a
strong patent system which would not allow compulsory licensing system and parallel
import. It was possible earlier to import cheaper drugs from any country if the drug of the
patent holder was found to be costly. This is known as parallel import. The imminent result
of WTO was found in South Africa where nearly 25 percent population suffer from
IIJV/AIDS. People were dying of this disease for high cost of drugs, which was S11,000 pet
year. When South Africa started importing these drugs from India at a cost of J35O per year
(I), 38 multinational companies filed a case against the government of South Africa. Only
after a global outcry was the case withdrawn. The MNCs also declared that they would
reduce the price of the drugs.
Revision of Patents Rill
The Patents Second Amendment Bill introduced in the Parliament allows changes from
'process’ to ’product' patent and extension of the patentability period from 57 years to 20
years. Even though India has time up to 2005, the pressure to change the Indian Patent Act
1970 has been tremendous.
The intensity with which the new Patent regime is being pushed, with bilateral pressure of
Super 301 under the US's Trade and Omnibus Act 1988 and multilateral pressure under
TRIPS (Trade Related Intellectual Properly Rights) and WTO, forcing India to change its Indian
Patent Act of 1970, the objective is to ensure that the technological gap between the
technologically advanced countries and India stays big enough, so that India's pharmaceutical
market is captured and so also the world market specially of the African and other countries
which prefer to import from India due to lower" cost, is also captured.
This basically means that with enforced product patent the advantage India had in bringing
our reasonably priced drugs is lost. According to the world standards, Indian drug prices
have been comparatively low though still high keeping in account the purchasing power of
the majority with 40 per cent below poverty line. This was possible because of the Indian
Patent Act, 1970.
rhe most serious implication of this is for Indian private and public pharmaceutical sector,
which will be literally wiped out, since in the absence of process patent, development of
cheaper and more efficient production process will not be possible. India is threatened again
and again to change its patent act, against its own people's interest at the earliest.
Protests in Seatde, Melbourne, Prague, Genoa and even in Doha had communicated that
policies made with trade interests, with serious negative implications for the poor majority
would be resisted. There has been tremendous resistance to the forced Intellectual Property
Rights changes on developing countries and the systematic failure to allow the use of the
TRIPS safeguards e.g., South Africa and Brazil cases. The giving in was ohly because of
global protests and the 'Access to Medicine Campaign' launched by HA I (Health Action
International), MSF (Medecins Sans Erontieres-Doctors without Borders), Oxfam
International etc. which has been challenging the drug companies and the US for not
allowing the use of'compulsory licensing' and 'parallel import' in TRIPS.
Pricing and Promotion - Amitava Guha
Prices of drugs had always been considered as the most important factor for earning profit.
Due to the development of the Public sector drug companies, the prices of drugs remained
one of the lowest in the world. The Central Govt, kept all the dugs under price control in
1970. NPPA {National Pharmaceutical Pricing Authority) would also monitor prices of decreased
drugs and formulations and oversee the implementation of DPCO. The number of drugs
under price control has been decreased from 80 per cent at one time to 20 per cent at
present. The decrease in the price control basket has been systematic. There has been
tremendous resistance against DPCO from the drug companies particularly from the
multinationals.
Number of Drugs under DPCO
387
343
36
19/4
19/8
19/9
1986
Year
1994
2000
I hc government would have the power of review of the price fixation/price revision orders/
notification of NPPA. Although prices of bulk drugs have been steadily decreasing these
have not been reflected in the retail price of non-scheduled formulations. High margins/
commission offered to the trade by printing high prices on the label of medicines is
detrimental to the consumer.
Rise of prices in the recent times have been very high. A study of over 820 brands for
different diseased shows that there has been rise of price in the last three years; for some
drugs were about 300 percent. Barring few antibiotics, painkillers and drugs for
gastrointestinal diseases, prices of almost all drugs increased. In a note circulated by th e
Govt, in November, 1997 it was stated that “Experience has shown that product wise price
control mechanism has led to stagnation in terms of newer products and to proliferation of
existing products in numerous different strengths and pack sized, creating confusion in the
minds of consumers as also rendering price control system impractical.”
Monitoring: 'Hie Drug Price Control & Research Committee's (DPCRC) recommendations to
have effective monitoring and enforcement system and to move away from the "controlled
regime" to a "monitoring regime" is important in view of increasing imports to compete with
local drugs in the domestic market.
