RATIONAL DRUG POLICY AND RATIONAL THERAPY ISSUES
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- Title
- RATIONAL DRUG POLICY AND RATIONAL THERAPY ISSUES
- extracted text
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RF_DR_4_SUDHA
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area.
New Delhi-110016
Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652008
D-lo/543
LOW COST DRUGS AND RATIONAL DRUG THERAPY
INTERNATIONAL CODES AND .IY0U
COMMUNITY HEA'-TH CF.LL
' 47/1, (First HoorlUt.
BANGAlO->£ ■
001
Last year the WHO was instrumental in passing an International Code of
Conduct of Marketing Practice of Baty foods.
This not only focussed the attention of the public, the health professionals
on the baby food issue, but placed the concept of breast feeding from
a 'rustic, old fashioned practice' to scientifically sound and recommended
one. What this will do to the commercial interests of the milk food
industry is anybody's guess? It is up to the aware public, the consumer
associations, the journalists to ensure that the code of conduct of which
India was a signatury - is firmly adhered to.
The contents of this code are being circulated for awareness and action
of the health personnel and the public.
Along with it is a copy of the International Code of Pharmaceutical
Marketing Practice, proposed by IFPMA (international Federation of
Pharmaceutical Manufacturers Associations).
A copy of this provisional code was given to the participants of our
Drug Workshop at Poona, for discussion and comments.
The code is being circulated along with extracts from the discussion
document prepared by Health Action International on .the code.
You are requested to read it carefully, share it with your colleagues
and pass it on. Your comments and suggestions regarding the international
code of pharmaceutical marketing practice are requested.
You are request,d also to bring to our notice, cases of malpractice by
drug companies which may be, by way of misinformation, selling of spurious
drugs, unethical marketing practices, commissions for prescriptions, cut
backs etc. Your participation is not only requested but is NEEDED for
us and other groups and organisations to take any legal action, for
malpractices to be curtailed before it is too late.
What is IFPMA ?
IFPMA is an International Federation of Pharmaceutical Manufacturers
Association, a Zurich-based trade organisation, set up and supported by
a ml mber of national associations of manufacturers of prescription drugs.
Altogether there are JO affiliated national associations plus 12
affiliated through the Latin American Association of the Pharmaceutical
Industry.
Why the' IFPMA Code was introduced and what it aims to be?
"The Paris-based International Chamber of Commerce has published codes of
advertising and marketing practice - which are meant to apply to business
of all kinds. However, the IFPMA Code (which makes no reference to the
requirements of the International Chamber of Commerce) is believed to be
the first ever attempt to introduce an international code of marketing
practice for pharmaceutical companies.
'...2/-
>10/343
MS-cb/23.582
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The preamble of the IFPMA Code (Appendix) explains how its terms of
reference extend to the drawing up of a voluntary code of practice. Though
the IFPMA does not state why it decided to introduce a code at this timd,
the following factors would certainly have been important:
1. There has been considerable criticism of the activity of the international
pharmaceutical industry, anu it appears to be increasing. The industry
has given little evidence hr suggest that it accepts such criticism - but
would certainly be aware, at least, that health-care professionals increasingly
find it legitimate and to the point. The relative success of the campaign
coordinated by the International Baby Food Action Network (IBFAN) has
demonstrated the potential for international action by media, consumer,
public interest and development and health action groups - particularly
where developing countries are concerned.
2. The need to avoid further statutory regulation of the industry at
either national or international level. The indications are that the
IFPMA proposed its Code in response to the threat of a move by the World
Health Assembly to work towards the setting up of a formal international
code of pharmaceutical marketing practice. In the event, the threat did not
materialise at the Summer 1981 World Health Assembly - but there remains
the possibility of future initiative, if not through the World Health
Organisation or UNCTAD, then possibly through the UN Centre on Transnational
*
Corporations
J'
3. The credibility of the industry - now clearly under threat - is a vital
commercial asset. Lack of confidence in the drug industry by those who
regulate, prescribe or use pharmaceutical products could be commercially
disastrous. It is clearly critical that the industry generally, as well
as individual drug companies, is trusted and seen to ’care'.
The IFPMA has responded to these (and perhaps other) imperatives by first,
issuing a statement of 'the obligations' of the pharmaceutical industry;
and secondly, by suggesting a number of 'general principles' by which
these obligations might be fulfilled.
It is important to recognise that, in doing so, the IFPMA is not trying to
introduce its own 'simple world code'. The IFPMA specifically says this
would be 'impractical' because of differences in local conditions. All
IFPMA is trying to do with its Code is 'to encourage' national member
organisations either to introduce or to revise their own voluntary codes."
What stage of implamentation is the Code in?
"The document has not yet been formally adopted or published: it is
reproduced here in the form in which it was circulated for comment to
IFPMA member associations, in March 1981. Since then., the Code has been
agreed by the IFPMA Council and, by the end of June 1981, it had been
approved also by all.of the major associations within IFPMA."
What is the purpose of the discussion document circulated by HAI?
"The purpose of this paper is
1.
to draw attention to the existence and provisions of the IFPMA Code;
...3/-
D-10/343
MS-cb/23.5.82
- 3 -
2.
to discuss briefly its significance in relation to controls that are
needed and which might be applied; and
J.
to suggest options for action by HAI participating groups. "
According to the discussion document, what are the three essential
ingredients of any code of practice omitted in this IFEMA's Code?
1.
Need for interpretation.
Reference to the need to ensure that the industry makes products which
have full regard to the needs of public health - appears a statement
so vague that it is hard to accept it as anything much more than an
advertising or public relations slogan.
2.
Need for monitoring
The question raised is 'what assurance is there,that the code will be
adhered to?' Is the Code to operate on the basis of a complaints
procedure? The mechanism for complaints handling and monitoring,
which are fundamental to a code have not been referred to.
3.
Need for enforcement
What happens if the Code is violated?
-
who judges? industry (through its association or otherwise) or
truly independent bodies.
-
whether enforcement decisions are published - or this is kept
a secret? Could it be possible to establish, on the basis of past
decisions, what practices are acceptable or unacceptable? And what
is the record of individual companies-where complying with the
Code is concerned.
-
what sactions would be applied if companies break the provisions
of the Code?
-
what incentive is there for firms to observe the requirement of
the Code?
What are the implications and significance of this for the HAI groups?
This is useful to refer to the obligations of the industry identified
by IFEMA;
Individual groups may think alternative or additional requirements which
might be needed t'o control abuse in pharmaceutical marketing, and to
consider how such requirements might effectively be enforced at both
national and international level;
D-lO/343
MS-cb/23.3.82
Groups might also wish to collect exmaples of apparent malpractice;
Collectively, groups may find it useful to exchange information or the
design and enforcement of standards under different voluntary (self
tegulatory) systems operating in their countries. Groups might also- wish to
compare and pool the evidence they obtain about apparent malpractice
and to publish and publicise this evidence both locally and internationally
through HAI.
HAI would like to know whether it should press for introduction of an
international code of pharmaceutical marketing practice which ha^'teeth,"
and which can reasonably be expected to work through WHO/UNCTAD and ■
national governments.
YOUR RESPONSE IS NEEDED URGENTLY
.
tnr
'
.'.m.'UNV'I00
-.9 Hllv-
3-4/378
k/17/7/84
CRITERIA OF A RATIONAL DRUG POLICY
(Background paper prepared by Dr, Sujit K. Dass &
Others, Calcutta for DRUG ACTION NETWORK (DAN)
Core Group meet, Wardha - July 30-31, 1984.)
Drugs may be defined as substances used in the exercise to
alleviate physical and mental ailments of living body as well as
to prevent illness. Hence, the use of drugs is a part of the
health care service for the individual .and the community. India
has no precise or comprehensive policy on health Care service.
A drug policy cannot but be an integral part of the health care
policy. The basic elements of desirable health care policy for
the country should, therefore, be, identified before we discuss'
the criteria of a rational drug policy.
Majority of the Indians suffer from the diseases of poverty and
ignorance i.e. Communicable diseases, diseases due to undernutri
tion, etc. These are preventable and curable. Industrialisation
and urbanisation have also led to spread of consequential diseases.
What we need then, is adequate nutrition, safe water, universal
sanitation, environmental protection and a primary medical care
service available to all. Obviously, this is a tall order at
present. Keeping therefore, all socio-economic-political-cultural
constraints in mind, the following should constitute the prio
rities of our health policy:
1.
Universal immunisation programme.
2.
Free clinical service to all indigent people (people living
below a pre-determined level of income).
3.
Provision of adequate Calorie for the indigent people.
4.
'Planned extension of sanitation and water supply.
3.
A rational drug policy.
These priorities may appear to be inadequate and imperfect.
But
these have been set up with a view to conf ine’ within• achievable
goals.
/■
Role of drugs
To the people, doctors and non-doctors alike,. drugs appear as
panacea for all ills. Health is still regarded as an individual
or personal responsibility and it is believed that freedom from
diseases could only be obtained by better and1.better and more and
more drugs. Such a belief, among educated and- illiterate alike,
h-is led to a universal craze for drugs and the DRUG CULTURE has
come to dominate the society. On the other hand another school,
comprised of obscurantist and progressives, point o.ut the harmful
consequences of the-drug culture and prescribe a journey-.back to
nature. We are told to reject this dependence on 'drugs and con
centrate on attacking the soci-econcmic causes of. illness..
It is not disputed that without. dicing free from inequality and
exploitation, a society cannot achieve freedom- from avoidable ill
ness. On the other hand, one cajjnot allow people t'o s-iffpf and
die till that real freedom arrives. Hence, in oiir sodlfety, medical
care service has an immediate, essential and priority- role to play
and the drugs .occupy a pivotal position in the me die a, care service.
Besides, there are preventive drugs--too ti'.g., vaccines etc..
.
; • •2/l
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x/17 .~l. 84
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 policy. It could be dis
cussed in the following aspects.
b.dico-scientific aspect
The- trend and pattern of drug production (including import) have
been fairly revealed in the report of the Hath! Committee (1975)
as well as in a few subsequent.works.
It has been conelusively
shown that drug production does not bear a parallel or reciprocal
relationship with the disease pattern or need of the country.
neither it is always governed by the medico-scientific justifica
tion. Medico-scientific justification should act as a primary
criteria and on this basis the following issues come up for con
sideration:
Efficacy:
a drug must be a drug according to its accepted
"
definition.
It must-have a tractable or measur
able role to play in protecting or maintaining or
restoring health.
In India, various substances are consumed as drugs in the prevail
ing different systems of therapy or even belonging, to no system at
all. In order to obtain license as a drug, a substance must fulfil
all the universal scientific criteria - no system of therapy
could claim any special criterion for itself.
Benefit/Risk. ratio should ba a guiding principle for the
introduction or continuance of a substance, .as drug. . Lower
the ratio, restricted be its indications.
Pharmakokinecics,
Toxicity and side-effects are the f ictors to consider.
Storage requirements and Shelf-life :
These cons ide r ations
hitherto neglected, should be accorded their due importance
and relevance. ...
Bioayailability: The issue of Bioavailability does not pose
a practical problem and should therefore, be ignored at
present.
Socio-political ^ppect
Priorities in tfya selection of drags for production, distribution
and research shQul d be governed by socio-political realities and
"necessities.
Since the drug industry and trade are dominated by
the TNCs and regulated by the .-trends of the international capitalist
economy, a psople-oriented drug policy will necessarily come into
conflict with the prevailing trend. Hance, a radical change in the
drug policy hardly appears to be an achievable object. The criteria
in -chis reg-.rd may therefore dwell on the considerations of opera
tive feasibility.
Priority drugs:
It hardly neeSs emphasis that we have to set up
priorities for the production of-’drugs according to the prevailing
disease pattern <_.e., drugs to -combat communicable and nutritional
diseases should claim priority. -The prevailing much used term
'essential drugs’1 appears to' rais’e some confusion-. Since every drug
has Its distinct efficacious-arole: to play, each one may be viowu-d
as essential - gome to many and seme to only. few. Hence, it is
suggested that the "Idea behind thtj: term 'essential drugs' may be
natter served by using the words ‘'’’priority drugs".
: 3 :
In any case, priority drugs ought to lie made available to all and
such a situation could hardly be achieved without total control
by rhe state. Presently, it appears that there is hardly any re<il
hindrance for the Govt, of India to exercise such control but the
fact remains that the Govt, does not exercise it and the parliament
has failed to take the Govt, to task for its dereliction of duty.
The experience of Sreelanka and Bangladesh has show that by pur
poseful and active intervention, the state could achieve effective
and significant change in the chaotic drug situation and this is
particularly so in respect of priority drugs. Hence, for the ade
quate production of priority drugs, an effective mechanism for
exercising state control should be formulated and implemented.
Distribution:
State health care service including drug distribu
tion should cover geographically the whole country/ and be delivered
free to only indigent people (living below a predetermined income
level). Dike health care, other categories of population will have
buy drugs .
Legislotion: A National Drug Authority as recommended by the
Hathi Committee be established alongwith the inclusion of repre
sentatives of the social action groups on Drug. The powers ..and "
functions 'of Drug Control Authority should be subordinated to the
'NDA. NBA should be empowered to impose control over prescribing
norms of the medical profession and should time to time issue
guidelines in this regard. NDA should ensure that all scientific
and legislative informations on drugs are circulated to the medical
profession. NDA should also recommended to the Govt, on the legis
lation in the matter of promotion, packaging, public education
regarding drugs.
Indigenous drugs: A distinct effort for the promotion of indigenous
drugs in the name of old glorious Indian tradition is noticeable and
should be looked into objectively and not emotionally. All indi
genous drugs ought to fulfil the medico-scientific criteria and be
evaluated on the economic basis (see below).
Research & Develoyynent •
Priority on R & D should be guided by the
disease pattern ar»d economic criteria. Foremost priority should be
accorded to those diseases which are jreal problems of Indian people
but have no ideal drug i.e., effective, safe, cheap etc. R & D of
indigenous drugs only for the sake of being indigenous have little
claim on priority unless it is economically more cost-effective
in comparison to available drugs.
Health Education; Education of the public on all aspects particular
ly hazards and cost of drugs should be .tn ■. integral part of Health
Education.
Nodical Education: The conversion of thu GENERIC education of the
medical students to the BRAND education after graduation should be
resisted. Informations on all aspefitr of drugs should be made avail
able to students. NDA should undertake the -responsibility of con
tinuing education of medical practitioner® op advanced information
of drugs.
Drug Culture:
Priority of health eciucation should be
towards an attack on the prevailing drug culture.
pointed
i-eneric name, (I.N.N,) :
Should be compulsorily introduced with
suitabl e legislation. A system be deviseci to introduce non
proprietory names for the combination drugs.
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4/378
17.7.84
Economic aspect
-Technology: Technological reality should be assessed and
necessary import of technology should be vigorously pressed
if necessary, in respect of priority drugs. An international
campaign shouldd be launched'for the dissemination of technology
know-how through international bodies.
Product!on:
Definite production quota for priority drugs should
be imposed on individual producer.
Price:
In respect of priority drugs, pbices should be uniform
without any mark up. All taxes should be abolished. All import
should be channelised through state agency.
^on-priority drugs:
should be licensed in a. separate Category and
so designated in the packaging. High taxation is desirable.
Other Issues -
Drugs banned in other countries:
should be banned in India till
its fulfilling the above criteria is -reevaluated and reestablished
Implementation:
with.
’ -
should be initiated in the state sector to begin
.
Nationalisation:
If other methods fail, Drug industry, and wholesa
trade should be nationalised.
oluntry Health Association of India,
C-14. Community Centre,
Safdarjung Development Area
New Delhi-] 1001$.
S-4/378(c) LGD&RT
VHAI:pt:17.7.'84
TOWARDS A RATIONAL DRUG POLICY IN INDIA
-
/inant Phadko.
Sven a cursory glance .tat, the existing firug-situaticn in'India would
rsveal 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 nocessity 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
following intermediate measures are to be demanded from tho Government.
These measures do not constitute a full-fledged Rational Drug Policy
in India but are steps in the right direction." We demand from the
Government tho 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". The recommendation of this committee to be
implemented without delay.
The Committee would 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.
g
The Drug Review Committee to prepare a Graded Essential Drug List
o J2 g
as outlined earlier and the Government should make it mandatory on x £ v
all. drug companies to produce drugs amongst this list only. All
S 2
other drugs recommended in standard text-books would be considered
■; '?
as non-priority drugs in India. A separate list of such non-priorityr — .
drugs shall be prepared by tho Drug Review Committee and drug
> g O
companies would be required to take permission to produce or market g 1 y
any drug from this list.
2 “ ,y
g £ a
Only those non-allopathic drugs which have been proved to be
o -effective and safe in research are to be allowed to be produced for °
general use.
«•
The Public. Sector should play a leading role in the manufacture
of ~1 ife-saving drugs and drugs used in the National Health Programmes
(for example - Tuberculosis Control Programme). It is the respon
sibility of the 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
consequent shortages-.
2/
E-4/373(c)LGD & RT
VK'J:pt:17.7.'S4
2
3
No technology transfer agreement shall be 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■repatfetion of
profits..
4.
Imports of drugs to bo governed by the same Graded Essential Drug
List and'conducted only through 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 be extended to all drugs.
However, the existing categories in the DPCO to be 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 salcs-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 namo. The company’s name
can be mentioned on the label in bracket. For example - Ferrous
Sulfate (Glaxo). But the generic name should be at least equally
prominently and clearly printed on the label as the company’s name.
8.
It shall be the primary responsibility of the manufacturer to ensure
the quality of drug products. Hovrcvcr, it shall ba the statutory
responsibility of the Drug Control Authorities to monitor the
standards and ensure a minimum uniform level of government control.
; Consdtjiently, the government shall take all necessary measures to
enable the Drug Control Authorities to function in an effective
manner and discharge the statutory duties cast upon them.
9.
It shall be the statutory duty of the drug control authorities to
irifiorm 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 Committee should also scrutinize all the over-thecounter drugs and only those drugs which are fully scientifically
justified to be sold- as over-the-counter should bo allowed to be
sold in such a manner. No vitamin preparation be allowed to be
advertised in the lay press and all advertisements in the lay press
should be preccnsored to prevent any misleading of lay people.
3/
E-4/378(c)LCD & RT
VHAE:pt:17.7.'S4
*
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 vrork 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.
18.
Education of the lay-poople 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.
Voluntary Health Association of India
Telegrams : VOLHEALTH
C-14, Community Centre
New Delhi-110016
Safdarjung Development Area
New Delhi-110016
668071
Telephones : 668072
E-4/37S(d) LCD 7 RT
VrL'I:pt: 17.7.'84
SOME DISTINGUISHING ORGANIZATIONAL FEATURES
OF COMMITTEE FOR RATIONAL DRUG POLICY
- Prepared by Anant Phadke
to help in the discussion on
Structure of Drug Action Network
Ales and Objectives:
*
Conducting and participating in Seminars, workshops,
discussions;
*
Conducting and participating in public educational
conpaign;
*
Publishing, circulating theoretical, educational
material;
*
Conducting relevant research;
*
Cooperating with and helping like-minded groups,
organizations, institutions;
*
Conducting any other activity consistent with tho
aim of the Committee.
COMMUNITY HEALTH CELL
, (t i.'si Floor) 3 1. Marks Road
- 560 001
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:-
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 membor on payment of
Annual Membership fee.
Annual Membership fee:
i)
INDIVIDUAL
(
o
Rs. 2,5/- for those earning
0
less than Rs. 750/- p.m. Q
0
Rs. 50/- for those earning
0
more than Rs. 750/— p.m. ()
(ii)
ORGANIZATION
Rs. 250/- per year.
Individual members cannot become office-bearers of this
Committee. Only representatives of organizations can become office
bearers .
2/
-J-^./373(d) LCD & RT
VHZI:pt:17.7.'84
The Committee would, not bo responsible for tho views
and actions of its members other than on the drugs-issuo.
Termination of Eomberahip:
i)
Resignation
ii)
Non-payment of membership foe for one yoar
iii)
Expulsion by the Executive Committee; if tho
individual or organization conducts or parti
cipates in any activity contrary to the aims
and objectives of this Committee.
Seven Stegs to success_in essential druc(s_sugglY
"Essential drugs are those that satisfy
the health care needs of the majority
of the people. They should, therefore,
be available at all times in adequate
amounts and in the appropriate dosage
forms."
(1)
NATIONAL DRUG POLICY
Every country's comprehensive health policy should include
a National Policy on Essential Drugs. WHO's role is to inform
governments about the basic concept and the benefits, then to
provide technical support for policy formulation, selection of
essential drugs, a plan of action, procurement, quality control,
programme management and aspects such as training, evaluation
and legislation. A national essential drug policy can provide
more drugs to more people at the same cost or even less.
(2)
SELECTION OF ESSENTIAL DRUGS
Essential drugs are those that satisfy the health care
needs of the majority of the population. Selections are based
on the most common local diseases and conditions and on the
capability of the health workers who use the drugs at different
levels in the health care system. More than 80 countries have
now adopted lists of essential drugs based on WHO's Model List of
Essential Drugs, as have various non-governmental organizations
and UN agencies.
2
2
(3)
DRUG PROCUREMENT
All too often countries pay more than they need for their
drugs. They can get better value for money by putting out bulk
orders to international competitive tender on the world market.
UNICEF and WHO help countries to strengthen their procurement
systems and to secure, if necessary and possible, reliable
financing - internal or external - for their purchase.
(4)
LOGISTICS OF SUPPLY
WHO’s goal is to make sure that people can get the 20 most
needed essential drugs whenever they require them, within an
hour's travel. The supply chain must work: correct ordering, packing
and storage; less waste through deterioration, loss or theft,
regular transport to the remotest dispensary despite climatic
and geographical conditions or fuel shortage. Several countries
have established efficient drug supply management systems with
support from WHO, UNICEF and bilateral agencies. The pharmaceutical
industry also provides expertise.
(5)
PROPER USE OF DRUGS
Both health professionals and the general public are in need
of better information and education about when and how to use drugs
Common problems are that the former tend to overprescribe while the
latter may fail to follow the prescribers instructions or dose
themselves. Drug information sheets are being considered by WHO
that would give the indications, contra-indications and side effects
of essential drugs. Several countries have produced their own
therapeutic guides and standard treatment schedules for use by
health workers. Consumer groups do valuable work among and on behalf of
the general public.
3
(6)
QUALITY CONTROL
Essential drugs must be of reliable quality as well as
efficacious and safe. Quality has to be assured upto the time that
the drugs are administered by good manufacturing practices and by
monitoring of products at all stages in the supply line.
The IFPMA member companies provide training in quality control for
nationals of developing countries. Any country lacking quality
control laboratories can obtain an assurance of the quality of
imported products at the time of export through the WHO certification
scheme on the quality of pharmaceutical products moving in international
commerce.
(7)
TRAINING
Many countries lack staff trained in policy formulation,
selection, procurement, management and use of drugs, in drug
legislation and regulatory control and in production and quality
control. WHO is approaching universities, training schools, non
governmental organizations and the pharmaceutical industry for
help with training materials and courses. At seminars and workshops,
countries that have developed successful national essential drugs
programmes demonstrate to others "how it
s
*
done".
from World Health, July 1984
^7-
co^^'t"66o«'
THE BAN OF HARMFUL DRUGS
The judgement of the Kerala High Court — extracts
"As between the lives of the citizens of this country on
the one hand and the loss that may result to the manufacturers
and traders by the immediate ban on the manufacture and sale
on the other, the Government has chosen to view the latter
as of more concern"
......
"Therefore whatever may be the way in which the idea is
expressed in the counter affidavits the plea reduces itself
to this that, drugs which ultimately are found injurious in
the matter of treatment of patients are being banned. If they
are being banned for that reason, the main and perhaps the
pre-dominant and overriding consideration must be the lives
and health of the consumer public. The value of. human life is
immeasurable. The state inany civilised country should treat
the life of each of its citizens as sacrosanct"
"But when injury or harm is not inevitable but is within
s
*
Sates
power to pr vent there can be no excuse and no platitude
and the duty to protect the citizen from such harm and danger
is absolute. We are mentioning this to emphatically point out
that loss to the consumer versus loss to the manufacturers
and traders should not be posed as a relevant issue at all
since these cannot be treated as competing claims"
"While it is necessary that the manuf cturer and the trader
must not lose in his industry or business, the insurance against
the loss should not be at the cost of human life or human health".
2
2
It, therefore, appears to us that the provision of a cut of date
for manufacture as well as sales is an irrational, highly unjust,
unfair and amoral approach adopted as a result of a distorted
appreciation of values."
.
It must necessary be for the Government of India to decide
which are the formulations that are injurious if used and which
ought not, for that reason, or for other equally good reason to be
allowed to be manufactured and sold in this country. They are now
empowered by the amendment of the Drugs and Cosmetics Act, 1940
to take effective steps for such prevention.
When once the Government of India has reached a decision that
certain drug formulations ought not to be allowed to be manufactured
and sold, apart from taking steps for enforcement there is the
responsible duty of the government to give duepublicity to this
decision. It would atleast serve as a warning to the consumer
public to be aware of the danger involved in purchasing and consuming
such goods. The reference to the 18 drug formulations in the
government order may not be sufficient for the common man to know
what are the drugs he should avoid purchasing, when he goes to the
market. The brand names corresponding to these 18 formulations must
be made know to the public so that they are alerted to give a wide
berth to such drugs even before government comes up with any steps
enforcing a ban on their manufacture and sale.
—Subramonian Poti, Ag. C.J
^7community he^th cell
3?6, V Main, I Elock
Korsmungala
Bangaicre.5fi0034
-9/^1 (d)
India
THE DRUGS AND COSMETICS ACT ----- Updating Necessary
Some of the aspects of the drug regulations have been
analysed and are discussed below:
I.
Expiry Dates and Shelf-Life of Medicinal Products
Regulations
In India, the expiry date is required to be given
on the label for medicinal products coming under
schedule P. For most of the drugs not coming under
schedule P, the expiry date need not be stated.
Expiry dates have to be specified for very few
products not coming under schedule P.
There is a current proposal to amend EEC Directive
65/C5, Article 13 to reguire an expiry date to be
stated for all proprietary medicinal products.
•
In UK, the UK Medicines (Labelling) Regulations
currently require an expiry date to be given if the
shelf-life of the product is less than 3 years.
It is not usually necessary to provide stability
date for established drugs, e.g., one which has a
British Pharmacopoeia monograph. The licencing
authorities satisfy themselves of the suitability
of the product for the intended use over the shelf
life of the product prior to issuing Product Licence
or Clinical Trial Certificates. Stability data of
new drug substance must be provided for a Clinical
Trial Certificate, summarised for a Clinical Trial
Exemption, or given as part of Product Licence
Application for a formulation. Appropriate stability
date is incorporated in labelling, package inserts
and data sheets .
Data collection in the subject is in progress.
above are only interim findings.
The
Lacunae
The regulations in India regarding shelf-life data
are not adequate. Appropriate precautions regard
ing data of stability tests to be given on labels,
leaflets accompanying proprietory medicinal products
and information dissemination to doctors by
pharmaceutical companies are not exercised.
Few companies specify dates of expiry for drugs
not coming under Schedule P, while others do not
do so.
There is an unwritten understanding that when the
expiry date is not mentioned by the manufacturer,
it should betaken as 5 years.
It does not appear that most doctors and pharmacists
are aware that when the shelf-life is not given by
a manufacturer, it should be taken as five years.
Some of them dispense/adm.inister such drugs even
beyond 5 years after their date of manufacture.
...2/-
For drugs not coming under schedule P, there is no
procedure to check that they are not being dispensed/
administered beyond a period of 5 years after the
date of manufacture or date of expiry, whichever
is earlier.
The nature of the pharmaceutical distribution
network, unscientific purchasing by the trade, and
lack of proper stock control procedures are some
factors likely to result in longer average period
elapsing from date of manufacture to date of
ultimate consumption/administration in India as
compared to Western countries.
II.
Labelling
Regulations
Rule 96 of the Indian Drugs & Cosmetics Act 1945
makes it necessary for the pharmaceutical companies
to provide (i) Name of Drug, (ii) Name & Address of
Manufacturer, (iii) Batch No., of Lot No.,
( iv) Date of Manufacture, (v) Expiry Date for Drugs
coming under schedule P, (vi) Warnings eg.,
"Poison", "For-External Use only", "To be sold on
the prescription of a registered medical practitioner
only," "Caution, etc. for drugs listed in certain
schedules. These regulations have not been revised
since long.
Section 105 (352) (F) of the Federal Food, Drugs &
Cosmetics Act of U.S.A, states that a drug or devise
shall be deemed to be misbranded "Unless the label
ling. bears (a) adequate directions for use, and
(b) such adequate warnings against use in those
pathological conditions or by children where it
may be dangerous to health or against unsafe dosage
methods or duration of administration or applica
tion in such a manner and form as is necessary for
the protection of users." Further data regarding
US labelling regulations has not been received till
now.
The Bureau of Drugs, Food and Drug Administration
in USA is the component of Public Health Service
which develops policy on labelling of all drugs for
human use ..
In UK, labelling regulations framed in UK in 1976
have been amended three times in 1977, 1978 and 1981.
These are covered by Statutory Instruments of
S/1976 No.1726, S/1977 No,996, S/1981 No.1791 and
S/1978 No.41. The UK regulations are in conformity
of EEC Directive 65/65.
Lacunae
There are too many lacunae in the labelling regula
tions in India and detailed perusal of EEC
Directives, UK and US labelling regulations is
necessary to arrive at specific and comprehensive
conclusions. Safeguards listed in Section 105(352)
(F) indicated above are not provided in India.
.. . 3/-
Risks of adverse drug reaction are likely due to
inadequate labelling-provisions in India. Besides,
inadequate labelling regulations in India are res
ponsible for lack of pertinent drug information
dissemination.
Ill.
Advertisements and Representations Directed to
Practitioners Regulations
In India, no regulations are laid down in the Indian
Drugs and Cosmetics Act for Advertisements and
Representations Directed to Practitioners.
In UK, Advertisements and Representations Directed
to Practitioners are regulated by the Medicines
(Data Sheet) Regulations 1972.
On and after the relevant date in the abovementioned regulation, no advertisement relating to
medicinal products of a particular description,
other than a data sheet, shall be sent or delivered
to a practitioner -
(a)
by a commercially interested party, or
(b)
by any.person at the request or with the consent
of a commercially interested party.
unless the conditions specified in subsection (3)
of this section are fulfilled.
On and after the relevant date, no representation
likely co promote the use of medicinal products of
a particular description referred to in the repre
sentation shall be made to a practitioner by a person
carrying on a relevant business, or by a person
acting on behalf of a person carrying on such a
business, unless the conditions specified in sub
section (3) of this section are fulfilled.
The conditions given in Subsection 3 are (a)
that a data sheet relating to medicinal
products of the description in question is sent
or delivered to the practioner with the adver
tisement, or is delivered to him at the time
when the representation is made, or that such
a data sheet has been sent or delivered to him
not more than fifteen months before the date
on which the advertisement is sent or delivered
or the representation is made, and
(b)
that the advertisement or representation is not
inconsistent with the particulars contained in
the data sheet.
The Medicines (Data-sheet) Regulations fulfil
partly the requirements of continuing education of
medical practitioners.
............. 4/~
: 4 :
The purpose of a data sheet is to provide the
practitioner with an objective statement/ in a
convenient form for reference, giving essential
particulars as specified in Data Sheet Regulations
of 1972 about the medicinal product. All advertise
ments and representations to the practitioner must
be consistent with the particulars contained in the
data sheet. Copies of data sheets are to be sub
mitted to the licensing authorities in UK and the
Department of Health and Social Security provide
guidance as to whether the data sheet complies with
the statutory requirements.
Information regarding the relevant regulations in
USA is awaited.
Lacunae
In India, due to non-existence of such regulations,
practitioners do not get all the relevant informa
tion required by them regarding drugs marketed in
the country. This produces less-informed doctors
in India.
Of course, the level of ignorance,
instantaneous recall and unaided recall, and memory
decay about drug information varies from doctor to
doctor. Doctors in India are deprived of drug
information which is provided to doctors in develop
ed countries like UjK because of their legislations.
It is possible for pharmaceutical companies to
suppress or exaggerate the drug information provided
to practitioners in India. The drug control adminis
tration does not have any statutory role in this
field, does not screen the information supplied to
practitioners by pharmaceutical companies and does
not ensure that' reliable and comprehensive informa
tion is supplied to the practitioners. The prac
titioners ' interests regarding drug information are
not safeguarded in India due to lack of any
regulations.
IV.
Information Leaflets supplied with Proprietary
Medicinal Products
Regulations
In India, no regulations are laid down in the Indian
Drugs and Cosmetics Act for preparation of leaflets
supplied with proprietary medicinal products.
In
UK, such leaflets are covered by the Medicines
(Leaflets) Regulations 1977.
The UK Regulations are in line with EEC Directive
75/319 designed to facilitate free movement of medi
cinal products within the Community,
If a company in UK wishes to supply leaflets with
proprietary medicinal products, it must comply with
the regulations- in UK.
5/-
: 5 :
Lacunae
The Indian Drugs and Cosmetics Act does not specify
the standard requirements regarding particulars to
be set out in the leaflets. The leaflets are not
approved by the Drug Controller (India.)
Since
there are no regulations, there is no breach of
regulations and consequently no penalties for
supplying in-correct/in-adequate information in
the leaflets produced in India.
V.
Advertisement to the Public
Regulations
In India, regulations exist regarding advertisement
to the public by pharmaceutical companies.
In UK, advertisement to the public is covered by
the Medicines (Labelling and Advertising to the
Public) Regulations 1978. These regulations specify
clinical conditions and diseases for which self
diagnosis or self-treatment are considered in
appropriate, and for which medicinal products for
human use may not be advertised to the public.
The list of prescription only medicines is contained
in the Medicines (Prescription Only) Order 1977.
There are special provisions regarding spermicidal
contraceptives.
Information regarding the relevant regulations in
USA is awaited.
Lacunae
The regulations regarding advertisement to the
public were formulated long ago. These would have
to be updated in view of the assessment of additional
warnings incorporated and restraints imposed by
drug control authorities in developed countries.
Note:
This material has been prepared by a friend of VHAI,
who wanted to keep the name anonimous, yet contri
bution towards our efforts towards a Rational Drug
Policy. We express our sincere thanks.
k/2/12/83
Low Cost Drugs & Rational Thera
peutics
VHAI.
COMMUNITY HEALTH CELL
326, V Main, I Block
Koianribngala
Bangalore-560034
India
’-9/335(a)
: 1.9/7/84
PHARMACY Acy
THE AMENDMENT AND ITS IMPLICATIONS
On 1st September 1984, Section 42 of the Pharmacy Act will be
enforced, and no unqualified persons will be allowed to
register as pharmacists, i.e. "NO PERSON OTHER THAN REGISTERED
PHARMACIST SHALL COMPOUND, PREPARE, MIX OR DISPENSE ANY
MEDICINE ON THE PRESCRIPTION GF A MEDICAL PRACTUjKNER" . This
provision has been extended and amended on numerous previous
occasions under pressure from State Governments, All India
Organisation of Chemists and Druggists (AICCD)
The opinion of the All India Organisation of Chemists and
Druggists and that of the Indian Pharmaceutical Association
and Indian Pharmaceutical Congress is split on this issue.
AIOCD.alleges that there are only 30,0 00 qualified’ pharmacists,
while the need in the country is of over 3 lakhs. -.They feel
that with increasing need of drug stores in rural areas
Drug Rule 65(15)C of 1945 should be revived.
The Pharmacy Act of 1948 had suggested that only diploma
holders dispense medicine, but even after 1 of the century only
3 out of 22 states had implemented it. UNDER DRUG RULE 65(15)C
"THOSE PERSONS HAVING WORK EXPERIENCE IN
DISPENSARY OR M'EDI~~'
C-AL.STORE FOR OVER 4 YEARS COULD BE CONSIDERED QUALIFIED AND
BE~AUTHORISED TO ESTABLISH A PHARMACY OR OPEN A RT TAI-L MEDIC
STORE." According to All India Organisation of Chemists and
Druggists, since every medicine is available in small packs
and does not need the ...knowledge of dispensing, there is really
no need for qualified pharmacist when an experienced person
can function just <s well.
With Pharmacy Act, December 31, 1969, had come s.tip ulations
for educational and training requirements in Pharmacy. .In
1977, the amendment was passed. Section 42 of the Pharmacy
Act was to be implemented by August 31, 1981, but was extended
to August 31, 1984, because of shortage of trained pharmacists.
Pharmacists Association and Pharmacy Council of India feel
that there are enough qualified pharmacists. According to an
Editorial in the Eastern Pharmacist, October 1983, from
130 pharmacy schools, 6,525 diploma pharmacists join the pro
fession annually, and from 35 universities and colleges,
1,350 graduate pharmacists pass out annually.
Since quite a few new pharmacist schools have started within
the past one year, 7,000 pharmacists will be coming out annual
ly. The strength of Trained Registered Pharmacists in the
country is about 2 lakhs and so by about 1st September 1984
their numbers would be adequate.
.... .2/i
IS :k: 19/7/84
: 2 :
What does all this mean to us?
Having adequate numbers of pharmacists, in no way ensures
their distribution in rural areas where the need is more.
There is no doubt that sanction is given to village health
workers to dispense limited numbers of drugs and that medical
practitioners are allowed to prescribe and dispense drugs.
The fact remains that in the Indian Context — where the first
contact of the patient is the chemist, — where large percentage of drugs are bought over the counter without prescription,
— where patent and potentially hazardous drug exist in the
market requiring Consumer Caution, it is important that the
chemist/pharmacist be qualified, experienced, accountable to
his/her Academic Institution/Association and to the public.
Selling drugs is a "business enterprise" just as much as
medical practice has become today. With increasing number of
potent drugs in the market medicine distribution has to be
stream-lined.
The question before us is that - will fulfilling of required
qualifications ensure that after implementation of Section 42,
the chemists .in question will not be asking for greater
commissions and will they on 'principle' opt to stock their
pharmacies with most of the reasonable priced quality drugs
which are essential and rn-.-et the need of the majority —
woul d the chemists do so even if the commission on Category I
St II drugs is lesser? Would they refuse to stock banned drugs
or drugs recommended for being weeded out voluntarily?
or would the. pharmacies be stocked mainly with products of
those manufacturers which give the greatest commission and
cut-back?
What we are interested in is not merely qualifications but,
responsible functioning of chemists, pharmacists. We cannot,
but, reiterate Dhanwantri's demand in January 1984, issue of
Eastern Pharmacist for a Code for Chemists, with very clear cut
do 's and don 1ts to act as guidelines.
I
Many of the small vol untary institutions who had failed to
ensure that all their functioning pharmacists, or the dispensery nurse were registered in time, will definetely face a
problem. Employing a trained pharmacist in a rural area at
shoe string budget is not very easy. If upgrading the salaries
of only one particular category of staff is raised i.e. when a
qualified pharmacist is involved - some of the smaller service
health institutions will have to close down, or land up in a
legal mess with their State Drug Controllers.
Should VHAI then take up the issue of demanding revival of
Rule 65 (15) C. If we bel ieve that well trained and super
vised para medicos and village health workers can function ade
quately, efficiently in the field, where preventive and cura
tive medical work is concerned, is having a qualified pharmacist:
all that essential?
The question here is not of how VHAI, CHAI, EHA and members of
similar health organisations react to this amendment, but the
question is of the impact or disimpact of an Act on the health
of the whole nation. Under Such circumstances obtaining the
views of others, health related organisations is crucial to
assess the implications of such an act on the Voluntary health
sector and on the people in rural areas.
0-9/335 (a)
MS:k:19/7/84
Shore Committee in 1948 had recommended withdrawal of the
Licentiate course and given encouragement to opening up of
the medical colleges, for M.B.B.S. graduates.
With 106 medical colleges with 1700 qualified medical doctors
passing out each year how significant has been the impact for
-the majority of the Indians, the common-man, every second
Indian man or woman who happens to be below poverty line, and
on all those people who still have no access even to basic
health care? What does Section 42 or Section 65(15)C mean to
them?
While we ire serious in giving thought to the issues related
to Pharmacy Act - today's Economic Times i.e. 13.7.84 headlines
inform th it "Chemists plan all-India stir." The agitation is
against the Government and the drug companies. Demands are:
( 1)
Scrapping of the Amendment 4 2 of the Pharmacy Act which
requires qualified pharmacists to handle medicines in
chemists shops and in dispensaries.
An increased retail trade margin of 15% and wholesale
margin of 8% on price controlled drugs.
.
complete
CQemist shops all over the country will be closed for/3_-days
■g^d then will be opened for only 8 hours till August 10,
followed
'
iQweg by
py mass
mass disobedience
disobedience, i.e.
only drugs prescribed bv
£-°cb°rs
be 9iven, with no substitution even if the
Prescribed drug is not available."
———■
.
(2)
/shops
According to this article in the Economic Times — 50% of the
chemist/will have to be closed from September 1 due to lack of
qualified pharmacists' (this st stement according to Pharmacy
Council of India is not true) .
Demanding relaxation of Amendment 42 of Pharmacy Act, would
indirectly mean supporting the AIOCD demands.
It must be
recalled that a similar attempt at blackmailing had‘been made
when restrictions on the sales of Schedule 'X1 drugs had been
placed by the Government. Under this it was demanded that
these drugs which could be dangerous and tended to cause
addiction should only be sold under prescription and records
kept.
Regarding the Trade Margin it had been fixed at 12% for retail
chemists and at 2% for wholesalers as early as 1976.
In 1982, a similar boycott of various products was master
minded by AIOCD. They demanded 20% profit instead of the usual
trade terms of 12%. The unethical pressure tactics paid off
when OPPI (Organisation of Pharmaceutical Producers of India)
and IDMA (Indian Drug Manufacturers Association) gave in and
agreed to increase the middle man's share of 26%, i.e. 8% for
distributors and 18% for retail chemists.
This time the chemists.demanded a higher trade margin for
Category III drugs as well.
It must be remembered that
: .
■ 7, ■ z
~LY
ul- -uc '-uL.e.L uxug icimuiations marketed
™=
1V, drut?s constitute about 20% of the formul
mar-v m^rketedJ f°r which the Drug Companies are allowed 100%
mark up.
hlg^turno^To^n^3^1^-- AI°CD planS tO bOycOtt ce^ain
(obviously to teach tSrn ’a lesion)
°f 6
canPan^s
35(a)
19/7/84
The most scandalous aspect of this whole story is th t it is
the consumer who has to ultimately pay this increased trade
off margin for the retailer and wholesale dealer.
In its scathing editorial M.I.M.S. editor in June '82 on
Amoral Accord on middleman's margin had said:
"The current
price increase has been forced upon the nation not for the
benefit of much maligned pharmaceutical manufacturers but by
middlemen".
In view of the recent increase in drug prices and the further
potential increase in the future, it seems to become all the
more urgent for Voluntary Agencies to intervene.
There is a desperate need for drug manufacture, bulk purchase,
effective distribution by setting up a network or drug outlets
where drugs sold are along the principles of Rational Drug
Therapy.
Priority always being given to essential and life
saving drugs, quality controlled at reasonable cost with
adequate drug information. N.G.O. initiatives in drug formula
tion, bulk purchase and distribution already exist. A syste
matic network of drug distribution channels and outlets is the
need of the hour. This is needed:
(1)
To do away with the unnecessary middle man's
profits.
(2)
To influence the drug utilization patterns, by
cartiful selection of the drugs sold, based on
essentiality of the drug based on people's
need rather than on mere profitability.
The national strike by the AIOCD is not just a demand for
increasing profits and stalling of a certain section of a
Pharmacy Act - it reflects the moral crisis in the medical
industry, involving all its chief actors. The drug manufac
turers, the retailers, drug distributors and dispensaries,
the doctors and other prescribers.
ihe victims in all this remain the Consumers who ironically in
this subtle game — playing,.end up looking at their "exploiter:
as the "guardians of their health."
An attempt to bring together various individuals,
groups and organisations concerned about the drugs
and heal ch issues is being made. An informal Drug
Action Network has slowly emerged. Since activities
of most of the health institutions is under the
aegis of coordinating bodies like,
Catholic Health Association of India (CHAI)
Christian Medical Association of India (CMAI)
Emmanuel Hospital Association (EHA)
and
Voluntary Health Association of India (VHAI)
are coming together and having a common stand on these
issues is urgently needed.
In October, 'various organisations involved in Drug Action will
be participating in/Drug Campaign against misuse of druqs.
The National signature campaign is part of the effort.
participation is needed and requested.
Your
Dr. J lira Shiva
Co-ordinator, Low Cost' D ?uqs &. Rational Therapeutics
^nPa<i
Legal Education
DRUGS AND COSMETICS ACT AND RULES AMENDED
The Drugs and Cosmetics (Amendment) 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 amendments 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. 10A
and Sec.26A empowering the Central 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. rj-his is an important provision since
hitherto the Central Government had no such power under this Act.
2.
The * definition of the term ’drug’ has been revised which
nov? covers mosquito repellent, substances intended for use as
component of a drug, empty gelatin capsules and devices. The inclusion
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 'adulterated drugs'.
2
2
4.
The powers of Drugs Inspectors have been enhanced (Sec 22).
Inspectors are now empowered to stop and search any vehicle,
vessel or any other conveyance which they have reason to believe is
being used for carrying a drug or cosmetic in respect of which they
have reason to believe that an offence under the Act is being committed
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 pressurise the State and Central
Drugs Controllers and Inspectors to use these powers and actually
implement the ban.
Source: The Drug Action network:Newsletter of the Low Cost Drugs
and Rational Therapeutics Cell, VHAI, New Delhi.
COMMUNITY HEALTH CELL
326, V Main, I Block
Korsmt-ngala
Bangalore-560034
VOLUNTARY HEALTH ASSOCIATION OF INDIAlndla
a'^ ' ’
■
c" 14 Community Centre,
Safdarjung Development Area,
NEW DELHI - 110 016
USING TETRACYCLINE FOR CHILDREN AND PREGNANT WOMEN
Introduction:
The question of Syp.tetracycline for paediatric
usage is not merely one of discolouration of the teeth. More importantly,
it is the question of SELLING AND PRESCRIBING'A POTENTIALLY HARMFUL DRUG
WITHOUT GIVING ADEQUATE INFORMATION TO THE PATIENT. It’is also a
question of the over use or misuse of a drug in trivial conditions when,
more often than not, it is not required; and of attempting to deal with
childhood infection with pills, while the causes of the infection and
increased susceptibility are allowed to remain untouched.
Looking at the drugs we prescribe or consume makes us realise
the necessity to know more about these drugs - not from the drug repres
entative but from authentic medical literature and the experience of others.
Realization of this discrepancy in the information from the drug companies
and their medical literature enhances our reponsibility in this, regard to
the patients.
RATIONAL THERAPEUTICS IS KNOWLEDGEABLE PRESCRIBING OF THE MOST
EFFECTIVE, LEAST COSTLY, MOST NON-TOXIC, EASILY AVAILABLE DRUG in-the
RIGHT QUANTITY, for the RIGHT DURATION and for the RIGHT PROBLEM in the
RIGHT WAY.
IT IS THE RESPONSIBILITY OF HEALTH PERSONNEL TO ENSURE THAT THE
RIGHT DRUGS ARE PRODUCED AND MABE AVAILABLE TO THOSE WHO MOST NEED THEM,
AND THAT HAZARDOUS OR IRRATIONAL DRUGS ARE THROWN OUT OF THE MARKET.
Ensuring that people get at least the minimum required to be
healtfayis our MAIN CONCERN. We re lize that drugs can play only a small
part in keeping people healtjiy. Therefore, by demolishing some of the
myths surrounding the unquestionable healing properties of all drugs, we
hope more and more individuals will begin to look beyond pills for a
cure for their ills.
The manufacture of Tetracycline for paediatrics is supposed to
be banned from January 1982. The date of the ban on marketing of the
drug has not yet been fixed. The reasons for banning the manufacture are:
1.
DENTAL DISCOLOURATION
"Children receiving long or short term therapy with tetracycline
may develop brown discolouration of the teeth. The larger the dose of the
drug, relative to body weight, the more severe is the deformity, the deeper
the colour, and the more intense the hypoplasia of enamel". The quantity
received is more important than the duration. Mild darkening of the perman
ent teeth occurred in 3 of 14 children who received 5 courses of the. drug,
whereas 4 of 6 who received eight courses had moderate darkening of the
enamel.
(fief: Grossman,E.R., Walchick,A; Freedman,H.: Tetracycline and
Permanent Teeth: the Relationships between doses and tooth colour:
Paediatrics: 1971, 47,•567-570).
"The risk of this is highest when the tetracycline is given to
neonates and babies prior to the first dentition".
"If given between the ages of 2 months and 5 years - pigmentation
of the permanent teeth may develop."
The earliest characteristics of this defect is yellow fluores
cence probably due to the formation of a tetracycline-calcium orthophosphate
complex! with time this progresses to permanent brown pigment.
- 2 -
D-9/334 (h)
as 25.8.82
2.
CATABOLIC EFFECT
"Tetracyclines exert a catabolic dffect, perhaps due to a
generalized inhibition of protoin synthesis in mammalian cells".
"Administration of 2.5 to 3 gms. of Chlortetracyclines given to under
nourished adults results in weight loss, increased urinary nitrogen excret
ion, negative nitrogen balance, and elevated servum non protein nitrogen
concentration."
(Goodman Gillmans page 1188, 6th Ed)
Goeke, T.M., Jackson,G.G.,Grigsby,M.E., Love,B.D. Jr, and Finland,M.
"Some effects of antibiotics on nutrition in man, including studies of
the bacterial flora of the faeces". Arch. Intern.Med. 1958, 101,476-513In India the majority of children who would receive tetracycline are
malnourished or bordering on malnutrition. They would be repeatedly
picking up infection - more often viral but bacterial infections as well.
Additionally, how much of this drug would get prescribe^ty different
doctors or consumed anyway, we don’t know.
3.
BONE GROWTH
According to Goodman, Gillman, 6th Edition (1980), Tetracycline
are deposited in the skeleton of the human foetus and young child. A 40$
depression of bone growth, as determined by the measurements of fibula,
has been demonstrated in premature infants treated’with these agents.
(Cohlan, S.Q., Bevelander,G., and Tiamsic, t.: Growth Inhibition of
Prematures Receiving Tetracyclines - Clinical and Lab-investigations.
Am. J. Dis. Child 1963, 105, 453-461).
4.
Tetracycline induced diarrhoea is not exactly uncommon and that supra-infection by other organisms may occur sometimes.
5.
"Tetracycline may cause increased intracranial'pressure and
tense bulging of the fontanels (pseudo tumor cerebri) in young infants,
even when given inusual therapeutic doses".
(Ref: Goodman, Gillman)
Increased intracranial pressure presents itself with severe
headache, vomiting, loss of function of certain cranial nerves, and limbs
and if severe, even death- The figures of the common or rqre this entity
is are not available to us right now.
6.
The ingestion of out dated and degraded, tetracycline is known
to cause Fanconi Syndrome - a clinical picture characterized by nausea,
vomiting, polyuna (increased passage of urine, polydipsea - increased thirst
acidosis, protienuria glycosuria and aminoacidune (passage of proteins,
glucose and aminoacids in urine).
Our drug control of sales of hazardous drugs, sales of out
dated products is not exactly good and whether the problems created by
out-dated tetracycline is more than discolouration of the teeth would be
interesting to know.
PREGNANT WOMEN
Liver Damage: According to Gooman,Gillman: 'Pregnant women appear to be
particularly susceptible to severe, tetracycline-induced hepatic, damage".
Schultz, J.G., Adamson, J.S.,Jri Workman,W.W.,and Morman,T.D.
Fatal Liver Disease after intra-venous Administration of Tetracycline
in High Dosage. N.Eng.J. Med. 1963: 269, 999-1004.
"Jaundice appears firs, and azotemia acidosis and irreversible
shock may follow. Although hepatic fat is increased'during pregnancy,the
quantity appears to be even greater after-exposure to a tetracycline.
"Disseminated intravascular aoagulation has been reported in a
pregnant woman who developed hepatic renal failure after given only 2 doses
P-9/554 (h)
as 25.8.62
-
5
-
of lOOnig-each of tetracycline intramuscularly (Pride-,G.L., Cleary R.E. &
Hamburger, R.J•
Disseminated intravascular coagulation associated with
tetracycline induced hepato renal failure during pregnancy. Am.J.
Obst- Gynae. 1973, 115, 585-586). This may be a rare phenomenon.
"Treatment of pregnant patients with tetracyclines nay produce
discolouration of teeth in the offspring. Ingestion of the drug between
mid-pregnancy to about 4-6 months of post natal period is dangerous for
deciduous anterior teeth (.temporary front teeth) and from 6 months to
5 years of age for the permanent anterior teeth. Children up to 7 years
may be susceptible to this conplication .of tetracycline therapy"
*
(Weyman,J.
Tetracycline and Teeth, Practitioner 1965, 195,661-665)
The argument offered for continuing its use is that
Tetracycline is cheap, easily available.
In 1 Australia, the Drug Evaluation Committee has recommended
the banning of all tetracyclined1 in paediatric formulas.
In Belgium, the Philippines, Italy and the U.S.A.the drug
has been banned from Paediatric formulas. In addition, there is the
compulsory warnings Not to administer in pregnancy and to children
below 8 years.
'
.
The International Organization of Consumer Unions has listed
Tetracycline as one of the 44 problem drugs, rated as a widespread serious
problem.
-
Tetracycline is a more expensive drug than penicillin or
sulphonamides. It is a bacteriostatic drug. For many‘infections it is
not so good. The yellowness of the teeth can be seen only months or years
later, and it lasts all thorough the patient's life.
A mother should not be given tetracycline after four months
of pregnancy
,,
*
nor should a child be given the drug if he is below 7 years,
unless He/is in danger.
COS'- -■'■■■;•
’’arks Aoad
W/hl^5;’squirt
The Crazy World of_Tonics
•Health’ tonics are a craze with the affluent in the cities frith
their supposedly hectic, energy-consuming life-st; les. Feeling tired?
Pop a pill or gulp down a spoonful and it will keep you going (nobody
knows where!).
The most commonly used tonics are multi-vitamin preparations with
highly excessive quantities of vitamins.
Incremin C, the famous growth tonic with the Giraffe logo, contains
an important amino acid lysine which the human body cannot synthesise
by itself. However, a teaspoon of Incremin contains only about 300
milligrams of lysine when just a handful of peas contains about 1800
milligrams of lysine. The advertising slogan that Incremin turns
"extra eating into extra growth" is medically unsubstantiated and
at best a half-truth. The quantities of vitamin constituents of
Incremen are absurds 10 times more vitamin Bl, 25 times more vitamin
B12, 2 times more vitamin B6 than required by the body daily. (1)
The daily requirement of the human body of vitamin C is about
50 milligrams, of vitamin Bl one milligram and some others in minute
quantities of a few micrograms. Against these well established norms,
most tonic preparations contain beuween 10 to 50 times the minimum
requirements (2) which are simply excreted away by the body - a
colossal waste of valuable nutrients in a poor country. Further,
most vitamins are needed in small amounts to stimulate the processes
of normal metabolism, they are not energy-giving in themselves.
It is almost certain that the high-potency multivitamin formulations
consumed by the well-fed are almost wholly rejected by the body.
For example, the daily requirements of vitamin C can be obtained
from a single fruit or a salad helping. Vitamin A, supplied by green,
leafy vegetables, is stored in large amounts by the body for proper
vision. Vitamin D is naturally synthesised by the skin from daily
sunlight. Despite all these simple facts, the craze for ’health1
2
tonics continue unabated. (2).
Why?
Manohar S Kamath in his article in THE DAILY MAGAZINE
provide the answers:
"The real culprits behind the ‘tonic craze
*
are the manufacturers
of such formulations. The principal reason for their hard selling
of such products is the fact that the tonics and vitamins fell
in ’category four
*
of the Drugs Price Control Act, which means that
there is no limit on profits made on these preparations —With
easy pickings and a readymade market, no wonder then that every
new company entering the pharmac utical world wants to market its
own brand of tonic rather than any life-saving drug!" (2)
Explaining how the ’tonic craze’ is the re ult of systematic
campaigns of the large companies, he says:
"The first part of the plan was the mounting of an intensive
sales campaign to influence doctors on the need for tonics in their
day to day practice. This was followed by free sampling...." (2)
"The other part of the marketing gimmickry in selling tonics was
by directly advertising in the mass media, to catch the public eye.
Slogans like "Do you feel tired at the end of the day? You need ...."
Dr "A woman needs iron every day" gradually made a deep impact on the
people until many were psyched into believing that they could not do
without a tonic." (2)
Waterbury’s Yellow Label Tonic, a brand leader in the Indian
tonics markets, contains only 3 milligrams of iron per teaspoon
just 1/10 of which may be absorbed by the body. The Indian Council
of Medical Research (ICMR) recommends at least 10 milligrams for women.
The producer claims that this tonic stimulates appetites and bujlds
bodies. But chemical analysis has revealed that it has 10% alcohol
3
i
3
content which is the real appetite-stimulant! (1),
We have noted that these tonics are not consumed by the poor
but mainly by the relatively rich whose ordinary die inadequately meets
their vitamin and other requirements. In recent years, evidence
has grown that the excessive vitamins may not simply be discharged by
the body but may even cause severe disor'ers. Prolonged consumption
of excessive vitamin C may form kidney stones, excessive vitamin A
may cause diseases of the hair, skin and liver and vitamin D in
excess may cause disorders of the kidneys and bones. (2)
Take this further example from South East Asia. In the U.K.,
Sanatogen is marketed as a ’nerve tonic’ for old women who believe
in its doubtful ability to tranquilise. But Sanatogen Powder is
marketed to students in Malaysia who believe in it.
ability to
stimulate their minds. "Worried about exams?" says the advertisement.
Sanatogen will give you "Greater energy and concentration". Can a drug
both stimulate and sedate? (3)
Thus, the sheer irrationality and deliberate exploitation of
consumers through this sinister "tonic racket" is obvious. The fact
that many such ’rackets’ continue unabated is a measure of the
enormous influence and power of the large pharmaceutical corporations
not only in India but in many other countries, particularly the
developing ones.
More than 20 years ago, the following words were spoken before
the Kefauvsr Committee hearings on drugs in the U.S.A,:
"The incidence of disease cannot be manipulated and so increased
sales volume must depend.atleast in part on the use of drugs unrelated
to their utility or need, or in other words, improperly prescribed.
4
4
Human frailty can be manipulated and exploited and this is fertile
ground for any one who wishes to increase profits. Thcjenormous sales of
so-called tranquillisers are only a small part of the crop reaped
from this ground. The pharmaceutical industry is unique- in that it
can make exploitation appear a noble purpose." (4)
References:
1.
Health for the Millions, VHAI, April-June 1981
2.
"Some Boost, and at what price?", The Daily Magazine, 7 May 1981.
3.
The Impact of multinational corporations on Health in Developing
Countries, by Charles Medawat, Seminar on Health, Food and
Nutrition, Consumers Association of Penang, Malaysia, 15-20 Sept 1977.
4.
Drugs and the Common Man, Science Today, November 1970.
VOLUNTARY HEALTH ASSOCIATION OF INDIA
D-9/334-(a» 1)
19.8.1982: a
C - 14 Community Centre,
S. D. A.
New Delhi 110 016
BACKGROUND PAPER PREPARED BY VHAI FOR DRUG-INFO RMATI0N4-SHARING
TO PREPARE FOR ACTION
THE CLIOQUINOL CONTROVERSY
Demanding its ban. A Just Demand. Or, Just a Demand?
COM
We are grateful to our friends in IOCU,Penang, Social Audit,UK,
for some valuable information they sent to us.
Historical Background
Hydroxyqu±nol±nes--vnara introduced into the Swiss Pharmaoopea in
1900 as a topical and antiseptic agent. In -the 30's it became a focus
of interest when its potential as an intestinal amoebicide was invest
igated.
It was around 1932 that classical animal studies established the
"therapeutic potential of the halogenated hydroxyquinolines as lumenal
amoebicides
i)
Ref: Leake, C.D. (1932) Chemotherapy of Amoebiasis.
of American Medical Association - 98. 195-199.
Journal
The initial clinical trial of clioquinol was conducted in the.
U.S.A, in 19^3.
ii)
Dhvid, N.A., Johnstone, H.G., Reed, A.C., Leake, C.D.,1933.
The Treatment of Amoebiasis with todochlorhydroxy-quinol'ine
(vioform N.N.N). Journal of American Medical Association.
IQU. 1658 - 1661.
Data cited in this report suggested "the compound might have a
useful spectrum of action against other enteropathogenic protozoa and
bacteria".
Since then "halogenated oxyquinoline derivatives HOQ" have been
popularly used for prophylaxis and treatment'of gastroenteritis, amoebiasis,
travellers’ diarrhoea (HOQ include a todochlorhydroxyquinoline, proxy
quinoline, halquinol, diiodohydroxyquinoline, chlorquirialdol,chiniofon).
In 1934 the first proprietaiypreparation was promoted"'to the
public for treatment of amoebic dysentery and: simple diarrhoea.~
As a result of a chance clinical observation, hydroxyquinolines
became established for twenty years for the treatment of acrodermatitis
enteropathica (a rare skin disorder) until“it was shown that it acted by
rectifying the underlying selective malabsorption of zinc by forming an
absorbable chelate and it was replaced by zinc.
\
WHEN WERE THE INITIAL OBSERVATIONS ABOUT CLIOQUINOL RELATE^-7
PROBLEMS NOTICED?
According to Dr- Ole Hansen, in 1935, the very first year after
CIBA (of Switzerland) had started marketing the drug - "a report brom
doctors in Argentina describing exactly the same side effects as tpe
Japanese cases in the 60’s and 70
* s wae.'received’by-CIBA".
'
\
"Frta internal documents in 1939, from Switzerland and documents
—released in the courts in Japan, it was discovered that experiments o£
the drugs with c^ts and dogs had proved fatal".
)
2,
ID-9/334 (a. 1)
asl9.8.82
- 2 -
"In the early 60's, a Swiss and a Swedish veterinarian reported'to
CIBA GEIGY that they had found dogs;, with diarrhoea treated with Enterovioform had died, in seizures".
According to Dr.Ole Hansen "attempts to hide facts, deny facts^"
(e.g. denial that the drug is absorbed) and attempts to convince doctors
not"to publish their negative experimental findings have been made'
throughout by CIBA GEIGY, the producersof Mexaform and Enterovioform.
Even before or during epidemics of SMON in’Japan, several reports
regarding systemic toxicity following partial absorption with oral
administration was recorded.
Cases of optic atrophy were observed in a small proportion of
children receiving the treatment for acrodermatitis enteropathica - this
was prolonged in' high dosage treatment. Since earlier, children never
survived without treatment, optic atrophy as a late manifestation of the
disease could not be excluded.
In 1964, reversible and unusual gait changes were noted in 20
out of 4000 institutionalized patients on long term treatment.
(Ref: Ghdlz, L.M., Arons, W.L.(1964): Prophylaxis and Therapy of
Amoebiasis and Shigellosis with lodochlorhydroxyquin.
American Journal of Tropical Medicine and Hygiene.13j396-401).
Convulsions in laboratory mice on high dosages was reported in
1969 and in "domestic dogs and cats treated for diarrhoea in veterinary
practice".
A reversible confusional state had been described following acute
dosage in man.
Five personal observations of "transient global amnesia after
clioquinol" have been reported in the Journal of Neurology, Neurosurgery
and Psychiatry 1979: 42, 1084-1090 by M.Mumenthaler, H.E.Kaiser,
A. Meyer and T.Hess from the Department of Neurology, University of Berne
and Basel, the State Hospital, Lucerne and .the Department of Internal
Medicine, Berne, Switzerland.
According to WHO's Drug Information: Jan-March 1978, though sporadic
oases for about 6-7 years were reported, it was only after three decades
of use of "clioquinol in the treatment and prophylaxis of diarrhoea in
Japan that SMON was recognized as a distinct clinical entity in 1964
(Tsubaki, T., Toyokura, Y., TSU Kagoshi, Hi (1965). Sub-acute Myelo
Optic Neuropathy following abdominal symptoms - A clinical and pathological
Study, WapanL Journal of Medicine: 4, .181-184).
HOW USEFUL IS CLIOQUINOL?
There is no evidence to sugges that clioquinol is effective in the
prophylaxis of travellers' diarrhoea.
British National Formulary, 1981
The claim for the value of clioquinol in the prevention and
treatment of that nebulous ragbag "travellers' diarrhoea" do not withstand
critical examination.
The Lancet (1977)
The Committee (on Safety of Medicines,UK) has reviewed the data
relating to the efficacy of clioquinol in the treatment of diarrhoea and
considers "that there is inadequate evidence to support the claim".
Pharmaceutical Journal (30.7.77)
page' 597.
..3/-
D-9/354 (a.l)
as 19.8.82
*- 3 -
The drug was excluded, from consideration by a WHO expert cocnnittee
convened in 1977 to prepare a model list of "essential'drugs" on the
grounds that the risks of treatment out-weighed the potential benefits.
(Ref: WHO 1975: Selection of Essential Drugs. Techn.Ref.Series
615? page 14).
-
The editorial inihe Journal of American Medical Association
10th April 1972} page 273 stated:
. .
/
".....iin the 40 years that clioquinol has been available
only one study which is not entirely convincing} has shown
it to be effective in preventing travellers' diarrhoe^ '/
whereas one other prospective study has shown it to be np
more effective than a placebo....."
. ,
/
I
"Hydroxyquinolines are active only on organisms present
within the intestinal lumen. Used alone? therefore} jshey
are active only in the absence of significant tissue' invasion a development that cannot be excluded with certainty 'even in
patients with asymptomatic amoebiasis".
PDT/di/78.1 WHO:Drug Information.
Jan-March 1978
i
Anti-diarrhoeal drug blinds and damages brain - M.V.Kamath?
Times of India? 20th June 1977.
./
i
"The scientific evidence for the value of clioquinol in tfye
treatment of prevention of traveller's diarrhoea is scanty".
According to Dr. P. 0. Kandiya of Jaipur} then President o‘f
the Pharmacy Council of India. "The Indian brand of. Mexaform contains
2 nore'drugs (besides Iodo chloro hydroxyquinoline the'basic drug phanquone and oxyphenonuin - and'has'come to be used'not only for
travellers' diarrhoea but diarrhoea of all descriptions including that
due to indigestion".
. .z
"The dramatic relief is due to oxyphenonuim which reduces the
spasm of the intestines'and bowel movements and thus markedly reduces
abdominal pain and discomfort".
.
",
The Hathi Committee had included clioquinol‘in the analogous list
of- essential drugs? "Due to its low cost in'relationship to alternative
treatment and having regard to the paucity of documented evidence of
SMON within the country".
But in India Hydiroxyquino lines are supposed to be obtained only
under'prescription (like many other drugs). How much !this restricts the
vigorous selling of the drugs over the counter is well known to all of us.
WHAT IS SMON?
SMON stands for .Subacute Myelo Optic Neuropathy.
"In its classical form, the'condition was<characterized by the
prodermal gastro-intestinal symptoms considered to be of neurogenic origin.
- an ascending numbness of both legs associated with severe and
persistent dyaesthesiae.
■ - frank myelopathy revealed by exaggeration of reflexes extensor
plantar responses a sensory level nn the trunk and sphincter
disturbances could also occur and the combination of exaggerated
patellar reflexes and absent ankle jerks was considered to ba
a characteristic finding.
..4/-
P-9/534 (a.l)
a:19.8.82
- 4 -
Disturbances in visual acuity developed, but they were not usually
an early manifestation.
The increase in the number of SMON cases reported annually was
substantial. In 1965 451 cases were reported and in 1969 the number
went up to 2340„
. „
(pDT/Dl/77.4 page 10): WHO Drug Information. 1977
"Females and elderly were particularly vulnerable and formed a
high proportion of patients who also suffered from serious chronic
diseases".
(Ref: Sobur, I., Ando, K., (1969) - Review and Comment on Myelo Neuropathy Accompanied by Abdominal Symptoms, Paisnin Igakn
24, 2390 - 2397.
More reports were received 'in summer "A correlation between the use of clioquinol and the occurrence
of SMON in a series of 171 patients was first reported in 1971".
/ (Ref: 1aubaki T. Honma; Hoshi, M.(1971): Neurological Syndrome
/
Associated with Clioquinol: Lancet 1, 696 - 697.
-
This was following the discovery of a green compound - later
identified as an iron chelate of clioquinol on the tongue of some patients
and in the urine and faeces of others by Professor Tsubaki of Sigata,Japan.
Regarding the effects of SMON which, according to some clioquinol
sympathisers, have allegedly been due to ididsyncrotic causes 'the relation
ship between SMON and Clioquinol has unequivocally.been shown.
According to the TOO report the fact that some 15^ of the victims
hada apparently never taken clioquinol may merely reflect the difficulty
in obtaining precise drug histories from patients;'alternatively, it may
indicate the existence of other factors in the etiology'of the disease,
or that SMON may not always bp readily distinguishable on clinical
_grounds^from other neuropathies.
/
/
Pharmaceutical Journal
30.7.77: page 597 .
Similarly, the reasons for having detected less number of eases
before 1955 could be attributed.
- to a low detection rate
- the absence of an unidentified aetiological co-factor
- relatively low volume of sales
- relatively low dosage and duration of treatment
- or to the existence of poorly absorbed formulations
•
The effect of particle size and presence of emulsifying agents
on the absorption of clioquinol, could have a bearing on the discrepant
results of long term toxicity test on animals.
Social Audit’s leaflet on Cliquinol:
"Bad infoxmation means bad medicine" has this to say about
SMON:
"Clioquinol has caused thousands of cases of SMON a condition
involving continuous pain, paralysis, blindness and, in
extreme cases, death. In Japan, cases of SMON reached-epidemic
proportions - affecting an estimated 10,000 - 30,000 people before
the drug was banned there in 1970".
The casual relationship between clioquinol and SMON has even been
accepted by the Japanese courts.
- 5 -
D-9/354 (a.l)
a: 19.8.82
WHAT IS THE INCIDENCE OF SMON OUTSIDE JAP/kN?
According to a Lancet editorial of the 28th Kay 1977, page 596,
"the companies deny that the neurological damage from clioquinol is a
serious risk outside Japan and identical abnormalities of the nervous
system have been reproduced in animals".
According to the Journal of the American Medical Associations
"The Absence of epidemics in other countries does not invalidate the
conclusion that clioquinol is neurotoxic. Clinicians from England,
Australia, Switzerland, Sweden, Denmark,, the Netherlands; and the USA,
have described patients who developed neurological symptoms while taking
these compounds.
.
The clinical symptoms of these patients were like the one that
characterized sjaon”.
Journal of the American Medical Association
23rd July, 1973: Page 296
According to an international survey-oh' recent reports concerning
intoxications with halogenated oxyquiaolines derivatives - "A survey
of- the literature has proved jtherfo 6 cases were reported as SMON or
intoxication of halogenated? oxyquinoline derivatives (including duspected
cases in 47 articles published outside Japan from January 1970 to
February- 1977").
According to Dr. N. H. Wadia in his article: "Some Observations
on SMON" from Bombay in the Journal of Neurology, Neurosurge'ry and
Psychiatry 1977: 40, 268-275 where he reported 9 cases of SMON by
retrospective study of their hospital records from 1967-71 and prospective
search from March 1972 till 1977.
.
"In 1977 it would be., imprudent totally to ignore the Japanese
experience. If the factor which makes for.the reported
difference in SMON prevalence'is.genetic, SMON may never
appear in India in epidemic form- But, if the factor is
environmental or infective then the change in the Indian
environment may result in the appearance of SMON".
(The above study was funded by CIBA.GEIGY). .
CIBA GEIGY one of the two main'manufacturing companies of hydroxy
quinolines has collated details of about 200 possible cases - published
as well as unpublished. .
•
.
.
.
The total number of cases of SMON reported from outside Japan
is less than 100, of these a high proportion are from Australia.
CLIOQUINOL - RESTRICTIONS,BANS,BOYCOTTS
Hydroxyquinolines are sold in more than 100 countries. In some,
there is a ban on its sale while in others sale is restricted to
prescriptions.
Some of the countries which have .imposed restrictions are Australia,
Denmark, Venezuela and Norway. In the Federal Republic of Germany, Finland
France, "Traveller's Diarrhoea" has been deleted from recommendedindications and the compound has been placed on prescription.
MORE SPECIFICALLY:
SWEDEN:
At first, HOQ was accepted for treatment of acrodermatitis
B-9/534 (a)
a:19.8.82
- 6 -
enteropathica. Later? however? Sweden totally withdrew it and replaced
it by zinc -alts, which is considered safer and more efficacious.
In the summer of 1976? Dr- Ole Hansen proposed that all CIBA GEIGY
.products should be boycotted in Sweden as the company continued to market
or promote their products of Enterovioform and Mexaform in spite of
conclusive evidence showing their relationship with SMON.
In 1977? the boycott started with doctors writing to the Swedish
medical journals protesting against the continued sales of clioquinol.
Thanks to the information obtained by a Swedish free-lance journalist
from the CIBA GEIGY's internal documents.
On September 27, 1981 the Swedish newspapers published that for
each individual drug? CIBA GEIGY lost 25% of their market in Sweden.
CIBA GEIGY is said to have lost 75 million Swedish Kroner, during-the
boycott years. In 1980? this was equivalent to the total turnover of
CIBA GEIGY (Sweden).
The boycott by the Swedish doctors and the public was their’way
of contributing to the developing countries, fulfilling their responsib
ility towards all peoples in preventing drug suffering.
38 individuals afflicted with serious side effects by taking
Mexaform; sued CIBA GEIGY for damages in Sweden. CIBA GEIGY grid Sraco
agreed to pay 1.8.million Swedish Kroner as'damages in an out of «ourt
settlement according to the Economic Times of the 14th April 1982.
JAPAN
About 10?000 persons are reported to be suffering from
SMON in Japan. The number of suits in various parts of the countiy in
September 1979? according to the Japan Times, was 5200.
It took more than 8 years and 4 months after the first SMON
damage suit was brought against the State and three pharmaceutical
companies (CIBA GEIGY - Japan -Takeda Chemicals and Tanabe Selyakulo)
for the Tokyo district court to reach two decisions:-
1)
2)
Clioquinol causes SMON
CIBA GEIGY et al. were liable in failing to pass oh information
about the dangers of clioquinol.
Regarding the demand for appropriate instructions and a warning
for doctors and patients, the company has argued:
"It is however not possible to achieve complete uniformity of
the information for the doctors end patients, because in
different countries there are different rules which are usually
laid down by the local health authorities".
(Br-J. Sobotkiewicz: Statement at Geneva Press Conference-on SMON)
Proc, of 28th April 1980: p.34.
(if there were no rules, more such drugs would be let loose
on the'public; and,'in countries where'the'rules are lax,
the people are obviously at the mercy of some unscrupulous
drug industries who knowingly take full advantage of these
rules).
Some of the SMON victims who have won their cases are using part
of their money to fight against needless drug induced suffering.
According to Michiko Kinoshita, a SMON victim from Japan, in an interview
"with ~the New Internationalist, Januaiy .1981:
"We want our fight against clioquinol in Japan to help secure
assistance for SMON victims in other countries, just as thalidomide
litigation in Europe and the lTSA...helped^in_asa±stanoe thalidomide victims in.Japan".
U.S.A.
According to the National Drug Regulations, 1961, the use
of clioquinol for amoebic dysentery is restricted. The maximum dose
recommended is : 22.5 gm. for 10 days.
BANGLADESH
The Bangladesh Government on June 12, 1982, acting on the
advice of an Expert Committee, banned the manufacture, import, distribution
and sale of 1707 drugs, which were considered irrational and harmful.
Mexaform and Enterovioform and all products containing hydroxyquinolines
have also been banned.
...
(A lesson India can follow from its small neighbour!)
ENGLAND
In 1973, the UK saw no reason -to restrict the Sale of HOQ.
However, in 1977, it was felt that oral clioquinol should be/vailable
only on prescription.
(fief: Pharmaceutical Journal 1977: 106,219)
In 1977, the Lancet had said:
. .
"The time has come to halt free sales of clioquinol (i.e.enterol
vioform) and similar drugs for vague intestinal ailments and to
demand good evidence before their use for other purposes is
allowed to continue".
In London, in May 1978, the Sunday Times and BBC television covered
in a programme'the clioquinol dangers. This was following the briefing
of a medical journalist and a TV producer by Dr
*
Ole Hansen.
Questions were raised in the parliament a few weeks later and just
two months after the press and TV coverage, the Ministry of Health demanded
that all bottles from pharmacies be withdrawn.and the texts on the bottles
and leaflets be altered. Even though these drugs are formally on prescript
ion only, they have just disappeared from the market in England.
(The role of the press and Government Health Ministry needs to
be.noted and appreciated).
A point to note:
The Medical authorities in Britain had said:
"This (SMON) is no
problem in Britain". Fortunately, in spite of them, these drugs have
disappeared from the market in Britain.
INDIA
According to the Hath! Committee, HOQ are supposed to be
prescription drugs, but they can be obtained in any amount over the counter
without prescription, without adequate warning. Even if the“details of the
warning were not written in such small print the English-knowing population
being so small, the caution hardly succeeds in warning most of the consumers.
Therefore, banning of dangerous drugs is the only solution in the absence of
adequate control.
TUR
PLAN
OF
ACTION
1.
Distribution of this briefing document amongst our drug core
groups and discussion at the Drug Workshop.
2.
Sending its summary to the Central and State Drug Controllers and
Health Ministers.
3.
Sending it to various medical
discussion and feedback-
and pharmacology heads for
- 8 -
D-9/334 (a.l)
23.8.82: a
4.
Dissemination of this information, via Health For The Millions,
to our members, asking.them not to prescribe this drug.
5.
Dissemination to our journalists friends and consumer
activists.
6.
Demand for a warning which can be understood by consumers.
Caution
- The use of this drug may lead to blindness,loss
of the function of your legs, loss of bladder
control or constant pain in the legs.
(Myelopathy, optic neuritis are meaningless for
a consumer - as long as we can hot ensure sales
of potentially toxic drugs without a’prescript
ion, it becomes our responsibility to ensure
adequate warning)•
7.
Demand that a cheaper alternative be made available.
8.
Letters to MIMS, CMS,
9.
Try to get figures of SMON or suspected SMON cases from our
colleagues in neurology or eye departments in the larger
teaching colleges, PGI, NIMHANS, AlIMS..
- .
10.
Keep pressure oh the Drug Controller to get Clioquinol
banned and make alternatives easily available at low cost.
IMA.JOURNAL.
.
-
g
References:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
■"An international Survey on Recent Reports concerning
Intoxication with Halogenated Oxyquinoline derivatives
and regul-tions against their use and supplement"
Kiynhiko Kalthaira, Ph.D, Tokyo Medical and Dental
University. Medical Research Institute.
Supplement of the above.
£
Bad Information means Bad Medicine: Clioquinol Pamphlet by ™
Social Audit, London.
Transient Global Amnesia after Clioquinol. Fiver personal
observations from outside Japan.
M. Mumlenthaler et al- Dept.of Neurology, University of
Berne and Basel, Switzerland. Journal of Neurology,Neuro
WHO Drug Information:
Surgery & Psychiatry,
Jan-March,1978. PDT/Dl/78.1 Page 9-11.
WHO Drug Information: PDT/DI.77.4 Page 10-15
The SMON Syndrome:
Utusan Konsumer' March 1982
Some Observations on 340N from Bombay:
N.H.Wadia, Department of Neurology, J.J^Hospital,Byculla.
SMON Victims Plaintiffs Make Compromise Accord
*
Japan Times'Sunday (Sept. 16. 1979)
Journal of Neurology, Neurosurgery and Psychiatry, 1977,
40 - 268-275
Goodman GiHman
D-9/334 (a.l)
a: 23.8.82
ALTERNATIVES
like Metronidazole (iNN)
.Nitponidazoles
Finidazole (iNN)
PROS
- have amoebicidal’action in the tissues as well as
in the intestinal contents.
they are fairly well, tolerated by the mnijcnity,
therefore-MeLronidazole can be used.. for amoebic
‘dysentery as well as hepatic amoebiasis.
CON’S
/
Occasional reports of neuropathy and mitogenic ’anil
carcinogenic potential in animal models (of uncertain
relevance to man), has led to statutory requirements
for warning labelling in the USA and India- ■
- Metronidazole is relatively costly.
/
/ Metronidazole is extensively absorbed in
intestines and hence for greater and adqi
in addition a lumenal amoebicide/shouldi
prescribed.
—
'
/Since
Diloxanide furoate
PROS
i
«/aV
iM/on
(tine sly. ^/i
/
- is highly effective against nonsynrptotiatic'
*
carriers
- in 95^ cases eradication of organisms has.’ been reported
— regarding its use in acute amoebic dysentery divergent
' results have been obtained - concurrent; use of tissue
amoebicide whenever possible is re/omc/ended.
P aromnmycine
Aminoglycoside
Antibiotic - Is effective both for symptom less causes and
acute amoebic dysentery
CONS
High cost
-• ..
Troublesome diarrhoea
Carbasone arsenical and GlycobiaHsol gave unimpressive
performance - isolated fatalities attribute;! /co carbasoneA/
- occasionally - evidence of cumulative tz^cLcity.
- the choice of lumenal amoebacide shou/dAbe \ased on its
effectiveness.
/
// /
"-------
10 D-9/334 (e,.l)
26.8.82s a
References continued.!
Ashworth,B. (1975) Neuro-ophthalmology, In recent Advancesin“Clinical
Neurology,~p.101. Edited'by W.B.Mathews, Churchill Livingstone,LondonTsubaki,TsHonma,Y., and Hoshi,M.(1971) Neurological syndrome associated
with clioquinol, Lancet,1, 696-697
Wadia, N.H. (1973^ is there SMON in India? Necrology India,21,95-103
Kean, B.H., (1972), Subacute myelo-optic neuropathy; Journal of the
AMA, 220, 243-244.
Kono, R.(1971) Subacute myelo-optico-neuropathy, a new neurological
disease prevailing in Japan, Japanese Journal of Medical Science and
Biology, 24, 195-216.
Le Quesne, P.M. (1975) Neurotoxic substances. In Modem Trends in
Neurology - 6,pp•91-93•Edited by D.Williams, Butterworths; London,
Meade, T.W.(1975). Subacute myelo-optip- neuropathy and clioquinol.
An epidemiological case history fordiagnonis. British Journal of
Peventive and Social Medicine, 29, 157-169.
Osterman, P.O.(1971), Myelopathy after clioquinol treatment;Lancet
2,544.
Pallis,C.A.(1976) Proceedings Honolulu Symposium on 'Epidemiological
issues in reported drug-induced illness. SMON and other examples',
McMaster University Press, Hamilton (Ontario).
Pallis,C.A. and Lewis, P.D.(1974). Neurological comppications of
clioquinol therapy. In The Neurology of.Gastrointestinal Disease,
pp. 179-188, Saunders: London.
Report of the Committee on Drugs and Pharmaceutical Industry (1975),
Ministry of Petroleum & Chemicals, Govt.of India, Chapter X pp.251-261
Selby,
(1972) Subacute myelo-optic neuropathy in Australia; Lancet
1,123-125.
Selby,G. (1973) Subacute myelo-optic neuropathy (SMON),Neurotoxicity of
clioquinols, Proceedings of the Australian Association of Neurologists,
9, 23-30.
’ ’
Shiraki, H (1973), Neuropathology of subacute myelo-optic-neuropathy,
SMON, Neurology India, 20, Supplement, 3, 395-419.
