ALL INDIA DRUG ACTION NETWORK
Item
- Title
- ALL INDIA DRUG ACTION NETWORK
- extracted text
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RF_DR_3_SUDHA
Voluntary Healtl Association of India
Community Centre
Sefdarjung Development Area.
New Delhi-110016
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A sahai
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Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652006
D J.0-343,.(p,II: a)
a»4.11.82
Dear Friend,
-
The summary of the Drug 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 Dr.Zafrullah Chowdhury for keeping us informed. Claude Alvares
is busy building support for the ban in various non-medical circles like the
IIT’s and has started a signature campaign. Dr-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 formulations was to have been stopped from
31st October 1982. Their sale henceforth is ILLEGAL- Please bring cases of
default to our notice. Dr* Kabra as well as the Consumer Education and Research
Centre of Ahmedabad will provide guidance and adviee 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 soon.
Ciba Geigy has decided to withdraw its popular anabolic steroid prepar*
ation DIANABOL because of its hazardous effects, Thia 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.
Dr- Ran© writes that drugs like Unienzyme, which contain iodochloz*hydroxyquinoline,should be included in our list and so also ALL ENZYMES
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 Drug Controller’s stand on the issue of the hazardous drugs
is amply clear: "Someone in the West takes up an issue, and our people promptly
dangerous^drugs" More PeoPle
in India from unsterilised needles than from
-u V*10?1 0Ur Peopi° cannot have basic health care, nor essential drugs
for basic hoalth 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.
47,A'%jxNGp'l'<”
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B-;10-343 (R.IT:a)
as 4.11.82
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The drugs issue 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".
We appeal tn our friends to BOYCOTT all hazardous drugs - the black
f2r
°f theSe dru®a has b30n prepared by VHAI - and to influence
other health groups and individuals to do the sameWe appeal for help in compilation of documented <case 'histories,
‘
review
oi recent medical literature regarding various hazardous drugs.
nbnn+
n®tw01,k.^comes bigger.we need to keep each other informed
about our efforts as individuals and groups.
a.
Locking forward to hearing from you and reminding you that our
nGL r3ar 3 Priori'fcies arQ anti-diarrhoeals and shortage of anti-TB (and
anti-leprosy) drugs and the misuse of anti-diarrhoeals.
With siixpeje- regards^'
r
y
* *
---
(Mira sfiiva)
Co-Ordinator
Low Cost Drugs & Rational
Therapeutics
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area.
New Delhi-110016
)
V |z
Telegrams : VOLHEALTH
New Delhi-110016
/ ”/
Phone : 652007, 652008
hi
%
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 ccmmittment*
If you know of other like minded individuals who could or
would like to contribute in any specific areas, it1s up
to you to get them in touch with 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
collect first hand information. We find Hormonal Preparation .
for pregnancy tests can be obtained over the counter even with
out prescription after without any accompanying literature.
They are prescribed widely by doctors with no accompanying
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
- 44 misused drugs by IOCU (International Organisation
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.
If you could send in your comments and what you have done and
are doing/ we could 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 incerely/
Mira "Shiva
r
Voluntary Health Association of India
C-14, Community Centre
%
Safdarjung Development AreaNew Delhi-110016
o
J'r'/
'D-lO/343'
MS:a/16.2.82
Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652008
REPORT OF WORKSHOP ON
’’DRUGS ISSUES AND SEEKING FEASIBLE ALTERNATIVES”
PUNE, JANUARY 8 - 10,1982
This report is divided, into three parts.
Part 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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PART I - LIST OF PARTICIPANTS
1.
13.
Dr-Vasundara Victor
Star of Hope Hospital,
Akividu, W.Godavari DtA.P. 534 235
Dr. D. A. Joseph,
105, Nibbana,
Pali Hill Road,Bandra,
Bombay 400 050
14.
Dr- Mishra,
Gram Nirman Mandal,
Sarvodaya Ashram,
Sokhodeora,Bihar 805 106
Mr.Claude Alvares,
Rustic, Thane,
Valpai, Goa 403 506
Dr. H- N. Antia,
Foundation for Research in
Community Health,
84-A,R.G.Thadam Marg,
Sea Pace Corner, Worli,
Bombay 400 018,Maharashtra
15.
Mr. Rajiv ^iwari,
Centre for Education and
Documentation,
3 Suleman Chambers,
4 Battery Street,
Behind Regal Cinema,
Bombay 400 039
1’6.
Dr- Anant Phadke,
Medico Friends Circle
50 L.I.C.Quarters,
University Road, Pune 411016
Dr- Wishwas V. Rane,
2117 Sadashiv Peth?
Pune 411 030
Dr. A. R. Patwardhan,
Arogya Dakshata Mandal,
1913 Sadashiv Peth,
Pune 411 030
Dr.P.B.I. Victor
and
2.
3.
4.
5.
6.
7.
8.
9.
10.
Mr. D. P. Pandey,
G-16/8 Rajouri Garden?
New Delhi 110 027
Mr- Pramod Kulkarni,
Consumer Education and
Research Centre,
Thakorebhai Desai Smarak
Bhavan,
Ellis Bridge,
Ahmedabad 380 006
Mr. Alan Crammer,
Mary Calvert Holdsworth
Memorail Hospital,
Mysore - 570 021,
Karnataka.
Sr- Pratiti
Sr. Angella
C/o Bishop’s House,
P.O.Kunkuri,Raigarh Dt.
MP - 496 225
Dr. Binayak Sen
CMSS Office,
P.O.Rajhara Kondy,
Dist.Burg - 491 228, MP.
OR
Kishore Bharti,
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.
17.
18.
19.
Dr* IT. N. Jajoo,
Reader, Department of Medicire
Sewagram Medical College,
Wardha, Maharashtra.
20.
Dr. P. K- John,
Christian Hospital,
Bissam Cuttack,
Orissa - 765 019
21.
Mr. D. P. Poddar,
Organizing Secretary,
West Bengal VHA,
41-L? Palm Avenue,
Calcutta - 700 019
22.
Dr. V. S. Mathur,
Prof.of Pharmacology,
PCI of Medical Education
and Research,
Chandigarh - 160 012,
2
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2^.
Mr. Jean Louis Bato,
Overseas Director^
SOLIDARITE,
Associationho 1901,
90 Chemin des CapeIles,
31300 Toulouse,
CCP Toulouse 2760 42M, France.
24.
Dr. Sacthyamala
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 Areas
New Delhi 110 016
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PART - III - SESSION REPORT
Janug,ry 8,1982
Objectives arid 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 ..core
core 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) : Introduction
There were totally
participants representing various interest
groups in drugs and pharmaceuticals. Their expressed interests in the
workshop included rational drug therapeutics; low cost Afrxaulation
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 A
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 Dr* 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 them 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 with 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.
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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, ”broad guidelines for hospitals of
various sizes, fulfilling various needs.
January 9,1982
Session 1: (8.30 - 9.30 am): Pharmacy Management
Since drugs formed an important part of all health care institutiono, whether they are hospitals, dispensaries or community health
programmes, a session was held to deal with the application of management
teenniques and principles in the management of a pharmacy. The subjects
discussed included ABC analysis concepts of buffer stock, lead 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
emphasized the need to exercise stock control measures for these and
stock the minimum required. He talked about the need to know the lead
time for 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
coot 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
(Nirman Bhavan, New Delhi) could be contacted for help and clarification.
Session 2: (10.30 - 1.00)
3
There were three subjects for discussion in this sessions (a) lov
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. Rane 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. Gaitohde’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. Jf 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
«inon-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 othejs^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: (2*00 - 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 possibleThe role of consumer groups according to Pramod Kulkarni of CERC...
was seen as an Information Group as well as a pressure .group•
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,Pune,
- C•£•!)• 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 ft&s felt. 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 shortageThe 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.
CERC 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-
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Claude Alvares strongly felt there has to be more7 demonstrative
out undesirable drugs from chemist shops.
social action like throwing
'
’ l on injectable pregnancy tests
It was decided to get•_ information
■
hormonal
preparations
like depo provera? etc., of
E.P.Porte- and other ]
’
s
grou]S
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 4: (4.15 - 5.45 pm): Rational Drug Therapeutics
Mira led the discussion- Rational drug therapy was defined^as
* ' • dosages,
'
~ . Phadke
using the right drugs at the right time and in the right
OTC
drugs
and
misuse
of
and Ulhas Jajoo shared briefly their papers on Cmrl
. lv • .’1Ulhas
for the
antibiotics respectively*
---- - said that making
~ it compulsory
-
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 information charts relevant for
the Indian context which can be used by a doctor as well as a
medical auxiliary*
3) Working on an Indianised version of the AMREF’s Therapeutic
Guidelines”.
4) Wide dissemination of scientific information on widely misused
drugs/barmed druggy etc.
5)’ Compilation of lists of drugs not to be used during pregnancy
or during lactation*
January 10,1982
Session l:(8.30-§.30 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
(i.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): Alternatives in Health Drugs
1) Sr* Pratiti and. Sr* Angella: Shared with the group 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.
c) 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* TheJ* presented.
samples of herbal plants used by them to treat people in their area*
ii) Louis Bato: 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 tochinques
in the manufacture of traditional medicines; provision for chemical and
laboratory trials; detailed studies in ethro-phBrmacology 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 organisation 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 medicine.
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 management. He 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 ibhsir 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-
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2
ACTION PLANS
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 represented.
The credit for the down to earth, need based action plans goes to
the members of this core group - the credit for the outcome of these action
plans also will go to them.
It was VHAl’s privilege to coordinate their getting together.
Action Plans according to-^ur 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
- Arogya Pakshata Mandal.
Medical Education
- Drug Industry
- Centre for Education &
Development (CED).
- Legal Actions organise
campaign
- C.E.R.C.
(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-
- ( Uihas, Mira)
Formulation of ’’Dear Doctor” series as part of attempt at unbiased ongoing
education for doctors- (Augustine, Mira)
k
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
- (Uihas)
Analgesics
- (Anant, Dr-Mathur, Mira, Rane and Patwardhan)
Misbranded drugs
- (Uihas)
Dissemination of information related to misused drugs- (Claude, Kulkarni, CERC)
Preparation of simple, readable comprehensive material/manual for field
workers.
- (Joseph, Uihas, 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
- (uihas, Alan Crammer, Mira)
Preparation of diagnostic flow charts and Management schedules for common
diseases - as an attempt to standardizing diagnostic and prescription
procedures.
- (uihas, Mira)
Field Trials
Obtaining information and undertaking comparative studies to assess
cost effectiveness oftreating patients with allopathic medicines/other
systems of medicine including herbal medicines- (Bato, Mishra, Mira)
s
g_10/343 \ M3:a: 16.2.82
3
UnderLakrng pield trials of herbal medicines
- (Joseph, Pandey, Mathur, Victor, Ulhas, Mishra)
Legal Action
Preparation of a leaflet hand-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 parame di c als.
- (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 Ms.
-(CERC, CDC, VHAI, Phadke)
D-10/343
MS:’a:16.^.62
APPENDIX - A
BACKGROUND INFOmATION ON PARTICIPANTS, DRUGS WORKSHOP ,PUNE 5
January
1.
2.
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, J WIN 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#
3.
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.
4.
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 rural areas- Involved
in supervising the small health centres, training programmes,
health insurance; and interested in collecting information about
the efficacy of ..herbal medicines.
5.
PRATITI, Sr-- One of the coordinators of RAHA- In charge of
Ambikapur area. Involved in similar activities as Sr.Angella.
6-
' PODDAR, D. P. Hr. - 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.
HATHURy 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.
J AJ 00, 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, Ahmedabad. 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.
12.
PHADKE, Anant, Dr*- Convenor, Medico Friends Circle (MFC), PuneInterested in the role of MNCs in India. Has written articles
on this issue. Writes for the Marathi press on health and
development.
IS.
JOHN? P.K. Dr.Dr.Surgeon at Christian Hospital at Bissamcuttack^
Orissa. Interested in reducing costs for small hospitals. In
the process of organising 12 small hospitals in Orissa to make
iP 10/343 ___
j;a;16.2>82
2
1 o » Wants to explore the possibilities of
bulk purchase of drugs,
small
manufacturing
unit for drugs. Extremely
setting up a l------.
interested in applications of modern management principles.
14.
15.
16-
17.
BIMAYAK 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.
TIWARI,- 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
———
—
_-u Health,
’ . Bombay. Was involved in the
for—
Research
in Community
if
for Alls An Alternative Strategy
research for the 1__1:
book "Health
---- --Interested in the rol? of drugs as related to
by ICMR-ICSSR. A
,
women and healthPANDEY, D.P. Mr*Interpreter in Parliament* Interested in integ
rating 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 Health.
Interested in the role of MNCs. He contributed to the Diug
Chapter in ’’Health for All: An Alternative Strategy”.
19,
ALVARES, Claude 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,
PATWARDHAN, A. R - Dr,- Editor, Pune Journal of Medical Education and
actively involved in Arogya Dakshata Mandal. Interested in
educating doctors in rational drug therapy.
22.
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
l. Has worked as
’ in creative ways of simplifying health educationa journalist for newspapers and periodicals. Interested in
consumer action for drugs.
SATHYAMALA,• Dr.- Involved in training for Community Health? small
dispensaries and projects. Interested in social action in
health and development. Revised Werner’s vJhere There Is No
Doctor for the Indianised edition of VHAI. Coordinator,
Community Health Team Training Programme. Member of MFC -
25.
26.
27.
•
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*
li-lQ/543
.16X2^2
3
tr-’ining in health care and health care equipment maintenance
and health care management training. J^ter®S
-ditor of Health for the Millions in VHAI• Has edited VHAI s
Management Process in Health Care (which will he out soon)28.
MIR/. SHIVA, Dr- Coordinating loxv cost drugs and rational ^ug
---- IKerarv activities. Other areas of involvement - alternative
in training for health in rural areas, school health, community
health and holistic health- Also a member of MFC oordinator
Workshop•
************
♦
D-10/343 . ._
MS:a:16.1.82
APPENDIX - B
LIST OF HAND-OUTS GIVEN IN THE DRUGS WORKSHOP
I
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.
Statenent 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 IndustryScientific Scrutiny of some over-the-counter drugs. - Dr.A.R.Phadke.
1.
67.
VHAI.
Home Remedies and their role in reducing dependence on institution
alised medicine- D.P- Pandey.
8.
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’
(Dumped in the Third World)
- VHAI
14.
16.
17.
PricingAlphabetical list of essential and
complementary drugs.
List of Essential Drugs.
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
15.
Homoeopathic treatment for common
ailments of Infants and Children.
*********
VHAI
WHO
WHO
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 LOMOTIL 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 fhenacitin.
We also would like to be informed whether WARNINGS eg.
- regarding use of Lomotil for infants ;
- hormonal preparations for pregnancy tests, etc
would have to be put on the LABi&S besides merely m the enclosed •literature’?
We are fully
supportive of your attempts being made against certain malpractices.
VHA1 coordinates the health activities of approximately 5,000 health institutions
in the voluntary sector all over the country.
“rtS are
- »»»
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 CONCiSRN and can help.
Hoping for an early reply.
With sincere regards,
Dr 4ira Shivi,®
Coordinator, Low Cost Drugs
and National Therapeutics
1
D-10*343”(R-Il)
MS:a:7.10.82
2 -
1.
Dr* J. S. Bapna. - Assistant Professor, Pharmacology Department,
University College of Medical Sciences, Ring Road,
Rew Dslhi, 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 Phadke. - Convenor, Medico Friends Circle (MFC), 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, Chetana Vikas Development
Programme,96/78 p.O.Gopuri, Wardha, Maharashtra 442 114
5.
Dr. Ashwin Patel - Foundei>-Member,Medico Friends Circle- Community
Health Programme, Mangrol, Rajpipla, Gujarat 39s 145.
6r
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, Hew Delhi 110 029.
7.
Dr. Binayak Sen. - Worked, with Friends Rural Centre, Hoshangabad.
Now works in Chhatisgarh with a minersf 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,
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* Na.rendra 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 Jajoo* - Reader, Department’of Medicine, SeVagrnn
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
Scicnco mid EnvironmGni. Now with Indian Express.
»
f
3
D. 1O.343-(R-II)
M!5:a: 12.10.82
17.
Dr. S. Srinivasan - Worked as a medical officer, Social Work and
Tilonia’
53’Sector i2,
R-K-purflm’
18.
Mr- J. S. Majumdar - General Secretary> -cedera'
Federation of Medical
Representatives Association of India
-------- , 1-E,Rajendra
Nagar, 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 9 Coordinator, Northwestern Region, VHAI.
23.
Mr. Augustine Veliath, Publications Officer , VHAI.
24.
Ms Christine De Sa, VHAI invitee.
25.
Dr. Sathyamala, Co-Ordinator s Community Health and Training Team,
(CHTT), VHAI.
26.
Dr. Mira Shiva, Co-Ordinator , Low Cost Drugs and Rational Therapeutics, VHAI.
D.10/343-(R-Il)
MS:a: 7.10.82
4 -
RSPORT ON THE DRUG WORKSHOP HELP AT JAIPUR
ON AUGUST 30-31,1984
INTROPUCTION
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
availability of clean drinking water, adequate food, sanitaiy living
conditions, drugs have a irQTy 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 availability 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 + immun
ization and a fow other foatureo) be equated with good healthcare.
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 more 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, mdre humane health
strategy is requd^pp^ which the mojori-cy (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
F1-
D. 10/543-(r-II)
Mbs a: 7.10;82
5
Pune and Jaipur? iand our inclusion of low cost drugs and
rational
therapeutics
in all
, .
-- our training programmes. All this is an attempt in
working towards feasible solutions.
The objective of both the workshops has been 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
—-- - viz*
follow-iup of- —
EP Forte"Campaign
“
____ 1_______ j "
- misuse of anti-diarrhoeals
it
” amidopyrines
_
ii
_
ii
_
ii
” anabolic"steroids
” clioquinol
’’^paediatric tetracycline
- Banning of drugs
- The need for an ethical marketing cod© by the drug
companies.
our support of the Bangladesh ban on hazardous and
irrational drugs.
f
AJ’rlef summary of the discussion at Jaipur is being shared
/
6
D*10/343~(R*Il)
MSsas12.10.82
PART - IV
August 30? 1982
PROCEEDINGS
Ists Session
The sessfc''' /commenced................
..
‘
with the
introduction
of•participants, their
backgrounds and reasons for their involvement.
Dr. Pramod Kulkami of the Consumer Education Research Centre,
Ahmedabad, shared his experiences with participants.
The objections raised by us in VHAI regarding certain claims made by
marketers 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
Vit.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 uhe topics discussed were anti-diarrhoeals and their misuse*
The mad- treatment of diarrho
is Oral Rehydration Therapy (ORT).
With the simplicity of its preparation, the ready availability of its
constituents and its low cost, ORT should have revolutionized diarrhoea
management everywhere.-
4.-
-'-forr. people about ORT and the dangers associated with
been deci<iQd to
taken on a campaign basis at the
General Body meeting and earlier at Pune.
r?}lG noe:
The Modico Friends Circle and VHAI have prepared material on
yy-^a:ghoeal3 to be used by journalists, health educators
and others-as background Material.
Amongst the anti-diarrhoeals it was decided to focus on the
Chloromycetin-streptomycin combination. Various reasons were given as to
why it should be removed from
’ '
given as to
---------the
—j market.
1
•
i: o%5XTtlve
“
2. Emerging strains of salmonella resistant to
- -----chloramphenicol
can cause a jmajor.calamity
’ “
in the future (2000 deaths in
Mexico with typhoid in
— 1975
- -3 due to resistance of
salmonella Typhi to Chloramphenicol. was not too long ago numerous reports of resistance strains are being reported
m our own country).
’■
‘r 0"b“ne * —Ti is combination is banned in developed countries
and now
even in Bangladesh.'
Tuer? Was a 00nsensus on a dem-nd being made for banning the
combination. This demand apart fL having an
educational value it would
=------ ‘t, Xflp shlft the focus from drugs to ORT in diarrhoea
management, whici ic
t.o much o.: a problem as protein-calorie malnutrition.
D*10/343-(ReII)
MS:a:12.10.82
7
The responsibility for making ORT and its preparation common
knowledge and skill
’ilrests
----- -3 upon us.
LOMOTIL
Xtg?8 u^ioously agreed that thia drug should not be used for
children below two years. Two colourful booklets brought out by Searles
clrc'}lflted amongst doctors by them to convince doctors that the
wiT/hn co^roJersy is baseless. These were shown by Dr. Ulhas Jajoo who
will be responding to them.
ho. 1„TTG/V1V-rtLSeYnt 1SSUG(i by Lr- H- M’ Lal’ Director, Medical Research
. U,®8 exdla ln th® March lssue of the Monthly Index of Medical Specialit_
lesAMIMS) was brought to the notice of participants. Mr. Charles Medawar
I author of Drug Diplomacy 1which
* * ' concerns Social Audit* s interaction with
Soarles over Lomotil) has been requested to respond to the Lal advertisement.
/in attempt to collate information on deaths of infants due to Lomotil
will be made.
jURTHER TOBK AND RESPONSIBILITIES UTOERTMEN BY VARIOUS PARTICIPANTS
To find:
\
■
mttch does streptomycin add to the spectrum of
chloramphenicol in its use in diarrhoea?
2) What
c^se fatalities due to chloramphenicol and,
if possible, the role of chloramphenicol-streptoraycin
combination in this?
3) Wat alternatives are preferable?
(Dr. Bapna will find out)
2Qgp.I^Ang_an_d_ co 11 action of dr ug rep res ent ati ve s1 p amp hie t s
^nowadays these are merely shown and taken back).
4
laking photostats of advertising folders in such cases.
Finding out the nnual drug sale of Chloromycetin and
stropt- mycin cci..' /.nation and Lomotil.
(Mr<_ J . > S. Majumdar will/feollate and send)
6) Reviewing the available medical literature end other
SLSis-Zi"-l.. chloramphenicol •
(Dr. Kabra will make the review)-.
5
Dr.Srinivasan and Mira would review these and compile the
information for the group.
?) 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 conserned, and will function as a clearing house.
A mandatory recommendation was formulated v/hich, 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^KPs.
It was felt that the Drug Controller.and the Drug Advisory Committee
could work out I.bw best this could be done.
The group placed a lot of emphasis on alternatives. The criteria
to be borne in mind in the selection of any alternative drug, was recommended
as follows:
P. 10/345-(H-Il)
MS«a»13.10.82
- 8
!•
2.
3.
4*
Efficacy
Cost
Safety
kagy 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 amoetiasis - 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-GEICrY' products by over 2000 Swedish
doctors and veterinarians. The reason of the boycott was ClBA-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
(blindness, loss 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 (UBA-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,
0
But,_£the manufacturers admit that they manufacture and sell what
others want to prescribe, it seems to be as much the responsibility of
the health_perspnnel_pre_scribin^ such drugs as of the drug houses producing
and marketing them.
~
ACTION
PLANS
We win collate infonnation about reported cases of SMON in India.
Padma will follow-up the SMON cases reported by Dr* Wadi a in ftombay*
C«E.R.C. will take up the cases to sue, J>rugjnanufacturers for
comp en sat ion^i f auc ate evi den cm? is, available.
i
P. 10/343-(R-I I)
MS: a: 13.10.62
- 9
Papua 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 n§SeSa^en
full dose really decrease the potential
of the drug toxicity, even/amoebiasis 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.? Session
Use of Honnonal Preparations 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 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 kexcept as oral contraceptives), not even for secondary amenhorrea."
According to Binayek the commonest causes of secondary amenhorrea were iron
deficiency, anaemia and
end genito-urinary
genito—urinary tuberculosis.
tuberculosis* Routine prescription
of
hoimones
was
not
indicated.
T
“i;
j .
------------------ ■» In recent medical- literature
the use of
high doses of progesterone followed by
small
doses
of__estrogens
v
___
_____ ___
_
ig
recommended and combination drugs have NO ROLE.
PLAN 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,
r <
....
■ f
Use of Hormones, in Threatened Abortions
S’athya presented her paper briefly (see Annexure.) •
paper was npt 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 Consumer Caution should be demanded to be
inserted by manufacturers warning women about the risk of foetal
malformations occurring through, the use of female hormones in pregnancy.
Information 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 end marketing figures of progesterone
- advertising literature used
- incidence of teratogenicity in Indian context
p. 10/545-(r-ii)
10
MSra:14.10.82
4th: Session
Amidopyrines 5 Aminopyrines and Dipy~_ ones
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
ayailabie 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
o .Lit®rat^re regarding the use of antipyretics in hyperpyrexia would
be reviewed and made available (Dr. Bapna).
Ulhas shared from his paper the choice of analgesics.and antiinflammatory agents.
regarded as the drug of choice because of its low cost,
easy availability, efficacy and comparative safety.
aQ„ = - + -Par?Cetain?1.iS Preferable’
children. It is indicated in patients
sensitive.to aspirin. Prolonged doses should, however, be avoided as
nepatotoxicity may occur, rarely.
dlscuss£*f anti-inflfflnmatory drugs, Ulhas mentioned that
Oxyphenbutazone was twice as costly,and more toxic (having a longer duration
nLSon.henoeJ cumulative-effect? than Phenylbutazone. Many of these
in c°ml’?-nat;L011
Steroids are available in the market (the latter
supposed to be weeded out according to the Drug Controller's list).
Ron-ayailability of plain Aspirin
While combinations like Aspro, Saridon, Anacin are readily available
MS3o“’orS,’“hdlff1CUltr ln ■’Moving plain aspirin.
^^i^S
, '
^1S subject, a consensus emerged about the need for consumer
education conceding sensible selection and !se of analgls^cs, as weS X
r nsuring their availability because they are cheap, e.g. Aspirin costs
2 paise but is rarely available.
P
g aspirin costs
5th: Session
Drugs and Magic Remedies Act
A„+Dr Kabra, who is also a lawyer and medical journalist, explained that
diseAseq'16^1 ^lth o^ectionabie advertisements in the Press. I/listed
advertised 4
and CUreB Which are Prohibited from being
for getting- abortion
a5:CC’rding to the Supreme Court an advertisement
getting abortion klet alone amniocentesis) is illegal*
Complaints can be filed
J^epo!ice through an F.I.R.(nobody is prosecuted)
in a Magistrate1 s Court
witn the State Drug Controller
to the Indian Medical Council (but only after an affadavit
is sworn in the Court).
It is r«‘La2CvPt?d £~act 0ven by thQ
Controller that; one-fifth
of all drugs are sub-standard
- - or spurious (between 1968-79). Dr. Kumud
Joshi also openly admitted in Parliament
that 17^ of the drugs are sub
standardc Although the punishment for
selling
such products is 10 years
imprisonment,
' > so far nobody has been prosecuted adequately
y' according to the
D. 10/343-( R-II)
MSsa:14.10,82
11 -
law.
inefficient drug con- -ol mechanism and only 600 drug
ne4 to'arou»nubl'-cntl^S-COU+try\Cne altcrnative see^E to be a desperate
need, to arousepublic opinion towards demanding better quality control, and
the establishment of free legal aid cells for social litigation on behaS
Kahi
k
?tatS‘ ThS TOle of C-E'R-C- and persons 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 testa.
ACTION TO BE TAKEN
Based on CoE.RoC’ s information •about the Drug; & Magic Remedies
Act,
a handout is being prepared by VHAI.
Dr- Kabra will let VHAI have more information con this
“
matter. Legal
assustwice from persons like Usha Hingorani could be sought?, if required.
Post-dinner Session
Spr^f Mr’ ^a2^ad2r.Shar®d With the £
r0UP his
group
his experiences
experiences as
as General
General
th + \aiy °
hG ^deration of the Drug Representatives Dnion.• He
He recalled
recalled
Sre b'ln, L2 to 3, S ™
°f the T1“ th“t
r»=»»tatx™s
hieb qplpf + d + exploit their own people - by compelling them to meet
high sales targets, or face losing their jobs. They are given inadequate
and biased drug information which they in turn very effeoUveJy pasl on to
the medical professionals and consumer.
7 P
-Mr. Majumadar observed that
xncuuuwg doctors
doctors mostly among tS you^rlle^Joup
including
- mostly
His Federation had formulated
1*
interest among 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 iriuftifierln^ Wh-Ch 7S raiS!d
c
•
wg
sales)
n
some Participants was whether
fied m levying taxes and excise duty on essential and life-
‘
rklae thoe<i 50 ”oh»»«
f,r t”
™
that Government gets about 100 crore rupees from annual drug
sales).
Low availability of these drugs in the PHCs makes it pH the more
?LC™Ty
^em?° bS PUt °UtSide the sc°Pe of
^d excise duty^
aboutri5nc to
Controller, excise duty has already been removed from
about 15 categories of drugs. The extent to which this has lowered their
prices
fact,’
checked and
up).whether,
” in
----------Order has been implemented has to be
t™
August 31, 1982
ZiL Support of the Bangladesh Ban on certain Drugs
+hp
supports the ban on hazardous and ineffective drugs imposed, by
J”*™'*1 - “>«»=>*"« the letall.1 orSorta Sa
Proibct
+aS J
was sent to VHAI by Dr. Zafrullah Chowdhury,
Project Coordlnato:l,, peopieis Health Centre, Bangladesh. Because of
D.10/543-(r-II)
MSsa:14.10.82
12 -
pressures by the multinational drug companies, support had been sought for
baxi from socially concerned groups and organizations.
organizations* VHAI feels that
the ban
success of the ban would have far reaching consequences in the third world,
and, more specifically, in India
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 as support to a
regime. .In vi-w of; tho. diff ronc^ in stand by different '
particip, 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.
This 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 to
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 DGTD gave the following figures:
1976
1977
1978
INH
INH
Installed Can-
;Producticn
Install
ed Cap
acity
374.56
tonnes
98
473.56
Actual production:
April-September 1980
69.18 tonnes
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
Chemicals and
and
fertilizers admitted in the Lok Sabha that there was a declining trend in the x
production
drugs,
f ~
\—J- 2 of essential
LI ~
including
first-line anti-TB drugs.w
P.QftVQrsely, imports of 2nd line drugs showed an increase. The import of
essential life saving drugs which are also produced indigenously were
reported as under:
Estimated
Production
Streptomycin
(tonnes)238
(Sources
Quantity
imported
Value:Rs.
in Lakhs
44.1
123.69
DGHS quoted in OPPI Bulletin,Nov-Dec 1981)
On the 20th April 1982, speaking in the Lok Sabha, Dr. Dalbir Singh,
attributed the trend of declining production of essential drugs to:
1* demand constraints or demand shifts2.- industrial unrest.
3* availability of cheaper imported drugs-
D> 10/343-(r-II)
MS:as 14.10.82
13 -
This, Jhowever, was not true in at least the
case of anti—TB drugs,
as is evidenced below:
AcfrUfi- production and requirements of anti-TB drugs in India
Actual
production
1977-78
INH
R
E
U
78 - 79
I
R
E
M
E
82 - 83
175
375
The position of imports of Rifampicin was as follows*
1.980-81
5413.5 fe
8948.5Kg
Cif (Cost including freight)
T
S
83 - 84
79 tonnes
1979-80
N
450
1981-82
15785.5 Kg
per unit in 1981-82 was Rs.4130/kg.