’Phe Maximum Allowable Post Manufacturing Expenses (MAPE) for all price-controlled drugs
would be 100 per cent. For category I, II, III and IV in 1979 the mark up was 40 per cent, 55
per cent, 75 per cent and 100 per cent respectively for price controlled drugs. Later it was
decreased to 2 categories and the MAPE- was 75 per cent and 100 per cent for categories I
and II DPCO, 1987. It was made 100 per cent in DPCO {Drug Price Control Order), 1995.
Banned and Bannablc Drugs : P.K. Sarkar
rhcrc arc large number of drugs which arc not only irrational but dangerous also. They arc
being sold without any hindrance and captured good sales. Taking advantage of weak,
inadequate and faulty law dishonest business practices arc let loose to sell such drugs. There
is no drug to cure most of the diarrhoeal diseases, colds, influenza, etc. Bdt large amounts of
antibiotics, anti-histaminics, vitamins and tonics are used for these diseases which is a waste
and at times, may worsen disease stale. A tendency of prescribing vitamins for any ailment is
i
i
-u.
4-'.. ■
not ' ■tttonal. Lot of adverse criticism about using vitamins at random has redtteed use of
ornvemtonal vttamtn mixtures but new types of drugs are now promoted. Combination of
anc, selenium, low dose Vitamin A and various forms of calcium arc replacing the
conventional vttamtn mixtures. Some arc more harmful and all of them are more expensive
I he process of ba.nntng these drugs is very difficult. In our country, some drugs have been
banned only when they were challenged in the court of law landing to lengthy legal process
sptead over years. J'.vcn if some drugs were banned but some producers including the
multtnattonals found method to market them. For example, the government banned
combtnatton of Vit Bl, Vif B6 and Vit B12. But the producers added other vitamins with this
combination and freely marketed them. It may be noted that a large number of drugs which
have high sales in the market but are more dangerous or more irrational which is consciously
overlooked by the authority. It is required that all drugs available in the market should be
periodically screened and objectionable drugs must be withdrawn forthwith. It is also
necessary that before marketing any new drugs or a combination of drugs, the producers
should establish its therapeutic validity.
"Drug
points"
Drug action points
” and Suggested areas of Intervention (Anant Pliadkc)-
Scrutinyofof
drugpromotion
promotionmaterial
materialbybysome multinational drug companies in India
1. Scrutiny
drug
multinational drug companies in India
and compare it with its version in the parent country.
2.
A
frw nof-nndv
,i________
> ■
A canipaitrn
campaign arainst
against na few
patently irrational drug
combinations
3.
4.
5.
Ads of substances touted indirectly as sex Ionics
Irrational claims in the ads on the 'IV
Exposing the IIRT scandal, I lep B universal immunization scandal
6.
I here are issues which can be converted into drug-action points - Compulsory
license, effects of TRIPS, patenting, promotion of rational drug information ( BODFH) die
effectiveness
or otherwise
of functioning
the funetionina
of nTAn /nrr.
----------or otherwise
of the
of DTAB/DCCI,
the
csscntia] dtugs
in
state government agendas and the effects on health
1
* * 'budgets and drug availability, monitoring
of and pricing of key drugs and comparison with international trends
• «« n .I . i1------------il.. . .
■
------ ----- running courses in
I* A I I/A
I,
rational drug therapy, pharmacy management, drug utilization studies (how to j '
" '
and actually do
it), patient leaflets in different languages, monitoring spi
sponsorship of medical conferences"
med rep information, monitoring drug industry-doctor incentives business, modifying drug
legislations to promote essential drugs, demystification of production technology, etc. etc.
7.
New topics beyond drugs, but where a lot ofcheating takes pl
t lace----- Publicizing of
standard guidelines for newer imodalities
’
‘
of investigations as SCREENING 'PES’I S - ECG,
stress test, mammography,
.
... CAT scan. Indications for surgical
o—' versus medical management of
11 ID, clarity on Ithe
1 indications of angiography,
■
stress thalium etc.
Snggcsfed trading: /Inant '.r background paper on ‘1K'7w/ can be done?”
Organizational aspects: (Gopal Dabadc)
By the end of this session, we intend to have some concrete plans and commitments-
A) H e need for a dc.nocratically functioning umbrella organization like JSA/AIDAN with
Secretary, President, Chairperson and few members.
B) With the details of its members and enrolling more new members.