Sobue, I; Ando,K: Lida M: Takayanagi,T: Yamamyra,Y: and Matsuoka^Y:
(1971), Myelo-neuropathy with abdominal disorders in Japan,Neurology
(Minneapolis) 21, 168-173.
Sobue, I: Ando,Ki Lida,Ms Takayanagi,T: Mukoyama M: and Matusoka,Y:
(1973) Subacute myelo-optica-neuropathy in Japan: Neurology India 20,
Supplement 3, 420-425.
A'
,f Indi#
D-1C:343
MS:k:5.1.82
>
r 14 Con>®unU5 C
Delhi-nG01&'
THE DRUG SITUATICT^^N INDIA
SfALTH CELL
-... j/urks Hoad
, .c - 5tiJ OQ1
The causes of the problems and the solutions of the present day
drug situation differs markedly when seen from the eyes of the
drug industry especially OPPI, the Drug Controller, WHO, IMA,
groups and organizations who see everything in terms of what is
socially just or not, and the consumer.
Many sighificant changes have occurred in the past few years
which are bound to have far reaching effects.
It is important
for all of us to be familiar with the problem, with the loop
holes, with the different versions of the various groups involved.
THE FACT THAT THE SOLUTION OF THE MAJORITY OF THE HEALTH PROBLEMS
IN INDIA DOES NOT LIE IN MORE PILLS, MORE DOCTORS, MORE HOSPITALS,
BUT IN SOCIO ECONOMIC & POLITICAL POWER RELATIONS IN SOCIETY IS W.
WELL ACCEPTED BY MOST OF US HERE.
The need for greater soaia.1 awareness is not only relevant for
the villager who gets deprived of his right to the least basic
needs, basic health care, but also for those involved in health
work (whether it is in a community hea 1th-piograinne, a dispensary,
hospital or even a teaching hospital).
to be
Knowing about dx-ugs is not/limited to their brand names, dosages,
side effects, but also their COST and their AVAILABILITY.
The various factors influencing these need to be analysed.
We will highlight some of the more important aspects which will
strongly .influence our search for solutions.
Here are sane questions that arise and need answers. How much
is our health budget for the 6th Five Year Plan? and how much of
it goes on drugs as a total percentage and what is the per capita
expenditure on health? (Medical & Public Health & Family Welfare)
a)
1821.05 Crores (1980-85) Centre/State &/Union Territory
Source :
(6th Five Year Plan - Pg.382)
b)
Traditional System of Medicine - Centre 29 Crores
Source: (Planning Commission - N.D.)
c)
Rs.15.05 (+ Rs.1.51 for Family Welfare) in 1977- 1 78
Source:
(Pocket Book of Health Statistics of India 1980 Pg.37)
What percentage of the Indian population utilizes the benefits
.of modem drugs :
- about 20%; according to some estimates only 10%
How self-sufficient are we in producina this?
We wtill import 50% of the raw material at stupendous rates inspite
of our Pharmaceutical industry being 33 years old and the biggest
in the Third World.
What is happening to drug imports?
Our imports tripled between 1963-64 to 1973-74 from Rs. 13..U.. crores
to Rs.37.50 crores ---- within next year it increased to"Rs.47-"crores
this constituted 35% of the bulk drugs utilized in formulations.
According to Dr. S. S. Gothoskar, the Drug Controller of India
"The last 3 yrs have witnessed a steady increase in the ’ requiparents
of imported raw materials by nearly 100 percent.
Thus while our
D-10:343
MS ; k : 5.1.8L
"
• z .
production increased by only 50% from 1976-77 to 1978-79 the ex
penditure incurred on import of bulk drugs, intermediates,
solvents etc. rose. by. nearly 80%.
The break-up of the drugs in the market is : Foreign Multinationals
.. 78%
Public Sector
..
Indian Private Sector
.. 16% (Source: Dr. Pankaj
Shah:Link - Aug. ‘81)
Pg. 12.
In 1978-79 MNC's produced
6%
.. 28% Bulk drugs (Basic drugs)
.. 44% Formulations
(Source: Dr. Thakor - Businss
India, July 1980,Pg.26)
jj'nat are the alleq a t i ons_ aga in s t Multinationals?
According to the Hathi Committee Report in 1975 th<= Mu Lt in at 3 trials; block others from producing drugs for a period of 16-20
years by invoking patent production,
- din the brand names into the minds of the medical
profession by employing a large force of medical detai l<=rs",
- resort to high pressure sales techniques, and,
- rig up prices to levels which have no relation to the cost
of manufacture of products or international prices.
.What were the Hathi Committee *s
major recommendations.?.
1)
Nationalise the Drug Industry,
2)
Foreign undertakings operating in the country should be
directed to bring down their equity to 40% with
progressive reduction to 26%
**
(Under the New Drug Policy it was added that Multinationals
maintain a ratio of 1:5 for production of bulk dru^ to
formulations)
**In the US more than 10% share by.a foreign undertaking
classifies the company as foreign.
What were the Hathi Committee‘s recommendation reaardina .generic
drugs?
1)
Abolition of brand names in a phased manner, beginning
to be made with 13 single ingredient drugs:
- analgin
- aspirin
- piperazine
- ferrous sulfate
- chlorpromazine
- chlorampheniol
- streptomycin
- Tetracycline
- reserpine
- tolbutamide
- INH
- INH & thiacetazone
Recommendations made in 1975.
In Jan. 17th 1981 decision was
taken to abolish brand names for
5 classes of drugs:
- analgin
- asprin
- chlorpromazine
- ferrous sulfate
- .piperazine
D-1C:343
MS : k : 5.1.82
2)
Production of all new single ingredient drugs to be
under generic names.
:
‘
On.what were these recommendations regarding generic drugs
based?
The Committee found that 1)
use of brand names led to
unnecessary increase in cost because of costly promotional
activities; 2) medical students were taught pharma/fcology
using generic names.
What are the Drug Industry's objections against abolishing of
brand names?
1.
It is illegal and discriminatory because it contravened the
protection afforded by the Trade and Merchandise Marks Act
1958 and there was no provision in the Drugs and Cosmetic Act
1945 to empower the government to abolish brand namegzf-.r
drugs.
2.
Since prices are fixed under clearly defined formulae by
the DPCO (Drug price Control Order 1979), generic names will
not reduce prices.
3.
Standard medical text books use both brand names and generic
names.
4.
Trade marks guarantee ethics in manufacture and in the absence
of brand names, customers cannot be sure of quality.
•
I
5.
Generic names will lead to wrong dispensing of drugs with
different pharmacological effects and harm patients' health.
t.
6.
The ban on brand names for single ingredient new drugs will
completely stop introduction of new drugs in the market.
;
7.
Drugs sold under brand names often have superior bid- availability than those marketed under generic names .
J.
The use of generic names takes aw--.y the choice from the
doctor to the chemist.
*
W
9.
The general prescription is difficult to remember and repro
duce, lengthy and cumbersome.
i
10.
The Hath! Committee recommendations would have been quite
different had it observed the results of the Pakistan
experiment.
(Source: S. Viswanathan:
Business India - Sept.28
Oc tobe r 11)
8.
What advantages are seen in having a planned generic policy?
1)
2)
It will eliminate monopolization because of brand names,
and it will encourage healthy competition.
>•
/
.
:
It will curb production of non-essential combination drugs
which only add to the increase in price and have no
additional benefit.
j
For example.: Aspirin is marketed undeptwo generic names :
(
- acetyl salycilic acid and aspirin
- 8 different brand names
’
- 7 brands marketing ASA and Caffeine
i
- 19 brands of ASA and Phenacetin and Caffeine
•
' ,J
D-10:343
MS : k : 5.1.82
: 4
Effect on Costs:
Manufacturer
Content
Name under
which drug is
marketed
Price per
unit( Paise)
Hoechst
Analgin (.5gm)
Novalgin
20.00
IDPL
Analgin (0.5gm)
Analgin
18.27
Haffkine
Analgin (.5gm)
Analgin
18.24
Nicholas
Aspirin (350 mg.)
-Caffeine 30 mg.
As pro
7.75
Sarabhai
Aspirin 350mg.
Kenalges ic
22.00
Boots
Aspirin 3'00 mg.
Aspirin
3.60
Haffkine
Aspirin 300 mg.
Aspirin
2.84
Source: Indian Pharmaceutical Guide 1980
Some more examples:
Anacin
Aspirin 389mg.
Anacin
Caffeine 16.2mg.
8
Quinine sulfate 8 mg.
Avedanplus
Aspirin 350 mg.
8
Acetyl Aminophehol 125mg.
Caffeine 30 mg.
Powe rin
Aspirin 350 mg.
20
Caffeine 65 mg.
Codeine 8.125 mg.
Paracetamol 65 mg.
\
Salicylamide 65 mg.
\
(Analysis 'of Painkillers done by Dr. Anant Phadke
in his paper) Scientific Scrutiny of Over the
Counter drugs)
\
Wat does WHO Expert Committee on selection of essential drugs
( 1st Report Technical series 615, 1977) recommend? It recommends
Acetyl Salicyclic acicTamongst “theWTTalge s ics because besides
being the cheapest it was therapeutically as effective as analgin
(aspirin is 1/6) APC and multiple other combinations.
What are the loopholes being made use of in this generic policy
by profit-motivated drug industry?
Since the use of generic named drugs applies only to the 5 single
ingredient drugs it does not touch the COMBINATION DRUGS
which anyway form the majority.
Drug companies will try avoiding the issue by producing more
combination drugs and less single ingredient generic drugs.
Since BRAND NAMES is to be ABOLISHED for ALL NEW SINGLE INGREDIENT
drugs, the drug industry will try introducing new drugs under
BRAND NAMES with more than two ingredients. So not only the cost
will go up because of the use of brand, but also because of
addition of often unnecessary ingredients.
Since the government, had emphasised that generic drug names should
be displayed more prominently than brand names with effect from
1st August 1981, the drug companies complain of difficulties in
making a long chemical name more prominent on small vials, ampoules
and pleaded of accumulation of stocks inspite of 7 months' notice.
D-10 343
MS : k: 5.1.82
What are the Drug Companies doing about this?
On 13th March, the industry's delegation met Mr. P.C. Sethi,
Minister ofChemicals and Petroleum, under which the drugs come,
having failed, Hoechst, Cynamid and Pfizer sued the Government
in the Delhi. High Court against abolishing of-brand names and
have got a stay order.
What is the New Drug Policy?
Three years' debate following the Hathi Committee's recommenda
tion ended with the New Drug Policy.
(Presented in Parliament
on the 29th March 1978 by Mr. Bahuguna, the former Minister for
Petroleum, Chemicals and Fertilizers).
The NDP, the primary objectives were "to develop self-reliance
in drug technology;" to provide leadership role to the public
sector,"to foster and encourage the growth of the Indian sector",
under NDP several limitations were imposed upon foreign sector
drug companies. These included -
the gradual reduction of the foreign share holdings of
Multinational Corporations,
- no further expansion of capacity to foreign companies
"engaged in the manufacture of household remedies".
-
the grant of licences to manufacture formulations to
foreign sector companies to be "linked with the production
of high technology bulk drugs from the basic stage".
- the grant of licences for the manufacture of high technology
bulk drugs to be conditional upon foreign sector companies
supplying 50% of their production to "non-associated
formulators".
(Source: Dilip Thakore - The Ethics of
the Drug Industry Pg. 27
Business India : July 7-20,'80?
Page 29.30)
If a multinational produced, say, Rs.100/- worth of bulk drugs,
half of it had to be sold to the Indian sector and the remaining
half used for formulating drugs under its own brand. The total
turnover of drugs could not exceed three times the worth of bulk
drugs, if produced, i.e., 100 x 3 = 300 lakhs.
What is the DPCO?
Drug price Control Order, an offshoot of the New Drug Policy
passed in 1979 is aimed to restrict prices of the bulk drug and
formulations produced by any pharmaceutical company in the
organised sector.
What are the stipulations under the DPCO?
Bulk or generic drug manufacturing companies are entitled to
12-14% return on net worth (capital + reserves) depending upon
the complexity of the technology utilized in the production
process.
Formulations (i.e. branded drugs) are divided into 4 categories'
Category
I
Category II
Category III
Category IV
- Life Saving Drugs
- )
/
- J in between
/
- Over the Counter Drugs'.
"Mark ups" above the cost of production to the extent of 40%,55%,
100% are permitted by the Ministry of Petroleum, Chemicals and
Fertilizers on Category I, II and III after a study of the
_
production costs to be submitted by the manufacturing company.
_Wh§t..does _ the Drug industry have to say about it?
According to Dr. S .K... Bhattacharya recently elected President of
the Organization of Pharmaceutical Producers of India (OPPI)
(which constitutes of 62 big and 54 medium firms and produces
60% of that total bulk drugs and formulations in the country),
the present drug shortage of commonly prescribed drugs is because
of the New Drug Policy and the rigid price control and it will
definitely get worse.
Which are the drugs which have had problems regarding availability?
Newsreports and A survey done by Medical Times (Glaxo's) Aug.
has revealed a shortage of painkillers
- antiepileptics
- anti-diabetics
- anti TB drugs
- sera vaccines .
'81
- Cardiac glycosides
- anti hypertensive
*Regarding prescription practices - surveyed by Medical Times
(Glaxo’s) use of brand and generic was concerned. Almost all
the doctors seemed to use brand drugs. Reasons:
1)
2)
3)
confidence in the brands
less chance of substitution by chemist
convenience in remembering
Any info what guides prescription practices?
A study done by NIN Hyderabad on drug utilization revealed that
14% of the population surveyed (1800 urban education population)
was taking drugs on the basis of advertisements alone.
Only
1.72% gave satisfactory replies on the proper use of drugs.
48% allopathy
18% homeopathy
14% naturopathy
11% ayurvedic
2% Unani
63% had erroneous idea about dosage schedules and mode of adminis
tration which could result in bioavailability and therapeutic
problems.
What is OPPI paying to build up public opinion against the
Government policies? OPPI has launched a Rs.24 lakh MEDIA CAMPAIGN
in what is says is a bid to help avert more serious shortages in
the future.
(Source: Vanishing Drugs: Hindustan Times April 27, 1980)
What is the situation regarding Drug Control?
The Drug Control situation in India is pretty bad. Only 3
(Maharashtra, Gujarat, West Bengal) our of 22 States in India
have machinery to regulate the manufacture, distribution and.
sale of pharmaceuticals.
p-10:343
MS:k:5.1.82
In Maharashtra, acknowledged to have the most effective drug
control administration, there are only 96 drug inspectors and
1 drug testing laboratory for over 2000 manufacturers and 15, 000
S hOTDS
■
*
.
(Source: Dr. S.K. Bhattacharya of OPPI in
Medical Times - August 1981)
In Delhi for 5 million, population there are 20 drug inspectors.
In Uttar Pradesh for 100 million population there are only 24 drug
inspectors.
.
,
.
„
. _.
j
Source: Rajender Ramer : Delhi Reporter
July 1981:Spurious Drugs dealing in
Death)
At the time of the Hathi Committee Report ( 1975) the .’J-'otal drugs
Inspectors in thv; whole of India was 305. Current estimates are
5'">0.
(Source: The Ethics of Drug Industry: Business
India, July 7-20, 1980 - Pg. 33)
W?j^ptux^n±a,g&_,oJL_driigs_„are_._c.ons.idered sub-standard in the Indian
-.a.rke.t?.
Conservative estimates arc 25-30%.
The Drug Control authori
ties accept this figure.
(Soured: Spurious Drugs: Delhi Recorder,
July 8)
52% drugs are substandard according to a survey quoted by Anil
Aggarwal in Drugs and the Third World
*
2% drugs are spurious
(According to the drug control authorities).
What. are..Xhem^3.s_Qns_klf_^JACJa_a_bi.gh__pfercen cage_of__spbstanjdard_
drugs?
1)
Inadequate drug control.
The centre can only lay down'policies, state governments have
control -over manufacturers., sale and distribution (the inter
state barriers are fully exploited by trade in spurious drgs).
Control, if any, is at the earlier stage -of production into#
bulk form or later formulations, improper storage, etc. are not
given that importance.
Shortage of certain brands of popular drugs gives an opportunity
to spurious and substandard drug producers to take advantage
of the situation.
Linked to this is high demand of life saving
and other common drugs.
easy availability of drugs over the counter without
prescription from \a qualified doctor
-
easier availability of drug selling licence
ignorance about drug adulteration and substitution
- the increasingly prevailing habit of chemists to stock drugs
of a company giving them commission in some areas
the desire of the consumer to buy cheaper drugs because of
the high cost of drugs (and his poverty in many cases)
- the buying of drugs by chemists without any bill to avoid
payment of taxes
- only drug control authorities have been associated with
checks and control unlike food aditeration where the consumer
can play a role.
.../-
D-10:343
MS :k:5.1.82
What can consumers do to deal with this problem of substandard and
spurious drugs?
1)
Buy drugs only from licensed chemists.
2)
Read the drug label carefully, verfy expiry date, price
and seal before purchasing. Check with the price lists of
manufacturers available with the chemists.
Ask for a cash memo-give the chemist enough time to fill
entries of drugs bought, your address, etc.
3)
4)
Don't swallow all the claims made by the advertisers of the
various drugs.
5)
Avoid self medication by use of patent drugs.
yourself witlj&ny drug you do not know about.
6)
Follow instructions given by your doctor, pharmacist or on
the medicine label regarding mode of administration of the
drug dosage, frequency, etc., and duration. Check if in
doubt specially if deasling with patent drugs.
7)
Avoid using left-over drugs or drugs that change colour,
taste, or look different. Keep drugs as advised - in a dark
and cool place.
Don't medicate
|
8)
Keep drugs away from children's reach.
separately.
9)
Destroy old cartons, labels, containers to prevent misuse of
spurious drug manufacturers.
10)
If you feel doubtful about the quality of any medicine, contact
the Erug Control Department.
11)
If in Delhi, ring up 22 60 18 be4ween 9 A.M. - 6 P.M..
After office hours and on holidays ring up 63 33 00, 63 40 73
and 63 11 16.
Keep poisonous drugs
The punishment provided in.Sec. 27 and 27A of the 1940 Drugs and
Cosmetics' Act to safeguard the consumer is maximum imprisonment
of 10 years, increased to life imprisonment by West Bengal.
What constitutes the public sector and how are they faring?
The public sector constitutes of -
IDPL
-
Indian Drugs &. Pharmaceuticals Limited
HAL
-
Hindustan Antibiotics Limited
SSPL
-
Smith Stanistreet Pharmaceuticals Limited
BEPL
-
Bengal Chemicals & Pharmaceuticals Limited
IDPL and HAL incurred losses of almost. 2 crores in 1979. Monthly
losses of IDPL and HAL are 2 crores and 45 lakhs respectively.
(Source: Policy Pitfalls: Ranjana Kaul:
Hindustan Times, April 27, 1980)
Why are they running at a loss?
The reasons given are mismanagement, inefficiency, poor'-coordina
tion, under-utilization of capacity, corruption, frequent machine
breakdowns.
Probably, one acceptable reason is the refusal of the MNC and
oth._-r private companies to go into production of essential and
life-saving drugs of Category I & II which allow mark-up of only
40 and 55% respectively (as they can make up to 100% profit on
non-essential over t ie counter drugs) and the public sector
halving to take on the burden.
.
D-10:343
MS;k:5.1.82
: 9, :
/
According to Mr. D.B. Telang, Fina/cial Manager of the company
for every kilo of streptomycin produced, a loss of Rs.25 is
incurred. The more esssential drugs are produced the more are
the losses incurred.
Losses are due to increase in the price of
raw materials, inflation - 35-40%; packaging 30%, power 30%, cost
of transportation. A,, this in the presence of fixed drug prices
apparently has caused the ever increasing losses in the public
drug sector. IDPL, HAL, IDRI were instituted to break foreign
monopolization and produce a reasonably cost essential drugs for
the Indian public. But even today, 33 years we still import drugs
for Kalazar, malaria, leprosy, diphtheria, TB. Losses can be made
up by raising production or by asking government to alter the
pricing structure.
How self sufficient are we regarding production of drugs? What
do the MNC's and OPPI have to say about production of essential
drugs?
of
SQys "We are business concerns. Why
Twh^cK actuallyGmc-ans lesi profitsincurrence of loss."
What is e.p.c.?
Chemicals & Pharmaceuticals Corporation is for channelizing drugs
and regulating their availability in the country. The Corpora
tion has had problems regarding availability and prices of
imported ingredients. There are reports of essential bulk drugs
not being lifted from the C.P.C. by the drug company on account
of low profitability.
On December 1, 1979, CPC had 4 crore worth
of canalized bulk drugs in stock. These included essential drugs
like tetracycline, streptomycin, doxycyc lin.
Drug
Company
Licensed capacity
in million/ tons
Actua L produc
tion in mil
lion tons
56.06
135.82
PAS
S) Biological Evans
b) Warner Hindustan
120
300
INH
a) Biological Evans
b) Ghas. Pfizer
c) Warner Hindustan
10
1.6
90
0.13
0.06
6.08
What are the objectives of C.P.C
The basic objectives of CPC in canalizing import of drugs is as
follows:
1.
Bulk purchase for all manufacturing units gave bargaining
power in world market so that concessional or low prices
could be secured.
2.
To prevent disturbance of indigenous production of drugs with
a certain therapeutic value - introduce and regulate imports
of newer, sophisticated drugs in a planned manner.
3.
To protect the indigenous production of drugs, especially when
the production is inadequate to meet internal demand.
4.
To ensure the equitable supply of raw materials at uniform
prices, eliminating middleman's profits,, so that formulations
from this are priced at a fixed uniform level.
D-10:343
MS;k:5.1.82
10:
5.
To help the small scale sector of the industry whose require
ments are small and who would otherwise find it uneconomic
and impractical to import.
6.
To regulate the import of drugs whose indigenous production
is substantial enough to warrant their being given protection
so that their growth and utility are ensured with a view to
achieving ultimate self-sufficiency.
7.
To secure those drugs which have very few world manufacturers
and monopolies at reasonable prices.
8.
To regulate the import of drugs whose imports can cause public
health problems, eg., addiction forming drugs, etc.
Loopholes points 4 and 5 were to avoid middlemen but unfortunately
since small units have to give their REQUIREMENTS AND ADVANCE
PAYMENT several months prior to time of supply (promptness of which
is not assured), the small scale agencies are unable to take full
advantage and it is the MIDDLEMEN who lift the STOCK, HOARD it and
sell it at 25-30% higher than the usual rate.
10% foreign firms have not utilized 3 industrial licences and
7 letters of intent for the manufacture of 16 bulk drugs.
40 firms in the Indian private sector failed to implement the
investment proposals with 31 industrial licenses and 27 letters
of intent.
Of 32 items of bulk drugs covered by 13 licenses, 21 items were not
produced by Glaxo laboratories for the last 5 years.
(Source: J.S. Mazumdar: Drug Industry
Instruments of Policy)
And with all this, useless non-essential drugs are pumped into the
market while essential drugs are not produced. Very obviously,
profit is the motive of the drug production industry and not ful
filling of the country's need as is often alleged.
The small scale sector feels itself financially ill-equipeed to
undertake any undue losses or profits and therefore also opts for
non-essential drugs.
What does the 6th Five Year Plan require regarding drug production?
From Present
Bulk 226 crores
By 1984-85
to
665 crores
Formulation Rs. 1150 crores
2450 crores.
VIth PLAN aims at:
1)
Developing self-reliance in technology,
2)
Ensuring availability of drugs with reasonable prices and
inadequate amount
3)
Dominant role of the public sector in the industry.
What's the situation?
Growth rate of bulk drugs has fallen from 13% to 6% and for formula
tions from 10% to 4%.
C-10:343
MS :k.5.1.82
: 11
IN THE FIRST YEAR OF THE PLAN, the foreign and big Indian
companies are not interested in manufacturing the drugs that yield
low profit margin.
In fact, by cornering the already sanctioned
licenses and letters of intent they are out to blackmail the
government in order to secure substantial price rise - by starving
the market of these drugs.
(Source: MNC's Fatten, Indian Die:
Dr. Pankaj Shah: Link, Aug. 2, 1981,Pg.10)
The Multinationals give the high prices because of the 'research'
they apparently finance. What all constitutes research?
It includes
- basic research
- product development
- toxicity tests
- research on formulations
- mass production methods
- clinical trials, etc.
it also includes studies on colour design of product, its packaging
to promote sales, general market studies, purchase of international
patents, solely to extend the company's monopoly position abroad.
(Source:
Link, Aug. 2, 1981, Pg.11
Dr. Pankajj Shah)
What percentage of their sales do they put into research?
•what percentage in publicity?
and
Glaxo in 1979-8Q spent Rs.1.52 crores on publicity — . . percent
on tropical diseases.
Amount MNC's spend on research is <^3% of their sales turnover
compaisi to 14-15% in Developed countries. Even so research acti
vities are seldom in nropical diseases.but in diseases like cancer
hypertension etc.
What are the country's health requirements based on priorities set
by Alternative Strategy: ICMR/ICSSR Study
Measures against
-
Communicable Diseases
-
Nutritional deficiencies
Family Planning. Fertility rate,
-
Basic health care
Some of the figures that indicate the seriousness of the problem
*IMR In 19 76 1.29/1000 live births (when Sri Lanka's is 45:1 in' 72
(pg. 129) )
★Maternal mortality 163 in 1976 (Percentage Distribution
(pg. 125)
★Birth rate - 33.3%per thousand per annum in 1978 (Pg. 13)
Health Budget set aside for the VIth Five Year Plan - 1821.05
Crores
50% of the Health budget earlier has been spent on curative ca:«
40% in construction and capital expenditure
and only 10% on preventive health care(Health Statistical
Intelligence Report)
j
50% of under fives and pregnant mothers are found to be anaemic. .% are clinically malnourished.
50% of Indian children get % the calories .that they require.
40,000 children become blind each year because of Vitamin A
defiency.
' -’•• •
z
• •/-
-10:343
S:k:5.1.82
12
*27,08,222 get malaria every year and 147 die of malaria in 1979
Incidence of T.B. is 2%, i.e., 8 million people. About (P<3’82;
2 million have open TB.
♦Incidence of leprosy is 25,59,566 cases on Record - Mar.'80 i
21,58,822 cases under treatment
oPg.89)
on Record - Mar. '80 j
(India harbours 1/3 of the world's leprosy, malaria cases).
(*Sounce: Pocket Book of Health Statistics
'80, CBHI, New Delhi)
The incidence of malaria - even Falciparum - Filaria, polio,
Kalazar, Japanese 'Becephalitis has shown an increasing trend.
The above becomes extra significant when we focus on the percentage
of people below or bordering the poverty level - a figure that is <
also showing a rising trend. 60% Indians are below poverty line
(assessed in relation to average caloric- requirement).
What is the production of drugs like in relation to these health
requirements:
Out of Rs.636.9 crores of drugs sold in 1980
19% were anti-biotics
10.21% vitamins
4.41% tonics
4.241% anti-anaemic preparations
4.71% cough and cold (increase in growth within
the last 5 years has been
70%) .
Talking in absolute figures 137 crores worth of vitamins were sold
in the year 1980.
Break-up of the above available in Dr. A. Patwardhan's paper
1,2, and 3.
All modern drugs are available to economically well off 5%.
^asic drugs available to another 20%.
Percentage of people denied availability of essential modern drugs
is 75%.
This is when our population is 65 million.
With annual expenditure of 636.9 crores.
By 2001 the population will be 950 millions.
Amount required for drugs with inflation, increasing prices of
raw material, etc, etc., will be
.
Our National Formulary has over 60,000 drugs and chemicals.
(15,000 brand drugs)
68% are obsolete and useless (only about 5000 are useful and 2500
of marginal use)
The Hathi Committee has identified 117 as essential drugs and WHO
about 200' drugs which would take care of the 90% of the EXISTING
HEALTH PROBLEMS .
D-10-.343
MS:k:5.1.82
: 13 :
Regarding essential drugs production what is happening?
Out of Rs. 1260 crores worth of drugs manufactured in 1979-80
essential and life saving drugs accounted for Rs.350 crores only the rest were tonics, digestive enzymes, formulations of medicines
with marginal benefit.
MANY VITAL BULK DRUGS IN HUGE QUANTITY HAVE BEEN WASTED WHICH
COULD HAVE BEEN UTILIZED FOR MANUFACTURE OF ESSENTIAL DRUGS.
(Source: Drugs : Industry Instruments of Policy
- U.S. Majumdar)
1978
1977
Installed ProducInstalled
Production
capacity
Tonnes
Anti-T.B. Drugs
capacity
tion
ronnes
1'onnes
tonnes
INH
5 09
57
5 39
94
PAS and its salts
1170
56
1290
558
Theacetazone
153
25
153
13
Streptomycin
257
194
25 7
225
DDS and its deriva
tives
26
17
38
17
Anti-filaria
DEC citrate
56
18
56
23
Anti-typhoid
Chloramphinicol
128
95
128
95
Halogenated
Quinolines
5 87
157
590
195
Metronidazole
137
16
170
55'
156
34
176
45
Anti-Leprosy
Anti-Dysentery
Anti-malaria Is
Chloroquin
Pfizer Ltd.
Products
Licensed capacity
Production during
1978
19 79
INH
80 metric tonnes
45 MT
52 MT
PAS and its salts
110
90 MT
54 MT
Te rramyc in
14
5 3 MT
54 MT
Protienex
110
269 MT
290 MT
Burrough 1 s We 1c ome
Licensed annual capacity
Production 1980-81
26 million tablets
187 million tablets
Septran
Similarly, Glaxo's production of Betamethazone has been increasing
while production of antibiotics - penicillin, streptomycin, serra
and vaccines is much below licensed capacity.
Make-up of Drug Industry at a glance?
*5000 pharmaceutical units
*1500 units based on loan
license system
*45 Multinational drug companies
which have foreign equity
more than 4 0%
******
3500 manufacuring units
118 canpanies in the organised
sector
Of the 20,000 formulations in tft®
market - 78% formulations in the
hands of Multinationals, 16%
Indian Private Sector, 6?^ Pub, ic
A to X/ OF DRUG POLICY ISSUES
COMMUNITY HEALTH CELL
47/1,(First I:‘oor)St. MarksRoaf
•
ORE - 560 007
ADVERTISING
Ohe of the main tools of drug companies to create
■r
I
a need for their products. Includes appeals for status,
modernity, even unnecessary uses and cosmetic embellishments.
BULK PURCHASING
Buying of drugs in bulk by competitive buying of generic
drugs in the international market. It does away uithbrand
names and private importers.
This is the basic, active chemical ingredient of a drug
BULK DRUG
formulation.
BASIC RESEARCH
This implies fundamental and innovational process or
product research. A necessary step to prevent dependence
on foreign companies.
BIO-AVAILABILITY: This means that the same chemical ingrecient, may be
therapeutically different because of the way of formulation.
A common but unconvincing argument against generic
prescribing by drug companies.
HAHe
- The-
v-e-zi
-re.cjTsfe.v'e&L
iKU
-------- ------------------ /
;
CONSUMER ALERT
AND CONSUMER “
ACTION
An important and growing need in the formulation of a
to -z-» <X
DUMPING
con
Ku
.
safe drug policy.
hKuuq r P
•nncsve-
f
Cun<£. ^h<uK'Ke
T>~>Cj-recL<’&^h,
Passing of old, unwanted, out-dated and banned or
otherwise inferior products on an unsuspecting public.
A common practice of multinationals operating in third
world countries.
.2
l2i
DRUG PRICE CONTROL
ORDERS
Government orders to control prices of drugs and
profits issued in 1963, 1966 and 1970 and 1979.
A list of medicinal products of proven efficiency,
ESSENTIAL DRUG
LIST
acceptable safety and suitability to satisfy the
health needs of the majority of the population.
FORMULATIONS
These arc finished products iihich are dir: ctly consumed
and contains in addition to the active drug compound
other ingredients such as diluents, binders, flavouring/
colouring agtnts, gelatin shells, chemical bases and
waxes and preservatives.
FOREIGN COMPANY
In India defined as a company with foreign shareholding
exceeding 40/ of the total share capital.
GER-ERIC PRESCRIBING
i
.
•
’
Prescription of drugs using the official, international,
nan-proprietary name and not trade or brand names, eg.:
- V'Aspirin not ftspro or Plusprin. /
1
HATH I; COI-ifilTTEE
REPORT
fin exhaustive report of far reaching importance, by the
Committee on Drugs and Pharmaceutical Industry, Government
of India, published in April 1975.
.3
:3j
HERBAL-F?EBICTf.‘E5
A irich source of medicines for all the common ailments.
Forms part of the rich cultural^b^ritage o\me.ny countries.
Vietnam and China promoted them as part of their drug policy.
international CODES
These are codes of quality or safety of products or
business procedures, eg., Code of Ethical Flarketing Practices
of Health Action International. An important step in
pressurising multinationals to stop exploiting the third
world.
Pr^
*
■JUNK
DRUGS
These are newer drugs in the market whose only additional
value are cosmetic embellishmentsg elegant packing,
irrational combinations all of which help to increase its
cost.
KNOW-HOW
fin important requirement for the technical improvement
of the drug industry. Often controlled by patent, royalty
rules and monoply of foreign companies.
xi— - L
UOTOT-Hz
Algood examples of drug sold in India which is banned in
most\countrics.Especially dangerous for yse with infants.
tiNO manual dismisses'tlie drug as of no value
*
FIE-TOO DRUGS
Those are products of research using molecular manipulation
which are profitable but not necessarily a scientific
advance.
4
<41
FiARK-UP
Is the hike in the price above the basic production cost
and is the amount used For sailing costs, administrative
expenses and profits. It is presently fixed by government
orders. The less essential the drug Formulation
higher the mark-up is allowed in India.
NET NORTH
RETURNS
Is an expression of the profit potential of a drug company
and is one of the highest in the chemical industry in India.
It makes drug companies one of the most attractive investments
in the organised industrial sector of the Indian economy.
ORT or ORAL
REHYDRATION
THERAPY
A very important need in the rational management of diarrhoeas
in children and its popularity will prevent use of many
anti-diarrhoeals that have doubtful therapeutic value.
PACKAGING
The art of packing drugs not only to ensure integrity of
product but to give it ’brand distinctiveness
*
'consumer appeal
.
*
PUBLIC SECTOR
and
Helps to increase cost of the drugs.
Includes drug manufacturing companies owned by the central
government. These have pioneered the production of bulk
drugs in the country. The government policy attempts to give
it a leadership role.
QUALITY
CONTROL
A vary important step in manufacture and distribution of
drugs. In India this is organised by the Drug Controller.
.5
151
RATIONAL DRUG
THERAPY
A method of prescribing which is efficient
safe, low cost
and easy to administer.
RESEARCH AND
DEVELOPMENT
(RID)
A much neglected arsa in the drug industry
A very necessary
requirement for a country to evolve its own indigenous
drug policy
SALES PROMOTION
Techniques aimed at consumers, dealers or intermediaries
*
to increase short term sales and inspire good will
For
drug companies it includes bonuses with purchase, contests
and competitions, samples and give ways
SAMPLES
*
Commonest method by drug companies to woo doctors
Other
methods are advertising in medical journals, leafleting,
sponsoring medical events, hospitality and providing gifts
TRANSFER PRICING
Inporting of raw materials from parent companies by
multinational subsidiaries at rates higher than the prices
in the international market thereby transfering cost to the
local consumer.
C^°
*N
U
AGENCIES
These include UNIDO, UNCTAD- UNICEF. All of these are
gearing up to help developing countries evolve relevant drug
policies
,6
«6:
VOLUNTARY ACTION
ONLY VOLUNTARY action and initiative can tackle
many drug policy issues. The GONOSHASTHYA KENDRA
and G.K« PHARMACEUTICALS are one example of such an
*
initiative
blORLD HEALTH
ORGANIZATION
Their expert committee reports and working group
reports are providing the technical back-up for the
evolution of a more health oriented policy in
member-nations *
X
y -
; -‘ -.- . . ■-■. ...
<i7] i.
IRRATIONAL DRUG USE
p/?£vC.R>8:H6
'- .,
,
’
. ,’V’ :' r
—-•‘.(JRE - 560 001
Type of Irrational
Occurs if a drug is prescribed when:
Drug Use
Extravagant
Prescribing
* a less expensive drug would provide compareble efficacy and safety
* symptomatic treatment of mild conditions
diverts funds from treating serious
illness
* a brand name is used where less expensive
equivalents are available
Over-prescribing
* the drug is not needed
* the dose is too large
* the tr atment period is too long
* the quantity dispensed is too great for
the current course of treatment
Incorrect
* the drug is given for an incorrect diagnosis
prescribing
* the wrong drug is selected for the indicatior
* the prescription is prepared improperly * adjustments are not made for co-existing
medical, genetic, environmental, or other
factors
Multiple
Prescribing
* two or more medications are used when
one or two would achieve virtually the
same effect
* several related conditions are treated
when treatment of the primary condition
will improve or cure the other conditions
Under-prescribing
* needed medications are not prescribed
* dosage is inadequate
* length of treatment is too brief
— _—*_ •—• — ____— . — — _— - —— — ——_■ —— _—*• ______ ?______?— ■ - «—- — — . ■ — a ——_f •
MANAGIWGrDRUG> SUE<EL^^fetoo^ej^ep^_SGi^riec<^_Qir Meai-thy Q3osion,
IRRATIONAL DRUG USE — CAUSES
In brief, the main causes identified by those who have studied
prescribing behavior are the followings
-.
1,
Inadequate training in clinical pharmacology — Despite
the daily use of medicines in clinical pra ctice, formal
training in drug use is usually brief and often limited
to the early part of medical training.
2.
Lack of continuing education and supervision - For the
medical auxiliary as well as the practicing physician,
there is usually little opportunity for regular review
of their prescribing habits. In addition, there are few
opportunities for them to learn about new drugs from
unbiased sources.
3.
The practitioner’s inappropriate desire for prestige In some areas a "good doctor" is expected to use many
different drugs and prescription of multiple drugs is
falsely c nsidered a sign of good care.
4.
Promotional activities of drug company representatives -
The role of commercial interests in promoting irrational
and costly prescribing has been well documented and nr.
cannot be over-emphasized. Even where the choice of
drugs is limited by centralized purchasing, company
representatives frequently promote overuse of drugs.
5.
Lack of time due to heavy patient load - Medications
are often given out to help end a patient visit, or
prescribed "just in case", to avoid a return visit.
2
2
6.
Pressure from patients — Even in the most remote areas,
patients quickly come to expect that every symptom has a
medicine to cure it. Because patient education can be slow,
time-consuming, and tiring, practitioners often give in
to the request for medicines.
7.
Fear—induced prescription - Diagnoses are rarely made
with absolute certainty and the course of an illness
cannot be predicted exactly. Medical practitioners often
try to "protect" themselves against this uncertainty
by extravagant, multiple, or overprescribing.
8.
Incorrect generalization about a drug from limited
experience - Unexpectedly favourable results or unfavourable
side effects are sometimes seen with the use of a drug.
Although these results may be totally unrelated to the
drug, practitioners may over-react and, depending on
the result, later overprescribe or underprescribe on the
basis of this anecdotal information, rather than on the
basis of scientific evidence.
From MANAGING DRUG SUPPLY, Management Sciences for Health, Boston,
Massachusetts, USA,
ARE
Y 1 RSCLf 7
BR \ITS. ST -)h HE ALTI< ISSUES .
It is the rbspanriibility of ths consumers to lesm tho hazards
*
of daugs and chemicals used in daily life, not only to saferjord
themselves but to work collectively so as to free policy makers
and manufacturers to rsmva definitely harmful druga and chemicals
Cjl f
from the market or to devise an affective warning system so that
§5
thesre substance ora not misused.
Tho message was strongly conveyed •& o? S
®
^(?0 Qr?g
by the members of panel of Brain Trust Society of Indio at Indian
Merchants Chambers, Committee room on 18th March 1934. Mamberasef
panel included Dr.Pawan Sureke,Chairman of Medical Committee of
Consumer Guidance Society of Indicia Dr,T,R.Motwani a Senior
sexgaSurgeon at Jaslok M Hospital, Dr.S.Adrenwala.President of
p &
Bombay opthslmologist
*
8 Society, Dr.Dinesh Daftary, s dentol
surgeon and Honorary oral pathologist st Tats Institute of F£in~
dements! Research, Dr.W.S.Rane Joint Honorary Secretary of Borabay
Arogya Dakshats Mnndals Dr. G.S.Hethi, n Child Specialist and
Mr. N.G.Wcglo, Consultant
chdtmical Technologist.
PAItt KILLER DRUGS.
Analgin, ap pein killer drug (Novalgin,Baralgan,Ultragin,
Neurolion etc.) esn causa damage to bone marrow causing deficiency
of frb.ite blood Cells ., ”Agranulocytosis,B a potentially fatal concsi
»
*
tian. A doctor who had himself taken Just two tablets containing
analgin, developed agranulocytosis and could survive with difficult
after : fight of nearly six months under intensive medical care»;
Analgin hss been benned in number of countrias including Bangla~
Desh but continue® to be manufactured aven by public pharmaceutical
companies and is frsely available in the market without any warning
system to consumers. Pain is a subjective phenomenon and .certain
'^$^xsr^^xSr5?s!j?xxs^:;’?
natural methods like taking rest, message with gentle hands, going
out for a walkj.' 'diversion of mind etc., are preferably to taking
drugs, Similaraly sponging of the body with ■ t-.-r or its cold packc
are better far simptone relief of fever and ehoy’.d bo used ae c
primacy measure.
(rover id basically body's defoneu m&ehsr.iewt
stress should *bo on proper diagnosis of came of fever and apecx-.treatment of that cause.I
aracetcmol{'sletecln,
*
Crocin, :jyrigesxc
is relatively cage drug and cm ba used for relief of pain sr fsue
Asprin soother drug( s,g. Diaprin) cihec iaksrs should ns con^um o
a gl.v s full of water cr milk and profi-rably after food.
. vf j
the market is being fleoddd by drug combinations of either uesl»e>«
f ■j 1.
s
mad i rt.L'nae and I'-.r'<<.'
preparation,
T?oT-\-<C.<2. .
C- 6 Sf
d£ff:Ci:T'’ tc
•
'
~;
/Jcrur
a
to_? 2^ ?r22i?m_Dru22
(A check list of hazardous, banned, bannable and dumped drugs in India.)
A
=
Analgin - is a potentially toxic drug and may cause
agranulocytosis. Fixed dose combinations (FDC)
any other category of drug in oral dosage form
are considered harmful.
Amidopyrin - was used as an analgesic anti-inflammatory agent
-™——for over 7 years.
It has now been found to increase the risk of
agranulocytosis and in large doses to be associated
..ith renal tabular necrosis (Banned July 1983).
Ancoloxin - a widely used anti-nausea drug which is reported
to have teratogenic potential and hence is a hazard to
pregnant
omefi. Sold in India without warning.
Anabolic Steroids - Synthetic derivatives of male sex hormone
which have an androgenic and anabolic (body building)
effect. It is chiefly indicated for tr atment of
senile and post-menopausal bone disorders and a-^plastic
anemia. In India it is advised for malnutrition, appetite
stimulant and for increasing growth. All these are foolish
especially in the light of irreversible harm it can have
on children’s growth and sexual development. After much
publicity of these side effects, CIBA Geigy has withdrawn
pre.p<Xr&J^C’-> S-
Dianabol,one of the commonest. Many more preparations
continue to be marketed in India.
B
=
Bromides - On prolonged administration, they replace chloride
ions in the body, cumulative poisoning manifest^
as conjunctivitis, gastro-intestinal symptoms,
dermatitis and mental disturbances. It was a commonly
used hypnotic of low potency but unreliable (Banned
in July 1983)
C
=
Chloral Hydrate - used as a hypnotic.has^found to be an
irritant of the gastric mucosa causing nausea,
vomiting, flatulence and epigastric distress.
It can also cause hepatic or renal damage. It
should no longer be used as a hypnotic (Banned
July
in
1983).
Clioguinol - or hydroxyquinolines have been popularly used
'or prophylaxis and trcament of gastro-enteritis
amoebiasis and traveller’s diarrhoea. Ever since
the report of its association with SMOF! (subacute
myelo-optic neuropathy) its use has been restricted
or banned in many countries. In India they are
supposed to be prescription drugs but are obtainable
over the counter. A warning in English (small print)
does occur on the product but it hardly succeeds
in warning consumers.
D = Dipyrone -
is the sodium sulphonate of amidopyrines having
similar properties and adverse effects particularly
fatal agranulocytosis. The incidence and risk of this
hazard far outweighs any benefit that can be derived
from its use.
E
=
£
©p Forte - these are high dose estrogen-progcsterone
combinations which are dangerous for use in pregnant
tietZ-CvrA or
women because of the associatedz fetal malform tion.
In spite of the banning of production and sales of
these drugs by the drug controller in March/June 1983
these continue to be misused for hormonal pregnancy
3
3
tests and for induction of abortion.
Enzymes - A very wide range of enzymes preparations are available
*■
in India as digestives and for specific conditions.
Though by themselves they are not harmful, their
production in large amounts along with tonics, vitamins
and he 1th restoratives are an indication of our
irrational drug policy at the cost of larger social
needs, 'these are mostly consumed by the relatively
well-fed urban population.
Ergot —
is an alkaloid effective in the treatment of migraine.
However fixed dose combinations with drugs like
paracetamol, prochlorperazine etc., have no therapeutic
advantage and hence are irrational (FDCs of ergot are
banned in July 1983).
F = FDC or Fixed Drug Combinations: These are formulations where two
or more drugs are combined for the folio ing reasons:
a)
synergistic action; b) corrective action;
c)
two or more drugs normally prescribed together ahi taken
by patient simultaneously; d) when dosage of each drug
need not be individualised; e) where combination ensure
better patient compliance due to convenience of
administration. Conve.sely FDCs are irrational and should
not be permitted if (a) adverse interactions occur; (b)
when one of the combined drugs becomes toxic on prolonged <a:
(c)
when abrupt withdrawal of one causes withdrawal symptom
(d)
if sub-therapeutic
doses are used in the
absence of clinically demonstrable synergism;
4
(e)
when pharmacokinetic behaviour of individual
agents is different. (22 FDCs were banned in July
1983 - refer Government order).
G = Gripe Water - These are popular preparations promoted for
colic in children. Contain alcohol and. sodium bicarbonate.
Chronic use of the latter can cause milk-alkali syndrome.
Uncomfortable but rarely dangerous gastric distension can
also occur. Despite toxicity and side effects gripe water
does a thriving business through medical and consumer
ignorance (Banned in Bangladesh in June 1982)•
H = Hydroxyquinolines or halogenated oxyguinoline derivatives
which induce iodochlor-hydroxyquinoiine, proxyquinoline,
halquinol, diiodohydroxyquinoline, chlorquinaldol,
chiniofon). For hazard see Clioquinol.
Hormonal Pregnancy Tests - Oestrogen-progesterone combinations
have been indiscriminately used in pregnant women
as a hormonal test to detect pregnancy. (See EP Forte)
Since there is an increased risk of foetal abnormalities
and the test is false positive in one out of five women
7Ae.
these tests should not longer bs doue.^Drugs controller
had • issued a directive to strengthen warning on packages
(March 1982) and banned manuf cture(Dec 1982) and sale
(June 1983)« Due to legal controversy, and professional
and consumer ignorance it still continues to be used.
I « Injections - have played a very important role in iatew modern
medicine and form one of its most distinctive features.
5
5
However, it has also lent itself to a very large degree of
misuse-overuse because of the mystique associated with it
in the minds of the public and the temptation of the metical
practitioners to pander to this need and pressure fix their own
economic gain,
J = Junk Drugs - these are newer formulations in the market whose only
additional values are cosmetic embellishments, added flavours,
elegant packing, irrational combinations - all of which help
to increase its cost.
K = Kaolin - is hydrated and purified aluminium silicate, a common
addition in antidiarrhoeal mixtures. Along with pectin and bismuth
salts it forms a group called adsorbents, astringents and binding
agents. These drugs may cause loss of electrolytes by preventing
absorption through gastrointestinal tracts. If at all, they arc
of cosmetic value and may actually mask the severity of disease.
L = Lomotil or diphenoxylate and Loperamide are drugs whose risks of
treatment outweigh their benefits especially in children. They
are commonly used in diarrhoeas and the dangers of paralytic
ileus leading to inaccurate assessment of fluid loss and toxaemia
if associated with gut infections make them especially dangerous
in pediatric practice. The use for children under six has been
banned in India. In most other countries its use is banned
altogether.
M = Methapyrilene and its salts (Banned in July 1983).
N = Nialamide or Niamid - a MAO inhibitor used in the treatment of
depressive disorders (Banned in July 1983)
6
O = OTC^dvugs or over the counter drugs. These are drugs that are
available to consumers without prescription and are mainly
painkillers, anti-cold, anti-cough preparations, cough
mixtures, tonics, food substitutes and protein powders. Many
The^
of them are costly compared to the benefits they render, have se?
some ingredients which are unnecessary or useless but helping
/he/
to push up cost.azd'are widely advertised with false claims
to push up s les. Their scientific scrutiny is a need as
also a systematic campaign against their irrational
ingredients or claims.
Oxyphenbutazone - these are a group of non-steroidal antiinflammatory
drugs which also have mild antipyretic and analgesic
properties . The dangers associated with use are bone
marrow toxicity and liver toxicity. 1’hey are widely used
/overused/misused group of drugs and there is great need
for building professional awareness and consumer alert
on this group of drugs. Recently these drugs have been
banned in the U.K.
P = Phenacetin - was a commonly used analgesic/antipyretic agent
which has been reported to cause kidney damage and
failure and hemolytic anemia. Hence fixed cose combinations
containing it are now considered outdated and hazardous.
These|iave been recommended for weeding out by the Hath!
Committee.
Phenylbutazones - another group of non-steroidal antiinflammatory
drugs which give only symptomatic relief and in no way
alter the course of the illness. Its mein indications
. 1
7
are for ankylosing spondylitis and rheumatoid and
gouty arthritis though they are being widely promoted
and used for non-rheumatic disorders and aches, pains
and fever. Bone marrow toxicity is a real danger with
the use of this drug and hence its use should be
severely restricted. Its present availability—freely
over the counter-should be drastically controlled and
its deadly combinations with amidopyrin, analgin,
paracetamol, diazepam, vitamin B, dextrapropoxyphene
acetaminophen should be banned or adequate warnings
in labels instituted.
Practolol (Banned in July 1983).
Penicillin - Still an important constitutent of antibacterial
therapy in spite of the risk of anaphylactic reaction
and allergic reactions. (Its combination with
sulphonamides and its preparations as skin/eye ointments
are ban- ed from July 1983).
Q =» Quinine - was the sheet -i. anchor of anti-malarial treatment
till safer 4 aminoquinolines and 8 aminoquinolines
were developed. Its use leads to black water fever
♦
so^is restricted now-a-days for treatment of
chloroquin resistant cases or sometimes in cerebral malaria
R «= Rational Drug Therapy - is the art/science of prescribing the
best suited drugs to individuals who need them taking
and not to those who merely want them. Its takes
into account factors like efficiency, safety (low
o
incidence of side effects), cost and ease of administration
It scruplously avoids extravagant prescribing^over or
under prescribing, multiple prescribing or incorrect
prescribing.
S
= Sulphonamides - These have an important role to play in the
therapy of infections. The combination with penicillins
is undesirable because of the antagonism of antibacterial
effect when bacteriostatic and bacteriocidal drugs are
given together. (FDCs of sulphonamides and penicillins
are banned since July 1983).
Streptomycin - Since it is one of the most effective drugs
in anti-tb treatment its use should be limited to
TB treatment and mixed infections of the gut. Its
combination with penicillins is undesirable since its
use in small doses promotes development of resistance.
Steroids - one of the most misused drugs in general practice
because of acute onset of beneficial effects. Patients
are exposed to a wide range of toxic cumulative effects
and adrenal insufficiency due to adrenal suppression.
Its a life saving drug to be used in special circumstances.
Their doses should be adjusted to the minimum that can
produce the effects. Fixed dose combinations with other
drugs are therefore irrational and objectionable since
this individualization of the dose cannot be done. (FDCs
of steroid for internal use except for treatment of
asthma are banned since July 1983),
9
Strychnine - This was a drug formerly used as an appetiser.
Its use in tonics can induce convulsions particularly
in susceptible individuals. An obsolete drug! (FDCs
of strychnine with caffeine, yohimbine, testosterone
and vitamins are banned since July 1983).
T = Tetracyclines - One of the most commonly misused/overused broad
spectrum antibiotic mistakenly thought to be free
of dangers. Reports of its ability to cause discolouration
of teeth, catabolic effect on protein synthesis,
diarrhoea, increased intracranial pressure o in children,
Fanconi syndrome (if outdated, degraded drug is used),
liver damage in pregnant women have put it in the
list of hazardous drugs. It should not be used in
paediatric practice ^and in pregnant mothers. Its
manufacturers supposed to be banned from January
1982.
Tonics - Apart from being an economic waste, most tonics in the
market contain alcohol which is the main appetite
stimulant and also vitamin and mineral constituents
in amounts greater than the physiological absorptive
qa. sfa>-
capacities of average17©retracts. I'heir overuse thus
mainly help to vitaminise our sewage systems!
U - Unani and Ayurvedic drugs - These are difficult to standardise
since official standardisation methods are not available
FDCs of these with allopathic drugs have no therapeutic
rationale or justification or proven MMBaggi efficacy.
10
10
(FDCs of ayurvedic and unani drugs with modern
drugs have been banned since July 1983)•
V = Vitamins - a typically misused/overused group of agents
nmll"?
Lzn
especially asycombinations and tonics. They are
"
r-,^ JV-,
ct
essential nutritional •^eqiiiremsnts test most people
get adequate amounts in a balanced diet. Specific an^d
separate preparations arc required for specific dsf
deficiency states or as adjuncts to therapy. (Their
FECs with analgesics, tetracyclines, anti-inflammatory
druqs, tranquillisers have no proven therapeutic effects
and have been banned since July 1983).
W = Waterbury's is oneof the brand leaders in the tonic market
whose main effects if any are because of the 9-10%
alcohol content. It contains insufficient amounts of iron
and. creosates and guaicols whose role in man has not ben
definitively established. Like incremin, phosphomin,
hemiphos their advertised claims far surpass their actual
chemical content. Advertisements of such tonics are the
most symbolic of high pressure, half truths gimmicry of
medical advertising.
X =
Y = Yohimbine - a drug often combined with strychnine, vitamines,
testosterone, arsenic, iron and vitamins.£as been found to
penetrate the CNS and cause centra excitation including
rise of blood pressure, heart rate, hyperexcitability and
tremor (Its use especially in such combinations is banned
since July 1983).
Further Reading
1.
Banned Brand Drug List,
2.
Hazardous.Banned,Bannable and Dumped Drugs.
3.
Rationality in Banning Fixed Dose Combinations-
4.
Seme painful facts about a pain killer called Amidopyrine,
5.
Why not to prescribe anabolic steroids?
6.
Irrational use of antibiotics,
Ji
'
7.
The clioguinol controversy,
8.
Using tetracyclines for children and pregnant women-
9.
Consumer Alert—Phenylbutazone and Oxyphenbutazone..
10.
Scientific scrutiny of some over the counter drugs-
11.
The case against EP Forte,
12.
National Drug Policy guidelines and list of banned drugs
(Bangbdesh)
say Available from Low Cost Drugs and Rational Therapeutic
Cell, Voluntary Health Association of India, C-14 Community
Centre, SDA, New Delhi 110016
Jo.ycj oi'-; —
0
A to Z of Drug Policy Issues
A
=
ADVERTISING
One of the main tools of drug companies to
create a need for their products. Includes
appeals for .status, modernity, even unnecessary
uses and cosmetic embellishments.
B
=
BULK PURCHASING
Buying of drugs in bulk by competitive buying of
generic drugs in the international market. It does a
away with brand names and private importers.
BULK DRUG
This is the basic, active chemical imgredient of
a drug formulation.
basic RESEARCH
This implies fundamental and innovational
process or product research. A necessary step
to prevent dependence on foreign companies.
BIO-AVAILABILITY
This means that the same chemical ingredient,
may be therapeutically different because of
the way of formulation. A common but unconvincing
argument against generic prescribing by drug
companies.
BRAND NAME
The registered trade mark name given to a
specific drug product by its manufacturer.
C
=
CONSUMER ALERT
An important and growing need in the formulation of
AND CONSUMER
a safe drug policy.
ACTION
COMBINATION DRUG
A pharmaceutical product containing more than
one active ingredient.
2
2
D
=
DUMPING
Passing of old, unwanted, out-dated and
banned or otherwise inferior products on an
unsuspecting public. A common practice of
multinationals operating in third world countries.
DRUG PRICE CONTROL
ORDERS
Government orders to control prices of drugs and
profits issued in 1963, 1966 and 1970 and 1979.
E
-
ESSENTIAL DRUG
LIST
A list of medicinal products of proven efficiency,
acceptable safety and suitability to satisfy the
health needs of the majority of the population.
EXPIRATION DATE
The date appearing on a drug product and
established by the manufacturer, beyond which
the manufacturer will not guarantee the potency,
purity, uniformity, or bio-availability of the
product.
F
“
FORMULATIONS
These are finished products which are directly
consumed and contains in addition tofche active
drug compound other ingredients such as
diluents, binders, flavouring/coloring agents,
gelatin shells, chemical bases and waxes and
preservatives.
FORMULARY
A list of approved or recommended drugs compiled b
an individual practitioner or a group of medical
and scientific professionals for the purpose
of a specific medical practice or supply system.
3
3
FOREIGN COMPANY
In India defined as a company with foreign
shareholding exceeding 40% of the total
share capital.
G
=
GENERIC PRESCRIBING
Prescription of drugs using the official,
international, non-proprietary name and not
trade or brand names, eg: aspirin not Aspro
or Plusprin.
H
=
HATHI COMMITTEE
An exhaustive report of far reaching
REPORT
importance, by the Committee on Drugs
and Pharmaceutical Industry, Government of
India, published in April 1975.
I
=
INTERNATIONAL CODES
These are codes of quality or safety of
products or business procedures eg., Code
of Ethical Marketing Practices of Health
Action International. An important step
in pressurising multinationals to stop
exploiting the third world.
IRRATIONAL
Extravagant prescribing, overprescribing,
PRESCRIBING
incorrect prescribing, multiple prescribing
or underprescribing of medications, as com
pared to good standards of treatment.
J
=
*
'JUNK
DRUGS
These are newer drugs in the market whose
only additional value are cosmetic
embellishments, elegant packing, irrationa,'
combinations all of which help to increase
its cost.
4
3
K
=
KNOW-HOW
An important requirement for the technical
improvement of the drug industry. Often
controlled by patient, royalty rules and
monopoly of foreign companies.
L
=
LABELLING
Placing written or symbolic instructions
on the immediate container in which drugs
are dispensed. Depending on the motive this
could be either a hall mark of consumer safety
awareness or a focus for consumer misinformation.
LEVEL OF USE
A classification of drugs according to the
medical practitioners who use them and the
clinical facilities at which they are used.
M
=
ME-TOO DRUGS
These are products of research using molecular
manipulation which are profitable but not
necessarily a scientific advance.
MARK UP
Is the hike in the price above the basic
production cost and is the amount used for
selling costs, administrative expenses and
profits. It is presently fixed by government
orders. The less essential the drug formulation
higher the mark up is allowed in India.
N
=
NET WORTH RETURNS
Is an expression of the profit potential of
a drug company and is one of the highest in the
chemical industry in India. It makes drug
companies one of the most attractive investments
in the organised industrial sector of the Indian
economy,
.,.4
4
0
=
ORT or ORAL
A very important need in the rational
REHYDRATION
management of diarrhoeas in children and its
THERAPY
popularity will prevent use of many antidiarrhoeals that have doubtful therapeutic value,
PuftLlC. SSCiOKP
=
PACKAGING
Includes drugmanufacturing companies owned by
the central government. These have pioneered
the production of bulk drugs in the country.
The government policy attempts to give it a
leadership role.
PATENTS
/o
Exclusive rights given,manufacturers for
A
fabrication of a specific product, use of a
specific process, or application of a product ,
or process in a specific way.
Q
=
QUALITY CONTROL
The testing of drug samples against specific
standards of quality. A very important step
in manufacture and distribution of drugs.
In India this is organised by the drug Controller
R
=
RATIONAL DRUG
A method of prescribing which is efficient,
THERAPY
safe, low cost and easy to administer.
RESEARCH AND
A much neglected area in the drug industry.
DEVELOPMENT (R&D)
A very necessary requirement for a country
to evolve its own indigenous drug policy.
S
=
SALES PROMOTION
Techniques aimed at consumers, dealers or
intermediaries to increase short term sales
and inspire goodwill. For drug companies it
includes bonuses with purchase. contests and
competitions, samples and give ways.
5
5
SAMPLES
Commonest method by drug companies to woo
doctors. Other methods are advertising in
medical journals, leafleting, sponsoring
medical events, hospitality and providing gifts.
SHELF LIFE
The length of time a material may be stored
without affecting the usability, safety, purity
or potency of the #item.
SYMBOLIC
A system for providing written instructions for
LABELING
patients using sketches and other graphic
representations.
T
=
TRANSFER PRICING
Importing of raw materials from parent companies
by multinational subsidiaries at rates higher
than the prices in the international market
thereby transfering cost to the local consumer.
THERAPEUTIC
Division of drugs according to their clinical
CATEGORIES
use. The categories often have a system for
assigning numbers.
U
=
UN AGENCIES
These include UNIDO, UNCTAD, UNICEF. All of
these are gearing up to help developing
countries evolve relevant drug policies.
V
=
VOLUNTARY ACTION
Only voluntary action and initiative can tackle
many drug policy issues. The Gonoshasthya Kendra
and GK Pharmaceuticals are one example of such
an initiative.
6
6
W
=
WORLD HEALTH
ORGANIZATION
Their expert committee reports and working
group reports are providing the technical
htreak up for the evolution of a more health
oriented policy in member-nations.
Legal Education
DRUGC AND COSMETICS ACT AND RULES AMENDED
The Drugs and Cosmetics (Amendment) 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 amendments 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. 10A
and Sec.26A empowering the Central 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. rxhis is an important provision since
hitherto the Central Covernmcnt had no such power under this Act.
2.
The Ml definition of the term *
'drug
has been revised which
now covers mosquito repellent/ substances intended for use as
component of a drug, empty gelatin capsules and devices. The inclusion
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 'aoulterated drugs'.
2
2
4.
The powers of Drugs Inspectors have been enhanced (Sec 22),
Inspectors are now empowered to stop and search any vehicle,
vessel or any other conveyance which they have reason to believe is
being used for carrying a drug or cosmetic in respect of which they
have reason to believe that an offence under the Act is being committed
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 anted itself with such sweeping powers,
it would be in the public interest to pressurise the State and Central
Drugs Controllers and Inspector. to use these powers and actually
implement the ban.
Source; The Drug Action network:Newsletter of the Low Cost Drugs
and Rational Therapeutics Cell, VHAI, New Delhi,
Voluntary Health Association of India
C-14, Community Centre,
Telegrams : VOLHEALTH
Safdarjung Development Area,
New Delhi-110016
New Delhi-110016
Telephones :
B. 4/3a)-________________
LCD & RT sVHAI:pt: 17.7 /SA
668071
668072
COMMUNITY HEALTH CELL
326, V Main, I Block
TIE. DRUGS AND MAGIC REMEDIES (OBJECTIOIj.'glg
ZPISRTI^MEiJTS) ACT AND RULES,
Koram..ng la
Bangalore-560034
India
(Sj-ciplified version)
-
Prepared by Rani Advani, Legal Researcher-,
Consumer Education Research Centre (CERC).
for Drug Action Network Core Group Meeting,
sVardha,
The Preamble of the Act i.e., the purpose of the Act is clearly
laid down at the beginning and it states that the Magic Remedies Act
is an Act to control the advertisement of drugs in certain cases and
to prohibit the advertisement of those remedies alleged to possess
magic qualities.
Section 2;
This section defines:- "Advertisement" as any notice,
circular, label or any other document and any announcement made orally
or otherwise. It is a very wide definition and can take care of most
situations.
"Drug" means a medicine for internal and/or external use; any substance
used, for diagnosis, euro, mitigation treatment or prevention of diseases
in human beings or animals; drug also includes any article which affects
in any way the structure or any organic function of the body of human
beings or animals.
"Magic Remedy" includes a talisman, mantra, kavacha or any other charm
which is supposed to possess miraculous powers for diagnosis, cure,
treating or preventing diseases in human beings, or affecting or
influencing the structure or organic function of the body of human beings.
Section 3:
No person is allowed to take any part in the publication of
any advertisement 'which suggests the names of any drugs meant to procure
abortions in women or increase or maintain the capacity for sexual
pleasure, or to correct menstrual disorder in women; or to cure, treat
or prevent any of the 54 diseases which are specified in the schedule
(attached hereto).
Section 4;
No person can take part in. the publication of any advertise
ment which refers to a drug so as to give, directly or indirectly, a
false impression regarding the true character of the Drug, or make a
false claim for the drug which is in any way misleading.
Soction 5'Nc person who carried on the profession of giving magic
remedies can take part in the publication of any advertisement which
refers to any magic remedy which directly or indirectly is supposed to
cure, treat or prevent any of the diseases which are specified in
Section 3 as well as tho schedule.
Explanation;
Taking part in a publication or publishing includes the printing
of the advertisement.
-Section 7:
Any person violating any provisions of this Act is
punishable with imprisonment upto 6 months or with a fine or both.
Where there is an earlier conviction, the imprisonment may be for
one year or with fine or both.
The Crazy World of Tonics
Waterbury's Yellow Label Tonic, a brand leader in the Indian
tonics market, contains only 3 milligrams of iron per teaspoon
just 1/10 of which may be absorbed by the body. The Indian Council
of Medical Research (ICMR) recommends atleast 10 milligrams for women,
The producer claims that this tonic stimulates appetites and builds
bodies. But chemical analysis has rove led that it has 10% alcohol
content which is the real appetite-stimulant!^
"The real culprits behind the ‘tonic craze' are the manufacturers
of such formulations. The principal reason for their hard selling
of such products is the fact that the tonics and vitamins fall in
'category four' of the Drugs Price Control Act, which means that
there is no limit on profits made on these preparations —. With
easy pickings and a readymade market, no wonder then that every
new company entering the pharmaceutical world wants to market its
o
own brand of tonic rather than any life-saving drug!“
Explaining how the 'tonic craze' is the result of systematic
2
campaigns of the large companies, he sayst
"The first part of the plan was the mounting of an intensive
sales campaign to influence doctors on the need for tonics in their
day to <5ay practice. This was followed by free sampling
"
"The other part of the marketing gimmickry in selling tonics was
by directly advertising in the mass media, to catch the public eye.
Slogans like "Do you feel tired at the end of the day?
You need...."
Or "A woman needs iron every day" gradually made a deep impact on the
people until many were psyched into believing that they could not
do without a tonic."
We have noted that these tonics are not consumed by the poor but
2
mainly by the relatively rich whose ordinary diet adequately
meets their vitamin and other requirements. In recent years, evidence
has grown that the excessive vitamins may not simply be discharged
by the body but may even cause severe disorders. Prolonged
consumption cf excessive vitamin C may form kidney stones, excessive
vitamin A may cause diseases of the hair, skin and liver and
vitamin T> in excess may cause disorders or the kidneys and bones.
2
Take this further example from South East Asia. In the U.K.,
Sanatcgen is marketed as a 'nerve tonic' for old women who believe
in its doubtful ability to tranquillise. But Sanatogeh Powder is
marketed to students in Malaysia who believe in its ability to
stimulate their minds. "Worried about exams?" says the advertisement.
Sanatcgen will give you "gr ater energy and concentration". Can a
drug both stimulate and sedate?
3
Thus the sheer irrationality and deliberate exploitation of
consumers through this sinister "tonic racket" is obvious. The fact
that many such 'rackets' continue unabated is a measure of the
enormous influence and power of the large pharmaceutical corporations
not only in India but in many other countries, particularly the
developing ones.
"The incidence of disease cannot be manipulated and so increased
sales volume must depend.atleast in part on the use of drugs
unrelated to their utility or need, or in other words, improperly
prescribed. Human frailty can be manipulated and exploited and
this is fertile ground for any one who wishes to increase profits.
The enormous sales of so-called tranquillisers are only a small
part of the crop reaped from this ground. The pharmaceutical industry
is unique in that it can make exploitation appear a noble purpose."4
3
References
1.
Health for the Millions, VHAI, April-June 1981.
2.
Manohar S. Kamath: Some Boost and at what Price?
The Daily Magazine, 7 May 1981.
3.
"The Impact of Multinational Corporations on Health in
Developing countries" by Charles Medawat. Seminar on Health
Food and Nutrition, Consumers
*
Association of Penang,
Malaysia, 15-20 September 1979.
4.
Drugs and the Common Man: Science Today, November 1970.
Voluntary Health Association of India
C-14, Community Centre,
Telegrams': VOLHEALTH
Safdarjung Development Area.
New Delhi-110016
New Delhi-110016
Telephones ; 068071
668072 COMMUNITY H»™ «•
326. V Ma>». I 0,“k
LCD £c RT
VU.'T:pt: 17.7.
■----------- fteramrnq"'3 —
*
Bangalore-6600'1
SOME DISTINGUISHTHG CRGJg-ilZATIONAL FEATURES
lnd&=py
OF COMMITTEE FOP. RATIONAL DRUG POLICY
- Prepared by Anant Phadke
to help in the discussion on
Structure of Drug Action Network
Aims and Objectives:
To work towards a Rational Drug Policy in India consistent with
the air. of a rational and socially appropriate Health Policy in India
The Committee would oppose the irrationalities in the production,
distribution and use of drugs in India. In furtherance of this aim,
the Committee 'would work on the following fronts related to Rational
Drug Policy:*
Conducting and participating in Seminars, workshops,
discussions;
*
Conducting and participating in public educational
coinpaign;
*
Publishing, circulating theoretical, educational
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COMMUNITY HEAL.n UilLL
7
^26, V Msin, I Block
Koramt-ngala
Bangalore-560034
India
-
a
5
Phenyl butazone - oxyphenbutazone
HAZARDOUS drugs
Prepared for:
Drag Action Network core
group meeting at Sevagram
30■- 31 July 1984
Dr. Mira Shiva, VHAI
On 6th March 1984, U K banned Phenylbutazone.
On 3rd April.’1984. Ciba Geigy withdrew Oxypheribu'c azone, a
breakdown product cf phenylbutazone from U K market.
In C-erg any 65 such drugs have been banned, and use of another
206 severely restricted.
In Finland, manufacturers have been asked to withdraw these
drugs.
In U S the Public Citizen Health Research Group has asked the
department of Health and Human Services for an imminent danger
ban.
Japan has severely restricted the use of these drugs.
IOCU has sent world wide consumer alerts. Norway, Federal
Republic of Germany, Italy, Australia, Sweden, Finland and
Bangladesh have severely restricted their sales.
It is not that, we have not been concerned aoout the misuse of
these antiinflammatory agents and their irrational combinat
ions, prior to the knowledge of these bans. We feel that after
receiving unbiased authentic information about the extent of
the adverse effects related to these drugs, it is our respon
sibility to alert others. The ptablic needs to be informed of
their dangers realizing that a significant number of patients
•-to buy the drug-'over the count er'unwarned and uninfoimied.
We are using this as yet another case where, double standards
have existed in the drug information given to doctors in the
West and to our own doctors.
The total annual turn-over of the two products of phenyls
butazone and Oxyphenbutazone (BUTAZOLIDIN & TANDRIL of Ciba
Geigy's) fetch 200'million Swiss-France ie. £ 65 million ie.
Hs 1170 million and these drugs have been in the market since
1952 and 1960 respectively and are well known). It is very
unlikely that, Ciba. Geigy will withdraw these products from
the third world, specially after having already stated their
decision to withdraw Mexaform(Clioquinol) and Dianabol(Anabolic
Steroid) from the world market. Withdrawing Butazolidin and
Tandril at this point would lead to a financial set-back. It is
unlikely that Ciba Geigy will give in very easily toconsumer
pressure- a stand already made clear by the makers of Butazolidin ani Tandril.
What are these drugs
for?
Phenylbutazone and Oxyphenbutazone are non-steroidal
antiinflammatory drugs which also have mild anti-pyretic and
analgesic properties. They give only SYMPTOMATIC RELIEF and
in no way ALTER the course of the illness. In the U.S. the
labelling indicates the drug for "acute gouty arthritis",
"active rheumatoid arthritis", "active ankylosing spondylitis",
"short term treatment of acute attacks of degenerative, joint
disease of the hips and knees, and not responsive to other
treatment and painful shoulders". Ciba Geigy warns that Tandril
should not be given to children below 14 years(The Physician
Desk Reference, U S A).
Simile,rly, warning for elderly patients is given, that
evei-y effort to discontinue the use of those drugs after a
period of 7 days should be made as there is "exceedingly high
risk of severe fatal toxic reactions".
In Malaysia, dose packages for children as small as 12
months carry inserts. Ciba Geigy states, that in elderly pat
ients as also in long term therapy, smaller maintenance doses
are indicated.
In West Germany, the use of the 2 drugs is severely res-4^
trictod to:
1) ankylosing spondylitis; and
2) gout for the maximum of 7 days.
(In a personal communication from Dr Olle Hannsen, January
6, 1984).
In the third world it is indicated for minor ailments
including joint stiffness of muscles and joints lumbago, head
ache, viral infection and fever and for long term treatment.
Phenylbutazone was introduced into India in 1949 strictly
for treatment of rheumatoid arthritis and allied disorders.
The drug is more of an OTC product in India being freely
consumed by public, often without prescription, for aches,
pains and fever.
Phenylbutazone with its equally potent relative oxyphen-^
butazone needs to be taken more seriously. IT IS A BAD BET TO™
GJ28LE WITH IT IN NON-RHEUl'iATIC DISORDERS.
" In India, oxynhenbutazorre is being used for treatment of
fractures, post operatively, in dental practice:' ordinary
common joint pains; bodyachus and backaches" according to Pune
Journal of Continuing Health Education, June 1981.
/in the
Dr W V Rane of Arogya Dakshata Mandal talking about oxyphenbutazone has pointed out that it is being promoted for
quicker post operative healing. Rot only is this unethical but
it is also unscientific and irrational. More painful is the
fact according to him that a study was conducted by *'
Professor of an Orthopaedic Department for bone healing and
that too on • Paediatric patient. The paper was presented to
an August gathering and most probably, received its quota of
applause and mutual back scratching from the Conference
sponsors. No one in that scientific gathering questioned the
rationale and ethics of conducting the study on children, when
the U.S/ Medical Pharmacology books the use of these drugs in
those below 14 is contraindicated.Probably the drug company
sponsoring the study preferred riot' to give tnis dismissnble
bit of information.
...3. ..
• "Phenylhut'azcne' and- oxyphcnbiitazone should not be Used unless the urlner'had been examined f 82"
* protein and a blood
examination and had shown that white cells and platelet counts'
were within the normal range. B it Ansell, Prescribers Journal,
1969, 8, 120 in Martin dale- the extrapharmacopia, 23th
oition, 1982. A routine urine and blood tost prior to usage of
the drug is recommended. In view of the additonal costs this
□ay not always be possible forthe poorer patients. An extra
caution and restrain in the utilization of these drugs is there
fare, indicated.
In India the drugs have' been recommended by certain manu
facturers for minor problems and feeble conditions. Gifford
1973 has been quoted in MIMS editorial, November 1932 that
.according to Pharmacology books "Phenylbutazone as an antipyretic and qn analgesic is relatively inferior to aspirin 1*
Phenlbutazone as an antiinflammatory agent, is effective, but
serious toxicity. limits its use in long term therapy. -In
rheumatoid arthritis, phenylbutazone has a limited ro.e and
should be used primarily for acute exac~fk;?.tions not relieved
by other .measures
WHAT ARE I HE DA IUERS A3S0CIATED WITH THE USE OF PHENYLBUTAZONE
OXYPHENBUT AZ ONE?
Bone Marrow Toxicity:
...plastic anaemia or pancytopenia ie. total bone marrow
shut down which is fatal in over 50% cases. Agranulocytosis,
which is a severe depression of white blood (granulocyte cell
production - fatal in about 35% cases). Leukaemia which is a
cancer of bone marrow; Gastro intestinal bleeding or peptic
ulceration - fatal in about 20% cases.
Other risks are liver damage Heratitis in less than . 1%
cases access to liver. It is mainly hepato-cellular necrosis.
Hepatitis usually starts within 4 weeks of starting treatment
but in 20% cases can be started upto or even after 1 year.
Cholestatic jaundice occurs in less than 3% cases. Serum
sickness type of hyper-sensitivity, ulcerative stomatitis,
nephritis(kidney failure) thrombocytopenia(depletion of plate
let count) are other serious side effects, though some of these
are much rarer.(Ref: Phenylbutazone and hepatitis-Eowler P D
Woolfe D, Alexander S Rheum Rehabilitation, 14, 17, 1975).
MIMS editorial adds that "because of its sodium and
chloride retention properties, phenylbutazone can increase
plasma volume by as much as 50%, thus straining cardiac funct
ions and occassionally causing acute pulmonary edema. Since,
toxic effects are more pronounced in the senior citizens, the
drug' is contraindicated for use in geriatic patients.
The seriousness of the Problem:
A STUDY IN SWEDEN OF DRUG INDUCED BLOOD DYSCRASIAS ATTRI
BUTED PHENYLBUTAZONE AS THE DOMINANT CAUSE. (Drug induced
dyscrasias in Sweden Battinger L E & Westerholm 11, British
Medical Journal, 3 339 1973).
...4
Incidence of bone marrow aplasi■ due to phenylbutazone
and oxyphenbutazone is assessed as 1 in 33000 to 1 in 99000.
Aplasie anaemia or agranulocytosis were quoted as underlying
or contributing causes of death. In 376 death certificates
in the year October 1974 to September 1975, the mortality rate
was estimated as 2.2 per 100,000 cases.
The study of fatal bone marrow depression with special
reference to phenylbutazone and oxyphehbutazone- Iman W H W,
British Medical Journal 1-1500 (1977). The effect of bone
marrow depression is serious, Drug induced agranulocytocisphenylbutazone. Pisciotta A V Drugs 15 132 (1978) Drug' induced
bone narrow depression by phenylbutazone, British Medical
Journal 4, 490 (1973).
Ciba Geigy's adverse effects department at its head office
in Basle in one its internal memos in February 1983, gave its
findings of 1182 reported deaths from these drugs ’
2724
detailed patient reports of other adverse effects. WelJj^
over 1/2 of these deaths were from bone marrow toxicity inclu
ding leukemia, gastro-intestinal bleeding or perforated ulcers.
Of the 6716 cases of undesirable side effects reported on the
drug, 777 persons have known to have died with Butazolidin
between 1952 and 1081. Of 4165 cases of side effects reported
with Tendril, 405 persons are reported to have died. 199 cases
of serious undesir?.ble effects and 18 deaths have been reported
in Japan.
After 12 years, the receipt of the first report of adverse
roeaction to Butazolidin from Great Britain, came from West
Germany indicating that identification of adverse reactions
come along only with experience and a high degree of alertness
and suspicion about possible adverse reactions. In third
world countries, adverse reaction reporting is depressingly
inefficient, as are the controls on potentially hazardous drugs.
Double standards in giving the drug information to tie health.
personnel makes matters worse.
a
Phenylbutazone and oxyp hentub a zone is poorly tolerated by
many patients. Even if diarrhowa, nausea, nervousness, insomnia
are associated with the drug, it is ignored that the potential
fatality cannot be overlooked. Some type of side effect is
noted in 10 to 45 °/° of patients and medication may have to be
discontinued in their cases. Its use should be limited to
short term therapy of not more than a week during any one trea
tment period. Even then, the incidence ofj disturbing the cblcfe
effects is about 10%. Phenylbutazone has a limited role in the
therapy of rheumatoid arthritis. It is primarily used for
relief of acute exacubations of the disorder that are not
relieved by the other measures.
Goiibdman Gillman: 5th Eiditicn
Chapter- 17.
According to Martindale : * Alt hough phenylbutazone is
effective in almost all rheumatic disorders including ankylo
sing spondylitis, osteo arthritis, rheumatoid arthritis and
reitusdeseas, it is GENERALLY RESERVED FOR USE IN TUB TREAT4
MEET OF RHEUMATIC DISORDERS where less toxic drugs have failed.
- Martindale’; 28th Edition
In 1975, a study was done in U.K. to determine the true
incidence as opposed to the reported incidence of deaths due
to aplastic anaemia, and agranulocytosis in people using
phenylbutazone or oxyphenbutazone. In U.K. even where all death
certificated mentioning a. drug have to be reported to the
Government Drug Authority, only 1 out of 4 deaths duo to drugs
were found, to have been reported. It was only because of the
study, that the relationship of the drugs and death could be
found. According to Oliver Gillie, medical correspondent,
Sunday Times, states "In Britain where the 2 drugs have been
used compnritively cautiously, 512 deaths associated with then
have been recorded between 1964 and 1980. But, the real total
is probably at least double that world-wide,as reported in
the Ciba Geigy internal report (Ref: Dr Hanssen) which records
1182 deaths associated with the drug upto 1982.
Since it is impossible that almost half of these deaths
secured in Britain alone, many deaths must have gone unrecorded
in . other countries and the actual figures would certainly run
into many thousands, giving Butazolidin and Tendril amongst the
highest death total for any drug
.
*
Scrip.fib. 854; December 12, 1983;
pg.18.
In U.K. the death rates were found to be 22 deaths per
million users of phenylbutazone-, and 38 deaths per million
users of oxyphenbutnzon. Dr Sidney Wolfe uses the companies
own estimates of patient exposure world-wide ie.75 million
users of phenylbutazone, 66 million users of oxyphenbutnzon to
estimate the number of patients that must have been affected.
Using the U.K. study result and their mortality rate duo to
these drugs as the basis, he estimates the following;
with phenylbutazone, about 75 million people exposed
by 22 deaths per million ic. about 1650 deaths.
with oxyphenbutazonc, about 60 million p&oplo expo
sed by 38 deaths per million ie. 2280 deaths. Total=
3930 deaths(ie. 1650+2280)
World wide from aplastic anaemia and agranulucytisis; 3930
deaths aush have secured many of which went unreported. The
internal document shows that ?.plastic anaemia and agranulo
cytosis constituted 37.8% of the deaths. If 3930 deaths consti
tutes only 37.8% of total deaths, then the total number of the
deaths due to these drugs would be approximately 10,400 ie.
10,400 deaths world-wide merely due to’use of 2 drugs. If we
try to extend this to other brands that are J available in the
market, then there would definitely be more deaths. By mid
1982, 311 deaths in U.S. were reported. It is known that only
one in ten deaths due to these drugs got- reported. In other
words total deaths would be over 3100.
According- to Dr Olio Hanssen another Ciba Geigy's internal
memo has stated in light of the -dangers of the"dfug.’•’-•s
"th<
presence of many newer equally effcctiw non-steroidal antiinfi.lamm.atcry drugs now available in the market with comparati
vely less toxicity, that it is reasonable and necessary that
the risk and benefit ratio i of Butazolidin ana Tandril should
be carefully reassessed for the indications of all forms of
inflammatory and degenerative arthritis ns promoted, to see if
such promotions are justified".