Therefore, to allege that demand has
decrease^ or shifted is incorrect.
46.19 tonnes of Elthambutal were 1.
imported in 1979-80 while only
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
— of
_ his 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^thP^^
"^nit by Pfizer management was unwarranted
and attributing the decreased production to labour unrest is another untruth.
pril"e s"ch
If m Spite of all the doctors and medical technology at our disposal
our case fln/liAg .is --still a hopeless 30%, giving such a high default rate,
the
leasti we.1—can‘ do- is to ensure a; regular and adenUA.te sunnlv to thcma whn
n 7^^
7hg>?'ita18 and healthTcte centres. 9 Whether the nonavailability of the drugs is due to mal-distribution or low production the
problem has to be sorted out by the health authorities^
ProdUctl°n’ the
are to be^u+^r ^ati°nal.TB Programme only the sputum positive TB cases
improved significa^iys^te^ms.^Thl^LvaKS r^^T^not
°"b" °f TB
seriouslv^and^lte^^13 °r
for common0infections.1VWith°TB
*“
A11 thiS recluirea to be looked into very
the str9p*?mycin“Penlcillin combination
s max s^diaX^r^’ H
d'l
for th/nast^/^J0 JhrUv M^ka^’ streptomycin was not available in Nipani
9 streptomycin was not available in Nipani
lor tne past ^/2 years even in the open market!).
14 D.10/343-(R-Il)
MSsai14.10.82
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), ilata accumulation has been
entrusted to the following persons who will cover zones
indicated against their names:
Dr. Abhay Bang
*••
Wardha district
Dr- Mira sadgopal
•*•
Hoshangabad
Dr. Arti ^awhney
Rajasthan & Himachal
Pradesh
Mrs Purabi Pandey
Ahmednagar
Dr. Dhruv Mankad
• i •
Mr. J.SoMajumdar
Nipani (only the open
market)
Bihar and Orissa
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 voluntaiy 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 (T’s and HMD’s in our respective areas for
sharing information on better TB care (as i52% of all TB patients
seek medical help, but, for various reasons5? 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 children:it is present in many tonics. Consequently, these
facts are ignored by some of the medical practitioners whenever they overprescribe these products for all typos of irrational
indications.
— . -- ---------. Most of
the indications mentioned in the promotional literature by the producers
15 D< 10/543-(r-II)
MS:a:14.10.82
and sellers of these drugs are incorrect and objectionable*
(For details - read 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 infonnation 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 Dianahol • This is a step in the right direction and has come not a moment
too soon!
Paediatric Tetracycline
•L
,L
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 moye 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 s 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.
...
r
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.10/545-(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- We continue to gather supporters'to
demand an ethical code and build a network of concerned health personnel
and individuals to ensure its implementation.
Some Suggestions for the Future
- We niued' 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
>
•
<
ANNEXERE
D. 10/343-(R-II)
MS:a:14.10.82
I
LIST OF HANDOUTS GIVEN TN THE DRUG WORKSHOP (ll)
1. Are Hormonal Pregnancy Tests Safe?: Dr.Sathyamala
Dr .Mira Shiva
2. References on Oestrogen-Progesterone Tests
D-9/331:a
for Pregnancyc
3. Controversies in contraception:
D-10.341-(b)
D-10.341:a
Dr-Sathyamala
Dr.Sathyamala
4. Review of supportive hormone therapy in
Obstetries:
Dr. Sathyamala
5. Low Cost Drugs: Managing Diarrhoea:
Dr-Mira Shiva
6* The Clioquinol Controversy;
Dr.Mira Shiva
7. Management of Acute Diarrhoea:
Dr .Mira Shiva
8. Drugs in the Treatment of'Diarrhoea:
Dr.Mira Shiva
9. Diarrhoea - Significance of the Problem:Dr .Mira Shiva
10* Diarrhoea and Malnutrition:
Dr-Mira Shiva
11. Causes of Diarrhoea:
Dr .Mira Shiva
12- Why Amidopyrines Must Go:
Dr .Mira Shiva
13. Using Tetracyclines for Children and
Pregnant Women:
Dr .Mira Shiva
14- Why Not to Prescribe Anabolic Steroids: hr-Mira Shiva
15. Drugs containing Irrational Combinations From MIMS
of Steroids and anti-inflammatory agents.
Snd CTMS
I
D-9/331:c
D-9/334-(a)
D-9/334-(a. 1)
D-9/334-(b)
D-9/334-(c)
D-9/334-(d)
D-9/334-(e)
D-9/334-(f)
D-9/334-(g)
R-9/334-(h)
D-9/334-(i)
D-10/340
D-9/334-(j)
16-. In Support of Bangla Desh* s Drug Policy: Dr. 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
20L Banning of Drugs:
Ms Chandra Kannapiran
ail Categories of Fixed Dose Combinations '
A. 4/119
recommended to be weeded out by the
Drugs Technical Advisory Board
22t List of Foreign Drug Firms in India
n
ii
A. 4/119
23 i Reasons for Weeding out Fixed Dose
Combinations.
241 A Study of Prevalent Diseases in India' J.S.M aj umdar, L.N.Chakravo rty,
and Production of some Essential Drugs: Santanu Chatterjee
25. CIBA GEIGY withdraws Dianabol
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 India.
Special Drugs Issue of Health For The Millions
The Ten Commandments and the antidotes to the Drug Industry
Pune Workshop Report & Seeking Feasible Alternatives.
• 4
Voluntary Health Association of India
C-14, Community Centre
Zv
Safdarjung Development Area,
c
New Delhi-110016
Telegrams : VOLHEALTH
iz
l-nj
4V
New Delhi-110016
Phone : 652007, 652008
P* 10/345-(R-Il)
MS: a: 7.10.82
REPORT ON THE DWG WORKSHOP (ll) HELD AT JAIPDR
ON AUGCTST 30-31 s 198^'2
This Report comprises five parts.
Part I contains our acknowledgements of
the assistance and encouragement we
received in our work.
Part II 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*
c'V..tAafUsR0
J. 10/343-(R-Il)
OtM ’Mo. 8 2
PART - I
-J
We offc'-*
sincere -thanks and appr&eXation for the
neip, encouragement and information received f*m«
- Dr. Yudkin
j
•
for valuable information and help regarding
amidopyrines, anabolic steroid, etc*
I.O.C.U
about Clioquinol, Bangladesh BanMr. Charles Medawar of Social Audit, London, for
the Lomotil Pamphlets: Drug Diplomacy.
Br.Zafruilah Chowdhury, Projects Co-Ordinator, People's
Health Centre
Centre, Bangladesh, and
- Diana Melrose of OXFAM
for their contributions on the Bangladesh Drug
Ban situation. - Dr. Pane 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 CMS
- 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
management side to make the workshop a success.
t
¥
*1
4
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area,
New Delhi-110016
/<
NA
W
0.1
k4.\
\
Telegrams : VOLHEALTH
iz
New Delhi-110016
jy
Phone : 652007, 652008
&
MS:k:D-10.344
February 4, 1983
Drug Workshop followup - Information
Sharing
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 sales, 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 BANNED, Or allowed to be misused for pregnancy
testing and attempts at inducing abortions etc.
Dr, Sathyamala of Voluntary Health Association of
India/ Dr. Pane of Arogya Dakshata Mandal/
Dr, Anant Phadkez Convenor/ MedicO-Frlends Circle,
Dr. Dhruv Mankad/ Medico-Friends Circle/ Vimal
Subramanian/ journalist/ Dr. Kabra/ Medical Journalist/
Lawyer from Ajmer, the C .S .D. Bombay, Rajiv Gupta of
C.S.E., Geeta Hariharan, 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 &n 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
c ampaign .
- • -
Dr., Palaniappan, Professor, Obstetrics & Gynaecology,
who had undertaken the much quoted Kilpauls Study in
Madras is appreciative of the group’s sincere efforts
and involvement in this very important issue, which
should have been resolved much earlier.
(Copy of his
original article is available with us in VHAI)
./ 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).
i
I
I
Bangladesh
Drug Ban
-/ A handout giving the summary of the review of the
Bangladesh Drug Ban situation had been sent by us
earlier.
. . 2/-
03-
s
o
o
o
to
t.l
w -,u
D re
2
£& °; 9
552 i S
‘■■■j
<2!
S ii. ta
o
Bi
.2.
MS:k:D-10.344
February 4, 1983
Our latest issue of Health for the Millions is devoted
exclusively to ft.
. . T_
Hazardous Dpaci - You must be aware that President Reagan on resuming
Presidentship of USA had reversed President Carter’s
policies
earlier decision to ban the export of hazardous and
affecting our
t ox ic chemic aIs (drugs & Pe s t ic ide s)- which we re
people
banned for sales in States.
Allowing export of these hazardous products after in
the absence of adequate arid 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 rcm any action, beeause of the
consequences .
If we continue to import these drugs/ 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
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).
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" need to
demand good drug control mechanism with adeguate number
and guality of drug inspectors, to ensure that no
drug "brand’1 or "generic’^feold in the market is sub
standard.
FUTURE FOCUS
shortages of
anti^TB drugs
and Rational"
TB Care
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 Circle-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 TB
problem and why it is important to take it up on a 7/
priority basis is being sent to you.
/like
--^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 ..on
our own specific roles as individuals and groups in the
sphere of "anti-TB drugs shortages and .rational TB Care."
.
.3.
MS:k:D-10* 344
With regard to
Your
c orrEr ibut i on
February 4, 1983
pStse info^
like to handle or
dteait
P Information
I will be waiting to hear f£om y
the
need to P°o1 U nreas
Yon could contribute signi-
irSSlng oui the following In your area:
1.
2.
3.
' 4.
‘
drug shortage in your area?
anti-TB
Is there are..
r bad is the shortage? And for which
if SO/ how 1----For how long has the shortage lasted?
lasted.
drugs? - — What is the pattern of usage of antj-TB drugs
in your area? eg. how often are irrational corn
er treat?
treatment started with
binations given?
Or
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?
_______
n Is it
What is the incidence of TB
in your area?
what
do
you
feel
are
the
inc re as ing? “ If sb / ;
~
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 iss crucial for the success of his
cure, and since v^riQus 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
Rec ommended
Reading
To keep ourselves abreast about the drugs issue the
following are some of the books recommended for reading:
a)
Bitter Pills by Diana Melrose of OXFAM,
(Deals
with the various drug related issues well,
it
It is
is
research in India, Bangladesh/
the Phi nIt
1 lippines •
7‘ is well thought out,f convincing, very relevant and de ils with initiatives taken
and that could be undertaken).
i
.4.
MS :k :D-10.34 4 :
19 83
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, activi-t.ists -in.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.
(Deadswith
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.
/is
The network
naming of
our stared
concern
February 4 z
Some persons have raised the question about the need
for our loose, informal network assuming a name.
O-thers 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 wha? should
« '
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/
(Dr. Mira
Coordinator
Low Cost Drug & Rational Therapeutics
SIGMAIW
A note to demand for a People Oriented Drug Policy.
Dear Friend,
This signature campaign is against misuse of drugs. It is
against continued sales of hazardous, irrational and banned
drugs, against allowing sales of substandard and spurious drugs.
It is a <demand for streamlining production, distribution
of drugs that are needed for the health
problemsi of the
'
majority. More than thatJit is addemand' for
‘
dealing with those
conditions that ensure ill health.
Please go through the text of the raemox‘anduxn which summa
rizes the basic demands of the organizations mentioned below
i b t
Kam?
Address
P^dur Organi'zaii6ns Tour" jobj Name
If possible ]
please give j
the capac itji
in which you
are working •
Ibei-e
i
?
I
I
♦
I
i
I
t
!
i
i
♦
If you feel strongly about the injustice in the healthand
dxug scene,
circulate this to others and obtain signature of
others supporting the demands.
■n-w.i-T
't,0 be. involved in the Drug Campaign join the
?-ru^,^cbiOn network which is paid; of an emerging 'ieorle’s
Health Movement'. If you would like the name of your org^nization included m uhe list of organizations who are taking a
strong stand against the drug misuse, let me know. Please also
specify tne responsibilities you would be willing to take
arid contributions you would like to make in Drug Action.
Within two months the New Drug Policy would have been
passed. The time' to express our concerns, to make our demands
and suggestions is ftow.
.
Probably what the most important need
of the ■ cioinent is to be- • able to organize ourselves around
this isaue, whether we u__
are' health groups. uuuemei
Consumer. .6fU
groups,
i or
Public pressure is crucial to
prevent vested interest from getting
,
J away unchecked with antipeople, policies- stands.
nl TrJ
4
_ _______ _? _1_
r9ople?^sg°Sl S^tr.-.lh?““Unity
✓>
.
.
.
1-
*
The signature campaign is to
- urge you for your support
“ iL1S,t0Kb?iH a network of groups to act as the watch
dogs on behalf of the people
”
builc*
pressure to demand public accountable
~u/ from our drug industry ;
health personnel and
policy makers.
Tf
s V+ry
minority feels concerned about issues
0;n+i? al'3^stiCa' To dGKiand apy People Oriented polio/
or health11 weShI,elaJe<a t0 hu?ian riShts, enviornmental issues
have *<>/Wort each other. Since health and
survival, are everyboay's concern and not the pregoratlve of
hails iith'usf ln health work
we h0Pe
will join
looking forward to your support, and solidarity.
Dr4fira Shiva
Coordinator
Low Cost Drugs & Rational Therapeutics.
V. H A I
4
M>IORAI\!DUI
—J c^COMMVNITV HEALTH
. rviarks Koad
fl7/1.(F‘rstF'oOrrJ,t‘ ”
BANGALOaE-560 001
We, the health personnel and citizens of India recognize health as a
iundamental 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.
m„+-
Wh31e W® suPP°rt th& overall perspective and approach of the new
ational Health Policy Statement and demand its proper implementation, we
a --tignal toug,Policy* is an integral part of a good National
neaiw Policy •
------------
We therefore, demand the following:
a right t° safe, essential, quality drugs which are in keeping
witn the health needs of the people, at costs which the majority can
afford.
e
2 . We urge our government to accept and implement the Hath! Ccmmittee
Recommendations which are 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 export multi disciplinary 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 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 after being marketed for sone
time in one country may not be 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. Comprehensive 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 pron ttUC+ 1?1
essential drugs list by the Central or State governments.
. V., -ecnir.logy, transfer agreement shall be legal; and binding which cont
ains restrictive practices, disproportionate and unnecessary use of
imported intermediaries or obsolete technologies or unfair arrangements
m nit
t0 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 shouid be made compulsory in medical education, prescribing and
abelling of drugs. Generic names should appear more prominently on a 11
packagings
•„ , .
1.
..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 Central 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 dr brands0 drugs 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 institutinnc
whereever 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 health
sector.
17. Drug companies should follow ethical marketing practices, and this should
be ensured by their own organizations like OPPI,1EMA, IFPMA. We deplore
the tendency of those companies and associations to get around every
progressive measure of the government through recourse^echnicalities of
the law and through the courts.
18. The marketing code drawn ’up by HAl(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 WHA and WHC to adopt ti.o Code in the interests of the other develo
ping countries and their peoples.
(IFPMA and HAI Code attached).
- Voluntary Health Association of India
- .Centre fur Science and Environment
- Centre of Social Medicine and Canmunity Health-Jawaharlal Nehru Univer
sity.
- Kerala Sahitya Shastra Parishad
- Medico Friends Circle
?'
■
/
- Arogya Dakshata Mandal
- Lok figyan Sanghatana
- Consumer Guidance Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of India.
^-10/341(e)
iviSsa.7.12.83
Meeting of the Drug Action Network held on December 5, 1985
at VHAI Qffice premises.
Present s
Sunita Narayan - Centre for Science and Environment
Krishna Kumar - Kerala Sastra Sahitya Parishad
it
Dr Ekba'l
P D & thews
- Indian Social Institute
»t
Ms Maria
Vona Daswani
- Foundation for Research in Community Health
Padma Prakash - -Lok Virgyan Sangatna
Dr Pane
- Arogya Dakshata Mandal
« Mira Shiva
- Voluntary Health Association of India
Chandra KannapiranIt
Aspi Mistry
■WAV'
,
H
*•*
The following decisions were arrived at;
lincent Panikulangara^ writ petition in the Supreme Court.
The representatives of the various groups present would go back and have
discussions within their organizations 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 groups. The.note will contain
the legal and other implications as well as a summary of the situation
so far to help the groups in their deliberations. Arogya Dakshata Mandal
and KSSP stated that they would quite probably decide to intervene in
the case. P D Ma
thews would also send to the VHAI office SO
fethews
50 copies each
of the original writ petition as well as the amended writ petition and
these will also be distributed to the groups.
2.
Campaign on Drugs Issues; A coordinated
__ 21___2 one week campaign towards the
end of March/ beginning of April
to focus *public
- - attention
------------- 1 on the various
issues. r._
1
Ihefollowing
were the suggestions accepted for the campaign;
(a) A nation-wide) signature campaign, signatures to be obtained on a short
one/two paragraph statement which can be easily understood by citizens.
Each 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 m each state, in the regional language to the respective state
legislatures.
(b) The •’memorandum" which was drafted in Delhi during Dr Zafrullah Chowdhury's
visit to be Circulated to other activists, consumers, citizens, civil
liberties groups and associations for their signatures. Ihe memorandum
vc be presented in the same manner as above.
C situation^ SUggestions for the week long campaign depending on local
Exhibition on drug issues- posters, display of drugs, drugs company
inducements, visualisers etc.
action Programmes such as organized currently by KSSP.
) rl^ shows, especially the films produced by NOVIB on drug and
health issues. Aspi to arrange for this with NOVIB. Mira to tiy and
\
Prlnts and video copies of the tape with her.
, . tiv) Publication of brand names list cf banned drugs.
(d) Campaign in the media as was done during the E P Forte campaign.
(e)
for the aii“india
tole
finalised during
(i)
5-
Drug Workshop III;
To *be held at Pune, FDe ~
Nobili College, last week
February, preferably 24,-• 25,
25, 26
26 re
February, dependingJ on availability of
boarding and lodging at De Nobili.
Tentative agenda;
(i)
Finalise
ki; ^
jia^Lise plan
plan for one week all India campaign.
.^icing^of Dyugs- ^Dr Pane will prepare background material.
~i
.0
’■
/ <*
i .
D-lQ/341(e)
MSsa.7.12.83
...2...
4-
5.
(iii) Grad&d
Essential
Drug List - Dr Ullhas Jajoo, Dr Mathur,, Dr Rane,
;____
_____________
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 Bobu Paul Jacob’s (CMC, Vellore) offer to
help would be taken up by Dr wiira Shivci. The drugs excluded from the
present banned list to be listed and campaign material prepared
for these.
(v)
Criteria for ca Rational Drug Policys Individuals, groups will send
their drafts, ideas and suggestions to Aspi by 7th January 1984. On
the basis of these and ether already available material and draft.
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 (2{ above to be also included in the next newsletter.
Other matters discussed:
(1) There was a suggestion from Dr Ekbal that we should collect and
publish material (extracts) from the established medical journals
such as JAMA, BMJ, Lancet which often contains articles which support
our stand cn 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.
(?) Virginia Beardshaw’s ’’Prescription for change” was introduced and some
copies distributed. VHAI will attempt to- get more copies.
(4) Similarly VHAI will attempt to get more copies of a picture postcard
entitled ’’Passing the Back”- games for Ihiltinationals” from W.ar on
Want. These cards be used as Christmas or New Year cards
dramas at
(5) KSSP invited all present to a performance of one of the
the FICCI auditorium on the 9th December 1983-
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 Community Centre
S D A, Opp IIT gate
New Delhi 110016.
Tels 6680?1/668072.
' D-10(M4)._.
MS:a/16.2.84
COMWl’JNITY HEALTH C -UBANGALOaE-560 001
Drug Action Network Meeting, CINI, Calcutta, 30th January 19QA*
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 50 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
Fimi,, 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 firs/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)
Arcgya Dakshata Mandal
CERC ( Consumers Education and Research Centre)
FMRAI (Federation of Medical Representatives AssociaCGSI (Consumers Guidance Society of’
;iion of India
Lok Vigyan Sangatna
n la*
KSSP (Kerala Sastra Sahitya Parishad)
Social Medicine Department JNU
CED. (Centre for Education and Documentation)
Dr Sujit Das of 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 oth^r drug action groups in West Bengal would translate information into
‘slogans and convert therfi into'actions. 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 Azad 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 in 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
4 building drug awareness. They also planned to be more involved in
drug action.
RepresentsN6rty..r Reg^ihal ‘
about the bfforts uadec
re.. ’ "
J
}
f-
4
„
fcprosant&tive Associfiticn ’ shared
1^ 4 L
.
r*v';
*
•
P-10/544
MSsa/16.2.84
..2..
Ashish Thakore would translate some of the information into Bengali and
circulate it.
Avitabh Guha Zonal Secretaiy of FMRAI» said i?MRAI gees itself focussing
on the issues related to essential drugs, dangerous drugs, Indian!zing 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 SHARES OF THE
FER/i COMPANIES TO 4^* This would mean that these companies will be treated
as wholly Indian companies. This would lift various restrictions applicable
to FERA cqmpanies eg. .Bulk Formulation ratio to 1?5 instead l?10 (as appli
cable to India), restriction of production diversification.
Since the National Drug Development Council report will be submitted
in Iviarch, urgent action is required.
In principle the gfoup agreed that we supported the dilution of the
PERA 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 to 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 desirable, for members to give their comments and feedback.
Second issue discussed was the NOTIFTCATION OF THE BAN issued by the
Drug 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 tfcis 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 Anant strongly felt that only these specific areas which needed
urgent handling should be discussed. This issue had been any way earlier discussed at MFC general -body meeting, and it was decided that Dr Satyamala
from Delhi and Anil Patel from Gujarat, on behalf 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 Bourd 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 WEUI held earlier were shared. Priority ar<;as 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 the above specific
areas for the Drug Workshop III were atj follows s
- Over the counter drugs -Lok Vigyan S^ngatna, Kerala Sast.va Sahitya Parish- Pricing -MRAl', (Dr Pane) of Arogya Dakshata Mandal
ad
- Criteria of Rational Drug Policy-Dr Sq'jit Das (of Health L'ervices Associai
;
tian), I
i
(Even though in Delhi responsibility for this had been te.ken, it was felt
1^10/344
ffisa/16.2.84
”
by the group that different view points would be presented by different
groups, Mr Guha Zonal Secretary
would present TOI’s views.
- Essential Drug List- Dr Ullhas, Dr fethur, Mira
” .Z
C
„
4 4- <
—'T •
n
’
’ " " *
-
■* *
*
..
"H ”
_
____ L
’’
Banned and Hazardous drugs - Mira(responsibility delegated)
With various organizations joining in, Arrant Phadke felt that Organiza
tional Structure of Drug Action Network should be discussed at the Coordina
ting Committee’s meeting. At this meeting the ideological stand of the orga
nization in relation to DAN and Drug work,J its strategy and future committ
ment would be shared. Whether there is a need to formaliie 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 Seva gram on j 0-?Is t 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
ha^the Drug Workshop III after the monsoons in October end or November beginning4.It will^ j
Calcutta. Pune as a venue was rejected due to diffi
cult access by train.
In the mean time Drug Information material would be sent to the various
individuals interested in drug work. The common complaint by Dr Sujit Dqs,
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 VHAle
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 efiort 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.
a
,b
Voluntary Health Association of India
%
C-14, Community Centre
Safdarjung Development Area
Telegrams : VOLHEALTH
New Delhi-110016
/o,
/v
New Delhi-110016
T I
u
668071
Te'eph0nes : 668072
grV17B(d)._ LCD 1 RT
VHjlgptrP/tVi^l
l^.P^IINGUKSl-gNG ORGANIZATIONAL FEATURES
POLICY
OF,.gOMCT^
- Prepared by Anant Phadke
to help in the discussion on
Structure of Drug Action Network
/Jjns 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 furtherence of this aim,
the Committee would work on the following fronts related to Rational
Drug Policy:Conducting and participating in Seminars, workshops,
discussions;
•jj-
Conducting and participating in public educational
compaign;
X5
a
Publishing, circulating theoretical, educational
material;
-K-
O jd Q
O
Gonducting relevant research;
o
< d
Cooperating with and helping like-minded groups,
organizations, institutions;
-K-
L-4
X - uU
>
Conducting any other activity consistent with the
aim of the Committee.
Membership;
/iny individual or group/erganization/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.
lUmual Membership fee:
i)
INDIVIDUAL
(ii)
O
t .2 i
- O
-
ORG/MZ/flION
R.S. 25/~ for those earning
v
less than Rs. 750/- p.m. (j
Rs. 250/- per year.
Rs. 50/- for t Itos a earning
Q
more than Rs. 75O/~ p.m. 5
Individual members cannot become office-bearers of this
Committee, Only representatives of organizations can become officobearers.
2/
8^$ •
LCD & RT
VH/JiptsrZ.V.’SA
2
:
The Committee woifLd not be responsible for the views
and actions of its members other than on the drugs-issuo.
Termination of Kqmbcrship?
i)
Resignation
ii)
Non-payment of membership foe for one year
Expulsion by the Executive Comoittoc; if the
indi’sd.dual 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-4/378(c) LGD&RT
VH/a::rt:17.7JS4
/
%
I2
W.-
O|
/V
Telegrams : VOLHEALTH
New Delhi-110016
. ,
668071
Telephones : 668Q72
COMMUNITY HEALTH CELL
_______________ V Main, I Block
Koramongala
r
Bangaiore-560034
TOWARDS A a/glONX DRUG .POLICY IN INDIA
/
India
Anant Phadko.
Evon a cursory glance i&t the existing dlru^-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. All 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 the 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,
politicians, government officials and the common people; and because
of tho weakness of the people’s Movement in general. Hence only the
fol 1 own ng 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 Review Committee to assist the Drug Controller
of India. It would scrutinize all the drugs currently marketed in
India, on the basis of principles outlined in the "Essentials of a
Rational Drug Policy”. Tho recommendation of this committee to be
implemented without delay.
The Committee wuld be a permanent body and would review the
drug policy every year in the 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 Gcvorrimcnt should make it mandatory on
all drug companies to produce drugs amongst this list only. Jill
other drugs recommended in standard text-books would be considered,
as non-priority drugs in India. A separate list of such non-priority
drugs shall be prepared by the Drug Review Committee and drug
companies would be" required to take' permission to produce or market
1
any drug from this list.
Only those non-allopathic drugs which have boon 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 the existing level ..of production of drugs listed
in the Graded Essential Drugs list, should be nationalized by tho
Government to prevent fall in the production of these drugs and the
cons equent s hortages•
2/
*
E-4/37^(c)LCD & IT
V Ill s pt: 1777.^4
3»
:
2
No technology transfer agreement shall bo legal and binding which
contains restrictive practices, disproportionate and unnecessary use
of imported intermediatorios or obsolete technologies or unfair
arrangements with respect to.prices, payments or ropatfetion of
profits.
' '
4. Imports of drugs to bo governed by the sama Graded. Essential Drug
List and" conducted only tlirough the public sector agencies in a
rational, planned manner and through competitive world-wide tenders
to reduce cost.
5.
The Drug Price Control Order of 1979 should bo extended to all drugs.
However, the existing categories in tlx? DPCO to bo abolished and a
uniform mark up to be allowed on all types 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 sales-tax on drugs commonly required
mainly by the poor people - antibiotics, antimicrobials, anti-helmi
nthic drugs, drugs used in the treatment of scabies, ringworm
infestation. Exemption to be 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 bo 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.
8
It shall bo the primary responsibility* of the manufacturer to ensure
the quality of drug products. However, it shall bo 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 arid discharge the statutory duties cast upon them.
9. It shall be 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 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 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 Cammttco should also scrutinize all the over-thecounter drugs and only those drugs which are fully scientifically
justified to be sold as dvor-the-counter should be allowed to bo
sold in such a maruior. No vitamin preparation be allowed to be
advertised in the lay press and all advertisements in the lay press
should be proceriporod to prevent any misleading of lay people.
3/
I
E-4/37£(c)LCD & RT
VHZIspt:!?.?.1^
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.
This Corporation to work on no loss no profit basis.
14.
Making mandatory for doctors to keep proper clinical records.
The records arc open to scrutiny and doctors answerable 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.
16^
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.
IS. Education of the lay-poo pie about over-the-counter drugs and about
misuse of drugs.
19.
All the above measures • should also be applied in case of all
non-allopathic drugs.
COMMUNITY HEALTH CfU
326, V Main, I Clock
Koramhngala
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
the data base for changes in policy as also
to study
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—mu3tiple 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 consisfeant 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
ii.
priority drugs which are listed in the categories
I & II DPCO 79 and (b) 100% for formulations based
on the rest cbf 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
The private industry
were for a common mark up of 75%.
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
ii.
wholesaler together* and
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
f or mulatto ns / again the^re were two views:
Given the frame work of recommendations the
1.
predominent view wa$ that in view of the insistance
on each producer marking 20% of the priority drutjs
and formulations this being a self limiting parameter,
there was no ^necesaAty 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
12% for those companies engaged in R & D.
3.
16.
17.
All agreed that there should be no overall profitabi
lity limit on bulk drugs.
The "
"independent"
independent" small scale sector should be outside
price control for formulations irrespective of the turnover.
On bulk drugs made by both small atid 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 drutjs.
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
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 20%
iv.
should be there and no free licensing^-.
The OPPI representative favoured free licencing, of bulk
drugs in the non-priootik^r area. The JDMA representative
was against free licensing in any area,
to National Industry.
as beilng harmful
21.
2 0% 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.
2.
The committee recognised the desirability of all sectors
confetibuting 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.
Duties on intermediates should be much less than those on
bulk drugs.
r*
In the priority list for those bulk drugs under basic
production/ there should be no customs duty on imported
I
inputs or domestic duties on production.
There should be exemptions from duty on formulations based
on priority drugs.
(a) One member felt that increase of import duties should
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.
ii.
decision and the matter is sub-judic, 'it would not
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
corporabj (income) tax on profits from generic
production and marketing as compared to normal rate
28.
of corporate
tax was proposed.
Details of imports 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 theCe were complaints of
transfer pricing, in intended benefits through imports etc.
1
30.
There were 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 insistance
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 -ja suggestion of individual
balance should be applied to all manufacturers who were
spending foreign exchange.
There was no consensus. 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.
32.
Registration of
all dealers and manufactuers with some National Agency
was considered possible.
A Code of conduct inciiiuding GMP (for manufacturers)
can be drawn up to be observed voluntarily by all
33.
manufacturers and dealers.
Any beach of the code of conduct if proved will entail
de—regiistration from the
34.
National Body and the fact
will be given due publicuty.
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
ment, may be provided to the small scale sector for
37.
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.
I
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
per rules.
39,
The recommendation 2.9 of the working Group on Pricing
& Procedure was accepted deleting the word ’’Permanently'’.
4 0.
The recommendations 2.10 of the same Working Group was
accepted deleting the words "along with their formula
tions".
41.
■Regarding DPEZa/ there were two views:
1.