,'>C!'tCr!' ‘,!"a,’asc °ral1 ll,c "Clive groups on drug issues in India.
D) Identify major areas of intervention.
Background paper for the Drug Action meeting - Sep 7, 2003, YMCA, Mumbai
WHAT CAN BE DONI-?
Anant Phadke
Standardization of Medical Care^
It would be clear from the account so far that if people are to get the right kind of drugs at
affordable prices, a rational drug policy is a must. In addition, the overall health-policy also has
to be rational, because the quality of prescribing can not be separated from the quality of health
care in general. Health care in India has a chaotic, mosaic pattern from faith healers in the remote
villages to five-star corporate hospitals in metropolitan cities. In the public sector, health-care
delivery ranges from Anganwadi workers, 'malaria doctors' to super-specialists in teaching
hospitals. There is neither standardization of medical care nor proper linkages between different
types of health-services. A large part of the precious resources of the people are therefore
squandered on irrational medical care. Patients are helpless in putting pressure on doctors to
prescribe rationally. Medical science is vast and complicated and despite heightened consumer
education, it is impossible for an average consumer in India, to find out whether the treatment
given by the doctor is rational or not. Secondly, the doctor-patient relationship has Its Inherent
politics. Doctor can legitimately explore all corners of patients' body and mind and people seek
the doctor's services when they arc unwell. It is more in the nature of seeking help than buying a
service. When a patient is cured or relieved of the suffering due to the doctor's treatment, there is
a sense of gratitude in the patient’s mind. I bis is different from the 'thank you’ given to say a
mechanic who repairs your T.V. or your vehicle. These two factors make the patient quite
vulnerable vis a vis the doctor. Hence it is difficult for patients to look critically at what doctors
do and prescribe. Somebody else has to do the watch-dog work in the interest of the patients.
Self regulation by professional organizations of doctors is one way out. In India, such a tradition
hardly exists. A beginning has to be made by laying down minimum standards and by evolving
consensus standard treatment guidelines under local conditions. 1 his may pick up under the
threat of the Consumer Protection Act because if a doctor follows standard guidelines, and yet a
mishap occurs, the doctor is not morally and legally liable. Preparation and enforcement of
standard treatment guidelines as decided by local professional organisations in view of local
conditions would not infringe upon doctors clinical freedom. It would be in the interest of both
doctors and the patients.
Towards Universal Health Insurance
'flic second step to serve the interests of both the doctors and patients is to have third
party payment systems. If patients arc insured and the insurance agency pays for the doctor's bill,
then doctor's advice and prescription can be critically examined by a medical expert employed by
the insurance agency to find out whether it deviates from standard guidelines. If the doctor has a
valid justification for any deviation, that can also be accepted by the insurance agency. However,
the private insurance companies would reach out to only the well to do. Even in the US more
than 30% people have no health insurance cover. Moreover, multiple private insurance agencies
have increased the administrative cost of health insurance in the US. In Canada and Australia on
the other hand, there is a far more economical and yet universally available universal health
insurance in which every citizen is by birth, under health insurance. Patients go to the private
practitioner but the government pays for most of the expenses at predetermined rates. Thus
nobody is deprived of medical care on account of lack of purchasing power. But at the same
time, there is scope for private practice. This system avoids the bureaucratism when doctors
become paid employees the state and also leaves scope for private initiatives. Bureaucratism is
quite inimical in a sensitive and personalized service like medical care, The system of universal
petition amongst doctors. In the
health insurance also avoids the problems of commercial competition
absence of commercial competition, doctors would get back the professional satisfaction of
concentrating on proper diagnosis and treatment of patients to relieve his/her suffering.
It may be asked, whether India has the resources today to give health care insurance to
everybody. The answer is yes. We arc already spending about 6% of our Gross Domestic
Product (GDP) on hcalth-carc. But the state's share in only 21% of this expenditure. Ibis share
is lower than that seen even in Bangladesh (A3%) and Pakistan (53%). In most developed
capitalist countries, this share is 70 to 80% and even in the U.S. - the supposed heaven of private
medical care, the state’s share in total health-expenditure is 44%. (Sengupta, Amit 1994, table 1).