6
Malay asin:
Consumer association of Penang report based on discus.iicns
with University Hospitals, Pharmacologists reports that
phenylbutazone and oxyphenbutazone are amongst the 5 drugs
accounting for the majority cf the adverse drug reactions
suffered by patients, .admitted into the hospital. Consurncr
Association of Penang has demanded an immediate recall of
the drug from the market for the safety and health of the
Maloyaeian Consumer.
Japan:
Mainichi Daily News which is a Japanese newspaper dedica
ted to International understanding'covered the news in its
headlines on 9th February, 1984. Ciba Geigy's antiinflamnntor
pain killing drugs killed 1182 in the world.
INTERNAL DOCUMENTS OBTAINED
BAN IS CALLED FOR
The newspaper covered the issue daily in its morning a-c
well as in the evening issue, including a strong editorial.
The headlines on February 11, stated that the Goyerhmeu-: ig"o.;
findings of courts in drug poisonings. Apparently,two litiga
tions took place about 10 years ago. Investigations should ha,o
been done. About 15 deaths in Japan due to these drugs have
so far been recorded. ”
. pharmaceuticals Co. stocking;
preparations of Ciba Geigy's declared withdrawal according to
Mainichi, February 10. February 12th- Mainich;,. "Documents of
side effects ordered severe restrictions being decided .»? ’ .
is possible for all drugs containing these drug".,
I nd i a;
Pune Journal of on-going' Education : In this issue no
*
57, June 81, in a letter to the'Managing Director of Ciba
—
Geigy, the Journal had raised strong objection against thei" W
new product parazolandin (parasolandin being a combination of
paracetamol and phenylbutazone) for indicating it for ccnditivim
like fever.
C BRO:
CBRC prepared a document on irrational and hazardous a’. ' .’ •
inflammatory agents, including phenylbutazone and oxypiiantna- >e
combination with amidopyrines. They had submitted this to th.. ■
Drug Control Authorities and demanded their ban. It is impor';ant for us to be constantly aware that the situation in Indi;.
is more serious than the countries mentioned earler.
1.
2.
5.
We have these d rugs available over the counters in any
dosage for any duration of time with our (falsely conti’-ui ~
to believe in the sanctity and magic of western nediciro-..
Patients are rarely given any warnings by their doctors
and if they buy the drugs over t he counter they can rarely
make head or tail of the medical literature inserts.,
Phenylbutazone and oxyphenbutazone have been available often
in dondl,y combinn.tions with amidopyrine, analgin, paraceta
mol, diazepan, Vitamin B, d ext rap rop oxy phene acetumir.opho..
which makes the combination.
Phenyl butazone and oxyphenbutazone are dangerous druo
Voluntary Health Association of India
C-14, Community Centre
O.(c )
0 7 34
Safdarjung Development Area.
New Delhi-110016
Telegrams : VOLHEALTH
New Delhi-110016
_ ,
,
668071 CO.MAZUNITY
H"'LTH CELL
668072 c?6, V Main,
I Clock
Koranibng.-'|a
____________________ Bangalore-560Q.34
India
HAZARDOUS, BANNED, BANNA3LE AW DUMPED DRUGS
(Prepared for Drug Action .Core Group meet at Wardha 30-31st
July '84 as a Background paper for discussion)
Tire issue of dumped drugs for past few years has been
much in the news. The multinationals involved in manufacture
and sales of such drugs have received their dure share of
condemnation. Foreign government policies which provided the'
scope for exports' of such hazardous products have been condem
ned by many of us eg. the Clayton Amendment Act and the U.S.
Resolut ion.
It is well known that sales of medical technologies and
drugs is .a commercial enterprise, the motivation is'profit
making and not ’service’ or ’welfare work’.
Realizing all this the question arises as to how much as
citizens of India, can we expect our. drug control authorities
to safe guard our interests. The pressure from the drug indu
stry is immense. It is not merely money power but political
connect ions A influence over the medical lobby. Many of the so
called medical experts are in their pay roll, many others are
conducting ’scientific studies' sponsored by the companies,
attending conferences sponsored by the companies, receiving
gifts and samples from the companies. This affiliation is not
unexpected. Inspite of knowing this our expectations from our
drug control authorities is high. After all our pharmaceutical
industry is the most developed in the third world, ( ie accord
ing to UNIDO it belongs to Category 5,-developed enough to be
self sufficient).
We have demanded that our imports, production and sales
sh®lff give priority to essential, life saving drugs over irra
tional and hazardous drugs. This being along with WHO's guide
lines for Essential drugs programme. The drug industry and its
supporters allege that concept of essential drugs is only for
struggling, lease developed third world countries and not for
a country like India, with its well developed industry and
high and advanced level of medical expertise .However, this
same lobby puts India in the category of less developed
countries when it comes to the issue of banning drugs and drug
control, claiming that considef-tin op hazards over efficacyare luxuries which we ccnnot~afford!
However, consumers anywhere in the world have a right to expect
that irrational hazardous drugs are not issued licences and
that licenses of such banned drugs should be withdrawn as soon
as possible, bans implemented, and that all drugs in the market
are quality controlled. We have 20% substandard drugs ieJin 5
will not be effective With increasing number of spurious drugs
floating in the market, the problem is beginning to take danger
ous proportion.
Since 1980 we've been concerned about this issue of dumped
and hazardous drugs. We widely circulated the list of combinat
ion drugs recommended for being weeded out and printed it in
our special issue of HEM on Drugs April-June 1981. Since then
the story of the drug ban has goc more and more convoluted and
fascinating. Our earlier belief is only reconfirmed that the
government is not serious about controlling the sale of
...2.. .
hazardous drugs. The budget allocation for ensuring this, the
expertise, technical personnel, quality control labs, qualified
drug inspectors, mechanism to keep the health personnel and
the public informed, about these drugs has remained depressing! •
inadequate. Inspite of all. the hue and cry raised by health
and the consumer groups, nothing very much has happened.
The health of the nation seems to be relatively unimport
ant, as indicated by decreasing health budget. The Central
Drug Contrl authorities allege that they have no real powers
where implementation is concerned as this depends entirely on
the state drug control authorities. They argue that they have
inadequate budget and infrastructure.
Dxoc-nditure on Health as a percentage of total plan
Programme
Health sub
total to plan
FYP I FYP II FYP III FYP IV FYP V
FYP VI
1951-56 1956-61 1961-66 1969-74 1974-79 1980-85
3.83
3.04
2.79
2.74
1.73
1.87
One glance at what is happening to the health budget is enough
to indicate the priorities health care is receiving in our
welfare state.
We have 600 drug inspectors in the country (Hathi Committee
has recommended). The required number is one-for
drug
units and
chemist shops. Only Maharashtra, Gujarat and
Kerala have the stipulated number of drug inspectors and an
adequate drug control mechanism.
In this paper we will not touch upon the extent of the
problem of substandard and spurious drugs and the name-sake
action being taken against those involved in their produce
and sales.
Our focus will be on what has happened to the drugs reco
mmended for being weeded out in 1980. In 1980 the Drug
Consultative Committee a statutary body consisting of medical
experts under Section 7 of the Drugs and Cosmetics Act(Central
act 23 of 1940) nominated a subspecial committee to go into
the rationality of 34 categories of fixed dose combination
drugs. They were to study whether these drugs should be with
drawn or allowed to be manufactured and sold.
The criteria Used by the Committee is very'sensible and^gtra^jtt
A Sub Committee of the Drugs Consultative Committee, com
prising state drug controllers, has laid down well thought
out and rational yardsticks to determine the desirability
of combinations of drugs. As per these norms, combinations
of drugs should only be allowed in the following cases:
If there is synergistic action
Where there is corrective action
When two or more drugs are normally prescribed toge
ther and taken by. ,the patient simultaneously..
d) When the dosage of each of the drugs need not be
individualized.
e) Where a fixed dose combination would ensure better
a)
b)
c)
.. .3
patient compliance due to convenience of admini
stration.
f) Where two or more drugs,, prescribed separately,
may lead to non ingestion of one of the drugs,
thus adversely affecting the health of the patient.
Conversely, fixed dose combinations of drugs should
hot be permitted under the following circumstances:
Where adverse interactions may occur
When one of the combined drugs becomes toxic' oh
prolonged use
c) When abrupt withdrawal of one of the drugs caused
wi t hd r a wa 1 symp t om s
d) If sub therapeutic doses are used in the absence
of clinically demonstrable synergism
e) When pharmacokinetic behaviour of the individual
agents is grossly different.
a)
b)
Thee riteria used by Bangladesh for banning 1742 drugs is
given in the appendix 1.
We'j.]. just look at what was involved in attempts to ban
a few drugs e^. Amidopyrines, High dose E P drugs, Paediatric
tetracyclin. steroid combinations are dealt with later under
ambiguity is the name of the game. ''
The sub committee submitted its report, recommended a ban
of 23 combination drugs and giving their reasons for recommend
ing the ban. 16. categories of these drugs were recommended for
immediate^ weeding and 7 of the categories to be weeded over.
a specified time. Over 500 brand drugs would thus be affected
(This list of 23 combinations and the reasons are attached in
the appendix);. This report was presented to the DOC at a
special meeting on 10.10later to DTAB and Ministry of
Health and Family Welfare accepted it in 1981. The DTAB(Drug
Technical Advisory Board) a Statutary body under section 5. o'-f
the. Drugs and Cosmetics Act Central Act 23 of 1940 recommended
banning' df-_18-Tixe'd'2'Jose 'c'omb"inat~ion('lis't 'at't’dnlied as appendix
...... ............... .............
■
2)
Under section 23 P of the Drugs and Cosmetics act 1940
the Central government has had the powers to issue such
directions to the State governments as required to execute
the Drug act. Under section 18 of the act the state governraen"
has had the power to 'prohibit manufacture,distribution and
sale of drugs by a gazette notification.
These drugs were randomly selected from the Pharmaceuti
cal Guide. Out of these 350 brands 44 brands were marketed by
foreign. secjt or, 8_ by puSlTc sect'or and ^Z5Bl^..J^.^ai^Jsect'or.
A point to note is that most of these drugs were being produ
ced by private Indian companies and not multinationals. This
■was to be . inphaseH ' discontinuation. According to the
authorities"the purpose was to give "time limit to firms who
may have already purchased the bulk drugs for manufacturing
the formulations". What compassion and consideration'shown
to the drug companies?
...4
AMIDOPYRINE
The Drug'Controller of India(DCI) by DO No.1275/77 DC
directed the State Drug Controller to ban the fixed dose cor;ination of amidopyrine on effect from 3.2.82. Orders were
issued to stop manufacture from 1st July '82 and sale by
October 31st '82. This ban was later extended further to 31.3.33
The DCI through his DO No. 19013/8/81D dated 22.4.82
directed the State Drug Controllers.to ban the manufacture ol
fixed dose combinations from 30.9.82 and their sales from
51.3.83. Sequel to V^S'.w'e panel report government decision tc
withdraw 350 unnecessary drugs was taken.
When Maharashtra IDA did ban amidopyrines. the multina
tional most affected managed to get a stay order on the grounds
that the drug"was allowed’ to be marketed ih other states by
their state EDA's. In" 1980 33 formulations of amidopyrine pro
duced by. 20 so manufactures were in the market. Multinationals
and other'big drug houses highly trusted by the public such
.
as Sulirfl Geigy, Sandoz, Suhudgeigy, Unichem, Ethnor, Theins,
"
Ind on were involved. Most of these drugs were being sold with
out adequate warning.
As Praful Bidwai on-19th August 1980 stated in the
Financial Times' Harmful drugs production still not stopped/'-reluctant to lose their market share, these companies have
merely continued to produce' and market amidopyrine and are
continuing to. sell their preparations without even an additi
onal warning about :the drugs side effects.
Mukaram .Bhagat Centre^ for Ediication’and Dcpisjentation/ .•
in ‘Aspects df'Drug ffadustry in IndiaL gives the example of
Tamilnadu government medical list for government' hospitals in
which drugs like amidopyrine, phenacetiri and analgin are very
much included even when they were considered harmful .and been
disallowed. •
,
'
PHENACETIN AND HOLOGENATED HYDROXYQUINOLINE;
Ban of (fixed dose combinations of phenacet in and hologenated and hydroxy quinoline was to be effective from 1.11.82.
The date', of the ban of fixed dose combination of amidopyrine,
phenacetin and halogenerated hydroxyquinolines was extended
to 31.3.83 through DO No. X19013/8/81-D dated 13.8.82.
In 1979 January the Drug Controller of India'.had issued
an order to gradually phase out amidopyrine as always 'phased
discontinuation' process was not meant to be. implemented as
there were no specific DEADLINES.
HIGH DOSE OF E P DRUGC:
Through another DO No. 12-48/79-DC dated 26.6.82 the DCI
directed the State Drug Controllers to ban the manufacture
of high dose estrogen and progesterone combination from
31.3.83 and their sales from 30.6.83.
M/S Unichem Labs Bombay (OP 2'927/82 of writ, petition
2928/82), M/S Nicholas Labs Bombay and M/S Organon (now know.’’
as Infar (India)Ltd Calcutta filed Writ petitions in Bombay
and Calcutta high courts against the DCI’s instructions to
ban these drugs, their conieirfrio'n
that Central government;
has no powers to ban the drugs. The high court of Bombay and
|
Calcutta have granted stay orders and these products continue
to be available in the market.
Sven though section 10A and 261 of the amedned Drug-, and
Cosmetics Act (April '82) empower the Central Government to
prohibit import, manufacture and sale of any drugs considered
harmful/toxic or irrational etc. Since the matter regarding
high dose E P drugs was in the court, these drugs have EOT be.. l
included in the gazette notification of the DCI issued on
23.7.83 banning 22 fixed dose combinations.
What is absolutely objectionable is the fact that(this it
inspite of the act of the Drug Controller of India's earlier
instruction dated 26.6.82 banning the production and sales of
high dose E P drugs from 31.3.83 and 30.6.83) M/S Organon
(INDIA) Ltd have managed to obtain extention of licences to
manufacture these products for another 2 years.
A sample of high dose E P drugs from Calcutta with manu
facturing date 31.12.83 indicates that the ban is not merely
being flaunted by Organon but by other drug companies manufa
cturing these products.
The misuse of these drugs for hormonal pregnancy tests
and for attempting to induce abortions continues massively.
PAEDIATRIC TETRACYCLIN
Manufacture of Paediatric tetracyclin drops was to be
banned from 1.5.82, no date was then given for marketing.
Paediatric tetracyclin have since been banned on paper. They
are still available, OTC, without warning.
Paediatric tetracy&lin ban too does not figure in the
gazette notification of July 23rd 1983.
On April '82 the Drugs and Cosmetics Act was amended
whereby the Central Government and the Central Drug Control
Authorities were given specific powers to 'ban the import,
manufacture and sale of drugs in public interest'. (This was
mentioned in the drug Action Network Newsletter October 'S3)-.
Section 3(b) (i) was substituted and section 10A and 26A
were inserted in the act. This came into effect from 1.2.83.
This means that had our Central Drug Control authorities wanted
it, gazette notifications banning the manufacture and sale of
these drugs could have been undertaken immediately under the
powers invested in it under section 26a of the act exercised.
The implications of this delay have been that certain
drug companies have challenged the drug Controller of India's
authority to ban these drugs. Some of them have even got stay
order against specific bans, making these bans ineffectual and
the whole drug control authority of our nation a laughing stock
The drug control authorities see their role as mainly advisory
and hence don't feel particularly perturbed. Actually to come
to think of it no one in the Health Ministry at Centre or Stat-;.
level seems to be particularly perturbed.
Allowing this extended time period, during which imports
manufacture and sales have continued amounts to 'arbitoriness
and discrimination' under article 14 of Constitution of India
. .6...
according to Vincent Panikulangara since these drugs would be
dumped in the market, substitutes withheld. With our effici.n
of drug control mechanism, products in the chemists shops wl
continue to be sold and never withdrawn.
According to Section 26a of the Drugs and Cosmetics
Act 1940
,
"Without prejudice to any other provisions cont
ained in this chapter, if the central government .
is satisfied that the use of any drug or cosmetic
is likely to involve .any risk to human beings or
animals or that any drug does not have the thera
peutic value claimed or purported to be claimed
for it or contains ingredients and in such quant
ity for which there is no therapeutic justification
and that in the public interest it is necessary or
expedient so to do, then that government may, by
notification in official gazette prohibit the manu
facture, sale or distribution of such drug or
Cosmetic".
Under section 10A of Drugs and Cosmetics Act of 1940 als
there is a mandate that following a gazette notification
imports of injurious drugs can be banned.
Article 47 of the Constitution of India lays down
that
"The State shall regard the raising of the level
of nutrition and standard of living, of its people
and the improvement of public health as among its
primary duties and in particular the state shall
endeavour to bring about prohibition of the con
sumption except for medical purposes of intoxica
ting driinks and of drugs which are injurious to
health".
Under section 53 P the DC I directed the State Drug Centre
Ilers to'.ban the' 20 fixed-dose combinations. The State Drug
Controllers under section 18 of the act could exercise their
power and prohibit their manufacture and sales by issuing, a
gazette notification. According to Vincent Panikulangara, the
State Drug Control authorities are guilty of not exercising
their power and taking responsibility. They have thus viola.tec
section 18 and 33 of the Drugs and Cosmetics Act and violated
the fundamental right of the public citizens to health and lif<
under section 21 of the Constitution of India. Article 14 of
the Constitution is also violated by their having acted in a
arbitrary and discriminatory manner contrary to public irrterem
in favour of the Drug companies. '•
Kerala High Court Judge Mr Potti's judgement on Vincent
Panikulangara1s writ petition speaks for itself.
"As. between the._liyes...of. the. citizens of this
country on the one iha.nd_.and loss that may ro.sult to
the manufactures and traders by the inn$diate~'b.an
on the manufacture “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
...7...
when th.e injury is not inevitable".
Acting Chief Justice
,P Subramanian Potti and
Justice Paripuran
Kerala High Court, in their dire
ctive to the Union of India to release
the list of brand names of banned drugs.
In October 1982 1'1/S Nicholas(India)Ltd Bombay filed a
writ petition in Bombay High Court against the decision.to bar
the fixed dose combination of aspirin and vitamin C. The
Bombay high court after the. hearing of the respondent ruled
that State Drug Control authorities, has no power under Sect! '
18 of the Drugs and Cosmetics Act to stop the manufacture ard
sale of these products. (The high court ruled that it would be
open to the respondents is and when the law has been enacted
to pass any frosh order as it is considered necessary in accori
ance with the law after following procedures prescribed by the
government).
Subsequent to the Drug_Amendment Act' coming into force or.
1.2.83 the manufacturers have again gone to court challenging
the central government and sections 26.1 and 10A of on grounds
of "LACK OF OBJECTIVE CRITERION for such ban".(,'. special hand
out on Rationale of the bn.n is available with us).
The Commissioner of EDA Maharashtra State(which.is suppo
sed to be having the best drug control mechanism) had informed
the DCI that in the light of the ruling_given by the Bombay
High Court "it would' not'be possible'for him to take any'’action
to stop the manufacture and sale of any ’of the fixed dose
combinations in quest ion".(Lett er dated 9 June 1984 by Drug
Controller of India to'us).
It was probably the above as well as Vincent's writ
petition against the state and central drug control authorities
for not having used their power that forced DCI to issue the
gazette notification. .1 point to note is that drugs banned earlier and at different types make the brand banned list. E P
drugs arC not’’included in~the'gazettea-nctifw^tion. x' .
The ambiguidty of the wording of the gazette • notification
hit us early, vrhen we attempted to compile the banned brand
list. It was not clear whether for eg. in Category 4 include
- any drug containing yohimbine or strychnine would be banned
(as neither of the two were considered to have therapeutic
value and infact could lead to serious side effects as state
even by the. DCC).
- or the ban was applicable to drugs containing both yohimbine
and strychnine.- or to yohimbine .and strychnine with test esterone or vitamins
- or ONLY to drugs which contained all 4 ie. yohimbine,
strychnine, testesterone and vitamins.
Another doubt was regarding criteria 12 ie. whether it
could effectively deal with steroid and antihistamines combi
nation which could be indicated for allergy as well as asthma.
First of all DCC had recommended .a banuof all steroid combinations. Making this exception would obviously encourage misuse.
After all, doesn't the. microscopic print in the medical litera
ture for high dose E.P drugs’now-a-d.ays say only secondary
amenorrhea and ‘isn't ’it t rue't'hat_'it' is mostly' used for pregn
ancy testing and attempting' abortion', "changing the indication
...8...
on paper of a hazardous drug won't alter its use. Similarly
allowing steroid combination for asthma won't present their
misused for other conditions.
The DGC had recommended banning of all fixed dose steroic
combination, DTAB decided to prohibit manufacture of fixed'
dose Combination of bronchodilators, antihistaminics and tran
quillizers with corticosteroids as early as October 4, 1980.
Dr B Snankaranand, the then DGHS, chairing a meeting had
said "The current medical practice in all the developed count
ries is to give corticosteroids separately and fixed dose
combinations of corticosteroids with other drugs are bein'.
disc ouraged".
Prof. Harkishan, Singh of the Department of Pharmaceutic
Sciences Punjab University stated „that there existed "public..
evidence to show that cortico steroids taken in small doses
over longer periods are more harmful than if taken in larger
doses over shorter time".
The Drug Consultative Committee comprising of all state
Drug Controllers entrusted the responsibility of evaluating
54 categories of fixed dose combination, on basis of their
rationality to a sub-committee. The sub committee comprising
of some distinguished medical experts recommended a ban on
steroid combinations. The Committee warned against compulsory
intake of steroid because the "fixed dose combinations of
steroids for internal use can produce serious side effects viz
fluid and electrolyte disturbances, hyperglyceria glycosuria,
increased suscesptibility to infection including TB, peptic
ulcers, osteoporosis, steroid myopathy, cushings syndrome and
hersutism, combination with bronchodilators etc.".
On December 51, 1981, the Drug Technical Advisory Board
constituting of exactly the same members reversed its own
earlier decision. It felt that there was a need for getting
wider medical opinion and further details and allowed the sale
of these products.
Dr Gulati MIMS Editor in his editorial MIMS India Vol.2
No.5 February 1982 writing about the " s arver s Quit on steroids"
says "they must have had very extraordinary "reason 'to
a) reverse their own earlier decision
b) ignore the advise of DGC
c) consider the opinion of the whole battery of eminent and
distinguished medical specialists from research institution
u
as .inadequate so as to ask further details and wider media- .
opinion".
It would be interesting to find out how and why this
change in their stand on fixed dose combinations of steroids
took place. We would very enthusiastically have undertaken thi
exercise, had obtaining information such as this, been a less
teSLious, less time energy consuming and less frustrating affai:
The Kerala High Court judgement, in response to Vincent
Panikulangara's writ petition OP 8459/1982 had directed the
Central and State Drug control authorities "t_o_publish the
list of tra.de/brancl names and the, names of the manufacturers
of' these drugs. This was".'in 1 982. Repeated requests., for the
same have been made to the Central Drug Controllers office.
Some of the' Drug Action networkers nave been requested to do
the same at the State level.
Excuses were made that the drugs have been licenced an:
registered with State health authorities and the centre ulle?- edly has no clue about the various formulations and brands
involved. The drug control mechanism is so ineff’-ieut that
even toobtain just the list of, these products has taken me.than one 'year?' To ensure their ban’or '• quality’ control' woul;.
definitely take a century.
it snould be noted that the drug ban will be ■applicab"
*
for lesser drugs than what we had anticipated. Tnsnite of th-.presence of irrational and hazardous ingredients only these
drugs will be banned that contain all tho ingredients menti- ♦. d
in tho various categories eg. under category 5 -only those
■drugs containing all the following ie. yohimbine + strychnin.- +
Testesterone + Vitamins wiil b& affected.
According to Dr Bas Gupta, “Asst.Drug Controller the
banned brand list will.be. ready in about 3 months. We had pre
pared our own black lists of banned or bannable drugs as far
hack as“1982 which have been circulated' amongst the health
care institutions in the voluntary sector and drug -action
networkers. These black lists have been for
1 ) Clioquin ols, hydroxy quinolines ie. mexaform .and Co
2) ijnid onyrines - abalgon Ergopyrine
3) Paediatric tetracyclin
4) Sifibenexjria/te - lomotil etc.
5 ) Ana, b u 1 i c steroids
’K
an^ streptomycin. )
pn ^cc recommendation-:
7) Chloramphenicol and streptomycin
8) High dose E P drugs
9) AntiinfIxmaiatory agents and steroids etc.
(Background papers based on the .above underlined drugs hv..’.
been prepared and are available).
2-3 attempts at compiling the banned brand list ..based u."
drug banned by the gazette notification have been made. Thre<things have prevented us from -widely circulating them.
i) Our expectations from our drug, control .author! ties_tojack
then available nt' 'least'-' after' the Kera.la High Court judgemn. ’t
-(nd'“’Supe"~C'ouff~ writ" p’cfit'iohj
ii) T'he~difficulfy"’in"'obtainingAjthe drug list of. formulation;
from the' State Drug 'Control Authorities.
iii) The' 'proc ess of reformulat i on”of-'vnri ous d rugs tnking plac .’
with our’not having "any’informat ion as to
a) which drugs were being formulated and sold as reformu
lating?
b) Which drug's were being reformulated but their banned
formulations under the same BRA® existed... .*
e.re sold
unscrupulously in the market?
c) Which wore the hazardous banned drugs still being manu
factured and sold ns such?
Our health and drug control .authorities get extremely ups- ?t
when we mention the achievements of Bangladesh in their o.ttei pts
towarts ?. Rational Drug Policy. Inforced to mention .bangaid ci a
again. It should be noted that after the issuing of the
Promulgation banning 1'742 drugs in June 1982 the time period
given to the drug companies of 3, or 6 or 9 months was given
to withdraw these prodnets from the market, to destroy these
products. even their export to other countries was strictly
prohibited. We. on the other hand have failed to implement a
recommended ban by our own governr.ient com.nii 11 e e s and ber.nod
by our -.own drug controller. The drugs banned were mere few
hundred, not over a 1000. The time period given was for the
. .. 10...
drug companies to complete the manufacture of their formal;. rr?
and sell off their stocks. The stocks surprisingly like Mee-;- 3
head never seem to finish off.
Nepal, Pakistan, Malaysia, Sri Lanka, and nangb.desh fee
that clibguihol '(hydroxy Quinoline) f ormulati pns. have no sign
ficaht therapeutic "Jvnlue ’and can hayejaajor side off opts,.-Th«
have decided to’ban these, drugs. Ciba Geigy makers. Qf.m.i>„-;f :
have' .announced " their plans t o withdraw .the drug from .interr atipnal market. We continue to allow them to be sold and pro
moted”under more than 90 brands (including those produced by
our public sector.)
The Drug c.ompaigners from Bangladesh, Sri Lanka have
complained about the outrageous smuggling in of tnese banned
products from India- Our continuing to allow.the manufacture
.nd
our.people, it also cr^ap.es .rdous to the health
problems for our littler neighbours .who are attempting to rat ■■
■
................... ”' '
lf
Intsrost,
If our government authorities cannot make all that goes
wit h ensuring "good EeaTEhV" available ~to it
i’ll i on pep pi
’it "has"~ho "Kusiriess" t"o _allow irraEional and__hazardous drugs t-.
b’e~ ihiTi ct" ccT "up on~t n ern.
We will compile our own banned brand list and while the
6^“°
Sves on uvWooa. the health, drug control authori
ties of centre and state', ..I the-irug industry and the- high
courts we will ensure that all these drugs are BOYCOTT HD by
health personnel as well as consumers.
The DCi had in one of his meetings last year pointed or.
that unhygienic conditions in the public hospitals, lack of
clean water, sanitation quackery and unethical practices by
medical personnel wore greater problems than continuing sal...
of fevr hazardous drugs.
We want to make it clear that the issue here is not
..pf
dS a few’ hazardous and. irrational drugs but it
As...t ,q__f ecus.,9.n..what is\goin’g uh in the name o+^ht'aTfh'
chrc
*
’ .
It. -is_t.y’higK_'lih7in; "tn,at"'when'causes "o"f "ixI“heaTfH’-lie“els’e^"
where ..
. "pealing
' .wiTF'fnere’-cbrie
dp.out_pu_s_ignifleant change_ih the."health status ,anti quality o:
£e ..o£_our__peop 1 e?' There"are.no eTFeolive ’ piITs~against
li.
poverty and the diseases of poverty. To deny people thc-ir
right to health care is ba® enough, but to let loose 'garb-->ge
and trash in the name, of medical care is is inexcusable / '''
inflaunting and totally unacceptable.
Low Cost Drugs &
Dr Mira Shiva
C o ord inator
Rat i onal T he rap e ut
,s
ARE THU HARMING Y ) HPCL
*
?
.cP
BRAIN TRUST ON HEALTH IboUES.
It is the rasponeibility of the consumers to lew-m the hazard’
of drugs and chemicals used in daily life, not
themselves but to work collectively so as to fren policy makers
and manufacturers to remove definitely harmful drugo and chemicals
from the market or to devise an sffectivo earning ©yntem ao that
these substance are not miausedo T ho mssasga was O’feE’ongiy conveyed
by ths members of panel of Brain Trust. Society of India ©t Indian
■'erchants Chambers, Committee room on fSth Morch 11904. Members»of
panel included Dr.Powan Sureka,Chairman af Medical Committee ®f
Consumer Guidance Society of India, Dr.T.R.Motwanj, a Senior
irfuraxSurgeon at Jaglok M Hospital, Dr.SoWranvala«Psoeident of
Bombay opthalmologiat’s Society, Dr«Dinash Daftary, e dental
surgeon and Honorary oral pathologist at Tata Institute of
demental Research, Dj.W.S.RQno Joint Honorary Secretary of Bombay
Arogya Dakehata M->ndal, Dr. E.S.Hathi, a Child Specialist and
Mr. N.G.Wagle, Consultant
chemical Technologist.
RAIN KILLER DRUGS.
Analgin, an pain killer drug (Novolgin,Baralgon,Ultsogin,
Neurolion etc.) can cause dsraaga to bone marrow causing deficiency -
of irhite blood cells, ®Agranulocytosis ,E a potentially fatal eondl
*
tinn.
A doctor who had himself taken juot two tablets containing
analgin, developed agranulocytosis and -could ourviv® with difficult
after a fight of nearly six monthe under intensive medical carov
Ansigin has baen banned in number of countries including Bsngla*
Dash but continues tc be wr.ufacturod even by public pharmaceutical
companies and is freely available in the market without any warning
system to consumers. Pain is a subjective phenomenon and certain
natural methods like taking rost, message with gentle hands, going
•1'v f
tiout for a walk^ diversion of mind ate., are preferably to taking
drugs. Similaraly sponging of tho body with w^tor or ica cold packs
are better for symptons relief of favor and uhould bo used as u
primary measure. Fever id basically body’s defense mechaniam and
stress should bo on proper diagnosis of cause of fever and specific
treatment of tha^ cause.Paracetamol('motacin, Crocin, Pyrigesic etc)
is relatively sage drug and can be used for relief of pain or fever.
Aspirin another drug( o.g. Diaprin) when taken should be consumed -ith
ij 018
*53
*.:
th
full of water for
ar*d
preferably aflter food.
Unfort^:-
markat is being fleoddd by drug combinations of either uat^spy
or h si■:« ful
medicines and it. .may . sometimes difficult to get Bin;;'
.":-.ug preparation.
Voluntary Health Association of India
C-14, Community Centre
0/ 540(b)
Safdarjung Development Area.
/25.5.84
New Delhi-110016
Telegrams ': VOLHEALTH
New Delhi-110016
^^WjNITY HEALTH CELL
326, V Main, I Block
Kofamnng--r.
____________
Bangalore-560034
Rationality in Banning Fixed Dose Combinatto<j>Rs
M C Bindal, RsS Saxena(Mrs), Suman Lata(Mrs) &’B P Jaju
Dept of Pharmacy & Pharmacology,
LLRK Medical College,. Meerut.
Ha'thi Committee (1975) appointed by Government of India
pointed out that the medicinal needs of the people in India
can be met by only 116 drugs. However, over 25,000 drug formu
lations continue to be sold and. prescribed in India. Many of
thee formulations are unnecessary variations of identical basic
drugs sold under different brand names ar without any proven
therapeutic effect or they are too toxic for human consumption.
Unless there is a clear cut proven therapeutic superiority or
a fixed dose combination, such combinations not only put finan
cial hardship to poor patients but also expose the patients to
the undesirable effects of the unnecessary medicament(s) of
such formulations. Dr H Mahler, The Director General of WHO
feels that 98 % of the drugs available in the developing world
aE not essentials hence nor required. The Drug Technical Advi
sory Board (DTAB) of India has recently (1982) recommended the
weeding out of the following fixed dose combinations with an
uniform cut off date of March 51, 1985.
Fixed dose combination of amidopyrine.
Fixed dose combinations of vitamins w...th antiinflammatory
agents and tranquilizers.
5. Fixed combinations of atropine with analgesics and antipyret ics.
4. Fixed dose combinations of strychinine and caffeine in tonics
5. Fixed dose combinations of yohimbine strychnine and testo
sterone and vitamins.
6. Fixed dose combinations of iron with strychnine and arsenic
and yohimbine.
7. Fixed dose combinations of sodium bromide/chloral hydrate
with other drugs.
8. Fixed dose combinations of ayurvedic, unani drugs with
modern drugs.
9. Fiied dose combinations of phenacetin.
10.Fixed dose combinations of antihistaminics with antidiarrhoeals.
11.Fixed dose combinations of penicillins with sulphonamides.
12.Fixed dose combinations of vitamins with analgesics.
15.Fixed dose combinations of tetracycline with vitamins C.
14.Fixed dose combinations of hydroxyquinoline group of drugs
except preparations which are’uswd'for the treatment of
drarthocik ahdadysentery.
15.Fixed dose combinations of steroids for internal use except
combinations of steroids with other drugs for the treatment
of a sthma.
16. Fixed dose combinations of chloramphenicol except with
streptomycin.
17.Fixed dose combinations of ergot except combinations of its
a Ikaloid ergotamine with caffeine.
18.Fixed dose combinations of prophylactic vitamins with antiTB drugs except combinations of INH with vitamin Bg
1.
2.
The rational for the undesirability of the’above said fixed
dose combinations can be based on the forthcoming arguments
andfacts. •
1.Fixed Dose Combinations of Amidopyrine-:
Fixed dose combinations of amidopyrine(amidopyrine) are
irational because amidopyrine is an outdated and obsolete drug
as it causes bone marrow depression leading co agranulocytosis
which may be fatal(Beaver 1965). Even though it has marked
antipyretic and analgesic properties, its "over the counter"
sal: in the united States had been prohibited since 1938(Moodbuiy 1970). In view of the recent development of newer and
safe? antipyretic analgesics, it is in public interest to drop
out amidopyrine altogether from physicians armamentarium.
2.
Fixed Dose Combinations of Vitamins with Antiinflammatory Agents
and Tranquilisers:
The addition of vitamins to antiinflammatory agents and
tranquillisers in fixed dose combinations does not yield anyproven increases in the therapeutic effects of these combina
tions. In a way they are just like placesbos but certainly en
hance the cost of formulations. In most of the patients requir
ing either antiinflammatory or antipsychotic therapy, vitamin
deficiency is not an usual associated feature even in our coun
try where malnutrition is so prevalent. Hence vitamin supple
mentation with these drugs is both a watte of vitamins as well
an unnecessary financial burden f-r^ the patients.
3.Fixed Dose Combinations of Atropine with Analgesics and Anti
pyretics:
’
.
Analgesics and antipyretics reduce the raised body temp
erature to normal (antipyresis.) .But .Atropine is known to cause
hyperpyrexia (ie. it may raise the body temperature). Hence
. such combinations is therapeutically antagonistic and is there
fore irrational. Furthermore, even in cases of visceral pain
(eg. colics), where atropine may be advised with the idea of
its antispasmodic property, simultaneous administration of an
antipyretic analgesic, which is ineffective against visceral
pain has hardly any therapeutic advantage. All the more such
combinations unnecessarily expose the patients to the potential
toxicity of antipyretic analgesics.
4.Fixed dose Combinations of Strychnine and Caffeine in Tonics:
Fixed dose combinations of strychnine and caffeine in tonics
areundesirable because strychnine (formerly used 'as an appetiser)
is now an (Obsolete drug and its enthusiastic use in tonics may
even indice convulsions particularly in susceptible individuals.
Similarly caffeine though, has a mild CHS stimulant effect
leading to little temporary mood elevation and relief from fat
igue, has no tonic effect on the body. Furthermore caffeine
products mild physical dependence and habitual use of this drug
in tonics may cause psychological and physical dependence for
such formulations.
Fixid
5.
Combinations of Yohimbine, Strychnine with Testosterone
and Vitamins;
Fixed dose combinations of yohimbine and strychnine with
testosterone and vitamins are irrational because yohimbine is
no longer regarded as therapeutically useful aphrodiasiac in
man even when mixed with methyltestosterone(Laurance,1980).
Furihhermore, yohimbine should not be used therapeutically beca
use of its side effects viz Central excitation, raised blood
pressure, increased heart rate. Strychnine is also how an
obsolete. Vitamins do not play any therapeutic role(except in
deficiency diseases) and simply act as placebo, of course, ■ giving
the psychological boost to the patient.
...3.
6.Fixed dose Combinations of Iron with Strychnine, Arnica and
Yohimbine:
Strychnine, arnica and yohimbine combinations are used as’
stimulant appetizers. In most of the patients (except women)
generally there is no deficiency of iron because iron is ad eq-'
uatJLy stored in the liver. However, in very specific anaemic
cases supplemental iron therapy may be given separately. To
add iron in these formulations is irrational and may be just
for the purpose of increasing the price of the formulation or
to seek patient rights for the formulations.
7.
Fixed cose combinations of Sodium Bromide/Chi oral Hydrate with
other drugs:
Fixed dose combinations of sodium bromid/chloralhydrate
with other drugs can now be considered irrational because both
these drugs are now obsolete due to their toxic manifestations.
Bromides on prolonged administration replace the chloride ions
of the body. Because of the slow onset of action, cumulative
poisoning, manifesting as conjunctivitis, GIT symptoms, derma
titis and mental disturbances is likely to occur. Further their
exeeding slow onset of action and low potency make these
bromides unreliable hypnotics.
Chloral hydrate, being an irritant of the ijucous membranes,
causes gastritis leading to a variety of GIT symptoms eg.nausea
vomitting flatulence and epigastric distress. Chloral hydrate
can even cause hepatic and or renal damagel In view of the
recent and more safer hypnotics there is now no justification
of prescribing chloral hydrate to patients.
8.
Fixed dose combinations of Ayurvedic and Unani drugs with
Modern drugs:
Th e modern (Allopathic) drugs are well, standardised and
their standardization methods are official. In case of ayurvedic
and unani drugs, official standardization .methods are not
available at present. Therefore, it does not argue well to have
a combination of ayurvedic and/or unani drugs with modern dru^s
bevause of the standardization problems of the resulting for
mulations. In view of the lack of authentic repeatable research
data on the efficacy of fixed dose combinations of ayurvedic
and unani drugs with modern drugs, there is no justification
of such formulations to be sold for use by the general publi^.
9.Fixed dose combinations of Phenacetin;
Phnacetin is gradually loosing its importance because it
causes kidney damage when used in large amounts or for long
periods. Hence it has no place in routine analgesic, antipyretic
and ant iinflammatory therapy. Therefore, fixed dose combinations
of phaiacetin are outdated and hazardous. Formulations contain
ing aspirin with phenacetin and often with caffeine are promoted
with claims that they provide greater analgesic effect and/or
cause fewwer side effects than does aspirin alone. In most con
trolled clinical trials such, claims nave not been found correct.
10.Fixed dose combination of Antihistaminics with Antidiarrhoeals:
The fixed dose combinations of antihistaminics with antidiarrhoeals is rational, only in certain specific cases where
the diarrhoea is due to allergy(like protein allergy). In these
specific cases, the antihistaminics may be prescribed separately
so that such combinations are not irrationally used in the tre
atment of all other types of diarrhoea. Routine use of these
...4..
combinations is not only a waste of ant ihist aminic drugs but
also it exposes the patients to the undsirable effects of this
class of compounds.
Fixed dose combinations of Sulphonamides with .Penicillins:
Even though sulphonamides and penicillins individually
do have important role in the therapy of infections. The com
bination of penicillin with sulphonamides is undesirable. This
is because the antagonism of the antibacterial effect may result
when bacteriostatic (Sulphonamides) and bactericidal(Penicillin)
agents are given concurrently,(Jawetz and Gunnison, 1953). In
addition oral combinations may even induce penicillin sensi
tivity.
12.Fixed dose combinations of Vitamins and Analgesics:
In the fixed dose combinations of vitamins with analgesics,
the vitamins do not play any therapeutically beneficial role
and rather act as placebo. Therefore, such combinations are
therapeutically irrational. Since such formulations are likely
to be misused by the patients and if administered for long
periods because of their vitamin contents, such combinations
are likely to expose the society to a veriety of undesirable
effects of analgesics.
11.
dose combinations of Tetracyclines with Vitamin C:
There is no specific therapeutic indication of giving
tetracylines and vitamin 0 together because tetracyclines
d
does not cause any specific vitamin G deficiency. Therefore,
this combination is of no therapeutic superiority and may be
produced by drug companies just for enhancing the cost of their
product. Further, in inflective conditions where tetracyclines
are indicated, vitamin G deficiency is not an usual associated
feature, such formulations should not be routinely employed.
Fixed
*
13
14.Fixed dose combination of Hydroxyquinolines group of Drugs
except preparation which are used for the treatment of Diarr
hoea and Dysentery:
Halogenaled hydroxyquinolines are indicated only in inte
stinal infection like amoebiasis. So the combination of hydro
xyquinoline with some other ant idiarrhoeal and antidysentery
drugs like enzymes for the treatment of dyspepsia is undesirable
because hydroxyquinolines may induce Subacute Myelooptic
neuropathy(SMON). Due to this toxic manifestation the use on
this drug in clinical practice has been abandoned in many ad
vanced countries. The clinical use of these formulations for
such simple conditions like dyspepsia exposes these patients
to the risk of SMON and hence should not be employed.'
15-Fixed dose combinations of Steroids for Internal use except
combinations of steroids with other drugs forthe treatment of
Asthma:
In view of the acute onset of the benefical effect of
steroids in a large number of clinical conditions, their use
has tremendously increased in recent years. However, fixed
dose combinations of steroids with other drugs are objection
able as it is extremely important to adjust the steroid dose
to the minimum that produced the desired effect and the dose
of the other drug if altered, not on the patients need for it
(other drug) but on his need for steroid. In view of the
widespread use of such combinations, the patients are exposed
■ to toxic cumulative effects of these drugs. However, in case
...5..
of asthma, since immumological factors play an important role
and adrenal steroids cause nonspecific reducat ion of the res
ponse to the antigen antibody reactions, the fixed dose combi
nations of steroids with other drugs in the treatment of
asthma is therapeutically rational and justified.
16.Fixed dosecombinations of Chloramphenicol except with Strepto-.
mycin'y
Chloramphenicol is a drug of cnoice only in the treatment
of enteric fever and gastroenteritis. Its combination with
streptomycin in the treatment of gastroenteritis is therapeuti
cally justified because this combination has been found thera
peutically superior to either of these drugs alone in the
treatment of mixed infections of the gastrointestinal tract.
But combination of chloramphenicol with other drugs(like tetra
cycline) is irrational because both the drugs have almost the
same antimicrobial spectrum and also because chloramphenicol
is more toxic as it may cause aplastic anaemia.
17.
Fixed dose combinations of ergot except combinations of its
Alkaloid Ergotamine with Caffeine:
Ergot alkaloid, ergotamine is effective in the treatment
of migrains because it is a vasoconstrictor agent and p; events
the rhythmic distension of extracranial arteries.
Caffeine may be allowed in combination also because of its
vasoconstrictor effect on intracranial vessels. However the
combination of ergotamine with other drugs(like paracetamol,
prochlorperazine etc) have no therapeutic advantage and hence
irrat ional.
18.Fixed dose combination of Prophylactic vitamins with anti
tub ere ular'drugs except combinations of I N H with vitamin Bg,
Fixed anti tubercular drug (except INH) are irrational
becuase in these combinations, the vitamines have on therapeu
tic role to play (of course unless there is a vitamins defi
ciency) and they simply act as placebo and might give some
psychological boost to the patient. However, because INH causes
vitamin B6 deficiency, its combination with vitamin B6 is
rational and therapeutically justified.
Another drug combination which has been recently banned
in this country after a much hue and cry from the medical
experts is that of Estrogen Progesterone (E P combinations).
These combinations were used for test for pregnancy. The use
of E P hormonal preparations were banned in U S A by the Food
and Drug Administration (FDA) in 1975 because these p.eparaticns were found to seriously damage the foetus.
It is often alleged that drug companies levy a heavy burden
on the common man by charging more and more through their
dubious multiple drug formulations which are their gb&rented
products. For example, the real pain killer in most ofthe
analgesic tablets is aspirin, the market is flooded with a
number of costlier pain killers containing in addition salicy
lamide, caffeine and quinine sulphate, which have no proven
synergistic efficacy. Similarly, amongst anti-cold ointments,
only menthol is said to be of any real therapeutic value. Here
too, other ingredients of dubious value like camphor, turpen
tine and thymol are often-tided in order just to put in market
a new formulation and thus increase the price of such .a
patented formulation.
.. .6.. .
In our opinion such anti-social problems must be tackeled
at all levels
.
*
The responsible persons of the society in the
medical and health field, like doctors and pharmacists should
keep a close watch on the drugs banned inthe developed countries
and also on the drugs which on clinical trials have not been
found safe and effective. These responsible men should
*
convey
all the clinical information on such drugs or their combinations
to the -.appropriate authorities of the Government of India.Though
the Drug Technical -advisory Board (DTAB ),Drug Consultative
Committee(DCC) and Director General of Health Services(DGHS)
have been entrusted with this job by the Government of India
but other responsible men in the medical field will also have
to keep a vigil so that there is no oversight on the part of
the official machinery and the harmful and obsolete drugs from
developed countries are not dumped in bur country any longer.
The World Health Organization(WHO) should also play an effective
role inthis regard and ensure that only safe aad effective
drugs are sold to member countries. In addition, the government
must adopt the recommendations of WHO on essential gcnnric
preparations. In a developing country like ours, the goal must
be to ensure availability o> essential drugs to patients and
health education to all about safe water, sanitation and finally
sufficient nutritious food.
However, the major problem lies in the fact that a large
number of drug1 formulations in India have not been adequately
evaluated for their safety and this again emphasises the need
to exercise strict quality cont: ■ol . This becomes much more
significant in the light of the recent statement by the Goverlament in Rajya Sabha that 17.5% of the drug manufactured and
sold in the country in tne last three years were found to be
substandard.
Over all, if employment of such fixed dose combinations
aids the busy physician and does not significantly represent
a lessoning of his individualized orientation to his patient
and are rational from the therapeutic point of view, they are
a boon to therapeutics otherwise a curse to the patient and
the society.
REFERENCES:
Woodbury, D M (1970) Analgesics-Ahtipyretics, -antiinflammatory
agents and inhibitors of uric acid synthesis in The Pharmacolo
gical basis of therapeutics by Goodman, L S and Gilman,IV
Edition, The Macmillan Company, London,pp 514-347.
Be_aver, W T(1965) Mild analgesics: A review of their clinical
Pharmacology. Am J Med Sci 250, 577.604.
Jawetz E and Gunnision J B (1953) Antibiotic synergism and
antagonism: an assessment ofthe problem .Pharmacol Rev.5,175-192
Laurence, D R(1980) Clinical Pharmacology, Ed fifth, E L B S
Publication, Churchill Livingstons, pp 331, 536,552,617,848
Source: The Eastern Pharmacist-June '83.
Circulated by the Voluntary Health Association of India
for Drug Action Net Workers for information
and necessary action.
For sharing this endeavour, we are grateful to the following
for their help and moral support in compiling the Essential
Drug List . . •
• .
• .
- ...
■.
-g -prof.-'yi M S vihuja/Head Departme-nt of Medicine, ..A--I- T M 3.
(Temporary--Advisor)- The use of Essential Drugs,Technical
Report Series 685, WHO.
Dr v S Mathur,PGI Chandigarh, Editor Drug Bulletin
for i) providing the graded EMRO list for which he was
a consultant
ii) for providing the PGI drug formulary
iii) for being with us at Pune Workshop -January 1982
where Pune Drug List was finalized.
Dr Qasem of Gohosasthya Kendra, for having kindly complied
to our request to send the graded Bangladesh drug list.
Dr Joel Fernando, Medical School, Sri Lanka for providing
the Sri Lanka drug list.
Friends in Echo and Action Medeor who sent their lists.
Late Mr John Agacy, Secretary Low Cost Drugs and Rational
Therapeutics, who tediously typed the first draft of the
Comparative Essential Drug list in alphabetical order.
Alphonse our Secretary of Low Cost Drugs and Rational
Therapeutics for typing this comparative drug list based
on WHO format.
c' z
--10
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COMMUNITY HEALTH CELL
326, V Main. I Glock
Korambngela
Bangalore-560034
TiIE DRUG SITUATION IN INDIA
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t,ow Cost Drugs £’■ >>
Voluntary Health A ‘On'L‘ ^'-?raPcu
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India
The causes of the .problems and the solutions of the present day
drug situation differs markedly when seen from the eyes of the
drug industry especially OPPI, the Drug Controller, WHO, IMA,
groups and organizations who see everything in terms of what is
socially just or not, and the consumer.
Manv significant changes have occurred in the past few years
which are bound to have far reaching effects.
It is important
for all of us to be familiar with the problem, with the loop
holes, with the different versions of the various groups involved.
THE FACT THAT THE SOLJTION OF THE MAJORITY OF Ti4E HEALTH PROBLEMS
IN INDIA DOES NOT LIE IN MORE PILIS, MORE DOCTORS, MORE HOSPITALS,
BUT IN SOCIO ECONOMIC & POLITICAL POWER RELATIONS IN SOCIETY IS W.
WELL ACCEPTED BY MOST OF US HERE.
The need for greater social awareness is not only relevant for
the villager who gets deprived of his right to the least basic
needs, basic health care, but also for those involved in health
work (whether it is in a community health programme, a dispensary,
hospital or even a teaching hospital).
to be
Knowing about drugs is not/limited to their brand names, dosages,
side effects, but also their COST and their AVAILABILITY.
The various factors influencing these need to be analysed.
We will highlight some of the more important aspects which will
strongly .influence our search for solutions.
Here are some questions that arise and need answers. How much
is our health budget for the 6th Five Year Plan? and how much of
it goes on drugs as a total percentage and what is the per capita
expenditure on health? (Medical & Public Health & Family Welfare)
a)
1821.05 Crores (1980-85) Centre/State &/Union Territory
Source
(6th Five Year Plan - Pg. 382)
b)
Traditional System of Medicine - Centre 29 Crores
Source: (Planning Commission - N.D.)
c)
Rs.15.05 (+ Rs.1.51 for Family Welfare) in 1977-‘78
Source:
(Pocket Book of Health Statistics of India 1980 Pg.37)
What percentage of the Indian population utilizes the benefits
of modern drugs :
- about 20%; according, to some estimates only 10%
2iQw_se.lfcSdfficient._a.re we. _in producing this?
We wtill import 50% of the raw material at stupendous rates inspite
of our Pharmaceutical industry being 33 years old and the biggest
in the Third World.
What is happening to drug imports?
Cur imports tripled between 1963-64 to 19 73-74 from Rs. 13^15..crores
to Rs. 37.5 0 crores ---- within next year it increased to' Rs. 47--crores
this constituted 35% of the bulk drugs utilized in formulations.
According to Dr. S. S. Got’noskar, the Drug Controller of India
"The last 3 yrs have witnessed' a steady increase in the requirements
of imported raw materials by nearly 100 percent. Thus while our
• Z
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:
production increased by only 50% From 1976-77 to 1978-79 the ex
penditure incurred on import of bulk drugs, intermediates,
solvents etc, rose by nearly 80%.
The break-up of the drugs in the market is : Foreign Multinationals
.. 78%
Public Sector
.,
Indian Private Sector
.. 16% (Source: Dr. Pankaj
Shah:Dink - Aug. '81)
Pg. 12.
In 1978-79 MNC 1 s produced
6%
.. 28% Bulk drugs (Basic drugs)
.. 44% Formulations
(Source: Dr. Thakor - Businss
India, July 1980,Pg.26)
What are the allegations against Multinationals?
According to the Hathi Committee Report in 1975 the Multinationals;
=% block others from producing drugs for a period of 16-20
years by invoking patent production,
- din the brand names into the minds of the medical
profession by employing a large force of medical de tailors,
- resort to high pressure sales techniques, and,
- rig up prices to levels which have no relation to the cost
of manufacture of products or international prices.
What were the Hathi Committee *
s
ma'j.or_recommendations.?.
1)
Nationalise the Drug Industry,
2)
Foreign undertakings operating in the.country should be
directed to bring down their equity to 40% with
progressive reduction to 26%
**
(Under the New Drug Policy it was added that Multinationals
maintain a ratio of 1:5 for production of bulk drucp to
formulations)
**In the US more than 10% share by a foreign undertaking
classifies the company as foreign.
What were the Hathi Committee
s
*
drugs ?
1)
recommendation reaardina .aeneric
Abolition of brand names in a phased manner, beginning
to be made with 13 single ingredient drugs:
- analgin
- aspirin
- piperazine
- ferrous sulfate
- chlorpromazine
- chlorampheniol
- streptomycin
- Tetracycline
- reserpine
- tolbutamide
- INH
- INH & thiacetazone
Recommendations made in 1975.
In Jan. 17th 1981 decision was
taken to abolish brand names for
5 classes of drugs:
- analgin
- asprin
- chlorpromazine
- ferrous sulfate
- piperazine
D-10:343
MS:k:5.1.82
: 3 :
2)
Production of all new single ingredient drugs to be
under generic names.
On what were these recommendations regarding generic drugs
based?
The Committee found that 1)
use of brand names led to
unnecessary increase in cost because of costly promotional
activities; 2) medical students were taught pharmacology
using generic names.
What are the Drug Industry's objections against abolishing of
brand names?
1.
It is illegal and discriminatory because it contravened the
protection afforded by the Trade and Merchandise Marks Act
1958 and there was no provision in the Drugs and Cosmetic Act
1945 to empower the government to abolish brand namegf :r
drugs..
2.
Since prices are fixed under clearly defined formulae by
the DPCO (Drug Price Control Order 1979), generic names will
not reduce prices.
3.
Standard medical text books use both brand names and generic
names.
4.
Trade marks guarantee ethics in manufacture and in the absence
of brand names, customers cannot be sure of quality.
5.
Generic names will lead to wrong dispensing of drugs with
different pharmacological effects and harm patients' health.
6.
The ban on brand names for single ingredient new drugs will
completely stop introduction of new drugs in the market.
7.
Drugs sold under brand names often have superior bid- avail
ability than those marketed under generic names.
8.
The use of generic names takes aw.-.y the choice from the
doctor to the chemist.
9.
The general prescription is difficult to remember and repro
duce, lengthy and cumbersome.
10.
The Hathi Committee recommendations would have been quite
different had it observed the results of the Pakistan
experiment.
(Source: S. Viswanathan:
Business India - Sept.28
Oc tobe r 11)
What advantages are seen in having a planned generic policy?
1)
It will eliminate monopolization because of brand names,
and it will encourage healthy competition.
2)
It will curb production of non-essential combination drugs
which only add to the increase in price and have no
additional benefit.
For example.: Aspirin is marketed unde^ztwo generic names:
- acetyl salycilic acid and aspirin
,
- 8 different brand names
- 7 brands marketing ASA and Caffeine
- 19 brands of ASA and Phenacetin and Caffeine
D-10:343
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4
Effect on Costs.:
Content
Manufacturer
Name undei
which drug 1
marketed
Price per
unit(Paise)
Hoechst
Analgin (. 5gm)
Novalgin
20.00
IDPL
Analgin (0.5gni)
Analgin
18.27"
Haffkine
Analgin (.5gm)
Analgin
18.24
Nicholas
Aspirin (350 mg.)
-bCaffeine 30 mg.
As pro
7.75
Sarabhai
Aspirin 350mg.
Kenalgesic
22.00
Boots
Aspirin 3’00 mg.
Aspirin
3.60
Haffkine
Aspirin 300 mg.
Aspirin
2.84
Source: Indian Pharmaceutical Guide 1980
S ome more examples:
Anacin
Aspirin 389mg.
Anacin
Caffeine 16.2mg.
8
Quinine sulfate 8 mg.
Avedanplus
Aspirin 350 mg.
8
Acetyl Aminophenol 125mg.
Caffeine 30 mg.
Powe rin
Aspirin 350 mg.
20
Caffeine 65 mg.
Codeine 8.125 mg.
\
Paracetamol 65 mg.
Salicylamide 65 mg.
(Analysis 'of Painkillers done by Dr■. Anant Phadke
in his paper) Scientific Scrutiny of Qver the
Counter drugs)
\
Wat does WHO Expert Committee on selection of essential drugs
( 1st Report Technical series 615, 1977) recommend? It recommends
Acetyl Salicyclic acid”amongst"the~ah aIgesics~because besides
being the cheapest it was therapeutically as effective as analgin
(aspirin is 1/6) ARC and multiple other combinations.
What are the loopholes being made use of in_this generic policy
by profit-motivated drug industry?
Since the use of generic named drugs applies only to the 5 single
ingredient drugs it does not touch the COMBINATION DRUGS
which anyway form the majority.
Drug companies will try avoiding the issue by producing more
combination drugs and less single ingredient generic drugs.
Since BRAND NAMES is to be ABOLISHED for ALL NEW SINGLE INGREDIENT
drugs, the drug industry will try introducing new drugs under
BRAND NAMES with more than two ingredients. So not only the cost
will go up because of the use of brand, but also because of
addition of often unnecessary ingredients.
Since the government had emphasised that generic drug names should
be displayed more prominently than brand names with effect from
1st August 1981, the drug companies complain of difficulties in
making a long chemical name more prominent on small vials, ampoules
and pleaded of accumulation of stocks inspite of 7 months' notice.
■J-10 343
MS:k:5.1.82
: 5
:
What are the Drug Companies doing about this?
On 13th March, the industry's delegation met Mr. P.C. Sethi,
Minister ofChemicals and Petroleum, under which the drugs come,
having failed, Hoechst, Cynamid and Pfizer sued the Government
in the Delhi. High Court against abolishing of brand names and
have got a stay order.
What is the New Drug Policy?
Three years' debate following the Hathi Committee's recommenda
tion ended with the New Drug Policy.
(Presented in Parliament
on the 29th ?1arch 1978 by Mr. Bahuguna, the former Minister for
Petroleum, Chemicals and Fertilizers).
The NDP, the primary objectives were "to develop self-reliance
in drug technology;" to provide leadership role to the public
sector,"to foster and encourage the growth of the Indian sector",
under NDP several limitations were imposed upon foreign sector
drug companies. These included the gradual reduction of the foreign share holdings of
Multinational Corporations,
- no further expansion of capacity to foreign companies
"engaged in the manufacture of household remedies".
the grant of licences to manufacture formulations to
foreign sector companies to be "linked with the production
of high technology bulk drugs from the basic stage".
- the grant of licences for the manufacture of high technology
bulk drugs to be conditional upon foreign sector companies
supplying 50% of their production to "non-associated
formulators".
(Source: Dilip Thakore - The Ethics of
the Drug Industry Pg. 27
Business India : July 7-20,'80?
Page 29.30)
If a multinational produced, say, Rs. 100/- worth of bulk drugs,
half of it had to be sold to the Indian sector and the regaining
half used for formulating drugs under its own brand. The total
turnover of drugs could not exceed three times the worth of bulk
drugs, if produced, i.e., 100 x 3 = 300 lakhs.
What is the DPCO?
Drug Frice Control Order, an offshoot of the New Drug Policy
passed in 1979 is aimed to restrict prices of the bulk drug and
formulations produced by any pharmaceutical company in the
organised sector.
, •'
What are the stipulations under the DPCO?
Bulk or generic drug manufacturing companies are entitled to
12-14% return on net worth (capital + reserves) depending upon
the complexity of the technology utilized in the production
process.
/
* emulations (i.e. branded drugs) are divided into 4 categories’
Category
I
Category II
Category III
Category IV
- Life Saving Drugs
,
- }
/
- ) in between
/
- Over the Counter Drugs7.
-
"Mark ups" above the cost of production to the extent of 40%,55%,
100%.are permitted by the Ministry of Petroleum, Chemicals and
Fertilizers on Category I, II and III after a study of the
D-10:343
MS:k:5.1.82
: 6
:
production costs to be submitted by the manufacturing company.
What _does the Drug industry have to say about it?
According to Dr. S.K. Bhattacharya recently elected President of
the Organization of Pharmaceutical Producers of India (OPPI)
(which constitutes of 62 big and 54 medium firms and produces
60% of that total bulk drugs and formulations in the country),
the present drug shortage of Commonly prescribed drugs is because
of the New Drug Policy and the rigid price control and it will
definitely get worse.
Which are the drugs which have had problems regarding availability?
News reports and A survey done by Medical Times (Glaxo's) Aug.
has revealed a shortage of painkillers
- antiepileptics
- anti-diabetics
- anti TB drugs
- sera vaccines
'81
- Cardiac glycosides
- anti hypertensive
*Regarding prescription practices - surveyed by Medical Times
(Glaxo's) use of brand and generic was concerned. Almost all
the doctors seemed to use brand drugs. Reasons:
1)
2)
3)
confidence in the brands
less chance of substitution by chemist
convenience in remembering
Any info what guides prescription practices?
A study done by NIN Hyderabad on drug utilization revealed that
14% of the population surveyed (1800 urban education population)
was taking drugs on the basis of advertisements alone.
Only
1.72% gave satisfactory replies on the proper use of drugs.
48% allopathy
18% homeopathy
14% naturopathy
11% ayurvedic
2% Unani
63%. had erroneous idea about dosage schedules and mode of adminis
tration which could result in bioavailability and therapeutic
problems.
What is OPPI paying to build up public opinion against the
Government policies? OPPI has launched a Rs.24 lakh MEDIA CAMPAIGN
in what is says is a bid to help avert more serious shortages in
the future.
(Source: Vanishing Drugs: Hindustan Times April 27, 1980)
What is the situation regarding Drug Control?
The Drug Control situation in India is' pretty bad. Onlv 3
(Maharashtra, Gujarat, West Bengal) our of 22 States in India
have machinery to regulate the manufacture, distribution and
sale of pharmaceuticals.
D-10:343
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: 7 :
In Maharashtra, acknowledged to have the most effective drug
control administration, there are only 96 drug inspectors and
1 drug testing laboratory for over 2000 manufacturers and 15, 000
shops'
(Source: Dr. S.K. Bhattacharya of OPPI in
Medical Times - August 1981)
In Delhi for 5 million population there are 20 drug inspectors.
In Uttar Pradesh for 100 million population there are only 24 drug
inspectors.
'Source: Rajendcr Rainer : Delhi Reporter
July 1981:Spurious Drugs dealing in
■Death)
At the time of the Hathi Committee Report (1975) the Total drugs
Inspectors in the whole of India was 305. Current estimates are
5 '10
(Source: The Ethics of Drug Industry: Business
India, July 7-20, 1980 - Pg. 33)
kiha-t—pi^cD.njL_agt^^o_Ldru.gs-_aru^j2J2ns.id.ered -subr-.sjtandar<i_a.n_the_Indian
Market?,
Conservative estimates arc 25-30%.
The Drug Control authori
ties accept this figure.
(Source: Spurious Drugs: Delhi Recorder,
July 8)
•
52% drugs are substandard according to a survey quoted by Anil
Aggarwal in Drugs and the Third World.
2% drugs are spurious
(According to the drug control authorities).
Wfaat are_rthe_be.asons of such a high percencage of substandard_
drugs?
1)
Inadequate drug control.
The centre can only lay down policies, state governments have
control over manufacturers, sale and distribution (the inter
state barriers are fully exploited by trade in spurious drgs).
Control, if any, is at the earlier stage of production into#
bulk form or later formulations, improper storage, etc. are not
given that importance.
Shortage of certain brands of popular drugs gives an opportunity
to spurious and substandard drug producers to take advantage
of the situation.
Linked to this is high demand of life saving
and other common drugs.
-
easy availability of drugs over the counter without
prescription from a qualified doctor
easier availability of drug selling licence
ignorance about drug adulteration and substitution
- the increasingly prevailing habit of chemists to stock drugs
of a company giving them commission in some areas
-
the desire of the consumer to buy cheaper drugs because of
the high cost of drugs (and his poverty in many cases)
- the buying of drugs by chemists without any bill to avoid
payment of taxes
- only drug control authorities have been associated with
checks and control unlike food adulteration where the consumer
can play a role.
D-10:343
MS : k : 5.1.82
: 8 :
What can consumers do to deal with this problem of substandard and
spurious drugs?
1)
Buy drugs only from licensed chemists.
2)
Read the drug label carefully, verfy expiry date, price .
and seal before mrchasirig. Check with the price lists of
manufacturers available with the chemists.
3)
Ask for a cash memo-give the chemist enough time to fill
entries of drugs bought, your address, etc.
4)
Don't swallow all the claims made by the advertisers of the
various drugs.
5)
Avoid self medication by use of patent drugs.
yourself witljdny drug you do not know about.
6)
Follow instructions given by your doctor, pharmacist or on
the medicine label regarding mode' of administration of the
drug dosage, frequency, etc., and duration. Check if in
doubt specially if deasling.with patent drugs.
7)
Avoid using left-over drugs or drugs that change colour,
taste, or look different. Keep drugs as advised - in a dark
and cool-place.
8)
Keep drugs away from children's reach.
separately.
9)
Destroy old cartons, labels, containers to prevent misuse of
spurious drug manufacturers.
10)
If you, feel doubtful about the quality of any medicine, contact
the Erug Control Department.
11)
If in Delhi, ring up 22 60 18 be4ween 9 A.M. - 6 P.M..
After office hours and on holidays ring up 63 33 00, 63 40 73
and 63 11 16.
Don't medicate
Keep poisonous drugs
The punishment'provided in.Sec. -27 and 27A of the 1940 Drugs and
Cosmetics' Act to safeguard the consumer is maximum imprisonment
of 10 years, increased to life imprisonment by West Bengal.
■What constitutes the public sector and how are they faring?
The public sector constitutes of -
IDPL
-
Indian Drugs & Pharmaceuticals Limited
HAL
-
Hindustan Antibiotics Limited
SSPL
-
Smith Stanistreet Pharmaceuticals Limited
BE-PL
—
Bengal Chemicals & Pharmaceuticals Limited
IDPL and HAL incurred losses of almost 2 ctores in 1979. Monthly
losses of IDPL and HAL are 2 crores and 45 lakhs respectively.
(Source: Policy Pitfalls': Ranjana Kaul:
Hindustan Times, April 27, 1980)
Why are they running at a loss?
The reasons given are mismanagement, inefficiency, poor-coordina
tion, under-utilization of capacity, corruption, frequent machine
breakdowns.
Probably, one acceptable reason is the refusal of the MNC and
other private companies to go into production of essential and
life-saving drugs of Category I & II which allow mark-up of only
40 and 55% respectively (as they can make up to 100% profit on . ■:
non-essential over tie counter drugs)and the public sector
having to take on the burden.
D-10:343
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: 9 i
/
According to Mr. D.B. Telang, Financial Manager of the company
for every kilo of streptomycin produced, a loss of Rs.25- is
incurred. The more esssential drugs are produced the more are
the losses incurred.
Losses are due to increase in the price of
raw materials, inflation - 35-40%; packaging 30%, power 30%, cost
of transportation. A,, this in the presence of fixed drug prices
apparently has caused the ever increasing losses in the public
drug sector. IDPL, HAL, IDRI were instituted to break foreign
monopolization and produce a reasonably cost essential drugs for
the Indian public.
But even today, 33 years we still import-drugs
for Kalazar, malaria, leprosy, diphtheria, TB.• Losses can be made
up by raising production or by asking government to alter the
pricing structure.
How self sufficient are we regarding production of drugs? What
do the MNC's and OPPI have to say about production of essential
drugs?
of
says "We are business concerns. Why
^whrcn actuallyCmoln£ less profits^ C'USe incurrence of loss."
What is S.P.C.?
Chemicals &Pharmaceuticals Corporation is for channelizing drugs
and regulating their availability in the country. The Corpora
tion has had problems regarding availability and prices of
imported ingredients. There are reports of essential bulk drugs
not being lifted from the C.P.C. by the drug company -on account
of low profitability.
On December 1, 1979, CPC had "4 crore worth
of canalized bulk drugs in stock. These included essential drugs
like tetracycline, streptomycin. doxycyclin.
Drug
Company
Licensed capacity
in million^ tons
Actual produc
tion in mil
lion tons
PAS
a) Biological Evans
b) Warner Hindustan
120
300
'•
56.06
135.82
INH
a) Biological Evans
b) Ghas. Pfizer
c)..'Warner Hindustan
10
1.6
90
0.13
0.06
6.08
What are the objectives of C.P.C .?
The basic objectives of CPC ih.„canalizing import of'drugs is as
follows:■
1.
Bulk purchase for Jail manufacturing units gave -bargaining
power in world market so that concessional or low prices
could be secured.
2.
To prevent disturbance of indigenous production of drugs with
a certain therapeutic value - introduce and regulate imports
of newer, sophisticated drugs in a planned manner.
3.
To protect the indigenous production of drugs, especially when
the production is inadequate to meet internal demand.
4.
To ensure the equitable supply of raw materials at uniform
prices, eliminating middleman's profits,, so that formulations
from this are priced at a fixed uniform■level.
D-10:343
MS ;k:5.1.82
.
10:
5.
To help the small scale sector of the industry whose require
ments are small and who would otherwise find it uneconomic
and impractical to import.
6.
To regulate the import of drugs whose indigenous production
is substantial enough to warrant their being given protection
so that their growth and utility are ensured with a view to
achieving ultimate self-sufficiency.
7.
To secure those drugs which have very few world manufacturers
and monopolies at reasonable prices.
8.
To regulate the import of drugs whose imports can cause public
health problems, eg., addiction forming drugs, etc.
Loopholes points 4 and 5 were to avoid middlemen but unfortunately
since small units have to give their REQUIREMENTS AND ADVANCE
PAYMENT several months prior to time of supply (promptness of which
is not assured), the small scale agencies are unagle to take full
advantage and it is the MIDDLEMEN who lift the STOCK, HOARD it and
sell it at 25-30% higher than the usual rate.
10% foreign firms have not utilized 3 industrial licences and
7
letters of intent for the manufacture of 16 bulk drugs.
40 firms in the Indian private sector failed to implement the
investment proposals with 31 industrial licenses and 27 letters
of intent.
Of 32 items of bulk drugs covered by 13 licenses, 21 items were not
produced by Glaxo laboratories for the last 5 years.
(Source: J.S. Mazumdar:.Drug Industry
Instruments of Policy)
And with all this, useless non-essential drugs are pumped into the
market while essential drugs are not produced. Very obviously,
profit is the motive of the drug production industry and not ful
filling of the country's need as is often alleged.
The small scale sector feels itself financially ill-equipeed to
undertake any undue losses or profits and therefore also opts for
non-essential drugs.
What does the 6th Five Year Plan require regarding drug production? "
From Present
Bulk 226 crores
By 1984-85
to
665 crores
Formulation Rs. 1150 crores
2450 crores.
VIth PLAN aims at:
1)
Developing self-reliance in technology,
2)
Ensuring availability of drugs with reasonable prices and
inadequate amount
3)
Dominant role of the public sector in the industry.
What's the situation?
Growth rate of bulk drugs has fallen from 13% to 6% and for formula
tions from 10% to 4%.
D-10.-343
MS:k;5.1.82
: 11
IN THE FIRST YEAR OF THE PLAN, the foreign and big Indian
companies are not interested in manufacturing the drugs that yield
low profit margin. In fact, by cornering the already sanctioned
licenses and letters of intent they are out to blackmail the
government in order to secure substantial price rise - by starving
the market of these drugs.
(Source: MNC's Fatten, Indian Die:
Dr. Pankaj Shah: Link, Aug. 2, 1981,Pg.10)
The Multinationals give the high prices because of the 'research'
they apparently finance. What all constitutes research?
It includes
- basic research
- product development
- toxicity tests
- research, on formulations
- mass production methods
- clinical trials, etc.
it also includes studies on colour design of product, its packaging
to promote sales, general market studies, purchase of international
patents, solely to extend the company's monopoly position abroad.
(Source:
Link, Aug. 2, 1981, Pg.11
Dr. Pankafj Shah)
What percentage of their sales do they put into research?
what percentage in publicity?
and
Glaxo in 1979-8Q spent Rs.1.5,2 crores on publicity - .. percent
on tropical diseases.
Amount MNC 's spend on research is <^3% of their sales turnover
compaisl to 14-15% in Developed countries. Even so research acti
vities are seldom in tropical diseases but in diseases like cancer
hypertension etc.
What are the country's health requirements based on priorities set
by Alternative Strategy: ICMR/ICSSR Study
Measures against
-
Communicable Diseases
-
Nutritional deficiencies
Family Planning. Fertility ra-fce,
-
Basic health care
Some of the figures that indicate the seriousness of the problem
*IMR in 1976 129/1000 live births (when Sri Lanka's is 45:1 in'72
(pg.129) )
*Maternal mortality 163 in 1976 (Percentage Distribution
(pg. 125)
*Birth rate - 33.3Yper thousand per annum in 1978 (Pg. 13}'
Health Budget set aside for the Vlth Five Year Plan - 1821.05
Crores
50% of the Health budget earlier has been spent on curative ca;£.
40% in construction and capital expenditure
and only 10% on preventive health care(Health Statistic?!
Intelligence Report)
>
50% of under fives and pregnant mothers are found to be anaemic.
S.O.-.8.O..% are clinically malnourished.
50% of Indian children get \ the calories .that they isquici.
40,000 children become.- blind each year b^ca-use of Vitamin A
defiency.
'
■
.•
• «/“
D-10:343
MS :k:5.1.82
: 12 :
*27,08,222 get malaria every year and 147 die of malaria in 1979
( Per 8?)
Incidence of T.B. is 2%, i.e., 8 million people. About
y*
2 million have open TB.
*Incidence of leprosy is 25,59,566 cases on Record - Mar.'80 5
21,58,822 cases under treatment
|Pg.89)
on Record - Mar.'80 J
(India harbours 1/3 of the- world's leprosy, malaria, cases) .
(*Source: Pocket Book of Health Statistics
'80, CBHI, New Delhi)
The incidence of malaria - even Falciparum - Filaria, polio,
Kalazar, Japanese 'Becephalitis has shown an increasing trend.
The above becomes extra significant when we focus on the percentage
of people below or bordering the poverty level - a figure that is
also showing a rising trend. 60% Indians are below poverty line
(assessed in relation to average caloric requirement).
What is. the production of drugs like in relation to these health
requirements:
Out of Rs.636.9 crores of drugs sold in 1980
19% were anti-biotics
10.21% vitamins
4.41%-tonics
4.241% anti-anaemic preparations
4.71% cough and cold (increase in growth within
the last 5 years has been
70%) .
Talking in absolute figures 137 crores worth of vitamins were sold
in the year 1980.
Break-up of the above available in Dr. A. Patwardhan's paper
1,2, and 3.
All modern drugs are available to economically well off 5%.
dasic drugs available to another 20%.
Percentage of people denied availability of essential modern drugs
is 75%.
This is when our population is 65 million.
With annual expenditure of 636.9 crores.
By 2001 the population will be 950 millions.
Amount required for drugs with inflation, increasing prices of
raw material, etc, etc., will be
Our National Formulary has over 60,000 drugs and chemicals.
(15,000 brand drugs)
68% are obsolete and useless (only about 5000 are useful and 2500
of marginal use)
The Hathi Committee has identified 117 as essential drugs and WHO
about 200’ drugs which would take care of the 90% of the EXISTING
HEALTH PROBLEMS.
D-10:343
MS:k:5.1.82
: 13 :
Regarding essential drugs production what is happening?
Out of Rs. 1260 crores worth of drugs manufactured in 1979-80
essential and life saving drugs accounted for Rs.350 crores only the rest were tonics, digestive enzymes, formulations of medicines
with marginal benefit.
MANY VITAL BULK DRUGS IN HUGE QUANTITY HAVE BEEN WASTED WHICH
COULD HAVE BEEN UTILIZED FOR MANUFACTURE OF ESSENTIAL DRUGS.
(Source: Drugs
Industry Instruments of Policy
- U.S. Majumdar)
1977
1978
Production
Installed PrcducInstalled
capacity
Tonnes
capacity
tion
Anti-T.B. Drugs
j-'onnes
Tonnes
tonnes
INH
5 09
57
5 39
94
PAS and its salts
1170
56
1290
558
Theacetazone
153
25
153
13
S tre ptomyc in
257
194
25 7
225
DDS and its deriva
tives
26
17
38
17
Anti-filaria
DEC citrate
56
18
56
23
Ari hi - typhoid
Chloramphinicol
17.8
95
128
95
5 87
157
590
195
137
16
170
55'
156
34
176
45
Anti-Leprosy
Anti-Dysentery
Halogenated
Quinolines
Metronidazole
Anti-malaria Is
Chloroquin
Pfizer Ltd.
Products
Licensed capac_ity
Production during
1979
1978
INH
80 metric tonnes
45 MT
52 MT
PAS and its salts
110
"
"
90 MT
54 MT
Terrarhycin
14
"
"
Protienex
110
"
Burrough's Welcome
Septran
5 3 MT
54 MT
269 MT
290 MT
Licensed annual capacity
Production 1980-81
26 million tablets
187 million tablets
Similarly, Glaxo's production of Betamethazone has been increasing
while production of antibiotics - penicillin, streptomycin, serra
and vaccines is much below licensed capacity.
Make-up of Drug Industry at a glance?
*5000 pharmaceutical units
3500 manufacuring units
*
*1500 units based on loan
* 118 companies in the organised
license system
sector
*45 Multinational drug companies
*
Of the 20,000 formulations in
which have foreign equity
market - 78% formulations in the
more than 40%
hands of Multinationals, 16%
Indian Private Sector, 6%„Puh? _c
Md-14
CHAPTER
Right and Wrong Uses
of Modern Medicines
This is a reprint from
\There There Is No Doctor
(Indian adaptation)
published by the
Voluntary Health Association of India
C-14 Community Centre
Safdarjung Development Area
New Delhi 110016
community health CELL
326, V Main, I Block
61
Koramongala
Bangalore-560034 -
India
CHAPTER
Right and Wrong Uses
of Modern Medicines
Some medicines sold in pharmacies or village stores can be very useful. Others
are of no value. Also, people sometimes use the best medicines in the wrong way,
so that they do more harm than good To be helpful, medicine must be used
correctly.
Many people, including most doctors and health workers, prescribe far more
medicines than are needed-and by so doing cause much needless sickness and
death.
There is some danger in the use of any medicine.
Some medicines are much more dangerous than others. Unfortunately, people
sometimes use very dangerous medicines for mild sicknesses. (I have seen a baby
die because his mother gave him a dangerous medicine, chloramphenicol, for a
cold.) Never use a dangerous medicine for a mild illness.
Guidelines for the use of medicine:
1.
2.
Use medicines only when necessary.
Know the correct use and precautions for any medicine you use (see the
GREEN PAGES).
3.
Be sure to use the right dose.
4.
If the medicine does not help, or causes problems, stop using it.
5.
6.
When in doubt, seek the advice of a health worker.
Always check the expiry date (last date before which to use) of the medicine. If
the medicine is given after this date, it may do more harm than good.
Note: Some health workers and many doctors give medicines when none is
needed, often because they think patients expect medicine and will not be
satisfied unless they get some. Tell your doctor or health worker you only want
62
medicine if it is definitely needed. This will save you money and be safer for your
health.
Only use a medicine when you are sure it is needed
and when you are sure how to use it.
THE MOST DANGEROUS MISUSE OF MEDICINE
Here is a list of the most common and dangerous errors people make in using
modern medicines. The improper use of the following medicines causes many
deaths each year. BE CAREFUL!
1, Chloramphenicol (Chloromycetin) (p. 401')
The popular use of this medicine for simple diarrhea and other
mild sicknesses is extremely unfortunate, because it is so risky.
Use chloramphenicol only for very severe illnesses, like typhoid
(see p. 229). Never give it to newborn infants.
2.
Oxytocin (Pitocin), Pituitrin, and Ergonovine (Ergotrate) (p. 424)
Unfortunately, some midwives use these medicines to speed up
childbirth or 'give strength' to the mother in labor. This practice
is very dangerous. It can kill the mother or the child. Use these
medicines only to control bleeding after the child is born (see
p.312).
3.
Injections of any medicine
(2-s
k/
„J_ JrC. J
' X
4.
Penicillin
The common belief that injections are usually better than
medicine taken by mouth is not true. Many times
medicines taken by mouth work as well as or better than
-------- injections. Also, most medicine is more dangerous
injected than when taken by mouth. Use of injections
should be very limited (read Chapter 9 carefully).
Penicillin works against only certain types of infections. Frequent use of penicillin
for sprains, bruises, or any pain or fever is a great mistake. As a general rule, injuries
that do not break the skin, even if they make large bruises, have no danger of
infection; they do not need to be treated with penicillin or any other antibiotic.
Penicillin ointment or powder usecLon the skin can make the person sensitive to
penicillin.
Penicillin is dangerous for some people. Before using it, know its risks and
precautions you must take (see p. 70 )
63
5.
Injections of penicillin with streptomycin (p 4001
There are many familiar brands names
These medicines are used too much and often for the wrong
reason They should not be used for colds for two reasons
la They do not work against colds and flu.
1 b. They can cause serious problems, sometimes deafness
or death
“ Give streptomycin for treatment of tuberculoaio only.
If you give it for any other disease, the person may
become resistant to streptomycin, and then will have
to lake more expensive medicines to cure tuberculosis.
Do not give this medicine for any other disease.
6.
Vitamin Bq2 and liver extract (p. 425)
These medicines do not help anemia or 'weakness' except in
rare cases. Also, they have certain risks when injected. They
should only be used when a health worker has prescribed them
after testing the blood. In nearly every case of anemia, iron pills
will do more good (see p. 147)'
7,
Other vitamins (p. 424)
As a general rule, DO NOT I NJ ECT VI TAM I NS. Injections are more dangerous,
more expensive, and usually no more effective than pills.
Unfortunately, many people waste their money on syrups, tonics, and 'elixirs'
that contain vitamins. Manv lack the most important vitamins (see p. 139’). But
even when they contain them it is wiser to buy more and better food. Body
building and protective foods like beans, vegetables, fruits, eggs, and meat,
are rich in vitamins and other nutrients (see p. 129 -131). Giving a thin, weak
person good food more often will usually help him far more than giving him
vitamin and mineral supplements.
A person who eats well does not need extra vitamins.
THE BEST WAY TO GET VITAMINS:
64
For more information about vitamins, when they are necessary, and the foods
that have them, read Chapter 11, especially pages 1 29 and '138
8.
Calcium
Injecting calcium into a vein can be extremely dangerous. It can
quickly kill someone if not injected very slowly. Injecting
calcium into the buttocks sometimes causes very serious
abscesses or infections.
Never inject calcium without first seeking medical advice!
Note: In countries where people eat a lot of corn or
other foods prepared with lime, it is foolish to use calcium injections or tonics (aa
is often done to 'give strength' or 'help children grow'). The body gets all the
calcium it needs from the lime.