DPEA should be abolished.
2.
It should be retained. There was no concensus.
At the VI meeting this was rediscussed.
It was
felt tljiat Govt, should substitute and arrive at a more
dynamic and workable scheme to solve the problems assodated with multiple costs and prices.
42.
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 Grcgip on
approvals.
1,
It was agreed in principle that wholly Indian
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
3.
'i4 5.
sectoral reservation as compared to wholly Indian
Companies.
The other views were for following the present
policy or for accepting the Working Group
recommendationgOn 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. This was the predo
minant view.
sr:
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,
H’Sving 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.
minant view.
This was the predo-
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:
lv
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.
49.
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 rib 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 re«ommT
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 an 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 Augustiji 1984 and on
18.8.84 and appoved amendments.
1.
2. :
Shri Mahendra Prasad, M.P. Chairman
Shri Krishna Mohan, M.P.
3.
Dr.
4.
Dr. Nitya Nand
5.
Dr. Gothoskar
6.
Dr. Nam Joshi
7.
Shri Khorakiwala, President, IDMA
Shri Danial, President, OPPI
Shri J.B. Kochhar, President AISDMA
8.
9.
B.B. Gaitonde
11.
Shri Gharpure, MD, HAL.
Shri H. Grover, Secretary IMA.
12.
Shri. V. Shah, President AIOCD.
13.
Dr. (Mrs.) Satyawati, Deputy Director General ICMR,
Dr. lagh. Chairman BICP
Shri S.L. Kapoor, JS Ministry of Ind. Development
SHri Mahta, CCIE
10.
14.
15.
16.
19.
2 0.
Shri Keltar, Economic Adviser.
Representative of M/0 Finance/Rev.
Shri. Chaturvedi, Planning Commission.
Shri, Keayla. A/O Commerce,
21.
Dr. V. Vankitanarayan, Member Secretary.
17.
18.
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 (0CCE)
3.
Representative of Ministry of Finance,
4.
Department of Revenue.
Chairman, Bureau of Industrial Costs and Prices.
5.
Representative of Ministry of Planning.
6*
7.
Repreaantative of Ministry of Commerce.
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
b.
4.
Report based on the recomm
endations of the respective Working Groups;
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 obnjiectives 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 11.30 A.M. in Room No. 353 'A* Wing.
(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.
j-7
© it
V
© Cr3
5
NEWSLETTER OF THE LOW COST DRUGS AND RATIONAL THERAPEUTICS CELL ZT
VOLUNTARY HEALTH ASSOCIATION OF INDIA C14 COMMUNITY CENTRE SDA NEW DELHI 110016
NEW DELHI
25
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 s’).
HIGHLIGHTS
• Meet! ng with
Mr Vasa nt Sat he
• Dr Zafrullah Chowdhury
- Press Clippings
• Estimates Committee
Report
• FERA Companies
- equity dilution
• Drug Utilisation Study
*
c:
o
is
4
r; s f
6
: - or
■X
9
10
12
c
. ••
c
*c i
network news
D-_r 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.*85.
This was organized by NISTADS to
utilize the opportunity presented
by Dr. Zafnullah’s presence in New
Delhi. The organizations represented 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 ple^
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 organieations 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
bv J onn Q
dJ mS
“as
organised
by
From 22-25 November, 39 nartioin
ants from 31 consumer and health
action groups from 14 countries
took part in this first regfomi
workshop held in Penang.
Highlights;- The workshop was
aimed at getting individuals and
mati on e^r
*
slcvant infor
mation, experiences and efforts
r. a ^°ordinated campaign
against irrational and socially
unjust Drug and Health Policies
and Practices.
Snvf ASE° ^WORK FOR
•ipfi o AC^I0N was another higtoricai event. Along with other
networkerg of Health Action Inter
national, HAI (U.K.) and HAI
ioind?n -kthe Asean Netw°rk will
nntheJcampaign 'for safe,
rational and economic use of
hLair+^C^^Cals and appropriate
wide^ delivei^ systems world-
"MP^sls on generic names
and i k Product information
Or details contact
mira Shiva at VHAI.
EVILS ANALYSED THROUGH
walk^of?? h°W pe°Ple from all
gether
be bought toanap^t^e^^SiL0
gr?u? ofrKS3pmS WuS presented by a
able
SP workers in a memorKeJala dfvrman?\On the occasion of
+
l,ay’ celebrated on Fridav
at the FICOI auditorium, heJe’
(9 Dec. Hew Delhi)...
Brecht?daYalam adaptation of Bertolt
y“r hanamOUSl?0ie? "Take the book
health
d”?n baifTrU1
A skit composed on the fight the
people of Calicut had put up against
h6 polduticn of Chaliyar rive?
showed the workers’ growing Iw^eatmo °h °aUses and consequences of
atmospheric pollution...
- Another major outcome of the
&Lth Policies,, The ten s^fic
areas of action agreed upon in
clude a call for
"the adoption of essential
rugs lists for both govern—
went and private health care
services
"legislation to prevent dumpIng 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
I
•Folk adaptations of Gorky's
"Mother" and other pieces oy
Brecht touch on many aspects of
education and knowledge,present
ed 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 of^er
trade unions in drugs and health
issues would be considered a
very significant contribution
of FMRAI.
J» FMRAI Annual Convention held.
On n Dec 1 98^.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.
1
drug news
| MEETING WITH Mil. V AS ANT SAT HE
whether after dilution these com
panies would be treated as Indian
companies he answered in the affirmat ive.
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
and Community Health^NU and
Dr. Mira
I^ira Shiva,VHAl.
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 50% 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^ihillah 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 Hathi Committee.
With regard to the extent to which
Hathi Committee recommendations
have been implemented, Mr. Sathe
spoke about the 40% dilution of
the FERA companies.
When asked
-
4
- to direct the licensing author
ities not to renew the licenses
for any drug except these H6y.-; x
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 Government fa
st reamline the licensing poljcy, r5
administrative acts and statute^
functions in such a way that^u&bless, injurious and harmful drugs
are weeded out and essential and
life saving drugs are easily made
available through the public 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 BRAUD 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
Court:
- 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 Hat hi Committee.
5
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
binations of potent drugs, combine, tn?n 90 n«l«e, 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
Ibere are other multinatio
and antacids.
“We thought, let us have our nal 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
trol 78 per cent of the market, and in developing countries
are
modem drugs reach only about 20 only 60 ml. a poor man is
Our Staff Reporter
per cent of the population, he say^
forced to pay for 120 mis—two
~ *‘Noval&in has been banned W tilt policy is not firm enough.
to get his
......._
Pakistan,
Sri Lanka, Bangladesh ahfl deed, the Indian drug policy is bottles—in brder
being
quoted
Malaysia. Unfortunately
our big
—
vmav*vuxtci^'ciy our
bis bro'
maw■
--------- by multinationals to dose”. The bottle sold
in the
— —
——o—.—ban,
wM.a, says
there has not yet done it. And it is o1™0*56 the
Bangladesh
?-est is of 100 ml. he said.
a study of the Voluntary Health Ascreating a problem for us”.
Terramvcin syrup was ban
This pain-killer was one of manv soclctipn of India, which organised ned from the Indian market in
drugs mentioned in a brief but im the talk.
passioned talk on “Drug Misuse &
* Blindness
is
a growing July this vear—“But why has
Drug Misinformation” in Delhi on problem in your country”, said the company been given one
Saturday by Dr Zafrullah Chowdhu
year
to
withdraw??’. He
ry, Director of the People’s Health Uj Ghowdbury. “Yet, the so- asks
**A
lot can
called
anti-diarrhoel
drug
Centre, Bangladesh.
pen m a year: governnilnts
The 42-year-old doctor was among Mexgfom is still in wide use.
those on the Drugs Expert Commit’ It has not only been conclu can change, policies can be retee whose proposals led to 1,579 sively established that it has v<rsed, there can be second
thoughts”
dangerous drugs being banned by seriotrs side-effects, can cause
Bangladesh.
Bangladesh's
Drug Control
In the country he calls ‘big bro cancer and leads to dimness of
announced
with
vision and blindness. BuT aiso Ordinance,
ther*, India, 43,606 drugs are resdsthat it has
no
therapeutic amendments on 6 September last
tered and sold. “Three quarter of
them are non-essential’*, says the
value whatsoever in treating year, allowed sue days for all
di ctor. “And the policy taken b ? diarrhoea”.
stocks of banned drugs to be
your country affects us”.
In 19?8 he said, the drug destroyed. Within four days
When Bangladesh declared its
new drug policy on 7 June, 1982 he I, ovalgin was found to derange the multi-nationals were seeksaid, multinationals
immediately some people’s ability to pro. ing permission to export the
brought tremendous pressure to duce while blood cells. A re- drug stocks to other countries
bear, to have the policy amended. piesentative of
the
pfizer like Saedi Arabia, West Af.
‘First the American, British, Dutch
•and German governments started a rompany, which makes the f-’oa, when it decides the matter,
times Bangladesh will insist
on a i
campaign with our government. drug, claimed at that
When that failed, the US Embassy tiat a pharmaceutical from label saying that the drugs ftad !
brought tn a 4-member expert sci
hitler's country
couldn’ti be
T
*
been
recommended for destrucentiflc committee from pharmaceuti- •wrong, ’Hitler is dtad, but lion by Bangladesh,
cal companies.
your country is
still selling
T'he Voluntary Health Asso
A report in the Washington Post
ciation of India plane to •'re
19 August, 1982 said that the US N ovalgin’, said the doctor.
sav
their sent the government with a
sav
their
was worried that its
. Multinationals
t50-bmion-dollar market In the de
drugs arej cheaper,
t.
:: Dr memorandum
said
demanding
veloping countries would be at stake Chowdhury, and withdrew
a among other things, that drugs
if otiier countries followed suit”.
The Bangladesh government stuck’ bottle of Ampicilin from •bis for India be chosen after exto its guns, lifting the ban from pocket “I bought this today, in amining their easentiality* offiyour city. It cost me Rs \90. i _ safety, cost, ease ofadonly.a token 128 drugs.
The Bangladesh drug policy weeds
The international
whoteKsrie ministration. avatiabiyty, and
out ‘all unnecessary, useless drugs. Drice of Ampicilin is Rs flO a potential for misuse.
“It is the common nui’g
body, not the doctor’s or the
htreaucmt’s, that is affected by
the drug
policy*,
said Dr
Chowdhury.
t
Big brother
is creating a
problem
for us’
6
INDIA YET TO EMULATE BANGLADESH
Harmful drugs still available
BY SUMANTA BANERJEE
— ■ —................ WH(5\.M.
ied from them, were based on the vv
kistan
and Malaysia.
He suggested continue
*0 recommend the old drugs
TVR.
ZAFRULLAH
-v __________
________
j list.
co-operation
between_ India and Ban- for those
ailments. When the ma1-ZChowdhury
During
his talks
talks with
with medical
medical and
and gladesh
gladesh to
to totally
totally eliminate
eliminate these
these chinery
chinery to
to check
check misuse
misuse of
of aa drug
drug does
di
niui v of
vi Bangladesh,
D
urjng his
recently. Dr. harmful drugs.
not exist, is it not better'to k..n
ban it?
who was instrumental in the health workers in Delhi recently,
—
.,9
•
There is no use blaming the drug
formulation and* passing
of the Chowdhury pointed out that ‘analgin’ h is sad that a medica| expert from a
> manufacturers, who are in this busi
ness not for any philanthropic pur-
Baffin
IS3SSS
were being diverted to other
4
—toed by
m 4 >-«
•
'
-
2------- ‘ f~T
medical practitioners, for many, me
Government
^
““e dical care has become a commercial
i
Until
.tK “SS
EM K=y •“ -t"
The Drug Controller of Bangladesh, fjcaith ancj Family welfare, issue/on
—“ was in Delhi recently, an following
of the
> •| 2233, 1983
following tne
the implementation
implementation of
the Ju
1983, prohibited
prohibited the
the to act to protect our people.
brought
pa^” of
But the Go~ SoVsTut
V’-- ; to our
j notice
•
n tha^the
1
U Bangladesh
Bangladesh Governmenfs
Governments. drugjx)licy
drug policy .»
“m
manufacture and
and ssale
of only
only 22
22
drugs banned m Bangladesh banning the drugs, had directed that categOries of drugs and drug comStiU "being * marketed
Stocks a
ofF the banned
of°the
4^/4 in
«m ct/v*lfc
KjinnftO drugs
nnips would
would have
have BiJltSns! BesideMhe’wording a
C tKp* us®,css ventures like arms
byfstj’.'s.is.:.”.sjasswaWt-w»».
India by the multinationals.
Dr. Chowdhury,
of the Bangladesh
multinational companies com- Ol
"„ ‘October
n,
loxn the Draw
Tech- SP'"1 sensibly, in preventing ill-health
mittee, recommended tha ban on the x* The
fhe0muliinational
w,*jn
’19807the
Drugs Tech
drugs on the basis.3f the World Health pUcd with the request by shipping the nical Advi
Board of the Govern on providing the essentials for good
orgamsation s (WHO) recommenda- stocks t0 the
of their respective ment of Indf prohibited the com- health — adequate food, safe water
tio„5 and «m«P» o aSK.;l'a' D™8 coufftries. but instead of taking them binalions of ,.steroids with bronchodiiK
The'. WHO^initiated
e^idTwkh
^ihD=X
List. The
WHO initiated the concept ^^Ihe^S
insidc these Western countries, the ,atnrs’0"stero
jds wjth Wantihistaminics
to
,n
Banned in West too
Not National
sonable cost
cost — aa f*^
factor ofr^umries
crucial
sonable
Explaining the reason, Dr. Chowd- wfth other drugs (except) for the tyu....™
Dnic Controller of
importance to developing countries v1._vK_„:d Xflt
or tke druES tr,,lmPni nf asthma”
Whenever the Drug contro.icr oi
like India where more than 50 per cent
,sa “
were also ba^ tre!ltment of
’
India’s attention is drawn to the conof the people live below the poverty
tinuing sale of drugs, which have been
line, anamedicines are a luxury which
> >n
m^ionaT “mpanies Implication
declar?d harmfu| gy mcdicai experts,
oni; a few can afford.
±'h were
SZp This had a subtle implication. Since the Controller repeats the argument
n
.
rj
Shrouih their suSariM In bS
of steroids with anti- that since such drugs "have been in the
Diversion of drugs
d„h EThe st^lai“ fro™^Banglatfesh histaminics can, at least technically, be market
market for
for aa long
long time
time itit may
may be
be
In such a skuMiondenying the therefore ’coSw not te“m?nrt?d into used in the treatment of asthma, this difficult
w.thdraw
these
Jt .to.
to
withdraw
preparations’.’ (Reply to the Consumer
Education and Research Centre’s
_ or “such combinations
arc being marketed in many countries
and cannot be considered as
drugs are "essential" for their health Lesotho and Yemen - banned, drugs
f“ h Droduct^haw beS irrational.” (Ibid).
The question is: is anything mark-
g»S£S SSttSS
EWEsisa« Piisttsvirini “« vESS
SS&'S.’iS
BS®£ asESSE
siiWrtres: k '^esgrL-arhsrss*- s? -......
Fong time, good” enough for public
health? What should be the yardstick
for judging the worth of a medicine —
the ability of its manufacturer to ad^:,‘‘7«Omm^ati^rand Mother developing 7^ntries"like mm of them in taMM, villngei - vertise and sell it, or its real effectiveg?adesT druB^iicy that Nepal, Bangladesh, Sri Lanka, Pa- of the change, so that they do not ness?
-
DECCAN HERALD
15-12-83
Banned drugs still
i n use m India
NSW DELHI,.'December 3 ,ric n.aiac« introduced. Bangladesh has
already started a campaign in th's
^n).
regard. Also, this wi’l cut down the
PERTAIN harmful drugi which price considerably. In. the U.K., thU
V havo bwn banned in Nepal,
WU1WU
resulted m
in a 42 per cent price
Bangladesh, Sri
^d ^dudjon^
jwiittedJ out.
-J—
Malaysia are still being administered
Dr.
Chowdhury
said in Bangladesh,
to patients in India, according to a village doctors could
directly pnes-
(amidopyrine)^ Dr. Zafarullah Chow been circulated.
dhury, director of Gono&hasthya
The
__ _____
kendra had started manufacturKendra (people's health centre), jng 30 /essential drugs to avoid ex
Dhaka regretted that India’1 emerging ploitation by multinationals, he said,
as a leader in the third world, is itiU
Pandi&U criticised the lack oS
penguins the us© ©f this.
avallabilsty of an inforsiatkm system
Dr, Chowdhury sa4 that brand
and uses,
siarpn should be abolished and
©onsufliibra sed ehemisU. They
7
TIMES OF INDIA
4-12-83
suggestod that a list of banned and
harmful drugs
(with
generic
and
brand names) should be widely cir
culated by government and .properly
advertised.
Dr. Samir Chaudhury, a primary
health worker from West Bengal, ex
pressed concern over th® very smidl
number * of drugs inspectors in the
whole country.
He said even easendal drug* and
vaccines to cure tuberculosis', diar
rhoea, blindness are not available in
right quantities to the rural poor.
Voluntary health organisations could
jointly take up production of
essential drugs, ho auggjested.
Political will needed
for drug policy: expert
TIMES OF INDIA
28-11-83
By A Staff Reporter
of medicine and work in rural areas.
According to Dr. Chaudhary, patho•i logy need not be a doctor’s forte otrfy.
“
Anyone
who can distinguish colour
A combination of political will
nnd has some basic intelligence can
and pressure from the medi- analv^
blood’’, he said. In fact, his
cal community is needed to formii- staT
Uiy done 7,000 tubectomies in
stall ;have
late a drug policy in this country thc _rural1 areas, surpassing the govern
to prevent it from being used as ment’s family planning record.
a dumping ground for banned
The regions in which thc 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 Bangladwh drug expert com ihe kendra worked on grant* from
mittee, was instrumental in the for charity and 'on money that came in
mulation nod passing of hi? country’s irom its health programmes, in which
vear. ne
JhC/C,nT°,d
dllkre™ Pric«
drug pu..uy
policy m
in June .ast
last year.
He tougni
fought
fj
'..I,
i
bitter battle AAnlnz-a
against —
multinational
LoHes°P
economic catcpressure on the Bangladesh government **
and even from the medical fraternity
to get drugs including novalgin.
novalgin, mexafor-i, some steroids, gripe water, a
combination of antibiotics, micropyrenei and tctracycling syrup banned.
BOMBAY, November 27
Dr. Chaudhary told “The Times of
India’, here today, that India with its
large complement of scientists and
qualified people, was fa a better posi
tion to formulate • its own'drug" policy
so that the above drugs which .had
shown several harmful side-cffccis
could be prohibited
HAITH REPORT
It was ironical that the Hathi com- mitiec report, which had inspired Ban
gladesh’s drug policv, 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 generic
names, because this would create 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 propaganda 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 attempt at eliminating from the market all useless
drugs and those of doubtful efficacy and
preparing a list of 150 drugs considered adequate for therapeutic purposes.
He said 1.707 drug formulations were considered 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 formulations. mainly pertaining to ointments and balms,
were rescinded. The formulations, the manufacture and sale of which were banned included li-,
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 oe manufac
tured and sold under their generic and not
trade names.
Drugs for rural dfsoasQA,* 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'n9
village-based, para-medical stfcff and
strengthening of community health services
could be achieved.
Banned drugs stiU 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 being administered to patients in India. He regretted that India, emerging as a leader In third
world, was still permitting use of analgin
(amidopyrine).
Drugs banned in Bangladesh were still being 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
generic names would avoid confusion'and re
duce profit-making .by various pharmaceutical
firms.i. In the U.S. and the* U.K., .generic names
had been intGodwogdt
e
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
iCONCERN".
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 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.
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...
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 0OMPANIES - SOME IMPLICATIQN3
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% tQj51% 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 hew 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 PERA companies.-
IDMA is strongly against DGTD re
gistration for 40% foreign drug
companies and permission to con
tinue with international brand
name8z as this would negate the
efforts put in by the wholly
Indian companies in introducing
newer drugs such as ampicillin,
ethambutal, mebendazole.
The company's performance during the past five years is
summarised in the following table:
{mpoes millions)
1962
198V
1980y
1979
1878
637.2
875.9
610.9
546.9
715.0
Sale*
34.2
32.5
86.9
61.3
73.3
Pre-tax profits*
32.2
31.0
493
36.8
Net profits
230*7
280.4
317.1
380.0
195.0
Gross fixed assets
12
12
102
12
Dividend/8hare(%)
12
'production at the Bombay factory waa affected by industrial action;
hn increased capital after a bonus issue.
SCRIP No. 827 Soptombor
1$83
r
:—nr
_•
Since the New Drug Policy is in
the offing it is crucial for those
involved in Drug Action to make
10
*
their contribution and interven
tion now.
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.
With the decontrol of Category III
drugs from Price Control, 75% of
the drugs in the market will be
decontrolled. With PERA 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 PERA 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.
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 Bhore 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.
• The government has raised the
price of bulk ampicillin and
amoxycillin, two popular anti11
•The Union Ministry of Chemicals
has slashed the prices of various
antacids, analgesics and a number
of other drugs falling under
category HI
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%.
• 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,
Pfizers1 sales turnover was Rs. 54
crores and its profit before tax
Rs. 6.19 crores (about 11%).
The
popular multi-vitamin nreparations
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.
- amongst self administered drugs
analgesics, nutritional products
and antibiotics topped the list.
DRUG UTILISATION SURVEY REPORT
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
sulrvey 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.7
- 58% of the self medicated drugs
were schedule ’L’ and ’H’ drugs,
which cannot be sold without
prescript!on,nor should be con
sumed without medical supervision^
because of the associated major
side effects and toxicity.
Vitaming 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-0omplex(B1,B2,B6,B12)
combinations and other vitamins
topped the list of sales figures.
7| CHRMlCAUS*
.explosives
Ant ibi otics:
- over '30% of the doctors’ pres
criptions contained antibiotics.
- approximately 12.8% of self
prescribed drugs were antibiotics.
THE COMPANY WONT ACCEPT" THIS REPONT
ON UNSAFE WORKING CONDITIONS.
ITS NOT TYPED DOUSIE SPACED I
- most antibiotic prescriptions
were for sulfa and trimethoprim
(from*Science for the People1)
12
combinations, tetracyclines and
penicillin, in that order.
drugs.
Last year we had demanded that the
following caution be printed on
all anti-d iarrhoea.1 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
regi onal languages.
The findings of the NIN and CERC
surveys indicate the urgent need
for publio 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
#it 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 contexf, 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 ant^Lbiotics and other
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
15
conii
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 regional 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
Associati on 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 X3 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- •.
°
hi
from
Social Action
News
u
reading
COMMUNITY HEALTH NEEDS AND INDIA1 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.
PUNE JOURNAL OF CONTINUING
HEALT H ^DUC ATI 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.
INTERNATIONAL CODES AND YOU.
This 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.
MEDICO FRIENDS CIRCLE 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.
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 3 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
50% 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
$ 10 from IOCU, P.O.Box 1045
Penang, Malaysia.
HEALTH FORTHg MILLIONS - SPECIAL
ISSUE ON i)lAB#HOEA is now available
with VHAI. The 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
6
E.N. MURTHY
Deputy Secretary
Tele: 336752
D.0.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 Shr\i
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
l
/vxx'7
N
(E.N.MURTHY)
To
.6
CO^^koO
-
o^'~
NEW
drug
P de ic_y_i ISSUE PAPER
off good quality a t
Plentiful availability □f medicines
functioning
for the effective
reasonable prices is eS sent ial
It is widely acknowledged that
of the health infra structure.
is the most diversified and
Indian pharmaceutical industry
the
c ount ries•
ertically integrated of all developing
self-sufficiency in formulations
.has acquired near
The country
(the finished
tablets,
are administered eg.
in
which
medicines
dosage fnrms
the active
number of bulk drugs (i.e.
capsules etc.) and a large
ingredients of formulations)•
also improving
as a result
p rop orticn of the imports
The trade balance in drugs is
and decreasing
of increasing exports
While
in total bulk drug c onsump ti on.
aceutical industry are impressive,
achievements
of
the
phar
’
the
if the health needs of the entire
miles
and
miles
to
go
it has
adequately met and if the export potential
met
p op u 1 a t i on are to be
Accelerated growth of the pharmaceutical
is^b e fully realised.
of urgency, in view of the
industry acquires a greater sense
the Parliament in 1983. If
approved
by
National Health policy,
c endue ive
be mot the policy frame should be
objectives
are
to
the s e
to :
• 3 with health needs in
(a) Growth of" output commensurate
export
potential;
the c<ou n try and the ( ,
eo^potltlvoncBsond tcehnol=1 progre.3ivcn=»■>
(b) Cost
fair to the consumers as well as
(c ) Prices which are
p roduc ers.
therefore is how far the
on that arises
The
basic
quest!
2.
aforemcnt ioned objectives.
present policy frame is conducive to the
C ontd*.•• »2/-
2
In the pharmaceutical
:
sector,
the policy
addition t© th e general licensing,
policies,
the specific
provisions
which
was laid
1970.
The 1970 Drug Policy,
on the
floor of
frame includes in
FERA and MRTP and import
of the Drug Policy statement
the Lok
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;
and
(b ) to make drug s available at prices fair to the
consumer ar well as to the industry.
3.
In prescribing the policy
frame for the
future
grewth
of the pharmaceutical industry, it is only appropriate to •
address the following questions:
(a) Is th e existing policy frame adequate?
(b) If so, is there need for improvement of implementation''
(c )
. 4.
If not, what arc the areas where reform is needed,
in what direction and in what manner?
The basic approach underlying report of the National
Drugs and Pharmaceutical Development Council
special attention need
(NDPDC)
is that
to be paid by the Government to the
’ priority drug s1
- drugs which are widely
practice and
requi ed for National Programmes for major
are
diseases like TB, Leprosy,
NDPDC
be
report gives the list
re-oriented to ensure
abundant
quantities at
may like to comment
on
Malaria
etc.
used in medical
Appendix VI
of priority drugs.
that the
drugs are
fair prices a nd w ith
the
of the
Policies should
available in
good quality. Experts
approach and its spcc if les,.
Contd....3/-
3
Among
5.
the
very
engaged a
which
of
operation
policy
the Drug policy,
attention
high
and
from
is
procedure.
is
the
summary
of
the
industry,
as
a
a
The
one
the
the NDi’DC ,
Annexe re-1
price controls.
pricing
existing
areas cf
vari ous
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
to the
(c )
further made that
point
the
production
is
pattern,
essential Category
the
up.
Thun
pricing
which
the
of price arc not related
actual costs,
the mark-ups are low
and' the faulty administered
pricing system has eroded the profitability of the
industry a nd s apped all incentives for investment
in further capacities and R&D .
The
ma rk
slow,
are
there is
system is
is
industry
system is
pricing
away
shifting production
and II
I
the
fermjlatiuns,
the criticism
not properly
from
the
implemented
to get away
able
which
with
distorting
the more
from
carry
other
as
a
a
lover
end,
that
result of
profits
unintended
d ue to;
(a ) faulty categorisation of products;
6.
the
of
(b)
failure to promptly revise the administered price
where the landed cos ts of inputs or of the market
prices of bulk drugs decline; and
(c )
failure to mop up
It
is for consideration
present pricing
the
produ ct by
to address
and their
system
the
are
unintended profits.
due to the
to the
implications.
various
of
inherent dificiencies
product price regulation.
oneself
the lacunae
as to how far
It will be
policy and
necessary
procedural alternatives
Total price decontrol
has
an
appeal
of
its cwn but given the structural characteristics of the industry
one can
not
be
sure
whether
the
performance
of un-regulated
C ont d
4/-
a
markets
are socially
question
that
it
a nd
how to devise
is
is simple,
strikes a
7.
to
easy
of
this value judgement
selective price control
administer and
det lil
consideration
(i)
a
Given
fair balance bwtween
The matters
need
optimal.
the consumer and
which
emerge from
system
in
optimal
socially
the
th-
tha x
ind ust ry.
repcart
the NDPDC
are:
Should pric e control be limited only to those
drugs which figure in the priority list?
bulk
(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 pricc competition?
(iii) What should be t he ma rk up . f or f or mulati ons of th e
bulk
drugs included
list?
in the priority
(iv) How to improve the pricing procedure so that the
quickly and
administered price responds
to changes in oosts?
(v)
Can there be
wh at a re its
An oth er
0.
approvals.
in
emerge
from
(ii)
(iii)
which merits
summary
the
pharmaceutical
sector.
the NDPDC
(v)
of
report and which
the
The
that
of
existing
matter
require
of
and
Should th ere
be
free licensing
of
so,
if
industrial
licensing
details
which
consideration are;
How to ensure 20% of the value of production
manufacturer comprises the priority drugs?
the
of
priority
every
drugs?
I s the present sectoral reservation consistent with
the stipulation that the production of every
manufacturer
(iv)
is
normative costing
attention is
a
Ann exure-11
policy
(i)
a rea
a system of
specifics?
smoothly
should
include
priority
drugs?
Should
there be any modification in the present
policies in regard to ex-FERA companies?
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 ent d.. .9 5/^
5
Another important area is that of
quality.
Administration
of th s statutory provisions relating to quality control,
un der
the Drugs and Cosmetics Act is vested with the State Government.
While the State Drug Organisation need to be strengthened, it
is also for consideration whet>.er it is possible to devise a
system of self — regulation and promotion of good manufacturing
practices by the industry.
This raises the related issue of
crgsn isa tion ; 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 nnexuro
PHICING POLICY A D PROCEDl'RES
Tho prices of over 75% of the bulk drugs and
formula
tions are controlled undor tho Drugs (Prices Control)
Order,
19?9
(DPCO) which was issued under the Essential Commodities
Act.
The DPCO lists 347 bulk drugs which aro statutorily
price controlled* ■ Drugs
not listed are
listed,
not price controlled*
Of tho 347 bulk drugs,
drugs
domestically produced.
Tho DPCO also lists tho therapeutic
groups cf
As
afocut 225 are
formulations which arc subject to price control.
tho classiciation is by therapeutic Groups,
it is
possible that formulations aro subject to price control,
^v?n
though tho bulk drugs which go into thoir manufacture are
not
price c o nt r o 11 o d .
Tho prices of bulk drugs are
study
fixed on the basis of the
of tho costs of manufacture by tho BICP.
The prices
recommended by tho BICP taka into account tho installed
capacity,
achieved capacity, optimum
raw materials,
norms of consumption of
utilities an! covorsion costs.
In determining
the prices for individual manufacturers return on n^tuorth
(a ;uity capital plus free reserves)
is also built in.
for
catogory I and II bulk drugs the return is 14% and that for
bulk drugs qoing into category
post
III
formulations
it
is 12%
tax on notworth.
for tho purpose of price control,
divided into
four categories
formulations aro
i
(a)
Category I
(b)
Catogory II which carry a mark up of 55%;
(c)
C3togory III
formulations which carry markup upto 100% &
(d)
Catogory IV
formulations which are outside orico control*
formulations which carry a mark up of 40%;
fl-ark up includes distribution cost,
trade commissions
II
promotional oxponsos,
and tho rr(a nu f ac tur or s margin. Category
formulations carry a lower mark up because they aro
essential formulations used in large tolumas.