To actualize the Alma Ata Declaration of Health for All by 2000 A.D.' the WHO has
recommended that the 5% of GNP should be spent on health-care. When even the governments
in Sri Lanka, Bangladesh, Pakistan can spend a higher proportion for health-care than private
health-expenditure, why can't the Indian government do this ? The people are already paying
4.5% of GDP in the private sector. If the government spends 5% of GDP on health-care by
almost quadruplicating its current health-expenses, then an additional special health-tax
proportional to income, to meet the extra needs for a Universal Health Insurance can be justified.
Instead of paying directly to the often exploitative private sector as is done today, people would
be willing to pay a health-tax to the local government who could in (mn pay the private
practitioners as per negotiated, rational rate-structure. ’Ums without people having to pay more
on health-care than what they arc paying today, India can provide for expenses for a Universal
Health Insurance of upto 9.5% of GDP. This much expense should suffice. I hough higher in
absolute terms, the health-expenditure in Japan, Germany, Canada, France is in the range of 4.5 to
9.5% of the GDP. What is needed in India is intensive public pressure on the Indian government
to divert more resources towards health-care.
In terms of human-power, by the year 2000 A.D., as mentioned earlier, we would have
one MDBS doctor per 2000 population and one graduate doctor of some patliy per 1000
population. If this human power is rationally organized and the Village Health Workers and other
paramedics are properly trained and supported, we will have enough trained human power to
make health-care of fair quality accessible to all.
Rational Drug Policy
Regulation
Regulation of
of medical
medical care through Universal Health Insurance would create a favourable
framework for proper use of drugs. However, specific additional measures would be re(|iiired Io
see that the right kind of drug arc available and used in the right way. Let us deal with these
measures briefly. These, measures have been suggested in the various meetings of the All India
Drug Action Network (AIDAN). (AIDAN has been the coordinating agency of various groups in
India lobbying for a rational drug policy, for the last 15 years).
1)
Assessing Drug Needs - There is a need to conduct systematic studies in different parts of
India of the extent of various health-problems in the community. The existing studies are too
inadequate in scope and are mostly clinic based. Comprehensive studies that record prevalence
of all common health problems al the Community level would form the basis of estimating the
drug-needs in India.
II)
Ban on Irrational Drugs - Only those drugs recommended by standard medical text books
or by other such standard sources should be allowed to be marked. All others should be banned.
Ill)
Essential Drugs List - I bis would be the single most important measure to make the right
kind of drugs available at affordable prices to all Indians. Amongst rational drugs, Essentia
Drugs should have a priority. The list of Essential Drugs and other drugs registered in India
should be reviewed every 3-5 years so that obsolete drugs can be replaced with better newer
drugs and other such changcs-can be made.
As mentioned earlier, the consensus l:sscntial Drugs last for India has been prepaicd in
April 1995 by a team of experts from NGOs. It's a graded list which lists which drugs aic
essential at what level of health-care - Village Health Worker, Primary Health Centre, District
Hospital and Tertiary, Super-Speciality level hospital. The Government of India should adopt
this list with whatever modifications its experts may suggest and see that resources must be spent
on a priority basis to make these drugs adequately available al all times in all government health
facilities al various levels.
IV)
No Unnecessary Syrups - With the exception of antacids which are preferably used m
liquid
form,
for all
all other
other drugs,
drugs, liquid
liquid form, for
liquid oral preparations should be allowed only for paediatric
ily. Syrup-preparations for
formulations since children cannot swallow tablets or capsules easily.
adults mean unnecessary costly preparations.
V) Only Generic NamesAs argued earlier, drugs should be available only under genet Ic
name. I he manufacturer's name may be pul in brackets alter this generic name.
VI)
Drug Company's Promotional Activities - should be regulated. A permanent committee
of experts should be formed to review the 'educational' material, which should conform to
WHO's Ethical criteria for drug-promotion. As health Action Internationl (I I Al) has put it - A
promotional literature for pharmaceuticals must be accurate, factual, balanced and up-to-date. It
must conform to legal requirements and to standards of good taste. It should be provided in a
language readily understandable to the person who will use it. It must not mislead, either directly
or by implication, by omission an information by tin-verifiable statements. Promotional material
should be screened by this committee on this basis and be allowed to be published only afier the
committee's approval.
fhe HAI has also demanded that routine provision of samples of prescription or non
prescription drugs to health-workers, health-institutions or to the general public should not be
allowed. This is because such gift of drug-samples has no role in rational therapeutics, but is a
mere indirect bribe to promote sales.
Samples of drugs for controlled, approved clinical trials or other research should be
allowed.