9.
'Feeding' through the veins (Intravenous or 'I.V.' solutions)
In some areas, persons who are anemic or very weak spend their last paise. to
have a liter of I.V. solution put into their veins. They believe that this will make
them stronger or their blood richer. But they are wrong!
Intravenous solution is nothing more than pure water with some salt or sugar in
it. It gives less energy than a large candy bar and makes the blood thinner, not
richer. It does not help anemia or make the weak-stronger.
Also when a person who is not well trained puts the I.V. solution into a vein,
there is danger of an infection entering the blood. This can kill the sick person.
Intravenous solution should be used only when a person can take nothing by
mouth, or when he is badly dehydrated (see p. 183).
Only a trained health worker should give these solutions.
If the sick person can swallow, give him a liter of water with a little sugar and
salt (see Rehydration Drink, p.182). It will do as much for him as injecting a liter
of I.V. solution.
For people who are able to eat, nutritious foods do more to
strengthen them than any type of I.V. fluid.
65
It is always dangerous to give a laxative or purge to a baby or
to anyone who is very weak, dehydrated, or has severe pain
in his belly. Unfortunately, people often believe that purges
bring back health or clean the bad things out of the body. In
Chapter 1 it is explained that purges or strong laxatives
nearly always do more harm than good.
To learn the correct uses of laxatives and enemas, see p. 21.
WHAT TO EAT WHEN TAKING MEDICINES
Many people believe that they should avoid eating certain foods like brinjal.
tomato, curds, oranges, guavas, eggs, meat and cooking oil when they take any
medicine. They think all medicines will do harm if they are taken with these foods.
This is not true I No medicines causes harm just because it is taken with these foods.
But in case of some illnesses, certain foods can make the illness more severe.
because the body cannot digest these foods:
diabetes................................................ see p 1 49
heart problems..............................see p. 3 71
high blood pressure........................ see p. 148
gall bladder problems..............................see p.375
stomach ulcers and heart burn........................ see p. 1 50
urinary tract infection in children........... see p. 357'
Certain foods can cause serious damage in these illnesses, whether or not any
medicine is being taken. Certain medicines will cause bad reactions if a person
takes alcohol (see metronidazole, page 407
66
WHEN SHOULD MEDICINE NOT BE TAKEN?
There are situations when, without a doubt, it is best not to use certain
medicines:
1.
Pregnant women or women who are breast feeding should
avoid all medicines that are not absolutely necessary.
(However, they can take vitamins or iron pills without
danger.)
2.
With newborn children, be very careful when using
medicines. Whenever possible look for medical help before
giving them any type of medicine. Be sure not to give too
much.
3.
A person who has ever had any sort of allergic reaction
hives, itching, etc.—after taking penicillin, ampicillin, a
sulfonamide, or other medicines, should never use that
medicine again for the rest of his life because it would be
dangerous (see Dangerous reactions from injections of
certain medicines, p. 83).
4.
Persons who have ulcers or heartburn should avoid
medicines that contain aspirin.
5.
There are specific medicines that are harmful or dangerous
to take when you have certain illnesses. For example, persons
with hepatitis should not be treated with antibiotics or other
strong medicines, because their liver is damaged, and the
medicines are more likely to poison the body (see p. 210).
6.
Persons who are dehydrated or have disease of the kidneys should be especially
careful with medicines they take. Do not give more than one dose of a medicine
that could poison the body unless (or until) the person is urinating normally. For
example, if a child has high fever and is dehydrated (see p.88), do not give him
more than one dose of aspirin until he begins to urinate. IXtever give sulfa to a
person who is dehydrated.
COMMUNITY HEALTH CELL
326, V Main, I Block
Koram, ng'-la
Bangaiote-560034
India
The book V/here There Is No Doctor is available
at Rs 29/- plus postage. Multiple copies of reprints
of various chapters are also available.
Please write to:
Publications Officer
Voluntary Health Association of India
C-14 Community Centre
Safdarjung Development Area
New Delhi 110016
Rs. 2.50
VOLUNTARY HEALTH ASSOCIATION OF INDIA
C-1 4, COMMUNITY CENTRE, S.D.A.
PHONES :
668071, 668072
NEW DELHI 1 1 O 01 6
GRAMS : -VOLHEALTH" New Delhi 110 016
DRUGGING OF ASIA—PHARMACEUTICALS
AND THE POOR
Workshop organized by IOCU, VHAI and ACHAN
Madras 6th—9th December 1 985
Summary of Workshop Conclusions on National Drug
Policy prepared by Dr. K. Balasubramaniam, Pharma
ceutical
Advisor,
Caribbean Community Secretariat
The Heads of States or Governments of Non-aligned and other developing
countries had at two of their summit conferences recommended unanimously
that each developing country should formulate and implement an integrated
national drug policy in order to ensure access of the entire population to
essential drugs at reasonable cost.
At the request of the developing countries, the United Nations Action
Programme for Economic Cooperation among Non-aligned and other deve
loping countries (UN-APEC) convened a meeting of a group of experts on
Pharmaceuticals in July 1976 in Georgetown, Guyana. This Expert Group was
mandated to prepare an Action Programme on Pharmaceuticals and present
it to the Fifth Non-Aligned Summit Conference held in August 1976 in Colombo.
The Summit Conference endorsed the recommendations of the Expert Group
in Resolution No. 25 on pharmaceuticals. In this Resolution, the Heads gave
an outline of an integrated pharmaceutical policy and also requested the
relevant UN agencies to assist developing countries by examining in depth
the pharmaceutical sector in developing countries and preparing a detailed
drug policy and programme suitable for these countries. Accordingly in 1978,
four UN agencies—UN APEC, UNCTAD, UNIDO and WHO constituted a Joint
Task Force on Pharmaceuticals and fielded an inter-agency mission to several
countries in Asia, Africa and Latin America to study the pharmaceutical
sector in these countries.
The Mission had discussion with relevant govern
ment officials involved in the public sector pharmaceutical supply system and
with the private pharmaceutical industry and reported its findings to the Joint
Task Force which then prepared a comprehensive report entitled, "Pharma
ceuticals for the Third World : Policy for Health, Trade and Production.”
The conclusions and recommendations of their report contained a detailed
description of an integrated national drug policy This report was
submitted to the Sixth Non-aligned Summit Conference held in Havana in
September 1979. The Conference endorsed the conclusion and recommen
dations of the Task Force Redort in their Resolution No. 8 on Pharmaceuticals.
(
2
)
From the foregoing it is clear that the developing countries have, at the
highest political level, underscored the imperative need for each developing
country to formulate and implement an
integrated national drug policy to
ensure access of the entire population to essential drugs at reasonable cost.
The policy recommended by the Heads was based on a limited list of
essential drugs.
Of the countries represented at the Asian Seminar on Pharmaceuticals
Bangladesh alone had in 1982 formulated and implemented a rational drug
policy based on the guidelines recommended by the Non-aligned Summit
Conference. Within a period of three years the pharmaceutical supply system
in Bangladesh has improved tremendously. Essential drugs are increasingly
available to larger sections of the population at reduced costs. On the other
hand countries which had not formulated and implemented a national policy
based on essential drugs are paying very high prices for their lapse. For
example the Workshop was informed that in India. A child was going totally
blind every 13 minutes due to the unavailability of Vitamin 'A'—a cheap and
essential drug. Some participants believed that it would be amounting to
criminal neglect if health authorities in other countries continued to delay the
formulation and implementation of a national drug policy based on essential
drugs, particularly when our Heads have on two occasions, given clear direc
tives to this effect.
The participants therefore, appeal to the Prime Minister
of India, Mr. Rajiv Gandhi, as the Current Chairman of the Non-aligned
Movement to use his good offices to force health authorities of the member
countries of the Non-aligned Movement, particularly those in South Asia, to
formulate and implement national drug policies based on essential drugs
and suited to their needs without any further delay.
The workshop also took the opportunity to identify the major components
of a model drug policy suitable to countries in South Asia, using as guide
lines the directives given by Non-aligned Summit Conference, Countries in the
region may wish to use their model drug policy as a basis to formulate their
own national drug policies.
A MODEL NATiOWAL DRUG POLICY
A national drug policy should be linked to the health needs of a country
and designed to ensure access of the entire population to essential drugs
at reasonable cost.
The supply of essential drugs involves the active participation of many
sectors including health, industry, trade, finance etc. It is, therefore, essen
tial that an intersectional drug committee with representatives from all
relevant sectors be established prior to the formulation of a national drug
policy.
Failing to observe this vital point and formulating a drug policy
(
3
)
without participation of all the relevant sectors would result in floundering
at midstream at some point in the implementation stage leading to an inter
ruption in the drug supply system.
In formulating the national drug policy
care should be taken to avoid undue influence of the private drug industry,
particularly the multinationals.
The following would be the major components of a model national
drug policy :
Drug Meeds :
National lists of essential drugs selected on the basis of
the health needs of a country should be established. Evidence from some
developing countries and the reports of the WHO Expert Committee on
Essential Drugs indicate clearly that a limited number of essential drugs of
about 250-300 would be sufficient to meet the major needs of the people.
Drug Names : International Non-Proprietory names (generic names)
should be used whenever possible.
Quality Assurance : Appropriate steps should be taken to assure the
quality of all marketed drugs. The success of a generic drug policy is
critically dependent on assuring the quality of drugs.
Objective Information on Drugs and Therapeutics: Health Authorities
should provide objective information to health persons.
Drug
Legislation :
covering registration,
A
country should enact appropriate legislation
of drug information including therapeutic
control
indication, mention of adverse reactions, contra-indication, drug interaction
price regulation and post market survey.
Price controls or monitoring should be introduced at the import, whole
sale and retail levels.
Any introduction, amendment, alteration, variation, deletion of any drug
legislation or releated laws shall be made available to all organization,
association and individuals.
Procurement :
At present drug imports are fragmented not only bet
ween the public and private sectors but also within each of these sectors.
Foreign exchange savings could be effected by pooling these purchases by
means of a centralised buying agency, some of the countries in the region
have a centralised buying agency for the purchase of the public sector
requirements but their bargaining power is limited since they do not have
the vital market intelligence.
Production :
All countries in the region have already established drug
manufacturing units.
In the majority of the countries, local production is
dominated by the private sector.
The commercial practices of the private
sector with emphasis on creating a demand and generating profits are counter
productive to the large scale production of socially useful essential drugs.
A national drug policy based on essential drugs cannot be implemented with
the uncontrolled practices of the private sector. Countries in the region
should therefore give a leading role to the public sector and to socially
conscious manufacturers like GK Pharmaceuticals of Bangaladesh.
Transfer of Technology :
The uncontrolled transfer of pharmaceutical
technology into the countries of the region has resulted in the manufacture
of a large number of non-essential expensive drugs.
Production facilities
brought into the country at high costs are not being used for the manufacture
of essential drugs.
Priority technological needs of the country should be identified when the
decision to acquire technology has been made.
Explore all possible sources
of technology and select the most suitable technology, if necessary with
assistance from relevant international agencies. The terms and conditions
of the technology transfer agreement should be carefully examined and all
restrictive clauses controlled
and reduced.
Priority should
be given to
acquiring technology from another developing country.
Promotion : Drug promotion by the drug industry must be controlled
by the drug regulatory authority.
Patents:
All countries in South Asia except India grant patent protec
tion to pharmaceutical products and processes. India grants protection to
processes only. Product patents enable the patent holder to gaida monopoly
of the market. The host country will be prevented by its own national patent
legislation from buying the same drug from a cheaper source.
The Non-aligned Summit Conference has recommended that pharma
ceutical products and processes should be excluded from patentability. If
process patents are granted, compulsory licensing should be used for ex
ploiting the patent locally. Other alternatives relate to shortening of the
duration of patents.
Regional Cooperation :
Some of the components of the drug policy
would be difficult to implement at the national level by some of the smaller
countries of the region.
These would include quality assurance, collecting
market intelligence and
local production.
Taking these constraints into
consideration, the Non-aligned Movement recommended the formation of
regional pharmaceutical centres by developing countries so that member
countries belonging to a regional centre could take joint action to implement
some of the components at a regional level.
Several years of multinational negotiation would be required before a
South Asian Regional Pharmaceutical Centre could be established. However
Health authorities in the region could initiate some joint activities.
1.
Market intelligence is totally lacking in the region.
Countries could
exchange information on manufactures, price trends, quality of products
etc. among themselves.
2.
Drug regulatory authorities in the region may wish to establish drug
quality norms and explore the possibilities of enacting
uniform drug
legislations. This would enable the smaller countries in the region with their
drug registration and quality assurance.
3.
Objective information on drugs and therapeutics is another compo
nent which could be provided regionally.
The crux of the matter still remains that the cheif responsibility
for the formulation of Rational Drug Policies lies with the
National Governments.
In the view of the availability of well defined WHO criteria for
such formulation - it is possible for Asian countries to have
such rational policies provided they have the political will to do so.
For more information on Rational Drug Policy contact
:
Co-ordinator, Low Cost Drugs &
Rational Theraputics
VHAI
Our medicare
system creating
Picassc u
-f;4« .
jSj.
'HE
realisation
that public health po
licies of developing
> . - countries
like India
iiaa been — wittingly or un„■ mgly — mortgaged to the
punt multinational companies
•vhich control the pharmaceu
tical industry and the national
companies
following
their
the banning of at least 23 of day ____ v.
of doctors
the many irrational drug com trainedthousands
at the expense of poor
binations?
Indians arc
iv rman
are alkvyed
allowed to
These are disturbing ques the public health services
tions. The answers are obvious England and Arab countnes
countries
to anyone
with some social
just because the country gets
consciousness.
Why did not
some foreign exchange.
•doctors, who should be most
Says Dr Chowdhury, who
concerned with these issues, recently visited Bangalore:
ask these questions so far —
Colonialism has .left much of
tchnicjue. is not .new-.. „
w.. answer them?
’.J-le -RuKaUmUA
.
*
- -HUWja- mil.
What is new is the feeling
Doctors
are tremendously . -health
systems largely irre
that doctors in India and coun ignorant .people,” says Dr. Zaf- levant
to their conditions.”
tries like it have become rullah Chowdhury of Bangla
The functions of medicine are
■pawns in the game — at the desh. a medical doctor himself social — fulfilling the social
cost of the health of the mil by training. The young project needs to promote good health
lions.
coordinator and co-founder of
prevent diseases, treat those
Gonoshasthya
Kendra
(.peo affected when the preventive
That the multinationals have
been making astounding pro ple’s health centre) at Savarmeasures fail and rehabilitate
thana
in
Bangladesh,
says:
fits (some limes more than
them. And yet the whole app
2000 per cent)
has been “Doctors and money are. for roach of medical education is
most part, safelv ensconed in
Jinown for decades.
Several
not that of a social science It
feeble attempts at controlling institutes designed to serve the
is presumed that the body is
the “mark up" of prices
by rich. From there they produce machine. Most of the treat
them have been made. When their scholarly papers saying ment is symptomatic and not
Dr. Triguna Sen became the that the poor also have pro prophylactic.
blems,
but not problems for
.Minister for Petroleum ana
Medical education is open
Chemicals in 1967, he initiat which treatment is available to only to the rich, who mostly
ed the move for abolishing them.”
have their values based on
Several seminars have been money. A student who pays
brand names for some popu
lar formulations
and make held in the last one decade in
a capitation fee of Rs 1-5
drug companies sell them un the country. Lengthy, academic lakh to 2.5 lakh to undergo
der generic names. Could it .papers have been read by the
be just a coincidence that mi doctors calling for a medicare
nistry
(which controls the system that is more suited to
the needs of the majority.
pharmaceutical industry) was
taken away from him. and the From time to time there is
talk of evolving a system of
proposal scuttled?
Could it be the normal red “barefoot doctors” and creat
“paramedical
cadres".
apism
and
official lethargy ing
ap
hat prevented
the
Govern- Frequently impassioned
nent from considering the re- peals are issued asking doc
ommendations of the Jaisukh- tors to go to rural areas. There
are
occasional
threats
to
make
l Hathi Committee which,
nong other
things, sought rural service compulsory for.
And yet a vast majority of
the doctors produced :.t
at t?._
the
expense of the tax-payers’ money
(the Government
spends on
training a doctor many times
more than the amount paid by
a medical student as fees) pre
fer to stay in cities even if
they have to live On a meagre
practice or take to teaching
physiology in schoolsBut
they would not go to villages
where they would be treated
as demi-gods, where they can
have a thriving practice and
also job-satisfaction.
The result is that even to
day thousands of quacks and
half-baked doctors have a
roaring practice in villages.
Even today various unscien
tific “systems of medicine’’
and “witch doctors” have a
field day, in villages. Even to-
T
the cosily and prolonged
course of studies is not going
to spend all that money with
out deciding in advance who
quickly it could be recovered
and how the investment could
be multiplied over the years.
One need not
expect the
medical practitioners to do
social work sacrificing their.
*«ct,tr5
-inlcr
.
lEifi
t
tP- - <
g. •
ffillEn
PILLS:
Medicines
Third World Poor by
Dis’»a tiM-ose
Osfarm publi'■“'ion Pa'S? 4 95 sterling Can
*
'•
ri™Tolldrm, 59, Miller
’‘“d.
SGOMO
Town Bangalore^""payment in rupee
equivalent.
Does increased life expectancy
in the Third World mean — at
least for the poor — more years
of pain and suffering? With po
verty itself the main cause for
ill-health, most developing coun
tries have, with their mixed-up
Priorities . not been
able to
evolve health policies that meet
. the conditions
and needs of
their own communities.
There has been a growing sus
picion for long that these poli
cies are influenced to a large
extent by the multinational com
panies or their national counter
parts which have a vested in
terest tin continued ill-health of a
majority of the people. Another
doubt
that has been gaining
ground in recent times is whe
ther modern
— by which is
meant Western — drugs offer a
solution at all to the health Pro
blems of the Poor countries
Oxfam, which has been doing
commendable work as a British
Voluntary
agency
promoting
.health — as a positive concept
of higher quality oY the life ra
ther than absence of disease —•
has brought out this book by
Airs. Dianna Melrose, based on
field experiences of Oxfam acti-
Mnqbul I'lda Husain
_A.il vnr ’youRt
expect'from them is not to be
racketeers, not to sacrifice the
interests of public health to
make a fast buck, not to be
come willing tools of com
panies trying to make money
On the sufferings of the mas
ses. Racketeer may’ be a very
strong word to use, but what
else would you call “general
practitioners” who would send
their patients to half a dozen
specialists unnecessarily t-o
get a commission from them,
who would prescribe costly
new brand names just because
the medical representative of
the company had given a good
gift? How many doctors really
keep abreast of the recent
developments
in
medicine
The book has a fund of use
ful information on health Pro
blems and services available in
developing countries. It pinpoints
the main Problem: the medicare
system is so drug-based and doc
tor-oriented that poor people of
ten buy unnecessary
Western
medicines they cannot allord, be
lieving that they hold the key
to good health, ‘Bitter Pills
*
ex
plodes this myth carefully nur
tured. It highlights the work of
organisations like Gonoshasthya
Kendra in Bangladesh crusading
against false claims of multina
tionals.
The book comes at a time
when there is a growing aware
ness of the need to evolve a
broader
strategy for
belter
health in the Poor countries, bas
ed more on preventive measures
and inexpensive, easily accessible
remedies and systems. This book .
will go a long way towards co-1
,
ordinating the efforts of several
groups in different countries to
evolve this alternative strategy. It
makes valuable reading for every-1
one who feels concerned and1
wants to bring about the socio-1
economic changes necessary fori
such a policy.
1
_ earn
ed
figure,
quietly
brings his Fiat car to
a halt at one of the Dhabas
in Nizamuddin. With quick
long strides he slips inside
this crowded, noisy, place
and sips his strong morning
“Cha”, listening to the talk
other than what the drug of those who struggle from
firms’ literature tells them? dawn to dusk for sheer exis
How many question
those tence.
claims or verify them?
.......
In this milieu of the hum
“Doctors need continuing
education. Nowhere in India ble, his bare feet and long
have I come across arrange flowing white beard
raise
ments made by the State for
In fact,
he
providing refresher courses no curiosity.
for the doctors. Most doctors seems to be so well accept
are too busy earning money ed, that a fellow stranger
to read anything” Dr Chowd questions, “Do they pay you
hury says.
■ The only books most well?” to which the old man
doctors read today are the politely answers: “Yes, my
bank (pass) book and the boss is good to me”. He is
Sahib’s
cheque book,” says a wag. mistaken as some
since
he
always
The way some of the mod driver,
comes
driving
a
car.
ern general practitioners
■This is Maqubul Fida’ Hu
function now, all that they
you a
need to know is a list of sain narrating to
broad spectrum antibiotics. case of his mistaken iden
tity.
India
’
s
Piccasso,
the
Even before you complete
telling the symptoms, a pre man who might well be des
cribed
as
the
Number
One
scription will be scribbled
and the palm extended — modern artist of this coun
try, Husain has a piquant
sense of humour and thor
oughly enjoys
the lighter
By Sonieswar
moments of life. He
was
amazed when a young cou
ple
spotted
him
at
Connau
for fflonev. Anything a little
c°ffiplicated wiU always be ght Place and he overheard
them
say:
“He looks
like
referred to specialists. Most
Husain is
well
the knowledge a private Husain!
Practitioner now acquires
after assing out of tbe me’
dical Jojiege is what the me
dical representative
dole
out-Jong"’ith freesamples
-_
— £ fTiYlP IS IHolcaILl
hinol
a
cognition, in his case it has
lead to some Yeiy
experiences and he
have a good laugh a l =
about it- A few years back
on a visit to New Yoik city
he went into a 24-hour res
taurant after a- lat.e
-—.e nighl
movie. IHe
T round
"
himself
l
corner seat —
A as he wait
and
ed to place the order,
ne>
~
he
moved aside a box of ciga
rettes he found lying or
the table top. His
move
ment was noticed by the
manager who was quick tc
confront Husain with t
rude yell: “Out, get out oi
this place.” They thought
him to be a tramp out tc
steal the cigarettes'.
Getting
this
celebrity
painter to talk about him
self wasn’t easy. Husain pro
mised to be interviewed or
a Sunday morning '
his recent visit to during
lore where he had Bangabeen
beep
specially invited to display
a selection of his works by
a five-star hotel. When 1
tapped on the door of his
suite at the appointed hour.
a young lady informed me
that Husain was out and
would return an hour later
Much later. I located him at
the hotel’s coffee shop ;md
reminded him of my inter
ailIt f ftvery
to condemA \tors butis t0 be
rcalk a° that they only reflec
rot m 1110 s,oclely
?y’. There *h mic.
Which nro',e 1
movement
against
h ■ he
"’f.nce has come
■f “S deca‘® inger and more
1 0111 the ^°ltrious doctors
tShOciaHy c°nTS are today
thenisiqves. * organisations
nearly 3 d°ze ’a scientists,
°fh4to(S
to evolve
Which tff® for the medical
a
etliaVd give it a new
pr°fessiri'c3inie of th® °-rg^
dlreetioP- S“ Medico Friend
nisati^ are’
Voluntary
Circle " paction of India,
Wealth .\ss°? ow Cost Drugs
T^!&
H,
-
|
Our medicare
system creating Picasso
of India
view. He cracks the boiled
egg he has
ordered
for
breakfast and tells me that
he “is not in a' good mood
to talk.” The interview is
then fixed for next morn
ing. I find him at the gal
lery giving some finishing
touches to his paintings.
Greetings over, I ask if
we can now sit down and
talk, but to my utter sur
prise, even
with out
an
“excuse me”, Husain walks
away from the gallery.
1
wait another
45 minutes
wondering where he
has
gone. Someone in his room
informs me he is at
the
gallery — another helpful
hotel stuff member tells
me he saw Husain
going
out of the hotel!
Puzzled
by this strange behaviour I
decide to leave the hotel.
only to find Husain coming
in a’ car up the drive. I ask
him if he is interested in
the Interview.
He renders
no apology for his absence
but effusively leads me to
the poolside and orders cof
fee as a prelude to the in
terview.
east 23 of
drug com
bing quesre obvious
line social
y did not
t be most
ese issues.
so far —
menauuslj3 Dr. Zaf•f Banglaor himself
ng project
ounder of
Ira
(<peoat Savaresh. says:
y are, for
isconed in
serve the
v produce
s saying
have prooblems for
vailable to
bave been
decade in
r, academic
sad by the
a medicare
e suited to
majority.
■ie there is
. system of
and creatcadres”.
ioned
apasking docreas. There
ts to make
ulsory for.
majority of
iced at the
yers’ money
spends on
many times
jnt paid by
« fees) prees even if
a a meagre
to teaching
oolsBut
to villages
be treated
e they can
ractice and
day thousands of doctors
trained at the expense of poor
Indians are allowed to man
the public health services of
England and Arab countries
just because the country gets
some foreign exchange.
Says Dr Chowdhury, who
recently visited Bangalore:
Colonialism has -left much of
health systems largely irre
levant to their conditions.”
The functions of medicine are
social — fulfilling the social
needs to promote good health
prevent diseases, treat those
affected when the preventive
measures fail and rehabilitate
them. And yet the whole app
roach of medical education is
not that of a social science It
is presumed that the body’ is
machine. Most of the treat
ment is symptomatic and not
prophylactic.
Medical education is open
only to the rich, who mostly
have their values based on
money. A student who pays
a capitation fee of Rs 1.5
lakh to 2.5 lakh to undergo
Close friends tell me that
he is “very forgetful” and
I let that be an explanation
for his odd, if not rude, be
haviour.
If Husain canvases are
large, so is his story.
He
punctuates his talk with co
lourful imagery and emer
ges as an ageless
figure
with amazing vitality. Two
hours quickly slip by as he
the costly and prolonged
course of studies is not going
to spend all that money with
out deciding in advance who
quickly it could be recovered
and how the investment could
be multiplied over the years.
One need not
expect the
medical practitioners to do
social work sacrificing then-
-.-jnictoersia'.
Air
By Aban K. A. Lal
BInqbul Eida Husain
one V'tyuld.
expect from them is not to be
racketeers, not to sacrifice the
interests of public health to
make a fast buck, not to be
come willing tools of com
panies trying to make money
On the sufferings of the mas
ses. Racketeer may be a very
strong word to use, but what
else would you call “general
practitioners” who would send
their patients to half a dozen
specialists unnecessarily to
get a commission from them,
who would prescribe costly
new brand names just because
the medical representative of
the company had given a good
gift? How many doctors really
keep abreast of the recent
developments
in
medicine
d even toquacks and
have a
in villages.
s tmscienmedicine”
rs” have a
ns. Even to
* - -S -DA.W.M. .breaks- ovoi:. ..axvara . iUial-.lna bisaiux- . looks
Ma >ld Delhi, a tall, boy.ZJMshly slim, white-hair
ed
figure,
quietly
brings his Fiat car to
a halt at one of the Dhabas
in Nizamuddin, With quick
long strides he slips inside
this crowded, noisy, place
and sips his strong morning
“Cha”, listening to the talk
othe? than what the drug of those who struggle from
finn| literature tells them? dawn to dusk for sheer exis
How many question those
tence.
clains or verify them?
In this milieu of the hum
“ftetors need continuing
eduation. Nowhere in India ble, his bare feet and long
have I come across arrange- flowing white beard
raise
menk made by the State for
In fact,
he
proving refresher courses no curiosity.
for the doctors. Most doctors seems to be so well accept
are
busy earning money ed, that a fellow stranger
to r$rl anything” Dr Chowd- questions, “Do they pay you
“%says.
‘ file only books most well?” to which the old man
doctors read today are the politely answers: “Yes, my
bank (pass) book and the boss is good to me”. He is
Sahib’s
cheqge book,” says a wag. mistaken as some
since
he always
The jvay some of the mod driver,
ern general
practitioners comes driving a car.
■This is Maqubul Fida' Hu
function now, all that they
you a
need to know is a list of sain narrating to
broad spectrum antibiotics. lease of his mistaken iden
tity.
India
’
s
Piccasso,
the
Even before you complete
telling the symptoms, a pre man who might well be des
cribed
as
the
Number
One
scription will be scribbled
and the palm extended — i modern artist of this coun
try, Husain has a piquant
sense of humour and thor
oughly enjoys
the lighter
By gomeswar
moments of life. He
was
amazed when a young cou
^y hing a jita ple spotted him at Connau
ght Place and he overheard
^caled W111 always be them
“He looks
like
of c£ed to specialists. Most Husain!say: Husain
is well
* i Pledge
P
a^tioner
now aacquire®
Does increased life expectancy
in the Third World mean — at
least for the poor — more years
of pain and suffering? With po
verty itself the main cause for
ill-health, most developing coun
tries have, with their mixed-up
Priorities , nor. been
able to
evolve health policies that meet
the conditions
and needs of
their own communities.
There has been a growing sus
picion for long that these poli
cies are influenced to a large
extent by the multinational com
panies or their national counter
parts which have a vested in
terest in continued ill-health of a
majority of the people. Another
doubt
that has been gaining
ground in recent times is whe
ther modern
— by which is
meant Western — drugs oiler a
solution at all to the health Pro
blems of the Poor countries
Oxfam, which has been doing
commendable work as a British
Voluntary
agency
promoting
health — as a positive concept
of higher quality oT the life ra
ther than absence of disease —
has brought out this book by
Air-. Dianna Melrose, based on
field experiences of Oxfam acti
vists.
•
The book has a fund of use
ful information on health Pro
blems and services available _ in
developing countries. It pinpoints
the main problem: the medicare
system is so drug-based and doc
tor-oriented that poor people of
ten buy unnecessary
Western
medicines they cannot afford, be
lieving that they hold the key
to good health. ‘Bitter Pills’ ex
plodes this myth carefully nur
tured. It highlights the work of
organisations like Gonoshasthya
Kendra in Bangladesh crusading
against false claims of multina
tionals.
The book comes at a time'
when there is a growing aware
ness ot" the need to evolve a
broader
strategy for
better
health in the Poor countries, bas
ed more on preventive measures
and inexpensive, easily accessible
remedies and systems. This book
will go a long way towards co
ordinating the efforts of several
groups in different countries to
evolve this alternative strategy. It
makes valuable reading for every
one who feels concerned and
wants to bring about the socio
economic changes necessary for
such a policy.
Photo: G. Narayanaswaniy
di£ Essing oul of the me
di college is what the meV representatives dole
an^
?ngWIlh freesamples;!
j. <a‘’fts.
isdoctors,
veiy but
easyit istotocon
^e!
flc„Sed tlial fhey only re.
itJ. the rot in the society
eX3 « wou,d also
an
do^eration to say that all
rWhi
y l°ts
fall into
catego. /
there
are this
exceptions
prove the rule.
/
Oii?e movement against I
fi;. decadence has come I
sori. ^e younger and more /
thn % conscious doctors I
nerves. There are today I
of
a' dozen organisations I
WhStors and scientists, I
a‘
are trying to evolve I
ethos for the medical I
d^sion and give it a new/
b Son
SomeMedico
of theFriend
orga- I
C
‘?lions’are:
Pune:
Voluntary/
At?11!) Association of India !
anlv belhi; Low Coat .^'uRs|
Vi? 'I'hcrapeutics Cell of I
h.Ml
Dehradun; Arogya /
Xta ^<ndal, Pune; Del-
wge 11, col 4 [
may sometimes earn
him talks of ifnporant landmarks!
the label of a ‘tramp’. If the in his 50-year-old career as I
price of fame is instant re painter extraordinary’.
Born
into a
relatively
cognition, in his case it has
lead to some
very’ funny poor family living in Guja
rat,
Husain
was
one
of eight
experiences and he likes to
have a good laugh talking children. His father was an
His mother, a'
about it. ■ A few years back, accountant.
on a visit to New York city, Gujarati woman, died when
he went into a 24-hour res Husain was a mere baby of
taurant after a late night one and a half years.
Husain’s
childhood was
movie. He found himself a
corner seat and as he wait spent at Baroda and Indore
ed to place the order, he He learnt Persian in school
moved aside a box of ciga and dreamt of being a poet s
rettes he found lying
on like his maternal uncle. “I I
the table top. His
move thought I might one day be
ment was noticed by
the come a poet or an art di
manager who was quick to rector for films, but I never
confront Husain with a thought of becoming a pain
He claims however.
rude yell: “Out, get out of ter.”
this place.”
They thought that he started painting as
and was
eleated
him to be a tramp out to a child
when two of his landscapes
steal the cigarettes!
Getting
tills
celebrity were sold for Rs 10 each,
painter to talk about him way back in 1932. “I felt
self wasn’t easy. Husain pro very confident about paint
mised to be interviewed on ing when I found that some
pay
a' Sunday
morning during one was prepared to
his recent visit to
Banga twenty rupees for them. In
lore where he had
been those days a whole family
specially invited to display could live on twenty five
a selection of his works by rupees a month. It was a
a five-star hotel.
When I big sum”. When asked what
tapped on the door- of his was price range of Husain
suite at the appointed hour, paintings today, he parried
a young lady informed me the question by saying that
that Husam was out
and the paintings he sold for in
would return an hour later. 1952 for about Rs 500 would
Much later. I located him at today fetch over Rs 40,000
the hotel’s coft'ee shop and
reminded him of my inter
On page 11, col 1
n to join the group
'ay known as
sain has been inspired by
the German painter Paul
Clay who had
some “un
derstanding of our Upanish
ads and vedas”., Husain’s
painting are best appreciat
ed in Germany where, he
feels, “they understand India” Some of his
major
works have sold
well in
England and 1he USA. He
finds New York “very competetive” in the
world of
art”., If you are good you
can sell there and it does
not matter from where you
come”., Husain
visits the
USA almost every year and
the
sive painters”.
troup, in the words
in, decided to give a
nguage to the coniry art scene”., “"’e
wish to follow the
British
school or
ivalist school of Ben; to discover a new
our own". Husain
latic about exposing
th that ’modern art’
•rn.” Its techniqut
but its
western,
oriental”, he says..
n feels that modern
--k;"
paint”...
Husain was so engrossed
in talking about
the art
world that he had failed to
notice that his coffee had
become stones cold and tht
end of his long snowy be
ard was dipping in it.. One
cannot help but like his nat
uralness., Although his glo
be-trotting has °taken him
Europe
over 50 times to
Husain spand lhe States -----eaks lovingly about India.,
“I am happy in India, I like
to Jive here and whether I
paint in India, Paris or New
York my themes are all In
dian”.,
Husain says that in his paintings he likes to capture
Indianness. He is influen
ced by the richness of colo.
ur that he finds in the Pa.
hari paintings and is fascin
ated by lhe gods and godIndia..
desses
of Hindu India.,
Some of his canvases have
featured Gupta
and Chola
styles of art., Husain says
that he does not care for
any "Ism”,.,
He likes to travel to diff
erent parts of India and to
observe the “mysteries of
lhe human panorama" and
then paint them. The sub
jects he paints varies from
lime to time; sometimes it
could be a horse, an umbr
ella. a cow a woman or a
child — the list
can be
mak-S £rCat intercsts in film< K1hg and he would like
hu’?ake a feature film” in
and white rather than
, colour"-. He has made a
beveh
experimental films
?,nd a few years ago Delhi
,,.0°r<larshan used one of
ttls films
“Through
lhe
®yes of a painter", which
'Vas an artist’s perception
, . Rajasthan.
They paid
C1111 the grand fee of Rs.,
50 tt
Husain feels ,_ there Is a
great paucity of art galler
ies in India and he would
like fhe government to con
oid building some in the
important cities of India.,
He js quick to point out
., there are
only two
that
publie art galleries In Bombay, one in Delhi, but sur
prisingly none In Calcutta.,
Hc was appreciative of
'he move undertaken
ny
'he Welcome group of ho
tels to sponsor exhibitions
of painting and recitals of
well-known and aspiring In
dian artistes. The new pa
trons of art tn India were
the industrialists and some
°f them like Talas, Birlas,
Goenkas and Modis were
helping to build up collec
tion of eminent Indian ar
tistes, he said..
Husain, whom T
would
place somewhere in the age
group of 1he late
sixties,
coi.euuon nas very few of
his own
paintings,
since.
they are all sold out., How
does it feel to be a painter
whose single painting can
command a lakh of rupees?
This is the price of fame
that Hussain has reached
from those days
m the
late 1930’s when he slogged
painting cinema hoardings
in Bombay earning”
six
annas a day”.
Husain’s
answer to all this fame is
to doubt his own fame., He
Is humility personified..
When asked about what
his initial M.F., stand for,
Husain jokingly replies that
1’ney stand “for Mother and
Father” In a sense he is ri
ght, for the Father-figure of
modern art tn India today
has a truly, paternal
ap
proach, whether It is en
couraging other budding pa
inters or painting with one
thousand school children as
he did in Bombay recently.
If the great painter Leo
nardo Da Vinci left an im
print of his greatness on
the Cistern Chapel, Husain’s
canvases capture the spirit
of India, in a
refreshingly
contemporary style., Behind
thoss bushy white eyebrow
two sensitive eyes peer at
you, sometimes sensitive,
sometimes smiling, but ever
ready to take in the human
panorama as only a Husain
can.,
■dr -
if--’ Y .' ■' '’.bl
■I'
:
.
. ':
Tractor run
by lhe sun
' ,:
-
From page 9
to India recently.
The Gonoshasthya Kendra
hi Science Forum;
Society
founded by Dr. Chowdhury
of Young Scientists,
New
and his associates in 1972
Delhi: Concern for Correct
created history last year and
Medicine, New Delhi; Consu gave the lead to organisa
mer Education & Research
tions in the developing coun
Centre, Ahmedabad; Centre tries including
India,
by
for Education and Documen- successfully campaigning for
tation, Bombay; LOCOS'I; a fart on ‘nazaruous ana irBaroda; Federation of Medi ratpnal drugs. A eight-memcal Representatives Associa . bet expert
committee
of
tions of India; Patna and po wheh Dr. Chowdhury was a
pular
science
movements menber, recommended ban
like Maharashtra Lok Vig- on 1707 products of medical
nyan
Sanghatan,
Shas- anc pharmaceutical compa
tra Sahitya Parishad of Ke nies in three categories. The
rala and Science Circle of firs included 265 locally
I.I.Sc.
male and 40 imported drugs
as positively haIt is at the invitation of regirded
some of these groups that zarlous which were recomDr. Chowdhury,
the one- meided for immediate ban
man crusade against exploi and destruction. The second
tation by multinational com category included 134 arugsreformulapanies, which has grown in whih required
to a movement now, came tion and were to he banned
■
f protrait by Husain
By P. S. Sharma
sulk of the energy
the kitchen are met
i-commercial sourfirewood, agricultus and cowdung. As
133 million tonnes
ad, 73 million tonwdung and 41 millis of agricultural
re burnt in India
ir. These non-comources together proar cent of the coun:ing energy requireCoal and kerosene.
ialive sources of
energy, are thus
or barely 13 per
mr cooking requireod,
indeed, has
main fuel since
remorial and it still
the major source of
or cooking in India.
per cent of such
n towns and cities
om this source. The
resources in the
have already reacritical stage and
i unabating denudaforests the situation
g. worse day by day.
old mean that people
find it progressively
fficult to meet their
tergy
requirements
ing.
of commercial as
non-commercial fuel
jistered a phenomenwhich is creating furistrainls. During the
ending 1980-81, while
■me rose only by 143
t, the wholesale priill commercial fuels,
light and lubricants
264 per cent. The
wices must, undoub-
tedly, have registered a still
greater increase though the
precise figures are not avail
able. Non-commercial fuels
like firewood are also cover
ed in this phenomenal rise.
Our enormous dependence
on firewood has been our
great disadvantage. Demand
has far outstripped supply
and the gap is widening
every day. Take Uttar Pra
desh for instance. The de
mand for firewood in the
State in 1978 was 42- million
cubic as against production
of only 18 million cubic me
tres. By 2000 A.D. the de
mand is expected to rise to
63 million
cubic metres,
while with unabated urbani
sation and deforestation, the
supply could further go
down.
The case of Madhya Pra
desh is still worse. In 1977,
as many as 30 out of 45 dis
tricts were already suffering
from a firewood famine.
And if the present rate of
demand continues, forests in
all but 15 districts would dis
appear in another 20 years.
In a state like Himachal
Pradesh, whose entire econo
my is dependent on forests,
constant denudation of for
ests is nothing but suicidal,
and yet it is going on reckl
essly.
There is another dimen
sion to the cooking energy
crisis. We have Io waste a
lot of energy Io obtain this
energy. In many villages,
an average family has
to
spend two to three hours
daily trekking a distance of
four to six kms to gather
firewood.
Children become
th? uuwdlms arid helpless
victims of this energy crun
ch: as adults are busy earn
ing a living or doing house
hold work, the children come
in handy to be assigned the
fuel-gathering work. Their
education, and mental deve
lopment suffer irretrievably.
The position is much
worse in villages, especially
in the desert and in lhe hilly
areas where long distances
have to be traversed and
long hours to be spent on
getting drinking water too.
Fanners with large herds of
cattle have set up biogas
plants and big
landlords
have started using crop re
sidues as fuel. But the pro
blems of those who own no
land have grown manifold.
When they hardly have en
ough money to buy food,
where is the question of
their buying firewood? It
seems that millions of rural
men and women have got
entangled in a vicious ener.
gy crisis. They eat food, to
produce energy and then
spend this human energy —
all of it — in producing food
and gathering fuel to cook
it. And so on and on in a
circle like the proverbial
bullock
going
round a
‘kolhu’.
The firewood crisis has
hit the city dwellers too. Ac.
cording to reliable statistics,
nearly three quarters of fire.
wood and about, half of the
dung used in urban India is
purchased.
A
substantia!
part of it is brought from
the villages on head, in bul
lock carts or in trucks. Most
wood stoves or chulhas have
an efficiency of only five to
ten per cent. So it may just
be that this firewood gives •
us less energy than is spent '
by trucks in transporting it.
Dltiniately, it comes down
,0 so much energy wasted.
Sensibly, firewood is meant
local consumption. Its
?ransportation lo the cities
,s both , uneconomical and
wasteful, and it should,
'berefore,
be completely
banned. The alternative so
urces of liquid petroleum
Sas available to the urban
1)0I>Uia(ion is highly restrictso that the vast majority
'■as still to depend on coal
°r kerosene. But supplies of
Cual and kerosene are also
brnited, and we have to find
°Ut newer and newer sourCes of energy for industrial,
.38ficultural and transporla'mq purposes. Hydro-eectn(i|y is one source; biogas is
a|ioti)er. Then there are the
Oeean and tidal waves, the
’"'clear energy and the inexliaustible source of solar
etoerHy
The potential js
vast but wc d" not have as
‘Vet ’lhe requisite technology
lo exploit it.
i’ven then, the most essen*‘"1 reouirement of energy
Mil s-till be for cooking purPosos We may close down
’he . :-r conditioners, but not
I’ll!.'cooking ranges. We
"’list therefore increase our
'irt„ood supply 1°
'east
r Id of its present qu■■Ultii’'
That is the crux of
th« natter- The forests, as
X
of firewood are
'ho " ine of the rural poor.
If i
indiscriminate denu""Ii 'C of f°resls is ”Ot CheC'
d
will spell doom on
.'/Jcultural and Indus-
X economy-
in six months and the third
742
loeallv manufactured
and
526 i::.,
_________
_
imported
drugs.
The last category either had
little or no proven therapeu
tic value or could easily be
manufactured by local com
panies, instead of the multi
nationals.
at much lower
easts,
TJio—,-opoct-
of ihe
committee,, submitted
on
May 12, 1982, was approv
ed by the Chief Martial Law.
Administrator <m May 29 ~
perhaps a speed record In
governmental
action.
On
June 12, the Drug Control
Ordinance was promulgated.
America exterted maximum pressure on behalf of
the US companies and was
joined in by
the British,
French, German and Dutch
governments. The US admi
nistration m Washington d:d
its best to hav-t the ban liftsome changes made.
Says Dr. Chowdhury: “Se
venty per cent of the an
nual drug sales in my coun-try are of drugs described as
useless or therapeutically in
significant by the British
National Formulary, the Na
tional
Research
Council.
USA and the Federal Drug
Administration, USA”.
He
said out of the 51 products
of Glaxo sold in his coun
try, only 17 were marketed
in UK and just one-third of
them listed
as
‘essential’
drugs by lhe WHO.
ed„ Dr., Ravi Narayan of
gned a prototype of a sol;
St., John’s Medical College,
who is actively associated
side it differs
from a con
by Medico Friends Circle,
ventional tractor by a broad
visor above
the
cabin.
VHAI and another similar
This
visor is
actually
organisation ‘search’ is wor
a
solar
cell
assembled
king with groups like the
of flat-shaped direct .solar
Science Circle to first mobi
energy converters. Tlie maxi
lise the science community mum caoacity
.40Q-600
walls. '
and -then generate public
buC
to activate lhe
opinion in favour of cheap
alternatives to the modern
age batteries. Tractors never
drug-based health system., operate non-stop. Some time
In an- article in the forth they idle, while energy ac
cumulation is a continuous
coming issue of the Bulletin
process, which does not stop
of Sciences published by the even on a cloudy day. The
Popular Science Movement
cells are sensitive enough to
and the Science Circle, Dr operate by scattered light.
The development of this
Narayan says that‘practices
prototype does not mean that
which needed to be checked
tomorrow it will go into serial
in India are:
1 production. Solar cell produc■I. Sale of drugs banned I lion is a very costly business.
in other countries, ed. Lo- ! This tractor, however, can be
motiland cliquinoi prepar- i effectively used for improving
lhe design and systems of the
ations.
machine. As soon as the cost
ii- Sale of irrational com of solar cell production comes
binations and formulations down to an acceptable level,
iii. Sale of drugs without the tractor will immediately
adequate precautionary pro go into massive production.
duct information.
iv. Sale of drugs as highly
inflated costs. For example,
Analgin is being sold at 20
1o 30 times the cost of pro
duction .,
Sri Lanka,
which
also
adopted a similar drug poli
cy buckled under the Ame
rican pressure. Pakistan was
too preoccupied
with Isla
mic fundamentalism to bo
ther about such progressive
measures.
The ‘failure’ of
these two countries to ban
these drugs
and the fact
that India, considered moreadvanced, had not. bothered
to ban any of these drugs
including t he acknowledged
harmful enterovioform and
maxaform are held out by
the pro-American lobby and
the multinationals as proof
that the Bangladesh policy
was wrong.
v„ Promotion of drugs for
indications that are not cli
nically proved and are of
ten potentially dangerous.
or example, pregnancy test
ing drugs which
induced
abortions were freely sold,
till a campaign was launch
ed against them, despite
well • documented scientific
evidence that the risk of fo
etal deformity is increased
by lhe use of these
haimonal preparations.
vi. Sale of spurious, ad
ulterated or poor quality
drugs Eg. turmeric powder
is sold as
tetracycline in
capsules.
vii., Sale of old, expired
and unused drugs
viii. Over - prescription
and misuse of tonics, higliprotein foods.
harmonal
preparations and baby foods.
ix. Sale of drugs without
prescriptions and
x. Production of drugs for
profits rather than health
“What, is
probably the
most humiliating comment
on the social consciousness
of India health
personel
is that the Indian drug po
licy is quoted by the multi
nationals to condemn the
Bangladesh ban. Drugs which
have been banned in Eng
land in the 30s and even in
Nepal in recent years
the
freely available across
This
counter
in
India.
makes banning them in Ban
gladesh more difficult as
they enter our country from
India,” Dr. Chowdhury says.
The social consciousness of
the Indian medical commu
nity haa finally been arous-
Quoting the Indian Coun
cil of
Medical
Research
(ICMR) and Indian Council
of Social Science Research
(ICSSR). Dr. Narayan says
that while drugs for dise
ases like leprosy and tube
rculosis are produced at onethird or one-forth of actual
requirements, tonics vita
mins and high protein sub
stitutes are being produced
in wasteful abundance.
A joint report by ICMR
and ICSSR has
warned against the erne
gence of a
doctor-drug
'« p.uuuver
producer __
axis"
lo exploit the people.
Can India not do what
even Bangladesh could do?
Dog bails
master out
A persistent dog won the
hearts of the police in Maduyear-old hawker, released on
hail. T.
Jeevanandam,
tlie
hawker, was arrested tor his
involvement
in
fight
and
placed in lock-up at the Tallakulant
police station. His
dog s fidelity the Inspector apnot leave till touched by the
dog's fideity tiie Inspector ap
proached tile legal aid celt lo
get Jeevanandam released on
bail.
Sold blood
800 times
five-year-old boy. is one oi the
estimated 60.000 people who
live on selling their
blood.
Over the. last 20 years Madan
Lal has donated blood about
800 times — at times thrice
group with negative Rh fac
tor fetches
him
customers
from far
off areas.
These
people haunt blood banks al
New
Delhi and put
their
blood
on sale for a measly
amount.
Solution io Word Sleuth
Plug In
7/
COMMUNITY HE-1 TH CELL
326. V Main. I Luck '
Koranihngala
Bangalore-560034
s
'ndla
'
DRZFT
OF THE RATIO?-AL
PREAMBLE :
DRUG
POLICY
........>rr:-<Ka,
Safcfarinn■.
New Delhi-J 10)16.
(’JAREHA DOCUKF.NT)
DlUG POLICY pi THE PERSPECTIVE OF HEALTH POLICY
The Committee for Rational Drug Policy would work towards a rational drug policy in
India and would oppose the irrationalities in the production, marketing and use of
riKdicines in India. The CP„P believes that a rational drug policy can be really
meaningful only as a .part of rational health, policy and hencd CRDP would work on the
drug issue within the framework of a broader perspective, of a rational health polic r
Majority of the Indians suffer from the diseases of poverty and ignorance i.e.
conmunicable diseases, diseases due to undemutrition, etc. These are preventable
and curable. Industrialisation and urbanisation have also led to spread of conse
quential diseases. That we need then, is adequate nutrition, safe water, universal
sanitation, environmental protection and a primary medical care service available
to all.
ROLE AND UTILITY OF DRUGS II’ 'TDIC/.L CARE
Though proper provision of food, water, shelter, physical and cultural environment
are essential and much more important in improving 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 ar individual or personal responsibility aid it is belie
ved that freedom from diseases could only be obtained by better and better and more
aid more drugs. Such a belief among educated and illiterate alike has led to a uni
versal craze for drugs end 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. ’de are told to reject this dependence on drugs and concentrate on attacking
the socio-economic cause of illness.
It is not disputed that without being free from inequality end exploitation, a socio
cannot achieve freedom from avoidable illness. On the other hand, one cannot allow
people to suffer and die till that real freedom arrives. Hence, in our society, meti
cal care service has an immediate, essential and priority role to plat1/ and the drugs
occupy a pivotal position in the nodical care service. Desides, 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
policy.
OBJECTIVES OF THE RATIOL'AL DRUG POUCY
(a)
(b)
(c)
(d)
(e)
To ensure availability of safe efficacious drugs to all the needy.
To eliminate harmful and irrational drugs.
To ensure production, distribution and use of all drugs on scientific basis
and in accordance with the need.
National seld reliance on priority drugs.
I ..
To ensure dissemination of relevant information to the medical profession
and consumers as well.
PRIORITY (ESSENTIAL uRUGo)
It hardly needs sr.phasis that we have to set up priorities for, the production of
drugs accordin • to the prevailing disease attorn i.e. drugs to combat communicable
and nutritional diseases should claim priority. The idea behind the term 'essential
drugs' may be better served by using the words 'priority drugs'.
- 2 ’hile there is paucity of essentia], end life saving drugs, the market is flooded
with irrational and even harmful drugs. 'There.is no effective measure..to ..curb th?
profitcring of the dominating l-u!HS, neither there.is much awareness amongst the
medical profession and people regarding the' unfair practices in the drug industry.
(Ref. Hathi Gomittee Report)
All the aspects of existing drug policy need to be completely overhauled-in order
to effect a Rational piug Policy. Such a change would involveamongst other things,
nationalization of all the major drug companies along with a social control over ill.
nationalised sector. Rut such a stepcannot be expectcdin immediate future: because
of the low level of awareness about .the"necessity of a Rational drug Policy" ar.cn
*
st
medical personnel, politicians, government, officials aid the common'people; and
because of tho weakness of the people/s i'iovonent in renera]. Hence only the follow
ing intermediate measures are to be"1 demanded front; the government, ..These measures
do not constitute a full-fledged Rational Drug Policy in India but are steos- in
the right direction
*
t’e demand from the Government the following:
■“■Setting up of an independent machinery, to scrutinize all the cirugs currently
marketed in India cn the following-principles.
;<The committee would be a permanent body and would review the drug policy
every year in the light of new information on older drugs and invention
of new drugs. No drug in India can be produced or marketed in India unless
approved by t’uis committee.
Such a committee should be formed at tho
state level.
.
"-Production and 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,
'
-rr *
"■Importance from the point of view of .community medicine, of diseases
against which the drug is to be used. For ecam.le, drugs to be-used in
diseases that cause larger mortality, severe morbidity, serious sequelae(after-effects) would get a, priority. Drugs used in the i-’aticnal fro; rames
of prevention and control of diseases (tuberculosis, goitre ,-etc.) to get
priority. Thus vaccines'to get priority over multivitamins, antibiotics.
^Therapeutics rationality -which included consideration of both efficacy and
safety (therapeutic index). Only those drugs and their combinations which
have been recomended by. latest edition of standard textbooks or by i-MC
to be produced.
■
"-Cost and self-reliance: jhsn there is no qualitative difference between
therapeutic rationality of two drugs, priority should be given to the chaap/er
one and/or the one, which is closer io the.requirements of national selfreliance.
. .
Further, the national drug formulary should be revised and compiled by an expert
':iuliidiscinltnary comittce kee ping tho following criteria in mind:
spatiality
KSafet;
■Sase of administration
•AvajJ^jJitx
•Potential for misuse
Such evaluation of the drugs, in the; market and revision of tho lists should be don:
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 'Indian Company'. No company
should be given the status of Indian cc pany unless the plant and machinaries are
installed on turn key basis a'd no stipulation is put for import of raw materials,
from the parent company.
Transfer technology should be
wn under bl rd 0 recommendation.-,. Only latest techno
logy can be imported on the basis of global tender from all the developed countries.
Preference should be given to the countricJ whoever accept 'Rupee' 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 discharg.
the statutory duties cast upon them.
No import of machinaries directly or without the guarantee from the end-users. No
import of machina les, 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. ho fashionable packs like tonic bottles, bliser pack
etc. should be allowed.
All taxes of pidority esserti"?. drugs should be abolished. Subsidy should be provided
for transport of essential drugs and raw materials.
"Leader Price" system is to be changed and maximum price of each drugs is to be
calculated on the basis of BIGP data., The ba?is cf 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 product i-n c apacity has to be determined by the Committee and.
it should be distributed to the manufact'jr3 for essential drugs which should form
the minimum base line for capacity ’f-ilfsati.cn.
No COB licence or production over the licenced capacity should be allowed.
QUALITY CONEROL
Adequate number of Drug testinglaboratories are to be established in different parts
oi 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.
bpecral statute and judicial set-up 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 expediteous trial.
In arrangement with the leading institutions in four zones of th.'b country trial
and study has to be made for eanh new drugs before its introduction.
Information regarding banning withdrawal of drugs from the market has to be publisted in mass media and mailing to the retailers, and medical professions. Drugs
should be immediately replaced to the buyers if any doubt is expressed even if a
part of the pack is used. Cosmetics, C'iC drugs, household remedies cannot be sold
from the shop where pharmaceuticals are sold in the cities and towns.
S; J .1,3 PrtCixCTI Oi ~
There should be a permanent Watienal Organisation for information on drugs and
therapy. Information is to be circulated by the organisation every month through
a journal, (updating N.F.I. and I.?.)
.Ci?, sales promotion activity, only scientific information can be circulated by the
manufacturers. .All sales promotion informations/advertiserents has to be checked
by the national organisation of information education and communication on medicines.
No physician sample should be given. Any form of .literature, visual, aids etc.
can be published without mentioning full indications, contra-indications, side effect
drug inter action raid anti-dotes.
uo gifts of any form shall be allowed to be given to the medical profession and t.^^H
retailers.
■ o sonlnar, scientific sessions can be held by -the drug companies.
-onus, incentive qystem on sales of the products by the distributors or retailers
has to be abolished.
’Hie marketing code drawn up by-HAI (Health ction 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.
Abolition of wholesale stockists and distributors - the unnecessary profit-making
middleman.
hstablidiraent df National Corporation for the distribution of drugs and Pharma
ceuticals to the retailers. This cornor;ti.on to work on no loss no profit basis.
Marketing of drugs only under generic name and abolition of brabd names should
appear.
The Drug Price Control Order of 1979 should be extended to all drugs. However,
the existing categories in the DPCO to be abolished end r. uniform mark up to be
allowed on all types of drugs on sales turnover prices to be reviewed periodically.
Ensuring proper utilisation and prevention of misuse, this vould 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 pharmacotherapeutrcs. Eedical audit Astern should be introduced,
l-'andatory adequate clinical recard-keeping by doctors and malting doctors answerable
as regards rational therapeutics to a committee of experts if a complaint of possible
misuse ox drugs is received from any person. Continuing education through different
media by Government about the use of over the counter drugs, misconceptions about
eortirim drugs and hazards of wrong use of drugs. Those drugs idiich are more likely
to give rise to life threatening or serious side effects, but which may 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.
For example, drugs like clinido«[,cin, oxyphenbutazone, dextropropoxyphene, diphen
oxylate, etc.
5
■jetting up a Drug Review Coinrittee entrusted with the task -.£ :
. c.. itoring. the changing pattern of diseases.
•ew information on old. drugs and invention of no-.; drugs.
"ffleecy of the existing policy of production, distribution and the use of dr-1 ’s
in the light of principles of ReJBbnal ih-ug folicy.
'■'his comitl.ee is to include oneWIpxesentativc each fro:. manufacturing sector,
6'.:s Covornrcut, redical experts e^gc.ged ‘n primary, secondary ano tertiary l-.-vcl
:f ■■.ci-iccl c;a:'e, chemists, consumer organisations etc.
fostering research on issues ’identified by the Jrug lie-view Con.ittee.
?ostering research on non allopathic drugs end production end use of those which
have proved to be therapeuticei.ly useful in sucii regef reh.
s.
All donated drugs should be obtained from a reliable SOUrCC,
comply with quality standards in both donor and recipient country
>n an expressed need
and Tschw
°Vo
Natural disasters k,
dependant on the disease pattern
recipient country
in Central America
The presentation, strengths and
formulation of donated drugs should be
Concrete list of request. Example:
RefogeeTlnEritrea]
quantity
and Ethiopea__j
size of
packing
1000
presentation
generic name of
the active substance
dosage
Amoxicillin
250 mg
similar to those drugs used
in the recipient country
After arrival the remaining shelf life should be
at least one year
CSSBmiLCJlKBfttBRAmE
The use of all donated drugs
should have been proved.
They should be part of the
National List of
Essential Drugs
or WHO Model list of
Essential Drugs
~
No drugs should
be donated that
have been
issued to
patients or
given as free
samples
Donated drugs should be presented in larger
quantity units and hospital packs
All drugs should be labelled in a
language that is understood
in the recipient country:
batch number,
dosage form
generic name of aclive substance
strength, name of manufacturer, quantity
storage conditions
and expiry date
All drugs donations should be packed according
to the international shipping regulations,with a
detailed packing list, not exceeding the weight of 50 kilograms
per carton. Drugs should not be mixed
with other supplies in the same carton
The value of a donation
should be based on the
wholesale price in the
recipient country
Recipients should be informed
in time of all donations being considered,
prepared or under way
Costs of transport, clearance etc
.should be paid by the donor agency
/ Imprint:
The WHO and fifteen main donor organisations published 1’96 the .Guidelines for Drug Donations-.
On European level four health organisations are active in rating awareness concerning these gutdel.nes:
$
DIFAM
J.
Germany:
AMH@difaem.de
H
^ '0.
i
. —~
l.pEMOS
PiiV.cD
France:
PimedParis@aol.com
Spain:
education@prosalus.es
Netherlands:
marjan.stoffers@wemos.nl
supported by a grant of the European Union and by IDA.
IDA is one of the suppliers of essential drugs IDA supports public health car In development countries
°^er’n9 Aual'*y
medicines and materials at the lowest possible price on a non commercial basis.
' DIFAM, Tubingen/Germany, November 2002
(£)
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SLET
Association for Rational Use of Medication in Pakistan
Bimonthly
ISSN 1022-257X
4
December 1997, Vol. 6, No. 6
NDIP on its first birthday
year has passed since the announcement of the National Drug Policy (NDP).
A
We were critical of the hush-hush way in which the NDP was announced by
the caretaker health minister in December 1996. Disregarding the history of
the development of the draft up to that point, the minister put a Quranic verse at the
top of the policy draft and announced it nevertheless, just to score another point for
Network Council
Prof Akhlaque-un-Nabi Khan
Dr Tasleem Akhtar
Mr Abdul Latif Sheikh
Prof A Samad Shera
Mr Aslam Azhar
Dr Azra Talat Sayeed
the caretakers.
The result is anybody's guess, but in just a year's time the Ministry of Health (MoH)
seems to have forgotten all about the NDP. The federal health bureaucracy neither
considers itself accountable to anyone nor does it like to be reminded of its respon
sibility in this connection. Lack of accountability' and amnesia suit it well.
Dr Inam-ul-Haq
Lt-Gen (R) Mahmud A
The two most important constituents of any' well-meaning policy are commitment to
Akhtar
goals and the provision of guidelines. But if the whole objective of policy' making is
Dr Masood-ul-Hasan Nuri
Prof M Shafi Qureshi
to only score points and offset the criticism for not having a policy, then the process
Prof M Naseem Ullah
becomes self-defeating and an absolute waste of time. This looks like what has hap
Prof Tariq Iqbal Bhutta
pened with the National Drug Policy.
Ms v°«qeema Mitha
(R) Zaheeruddin
The NDP, its high-set objectives and its commitment to essential drug concepts now
lies gathering dust on some inaccessible shelf of the MoH. It is unfor
tunate how the officials involved in the making of the policy' have
conveniently let the present political decision makers forget all
about the NDP.
We urge the health authorities to come up with the much-
needed resolve to overcome the chaotic pharmaceuti
cal situation in the country. We still hold that a
well thought-out NDP with back-up support is
The Network's
the solution. One of the biggest weaknesses of
mission is to promote the
the NDP is that it does not provide any' system
rational use of medication
to monitor and evaluate its implementation.
and essential drugs concept
in Pakistan in order to opti
mise the usefulness of drugs
Without such accountability one' can never
judge the achievements or failures of any' poli-
and help bring equity in their
(cy. The government needs to look at all these
access.
^issues if it is serious in introducing health reforms.
DrugNews
Newsletter
Products containing
terfenadine
banned
erfenadine, the
non-sedating aller
gy ding implicated in heart problems when
used improperly, is being pulled from the US
market, drug maker Hoechst Marion Roussel
announced last month.
introduced in 1985, terfenadine was the first
prescription antihistamine that did not cause
drowsiness. It once held 80 per cent of the huge
market for allergy drugs taken by tens of mil
lions of sneezing, sniffling hay fever sufferers in
the US. Last January, the US Food and Drug
Administration recommended that terfenadine
products be removed from the market due to
the risk of cardiac complications when used in
combination with certain antibiotics and anti
fungal medications.
The drug has also been taken off the shelves in
France, Greece and Luxembourg. In September
1997
the UK Committee on the Safety of
Medicines decided to change the status of the
drug from over-the-counter to prescriptiononly.
Terfenadine is available in Pakistan in at least 11
brands manufactured or imported by national
and international pharmaceutical concerns. The
following table provides information about the
availability of the drug in Pakistan for con-
Brands containing terfenadine available in Pakistan
’ | No Trade name
Ingredients
Dosage / Formulation
Manufacturer
fi 1
Bronal
Fenade
Terfenadine
Terfenadine
Galcnika /Akhai International
Sami Pharmaceuticals
13
Fendina
Terfenadine
14
I5
Histacam
Hypofen
Terfenadine
Terfenadine
60 mg/tab
5m 1/30 mg/Susp
60 mg/ 120 mg tab
5ml/30mg/Susp
60 mg / 120 mg/tab
5 ml/30 mg /Susp
5ml/30 mg/Susp
60mg/tab
5ml/30 mg/Susp
60 mg/tab
60 mg/tab
5ml/30 mg/Susp
60 mg/tab
5m 1/30 mg/Susp
60 mg/tab
5ml/30 mg/Susp
60 mg/tab
60 mg/tab
1 2
16
18
19
1 10
Hi
•
7
2
Meldane
Terfenadine
Nebral
Talergin
Terfenadine
Terfenadine
Teldane
Terfenadine
Terfen
Terfenadine
Terfen al
Terfenadine
Highnoon Laboratories
Mendoza
Epla Laboratories
Pacific Pharma
Siza International
Wilson's Pharmaceuticals
Merrel Dow/
Pacific Pharmaceuticals
Ferozsons Laboratories
Opal Laboratories
sumers to beware and for the Ministry of Health
to take appropriate regulatory action.
0 he toxac plague
oxic chemicals are to us now what virus
es were a century ago: the hidden enemy
and the source of much illness. In our
everyday life we are now so immersed in chem
icals — at last count there were 70,000 of them
out there — that most of the latest syndromes
are being named after them. There is now sick
building syndrome, wood preservative syn
drome, solvent intolerance, chemically associat
ed immune dysfunction, Gulf War syndrome,
not to mention the more obtuse appellations
like ecological disease, clinical ecology syn^_
drome, chronic fatigue syndrome, fibromyalgiW^z
and, our latest, multiple chemical sensitivity
(MCS) all hinting at an environmental cause.
Despite increasing evidence that chemicals are
making many people ill, the medical establish
ment stubbornly hangs on to microbes as the
one and only source of illness. This was the con
clusion of the 1996 Royal College's Report on
chronic fatigue syndrome and on MCS prob
lems. Nevertheless, the editor of The Lnncet, Dr.
Richard Horton, took a brave step forward by
arguing: "Somehow I cannot accept that pesti
cides, sprays and gases are the harmless accou
terments of today's life. But.how do we prove it
one way or the other?"
Although several reliable scientific studies have
already proved that some people are hyperseiv-x
sitive to chemicals, the crux of the problem
really finding out exactly how these chemicals
damage us. There is no way to determine, for
instance, if a single chemical disrupts hor
mones, say, simply by examining its molecular
makeup. It has to be subjected to a battery of
tests, which, incidentally, have yet to be
devised.
Consumers must demand that far fewer chemi
cals be used; that pesticides be employed only
for emergencies; and that manufacturers have
the burden of proof. Perhaps most important,
we must no longer allow the deadly triad of the
medical, pharmaceutical and chemical giants to
pretend that the beginnings of an environmen
tal plague are all in our heads, a pretence that
allows them to get away with murder.
Consumer Currents , No 199, Nov-Dec 1997
The Network — Association for Rational Use of Medication in Pakistan
Chloroform being used
as anesthetic
A counterfeit version
of fluothane, a wide
ly-used gen
eral anest h e t i c
agent
manufactured by UK
based Zeneca, is
being marketed in
Peshawar.
The
provincial
Drug
Testing Laboratory
(DTL) has confirmed
that "it is fatal for human consumption, and
contains chloroform instead of halothane."
Chloroform is no longer used as anesthetic
anywhere in the world due to its potential to
cause liver and kidney damage, respiratory
depression and cardiac arrest.
The manufacturers have replaced the genuine
ingredient (halothane) with commercial chlo
roform, which was sporadically used till the
late fifties and sixties but which is now
known to be a hazardous drug.
The counterfeit drug effectively mimics the
^pnuine and was recovered by Hayat
bhaheed Teaching Hospital's (HSTH) admin
istration from a patient who had purchased it
in the local market. The culprit manufactur
ers, marketing managers and sales represen
tatives of the drug are yet to be caught.
The most dangerous aspect is that the prod
uct is being supplied to a number of private
and public hospitals. An anesthesia techni
cian has alleged that "it was also used for a
few cases in the 1,200 bed HSTH in July and
August."
The counterfeit drug's trade has been flour
ishing in the secondary care centres and pri
vate hospitals in most districts of the
province. This is mainly because there is often
little or no government control on pharma
ceutical laboratories.
The health department recently directed
administrators of all hospitals in the NWFP to
purchase the anaesthetic from authorised dis
tributors.
Dr. Khabir Ahniarl
The Frontier Post (December 4), Peshawar
Senate passes Patents
and Designs
(Amendment) Bail
MarketScan
Counterfeit
fiuothane on sate on
Peshawar
The Senate passed three bills on Wednesday in
a matter of minutes in the absence of opposi
tion and without any discussion on the merit
of the three laws with one of the bills being the
Patents and Designs (Amendment) Bill, 1997.
Minister
for
Parliamentary
Affairs
Muhammad Yasin Wattoo had introduced the
bill to amend the Patents and Designs Act,
1911. Under the bill, Pakistan seeks to achieve
the objectives of Article 27 of the World Trade
Organisation (WTO) Agreement. At present,
patents are granted by the Patents Office under
the Patents and Designs Act, 1911, which does
not admit patents for pharmaceutical and
agro-chemical products.
Article 27 of the WTOs, on the other hand,
provides for admitting the application for
protection of such product with effect from
January 1995, the date of coming into force of
the WTO. According to the bill passed
Pakistan is a signatory to the Marakash
Agreement, which concluded the Uruguay
Round of talks and provided for the estab
lishment of the WTO. It also provided for the
agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPs) to reduce
impediments to international trade, and pro
mote adequate protection of TRIPs.
To meet its obligations under TRIPs, Pakistan
is required to amend its existing laws, partic
ularly to avoid any penal clauses of the TRIPs
Agreement. It is also necessary to urgently
give effect to the provisions of Articles 70.8
and 70.9 thereof.
The Network — Association for Rational Use of Medication in Pakistan
Mohammad Yasin
Dawn (November 13)
3
O
rl ®
n
regnstirarooo ossqms ° 0
o
In a two-part article
Dr. Zafar Mirza
dwells deep
into the mist
surrounding the
registration of
pharmaceuticals.
Part-1 is an
overview of the
issues while part-ll
will deal specifical
ly with the state of
these issues with
particular refer
ence to Pakistan.
harmaceutical products are not ordi
nary commodities. They are special
chemical entities with remarkable
therapeutic properties. But at the same time all
drugs have potentially harmful side-effects.
Both these properties make drugs of immense
public health importance and raise concerns
about the safety of its users.
□
To be confident about the therapeutic potential
of the drugs and to ensure safety,
rigorous methods are followed
during their development
and
production.
Governments
require
drug manufacturers to
strictly follow Good
Manufacturing
Practices (GMP) and
Good
Laboratory
Practices (GLP) at all
levels of their busi
ness to ensure the
safety, efficacy and
quality of their prod
ucts. But before allowing
the company to take its
new pharmaceutical product
to the market governments have
yet another system to critically check
the credentials of a drug: the drug registration
system.
Thalidomide disaster
Over the centuries the concept of drug regulation evolved due to a number of factors: concern with commercial production of
drugs, their advertising, marketing of
useless or even harmful "remedies",
unethical methods of drug promo
tion, high cost of drugs, etc.
In the 19th century a movement
began to take shape to control
narcotic drugs; for example, in
Britain the Pharmacy Act was passed
in 1868'. Most of the modern drug
legislation, however, has been enact
ed during this century, a major
wave of which came in the sixties
after the thalidomide tragedy.
In 1938 the US Food and Drug Administration
was born after a drug tragedy. At the time sul
fonamides were very popular as the first treat
ment for infections. Sulphanilamide was par
ticularly widely prescribed. But as the drug
tasted very bad, it was mixed with sweet-tast
ing diethylene glycol and the elixir marketed
for children. The solvent was highly poisonous
and killed at least 107 people. It was
withdrawn from the market and
soon after the US Congress
passed the Food, Drug aivKV
Cosmetic Act2.
In Europe it was the
thalidomide disaster
that led to a number
of regulatory initia
tives. Thalidomide, a
sedative and anti
emetic drug marketed
in West Germany in
1957, was found by an
Australian
obstetrician
Dr. William McBride to be
responsible for causing con
genital defects in babies. The drug
caused a rare congenital disorder, phocomelia ('seal limbs') in babies whose mothers
had taken the drug mostly for morning sick
ness. It was estimated that the drug causetf')
more than 10,000 cases of birth malformations
in West Germany alone, while it was marketed
in 46 countries’ under no less than 50 brand
names.
The tragedy had a profound impact on drug
regulators and many legislative initiatives
were taken. For example, in the UK, the
Committee on the Safety of Medicines was
established and a law enacted for independent
evaluation of drugs for their safety before
being marketed. This has been called a "turn
ing point" which provided the "greatest single
impulse" to the development of new drug leg'
islation in Europe and elsewhere1.
In
the
backdrop
of
these
tragedies
governments in a number of countries devised
The Network - Association for Rational Use of Medication in Pakistan
a system of drug registration. This is now con
sidered one of the basic systems which regu
lates drugs. It is a process through which phar
maceuticals are permitted in the health-care
system by the authorities after appropriately
evaluating them against set criteria, most
importantly of safety, efficacy and quality.
Procedure
..
The process involves an appli- \ 6 «
"/
cation on a prescribed form by \ ■'.A/
the manufacturer or the importer V—/
j I
I
to the drug control authority, (usually the Ministry of Health), which
then processes the application
3
according to the stipulated criteria
and conditions.
1
I
If the application meets all the conditions set
out in the law and satisfies the members of the
Drug Registration Authority, the applicant is
provided with a certificate. This is usually for
a limited period of time after which the regis
tration status of the drug is reviewed. The
WHO in 1983 laid down the process of
Establishment of Statutory Drug Regulation in
Developing Countries in which drug registra
tion is also dealt with5.
The application for registration requires two
kinds of information: administrative and tech
nical. Administrative details include name of
the product, details about the manufacturer, if
imported the drug's status in the country of ori
gin and in other countries, the appropriateness
of the content of labeling and advertising, etc.
The technical details include pharmaceutical
(stability, bioavailability, etc.), pharmacological
(pharmacokinetic and pharmacodynamic) and
clinical trial studies. Detailed information
about these studies comes as attachments to
the application. The entire documentation can
be extremely voluminous6.
A few countries require some additional
details7:
» price of the drug;
> comparative therapeutic and/or safety
advantages, local manufacture of a similar
product;
» the availability on the market of several
products with the same active ingredient;
I combinations not offering an advantage
over individual products;
D therapeutic justification and medical needs;
B GMP certificate in case of imported drugs;
D free sale certificate in the country of origin in
case of imported drug.
The period for which the drug is registered
also varies among countries.
This process of drug registration is of utmost
importance to potential consumers. Any incor
rect decision at this stage can lead to physical
injury to the user. The extent of harm can even
amount to death due to toxic potential of the
drug.
Research in
drug registration
MLz
Drug registration is generally a ’ . F
poorly researched area. Most research
work has been done in industrialised countries
and involves various aspects of drug regula
tion. Bulk of the studies has been undertaken
by industry to prove how regulations have
hampered its research and development activ
ities6. However, WHO European Studies of
Drug Regulation have also looked into regis
tration procedures through comparative stud
ies of two or more regulatory systems by using
different approaches’.
Developing countries have lagged behind in
efforts to assess their drug regulation systems.
Recently though, researchers have started pay
ing some attention to these aspects'"". This
interest has evolved primarily due to three fac
tors: several incidences of adverse drug
injuries'2, gradual strengthening of consumer
organisations, and international organisations'
interest in rational drug use research in devel
oping countries, which indirectly stimulates
interest in drug regulation research.
Drug regulation
Drugs in Pakistan are regulated central
ly through the Drugs Act, 1976,
(Manual of Drug Laws, 1995). This
j
legislation was enacted
four years after unsuc1
cessful experience with
the Drug (Generic Names)
, j 1 i jz
I_ 1 ■
the use of trade names and was
The Network — Association for Rational Use of Medication in Pakistan
later repealed. According to Reekie & Weber
(1979), this failing of the Generic Act in fact
strengthened the multinationals13. The Drugs
Act, 1976, superseded the Drugs Act, 1940, but
is not in derogation of the Dangerous Drugs
Act, 1930.
The Drugs Act, 1976, aims "to regulate the
import, export, manufacture, storage, distribu
tion and sale of drugs". It has an impressive
mechanism of distribution of powers, duties
and responsibilities between the Centre and
the Provinces14. It is a comprehensive legisla
tion with 45 sections dealing with various
aspects of drug regulation.
The law also provides for the setting up of spe
cial drug courts to hear drug-related cases. A
system of checks covers drug imports by
authorising customs officials or drug inspec
tors to control the type and quality of drugs
imported in the country.
However, all is not well with the drug law. The
Senate's Special Committee on Medicine
Sector in 1991 recommended several amend
ments in its report and suggested that these be
made in the Drugs Act before the start of the
next fiscal year. They were never carried out.
References
Berridge V. (1977), 'Opium and the Historical
Perspective', The Lancet, July 9, 1977, 78-79
2.
Youngson R & Schott 1. (1996), Medical Blunders,
Robinson Publishing Ltd., London
\)
3.
Braithwaite J. (1984), 'Corporate Crime in the
Pharmaceutical Industry', Routledge and Kegan Paul,
London
4.
Dukes M.N.G. (1985), 'Effects of Drug Regulation',
WHO, Buller & Tanner Limited, Frome and London
5.
WHO (1983), Establishment of Statuary Drug Regulation
in Developing Countries; unpublished report of WHO
Inter-Country Consultation of Drug Legislation,
Khatmandu, April 25-29, 1983
6.
Eddy David M. (1990), 'Should we Change the Rules
for Evaluating Medical Technologies?', in Gelijins AC
(ed.), Modern methods of clinical investigation, National
Academy Press, Washington DC
7.
Jayasuriya D. C. (1985), Regulation of Pharmaceuticals in
Developing Countries; Legal issues and approaches, WHO,
Geneva
8.
Dukes M.N.G. (1985), 'Effects of Drug Regulation',
WHO, Butler & Tanner Limited, Frome and London z*
9.
Dukes M.N.G. (1984), The Registration History of
*
Cromolyn Sodium; A five country analysis (to be pub
lished) as quoted in 'Effects of Drug Regulation' by
M.N.G. Dukes (1985), WHO, Butler & Tanner Limited,
Frome and London
10.
Bhutta T. I. & Balchin C. (1996), 'Assessing the Impact
of a Regulatory Intervention in Pakistan', Social Science
Medicine, Vol. 42, No.8, pp. 1195-1202
11.
Hilbrand Haak & Mariam E. Claeson (1996),
'Regulatory Actions to Enhance Appropriate Drug
Use: The Case of Antidiarrhoeal Drugs', Social Science
Medicine, Vol. 42, No. 7, pp. 1011-1019
12.
Bhutta T.I. (1990), 'Loperamide Poisoning in Children',
The Lancet, 335, 263
13.
Reekie W.D. & Weber M.H. (1979), Profits, Politics and
Drugs, Macmillan, London
14.
Jayasuriya D. C. (1985), Regulation of Pharmaceuticals in
Developing Countries; legal issues and approaches, WHO,
Geneva
1.
The Act makes it mandatory for all ding man
ufacturers to obtain a licence from the Central
Licensing Board. All drugs must be registered
with a Drug Registration Board. A list of all
registered drugs is required to be compiled,
published and reviewed from time to time.
A system of hearing appeals of the aggrieved is
also required by law. For the purpose there is
the Appellate Board, which consists of repre
sentatives of the federal government and the
provincial governments. The federal govern
ment can also constitute committees of experts
when necessary.
The Act, however, covers only allopathic drugs
and excludes drugs of Unani, ayurvedic and
homoeopathic systems.
The federal government is required to estab
lish a Federal Drug Laboratory and Appellate
Laboratory; each provincial government is
required to establish a Provincial Drug Testing
Laboratory and appoint government analysts
in each laboratory, and to set up a Quality
Control Board to assure the quality of drugs.
Governments are also allowed to appoint gov
ernment analysts.
The Drugs Act provides for inspection services
comprising federal and provincial drug inspec
tors with defined powers and set procedures to
follow. It empowers the federal government to
fix the maximum price for drugs. It prohibits
the import, export, manufacture and sale of
spurious and sub-standard drugs. Strict control
on drug advertisements, sampling and printing
of labeling is emphasised; any offence entails
strict penalties ranging from 3-7 years impris
onment and/or fine of Rs. 100,000.
The Network — Association for Rational Use of Medication in Pakistan
Pakistan's dubious record in
public health is underlined by
the high incidence of polio in
the country. An infectious dis
ease which attacks the central
nervous system, polio can be
fatal or crippling. The pity is
that the affliction still affects a
large number of children in
Pakistan in spite of the fact that the disease is
preventable and has been eradicated from
most other countries of the world. In fact, in
1996 150 countries reported no case of polio. In
this context it reflects dismally on our health
care programme that 25 per cent of all polio
cases in the world — and 75 per cent in the
pastern Mediterranean region — should occur
in Pakistan....
It is time the health authorities in this country
took the polio eradication programme more
seriously than they have. The strategy adopt
ed by WHO in 1988 when the polio eradica
tion target was set was to organise national
immunisation days (NIDs) when all children
under the age of five are to be administered
the polio vaccine drops. Other countries such
as China and India have managed their NIDs
very successfully.... It is not clear why
Pakistan has not been able to achieve the same
kind of success, especially when polio days
are being organised in this country every year
since 1993. Every time an NID for polio is
organised the number of children covered is
■said to be increasing. Thus, the polio day in
December 1996 is claimed to have achieved 99
per cent of the coverage target. If that is actu
ally so, there is no reason why there should
not be a drastic drop in polio cases as hap
pened in China after it had organised its
first NID.
It is, therefore, important that the campaign is
organised efficiently, correct targets are set and
the process and its impact are monitored prop
erly. The importance of this should be under
stood because in the absence of a meaningful
response from the people, the temptation
would be there for the health authorities to
exaggerate the figures of the children immu
nised. There is also the need to store the vac
cine in prescribed conditions in so far as tem
perature is concerned if it is not to lose its
potency.
In 1995 Pakistan reported 421 polio cases
(counting in the unreported ones the incidence
would be higher). This speaks of apathy and
callousness in dealing with a disease which
generally affects children, often killing or
maiming them for life. Surely, Pakistan would
not want to be the country to have the dubious
distinction of being the last sanctuary of polio
in the world when all other countries have
been declared polio-free. But that is what we
seem to be heading for.
Dawn, Editorial (November 23)
LHC veroloct on
dealers selling
{banned drugs
Mr Justice Faqir Mohammad Khokhar of
Lahore High Court, Rawalpindi Bench, on a
writ petition directed the government to take
action against those drug dealers selling
banned drugs in the country.
The court took action on a writ petition filed by
advocate Mohammad Kowkab Iqbal, who
brought to the notice of the court that a health
hazardous drug, chlormezanone, was being
sold in the market. In his petition Iqbal stated
that the drug is banned in Europe and the US
for its fatal effects on patients.
The lawyer said that the use of the medicine
can cause a number of skin diseases. In some
cases it can also lead to the death of users.
The standing counsel appeared on behalf of
the government and submitted before the
court that the drug had already been banned in
the country by the Ministry of Health.
Challenging the counsel's argument Iqbal
showed a number of receipts to the court bear
ing recent dates when the drugs were pur
chased from medical stores.
The court directed the Ministry of Health to
take strict action against those drug dealers
who were violating the ban on the sale of
drugs containing chlormezanone.