I a nJ
A nnox u r_p,_J_L
1 hausiRJA^
iniustrial apo^o^1
Control tc ths existing schamj of tho
policy in th 3 drug sector is :
(a)
into five
the classiciation of dr jg uni er takings
catagor ios s
i)
small scalo ontorprises;
ii)
I n Jian □QD-fORTP companies;
I ndian [*1RTP companies
public sector companies;
iv)
the
companios (i.o. companies coming uithin
forcig
n
v)
purv icu of FERA)
those- caateoovios io
□ iff ore ntial trootmo ntt gf each of n-i
policy parameters nr procedures.
.
regard to the [
iii)
(b)
The OruQ Policy c
i)
ii)
lit)
lassi fi^s bulk '.iru
3
into throo c?.te'? or ies *
ublic sector;
o nly for ths p
the Indian sector (i.e.
those open to licensing for
FERA companies) and
all undertakings other than
oil sectors i re lee! i ng
those open tn i.tconsinq for
those open to licensing
FlRA companies
□ ns i ng po
1 icy >
n.jral inlustial licensing
policy,
In addition,
under the g1
a
r3S,.,.i for the
the small
5H.O11 seals sector.
number of bulk drugs are
to licensing for all sectors,
Even in regard to bulk drugs open
additional stipulations that
FZRA companies aro
subject
to
the
ar a
must involve hinh tochnolony and
nufacturing process
the ma
basic stage.
The
The drug
drug policy also
from
the
pr oductio n must bo
mu.nl 9 I r i ia n non-MRT?
ccmpanie:
no n—1
lays down that other t h i no s b c i no
The drug
and lastly thu PER
f - A comparias.
Indian MRTP comnanics
upply to
number of parameter s ( a . g • s
3
d
ou
n
a
fr cm
policy also lays
n.ornmotors) which vary
rntio rPormulations
9
non-associatod ‘
aro -Ivor in tnc
These doteils
category to category,
exhibit enclosed.
/-
Approval procedures also vary
from cateqory to category.
Small scale enterprises are not required to secure either DGTD
registration of an industrial liconce.
It
is sufficient if
they get themselves rogistered with
the State Director of
Ncn-FERA and
non-HRTP companies are
Industries concerned.
nligiblo
for registration uith the DGTD instead of going through
the moro elaborate procedure for
industrial licensing provided
investment in plant and machinery doos
not exceed Rs. 5 crores and
the roquiremorts of foreign exchange for raw materials and
contents does not exceed th^j certain limitos.
Others are
required to secure an industrial licence.
i
I
EXHIBIT
□1.
Ab.
Ki).’Zl2Z_
1.
2,
public sector
Parameter
Sectoral
><:servatic n
Sulk drug
mo nufactoro
Z_ZLz'".
Can manufacture
all drugs
InJxan Co . ( Ncj n-F LKa,
Non-fiRTP Co. other
than Public Sector)
h
:
Can manufacture all
drugs
othar trFor
________________
those
reserves:
the public sector
subject to securing
industrial appr eval.
Company
Cc.n manufacture all
drugs other than thosa reserved for the
public sector subject
to securing inlust
rial approval.
No s-scial parameters
under the- n . j Orun
Policy.
1:10
10
Fofjign (F'tR’A')' Company"
LIZ
■(5)" .
77:7
No, Spl. para
meters u nd o r the
new drug policy.
r am a t c r s_ •
I) MM.0 Parameters
IrZia h'Tnn.7 '
1
Ca n ma nu factor e only
drugs open to licenses
for all sectors inclu
ding foreign companies.
Only high technology
bulk drugs and drug
intormadiatos from the
basic stags.
: 5
: 10
exfactory value of
production of bulk
drugs to ox-factory
value of formulations.
No foreign company will bo
given licence for formula
tion not ccnr.ectod with
manufacture of bulk drug of
high technology of their own
b)
additional stipu
lation for foreign
com pa nios
c)
ratio betwaen value
1 • 2
of importod/canalisod bulk
drugs and value of indigenous
bulk drugs in the total
formulation activity.-
4.
Supply to no n-associatod formulators.
5.
Loan licensing
40%
1
:
2
3 0%
No restriction
1
: 2
1
5 0$
50%
: 2
Not eligible for fresh
loan lie ansi ng a
V3
f’
L-9/j3O(c)
LOL' ; a. 24.9.84
Sub: Banned Brand Drug List.
Dear Friends,
COMMHMHTY HrALTH CELL
47/1^ (First i ioorlOi.
The banned brand drug list is being sent to'you. 'Sfie'iis^ 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,
.test
ester one and tonics. Any drug containing yohimbine air
'.SS
—‘strychnine or testosterone in tonics is just as irrational
as a drug containing all the 4(obvieusly the number of drugs
affected this way are much less.
Class HI : 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 recommendation..
Class V: Problem drugs that should be severely restricted if not
banned, eg. Anabolic steroids for children. Phony land
oxyphen butazones.
Class VIA 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 threa obliques x/x/x indicate DCC/DTAB/Gazette Notification to
facilitate cross checking. If there are any errors they are uni nt er-^ie
You are requested to review the list, add/substract/modify
according to most recent information. T-.herg is natmachinary fur
sharing unbiased drug information ericas 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.
Notes - It is possible that some brands have been ref ormuJa 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 diree^ivo^had^ bee ••
given to State and Central health authorities to make the banned \
brand drug list available to the Public. It is end of September ’ 84 o
This list is made in Public Int erest .Use it in whatever ways you car,
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 Drug 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
fBlack Lists’. For the final version we owe our thanks to Alphonse.
In solidarity,
Dr Mira Shiva
Coordinat or
Low Cost Drugs & Rational Therapeu
tics, VHaI.
♦
*r
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. AIDANis 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 than unless unscientific, use
less drug combjnations which constitute the majority of
drugs available in the market are withdrawn, enough .. ' -c
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 different ministries 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 its 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”.
ir V
a*
XJ
S3
d cc
® « ro 1- O
E e.-51
S< j
LLJ
Z iZ
.z
£2<
■
•
;
2 0
15 f-1: <Cu
o t.
'll
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 ?olicy 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
• the Health Action International; proper drug distribution
to the ■/: poor and the needy, through Governmental cnannels;
abolition of taxes on priority drugs; plugging the specific
loopholes identified by AIDAN in the import of technology
drua and in the licensing policv to ensure self reliance;
adoption of the 1975 Helisinki (Mark II) Declaration,on
chtical drug trial on human subjects ... etc. It points out
4 that all those 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, era terion
for the drug industry.
;; ’
Correspondence, meeting
various officials ano oven
the Minister has failed to bring about any change in their
concerns. ATn?'N has therefore'decided, to take these issues
to the people and. also show by way of demonstration, how
things can be done. Member organizations of . .TDAN are publishing lists of brands of banned and bannable hazardous drugs.
Two pilot st'.idies 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 cert-in essential drugs based on the actual
incidence of diseases. A critical analysis of. the drug
industry-in Indra is already being circulated in regional
languages 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 ° 0 ° 0 ° 0
° o c
A
IB/FT OF THE RATIONAL DRUG POLICY
PHEjMBIE :
(WARpi A DQCUTJfT)
DAJG PQUCT IN TIEE PiasiJECTIVB OF HEAISH POLICY
The Committee for Haticnal Drug Policy would work towards a rational drug policy in
India and would eppose the irrationalities in the production, marketing and use ox
medicines in India. The CRUP believes that a rational drug policy can be really
meaningful only as a part of rationci health policy and hened CROP would work cn the
drug issue xd.thin 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.
communicable diseases, diseases due to undemutrition, etc. These are preventable
and curable, Industralisation and urbanisation have also led to spread of conse
quential diseases. Lhat vje need then, is adequate nutrition, safe water, univocal
sanitation, environmental protection and a primary medical care service available
to all.
HOLE AND UTILITY OF DRUGS IK "JUDICAL CA3E
Though proper provision of food, water, shelter, physical and cultural environment
are essential and much more iinportant 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 ai 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 comprised 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 cn attacking
the socio-econonic cause of illness.
It is not disputed that without being free from inequality and exploitation, a socio
cannot achieve freedom from avoidable illness. On the other hand, cne cannot alia-/
people to suffer and die till that real freedom arrives. Hence, in our society, meed cal care service has an immediate, 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 of a rational drug policy should therefore be discussed in this perspective
and with the view that the drug policy should be consistent with the rational health
poLLey.
_> g
OBJECTIVES OF THE RATIOL'AL DRUG POLICY
O
o
X rtt
«
«=•-’
To ensure availability of safe efficacious drugs to all the needy.
4 J o
t' {. J UJ
To eliminate harmftil and irrational drugs.
(c) To ensure production, distribution and use of all drugs on scientific basis ; so
and in accordance with the need.
(d) National seld reliance on priority drugs.
3 •; a
(e) To ensure dissemination of relevant information to the medical profession
-4
S I. 3
and consumers as well.
O 't
(a)
(b)
o
PRIORITY (gSSEi/TIAL DRUGS)
It hardly needs emphasis tliat we have to set up priorities for the production of
drugs accordinq to the prevailing disease attem i.e. drugs to combat conimunicaole
and nutritional diseases should claim priority. The idea behind the term ’essentia.•
drugs1 may be better served by using the words ’priority drugs’.
T
i
- 2 -
’hile there is paucity of essential, and life saving drugs, the market is flooded
with irrational and even harmful drugs, /‘here is no effective measure to curb the
prof itcring of the -donrinating MNHS, neither there is much awareness, amongst the
medical profession an$i people regarding the unfair practices in the drug industry.
-(Ref. Hathi Comittee Report)
/ill the aspects of. existing drug policy need to be completely- overhauled in order
to effect a Rational drug Pblidy., Such a change v/ould involve amongst other things,
nationalization .of all the major drug ccr.xpariics along.with n social control ovex’ ihe
nationalised sector. Rut such a stepfcannot be expected in i?-.modtate. future becav.sc
of the Ioi-j level of awareness about t|ie necessity of a Rational Rrug folicy auon st
medical personnel, politicians, government■ officials aid the common people; and
because of the weakness of the people/s Movement in genera] . Hence only the follcwing; int©mediate measures are to be demanded from the .government. These measures
do’not constitute a full-fledged katibnal-Srug Rclicy in India but are stens in
the right direction^, be demand from .the Government the following::
■^Setting up of an independent machinery, to scrutinize all the drugs currently,r
marketed in India cn the follovdn.g principles.
•''■The cofomittee would.be a permanent boctf and would review the drug policy
every year in the light of nexv infonaation on older drugs and inve ntion
of new drugs. No drug in India can be produced or marketed in India unless
approved by tills committee.
Such a committee should be forced at the
state level.
^Production md. import 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 self-reliance.. To pursue this
aim, it would be necessary,
.^Importance .from,the ’point of view of caraunity medicine, of diseasesgainst which.the dru/g is to Ido used. For exay le, drugs to be used in.
diseases that cause larger mor tali severe .'morbidity;, serious sequelae
(after effects) would get a priority. Drugs used in the National bro,Tames
of prevention and control of diseases (tuberculosis, goitre, etc.) to get
priority. Thus vaccines tc get priority over multivitandns, antibiotics.
^■Therapeutics rationality -which included consideration of both efficacy and
safety (therapeutic
(therspeutic inclox).
index). Only those drugs and their combinations which
have been reconraended by latest edition of stands rd textbooks ox’ by ypC
to be produced.
y,:
^•Cost and selfrollance: Then
..hen there is no qualitative difference between
therapeutic ratiohalit,. of two. drugs, priority should be ■iven to the chaap/er
one and/or the one, which is closer to the requirements of national selfreliance.
.
Tucther ihe national, drug fo^vilary.-should be revised and compiled by an exsert
■'•i.ultidi.sciplinaiy comittce kce ing the follad.n.• criteria in mfmd:
^gs sentiaJi ty
^rficacy
^Safety.
•^Cost
* Sase of ad:ihiis tr at ion .
Av aj labi lity
^•Pote.nticd. for nisuse
Such evaluation o£ the drugs in the market and revision of the lists should be done
periodically.
- 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 1 Indian Company1. No company
should be given the status of Indian company unless the plant and mac binaries are
installed on turn key basis aud no stipulation is pu4: for import of raw materials,
from the parent company.
Transfer technology should be gul.-vrr uhu'er URiSO r ecommend at iont,. Only latest technclogy can be imported on the basis of global tender from all the developed countries.
Preference should be given to the countries whoever accept ^upee’ as transfer
currency and indegenous plant and machinery are accepted.
TNCs 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 -ies, 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 of fixed dosage forms - uniformity 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 drags and raw materials.
’’Leader Price" system is to be changed and maximum price of each drugs is to be
calculated on the basis of BICP 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 determined 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 CONTROL
Adequate number of Drug testinglaboratories are to be established in different parts
of the country, All 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.
Special statute and judicial set-15) 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 exped it eo us trial ■
In arrangement with the leading institutions in four zones of thlb country trial
and study has to be made for eaoh new drugs before its introduction.
~ 4 ~
Information regarding banning withdrawal of drugs from the market has to bo pubMsiied in mass media and mailing to the retailers, and medical professions. Drugs
should be inraediately replaced to the buyers if asiy doubt is expressed, even if a
part ox the pack is used. Cosmetics, OiC drugs, household renodies cannot be sold
irom the shop whore pharmaceuticals arc sold in the cities and towns.
SALKS PHa-xCTIOi-T
There should be a permanent National Organisation for information on drugs and
uhcrajy. Information’ is to be circulated by the organisation every” month through
a journal, (updating N.F.I. and I.?.)
,fo. sales promotion activity, only scientific information can be circulated by the
manufacturers. AH sales promotion informtions/advortisements has to be checked
by the national organisation of information education and comuni cation on medicines,
No pJBysician sample should be given. /ny forn
"
of literature, visual aids etc,
can be published without mentioning full indications, contra-indications,> side oxxect:
dru.g inter aci.ion and anti-dotes.
tvO fifbs of eny form shall be allowed to be riven to the medical profession and the
■ retailers.
Ao scT-rmar, scientific sessions can be held by the drug companies.
^onus, incentive
stern on sales of the products
has to be abolished.
the distributors or retailers
f
ihe jn-irketing code drawn up b^ HAI (Health ction International) should form tho
basis for a National Code for Marketing Practices. This should be accepted by our
/_ovcmrnent and should be suitably inplcn*.en.ted t'trough legislation.
abolition of wholesale stockists and distributors ~ the unnecessary profit-iaakin ;
middleman.
.ibstaoli dimen t If National-Corp oration for the distribution of drugs rnd fharnaceuticals to the retailers. This corporation to work on no loss no profit basis,
marketing of drugs only under generic name and abolition of bx’abd hceds should
appear.
ihe Drug Price Control Order of 1979 should.be extended to all drugs. However,
the existing categories in the DPCO to be abolished end a uniform mark un to be
allov-red on all tyj^cs of drugs on sales turnover prices to be reviewed periodically.
Ensuring proper utilisation and prevention of misuse, this would involve inclusion
of National Drug Policy in medical education.
Compulsory continuing education of
doctors and other medical personnel (like paramedics, chemists) in latest trends in
rational, low-cost pharmacotherapeutics. Kedical audit ^/'stem should be introduced,
mandatory adeouate clinical re cord-keeping b> doctors and.-malcing doctors answerable
as regards rational therapeutics to a committee of experts if a coxplcint of possible
nisuso of drugs is received from any person. Continuing education through different
media by Govcrninent about the use of over the counter drugs, misconceptions about
eortidn drugs, and hazards of wrong use of drugs. Those drugs which are more likely
to give rise to life threatoning or serious side effects, but which my have to be
used in certain conditions, would be allowed to be used only under the supervision
of post. graduates, doctors who would be required to keep a close watch on the
possible serious side-effects and keep adequate clinical records of side effects.
Por example, drugs like clinido^ycin, oxypheributazone, de-xtropropoxyphene, diphen
oxylate, etc.
5
Setting up a Drug Review Committee entrusted vzith the task of :
w.xtorj.ng the chan;5.n^ pattern of diseases.
• -evr information on old drugs and in-vention of ne'..' drugs.
Efficacy of the existing policy of production, distribution and the use of drugs
in the light of principles of Rationed. Drug Policy.
This comi the c is to include one representative each frorx manufacturing sector,
the Government, radical experts e^paged ‘n pri?iary, socondar?/ and tertiary levels
of medical care, chemists, consumer organisations etc.
Postering research on issues J.identified by the Drug uovievr Coi^iittee.
Postering research on non allopathic drugs and production and use ox those vrhich
haw proved to be therapeutically useful in such research.
RAHAKKAf5 STORY
Ramakka, wife of Veerabadrappa has two children. She goes to work in
Periaswamy’s field for the wage of Wrupee a day. Her younger son,
Llnga, 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 uaje, 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. She gave her some herbal
medicines. But the situation became worse and so Ramakka, with the
money
her husband borrowed, took the child to the local doctor,
who has no training but some knowledge received by watching his uncle
who was a compounder. He gave an injecti ?n worth
?/-• The child
got temporary relief* When the sedation power of the injection got
over, the diarrhoea started again. The local ai, advised Ramakka
ho borrowed
to take the child to the district hospital 20 Kms away.
^.20/- from the money lender on the condition that the amount with the
one third of it as interest will be paid pack in paddy t during the
harvest ssison,
Thus they reached the hospital, She was ignorant of the proceedUras
of the Govern ent Hospital, She had to giva fc*2/* to the gate keeper
for entry. The hospital personnel were sc busy that they could attend
to the child only very late* The scolded Ramakka for the delay in
bringing the child for medical care. She could not tell the doctor
that their trip erst her three week’9 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 3s*60/-. Rut Ramakka did not
have that much money. She bought few tablets and returned home.
hile an her way back home, the child breathed its last on Ramakka’a
shoulder•
-xxxxxxxxxxxx-
r
RANAKKA^S STORY
Ramakka, wife of Veerabadrappa has two children. She goes to work in
Periaswarny1 s field for the wage of lOrupee a day. Her younger son,
Lings, only 11 months old, got diarrhoea which is a common problem
leading to death in the village.
ith one rupee which she got as that
day’s uaja, she bought 50 paise worth of powder medicine from the
nearby patty 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 Dai Yellamma for help. She gave her some herbal
medicines.
money
Eut the situation became worse and sc Ramakka, with the
her husband borrowed, took the child to the local doctor,
who has no training but some knowledge? received by watc ing his uncle
who was a compounder. He gave an injection worth %.7/*. The child
got temporary relief,
when the sedation power of ths injection got
over, the diarrhoea started again. The local Dai, advised Ramakka
to take the child to the district hospital 20 Kms away. She borrowed
^.2j/- from the money lender 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 praceodures
of the Govern'-ent Hospital, She had to give &.2/- to ths gate keeper
for entry# The hospital personnel were so busy that they could attend
to the child only very late* Th© scolded Remakke for the delay in
bringing the child for medical care.
She could not tell the doctor
that their trio cost hot three week’s pay which she should pay back
with interest. The doctor also scolded Ramakka for not bringing the
child early, and furiously urots a long prescription including four
I.V. fluids. The pharmacist billed her ^.60/-. But Ramakka did not
have that much money. She bought few tablets and returned home,
while on her way back home, the child breathed its last on Ramakka’s
shoulder•
-xxxxxxxxxxxx-
TUL 1
Hot er ic d nMrei
,
■
cinu?n sanctum
Linn
,
Synonyms
Tul^si
H1 ndi
B ng011
Ksnnada
Tulsi
T ulai
Tulasi
Tul si
Tul si
T
T sIuqu
Lnglieh
Ttfleai
-acred Oasilt Holy Sa^il
Guroral Oescri: tl.n:
An annual 5.Fawiatic hairy herb found thrcM^hout
India* it is ostly rjrown y Hindus in their
Houses f r its s^credness*
Stem greenish, sometiwe ur^lish* Leaves
2*5*5 era softly hairy, ablontj. flouers rran *
§«d in s ikes -iving a cylln Ulcal ®p;?earence*
*e©ds ai- r^d br un ;nd sli ghtXy c .mpre-ned.
*■
Pert© used:
Leaves
Iaste:
^stringent and acrid«
Cowman uses:
Loss of apnetite* ceuqht hiccouqht recpirstory
dise:-isest fevers, cold*
Prop ration and .io^e:
One teaspoonful of leaf Juice with powder of
one or two j@p .reorns reli v^s res iratory
disease© and fevwr* One teas nonful of -louder
of the dried drug along with homy or water
twice daily clears can ? stion of the throat*
* decoction
a using Ohanyaka (.i p rt),
ft richa (1 part), Tulasi (1 p rt) ind Sunthi
11 p- rt) is feund honefic-.1 in i fluenz/. and
f - v«?rs ^ssoc.i'-ted with chill*
*
4 A Workshop on ’Pharmaceutical^
and Health Policies’ organised
by I0CU 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 scientific ally
analyse their social hnd 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 appropriatehealth 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^
Mealth froliciesT 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
R
3
COMMUNHY HEALTH CELL
• >. I'."
’Folk adaptations of Gorky’s
------------ ” and other pieces by
’’Mother
Brecht touch on many aspects of
education and knowledge,present
ed 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
■On 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
MgBTIMS- WITH MR. V AS ACT SATHE
whether after dilution these com
panies would be treated as Indian
companies he answered in the affir
mative.
0'h 3 Dec ’83 an informal meeting
took place between Mr. Vasant
Sathe and Dr. Zafrullah along
with s|pi^e 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
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. Sathe
how the Bangladesh Expert Committee
on Drugs had got inspiration from
t^e Hathi Committee Report.
Mr Sathe was incidentally a
member of the Hath! Committee.
Wifth regard to.the extent to which
Hafthi Committee recommendations
halve been implemented,, Mr. Sathe
sppke about the^
’ ’
th^ 40% dilution
of
the F ERA c. ompjani.esA
i,e s4
Whan asked
4
- to direct the licensing author
ities not to renew the licenses
for any drug except these 116.
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 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 public 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 groups1 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 1983)
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 harassed1.
The Bombay High Court had directed
the requisite notification under
Section 26A with the list of for
mulations proposed to be banned be
puWished in the Gazette.
The
noiification 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:
»
- 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 Hath! Committee.
5
TO nxmrcN^
Tuesday, December 6, 1983
and drugs of doubtful efficacy"
from the market They include li
quid vitamin mixtures, multiple com
binations of potent drugs, combinations of antibiotics griVTate're,
gripe •“zicrc,
cough mixtures, tonics, balms, digestive enzymes, addictive drugs
and antacids.
"We thought, let us have our
own ulcers — instead of getting
them from multinationals”, said:
Dr Chowdhury.
In India, where multinationals con
v.vd
trol 78 per cant of the market, and
modern drugs reach only about 20
per cent of the population, he says,
the gplicy is not firm enough. la;
deed, the Indian drug policy, is
kilogram. This
bottle's basic
cost is . therefore not more
tn?n 90
and cannot be
more than Rs 3 or 4 after adding taxes a^d other charges,
»itiere are other multinatio
nal tricks. "To take the mini
mum dose of ^Ampicilin
for
five days, which is the presciibed course, you need 100 ml.
But the bottles that are sold
oeveloning countries
are
only 60 mL A poor man is
Our Staff Reporter
forced to pay for 120 mis—two
<4Novaliin has been banned
bottles—ip order
to get his
The bottle sold in the
there has not yot done it And it is criticise the Bangladesh ban, says ?est is of-100 mb he said.
a study of the Voluntary Health As
Terramvcin syrup was ban
creating 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
July this vear-?r"But 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 year
to
withdraw?". He
Saturday by Dr Zafrullah Chowdhu Ej Chowdhury. "Yet, the soasks
“MA
lot can
>pry, Director of the People’s Health caHed
anti-dierrhoel
drug pen in a year: governntilnts
’ Centre, Bangladesh.
The 42-year-cld doctor was among fiex^om is still in wide use. can change, policies can be re
those on the Drugs Expert Commit It h-*s not only been conclu- versed. there can be second
tee whose proposals led to 1,679 s-ve’y established that it has thoughts"
dangerous drugs being banned by afriotm s’do.ejects, can cause
Bangladesh’s
Drug Control
Bangladesh.
e cancer and leads to dimness of
In the country he calls ‘big bro- < vision and blindness, but also Ordinance,
announced
with
ther’, India, 43,606 drugs are regis
therapeutic
amendments
on
6
September
last
that it has
no
tered and sold. ‘Three quarter of
value whatsoever In treating year, allowed six days for all
them are non-essential", says the
stocks of banned drugs to be
dirtor. "And the policy taken b^
dia-rboea".
your country affects us".
Io 19?8 ho said, the drug destroyed. Within four days
When Bangladesh declared its
pie multi-nationals were seek
siew drug policy on 7 June, 1982 he h ovalgin was found to derange ing
permission to export the
said, multinationals immediately some people’s ability to pro.
brought tremendous pressure to duce white blood cells. A re- drug stocks to other countries
bear, to have the policy amended. piesentative of
pfizer like Saadi Arabia, West Af.
the
‘First the American, British, Dutch rompany, which makes the r'ca, 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 that « pharmaceutical from label saying that the drugs thad *
couldn't be been recommended for destruc
Hitler’s country
brought
a 4-member expert sci
entific committee from pharmaceuti wrong. /Hitler is dSad, but tion by Bangladesh.
cal companies.
still selling
The Voluntary Health Asso
your country Is
A report in the Washington Post N ovalgin’, said the doctor.
ciation
of India plane to Teon T9 August, 1982 said that the US
Multinationals
sav
I
tbeir
sent the government with a
government was worried* that its
drugs are cheaper,
i
said
Dr memorandum
demanding
'•30-billlon-dollar market In the de
veloging countries would be at stake Chowdhury, and withdrew
a among other things, that drugs
If other countries followed suit”.
bottle of Ampicilin from his for India be chosen after ex.
The Bangladesh government stuck’ porket. “I bought this today, in amining their essentiality, effi
to its guns, lifting the ban from
your city. It cost me Rs ‘'.90. cacy, safety, cost, ease of adonly a token 128 drugs.
whoteaale ministration,
________ availability, and
The Bangladesh drug policy weeds The international
out "all unnecessary, useless drugs- urice of Ampicilin is Rs <M> a TOtedtial for misuse.
“It is the commcm 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'
JS
dor-.
INDIA YET TO EMULATE BANGLADESH
Harmful drugs still available
BY SUMANTA BANERJEE
7 APR I ]i I AH emerged from them, were based on the kistan and Malaysia. He suggested 5ontl,I?u®'Oa;u2p?t?9enwhpn
TY*
ZA/o
7 4 u WHO list.
co-operation between India and Ban- for those ailments? When the ma
UChowdhury of Bangladesh,
During his talks with medical and gladesh to totally eliminate these chmery to check misuse of a drug
Who was instrumental in the health workers in Delhi recently Dr. harmful drugs.
n°V^1’ k ^use b amin^he drug
formulation and passing of the Chowdhury pointed out that‘analgin
h is sad that a medical expert from a m?nhuyi.lurers who are in this busiinternationally acclaimed Nain sm“!1nd":ifhob?uXgdX^The^
phihnthrophic purtional Drug Policy
Indil Besides, he pointed out that committee of the Drugs Consultative ^^“‘^iHonei's8 fTmany ’ me'try in 1982, which aimed at slOcks of the banned drugs m Bangla- committee set up by the Government JJ!ed,c" Pr^ 1 .
’
commercial
banning over 1,000 hazatdous desh were being diverted to other f lndi^ rccOmmcnded in 1980 the ^^al
becom
.
f
and irrational drugs - mainly Third World countries. How was this wccding out of several drugs But the
combinadon in the
manufactured by multinationals be^ d°^g Controller of Bangladesh, &e “d Famd? we fa're issued on county, one expects the Government
^was in Delhi recently and f
n7t^mplementationEof the “
the toto spend
brought to our notice that the Bangladesh Government’s drug policy ..m^nufacture and sale” of only 22 B“‘ ‘he Goverinment,
«e,? sS" betas" marketad'in «“Wta.
" "J
mittce, recommended tha ban on the
Thc multinational companies com- In Octobcr 1980, the Drugs Tech- spent sens biy, ini pre co g
drugs on the basis of the World Health plied with the request by shipping the nical Advisory Board of the GovernK0V^,naLahuatrS^d safe water
Organisations (WHp) recommwda- stocks t0 thc ^5 of their respective ment of Indfat prohibited the comsanitadon The money alloltioni and concept of Essential Drug coufltries, but instead of taking them binations of “steroids with bronchodiP0? ^anit
_
obviously
List. The WHO initiated thc concept insidc thcse WcstCrn countries the
steroids with antihlstaminics
CwU£t1^^
of essential drugs and rational drug companies shipped themto ports in add steroids with tranquillisers.” But
.
medicines
therapy which is not merely based on -j-hird World countries.
iatcr thc phrase “combination of ste- zardous median .
efficacy, safety ease in administration
.
roids with bronchodilators” was reintand easy availability, but also on tea- Jjantieu in rVCSttOO
erpreted as “combination of steroids NotITTUtlOndl
a^sssgagy
Diwrw. of drugs
X”
41
“taV
saxUVRS
S”i‘as
essential, quality drugs with the right diverted to the ThirdWorld wunt
Advisory Board — can escape the memorandum), or “such combinations
amount of information is unethical, ^here there wM no Mn. A^rdmg to .y . ^he manufacturers can now arc being marketed in many countries
Hypnotising them into believing that Dr. ChowdhurysBt SthS n future
cannot be considered as
of the irrational, and hazardous least two Third World
- "Xdrugs for asthma only, although irrational.” (Ibid). .
drugs are “essential for their health psolho and Yemen
b”"™
8
"h(.
such pro<iucts have been The question is: is anything markneeds and making them use their h- from
talks Fri vigorously promoted for all types of etable, or enjoying a wide market for a
i** •“sxtiw.■sjWJyss
drugs sold in the ntarkeuDr Mlah drug.^wbeh*' ‘X
S* r"a^°"hem in far-flung villages - vertise and sell it, or its real effeenve« tahnadt ^parttdWri*0® Pa of L change, so that they
not ness?
DECCAN HERALD
15-12-83
Banned drugs still
in use in India
,ric name* introduced. Bangladesh has
X3
C'i
du’ O -r”
suggestod that a list of banned and
harmful drugs (with generic and
•x.
L1" 4 °
NEW DELHI, December 3
already started a campaign In th s
(PTI).
, , ,
. , .
. • v regard Also, this wIU cut down the brand names) should be widely cir
which
pERTAlN harmful drug, whtch
con^d(.rEi,y.
the u.K., thl. culated by government and properly
V have been banned in Nepal,
resulted in a 42 per cent price advertised.
Dr. Samir Chaudhury, a primary
Bangladesh Sri Lanka, Pakistan, and reduction, he pointed out.
health worker from West Bengal, ex
Malaysia are still being administered
Dr.