'VII)
’•')
Sponsorship of Symposia and Other Scientific Meetings - I lere again, the guidelines laid
down by the Health Action International arc appropriate.
The organization by pharmaceutical manufacturers or distributors of symposia
(1)
and other scientific meetings should only be permitted if approval for such a meeting has been
granted by the relevant national or international health worker association, health institution or
government department; an independent panel of scientists and/or health woikers has been set up
to review the content of the meeting and full disclosure of the sponsorship is stated in all
communications related to the meeting, and at the meeting itself.
I
I
I
(2)
IPartial sponsorship of such meetings may be permitted if such sponsorship is
•
■ •
.i
r 11 i •
'i
rJ
I *
*
requested by the organizers, subject to the full disclosure of the sponsorship.
One would add that the drug company should not have any say in the scientific content of
the meeting, selection of the topic or of the speaker.
Thus overall, sponsorship of scientific or professional meetings by drug-companies
should be seen as drug industry's contribution towards continuing Medical Education and not as a
direct promotional activity.
*
VIII) Proper Labelling - Labelling of drugs should enable lay-people to use drugs properly. It
should also mention most common side-effects and should mention danger signals to enable
patients to contact the doctor immediately. Special precautions in case of children, pregnant and
lactating mothers and old people, should be mentioned clearly. The labelling should be printed in
adequately bold size.
IX)
Over the Counter Drugs - Some drugs like antacid for temporary relief from burning
sensation in stomach; mild laxative for constipation, paracetamol for body-aches and simple
fever, oral ichydration salt for diaiihora; antiseptic for wounds, pain balms for aches and
sprains
can be safely used by lay-people without doctors' prescription. A list of such drugs
should be made and only these drugs be allowed to be sold O.T.C. All other existing irrational
O. I .C. drugs should of course be banned. ,
The labelling in case ofO.T O. drugs should be more
detailed, giving all indications, contra-indications, common side-effects and danger-signals. The
labelling should be made in English, Hindi and a regional language. It should accompany every
pack of 10 tablets.
Information about scientific treatment at home, of minor ailments, with the help of
O.T.C. drugs should be widely and repeatedly publicized by the state media. Advertisements of
O.T.C. drugs should be precensored by an expert committee before release. This committee
should have a consumer's representative on it to put forward consumers' viewpoint about the
impact of these advertisements.
X)
A limit on Cross-Practice - As has been argued earlier, non-allopaths should not be
allowed to prescribe allopathic drugs beyond a short list of drugs for which they should be given
appropriate training. Similarly allopaths should not be allowed to use non allopathic drugs unless
they have been trained to use some of these drugs by a recognized training institute.
XI)
Compulsory Continuing Medical Education of Doctors ? As pointed out earlier, this is a
must, in today's fast changing world. Doctors have to renew (heir registration with (he state
Medical Council every five years. All that is needed today for this is to pay Rs. 50/- towards
renewal charges. Instead, renewal should be given subject to proof of undergoing minimum
CME. The Medical Council should run magazines for CME for general practitioners. Since
today, there is no specific magazine for CME of general practitioners whereas professional
organizations of specialists have their own magazines.
An open book examination containing multiple choice questions should be conducted
every
five years
to ensure that
doctors
read
these educational
magazines.
Satisfactory
performance in these exams should form a pre-condition for renewal of registration of doctors.
‘J '
5
Similar measures will have K, be taken for non-allopalhie doelors ami paramedics using
,(Imgs.
ethical issues in drug-promotion and in a better
better way.
way.
XIII) Research on Non-allopathic Drugs should be encouraged with funds, facilities and prestige.
Thus to ensure that resources spent on drugs are properly utilized so
that the right kind of
.drug 1S used m the correct way, many changes will have to be made in what is allowed to be
produced, how it is promoted, how issues concerning drugs are taught and how they
are used by
health-professtonals and the lay-people. All these changes indicated above arc
simple to make,
provided there is political will or pressure to do so.
1 he above measures cannot be separated from measures to protect and promote the wellearned reliance of the Indian drug industry, from being squandered through (he New Economic
lohcy and the signing of (he Now Palcnl Regime of (he World Tinde ()ipnnl/nllon
Am
rtientioned in the beginning, we have not dealt with (his aspect in this book because (his topic has
been well covered by other authors. We reiterate that the steps towards self-reliance are no less
important than the above measures towards bringing rationality into this field.