Abrar Saeed, The Nation (October 2S)
The Network — Association lor Rational Use of Medication in Pakistan
Media Watch I
Eradicating polio
Salient features of
the new health
policy
renewed Health For All strategy. There is a lack of
focus on the district health system which is the foun
dation for health-care delivery in the country. Many
priority health areas have not been given proper
emphasis. The same is true for new and re-emerging
health areas like chronic and non-communicable dis
eases.
Begin nings
Here are salient
'
features of the new
National Health
Policy. These are
being presented to
inform our readers
of the government's
plans to bring about
changes in
Pakistan's health
sector. We will
present an in-depth
critique of the health
policy in the
April 1998 issue of
our newsletter in
light of the
S
responses we
receive from
readers. You can
send/fax us
comments at the
address/number on
the back page or e-
mail them to us.
Pakistan started with a very weak base in the health
sector in 1947. At the time of Independence, the coun
try inherited very poor medical facilities comprising
one medical college, 78 doctors, widespread malnutri
tion, unsanitary environmental conditions and a high
prevalence of communicable diseases. In spite of a
steady expansion in health facilities and manpower,
the present health system has not adequately met the
requirements of the population. Pakistan's health indi
cators present a very dismal picture as compared to
countries al the same level of economic development.
The health status of the nation after 50 years of inde
pendence is characterised by a population growth rate
of around 2.8 per cent, infant mortality rate of 86 per
cent thousand live-births and maternal mortality rate
of 350 per 100,000 live births which is one of the high
est in the world. In the context of health-care needs, the
major concerns in respect of various population seg
ments are:
Children: Diarrhoea and pneumonia
Women of child-bearing age: Pregnancy complications
Adults: Accidents and cardiovascular diseases
Elderly: Cancer
Drug abuse has emerged as a public health problem
while malaria and tuberculosis continue to be potential
threats. Poor maternal nutrition status results in the
high incidence (about 25 per cent) of low birth-weight
babies.
Shortcomings
The last National Health Policy was developed in 1990
to form the basis for health sector development in the
country. The implementation of the policy has led to a
certain degree of improvement in the health-care sys
tem. However, progress has not been uniform or across
the board and many deficiencies and weaknesses per
sist. Most of the health indicators are still poor and
need significant improvement. The health-care system
suffers from poor management at all levels. Health sec
tor is not well regulated, especially with regard to the
private sector. Good quality essential health-care is still
out of reach of the poor. These deficiencies are due to
the fact that the policy does not adequately cover all
areas of essential care, especially in view of the
Proposals
This situation calls for active remedial measures and a need to revise
—
the health policy. There is also a
> \
need for a more action-oriented
K
|
H j
approach in policy guidelines.
■
/!
Practical approaches for com munity and private sector participation and inter-sectoral collaboration
x
need to be highlighted. Furthermore, the newly electee!/,
government has promised some basic reforms in the
health sector in its manifesto that need to be incorpo
rated in the policy. Therefore, under a directive of the
Prime Minister, the Ministry of Health has prepared a
new health policy for consideration by the Cabinet.
Objectives
The major objectives of the policy are to:
i)
consider health as a developmental issue;
ii)
address fundamental issues like poverty and popu
lation growth, which inhibit a lasting change in
health status;
iii)
develop sound strategies for investment by the pri
vate sector to enhance the capacity of the system to
deliver health care to all;
iv)
introduce alternative approaches to financing
health-care through the involvement of the privat^^
sector and the national health-care scheme;
r?.
v)
address the health problems in the community by
providing promotive, preventive, curative and
rehabilitative services to which the entire popula
tion has effective access;
vi)
bring about community participation through cre
ation of awareness, change of attitudes, organisa
tion and mobilisation of support;
improve
vii)
the utilisation of health facilities by bridg
ing the gap between the community and health ser
vices;
expand
viii)
the delivery of reproductive health services
including family planning both in urban and rural
areas of Pakistan;
ix)
gradually integrate existing health-care delivery
programs like EPI, malaria control, nutrition and
MCH within the Primary Health Care (PHC);
x)
improve the nutrition status of mothers and chil
dren and reduce the prevalence of malnutrition;
The Network — Association for Rational Use of Medication in Pakistan
Newsletter
promote proper inter-sectoral action and coordina
for upward movement;
tion at all levels;
f) offering a service package for qualified profession
xii)
develop innovative control strategies for prevailing
als including overseas Pakistanis to serve in the
communicable diseases such as tuberculosis, viral
country;
hepatitis, acute respiratory infections (ARI) diar
g) integration of priority health programs under PHC
rhoeal diseases, and major prevalent non-commu
to reduce cost, avoid duplication of services, and
nicable diseases.
improve quality of care;
h) availability of emergency care for all patients
regardless of their ability to pay;
i) setting up of monitoring and Evaluation Cells al
The new health policy has been designed to bring
provincial and district levels;
about a faster, consistent and more sustainable
j) strengthening of accountability through establish
improvement in the health situation in Pakistan
ment of a Health Institutions Database, quality
through some fundamental and radical policy shifts.
assessment and assurance, supervisory checklists
This change in policy will be a major step in the coun
and modern record keeping and audit systems;
try's reform process that will bring about a progressive
k) better regulation of private sector health care
change in attitudes, structure of organisations, gover
including the pharmaceutical industry;
nance and definition of roles and responsibilities. It is
1) mobilisation of the private sector to take up more
Mimed that through the implementation of this policy,
responsibilities in areas of preventive services, fam
the health indicators of Pakistan will improve signifi
ily planning, drugs, rural health services, etc.;
cantly in the next five years, with a decrease in infant
m) authorisation to DFIs to lend to the health sector
mortality from 86/1,000 live births to 40/1,000 live
facilities including viable non-profit institutions.
n) lead role for the Pakistan Medical and Dental
births, maternal mortality from 350/ 100,000 live births
Council (PMDC) in developing health legislation to
to 200/100,000 live births, and low birth-weight babies
from 25 per cent to 10 per cent.
ensure quality of services and restrict unauthorised
practice to medicine in the public and private sec
The life expectancy will
tor;
increase from 62 to 65 years and
o) preparation of a National Epidemic/Disaster
the percentage of children
Preparedness Plan, based on early warning system
below seven years (who are
and close surveillance;
fully immunised ) from 65 per
p) upgradation and regulation of traditional medi
cent to 90 per cent while polio
cine, for maximum effectiveness and reliability.
is expected to be eradicated by the year 2000.
xi)
Expected outcomes
Major components
Government commitments
i)
Health sector reforms
ii)
New initiatives to fulfill government commitments
Jjiii) Review and consolidation of ongoing projects
under SAPP-II
iv) Strengthening of the pharmaceutical sector
v) Health legislation
A.
a)
Health sector reforms
The salient strategies for reforms in the health sector
include:
a)
promotion of good governance, through proper
training and supervision;
b)
improvement of gender staffing mechanisms and a
reduction in gender disparity;
c)
delegation of more administrative and financial
authority to grass-root levels;
d)
incentives to doctors, teaching faculty, and health
workers serving in rural and backward areas;
e)
developing a comprehensive career structure for all
cadres, with provision for training and incentives
New initiatives in PHC:
Provision of reproductive health services at all lev
els of service delivery
b)
Launching the National Programme for TB Control
c)
Inclusion of Hepatitis-B vaccination under EPI to
prevent widespread risk of infections
d)
Introduction of home health care to take health to
the houses and mothers
e)
School Health Programme for elevating the health
of children
f)
Environmental health for clean water, air and sani
tation
g)
Community-Oriented Medical Education (COME)
to train medical graduates in line with the needs of
the community
h)
Enhancement of vaccine-production capability to
attain self-sufficiency
B.
Poverty alleviation through WHO recom
mended approach to Basic Minimum Needs
The Basic Minimum Needs (BMN) programme will
The Network — Association for Rational Use of Medication in Pakistan
9
be implemented throughout the country in a phased
manner. Through this multi-sectoral programme,
interest-free loans will be provided to communities
for:
i) income-generating projects;
ii)
provision of health and social services;
iii)
training and capacity building.
C.
National Health Care Scheme (NHCS):
It will be an alternative health-care financing and
management mechanism based on public-private
partnership that aims to:
i) improve the quality and utilisation of services;
ii) decrease the cost of care to the public and the gov
ernment;
iii)
extend essential health care to all.
Main components of the NHCS are:
i) district Health Authorities (DHAs) with represen
tation from government departments and the
community, to supervise the management of dis
trict health systems;
ii) autonomy to selected hospitals run by Hospital
Management Boards, under the supervision of
DHAS, with authorisation to levy user charges;
iii) privatisation/leasing of selected Basic Health
Units (BHUs)/Rural Health Centres (RHCs) con
tracted out to private physicians, NGOs or exist
ing staff, to deliver a standard package of services
at fixed user charges, under the supervision of
Community-Based Organisations (CBOs).
iv) National Health Cards for families in rural and
1 New National Health Policy financial requirements (1998-2003) |
Rs. in billion
Preventive programme (Including FP)
27.0
Non-communicable diseases
5.0
Health manpower development
5.5
Health infrastructure
6.5
Specialised care
5.5
Nutrition
3.0
Drugs and logistic supplies
9.0
Vaccine production
0.6
BMN programme
17.0
National Health Care Scheme
20.0
Health Foundation/NGO Collaboration
1.6
Health System Research
0.7
Traditional medicine
1.0
Health Management Information System (HMIS)
1.0
Environmental health
0.6
Prevention and control of drug abuse
I TOTAl
10
_______
1.0
105.0
under-served urban areas, to provide essential
health services at nominal charge (and free for
poor families) through privatised health facilities.
Review and consolidation
of ongoing projects
The following priority health programmes will be
strengthened and implemented under the integrated
PHC system:
a)
National EPI Programme
b)
National AIDS Control Programme
c)
Family Planning and Primary Health Care
Programme
d)
Maternal and Child Health Programme
e)
National ARI Control Programme
f)
Malaria Control Programme
g)
Health Education and Health Promotion^
*
Programme
Pharma sector reforms
A comprehensive drug policy will be implemented
throughout the country. The important measures pro
posed are as follows:
a)
provision of essential drugs free of charge in emer
gencies and to the poor;
b)
promotion of rational use of drugs;
c)
imposing restriction on the sale of drugs without
prescription;
d)
involvement of the private sector in procurement
and distribution of drugs to government facilities;
e)
appointment of qualified pharmacists at all levels;
f)
establishment of a system for drug surveillance
and information;
g)
enforcement of good manufacturing practices;
h)
rationalisation and stabilisation of prices of drugs|
Health legislation
The following legislation will be enacted/amended to
implement the Government's commitments to con
vention on the rights of the Child (CRC), Convention
on the Elimination of All Forms of Discrimination
Against Women (CEDAW), Health for All (HFA) etc:
a)
Universal iodisation of salt
b)
Marketing of Breast Milk Substitutes
c)
Food fortification (e.g. iron supplement)
d)
Pure Food Ordinance (to be amended)
e)
Maternity benefits
f)
Child rights to survival and development
g)
Prohibiting juvenile smoking
h)
Mental Flealth Act
i)
Regulation of the private sector
j)
Traditional Medicine Act
The Network — Association for Rational Use of Medication in Pakistan
Network [Resource
Centre expansoon
picking up
.,....^5_______
Over the past few
months, The Network
has been working to
expand its Resource
Centre. The acquisition
O ■■ ? T. T CD'RT
netwokk’r’esource centre databases has stiength-
ened The Network's
ability to provide timely responses to informa
tion requests from both medical professionals
.and consumers of health services.
The Medical Information CD contains the full
text of 12 important medical reference works,
including the latest editions of Current Medical
Diagnosis and ~
Treatment, Current Emergency
Diagnosis and Treatment, Current Ob/Gyn
Diagnosis and Treatment, Current Pediatric
Diagnosis and Treatment, Current Surgical
Diagnosis and Treatment, William's Obstetrics,
Smith's Urology, Basic and Clinical Immunology,
Basic and Clinical Pharmacology, Review of
General Psychiatry, Handbook of Adverse Drug
Interactions, and Medical Leiter on Drugs and
Therapeutics (198S-1996).
The Health Source Plus CD contains citations to
articles from over 500 medical and healthrelated journals, magazines, etc. The database
also features full-text articles from over 200
publications, including such prestigious med
ical journals as BMJ: British Medical Journal (US
edition), The Lancet, New England Journal of
t
Medicine, Medical Letter on Drugs and
Therapeutics, and Pediatrics, as well as maga
copies of articles, or portions of medical refer
ence works of up to 20 pages, on request. A
minimal fee of Rs. 100 per search and Re. 1 per
printout page will be charged. Please phone
The Network for further information. A detailed
brochure about the resource centre is under
preparation.
A gearing-up seminar
A one-day preliminary seminar meeting on
Role of Medical Professionals in the Rational
Use of Drugs was arranged in the
Pharmacology Department, Liaquat Medical
College (LMC), Jamshoro, on December 23.
The seminar took place in response to Head of
Pharmacology Department, LMC, Prof. Abdul
Rahim Memon's request for one.
Thirty-five participants from departments of
pharmacology, community medicine and med
icine attended the seminar. In the first session
Dr. Zafar Mirza spoke on the pharmaceutical
situation in the country, and Dr. Inam ul Haq,
ex-drug controller, on Issues in Drug
Regulation in Pakistan. The talks were fol
lowed by open discussion by participants and
speakers.
In the second session Principal, LMC, Prof. Jan
Mohammad Memon was kind enough to
attend the proceedings. In this session
Member, The Network Council, Dr. Azra Talat
Sayeed spoke on Essential Drug Concepts, and
Dr. Zafar Mirza on Rational Drug Use
(Intervention Strategies) followed by open dis
cussion by participants and speakers.
The following action points were discussed to
promote rational drug use at the local level:
lished.
forming a local group for rational drug use;
monitoring WHO Ethical Criteria for Medicinal Drug
Promotion;
iii)
investigation of drug use in health facilities and com
munities;
iv)
investigating prescription patternsof non-registered / registered medical practi
tioners;
v)
developing an ethical code of
medical practice;
vi)
continued medical education pro
grammes;
viijpatient education programs.
The Network staff will search for information on
specific topics, and, in accordance with inter
national copyright protocols, provide single
The participants agreed to
start work in accordance with
the action points.
zines and newsletters with a consumer health
focus.
In addition, the CD contains the full text of
LISP DI: Volume 2 Advice for the Lay Patient and
of nearly 1,000 health-related pamphlets. The
database will be updated monthly through
1998. Full-text articles generally appear in the
database 2-3 months after they have been pub
i)
ii)
The Network — Association for Rational Use of Medication tn Pakistan
NetworkNews
Newsletter
GUIDE TO GOOD PRESCRIBING
© World Health Organisation 1995
harmacology training for most medical students concentrates more on theory
than on practice. The material is often drug centred and focuses on indications
and side-effects of different drugs. But in clinical practice the reverse approach has to
be taken: from the diagnosis to the drug. Moreover, patients vary in age, gender, size
and socio-cultural characteristics, all of which may affect treatment choices. Patients
also have their own perception of appropriate treatment and should be fully
informed partners in therapy. All this is not always taught in medical schools, where
the number of hours spent on therapeutics may be low compared to traditional phar
macology teaching. As a result although pharmacological knowledge is acquired,
practical skills remain weak.
P
This training manual meets that need. Il provides step-by-step guidance to rational
prescribing and teaches skills that are not time limited but which remain valid
throughout a clinical career. It demonstrates that prescribing a drug is part of a
process that includes many other components. The manual explains the principles of drug selection and how to develop
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■■
Simonlhly
SjDE...
ISSN 1022-257X
\
Jan / Feb 1998, Vol. 7, No. 1
Need G© evaluate drug
registration procedures
. . i
WHO s plan
I to fight antibiotic resisi tant?.', and the sweet
iclory of the U100
s Pakistan's drug gatekeeper since 1976 the Drug Registration Board (DRB)
A
registration
has been allowing more and more drugs into the country. More than two
The drug registration
system needs a com
plete overhaul. Dr
Zatar Mirza explains
11
decades later after over 20,000 pharmaceutical products having been regis
tered the system continues unchecked, like an out-of-control pathogen.
'Action Points
l_. . ISix ways to
improve rational drug
use
Strong signals are apparent of mismanagement, corruption and lack of respect for
rules in the organization. Moreover, how the DRB works is shrouded in secrecy,
thus making all drug registering procedures non-transparent. There being no law
in Pakistan which allows freedom of access to information, the performance of the
The latest on missing
essential drugs, anti
obesity drugs,
chlormezanone and
terfenadine
D
DRB remains hidden. The only indicator of its functioning is rapid increase in the
number of registered products, which also allows large numbers of problem drugs
to enter the market. No one seems concerned about the unreported harm to
patients. The entire blame rests solely with the DRB for the present state of affairs.
Network Mews
An editorial in the
British Medical Journal
comments on the stale
of afljtept diagnostic
equijwrnt in the third
world, and mentions
The. Network's findings
in the area
Health activists and the national media have been raising this issue time and again,
but the Ministry of Health (MoH) remains committed to not doing anything to
reform the system.
BIS Dialogue
In the two articles on drug registration,
■OLetters and The
Network's response
we look at different dimensions of the
issue. Suggestions are made for a frame
work to evaluate the structure of drug
registration, the process, and, finally, the
outcome.
The Network's
We strongly urge the MoH to look into
mission is to promote the
the issue keeping in view the immense
‘ional use of medication
responsibility it carries towards protect
and essential drugs con' cept in Pakistan in order
' to optimize the usefulness
ing public health. The Network offers to
assist the MoH to devise a methodology to evaluate
of drugs and help bring
'■
the working of the Drug Registration Board.
•
.
W© [©to to Mt
antibiotic
resistance
bO
The World Health Organization (WHO) has
issued a three-part plan aimed at halting the
spread of antibiotic resistant infections.
Infectious disease experts have long warned
that overuse and inappropriate use of antibi
otics is causing bacteria to mutate into new
strains that don’t respond to treatment. The
threat posed by such infections is global,
according to WHO.
. ii
In a commentary in the February' 20th issue of
Science, Rosamund J. Williams, a WHO infec
tious disease specialist, outlines the proposed
course of action. "We propose a broad strate-
How do we protect
future from resistance?
Consumers should use antibiotics only
when needed, at the correct dosage, and
for the prescribed time period.
Medical associations and schools should
provide continued and updated education
on current antibiotic uses to prescribers
and users. This can be done by including
these subjects for discussion and presen
tation at medical meetings and as up-todate lectures to medical, dental, veterinary,
and agricultural students.
which resistance mechanism have not yet
emerged.
■ Medical personnel should develop alterna
tives to antibiotics to treat infectious dis
eases. Vaccines against common bacterial
diseases and improved public health mea
sures worldwide will do much to decrease
reliance on, and overuse of, antibiotics.
Public health authorities should improve
public sanitation, especially water quality,
in developing areas of the world where the
spread of infectious diseases is high and
where antibiotics are clearly needed.
■ Research scientists and drug manufactur
ers should continue to acquire insights into
the mechanisms of resistance and the fac
tors associated with their spread. With this
information, investigators can begin to
design ways to circumvent these resis
tances and to prevent their spread. One
approach is to design antibiotic substrates
that block, trick, and confound the resis
tance mechanisms.
■ Surveillance of clinical isolates should be
instituted or performed on a regular basis.
This helps epidemiologists identify areas
of endemic resistance and aids doctors in
the selection of appropriate antibiotics.
Together they can limit spread to non
endemic areas.
■ Pharmaceutical companies should be
encouraged, even by tax and patent
advantages, to discover new antibiotics for
The Antibiotic Paradox: How Miracle Drugs
Are Destroying the Miracle
by Stuart B. Levy, M.D.. (New York. 1992)
gy: improve the rational use of antibiotics in
human medicine, reduce the global selective
pressure of antibiotics by reducing or elimi
nating uses other than in human medicine,
and reduce the spread of resistant organisms
by improving hospital hygiene and public
health infrastructure."
"Rational use” is a difficult goal, Williams
writes, because most prescribing of antibiotics
is based on instinct or habit, rather than scien
tific fact. "Twelve million antibiotic prescrip
tions to adults in the United States in 1992
were for upper respiratory tract infections
and bronchitis, on which these drugs have lit
tle or no effect." That level of over prescribing
results, she writes, "from patients' expecta
tions and physicians' habits."
The only way to break those habits is through
education of both physicians and patients,
according to the WHO expert. But currently
most of this education comes from pharma
ceutical companies, a source that may be
biased. Williams said it would be better to
develop unbiased curriculum, including
"WHO's List of Model Essential Drugs and
Disease Specific Treatment Guidelines."
A key element in responsible prescribing is
the use of laboratory tests to confirm the pres
ence of bacteria. But often such tests require
special equipment and additional time. WHO
wants cooperation to develop new "diagnostic
tests that permit close-to-the-patient testing"
so that pathogens can be correctly identified
before prescriptions are written.
0
Resistant infections are spread as easily as
common infections and for that reason WHO
is urging renewed efforts to control infections
originating in hospitals. In the US, treating
these infections cost $4.5bn each year.
According to WHO, reducing the rate of hos
pital-based infections by just 6% would be
cost effective.
Along with control programs, surveillance is
needed. The program in Denmark, where
antibiotic resistance is very low, best illus
trates the utility of good surveillance. That
country, "has introduced comprehensive mon
itoring of the consumption of antimicrobial
drugs and the occurrence of resistant micro
bial strains in animals, food and humans."
Finally, WHO is urging statutory regulation
aimed at eliminating the profit motive from
THE NETWORK’S NEWSLETTER JAN/FEB 1993
Source: Science (1998;279:1153-1154)
Courtesy Reuters
Diabetes
Media reports on the government's phasing
out of U40 insulin and injections by March 30,
^£98, on the recommendations of the World
Wealth Organization and the International
Diabetes Federation (The News, The Nation,
Jan. 22; Dawn, Jan. 25, 1998) were surprising
to some but good news to others.
Surprising because the government's move
came at a time when evidence was emerging
that U40 insulin was proving 'ineffective' to
treat hyperglycemic patients. And good news
because the move is being made at the behest
of foreign health organizations to end a
potential health hazard.
The Network was alerted to the product's 'inef
fectiveness' by a doctor in Rawalpindi who
said that the drug was linked with deaths of
at least two patients after they had developed
ketoacidosis, even after several U40 injections
been administered.
But it is confusion over drug concentrations
that has led experts to believe that it would be
better if U40 were phased out in favor of
U100. According to Karachi-based Prof. A.
Samad Shera (also Honorary President,
International Diabetes Federation - IDF), the
'ineffectiveness' of U40 may be due to:
"(a) Injecting insulin at wrong sites; (b)
wrong injection technique; (c) suboptimal
dose of insulin; and (d) direct exposure to
sunlight or keeping insulin at temperatures
over 28°C. (a) and (b) are the two most impor
tant causes of apparent 'ineffectiveness' of
insulin therapy."
Prof. Jak Jervell, President of the IDF,
Brussels, Belgium, in a fax sent to the organi
zation's Pakistan chapter, cites several reasons
for the phasing out of U40 insulin. The IDF
THE NETWORK’S NEWSLETTER JAN/FEB 1998
reached this conclusion after discussing the
situation with its governing bodies, the WHO,
and major insulin and syringe manufacturers.
The worldwide change from U40 to U100 is
being done due to the following reasons:
i)
The presence of many strengths of insulin
on one market may cause problems as users
may mistake concentrations.
ii)
Diabetics who travel widely may have to
buy insulin in a country where a different
strength is used.
iii)
Insulin is sometimes sent from one coun
try to another to alleviate shortage (on
'humanitarian' basis). The strength of the
insulin sent may differ from that used in the
recipient country, thus leading to possible
confusion.
iv)
A change to one strength
would simplify
production and
distribution.
v)
A large number
of both devel
oping and devel
oped countries
have changed over
to U100. They have
demonstrated that the change can take place
smoothly and without any major problems.
But, as the IDF points out, it is essential that
countries plan ahead and prepare for the
changeover:
i)
All "old strength" insulin and syringes must
be withdrawn and only new concentrations
allowed.
ii)
An education process should begin at least
six months before the change starts. This
should be intensified immediately before and
during the changeover period both orally and
through the print and broadcast media.
iii)
Only "new" insulin should be sold in new
syringes.
iv)
All health professionals must receive infor
mation about the change.
v)
A task force comprising representatives
from health authorities, the national diabetes
association, health professionals (especially
pharmacists), and representatives from the
insulin and syringe manufactures and suppli
ers should be constituted to oversee the
process.
vi)
Relevant information can be requested
from countries which have successfully
changed over to U100. ■
DrugNews
over prescribing. "No amount of education of
technical advance will change prescribing pat
tern? if individual or hospital income
depends on profit from prescribing. In health
care, other sources of income may need to be
identified to compensate for the income loss
because of reduced prescribing."
registration issues - II
In part-1 of this article’
Ur-Zafar Mirza present
ed :< historical back-
drop to drug regula
tions ar<iegistrajtjt>r>.
Hg oudiaed the
promise of reglsimtlon
ams ImirerS;? research
in drug idyisiradan
and an
* ’ rtStjukitifKi in
?. ata sszwsd and .las’
piiri'n- fe- article r®
examine^ several
itopertairt issue-: in
drug rauistrstion with
speckle reference to
Pakistan and presents
improvements in the
system.
ince 1976, when registration was intro
duced through the Drugs Act, the num
ber of registered pharmaceutical prod
ucts in the country has swollen from a mere
3,6632 in 1977 to well over 20,000 today. A
registered pharmaceutical product does not
necessarily mean a new chemical entity; it
most often means a different dosage form
(tablet, injection, syrup, etc.) or the same
drug manufactured by' different firms under
different names.
S
According to one estimate the
’real’ drugs in Pakistan are
around 3,500 against which
more than 20,000
dosage/forms are registered.
The comparison of 300 odd
drugs in WHO’s Model List
of Essential Drugs with more
than 20,000 drugs is flawed
because the model list con
sists of 300 ’individual drugs'
or chemical entities. However,
a comparison does make
sense with 3,500 individual
drugs as against the 300 or so
suggested by WHO.
exist of independent drug information provi
sion as do stringent quality control checks at
all levels; the post-market surveillance is
more efficient, and adverse drug reaction
monitoring systems work quite well. Also,
health insurance companies in industrialized
countries generally make it obligatory for
physicians to prescribe drugs from limited
lists that are in line with WHO's essential
drugs list.
On an average
0
8.5 drugs were
approved every
working day in
nearly two years.
In the US it takes
over two years
Yet some countries have
opted for fewer registered
products e.g. Norway,
which till recently had only
2,500 registered drugs. In
the past it could keep this
number low by virtue of a
’need clause’ in the statute
books. The provision
empowered the country's
registration body' to assess
the public health need of
any new applicant drug.
Unfortunately, however,
after joining the European
Union Norway had to scrap
that particular clause?
to get a drug
The number of drugs regis
tered in the country has expo
nentially increased over the
years with the number today
nearly six times what it was
22 years ago. The standard response of the
federal health authorities to offset any criti
cism is to refer to those industrialized coun
tries where a higher number of registered
drugs exists as compared with Pakistan
(50,000 in Germany, 23,000 in the UK, 25,000
in Switzerland, etc.). But they forget the fun
damental differences in regulatory controls
and their enforcement that are in place in the
developed and the developing world.
In Pakistan the increase in
the number of drug regis
trations was comparativelv
slower in the beginning
(1977-84) than in recent
years: the cumulative percentage increase
over the first seven years was 75% whereas
between 1985 and 1986 this increase was
around 117%. (See table)
registered
For example, in industrialized countries
drug regulatory' authorities are autonomous,
empowered and have the capacity and
expertise to undertake the related work;
drug registration procedures are compara
tively stricter; prescription drugs cannot be
bought without prescription; consumers are
relatively' better informed; efficient systems
An interesting correlation is discernible here:
the Structural Adjustment Program (SAP)
was initiated in 1988 with three policy'
instruments: liberalization, deregulation and
privatization. Under the program, the prices
of pharmaceuticals were partially deregulat
ed in 1993.
Although there is no evidence about SAP
directly demanding liberalization in registra
tion procedures, the overall policy environ
ment during the period did seem" to have
influenced drug registrations. Similar corre
lations have been reported from other third
THE NETWORK’S NEWSLETTER JAN! FEB 1993
world countries, especially from Latin
America.
□ [Pro©eclurai issues
More disturbing than numbers is the process
through which new products are provided
legitimacy of registration. On average the
Drug Registration Board (DRB) meets four
times a year. In a one- or two-day meeting
the DRB on average registers 250 pharma
ceutical products. This is a huge number of
drugs to be discussed and decided in one or
two days.
And these are just crude averages.
Sometimes the number of drugs is much
more. For example, in an April 1997 meeting
ihy DRB considered at least 700 applications
W.c’r drug registrations; on March 17-18, 1997,
it considered 310 drugs'. On June 16, 1997,
the number of new applications was stagger
ing — 550, of which more than 300 were reg
istered5. In a March 20, 1996, meeting 412
drugs were approved6. And between May 1,
1994, and March 20, 1996, 3,969 medicines
were registered. This means that on an aver
age 8.5 drugs were approved every working
day during this period!
New registered drugs
The number of new drugs registered in Pakistan rocketed
to an all-time high of 2,620 in 1995. Compare this with 113
new drugs registered in 1984 (the lowest). Over a period
of ten years (1986-96) the total number of drugs registered
nearly doubled.
No of regis
New regis
tered drugs
tered drugs
Increase
(%)
Cumulative
increase (%)
1977'
3,663
Data unavailable
Unknown
Unknown
1978
1979
4,595
5,401
932
25.44
17.54
None
42.98
1980
5,734
1981
6,228
333
494
1982
6,700
7,236
7,349
472
06.16
08.61
07.57
49.14
57.75
65.32
536
08.00
73.32
113
8,454
10,786
10,987
1,105
2,332
01.56
15 03
74.88
89.91
117.49
In comparison, in the US it takes over two
years to get a drug registered7.
Year
Although the statute books lay out a detailed
procedure for the registration, some former
DRB members claim that registration appli
cations are designed to fulfill the letter
Jier than the spirit of the law. The applican form for registration consists of 22 high
ly technical questions requiring nearly 75
ancillary answers and adjunct clarifications.
«
A source in a pharmaceutical company when
interviewed said that the minimum time in
which one can complete the application
forms is never less than a month, even if the
best of private organizations (which are usu
ally staffed with well-qualified people) work
on them8. A registration application is
received by the Drugs Controller (DC) who
passes it on to the Deputy Drugs Controller
(DDC) for review. Although applications are
required under law to be in quadruplicate to
allow specialists to scrutinize them, in prac
tice the DC and DDC are usually the only
people to review the application.
A former DRB member, on condition of
anonymity, said that a number of procedural
THE NETWORK’S NEWSLETTER JAN/FEB 1998
1983
1984
19852
1986
1987
1988
1989
1990
1991
1992
11,284
11,600
12,679
13,469
806
201
297
316
1,079
790
418
1993
13,887
Data unavailable
Data unavailable
1994’
15,188
1,301
1995'■
19965
17,808
19,157
2,620
1,349
27.58
01.86
02.70
02.80
09.30
06.23
03.10
Unknown
09.36
17.25
07.37
119.35
122.05
124.85
134.15
140.38
143.48
Unknown
|
152.84
170.09
•
177.66
1. Data from 1977 to 19M from Burhanuddin et al (1934). Report of the Commission on the Administration of Hospitals and Medical
Educational Institutions (unpublished). Federal Ministry of Health. Islamabad.
2. Data from 1985 to 1992 from Mohydin et al (1986), Review of National Formulary. Pakistan Medical Research Council, Islamabad
3. Dawn daily newspaper, April 26, 1996
4. The Network's Newsletter, Sept. 1995, Vol. 4, No. 3
5. The Network's Newsletter, March 1996, Vol. 5. No. 1
1
Drug registration issues - II
problems prevail in registration. For exam
ple, the agenda of the meeting is not circulat
ed beforehand, although Ministry of Health
(MoH) officials claim that it is distributed 15
days in advance. Moreover, the agenda con
tains only a list of drugs to be considered for
registration with no scientific data to review.
The fact is that members do not bother to
read the agenda because of incompetence
and disinterest, even if it is circulated before
hand.
There are many resource constraints in the
drug regulation department of the MoH.
There are not enough people and also a
severe lack of expertise and facilities. The
DDC, whose job is to ensure that the applica
tion details conform to law, in an interview
claimed that the task is performed by no less
than 14 people in Norway. This aspect
requires immediate attention of planners.
Nevertheless, it is no excuse for the present
irresponsible attitude of drug approvers. For
example, although concerned MoH officials
have sweeping powers under the Drugs Act
to formulate expert committees and tap out
side specialist resources when reviewing a
drug application, a former DRB member
The drug
registration
system needs
to be evaluated
in three areas:
Structure
could recall only a single expert sub-commit
tee formed during his more than 10 years on
the Board.
■ Structure of Drug
Registration Board
The Drug Registration Board was established
under the Drugs Act, 1976. It is made up of
18 members, who are also members of the
Central Licensing Board. Health administra
tors are DRB members by virtue of their
posts: the Federal Director-General Health
(Chairman of the DRB), the Drugs Controller
(Secretary of the DRB), all provincial
Director-Generals Health, along with senior
representatives (BPS-20) of the Ministries of
Commerce, Industries, the Central Board off"Y
Revenue, and the Justice Division. Other
DRB members who are medical specialists or
belong to the pharmaceutical field are direct
ly appointed, which means that the views
and composition of the Board can vary con
siderably.
The Act lays down specifically members of
the DRB: two pharmacologists, one pharma
cist, one medical specialist from the Army
Structure
Process
♦ Critical analysis of the section of the Drugs
Act, 1976, which deals with drug registration,
and comparison with WHO recommendations
(WHO, 1981,83, 85).
❖ Critical analysis of the relevant section of the
Drug (Licensing, Registration & Advertising)
Rules, 1976, and comparison with WHO rec
ommendations.
♦ Assessing the qualifications of the members
of the DRB and their rules of business.
♦ Is the WHO Certification Scheme on the
Quality of Pharmaceutical Products Moving in
International Commerce used systematically
(WHO, 1994), and if not, why?
♦ Listing the resources available with the MoH
for drug regulation but specifically for regis
tration. Are they adequate and how they have
grown with the number of registered prod
ucts? What are the DRB and MoH's per
ceived constraints in better drug registration?
Is the Drugs Act and the rules made thereun
der applied in letter and spirit?
Is the WHO and the IFPMA Code of
Pharmaceutical Practices being followed in
Pakistan?
♦ Detailed recording of the present registration
process.
♦ Recording the frequency and duration of DRB
meetings, selection of members, decision mak
ing; sample of a typical DRB meeting-and the
decisions taken.
»
Outcome
♦ Recording the number of registered drugs, fre
quency of new applications and looking at how
this frequency has changed over time and
why. How many applications are rejected
and on what grounds are they refused registra
tion?
♦ Calculating the percentage of registered drugs
included in the latest National Essential Drugs
List.
Calculating the number of registered drugs
I banned in other countries out of the total num
ber of drugs registered in Pakistan (WHO,
1994).
♦ Calculating the number of newly registered
combination drugs as compared to the total
number of newly registered drugs (WHO,
1994).
THE NETWORK'S NEWSLETTER JAN/FEB 1998
Drug registration issues ■ II
Medical Corps, one pharmaceutical chemist
or expert in quality control, one physician
and one surgeon. The Pakistan
Pharmaceutical Manufacturers' Association
also has a representative on the Board,
though not provided for in the Drugs Act.
However, until a few years ago there was
not a single pediatrician or pharmacist on
the panel. Former DRB members note that
direct appointments to the Board are largely
political and not based on rational considera
tions.
It is believed that, generally, drugs are regis
tered after receiving kickbacks and that deci
sions are not based on merit. This is evident
from the number and types of drugs regis
tered: more than 20 brain tonics, various
.'tfyver tonics, appetite stimulants, irrational
combinations of vitamins, cough syrups,
antidiarrheal preparations for children, etc.
Drug registration software
It has been quite a while since the WHO developed a computer software
to help national drug regulatory authorities manage thousands of their
registered products. The WHO’s system (formerly called SIAMED) can
greatly facilitate drug registration by improving access to information.
More than 64 countries today use this software to handle drug registration
information.
The drug registration system in Pakistan is still mostly manual. Retrieval
of information is extremely slow and the system inefficient. About a
decade ago the WHO offered to help in computerizing information about
drug registration. It also supplied some computers. But the drug regulato
ry authorities failed to take advantage of the offer.
Although the WHO software is recommended for use by small- and medi
um-sized users, it can also be used as a basis to customize any country's
national drug database. The Ministry of Health would do well to look into
Although pharmaceutical industry represen
tatives sit in the meetings of the DRB, repre
sentatives of specialized consumer groups
like The Network, despite repeated demands,
are not allowed to attend. The working of
the DRB is shrouded in secrecy and is totally
non-transparent. In the absence of a freedom
of information law in the country the DRB
and its functioning become even more
opaque to the public.
■ E)rag registration
evaluation: a
Suggested framework
Pharmaceutical registration procedures have
never .been evaluated for their performance.
This has been pointed out by many bodies
formed to look into pharmaceutical issues.
Some of these, however, have led to short-
References
1 Mirza, Zafar (1998), 'Issues in
drug registration', The Network s
Newsletter, Dec. 1997, Vol. 6,
No. 6
: Burhanudin el al (1983), Report
of the Commission on the
Administration of Hospitals and
Medical Educational Institutions
(Unpublished), Federal Ministry
of Health, Islamabad.
’ Andrew, Marit et al (1995),
Norway's National Drug Policy: Its
Evaluation and Lessons for the
the possibility of adapting the software to the country’s needs.
term measures. For example, subsequent to
the National Formulary Review (1984-86),
between 300-400 formulations (129 drugs)
were deregistered.
But to date there has been no systematic
stocktaking of the registration practice in
Pakistan.
A framework is needed and a list of indica
tors must be compiled to assess the drug
registration procedure. Using these indica
tors a study can be conducted to show how
pharmaceuticals are evaluated before being
accepted. The results would provide an
opportunity to policy makers to consider
appropriate action. It would also provide a
baseline for future research in this crucial
area.
Future, Development Dialogue,
1995:1, p25
4 Internal documents, Federal
Ministry of Health, 1997
5 The Network's Newsletter, June
1997, Vol. 5, No. 3
6 The Network's Newsletter, March
1996, Vol. 5, No. 1
7 Manual of Drug Laws (1995),
Mansoor Book House, Lahore,
Pakistan
8 'Record number of drugs regis
tered', Dawn, April 26, 1996
’ Burhanudin et al (1983), Report
of the Commission on the
THE NETWORK’S NEWSLETTER JAN I FEB 1998
Administration of Hospitals and
Medical Educational Institutions
(Unpublished), Federal Ministry
of Health, Islamabad
“ 1984-1986 Review of the National
Formulary
" Senate's Special Committee on
Medicine Sector in 1991
11 Study to demonstrate the use
fulness of the "UN Consolidated
List of Products whose
Consumption and / or Sale have
been Banned, Withdrawn,
Severely Restricted or Not
Approved by the Governments”
rrational drug use concerns and its deter
minants need to be institutionalized at
the local level. Formation of local activist
groups to promote rational drug use can help
set off the process and ensure continuation of
work on the issue.
I
The type, modality and agenda of work
should be decided by the members of the ,
group. It should be independent of any
industry involvement or influence. It should
chart its periodic work plan with ways to
work for the promotion of rational use of
drugs by using strategies of simple action
research, advocacy, information, education
and communication.
All the following ideas can be incorporat
ed in the work plan of these groups;
however, in no way should they be lim
ited to it.
Monitoring WHO Ethical
Criteria For Medicinal
Drug Promotion
1
Enough evidence is available
on the unethical promotional practices of pharI
maceutical companies
and the resultant nega^ve implications on ratio/
nal use of drugs. Aware of
ZT
/ 1
/ JI
this worldwide problem,
WHO with the help of inter
national experts has devel
oped Ethical Criteria For
Medicinal Drug Promotion. This
code lays the foundation for proper behav
ior concerning the promotion of pharma
ceuticals and provides minimal criteria which
the industry should observe while promoting
its products.
'
ll
I
Every medical practitioner should be aware
of the code's existence and, with its help,
monitor the promotional practices of the
industry. S/he should also try to develop a
local evidence base which can be used in var
ious ways for a meaningful change. This evi
use at the local lev
dence base can feed into advocacy campaigns
through the media, hold dialogue with the
responsible and interested companies, apply
pressure to tighten up the Drugs Act, etc. The
process should be consistent.
Copies of the WHO Ethical Criteria are avail
able with The Network.
Investigating drug use in
health facilities,
communities
2
Bad prescription leads to irrational drug use.
The general feeling is that the quality of
doctor's prescrip
tions is not up to
the mark, but
hard evidence
is unavail
able to
support
this per
ception.
There is
need to carry
out welldesigned studies
for a macro-analysis of prescriptions. If a
group of doctors, under strict confidentiality,
can begin such work and provide feedback to
the study population to highlight the prob
lems, causes and possible solutions, this can
be a valuable exercise. The core idea should
be improvement in prescription and not to
blame anyone. The results can be compiled
for the group's own analysis.
Then there are several little-known issues:
patient compliance, self-medication and other
aspects of drug use patterns among people,
for example. Medical professionals should be
concerned about these issues because a good
prescription alone cannot ensure rational use
of prescribed drugs. A lot depends on the
patient in terms of health beliefs, attitudes,
etc.
WHO has developed after widely testing two
important research tools in many countries:
THE NETWORK'S NEWSLETTER JAN/FEB 1998
'How to investigate drug use in health facili
ties', and 'How to investigate drug use in
communities'. Both are available with The
Network.
Investigating prescription
patterns of non-registered
medical practitioners
3
Registered general
practitioners
(GPs) usually
blame their non-registered counterparts
(and quacks) for being an
unhealthy influence on their
profession. Registered GPs have to
compete with the unregistered for
the treatment of patients. The
Pakistan Medical Association (PMA) has for
long demanded of the government the end of
quackery from the country.
But despite non-registered medical practi
tioners being castigated there is not a single
study in the country that details their prac
tices. Such a study can provide a deeper
understanding of the situation and could also
.strengthen the case of the PMA and GPs. A
^combination of various research methodolo
gies can be tried for the purpose.
Developing an
Ethical Code of
Medical
Practice
4
How many
doctors
really
know and
understand
the Hippocratic oath? How many doctors
remember the oath they took while register
ing with the Pakistan Medical and Dental
Council? These are important but difficult
questions to answer.
THE NETWORK’S NEWSLETTER JAN/FEB 1998
Time has come to develop a minimal but
pragmatic code of medical practice which
should be broad based, widely accepted and
well promoted. This would involve proactive
thinking on the part of the medical profes
sion in Pakistan toward medical ethics and
self-accountability. But who will set off the
process? Would you like to become a pio
neer?
5
Continued medical
education programs
Medical education programs
need to be put in place and
conducted regularly for local
activist groups to keep up with
the pace of global research and
familiarize themselves with
emerging issues.
6
Patient education
programs
Doctors are quick to blame
patient pressure as one of the
important factors which
makes them prescribe
unnecessarily more and
expensive drugs. Patients are
also blamed for bad drug com
pliance. But is continued blaming
enough? What has the medical
profession done to educate patients?
Are we interested in patient education?
If we are, let us start thinking what can
be done on this front.
These are just a few ideas that local groups
can consider for rational drug use. There are
numerous others. If you are interested in
forming a group or wish to individually pur
sue any one of these or other ideas for the
promotion of rational use of drugs, please
feel free to contact us at The Network. We
would be happy to look into the possibilities
of further developing your ideas, collaborat
ing with you and supporting you.
Individuals are welcome, but coordinating
with groups is preferred.
ActionPoints
Promote
Campaigns Update
drugs
An essential drug is...
(Spencer Pharma), anti-asthma inhalant.
o Warfarin: Coumadin® (Sandoz), a life-sav
ing anti-coagulant; unavailable for the last
three months.
Chlormezanone
©ODO
<>one which has proven efficacy
. is acceptably safe
relatively cheap
, and can satisfy the health needs
of the largest number of people
Essential drugs include life-saving drugs and
should be available at all times in adequate
amounts and in the proper dosage forms to
the majority of people.
The WHO's 1998 Model List of Essential
Drugs (tenth list) prepared in December 1997
comprises 307 individual drugs. These cover
the most common diseases prevalent in the
third world such as respiratory infections,
diarrhea, tuberculosis, measles and malaria.
The Pakistan National Essential Drugs List
(PNEDL) comprises 470 drugs. Because of
the great differences between countries, the
preparation of a drug list exactly the same as
that of the WHO is not feasible or practical.
Since a number of diseases are more common
in some countries and rare in others,
every country needs to come up with its
own national EDL to suit its population.
After conducting surveys in various
cities of Pakistan, The Network has dis
covered that the following drugs (on the
PNEDL) are currently unavailable or in
short supply with chemists:
Atenolol: Tenormin® (ICI), a beta-blocking
agent.
Azathioprine: Imuran® (GlaxoWellcome),
an immunomodulator.
Glyceryl trinitrate: Sustac® (Searle) for
angina prophylaxis.
Phenytoin sodium: Dilantin® (ParkeDavis), an inexpensive remedy for epilepsy
patients. Alternatives are far more expen
sive.
Salbutamol: Ventolin® aerosol
(GlaxoWellcome), anti-asthma inhalant,
and an alternative Venex® (Pharmatec)
Selegiline: Jumex® (Searle), an anti
Parkinsonism preparation.
Sodium cromoglycate: Intal® aerosol
©Effloou
Chlormezanone, a muscle-relaxant, was
withdrawn in France by manufacturers
Sanofi-Winthrop in the second half of 1996
because it was found to be linked with caus
ing epidermal necrolysis (a condition charac
terized by widespread bubbling and slough
ing off of the skin resulting in large areas of
skin loss) and Lyell's syndrome.
The Network has found a number of chemists
in major cities of the country that still have
supplies of chlormezanone-containing medi
cines, especially Samerol®and Beserol®. Other
brand names are Cetazone®, Delgesic®,
DoseroL, Muscerol®, and
Novorol®.
In a March 25, 1997, letter
to the DG Health The
Network urged the federal
government to ban the
drug in Pakistan. The
Ministry of Health
responded by informing
those pharmaceutical
companies manufacturing
or using the drug in their
medicines that all
chlormezanone-containing drugs had been
de-registered, specifically naming products
(letter no. F.4-2/97-Re-Il, Sept. 2, 1997).
•,
'<
Registration of seven companies manufactur
ing/using the drug were canceled: Dosaco
Labs, Lahore; Krka-Pak, Karachi; Pharmatec
Pak, Karachi; Progressive Labs, Karachi;
Sami Pharma, Karachi; and Unexo Labs,
Lahore. Searle-Pakistan, in a April 3,1997,
letter had already written to the Ministry of
Health that it was voluntarily withdrawing
the drug from the market.
Two things stand out as unfortunate. One,
the government took five long months to
respond to The Network's letter to ban
chlormezanone-containing medicines. During
this time the number of patients exposed to
potential risk can well be imagined. And
two, the companies concerned have failed
to withdraw their products from the
THE NETWORK'S NEWSLETTER JAN/FEB 1998
market immediately after the government's
ban on the drugs. Instead they are waiting for
chemists to sell off their stocks, again pro
longing the time during which patients are at
potential health risk.
The Network endorses the Federal
Ombudsman's orders (dated February 25,
1998, copy addressed to the Secretary,
Ministry of Health). It urges the government
to take immediate action against those violat
ing its ban on the manufacture and sale of
banned drugs in Pakistan, and to put in place
a mechanism to monitor the implementation
of the government's directives.
Terfenadine
Terfenadine has been banned in the United
States, France, Greece and Luxembourg, and
severely restricted in the United Kingdom
(Newsletter, Dec. 1997). The drug has been
proved to cause fatal heart arrhythmias when
taken with certain antibiotics and antifungal
medicines. It also has the propensity to react
unfavorably with grapefruit (British Medical
Journal, May 3, 1997; The Lancet, October 18,
1997).
The Network has decided to take up the issue
with the Federal Ombudsman and lodge a
formal complaint.
Terfenadine-containing medicines include
Bronal®, Fenade , Fendina , Histacam ,
Hypofen® Meldane ; Nebral , Talergin ,
Teldane®, Terfen®, and Terfenal .
Anti-obesity drugs
Heart anomalies
The US Food and Drug Administration (FDA)
recently withdrew fenfluramine and dexfenfluramine from the market as findings sug
gested that the drugs can cause heart valve
problems. The drugs were being used in the
treatment of obesity.
In Pakistan at least two medications contain
the drugs: Pondrel® and Isomeride (Les
Laboratories Servier).
f
According to S. Nasim Bokhari in a letter
to the editor (The Nation, Dec. 31, 1997)
the French company claimed through an
advertisement in the national press on
September 18 that it was withdrawing
Isomeride from the market and buying
Y
S
back stocks.
But in Pakistan terfenadine-containing medi
cines continue to be sold as the government is
yet to ban it. This despite Section 6.5 of the
National Drug Policy, which states that any
drug banned for safety reasons in the US,
Canada, European Union, Japan, Australia,
China, Switzerland or its country
(<?>of origin "shall not be allowed sale in
Pakistan".
The Network has time and again issued press
releases highlighting the dangers of terfena
dine-containing drugs and urged the Ministry
of Health to deregister the drug, ask manufac
turers to stop the drugs' production and with
draw it from the market, and chemists to
return all stocks to the relevant companies
forthwith.
All this makes sense even more as terfenadine
is not an essential drug, it is not life-saving,
and its risks outweigh its benefits. Also, safer
substitutes exist.
Unless the government places an immediate
ban on terfenadine-containing drugs, allergy
patients will continue to be exposed to
potential cardiac complications.
THE NETWORK’S NEWSLETTER JAN/FEB 1998
Mr Bokhari praised tills action and said that it
was "undoubtless [sic] a tribute to modem
medicine for not taking any chances at any
expense insofar as there is even a whiff of sus
picion of any possible harm coming to the end
users." He was in favor of awarding the phar
maceutical company "a medal for its highly
ethical performance [sic]". He also hoped that
The Network would get its facts right to "make
[the Newsletter] professionally passable".
Isomeride® is still available. A medal is surely
due for the company has managed to prolong
the shelf life of its product. Patients face the
risk of developing cardiac valve anomalies
while Les Laboratories Servier merrily finish
selling off present stocks.
The Network urges the Ministry of Health to
ensure that the medicine is immediately and
completely withdrawn from the market. The
manufacturer and distributors must stop pro
ducing/ marketing any medicines that contain
fenfluramine or dexfenfluramine. Doctors
should not prescribe these medicines and
people should not buy them for fear of devel
oping cardiac anomalies. And that's a fact. ■
Diagnostics m
developing
countries
Diagnostics are big business in developing
countries. In Lahore private clinics advertise
magnetic resonance imaging on public bill
boards, diagnostic clinics abound, and ultra
sound examination on demand costs $2.50 to
$10....
The British Medical
Journal, one of med
icine's most
renowned and wide
ly quoted publica
tions, comments on
the state of affairs of
diagnostic equip-
ment in the third
;; ..' world, quoting one of
The Network's findt i.
ings in the area.
By Paul Garner,
AyyazKiani,
and Anuwat
Supachutikul
While some of these changes might be antici
pated as government policies shift towards
enabling provision of private care, there is
some evidence that governments themselves
are spending public money to expand diag
nostic services. For example, one provincial
government in Pakistan borrowed $8m to
upgrade basic health-care facilities by provid
ing medical equipment — mainly x-ray
machines, ultrasound scanners, and micro
scopes;... similar large expenditures are being
considered by donors or governments in coun
tries from Peru to Palestine. The investment is
sometimes large: in Pakistan, for example, the
Network for the Rational Use of Medication
estimated that in 1995 the value of the market
for medical equipment in Pakistan was
$0.25bn, while the pharmaceutical market in
the same year was $0.91bn.
The trend towards providing better diagnostic
equipment is partly driven by the desire to
make diagnostic tests more accessible —
something that the World Health Organization
has promoted. However, there are other pres
sures at work. Gleaming equipment and labo
ratories provide a professional veneer that is
attractive to both doctors and patients. Some
private practitioners own their own laborato
ries, and commercial laboratories in some
countries pay doctors for patients referred. In
some instances, unscrupulous equipment
manufacturers encourage purchase of equip
ment through incentives for the administra
tors who sign the requisitions forms.
Sometimes overseas aid programs use funds
to stimulate their own industrial base, includ
ing the manufacture of medical equipment.
Yet it is expensive to install, staff, maintain,
and buy consumables for any diagnostic
equipment, particularly x-ray and ultrasound
machines, microscopes, spectrophotometers,
and kit assays.
Therefore, ministries need to be sure the
investment is likely to benefit patients, and
good science and technical support should
help here. Technical advice from the WHO and
other aid and donor agencies generally focus
es on efficient delivery' of medical tests by
ensuring that equipment is regularly serviced,
gives accurate measurements, and is supplied
with consumable materials. This is clearly a
prerequisite if a test is to have any potential
impact. But we need to step back a little.
Providing x-ray machines and basic laboratory
equipment for a 100-bed district hospital
seems sensible, but will such investigations
mean better primary' care at smaller, less
sophisticated, walk-in clinics?
This can be answered by' addressing three
questions. Firstly, will the tests actually result
in altered decision making, change the timing
or type of treatment, and thus result in a better
outcome? To answer these questions, we
would need to evaluate the skills of the clinical
staff at these facilities and the case mix of the
patients. Secondly, given the additional infor
mation provided by' the test and its potential
to improve outcomes, can the health-care sys
tem as a whole provide the care that will result
in these better outcomes? Thirdly, "Is this loca
tion the most cost effective for this test?" ’
Economies of scale mean that low throughput
results in high unit costs, so that an x-ray unit
at an urban primary health facility' seeing 25
general outpatients a day is unlikely to be a
sensible use of scarce resources.
These are difficult questions. In the face of spe
cialist clinical demand and strong commercial (
pressures, health-care planners need support
and information. We propose an essential
diagnostics program that promotes the ratio
nal and effective use of diagnostic tests in the
developing world. Such a program could
refine a series of basic tests linked to symptom
complexes in standard treatment regimens.
Methods for doctors and managers to audit
diagnostic practices should be developed and
disseminated, and the effectiveness of tests
should be debated in the public arena, along
the lines of the WHO’s excellent essential
drugs program. In the meantime, ministries
and donors aiming to improve the quality' of
primary' health care should examine carefully
whether buying medical equipment for prima
ry care centers is an efficient or effective use of
scarce resources.
Editorial, September 27,1997
BMJ No. 7111, Volume 315 ■
THE NETWORK'S NEWSLETTER JAN / FEB 1993
-x
?
Hepavar3, again
'i
H This refers to your report "Unethical pro-
L S motion of Hepavar®" (Newsletter, October
1997). A field manager and medical representa
tive from Amson Farmaco visited me and told
me about the "curative" effects of Hepavar®. I
asked them to tell me about the mechanism
through which the drug "cured" hepatitis and
to provide me relevant reference material.
On their next visit they gave me an 80-page
booklet about the drug. After going through it
I could find no evidence that the drug had any
curative effect on hepatitis patients.
When the representative came again I told him
to provide me concrete proof of the drug's effi
cacy. But the company has no proof of the
drug's effects on curing hepatitis. It is only pro
paganda.
Dr Zahid Iqbal Jamshed
Pir Mahal
example, the companies host lunches and din
ners in five-star hotels and call them ’seminars'
and 'symposia'. Companies arrange tour pro
grams for doctors, their friends and families
and accommodate them in expensive hotels.
The industry also bestows doctors with expen
sive gifts.
Pharmaceutical companies sponsor musical
nights and cultural shows in five-star hotels.
Sometimes they also give cash to doctors to
decorate their clinics and offices.
Thus the pharmaceutical indus
try spends a lot of money annu
ally on the promotion of the
drugs they produce. This is
added to the cost of the drugs
which the poor patient has to
pay. This unethical promotion of
medicines must be stopped immediately.
Qasim Jan (Pharmacist)
Charsadda
The manufacturer's claim of the use of
Hepavar® "for prevention and treatment
of hepatitis" is incorrect.
End of smallpox?
I hope the Ministry of Health takes up this
matter and asks the company to immediately
stop the unethical promotion of Hepavar®.
Dr S. Manan Bangash
Hangu
Reining in medical reps
i h ’ Our hospitals are flooded with medical
l_
representatives. They reach hospital early
in the morning, sometimes before the medical
S) officers of OPDs. Wearing three-piece suits
with a bag in hand they look like a foreign del
egate. These people know how to impress the
MOs, but then we also know how to control
them.
I have strung a banner in the verandah of the
hospital where I work which reads: Medical
Representatives are not allowed to visit MO
before 12 o'clock."
Munsif Ali
Svvabi
Promotional tactics of
pharma industry
The pharmaceutical
companies indulge the
members of the medical
profession in different
. ways, which adds to the
prices of medicines. For
THE NETWORK’S NEWSLETTER JAN I FEB 1998
'■ TiThis refers to your October 1997 newsletLtes ter. On page 8 you say that "the last new
case of smallpox was seen in 1997." As far as I
know, the last case was seen in 1977 in
Somalia, and his name was Muhammad. Can
you please quote the reference of your report?
Major Dr Iqbal Ahmad Khan
Rawalpindi
The year should have been written as 1977 instead
of 1997. We regret the typographical error. — Editor
More on Fansimef®
Tl Your Newsletter (October 1997) lays out in
detail the adverse effects of Fansimef. A
year ago 1 wrote to the manufacturers Roche
telling them to review the dosage of their
product as many patients complain about
gastritis after using the drug. The trouble is so
severe that patients forget their fever and
instead ask to be cured of troublesome
gastritis.
I suggest that practitioners also keep in mind
gastro-intestinal disorders while prescribing
Fansimef®.
By the way, Roche has yet to reply to my letter.
Dr S. Manan Bangash
Hangu
Hurdles in rational drug use
■a T’A 4th-year MBBS student, I have been
■y=ijreceiving your Newsletter for a year. The
existence of your organization is extremely
encouraging for students like myself because it
is a beacon of light and ray of hope in the pre
vailing suffocating situation.
I hope you will also highlight the dangers of
self-medication and age-old medicines.
Moreover, the issues of public apathy, political
expediency and professional dominance,
which are the greatest obstacles to the rational
use of medication, should also be looked into.
Muhammad Saaiq Seljuki
Peshawar
Hidden poison
a ~j Aluminum phosphide is available easily
asiin the market in the form of pills to be
kept in wheat, rice, pulses and other
agricultural products as a fumigating agent.
Several people have died due to unknowingly
eating grain containing the poison.
Kindly help me and the medical profession to
find the antidote of aluminum phosphide
through your publication or the electronic
media.
The loss of precious lives can be prevented by
banning this chemical or its use restricted only
to professional fumigators.
Dr Muhammad Salecmullah Khan
Gujranwala
Detailed information about aluminum phosphide poi
soning has already been sent to Dr M. Saleemullah
Khan. — Editor
Here is a summary:
Following an ingestion of aluminum phosphide
patients will present with profuse vomiting and pain
in the upper abdomen. Clinical presentation may
also be characterized by a marked tachycardia,
altered sensorium, anemia, and pulmonary edema.
Intractable shock is usually present, and death
occurs within half an hour to 3 days of admission.
Supportive treatment with fluids, bicarbonate, oxy
gen, and vasopressors have been unsuccessful in
many patients with severe poisoning.
Corticosteroids appear to be ineffective.
Pulmonary edema and shock should be treated
symptomatically. Intravenous magnesium sulfate
has been attempted without clear therapeutic
results.
If fumigant liquid or solid has been ingested less
than several hours prior to treatment, quantities
remaining in the stomach should be removed as
effectively as possible by gastric intubation, aspira
tion, and lavage after all possible pre
cautions have been taken
to protect the respiratory
tract from aspirated gas
tric contents.
Antidotes
There are no antidotes.
Ellenhom’s Medical
Toxicology
Diagnosis and Treatment of
Human Poisoning
By Matthew J. Ellenhom
(Second Edition, Williams and Wilkens (Electronic),
1997)
Drugs in the media
A number of advertisements appear on TV and
in newspapers, promoting a variety of medi
cines. Some examples are Dispirin ,
Paracetamol®, Pain Gay", lodex®, Josheena',
herbal and homeopathic tonics, cough syrups,
Eno3 and a variety of homeopathic medicines.
Most of these medicines must have side
effects. Moreover, they might be being used
when not indicated; this could result in wors
ening of the disease.
The government is requested to impose a com
plete ban on the advertising of all allopathic,
homeopathic and herbal medicines on the pub
lic media, along with a complete ban on overthe-counter sale of drugs.
Dr Rashid Mahmood
Peshawar
Take1 Fluothane®
The Network's Newsletter (December 1997, p.3)
carried a summary of a news report ’Counterfeit
fluothane on sale in Peshawar’. This ruffled sev
eral feathers — but all the wrong, ones.
Distributors for Zeneca UK — Pakistan ICI —
complained that our write-up "does not narrate
the whole story" which has "left confusion and
allegation over the manufacturer, M/s Zeneca in
UK and local distributor M/s ICI Pakistan". This
was not intended.
The Network’s policy is to point out, among oth
ers, illegal drug practices and to urge govern
ment and drug manufacturers to keep a constant
check on drugs for quality and consistent supply.
The write-up, if read in the right context, men
tions nowhere that Zeneca is involved in the pro
duction of a counterfeit version of Fluothane3.
The word manufacturers' implied producers of
fake Fluothane1.
It is heartening to see multinational companies
vigilant and acting promptly against the produc
tion of spurious drugs. Hopefully, the fruits of
such exercises will one day be passed on to the
consumer.
THE NETWORK’S NEWSLETTER JAN/FEB 1993
Death drugs
ED)© [©gjfioemifLS eOessrw SM©[h) tnrD@^n©D[m@§T
In the plains of rural Punjab, the
Land of the Five Rivers, the sun
shines bright, water is aplenty
and the crops grow tall. The men
and women work together in the
fields and are committed to their
homes and children. In the sum
mer evenings as the grasshop
pers chirp and the mosquitoes
buzz, the air fills with smokey
aromas.
But all is not well. The state of
health here has rotted to the
core. Villagers visiting one Basic
Health Unit (BHU) in particular
for treatment of minor ailments
are getting sicker.
Absent dispensers in BHUs,
non-existent hospitalization facil
ities, and missing medicines are
all too common in the country’s
rural areas. But giving fungusridden pills to patients is inexcus
able.
The pills shown above are mag
nesium trisylicate, an antacid.
These were being dispensed by
the in-charge compounder. One
of our workers, while on a visit to
various health units in Punjab,
saw these tablets being given to
patients. After pointing out to the
compounder that the pills were
unsuitable for human consump
tion and asking him to desist
from dispensing them any fur
ther, our worker brought back the
medicine bottle. Another bottle
containing fungus-tainted aspirin
was also recovered.
countries have strong national
campaigns for patient rights
charters. The eight international
ly accepted fundamental rights
of patients are:
How long will
Pakistanis,
whether rural or urban, continue
to take such treatment? For how
long can our people suffer in
silence the whims of criminal
compounders, incompetent doc
tors and inefficient hospital staff?
Time has come for the patient to
stand up and demand his rights.
0 Right to accessible and
appropriate health care
0 Right to freedom from dis
crimination
0 Right to adequate informa
tion
0 Right to choose a health
provider
0 Right to informed consent
about treatment
0 Right to participate in health
care decision-making at the
individual and community
level
0 Right to respect, privacy,
confidentiality and dignity
0 Right to complain and have
redress in the event of injury
As a first step in this direction,
The Network intends to draw up
a Charter of Patients Rights in
Pakistan. Several third world
The Network invites readers’
comments, criticism and sugges
tions to help it formulate a force
ful nation-wide campaign.
THE NETWORK’S NEWSLETTER JAN/FEB 1998
15
Feeding Fiasco
Pushing commercial infant foods in Pakistan
hy are women doubting their natural ability to provide their children with the most nutritious, anti-infec
W
tive food available? Why do mothers believe they cannot produce enough milk to satisfy their babies'
hunger, when their mothers and their mothers’ mothers knew no other way of feeding babies? Why are their
doctors quick to recommend infant formula to ‘supplement’ breastfeeding, rather than helping mothers to
breastfeed with ease and success?
The Network’s interest is in the protection of breastfeeding in accordance with
Article 11.4 of the International Code of Marketing of Breastmilk Substitutes
(1981). This report, therefore, is primarily a qualitative examination of the
infant food industry's promotional practices which undermine breastfeeding
and/or promote artificial feeding, especially bottle feeding, as the norm.
Feeding Fiasco: Pushing commercial
infant foods in Pakistan by Tahir Mehdi
and Tracey Wagner-Rizvi, Published by
The Network. Islamabad, 1998. 88pp.
Rs 150, USS15 (overseas, incl handling
and postage)
Violations of various articles of both the International Code and the Saarc
Code are presented. In addition, any finding which was found to have a neg
ative influence on breastfeeding is also examined.
Who should read this report
Maoon Kay Gehnay Companion Ney
Pehnay (brief Urdu version). 15pp,
Policy makers, health professionals, pediatricians, gynecologists, obstetri
Rs 25, US$2.50
cians, employees of infant food manufacturers, public representatives,
journalists, chemists. The report can also benefit expectant and new mothers, medical students and concerned citizens.
[p[?©C®0®!nra Drugs
International Advisors
ens J thousands of drugs are on sale all over the world. Most are at best ineffective or a waste of money;
T
’
i
Dr Andrew Herxhetaer
FCWf Chanran ireamaSans
Sc&ety of Drug Bries. UK
:
Dr K Baiasubramaniam
i
1
PharmaceuScai Adviser Casw«s
lnrsrra2,?nai Penang. Mafajss
i
Dr Leo Offerhaus
i
I
Philippa Saunders
Essential Drugs Protect. UK
some are actually unsafe. This book names them. It also assesses the consequences for public health of their
frequently inappropriate or unnecessary use. In this carefully documented and up-to-date analysis, which draws
on the experience of health workers from around the world, Andrew Chetley covers a wide range of drugs includ
ing antibiotics, anti-diarrheals, analgesics, cough and cold remedies, contraceptives, drugs for use in pregnancy,
hormone replacement therapy (HRT), psychotropic drugs, growth stimulants and vitamin supplements.
Who should read this book
AU consumers but especially health workers, chemists, policy makers, medical students and journalists.
Problem Drugs by Andrew Chetley.
Published by Zed Books. London:
reprinted 1996. 338pp.
Rs 325 (incl. handling and postage)
ft© @©@®]
i
!
Dr Zararu'lah Chowdhury
j
Projects
Cense BangWosn
harmacology training for most medical students concentrates more on theory than on practice. The
P
material is often drug centered and focuses on indications and side-effects of different drugs. But
in clinical practice the reverse approach has to be taken: from the diagnosis to the drug. Moreover,
Network Council^’*
Akffeque-un-MabiKi...^'. !-l
patients vary in age, gender, size and socio-cultural characteristics, all of which may affect treatment
Dr Tasieem Akhtar
Mr Abdi.-. i_asf Sfteikh
choices. Patients also have their own perception of appropriate treatment and should be fully informed
Prof A. Samad She
*
partners in therapy. All this is not always taught in medical schools, where the number of hours spent
Mr Asiam Azhar
Or Ara Talat Sayeed
on therapeutics may be low compared to traditional pharmacology teaching. As a result although phar
macological knowledge is acquired, praclical skills remain weak.
.
J-
Dr frwa-Haq
This training manual meets that need. It provides step-by-step guidance to rational prescribing and
teaches skills that are not lime limited but which remain valid throughout a clinical career. It demon
explains the principles of drug selection and how to develop and become familiar with a set of drugs for
p-olfr-te’iQurPShr
Fret M ’teeam ISan
Pre: Aris ii^aiBheta
regular use in practice, called P(personal)-drug. Practical examples illustrate how to select, prescribe
fewwaM-D
strates that prescribing a drug is part of a process that includes many other components. The manual
Guide to Good Prescribing by TP.G.M de
Vries et al. Published by World Health
Organization, Geneva, 1995.108pp. Rs 80
and monitor treatment, and how to communicate effectively with patients. The advantages and disad
vantages of different sources of drug information are also described.
Who should read this book
Although intended primarily for undergraduate medical students who are about to enter the clinical phase of their studies, postgraduate students
and practicing doctors may also find it a source of new ideas and, perhaps, an incentive for change.
Please do not send ns cheques less than Rs. 500. For lesser amounts send money via
money order or bank draft in favor of:
Association for Rational Use of Medication in Pakistan
Quoted prices are inclusive of handling charges.
Any part of this newsletter can be
appreciate il it is credited, and a copy sent to its office.
3
How pharmaceutical
industry is making
more and more money
by selling less and
less medicines
riefing paper
Report of a study conducted by The Network
Association for Rational Use of Medication in Pakistan
60-A, St:39, F-10/4, PO Box 2563, Islamabad, Pakistan. Ph; 281755, Fax 291552, E-mail: zafar@arump.sdnpk.undp.org
around 20%, these drugs are on the
he pharmaceutical market
companies sold less drugs in 1995
in Pakistan is growing at a
than in 1994. Then how did they
controlled list (SRO471 (D/93
phenomenal rate of 25 per
earned Rs 6.34 billion more in 1995
Controlled Drug Serial numbers 53
cent annually for the last six years.
compared with 1994? The answer
to 57). Similarly prices of Daonil
The total value of the market in
is simple. Through price rise alone.
tablets, Incidal suspension,
stood at Rs 27.93 billion in 1995, a
During the politically turbulent
Buscopan plus tablets and Ciproxin
cumulative growth of 151 per cent.
period of 1993, the Government of
infusion were raised by 16 to 20 per
This high growth rate out paces the
Pakistan over ruling the Drug Act
cent despite the fact that all these
rate of population growth in the
1976 had deregulated price control
drugs are on the control list.
country which should mean that
and awarded the industry across
Besides these frequent increases by
people's access to modern medicine
the board raise in drug prices. The
the individual companies, the phar
is fast growing. This is what the
medicines were divided into two
maceutical industry has been suc
cessful in winning many across the
1990
Resochen tablets, Siastagin ampules
was Rs 11.01 billion, while it
proponents of free market economy
lists - controlled list and decon
are trying to make everybody
trolled list. Legally, the industry is
board price raises for the controlled
believe. But in reality, the situation
free to price drugs in the decon
list drugs.
is exactly the opposite.
The situation is for sure rosy (for
trolled list alone. But practically, the
As evident from the graph on page
Ministry of Health has no will or
2,
mechanism of controlling prices in
the growth rates in value sales and
there was some cohesion between
the industry) if we look at the mar
the decontrolled list as well. It only
volume sales till 1993. The gulf has
ket in terms of value or turn over of
relies on the 'gentlemen's promise'
widened after the 1993 deregula
the companies in rupees. But con
by the industry not to raise prices
tion. Through successive price rais
sidering the sales volumes offers an
without its consent. The gentlemen
es, the government has made it
entirely different story. The pharma
in the industry, however, give this
possible for the companies to sell
ceutical market in Pakistan is grow
promise a damn.
less drugs and make more money.
ing at a rate of 3 per cent in terms of
On June 1, 1996, Hoechst raised
From the marketing point of view,
units of medicines sold since last six
prices of Avil tablets, 25 mg, 50 mg,
the companies have two ways to
years. In 1990, the industry sold
Retard and Avil injection 5 ml by
raise their profits,
585.5 million units of med
a: make their product
icines, while in 1995 it sold
accessible to a large
698 million units, a cumu
number of consumers
lative increase of 19 per
by keeping its price low
cent. The trend in rise in
and hence sell more and
volume sales was uniform
more
till 1994 as each year the
b: price the product high
volume sales rose over the
with huge profit margin
previous year. But the
and target only rich con
1995 showed a negative
sumers.
trend as number of units
The first choice leads to
of medicines sold tins year
an efforts intensive mar
were one per cent less
keting strategy while
than the previous year (a
the second one is the
net growth of -1%). This
easy choice as the rich
simply means that the
consumers are concen-
2
N
Is price control a sin?
Price control in particular and any type of control in
drugs in 1960, but after successive reductions and con
general is considered against the spirit of free market
trols on prices it spent only 7.8 per cent of its 1985 health
economy. But the countries which are the biggest advo
budget on pharmaceuticals. Following are the details of
cates of the free market themselves acknowledge that
selected drug price control mechanisms working suc
the market forces alone should not decide the prices of
cessfully in five countries:
the medicines. They intervene in the market on people's
France: Patients in France are reimbursed for the cost
behalf to ensure that medicines remain available to their
of treatment under the social security system. The
population. The governments in these developed coun
Ministry of Health forms lists of drugs and assigns each
tries impose price controls through different mecha
list different levels of reimbursements. For example,
nisms and such measures are unopposed, even by the
drugs on the special list are reimbursed 100 per cent,
pharmaceutical companies.
drugs for the least severe conditions are reimbursed at
Twelve out of the 16 West European countries con
40 per cent and most standard drags at 70 per cent.
trol prices of individual drugs directly. All 16 have
These lists are made by considering the cost-effective
schemes for reimbursing health care costs, thus indi
ness and the therapeutic advantages of a drug. If a man
rectly helping control prices. The proposed price of a
ufacturer prices a drug higher than the government
new drug is compared with its available alternatives,
finds appropriate, the drug is placed on a lower per
and decisions made accordingly. Many countries also
centage reimbursement list, which substantially limits
control prices by putting a limit to the profit a company
the drug's market potential as less patients would want
their physician to prescribe a drug for which they
can make.
Except for Ireland and Austria, all 16 countries
would be reimbursed less.
have official policies to encourage doctors to prescribe
Since 90 per cent of the drugs consumed by the
generic drugs (always cheaper than brand drugs). In
French are partly or wholly reimbursed by the govern
most of these countries generic drugs are a popular
ment, the manufacturers are forced to keep prices low
method of defeating the price hike the generic drug
so that the drag is listed on a high reimbursement list
market share in Germany and UK tripled in 1980-85.
and thus prescribed more frequently. Moreover, price
Many may argue that drug prices in the West are still
changes are also heavily regulated, and reviewed after
much higher than in Pakistan. But if the cost of treat
30 months. If the government concludes that excessive
ment in these countries is compared to the patients' pur
profits have been gained, the price is lowered. Medicine
chasing power, it is actually far less expensive than in
prices in France have not risen in proportion to inflation
countries like Pakistan.
during recent past because of these controls. Their effec
Most importantly governments in these countries
tiveness can be judged from the fact that prices of non
consider health care as their prime responsibility. They
reimbursable drugs have increased about three times
enact laws, launch schemes and negotiate prices with
the amount that reimbursable drugs did from 1984 to
the companies on the people's behalf. For instance,
1989.
Germany demanded and received price reductions in
A similar system in Australia, the Pharmaceutical
the 1990s. As a result in 1993 it spent 20 per cent less on
Benefits Scheme, has kept drug prices at the lowest in
drug
purchases
than
the year before. Similarly,
Australia spent 22.5 per cent of its health budget on
the developed world.
United Kingdom: The pharmaceutical pricing system
in the country that founded the privatization-based new
prise over 35 per cent of drug sales in the country (in
model of economic reconstruction, is considered the
terms of value/$).
most comprehensive in the world. The Department of
Bangladesh: Drug price control in developing coun
Health's Pharmaceutical Price Regulation Scheme
tries is a complex issue, partly because they import rather
determines target profit levels individually for each
than produce raw material. Many of these countries have
company, based on its contribution to the UK economy.
attempted to evolve a formula for drug pricing which
A percentage return on the capital used by the company
usually comprises cost of production plus a profit margin
in research and development of a product (currently
(cost plus formulas). But these formulas are failed by
between 17 per cent and 21 per cent) is established as a
multinational companies through transfer pricing.
profit margin to be gained on drug sales.
Bangladesh adopted a comprehensive, praisewor
Excessive profit gam is corrected either by a reduc
thy National Drug Policy in 1982. It set a cost plus for
tion in prices or by directly reimbursing the excess prof
mula for drug pricing and made extra efforts to abolish
it to the Department of Health. This means that if a
transfer pricing. As a result in the following ten years
company sells a product more than it expected to. and
drug prices in Bangladesh rose nine times less than the
thus makes more profit than initially agreed with the
prices of other common use goods. In 1982 the import
health authorities, it either has to lower the price of its
price of the raw material Doxycycline in Bangladesh
product or pay the extra profit to the Department of
was $1500 per kg by 1992 it was reduced to $180 per kg.
Health.
Similarly import prices of Clibenclamide crashed from
United States: The US government intervenes in drug
$2,350 a kg to $180, of Mebendazole from $287 to $19 .
pricing least. It has health care programmes, like
Sri Lanka: Sri Lanka also has a cost plus formula to fix
Medicare and Medicaid which indirectly control prices,
drug prices, which in practice is of little use because of
like
system
and
the transfer pricing problem. However, the island has
Pharmaceutical Benefit Scheme in Australia. But these
developed another innovative way of not only control
programmes do not have a major impact on prices.
ling prices but also checking the irrational use of drugs.
the
social
security
in
France
The real control on prices there comes from the
In the early 1970s, Sri Lanka formed the State
consumer. Community pharmacy chains, hospitals and
Pharmaceutical Corporation (SPC) which had the sole
even small pharmacies in America jom hands to negoti
rights of importing drugs for the public sector, and late
ate lower prices with manufacturers through volume
ly for the private sector as well. Though the private sec
discounts. Because of their huge size and vast access to
tor was lately allowed to import drugs, the SPC has
consumers, these buying groups extract hard deals from
remained the sole supplier of drugs to.the public sector
manufacturers. Such is the effect of these collective buy
and the main supplier to the private sector. The SPC
ers on the companies' profitability that in 1993, US
imports generic drugs (not brand name drugs) through
pharma company Merck paid $ 6.6 billion to buy Medco
international tenders. Generic drugs are usually time-
Containment Services, one of the big buying groups.
tested and cheap. Before the SPC was formed, compa
Similarly, SmithKIine Beecham spent $2.3 billion to buy
nies used to import drugs at high prices from their
Diversified Pharmaceutical Services the following year.
parent organisations, but the corporation looked for
Commenting on the issue Time magazine wrote that the
cheaper sources. It started importing from Eastern
companies "have decided if you can't beat them, buy
Europe and then from China and India as well.
them."
This state monopoly significantly lowered the cost
The US is the world's biggest user of generic
of treatment in Sri Lanka, and the results are evident —
drugs. In 1987, 36 per cent of prescriptions there were
despite a per capita income comparable with Pakistan
written in generic terms. The market share of generic
its infant mortality rate is 17.2 deaths per 1,000 live
drugs has grown steadily since 1974 and currently com
births compared to 95 in Pakistan.
trated in urban centers and have
money to spend and access to the
media. The net profit of a company
largely remains the same whichever
strategy they choose, however the
first choice makes it harder to earn
money compared with the second
choice. Price control mechanisms
enforced by the governments play
Unfair deal
All figures
for 7 persons
for a period
of one year
the vital role in the companies'
choice of strategy. If a government
1408.35 .
Every family of 7 persons spent on
drugs in 1995 double the amount it
spent in 1990 for 6% less quantity.
703.12
Rupees spent
866.02
90739
1992
1993
745.55
force keeps the prices low, the com
panies are forced to reach out to
more and more consumers to keep
their profits afloat. While the decon
trol makes the companies to switch
to the easier choice - sell less with
high profit margins.
1990
1991
1994
1995
Introduction of price controls
through a National Drug Policy in
are reimbursed at 40 per cent and
Bangladesh in 1982 resulted in a
most standard drugs are reim
their strategies to only concentrate
sharp reduction in drug prices. Dr
bursed at 70 per cent. If a manufac
on 'haves' among the consumers.
This is squeezing a majority of the
profit margins, they are tailoring
Zafarullah Chowdhury, the father
turer prices a drug higher than the
of Bangladesh's National Drug
government finds appropriate, the
needy 'have-nots' while the people
Policy writes, "Drug manufacturers'
drug is placed on a lower percent
at the peripheries are being pushed
total profits have gone up, because
age reimbursement list. Since 90 per
out.
of the increased volume of produc
cent of the drugs consumed by the
tion, while the unit profit has gone
French are partly or fully reim
down, to the benefit of
bursed by the government, the
consumers."1
manufacturers are forced to keep
This is exactly what the govern
prices low so that the drug is listed
ments and the industry in many
on a high percentage reimburse
developed country do. Consider for
ment list and thus prescribed more
example France. Patients in France
frequently. Or in other words the
are reimbursed the cost of treatment
government in France through its
under the social security system by
policy has forced the industry to
Drug availability
Table 1: Number of drugs available to a
person annually is continously declining.
1990
Pop. in
millions
Sales in Per capita
million consumption
units
in units
109.6
585.5
5.34(100)
the government. The Ministry of
make profits by lowering per unit
1991
115.8
611.4
5.29(99.1)
Health forms lists of drugs and
profit margin and selling more units
1992
121.5
646.1
5.32 (99.6)
assigns different levels of reim
and not by raising the profit mar
5.21 (97.6)
bursement to the lists. For example,
gins and selling it to a selected few.
1993
127.3
663.3
133.0
705.1
5.30 (99.2)
138.8
698.0
5.03 (94.2)
drugs on the special list are reim
The current policy of our govern
1994
bursed 100 per cent, the treatment
ment is exactly the opposite. As the
1995
cost for the least severe conditions
companies find it easier to raise
i
Table 1 page 3 shows that the units
points while Drug Price Index
of medicines available per person in
jumped 80.6 points.)
Pakistan are on the decline. The
comparative figures in parenthesis
in column three depicts that if 100
Table 2: Prices of drugs have grown
faster than those of other items
units of medicines were available to
The pharmaceutical industry is once
again lobbying for an across the
board raise in prices. Pharma
CPI
DPI
Ave. price
per unit (Rs)
1990
100.0
100.0
18.80
Graph on page 3 offers simple mul
1991
108.0
107.1
20.15
public and private lobbying efforts.
tiplication of these figures for a
1992
119.6
123.8
23.28
The representatives of the industry'
1993
132.0
132.2
24.86
1,408.35 for 35.2 units of medicines
1994
151.0
162.8
30.62
1 on the pricing issue. The deal has,
in 1990 compared to Rs 703.12 for
1995
168.8
212.8
40.01
however, not yet been made public.
a person in Pakistan in 1990, s/he
had only 94 in 1995 or a loss of 6%
in number of available drugs.
family of seven. Every Pakistani
family (of 7 persons) spent Rs
Bureau of Overseas Chamber of
Commerce and Industries, repre
senting 31 multinational corpora
tions is on the fore front in all these
have held a meeting with the
Ministry of Health officials on July
37.4 units in 1990 or it spent double
the amount for a 6 per cent less
CPI: Consumer Price Index
DPI: Drug Price Index
he Network considers the issue
quantity of drugs in 1995 compared
Col. 3: Sales in value divided by sales in
21 of drug pricing as a fight
with 1990.
volume gives average per unit price.
between the people and the profits
These figures are generalised -
and calls for stringent control over
entire population divided into fami
average of $420 will be the worst
prices. Experiences of many coun
lies of seven without taking into
victim of the drug price rise.
tries make it clear that regulation is
factor (due to lack of specific infor
The rise in drug prices cannot be
accessibility of medicines to all the
mation about drug use by different
justified on the routine pretext of
people.
income groups). However, it is evi
inflation. See Table 2 above. The
dent that the situation had become
Consumer Price Index which takes
grave for the low income groups.
into account the prices of a large
According to the World
number of daily use items grew by
Referneces:
Development Report 1995, pub
around 69 per cent during the peri
1: Development Dialogue, 1995:1, Dag
lished by World Bank three fifth of
od 1990-95. While the prices of
Hammarskjold Foundation, Upsala,
the population in Pakistan (83 mil
medicines during the same period
Sweden; p 120
lion) earns less than the per capita
grew by 113 per cent. Special to
All market related basic figures are quoted
from the book "The Pakistan
consideration the economic class
the key to ensure availability' and
average income for Pakistan - S420.
note is the fact that the rise in drug
The poorest 20 per cent earn an .
prices was in harmony with the rise
Pharmaceutical Industry" by Pharma
average of only $180 per year. The
in prices of other consumer items
Bureau, Overseas Investors' Chamber of
second 20 per cent make $270, the
till 1993. After the deregulation of
Commerce and Industry. Others have been
third quintile $354, the fourth $466
price control in 1993, the drug
picked up from publications of Federal
and the richest 20 per cent earn
prices rose at double the rate of
Bureau of Statistics, Unicef, UNFPA .