Chowdhury
said
in
Bangladesh,
pressed
concern over the very small
to patients in India, according to a village doctors could directly pres
number' of drugs inspector.; in the
medical expert from Bangladesh.
cribe'
12
drugs
for
which
a
list
nad
whole country.
Citing the example of analgin
He said even ^rnntial drugs and
(amidopyrine). Dr. Zafaryllah Chow been circulated.
The kendra had started manufactur- vaccines to cure tuberculosis, diar
dhury, director of
Gonoshasthya
Kenara (people
{.people’sn health centre),
oentre), jng 30 essential drugs • to avoid «• rhoea, blindnett are not available in
Kendra
Dhaka regretted that India' emerging plokation by multmationai, he said, right quantities to the
i poor
as < leader in the third world, is still
tuil
panelists criticised the lack of Voluntary health organic ims could
’ [ the
permitting
th® use of this.
availability of an information ?yjrtem jointlytake
upproduction of soma
essentialdrags,
drags, he suggested.
auggested.
Dr. Chowdhury
,aowdhury said that brand on drugSj ju formuktioni and uses, essential
staipM should be abolished and genesene- to consumers ®®d_ chemists. They
'7 '
s
TIMES OF INDIA
4-12-83
O
O
'■i
H S
<
<
u cn uj
X
at
o O
£ 2
a o
B «2
52 .i <
IL.
o
o c
Political will
will needed
needed
for drug policy: expert
A
TIMES OF INDIA
28-11-83
B, A SM Reporter
^"ork i„ rura! .Kat
BOMBAY. November 27 « 10^
?T Dr--CbMdtary, patho• logy need
...
nvC(1 not
noJ be
bc a'
* doctor's forte only.
combination of political will
who T*n distin^'«h colour
and nressnrA fro™
nnd hiMi cnm-
ment s family planning record.
drugs according to Dr. Zafrullah ..Ji’S r,egIon5- •" which the ken.lra
worked showed no maternal mortalitv,
Chaudhary.
a low infant mortality, and popularity
Dr Qiaudhary. as a member of o?
ot •mmunisation
immunisation programmes
programmes.’. hc said',
said.
the Bangladesh drug expert com- A ®hkcndr? *or,ted
from
miltce, was instrumental in the for- , "x a"f* ,on money that came in
nulabon and passing of his country’s Ir°r
hcal,h Programmes, in uhich
drug policy m June last year. He fought MedJf’nn? S?rei.$?,d at di,,crent prices
rut!er
° . 10
DCODlO/of
gorie3°
P15>
d,ffcr<:n< ecaaomic catebitter hottie
battle against multinational
Pressure on the Bangladesh government
and even from the medical fraternity
lo get drugs including novalgin. mexaor’’1« some steroids. ■ gripe water, a
Combination of antibiotics, micropyre
nes and tetracycling syrup banned.
. Jr. Chaudhary told “The Times of
India , here today, that India with its
iprge complement of scientists and
qualified people, was m a better posi
tion to formulate its own dnjg•• wlicy
that the above drugs which had
shown several harmful side-effects
could be prohibited
IIATIII REPORT
It was irohicaf that- the Hathi committee report, which had inspired Ban.
gladcsh’s drug policy, had not been
implemented m India, Dr. Chaudhary
said.
Bangladesh today had managed to
kfep 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 generic
names, because this would create 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 DELHI, 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 world’, organised by the Council of trade names.
Scientific and Industrial Research here, said he
Drugs for rural disoa^o^; Voluntary health
was*burprised 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
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
Medical Association auditorium on Friday. At groups, monitoring of drug control laws, train
.the foyer of.the building was displayed the pro ing of village-based, para-medical sttff and
paganda by multinational companies some of strengthening of community health services
whose products should be on the banned 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 ing administered to patients in India. He re
quate for therapeutic purposes.
gretted that India, emerging as a leader In third
•j He
1.707
drug
were con- world, was still permitting use of arialoin
....
•
—
s> formulations
;------------- ~..w.wwv..
sidered harmful or useless and pharmacies (amidopyrine).
were given three months to dispose of 'their
Drugs banned in Bangladesh were still be
But because
^ca^se of pressure from U.S.- ing
■.■SJ marketed in
m iiimiq
uy multinationals.
inuiunauonais. These
inese
India by
ttons/ma^pert^^
based multinationals, ban orders on 60 formula- found their way to Bangladesh, he alleged and
----------- „.J two
r
£
.
. •.
...
were »*A«*z*a**WM^J
rescinded. TLThe. formulations, the manufaccountries in totally eliminating these harmful
Jyresnd sale of which were banned included II-, drugs.
qulfl vitamin mixtures, multiple combinations of
Detailing^advantages of abolition of brand
pcrient drugs, alkali mixtures, g.
gripe waters, names. Dr. ''Choudhury said introduction'* of
^4:.
enzyme
^•**-*-*-^
— names
— — ..
—
.
cough mixtures, tonics, digestive
generic
would
avoid confusion'and
re^
preparations and habit forming drugs.<.
duce profit-making by
bv various pharmaceutical
All health workers and villagedoctors
i
in firms. In the U.S. _and Ithe' U-K... generic names
Bangladesh were supplied with 12 basic drugs^ had been intoodHOid^
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...
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 - SOWS 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% to.51% 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.
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:
■bf*-
- obtaining of industrial licence
only for high technology bulk drugs
from basic stage.
- eligibility for registration with
DG-TD 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 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, Bombay and Kandla, and
on new projects, in 1983 and 1984.
The company's performance during the pasi five years is
summarised in the following table:
*rupees millions)
1980
1982
1978
1981'
1979
610.9
637.2
875.9
548.9
715.0
Sales
32.5
34.2
61.3
73.3
86.9
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
12
12
102
Dividend/share(%)
Auction at the Bombay factory was affected by irviustrial action;
^on increased capital after a bonus issue.
SCaiP No. 827 SepwnbM
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,
ethamb ut al, mebe ndazole.
Since the New Drug Policy is in
the offing it is crucial for those
involved in Drug Action to make
-*-*3
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. 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
iction 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 111
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 Bhore 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 Hath! Committee
recommendation to gradually decrease
foreign equity to 40 and then
26%, without ensuring production
and supply of essential life savi ng dT^gg to th.© pGopl® will be
a big farce and a meaningless
exercise where consumers are
concerned •
DRU& PRICIM&
W The government has raised the
price of bulk ampicillin and
amoxycillin, two popular anti-
It
• The Bombay High Court has grant
ed an ad interim stay of the
operation of the Union Government^
order revising the prices of multi
vitamin preparations of Pfizer Ltd,
During the year ended Nov. 1982,
Pfizers1' 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 it.s
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 '83, 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
This survey was conducted by the
National Institute of Nutrition
(NIN) in cooperation with the
ipirectorate 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 pharmaceutical shops.
Some of the findings of the
survey are as follows:
- 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 antiijifectives (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.
- 30.2$ of the self prescribed
analgesics, antipyretics and anti
inflammatory agents were scheduled
drugs. These were mainly analgin,
phenylbutazone(with or without
corticosteroids?and ibuprofen.
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.
/["chemicals7
plosives
^3
^2)
Analgesics, Antipyretics and Anti
inflammatory drugs:
- an earlier survey, by the GERO
(Consumer Education and Research
Centre, Ahmedabad) had shown that
of 1J 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%.
/dy r
- amongst self administered drugs
analgesics, nutritional products
and antibiotics topped the list.
Antibiotics:
- over 30% of the doctors’ pres
criptions contained antibiotics.
5;
- approximately 12.8% of self
prescribed drugs were an+ibiotics.
© 78/ms
THE COMPANY WONT ACCEPF TN/S REPORT
ON UNSAFE WORKING CONDITIONS.
ITS NOT TYPED DOUSLE SPACED .•
- most antibiotic prescriptions
were for sulfa and trimethoprim
(from*Science for the People’)
12
combinations, tetracyclines and
penicillin, in that order.
d rugs.
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 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 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
it 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. cConsumer
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 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:
- 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.
- 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-..
- 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 t
of each group.
# Workshop on Producing Low Cost
Health Education Material^ 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 * X3 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.-
fflaa |psa
*
from
Social Action
News
3^ G
4
1 f SEP WS
•
U)
• /;). 9 •
♦
;ote s
•••/nn..
1.
3.
' ruj 11 d; is b.-ing divio.^. into 6 Claras;
Jri-y; b/ nnect under the Gazette wotilieation
□rug : thet sh ’aid have been banned under Gazette .iotiticc-tion in
the ait^jigious wording*
or modification*
urugs that wore recommended for being weeded out by DCC uno :.jere
: iO OUt.
/. t •
drugs that were banned earlier separately* ®g*
•
;-'’L
roblem Drugs that should be severely restricted if not d !
.
Jut zolidine Tendril* Hydroxygninolina, /diabolic steroids for
chi 1 - en •
rr< tion- 1 » .mibinetion i o. ionics.
c
o-lon^in/ to Class I are boing doelt with first, t/’w
us-c for th various categories is based on the sequence os in
.;t . .ic-tion.
Category
jus use. in
UCC. D'VAU/
Je z-itto NotilIgktian res.. ’
Name of the Drug House
Drugs
Content
-n<. .
joarce
Zi.v ail able
in the
market
or not
..iv .•
____ .__ ... '• 3
-! cav
•. cJ-> 1
_ yia^s aoad
550 a°A
.^uuo^yrino cnu its
2/1/1
i4 IL
'urr.- of these bre ndu now contain
•■»: lirOpyrine^ jorne of the or< n*.- ■ :-■
. VG De m rith Lr-- .G, others refoxmul ted.
uoi ‘1GD-: in
uCG/ 1VUJ/
... .ti
tle <ti on res^ JG Lively .
5.7272
C v-gury
t -j >ry
banned
Banned
Name ot
or the
Nome
Drug
drug
Drug House
Content
content
jourcc
>ourae
iL
c bl^ u>=
■
___
-
- -
-
)X
---- ------- ---- —— -------- --- ---- ------------------- —--------- • .’tJL-.
~ixed dose currbiar tionB of Vitamins jjith anti,, inil. m-r
a on t s and tranqu.i 111 sors s
Placidin
Lupin
>- 3IYI.3 x'roxyvon-1»vc Khc rdt
Dicyclomine iiCL,Dexhoproxhphenu IC #Acet ainopho ■>
Clbriazcphoxide
;u..hinol-F-.C compound-Ranbaiiy-LQxnoprop
Ute,
Paraxetamol bi;-sephcim
PyJ ul irb coieine — Jithnor—AGuttu.iinophon/Coreint;
—
tru.jro .hyhenPardeetamolt
diazephem
Cctor Wallace
ualog^ic
Ci tade1
Analgin* Coedine#phbd
Concril
TTR dharma
a ran al
...
diazepam
t
2
A-o-th
Uf:i-
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jiliqan
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rot
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jtc-ndc■£.
. ;.1.:
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- OS’■•-'- ■ ■' :• • •
of
an nine
Ml
of Y.xiii .oine onvith iV'stost.erona n 7 vitciiains ;
cur.jinctiuns or
^xsi’x 1 oninoinc t
y^iEbin- tx-
Ml
Jil.
- o.'.' .. . L- Lt-OllA -i.
z
,
•
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or
#
3 13/9/8
..^enac.rtin <.n- its
NIL
oin-. ti-ons:
hfone of these brands now
contain Phenacetin.
1/10/9
Fixed dose corubinati-jns of enci histouiinlc.^ .J.th
anti diarrhoeiils»
NIL.
2/11/10
Fixed dose ccnbinations of Pencillin and
Julohon ami des.
CryJtastrep
J'iy* a.
None of these brands are now
listed in ?ilh^r not avail-able.
5/12/11
coziDiD./cl'.-nj or vitrains /it;- ,J1. l j J31C , 8
tithed ew'il.
0/13/12
1UL.
Fixed dose Cx^nb.tnations 3f Tetracycline . itb Vitamin C.
1) Achromycin I.V.
2) Minicilin
Luderle
Ethico
3) Terramycin JF VXT. .
0/14/13
Pfizar
Fixoa dose cuiidoln;■ tlono or y. ■' roxy-.,uinoline -jroao
of drugs except preparations which are
for the
treatment of di rrhoea and ysentery <\nc f$>r external
use only. Stadited
•jtt.lfitaa totSrozyine
yntxoisi’.'ie -
Oiastase
Bl#32 ^ioCin
arnlde.
(.jftadxr.ed)
I
1/15/14
Fixed -lose c.>rbin. tions of ~toi -if a .. ui 1 X^rnal
ise except combination of steroias ■•ith other
for the trecti-nt / <•••.>th•
Ccrtibist
logo
-re. ni
chi orphaned line
Maleate
Perid jga
riorck dharpe
. ,)exc■,>no tn a sone t
J. Oohmecy. > rc 1; e: > t <. 'u in©.
A^oivcrn J12
Nicholas
•?x e o t s s te s ■ rone9
Vo.312
Mix<.xjen
Xiii^x Xadie
2thlny1 oestradiol,
i t j Jt^.y.tc-rone.
Xnj .riixogen
j-o s t r <;.d 1 o 1 i :?.onooenz. o^;. t •s
Z/jtbyl
"‘phyenyipro .lunate,
‘Z1 o $ to s te rone, x opi ona te
pt: any Ip £ op i on. ~ & t
i \o v-:‘px\ite.
Pasums •strong* ~
Merck
ikithyl t................ ■
, .
'
Testiobi cm * > i s ec ro n Fu rte
Lynoral
Merck
^ichoias.
■
.
•'I...
: •
(t
T eto s te i’one, VI t. a.
”
,Vit<E, H6, B12.
. • xoge strone,uastraaio1,
benzoate.
f
7/1U/17
- 5 •
c^iGbinationj of VItegmina, ith
except c^nbinetion of I^oniczide
_i ':_ ?y ridoz ine ? ly ., roch lor ide (V i t« 36] ;
Hx-J'-...
Nib
0/0/18
p-2.ncJ.llin
0/0/19
vintiueHt^
.liquid or^l prepdrution^s
£x^x<ii^x>.MWxK
Mxtoofcx®
^CXXMX
Terremycin syrup
-
Tsrranaycia Paed drops
Ale ye 1.1 a-u
Pfizer uxytetracycline
u
M
Alembic
ci^o b
H
;xyt**tracycline
lidoceinc^anhydrous
oxy te-trocyc line.
.in £
Voluntary Health Association of India
^-9/330(1)
LCD / a/ 1 6. 7.84-C -14, Community Centre
Safdarjung Development Area
New Delhi-110016
/<
c
(i\ M
Telegrams : VOLHEALTH
r
J-n
New Delhi-110016
T . .
668071
Telephones: 66g072
Graded Essential Crux List
,r,
Explanatory Note:
/ * (• i.
HEALTH CELL
)3c, Marks noad
- 550 001
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 , Technical Report Series 685. An outline
(hf it is given. It should^be noted that certain drugs axe
repeated as they are used more than one disease entity.
The various drug lisiS as they appear in the compiled form
are as follows:
IMRO(Eastern Mediteranean Regional Office)- WHO
List A - for 8th class passed
List B - for that are class 10 passed and have had training
Banglad esh drug list:
Category I - for village level workers
Category II ~ for Primary Health Cere.up to Thana complex lev<i.
CMC Christian Medical Council list - Contact No..63yAugust
1981 9 ’’Getting Essential Drugs to the People”- Stuart
Locost; Low cost standard therapeutics a collective volun%*n^V
enterprise for rational therapeutics
C/0 Amr.l, G P 0 Box No.7, Vadodara 590001.
PU:~
Essential drug list drawn up. by sub-group dealing w±4u
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
G:
formulary.
An English NGO supply equipment and drugs to Charity
Eg ho
Hospitals overseas.
AM:-?
Action Medeor. Qur humble recommendations
for trained village health worker level
for
trained Paramedic or middle level workers
B- )
for
doctors involved in primary health care
S- )
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^iOur 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 the current create
by the market forces. It is a true test of our conviction ■■■■ :
our capability o convince others.
NOTE:
* - /alternative substitute from the same therapeutic ..’roup
can be selected based on comparative lost and availablli >..y
equivalent products, eg. Hydrochlorothiazide: any orher thia
zide type diuretic currently in broad clinical use.
lumbers in the Paren thesis following the drug
names indie
1) Drugs
subject to international
.
z control under the 3 ingle
Convention on Narcotic Drugs(1961) and the Convention or
Psychotropic substances(1971)
expertise diagnostic precision or special equip
2) Specific expertise,
ment required for proper use
3) Greater potency
4) In renal insufficiency 9 .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 Lcated 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 ox
inappropriate for a given individual
C. Por use in rare disorders or in exceptional circumstances.
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 been
dealt with earlier. In the text of the paper the format of the
drug list is as follows:
Retrised model list of Essential Drugs - a WHO ~
~ mj.ttp:'
Expert Ccm
Report - Technical Report Series
11.2.
1.
anaesthetics
1.1 general anaesthetics and oxygen'
1.2 Local anaesthetics
2.
Analgesics, antipyretics, nonsteroidal antiinflammatory
drugs and drugs used* to treat Gout.
2.1 non - opioids
2.2 Opioid analgesics and antagonists
Antiallergics
3,
4.
Antidotes and other substances used in poisonings
4.1 general
4.2 specific
56.
Ant i ep ilept i c s
Antiinfective drugs 6.1 anthelmintic drugs
6.2 a nt lam oe b ic d rug s
6.3 antibacterial drugs
6.3.1 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 antischistosomal drugs
6.9 antitrypanosomal drugs.
o.iii...
Ant im ig ra ine d rug s
Antine op1ast ic and immunosuppres s ive drugs
Antiparkinsonism drugs
Blood,drugs affecting the
10.1 ant ianaemi a d rug s
10.2 anticoagulants and antagonist
11. Blood products and blood substitutes
11.1 plasma substitute
11.2 plasma fractions for speoiilc
11.3 plasma substitute.
use. .
12.1 antianginal drugs
12. Cardiovascular drugs
12.1 antiarrhythmic drugs
12.3 antihypertensive drugs
12.4 cardiac glycosides
12.5 drugs used in shock or anapby_13.1 antifungal drugs
axi. .
1J. Dermatological drugs
13*2 antiinfactive drugs
13.5 antiinflammatory and antic:. > ■
.
k ■ , .
. t
tic drug;-.
13.4 astringent drugs
13.5 keratoplastic and keratol; ••.1.
13-6 scabicides and pedi- ’ -iur-L
culicides
14.1 ohalmi c d r ug s
14. Diagnostic agents
14.2 rad ioc ont rast m edia
15. Disinfectant 3
16. Diuretics
17. Gastrointestinal drug's 17.1 anacids and other antiulc^
a.'"uo.
17.2 antiemetic drugs
17.3 antihaemorrhoidal drugs
17.4 antispasmodic drugs
17.5 c at hart i c d rug s
17.6 diarrhoea, drugs used in
17.6.1 ant id iarrhoeal(symptomatic
17-6.2 replacement solution. dru:;. .
18.1 adrenal hormones and synthetic
18. Hormones
18.2 androgens.
substitutes
18.3 estrogens
18.4 insulins and other antidiabet
18.5 oral contraceptives.
agent:
18.6 ovulat ion induc ers
18.7 progestogens
18.8 thyroid hormones and antithyx-fio
19-1 Sera and immunoglobulins
1
Immunologioals
19.2 vaccines
19.2.1 for universal immunization
19.2.2 for specific groups o: indi’^x20. Muscle relaxants(peripherally acting) and choline- duals>
sterase inhibitors.
21. Ophthalmological preparations. 21.1 antiinfective agents
21.2 antiinflammatory agents
21.3 local anaesthetics
21.4 mi ot ic s
21.5 myd ri atic s
22. Oxytocics
21.6 systemic preparations
23. Peritoneal dialysis solution
24- Psychotherapeutic drugs
25. Respiratory tract,drugs acting on the 25.1 antiasthmatic
25.2 antitussives
i-ru&o
26. Solutions correcting water electrolyte and acid-base distux26.1 oral
banc•
26.2 parent e ral
27- Vitamins and minerals.
7.
8.
9.
10.
'Mju-ve.. >■ nU.al . DrtM. zA-flU.... .....
Com.plemein.-ur/- List
.over; of .rlministrat ion dosage
LlsiIish^o^UlptdsL G
_ Em^o__ h'^Dosfc
........... —__________________ rQXMnq .and .str.eagth^
S AM
C
I
1.1 General anaesthetics and Oxygen
ether,anaesthetic(2)
C
inhalation
powder for injection,©.5g,1.Og
(Sodium salt) in ampoule
c
1.2 Local.anaesthetics
B
.5% inj, 1,2(hydrochloride)in vial
inj.1%, 2% + epinephrine 1:100000
topical forms 2-4(hydbrochloi’ide^^
2. Analgesics,antipyretics,Nonsteroldal antiinflammat or/
Drugs and drugs used to treat Gout <,
Ifon- op i old s
. ■ agetyIs.alicylic
■^ibuprofen
ind omet acin
para, cet amo 1
tablet 100~500mg, suppository,
5O-15Omg poed Aspirin
A
tablet 200mg
capsule or tablet 25 mg
tablet 100-5OOmg,suppository 100m
+ syp
A
%.•,9piold.2^-ist s
(P h e ny lb ut a z on e.) / 0 xyp h enb ut a z on e
inj 10mg(sulfate or hydrochloride)
morphine(1)
in 1 ml ampoule
A
pethidine He 1 5ml/ml
3# Antiallergics
* c.h 1 orp h enamine
tablet 4mg(maleate)
inj 10mg in 1ml ampoule
epimiephrine
inj 1mg(as hydrochloride in 1ml
ampoule
A
i
|A
i
/ .b 13 £
tiation dcsage
f o rm s a nd s i -r e ng ths
£ B f
Emfo
G E
c it
Uo.it
A il II
1*, Arij.iaotes .afth..other substanoes iig ed in poisonin S
4. 1 General
l....
<
chare oal? act ivat ed
Powder
A
4.2 specific
atropine
diazepam
5.Ant iep ilept ic s
phenobarb it al (1)
inj 1mg(sulfate)in 1ml ampoule
ini 5mg/ml in 2ml ampoule
A
B
tablet 5Ong,1OOmg,syp 15mg/5ml
capsule or tablet 25mg,1OOmg(sodium,
inj 50mg(sodium salt/ml in 5ml v?a±t
B
• |
phenyt .in
i
C
0
i
i
6. JAntiinfective drugs
6.1 hathelmint.ic drugs
ineLend azZole
i
tablet 100mg
A
piperazine
tablet 500mg(citrate or adipate)
senna tablet Xlevamisol)II tablet elexir.
hlexir or syp (as citrate)equivalent I
A
B
to SOOmg hydrate/5ml
5
6^2 ..totiariodj ic drugs
chloroquine
diloxand.de ■.
tablet 200mg(as phosphat e or sulfate)
tablet 500mg(furoate)
A
B
B
metronidasole . .
’
tablet 2OO-5OOmg
dehyro emetine(B)X1,7) inj 60mg(hydrochloride)in 1ml ampodle
furazolidine
inj 60mg
B
A
pt h alyl, gulp hath i azole
I
II
i
«^-= - • -V—'•
F1M1IL~_--------------- -----
jl.-tui
-I
-r-
..........................................
<»■>—*
G o5"? r-1 ‘ i o nt aiy 1 i st
Main 11 £t-
6.3 Ant it act ejriald rugs
“
‘
1 Penicillins
* ample illin(4 )
.
-------
*•»
nout
of adminisi- rat 1 on d osage
f oriiis a nd st r etigt hs
4st :ld>5-tIcaC! LoV
Em 14
5
PQ 1SL G- • E i ;ii
post
lest
----------- L4—
6S ..............
Capsule or tablet 25Omg,5OOmg
(annydrous)I
powder for oral suspension 125mg
(anhydrous)/5ml
powder for ini 500mg(as sodium
salt) I in vial
b enzathine benzylpenicillin(5)
inj 1.44mg benzylpencillin
fortified benzyl penicillin
procaine benzyl penicillin 30000
u/ml + benzyl
pencillin 10000 u/ml
powder for inj O.Sg
Imllion IU) 30Og(=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)
3g(=3 million IU)
n'sylpeni c ill i n
phenoxyisethyl penicillin
procaine benzyl penicillin(7)
6. 4Qtiinfective. drugs
j
6.372^ other antibacterial drugs
I
•^chloramphenicol(7.)
capsule 250mg
powder for inj 1g(as sodium succinate)
in vial
capsule
ort
ablet
250mg(as
lactoerythromycin
b i onate )/-5ml
powder for inj 500mg(as lactobionate) in vial
ini 10mgo40mg(as sulfate)/ml in
*g ent amjc in (4)
2ml vial
i
tablet 2OO-5OOmg
m e t i' on id a z o 1 e
B
B
B
B
J
B .
B
B
B
J
0
C
B
lie’;
u g;.i p 1 gl. e nt a xy list
.^.S.ul£adi.audine..(4) (sulphadiazine)
* s nl fto e t h. o xa z o 1 e +1 r im e t h op r im ( 4)
Route oi administ rat ion dosage
f o rm s a nd st r eng t h s
4 st L^siiCMC
’ ■
L ow
A
ilita_______ $Ost PU1G-1
inj BOOmg in 100ml
Suppository BOOmg, 1g
tablet BOOmg,oral suspension ^O0mg/
inj 1g(sodium salt)in Jml ampoule
tablet 100mg+20mg,400mg+80mg
A
B
SI G E >1 C I
II
A
B
t .et rag vc 1 in e (4.)
doxycyline(B)(5/6)
capsule or tablet 2B0mg( hydrochi or .de)
capsule or tablet 100mg(as hydrochiloride)
inj 100mg(as hydrochloride)/Bml in
A^r2£l££arjiP2iLlA»B) (4,7) tablet 100mg
ampoule
Hyd r o xy Q. ui n o 1 in e s
100mg tablet
• 3*3 Antilepr ^.sy c rugs
clofazimine
capsule 1OOmg
dapsone •
tablet 5Omg91OOmg
rifampicin
et ham_t>>nt ol
pyrazinamide
0
. A
. 0
capsule or tablet 15Omg/3OOmg
66* 3 *4 Ant it ub ereulosis drugs
t ab let 100- 5 OOmg (hyd r oc hl. or id e)
isoriiazid
-
. c
tablet 100-300mg
B
tablet BOOrpg
0
rifampicin
’capsule or tablet 1B0mg,300mg
. c
s-L£gp. Istf yfiia (4)
thiQacetazone^is ohiazid
povvder for inj 1g(as sulfate)trivial
• B
. B
B
tablet BOmgrlOOing, 1 BOmg+JOOmg
Thiacetazone
$ ,.4 . Ant if'ilnj^a^l^^rug^s
■
tablet BOng(citrate)
6.5 Antifungal J^rugs
nystatin
*
B
C
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s od iun st ib ogl uc onat e
pentanidi’-ie
6.7 .Lntarial
Cosrpu?Gi SL
B I 11
0
E
inj 33% equivalent of 10% antinomy
in 30d1
povjder for inj 200ng in vial
(0
0
tablet 150ng(as phosphate or
syrup 50mg(as phosphate or sulfa
,
/ 5nl
tablet
yi
j
tablet 300r.ig(as bhsulfate or
inj 300iiig(as di&yirScSloride)/
ml in 2..il ampoule
primaquine
B
B
B
p y rqoet ban i n e
sulfadoxine+pyrimethamine(B) tablet 500iig+25ng
7• Antimigraine drugs
tablet 2.ag(as tartrate)
ergotamine(2,7)
10-1.BAQod ?drugs affect.ing__t.he___blQQ.d10.1 An'u i ana co i a d rug s
tablet equivalent to 60ng iron
ferrous salt A
(as sulfate or fumarate)
oral solution equivalent to 15mg
iron(as sulfate)in 0.6ml
tablet
1mg
folic acid(2)
inj 1mg(as sodium salt)in 1i.il amoul
inj 1mg in 1nl ampoule
*hydroxoc obala.uin( 2)
inj equivalent to 50mg iron/ml
*iron dartran(B)(5)
in 2ml ampoule
1 2. ~ JJ a rd i. oy. . s sculax drugs
1271 intioig inal drug&
I
t?blet (sublingual)0.5ng
~!
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t ablet(s ub1ingual)5ng
t ablet 10ng,40ug(hydrochloride)
inj 1ng(hydrochloride)in 1nl anponle
tablet 40ng,80ng(hydrochioride)
in j 2.5ng/nl(hyd rochlorid e)in_ 2nl
*isosorbide dinitr?,to
*
propranolol
*verapam.l
C
0
Q
c^.-drugs
*procaina:.iid -o
---- --------- Tablet 250ng 9 500mg (hydrochlorid e)
inj 100sg(hydrochloride)/i2l in
lOrol anpoule
12.3 Antihypertensive drugs
12^2.
—
*hyd ral a z in e ■“ —-
e t 5 Ong (hud r oc hl or id e) 11
*hydrochlorothiazine
tablet 50ng
•^propranolol
tablet 40ag J,80ng( hyd rochl or ide)
tablet 0.1ng,0.25ng
inj log in 1ml ampoule
*reserpirw(A)(?)
digaxin(4)
C
B
Q
1 2.4_. Cardiac JR/eosides
-------- —n tablet 0.0625 mg,0.25mg
oral solution 0.25 ng/nl
inj O.25mg/nl in 1ml ampoule
12.5 Brw£s use"3 •in s hock or anaphylaxis
epinephrine
: ilj^lmg(as hydrochloride)in Inlanpoule
*
>Ui —.1 » ■■-
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t Wl
IMBIOTMO '■ •
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inj^mephent eramine ..sulpriatp
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;
?
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1 5mg/ml
C
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>
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ol0.1 c al d rugs
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acid + salicylicao^d'
“* : ‘
Whitfield oX^OQ^a^hi)
’ ' ‘ ”
15.2
L. ;.j. • ,.-ct ? 7€ drugs
j: ..-i’L * o Ita . n
ointrent 5mg neomycin sulfat e+500Il
b a c it r- ■ ■: in sin z/g ■
B
B
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Hin last
C o ip 1
e nt a ry list
^iJs^CMClow [ •
]
Route of adi. inis'eration dosage 1 i)st B
(SostfTUPGI ST
forms and strengths
Bare:
!
E
4 I II;
c
----------------------—----- *------
t et racycline ointment
ch1oramph enic ol
1 3 3. Antiinflaqmatqry_ajid_antj^ruritic jlrugs
071%(as valerlte)
*betamet ha z one(3)
oointmentor~creab
intnent
*calanine lotion
lotion
*hydrocortis one
B
B
B
ointment or cream 1%(acetate)
1 3.5...K£rat opla£ t io and kerat olyticn.agents
solution topical 5%
1 3*o Scabicides and...p idiculicid es
b eiizvl. benzoate
lotion 25%
B
salicylic acid
1 lx. i^no^ic_a^jjnt £
tub ere ulin ? purified
p urifi ad ‘ p’roti
fdfieh
en
d erivative (BPD)
fluroesc 3in
14.1 Ophthalmic d rug s
A
injection
B
eye drops 1%(sodiua salt)
C
solution 5%(gloonate)for dilution.
solution 2.5%
B
o ■ B isinf ect a.i5
*chlorhexidine
-iodine
16. 1Diuretics
'
. B
tablet 4Gag
in j IGag/al in 1al aapoule
*hydr ochlorot mi azide
tablet 5Ong
. B
Gastrointestinal drugs
.