J
Mi ra on Policy 2002
Background paper for the Drug Action meeting - Sep 7, 2003, YMCA
, Mumbai
PHARMACEUTICAL POLICY
2002
Dr. Mira Shiva is Director, Women and Health and Rational Drug P
olicy, Voluntary Health
Association of India, New Delhi Source.. ’Health for the Million
s Vol. 28 No. 1 April - May 2002,
p 8-11 .
The Ministry of Chemicals and Fertilisers, Government of India,
recently released the new Drug
Policy of the country under the name the ’ Pharmaceutical Policy
- 2002". The first few lines of
the new Policy clearly spelt out the following two main guiding
forces in its formulation.
. The WTO obiigallons
. The policy of economic 1iberalisation set in motion in 1991.
The Drug Policy as well as many others in the offing e.g., priva
tisation of water, privatisation
of health care, research, education, labour laws etc. are emergi
ng basically from the same policy
framework of trade which gives private profit priority over basi
c needs and health rights of the
people. With about 80 per cent of health care in private hands,
further push for increasing 'user
charges' 'fee for service’’ with increasing medical care costs any increase in drug prices will
add to ’decreasing access to medicine or - increasing indebtedne
ss' among the poor and
marginalised.
In the absence of distributive justice, even the fruits of Resea
rch and Development (R & D) of
decades, will not bo accessible to those who need them Lhe most,
i.e., who have the greatest
disease burden,
The Drug Policy of 1986 was announced as the Rationalisation Mea
sures for the growth of Drug
Industry. The major changes were greater decontrol and removal o
f production control. The price
f
decontrol resulted in increase in drug prices.
In 1991, the New Industrial Policy and the New Economic Policy w
ere announced. The process of
deregulation, decontrol, liberalisation further hastened the pro
cess. The changes that took place
were increasing imports, with lesser and lesser interest in prod
uction from basic stage in
production of raw material or bulk drugs, Ironically several bul
k production units and several R
& D centres of MNC's closed down.
The process of liberalisation also considerabJy reduced the scop
Page 1
Mira on Policy 2002
e of industrial licensing. In the
Drug Policy 2002, industrial licensing for the
manufacture of al
1 bulk drugs cleared by the Drug
Controller and their formulations and their intermediates has
be
en abolished except for bulk
drugs produced by recombinant DNA lechnology and bulk drugs
requ
iring j.n-vivo use of nucleic
acids <as the active principle and special
cell/tissue targeted f
ormulations.
Foreign investment through automatic route raised from
cent in March 2000
51 PSr CS
nt to 7 4 j-per
has been raised now to 100 per cent. There was a time when
compa
nies with 40 per cent fore!gn
equity share were considered foreign companies
in India. Now wha
t could be the implication of 100
per cent foreign investment under the WTO (World Trade
Organizat
ion) regime? Only time will tell
if financial inveslmcnl is for prof if o r I o fir; I v< * I hr;
.' u 11 (nr I 11 < |
humanity.
With foreign companies obligatorily to be given
"national treatm
ent" i.e., same treatment as
domestic companies, the later would lose out.
When the former ha
ve greater financial clout, more
aggressive marketing, transfer
pricing etc" 1
’
the
smaller competitors will be-wiped out.
Disinvestment and privatisation of the public sector units
and i
ncreasing imports with import
tO
ke place in the name of "increasing compe
i-iti.on as stated in the policy
document.
"Automatic approval for foreign technology
agreements" will be a
vailable in case of all bulk
drugs 'cleared by Drug Controller, Government of India and their
formulations and intermediates
’SSS LeO»„neO1°?ytbe°d„^fPhar,"aCeUtl!:al lnd“St^
important knowledge based industries.
There have been’delays in
revision of drug prices when raw
material and other costs increase
according to the manufacturers
on one hand and complaints of
spiralling of drug prices by the consumers.
The Pharmaceutical P
olicy 2002 has incorporated a
section on monitoring.
Revision of Patents Bill
The Patents Second Amendment Bill introduced
in (the Parliament a
llows changes from 'process' to
’product' patent and extension of the
patentability period from
57 years to 20 years. Even though
India has time up to 2005, the r---pressure to change the Indian Pa t
ent Act 1970 has been tremendous.