$833. It could be well imagined that
other consumer goods. (During the
the 60 per cent of the population
two years after deregulation the
Study conducted by Tahir Mehdi
earning less than the per capita
Consumer Price Index rose by 36.8
C<in«paig>i Officer, The Network.
Briefing Paper
TN/BP/002/010897
CmORMEZANONE
Banned for toxic
^NETWORK
Association for Rational Use of Medication in Pakistan
Briefing Paper
CHLORMEZANONE
Banned for toxic reasons elsewhere, still openly available in Pakistan!
What IS it? Chlormezanone is a minor tranquilizer
that has muscle-relaxing properties and sedative
effects. Frequently formulated in combination with
pain killers, chlormezanone has been suspected of
inducing severe skin reactions for many years]
The Evidence
As a result of reports about
lethal side-effects of Chlormezanone the drug was
withdrawn by the manufacturers from the French
market in October 1996. After the withdrawal a
pharmacovigilance survey2 was conducted in
European countries between January 1988 and May
1995 which established a causative relationship
between use of chlormezanoneand some serious skinrelated side effects.
According to a summary of the survey, there
were reports of 153 cases of toxic epidermal necrolysis
(a condition characterized by widespread bubbling
and sloughing off of the skin resulting in large areas
of skin loss) which were linked with chlormezanone
use. Out of these, 13 cases were of Lyell's syndrome
which resulted in seven deaths?
Double Standards
Since the risks involved
with chlormezanone use were clearly much greater
than the limited therapeutic benefits, the worldwide
leading manufacturer of this compound, Sanofi
Winthrop, found it prudent to withdraw it from a
number of Western European as well as American
markets during the second half of 1996. However,
as is the practice of multinational pharmaceutical
corporations in such cases of known .product toxicity,
people in the minority world (industrialized world)
would be meted out a more civilized treatment in the
form of a "voluntary" withdrawal of such products;
people in the majority world (developing world)
would have to fight many a pitched battle before a
similar decision could be effected, if at all, in their
countries.
Brand names m Pakistan
Chlormezanone has been sold in Pakistan as an
ingredient of at least six products (see box). The
leading product, Baserol®by Sanofi Winthrop, has
been in the market for a very long time now, and it
is widely abused by addicts. The market was found
to be lucrative enough that a couple of new products
(Muscerol® by Pharmatec and Samerol® by Sami)
entered the market recently with a lot of promotional
effort behind them.
In our country, where drugs are available
without a prescription and where there is no scientific
system of accumulating data on adverse drug
reactions, these drugs have the potential to cause
unimaginable morbidity and mortality.
Apathy ah over
When The Network first
got news in March this year of chlormezanone's
adverse reactions, we knew we had a tough campaign
ahead. We knew that we would have to confront the
Government Regulatory Agencies to make them first
realize their responsibility to protect the people in
this matter, and then do what ought to be done. It
was clear to us that the same manufacturer who had
behaved so responsibly elsewhere would try his level
best to sell the last possible tablet in our country
before all his excuses to do so were exhausted. We
also knew that the apathy we have experienced
commonly from the medical community in similar
matters would not make them our strong allies and
we would have to fight this alone. The only ally we
could count on was perhaps the print media which
had been very supportive and responsive in the past.
Campaign fbegsims
To begin our campaign,
we wrote letters to the Director General of the Federal
MoH and the manufacturers of chlormezanone
containing products in Pakistan, urging them to effect
a removal of these products from the market in line
with the action taken in the industrialized countries.
As was expected, we received no response from any
of them.
While the companies' silence could be
understood, and was anticipated, as they have a long
history of double standards in majority world
countries, the MoH's silence was hard to interpret.
The Network - Association for Rational Use of Medication in Pakistan
Briefing Paper
Trade Name
Ingredients
Dosage Form
Manufacturers
BESEROL®
Chlormezanone
Paracetamol
100 mg + 450/ tab
Sanofi Winthrop
Searle Pakistan Ltd.
MESCEROL®
Paracetamol
Chlormezanone
450 mg -r 100 mg/tab
Pharmatec Pakistan
(Pvt) Ltd. Karachi.
DELGESIC®
Chlormezanone
Compound
tab
SAMEROL®
Paracetamol
Chlormezanone
450mg + 100 mg / tab
Sami Pharmaceuticals
(Pvt) Ltd.
CETAZONE®
Paracetamol
Chlormeza none
450mg + lOOmg / tab
Unexo Labs (Pvt) Ltd.
Lahore.
DOSEROL®
Paracetamol
Chlormezanone
450mg + lOOmg / tab
Dosaco Laboratories.
Lahore.
However, the response came after we took the matter
to the press. The MoH claimed in its clarification in
the press that the companies concerned had already
been directed to refrain from manufacturing and
importing this product and to withdraw it from the
market, and that all companies had complied.
However, this proved to be a little more than wishful
thinking.
The MoH also announced in the press that
they had framed and notified new rules to ban the
sale of any drug in Pakistan if it had been banned
for safety reasons in the US, EU, Canada, Japan or
Australia. The Ministry spokesman was reported to
jaave said: "If, in any of the aforesaid countries, any
restriction is imposed on any drug regarding its sale
or claims for indication for use for safety reasons, the
same restrictions shall apply on the sale of drugs in
Pakistan, too." The rules would also make it
mandatory that the company report any adverse
drug reactions to the Drug Registration Board in any
of the above mentioned countries. The spokesman
also said that the Ministry would maintain direct
links with the drug regulatory agencies of these
countries in order to have the latest drug reaction
information so that prompt action could be taken
here to ban that drug immediately. This proved to
be only rhetoric, as chlormezanone products are still
freely available in the market even today.
The drug ss still available
Our survey
of the market after this Ministry clarification found
that these drugs were available at most medical stores
Progressive
Laboratories Pakistan
(Pvt) Ltd.
in Islamabad in any quantity without the prescription
of a registered medical practitioner. The distributor
of Sanofi Winthrop in Rawalpindi, International
Brands Ltd., told us on inquiry that Baserol® was
available in sufficient stocks. On further probing to
assess whether the company had instructed
distributors not to sell this product, the manager was
unaware of any problems associated with this drug
and said he had had no such instructions. In fact, he
mentioned that they had recently made a bulk supply
of Baserol® to a hospital in Rawalpindi.
The fact of the matter is that there is little
political will in the Government to bring about any
enduring changes in the way the Ministry handles
drug quality issues and to react responsibly to such
matters of dire consequence to a large population of
country. The inspection arm of the Ministry, which
is responsible for ensuring the implementation of
rules and regulations, is extremely short of
wo/manpower and infrastructure and is just not
sufficient for this task.
Under the present circumstances, the Ministry
would not be able to implement its own notifications
to ban products or restrict their use and so on. That
is to say, even if it wanted to. However, it is quite
clear that in the absence of the requisite political will
and in the presence of rampant cormption at all levels
of the bureaucracy, any gesture of regulatory action
would at best be only: a gesture, meant only to silence
the criticism. Those who are affected in this confusion,
the people of this country, meanwhile, can only await
their fate.
The Network - Assodation for Rational Use of Medication in Pakistan
Action Points
For Consumers:
► Do not use these products and inform others.
> Write to Federal and Provincial Governments (President, Prime Minister,
Chief Ministers, Secretaries and Director Generals of Health, etc.)
► Send letters to the manufacturers and to "letters to the editor".
For Courts, Ombudsman and Ehtesab Cell:
> Take suo-moto action in this matter of utmost public safety.
For Medical Practitioners:
> Do not prescribe these products and inform your patients.
> Mobilize your professional associations.
> Write above mentioned letters.
I
For NG Os:
> Inform your partner organizations by widely circulating this report and join
our advocacy campaign.
For Media:
> Highlight this report in your publications and build pressure for required action.
For MoH:
> De-register all Chlormezanone containing products.
t> Direct manufacturers to withdraw these products from the market with
immediate effect.
> Inform health professionals and the public about these measures.
For Manufacturers:
> Be responsible corporate citizens and immediately withdraw all stocks of these
products from the market.
References:
1. Roujeau JC et al. "Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis", New England
Journal of Medicine 1995; 333 (24): 1600-1607
2. "Market withdrawal of Chlormezanon', Prescrire International, Feb. 1997, Vol. 6, No 27, p 17.
3.
"Chlormezanone - Enquete nationale de phamrmacovigilance - Resume" communication from Therabel Lucien Pharma:
1 page, as quoted in "Market withdrawal of Chlormezanon', Prescrire International, Feb. 1997, Vol. 6, No 27, p 17.
^NETWORK
Association for Rational Use of Medication in Pakistan
60-A, Street 39, F-10/4, Islamabad- Pakistan.
P.O.Box 2563
Ph: 92-51-281755, Fax: 92-51-291552
e-mail: zafar@arump.sdnpk.undp.org
internet: arump@isb.comsats.net.pk
Networking in Development,
Advocacy & Consumer Protection
through Quality Publications.
This briefing paper is jointly prepared by The Network team.
T>P- 4--
VHAI-AIDAN-NCCDP-RDCC DRUG CONSULTATION
ON
IMPACT OF POLICY CHANGES ON DRUG POLICY AND DRUG USE
26,
27 August 1996
list or Essential Drugs
for Hospitals in the hatiohal
-CAPITALTERRITORY OF DELHI
$l^TT
- ?5^
* ?’*
rWi k
•
list of Essential Drugs
for Hospitals in the national
CAPITAL TERRITORY OF DELHI
SELECTIVE USE OF DRUGS
Certain drugs because of their cost 01 because they should be used only by
specialists, have been classified under the category SELECTIVE DRUGS. This
is denoted by an astcrisk(‘)-Each hospital should work out its own mechanism
for the prescribing of these drugs. The drugs selected for outpatients will be
available to inpatients also.
The Government of National Capital Territory of Delhi
1.994
tt^tq tiTitu-it era fesfi
GOVT, or NATIONAL CAPITAL TERnitOHV Of DELHI
TTrrr trfTiHii, tefi-no om
OLD SECRETARIAT. DELHI-110 054 .
FOREWORD
When I assumed charge as the Minister for Health and Family Welfare. I visited hospitals and
health centres in the National Capital Territory of Delhi to look at the prevailing situation from
my new perspective One of the first things which struck me was the chaotic situation
regarding the availability of medicines at these hospitals. At nearly every hospital I visited there
were complaints from the patients that drugs were not available. Other complaints were ielated
to the quality ol dings, the system of procurement and distribution of drugs and the informa
tion provided to the patients about the use of drugs. Every hospital had its own list of drugs,
medicines were coming to the hospitals in many different brand names, the supply was erratic
and the prescribing,very often, unrestrained
What made the situation more disturbing was the lad that a large percentage of the health budget
is spent on medicines. It has been calculated that about 30 % ■ 35% of the national in-'illh budget
of the country is spent on medicines. Inspite of this a regulni supply of
good quality drugs to the patients was not achieved and the patients and lb- public, not
withstanding the other care received at government hospitals, became de.•..im.fieri and
critical ol the facilities and of the doctors because ol the lack of drugs. The fact that ibeie was no
drug policy lor National Capital Territory made me determined to do something in this, vitally
important i
I had a series of meetings with national and interntri.-.eexperts as to how things could be
improved. We studied how countries like U.K., Norway. Australia. Bangladesh. Iran and the Philippines
had ensured rational use of drugs. We went deeply into the policies and programmes on essential
drugs recommended and implemented by the World Health Organisation and UNICEF in different
countries in the world. It became clear that what was urgently needed was a Drug Policy for the
National Capital Territory of Delhi.
The Drug Policy of the National Capital Territory has several components which are delineated
below but the cornerstone of the policy around which'the other components arc being
developed is the list of essential drugs to be used by all hospitals. This one single step has helped
in rational drug use' in several countries and several hospitals around the world. I am very pleased
that leading experts from different disciplines have prepared The List of Essential Drugs for Hospitals
in the National Capital Territory of Delhi. This list has been approved for use in all Delhi hospitals
and health centres.
As I mentioned earlier the Drug Policy of the National Capital Territory of Delhi • the fir*
policy to be formulated for any state in the country, consists of the following elements
i. availability of sale and effective drugs at all the hospitals and health centres;
ii. a good quality control and assurance system;
Hi.
improved procurement, storage and distribution of drugs;
vi. strengthening of health education programme: and
2nd.
SEPTEMBER. 1994
(DR. HARSH V/-TDHAN)
HEALTH MINISTER. DELHI
I
GENERAL ANAESTHETICS
Diazepam
Inj. 5mgrnl
Sodium thiopentone
Inj. 0 5.1 gm/vial
Halothane inhalation
Ether inhalation
N-irons oxide initiation
Oxygen inhalation
Ketamine
Inj l»Onuj
It.ollurnne inhalation
LOCAL ANAESTHETICS
2. ANALGESICS. ANTIPYRETICS AND DRUGS TOR GOUT
Acetyl salicylic acid
■«»
lab
10(), b'XJrnn
lab. di:;prr'.;>lc
Allopurinol
Tab. 1 OOmc
Paracetamol
Tab. 100. 5S0rng
Syp. 1 25m
Probenecid
I ah !«0''m<i
Pi otazocin lactate.
Inj. IlOri.g'ial
*
Morphine
In). ICentfml
Pethidine (HCI)
Inj. ‘lOmq.'ml
Tab. 50. lOOmq
5ml
Fab.
Ibuprr-fr..-.
Fab. 200mg
Indomethacin
Tab. 25mg
Mcfanamic acid
Diclofenac sodium
Tab. 250ma
Colchicine
Tab. 0.5mg
3.
Promethazine
Chlorpheniramine
Tcrfcnadine
Prednisolone
Epinephrine (HCI)
Tab. 50mg
ANTIALLERGIC
AND
Tab. 10. 25-ng
Syp. 5mg/5-al
Tab. 4mg
Tab. GOmg
ANTIANAPHYLACTIC
Dexamethasone
DRUGS
Tab. 0.5mg
Inj. 4rng/ml
Hydrocortisone sod. succinate
Inj. 100rng/vial
Tab. 5rng
Inj. Img/ml
ESSENTIAL onuGS fOH IIOSnilALS
ax1
4.
ANTIDOTES
AND
OTHER
SUBSTANCES
USED
IN POISONING^
Activated charcoal powder
Inj. Irng ml
Atropine
•PAM
Inj. Igm/vial
Nalorphine
Inj. 10mg/ml
• Dimcrcaprol
Inj. in oil 50mg/ml
in 2ml ampmili!
Cup. ?fi()r»»<|
Sodium calcium cdeiait: Inj. ZOOmg.'ml
in 5 ml ninpotih!
Penicillamine
Sodium nitrile
Inj. 30mg/ml in
10ml runpotih-
Sodium thiosulfate
Inj. ZSOmg'ml
in 50ml ninp.oult!
Anti r.niikc venom
• Methylene bint?
Dcsf errioxaminii
5.
ANTI-EPILEPTIC
Hienytoin Sod.
Tab. 7b. WOmg
rhenobiirt.iilal
I ah. 30 GOmg
Inj. f»c»’vv«
*nl
Inj. lOmg/ml
Inj
500mg Tn vial
DRUGS
Diazepam
Inj. bmp/inl
[h>tf 15mg/5nilfc
Tab
Z-nt|. valproat
**
100. 200mp
lab. ZOOmg
6. ANTI-INFECTIVE DRUGS
I
• P'aziquantal
rn ESTINAL ANTHEI.MIM TICS
<• Jbcndazolc
Tab. -lOOr o.
Dyranicl pamoate
Tap. 7.00
Piperazine
Tab. 500n.-j
rbcrr.:?:in
1 nb. SOOmq
Ini
1, Sgm/vial
:
antifilarials
C’cthylcarbamazinc
Tab. 50mg
Cr ystalline penicillin
Inj. 5 MIU/vial
Amoxicillin
Cap. 250, 500mg
Powder 125mg/5ml
Pr ocaine penicillin
Inj. GOO,000 u/vial
Ampicillin
Cap. 500mg
Powder 125mg/5ml
Gc ntamicin
Inj. 40 mg/rn!
antibacterials
Inj. 500mg/vial
□oxacillin
Cap. 500mg
Powder 125mg/5ml
Inj. 500/vial
Benzathine penicillin
•Arnikacin
Inj. 2. 4 MIU/vial
ESSENTIAL DRUGS F€)R HOSPITALS
Inj. 100. 250.
500 mg/2ml
|
Chl'yamphcrucol
Erythromycin
Cap. 250nig
Nalidixic acid
lab. 500ing
Ciprofloxacin
Tab
Cchizolin
Inj
•Cefotaxime
Inj. 250mg, 1,2gm,
lab. 250rng
Powder 125mg/5ml
(as stearate)
Sulfamethoxazole +
Trimethoprim
lab. 10Omg + 20mg
Tab. 400mg 4
Tetracycline
Tab. 250nig
Norfloxacin
Tab. 400mg
AN III I PROSY DRUGS
Clot a/miilit:
80mg
250mg
250mg. Igm
250. GOOinp
•Celt.'izidinic
ln|
• Crphnlr xm
Cup. ?5O. SOOiiir;
Igm
Syp. 1 Pbmg/bm!
Cap. bU. lOOmg .
Dapi.onn
lab. bO. lOOrng
Ril ampicm
Cup. 1 50. 300mg
AN1I1UBI RCULOUS DRUGS
Ethainhutol
lab. 400. fJOOmg
Isonm/id
lab. 100. :K)Ornq
Rifampicin
Strnplomyi.m
Pyrn/innniiibj
Cup. 1 b0.300.-1b0inji
Inj. Ipm/vinl
1 ab. bOOmg
ANTIFUNGAL DRUGS
Grisrohilvin
1 ab. 125. 250mg
Kmoconazole
Tab. 200mg
ANTI PROTOZOAL DRUGS
Chloroquine
lab. 1 50mrf
Quinine
*
Priniao
“ii
**
Sulfadoxip
Pyrimuoi
Tinidazolc
Tab. 500mg 4
Tab. 300mg
Diloxanide furoate
Tab. 500mg
25mg
Metronidazole
Tab. 200, riOOmr
Inj. 500mg/100ml
L_
Biperiden
r ...
Levodopa -f Carbidopa
7.
ANTIPARKINSONIAN
Tab‘ 2m°
DRUGS
•Selegiline
Tab. 5mg
J
Tab. 100mg’+ 10mg
Tab. 250mg + 25mg
ESSENTIAL DRUGS FOR HOSPITALS
3
" Ue|hi hospital
■WiW^
1
1__
8.
DRUGS
AFFECTING
THE
BLOOD
ANTIANAEMIC DRUGS
Ferrous sulfate
‘Tab. equivalent to
Folic acid
60mg iron
Tab. 1, 5mg
iron dextran
Inj. equivalent to
50mg iron/ml
in 2ml ampoule
DRUGS AFFECTING COAGULATION
Vitamin K
Heparin
•’£
Inj. lOmg/inl
Warfarin
Inj. 1000 IU/ml
Inj. 5000 IU/ml
lab. 5ni(|
Streptnknuisa:
Inj. 250.000 IU
r'fotnmin(i sulphate
Inj lOnig.-inl
in 5ml tinipruilii
Inj
|
9.
BLOOD
PRODUCTS
&
750,000 IU
;
SUBSTITUTES
•Hiiomiiciml
" h.xtran 70
I
____
In,
I'M
10. CARD1OVASiCULARDRUGS
AfJTIANGINAL DRUGS
Froprenolol
G-’vcfi J ’'ir.’trate
• :-:nnir.'
.-sorbide umitrate
Tan. 10, 4Omg
'a!:. C.5 mu
|ab. 50. lOUmy
Tab. 5mg
ANTIDYSRRHYTHMIC DRUGS
Verapamil
Tab. 40, 8Omg
Inj. 5mg/2ml
•Lignocaine
Inj. 2% (21.3mg/ml)
Diltiazem
Tab. 30, 60mg
•Mexilctinc
Cap. 50, 150mg
“Disopyramide
Cap. 1 00, 200mg
•F^rocainamide
Tab. 250, 500mg
•Amiodarone
Inj. 100mg/ml
Tab. 200mg
Inj. 250mg/10ml
ESSENTIAL DEUGS TOR HOSPITALS
iano'n'-
De"’' '’°spi(ols
Benzoyl peroxide
Cream 2.5, 5, 10
Benzyl benzoate
Lotion 25%
Para amino benzoic
Cream, or gel
ULTRAVIOLET BLOCKING AGENTS
I rimethylpsoralcn
5 - mcthoxypsoralcn
1 rib. 5. ?5mg
Oint. 0.25%
ESSENTIAL DRUGS FOR HOSPITALS
5
D
p/k'- h°s
OSp/f
a/s
Je/h
pita/s
12. DIAGNOSTIC
Conray
’Jrograf fin
AGENTS
Inj. 4 20/280
Inj. 7G. 60%
Inj. 75. 60%
Urovedio
Omnipaque
Inj. 180. 240.
300mg/ml
lopenoic
Tab.
Histamine
h>j.
Barium sulphate
aqueous suspension
500rng
Sod. iodide
DISINFECTANTS
13.
|
Cctrirnido +
Chlorhcxldinu
AND
ANTISEPTICS
Letter. 2%
Glutaraldehyde
Cre
Tincture benzoin Compound
irbolic acid
Absolute
•>cllol cream iiaudiritric)
Sol.
Sol.
Mcrcurochrorno
Paint
I’otassium permanganate Sol.
.
i
.
a..••.•i.H’Gthiazide
*r.u-.k
Frur<
’
i
DIURETIC1?
Tab. 2:». 50: ng
Tub. 40mg
Inj. IO?:-
• Mannitol
Spironolactone
• '
Tab. 25mg
Inj. Wmg-ml
15. GASTROINTESTINAL
ANTACIDS
Aluminium hydroxide +
Magnesium
Ranitidine
hydroxide Tab., gel
Tab. 1 50mg
DRUGS
■
_______ I
Omtipr nzoln
1 rib. 2()iim
Cisapride
Tab. lOmg
Domperidone
Tab. 10
Inj. 50mg/2ml
Dicylomine HCI
Tab. 10mg
Sucralfate
Tab. 1gm
ANTIEMETIC DRUGS
Promethazine
Tab. 10, 25mg
Inj. 25mg/rrJ »
* Desmopressin
Inj. 1mg/ml
Inj. 4mcg/ml
ESSEHTfAL DRUGS FOR HOSPITALS
•
netPed
erY Pleased
Jel°[h°SPi’als
11 hospiuts
INSULIN AND OTHER ANTIDIABETIC DRUGS
caproate
Inj. 250, SOOmg
Glibenclamide
Tab. 5mg
Tolbutamide
Tab. 5C0mg
• Insulin
Inj. 40 lU/in!
Metformin
Tab. 5CO, 850mg
•Insulin semilente
Inj. 40 lU/inl
•Insulin lente
Inj. 40 lU/ml
THYROID HORMONES AND ANTITHYROID
DRUGS
Thyroxine sod.
Carbimazole
Tab. lOOmcg
Tab. 5mg
Pot. iodide
liquid 8gm/5ml
ESSENTIAL DRUGS FOR HOSPITALS
sforn Cas°d
lelfri hn SPi,°,s
hosPita(s
i
17. IMMUNOLOGICALS
Tetanus toxoid
•MUR
Inj.
Inj.
•Rubella
Inj.
D. P. T.
D T
Inj.
Inj.
Inj. .
•TIG
•Hepatitis B
Measles
Inj.
•Meningococcal
Poliomyelitis
Oral
•Anti gas gangrene
Inj.
Inj._
Anti rabies
Inj.
•Typhoid
Inj.
e. C. G.
I
■
18.
Inj.
MUSCLE
Neostigmine
Inj.
RELAXANT & ANTICHOLINESTERASE DRUGS
T nb. 1 5ing
Inj.
Inj 7in(|/ml
Tubocurc.rinc
• Pnncuroniun
Ncnr.tigmniii
Inti
Inj 0.5,
Suxamethonium
|
19. OXYTOCICS
I 'HOinotrine
Tab. Imp
l-.nxr.uprino
Tnb. 10mg
l()in(|7ml
AND AN HOXYTOCICS
• Dinoprostone
Inj. O.Stng/rnl
In] fiOmg/ml
Inj
• Atrnrurium
Oxytocin
M.'innosium sulphate
Inj O.bmg/r.yrinir
Irij. 10 lU/ml
Inj.
Inj. bmg/rnl
I
20. PERITONEAL
DIALYSIS
SOLUTIONS
i
Aluminium hydroxide
Intraperitoneal dialysis sol.
21. PSYCHOTHERAPEUTIC
Chlorpromazine
T
DRUGS
50, lOOmg
Ini- Z'?'..g/m!
Syp. 25mg/ml
Fluphenazine
Inj. 25mg/5ml
Thioridazine
Tab. 5mg
Haloperidol
Tab. 8, 10mg
Lithium carbonate
Nitrazepam
Lorazepam
Diazepam
Amitryptyline
Imipramine
Tab. 300mg
Tab. 5, lOmg
Tab. 1, 2mg
Tab. 5mg
Tab. 10, 25, 75rng
Tab. 25, 75mg
ESSENTIAL DRUGS FOR HOSPITALS
- "ns />c;,
'OsPitnls
DRUGS ACTING
ON THE RESPIRATORY
Dcriphyllme
Tab. 100. 300mg SR
Sod. cromogiycalate
Salbutamol
Inh. 20mg/caru id go
Aminnphyllme
Beclorncthar.onn
T crbutalinc
ANTITUSSIVE
Cough syrup
Expectorant
Codeine Imctus
23. SOLUTIONS
Vit. B1
BG, Bl 2
CORRECTING
WAI ER
24. VITAMINS
AND
ELECTROLY TE i~MBALAN C E
|
MINERALS
Tab.. Inj.
fab.. Inj.
• •t. .IJ
b Complex
Tab..Granules
Vit. C
Tab. 500mg
Folic acid
Tab.
Tab., Inj.
Tab. 25mg
Calcium gluconate
Pyridoxine
Multivitamin
Tab.
Tab.
25. DENTAL
PREPARATIONS
Tannic acid gum paint
Analgesic gum paint
Desensitising paste
Disclosing Sol..Tab.
Gel for oral ulcer
ESSENTIAL DRUGS FOR HOSPITALS
9
□
(fetaswssifitau
Z]
26. OPHTHALMOLOGICAL PREPARATIONS
ANTI-INFECTIVE AGENTS
Sulfacetamide
Acyclovir
Drops 20%
Tetracycline
Chloramphenicol
Soframycin
Oint., Drops 0.5%
Oint., Drops 0.5, 1 %
Miconazole
Drops 1 %
ANTI-INFLAMMATORY AGENTS
Dexamethasone + Neomycin
MIOTICS AND ANTIGLAUCOMA DRUGS
Drops 2%
Pilocarpine
Timolol
Drops 0.5%
Sol. 20%
Glycerol
Liquid
MYDRIA1 ICS
Uom/moptno
Drops 2%
Atropine
Cycl(HMjntotnto
1 rojiicarnirh-
Oint. 1%
Drops 1%
Drop-. 1 %
Phenylephrine
Drops 5%
LOCAL ANAESTHETICS
1 ignorame
Drops 2%
I ignocaine i- Adrenaline Drops 2%
27. ANTICANCER DRUGS
Inj. 50mg
Tab. 2mg
Mclphalon
T amoxifcn
Cyclophosphamide
Tab. 50mg
Inj. 200. 500mg
Cyclosporine A
Tab. 50mg
Cap., Inj. 50mg.'ml
Cytosin arabinoside
Inj. 100,500.1000
Bleomycin
Inj. 15rr.g/vial
Cisplatin
Adriamycin
Inj. 10, 50mg/vial
Vincristine
Inj. 1, 5rng ampuolc
Procarbazine
mg/vial
ESSENTIAL DRUGS FOR HOSPITALS
o
10
id
id
Is
Is
VIIAI-AIDAN-NCCDP-RDCC DRUG CONSULTATION
ON
r.c
IMPACT OF, POLICY CHANGES ON DRUG POLICY AND DRUG US
26,
27 August 1996
COMMUNITY DEVELOPMENT MEDICINAL UNIT
Head ON.ce : 86C. OR. SURESH SARKAR ROAD • ENTALLY • CALCUTTA-700 014 • WEST BENGAL • INDIA • PHONE (033) 245-2363. 245-4758 • FAX : 0091-33-249285;
Siliguri Unit . 195/276, RASH BEHARI SARANI • HAKIMPARA • SILIGURI - 734401 • DARJEELING • WEST BENGAL • INDIA • PHONE . (0353) 432857
Documentation Centre : 47/lB. GARCHA ROAD • CALCUTTA-700 019 • WEST BENGAL • INDIA • PHONE
(033) 74-8553
HHI AIRLIFT OF DONATED MEDICINES TO CALCUTTA AS RECEIVED ON 01.04.1996.
PRESS RELEASE ON 8th.
April,
1996.
CDMU
Documentation
Centre,
the drug information unit
of
the
Community
Development Medicinal Unit (CDMU) expresses its deep "concern over Heart
to
Heart International's drug donation to Calcutta.
E.^Jkged
in
the rational
drug
movement
in
India
for more than
a decade.
the
CDMU owes a moral responsibility to try in its humble capacity to safeguard
the
interest of the people of West Bengal who are going to
consume
these
donated
medicines. We are on principle, not against donations and we
nave
high regard for the good spirit and noble intentions behind a donation bid.
But when the donation item is none other than medicines the matter deserves
a
more
serious consideration. The CDMU had kept an watchful
eye
on
the
move
by
the HHI right from the beginning and interacted
with
the
world
Health
Organisation
(WHO)
and also the
Health
Action
Network
me-bers
worldwide.
Our views endorsed by the
WHO and other Health Action
Network
people
and in fact we received a communication from the HHI that trie:
to
allay our apprehension and promised to meet us on their next visit to India.
However, the HHI team was pos.sj.bly too busy to find any time for us
d.ring
their next visit to Calcutta.
Finally
on
April 1, 1996, amongst much fanfare an airlift of 50
tons
of
medicines
with a claimed value of $12,000,189.50 was received at
Calcutta
Airport.
A
customs duty of Rs.25 crores was reportedly
waved
for
this
a^^l i f t.
The
HHI Airlift Packing List came to our hand from some source only a few
days before it's arrival of Calcutta. We made an analysis of this list. Our
analysis
was based on the criteria as laid down, in the WHO
guidelines
on
drug donations.
1.
Selection
of
Drugs
Whether the donated drugs appear in the WHO Model
Drugs?
Total
no.
of
airlift
packs..................... .“....
Packs containing drugs
No.
of
drug
Essential
.....................................
items in these packs
drugs
List of Essential
708
407
...................
46
........................................
9
A PROJECT COMMITTED TO RATIONAL THERAPEUTICS.
COMMUNITY DEVELOPMENT MEDICINAL UNIT
Head Ollicc 86C. DR SURESH SARKAR ROAD • ENTALL
*
• CALCUTTA-700 014 . WEST BENGAL • INDIA . PHONE : (033) 245-2363. 243-4758 . FAX W • 33-2492803
Siliguri Uml 19 5/276 RASH BEHAP-SARANI. HL' VPARA . SILIGURl • 734 401 • DARJEELING • WEST BENGAL ■ INDIA • PHONE (035;, 4 32807
Documentation Centre
47'1B GARCHA RO-0 • CALCUTTA-700 019 • WEST BENGAL • INDIA • PHONE
1033
74-8553
(Ibuprofen oral tab. 200mg, Acetaminophen oral tab. 500mg, Chlorpheniramine
maleate Cap. ?Strength, Cefaclor susp. 250mg/5ml , Gentami ci n 0.37. eye
drop,
Amoxicillin
susp.
?strength, Silver sulfadiazine oint.
?strength,
Mixed
Antacid tab. ^strength, Frusemide oral tab. 40mg.)
alternative/border1ine'
'Essential
Rest
:
COMMENT
2.
:
cithers
drug
’Non-essentials'
........................
7
........................
30
The cost of these non-essential 30 drug items constitute
9SZ of the total cost of the drug contingent.
about
Shelf-1i f e
Whether the donated drugs have a remaining
after arrival at Calcutta?
Total
valuation of
drugs
shelf-life of
received
Valuation of drugs that have either expired already
at the time of arrival at Calcutta airport or
would expire before 31.03.97
(This constitutes 70.597. of the total valuation)
at least one
$10
$ 7,434
year
91
5. 00
Comment
:
The whole contingent of antihistamines and the lion's share
of
the
antibiotics, analgesics and anti—inflamatory
drugs
and
cough remedies are not worthy of donation
as per the
shelf
life criteria of WHO guidelines.
3.
of
Transport/Customs Clearance
Cost
Whether cost of International ^nd National transport, custom clearance were
paid
by
the
donor
or was it
*
specifically
agreed
otherwise
with
the
recipient in advance?
Although
the Transnational transport was reportedly arranged by the
donor
agency,
it
is ridiculous to note that the Government of India
wa/ed
the
customs duty of Rs.25 Crores.
□ur analysis reveals that the 3 items namely, Terfenadine, Sucralfate and
Glyburide
tabs.
that
constitute
about 847. of the
total
cost
of
drug
contingent ($10.5mi11ion as quoted by HHI) would cost only Rs.0.24
crores,
had
they been procured from Indian market. Thus, the whole drug
co-.tingent
valued at $10.5 million ( = Rs.37 Crores Approx.) could probably cost as not
more than Rs.0.5Crore only, had they been purchased from Indian mar.et.
A PROJECT COMMITTED TO RATIONAL T-EPAPEUT '
REGISTERED UNDER THE WEST BENGAL SOCIETIES ACT 1961.
DONATIONS EXEMPTED U/S BOG OF INCOME
ACT 1961.
COMMUNITY DEVELOPMENT MEDICINAL UNIT
Head Otlico BSC. DR. SURcSn SARKAR ROAD • ENTALLY • CALCUTTA-700 014 • WEST BENGAL • INDIA • PHONE (033) 245-2363. 245-4758 • FAX 0091-33-2492603
Siligun Uml : 195 276. RASH BEHARI SARANI . HAKIMPARA • SILIGURI ■ 734401 ■ DARJEELING • WEST BENGAL • INDIA • PHONE (0353) 432607
Oocumenlalion Ccnlre
47/1B GARCHA ROAD > CALCUTTA-700 019 • WEST BENGAL • INDIA • PHONE
(033) 74-6553
If one adds to it another Rs. 0.5 Crore to accommodate the cost of
non-drug
items and appliances worth $1.5 million (“Rs.5 Crore approx.), the cost
of
the
total airlift (as per Indian market price as it stands today) would be
limited
to nearly Rs. 1 Crore only, for which Rs.25 Crores of customs duty
has been waved by the Govt, of India.
Comment
4.
Ri di cliI ous.
duality Assurance
9
Whether
the WHO Certification Scheme on the Quality
of
Products Moving in International Commerce
has been used or
of these medicines would be ensured?
Pharmaceutical
how the quality
To the best of our knowledge the said WHO Certification Scheme has not been
used
in this case. Neither there is any attempt to ensure the
quality
of
these donated medicines by the Drug Control Authority of India.
Comment
The lack of initiative on the part of both the
and
the recipient organisation is enough to
very intention of this donation bid.
donor
agency
quest i on
the
Our concluding remarks
:
We can only expect that will learn the
lesson
from
this
experience
and
in
future
the recipient organisation as well
as the country will consider the whole issue of any drug donation bid
wore
Beriously taking into account not only the WHO guidelines but also ensuring
Tzhe provision of monitoring the donated items on all aspects once they
are
received. All these
are essential to safeguard the public interest.
A PROJECT COMMITTED TO RATIONAL THEPaPEU''-.:.
REGISTERED UNDER THE WEST BENGAL SOCI£~IES AC 1961
ViV*
il /c
AF If'^AHC TiX AC’
WHO GUIDELINES ON DRUG DONATIONS
Three meetings on pharmaceuticals took place in WHO, Geneva on
30 April and 1 May: the first on WHO Guidelines on Drug
Donations, the second on Supply of Narcotic Drugs for Emergency
Care, and the third on the Model List of Drugs for Use in Acute
Emergencies.
This paper focusses on the first, but also summarises the others.
The paper has been written for the Essential Drugs Project's
funders, the HAI/Wemos donations working group, and colleagues
in other organisations who are concerned to bring about
improvements in the quality of drug donations.
1.
Meeting of the Inter-Agency Group on Drug Donations
1.1 The purpose of the meeting was to finalise the guidelines
on drug donations, which had previously been circulated to more
than 100 organisations and individuals for comment.
The
guidelines, which aim to improve the quality of donations, build
on earlier versions produced by the World Council of Churches/
Christian Medical Commission a decade ago.
Widespread support
reflects increasing concern by many agencies about the nature and
scale of donations, which range from million-dollar consignments
from industry to 'charity' parcels of samples and unused
medicines.
1.2 The meeting comprised members of the inter-agency group
(WHO, UNHCR, UNDP, Unicef, the International Committee of the Red
Cross, Mddecins sans Frontieres, CMC and Oxfam).
It was well
prepared by Dr Hans Hogerzeil of the WHO Action Programme on
Essential Drugs and the task was completed in three hours. WHO
was able to send out a press release on the day of the meeting
itself.
Thanks to Wilbert Bannenberg's 'e-drug', the revised
text can be obtained via e.mail by sending a message to
majordomogusa.healthnet.org
get e-drug donation.txt
1.3 The background to the meeting was not without difficulties.
There had been heavy pressures on WHO to modify the guidelines.These emerged from two meetings which took place in the USA.
earlier in the year.
Fifteen industry representatives and
fifteen PVOs (private voluntary organisations - the agencies
responsible for distributing the American industry's donations)
objected to the 'regulatory' tone of the guidelines and to two
clauses in particular: paragraph 2 - selection (compliance with
the Model List);
and paragraph 6
- 12-month shelf-life
requirement. WHO agreed to discuss these concerns with the IFPMA
in Geneva, and they were subsequently incorporated with other
comments from the wider consultative group for discussion at the
meeting.
1.4 The main points of the text remain unchanged. However the
introduction now spells out the nature of the document as a
consensus guideline and not a regulation.
Paragraph 2 which
concerns compliance with the national list or WHO Model List now
says 'unless specifically requested otherwise by the recipient'.
2
Paragraph 6 now includes a waiver for direct donations to
specific centres 'providing the recipient is aware of the
shelflife and that this allows for proper administration prior
to expiry'.
It was decided that vaccines, sera and biologicals
require separate guidelines.
1-5 The guidelines will nevertheless be an important step
towards improving the quality of donations and ensuring that
these will, in future, better meet recipients' needs.
They
empower recipients to negotiate with and be in control of their
relationships with donors.
They provide a benchmark for
monitoring inappropriate donations.
And they also provide a
basis for adapting and integrating the guidelines in drugs
policies.
1.6 The group discussed publicity, distribution and publication.
It was agreed that the guidelines will be ready in about six
weeks in a format that allows for easy, cheap distribution.
1.7 The guidelines will initially have the status of an inter
agency group document. This should be recognised as an important
opportunity, as there is a commitment to revising them in a
year's time, prior to their being adopted in the WHO Technical
Report Series in 1997. We therefore have a year to see that they
are circulated as widely as possible, and to ensure that any
important loopholes are brought to light before April 1997.
1.8 I raised the need for monitoring continuing inappropriate
donations and asked how the impact of the guidelines will be
measured..
It was felt that it was the responsibility of
governments to adapt and to monitor implementation of the
guidelines, and that it would be difficult for WHO to undertake
this function.
I was not very happy with this as there is
clearly a need to record information about inappropriate
donations, especially during the next 12 months.
Perhaps the
donations working group can come up with a mechanism.
SUMMARY AND IMPLICATIONS FOR ACTION
We now have an authoritative document which opens the door to
improving drug donations in the ways that have been described
(1.5). This will be available in weeks, in a format which allows
for easy distribution.
Bearing in mind that we have 12 months to identify problems and
to make a case for changing the guidelines if they fail to
protect recipients in important ways, what steps are now needed
to ensure, they makq the maximum possible impact?
Distribution and Publicity: The guidelines need to be as widely
distributed as possible, both to donors and to recipients.
The
WHO Drugs Monitor will publish them, which means they will be
available in English, French, Spanish and Russian. Unicef agreed
to make them available for onward circulation through all country
offices.
We can anticipate cooperation through NGOs with an
interest in health. Perhaps AHRTAG will agree to publicise then
3
through their various newsletters,
and low-cost drug and
equipment suppliers such as ECHO and IDA may be willing to
include them with orders.
CMC Pharmaceuticals Programme and
Contact could be a great help.
Additional Action: In view of the strength of vested interests,
it is likely that distributing the guidelines widely will not be
enough. At least $350 million worth of drugs are donated by the
US industry alone, not including the value of collections by
Rotary, church groups, etc. In addition there are tax advantages
from offloading drugs which may be nearing expiry and also
benefits from indirect promotion.
Therefore additional actions are likely to be necessary,
including the following: monitoring, publicity for drug donations
which continue to cause problems, support for recipients working
to incorporate the guidelines in drug policies, and education of
donors (government, corporate and NGO) . In particular, we need
evidence of damaging practices which are not covered by the
guidelines, before April 1997.
In view of widespread interest
in the guidelines, if the donations working group can come up
with a plan to coordinate elements of these activities during its
meeting on 10 May, the time is now probably ripe to find funding.
2.
Supply of Narcotic Drugs and Psychotropic Substances for
Emergency Care
This meeting provided information on establishing guidelines for
the
supply
of
narcotic
and
psychotropic
substances
in
emergencies, discussed by the United Nations Commission on
Narcotic Drugs in April. Difficulties with national regulations
in some European countries (Holland, Denmark, France), and on the
procedure for adoption of the guidelines by WHO, were on the
agenda.
The updated guidelines will be presented to ICDRA in
Bahrain in November 1996. Contacts for further information are:
Dr Hans Hogerzeil, Dr Robin Gray, WHO.
3.
Model List of Drugs and Supplies for Use in Acute
Emergencies
I did not attend this meeting.
Its purpose was to finalise the
model list of drugs and medical equipment for use in acute
emergencies which will appear as the second volume of the UNDP
Emergency Relief Items - Conpendium of Generic Specifications.
(Volume 1 deals with communications, shelter and housing, water
supply, etc.)
Dr Robin Gray is the responsible person in WHO.
John Svendsen is the UNDP/IAPSO contact. I have asked to receive
any paperwork that came from this meeting.
(NB: The Model List of Drugs for Use in Acute Emergencies should
not be confused with the WHO Model List of Essential Drugs, nor
with the WHO Emergency Health Kit list which is also used to
select drugs for primary health care.)
Philippa Saunders
Essential Drugs Project
tel/fax (0)181-318-1419
e-mail edp@gn.apc.org
Guidelines for Drug Donations
List of contents
Introduction
1
Guidelines for drug donations
2
Background information
The need for donor guidelines
Core principles
Other ways donors can help
8
9
10
11
The New Emergency Health Kit
Donations in cash
Additional guidelines for drug donations as part of
development aid
How to implement a donor policy
12
Management of drug donations by the recipient ■
Actions required from donor agencies
References
15
Annex: Problems with drug donations
16
Introduction
These Guidelines for Drug Donations have been developed by the World Health Organization
(WHO) and reflect a consensus between the major international agencies active in
humanitarian emergency relief (WHO, UNHCR, UNICEF, ICRC, IFRC, MSF, CMC and
OXFAM). In several rounds of consultation, comments by over 100 humanitarian
organizations and individual experts were taken into consideration.
The guidelines aim to improve the quality of drug donations, not to hinder them. They are not
an international regulation, but intended to serve as a basis for national or institutional
guidelines, to be reviewed, adapted and implemented by governments and organizations
dealing with drug donations. They are published as an interagency7 document and will be
reviewed after one year on the basis of comments received during their use.
There are many different scenarios for drug donations. They may take place in acute
emergencies or as part of development aid in non-emergency situations. They may be
corporate donations (direct or through private voluntary organizations), aid by governments,
or donations aimed directly at single health facilities. And although there are legitimate
differences between these scenarios, there are many basic rules for an appropriate donation
that apply to all. The guidelines aim to describe this common core of "Good Donation
Practice". When necessary' for specific situations, possible exceptions to the general guidelines
are indicated.
The four core principles underlying the guidelines are: (1) a drug donation should benefit the
recipient to the maximum extent possible; (2) a donation should be given with full respect for
the wishes and authority of the recipient, and be supportive of existing government policies
and administrative arrangements; (3) there should be no double standards in quality: if the
quality of an item is unacceptable in the donor country, it is also unacceptable as a donation;
and (4) there should be effective communication between the donor and the recipient:
donations should be based on an expressed need and should not be sent unannounced.
The general drug donation guidelines are presented below, each with a short justification and,
when appropriate, possible exceptions. The second part of this document contains more
detailed background information on common problems and the need for guidelines. It ends
with practical recommendations on how all stakeholders, donors and recipients could make
use of the guidelines in their own situation to maximize the quality and potential impact of
drug donations.
Guidelines for Drug Donations
Selection of drugs
1.
All drug donations should be based on an expressed need and be relevant to the disease
pattern in the recipient country. Drugs should not be sent without prior consent by the
recipient.
Justification and explanation
This provision stresses the point that it is the prime responsibility of the recipients to
specify their needs. It is intended to prevent unsolicited donations, and donations which
arrive unannounced and unwanted. It also empowers the recipients to refuse unwanted
gifts.
Possible exceptions
In acute emergencies the need for prior consent by the recipient may be waived,
provided the drugs are amongst those on the WHO Model List of Essential Drugs that
are recommended in the list of Emergency Relief Items
*
(ref) for use in acute
emergencies.
2.
All donated drugs or their generic equivalents should be approved for use in the
recipient country and appear on the national list of essential drugs, or, if a national list is
not available, on the WHO Model List of Essential Drugs, unless specifically requested
otherwise by the recipient.
Justification and explanation
This provision is intended to ensure that drug donations comply with national drug
policies and essential drugs programmes. It aims at maximizing the positive impact of
the donation, and prevents the donation of drugs which are unnecessary and/or
unknown in the recipient country.
Possible exceptions
An exception can be made for drugs needed in sudden outbreaks of uncommon or
newly emerging diseases, since such drugs may not be approved for use in the recipient
country.
3.
The presentation, strength and formulation of donated drugs should, as much as
possible, be similar to those commonly used in the recipient country.
Justification and explanation
Most-staff workjng at different health care levels in the recipient country have been
trained to use a certain formulation and dosage schedule and cannot constantly change
. their treatment practices. Moreover, they often have insufficient training in performing
the necessary dosage calculations.
2
Quality assurance and shelf-life
4.
All donated drugs should be obtained from a reliable source and comply with quality
standards in both the donor and recipient country. The WHO Certification Scheme on the
Quality of Pharmaceutical Products Moving in International Commerce should be used.
Justification and explanation
This provision prevents double standards: drugs of unacceptable quality in the donor
country should not be donated to other countries. Donated drugs should be authorized
for sale in the country of origin, and manufactured in accordance with international
standards of Good Manufacturing Practice (GMP).
Possible exceptions
In acute emergencies the use of the WHO Certification Scheme may not be practical.
However, if it is not used, a justification should be given by the donor. When donors
provide funds to purchase drugs from local producers, those which comply with
national standards should not be excluded on the sole grounds that they do not meet
quality standards of the donor country.
5.
No drugs should be donated that have been issued to patients and then returned to a
pharmacy or elsewhere, or were given to health professionals as free samples.
Justification and explanation
Patients return unused drugs to a pharmacy to ensure their safe disposal; the same
applies to drug samples that have been received by health workers. In most countries it
is not allowed to issue such drugs to other patients, because their quality cannot be
guaranteed. For this reason returned drugs should not be donated either. In addition to
quality issues, returned drugs are very difficult to manage at the receiving end because
of broken packages and small quantities involved.
6.
After arrival in the recipient country all donated drugs should have a remaining shelf
life of at least one year.
Justification and explanation
In many recipient countries, and especially under emergency situations, there are
logistical problems. Very often the regular drug distribution system has limited
possibilities for immediate distribution. Regular distribution through different storage
levels (e.g. central store, provincial store, district hospital) may take six to nine months.
This provision especially prevents the donation of drugs just before their expiry as in
most cases such drugs would only reach the patient after expiry.
Possible exceptions
An exception to this guideline should be made for drugs with a total shelf-life of less
than two years, in which case at least one-third of the shelf-life should remain. An
exception can also be made for direct donations to specific centres in the recipient
country, provided the recipient is aware of the shelflife of the donation and the
remaining shelflife allows for proper administration prior to expiration. In all cases it is
important that the date of arrival be communicated to the recipient well in advance.
3
Presentation, packing and labelling
7.
All drugs should be labelled in a language that is easily understood by health
professionals in the recipient country; the label on each individual container should at least
contain the International Nonproprietary Name (INN, generic name), batch number, dosage
form, strength, name of manufacturer, quantity in the container, storage conditions and
expiry date.
Justification and explanation
All donated drugs, including those under brand name, should also be labelled with their
International Nonproprietary Name or the official generic name. Most training
programmes are based on the use of generic names. Receiving drugs under different and
often unknown brand names and without the generic name is confusing for health
workers and can even be dangerous for patients. In case of injections, the route of
administration should be indicated.
8.
As much as possible, donated drugs should be presented in larger quantity units and
hospital packs.
Justification and explanation
Large quantity packs are cheaper, less bulky to transport and conform better with public
sector supply systems in most developing countries. This provision also prevents the
donation of drugs in sample packages, which are impractical to manage. Ln precarious
situations, the donations of paediatric syrups and mixtures may be inappropriate
because of logistical problems and their potential misuse.
9.
All drug donations should be packed in accordance with international shipping
regulations, and be accompanied by a detailed packing list which specifies the contents of
each numbered carton by INN name, dosage form, quantity, batch number, expiry date,
volume, weight and any special storage conditions. The weight per carton should not
exceed 50 kilograms. Drugs should not be mixed with other supplies in the same carton.
Justification and explanation
This provision is intended to facilitate the administration, storage and distribution of
donations in emergency situations, as the identification and management of unmarked
boxes with mixed drugs is very time and labour intensive. This provision specifically
discourages donations of small quantities of mixed, drugs. The maximum weight of 50
kg ensures that each carton can be handled without special equipment.
4
Information and management
10.
Recipients should be informed of all drug donations that are being considered, prepared
or actually underway.
Justification and explanation
Many drug donations arrive unannounced. Detailed advance information on all drug
donations is essential to enable the recipient to plan for the receipt of the donation and to
coordinate the donation with other sources of supply. The information should at least
include: the type and quantities of donated drugs including their INN name, strength,
dosage form, manufacturer and expiry date; reference to earlier correspondence (for
example, the letter of consent by the recipient); the expected date of arrival and port of
entry; and the identity and contact address of the donor.
11.
In the recipient country the declared value of a drug donation should be based upon the
wholesale price of its generic equivalent in the recipient country, or, if such information is
not available, on the wholesale world-market price for its generic equivalent.
Justification and explanation
This provision is needed in the recipient country to prevent drug donations being priced
according to the retail price of the product in the donor country, which may lead to
elevated overhead cost for import tax, port clearance, and handling in the recipient
country. It may also result in a corresponding decrease in the public sector drug budget
in the recipient country.
Possible exception
In case of patented drugs, for which there is no generic equivalent, the wholesale price of
the nearest therapeutic equivalent could be taken as a reference.
12.
Costs of international and local transport, warehousing, port clearance and appropriate
storage and handling should be paid by the donor agency, unless specifically agreed
otherwise with the recipient in advance.
>
Justification and explanation
This provision prevents the recipient from being forced to spend effort and money on
the clearance and transport of unannounced consignments of unwanted items, and also
enables the recipient to review the list of donated items at an early stage.
5
THE ECONOMY
Dangerous
prescription
Selling out the people's interests
Amit Sen Gupta
ROM the basic contours of die
new drug policy announced on
September 15 it is apparent that the
Government has decided to go along
with the demands of the industry for
fewer controls. The number of price•bntrolled drugs is to be slashed from
^42 to 73. Greater profitability (up by
4 per cent) will be allowed for bulk
drug manufacture. The number of
drugs reserved for.the public sector is
to be further reduced to just five.
Further, companies with 51 per cent
foreign equity participation will be
treated on a par with Indian compa
nies.
In August 1992, the Government
circulated a note to Members of
Parliament
regarding
proposed
changes in the 1986 drug policy. One
of the reasons cited for the need for a
review of the 1986 policy was that
major changes had been made in the
industrial policy and the drug policy
had to be suitably tailored. While not
wishing to resort to polemics regarding
the advisability of India’s structural
adjustment programme, it needs to be
emphasised that even developed mar
ket economy countries treat the drug
^fcdustry differently from consumer
^Bods industries. Price and production
control mechanisms are in place in all
these countries except probably to an
extent in the U. S.
In the past too, especially since the
1978 drug policy, the Government has
reacted positively to the demands of
the industry by gradually easing con
trol mechanisms. Today when similar
points are being raised, earlier attempts
at reducing controls merit a closer
look. The industry is composed of a
number of sectors - multinationals, the
public sector, Indian organised sector,
the small-scale sector, etc. - each with
its own sectoral interests. Hence a
F
Dr. Amit Sen Gupta is a member of
the Delhi Science Forum.
96
review of the role played by various
sectors at different points of time
would also be pertinent.
EARLY STAGES
At the turn of this century the Indian
drug industry was set up through the
pioneering work of scientists like
Acharya P. C. Ray and Prof. T. K.
Gajjar. However, the Indian market
was soon taken over by multinational
corporations (MNCs), mostly of
British origin. All these companies
merely acted as trading centres import
ing drugs from parent countries and
little attempt was made to start produc
tion facilities in India.
'This situation continued even after
Independence and the Indian market
continued to be dominated, over
whelmingly, by the MNCs. With the
advent of the antibiotic era (after die
Second World War), these companies
earned tremendous profits by over
pricing. At that time drug prices in
India were one of the highest in the
world. In dais period, the Indian
Government virtually went around
with a begging bowl to all the MNCs
and Western nations for technology to
produce vital drugs indigenously.
These requests were denied and antibi
otic production finally started indige
nously when Hindustan Antibiotics
was set up with help from die World
Health Organisation (WHO) and the
United Nations Children’s Fund in
1954. Subsequently, the Indian Drugs
and Pharmaceuticals Limited (IDPL)
was set up with Soviet technology in
1961.
With the setting up of die Indian
public sector, antibiotic prices came
crashing down - in some cases by 60 to
70 per cent. The MNCs, in order to
survive in the Indian market, slashed
their prices. Interestingly, it was pre
cisely in this period tiiat they started
production of basic drugs in India.
Today, when it is fashionable to blame
the public sector for every ailment in
the Indian economy, it would be
worthwhile to recall that it was this
much-maligned sector which actually
started basic production of vital drugs
and thereby forced the MNCs to do
likewise. In die 1960s, the Indian pri
vate sector also started growing. Unlike
die foreign sector, it also set up sub
stantial capacities for production of
bulk drugs. However, the former, in
view of their superior marketing net
work, managed to keep a stranglehold
on the Indian market.
HATHI COMMITTEE
It was in this background that the
Hathi Committee was appointed by
the Government in 1974 to undertake
a thorough analysis of the Indian drug
industry. Its report, submitted in 1975,
came to light only in 1977. The Hathi
Committee made some extremely
important observations and recom
mendations.
☆ The
Committee unequivocally
decried the role played by the MNCs.
•k Made an attempt for the first time to
draw up an essential drug list.
* Recommended a gradual shift to
generic names from brand names.
★ Recommended a package of price
control measures to make life-saving
and essential drugs affordable.
■A- Recommended measures to ensure
production of essential drugs.
★ Unanimously recommended imme
diate dilution of foreign equity in drug
firms to 40 per cent and progressively
to 26 per cent. In fact, by a majority
decision, it recommended nationalisa
tion of all foreign drug companies.
★ Recommended a leading role for the
public sector.
★ Recommended reservation
to
encourage growth of the Indian sector.
The Committee was sharply critical
of the foreign sector because of its
reluctance to produce bulk drugs as
well as its non-performance in produc
ing essential drugs. It was noted that
these firms were more interested in
producing inessential drugs or those
requiring low technological inputs.
The drug policy of 1978 and the
Drug Price Control Order (DPCO),
1979 were based, albeit partially, on
the recommendations of the Hathi
Committee. For the first time, compre
hensive price control was introduced
(though some measures had been in
force since 1970). The new DPCO
categorised drugs into four categories:
I. life-saving, II. essential, III. less
essential and IV. non-essential/simple
remedies. The first three categories
were price-controlled with a mark-up
(profits allowed) of 40 per cent, 55 per
cent and 100 per cent respectively.
The aim was to make more essential
Frontline, October 21,1994
drugs cheaper. While it is possible to
by the MNCs, started making belliger
Drug production in
fault, in some cases, the process of cat
ent noises for reversal of the 1978 poli
response to pricing policy
egorisation, an attempt was at least
cy - for decreased controls. The
made to come up with a graded essen
industry argued that drug production
DPCO Category
1978 1979 1980
tial list of drugs.
was becoming unprofitable, and even
(%)
(%)
(%)
The 19~8 policy also reserved major
reduced production of essential drugs.
I (Life Saving)
4.5
4.2
areas in the market for different sec
3.6
In this campaign, the MNCs were
II (Essential)
16.7
14.8
13.2
tions in the Indian sector - both private
joined by large Indian companies
III
(Marginal)
67.1
67.0
68.6
and public. Further, it stipulated that
which
had by now consolidated their
IV (Decontrolled)
11.7
13.2
14.6
the process of shift to generic names
position. The Government gave in,
would be started with five drugs:
first
by
delicensing a number of drugs.
Source: The Indian Pharmaceutical Indus
Analgin, ferrous sulphate, aspirin,
This led to even greater anarchy in
try — Problems & Prospects, by P. L. Narayana. NCAER.
piperazine and chlorpromazine.
production.
These measures led to a rapid
The 1986 policy, in one sweep,
growth of the Indian sector, which cent in order to be treated on a par reduced the span of price control from
rapidly gained the capability to pro with Indian companies. Most FERA 347 bulk drugs to 166 drugs. It
duce most essential drugs. In fact, in companies readily complied, as it is decreased the number of controlled
1980, the United Nanons Industrial always possible to control a company categories to two and increased the
Development Organisation identified with 40 per cent block holding of mark-up in these to 75 and 100 per
India as one of the countries with the shares, provided the other shares are cent. This was in addition to various
capacity to produce all essennal drugs widely dispersed. Today, almost all liberalisation measures initiated from
indigenously.
major foreign (except 6-7) firms such time to time. The implementation of
The foreign sector continued to pro as Glaxo, Hoechst, May & Baker, and the DPCO of 1987, based on the 1986
duce principally in low-technology Parke Davis are treated on a par with policy, led to an immediate hike in
areas and increased production of Indian companies.
drug prices. Pious pronouncements
inessential drugs. It showed little incli
The shift to generic names was that it would increase production of
nation towards increasing bulk drug blocked by Hoechst. Cyanamid and essential drugs were belied (see table
production whiie increasing produc Pfizer, which obtained orders from the below).
tion of formulations enormously. In Delhi High Court in 1981. The case
If you look back at the various policy
essence it continued to play the role of continues to languish in the Supreme initiatives and their impact on essential
trading centres. In fact, the small-scale Court and a final judgment is still drugs, the following stand out:
sector was engaged in producing more awaited.
1. A differential price control mecha
bulk drugs than the whole foreign sec
During this period, the public sector nism in the absence of production con
tor put together. So much for the claim came to be increasingly marginalised. trols has led companies to shift
of the MNCs that they bring in new Due to bureaucratic and administrative production to non-essential areas
technology. Such a situation continues bungling as well as rampant inefficien where returns are higher.
today and there appears little justifica cy and corruption, public sector units
2. Because of the proliferation of
tion to the conunued presence of the ran up huge losses and were in no posi large number of formulations (between
MNCs if they are to produce simple tion to play a leading role. This was 40,000 and 80,000) and drug manu
remedies like vitamins, tonics, cough indeed unfortunate as a strong public facturers (between 800 and 1,200) the
syrups and rubs and balms.
sector could have been used to counter Government has consistently reduced
In the wake of the 1978 drug policy, the arm-twisting tactics of the rest of the drugs under price control in order
the organised Indian private sector cre the industry. In formulating an essen to make its task more ‘manageable’.
ated a solid base for itself. Having done tial drug list and weeding out haz3. The foreign sector has ‘created' a
so, it joined the MNCs in the cam ardous/irrational drugs, no significant market for many of its irrational and
paign for reversal of the 1978 policy. progress was made.
inessential branded products, and con
Before going into that aspect, it would
By the early 1980s. the industry, led centrates on the low-technology areas.
be interesting to recapitulate how loop
holes were utilised to make large sec
Shortfall in production of essential drugs
tions of ±e 1978 policy infructuous.
A major lacuna was the lack of pro
1986-87
1991-92
1982-83
duction control measures. This was
Total
Demand
Total
Demand
Total
contrary to the Hathi Committee recName of drug
Unit
availa
availa
esti
availa
esti
ommendauons. The policy had no
bility
bility
mate
bility
mate
clause to compel manufacturers to
produce essential drugs. This, coupled
305.97
Penicillin
360.32
330
255.79
370
MMU
with the graded pricing structure,
247.87
276.32
Streptomycin
270
180
167.98
T
proved disastrous. Companies reduced
111.46
98.12
200
Chlorompherucol
300
107.02
T
production in categories I and II,
258.17
456
Ampicillin
200
•■ 142.27
*
360.58
T
where the mark-ups allowed were
93.64
. 52.00
Vitamin-A
77
71.19
MMU
no
lower (see table).
INH (anti-TB)
250
288.40
57.84
333
*
25.45
T
Chloroquine
200
194.57
200
196.22
T
140.10
At the same time, the whole concept
Dapsone
200
86.90
51.50
58
13.30
T
of sectoral reservation was diluted asi
(anti-leprosy)
the Hathi Committee recommendation
Diptheria
136.00
NA
800
653.57
NA
MU
for equip.’ dilution was ignored.
anti toxin
Companies covered by the Foreign
Exchange Regulation Act (FERA),
* Major production in small scale sector which is not reflected here
under the 1978 policy, were required
Source: Indian Drug Statistics. 1984-85, GOI; & Annual Report
Department of Chemicals and Petrochemicals. 1987-88, 1988-89,1992-93
to dilute their foreign equity to 40 per
98
Frontline. October 21,1994
While the industry has grown con
Growth in Sales & Profits of top drug , companies
siderably, a disturbing trend is dis
(Figures in Rs. crores)
cernible. Most manufacturers have
Company
Sales% Change
Profit
started vying for the up-market section
Change % Dividend
where consumers can pay heavily to
__
Total
7028
25
605
46
‘buy’ health care. Hence the indiffer
Ranbaxv
688
22
71
79
40
ence to production of low-cost essen
Glaxo
551
28
32
49
27
tial drugs.
Hoechst
351
32
23
136
25
Sandoz
In doing so the industry' is also in
290
22
1
3
25
Alembic
262
56
5
1
danger of falling into a self-destructive
Cipla
244
24
24
21
32
loop where 1,000 manufacturers fight
Torrent
229
39
25
54
30
for the drugs market among 5 per cent
Ambalal Sarabhai
7
220
11
783
of the population who can pay. This
Pfizer
214
25
20
86
30
will act as a major constraint to further
Procter & Gamble
206
41
-17
development of the industry.
Dr. Reddv’s
175
31
33
23
30
The proliferation of irrational drugs
Burroughs Wellcome
169
20
10
61
22.5
has to be seen not only in tire context
Kopran Ltd.
159
18
18
59
Boots
154
18
16
23
38
of health needs, but also in terms of the
Gordon Herbert
142
188
4
101
20
impact it has on the regulatory bodies.
Ipea Labs
140
22
15
49
25
ch proliferation makes it virtually
Parke Davis
7
17
137
13
35
possible to impose price control
Wockhardt
136
38
22
46
mechanisms on all drugs. The
Smithkline
14
-15
-25
24
123
Government and the industry argue
E. Merck
121
2
9
85
15
that the way out is to keep most drugs
Nicholas
108
19
22
38
22.5
outside price control. A more rational
TTK Pharma
103
32
6
48
Unichem
103
5
76
60
11
solution is to restrict the kind of formu
Lyka Labs
20
5
39
103
lations that are to be allowed, so as to
Core Parenterals
103
127
28
114
40
make controls for all drugs feasible.
In the new policy, the Government
Source: 'rhe Economic Times, Aug. 22, 1994
has granted major concessions to the
Note: % Change calculated against previous year
industry in terms of reduced price and
production controls - slashing down
industry is that drug costs account for
Household Expenditure on
the number of drugs under price con
a small percentage of health care costs. trol and increase in returns allowed for
medical care (January 1985)
While it is true that there is scope for
bulk drug manufacture. These mea
reduction of health care expenses in
(Rs. crores)
sures will lead to price escalation while,
other areas, such as doctors’ fees, diag
Total
Region
Drug
given the dynamics of the industry,
%
noses, hospital expenses and so on,
Costs
Health
none of them can in any way boost'
the table (left) shows the actual posi
care
production of essential and life-saving
tion in regard to the ratio of drug costs
costs
drugs. A proposal for domestic treat
to total health care costs.
443.42
54.28
ment of companies with 51 per cent
Rural
240.7
The next question is the issue of pro
705.22
1100.72
64.06
Urban
foreign equity participauon has also
duction controls. An analysis of pro
1544.14
61.26
Total
945.92
been cleared and the number of drugs
duction patterns of 58 monitored bulk
J^rved for the public sector is sought
drugs shows:
Source: NCAER Study quoted in Report of
^^>e reduced - a further attempt at
the Committee on Category II Drugs, Aug.
* In the case of 14 drugs main pro
'87, GO1
emasculation of the public sector.
duction is in small-scale sector and in
Thus all the positive points emananng
one case the small-scale sector has a
from the Hathi Committee are going to on Category II Drugs, GOI, 1987 says significant contribution.
be reversed.
“compared to other industries, this is ★ Top 20 MNCs which account for
The basic plea from the industry much less capital intensive... capital 31.5 per cent of the market share
(which has reacted positively to the invested for drugs & pharmaceutical (source: Indian Express March 30,
new policy), is for decontrol - both industry... works out only to Rs. 1993) have over 50 per cent share in
with regard to production and pricing.
94,000 per labour... in comparison (to) eight drugs, over 25 per cent in four
First, the issue of profitability and industries such as fertilizers, petro drugs and over 10 per cent in five
the claim by the industry that prof chemicals and synthetic fibres (where) drugs. Of the eight drugs in which they
itability' has been going down due to capital invested per labour employed have major share one is totally inessen
excessive controls. As can be seen from works out to 61 lakhs, 38.9 lakhs and tial - Vitamin E, and one is hazardous
the table, profits as well as turnover of 24.1 lakhs.’’) Hence a relatively small - Baralgan.
drug companies have shown a large capital investment can produce a large ★ Top 20 Indian companies which
increase. Drug companies have tried to turnover.
account for 31.5 per cent of the market
obfuscate the issue by claiming that the
Even a comparison with other sec share (source: Indian Express, March
ratio of profits to sales turnover is not tors of industry shows that both sales 30, 1993) have over 50 per cent share
adequate. To buttress their point they and profits have been growing at a in nine drugs and over 25 per cent
have tried to compare this ratio with faster rate in the pharmaceutical indus share in three drugs.
that of certain other industries. This is try. Even the ratio of gross profits to * The public sector has over 50 per
a fraudulent argument as inter-indus sales is near the industry average. Yet cent share in eight drugs, over 25 per
try comparisons of this kind are mean the Government has reposed uncritical cent in four drugs and over 10 per cent
ingless. The pharmaceutical industry is faith in the industry’s claims.
in two drugs.
not capital-intensive. (The Committee
Another argument used by the * Indian sector companies (not in top
K
Frontline, October 21,1994
99
Oligopoly in drug industry
20) have over 50 per cent share in 13
drugs, over 25 per cent in four drugs
and over 10 per cent in three drugs.
★ Thus 40 top companies, which
account for 63 per cent of the formula
tion market share, have over 50 per
cent share in only 17 out of 58 drugs.
This clearly shows that larger com
panies are not interested in producing
bulk drugs, but rather prefer to act as
mere traders and middlemen by con
centrating on the formulations market.
In such a situation there can be no jus
tification in liberalising production
controls, and in fact more stringent
production controls are called for.
The Government's pious hope that
market forces will work to keep prices
of drugs stable is not borne out by
experience. After the last round of
price decontrol through the DPCO of
1987, prices of drugs spiralled up
The market forces logic is even less
applicable to the pharmaceutical
industry than other sectors. Unlike
consumer goods, drugs are nor pur
chased by the consumer on the basis of
his choice or preference. The drug
companies have built up a market
through their extensive marketing net
work. The consumers have little or no
choice in such a ‘‘rigged” market and
are forced to buy anything and every
thing that doctors are “induced” to
prescribe by the “friendly neighbour
hood” medical representative. This is
surely not the best climate for market
forces to stabilise prices. In the indus
try the tendency is towards cartelisa
tion with a few companies holding
monopoly share of particular seg
ments.
What is possibly even more impor
tant is the manner in which the list of
price controlled drugs has been worked
out. In the DPCO of 1979, essentiality
was the basic criterion used to decide
the categorisation of drugs, and more
essential drugs were kept under price
control. The Kelkar Committee, which
formulated the list of drugs for DPCO
1987, used essentiality’ as only one of
the criteria. Other aspects such as
turnover of drugs, monopoly within a
certain sector, etc., were also taken
cognisance of. In the new policy,
essentiality’ appears to be not a consid
eration at all and reliance is to be
placed only on the turnover to deter
mine which drugs are to be price-con
trolled. Obviously, the health needs are
not being addressed at all.
With rapid developments in science
and technology there has been an
explosion in the number of drugs avail
able. Only a small minority’ of drugs
entering the market offer therapeutic
advantage over existing drugs. There
are an estimated 60,000 to 80,000
100
Therapeutic Group
Total
market of
group
Share
of top
brands
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11
12.
13.
14.
15.
16.
17.
18.
19.
Antacid etc.
Genl. Nutrients
Vitamins
Anti Anaemic
Tonics
Mineral Supplements
Top. Antibiotics
Top. Steroids
Sys. Steroid
Anti T.B.
Anti Inflam.
Analgesics
Anu Spasmodic
Anti Parasitic
Anti Asthmatic
Rubs & Balms
Cough & Cold Preps.
Anti Histamine
Antibacterials
17,90,065
7,58,531
23,53,495
10,38,274
4,60,426
3,92,072
3,35,372
7,94,162
5,54,532
13,82,519
20.35,595
11.44,683
4,26,096
11,66,858
7,75,677
3,55,200
18.57,988
6.84.380
17,57,643
6,94,646
2,64,545
10,04,507
3,64,094
69,413
1,67,675
2,19,387
3,13,139
2,69,697
6,22,082
6,28,168
4,81,458
1,31,772
2,35.602
81,812
2,62,211
5,89,023
226.826
10,77,863
20.
Antibiotics
73,53,705
20.1
20.2
20.3
20.4
20.5
20.6
20.7
20.8
20.9
20.10
Tetracyclines
Chloramphenicols
Ampi/Amoxvcillm
Cephalosporins
Cotrimoxazole
Erythrocim
Stretomvcin/Comb
Penicillins
Pen-Strep Comb.
Others
21.
22.
23.
24.
25.
26.
Digestive Enzymes
Antiseptics
Sex Hormones
Oral Electrolytes
Anti Diabetic
Anti Epileptic
Share
%
Brand
(No)
COS
(No)
38.81
34.88
42.68
35.07
15.08
42.77
65.42
39.43
48.64
45.00
30.86
42.06
30.93
20.19
10.55
73.82
31.70
33.14
61.32
5
3
8
3
1
2
2
3
2
4
4
5
I
3
1
3
6
2
7
5
2
5
3
1
2
2
2
2
2
4
5
1
3
1
3
6
36,88,295
50.16
31
7,37,617
3,30,974
25,15,369
12,54,491
9,61,144
6,52,952
1,11,315
3,29,365
1,73,052
2,87,426
4,38,846
1,00,145
11,91,674
4,62,061
6,73,516
4,90,152
83,541
1,72,413
1,51,741
68,139
59.50
30.26
47.38
36.83
70.07
75.07
75.05
52.35
87.69
23.71
4
1
10
3
4
3
1
2
2
1
4
1
10
3
3
3
1
2
2
1
5,45,152
2,65,384
7,66,729
2,03,395
4,93,109
3,40,099
2,03,111
1,30,053
1,41,067
1,68,333
1,81,844
1,93,402
37.26
49.01
18.40
82.76
36.88
56.87
3
2
2
1
2
3
2
1
1
2
2
2
4
Note: Based on an analysis of ORG statistics of 120 Top Selling Products in Dec. 1992. The
table shows the market share enjoyed in each therapeutic group by these top selling brands as
well as the market share of companies owning these brands. It will be appreciated that the
market share of top companies is likely to be higher as the above statistics pertain to only top
120 products. It may also be mentioned that though there are 60-80,000 brands in the market
the top 120 brands account for 35.3% of the market.
brands of various drugs available in the
Indian market. In this situation of
extreme anarchy, the task of an already
overstretched Drug Control Authority
becomes almost impossible. A majorin’
of the products are hazardous, irra
tional or useless. The problem is com
pounded by the fact that there is
almost no source of regular, unbiased,
authentic informanon on the drugs
available. A bulk of medical practition
ers depend on promotional material
supplied by the companies.
The need to increase drug produc
tion to Rs. 15,000 crore by the year
2000 from the present Rs. 7*,000 crore
has been repeated ad nauseam both by
the industry and the Government. But
no thought seems to be given to what
kind of drugs this large volume would
include. What is to prevent a major
share of the production from being
diverted into non-essential areas? The
new policy has no ideas to offer and
only talks of liberalisation. More liber
alisation may well mean licence to pro
duce more hazardous, irrational and
inessential drugs.
It is thus important for the
Government to step in, to control and
regulate the growing business of medi
cine as is done the world over by the
food and drug administrations. The
fundamental right of trade in business
of medicine cannot be a cause for the
drug control authorities to behave oth
erwise.
The review note, earlier circulated
by the Government, derived satisfac
tion from the positive trade balance
achieved by the industry. What is
glossed over is the fact that the figures
quoted actually conceal increased
dependence on imports in bulk drug
production. The Government’s note
claims that almost the entire formula
tion demand is met indigenously,
meaning that almost the entire imports
Frontline, October 21,1994
Comparative Contribution of different sectors
in production of different Therapeutic group
(for top 120 products) in Rs. crores
Foreign
Sector (%)
Indian
Sector (%)
21.93
383.22
107.79
62.21
23.56
29.60
39.75
0
12.68
29.00
70.40
60.25
100.00
87.32
71.00
26.22
58.90
26.45
117.22
53.25
110.96
74.08
77.78
100.00
100.00
100.00
81.94
25.92
22.22
0
0
0
18.06
Total
1.
Total turnover
(for top 120 products)
2.
Essential drugs
*
2.1
2.2
2.3
2.4
2.5
Cardiovascular
Antibiotics
Anti Bacterial
Anti T.B.
Anti Parasitic
1357.97
3. Simple remedies, Vitamins,
cough syrups etc.
>
3.1
3.2
3.3
3.4
3.5
3.6
Rubs & Balms
Cough & Cold Prep
Gen Nutrients
Vitamins & Minerals
Topical Ointments
Anti Inflammatory &
Analgesic
Sources: Calculated from ORG Retail Survey, Dec. 1992.
rough iteration.
are for bulk drugs. Thus the relauve
figures for bulk drug production and
imports (in crores of rupees) would be
as in the table below.
Formulation production is a relative
ly much simpler exercise and even
countries like Bangladesh are relatively
self-sufficient in this area. Self-reliance
in bulk drug production is actually the
true indicator of development of the
drug industry. If the above trend con
tinues, India may soon become a
'banana’ republic, depending largely
on imported bulk drugs.
The Government would do well to
go back to the Hathi Committee report
detailing the sins of omission and com
mission of the foreign sector in the
industry before it rolls out the red
^Wpet for the MNCs. Nothing has
changed since then, in fact the situa
tion has worsened. The foreign sector
is the worst offender when comes to
production of irrational and hazardous
drugs and non-production of essential
drugs. The measures outlined in the
1978 drug policy restricting this sector
constitute the single most important
factor responsible for the growth of the
Indian drug industry’ in general and the
Indian sector in particular. The foreign
sector has never brought in new tech
nology and will not do so in the future.
Allowing concessions to it (in the form
of national treatment to companies
Criteria for essentiality is a
W’ith 51 per cent foreign equity) will
only result in emasculation of the
Indian drug industry.
The new policy dismisses the role of
the public sector and in fact talks of
further denuding it. Deliberate neglect,
mismanagement, corruption and sabo
tage at various levels have brought the
public sector to its present pass.
Instead of thinking about measures to
revitalise it the Government wishes to
initiate its funeral rites.
Today, when the global pharmaceu
tical industry’ is poised for a new revo
lution with the help of biotechnology’,
only the public sector has the capacity’
to compete with the MNCs and ensure
a self-reliant growth. No company in
the private sector has either the inclina
tion or the will to make the kind of
investment necessary to keep pace with
technological developments in frontier
areas. Ultimately, the demise of the
public sector will write finis to the
whole indigenous drug industry.
Steps to encourage research and
development (R&D) in the drug
industry, mentioned in the policy, are
welcome. But mere pronouncements
cannot stimulate R&D efforts in a cli
mate where the industry’ spends a mere
1-2 per cent of its turnover on R&D
and most of the R&D done has very litde innovative content. Moreover, the
strength of the R&D base in the drug
Bulk drugs Production and Imports
Year
Production
Imports
(in crores of rupees)
Availability
% of
imports
1980-81
240
*
100
340
29.4
1990-91___________ 700____________ 650
*
____________1,350__________ 48.2
Frontline, October 21,1994
industry, for whatever it is worth, lies
in the area of process technologies.
If the Indian Patent Act is changed
in line with the GATT agreement, in
one sweep this base will become mean
ingless. Today the industry is not, by
and large, in a position to invest in
development of new product technolo
gies. Investments required to develop a
new product with definite therapeutic
advantage is far in excess of the total
turnover of most Indian companies.
Compare the present R&D expendi
ture of about Rs. 100 crore annually to
the estimated cost of development of a
new drug, which is about 300 million
or roughly Rs. 950 crore.
Whatever scattered efforts have been
made in development of product tech
nologies have come from the laborato
ries of the Council of Scientific and
Industrial Research (CSIR). Recent
examples of this are the development
of Centchroman, a non-hormonal con
traceptive, and the ongoing trials on
the cerebral stimulant effect of
‘Brahmi’. Both are research efforts of
the Central Drug Research Institute
(CDRI), Lucknow. What measures are
being suggested to encourage this? On
the contrary, Centchroman continues
to flounder in the market, in the
absence of a planned strategy for its
promotion and marketing. Merely giv
ing incentives to drug companies
which use technologies developed by
CSIR laboratories is not going to give a
boost to R&D efforts.
In conclusion, it may be mentioned
that the drug industry has to be viewed
differendy from other industries.
Market demand is not regulated by
prices of drugs, as demand primarily
depends on prescription habits of doc
tors, disease profiles, drug resistance,
etc. Hence the market cannot ever be a
proper mediator of prices of drugs.
Further, this is compounded by the oli
gopolistic nature of the industry where
a few companies have monopoly with
in various therapeutic groups. In such
a situation, abandoning price and pro
duction controls with the fond hope
that the market shall regulate prices
can only lead to unjustified rise in
prices.
Use of tariff measures or price con
trol mechanisms to regulate production
cannot work and specific production
control measures are necessary.
Concessions to the foreign sector are
aimed not at improving the health of
the nation but at improving the health
of the balance sheets of MNCs. It is
indeed
unfortunate
that
the
Government has chosen to sell out the
interests of the people to the interests
of profiteers in the industry and the
MNCs. ■
101
Makerere University
World Health Organization
University of Amsterdam
announce an international training course
PROMOTING RATIONAL DRUG USE IN THE COMMUNITY
11-24 November 2001
Entebbe, Uganda
This is a two-week course for health programme staff from ministries of health, universities, development agencies, nongovernmental
and other organizations, and individuals interested in improving drug use in the community.
Trainers: Andrew Chetley, Daphne Fresle, Ane Haaland, Anita Hardon, Catherine Hodgkin, Ayyaz Kiani
OBJECTIVES
This ground breaking course was developed to meet requests from many individuals and organizations, and to respond to a clear need
for more effective planning, research and implementation of rational drug use activities in the community. The course concentrates
on methods to study and remedy inappropriate drug use in the community, including an essential analysis of what shapes drug
demand. Participants will learn practical approaches to investigating and prioritizing drug use problems, and how to develop effective
strategies for education and change.
DESIGN
The course is participatory in nature and uses the knowledge, skills and experiences of participants as a major resource throughout.
Teaching methods include group activities, field work, presentations and discussions. Participants will spend the two final days
preparing a detailed plan of action to confront an important community drug use problem in their country of origin. The course is
conducted in English, and given its interactive nature participants need a good command of that language to participate fully. Course
materials were developed by WHO and the University of Amsterdam, m collaboration with colleagues throughout the world.
Participants will thus be exposed to a wide range of international experience. The course complements and follows a similar approach
to the international training course on promoting rational drug use held regularly by the International Network for Rational Use of
Drugs (INRUD) and WHO.
HIGHLIGHTS
I
■
Factors that shape drug demand
■
Methods to identify community drug use problems
■
How to prioritize drug problems
■
Field exercises to assess drug use
■
Moving from research to practice
■
Use of different media channels
■
Face-to-face education
■
Pretesting materials
■
Advocacy and networking
■
Planning and evaluating interventions
FEES AND APPLICATION
The fee of US$ 2950 covers tuition, course materials (including a core library for participants to take home), and shared hotel
accommodation at a beautiful site overlooking Lake Victoria. Single rooms are available for an extra USS 20 per night payable by
participants. The fee for local participants without accommodation, breakfast or dinner is USS 1500. Participants should plan to bring
sufficient funds for incidental expenses such as laundry, postage, telephone calls, souvenirs, airport tax, etc. Airfare and health
insurance are the responsibility of participants or their sponsoring organization. Application forms are obtainable from the address
below or can be printed out directly from the EDM web-page al http://www.who.int/medicines/organization/par/secondcourse.html.
The deadline for receipt of applications at the address given below is 1 October 2001. Fees are payable before 25 October 2001.