«...
tablet 500mg
al Ui i niiur i hyd r ox iu e (.Lj
oral suspension 320ing/5ml
n agn e s iua hyd r oxide-
oral suspension equivalent to
550ng magnesium oxide/IOrl
*prooTethaziae( A) 17.2 Anti emetic dngs tablet tOmg., 25mg I hydrochloride)?
-■loril.)
QAlorpino
< 71 oy■? J,
A
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17.5
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A
B'
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piKls..
AM A II II
B
4.
&eavrtefrpid^l.d ru^8
♦local anacsth.etics astringent
and ant iinflac..;at ory drug ’ '
ointment or suppository
Oxyphenoniu/i bronide
*at roping (Hat hi) 17.4 Ahti spasmodic drugs tablet 1i?g( sulfate)
.
inj Ing(sulfate in 1nl anpoule
17.6.1
i7.6.1 Ant idAri Ao§.a;IIaympt
aynptomQilcJd
ojnajic.) drygs
rygs
tablet 30n. (phosphate)
,
*codSine(1)
B
oral rehydrationn 1_2.sj5.s_2 Replacement solution
salts(for glucose-salt solution)
/p ec ac uanha
antiflatulert
activated chare pal
3
A
I
A
ganna benzene hexactiloride(A)
s olut ion
f
iQ* .Hornones
*18*1 Jdfenhl’ hoenoi es and synthetic substitutes
*d exanothas one
r.ic
tablet 0.5ng,4mg
inj 4ng(sodiun phosphate)in 1ml
ampoule
^.qlriisoione ;
tablet 5ng
*et hinyl.est rad i ol 18 < 3_.^strog( ns'
• tablet 0.05ng
*glibenclaaida
iaa.nlino^
11.4 InsuJ.ins and_ pt her ant id ab et ic agent s
tablet 5ng
V
J?olubutrinide, r
injection
0 al o rp r op ati 1 d. e
18.5 Oral contxacunlives
et hi nyil^st rad ip J.
tablet O.O3r:g+15Dg+o. 25ng
trnw.— -at ,
AdAAlmx/-'
0
0
C
0
c
n^ri, .
I c
<. J.
-y list
" 'I i striWfund 1'1 o “
v linn e oi
.mist mt ion doso^e
f ore■ s •nd s t r engt h s.
Emro
r
jCosV PUPGI SL
B
• -x ~ J_.'
18 • Q . Ihyroid horig ongg -ipB^ant ihyd r oid d rugs
levothyroxine
tablet 0.05^-g$0.1mg( sodium salt)
potassium iodide
tablet 60mg
tablet
*propylthieuracil
i
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i
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eye ointment 10$(sodium salt)
*tetracyclinecchloramphenicoi’
solution(eye drops)10% sodium salt
1 B
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i
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B
i
I
i
i
sulfacetamide
^1-
I
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I
Qpil-iln- ologh cal preparations
silver nitratev21.1 antiinfectivo agents solution/eye drops) 1%
eye ointment 1% (hydrochloride)
.ini 1 n.flammatpry jgpnt s
i
t
I
19.2.2 cholera TAEC9small pox
21.2
I
II
I
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inj)
vaccine.(liveattenuated )inj/oral solution
I
0
*
Immun ol og
eg iicals
c als
Ippunol
ant ivenom sera 19. t Sera’and aim one ^1q ulins
all plasma fractions should
, comply with V/HO requirements
diptheria antitoxin
inj) for the collection?processirg
) and quality control of humai
) blood and blood products
inj)10000 IU
20000 IU in vial
•t. e t anus ..ant it pxin
inj 50000 IU in vial
19.2 Vaccines
1.9# 2^ 1. if or universal. Jmounizat ion
BOG vaccine(dried)
inj )all vaccines should.<comply ^ith
BapW
etanus_ci;.Q.GUn.e.inj ) tne WHO requirements for
diphtheria-tetanus vaccine
inj) kiol|pical substances•
t etanus vac cine (WHO 9 Hat hi)
LE
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forms and strengths <>
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1
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f
*
pilocarpine
c.
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2J...4_Niot.ics
solution (eye d rops) 2%?4%(hydroclc ride or nitrate)
2 • 5 Myd r<<£t ic s
Wsiost^mine^^x;
$ Oiiat rgapinej A )
i
i
solution( eye drops)2%(hydrobrodiide)
22. Oxyt ocio s
* erg OEiet nine
oxytpcin
24
<*chl-orp r oxazine
tablet 0.2ng(naleate),
in j 0.2ng Inal eat e)m 1ml
1.^1 ampoule
anpoule
imj 10 IU in 1nl ampoule ■
Payehotherap out ic drugs
tablet 100mg(hydroohloride)
syrup 25mg(xhydroehloride)/5nl
inj 25mg (hydrochi or id e)ni in 2 ml
*diazepan
Ar.
tablet 5 ng
ampoule
ory tract y di'ugs acting on
* an in op hy1 ?l in e 2 5 1 a nt ia s t nm aT i c ” S i ug s ' " ' '
tablets 200ng
inj 25ng/ml in 10ml ampoule
i
;
epinephrine
inj 1mg(as hydrochloride)in 1ml
aiip o u 1 e
*salb ut an ol
' t ab1et 4ng(s ulfat e)
oral inhalation(aerosol)0.leg pci.
syrup 2Eg(sulfate)/Sal
loss
adrc-nalin tartarate vallate in 1000
i
t
i
0
I
* i
I
J
J
t
cl
I
i
C
phenjjbo.rd 5-g, cphtdr.-Jne 10r.g,
t.il.e.ppbyliuo. pgi (S§.thi)
nos cap inc (cough, suppressant)
ephedrine.(h)
i
B
j
3
tablet JOng(as hydrochlorid e)
9
I
i
I
i
o X 0 1 1 . o o
Cp 1 c;.:onLary list
xlain 1 ist
T
Route of administration dosage
forris and st rengtrhs»
lisi listCW
low i
B
r^_44
costjPU pGI SL G E AM I I II c
Et. ro
Jointions con ecting water, electrolyte and acid-bas'
disturbance;.
-oral rehydratio^oSal£s?ior
"Iucoe e-salt solution) (for conpositon see
17.6,2 replacement solution)
p ot a s s i wa c hl or id e
oral solution
glucose' (dextrose)26,2 Parenteral injectable solution5% isotonic, 50%
hyp&rtonic
glus ose_igith_ s odiua chi arid
injectable solution 4% glucose 0.18
sodiun chloride
(Na+Onnpl/1) (01-50 nnol/1)
p ot as s iun chiorid e
injectable solution
sodiuD bicarbonate
Sodiur. chloride (cholera fluid)
calcium carbonate gluconate
water for injection
27. Vitamins and
ascorbic acid
*ergocalciferol
A
B
B
B
B
"
" 1.4% isonic(Na+167 nc ol/D
(HC05-167 rmol/1)
injectable solution 0.9% isotonic(
(1^+154 nool/l) (01-154 nmol/1)
in 2.ml,5ml, lOml ampoules
rib oflavin
s od iuh fl ui**:d e (8)
vit ami n . &JX
vi.t B cu;n.lox (Prophylactic KPI therapeutic NBI with Vit 0+ folic acid)
4- injection)
tablet +
3 12(iiathi)
.:i n
I
B
B
I
I
eineraIs
....~TaFTet 5Ong
capsule or tablet 1.25ng(5OOOO IU)
oral solution .25ng/nl(10000 IU)
tablet 5Ong
tablet 25ng(hydrochloride)
capsule or tablet 7.5ng(25000 IU),
60mg( 20000 IU()
oral solution 15ng/nl(5000 IU)tab.5n y
tablet 0<,5ng(
0.5mg(as fludride)
*nic ot ina.uid e
pyridoxine
^otinoA
1
i
B
A
t
t
i
B
i
xl
»
I
B
B
A
A
B
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area
New Delhi-110016
'V \
Cl M
V\
Telegrams : VOLHEALTH
New Delhi-110016
/o,
.3-344
Telephones :
“7;723™85
PRIORITY DRUG LIST AS SELECTED BY NATIONAL
DRUGS AND PHARMACEUTICALS DEVELOPMENT COUNCIL
THE STEERING COMMITTEE
MINISTRY OF CHEMICALS ANTD FERTILIZERS
GOVERNMENT OF INDIA
AUGUSTt 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)
Ch 1 o rphe ne r ami ne
10)
Epinephrine
ANTI—INFECTIVES
11)
12)
13)
AntheImi ntic
(a)
Mebendazole *
Piperazine
Behphenium Hydroxy Naphthoate
(b)
Antiomoebic
16)
Chloroquine
Metronidazole
Ampicillin
17)
Benzathine Bonzyl PenciIlin
18)
19)
20)
Benzyl Pencillin
Procaine Benzyl Pencillin
Chloramphenicol
21)
22)
Sulphadimidine
Sulphamethoxazole
14)
’15)
cont’d
2
s
• 344
2
25.
Trims thoprim
Tetracyclines
Oxytetracyline
26.
E ryth romyc i n
23.
24.
Anti-Leprosy
27.
28.
29.
Chlofazimino
Dapsone
Rifampicin
ANTI-TB
31.
Ethambutol
Isoniazide
32.
33.
34.
Pyrazinamide
Streptomyc i n
Thiacetazone
30.
ANTI-FILARIAL
35.
Diethylcarbamazine
ANTI-FUNGAL
36. Griseofulvin
ANTI-MALARIAL
Primaquine
38. Amodiaquine
IMMUNO-SUPPRESSIVE
37.
39.
Busulphan
40.
41.
42.
Ch1orambuci1
Cyc1opho shamide
Flurouracil
ANTIANAEMIC
43.
44.
45.
Ferrous Salts *
Folic
Acid
Hyd roxoc ob a 1 ami ne/Cyanoc ob a 1 ami ne
cont’d •• 3
t
. -344
s
3
s
PLASMA SUBSTITUTE
46. Dextran
CARDIO VASCULAR
47.
48.
49.
50.
Glyceryl trinitrate
Isosorbide dinitrate
Propranolol
Verapanil
51.
Hydrallazine
Hydrochlorothi azide
52.
53.
54.
Methyl dopa
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
&'■
GASTRO-INTENTINAL
66.
67.
Premethazine
Oral Rehydration Salts (deleted in the
meeting of Steering Committee)
cont’d .. 4
*
%
• 344
2
4
S
HORMONES
68.
Dex ame th a s o ne
69.
Prednisolone
ORAL CONTRACEPTIVES
70. Ethinyl Oestradrol
71. Leveno grge s tro1
72. Ne re th i s t e ro ne
ANTI-DIABETICS
73. Insulins
74.
75.
76.
Glybenelamide
Chlorop rop ami d e
Tolbutamide
MUSCLE
77.
78.
RELAXANTS
Neostigmine
Sux ame thomi urn
OXYTOCICS
79.
Ergometrine/methyl orgomotrino
80.
Oxytocin
PSYCHOTHERAPY DRUGS
81.
Ami triotyli ne/lmipyrami ne
82.
Chlorpromazinol (substituted)
83.
Trifluperazine
RESPIRATORY
84. Aminophyllin/theophyllin
85.
86.
Hydroxy Ethyl Theophyllin
Salbutamol *
87.
Ephedrine
cont’d.. 5
4
t
■34
5
s
VITAMINS
88.
Vitamin A
89.
Vitamin D
90.
Vitamin C
91.
B Vitamins Nicotinamide
92.
Pyridoxide
93.
94.
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
%
Telegrams : VOLHEALTH
!/
New Delhi-110016
ld.\
Telephones : bboU72
...34 4
---2319.85
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.
This letter is being sent to you to obtain
your expert views on
(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
2
3
■. j
Q
t§
<■
o <5
- LU fi
« is
i.-
s
85
2
2
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
Drugs & Pharmaceutical Council Working
National Drug
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".
(2) Quoting Dr Halfden Mahler, Director General, W.H.O.
I '1°
nnL*0
"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 irretrievably5, •
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
72TT5TS5
s
3
Needless to say that prices of drugs
outside this essential drug list will be decontrolled
and shoot upz 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*
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 regardsz
Yours sincerely.
Dr Mira Bniva/ MoD.
Coordinator
Low Cost Drugs & Rational Therapeutics
ends s as above
^Indian Academy of Paediatrics/ Gorakhpur/ UP
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area
New Delhi-110016
/X'
Telegrams': VOLHEALTH
c
tn M
\
0
New Delhi-110016
. .
668071
Telephones : 66go72
/14.10.85
V
October 14, 1985
Subjects/ US BILL to allow export
from UNITED 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 BILL1, 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 ?
•) Sen Edward Kennedy
US Senate
113 Russel Senate
Office Buildings
Washington DC 20510,
USA
and if possible a copy to s
Ij) Mr Joe Coffman
Public Citizen
Congress Watch
215 Pennsylvania Ave
Washington DC 20003
cont’d
M’-ALTH CELL
47/a, (riru; ; ?w
Hoad
BANGA4.OHe-5uu uOi
2
-10/344
s
2
s
2) 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.
1;ast 'Drug Action Network' newsletter
-we nad informed you all about the U.N. consolidated
list of hazardous drugs and chemicals which have been
banned or restricted.
There is a move to EXCLUDE the brand name
and the manufacturing data and also to exclude drugs
t2aLW?re recommended for being weeded out because
of 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 followingf s
1) 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.
united
playing a major role in compilation of the 1986
consolidated list.
con’d..3
ir
3
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 ?
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 'ALERT1 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,
/j
:'f /
Dr Mira'Shiva
Coordinator, Low Cost Drugs &
Rational Therapeutics
&
All India Drug Action Network
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New Delhi-110016
^<^@w^6elhi -110016
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Telephones . 668072
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E-10/344
MsJs5.11«1985o
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
TD
a
Sri Lanka. Following an alert sounded by VHAI it came from
j °
the Consumer Guidance Society of India, Medico Friends Circles, 5 ccV) vArogya Dakshata Mandal, Consumer Education Research Section,
-r- fl o
Catholic Hospital Association of India, KSSP and other member
o
E 2 r.3
organizations of The All India Drug Action Network. Drug
< w
IA Lfl
Action Forum, West Bengal one of the coordinating Committee
X
U
members of AIDAN had organized a ’morcha' in Calcutta in
6
o
protest.
H 0
2 t$
2 U 3
Health Action International played an important role in
2 t -42
first world groups informed about the implications
5 tu ca
of the Bill
oQ rand their social responsibilities. I2_.
Many first
world groups joined hands with the third world KjGOs in
Gr
expressing their concern. P
’ "' interest groups in U.S. played
Public
a key role. After all the public outcry.j 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
’..’ith "<
"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
patients is consistent with’ toJs^benigr^X^o™’^43
™alethVS:reS WOUla
?
h’a
allowed i£ 1 flrs?
The third tier would constitute of all other countries
to which export would not be authorized except of druos for
tropical diseases.
y
contd....2
a
E-10/344
2
MsJs5.11.1985
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 prescription 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.
coBjtd. • o 3
E-10/344
3
MsJs5.11.1985.
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 1982.
(Dr. Mira Shiva)
Coordinator
Low Cost Drugs and Rational Therapeutics
Convenor
All India Drug Action Network
5?^
O
-- "E-4 l/378
11.85
ALL INDIz^ DRUG ACTION NETWORK
NEEDED INTERVENTION IN THE NATIONAL DRUG POLICY <»
Dear Friends^
M°sL°f y°u are already aware of the exploitative functioning
of the pharmaceutical companies in third world countries.
You are also aware that the National Drug Policy is under
formuiation. The outcome will be mainly decided by the pressure
and 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
looked into the mere pricing and production aspects of the
drug problem and that too from the point of the drug industry.
There is a r
'
strong
possibility that the National Drug Policy will
be like the Textile Policy.
It is crucial that the peoples interest 1^
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 oSteering 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
friends, your organisations network and request them to take
whatever action they can take. From writing protest letters
invoived, to editors in holding meetings.
Since medicines deal with health and
and lives
lives of
of people
people and
and no
matter what area of work you all are involved in - if you could
drop
a to
letter
policy
ttei? concerning your
y°ur views about a people oriented drug
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-4/378
2 MsJ:5.11.85
with a*copy to me. Your contribution would be deeply appreci. tod
and would make a GREAT DIFFERENCE.
Our demands are very rational and fundamental.
of essential and life su.i..
aving drugs (i. e. ade-?r/ -■ t
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).
Adequate Quality Control and Drug Contro1
(so that every Sth drug in the market is not substandard as
it is at present according to Government's own figures, an.
has^oTF^sured?^ 6XiSting drug control:mechanism ' -
Drug „j-_^9
legislation
.DE!Ag.
lsfatJ-Qn reform
need to prevent drug companies
from misusing legalistic loopholes against the people.
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
nowing 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, ensuring drug distribution has been TOTALLY
contd.... 3
r
%
E-4/378
Msj75.ll.1985
3
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.
Ends AIDAN
RDP Report
(DR. MIRA SHIVA)
Coordinator
Low Cost Drugs & Rational Therapeutics
and convenor
All India Drug Action Network
Note s
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.
a list of drugs that are hazardous and irrational/has notdome.
Failure in monitoring exact mode of drug use misuse and
drug shortages will prevent identification of problem areas and
formulation of functional strategies that are required.
E-10/344
•TBsSM?
8.11.1985
,?aar 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
]3atient
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 heel’i ■
personnel, policy makers druggists and chemists a.iif
consumer groups in rational drug was registered.
I felt and still feel that our energies have to b-.
focussed in key intervention areas. Preparing dr ;
education material for individual patients in my
mind is neither strategically sound, nor effect!' e
and feasible with the drug education. Communicator
can turning to be indifferent, ignorant or corrupt..
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’s
preparation of drug education material.
Mate ri al
Drug
no1joy
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 Chemic.-i
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 drugso
(First Ft
fiAAlGAtOi^E
I
V
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 dedicating it to Dr. *oTle
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 Group 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 covered at
the Ne i rohi mo-oti na .
1. Sources Types and availability of infonwti.on.
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 accessible0
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 FOR A RATIONAL DRUG POLICY
I he 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
the
over
use of expensive, irrational and even harmful preparations in most countries
of the region.
This situation has arisen as a result of unethical
drug industry, particularly the multinational
practices of the private
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
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
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bodies and lack of quality assurance facilities.
TJ
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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
!
<
w C5
6 r-?
rs
2
-
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.
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 of- 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
if
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 assurance
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
-1 "
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 t<o continue to apologize for it till it
actually comes out).
There was a ?lot of- 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 Drug Policy. The need to make written
complaints was emphasised.
A need for an URGENT SURVEY to document the existing
^a^eting situation regarding banned drugs was unanimously
The NEED j?0 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 givingJ name.
name, the content and
m^nufacture as part.if 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 ih: the Banned Brand Drug List.
THIS INFORMATION IS CRITICAL FOR JUSTIFYING AW 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. IWe
’ cannot
.’
afford to be ill informed
about the present situation
-a regarding banned drugs, at
least in our own areas. r
’’
Please
take this as a priority
request and respond at the earliest.
If needed, all expenses will be reimbursed by VHAI._ _ For
hazardous drugs campaign 4 drugs were selected for future
action"
- EP drugs
- An'abolic Steroids
- Chloramphenicol
Streptomycin
- Analgin
Dr.Mira Shiva
Dr. Pawan
VHAI
Dr. Sarkar
ACASH
DAF«WB
Dr.Dane
Cheenu
ADM &
LOCOST
Preparation of material for following 2 other drugs would
also be undertaken side by side
'
©
- Streptomycin-Penicillin
- Diadoquin
contd.o o o
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. Anil Pilgankar would compile information
alternatives to injectable analgin <and compare the costs,
side-effects
<
~
availability
scope for misuse,
r existence of
better substitution
---- i etc.
The fact that the book is being brought, out in public
interest for health safety and education should be stated
m 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 eimbay 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 VH^I a high priority
has been given to this, <as reflected in the paper Essential
Drug need for prioritization,, documentation
C
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
2. Data availability
documenting shortages.
Pawan
Cheenu
ACASH
LOCOST
3. Vit1 A' , iodized salt
Mira Shiva
VHAI
4. Phenobarbitone
Ashwin
MFC
Since production of such material would require presence of
these communication skills, a workshop
l bringing together
potential producers 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. All those interested in contributing and partici
pating please inform:
contd....
7
Dr.Ullhas Jajjoo
Reader - Medicine
Sewa Gram Medical College
Wardha-442102
(with a c°py to :
Dr.Mira Shiva, 14-c, C
Community Centre,
Safdirjung Development- Area, N.Delhi-110016)
Listing of existing material
A^ request
was made to all the AI^AN members to give a
list
nt
list
of
all
the drug material, articles posters etc. produced
t,
by them.
r
'"
- * Compilation
of all such material was needed to
facilitate exchange and for categorization of the material
according to key subjects areas is needed.
e.g. 1. Diarrhea campaign and rational
diarrhea care
2. ORT drugs
3. Rational Drug Policy etc.
Organizations that have brought cout a large amount of such
material e.g.^Arogya Dakshata Mandal,
’ r MFC, LOCOST, DAF-IVB,
VHAI are.specially requested to do so. An attempt to prepare
such a list as recommended reading has been
. _-i made by VHAI in the
tne Banned Brand Drug List.
?Sed tO keep each othsr
other informed
informed and
and sending
sending of
of
complimentary copies
of
all
p'
'
•
---------- material produced to the
coordinating Committee, if
‘" possible was stressed.
The need to promote feach others drug and health education
material was also emphasised.
There is ra great
;-- * scope to promote Pune Journal, DAF.WB’s
Rational Drug Therapy newsletter,, MFC* s rational analgesic
and anti-diarrheal study etc. VHAI* s Banned Brand Drug List.
A mention of AIDAN on drug related material being oroduced
by the members would be in keeping with the ethos of
c llective functioning and it cannot be made mandatory
I
°Ut thet while g^ing references - material
and referSd°SerS AIDAN members' if
should be quoted
and referred to increase each others credibility.
Material in the Pipeline
D AF. T/7B
KSSP
VHAI
Rational Drug Therapy (Quarterly)
Video in Bengali on drugs
Report on a decade after Hathi Committee
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.
lo
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
e<j 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 rgioney. 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 organization 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 E&AIDAN Diary
By 20th Feb. RDP related material to reach Dr. Rane
21st
- Parliament Budget Session starts.
- DAF.WB convention
22nd
7th Mar - Editorial Committee meets in Bombay to finalize
RDP draft.
8th Mar - Women's Day
15th Mar- Consumer Rights Day
contd....
10
Lau.nching 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.
23rd May
Dr. 01le Hansson1s 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 Parliament.
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 D.Advani
H.K. House
6th floor.
Ashram Road
Ahmedabad-9
Law
3. T.Vijayendra
B-2, Marg 2, Saket
New Delhi-110017
Information of
Consumer level.
4. Sashidharan EeM.
C/o Friends Society.
Fatehganj Main Road
Baroda-390002
ORS (ORT)
5
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.
Ravindra R.P.
6. Karunakono
Pattnayak
Comprehensive Health Community
Community Health
and Development
Project,PO PACHOD,
Aurangabad-432121 .
contd
si
r
11
7. Meena Dalal
V-305 Sunder Nagar
Malad (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.
VHAI
Rational Drug Policy
C-14,Community Centre and Rational Drug
S.D.A.
Use
New Delhi-110016.
Mira Shiva
12. Wishwas V.Rane
2117 Sadashiv Peth
Pune
Health Education
13. Pawan R.Sureka
Vl/505 Sunder Nagar
Malad (W)
Bombay-400064
Promoting RDP
among Health
Professionals .
i
7
r
NATIONAL DRUG POLICY UPDATE
According to recently available information, the
Essential drug list has been further slashed down to 65
drugs from 95
rest.
-
meaning virtual orice decontrol of the
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 Policy 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
An S.O.S. for your views and your presencemay be
sent according to the contents of draft. Concerted action
of it.
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.; 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.
.-.Sr
On behalf of the doctors, a private practitioner from
Sri Lanka who also has connections with Pfizer and
" 3.
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
74*t meets a medical need and is comparatively superior to
what exists 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 details.
contd.oooo.2
66°
>
;;k;-
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 ISth
a meeting between Dr. Zafrullah and the Prime Minister
will be arranged.
AIDAN
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 come, 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.
--
ALSRT
(Confidential'
I also want to inform you that Dr. Joseph Daniel of
Bombay came to the Madras meeting self invited and
he told Dr. Pram John, Coordinator, '•-.CHAN 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.
■
His hotel bill was naid by Infar i.e. Organon.
Dr. Joseph should not be invited to any of the AIDAN
meetings and tht fact that we are aware of all this
should not be known to him. He should be closely
oh^oived.
We will be intensifying the
nrnxo
1 ‘ji
mu
t $ o.<»
how to go about it were discussed, post Madras meeting between
Dr.zafrullah. Dr. oasem, Amitava Guha, Dr. Ekbal.
Your suggestions in formalizing the plans in planning out Asian region
apd national level and local level drug action would be very helpful.
With warm regards,
Encl °o AIDAN Statement
DAN newsletter
Madras Declaration
Sln/F^.
(Dr. Mifa Shiva)
Convenor
All India Drug Action Network
D 3 - <2 &
'S
4
•
MffiOTUIWai
Wej 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 foodI, 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, wo
believe that a 1 Rational Drug Policy1 is an ihtegral 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 major!tv can
afford.
We urge our government to accept and implement the Hath! Ccmmittcc
Recommendations which are also in koop-i nsr wi+.h
tjito o.-xj.-->.x.—
...
a Rational Drug Policy.
Further the national drug formulary should be revised and compiled, by.
an export multi dixiplin-inz committee keeping the 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 pGlicjr 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 a.s 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 net bo submitted for clinical trial or marketing
in India. TFic onus of proving why a non-essential drug should be intro
duced or allowed to continue on the market should be with the ma.nuf3.cturer 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 be incor
porated to serve the objectives of the national drug policy and there
should be n^ levies, sales tax or excise duty on any phamaceutical pro
duct in the essential drugs list by the Central or State governments.
11. No tochnclogy transfer agreement shall be legal, and binding which cont
ains restrictive practices, disproportionate and unnoCossars’- use of
imported intermediaries or obsolete technologies or unfair arrangements
with respect to prices,■payments or repatriation of profits.
12. The Nati'..-na.l Drug Policy should state clearly the steps towards a
complete abolition of brand names and as a first step use of generic
names should bo made ccmpulsory in medical education, prescribing and
labelling of drugs. Generic names should appear more prominently on all
packagings
<r
-.2..
13. It shall be the primniy 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 cc?ntrcl authorities to inform
health personnel and pons unions cf the essential drugs lists, policies,
categories or brands0 drugs banned for manufacture or sale, through pub
licationin the national newspapers, magazines, medical journals with
adequate explanations and details.
15. A-trco 1 'sW 1-i fy of drugs required in the Governments National Programmes
sh-'uld 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 tc be effective.
16. In all review committees, statutory bodies and ether 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,1DMA, IFPMA, VJe deplore
the tendency of those companies and associations to get around every
progressive measure of the government through re ccursetQtechni call ties of
the law and through the courts.
18. The marketing code drawn up by HAI(Health Action International) should
form the bosis for a National Code for Marketing Practices. This should
be accepted by cur government and should be suitable implemented through
legislation,
19. The government cf India should take a lead and endeavour tc influence
the v'JHA and VJHO to adopt the Code in the interests of the other develc*ping countin os and their peoples.
(IFPMA and HAI 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 Dakshata Mandal
- Lok Vigyan Sanghatana
- Consumer Guidance Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of India#
*♦
E-4/377
MS7jb75'.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 being held in Khandala
and since the drug action groups old and new from Bombay,
Pune etc. not met togethert a western region AIDAN meeting
was contemplated. The agenda items had been circulated
earlier to the AIDAN members (please see communication-I
and communication-ll 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 s
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, AIDAN'S role and structure.
7O Time schedule for all activities.
1. 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 belowc
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
Al
A2
Bl
Essential Drugs
Irrational Drugs
B2
Production & Price
Control
Registration and
Monitoring.
C
Drug Distribution
DI
Drug Information
Name of person
responsible
Dr. Mira Shiva
Dr.Sujit Das
Srinivasan
Organization
VHAI
DAFIVB *
LOCOST
Dinesh Abrol
DSF*
Amitava
(Fr.John)
Dr.Mira
Dr. Ekbal
FMRA
(CHAI)*
VHAI
KSSP*
D2(i-v) Unethical marketing
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
F
Research &
Narendra
Development
Mehrotra
G1
Drug Legislation
Rani Advani
labelling
Magic remedies.
02
National Drug &
Therapeutics
Authority.
Dr.Mira Shiva
H
Human Power Deve
lopment.
Dr.Mira Shiva
ACASH
MFC
LOCOST
DSF
SYS/NISTADS
CERC
VHAI
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, SadashiV7~^une-411Q30.
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 the 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 for bearing the printing cost and undertaking-
3
Effort at
the material
J™Mebe°maaI.the
r-
Lobbying with Policy Makers
While not all organizations felt much inclined
to undertake
this role, VHAI has given it high priority.
S^LSfamenXry^ Ind£st J
-^he^nstitSS^ofS
finalized Z^wn)?9 C°nSUltatlVe Committee is yet to be
The need to select socially conscious Parliamentarians
for
raising Questions in the Parliament, dealing with inadequate
replies was expressed.,
Publicity to,wrong replies and
challenging them should ■also be builtin.
procedures bv s Snr^fO^OrS. -A n°te °n using Parliamentary
been nren-red
for drug alSon?
' ■ n f the Liaison Division of VHAI has
”
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 <u
apprehension
that the drug policy may be brought
in and
passed
like the 4 bills passed in
.
irko
the last Parliament
Session ALL within 15 minutes, without any
discussion with
more than 50% MP’s not even attending the Sessions as a
routine.
*
Legal Action on Drug Front
Resoa^charL^S?Caate* W±k CERC (Cons™er Education and
druns
!
dlscussed the role of legal action where
drugs issue was concerned.
*
She stated that the Judiciary could not touch any
Parliamentary Procedure unless
--- the harmful effect of the
policies is shown.
The EP <Iki (brgh d°se_ 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 profound
- 1 concern.
vr^rDLOn?-diSCUSSiOn it W3S decided that Rani would file
a
ln Gujarat_High Court. ACASH in Bombay,
DAF. ,aJB m Calcutta could intervene in the cases filed bv
UNICHEM, NICHOLAS and ORGANON (Infar) respectively.
7
4
Rani said till the time judgement was given, intervention
could be made. Regarding 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 s
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 eutside;
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. :
-------- 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 o£ 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 majsr Drug action t-rarixpraign
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
3 3-a?