The intensity with which the new’patent regime is being pushed,w
Page 2
Mira on Policy 2002
ith bilateral pressure of Super
301 under the US’s Trade and Omnibus Act 1988
and multilateral p
resssure under TRIPS (Trade
Related Intellectual Property Rights) and WTO,
forcing India to
change its Indian Patent Act of
1970, the objective is to ensure that the
technological gap betw
een the technologically advanced
countries and India stays big enough,
so that India’s pharmaceut
ical market is captured and so
also the world market specially of the African
and other countri
es which prefer to import from
India due to lower" cost, is also captured.
tags .ZS TrKlX’oS enfOt°ed Pr°dUCt P*tent
•d”n
reasonably priced drugs is lost. According to the world
standard
s, Indian drug prices have been
comparatively low though still high keeping in account tho
pu rch
asmg power of the rnajoriLy with
40 per cent below poverty line. This
was possible because of the
Indian Patent Act, 1970.
The most serious implication cof" this
' ’
is for Indian private and p
ublic pharmaceutical sector which
will be literally wiped out, since in the absence of
process pat
ent, development of cheaper and
more efficient production p
process will not be possible. Due to t
he inadequate resource base of
these companies, basic research is not possible.
While several R
& D units of the MNCs in India
have closed down, even the research done by the
subsidiaries is
owned by parent companies. Over
~
80 per cent of these patents are bought by the parent
companies
with R & D budgets, more than
entire pharmaceutical sales and health budget
s of several deve.lo
ping countries.
Ironically, the US Patent law does
not recognise anything nonwes
r
’ ’ ' '
~tern,' ^-Published
in English as
Prior
Art. Majority
!* '
-- ---of the patents are filed in US by US
corpora
tions under the US Patent law,
while US would like to continue,
to make its profits and continu
e with its patent laws,r which
allow this non recognition of Prior
Art and which differs from T
RIPS. India <on the other hand is
threatened again
andJ again
<
to change its patent act, against its
own people’s interest
-_—„
at 111 e
earliest.
Protests in Seattle, ['
Melbourne, Prague, Genoa and even in Doha h
ad communicated that policies
made with trade interests, with serious
negative implications f o
r the poor majority would be
resisted. There has been tremendous resistance to the forced Int
ellectual Property Right s changes
on developing countries and the systematic failure
to allow the
Page 3
Mira on Policy 2002
use of the TRIPS safeguards e.g..
South Africa and Brazil cases. The giving in was only because of
global protests and the ’Access
to Medicine Campaign’ launched by HAI (Health Action Internation
al), MSF (Medecins Sans
Frontieres-Doctors without Borders), Oxfam International etc. wh
ich has been challenging the drug
companies and the US for not allowing the use of ’compulsory lie
ensing’ and ’parallel import’ in
TRIPS.
The Pharmaceutical Policy, 2002 recognises that the obligations
under TRIPS and the process of
globalisation would impact longterm competitiveness of the India
n Industry.
Reorientation of the objectives of the present policy is based O
n the recognition of the
’’essentiality of Improving Incentives for R & D" . The Pharma HOC
tor has welcomed the drug policy
2002.
Monitoring
The Drug Price Control & Research Committee's (DPCRC) recommenda
tions to have effective
monitoring and enforcement system and to move away from the "con
trolled regime” to a "monitoring
regime” is important in view of increasing imports to compete wi
th local drugs in the domestic
market.
The Maximum Allowable Post Manufacturing Expenses (MAPE) for all
price-controlled drugs would be
100 per cent. For category I, II, III and IV in 1979 the mark up
was 40 per cent, 55 per cent, 75
per cent and 100 per cent respectively for price controlled drug
s. Later it was decreased to 2
categories and the MAPE- was 75 per cent and 100 per cent for ca
tegories I and 11 DPCO, 1987. It
was made 100 per cent in DPCO (Drug Price Control Order), 1995.
A new system to monitor market prices needs to be evolved and co
ntrols applied selectively-where
profiteering and monopoly profit seeking is noticed, NPPA needs
to be revamped and reoriented.
NPPA (National Pharmaceutical Pricing Authority) would also moni
tor prices of decreased drugs and
formulations and oversee the implementation of DPCO. The number
of drugs under price control has
been decreased from 80 per cent at one time to 20 per cent at pr
esent. The decrease in the price
control basket has been systematic.