University of Amsterdam
Faculty of Social and Behavioural Sciences
PRDUC course
Attn. Dr Ria Reis
Oudezijds Achterburgwal 185
1012 DK Amsterdam, The Netherlands
Tel: +31 20 5254779
Fax: +31 20 5253010
E-mail: prduc@pscw.uva.nl
COLLABORATING INSTITUTIONS
WHO’s Department of Essential Drugs and Medicines Policy (EDM), Geneva
The Department of Essential Drugs and Medicines Policy provides global guidance and works with countries to develop and
implement national drug policies and programmes. The aim is to ensure that essential drugs are accessible to all the population, and
that drugs are safe, effective and rationally used. EDM also conducts training and research to tackle problems in drug procurement,
accessibility, safety and use that countries face in a rapidly changing pharmaceutical environment. The Department has an extensive
publications programme including series on research, health economics and drugs, and interagency guidelines. EDM’s Essential
Drugs Monitor - published in English, French, Spanish, Russian and Chinese - is an important source of information on new
developments and experience.
Child Health and Development Centre (CHDC), Makerere University
The Centre was established within the Faculty of Medicine in 1989 as a multidisciplinary and inter-sectoral department, initially to
foster the UNICEF-initiated child survival and development strategy in the Africa region, in which Uganda participated. The Centre
aims to promote: widespread proficiency in applied research; multidisciplinary and inter-sectoral collaboration for training; and
university-community-govemment links to develop community empowering health and development strategies. Over the years, the
Centre has grown into a substantive training and research institution. It is currently involved in long-term collaboration in district
health systems research with the Universities of Aarhus and Copenhagen.
Medical Anthropology Unit (MAU), University of Amsterdam
The Medical Anthropology Unit, part of the Faculty of Social and Behavioural Sciences, has a long tradition in applied and critical
social science. It collaborates with many national and international academic institutions and development organizations. The MAU
is known for its action- and policy-oriented research on the use and distribution of pharmaceuticals, gender and reproductive health,
and injections and culture, which has resulted in a steady stream of publications in Dutch and international journals. Within The
Netherlands, the MAU is the sole provider of a comprehensive master’s course in medical anthropology, attended by social science
and medical students of the University of Amsterdam and other universities. The Unit also regularly organizes conferences on current
issues in international health.
LOCAL ORGANIZERS AND FIELDWORK LEADERS
Dr Jessica Jitta is director of the Child Health and Development Centre, a paediatrician and senior lecturer in the
Department of Paediatrics and Child Health at Makerere University Medical School.
Mr John Arube-Wani is a lecturer in the Department of Paediatrics and Child Health, and head of the community section at the
Child Health and Development Centre, Makerere University Medical School.
TRAINERS
Ms Daphne Fresle (joint course director) is a public health communications specialist with the WHO Department of Essential
Drugs and Medicines Policy. She coordinates the communications activities - including technical publications, drug information and
consumer education - of the Policy, Access and Rational Use team, and is editor of the Essential Drugs Monitor. Ms Fresle has
worked on the development of public education programmes related to the appropriate use of pharmaceuticals in many countries. She
recently conducted an analytical global survey of rational drug use activities in the community.
Dr Anita Hardon (joint course director) is head of the Medical Anthropology Unit, University of Amsterdam, a medical biologist
and medical anthropologist. Her doctoral research on the use and distribution of medicines in the Philippines has been followed by many
other published studies on medicine use, applied health research, quality of care, and fertility regulation. She is author of a WHO manual
on how to study drug use in communities and leader of an international collaborative study in this field. Her activities include running a
five-week course on anthropology of health and health care, and working with consumer organizations on rational drug use and women’s
health.
Mr Andrew Chetley is the director of Exchange, a networking and learning programme on health communication, that aims to
identify and share good practice. A trained journalist and communications specialist, he has worked with a range of NGOs and
international organizations in the field of health, education and development. He is the author of five books on public health issues,
including the rational use of drugs, and has experience of training health workers and the media in effective communication.
Ms z\ne Haaland is a communications trainer with a background in social science, journalism and photography. She conducts
intervention research on training aspects of rational drug use for providers and community members, and has developed a number
of manuals on the subject. During 15 years based in the field in Asia and Africa she has focussed on research and development of
visual methods to communicate with low-literate audiences, and on programme implementation and evaluation. She teaches on
participatory learning methods, interpersonal communication and journalism.
Ms Catherine Hodgkin is head of the Health Department of the Royal Tropical Institute in The Netherlands (KIT): a
multidisciplinary group of consultants and trainers working in the field of health and development. For ten years she was international
coordinator of Health Action International (Europe), an international network of NGOs and public interest groups working to promote
a more rational use of drugs. She has extensive experience in the field of drug policy and consumer advocacy, and has contributed
to a variety of training activities for consumers, health professionals and policy makers.
Mr Ayyaz Kiani is founding head of Sanjh Public Health Center in Rawalpindi, Pakistan. "Sanjh" (a local word meaning people
working together) is a pioneering health cooperative, with rural and urban components, comprising a multidisciplinary group of health
professionals and consumers. He has extensive experience of advocacy in the field of drug policy and has contributed to a variety
of training activities for consumers, health professionals and policy makers throughout Pakistan. His ten years' commercial marketing
experience prior to joining the rational drug use movement brings valuable insight into how medicines are promoted to prescribers
and consumers. He has degrees in pharmacy, business management and public health.
In the Indian Scenario
A WHO-INDIA Initiative
Promotion
of Rational
Use of Drugs
In the Indian Scenario
Foreword
I)
his small publication
T
provides the reader with a
glimpse of what is happening in several states of
India as a result of programmes initiated by the Government
of Delhi, the Delhi Society for Promotion of Rational use
of Drugs and the India-WHO Programme in Essential
Drugs. These are being implemented with
the state governments. The
programme in Delhi State was initiated in 1992. Programmes in the other
states were developed and implemented in 1998. Their response has been
remarkable.
A national or state programme in rational use of drugs leads to greater
availability of good quality medicines, improved prescribing, optimal use of
resources and better therapeutics.
£
The achievements so far have been possible only because of the close
harmonious relationship amongst the political leadership, the enlightened
bureaucracy and the dedication of a large team of professionals who have
participated voluntarily in the programme.
National Institute
of
Immunology
New Delhi
RANJIT ROY CHAUDHUR
Preside
Delhi Society for Promotion of Rational Use of Dre
26 April. 19i:-'
Delhi can now boast of being the
the success of the programme in these states
only state in India to have a comprehensive
will induce others to follow suit so that the
rational drug policy - a policy which provides
slogan ‘Health for All by 2000’ will become
succour to the poor. This is also the first
a reality.
time that WHO is working in tandem with
a state government
(i.e.
Delhi)
and
the
Delhi Society for Promotion of Rational
Use of Drugs, a non-governmental organisation.
Thanks to the concerted and collective efforts
The Delhi Model
The programme of rational use of
drugs was put into action in 1994. Conditions
^f doctors, ministers and drug controllers,
in hospitals run by the Delhi Government
this far-reaching policy has injected a new
before that could at best be described as
lease of life into a health system earlier
chaotic. The words of Dr. Harsh Vardhan,
crippled with inadequate planning and lack
Minister of Health and Family Welfare at
of foresight. This saw the right medicine
that time best exemplifies the sitation. “At
This is the first time that WHO
is working in tandem with a state government
and a non-governmental organisation
used for the right period of time in the right
nearly every hospital I visited there were
doses.
complaints that drugs were not available.
Other complaints related to the quality of
The best brains in the Delhi Government,
drugs, their procurement and distribution
the WHO and the Delhi Society for Promotion
and the information given to patients about
of Rational Use of Drugs saw the genesis of
the use of drugs. Each hospital had its own
the Rational Drug Policy. Hailed by WHO
list of drugs, medicines came to hospitals in
as a major breakthrough, this policy is now
many different brand names, supply was
being emulated by other state governments
erratic and
such as Maharashtra, Rajasthan, Himachal
unrestrained.” All this naturally made hospital
Nadu
the prescribing, very often,
Pradesh,
Punjab, Tamil
West
visits a frustrating experience for rhe patients.
Bengal.
Bihar and Madhya Pradesh have
Though 30-35% of the budget of hospitals
now joined the programme. It is hoped that
was spent on medicines, their shortage was
G
and
Ninety percent of
the drugs budget in
hospitals was spent on
essential drugs
Dr. Harsh Vardhan, Minister of Health & Family Welfare, Delhi
State, Dr. H.V. Hogerzeil of W.H.O. Headquarters & Prof. Ranjit Roy
Chaudhury, President of DSPRUD at conclusion of meeting on
30th Nov. 1997 at which it was decided to initiate the WHO - India
almost four million visit the out-patient
Programme in Essential Drugs.
departments annually. All medicines are free
irrespective of where the patient is from.
chronic. However all this changed. Within
The doctors of the team implementing this
four years of the introduction of the new
programme visited all hospitals within the
drug policy, there was an almost unbelievable
ambit of the Delhi Government at least
change. The most important feature was
once and explained the programme to the
that safe, effective drugs were actually available
health professionals.
for the distressed patients, many of whom
were poor and needy. This is an absolute
List of Drugs
necessity in a country where a majority of
the population still lives hand-to-mouth.
A.
high-powered committee made a
Ninety percent of the budget in hospitals is
common
list of 250 essential drugs and
now spent on essential drugs, the quality is
another list of 1 00 drugs for smaller hospitals.
generally above board and there is much
The first list of essential drugs was made iiy
more of rational prescribing.
1994. It included 329 drugs in 28 different
categories and was prepared on the basis of
The Transformation
WHO guideli nes save that separate lists for
indoor and outdoor patients were selected,
Delhi State has two teaching hospitals,
drugs for dental practice were included and
15 smaller hospitals and 158 health centres.
those for use by specialists only were indicated.
These are 4000 beds for in-patients and
Dispensaries and sub-centres were also included.
A list of essential drugs for these too was
located in Delhi. This system however had
formulated in 1995 to include 95 drugs in
its drawbacks. Indentors were in the dark
19 categories.
the lists were again
about the prices of drugs procured as this
revised in 1996. Another revision took place
was done centrally and bills were sent to the
in 1998 to include 18 new drugs; 12 were
pay and accounts office. By the time drugs
Both
deleted.
from the depots reached hospitals they were
close to their expiry date. Only some drugs
Primary Health Care
were procured centrally. For the rest, the
Cluidelines for treatment at primary
hospitals and the Directorate of Health
health centres were also made making the
work of doctors there much easier. These
included treatment for 15 common diseases
of adults and five of children encountered
by physicians at the centres, a list of essential
drugs and vital information for the patients.
For the first time, all hospitals run by
hospital had to fend for irself. Besides, 10
Services for primary health centres were not
covered under this scheme. Now, a much
more improved system of getting a technical
bid and a price bid in two separate envelopes
ensures that only serious players who fulfil
all criteria are considered. Two to three
suppliers are selected for each drug. Hospitals
could
order
their
supplies
from
these
Delhi Government used the same medicines.
pharmaceuticals. Only those pharmaceuticals
A common pool for procuring medicines
which have a minimal turnover of U.S.
was introduced and was looked after by a
Dollars 1.9 million are considered.
Special Purchase Committee.
An Indian Express report said, “The
confidence the system created among top
I
Procurement of Drugs
drug companies was evident in their participation
,,
IVledicines were earlier procured by
in the centralised bidding system.”
indents raised by hospitals. Manufacturers
supplied drugs to the Medical Stores Depot
For the first time all
hospitals run by Delhi
Government used the
same medicines
a
Meeting of the Special Purchase Committee for the
Procurement of Drugs for Delhi State.
From left: Dr. R.K. Agarwal, Prof. Usha Gupta, Mr. Parmeswar
(Chairman) Prof. Ranjit Roy Chaudhury, Dr. Abha Dhalla,
Dr. Jeevan Jha.
Prayers at the inauguration of the National Workshop on Rational Use of Drugs at the
Christian Medical College, Vellore.
Doctors were
requested
to prescribe
only those drugs on the list. However, the
The confidence
hospitals were given some leeway as they
could prescribe drugs outside this list upto
the system created
among top drug
companies
10 percent of their budget.
Keeping Up Quality
(Quality of the drugs was also ensured
by inspection of pharmaceutical factories
was evident in
where parameters such as facilities, competence
their participation
were considered. A panel of 12-15 experts
of staff employed, hygiene, equipment etc.
carried out the inspections in batches of
in the
two. Out of the 27 factories inspected, 20
centralised
was also carried out to make certain that
passed the test. Random checking of samples
sub-standard drugs were not purchased.
biding system
B
The Government is constructing a State Drug Authority
at Karkardooma which will be responsible
for procurement, storage and distribution of drugs.
Availability of Drugs
Researchers also kept monitoring the
setting up of a State Drug Authority at
Karkardooma, construction of which has
already commenced. It will be responsible
availability of medicines to hospitals. Doctors
for procurement, storage and distribution
were given training in rational prescribing.
of drugs. Modern techniques of storage and
Publications such as “Delhi State Essential
inventory control are in the offing.
Drugs Formulary,” “List of Essential Drugs
for Delhi Hospitals” provided a wealth of
Money Savers
information to the doctors. Listed in the
TThe above mentioned measures saw a
formulary publications were the category of
drugs, cautions, contraindications, side effects,
sharp plummeting in . the prices at which
dosage etc. More training courses for doctors,
these essential drugs were being obtained-
pharmacists and nurses are on the anvil
(See Table
during 1999. The government has also approved
reduced the cost of the medicines.
1).
Buying in bulk naturally
Table 1 : Comparative prices in rupees at which drugs were purchased
A
B
Syrup Amoxicillin
11.4
7.5
Injection Cloxacillin
13.5
4.7
Tablet Erythromycin 250 mg
5.7
1.5
Syrup Erythromycin
20.8
9.8
Injection Amikacin 500 mg
92.8
23.6
A — Drugs obtained by a national drug procurement agency.
B — Drugs obtained by Delhi State by pooled procurement and selective tender.
Dr. Harsh Vardhan, Minister of Health,
Delhi State & Dr. Halfdan Mahler, former
Director General, WHO, during the latter’s
visit to the Delhi Society for the Promotion
of Rational Use of Drugs.
uDr. Mahler initiated the WHO Programme*
of Rational Use of Drugs & Dr. Harsh
Vardhan initiated the programme In India
Availability of Drugs in
Delhi Hospitals
A
warming and were along expected lines.
Whereas 70- 90 percent of drugs prescribed
by hospitals of the Delhi government were
total of six hospitals were studied
actually given to the patients, corresponding
to see the availability of drugs and patterns
figures for Central Government hospitals
of drug use. Four of these were run
by the
were a dismal 15 percent. This goes to show
two by the
the high figure of drugs actually reaching
Delhi state government and
central government. The results were heart
a
the needy patients-See Table 2 below.
PROGRAMMES IA STATES
The rational drugs programme is being
Pradesh, Andhra Pradesh, Gujerat and Bihar.
implemented
in
Maharashtra,
Rajasthan,
Himachal Pradesh and West Bengal. Programmes
Supportive programme are being conducted
in Tamil Nadu and Punjab.
will soon be initiated in Haryana, Madhya
Participants at the Coordination Meeting of the
Rational Use of Drugs in States - Delhi,
Maharashtra & Rajasthan.
MAU UtASHTItA
T. he programme was launched in July,
were taken, (a) Morbidity data from the
1998, with a workshop. It was introduced
three teaching hospitals, two peripheral hospitals
in the Municipal Corporation of Mumbai
and 20 dispensaries and nursing homes was
which has three medical colleges, five specialised
taken,
hospitals, 14 primary health centres, 162
^health post and 176 dispensaries. The Delhi
based on this morbidity data were prepared.
Model was sought to be replicated here. To
standard treatment schedule has been prepared.
(b)
Standard treatment guidelines
(c) A list of essential drugs based on the
develop a list of essential drugs three steps
Prof. Ranjit Roy Chaudhury lighting the ceremonial
lamp at KEM Hospital, Mumbai, Maharashtra.
A list of essential drugs based
on the standard treatment schedules
has been prepared
RAJASTHAN
Dr. Uma Tekur and Prof. Usha Gupta handing
over cheque to Prof. Rameshwar Sharma
(Coordinator Rajasthan) for activities in rational
use of drugs.
1
rational drug use programme
to motivate prescribers towards the rational
was launched here in 1998. It included a
use of drugs. In addition about one hundred
he
selection of essential drugs and training of
new entrants to the Rajasthan Medical Service
doctors. A two-day course for 30 medical
were exposed to the concepts of rational use
experts took place which mainly focused on
of drugs.
educational and persuasive intervention strategies
HIMACHAL PRADESH
1998
saw the birth of the programme
Director of Health Services, doctors and the
in this hilly state. A workshop held on 9th
Drugs
and IOth November’98 was well attended
of
by the Health Minister, Minister of State,
a meeting
health personnel, the Secretary of Health,
27th March,
Controller
essential
drugs
held
of
the
was
A
up
at
26th
and
at Shimla on
1999.
The course focused on educational and persuasive
intervention strategies to motivate prescribeers towards
the rational use of drugs
8
list
state.
drawn
Mr. R. Parameswar, Mr. Mohan Lal, Minister of
State for Health, Dr. Jagat Prakash Nadda,
Minister for Health, Himachal Pradesh, Dr
Ranjit Roy Chaudhury, President DSPRUD &
Dr Joshi.
e
WEST BENGAL
TTlie programme was introduced at
1999 and a comprehensive plan to implement
Calcutta in November 1998.
Discussions
were held with teachers in medical colleges
rhe policy at the panchayat and district level
will be made.
and officials. Workshops will be held in
Dr.
K.
Kafle
addressing
participants at the WHO INRUD - DSPRUD Training
Course in Rational Use of Drugs.
A
TRAINING ABROAD
W1I0/INRI D/DSPRUD
TRAINING COURSE
Several teachers at medical colleges
training course for 34 participants
and specialists were sent abroad under the
13 states was held at New Delhi in
umbrella of WHO to widen their perspective
December 1998. The training focused on
on rational drug policy. The centres included
methods
Aberdeen, Groningen, Pretoria, Geneva and
from
use,
of studying inappropriate drug
identifying
problems
involved
in
prescription, dispensation and consumption
of drugs.
London.
IIMW WWIMt HR
HEALTH PMSSHK
ON
RATIONAL DRUG USE
* - *13 FEBRUARY, i©£>©
12
SPONSORED BY=WHO ESSENTIAL DRUG PROGRAMME, DSPRUD,
UCMS & G.T.B. HOSPITAL. PELHI
Dr. Uma Tekur addressing the Training Programme for Health Professionals on Rational Drug Use
Ise of Media
F
whose “success has been commended by the
WHO as a positive initiative for delivering
or any message to reach a wider
audience, the role of the media is crucial.
Here too TV and press coverage were good
and led to a growing awareness among the
public who became convinced of the efficacy
of this drugs programme.
effective health care.... the fact that drug
prices have shot up several fold following
introduction of the economic liberalisation
in the past few years.... further added to the
importance of the initiative.” Indian Express
said, “It is a common sense solution to a
An editorial in the Hindustan Times
called the Delhi Model a ‘Healthy Model’
chronic malady of our healthcare delivery^
system.”
The programme would like to acknowledge the financial and technical contribution
of the WHO Essential Drugs and other Medicines Department (EDM).
The Indian Express said,
“It is a common sense solution to a chronic malady
of our healthcare delivery system.”
1
REQUIREMENTS FOR SUCCESSFUL
PROGRAMMES IN
RATIONAL USE OF DRUGS
POLITICAL WILL
ENLIGHTENED
BUREAUCRACY
PROFESSIONAL
EXPERTS
1
w
Delhi Society for Promotion of Rational Use of
National Institute ol Immunology
Aruna Asaf All Marg, New Delhi-110067
egs
IMPLEMENTATION
OF A PROGRAMME
55
RATIONAL USE OF
DRUGS
DELHI STATE
RANJ1T ROY CHAUDHURY
UNESCO Chair, Rational Use of Drugs
The College of Public Health, Chulalongkorn University
Bangkok, Thailand
Appeared in International Use in Rational Use of Drugs (1996) Vol. II, 108-123
published by Chulalongkorn University, Bangkok, Thailand
IMPLEMENTATION OF A PROGRAMME OF
RATIONAL USE OF DRUGS IN DELHI STATE
RANJIT ROY CHAUDHURY
UNESCO Chair, Rational Use of Drugs,
The College of Public Health, Chulalongkorn University,
Bangkok, Thailand
INTRODUCTION
In 1993 the National Capital Territory of Delhi became, by Act of Parliament,
a state and Dr. Harsh Vardhan joined as Minister of Health and Family Welfare of
the new State in December 1993. immediately after assuming office he visited a
large number of hospitals and health centres in Delhi and discussed with the
patients and public the difficulties they had encountered and the problems they
faced. He was very disturbed about the prevailing situation regarding the availability
and use of good quality medicines. His feelings at that time are described in his
Foreword to the publication, “List of Essential Drugs for Hospitals in the National
Capital Territory of Delhi'.” He says, "One of the first things which struck me was
the chaotic situation regarding the availability of medicines at these hospitals. At
nearly every hospital I visited there were complaints from the patients that drugs
were not available. Other complaints were related to the quality of drugs, the
system of procurement and distribution of drugs and the information provided to
the patients about the drugs. Every hospital had its own list of drugs, medicines
were coming to the hospitals in many different brand names, the supply was
erratic and the prescribing, very often, unrestrained. What made the situation more
disturbing was the fact that a large percentage of the health budget is spent on
medicines. It has been calculated that about 30-35% of the national health budget
of the country is spent on medicines. In spite of this, a regular supply of good
quality drugs to the patients was not achieved and the patients and the public,
notwithstanding the other care received at government hospitals, became dissatisfied
and critical of the facilities and of the doctors because of the lack of drugs.”
The Govt, of Delhi decided therefore to launch a programme of rational use
of drugs in the state along the lines recommended by the World Health Organization
Programme of Rational Use of Drugs2'3. The writer was invited to be the Adviser
to the Government of Delhi on Drug Policies and a network of academicians,
clinicians, and public health personnel worked closely with the government officials
in developing and implementing a programme of rational use of drugs. This paper
describes the changes introduced in the last twenty four months and the results
obtained. At this time, June 1996, all hospitals in Delhi State have obtained the
same common list of medicines. Instead of procurement of medicines by different
hospitals, pooled procurement of these medicines has enabled the government to
obtain drugs at about 30% of the rates being paid by other government agencies
for the same drugs. A system of inspection for Good Manufacturing Practices and
for random testing of samples has been set up thus ensuring the quality of the
drugs received. Programmes for the training of the doctors in rational prescribing
and for providing information to the patients about the use of medicines are under
way. At the moment there does not appear to be any shortage of essential drugs
in the hospitals. Newspaper headlines which used to appear in the national press
about shortage of medicines in Delhi State hospitals have disappeared. On the
contrary if hospitals were thought not to be following the new guidelines they were'
faulted in the press4.
DELHI STATE
Delhi State has an area of 1483 sq.km. The population is 14 million out of
which 89.9% are classed as urban. Unfortunately Delhi has different health systems
operating in the city. The majority of hospitals are run by the State of Delhi. There
are other hospitals in the public sector run by the Central Government and the
New Delhi Municipal Corporation. This programme relates only to those hospitals
and health centres run by the State of Delhi. There are two teaching hospitals
attached to the Maulana Azad Medical College and the University College of
Medical Sciences, fifteen other hospitals, and 158 health centres. The total number
of beds in all Delhi State Hospitals are 4078 while 3,902,379 patients are seen
yearly in the Out Patients Departments of these hospitals. All medicines are supplied
free by the government to all persons attending the hospitals - irrespective of
whether they are from Delhi or from the states of Punjab, Haryana, Rajasthan, or
Uttar Pradesh.
DRUG POLICY STATEMENT
In April 1994 the State of Delhi issued a Drug Policy Statement5 of the
government which had been approved by the Cabinet. This Drug Policy would
endeavour, it was stated, to attain the following:
1.
availability of safe and effective drugs at all hospitals and health centres,
2.
establishment of a good quality control and assurance system,
3.
an improved system for pooled procurement, storage, and distribution of
drugs,
4.
prescribing of drugs by generic names,
5.
strengthening the health education programmes regarding the use of
drugs and
6.
research on all aspects of drug use.
The Drug Policy Statement also listed the series of steps which would be
taken to implement the drug policy and achieve the objectives outline earlier.
These steps were:
i
1.
selection of one common list of essential drugs for all hospitals in Delhi
State
2.
pooled procurement of drugs for all hospitals in the state by a method
which would help in obtaining only good quality drugs'
3.
preparation of a Delhi State Formulary
4.
setting up a system of inspection of pharmaceutical houses for Good
Manufacturing Practices
5.
setting up a system of testing drugs for quality at selected laboratories
6.
setting up a training programme for doctors in rational prescribing
7.
providing objective, up-to-date information about drugs to doctors and
other health personnel
8.
preparation of standard treatment schedules for those drugs being used
at the primary health centres
9.
ensuring that ethical criteria for drug promotion and advertising are
observed and
10.
providing information to the patients about the medicines they are being
asked to take.
■
*
PRE-IMPLEMENTATION VISIT TO ALL HOSPITALS
#)i
A team consisting of the writer, Prof. J.S. Bapna, Director, Institute of Human
Behaviour and Allied Sciences, Prof. Usha Gupta and Dr. Uma Tekur was formed
to visit every hospital in Delhi State and document the problems being faced at
these hospitals regarding medicines. At the same time the new drug policy of the
government was fully described. These visits were very useful in enabling the
doctors who would be using the new system to know more about the system and
to ask for more information on any aspect of the system about which they had
doubts. It became very clear that the doctors were very unhappy about the prevailing
system for different reasons. Some of the weaknesses pointed out by the doctors
were:
1.
many drugs required to be prescribed by them were not available
2.
the hospitals had been sent drugs not required by them
3.
combination of drugs was being supplied when unnecessary
4.
in many hospitals, traditional medicines were being supplied when these
had not been asked for, were not needed, and would never be used
5.
drugs required were in short supply, thus patients had to purchase the
drugs prescribed from outside the hospitals
6.
sometimes the drugs supplied had only a few months to go before the
expiry dates became operative and these drugs could not be used before
these dates
7.
the quality of the drugs was questionable and there was no regular
system for checking on the quality of the drugs supplied
8.
the patients were given drugs to take while knowing very little about
these drugs, when to take them, at what dose etc.
LIST OF ESSENTIAL DRUGS
The cornerstone of the new Drug Policy of Delhi State is the List of Essential
Drugs. Thus, the first step taken was to prepare such a list. A Committee for
Selection of this List was constituted. It was made up of clinicians, pharmacologists,
microbiologists of the concerned hospitals, other leading experts from outside the
Delhi State Hospitals and the Drugs Controller of India, the Drugs Controller, and
the Director of Health Services of Delhi State. Prof. J.S. Bapna was appointed
Chairman of this committee. After considerable discussions, taking into account all
points of view, this List was prepared and widely circulated.
The List was printed on the 2nd of September 1994 and contains both a list
of drugs for Out Patients and for In Patients. The medicines available for the Out
Patients, 177 in number, would also be available for the In Patients. The total
number of drugs for the In Patients came to 275 drugs. In addition there are
fourteen vaccines out of which only seven are available for the Out Patients. Also,
there are twelve solutions for correcting water and electrolyte balance.
Several countries and hospitals have lists of essential drugs but in only a few
countries are these lists enforced to introduce changes in drug policy such as was
done in Iran6 and Bangladesh7. It was essential therefore to take steps to use the
list of essential drugs developed at Delhi. Immediately after the list was distributed
to all hospitals they were asked not to procure any drugs outside the list except
for 10% of the budget spent on drugs which was decided earlier. Any infringement
of this order issued by the Minister of Health and Family Welfare in June 1995
would be looked into carefully. This change from obtaining drugs without any
common list to obtaining those only on the list was carried out even before the new
procurement system had been introduced. It was so done to convince the prescribers
that once a common list had been prepared by them it was important not to
prescribe any more drugs outside this list as that would be irrational. A further List
of Drugs to be used at the Primary Health Centre and Dispensary level has also
been prepared, which contains seventy five drugs. Only these seventy five drugs
are being supplied to these primary health centres and dispensaries, thus they
have to use only these drugs. Standard Treatment Schedules being prepared for
use at this level and dealing only with these limited drugs will be described.
The Selection of the Essential List of Drugs is a dynamic process and already,
before the second procurement cycle begins, meetings have been held to modify
the first list as necessary. Some drugs from the first list have been dropped because
the committee felt there was no need for them. Others were dropped because they
were not available in the market.
The only change made during the implementation of this programme from
what was stated in the Drug Policy Statement was that for one highly specialized
hospital in the Delhi State the quantum of drugs to be purchased outside the list
was raised from 10% to 20% in view of their need, in limited quantities, for special
drugs for high sophisticated procedures. Experience in limiting prescribing to the
drugs on the list is most satisfactory - drugs not on the list are not obtained and
not available at the hospitals.
ESTABLISHMENT OF A NEW COMMON PROCUREMENT SYSTEM
The aim of the new procurement system is to ensure that good quality drugs
are procured at competitive prices and that there would be a regular supply of
these drugs so that these would always be available. In an endeavour to attain
these goals, a Two Envelope Selective Tender System was put into place which
would eliminate those suppliers who may not have the necessary infrastructure
and back up to supply, whenever needed, the drugs required. This system is a big
change from the open Tender System used earlier when any pharmaceutical house
or agent could quote for supplying drugs. The procedure followed is outlined below.
Details are not given due to space limitation but could be obtained if necessary
from the author. All these activities were monitored by a Special Purchase
Committee under Mr. C.R. Vaidyanathan, a former Secretary of the Dept, of Health
and Family Welfare of the Government of India. The committee had, not only the
Secretary of the Department of Health of the State Government, but also the
Secretaries of the Departments of Finance and Law as its members.
1.
Quantification of Drugs Needs
The quantity of each of the drugs on the Essential List of Drugs which would
be required for one year for all Delhi State Hospitals was calculated by looking at
the last three years use of each of these drugs. Although it was not very accurate
as the earlier figures appeared to vary sometimes between the years this method
for calculating the drug requirement was used rather than the method based on
Standard Treatment Schedules suggested by WHO8. This was because no standard
treatment schedules are yet being followed.
2.
Criteria for Tender Forms
A special sub-committee for preparation of the new tender forms was set up
with Mr. R. Parameswar, a former Deputy Auditor General of India, as Chairman.
After seven meetings of the main Special Purchase Committee and six meetings
of the Sub-Committee the four tender documents were approved. These consisted
of:
1)
Form CPA-1 - a proforma for the technical bids i.e. for pre-qualification
of the manufacturer whose price bids would be opened.
2)
Form CPA-2 - a proforma for price bids in which the tenderer would
tender price bids
3)
Document CPA-3 - containing general conditions for the purchase of
drugs and chemicals on a running rate contract and
4)
Document CPA-4 - containing instructions for the rate contract holders.
The system set up a list of criteria which had to be fulfilled when the Technical
Bid (Form CPA-1) was scrutinized. The Price Bids of only those firms which fulfilled
these criteria were opened. The CPA-2 - i.e. price bids of those who did not fulfill
the criteria were returned together with the earnest money.
It is not possible to list all the information gathered from the technical bid.
This related to General Information, Technical Information, and Information relating
to Financial Aspects. Twenty columns had to be filled out.
There were nine criteria which had to be fulfilled. These related to the legal
standing of the manufacturer, the facilities available, the quality of staff in position,
and the annual turnover. Firms with a turnover below a certain level were not
considered.
In this particular exercise the total number of bids received were one hundred
and twenty four. Eighty bids were rejected as the technical data supplied did not
fulfill all the criteria. Only tenders from forty four firms were opened and evaluated
for price by the Special Committee. It is beyond a doubt that this system helped
to obtain drugs of good quality.
3.
Selection of Firms and Placement on Rate Contract
Once the price tenders were opened the Committee usually selected the
pharmaceutical firm which quoted the least for a particular drug. Since it had been
decided to have at least three firms on the Rate Contract for each drug the two
firms which were quoting higher than the lowest tenderer were contacted by the
governmental department concerned and asked whether they would be willing to
supply the drugs at the price offered by the lowest tenderer. In most cases these
firms agreed and the rate contract therefore had three firms willing to supply the
drug at the same price. A Rate Contract list of firms for each of the Essential
Drugs was drawn up and sent to all the hospitals which were asked to order
directly from the firms on the Rate Contract. It was expected that orders would be
placed on all three firms. The hospital authorities have ordered these drugs and
these have been supplied. As stated earlier there is no shortage of essential drugs
at the moment, but there are problems regarding drugs for which there are no
quotations or only one quotation. These will be discussed later when discussing
the problems encountered in implementing this new drug policy. The essential
features of the new system for procurement are therefore:
1)
pooled procurement for alt hospitals
2)
quantification of drug needs
3)
a two envelope system of selective tenders
4)
selection of the lowest tenderer of those which has qualified
5)
negotiation with other tenderers to reduce quotations
6)
preparation of a rate contract which was sent to all hospitals with three
suppliers for each drug
7)
making sure hospitals ordered drugs direct from the firms on the rate
contract.
QUALITY CONTROL AND ASSURANCE
A system for ensuring that only good quality drugs are supplied by Delhi
hospitals has been set up by Dr. R. Pabrai, former Director - Drug Control
Laboratories Ghaziabad of the Govt, of India and is being implemented by the
Director of Health Services and Drugs Controller, Delhi State. The two mechanisms
being used are inspection of facilities to see if Govt. Manufacturing Practices are
being followed and random sampling of the drugs being obtained at selected
laboratories.
GOOD MANUFACTURING PRACTICES (GMP)
A team of experts in GMP has been formed and members of the team have
visited and inspected suppliers to see if GMP is being followed. Up until now all
the pharmaceutical concerns inspected have passed this evaluation although in
several instances suggestions for improvement have been made by the team.
These inspections are carried out according to the recommendations of the World
Health Organization.
Samples obtained from firms supplying the drugs are sent for quality control
testing according to WHO specifications9 at specially selected laboratories from
the private sector. These laboratories send in their reports within a week and they
are paid speedily for their services. It is important to ensure that rapid payments
are made. As of now all drugs sent for analysis have shown they are of the
standard expected quality. In one particular case it was suggested that the price
at which Diazepam was obtained was so low that the quality and quantity of drug
would be found wanting. An independent test by a selected laboratory has clearly
demonstrated that the quality and quantity of drug is up to the standard required.
A system has been worked out by the Committee to ensure that GMP inspections
and random screening is carried out. throughout the year. The importance of
continuing this programme cannot be overemphasized. Not only will this act as a
deterrence to being supplied inferior drugs but the results of these analysis will
help to convince doctors and other health administrators that although these drugs
have been obtained at low prices, their quality is still up to the standard required.
All doctors at all hospitals have been informed that facilities for quality control of
drugs exist and that they are welcome to use these facilities whenever they so
desire.
PRESENT SITUATION - JUNE 1996
Two important changes have already been introduced in the programme of
rational use of drugs in Delhi State. These relate to 1. Introduction of a pooled
procurement system of drugs 2. Establishment of a system for Quality Control
and Assurance of the drugs being used.
There are two remaining areas which remain to be tackled and which are as
important as those already effectively introduced. These are to (1) Ensure rational
prescribing by the doctors and paraprofessionals and to (2) Ensure proper
compliance by the patients by providing them information about the use of drugs.
Several steps are being taken at this time to introduce mechanisms to attain
these two objectives. These will be briefly described below.
RATIONAL PRESCRIBING BY DOCTORS AND PARAPROFESSIONALS
An orientation talk has already been given to doctors at all hospitals on
Delhi's new drug policy - its advantages and benefits. This is going to be followed
up by a Training Course on Rational Prescribing to the doctors and an Awareness
Programme on Rational Use of Drugs for all members of the faculty This will be
carried out along the lines already developed for such programmes10. The List of
Essential Drugs, already prepared and distributed will be instruments which will be
used for this. Several other instruments are also being prepared.
1.
Delhi State Drugs Formulary
A Delhi State Drugs Formulary is being prepared and will be made available
to all doctors in the government services of the State of Delhi. If funds become
available these will also be made accessible to doctors in the private sector. There
will be a one page description under each of the Essential Drugs listed. The
information contained will be:
Category of drug
Indications
Cautions
Contraindications
Side effects
Drug interactions
Dosage forms
Dosage
The Formulary is being compiled and should be ready by October 1996. The
importance of such a Formulary in developing a programme of rational use of
drugs has been described fully elsewhere”. A large Formulary Committee of experts
with the writer as Chairman is monitoring the writing of the Formulary.
2.
Standard Treatment Schedules
A document containing Standard Treatment Schedules for Primary Health
Care and Dispensaries is being prepared and will be ready by October 1996. It will
deal with all the common illnesses and symptoms of diseases seen at the primary
health care level. There will be three sets of information for each condition. These
will pertain to:
1)
Diagnostic Information
2)
Therapeutic Information and
3)
Patient Information
The drugs mentioned will be only those which have been included for use in
the list of drugs for primary health care and dispensaries. The Schedules have
been prepared according to the recommendations of an intercountry meeting held
in Bangkok in 1993'2
3.
Delhi State Drugs Information Newsletter
To initially bring objective unbiased information on drugs to all doctors in the
State health service and eventually to all doctors in Delhi it was proposed to bring
out a quarterly publication called Delhi State Drugs Information Newsletter. This
will be along the lines of earlier similar publications started by the writer - the
Drugs Bulletin of the Postgraduate Institute of Medical Education and Research
Chandigarh and the EMRO Drugs Digest of the Eastern Mediterranean Regional
Office of the World Health Organization at Alexandria, Egypt. It is expected that
wide dissemination of a publication of this type will encourage rational prescribing.
The importance of such bulletins in influencing prescribing behaviour particularly
in developing countries has been recently emphasized'3.
PROVIDING INFORMATION TO PATIENTS ABOUT USE OF DRUGS
Patients need know about medicines if they are to use them better. Such
information, it is expected, will enhance compliance, reduce wastage and ensure
more effective use of medicines. At the present time an exploratory survey suggests
that patients know very little about the medicines they are given. A programme for
imparting carefully prepared, well selected information about medicines will be
initiated first at the L.N.J.P. Hospital and depending on the results obtained will
then be started at all hospitals and health centres of the state. The programme is
being put together now. The tools being considered for this programme include the
development of a Drug Information Kit, a one page pamphlet on drug use, setting
up an Information Counselling Desk for patients, closed circuit television, posters,
hoardings, and distribution of Lists of Essential Drugs and List of Prices of Drugs.
Several of these measures have been shown to improve use of medicines'4.
RESEARCH ON IMPACT OF THE INTERVENTION PROGRAMMES
A baseline survey on drug use at L.N.J.P. Hospital has already been carried
out for a few months after introducing the concept of essential drugs and common
procurement of drugs. This study has yielded some very interesting information.
Two new intervention studies - i.e. training of doctors and paraprofessionals and
provision of information about drugs to patients are now being initiated after the
baseline studies have been completed. A post-intervention study on drug use will
be carried out a year after introducing these two programmes. The results obtained
then will indicate whether providing training to doctors and information to patients
has indeed improved both prescribing practices and the more rational use of drugs.
RESULTS OF INTRODUCING THE CONCEPTS OF ESSENTIAL DRUGS AND
POOLED PROCUREMENT
There have been two remarkable results of introducing the concepts of
essential drugs, preparation of a list of essential drugs and pooled procurement of
the drugs on the list. (1) There has been an increase in the availability of the
essential drugs (2) The drugs have been obtained at an unexpectedly low
cost. Several of these drugs have been tested for quality and were all up to the
standards required. This has resulted in considerable savings of the budget used
for drugs, thus a greater quantity of drugs can be purchased inevitably resulting
in a greater availability of drugs.
Increased Availability
There is at the moment no shortage of drugs and as time goes on it is
expected that more and more drugs of good quality will become available.
Drugs Obtained at Low Cost
The low cost of the drugs procured has been a matter of some surprise and
great satisfaction. When launching the programme the Minister of Health and
Family Welfare made a statement to the press15 that common pooled procurement
of drugs would enable us to obtain drugs at prices about 30% lower than the prices
one would normally obtain the drugs. However for several drugs the reduction in
price is greater. Table 1 shows the comparative prices for the same drugs obtained
by four different means by different government agencies. The prices of drugs
Table 1. Comparative prices at which drugs were purchased - 10 examples
(in Rupees)
A
B
C
D
Syrup Amoxicillin
14.65
23.10
11.45
7.50
2.
Injection Cioxacillin
8.19
19.22
13.50
4.79
3.
Tablet Erythromycin 250 mg.
3.24
3.75
5.78
1.54
4.
Syrup Erythromycin
12.95
26.00
20.80
9.80
5.
Injection Amikacin 500 mg.
47.88
68.00
92.85
23.61
6.
Tablet Ciprofloxacin 250 mg.
1.85
4.25
2.88
1.36
7.
Tablet Norfloxacin 500 mg.
2.18
3.75
4.09
1.22
8.
Tablet Atenolol 50 mg.
0.42
0.50
0.55
0.17
9.
Injection Ranitidine
1.87
3.80
4.25
1.63
10.
Injection Diazepam
5.53
7.70
5.20
0.93
Number
Name of Drug
1.
A B C D -
Drugs obtained by a government agency by Open Tender
Drugs obtained by a government outlet for selling to the public
Drugs obtained by a national government drug procurement agency
Drugs obtained by Delhi State Govt, by pooled procurement and selective
tender.
obtained by a government agency by means of open tender (A), by a government
outlet for selling to the public (B), and by a national governmental drug procurement
agency (C) are compared with the prices of drugs obtained by the Delhi State
Government by means of pooled procurement and selective tenders (D).
One tablet of 50 mg of Atenolol cost 42 Naya Paise through Open Tender,
50 Naya Paise at the government outlet, 55 Naya Paise at the national drug
procurement agency, and only 17 Naya Paise when purchased through the Delhi
State System.
One ampoule of 2.0 ml of Diazepam (5 mg/ml.) costs Rupees 5.53, Rs. 7.70,
and Rs. 5.20 at the three other centres while it costs only 0.93 Naya Paise i.e. less
than Rupee one when purchased through the Delhi State System. The drug was
tested for quality and was found to be up to the standard.
One hundred Naya Paise make one Rupee and one dollar is equivalent to
approximately thirty Rupees. The magnitude of the savings for all the drugs can
be imagined. The savings are used for purchasing more of these drugs for the
hospitals.
A third beneficial result of this programme is that the quality control system
is working, for both drugs are being tested for quality and pharmaceutical factories
are being inspected for Good Manufacturing Practices.
RESULTS OF BASELINE STUDIES AT L.N.J.P. HOSPITAL
Some very interesting information has been obtained from the baseline studies:
33% of the budget for drugs is spent on ten drugs while 80% of the budget is spent
on only sixty-five drugs. The remaining 20% of the budget was spent on 210
drugs. So naturally, the training programme for both rational prescribing and
providing information to patients will concentrate on these sixty five drugs.
The information about prescribing patterns is given below in the form
recommended by the World Health Organization to assess rational drug use16
Average number of drugs prescribed per encounter - 3.2
Percentage of drugs prescribed by generic names - 44.6
Percentage of drugs prescribed from the Essential Drugs List - 84.1
Percentage of encounters with injectables - 23.7
Percentage of encounters with combination drugs - 20.1
Percentage of encounters in which the patient has a complete understandina
of drugs - 39.1
M
Percentage of times when dispensed drugs were labeled - 55.5
Another survey will be conducted a year after the two intervention modules
are introduced for the whole year - training of doctors and nurses and providing
information to the patients. The results of this baseline survey clearly indicate that
the understanding of the patients about drugs is very poor.
PROBLEMS ENCOUNTERED
A review of the Delhi State endeavour to introduce a programme of rational
use of drugs will become more valuable to readers if the main problems encountered
are discussed. The means whereby we are attempting to overcome these problems
may also be of some interest.
LIST OF ESSENTIAL DRUGS
Specialized hospitals and clinical specialists feel that the List of Essential
Drugs is not large enough for their specialist needs. As a concession to such
thinking one specialist hospital was allowed to spend 20% of its budget purchasing
drugs outside the list. It is very difficult to convince specialists that the List of
Essential Drugs is adequate. It should be mentioned that several drugs on the list
have been marked by an asterisk. This means that particular drug should be
prescribed with circumspection either because it is an expensive drug or its use
is for a very limited number of conditions. Each hospital should plan how these
specially identified drugs should be prescribed.
PROCUREMENT OF DRUGS
There were some drugs for which no quotations were received because either
the requirements were very low or no pharmaceutical firm manufactured them.
Since these drugs are presumably needed the only way to obtain these medicines
was to contact the manufacturers and negotiate an agreement for supply of these
drugs.
Another problem is encountered when a firm that has been put on the rate
contract is not able to supply the drug when the ordered due to possibly an
inadequate infrastructure or an insufficient profit margin. Although such a firm is
then blacklisted for future orders and the earnest money forfeited this does not
resolve the problem of obtaining the much needed drugs immediately. Fortunately
the Rate Contract would contain names of other firms from where the drugs could
be obtained. In our first round of procurement there was one firm which was
included in the rate contract for many drugs, but when drugs were ordered by the
hospital, the firm did not supply even one drug. Hospitals lose confidence in the
system when this happens.
A firm like this should not have passed through the Technical Bid. Unfortunately
the information provided in the Technical Bid was accepted without a site inspection
or checking what had been stated. Where there is suspicion a site visit should be
organized before putting such a firm on the Rate Contract.
INELIGIBILITY OF FIRMS WITH A TURN OVER BELOW THE QUALIFYING
LIMIT
Several small firms have argued that if they become ineligible because of a
low turnover they will be put out of business. It was explained to them that a cut
off point in turnover was kept so that we could be certain that the firms on the rate
contract list would always be in a position to supply the medicines. At this time,
we can not put their, minds at ease.
SUCCESS OF THE PROGRAMME
Up until now this programme appears to have been successfully planned and
implemented. Other states in India have also taken up this model and adopted the
List of Essential Drugs. The World Health Organization has recognized this
endeavour by bringing out an article 17 under the heading. “Delhi leads the way
with new drug policy.” A National List of Essential Drugs for the whole country has
now been prepared and the Delhi State List was used as one of the lists from
which the national list was prepared.
The programme could achieve what it has been able to do in such a short
period because of the political will of the government, the dynamic leadership
provided by the Minister of Health and Family Welfare, and the dedication and
close involvement of the permanent government officers who implemented the
programme. This included great managerial strengths provided by the Principal
Secretary of the Department of Health, the Director of Health Services, the Assistant
Director in charge of Procurement and her staff, the Drugs Controller and Deputy
Drugs Controller and their staff, and the superintendents of all the hospitals
particularly L.N.J.P. Hospital.
Finally the third side of the triangle was completed by a complementing group
of outstanding experts and advisers who both shared their tremendous expertise
and gave liberally of their time to make this programme a success. The team work
between the Minister and his staff, the enlightened beauracracy, and the dedicated
experts and advisers made it all possible.
ACKNOWLEDGMENTS
I would like to acknowledge the help of the following people for enabling this
programme to be initiated and implemented - Dr. Harsh Vardhan, Mr. Ramesh
Chandra, Dr. S.K. Chaudhuri, Dr. Ava Dhalla, Dr. L.L. Agarwal, Mr. P.P. Sharma
Mr. Sinha, Mr. D.N. Singh, Prof. J.S. Bapna, Prof. Usha Gupta, Dr. Uma Tekur, Dr.
N. Tiwari, Mr. C.R. Vaidyanathan, Mr. R. Parameswar, Dr. P. Das Gupta, Dr. R.
I.
Pabrai, Dr. J.L. Kaul, Mr. M.C. Mehra, Prof. K.B. Sharma, and Dr. Ajay Kumar.
I would also like to acknowledge the help received from the World Health
Organization (Dr. Helling Borda, Dr. Pascal Brudon and Dr. Hans Hogerzeil), the
UNICEF (Dr. Jon E. Rohde), A.F. Ferguson & Co. (Ms. Poonam Khanna), and
Ogilvy and Mather Public Relations (Mrs. J. Ghosh).
REFERENCES
1.
Harsh Vardhan. (1994) Foreword to List of Essential Drugs for Hospital in the
National Capital Territory of Delhi, New Delhi.
2.
WHO Technical Report Series Number 850. (1995) The Use of Essential
Drugs. World Health Organization, Geneva.
3.
Nakajima H. (1992) How Essential is an Essential Drugs Policy. World Health
Organization, March-April 3.
4.
Rajalakshmi TK. (1995) GTBH Purchase Department Flouts Norms to Buy
Excess Drugs. The Pioneer, New Delhi, July 23, 1995.
5.
Drug Policy Statement of Delhi State. (1994) New Delhi.
6.
Chaudhury RR, ed. (1994) Rational Use of Drugs in the Islamic Republic of
Iran in International Experience. In: Rational Use of Drugs. Bangkok:
Chulalongkorn University.
7.
Chetley A, and Rohde JE. (1994) National Drug Policies as the first Step
towards Rational Drug Use: the Experience of Bangladesh in International
Experience. In: Chaudhury RR, ed. Rational Use of Drugs. Bangkok:
Chulalongkorn University.
8.
WHO. (1988) Estimating Drug Requirements. A Practical Manual, World Health
Organization, Geneva.
9.
WHO. (1990) Report of Expert Committee on Specifications for Pharmaceutical
Preparations. Technical Report Series 790, World Health Organization,
Geneva.
10.
Bapna JS, Shashindran CH, Venkatadri N, and Oumachigvi Asha. (1987)
Curriculum for Interns on Essential Drugs and Cost Effective Prescribing. Int
J Med Education 26, 17-24.
11.
Petrie JC, and Scott AK. (1987) Drug Formularies in Hospitals. Brit Med J
294, 919.
the information provided in the Technical Bid was accepted without a site inspection
or checking what had been stated. Where there is suspicion a site visit should be
organized before putting such a firm on the Rate Contract.
INELIGIBILITY OF FIRMS WITH A TURN OVER BELOW THE QUALIFYING
LIMIT
Several small firms have argued that if they become ineligible because of a
low turnover they will be put out of business. It was explained to them that a cut
off point in turnover was kept so that we could be certain that the firms on the rate
contract list would always be in a position to supply the medicines. At this time,
we can not put their, minds at ease.
SUCCESS OF THE PROGRAMME
Up until now this programme appears to have been successfully planned and
implemented. Other states in India have also taken up this model and adopted the
List of Essential Drugs. The World Health Organization has recognized this
endeavour by bringing out an article 17 under the heading. “Delhi leads the way
with new drug policy.’’ A National List of Essential Drugs for the whole country has
now been prepared and the Delhi State List was used as one of the lists from
which the national list was prepared.
The programme could achieve what it has been able to do in such a short
period because of the political will of the government, the dynamic leadership
provided by the Minister of Health and Family Welfare, and the dedication and
close involvement of the permanent government officers who implemented the
programme. This included great managerial strengths provided by the Principal
Secretary of the Department of Health, the Director of Health Services, the Assistant
Director in charge of Procurement and her staff, the Drugs Controller and Deputy
Drugs Controller and their staff, and the superintendents of all the hospitals
particularly L.N.J.P. Hospital.
Finally the third side of the triangle was completed by a complementing group
of outstanding experts and advisers who both shared their tremendous expertise
and gave liberally of their time to make this programme a success. The team work
between the Minister and his staff, the enlightened beauracracy, and the dedicated
experts and advisers made it all possible.
ACKNOWLEDGMENTS
I would like to acknowledge the help of the following people for enabling this
programme to be initiated and implemented - Dr. Harsh Vardhan, Mr. Ramesh
Chandra, Dr. S.K. Chaudhuri, Dr. Ava Dhalla, Dr. L.L. Agarwal, Mr. P.P. Sharma,
Mr. Sinha, Mr. D.N. Singh, Prof. J.S. Bapna, Prof. Usha Gupta, Dr. Uma Tekur, Dr.
I.N. Tiwari, Mr. C.R. Vaidyanathan, Mr. R. Parameswar, Dr. P. Das Gupta, Dr. R.
Pabrai, Dr. J.L. Kaul, Mr. M.C. Mehra, Prof. K.B. Sharma, and Dr. Ajay Kumar.
I would also like to acknowledge the help received from the World Health
Organization (Dr. Helling Borda, Dr. Pascal Brudon and Dr. Hans Hogerzeil), the
UNICEF (Dr. Jon E. Rohde), A.F. Ferguson & Co. (Ms. Poonam Khanna), and
Ogilvy and Mather Public Relations (Mrs. J. Ghosh).
REFERENCES
1.
Harsh Vardhan. (1994) Foreword to List of Essential Drugs for Hospital in the
National Capital Territory of Delhi, New Delhi.
2.
WHO Technical Report Series Number 850. (1995) The Use of Essential
Drugs. World Health Organization, Geneva.
3.
Nakajima H. (1992) How Essential is an Essential Drugs Policy. World Health
Organization, March-April 3.
4.
Rajalakshmi TK. (1995) GTBH Purchase Department Flouts Norms to Buy
Excess Drugs. The Pioneer, New Delhi, July 23, 1995.
5.
Drug Policy Statement of Delhi State. (1994) New Delhi.
6.
Chaudhury RR, ed. (1994) Rational Use of Drugs in the Islamic Republic of
Iran in International Experience. In: Rational Use of Drugs. Bangkok:
Chulalongkorn University.
7.
Chetley A, and Rohde JE. (1994) National Drug Policies as the first Step
towards Rational Drug Use: the Experience of Bangladesh in International
Experience. In: Chaudhury RR, ed. Rational Use of Drugs. Bangkok:
Chulalongkorn University.
8.
WHO. (1988) Estimating Drug Requirements. A Practical Manual, World Health
Organization, Geneva.
9.
WHO. (1990) Report of Expert Committee on Specifications for Pharmaceutical
Preparations. Technical Report Series 790, World Health Organization,
Geneva.
10.
Bapna JS, Shashindran CH, Venkatadri N, and Oumachigvi Asha. (1987)
Curriculum for Interns on Essential Drugs and Cost Effective Prescribing. Int
J Med Education 26, 17-24.
11.
Petrie JC, and Scott AK. (1987) Drug Formularies in Hospitals. Brit Med J
294, 919.
12.
WHO. (1993) Report of an Intercountry Meeting on Developing Learning
Materials on Rational Use of Drugs for Medical and Nursing Schools. Bangkok,
Thailand.
13.
Hogerzeil HV. (1994) Promoting Rational Prescribing: an International
Perspective in International Experience. In: Chaudhury RR, ed. Rational Use
of Drugs. Bangkok: Chulalongkorn University.
14.
Soumerai S. (1984) Factors Influencing Prescribing. Australian Journal of
Hospital Pharmacy 18 (Suppl), 9-16.
15.
Times of India. (1995) New Drug Policy Set for Launch by City Government.
February 1.
16.
WHO Report. (1993) How to Investigate Drug Use in Health Facilities: Selected
Drug Use Indicators: WHO/DAP/93, World Health Organization, Geneva.
17.
Essential Drugs Monitor. (1994) Delhi Leads the Way with New Drug Policy.
18,
13.
•P|2. - Cy- •
■ Vi
Q
<X> Z /
---- \ CRITERIA FOR SELECTION OF
>•
manufactures for supply of
MEDICINES TO THE GOVT. OF NCT OF DELFII
7
1.
The manufacturer should have a valid license under the Drugs and
Cosmetics Act for Medicines that he intends to tender for supplies.
2.
The manufacturer should have a turnover of not less than Rs. 8 crores.
3.
The firm should be found satisfactory after inspection by especially
approved inspectors.
4.
The inspectors selected to assess and audit the manufactures’
compliance with Good Manufacturing Practices should be persons with
a high degree of competence and credibility from outside the
Government.
5.
In the interim period, suppliers already on the list would be allowed to
continue supplies but if found unsatisfactory during GMP Inspection,
their names were to be removed from the list.
6.
Random samples picked up by inspectors should conform to approved
standards when tested by one of the specially selected testing
laboratories.
GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF DELHI
CMP Inspection Form
(To be filled by the inspecting GMP experts)
I
Names olThe inspecting GMP experts :
a)
b)
Dates of inspection
Part II: Information to be furnished by the unit to be inspected
Any documents attached must be appropriately cross-indexed or identified by the firm.
All
pages of this part including any attached documents should be signed by firm's representative
and handed over to the inspecting GMP experts.
I
2
Name of the firm
Address of the firm's office
(for correspondence purposes)
Address of the firm's unit or
factory to be inspected
4.
(a) Name of the contact person
(b) Telephone No (Off.)
(c) Telephone No. (Res.)
(d) Fax No.
(e) e-mail
2
(a) Does the firm have any other
Yes/No
additional unit manufacturing
items mentioned in the R/C or
their application
(b) If yes, give address(es) of such
other unit(s)
(>.
Year of establishment
7
Annual turn over of the Company
8
(a) Licencing authority (LA) under
the Drugs & Cosmetics Act
(b) Licence No(s)
(c)
9.
:
:
Valid upto
:
Plan of premises at the time of
granting licence by LA
(Attach line sketches/blue prints
and mark clearly the areas allocated
for various functions)
10.
(a) Any changes made since the
last approval by LA
(b) If yes, give details
(Attach additional sheets, if
necessary)
11.
(a) Total land available for the unit
to be inspected.
(b) Total area utilized for admini
stration. utilities/facilities,
production and quality control
:
Yes/No
3>
-■ 3
Manufacturing aieas allocated
(c)
to various sections
i)
Tablets
ii)
Capsules
iii)
Oral Liquids
iv)
Oral Powders
v)
Injectable preparations
vi)
Ophthalmic preparations
vii)
Any other dosage form
(If yes, name the category)
viii)
Bulk Drugs
(If yes, name the products)
d)
e)
:
Is factory centrally air-conditioned:
If no, indicate areas air-
Yes/No
:
conditioned. Also show clearly
in plans attached against items 9
and 10.
12.
Products with formulae permitted
to be manufactured (list to be
attached by the firm)
13.
Organisational chart of the firm
(Attach separate sheet, if necessary)
14.
(a) Total number of employees
Male
Female
(b) Total number of technical
personnel
Male
Female:
4
15.
Name, qualifications and experience :
of the head of the Production Deptt.
16.
Name, qualifications and experience
:
of the head of the Quality Assurance
Department
17
Name, qualifications and experience :
of the head of the R.&D Deptt.
18
Department-or section-wise list of
technical personnel engaged in
manufacturing/maintenance/quality
control functions (Attach list indica
ting the qualifications, experience and
department/section in which working.
Also indicate the names of the person
nel approved, if any, by the LA)
19.
20.
Does a Quality Policy exist in the
Company? If so, attach copy
:
List of Standard Operating Procedures
(SOPs) followed in the company. (Use
separate sheets, if necessary)
:
21.
List of documents maintained by the
Co. in support of GMP compliance.
(Use separate sheets, if necessary)
(Signature of the person
submitting the information
on behalf of the company)
Name
Designation
Date
GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF DELHI
GMP Inspection Form
Part III
Observations of the GMP Experts
(Record your observations in brief against each parameter
attach separate sheet and cross-link it suitably.
If space is inadequate, please
Observations
I
1.1
Location and environment:
Any source of pollution in the
Yes/No
neighbourhood 9
1.2
Any open drain, or public
Yes/No.
lavatory nearby 9
1.3
Are any products other than
Yes/No.
drugs manufactured in the same
or adjacent building and are
these safe 9
Factory premises:
2.1
Layout and construction
2.1.1
Are materials of const
ruction satisfactory 9
Yes/No
6
Observations
2 I 2
Are buildings and facilities/
Yes/No
utilities properly located and
constructed for smooth
operations and maintenance?
2 1 3
Do adequate measures exist
to check entry of rodents,
Yes/No
insects and birds ?
2 1.4
Are lighting and ventilation
adequate 9
Yes/No
Adequacy of space'
Are sufficiently large and suitably
equipped areas available for:
2 2.1
Receiving and despatching
Yes/No
ofgoods
2.2.1 1 Is a separate dispensing area
provided 9 #
Yes/No
2 2.2
Storage of raw materials (RMs)
Yes/No
2.2.3
Storage of packaging
materials (PMs)
Yes/No
3 Observations
2 2 4
Storage of intermediates or
Yes/No
scmi-liiiishcd pioducls
2.2 5
Storage of finished products
Yes/No
(FPs) before transfer to main
warehouse and distribution
2.2.6
Manufacturing operations for
Yes/No
which the firm is licenced ?
Cleanliness and maintenance:
2 3 1
Are floors, walls and ceilings
Yes/No
properly constructed and easy
to clean, maintain and disinfect ?
2 f 2
Are sewage, trash and other
Yes/No
effluents disposed off
properly ?
2.3.3
Are areas where penicillin,
Cepha or penicilin- or
Cepha-based products are
manufactured completely
separated from areas used
for manufacture of other
products
Yes/No
4
Observations
2 4
Facilities and utilities:
2.4.1
Are air handling units adequate
and properly located and
Yes/No
functional ?
2 4.2
Is air conditioning system
Yes/No
adequate and functional ?
2.4.3
2.4.4
Are steam generation facili
ties adequate and functional ?
Yes/No
Is vacuum system
Yes/No
adequate and functional ?
2.4.5.
Is compressed air system adequate
Yes/No
and properly functioning ?
2.4.6
Is water supply system
Yes/No
alright 9
2.4.7
Is distilled water quality and
supply system alright 9
Yes/No
Observations
2 4 8
Is demineralised water supply
Yes/No
system alright 9
2.4.9
Is standby electrical generation
provided 9
2 4.10 Ate SOI’s in existence lot
Yes/No
Yes/No
regulation of the above actitvities 9
3.
Person nel:
3 I
Are the technical personnel
Yes/No
responsible for manufacturing and
quality assurance functions adequate
in numbers 9
3.2
Does the stalfin the above operations
Yes/No
have adequate qualifications and
experience ?
4.
4 I
Training:
Is personnel engaged in manufa-
Yes/No
luiing, quality assurance, ware
housing, cleanliness and main
tenance operations periodically
trained in accordance with needs ?
4.2
If yes. are any SOPs for training in
existence 9
Yes/No
b
Observations
4 3
Was documentation in support of
sin h liainiiii'. available foi
Yes/No
inspection ? If yes, record youi
observations
Hygiene and health:
5.1
5 2
Are medical check ups conducted:
(a) on entry of personnel
Yes/No
(b)periodically thereafter
Yes/No
Are facilities for changing street
Yes/No
clothes, footwear, washing and
toilets adequate and satisfactorily
maintained
5.3
Are protective steps against likely
Yes/No
damage to health due to occupational
hazards satisfactory ?
(>.
Technical equipment:
Is equipment for each section
adequate
Yes/No
Please record observations
for each section.
Yes/No
Yes/No
7 ■Observations
Are equipments installed in a
Yes/No
mannei that corrosion is avoided ?
0.3
Are the equipments maintained in
Yes/No
a manner that contamination with
lubricants, dirt, etc is avoided 9
0
4
Are records of setting up. main-
Yes/No
tenance and calibration of equipment
kept and available for inspection ?
Ifyes, comment on their adequacy
0.5
Are weighing balances appropriate
Yes/No
to the quantities to be weighed 9
0.0
Aie cleaning SOI’s in existence and
Yes/No
followed 9 Check logs
0.7
Are sequential records of manufactured
Yes/No
batches on an equipment available ?
0 8
Are procedures for line clearance for
product change over adequate
Yes/No
Observations
Is equipment status in terms of'
Yes/No
'( I EAN', 'IN USIA 1 IO Bl. CLEANED'
properly indicated and relevant details
of the product, its batch No etc. noted
on the equipment dining manulacluting
operations ?
7.
7 1
Production or manufacturing:
Is master formula (MF) available
Yes/No
for each product ?
7 2
Does the MF for each
Yes/No
product contain the requit ed details ?
7 3
7 4
Is production carried out in accord
ance with the instructions?
Yes/No
Are batch production records
Yes/No
(BPRs) maintained in accordance
with the MF
7 5
Is each step of manufacture duly
signed/initialled by the operator and the
supervisor in token of compliance with
proper'DOER-CHECKER' drill for
manufacturin'." controls ’’
Yes/No
- 9 •-
Observations
7 <>
Arc alterations Io processes
Yes/No
recorded and authenticated by
competent authorised persons
7.7
Do all containers of active RMs.
Yes/No
excipients and intermediates bear
appropriate labels at all stages of
manufacture 9
If no. give details
7 8
Are only materials, containers and
Yes/No
appliances necessary for the job
in hand stored in the vicinity of the
manufacturing areas and are these
properly labelled with name of the
product, batch No , dates, etc 9
7.9
Ate containers checked for cleanli-
Yes/No
ness and suitability for packaging
before use ?
7. It)
Are containers of intermediates and
FI’s intended for use in the plant or
for transport outside closed in such
a manner that unauthorised inter
ference is not possible (eg by seal
ing. etc )
Yes/No
- 10 -
Observations
7.1 I
Are empty containers freed of old
Yes/No
labels and checked immediately prior
to use ?
7 12
Do all apparatus/equipment bear
Yes/No
appropriate labels to identify the
product for which the equipment
is used, its batch No., date etc. ?
7.13
Are RMs. PMs and solvents used
Yes/No
after approval by the QC Department ?
If no, give details
7 H
Are labels on containers of KMs to
Yes/No
be used in manufacture checked
with regard to identity, quantity
and QA appt oval
If no, give details
7.15
Are all volume and weight
Yes/No
measurements checked by a
second person before use 9
If no, give details
7 lb
Is stage of manufacture clearly
indicated on containers ”
Yes/No
- 11
Observations
7 17
Are working instructions available
Yes/No
at place of work 9
if no. give details
7 IS
Do the manufacturing iecords
contain all relevant particulars
like
a)
Batch No
b)
Date of manufacture
c)
Names of persons directly
responsible for operation
and supervision
d)
Details regarding apparatus
used (eg eqpt No , etc )
e)
Balch size
f)
Yield by weight/volume
g)
Percentage of theoretical
yield
h)
Reasons for abnormal
variations, if any
i)
List of RMs. PMs used with
their weights/volumes/quantities
and analytical reports under
which approved by QA.
j)
Description of work
carried out
Yes/No
-
12 -
Observations
k)
Details regarding in-process
QC checks
I)
Details regaiding Quality
Assurance approval of FP
nt)
Certificate by QA or other
authorised pet son to (he effect
that everything concerning the
batch is in accordance with
GMP requirements.
7.19
7 20
Is batch integrity maintained during
a)
manufacture
Yes/No
b)
packaging
Yes/No
c)
stocking
Yes/No
Is there a system of identification
Yes/No
and segregation of rejected batches ?
Give details
7.21
Is reworking of rejected lots properly
Yes/No
documented 9
If yes. comment on the same
7 22
Is tamper-evident sealing of the
finished product done
Yes/No
-■ 13
Observations
7.23
Is inert gas used in any operations
Yes/No
including packing 9
H yes, identify the gas and the products
lor which used 9
7 24
Is filtration of water, solvents, air.
Yes/No
gtis. etc dining the final stages of
manufacture satisfactory 9
7 25
Are plant working instructions
Yes/No
available at each place of work 9
7.26
Are written SOI’s and specifications
Yes/No
for packaging and labelling in existence 9
7 27
Are SOPs for reworking of non
Yes/No
conforming batches in existence 9
If yes, check records
7.28
Are appropriate in-process checks
Yes/No
carried out by QC personnel and records
maintained 9
8.
Warehousing:
8.1
Are areas for storage of RMs. PMs
and FPs adequate and properly
semegated
Yes/No
-
14 -
Observations
Are all areas clean and ordcily ’’
Yes/No
Are the stoics protected from
Yes/No
entry of rodents, birds, insects, etc. ?
8.4
Are incoming materials properly
Yes/No
quarantined into "QUARANTINED"
"UNDER TEST", "APPROVED" and
"REJECTED" categories with distinct
labels for ease of identification 9
Check SOP and compliance
8 5
Are areas requiring controlled
Yes/No
temperature and humidity adequate ?
8 6
Are FPs requiring controlled
Yes/No
temperature and humidity stored
properly 9
8.7
Are flammable, corrosive and toxic
materials stored separately with
proper safety measures 9
Yes/No
15 .-
Observations
’>
9. I
Standard Operating Piocedmes:
Are SOI’s for various activities in
Yes/No
existence ?
Check with the list
supplied by the firm in Part II
9 2
Arc the SOI’s adequate and clearly
Yes/No
wi i t ten ?
9 3
Are the SOI’s followed 9 Please
Yes/No
check documentation in support
9.4
Are the SOI’s reviewed periodically 9
Yes/No
If yes, what is the frequency
It).
10 1
Documentation:
Is a duly-approved Quality Policy
Yes/No
in existence 9 If so, examine it and
comment on its adequacy
10 2
Are batch records capable of giving
complete history' of the batch right
from the RM stage to the distribution
of the FP ■’
Yes/No
Observations
IO..i
Are control documents and contiol
Yes/No
samples readily available 9
10.4
Are control samples and records
Yes/No
maintained in accordance with the
requirements of the D&C Act and
the Rules 9
Are analytical repotts and in-process
Yes/No
controls adequately supported by the
raw data 9
10 6
Is the data/information recorded
Yes/No
concurrently with the operations ?
I 1
Safety
III
Isa safety manual available ?
Yes/No
Are safety equipments like helmets,
Yes/No
I 1.2
shoes, goggles, gloves, showers,
aprons, masks, breathing aparatus.
etc available in the factory ?
-
17
Observations
I 1.3
Is adequate first-aid equipment
Yes/No
available al convenient places in
the factory
115
Is periodic first-aid training given to
Yes/No
Aie elecliical connections, wiiing
Yes/No
etc. checked regularly 9
11.6
Is flame-proof equipment used
Yes/No
where flammable solvents or materials
are stored or handled during
manufacture ?
11.7
Is adequate fire fighting equipment
Yes/No
like fire extinguishers, ladders, fire
buckets filled with water/sand,
etc available 9
11.8
Is the building safe and provided
Yes/No
with emergency exists, escape
routes, ladders, etc. ?
I 1.9
Does the firm maintain accident
history/record 9
If yes, comment on its adequacy
Yes/No
Observations
12.
12 I
Utilities:
Are arrangements for the following
adequate 9
Raw water
Yes/No
12 I 2 Demineralised water
Yes/No
12 1.3 Vacuum
Yes/No
12 I 4 Compressed air
Yes/No
12 I I
12.1.5
12.2
Steam
Yes/No
Are measuring devices for.
volume
Yes/No
temperature
Yes/No
pressure
Yes/No
vaccum
Yes/No
properly calibrated in accordance
with the written down procedures ?
II yes. record observations
aeainst each
19
Observations
13
13 1
Pollution control:
Are arrangements for the following
Yes/No
adequate 9
13 1 1
Disposal of solid/semi-solid
Yes/No
waste
13 12 Disposal of sewerage
Yes/No
13.1.3 Disposal of liquid laboratory waste
Yes/No
13 14 Management of gaseous pollutants
Yes/No
13.2
Is effluent treatment plant in
existence 9
Yes/No
Ifyes, comment on it
13 3
Are fume hoods of adequate design
Yes/No
in existence and used wherever
necessary
14.
14 1
Packaging:
Ate written procedures and specifi
cations available for:
14 2
a)
Packaging components
Yes/No
b)
Packaging operations
Yes/No
e)
Labels and label conti ol
Yes/No
Is batch separation maintained
Yes/No
during packaging operations 9
20 -
Observations
( '<>inplaints and recalls:
Yes/No
Is a iecord of complainls/recalls
maintained ?
If yes. comment on the same
Yes/No
Arc adequate measures taken in
such cases and recorded
If yes. comment
10
Summary and recommendations
Signatures of the GMP Experts
Name
Name
Address
Address
GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF DELHI
GMP Inspection
SAMPLE RECEIPT FORM
Institution/Company (under inspection)
Address
Dale of inspection
Name of representative of the inspected establishment
Name(s) of Inspector
.
Name of the Drug sampled
Dosage form
BatchNo
Date of manufacture
Date of expiry
Place samples (warehouse, production line, packaging section, etc )
No of samples taken (tins, strips, packets, etc.)
(Signatures and name(s) of inspectors)
Signature and name of
representative of the
inspected establishment
Community Health Ceii
rrom:
Tc:
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"drug action India" <drugactionindia(Q).healthyskepticism.org>: <PHMSec(3>touchtelindia.net>
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F-mail rruc Page |
ToHsv’r
Deccan Herald » Edit Page » Full Story
Metrelife
High drug prices without rationale
View Of
Matter or fre
Druq companies influence doctors and impose an unfair druq oricinq reaimo which
causes hardship to the poor
Ailing systen
Csn Conors
RY nOPAI nARAHF
Tnnav's Pnrnr-.n
Front Psgg
Drug prices play an important role in the overall health care of any
communitv. It is astonishing that life-saving essential drugs, when
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Ssarrh HFf
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One company seiis inis drug ai the rale of Rs 4.8 i for every iabiei of 5 mg and an
U.bU. A whopping price dirterence ot 832%! mere does not appear to be any logic
□rice difference. The tablet Fluconazole 150 mg. used to treat fungus infection.
nnmnanv
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News
Huge price differences
Business
Foreign
These huge drug price differences often make one wonder whether the costly druos ;
Oftan ncnnlo k>dliax/o fkinf fkica mcfliar fries rlri in ffica KcsHcar if mm ilrf arf On fHca nnnfrr
ts known uiai inuid i idb some unbui upuioua diuy mdnufautui ei &. Bui. uiu piicuo of d
aoove are rrom leading drug companies. Moreover, drug samples rrom an Kinds or c
shown to perform equally well or badly on quality testing.
T^nac fho nrino rlifforonc'ci Hanonrl ryrt fhcj nnmnanv Hpainn nafinnol nr mi ilfinof innalQ I
Economy & Business
Metro Life - Mon
Spectrum
^science & i ecnnoiogy
DM Frbir»*non
Lrvino
She
Open Sesame
Metro Lite - bat
diuy uompdiiiuo making diuya, which die oiiedpei oi Cuoiiiui'. oui. uicie IS One impvi
onen repears — cosnier drugs more onen nave a wider marKer. it a drug can oe
company at a fraction of the cost of the same druq made by another company, it woul
cost of production is far Iass than thn selling price of fhA. company This is in fact the
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uidi. diuy iiiaiiufauiuiei & quote foi’ tenuci S. Lei. u& look di a Cui iui uie eXaii'tpte. Thu ui
(worm-removing ageni} is sold oy a company ror ks o.9y. ine same company ror
when invited for the tender supply from Tamil Nadu Medical Supplies Corporations, i
There are huge margins for the manufacturers in the pharmaceutical trade (inciudmc
and retailer) in selling drugs. Drugs are being sold at lower prices because the rr
increasing the market share, can afford to do so. On the other extreme drugs that are
which nftan have hich market chare can continue tn he cold at thece nrices hecai icc
patient in the form of higher prices.
Advertisements
This kind of drug pricing is causing untold hardship for boor people, making it diffi
accecc treatment leadinn to i intreated illneccec oreater mnrtalifv and morbidity Car
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ui~tciWcii~6 vi uic CviTipi&XitiGS vi uTuy pTiCii'iCj. OfiCi'i u'lcy ai’o initoreiLC tiiLiS Gu»Tip»iu<aiii
So frequently doctors have io make the ftnai decision.
GIFTS FLOWERS Delivery
oeiKjdKHe, cneiUMi, LhcllM,
Can doctors brotect the interest of the consumers? The doctors have all the know-h<
th»=. natientc’ intAr^qtc hv nr^cnrihinn the mncf nnGt-.pffpr.five mpdir.inPG
Rnt mn«
Pslisleading promotions
Reviews
QaaI< Da^auw
MiTVlw
pro.i.ctionc. The huge •••ergms :r» drug pricing are used to organise sponsor cCmiiiCi
u iu mouiuai piufcssiun.
Horoscope
Many uS laCuity meiiibei& un the institutional levicw uoaiu
me mousiry says a recent report in me tsntisn Meoicai journal (August 23, 2LIC
companies are known to sponsor holidays and medical seminars for doctors.
Wecklv WrvrKrnnn
Year's HoroscGoe
rievivua Euitiviis
Yesterday's Edition
duutvis’ pieaui iptions. Oitei i auvOiiisements and statements num diuy companies
Archives
promotion materials mat exaggerate benefits ana skip tne nsKs onen tnreaten a panel
Omers
PH Cartoon
DH Classifieds
Waathar
The Government of India should regulate the drug industry It is for the Government f
ocjriartPc iptaroefe
th~ doht to sccess effc?rdet?ie !rr,<art'r'’r*oc h?r ^^e^h ,r'rf»^iArr,ct ”t
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DRUG INFORMATION SERVICE : FRONTIER OF RATIONAL DRUG THERAPY
Krishnorrgshu Ray
India has an exploding drug market, one of the largest
in the world There are around sixty thousand drug formu
lations whereas in most of the European countries the
number is restricted to only three to four thousands. Out
of this vast number, only 15% are considered useful and
the majority of the rest are ineffective, useless or even
harmful. In a developng nation, drug is probably a minor
aspect when compared to poverty, illiteracy, malnutrition,
lack of safe drinking water and poor environmental sanita
tion. However, the drugs when they are needed and if
given rationally, can play a vital role in improving the health
of the people
'Drug Information' is scientifically-derived and docu
mented body of knowledge involving the pharmacological,
toxicological and therapeutic use of drugs. It comprises
informations such as chemical names, structures and
properties, identification, diagnostic or therapeutic indica
tions, mechanism of action, recommended dose sched
ules, drugkinetics, therapeutic and chemical interactions,
comparative data and other pertinent information useful in
the diagnosis and treatment of patients. Drug information
service (DIS) includes the gathering, reviewing, evaluat
ing, indexing, organizing, storing, summarizing and dis
tributing information on drugs in various forms by various
methods to actual and potential users. The first official
Drug Information Centre (DIC) in North America was
started in 1962. In the late 50's and 6'0s, several profes
sionals in the field of medicine and pharmacy agreed that
an organized programme in hospitals was necessary to
achieve rational drug therapy, and the pharmacists are
responsible to provide information sources for the
prgramme. However the new developments' in hospital
health care such as pharmacy departments receipt of
physician's original directions, the development of patient
profiles intravenous additives, unit-dose drug distribution
system etc., freed the pharmacists a little and allowed for
more clinical discussions with doctors and nurses.
The chief usefuness of DIC is to act as a bridge in the
communication network between thewealth current infor
mations available and the active health professional. It
facilitates access of the health professionals to the data
in a highly specific and efficient manner to enable them in
(arriving quicker and more rational decisions. DIS may be
both active and passive types. Active information dissemi
nation occures when relevant information is passed on
directly to the physicians, usually at the bed side to interact
patient-care immediately. Passive servicewould consist of
the pharmacist responding to queries received at the
centre. The organization and content of the centre will
depend upon the main user i.e. patient-oriented, clinicianoriented or community-oriented. A community DIC acts as
a resource base for questions on poisionings, drug abuse.
OTO products, proper administration of medications, side
effects etc.
Organizationally, a simple DIC can consist of one or
two desks, a shelf, filing cabinets, a telephone and access
to xerox machine. In addition, some basic reference texts,
some current journals of medical and pharmaceutical
orientation, access to medical library and essential tele
phone numbers (poison control centres clinics and other
hospitals) are the essential requisites. The core of the
centre is the files which contain organized information on
drugs and diseases. Usually at least one trained pharma
cist is employed to operate the centre. The person should
have sound pharmaceutical knowledge base, blended
with clinical aptitudes and familiarity to information tech
nology with excellent communication skills. This expertise
is usually developed via a combination of formal training
and on-the-job education. Answered queries are usually
recorded which may be preserved for future references
and for statistical purposes to determine the type and
number of questions answered and who the major users
of the service are. The reference sources of DIS may be
tertiary ( text books, pharmacopioea), secondary (ab
stracts) or primary (journals, research papers). Several
on-line computer searches like Med-line, Drugdex.Toxline
etc. may be presssed into service. Other comprehensive
modalities such as Iowa Drug Information Service (IDIS)
Paul de Haen Drug Information Service are some of the
popular retriveval services.
The underlying theme of DIC is the development of an
increase in communication between various members of
the health care team. The function of a DIC is to keep
everyone abreast of current knowledge with regard to
drugs and drug therapy. With the tremendous advances in
telecommunications, this knowledge can be disseminated
on a global scale. Information on references of new
advances or in therapy may be identified, compiled and
sent to various locations around the world using Facsimile
machine. In supplement to all these services of informatics,
DIC can function as one of the bases of active training in
the hospitals. The centre can be responsible for organizing
journal clubs, educational talks to keep the staffs up-todate about new drug developments. This can be accom
plished by publication of newsletters, bulletins, the format
of which may depend upon the group that is targeted.
Liason with the government eventually play a vital role in
shaping rational drug and health policy by providing unbi
ased information. It is trusted that increases in up-to-date
pharmaceutical communication amongst physicians would
hopefully lead towards rational therapeutic practice.
Dr. A.K. ROY IS NO MORE I
Dr. A.K. Roy, the erstwhile Editor of the ‘Rational Drug Bulletin', is no more with us. He passed away following a brief
illness on 19th May, 1993.
Dr. A.K. Roy was born on 11th November, 1910. Throughout his life, he taught for justice through his association with
many social service organisations.
Dr. Roy, the Founder Treasurer of the CDMU, was a constant source of inspiration in continued struggle for the justice
in the field of health care.
His patriotism, selfless devolion to work, clear judgement and prophetic vision had won spontaneous love and respect.
His demise Is great a loss to us.
\7e pledge to strengthen our effort to promote rational use of drugs in India, and that is the best way to pay homage
to his departed soul, we trust.
HAi
drugs
A new campaign and information pack
for a more rational use of drugs
HAI
Health Action International
HAI-Europe
Jacob van Lennepkade 334 T
1053 NJ Amstei dam
The Netherlands
tel:+31 (0) 20 683 36 84
fax:+31 (0) 20 685 50 02
tlx: (+402) 6105915 gma hi
E-mail: (GE02:) HAI-Europe
Under strict embargo until 15 September 1993
Worldwide consumer campaign on problem drugs
Today, Health Action International (HAI), an international network of
consumer, development and health organisations, is launching Problem
Drugs, a new information pack on medicines.
Problem Drugs, written by Andrew Chetley, covers 10 categories of
medicines: antibiotics, antidiarrhoeals, analgesics, cough & cold
remedies, growth stimulants, drugs in pregnancy, contraceptives,
hormone replacement therapy and psychotropics. It contains detailed
information on the "problem drugs" currently being marketed,
recommendations for rational drug treatments, and priorities for action
which will be taken up in campaigns by HAI groups in over 70 countries
worldwide.
Overall, this information pack documents an excessive waste of
resources:
*
4 out of every 5 antidiarhoeal products on the market are of no
value in the treatment of acute diarrhoea;
*
more than 4 out of every 5 cough and cold products contain
ineffective ingredients, while more than 1 out of every 2 contains
ingredients liable to cause harmful adverse reactions;
*
1 out of every 3 analgesics is a combination product, and 1 out of
every 5 contains a potentially harmful ingredient;
*
*
.
more than 1 out of every 3 non-steroidal anti-inflammatory drugs
(NSAIDs) should be removed because of a poor safety record,
lack of significant therapeutic advantage over safer preparations,
and, in most cases, much higher cost;
more than 4 out of every 5 vitamins cannot be recommended;
nearly 3 out of every 5 are promoted for unproven indications;
more than 2 out of every 5 contain non-essential or ineffective
ingredients; more than 1 out of every 2 is irrationally formulated;
and nearly 1 out of every 2 contains excessive dosages.