V
1
A
cc
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NEWSLETTER OF THE LOW COST DRUGS AND f
----------- ~THERAPEUTICS CELL
RATIONAL
VOLUNTARY HEALTH ASSOCIATION OF INDIA 014^ 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 Newsletter’.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 incorn orate 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
• Meeting with
'
Mr Vasant Sathe
4
•Dr Zafrullah Chowdhury
- Press Clippings
• Estimates Committee
»
Report
• FERA Companies
- equity dilution
• Drug Utilisation Study
6
9
10
12
network 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.
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.’S^.
This was organized by NISTADS to
utilize the opportunity presented
by Dr. Zafrullah’s presence in New
Delhi.
rThe
"
‘
organizations
represented were VHAI, Arogya Dakshata
Malndal, Lok Vidnyan Sanghatna,
Centre for Social Medicine and
Community HealthjJNU, Child in
Need Institute,Calcutta, CRHPt
Jamkhed.
please contact Dr. N. N.Mehrotra
at NISTADS, 12, Hillside Road,
New Delhi.
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.’85, 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
fajiled 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 ^ur 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 net dis about the meeting
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.
1
^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 action0
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 areaso
"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
wasteso In recognition of IOCU's
work in setting up the Interpol
system,Anwar Fazal received the
1982 Alternative Nobel Prize.
* Dr Pile Hanson (who was the
first to report the link between
clioquinol and optic neuritis and
had successfully challenged CibaGeigy’s claim that the drug is
not absorbed systemically) and
Mats Nillson, 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 23 ’’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
1983 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
Strychnine and caffeine in
5
tonics
4
Yohimbine and strychnine with
testosterone and vitamins
5
Iron with strychnine, arsenic
and yohimbine
6
Sodium bromide/chloral hydrate
with other drugs
7
Antihistaminics with antidiarrhoeals
Penicillin with sulfonamides
8
Vitamins with analgesics
9
10 Tetracycline with vitamin C
11 Hydroxyquinolines with other
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
13 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 O’ 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,i.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
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
steroid/antihistaminic 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’
5
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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
THE TROUBLE V/ITH THEM
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5
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, 1983.This
Act was first enacted in 1940 and
has now gone through six amend
ments since then.
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 Cen
tral 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.
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
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 included
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 an! 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
c ommitted.
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.
MEETINGr WITH THE ©RUGS CONTROLLER
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 Bhavan, 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.
6
J
The following were some of the
highlights of the meeting:
I
1
IT
♦ On olioquinol - the DCI stated
that in his opinion this was a
safe drug - he took it himself
axkL 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 re-evaluate
the product,he said he did not
feel the need to do thiso
Regarding the lack of efficacy
of olioquinol, 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 EP 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 field*,
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.
BOILINj does not DETOXIPY khesari
DAL - BANNINt 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 32000 lathyrism cases,
respectively. The majority of those
afflicted are labourers many of whom
are bonded labourers and who receive
khesari dal as wages.
Studies by Dr Kamal Ahmad from the
Institute of Nutrition and Pood
Sciences, University of Dhaka,show
that boiling the seeds with water
five times,discard!ng each time the
aqueous filtrate,DID 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 »=£>?**<
7
CERC REPORT ON DANGEROUS
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 Me spray tins (Nestld*).__________
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
(Delhi)CERC(Ahmedabad)MFC,Arog’
ya Dakshta MandaKPune)CED,Lok
yldnyan 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 products1....
SCRIP No. 811
July 13 1983 and SCRIP No. 803,UK, June 15 1983.
------------------------ - -------------------------------------------------------------------------------------------------------------------------------- -------------------------------------- ----
8
“’
I
dextropropoxyphene with paracet
amol or aspirin. M
A FORMULARY BASED ON RATIONAL
THERAPEUTICS
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.”
"Regarding the combination of
dextropropoxyphene with paracet
amol, such combinations are being
marketed in many countries and
cannot be considered as irrational"
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”
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.
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.
i
9
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.
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 glas© of water.
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.
^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.
>Dr Zafrullah Choudhary will be
in India from 25 Nov to 4 Dec.
His schedule roughly is as
follows^and programs in the
various cities are being organised
by the persons mentioned:
25 - 26 Dr Anant Phadke
Dr Rane
Bombay
28
Dr
Raj Anand
27 Dr Antia
Trivandrum 29 - 50 Dr Ekbal,KSSP
Bangalore
1
D r Ravi Na raya n
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.
4 The Pune branch of the Indian
Academy of Paediatricians hosting
the next academy conference in
November has turned down financial
JtlOCU is organising a workshop on
Pharmaceuticals and Health Policies
22-25 Nov 1985 at Penaig,Malaysia.
Some of the important topics for
discussion include: Developing a
National Health Policy, A Code for
Marketing Practice, Representation
of Rational Groups * Work Plans.
Mira Shiva has been invited for
this meeting.
IO
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i
%
Wej 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.
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 Policy1 is an integral part of a good National
Health Policy.
i
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 the people, at costs which the majority can
afford.
We urge our government to accept and implement the Hath! Canmittec
Recommendations which are also In koopin^ wi’+h
wuo
a Rational Drug Policy.
.
,
Further the national drug formulary should be revised, and canpiled cy
an expert multi disciplinary committee keeping the 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.
The Essential Drugs Policy should bo adopted for all health services,
government and private, and priority in production, distribution and
dispensing should be given to these essential drugs.
5- Trie 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 after being marketed for some
time in one country may net be submitted for clinical trial or marketing
in India. Tnc 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.
12. Comprehensive 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.
11. No tcchn<logy transfer agreement shall bo legal and binding which cont
ains restrictive practices, disproporti"nate and unnecessary use of
imported intermediaries -:r obsolete tochn••logics or unfair arrangements
v;ith 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 bo made compulsory in medical education, prescribing and
labelling of drugs. Generic names should, appear more preminently on all
packagings
•„ .
•r1
I
-.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 teensumers of the essential drugs lists, policies,
catcgori.es or brands0 drugs bannod for manufacture or sale, through pub
lication in the national newspapers, magazines, medical journals with
adequate explanations and-details.
z
15.
li far of drugs required in the C-ovornoents National Programmes
should bo ensured on a priority basis to the government as well as
voluntary and private health institutions. Quotas for anti TB, anti
leprosy, r?„nti malarial drugs, iodized salt etc should be made easily
available with regularity of supply -bo the voluntary health institutions
whereever possible, specially when their performance, in health care
delivery is known to be effective.
16. In all review cemmitteos, statutory bodies and other such bodies, there
should be, adequate representation of consumer groups and voluntary 1 tea 1th
sector.
17. Drug companies should follow ethical marketing practices, and this shcule
be ensured by their own organizations like OPPI,1IMA, IFPMA. We deplore
the tendency of those companies and associations to get around every
progressive measure of the government through recourse ‘technicalities ox
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 to influence
the WHA and ViHO to adopt ti_o Code in the interests.of the other develo
ping countries and their peoples.
(IFPMA and HAI Code attached).
- Voluntary Health Association of India
- Centre for Science and .Environment
- Centre of Social Medicine and Canmuni ty Health-Jawaharlal Nehru Univer
sity.
- Kerala Satiitya. Shastra Pari shad
- Medico Friends Circle
- Arogya Dakshata Mandal
- Lok Vigynn Sanghatana
- Consumer Guidance Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of India*
/
.
*
AIDAN
All India Drug Action
Network (AIDAN)
.All 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.
~F
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iii
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iii
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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 policy 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 Drug'1
(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.
★ 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.
(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.
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-
I
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iii
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iii
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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 Drug Policy 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 Drug0
(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.
<
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
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-
>
Voluntary
Health
Association
9 f
India
C -14, C ommunity
c e n t r e
Safderju ng
dev
development
Area
New
Delhi-110016
July 17, 1984.
4
ESSSmZiL DRUGS
A DW^D FOR PRIORITIZATION
Prepared for
V H A I members,
Drug Action Nctiorkors
and al l thoso who believe
in the concept
and implementation
of Rational Drug and Health Policy
Background paper
for
Drug Action Netwrk
Core Group Meeting
Wardha
30 - 31st JULY 19^4.
Dr. Mira Shiva
Coordinator
Low Cost Drugs
and Rational Thorapautics
V.H.A.I.
E-4/378(c) LCD & RT
7H/l;pt:19.7.'84
ESSENTI/I, DRUGS ~ A DEMAMD for prioritizattgm
- Dr. Mira Shiva, VIL'Jl.
Content Outline
I. Essential Drugs - An Introduction
11 • Courageous Efforts - Brief Review
Chile
Srilanka
Pakistan
Mozambique
Bangladesh
WHO
India
III.
pur efforts in the area of essential drugs
IV•
Tbe Sei eci-.ipn. of essential drugs and the essential drug prograrma
- W H 0 Recommendations.
'
~
V* -~~Aabi2j£g4g_of Essential Drugs
Drug List?
or Why do we need an Essential
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.
& J
C. Poor-performance, of multinationals iin production of essential drugs
' D. dilution of t’ERA 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
iiaporting excess inessentials.
2... ensuring preventive health measures before proircting
inessential drugs.
■tit ■ ■
3.
ensuring placing essential drugs before inessential drugs
4.
increasing -production of essential drugs, decreasing
drug costs through econon^ of scale.
5.
ensuring bulk purchase of selected essential drugs and
thus cutting costs.
....2/
4
E-4/37S(q) LGJ & RT
VH'I:pt39.7.»&|.
2
:
F.
Subsidizing costs of essential drugs
G.
Need for influencing market demand and thus the drug
production pattern in favour of essential drugs
He
Need to decrease drug misuse and overuse
I.
Need for efforts in. preventing Iatrogenesis
J.
Need for
*
'“ '
personnel and consumers.
K.
Need for ensuring better quality control
L.
Need for insuring generic proscribing
VI ♦ Graded Essential Drug List
I.
ESSENTIA 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 drugs, the health care status of
our people -will dramatically improve. We are focussing on it to high
light the fact that majority of our popple are not merely deprived of
health care facilities, but whatever they are given by way of health
care does not necessarily have thoir interest in mind. The kind of
health care facilities, medical technologies and drugs being promoted
under the garb of n sc iontificity” and "modern advances” and as "latest
break through" usually servo the interest of tho "m^cal industry" i.e.
the drug industry and the medical establishment. Some of these modern
myths and superstitions have to be demolished. Eg. Myth I - medicine
is a noble profession brimming with selflessness, putting patients
interest and welfare, above self interest. Myt-h II - Tho drug industry
produces ’pills 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 ift a welfare state,
signatory of the Alma Ata Charter giving priority to Primary Health Care,
and that our health policies are people oriented and arc guided by reco
mmendations of Committees like tho BJorc Committee, 1946, Hat hi Coinmitt eo
1975. Alternative strategy Health for All "ICNR-ICSSR Report 1961" and
oven the last year*, the’National Health Policy Statement’’all of which
emphaziSQ that the health needs of the majority, have to take priority
ovci' sophisticated, centralised, costly, high technology medical services
meant for the minority with the purchasing power.
\V.'.
•
’
■r
':{
-7T^'
^4/37^(c) LCD & RT
VH/a:pt:19.7.’84
:
3
The concept of essential drugs, questions the health personnel
who are supposed to safeguard the health of tho people; it questions why
their 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
inclement such bans. It focusses the attention on the present day medical
services- private and government; tho proscription patterns; the grots
lack of accountability to the public or to any medical council. The
doctors bask in the prostigo that comes, with tho practice of 1 white
man’s’ medicine. It is the public that pots them on'a pedestal (not
far bolow th© one meant for tho Almighty). In reality, they, like the
drug manufacturers and their representatives aro no better than salesman;7
and medical care is debased into a ’commercial saryiao’and it sella,
even if tho people needing it have to bog, borrow, or steal.
>
If tho proscription patterns have to bo based unnodifiodblindly, unchallenged on the medical text book written by and for ths
West - than wo should also onsuro that their control^ go with thorn.
There should bo rogistratian with tho nodical council, hood to pass
board exams after certain years of practice, medical audit and withdrawal
of modical licono© for unethical medical practice. If our state mechanism
is meant to ensure anything, it is to onsuro total safeguard against
those who in tho name of medicine, boliovo in making quick money, and
usd their medical license, to exploit the people. Not merely aro 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 ..unstaff ed,
unequipped and disfunctional. Rarely do the prestigious medical establish
ments raise a huo and cry over tho evor incroasirig nodical swindles;
against the decreasing health budget of the 5/year plans; against
the drug bans that never cone or arc never implemented; against health
and drug policies that aro not in the interest of the pooplo.
IX - 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 information; their ensuring the pnnehase 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 ere produced by small scale drug outfits
with as much quality control as most other small scale drug companies.
All commercial enterprises serve a purpose, but a few like
drug ^industry start sharing the role of a toaler, server, educator
benefactor, tiaving touched tho dizzy heights of highly technical 9
mystified science•
Myth.Ill - The third nyth of course is that our health policy is
goared to fulfil tho health needs of tho majority.
The ^health budget has steadily decreased. It may have been
broken up under different heads but with increasing population aid
increased need for health services, health budget should bo going up
much more rapidly.
V
^-4/37^o) LCD & RT
VIIAIjpt: 19.7.
•
k :
How has the money boon spent? V-fhat are the disparities existing?
Wliat has boon the role of the policy makers? What has happened to the
various recommendations mentioned earlier? The perspective should have
been set when wo attained independence. The direction being pursued now
: hasnft changed very hueh from the pro-independence period.
The public
has had ho .say i# deciding the kind of doctors it- wants trained with its
money;-and. what -kind of health facilities and drugs it heeds. Such an
intervention by thd consumers .remained impossiblo inspite of the numbers
• because sc'jf.arT:.they- havp remained unorganized and fragmented.
••'•Focussing .publid'■attehtion;:on tM-issue of. essential drugs provides
p r . acplatform for. urgahi'zfeg?’tip consumers f0.3?. focussing attention on our
... health1 car o' pory-ipes, oh bur .legislations, policies, education and
..... .■OS1’■'■-■■ ■; tJ V
■
4
"■ r
. .-y
*;
"ic^W’ ih to fopus;-on thp'role the cbiperts, the committees and policy
' played.;in thd past (many of whom- are known to have been
bpug-hb and’-sold). It focusses .on the‘r ole of consumers and on their
demand for participation in’decision making as a majority, for the benefit
J-
:.;d
• .Demand-i6T essential and life saving drugs’as a priofrity is an
exercise-, in dbirystj^ydi^jmedicinef it iS; an, exercise in public education,
; ;i .;gn exercise' iii.cnsur:irig‘'that- public’ needs guide and influence decision
making.. -- Ibis .iepand is also an exorcise in learning to 'boycott drug
yb ’ . decisions-ahd‘policies whichlare thrust down peoples throats against
their will and, against the interest of the majority.
..A
'■
•..•.< ISM
•
.:
'■ ?ylt -is -part of? a -slowly emerging•. consumer movement, peoples science
/. movement and,.also peoples health movement. It is an integral part of a
41' .larger process and not-'a-piece-meal demand of a minor rectification.
"■
‘
-'v
.j
Thd politics of health at the concrete level can only be based on
■’I .... pOQ.plSs action.; As Fritjbf Capra points out in the Schumacher Lectures
" . - ,^Refusal' to take, even a single pill is such a political act1. On this
political philosophy is .based the 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.
CQURAGSOUS EFFORTS - A Brief Review
. . The concept of essential drugs list is nothing .new nor did it have
its origins in WPD’s Technical Report Scrips No. 6l5 (1977) as many believe a
Many efforts had been made prior to this. Wo just mention few.
CELLS:
As far back as 1973, the Chilian Medical Comission comprising of
Dr. Salvador Allende had believed in limiting the drugs to those that had
demonstrable therapeutic value and thus 1 scale down the pharmacopea1.
All ends during his short tenure as President quite successfully compelled
the medical profession to serve "basic” rather than profitable needs.
He uroposed to ban drugs not prescribed for clients in North America
or Europe.
......... 5/
g-A/37^(o) LCD & RT
VHAI:pt:19.7.’S4
5
Within ono week after the talcing over of the military junta on
11th Sept amber 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, are seldom
appreciated.
SRI LANKA:
In 1971 under the guidance of Seneka 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 calling international tenders. Within 6 months there were savings
of about 4$ in relation to expenditure incurred earlier.
It is absolutely essential for those of us involved in drug work,
to know how the resistance from multinationals, their governments; with
support from Sri Lanka’s own medical establishment forced the Sri Lanlc...
government, to give into vested interests and revert some of itsown
brave and correct decisions.
PAKISTAN:
Pakistan’s attempts at restricting the drug list to essentials,
with rejection of unessentials met with similar resistance from the
2 most powerful lobbies in the medical industry ’the drug industry
and the medical establishment’.
INDIA;
In 1975 the Hath! Committee in India recommended a restricted
todav for interested health and consumer groups no copies °i y®
ionals and has till recently remaned an official xerci^uliah
tfXS? S^r.1^ £sS°S bUSk, Dr.
/llonde of
Chile.
MOZ>BIQlg:
After its liberation from Portuguese rule in ^76 ^ ^ozambique
too*
policy. Health Kas naticnJjJ cd
of
docreased from
one “onth of indopcgenc .
A
Essentiai^rugSlist was revised
198O aS SntSed^^Sugs. ,ONLT
COUW ®
PRESCRIBED.
........... 6/
1
Il-4/37B(o) LCD & RT
VK'iI:pt;19.7.!84
6
The result of streamlined contracts was that the drug prices of many
essential drugs came down to 1/3 cf the:lr original prices. Tho ossontiaT
drugs became available, to more people in remote areas, not just to tho
privileged few. This could be done with the drug import costs the same
as they vrare 10 years ago because the selection was more sensible.
I
W H 0:
£
€
The WHO Expert Conunittee on essential drugs in Technical Report Series
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. Ropcr!'
Series 6S5 which dealt with the ’use of Essential Drugs1 and gave the.
essential drug list for emergency situations and primary health care.
B/iNGWESH:
In June 1982 Bangladeshis Military regime under General Ershad,
promulgated a Drug Policy based on WH3 ‘recommendations. 1742 drugs
were banned because of their hazardous and irrational nature. Tliis
of course had been pre-coded by educational campaigns about rational
drug use by some of the individuals involved in pushing the National
Drug Policy. The January 1982 international conference on Health and
Pharmaceutical Policies was one such attempt organized by Gonoshasthya
Kendra. Through its monthly magazinoHGonoshasthya 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
In Bangladesh the resected drug list constitutes of 150
policy,
drugs. Tho grading of 150 selected essential drugs has also been 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 7e supplementary di‘ugs for restricted use which
after discussion will bo 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 WH3 guidelines for Rational Drug use - has come from the multi
national drug lobby and ths 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
aIlow unrestricted sales of drugs banned in Bangladesh, the drugs must
bo safe and wonderful, iiftor all Indian Medical Establishment with
all its brains and advanced technology can't be wrong - (any way we
al I ow continued manufacture and sales of drugs banned by our Drug
Controller of India and recommended for withdrawal by our expert
committees.)
Efforts to gather support for Bangladesh's crave drug policy had
boon made by us right from the beginning and our efforts continue;
since survival of Bangladesh drug policy is crucial for une people of
Bangladesh and other third world countries including India.
7/
^-4/3rMQ) LCD & RT
7
.ZIMBABViS;
1
Zimbafewols Government has selected 376 essential drugs to be
used in the public health system. Government will not make foreign
exchange available for importing drugs outside this list.
■^hy is this concept of essential drugs seen as. such a big threat bv
medical establishment and tho drug lobby? The reason is very obvious.
It interferes with the drug companies profit making oven though in
reality it benefits more people.
A': •.
■'
, •? 3
III.
our imimvEs in pr.qmoting aw^iess of
nSSSSNTI ^DRUGS
‘
“
By the end of 1930, the drug issue,the 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
wrkors, holistic health workshops, community health or health care
management training programmes.
By January 19o0 a clearly defined strategy of drug work was drawn
up. ibis was later presented to VHAI’s general body for ensuring organi
zational support. This work strategy figures in the special issue of
Health for the 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 trainers* policy makers,
drug companies, multinationals and international drug and health action
groups).
In April-June 1931 issue of our bi-mont.lily we informed our VRAI
members and HFM readers of the concept of essential drugs and gave tho
essential drug list meant for Primary Health Caro. Tho list of irra
tional and-hazardous drugs which was at that time recommended for being
weeded out, was also disseminated to warn the health personnel and
health institutions about them.
■ '
Sy 1931 end a sorious attempt to draw up an essential drug list
of 50 drugs and recommended management 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 ivore 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 WHO’s essential drug list.
In January 1932, tho first drugs works hop ’Drugs Issues and
Feasible Alternatives? -was- organized in Pune to bring socially
conscious health pcrsonnol, consumer group activists for drug acticn
together. Tho- Hath! Committ.oc and WHO essential drug lists were
mado available to the participants ,of the-’first Drug Workshop in Pune
as -woll to the participants of various training workshops and organization Development (OD ) seminars etc • conducted by VHAE and dissemina
ted amongst various levels 'of health and non-liealth personnel.
A sub group constituted of doctors and pharmacologists mot during
tho 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). See Annexurc I.
8/
g-4/378(o) LCD & RT
VHZiE:pt^ 19.7.’34 '
8
:
By August 19B2 it ws fully realized that an essential drug list
drawn up by us even. as a group would not necessarily bo acceptable to
healt h personnel« ■tittd if while attempts to influence government autJx>~ritios went ccn side by side^in the voluntary health sector, the acceptancc and iiiiplcixiantation of this 1_1
had to ij
be ensured*
The exercise to draw up a comparative essential dr-'ia list wa.s
undertaken for 3 reasons:
1.
io demonstrate that any rational drug policy formulated
had a lot in conanon,no niatter from, which country.
2.
That.it was not a handful of concerned persons but expert
committees that had drawn up these lists. The fact that
these exports believed in the concept of essential drugs
we felt would have greater convincing and educational value.
3.
-ra&ing the comparative drug list available
■o the ^individuals in the field and solicit a response from
those informed 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:
t -
WH)
Hat hi CouEiittoe
PGI (Post Graduate Institute list) Dr. V.S. Matihur
Pune Workshop list
Sri Lanka list
Restricted lists used by ECHO UK and Action Kedeor (both
agencies are involved in bull; purchase of essential drugs for
tbird world countries).
linesIford^H^^. t'^at phGS? csscntial
lists would provide guide-
+?
J election xor larger medical institutions. But for smallGr
hecJ-th prograufiiies with which I was mainly involved in the course of w
wofa., .there was a neea^for a graded essential drug list, based on the
experience, qualifications «iof the health personnel
- uhe 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.
n • .3f£0rt to obbain graded essential drug lists from Bangladesh,
6r2. LanlEa., Mozanxbiqua and 3MR0 have been made,
with Rpgistanc<3£
The most vocal argument against the concept
of essential
concept of
essential drug
driig list
list
by the drug lobby and its supporters is that it is relevant on^lor
t.xc extremely poor countries and not for developed countries nor o
th^thTrf^0
inDSt' devsloPGd Pharmacoutical industry in
the third world, ibis is far from tme sin.ee drug lists of raw dovr-looe’
T ai?W rationadi^d
Itoitod. 1-rolificaticn 5
*
teusontial drugs -±s no indicator of development.
....97
E~4/37S(q) LCD & RT
9
In 1982 a request to the Editor MIMS was madp to:
1) delete the drugs that wore recommended for being 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 struggling
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
demonstr at od at that country’s independencen. This was an attempt to
show that the concept of essential drug list is meant only for extremely
poverty stricken and not countries like ours.
This is totally untrue.
Developed countries have made more serious efforts to restrict drugs.
In UK, the- 6500 preparations is considered too many by the Rational
Health Campaigners and^Charles 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 thca^selves.
How long in the name of ’free enterprise’ and so callod ’clinical freedom1
will irrational and rnzardous drugs continue to bo inflicted upon the
people specially when they are ill affordable by them at the cost of
their actual health care needs being met?
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 intprnalizo the...eoncept of ossontial drugs, so that they can rnake an
informed choice about essential and wicsgontial*' ~~
"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
bettor information about drug use and less confusion about which drugs
to use”. (Charles Medawar ’The Wrong Kind of Medicine1 page 15).
Dr..John Yudkin who has long been concerned about third world
drug policies says ’the drug companies must not bo permitted to bcccmo
a hazard.to health in the underdeveloped world by failing to provide
information or by drawing scarce resour cos, away from more effective
projects’.
10/
S-4/37^(q) LCD & RT
’ \W:pt:19.7.tS4
10
IV ’
SggCTION OF ESSENTIAL DRUGS AND 3BSPS FOR
~ MP. RECOMMEND iXTIONS
Ln order to ensure that an essential drugs programme is adequately
instituted at the National level, several stops aro advised:
Lst/ablishment of a list of essential drugs5 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-proprietary (goneric) names for drugs
or pharmaceutical substances should be used whenever possible and
prcscribors should bo used whenever possible and prescribcrs 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
administr at ion of supply, storage and, distribution at every poimt 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 shelf Hie o^
require refrigeration.
6* S^^A2gL_^agoment of stocks is necessary. To eliminate
waste and to ensure continuity of supplies, a Procurement Policy should
be.based upon detailed records of turnover. In Sow instances drug
.ikLlization studies may contribute to a better understanding of true
requirements.
7• Need for both clinical and pharmaceutical research under
local conditions.
j-5-
sole ct ion of ess ent lai dru^s;
ESSENTIAL DRUGS ARE TIDSS THAT SATISFY TFE
HEALTH CARS .NEEDS OF TPE MAJORITY OF TIE
PEOPLE. THEY SHOULD THEREFORE, BE /W/ILABLS
AT iiLL TIMES IN ADEQUiYTE /MOWS,AND IN THE
APmOPRIATS DOS A® FORMS. .
AhQSQ ^rugs should bo selected for which sound and adequate
data.on efficacy and safety are available* And from adequate clinical
studies and for which evidence of performance in general use in a variety
of nodical settings has been obtained.
11/
/
gr4/373(o) LCD & RT
VH/iI:pt:l9.7JB4
11
qualit/^ncfS^^-?^
in a form in which adequate
y? gilding bio-availability can be assured. Its stability ui'dr^
tho anticipated conditions of storage and use must be ostaSOlehaZ
The choice between 2 or noBo drugs which are similar in all the
Sj:Sp9CS Shou¥>
careful evaluation of the£ ^aWo
and no+J4r-iGT?
Ppco <of thc cost of taking a full course
and not merely the unit cost) and availability.
be kept in mind are 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 separately in
therapeutic effect, safety or comp!iannn.
Sploc'ticn of Dosage forms;
and established local prefeiance/01^1
clvailaDilit^ cf excipients
Z A ra?so of dosage strengths is provided from which suitablestrengths should be selected on the basis of local availability and need.
- The use of scored tablets is recommended as a sipjple method
of making dosage more flexible.
D , „ ~ ^'’1Gre is 2- need to periodically revise and undate •‘■lio
rSuS^isStS^f^n^^c31,0 C19arly ^o^Sle since th^
hive imnnctX ?
of P~oc^”t and distribution and may
nave implications for the training of health personnel.
^a^3^i^_jj£fcriation on essential dru,--s:
J?0?0150’ ^cc^a^e and comprehensive information on the uso of
essential
drugstoshould
available to all nrosrr-ih-T'Q SaLi^T'
. p
2 x~
is appreciate
their boresponsibilities^nTlovols'of
Drug informtion shoots for tho doctors by WHD’s Expert Cofwi+ton
on the selection of essential drugs
^S"locUc”of
1“ >
1.. International Nonproprietary Namo(lNN) of each active
.
-------- U
—dVW-LVU
substancee, andJ recommcndod
recommended dosage form.
coloeicJi
:L?for^tion: bri3f description of pharmacoj.og.uCoj. oiiects and mochanxsin of
of action.
action.
3.
Clinical information:
3.1
y?sn?ve!r'
is ^nought
thought appropriate,
appropriate, simple
q o ^Lci^ri0S^lct criteria should bo
provided.
o provided.
3.2 Dosage regimen and relevant pharmacokinetic data;
12/
1
g=4/376(o) LCD & RT
VH/jL:pt:19.7.'S4
12
3.2.1 .xvoragc dosage and range for adults
and childron
3.2.2 loosing interval
3.2.3 dvc^age duration of treatment
3.2.4 special situations, eg. renal, hepatic, cardiac
or nucritional insufficiencies which require either
upward or downward dosage adjustments.
3.3
Contraindications
3.4
5fef9rence/GO pregnancy, lactation etc J
3.5
foots (quantitate by category, if possible
3.6
:
interactions (to bo mentioned only if
Sd’u'iiSS)’
for
3.7
<Overdosage:
3.7.1 , Brief clinical description of symptoms
3.7.2' aOn
-treatment and supportive therapy
3.7.3 Specific antidotes
4.
V.
Pharmaceutical information.
TdgjR/glObi/lE pg ESSENTIAL DRUGS
The concept of essential drugs is tho backbone of any Rational
Policy. The repercussions
essential drug list are too many,o_ 1acceptance and non-acceptance of an
is onc unanimous demand which
has to come from us people it has to U
e
bo
the
selection
of an essential
given t*13^ kased on
health needs of
- — majority, for priority to bo
- ensuring their production
- ensuring their efficient distribution
aSS7+t8isto‘!ktnS of Plraraiaslos with those *»Es
s’a
“i ?r“ticos u *»
altered or improved 'proscription wfctico^ ^°n
is obvious tint,
consumption patterns. With the degre- of soif10110 G£®not altcr tho drug
selection of essential ovor unosS^i
of drugs, '
Specially if this is associated with
^VG S
and health personnel, of highly irrntional^nHT301*,?7 1,110 conSumors
done by Swedish doctors.
Tto bovcott^^ and hazardous drugs-as was
Neurologist, in the internatioLf caSiiim ^^n^ °^G H?nssOll» Paediatric
related drugs vras later joined by doctors
cllocluinol5- moxaform
by over 3000 doctors and vSSans
Norway, Donmai-k - totally
urugs list needs to be done urgently and ?fplGniGrita'tion of essential
arc given belowi
oC-ntly and the reason why it is so crucial
j-OTy priority to ess&ntial
issues boir^doalt SoJintoS! "So So?±tv oFS
the ■p
toalth
are unessential and not based on tbo hrni+?
f ?*USS raanufacturod
1260 crores -worth of drurs r-nvfn + ’ -s
n<?uds of our people. Of the
owe »rth
“™£1?<£‘Ua 1” t’79-’80’”^113- 35°
mW non-essontiS drugs.
1
avine
thc r^t wro
13/
E-4/-378(q) LCD & RT
VHAI: pt: 19.7/84
:
13
The following figures speak for themselves:
Table
Category
197^
1980
I
4.5$
3.6$
II
16.7/$
III
67.1$
68.6$
IV
11.7$
14.6$
.
Source:
13 >2$
MRAl News
July 1984.
The production of category I drugs i.e. essent-ial 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 Chloroquin, and tho anti tuber
culosis PAS, INH and thiacotazono fell short of estimated demand by
about 84, 50, 44 and 70$ respectively in 1979~,SO, except for a small
increase in INH. production for all these drugs decreased further in
193O-’81.