1974-450
1979-343 bulk drugs
1986-142
1994-74 drugs under price control 2000-36
Page 4
Mira on Policy 2002
The government would have the power of review of the price fixat
ion/price revision orders/
notification of NPPA. f''
’
Although
prices of bulk drugs have been st
eadily decreasing these havej inot
been reflected in the jretail
’ *' price of non-scheduled formulations
. High margins/ commission
offered to the trade by printing high prices on the label of med
icines is detrimental to the
consumer.
It has been proposed to strengthen NPP A by providing appropriat
e powers under DPCO which would
9 pProPriat
make it. mandatory for the manufacturers to furnish all informati
on as called for by NPPA and also
to regulate such prices whenever required." There has been a fai
lure on the part of the
manufacturers to provide adequate information in the past.
DPCRC
recommendation of giving powers
to the drug control mil hot ii i O.rl to di npo.’io of f .•iiii.i | |
and pcll y o
ffences etc., will require an
amendment to the Essential Commodities Act.
Quality Aspects
The
issuet„eof Health
Quality
Control
is
x u„oor
Ml„
islry. The^
b6
C°ntrO
1 under the Health Ministry.
1986 drug policy recommended formation of NPPA to look at drug
P
ricing and NDA (National Drug
Authority) for many other things such as Quality Drugs. While th
e NPP A was put in place, the
formation of National Drug Authority fulfilling the role
as envi
saged, has still not taken place.
The Essential Drugs List
In spite of the formulation (of" two
‘
drug policies in 1986 and in
199^, there was no formulation of
an Essential Drug List. After several decades of
requests, recom
mendation, demands and pressure,
formulation of a National Essential Drug List by He
alth Ministry took place and was
presented in the Supreme Court where aa public interest 1 i f -i
■
n was filed by DAFK (Drug Action
interest litigatio
Forum Karnataka), AIDAN (All India Drug Action Network) NCCDP (
National Campaign Committee on
-uworK;, NCCDP (
Dfn9thOliHy) f°r kanning of hazardous and irrational
drugs. Yet,
in the absence of an Essential
Drug Policy for the manufacturers there is
absolutely no mandate
given to ensure adequate
production ofof ch
essential
drugs.
epartment
536"
drU9S' the drU9 PolicV boing under the D
epartmenL of Chemicals under the
Industry Ministry, In reality it is basically
a drug pricing and
production policy as many of the
components of what should constitute a
drug policy are under the
Health Ministry.
Page 5
M i ra on Policy 2002
♦
WHO had promoted the concept of Essential. Drugs, and the WHO's D
rug Ac I ion Programme1 was one of:
its most progressive programmes, However, the fact that WHO in i
ts Health Strategy for 21st
century does not even mention Essential Drugs reflects the chang
ing priorities at national and
global levels. The entire concept of Essential Drugs is based on
the concept of Primary Health
Care and right to 'basic health care'. Twenty two years after Al
ma Ata Charter the very concept
of primary health care is being replaced by top down, technology
centric, capital intensive,
vertical health programmes where principles and concept of compr
ehensiveness, integration,
holistic health have little or no value and meaning. There is a
replacement with
pharmaceuticalised, commercialised, curative care-oriented techn
o.logical fixes, which arc
adequately remunerative, in terms of trade, irrespective of the
question of affordability
acceptability and sustainability. With increasing globalisation
of 'Health Policy', making
globalised solutions are recommended irrespective of the health
needs and health priorities of
different countries.
Linkage with other policies
The drug policy cannot be seen in isolation, It has to be seen a
long with the National Health
c
Policy. The international trade regime, which has influenced the
drug policy, is bound to
influence the health policy.
How the National Health' Policy addresses the drugs issue is yet
to be seen. In the past at
critical junctures when decisions related IPR and WTO, especial 1
y TRIPS, GA TS (General Agreement
in Irade in Services) were to be taken it was the Commerce Minis
try that was calling the shots with the Health Ministry having very little to contribute.
As the health of the nation deteriorates, the trade oriented gio
balised health and
pharmaceuticalised policy making will ensure that the inequities
get worse. This is especially so
due to the withdrawal of Basic Health Care for majority. The fis
cal cuts on 'wasteful subsidies'
'of free care on the one hand and spiralling cost ot' drugs/medic
al'
care’ on the other and corporatisation and take over of the indi
genous knowledge and resources
under the new
instruments of an unjust international trade regime, wi11 have I
ong-term adverse effects on the
Page 6
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