Estimated demand Production in tonns MT Estimated Production
1979-30
■79-30
“ 1
"80-81
81-82
82-83
Antimalarial
Chloroquin
Amodiaquin
250
40
35.16
33.49
34.62
23.15
58.96
26.02
70.00
33.00
Afitit ub ijt cular
PAS & Salts
INH
Thiacet azono
Streptomycin
600
200
40
300
481.78
405.46
129.20
261.97
110.40
290.00
8.44
227.33
13.93
255.45
25.00
266.00
Antifilarial
DEC
30
21.57
13.99
16.43
13.00
Antilcprosy
DDS
28
16.20
21.05
25.61
90.00
Ref:
112.43
12.55
220.16
128.00
Dr. W.Y. Rane - Why don’t our drugs match our diseases Science Today - October 1982.
....14/
g-4/373(c) LCD & RT
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14
:
D^aral Proiection lor Bulk drugs for the period 1979-80 to 184-185
Hasp year
Estimated Requirancr.it
79-80
80-81
81-82
82-83
83-84
84r35
250
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
DDS
28
3?
37
45
50.
56
Ant imperial
Chloroquin
dmdiaquin
Anti Tubercular
PAS
INH
Thiacctazone
Ref:
The Indian Pharmaceutical Industry Problems and Prospects^'P.L. Narayan, NCj® Study National Council of /applied Econoimic
Research - January 19^4.
ICMR and.ICSSR study on Alternative Strategy had indicated the
grossly inadequate drug production for TB and leprosy which happen
to bo our priority health problems.
With hail of the TB patients
01 the world in India our production of IN® was less than 1 /3 of the
minimum requirement..
Tha Malaria deaths in Rajasthan -were net merely due to drug
resistance and cerebral malaria, but due to non-availability of
ctuoroqian 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 needed.
Chlorogimi iraports in tons
1979-^0
^ ^80 - <81
1931 - ^2
Production
Imports
Production
Imports
Production
Imports
35.2
52.8*
34.6’
71.3
59
166.3
Ref:^ O/BR Roport - The
Indian Pharmaceutical Industry.
ihomic Research.
15/
S-4/3?3(c) LCD & RT
VIliI:pt:19.7.!84
15
— There are an estimated 60 million iodine defn-ciency cases
of goitre , in India, It is know, that children of' iodine
deficient mothers are known to bo born as cretins, deaf,
mutes and mental subnormality.
The simple technology of production of iodized salt is known.
Merely 50 pai-se worth of iodized salt can make all the difforo- ■o
between a child being normal and subnormal.
Wc still produce only 20/ of the iodized salt required.
Required amount of iodized salt is - 7 lakh tons
/miount produced
2 lakh tons
/jnount sent to Nopal
1 lakh tons
Amount loft 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 bo imagined.
In SSSSj 111 a Pilot project funded by DANIDA and. SIDA, supplied
of drug kits containing 39 drugs in 1,5 rural districts has increased the
accessibility of essential medicines for the rural population from
1Cfo to W.
B.
DPCO andjts negative impact on Production of Category I and II drurs:
.Under.DPCO (Drug Price Control Order) the mark up on Category I
drugs is limited to 4^° and that on, Category II is 6C$>. Producing category
IV drugs because- of th), .high mark up allowed arc thoroforo dofinitclv most
profitable.
•
For the decreasing priority being given to essential and life savii
drugs DPCO is therefore blamed. With the decontrol of prices of 75^ of
the drugs as is being recommended 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.
Pg.Qr. performance of Multinationals in production of essential dru y
.The outright, calcuJ.ated neglect of tho priority drug needs of
the majority is well known. The following table speaks volumes. (Sec
/nnoxurc II - Production of Essential Drags by Multinationals and Cr/zar^
Sector)
D.
Dilution of FSR.A Companies - ..an invitation to more formulations:
k'ith the dilution of foreign.’equity shares to 4Cg, various
concessions arc being granted to the FERA companies so that bulk to
formulations ratio will be increased from 1:5 to 1:10. With the drug
production pattern as it is, wo can look forward to more formulations
and more unessential drugs irrelevant to our ^pcoplos health need.
Bulk production by foreign sector for 1982-’S3 was Rs, 55 croros worth:
the formulation turnover according to 1:5 ratio should not have exceeded
Rs. 275 croros, however, Rs. 515 croics worth of formulations wore
produced i.o. more than 1:10 ratio when only 1:5 was allowed.
16/
d
■s
3-4/378(0) LCD & RT
VEU:pt: 19.7.‘S4~
16
K' E..
:
Rational use of scarce resonrcos:
i)
o£
foreign oxchaiigc: India with its level of
indebtedness to IMF VJorld Bank, IDA etc., can hardly afford to sqandor
its scarce foreign 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
drugswhen they can hardly afford adequate food and clothing and bare
essentials. When the percentage of people, below or around the poverty
line happen to be around 60 * 7(^ of a country’s population - the very
production and heavy promotionaB of costly irrational and hazardous drugs
is criminal. . A strong public opinion alone can ensure withdrawal of
such urugs, with priority being given to essential and life saving drugs.
±:L^;
- vs essential drugs: Often inessential drugs
are bought at the cost of specifically needed essential drugs. For the
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.- ^L1 written in the
same proscription - does not exist. This was shown by Veena Shatrughana!s
study of Prescription writing and drug consumption. By ensuring
priority availability and prescription of essential drugs, wo would be
contributing to preventing the wastage.
o£ scalo increased; If essential drugs wore given ;•
p aority in production, through sheer economics of scale, the production
cost would decrease for the manufacturer and thus the consumer^
v2
essential
essential drug list
list can ensure bulk purchase
of selected essential drugs, which can cut down drug costs.
r
demand and thus the Drug Production pattern in
labour of ossontial drugs:
.
------------- ---- ---------------
by choiS fo0XCXati^SC^ -al
liSt W1S
y cnoicc c„ oy legislation, uhis would necessarily influence the
^■•Cr^^>n.,rsfct^n
honce
accouted
^Ldomand in t.te market. This wuld
definitely alter ths drug production pattern towards essential drugs.
G«
Decrease drug misuse and over use;
no + • h1118 S11 f? d°nB W±th xa>jntification of- drugs which are - therapeuticaLy effective, safe, easy to administer, and of appropriate cost
iiroferabl^ single ingredient well tried drugs. The use of drugs which
f270-°L
value, costly, irrational and hazardous drugs should bo
avoided. Majority of tho drugs available aro combination
This
increases costs as these drugs are often in subtherapeutic and irrational
dosages, according to Halfden Mahler, 9$ of drugs in the developing
countries are non essential.
H•
A
iV
Iatrogenesis (Drugs induced health hazard):
as lopg as potentially hazardous drugs with very high risk
(compared to; benefits, ratio arc misused and overused, unwarranted high
incidence of; iatrogbnesis is. bound-to occur.
17/
?
‘si
/'
^4/378(e) LCD & RT
vwoTpt-
17
j
In USA whera the drug control and. tho proscription practices
aro irruch bettor- controlled, the incidenco of iatrogonesis is very high*
One in 5 hospital admissions are known to be due to iatrogenesis. In
ndia
have such a high degree of self' prescription, prescription
wriciag by.unqualliied health .personnel and by qualified personi3,el who
are mde highly biased by drug representatives^ This along with poolcrug ^controls ensures drug misuse, overuse and iatrogenesis* Most
cases of iatrogenesis are not diagnosed in India. This of course doos
not imply that they don’t exist.
1^
the combination drugs have 2 -or -more ingredients. It is
Known^that with consumption of over 6-drugs compared to 2, chances of
drug interaction increase
.S^has compared to
.
I.
Ui.Wl Information for he ilth personnel and- consumers possible:
With 30,000 drugs in the market it'.is impossible not to be
confused about them. A doctor-may be~ familiar, with ths 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'<xritically or. cJxonically. sick patients.
Confusion abounds, since majority of the health personnel have no
access to 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-matters 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
caut ion, be ..ensured?
Studies also indicate that it is impossible to remember dot,pi 1 n
of even 100 drugs in routine practice. Ensuring that these prescribed
drugs are tee ones that people need and not what are'most heavily pushed
by the drug exmpani^s because of their profitability, is our responsibility.
Focussing on all aspects of essential drugs and rational drug use in
medi_cal education wojp.d ensure their better use which, would be better
for ibhe.nation .and the patients.
J.
Ensuring better quality control;
There are 30,000 for-mlations. in the market. Most of them are
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, with even-these being-substandard, is really unacceptable.
insuring generic proscribing:
Generic prescribing is recommended by TO.itself as it cuts down
orug costs.
Pharmacology input during medical education^ nomenclature used
in medical literature and medical journals is based entirely on generic
names.
IS/
I
Jt
^A/37^1 LCD & RT
VIVI: pt: 19.7J^4
18
:
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. LEVELS. Brand name prescribing is no solution
for substandard drugs. Brand names do not prevent spurious drugs enter
ing the market as most spurious drugs arc imitations of well known
brands. Name of the specific -drug house can bo writton if it is felt
absolutely necessary. Generic prescribing is possible with single ingre
dient essential drugs which arc quality controlled.
L•
Subsidizing costs of essential drugs:,
.With restricted list of drugs meant for the health needs of
the majority, subsidising is possible by removing sales tax, excise duty
and octroi for these. Any loss in the taxes can be compensated by
increasing taxes on cigarette0, alcohol and other ^uch anti-hpalth
products or more so on luxury items meant for the rich. In conclusion•>
demanding an essential drug programme is aimed at focussing attention
and giving priority to health needs of the majority.
CON CLUSIOl'I /SIKOIY
Dcmnding 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 domand for employment, fair wages,
fpod, water, sanitation and all that goes to ensure good, health. Our
fight, for essential drugs and health care as a fundamonfial right of
every Indian, specially the deprived sections is a fight against the
unjust ice of the present socio-political system, which in reality
accepts this ^deprivation of health and basic health care as a normal
phenomenon.
■
E-4/373(o) LCD
“.J
WIsptsIQ.V.'gp
Annaxixro HI
-OF SSSENTEAL DRUGS BY MULTINATIONALS AND ORGANIZED SECTOR
Name of the firms
INH
PAS
THE ACIT AZONS
ETH/fiBUTOL
RIF/MPICIN
STREPTOMYCIN
Abbott
Nil
Nil
Nil
Nil
Nil
Nil
ACCI
Nil
Nil
Nil
Nil
Nil
Nil
Hoechst
Nil
Nil
Nil
Nil
Nil
Nil
S.K. & F.
Nil
T’Til
Nil
Nil
Nil
Nil
Searle
Nil
Nil
Nil
Nil
Nil
Nil
Sandoz
Nil
Nil
Nil
Nil
Nil
Nil
Roche
Nil
Nil
Nil
Nil
Nil
Nil
Parke-Davis
Nil
Nil
Nil
Nil
Nil
Nil
Sarabhai
Yes
Nil
Yes
Yes
Nil
Yes
Beobringcr Knoll
Nil
Nil
Nil
Nil
Nil
Nil
Czlaxo
Nil
Nil
Nil
Nil
Nil
Yes
E* Merck
Nil
Nil
Nil-
Nil
Nil
Nil
Giba-Giegy
Nil
Nil
Nil
Nil
Nil
Nil
Pfizer
Yes
Yes
Yes
Nil
Nil
Yes
Warner
Yes
Nil
Nil
Nil
Nil
Nil
Burrough Wellcome
Nil
Nil
Nil
Nil.
Nil
Nil
German Remedies
Gynamid
Ethnor
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Yes
Nil
Nil
Nil
Nil
Nil
Nil
Nil
SOIIMW
.
Prih'orti^''! Dio-^rio in India, by J.S. Majumdar; pron-rod for tho Drug Workshop in Jaipur, organized by V,r-: ■
DRUGS BANNED IN INDIA
Under section 26(a) of the drugs and Cosmetic Act-G.S.R.
578(e) dated 23.7.1983.
8.
9.
Amidopyrine c
Fixed-dose combinations of Vitamins with anti-inflammatory
agents and tr^nsquiUsers.
Fixed-dose combinations of Atropine in analgesics and
antipyretics.
Fixed dose combinations of strychnine and caffeine in tonics.
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
a id. yohimbine.
Phenasetin.
Fixed-dose combinations of anti-histaminics with antidiarrhoeals.
10.
Fixed-dose combinations of pencillih with sulphanamides.
1.
Fixed-dose combinations of vitamins with analgesics.
12.
Fixed-dose combinations of tetracycline and Vitamin C.
13.
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 certicosteroids with any other
drug for internal use.
1,
2.
3.
4.
5.
6.
7O
14.
15.
Fixed-dose combinations of enloramphenicol with any other
drug for internal use.
16. Fixed-dose combinations of Ergot.
17 * , Fixed-dose combinations of vitamins with anti-TB drugs,
except combinations of isonizid with pyridoxine
hydrochloride (B6) .
.> la. Pencillin skin eye ointment.
'Hp. •’ Tetracycline liquid, (oral) preparations.
20.
21.
Nialamide.
Practolol.
22.
23.
24.
25.
Methapyritene as .salts. (G .8.R.49 (e.) 31.1.84).
Metriaqualone (G.8.R.322(e) 3.5.84).
Oxytetracycline liquid (oral) preparations.
Demoelocycline liquid (oral) preparations (G.S.R.863(e)
22. 11., 85).
26.
Combination of anabolic steriod with other drugs (G.S.R.700(e)
15.6.83).
27.
Fixec-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 analge.s ic-antopyretics.
28.
«.rr
,1
' I
■
^'2—-
29.
othe^ anti
Fixed dose combination of pyran inamide j-v
•
r'.a
inamIda v.’ith
tubercular drugs sxcept comoxnution
Rifampicin and I-TH as per r c co^ic ndod daily dose given below?Xoozimum
Minimurri
Dry-.c^s
6 0 Omg.
450 mg.
Rifampicin
INH
Py r a z i nam i cl e
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41
42.
300 mg.
lOOOmg..
400mg*
ISOOmgo
-receptor antagonistsFixed dose combination of histamine
combinations approved by the
with antacids except for those
a-- --drugs controller, India.
The patent and proprietary medicines of fixed, dose combinations
of essential oils with alcohol having percentage higner thon
20% proof except preparations given in tne Indian pharmacopoeia.
All pharmaceutical prepations containing chloroform exceeding
0.5%’w/w or v/v <dxichever is appropriate.
Fixed dose cobination of ethambutol with ±RH other than tne
followings INH 200mg. and ethambutol 600mg.z and INH 30^mg.
and ethambutol SOOmg.
Fixed dose combination containing mor|rthan one antihistamine.
Fixed dose combination of antIhelmintic.
©athetric/purgatives except for piperazine.
Fixed dose combine-; ion of salbutamol or any other bronchodilator
with centrally avting’ anti-tussive and/or anti histamine.
Fixed dose combination vz laxarives and/or anti—spasmodic
drugs in enzyme prepations.
Fixed dose combination of metoclopramide with other drugs
except for preparations ccntainin< metoclopramide and
as p i r i n/paracetamo1.
Fixed dose combination Of centrally acting,, anti-tus^ive with
antihistamine having hig.n .atropine like activity in
expectorants.
Preparation claiming to cor’ at cough associated with asthma
containing centrally acting anti-tussive and/or antihistamine.
Liquid oral tonic prepations containing glycerophosphates and/
cat lychei- phosphates :.wd/or central nervous system stimulant
and such prepations contirzing alcohol more than 20 percent
proof.
Fixed dose combination containing pectin and/orJkaolin with
any drug which is systemically absorbed from GI tract except
for combinations of pectin and/or kaolin with drugs not
systemically absorbed.
&
Page 1 of 2
PHM Secretariat
From:
To:
Sent:
Subject:
sahajbrc, renu and chinu <sahajbrc@icenet.net>
Dr Dabade <drdabade@sancharnetin>; Sudarshan H <vgkk@vsnl.com>. Shyamala
Braskaran <vani3@hotmail.com>; <shyarhanarang@hofmail.com>;
<esparun@bgl.vsnl.net.in>; Community Health Cell <sochara@vsnl.com>; <van@vsnl.com>
<prasanna_aid@yaho.o.com>. Prasanna. PHM Secretariat <phr sec@touchtelindia.net>
Tuesday, August 19, 2003 9:06 AM
News
DECCAN fe HERALD
Wednesday, November 13, 2002
■
National
State
District
Directive to Centre
on pharma policy
Business
Foreign
DH News Service BANGALORE, Nov 12
Sports
Edit Pace
The implementation of Centre's 'Pharmaceutical Policy-2002' received, a
setback today with the Karnataka High Court dr ecting the Centre not to
implement the policy till a iist of essential and lifes-aving drugs is prepared
and such essential drugs are brought into the basket of essential drugs
under price control mechanism.
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The High Court also directed the Ministry of Health and Family Welfare to
review essential and lifesaving, drugs while also taking into consideration
such new drugs, before implementing the policy.
A division bench consisting of Chief Justice N K Jain and Jus-tice V G
Sabhahit passed the above order on a public interest vc it 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 essentia! drugs out of the limit of Drugs Price Control Order (DPCO)
which was highly detrimental to the public interest. The petitioners further
argued 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.
Their 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 of 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.
Appearing for th® Centre, additional solicitor .general, V T Gopalan had
o
-3
8,19.03
Page 2 of 2
responses :
Contact Us
argued that the policy was framed keeping in mind* the W IO agreements
and globalisation of economy.
He contended it 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.
Wrting 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
I
I'
8.19 03
A
PORUM FOR
MEDICAL ETHICS
www.issucsinmcdicalethics.org
ALL-INDIA DRUG ACTION REVIVAL MEET
Sept 7, 2003 (Sunday)
II floor Hall, YMCA, Mumbai Central, Mumbai
10 AM - 5:30 PM
§o
g
*
YMCA ROAD
t
PETROL FUMf
METHODIST HOME
CLUB ROAD
MARATHA MANDIR
CINEMA
RESERVE BANK
J A
YMCA
INTERNATIONAL HOUSE
BELASSIS ROAD
A
H
O
(Only on Invitation)
Please note: There is NO CLASII OF DATES WITII THE JSA MEETING
The (SA meeting on “Right to health care” is to be held on 5,h and G'1' September, 2003, at the
Retreat House, Bandra (West). The Drug action rcvival-FME meeting has been planned for the
7’h 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 6,h are 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 G'’’ of September at the YMCA. (Separate
program sheet — please ask for it)
Contact persons:
Nobhojit Roy (098212-91225 or nobsroy@yahoo.cofn)
Mu did bar V. (mu rli d h a rv@v sn 1. con i)
MEETING SCHEDULE, STRUCTURE AND AGENDA
Background:
'Hie genesis of this meeting was an appeal sent out on the MFC e-forum by Chinu
Srinivasan (LOCOS'I) and Anant Phadke (CEHAT-Pune), which sums up the mood of
drug action in India today:
'The Drag 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 drug-policy, as the government has adopted the "Tharmaceutical Policy 2001" and it
is unlikely that rve 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:
I'hc 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. Potal 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
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 GATF 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 do 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.
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 Ethics” 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
ACASH
Mumbai
R K Anand
ACASII
Mumbai
Dr.T.Sundararaman
State I lealth 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
Ahmcdabad
Kliyati Shah
Worker, SEWA
Ahmcdabad
Third SEWA worker
Worker, SEWA
Ahmedabad
Kamaxi Bhate
PSM KEM
Mumbai
Peter R Mansfield
I Icalthy Skepticism Australia
Amit Sengupta
I)elhi Scirnee Foniin
Delhi
Anant Phadkc
CI'JIA'P Pune
Pune
Meenal/Bashir Mamdani
FME
Pune
Atiya R. Famiqui
M.D. student in Pharmacology
CMC, Vellore
S. Jacob Prabhu
Faculty in Pharmacy CMC, Vellore
J.S. Raja Thomas
Faculty 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)
MPII student
'I’rivandrum
Aravind (Kerala)
MPH student
Trivandrum
Senthil Arasi (Tamil Nadu)
MPI I student
I’rivandrum
Sree I lari ( Karnataka)
MPH student
Trivandrum
Cho (Myanmar)
MPH student
Trivandrum
Chinu Srinivasan
LOCOST
Baroda
P.K. Sarkar
BODHI
Kolkata
Santanu Tripathi
CDMU
Kolkata
Amitava Guha
I-MRAI
Kolkata
Saumya Panda
BODHI
Kolkata
Prasanna
CMC
Bangalore
Mathew Abraham
CHC
Bangalore
Murlidhar V.
Organiser
Mumbai
Nobhojit Roy
( )rganiser
Mumbai
Sandhya Srinivasan
FME
Mumbai
Neha Madhiwala
CEHAT
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
PUlhas 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
Wahlha
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:
fhc 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 WTO obligations
. fhc policy of economic liberalisation set in motion in 1991.
Abolition ofindustrial licensing.
No industrial licensing would be required for bulk drugs, their intermediates and
formulations if cleared by the 1 )mg Controller (Jcneral. This decision has al fee tec I drug
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. I hcrc is a replacement with pharmaccuticaliscd, 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 - Cliinu 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
I
I
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. Tills
act The Associations of multinational drug companies in the USA, Europe and Japan have
strongly lobbied to include patent in the GAIT system. GAIT was a platform to negotiate
trade among the countries. There was no basis to include the monopolistic right like patetit
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 cosdy. This is known as parallel import. The imminent result
of WTO was found in South Africa where nearly 25 percent population suffer from
IIIV/A IDS. People were dying of this disease for high cost of drugs, which was S11,000 per
year. When South Africa started importing these drugs from India at a cost of $.350 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 diat 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 Property 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.
’fhe 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 (I lealth Action
International), MSF (Medecins Sans Frontieres-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.
I
I
Pricing and Promotion - Amitava Cuba
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, rhe 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
1974
1978
1979
1986
Year
1994
?()()()
The government would have the power of review of the price fixation/pricc 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 the
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: 'fhc 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.
'Hie 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 Ordei)^ 1995.
Banned and Bannablc Drugs : P.K. Sarkar
There arc large number of drugs which arc not only irrational but dangerous also. They are
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
'tiltonal. Lot of adverse criticism about using vitamins al random has reduced use of
com r nttonal vnamm mixtures. Some are more harmful and all of them are more expensive
he process o banmng 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
spread over years. I ven if some drugs were banned but some producers including the
multinationals found method to market them. For example, the government banned
com nnation o
it Bl, Vit B6 and Vit B12. But the producers added other vitamins with this
combmation and freely marketed (hem. It may be noted that a large number of drugs which
have h.gh 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
Drug action points"
points” and Suggested areas of Intervention (Anant Phadkc):
Scrutinyofof
drugpromotion
promotionmaterial
materialbybysome i
1. Scrutiny
drug
multinational drug companies in India
and compare it with its version in the parent country
2.
Ac•
•
- irrational drug
y
A campaign
against
a few
patently
combinations
3.
Irrational claims in the ads on the PV
4.
Ads of substances touted indirectly as sex tonics
5.
Exposing the HR I scandal, I lep B universal immunization scandal
6.
There arc issues
------- which
------1 can bc converted into drug-action points - Compulsory
license, effects of .I RIPS, patenting, “promotion ofr rational
info
'
’ drug
o---"jfmation
(BODHI), the
effectiveness or
- otherwise of the -functioning
..
of DTAB/DCCI, the essential drugs concept in
state government agendas and the effects on health budgets and drug availability, monitoring
of and pricing of key drugs and comparison with international trends, running courses in
rational drug therapy, pharmacy management, drug utilization studies (how I
Io and actually do
it), patient leaflets tn different languages, monitoring 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.
New topics beyond drugs, but where a lot of cheating takes place----- Publicizing of
standard guidelines for newer modalities of investigations as SCREENING TESTS - ECG
stress test, mammography, CA T scan. Indications for surgical versus medical management of
II?, clarity on the indications of angiography, stress lhalium etc.
Suited muiinv;. Anam's backend paper on ‘1F/w/ can be done?”
Organizational aspects: (Gopal Dabadc)
By the end of (his session, we intend Io have some concrete plans and cotnmihncnls:
A) I he need for a democratically 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.
( ^‘ate a database of all the active groups on drug issues in India.
13) Identify major areas of intervention.
I kick ground 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 are 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. This 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. Ibis 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
I he second step to serve the interests of both the doctors and patients is to have third
party payment systems. If patients are insured and the insurance agency pays for (he 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, (hat 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 (he 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 rales. 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. Phis system avoids the bureaucratism when doctors
become paid employees (he slate and also leaves scope for private initiatives. Bureaucratism is
quite inimical in a sensitive and personalized service like medical care. I he system of universal
health insurance also avoids the problems of commercial competition amongst doctors. In the
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 health-care. But the state's share in only 21% of this expenditure. This share
is lower than that seen even in Bangladesh (M%) 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 linn pay the private
practitioners as per negotiated, rational rate-structure. Ihus without people having to pay more
on health-care than what they are 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
MBBS doctor per 2000 population and one graduate doctor of some pathy per 1000
one
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 required 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).
I)
Assessing Drug Needs - I licre 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 at the Community level would form the basis of estimating the
drug-needs in India.
11)
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, Essential
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 Essential Drugs List for India has been prepared in
April 1995 by a team of experts from NGOs. It's a graded list which lists which drugs arc
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 at all times in all government health
facilities at various levels.
IV)
No Unnecessary Syrups - With the exception of antacids which arc preferably used in
liquid form, for all other drugs, liquid oral preparations should be allowed only for paediatric
formulations since children cannot swallow tablets or capsules easily. Syrup-preparations for
adults mean unnecessary costly preparations.
■
As argued earlier, drugs should be available only under geneilc
V) Only Generic Names I hc manufacturer's name may be put in brackets alter this genetic name.
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 un-veriliable statements. Promotional materia
should be screened by this committee on this basis and be allowed to be published only after the
committee's approval.
Ihc IIAl 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.
Sponsorship of Symposia and Other Scientific Meetings - Here again, the guidelines laid
VII)
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 workers 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
I
v
(2)
IPartial sponsorship of such meetings may he permitted if such sponsorship is
•
i •
,I
r 11 i •
11
rn
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.
i
Thus overall, sponsorship of scientific or professional meetings by drug-companies
should be seen as drug industry's contributjon 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 rchydrntion salt for diaiihoca; antiseptic for wounds, pain balms for nchrs 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 ().T.C. All other existing irrational
O. f.C. drugs should of course be banned. .
I
The labelling in case of O.T.C. drugs should he more
detailed, giving all indications, contra-indications, common side-effects and danger-signals. The
labelling should be made in Imglish, 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 (raining. 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 their registration with the stale
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. fhe 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.
3
Similar measures will have Io he laken for non-allopalhie doctors and paramedics using
.(hugs.
XI )
Improvement m Medical Education - Medical students should he taught the basics of
political economy of health and the drug-industry; about the history of drug-regulation in India
and ethical issues in promotion of drugs. Such education would enable the doctors to deal with
ethical issues in drug-promotion and in a better way.
XIII) Research on Non-allopathic Drugs should be encouraged with funds, facilities and prestige.
I hits to ensure that resources spent on drugs are properly utilized so that the right kind of
.drug is used in 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-professionals and the lay-people. All these changes indicated above arc simple to make
provided there is political will or pressure to do so.
I he above measures cannot be separated from measures to protect and promote the wellearned reliance of the Indian drug industry, from being squandered through the New Economic
Policy and the signing of the New Patent Regime of the World Tm,|(. (hgnnlznllon
As
mentioned in (he beginning, we have not dealt with this aspect in this book because (bls 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.
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 obligations
. The policy of economic liberalisation 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 thorn the 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 considerably reduced the scop
Page 1
Mira on Policy 2002
e of industrial ?licensing.
'
In the
Drug Policy 2002,z :industrial licensing for
the manufacture of al
1 bulk drugs cleared by the Drug
__ J
Controller and their formulations
and their intermediates has be
en abolished except for bulk
drugs produced by recombinant DNA Technology and bulk drugs
requ
iring in-vivo use of nucleic
acids <as the active principle and special
cell/tissue targeted f
ormulations.
Foreign investment through automatic route raised from
51 per ce
nt to 74 per
cent in March 2000
has been raised now to 100 per cent.
There was a time when compa
nies with 40 per cent foreign
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 investmen I is for profit o r I o
no i v< ? I he mi I (c• r I ikj
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
liberalisation is
— to take place in the name of "increasing compe
tition" 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.
Information technology and the pharmaceutical
industry have been
identified as one of the most
important knowledge 1based industries.
There have been’. delays in
revision of drug prices3 when raw
material and other costs increase a
ccording 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
------ 1 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 i----pressure to change the Indian Pa t
ent Act 1970 has been tremendous.
Ihe intensity with which the new Patent regime
is being pushed,w
Page 2
Mira on Policy 2002
ith bilateral p
----pressure
of Super
301 under the ~3^s
US'
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
-.-t 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,
tag! ?nd?!ahad
enfOrced Prod^t patent the advan
ldye j. naia nad in bringing our
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 punch
asing power of the ma jor Ily with
40 per cent below poverty line. This
was possible because of the
Indian Patent Act, 1970.
The most serious implication of 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 process will not be possible
he inadequate resource base of
:
. . Due to t
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 develo
ping countries.
Ironically, the US Patent law does
not recognise anything nonwes
tern,, inon-published
....
in English as
Prior
I* ‘
. . --- 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 and
<
-1 again
to change its patent
act, against its
own people's interest
----- ^tatthe
earliest.
Protests in Seattle, Melbourne, Prague,
Genoa and even in Doha h
ad communicated that pol j.cies
made with trade interests,, with serious
negative implications fo
r the poor majority would be
resisted. There has been tremendous
resistance to the forced Ini
ellectual Property Rights 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 A I)" . The Pharma BBC
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 selective!y-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 have
. j 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 med
icines is detrimental to the
consumer.
It has been proposed to strengthen NPP A by providing
appropriat
e powers under DPCO which would
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
required.
lure on the part of the
manufacturers to provide adequate information in the oast
DPCRC
recommendation of giving powers
to t he drug control an I ho i i I i r*n f o d | npo.’i oil
I I I and pel I y o
ffences etc., will require an
amendment to the Essential Commodities Act.
Quality Aspects
The issue of Quality Control is to be covered by the Drug Contro
1 under the Health Ministry. The
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
1994, there was no formulation of
an Essential Drug List. After several decades of requests.
recom
mendation, demands and pressure,
i?^9M6'.the forrnulation of a National Essential
Drug List by He
alth Ministry took place and was
presented in the Supreme Court where a
public interest litigatio
n 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
drugs. Yet,
Drug Policy for the manufacturers there is
absolutely no mandate
given to ensure adequate
production of essential drugs, the
I '
drug policy being under the D
epartment of Chemicals under theJ
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 Lhe
Health Ministry.
Page 5
Mira on Policy 2002
WHO had promoted the concept of Essential Drugs, and the WHO's D
rug Act ion Programme 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
ological 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.
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
’ TRIPS, GA TS (General Agreement
y
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 of drugs/medic
al '
care' on 1the other and corporatisation and take over of the indi
genous knowledge andI resources
under the new
instruments of an unjust international Lrade regime, wi11 have I
ong-term adverse effects on the
Pr.igo 6
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RF_DR_3_SUDHA.pdf
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