Obsolete and dangerous drugs continue to be marketed. The pain killer
dipyrone has been banned or severely restricted in twenty-three countries
because it has caused deaths, yet it is widely promoted in Latin America,
Africa and Eastern Europe for indications like fever and pain.
- over HEALTH ACTION INTERNA11ON IS AN INFORMAL NETWORK OF SOME 100 CONSUMER, HEALTH, DEVELOPMENT ACTION AND OTHER PUBLIC INTEREST
GROUPS INVOLVED IN HeHtH AND PHARMACEUTICAL ISSUES IN 60 COUNTRIES,WOUND THE WORLD, HAI ACTIVELY PROMOTES A MORE RATIONAL USE OF DRUGS.
ALL DRUGS MARKETED SHOULD MEET REAL MEDICAL NEEDS, HAVE THERAPEUTIC ADVANTAGES, BE ACCEPTABLYSAFE AND OFFER|ALUE FOR MONEY.
Other coordinating HAI offices:
HAI Clearinghouse/Action for Rational Drug for Asia (ARDA), c/o IOCU, PO Box 1015, 10830 Penang. Malaysia tel: + (601) 371396 fax: + (601) 366506 telex: MA 40164 apiocu
AIS Latin/Xinerica, c/o Accion para la Salud, Avda. Palermo 531, Dpto. 104, Lima 13. Peru, tel: *-(511-1) 712320 fax:+(5114) 712320
"People may not be aware that the drug they buy at their pharmacy or that doctors
prescribe to them has been banned for safety reasons in another country," says HAIEurope coordinator Catherine Hodgkin. "We want to make this information known and to
clearly recommend the steps needed to protect public health."
The problem, however, is not restricted to a few "bad apples". It is an inevitable result of
the way the pharmaceutical industry puts profits above health. Lack of adequate
regulatory controls and overpromotion exacerbate this situation. "The company with the
best marketing strategy often succeeds, even if its products offer no advantage," says
author Andrew Chetley.
HAI makes clear recommendations for change in Problem Drugs, pointing out the
responsibilities of users, prescribers, government and industry. To list a few:
*
Products which have been withdrawn for safety reasons in one country should be
withdrawn in all countries;
.
Governments should review the drugs on the market and remove products which
are obsolete, ineffective, or harmful;
*
Stronger controls are needed on promotion;
*
Prescribers and consumers should have access to independent drug information;
*
Uniform labelling should be adopted for drugs in pregnancy;
Above all, drugs should only be marketed if they meet a real medical need, are
acceptably safe and effective, and offer satisfactory value for money.
These recommendations, and many more, will form the basis for campaigns for better
national and international drug policy by HAI groups all over the world.
* Review copies available on request *
Chetley A., Problem Drugs, Amsterdam, Health Action International, 1993
208 pages, indexed by subject, company and drug. ISBN 90-74006-X
Problem Drugs was first published in 1986 and has been used by thousands of
health workers, educators, journalists, students and activists around the world. It
has been translated into Spanish, French, Arabic, Bangla and Indonesian. The
revised edition will also be translated into Spanish, French and Russian in 1994.
Price: Dfl 30 + Dfl 5 for postage and handling
Payments in Dutch guilders only by Eurocheque, Postal Order or credit card (VISA,
Mastercard or American Express)
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
Jacob van Lennepkade 334 T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84; Fax: (31 20) 685 50 02
Andrew Chetley (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel and Fax: (44 223) 41 36 67
2
Take your medicine and you’ll get better.
Right? Well, not necessarily...
Tens of thousands of drugs are on sale all over
the world. Most are either unsafe, ineffective or a
waste of money.
Many are used unnecessarily or inappropriately.
Comments on the first edition of Problem Drugs:
Very useful...gives us the information which cannot be obtained
from manufacturers.” - Tanzanian Bureau of Standards
"The recommendations are generally clear, entirely acceptable,
and obviously necessary.” - The Lancet
"Its findings, particularly with respect to the developing
countries, are disquieting.” - British Medical Journal
"Health educators love it."- Health educator, Nigeria
"Essential and thought provoking reading" - Nursing Times
A new campaign and information pack
for a more rational use of drugs by
Health Action International
revised and updated in 1993
by Andrew Chetley
Please turn over for ordering,informa
,> 'M1'
Chetiey, A. Problem Drugs,
Amsterdam, Health Action
International 1993
20S pages, indexed by
subject, company and drug
ISBN 90-74006 06-X
Problem Drugs was first
published in 19S6 and has
been used by thousands of
health workers, educators.
pharmacists, journalists.
students and activists
around the world It has
been translated into Spanish.
French. Arabic. Bangla and
Indonesian. This revised
edition will also be translated
into Spanish. French and
Russian in 1994.
problem
• contains well-documented and up-to-date information sheets
on many types of drugs, including antidiarrhoeals, antibiotics,
analgesics, growth stimulants, cough & cold remedies, drugs
in pregnancy, contraceptives, hormone replacement therapy
and psychotropic drugs
♦ has special sections on drugs and children, women and the
elderly
• highlights examples of unethical marketing, double standards
and failure to meet real health needs
• is international in scope
• gives clear recommendations for action
Return to: Health Action International (HAI-Europe)
Jacob van Lennepkade 334T
1053 NJ Amsterdam, The Netherlands
Name
Organisation
Address
Price: Dfl 30 + Dfl 5 to cover postage and handling costs
Bulk rates: For 10-20 = Dfl 25/copy + 10% postage and handling
20-50 = Dfl 20/copy + 10% postage and handling
Reduced rates available for groups in developing countries,
HAI members and larger orders. Please write for details.
Please send me
copies of Problem Drugs
Dfl.
Postage and handling
Dfl.
Total
Dfl.
Please include payment with this order. Payments are to be made in Dutch guilders
(1993 exchange rate: Dfl 1 = about US $0.55). by Eurocheque, Postal Order or credit
card (VISA, Mastercard or American Express).
For credit card payments'
I wish to pay by Mastercard/VISA/American Express
HAO
Health Action International
Card number:
Signature:
Expiry date:
HAi
Health Action International
HAI - Europe
Jacob van Lennepkade 334 T
1053 NJ Amsterdam
The Netherlands
tel:+31 (0) 20 683 36 84
fax:+31 (0) 20 685 50 02
tlx: (+402) 6105915 gmalu
E-mail: (GE02:) HAI-Europe
Under strict embargo until 15 September 1993
Worldwide consumer campaign on problem drugs
Today, Health Action International (HAI), an international network of
consumer, development and health organisations, is launching Problem
Drugs, a new information pack on medicines.
Problem Drugs, written by Andrew Chetley, covers 10 categories of
medicines: antibiotics, antidiarrhoeals, analgesics, cough & cold
remedies, growth stimulants, drugs in pregnancy, contraceptives,
hormone replacement therapy and psychotropics. It contains detailed
information on the "problem drugs" currently being marketed,
recommendations for rational drug treatments, and priorities for action
which will be taken up in campaigns by HAI groups in over 70 countries
worldwide.
Overall, this information pack documents an excessive waste of
resources:
*
4 out of every 5 antidiarhoeal products on the market are of no
value in the treatment of acute diarrhoea;
*
more than 4 out of every 5 cough and cold products contain
ineffective ingredients, while more than 1 out of every 2 contains
ingredients liable to cause harmful adverse reactions;
*
1 out of every 3 analgesics is a combination product, and 1 out of
every 5 contains a potentially harmful ingredient;
*
*
i L
.
more than 1 out of every 3 non-steroidal anti-inflammatory drugs
(NSAIDs) should be removed because of a poor safety record,
lack of significant therapeutic advantage over safer preparations,
and, in most cases, much higher cost;
more than 4 out of every 5 vitamins cannot be recommended;
nearly 3 out of every 5 are promoted for unproven indications;
more than 2 out of every 5 contain non-essential or ineffective
ingredients; more than 1 out of every 2 is irrationally formulated;
and nearly 1 out of every 2 contains excessive dosages.
Obsolete and dangerous drugs continue to be marketed. The pain killer
dipyrone has been banned or severely restricted in twenty-three countries
because it has caused deaths, yet it is widely promoted in Latin America,
Africa and Eastern Europe for indications like fever and pain.
- over HEALTH ACTION INTERNATION IS.AN INFORMAL NETWORK OFSOMK 100 CONSUMER, 1IEAI.TH, DEVELOPMENT ACTION AND OTHER PUBUC. INTEREST
GROUPS INVOLVED IN HEALTH AND PHARMACEUTIC AL ISSUES IN 60 <LOUNTRIES AROUND VUE WORIJJ. HAI ACT IVELYPROMOTES A MORE RAI1ONAL USE <>F DRl ’
ALL. DRUGS MARKETED SHOULD MEET REAL MEDICAL NEEDS, HAW. 11IF.RAPEU 1IC ADVANTAGES, BE ACXIEITABLYSAFE AND OFFER VALUE FOR MONEY.
Other Coordinating HAI offices:
HAI Clearinghouse/Action for Rational Drug lor Asia (ARDA), c/o IOGI’, PO Box 10-15. 10830 Penang, Malaysia tel: + (G0-1 > 371596 fax: ♦ (601) 366506 telex; MA 40164 apiocu
AIS Latin America, c/o Accion para la Salud, Avda. Palermo 531. Dpto. 101, Lima 13. Pent, tel: *-(511'1) 712320 fax: +(5114) 712320
"People may not be aware that the drug they buy at their pharmacy or that doctors
prescribe to them has been banned for safety reasons in another country," says HAIEurope coordinator Catherine Hodgkin. "We want to make this information known and to
clearly recommend the steps needed to protect public health."
The problem, however, is not restricted to a few "bad apples". It is an inevitable result of
the way the pharmaceutical industry puts profits above health. Lack of adequate
regulatory controls and overpromotion exacerbate this situation. "The company with the
best marketing strategy often succeeds, even if its products offer no advantage," says
author Andrew Chetley.
HAI makes clear recommendations for change in Problem Drugs, pointing out the
responsibilities of users, prescribers, government and industry. To list a few:
*
Products which have been withdrawn for safety reasons in one country should be
withdrawn in all countries;
*
Governments should review the drugs on the market and remove products which
are obsolete, ineffective, or harmful;
*
Stronger controls are needed on promotion;
*
Prescribers and consumers should have access to independent drug information;
*
Uniform labelling should be adopted for drugs in pregnancy;
Above all, drugs should only be marketed if they meet a real medical need, are
acceptably safe and effective, and offer satisfactory value for money.
These recommendations, and many more, will form the basis for campaigns for better
national and international drug policy by HAI groups all over the world.
t Review copies available on request *
Chetley A., Problem Drugs, Amsterdam, Health Action International, 1993
208 pages, indexed by subject, company and drug. ISBN 90-74006-X
Problem Drugs was first published in 1986 and has been used by thousands of
health workers, educators, journalists, students and activists around the world. It
has been translated into Spanish, French, Arabic, Bangla and Indonesian. The
revised edition will also be translated into Spanish, French and Russian in 1994.
Price: Dfl 30 + Dfl 5 for postage and handling
Payments in Dutch guilders only by Eurocheque, Postal Order or credit card (VISA,
Mastercard or American Express)
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
Jacob van Lennepkade 334 T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84; Fax: (31 20) 685 50 02
Andrew Chetley (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel and Fax: (44 223) 41 36 67
2
___ HAS
Health Action International
September 15, 1993
Children and drugs: starting the habit of a lifetime
In 1986, the US-based company, Merck Sharp and Dohme (MSD) told a UK
public interest group, Social Audit, that it would no longer promote its antihistamine
drug, Periactin (cyproheptadine), as an appetite stimulant. A year later, the company
began a string of six successive years as the recipient of Fortune magazine's "most
admired corporation" award. Among the attributes that were assessed to make up the
award were community and environmental responsibility. In 1991, MSD's Indian
subsidiary, Merind, was still promoting cyproheptadine as an appetite stimulant for
children. The product was also on the market in Pakistan and throughout Africa —
including in countries where famine conditions existed.
"This is one of the most disturbing examples of pharmaceutical industry
marketing of inappropriate and unnecessary products for children", says Andrew
Chetley, author of Health Action International's latest publication. Problem Drugs. "As
long ago as 1971, independent sources in the USA were telling companies like Merck
Sharp and Dohme that promoting cyproheptadine as an appetite stimulant for children
would do more harm than good. Twenty years later, this company still does not seem
to have heard the message."
The World Health Organization (WHO) has stated that there is no evidence that
the products being promoted as appetite stimulants have any effect on appetite, and
says these preparations "should not be used".
However, they are not the only drugs that children should not use. According to
WHO, two-thirds of all drugs used by children may have little or no value. At least $1
billion is wasted every year on inappropriate antidiarrhoeal drugs and cough and cold
remedies for children. Many of these preparations are useless and some are potentially
dangerous. Ineffective products such as antidiarrhoeals and appetite stimulants can
detract attention from effective therapies or from efforts to identify and treat the real
causes of poor growth and development among children.
The use of "brain tonics" and other substances to improve children's
performance at school is another area where money is wasted and unnecessary
products are consumed. In Peru in 1991, the Belgian company, UCB, advertised that its
piracetam product, Nootropil, would help children with "school difficulties" such as
"memory problems, difficulty learning, lack of concentration, intellectual tiredness, poor
1
Common examples of drug misuse in children
performance, agitation and
antibacterials for viral upper respiratory
infections
decongestants for colds, resulting in
unacceptable adverse effects
drugs in diarrhoea
oral anti-emetics for vomiting
antipyretic agents for fever
tricyclic antidepressants for bed-wetting
sedatives for sleepless children or those
labelled hyperactive
spasmolytics in abdominal pain
appetite stimulants
•
irritability". There is no evidence
that piracetam can perform any of
these miracles. The product was
licensed in 1993 in the UK, but
only for the treatment of a rare
condition that results from brain
damage, cortical myoclonus. During
1992, in the UK, three vitamin
•
•
•
•
•
•
•
•
manufacturers were successfully
prosecuted for claiming that their
vitamin products could increase children's intelligence.
Aside from the waste of resources, the excessive use of drugs by children has
its own health consequences. Adverse reactions to the drugs is one such consequence.
In Mexico, for example, 12% of paediatric hospitalisations were due to adverse effects
of medication. Because infants and children react to drugs in a different way from
adults, they usually need lower dosages. The exact way children respond to a particular
drug can only be determined through research and experience; however, most drugs do
not have established doses for infants and children. About three-quarters of the drugs
on the market in the USA are either contraindicated or contain strong precautions for
use in children, and 9 out of every 10 contain warnings against use by infants and
toddlers.
A long-term consequence of excessive and inappropriate drug use in children is
that they may grow up believing that drugs are the only solution to many of life's
problems. HAI is calling on health workers and governments to take action to ensure
that children do not get started on a lifetime habit of taking unnecessary medicines. It
also is calling for the removal of paediatric medicines that are hazardous or ineffective
and is urging stronger controls over the promotion of medicines for children.
— ends (680 words) —
Note to editors
This feature is based upon the information contained in sections 1B (Drugs and
children), 5A (Cough and cold preparations), 6A (Growth stimulants), 6B (Brain tonics)
and 6C (Vitamins) of Problem Drugs. Publication details are as follows:
Chetley, A., Problem Drugs, Amsterdam, Health Action International, 1993.
208 pages, indexed by subject, company and drug. ISBN 90-74006-06-X
Price: Dfl. 30 + Dfl. 5 postage and handling
Payment can be made in Dutch Guilders by Eurocheque, Postal Order or credit
cards (VISA, Mastercard or American Express).
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
J. van Lennepkade 334-T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84; Fax: (31 20) 685 50 02
Andrew Chetley (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel and Fax: (44 223) 41 36 67
2
FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0
September 15,1993
Antidiarrhoeals: dying for lack of a drink
Executives from the US-based Johnson & Johnson company watched a British
television documentary in 1990 in stunned silence as, before their eyes, a child in
Pakistan died. The child died as a result of paralysis of the intestinal muscle, caused by
the world's leading antidiarrhoeal drug. The drug, loperamide (Imodium), manufactured
by Johnson & Johnson's subsidiary, Janssen, should never be used in young children.
Loperamide is only one of the many antidiarrhoeal products that should not be
given to children, says Problem Drugs, the latest publication from Health Action
International (HAD. It found that more than 8 out of every 10 antidiarrhoeal products on
the market in developing countries in Asia, Africa and Latin America were unsafe or
ineffective. As the World Health Organisation (WHO) puts it, "most medicines for
diarrhoea are either useless or harmful".
Yet four million children die each year from diarrhoea. Most of those deaths
could be prevented through better infant and young child feeding practices, better
hygiene and sanitation, and by treating the dehydration caused by diarrhoea.
It is this dehydration that causes most deaths from diarrhoea. The solution is an
inexpensive and easy to prepare drink of water, salt and sugar that helps restore
children's fluid and mineral balance. This oral rehydration therapy (ORT) costs little
more than 50 cents a child.
"The continued production and promotion of antidiarrhoeal products that detract
from effective and affordable therapy is one of today's biggest public health scandals,"
says Problem Drugs author, Andrew Chetley. "It's time action was taken to stop this
waste of resources and this loss of lives."
HA, is calling on governments to review the antidiarrhoeal products on national
markets with a view to removing all those that are ineffective and introducing bans on
products that contain hazardous ingredients.
Drugs that are singled out for removal because of safety risks include a number
of products containing hydroxyquinolines. These first came to public attention in Japan
in 1970 when an epidemic of subacute myelo-optic neuropathy (SMON) — a disease
1
that could cause total paralysis and blindness — swept through the country. Clioquinol
was the drug that caused the disease, but similar concerns were raised about the
adverse neurological effects of its close relatives — iodoquinol and broxyquinoline. Lack
of proven efficacy of these products in the treatment of diarrhoea makes their use even
more foolhardy. According to WHO, "there is no rationale for their continued production
and sale".
Loperamide preparations for children and paediatric preparations of a similar
drug, diphenoxylate (sold as Lomotil by G.D. Searle) are also products that are overdue
for a ban, according to Problem Drugs. In both cases, WHO has said "there is no
rationale for the production and sale of liquid and syrup formulations for paediatric
use". Following the international publicity surrounding the child deaths in Pakistan,
Janssen withdrew oral and liquid formulations of Imodium (loperamide) in many
countries; however, not all manufacturers have done the same, and several
governments are now considering bans.
The inclusion of antibiotics in antidiarrhoeal products is another dangerous
practice that Problem Drugs has highlighted. It found that one out of every two
antidiarrhoeal products around the world contained an antibiotic, while in Latin
America, it was two out of every three.
The indiscriminate use of antibiotics encourages the development of resistant
micro-organisms, alters the normal bacterial content of the gut which can lead to
possible fungal infections and the overgrowth of resistant bacteria, can increase the
risk of relapse, prolong the period when the patient with an infection can pass on the
disease, and can also interfere with subsequent bacteriological diagnosis. However, in
India in 1991, G.D. Searle produced a regular magazine, Diarrhoea Update, that told
doctors that the combination of diphenoxylate and an antibiotic was an "advantage" in
fighting diarrhoea.
Products containing neomycin, streptomycin or dihydrostreptomycin,
chloramphenicol, and/or one of the many sulphonamides are of particular concern.
According to WHO, there is no evidence that these antibiotics are effective in the
treatment of any type of diarrhoea. It says that "the. production and sale of these
products cannot be justified".
The firm conclusion is that the vast majority of antidiarrhoeal drugs on the
market worldwide are, at best, unnecessary and, at worst, ineffective and sometimes
dangerous.
— ends (700 words) —
See next page for note to editors
2
Note to editors
This feature is based upon the information in the five sections of Problem Drugs dealing
with antidiarrhoeal drugs: 2A (Antidiarrhoeals); 2B (Antidiarrhoeals containing
antibiotics); 2C (Hydroxyquinolines); 2D (Diphenoxylate); and 2E (Loperamide).
Publication details are as follows:
Chetley, A., Problem Drugs, Amsterdam, Health Action International, 1993.
208 pages, indexed by subject, company and drug. ISBN 90-74006-06-X
Price: Dfl. 30 + DfL 5 postage and handling
Payment can be made in Dutch Guilders by Eurocheque, Postal Order or credit
cards (VISA, Mastercard or American Express).
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
J. van Lennepkade 334-T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84; Fax: (31 20) 685 50 02
Andrew Chetley (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel. and Fax: (44 223) 41 36 67
3
0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0
problem
HA?
Health Action International
September 1 5, 1993
Antibiotics: wasting a valuable resource
Australian microbiologist Dr Ken Harvey is worried that the global misuse of
antibiotics in humans and animals may leave us defenseless against severe infections.
"We may look back at the antibiotic era as just a passing phase in the history of
medicine, an era in which a great natural resource was squandered and where the bugs
proved smarter than the scientist," says Dr Harvey.
His concern, and that of many other experts in infectious disease control, is
outlined in Problem Drugs, a new publication from Health Action International. It points
out that the indiscriminate use of antibiotics has led to the development of bacteria that
are resistant to the standard, effective and inexpensive drugs normally used to treat
common diseases. This is described by a Dutch specialist in paediatric infections,
Ronald de Groot, as "a global problem with a major impact on health care in developed
and developing countries".
The inability to treat infections with the usual antibiotic of choice (or any other
drug) can be disastrous. In recent years, resistant strains of bacteria have triggered
severe outbreaks of gonorrhoea, dysentery, pneumonia, meningitis and deadly hospital
infections in many countries. Infections caused by resistant bacteria are more likely to
cause prolonged illness, frequent and prolonged hospitalisation and a higher death rate.
This human suffering is accompanied by financial burdens as well. In the USA alone,
the cost of antibiotic resistance has been estimated at more than $100 million a year.
There is no shortage of evidence about the misuse of antibiotics. Studies from
the USA, the UK, Canada, Italy, Australia, New Zealand, Uruguay, Nigeria, the Middle
East and Brazil confirm the indiscriminate and often unjustified use of antibiotics.
Anywhere from one-third to two-thirds of antibiotics prescribed in settings as diverse
as the USA, New Zealand and Nigeria are inappropriate.
In developing countries, more of the national health budget and personal income
is spent on antibiotics than on any other class of drug. In industrialised countries, too,
sales are high, which all contributes towards a global market of some US$22 billion. By
the turn of the century, the global antibiotic market is expected to top $40 billion.
1
sales are high, which all contributes towards a global market of some US$22 billion. By
the turn of the century, the global antibiotic market is expected to top $40 billion.
Antibiotics as a percentage of the total pharmaceutical market in selected countries
Country/Region
Year
Sales of
antibiotics as
% of total market
Iran
Middle East
Indonesia
Philippines
Mexico
Argentina
1990
1989
1989
1989
1990
1990
31
29
25
23
15
12
Total sales of
antibiotics
US$ million
71
100
98.9
300
177.5
In some countries, a large percentage of the antibiotics produced are given to
animals. In the USA, for example, about half of all antibiotics produced are used to
prevent or treat animal disease, or as growth promoters in feed stock. One
consequence of this extensive use of antibiotics has been the spread of antibiotic
resistant salmonella infection from animals to humans.
Whether antibiotics are used for human or animal consumption, the
pharmaceutical industry invests heavily in promoting their use. Almost two-thirds of the
antibiotic market is dominated by sales of three types of drugs: penicillins,
cephalosporins and the newer quinolones. Misleading promotion abounds for these
products; much of it encourages doctors to prescribe the latest — and most expensive
— antibiotic as first-line therapy for a broad spectrum of infections. In most cases,
independent advice from bodies such as the American Medical Association, the British
National Formulary, or Australia's Antibiotic Guidelines is that these newer antibiotics
should be used only for well-defined indications or as second or third line therapy when
other drugs have failed due to resistance.
The World Health Organization suggested in 1990 that governments establish
such a "reserve list" of antibiotics that would include many of the newer
cephalosporins and quinolones. It said that although such antibiotics were effective in a
wide range of infections, they were inappropriate for unrestricted use because of the
need to reduce the risk of resistance to them or because of their high cost.
In the same year, UK-based Glaxo was promoting its cephalosporin antibiotic,
Ceporex (cephalexin), in Pakistan with the picture of the hands of a baby and an elderly
person linked together and the headline: “from early days, till autumn years, an
2
indications that read like a who's who of epidemiology — everything from skin, ear and
eye infections to respiratory, intestinal and reproductive tract infections.
"Antibiotics are too valuable a public health tool to waste simply because the
pharmaceutical industry wants to recoup its investments a little faster," says Andrew
Chetley, author of Problem Drugs. If we want to avoid future epidemics of infections
that are difficult or impossible to control, we have to start using antibiotics more
wisely, right now."
Health Action International is calling on governments to develop strict antibiotic
policies as part of their national health and drug policies. Such policies should include
developing a limited list of antibiotics, including the reserve list suggested by WHO;
producing and regularly reviewing a set of therapeutic guidelines for antibiotic use; and
studying the use of antibiotics with a view to introducing education programmes to
encourage more rational use where necessary. HAI also recommends that governments
introduce stronger controls to prevent misleading promotion of antibiotics.
— ends (880 words) —
Note to editors
This feature is based upon the information in Section 3A (Antibiotics) of Problem Drugs.
Publication details are as follows:
Chetley, A., Problem Drugs, Amsterdam, Health Action International, 1993.
208 pages, indexed by subject, company and drug. ISBN 90-74006-06-X
Price: Dfl. 30 + Dfl. 5 postage and handling
Payment can be made in Dutch Guilders by Eurocheque, Postal Order or credit cards
(VISA, Mastercard or American Express).
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
J. van Lennepkade 334-T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84; Fax: (31 20) 685 50 02
Andrew Chetley (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel. and Fax: (44 223) 41 36 67
3
0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0
problem
ilt Li.Ar.S
HAI
'—Health Action International
September 1 5, 1993
Dipyrone: a drug no one needs
In the early 1980s, 94 people died in Germany after taking a pain killer that
contained dipyrone. As a result, the German drug registration authority (BGA) restricted
the indications for the drug to severe pain after surgery or accident, as a result of
cancer, or because of intestinal colic. Combination products containing dipyrone were
withdrawn from the market. In 1990, the BGA re-emphasised that it considered
dipyrone a drug of last resort, primarily for cancer pain.
The world's leading manufacturer of dipyrone is the German company, Hoechst.
The restrictions on dipyrone in its home country have not stopped Hoechst from
promoting its dipyrone products widely in other countries, says Health Action
International's (HAI) latest publication, Problem Drugs. In 1992, Hoechst was
advertising dipyrone's "ample safety margin" in Latin America and recommending the
product for all types of fever and pain.
Promotion such as this ensured high sales. Globally, dipyrone contributes more
than 2% to the company's overall pharmaceutical sales. In countries such as Pakistan
or the Philippines, dipyrone brings in anywhere from one-quarter to one-third of the
company's national turnover.
Besides Hoechst, many local companies manufacture dipyrone-containing
products. At least one out of every seven pain killers in markets in Pakistan, the Middle
East, Africa and the Caribbean during 1990 contained dipyrone.
In 1977, the American Medical Association described dipyrone as "obsolete"
and the US Food and Drug Administration withdrew approval of the drug because of
the availability of safer alternatives. Ten years later; the German Medical Association
said that even a small risk of a life-threatening condition was "an unacceptable price to
pay for pain relief, especially since it cannot be maintained that alternatives are not
available".
Dipyrone can cause two life-threatening conditions: agranulocytosis (severe loss
of white blood cells due to bone marrow damage), and anaphylactic shock (a severe
allergic reaction). In both cases, it is impossible to predict who is likely to be at risk
from these conditions.
1
In the mid-1980s Hoechst
helped to pay for an international
study which the company hoped
would show that dipyrone was not
a significant factor in causing
agranulocytosis. Instead, the study
found that one out of every four
Dipyrone is an analgesic (pain killer) with
anti-inflammatory and antipyretic (fever
reducing) properties. It is the sodium sulphonate
derivative of amidopyrine or aminopyrine and,
like propyphenazone and phenylbutazone, it is a
member of the pyrazolone group of chemicals.
The drug was first introduced by the German
manufacturer, Hoechst, in 1922.
cases of drug-induced
agranulocytosis in the participating
countries occured as a result of
taking dipyrone. Subsequent
examination of the data in the
Dipyrone is known by many names: analgin,
analginum, metamizol, aminopyrine-sulphonate
sodium, sodium noramidopyrine
methanesulphonate, sulpyrine, methampyrone,
novamidazofen, natrium, novaminsulfonicum,
noramidazophenum, and noraminophenazonum.
study suggest that there could be
as many as 7,000 cases of
dipyrone-induced agranulocytosis worldwide each year — up to 2,000 of which could
be fatal.
"The purpose of an analgesic is to kill pain, not people," says Andrew Chetiey,
author of Problem Drugs. "Dipyrone is a drug that no one needs. It is a disgrace that
Hoechst and other companies have refused to take it off the market."
HAI is very clear about what needs to be done: ban dipyrone immediately.
— ends (545 words) —
Note to editors
This feature is based upon the information contained in sections 4A (Analgesics) and
4B (Dipyrone) of Problem Drugs. Publication details are as follows:
Chetiey, A., Problem Drugs, Amsterdam, Health Action International, 1993.
208 pages, indexed by subject, company and drug. ISBN 90-74006-06-X
Price: Dfl. 30 + Dfl. 5 postage and handling
Payment can be made in Dutch Guilders by Eurocheque, Postal Order or credit
cards (VISA, Mastercard or American Express).
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
J. van Lennepkade 334-T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84; Fax: (31 20) 685 50 02
Andrew Chetiey (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel and Fax: (44 223) 41 36 67
2
0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0
problem
drugs_____________ hai
Health Action International
"
September 15,1 993
Norplant: contraceptive freedom or coercion?
It took 24 years to develop, test and approve the implantable contraceptive
Norplant. It took less than two weeks for Norplant to be billed as a new method of
coercion. Within days of licensing in the USA, a Philadelphia newspaper published a
racist editorial recommending Norplant in the fight against black poverty; a judge in
California included compulsory use of Norplant in the sentence of a woman found guilty
of child abuse; and the state legislature in Kansas held hearings on a bill to encourage
mothers receiving state welfare benefits to get the implant.
This new contraceptive consists of six silicone rods filled with the hormone
levonorgestrel which are inserted under the skin of a woman's upper arm. Norplant has
one of the longest periods of effectiveness for any contraceptive, five years.
Specialised minor surgery is needed for insertion and removal.
A disturbing feature of Norplant's design is that women cannot just stop using it
when they wish, says Health Action International's (HAI) latest publication, Problem
Drugs. They need to find a specially trained health worker who agrees to remove the
implants. This is not always easy. "Women are sometimes pressured into continuing to
use the method when they don't want to," says Problem Drugs author Andrew
Chetley.
In Thailand, women are routinely told that Norplant will not be removed for
minor side effects. Reports from the Dominican Republic, Egypt, and Indonesia also
found that "removal on demand" did not occur to the satisfaction of the users.
Norplant has been approved for use in at least 26 countries and more than 1.5
million women have used it. The developers believe that — despite its high cost —
more than 30 million women could be using it by the end of the decade, most of them
in developing countries.
National promotional campaigns are being used to help meet those targets. In
Zimbabwe in 1992, posters proclaimed that Norplant was a "five-year insurance plan"
with "no surprises", a convenient slogan that ignored the lack of knowledge of long
term effects of this contraceptive. Immediate effects are better known: at least two-
thirds of all women using Norplant experience irregular menstrual bleeding. In one
1
Overall, women need to have a greater voice in setting the policies and practices
that will determine not only how contraceptives — but all drugs — are researched,
developed, produced, marketed, used and provided. "Women make up the majority of
health care consumers and health care workers and should have a major voice in
determining health and medical care policy," says Yvonne Bogaarts.
— ends (850 words) —
Note to editors
This feature is based upon the information contained in sections 1C (Women and
drugs), 8A (Contraceptives) and 8E (Implants) of Problem Drugs. Publication details are
as follows:
Chetley, A., Problem Drugs, Amsterdam, Health Action International, 1993.
208 pages, indexed by subject, company and drug. ISBN 90-74006-06-X
Price: Dfl. 30 + Dfl. 5 postage and handling
Payment can be made in Dutch Guilders by Eurocheque, Postal Order or credit
cards (VISA, Mastercard or American Express).
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
J. van Lennepkade 334-T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84;
Fax: (31 20) 685 50 02
Andrew Chetley (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel. and Fax: (44 223) 41 36 67
3
0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0 FEATURE 0
problem
Health Action International
September 15, 1993
Tranquillisers: a tale of dependence
A British woman, Tess Higham, went to her doctor suffering from exhaustion
and anxiety. The doctor prescribed antidepressants and sleeping tablets. This
prescription began a dependency on psychotropic drugs that lasted 21 years. She
described them as "lost years" and said the experience was like a "chemical lobotomy".
Her experience is not unique. According to Health Action International's (HAI)
latest publication, Problem Drugs, the benzodiazepine drugs used to treat anxiety and
sleep disorders follow in a long tradition of drugs that were introduced as being safer
and less likely to cause dependence than their predecessors. But it was to be a false
promise.
Between 1 5 and 44% of long-term users become dependent on
benzodiazepines. Although they are among the most frequently prescribed drugs
worldwide, benzodiazepines do not cure any anxiety disorders; they suppress
symptoms that may return once the drug is stopped.
World Market for Psychotropic Drugs
Therapeutic type
World Sales 1991
$ Million
Hypnotics
Anti-anxiety drugs
Antidepressants
*
Antipsychotics
406
1,200
1,500
1,244
Total
4,350
* includes anti-epileptics and drugs to treat Parkinson's disease
Nonetheless, used wisely and for a limited amount of time, benzodiazepines can
provide valuable breathing space when an emotional crisis becomes intolerable. Expert
advice, such as that given by the UK Committee on Safety of Medicines (CSM), is that
benzodiazepines should only be used for the short-term (two to four weeks) treatment
1
of anxiety that is severe, disabling or causes extreme or unacceptable distress. The
CSM says that their use for "mild" anxiety is inappropriate and unsuitable.
Unfortunately, misuse through overprescribing is common. Problem Drugs
reports on studies in the UK, France, Spain, Canada and South Africa that found
widespread overprescribing, often for long periods of time. In one UK study, at least
one out of every three people taking tranquillisers had done so for periods of more than
four months.
One cause of poor prescribing is the promotional effort of the pharmaceutical
industry. In Peru in 1991, Multifarma promoted alprazolam (Alpaz) as a treatment for
virtually every condition of daily life. It promised relief for:
•
the "syndrome of the modern woman" — who suffers from increased worries
•
the "syndrome of today's man" — who worries about the future, his increased
about work, and an increased workload, emotional worries and stress;
responsibilities, frustrations at not reaching his goals, financial problems and
stress;
•
the "syndrome of the housewife" — who worries about the children's
education, having too much work, financial problems, fear of domestic
accidents and a fear of the house being burgled; and
•
the "syndrome of the elderly" — who fear being lonely, worry about their health
and future, have limited finances, and lack affection.
In 1992, also in Peru, Upjohn used a similar theme for its brand of alprazolam
(Xanax), indicating it for "a large variety of patients with anxiety", including a business
executive who is under pressure, a housewife coping with family conflicts, a lonely
elderly woman worried about her health, and a cardiac patient with digestive problems
and fears of another heart attack.
"This medicalisation of life may help the pharmaceutical industry sell more
drugs," says Andrew Chetley, author of Problem Drugs, "but it bears no resemblance
to appropriate health care."
Women and the elderly are particular targets for benzodiazepines,
antidepressants and other psychotropic drugs. In most industrialised countries women
are two to three times more likely than men to be using tranquillisers or
antidepressants. For example, a study in the Netherlands found that doctors were two
times more likely to prescribe benzodiazepines for women than men when neither the
symptoms nor the diagnosis warranted the drug. In developing countries, too,
promotional materials clearly identify women as needing powerful drugs to cope with
daily life. In India, for example, Sandoz recommends giving women suffering from
anxiety an antipsychotic drug, thioridazine (Melleril-10), usually reserved for the
treatment of severe psychoses such as schizophrenia. The Indian subsidiary of Merck
2
Sharp and Dohme suggests that women undergoing the menopause would benefit from
a combined tranquilliser and antidepressant (Libotrop). Menopause is not a valid
indication for either drug; together, they make an irrational combination drug which
should not be used to treat any condition.
In the USA, the elderly, who make up one-sixth of the total population, are
prescribed one-third of all tranquillisers and more than half of all sleeping medications.
Studies from other countries confirm that the elderly receive a disproportionately high
amount of prescriptions for benzodiazepines. The adverse effects of these drugs are
often more severe among the elderly. These include confusion, disorientation and lack
of coordination — symptoms that can be misdiagnosed as signs of dementia. In
addition, the lack of coordination caused by benzodiazepines can lead to falls and
broken bones.
HAI is calling on governments and health workers to take action to limit the use
of benzodiazepines in the elderly in particular, and to generally restrict their use for
severe anxiety or severe sleep disorders. HAI is also calling for better independent
information about the rational use of psychotropic drugs and strict penalties for poor
quality promotional material. The development of national and local formularies and
therapeutic guidelines for the treatment of anxiety, insomnia and depression and the
encouragement of non-drug solutions are seen as ways to improve the current
situation.
In the words of consultant psychiatrist, Brian Ballinger, "More emphasis should
now be placed on managing sleep disorders and anxiety without using drugs."
— ends (840 words) —
Note to editors
This feature is based upon the information in section 10A (Psychotropics) of Problem
Drugs. Publication details are as follows:
Chetley, A., Problem Drugs, Amsterdam, Health Action International, 1993.
208 pages, indexed by subject, company and drug. ISBN 90-74006-06-X
Price: Dfl. 30 + Dfl. 5 postage and handling
Payment can be made in Dutch Guilders by Eurocheque, Postal Order or credit
cards (VISA, Mastercard or American Express).
For further information, please contact:
Barbara Mintzes, Press Office, HAI Europe
J. van Lennepkade 334-T, 1053 NJ Amsterdam, The Netherlands
Tel: (31 20) 683 36 84; Fax: (31 20) 685 50 02
Andrew Chetley (author)
24 Speedwell Close, Cambridge CB1 4YZ, UK
Tel and Fax: (44 223) 41 36 67
3
0 FACTS & FIGURES 0 FACTS & FIGURES 0 FACTS & FIGURES 0 FACTS a FIGURES 0
HA!
Hearth Action International
Problem Drugs: Facts and Figures
Size of the world market
The value of the world pharmaceutical market was estimated by the European pharmaceutical
industry (EFPIA) at $164.5 billion in 1989. The 1990 market was estimated at being between
$174 billion and $186 billion. The major market areas were: North America, 33.0%; Western
Europe, 31.9%; Asia, 25.4%; Latin America, 3.9%; Eastern Europe, 3.1%; Africa, 1.8%; and
Australasia, 1.0%. Forecasts for the year 2000 suggest that the global market could reach
$330 billion.
Drug category
Antidiarrhoeals
containing antibiotics
Antibiotics
penicillins
cephalosporins
quinolones
aminoglycosides
Analgesics
NSAIDs
Cough and cold remedies
Cognitive enhancers
Oral contraceptives
Psychotropics
hypnotics
anti-anxiety drugs
antidepressants
antipsychotics
Global sales
US$ millions
600
150
22,000
3,000
6,800
2,250
620
15,000
6,000
7,300
1,500
1,800
4,350
406
1,200
1,500
1,244
Year
1993E
1989E
1993
1988
1988
1990
1988
1995E
1991
1990 (OTC only)
2000E
1989
1991
1991
1991
1991
1991
Notes: E = estimated; OTC only = over-the-counter products and does not include
prescription medicines
Increasing demand by misleading promotion
A 1990 survey of doctors in the UK found that 66% of doctors said a pharmaceutical company
sales representative had claimed more indications for a product than were permitted on the
approved data sheet.
Imitative research
Of the 348 new drugs from the 25 largest US drug companies between 1981 and 1988, the
US Food and Drug Administration (FDA) said that at the time of introduction:
3%
(12 drugs) made an "important potential contribution to existing therapies";
13%
made a "modest potential contribution"; and,
84%
made "little or no potential contribution".
1
Population groups where caution is needed
Women make up about 52% of the world's population; children under 15 account for about
32%; people over the age of 65 account for about 6%. All together, at least two-thirds of the
world's population are in "special case" categories where more care needs to be taken in the
use of drugs and where less is known about the effects of the use of drugs. These are also the
groups of people who are most likely to use drugs.
Children: According to the World Health Organization (WHO), two-thirds of all drugs used by children
may have little or no value. At least $1 billion is wasted every year on inappropriate
antidiarrhoeal drugs and cough and cold remedies for children.
Women: Women are more likely to use vitamins than men; two to three times more likely to be
prescribed tranquillisers, sleeping tablets and antidepressants; and three times more likely than
men to use contraceptives.
The elderly: In the USA, 1 out of every 6 people is over 60, but they consume:
1 out of every 3 tranquillisers
1 out of every 2 sleeping pills
1 out of every 3 antidepressants
2 out of every 3 antihypertensives
2 out of every 5 gastrointestinal drugs
Misuse of antibiotics
Studies from around the world show that between one-third and two-thirds of antibiotic use is
inappropriate and unnecessary.
Inappropriate pain killers
Combination pain killers offer no real advantage, are more costly and can be harmful. They are
more likely to produce kidney damage than single ingredient pain killers. Yet one out of every
three pain killers on the market in developing countries in Asia, the Middle East, Africa, and the
Caribbean in 1990 was a combination product.
NSAIDs: a high risk of adverse effects
Non-steroidal anti-inflammatory drugs (NSAIDs) account for 5% of all drugs prescribed in the
UK, but are responsible for 25% of all adverse drug reactions reported to the Committee on
Safety of Medicines.
Consequences of vitamin misuse
Misuse of vitamins can do harm. For example, it can:
• distort national health priorities;
• drain limited national economic resources and foreign exchange;
• waste limited individual and family financial resources;
• encourage harmful beliefs about the nature of health; and
• encourage ineffective and harmful practices.
Drugs in pregnancy
Surveys from more than 20 countries around the world show that 8 out of 10 women take at
least one drug during pregnancy, with an average of three to four drugs.
Prescribing in pregnancy
The editor of a book on drugs in pregnancy, Dr D.F. Hawkins, a consultant obstetrician,
gynaecologist, and pharmacologist suggests four basic rules for prescribers.
1.
Review all patients with medical disorders before they conceive, regarding every
woman of reproductive age as a potential antenatal patient, and encouraging them
to attend for counselling before planning a pregnancy.
2.
Question the real need for any drug in pregnancy, giving due consideration to
alternative methods of treatment.
3.
Review all drug regimens in pregnancy to see how careful therapeutics and good
control can minimise risks.
4.
Use medicines that have been widely employed in pregnancy for years in preference
to the latest drugs.
2
Contraceptives
The pill: Four out of every 10 oral contraceptives
on the market in Asia, the Middle East,
Africa and the Caribbean during 1990 and
1991 should be avoided because they
contain a high level of the hormone
oestrogen, or the balance between the
oestrogen and progestogen is not
acceptable.
IUDs: A woman who uses an intrauterine device
(IUD) is about twice as likely to suffer
from pelvic inflammatory disease (PID) an infection within the fallopian tubes,
ovaries or uterus. PID develops in an
estimated 1 % of young women annually
and causes more illness in women of 1 5
to 25 years of age than all other serious
infections combined. PID is a leading
cause of infertility.
Global estimates of the number of people
using different methods of contraception
(1980s)
Method
Sterilisation
male
female
Hormonal contraceptives
oral
injectables
implants
IUD
Condom
Other barrier methods
Natural birth control
Withdrawal
Number of users
42 million
140 million
63 million
6 million
1.5 million
80 million
*
40 million
8 million
32 million
32 million
Hormone replacement therapy (HRT)
*nearly 60 million IUD users are in the
In 1988, the most often prescribed drug
People's Republic of China
in the USA was a brand of amoxycillin,
Amoxil, produced by Beecham. By 1992,
the most widely prescribed drug was an
oestrogen product, Premarin, produced by Wyeth-Ayerst and promoted as hormone replacement
therapy for postmenopausal women.
Preliminary findings from one health region in the UK suggest that the use of HRT for 10 years
from the time of menopause would lead to a reduction of hip fractures 20 years in the future of
only some 5 to 10%. Five to 30% of women who receive HRT at a dosage level considered to
be sufficient to prevent bone loss nonetheless still suffer a reduction of bone density. As well,
most deaths in women with low bone mineral density are unrelated to the occurrence of
fractures.
The whole concept of hormone replacement therapy is itself promotional. The hormones are not
missing: they do not need to be replaced.
Psychotropics
I
In the UK, nearly one out every eight people take tranquillisers for periods of four months or
more. The UK Committee on the Safety of Medicines advises that these drugs should only be
used for the short-term relief (two to four weeks) of anxiety or insomnia that is severe,
disabling or subjects the individual to extreme or unacceptable distress.
3
0 QUOTES 0 QUOTES 0 QUOTES 0 QUOTES 0 QUOTES 0 QUOTES 0 QUOTES 0
Health Action
A few quotes in Problem Drugs
"There is an inherent conflict of interest between the legitimate business goals of manufacturers
and the social, medical and economic needs of providers and the public to select and use drugs in
the most rational way."
— World Health Organization, 1993
"Prescription drugs are marketed as if they were cosmetics or candy. Claims are made beyond
what the product will do. Demand is inflated beyond the medical need. Uses are promoted that
are neither healthy nor wise."
— David Jones, former executive at Abbott and Ciba-Geigy, 1990
"There are simply not enough sick people around to satisfy the desires of the marketing
managers of drug companies. There are not enough sick people around to absorb all the new
variations on old drugs which are produced."
— Professor Bill Inman, Drug Safety Unit, University of Southamptom, UK, 1991
"The most important objective of the short-term component of public health policy under
conditions of poverty is to set priorities.... Setting priorities, in fact, means preventing avoidable
death. It certainly does not mean treating self-limiting diseases."
— Dr Klaus Leisinger, Head of Third World Relations, Ciba-Geigy, 1989
"Children may tend to grow up believing that drugs are the solution to many of life's problems."
— World Health Organization, 1987
"A major factor in the number of adverse drug reactions among the elderly is their doctors' over
reliance on promotional materials provided by the drug manufacturers."
— US Department of Health and Human Services, 1989
"Antidiarrhoeal drugs generally divert attention from oral rehydration and are also too expensive
for most families."
- Rolf Carriere, UNICEF India, 1987
"There are no drugs available at present that will safely and effectively stop diarrhoea."
— World Health Organization, 1989
"Rather than attempt to overcome or pre-empt resistance by prescribing yet another agent, the
objective should be to prevent resistance by limiting the amount of antibiotic prescriptions."
— T.D. Wyatt and colleagues, British Medical Journal, 1990
"NSAIDs [non-steroidal anti-inflammatory drugs] are overvalued as symptomatic treatments, yet
they continue to be prescribed in high quantities.... Empirical evidence suggests that a high
proportion of long-term NSAID users can be safely switched to simple analgesics without
compromising their therapy.... Not only would there be a real saving of health expenditure
through the use of cheaper drugs, but also there would be a considerable reduction in mortality
and morbidity from NSAID side-effects."
— P.A. Dieppe and colleagues, Lancet, 1993
1
"NSAIDs are one of the most common cause of adverse reactions reported to drug regulatory
authorities."
— P.M. Brooks, Lancet, 1993
"Although cyproheptadine stimulates appetite in some children, Medical Letter consultants
believe that promotion of the drug as an appetite stimulant will do more harm than good."
— The Medical Letter on Drugs and Therapeutics, 1971
"In general, little or nothing is gained by stimulating appetite by drugs."
— D.R. Laurence and P.N. Bennett, Clinical Pharmacology, 1987
Age-associated memory impairment is "a pseudo-disease. It's having a drug and wanting an
illness for that drug. It's a modern disease, when pharmaceutical chemists can produce hundreds
of molecules and the industry is desperately wanting to get these molecules on the market."
— Prof. Ian Hindmarch, University of Surrey, UK, 1991
"There are few valid indications for vitamin or mineral supplements."
— American Medical Association, 1986
"The routine prescription of multivitamin and mineral supplements for pregnant and lactating
women is common but generally unnecessary. A well balanced diet designed to meet the needs
of pregnant and lactating women minimises the need for supplementation."
— American Medical Association, 1986
"DES [diethylstilboestrol] present risk without benefit."
— R.J. Stillman, American Journal of Obstetrics and Gynecology, 1982
"The burden of ill health associated with reproduction is divided very unequally between the two
sexes, with women bearing the brunt of it.... Contraceptive use worldwide is three times greater
among women than men, and among all available methods, those used by women carry more
potential health hazards."
— World Health Organization, 1992
"In trying to find a method of birth control, the main action is to interfere with a normal body
process and this means taking extra-special care. The method will be used by initially healthy
women or men and should not make them unhealthy; on the other hand, it could be used by
people who are already unhealthy and must not do them additional harm."
— Dr J. Guillebaud, The Pill, 1991
In Thailand, "because of the cost of the method, women are routinely informed when choosing
Norplant that the implants are appropriate for long-term spacing and will not be removed for
minor side-effects."
— M. Zimmerman and colleagues, Studies in Family Planning, 1990
"Menopause is not a disease, but a life-cycle transition."
— Margaret Lock, medical anthropologist, 1991
"Benzodiazepines do not cure any anxiety disorders — they suppress symptoms which may
return when the drug is stopped."
— Prof. Gavin Andrews, Australian Prescriber, 1991
"More emphasis should now be placed on managing sleep disorders and anxiety without using
drugs."
— Dr Brian Ballinger, consultant psychiatrist, 1991
"Since 1958, when imipramine (Tofranil) was first reported to be effective in depression, no
other antidepressant has been widely shown to be any more effective."
— E.H. Rand, American Family Physician, 1991
2
problem
Health Action International
Merck, Sharpe and Dohme’s Indian subsidiary,
Merind, promotes cyproheptadine as an appetite
stimulant in 1991. Cyproheptadine is an
antihistamine used to treat allergic reactions.
“Although cyproheptadine stimulates appetite in
some children... promotion of the drug as an
appetite stimulant will do more harm than good."
Anon, "Cyproheptadine (Periactin)'', The Medical
Letter on Drugs and Therapeutics, Vol 5, No 3.
March 1971
“in general, little or nothing is gained by
stimulating appetite by drugs.” Lawrence DR and
Bennett, PN, Clinical Pharmacology, Edinburgh,
Churchill Livingstone, (6th edn), 1987, p365
pi’ttblein
Health Action International
NOOTROPIL Jarabe ggg.
** "—
principio BCiitro: Piracetam
PROBLEMAS DE MEMORIA
DIFICULTAD DE APRENDIZAJE
FALTA DE CONCENTRACION
CANSANCIO INTELECTUAL
RENDIMIENTO DEFICIENTS
AGITACION - IRRITABILIDAD
POSOLOGIA SIMPLE
TRATAMIENTO SEGURO
A drug which can improve a child’s grades? Misleading
promotion for piracetam (Nootropil) by UCB in Peru in 1991
NOOTROPIL
MEJORA LA COMUNICACION NEURONAL
HA!
Health Action International
Lomofsl
Provides fast, antidiarrhoeal action
The desire to defecate diminishes after
approximately one hour1.
Preferred alternative to__________
The
Imodium (Loperamide)__________
Rapid Control
Anfidiarrhoeal
prescribed by Economical____________________
physicians
in over
Lomotil
70 countries
In a multicentre trial it was found
“that on an average Lomotil treated patients
reached a cure ‘nearly six hours before
those receiving Imodium”2.
Available to patients at just 19 paise per tablet.
For prompt control of diarrhoea
1991 ad in Searle’s Diarrhoea Update in India for
Lomotil (diphenoxylate + atropine), featuring a picture
of the Dutch queen.
Lomotil has been described as “the worst means of
treating" infectuous diarrhoea because it can prolong
the length of time that toxins from the bacteria remain
in the intestinal tract. Lappe, M, When Antibiotics Fail,
Berkeley, North Atlantic Books. 1986. pl54
problem
Health Action International
Fiebre,
...Dolor?
Novalffina®
Dipifona
• Maxima eficacia
• Amplio margen de seguridad
• Rapidez de accion
• Facilidad de administracion
Hoechst E
Hoechst advertises dipyrone's "ample safety margin"
in Comahue Medico in 1992 in Latin America. Fever
and pain are listed as indications.
Dipyrone has caused deaths from agranulocytosis
(severe loss of white blood cells due to bone marrow
damage) and anaphylactic schock (a severe allergic
reaction) and has been banned or severely restricted
in many countries.
"Since effective, less dangerous alternative drugs are
available there is no case for the continued use of
aminopyrine and dipyrone." Dukes, MNG. Side
Effects of Drugs Annual 4. Amsterdam. Elsevier,
1980. pp63-4.
problem
ftl
e.
Health Action International
We have taken a Five Year
Insurance Plan...
We have left no room for Surprises
\W i / /
\\\'//
\W//
NORPLANT
The 5 year contraceptive plan
t
fc farther ir.forwi&itnikte /sur it<»! C'i'.'tr; •I.
f
nr
faith rtnlrt
tvs incentre
**<
FAMILYFlANH1MCOUNCIL
ftvrpirtfttr&axv‘^
1992
poster promoting the contraceptive Norplant
(levonorgestrel implants) in Zimbabwe.
No room left for surprises? The long term risks of
this hormonal contraceptive to users - or to babies
exposed during breastfeeding - are unknown.
problem
‘
I •'
:
Health Action International
OESTROGENEN EN PROGESTAGENEN
ZIJN VOOR HEN NU AL
DE GEWOONSTE ZAAK VAN DE WERELD.
DAT GELDT MET ZUMENON EN DUPHASTON
STRAKS OOK VOOR HUN OVERGANG.
Voor veel jonge vrouwen van nu bchoort
het innemcn van homioncn tot de routine
van alledag. Straks - rond cn na de overgang kan dat wecr aan de ordc zijn. Dan inimcrs
worden bchandeling cn prcvcntic van emstige
posmicnopauzalc klachtcn actucel en kan hormoonsupplctic geindicccrd zijn
Zumenon en Duphaston voldoen ruinischoors aan de eisen voor verannvoorde hormoonthcrapic. Het oestradiol van Zumenon is
idcntick aan het lichaamseigen oestrogeen,
terwijl Duphaston zorgt voor optimale progcstagcne bcschcrming. En om het paticnten
extra makkelijk te maken zijn zc ook nog in
edn verpakking verkrijgbaar. Onder de naatn
Zumeston.
Tegcn de tijd dat hormoonsupplcticgcwenst
is, ligt de kcuzc dan ook voor de hand. Voor
de jongcrc generatic zijn homioncn iinmcrs
nu al de gewoonste zaak van de wcrcld
ZUMENON EN DUPHASTON
OMDAT HORMOONTI-IER/XPIE ZO ZUIVER MOGELIJK MOET ZIJN.
“Oestrogen and progestagen are already the most normal thing
in the world for them This will also be true for Zumenon
(estradiol) and Duphason (dydrogesteron) during their
menopause."
Duphar promotes their "as pure as possible" hormone therapy
for women in the Netherlands in Nederlands Tijdschrift voor
Geneeskunde. May 1993
problem
Health Action International
para el tratamiento eficaz
de una mayor variedad
de pacientes con ansiedad
Elejecutivosobrecargadode trabajo
que esta lenso. irritable y lien&dificultad
de concenirarse debido a presiones
financieras o a cambios de
re^ponsabilidades
El pacicnle de edad avanzada. solilario.
a mcnudotristc.quese preocupa por su
mala salud y tiene dificultades para
dorfriir y aprension con respecto al
fuluro.
LI ama de casa ansiosa que se preocupa
por la finanzasde la familia y tambien
por conflictos con los hijos. y se pone a
lorarfacilmcntc.
El pacicntecardiacoasustadoque terne
ot ro ataque de corazon, no puede
relajarse.se preocupa por su familia y
con frecuencia experimenta trastornos
digest i vos y ma reos.
Tranquillisers for the pressures of everyday life
Notepad from Upjohn for doctors in Peru in 1992, promoting a
benzodiazepine (Xanax or alprazolam) for treatment of “a large
variety of patients with anxiety": the executive who is tense
because of financial pressures and new responsibilities: the
housewife who is preoccupied with family finances and conflicts
with her children; the elderly patient who is lonely and concerned
about her poor health; and the cardiac patient worried about
having another heart attack and experiencing digestive problems.
problem
Health Action International
Sandoz promotes an
antipsychotic, thioridazine, in
India in 1990, as a substitute for
diazepam, and suggests
treatment of symptoms such as
“feeling inadequate” and
“indecisiveness”.
The indications for this drug in
the British National Formulary are
“schizophrenia and other
psychoses, mania" and short
term management of psychotic
episodes or severe anxiety,
agitation and restlessness. BMA
and the Royal Pharmaceutical
Society of Great Britain, British
National Formulary, London, BMA
and The Pharmaceutical Press,
No 25. Mar 1993, ppi 49, 154
DEPRESS!}
Common symptoms:
r
Low Mood
Hopelessness
Loss of motivation
Feeling inadequate
Sleep disturbance
Conscious Guilt
Loss of interest
Suicidal wishes
Indecisiveness
Put your patients
on Melleril-25 rial
Loss of appetite
See them respond
& WITHIN A WEEK
WHAT IS HEALTH ACTION INTERNATIONAL?
Health Action International (HAI) is an informal
network of some 150 consumer, health, development
action and other public interest groups involved in
health and pharmaceutical issues in 60 countries
around the world. HAI has active participants in
Africa, Asia, Europe, Latin America, North America
and the Pacific region.
HAI believes that all drugs marketed should:
• meet real medical need;
• have therapeutic advantages;
• be acceptably safe;
• offer value for money.
In 1988 the World Health Organisation (WHO)
calculated that of the 5 billion people in the world,
between 1.3 and 2.5 billion have little or no regular
access to essential drugs. At the same time it is
estimated that as many as 70% of the drugs on the
global market are inessential and/or undesirable
products. HAI supports the Essential Drugs Policy of
the WHO which concentrates on the supply and use
of some 250 drugs considered to be the most
essential. HAI also believes that the problem of the
enormous numbers of inappropriate and ineffective
products must be tackled.
HAI recognises that access to appropriate medicines
is only one element of health care and that a
significant improvement in world health will be
achieved only if the problems of poverty, poor
sanitation, and malnutrition are addressed.
HAI works through research, education, action
campaigns and dialogue. HAI publications are used
by health workers, government drug regulatory
agencies and consumers around the world. Research
undertaken by HAI’s participants contributes to better
education about drugs, and is the foundation for
campaigns calling for stronger regulations on the
production, distribution, marketing and use of drugs.
HAI participants organise and participate in
educational and training seminars in many parts of
the world. Special attention is given to the use of
medicines by women and to the development of user
information. HAI participants are active in
monitoring promotion practices, supporting efforts to
establish national drug and health policies, and
encouraging the supply of essential drugs.
In the few years since its foundation, the HAI
network has achieved successes at both international
and national level. HAI’s contribution has been
important in areas such as:
• achieving a gradual improvement in the
advertising standards of many of the major
multinational pharmaceutical companies;
• promoting the essential drugs concept and in
winning both political acceptance and public
understanding of rational drug use;
• establishing an international network which has
become accepted as the group protecting the
interests of users of medicines;
• campaigns leading to regulatory action in various
countries to:
- ban harmful antidiarrhoeals,
- stop the inappropriate use of high dose
hormonal drugs,
- end the use of anabolic steroids as growth
stimulants for children,
...many examples can be given but much work
remains to be done.
HAI works at many different levels: with health
workers in many countries; with academics and
trainers; with government officials and national
health associations; with regional decision making
bodies such as the Commission of the European
Community; with the pharmaceutical industry; and at
the international level. HAI participants have taken
part in many consultations and discussions organised
by the WHO as part of its revised Drug Strategy and
been active in mobilising support for the WHO
Action Programme on Essential Drugs and Vaccines.
If you would like more information or would like to
become involved in HAI, contact one of HAI’s three
regional coordinating offices:
HAI Clearinghouse/Action for Rational Drug Use
for Asia (ARDA)
c/o IOCU, P.O. Box 1045,
10830 Penang, Malaysia
tel: + (604) 371396, fax: (604) 366506
AIS Latin America
c/o Accion para la Salud,
Avda. Palermo 531, Dpto. 104,
Lima, Peru
tel/fax: (5114) 7123202
HAI-Europe
J. van Lennepkade 334-T
1053 NJ Amsterdam, the Netherlands
tel:(31 20) 6833684, fax:(31 20) 6855002
Hai believes that all drugs marketed should meet real medical need, have real therapeutic
advantages, be acceptably safe and offer satisfactory value for money.
Health Action International is an informal cooperating network of some 150
consumer, development action and other public interest groups worldwide. The HAI
network works to further the safe, rational and economic use of pharmaceuticals
worldwide; to promote the full implementation of the World Health Organization’s
Action Programme on Essential Drugs and to look for non-drug solutions to the
problems created by impure water and poor sanitation and nutrition.
Health Action International
Cgitre to take
control of
vital drugs
Lucknow: The Central Gove
rnment is contem
plating taking ov
er control of the
life-saving drugs in
the country under
its purview to ma
ke easy availability
of the drugs to the
patients on a rea
sonable price.
. ‘‘Tlie Centre had already
set up a committee under a
joint secretary in the Health '
ministry to give its report on
the matter by next, month,”
Union Chemical and Fertilis
er Minister Ramvilas Paswan
sai^Bre on Saturday
Paswan told media persons
here that there was an irnme- ,
diate need for taking control
’ of the life- saving drugs so
that the patients get them at
reasonable price.
Reiterating that the price
of medicine would not be
hiked any more till March
2005, he said at present the
life- saving drug of cancer
and AIDS were very costly
and the government would
also take on all possible steps
to make it cheaper.
The minister also revealed
that during a checking it was
found that at least 45 drugs
were being sold at much
higher price than then- costs.
"We have talked to the people
of the industry about such
anomalies and have directed
them to immediately rectify
it,” he said.
J
/A
Article 14: Review procedure
WHO and UNCTAD shall submit a report in four years to the World
Health Assembly and the United Nations Conference on Trade and
Development, reviewing all the aspects of the Code with proposals
for the improvement and further development of the Code.
52
Article 14: Review procedure
WHO and UNCTAD shall submit a report in four years to the World
Health Assembly and the United Nations Conference on Trade and
Development, reviewing all the aspects of the Code with proposals
for the improvement and further development of the Code.
52
tions is inappropriate to meeting the health needs of the people . par
ticularly in developing countries;
!AI —A Draft International Code on Pharmaceuticals
reamble
9.
Bearing in mind that in a number of instances the prices of phar
maceuticals do not relate to the actual cost of manufacture but are
determined by what the market can bear;
10.
Drawing attention to the fact that there are wide discrepancies in the
prices of drugs on the world market which cannot be explained by
"he participating countries:
Reaffirming that good health is a fundamental human right;
2.
Recognising that governments have a responsibility for ensuring the
health of their people;
3.
Recalling that a main social target of governments, international
organizations and the whole world community in the coming decades
should be the attainment by all the peoples of the world by the year
2000, of a level of health that will permit them to lead a socially and
economically productive life;
market forces;
1.
Convinced that the promotion and protection of the health of the peo
ple is essential to sustained economic and social development;
5.
Drawing attention to the fact that provision of an adequate supply
at reasonable cost of essential drugs is, among other things, a prere
quisite for the promotion and protection of the health of the people;
5.
Aware that a majority of the world's population, particularly those in
the rural areas and urban slums of developing countries, does not have
regular access to even a few essential drugs necessary for primary
health care whilst the drug bills in these countries may account for
up to 40 - 50 per cent of the total health expenditure;
7.
Affirming the right of every sick person to have access to essential
pharmaceuticals;
8.
Considering that a limited number of transnational corporations bas
ed in developed countries manufacture almost SO per cent of the world
output of pharmaceuticals and control drug technology and world trade
and that the existing svstem of marketing practices of these corpora-
26
11.
Recognising that the pharmaceutical industry is characterised by an
unusual degree of market power;
12.
Recalling that the non-aligned and other developing countries have
expressed an urgent desire to reform the existing system for the pro
curement and provision of pharmaceuticals;
13.
Taking into consideration that a large number of developing coun
tries have already established local manufacture of pharmaceuticals
and are purchasing pharmaceutical technology on the world market
and that some of them are forced to pay exorbitant amounts of foreign
exchange for their technology imports;
14.
Convinced that the development and strengthening of indigenous
technological capacity in the pharmaceutical sector is critically depen
dent on ongoing research and development activities and that a
research base in developing countries is necessary to insure against
underdevelopment;
15.
Believing that certain fundamental principles associated with trade and
technology in the pharmaceutical sector transcend national and
regional boundaries and are universally applicable;
16.
Recognising that the indispensable role of pharmaceuticals in the con27
trol of disease and the prevention of human stiff _,ing distinguishes
them from other consumer goods which are subject to the laws of
supply and demand;
17.
18.
Believing that, in the light of the foregoing considerations, an Interna
tional Code of Pharmaceutical Marketing Practices, including norms
on promotion, pricing, sales, distribution, trade, technology, research
and development, in the pharmaceutical sector would, under mutually
agreed and advantageous terms to all parties, enable all participating
countries —particularly developing countries —to provide to all their
people, safe and effective essential drugs at prices they can afford.
Article 3: Definitions
3.1
"Active substance": That portion of a drug product intended to pro
duce a therapeutic effect.
3.2
"Adverse reaction": A reaction to a drug which is noxious or unintend
ed and which occurs at doses normally used in man for the prophylaxis,
diagnosis, or therapy of disease or for the modification of physiological
function.
3.3
"Advertisement”: Any representation conveyed by any means
whatever for the purpose of promoting directly, or indirectly, the
distribution or sale of any drug.
3.4
"Auxiliary pharmaceutical substance": A substance added to the ac
tive substance to give the latter suitable consistency so that a conve
nient dosage form can be formulated.
3.5
"Benefit/risk ratio": The ratio of benefit to risk in the use of a drug:
a means of expressing a judgement concerning the role of the drug
in the practice of medicine, based on efficacy and safety data along
with consideration of misuse potential, severity and prognosis of the
disease, etc. The concept may be applied to a single drug or in com
pelling two or more drugs used for the same indication.
3.6
"Clinical trial": A procedure for comparing the relative advantages
and disadvantages of one drug with another by administering them
according to a planned protocol to a group of patients under con
trolled conditions.
3.7
"Contra-indications": Conditions which make the administration of
a drug positively harmful. These conditions include diseases,
physiological states leg pregnancy, lactation) and specific groups
(neonates, infants).
Agree on the adoption of the following International Code of Phar
maceuticals Marketing Practices.
Article 1: Aim of the Code
The aim of this Code is to enable consumers, particularly those from
the developing countries, to procure safe and effective pharmaceuticals
essential to their real health needs, at costs they can afford.
Article 2: Scope of the Code
2.1
This Code shall apply to all international activities connected with the
procurement of pharmaceuticals and pharmaceutical technology.
2.2.1
The Code applies to the following activities associated with the phar
maceutical sector: drug registration; registration of new drugs: pre
registration clinical trials of new drugs; provision of information; labell
ing, package inserts and promotional material; sales promotion of phar
maceutical products; pricing, sales and distribution; pharmaceutical
technology; research and development.
28
29
3.8
3.9
3.10
3.17
"Drug registration": The term used for the procedure of release, com
pliance or approval for marketing after a drug has undergone the pro
cess of drug evaluation (by a competent health authority).
"Over the counter drug": A drug that can be purchased without ;
prescription from a medical doctor or other authorised health person
nel. This is also referred to as a proprietary drug.
3.18
"Package insert": A leaflet containing specified relevant informatiot
on a drug included in every package containing that particular drug
"Efficacy": The ability of a drug to produce the purported effect as
determined by scientific methods.
3.19
"Pharmaceutical manufacturers": All persons involved in the produc
tion of a drug, including processing, compounding, formulating, fill
ing, packing, repacking, altering, finishing and labelling with a view
to its storage, sale and distribution.
3.20
"Pharmaceutical traders": All persons involved in the process of im
port, storage, sale and distribution of drugs whether as wholesalers
or retailers.
3.21
"Purity": The degree to which other chemical or biological entities
are present in any substance.
3.22
"Sample": Single or small quantities of a product supplied without
cost.
3.23
"Side-effects": Expected but noxious or unpleasant effects produc
ed by a drug at normal doses.
3.24
Trade name (also called brand name): This is a name given to <
drug by the manufacturer which if registered and protected under na
tional legislation, can be used exclusively by the manufacturer tc
distinguish his product from other products containing the identica
active chemical substance or substances.
3.11
"Ethical drug": A drug that can be purchased only after obtaining
a valid prescription for it from a medical doctor or other authorised
health personnel. This is also referred to as a "prescription drug"
3.12
"Interactions": A noxious or unintended reaction which occurs when
two or more drugs are administered simultaneously at normal doses.
This term also refers to similar reactions between a drug and food
taken together.
3.13
marketed for medical purposes, including any new salts and ester
of an active substance, new fixed combinations of substance
previously marketed, or of any drug previously marketed if its indica
tions, mode of administration, or formulation, are changed.
"Drug" (synonymous with "pharmaceutical product"): Any substance
or a mixture of substances that is manufactured, sold, offered for sale
or represented for use in: (i) the treatment, mitigation, prevention or
diagnosis of disease, an abnormal physical state or the symptoms
thereof in humans or; (ii) the restoration, correction or modification
of organic functions in humans.
"International non-proprietary name" (INN): This is the official name
assigned to a drug by the World Health Organisation and is interna
tionally recognized. It is also known as a generic name.
3.14
"Label": A display of written, printed or graphic matter upon the im
mediate container or the outside container or wrapper of a drug
package.
3.15
"Marketing": Product promotion, distribution, sales, advertising, pro
duct public relations and information services.
3.16
"New drugs": A drug which has not been previously registered or
30
31
marketed for medica1 purposes, including any new salts and esters
of an active substance, new fixed combinations of substances
previously marketed, or of any drug previously marketed if its indica
tions, mode of administration, or formulation, are changed.
Article 4: Drug registration
4.1
All pharmaceutical products, both ethical drugs and over-the-counter
(OTC) preparations offered for sale in a country, should be duly
registered by a competent authority in that country.
4.2
Pharmaceutical manufactures and traders will abstain from making
available in a country pharmaceutical products which are not registered
in that country.
4.3
4.4
4.5
4.6
3.17 "Over the counter drug": A drug that can be purchased without a
prescription from a medical doctor or other authorised health person
nel. This is also referred to as a proprietary drug.
3.18 "Package insert": A leaflet containing specified relevant information
on a drug included in every package containing that particular drug.-
Pharmaceutical manufacturers and traders must provide the national
registration authorities with all the information available to them on
a pharmaceutical product, including all information they have given
to countries with an efficient drug registration system, even if all this
information has not been requested by the registration authority.
3.19
"Pharmaceutical manufacturers": All persons involved in the produc
tion of a drug, including processing, compounding, formulating, fill
ing, packing, repacking, altering, finishing and labelling with a view
to its storage, sale and distribution.
Pharmaceutical manufacturers and traders must provide the registra
tion authority with a list of all countries in which the specific product
has not been accepted for registration.
3.20
"Pharmaceutical traders": All persons involved in the process of im
port, storage, sale and distribution of drugs whether as wholesalers
or retailers.
3.21
"Purity": I he degree to which other chemical or biological entities
are present in any substance.
3.2z
Sample : Single or small quantities of a product supplied without
cost.
Pharmaceutical manufacturers and traders should inform the registra
tion authority if a pharmaceutical product already registered in that
country has been removed from the register of any other country
together with the reason for its removal.
Pharmaceutical manufacturers and traders, when applying for registra
tion of a product, must undertake that subsequent to the product's
registration they will provide the registration authority and consumers
with all new information they receive on its effects, adverse reactions
and interactions.
3.23 "Side-effects": Expected but noxious or unpleasant effects produc
ed by a drug at normal doses.
3.24
Article 5: Registration of new drugs
5.1
Pharmaceutical manufacturers and traders shall apply for registration
of a new drug only if the new drug:
32
"Trade name" (also called brand name): This is a name given to a
drug by the manufacturer which if registered and protected under na
tional legistation, can be used exclusively by the manufacturer to
distinguish his product from other products containing the identical
active chemical substance or substances.
31
a)
Article 4: Drug registration
4.1
4.2
4.3
4.4
All pharmaceutical products, both ethical drugs and over-the-counter
(OTC) preparations offered for sale in a country, should be duly
registered by a competent authority in that country.
Pharmaceutical manufacturers and traders must provide the registra
tion authority with a list of all countries in which the specific product
has not been accepted for registration.
4.5
Pharmaceutical manufacturers and traders should inform the registra
tion authority if a pharmaceutical product already registered in that
country has been removed from the register of any other country
together with the reason for its removal.
4.6
Pharmaceutical manufacturers and traders, when applying for registra
tion of a product, must undertake that subsequent to the product's
registration they will provide the registration authority and consumers
with all new information they receive on its effects, adverse reactions
and interactions.
/
i
ii
iii
Pharmaceutical manufactures and traders will abstain -from making
available in a country pharmaceutical products which are not registered
in that country.
Pharmaceutical manufacturers and traders must provide the national
registration authorities with all the information available to them on
a pharmaceutical product, including all information they have given
to countries with an efficient drug registration system, even if all this
information has not been requested by the registration authority.
Article 5: Registration of new drugs
Pharmaceutical manufacturers and traders shall apply for registration
of a new drug only if the new drug:
32
has an equal or superior benefit/risk ratio or
has equal or better pharmaceutical properties or
can be marketed at a lower price
(b) is recommended for a condition for which no suitable drug
treatment is available.
Article 6: Pre-registration clinical trials of new drugs
6.1
’ Nd new drug comprising of a single or more than one pharmaceutically
active substance may be tested on human beings without formal and
written permission from national, regional or international public health
authorities.
6.2
Clinical trials of new drugs on human beings will only be permitted
for products which have been accurately tested in experimental
animals. Animal tests will be carried out in accordance with national,
or international legislation and must provide, in the case of each new
drug, complete information on the main general and organ system
directed pharmacological effects; whether such effects may be
therapeutically useful or not; on the absorption, distribution,
metabolism and excretion of the active substance/substances
contained in a drug; on interactions with other drugs in use,
environmental chemicals or food; on acute and short-term toxicity for
all drugs and on long-term toxicity for such drugs as may be used
for extended periods in human beings and on the environmental toxicity
of drugs or drug matabolites liable to be excreted by users of the drugs.
6.3
Requirements for animal testing of new drugs before human trials
should be unified and internationally standardised.
6.4
Laboratories both within the premises of pharmaceutical manufacturers
0
5.1
in comparison with existing drug/dru", used for the same
conditions:
33
or those consulted by manufacturers must bo open to inspection •' ■
*public
the
health authorities of all countries in which a new drug may
be submitted for trial on human subjects.
6.5
6.6
6.7
Clinical trials of new drugs on human subjects may only be carried
out by suitably qualified and experienced researchers who must be
qualified physicians, and according to procedures which must be
authorised by the public health authorities. The conduct and protocols
for the conduct of clinical trials must be open to inspection by public
health authorities at any time. Protocols and information on these trials
must also be made available to the registration authorities of countries
in which a drug, which has been primarily tested in another country,
is proposed for marketing.
Whenever a new drug is tested on healthy human subjects or on
patients, the clinical trial must be authorised and monitored by a local
"ethical committee" and must be carried out only with the full informed
consent of the people and patients concerned. Governments may
require written consent in countries in which the majority of the
population is literate; and in countries where the majority of the
population is not literate, orally, in the presence of a witness. Consent
to volunteer to participate in the trial of a new drug can only be given
by the subject, not by his/her legal representative. In the case of
children and the insane, consent given by a legal representative to
the use of a new drug will be accepted only in situations in which
there is a serious and nearly certain danger to the life or to the health
of the subject which cannot be averted by existing available
pharmaceutical products.
If permission for the clinical trial of new drugs on human subjects has
been refused by the competent authorities of one country, any
attempts to obtain such permission in other countries may only be
undertaken with the disclosure of full information on the previous
refusal of permission and submission of all the documents relating
to this refusal of permission.
6.8
Drugs which have been banned from ale after being marketed for
some time in one country may not be submitted for clinical trials or
marketing in another country, unless the competent authorities of the
second country are provided with complete information on the reasons
for the drug’s withdrawal from the market.
6.9
Physicians in charge of clinical trials of a new drug must rapidly be
brought up to date with all new findings on the properties of the drug
obtained during the time of a study on human subjects.
6.10
Unnecessary duplication of trials of new pharmaceutical products
should be avoided. Procedures for pre-registration trials of new drugs
should be internationally agreed.
Article 7: Information
7.1
Governments should be responsible for ensuring that objective and
consistent information is provided on all pharmaceutical products
marketed in the country'. This responsibility should cover either the
design, provision and dissemination of information or their control.
7.2. All information on pharmaceutical products must be accurate,
balanced, objective and complete. It must be presented in such a way
as to conform to legal requirements, to defined ethical standards and
to standards of good taste. It should not mislead either directly or by
implication. Information must be provided in a language readily
understandable to the person who will use it.
7.3 All information provided must be based on up-to-date evaluations of
all available scientific evidence and must reflect this evidence accurately
and clearly. Sources of evidence must be identified.
’ 7.4
Information submitted to registration authorities and other public health
authorities should include both all information required by these
authorities and all other information which the pharmaceutical
34
35
manufacturer possesses which may be relevant to their deliberations.
or scientific terms a_ ure used must be explained in lay language.
7.5. The minimum information which must be made available by
pharmaceutical manufacturers for all products to be marketed will
For drugs sold without a prescription, the package insert must
explain for how long a drug may be taken without consulting a
health professional and the period of time after which a health
professional must be consulted in the case of lack of effect of the
pharmceutical product or after the occurrence of side-effects.
include:
(i) package inserts—a package insert must be added to every package
to be sold to a consumer. For drugs sold to public health authorities
for distribution, a sufficient number of package inserts for
distribution to each potential user must be provided.
For over-the-counter (non-prescription drugs) the package insert
must state the name of the drug, the names of all its
pharmaceutically active ingredients which must be given as
approved international non-proprietary names if such names exist,
and the names of all auxiliary pharmaceutical substances.
Furthermore, the package insert must state the indication or in
dications (use or uses) of a drug and precise instructions for dosage
and the spacing of doses in adults, as well as in children of the
main age groups. If a drug is not to be used in a certain age group,
this must be stated in the package insert.
Furthermore, the package insert must enumerate all major side
effects of the active drug(s) and possible known side-effects of
the auxiliary pharmaceutical substances and must instruct the user
on what to do if such side-effects occur. Furthermore, warnings
of known interactions (instructions as to which drugs or food
should not be combined with that particular pharmaceutical
product) and precautions (eg drugs not to be used in pregnancy
etc) must be enumerated. Package inserts for drugs sold overthe-counter, as well as for prescription drugs or drugs to be
distributed by health officials, convey information so that it is
readily intelligible to all prospective consumers and not in a
language restricted to the prescriber or distributor. Such medical
36
(ii) Scientific data sheet for the use of physicians and other health
professionals. This data sheet may be written in a language
intelligible to its prospective readers, ie physicians or health
professionals. It must contain a full description of the
pharmaceutical product, listing all active substances by their
international non-proprietary name, if such a name exists, and their
doses, and must enumerate all auxiliary pharmaceutical substances
used. In the case of organic chemicals for which there is no
accepted non-proprietary name, chemical names should be given
and illustrated by structural formulas. The scientific data sheet
should briefly summarise experimental pharmacological and
toxicological data on the pharmaceutically active substances used.
It must contain a full description of suggested and accepted
therapeutic uses of the pharmaceutical product. Suggested uses
may only be included if they are substantiated by reliable scientific
evidence which must be quoted. Furthermore, there must be a
short but complete description of contraindications to use of the
pharmaceutical product; precautions over its use; mechanisms of
action (if known); known interactions with other pharmaceutical
products, chemicals or food and of dosage regimens in adults,
as recommended for the different indications. Doses for children
of different age groups must also be stated unless the
pharmaceutical product is marked: "Not for use in children under
the age of....... " Doses in the elderly must be stated if they are
different from doses in other adults.
The scientific data sheet must include the address/es ot the
37
manufacturers and their representatives or tl address of other
persons from whom additional information on a pharmaceutical
product may be obtained. Futhermore the data sheet must state
the address of the manufacturers' representative or the competent
national authority to be informed in the event of unforeseen side
8.2
The international non-pmprietary name of each pharmaceutically acme
substance for which such a name exists must be stated prominently
on each package insert and on all promotional material. For
pharmaceutically active substances for which no accepted non
proprietary name exists, a suggested non-proprietary name should be
indicated.
8.3
In countries in which drugs may be sold and prescribed only under
their international non-proprietary names, the packages must not bear
any trade name for pharmaceutically active substances. However, the
information from the manufacturers may refer to trade names used
in other countries, specifying the country in which a given trade name
is used.
effects or interactions.
7.6
All materials containing drug information must be cleared by the
national registration authorities which must also be consulted before
any changes can be made to subsequent editions of the materials.;
7.7
Information must be presented in scientifically acceptable, precise
terms. None of the following words—"safe", "effective", "potent",
or "cure" should be used without qualification.
7.8
Longer information booklets on a specific pharmaceutical product must
include the standard information contained in the scientific information
sheet and as much additional information as the manufacturer can
provide. The information reproduced should be reliable and its validity
must be capable of scientific substantiation by independent experts.
Longer information booklets should not be distributed to all potential
prescribers or distributors, but only to those who specifically request
them after learning of their existence from publicity or promotional
material. The contents of information booklets must be modified if
registration authorities require amendments.
On the packaging material, the names of manufacturers may be
mentioned in brackets after the non-proprietary name and in lettering
of the same size as that used for the non-proprietary name.
8.4
In countries where drugs may be sold or distributed under protected
trade names, non-proprietary names of the pharmaceutically active
ingredients must be stated on all packages and promotional materials
in a size of lettering not smaller than one half the size used for the
protected trade name.
8.5
Each pharmaceutical product belongs to a class and/or a category
or a sub-category of therapeutic or diagnostic products. The class
and, if relevant, the category or sub-category must be stated on the
packaging material.
8.6
Indications for the therapeutic or the diagnostic use of a pharmaceutical
product will not be stated on the packaging material but will be
enumerated in package inserts and information for health professionals.
Only indications approved by the public health authorities, or generally
recognised and endorsed by reputable and independent scientific
publications will be included.
Article 8: Labelling, package inserts and promotional material
8.1
Pharmaceutical products are either sold to the public for
medication (over-the-counter drugs) or sold to the public on
prescription from a physician or other health officials, or used by,
physicians or other health officials on human beings. The intended mode
of sale will be clearly indicated on all containers and packaging materials
for pharmaceutical products.
38
39
8.7
Contra-indications against the use of a pharmaceutical product will
be mentioned on the packaging material if the use of a pharmaceutical
product in certain categories of human beings may endanger their life
or severely endanger their health. All other known contra-indications
will be explicitly stated in the package inserts and in the information
reasons. All proc, Aional material must be cleared by the drug
registration authority.
9.2
Drugs that may legally be sold only on prescription by physicians
or other professionally trained prescribers cannot be advertised
public!' and must not be promoted through either advertisements
or a. udes inserted in the lay press or by radio, television or interviews.
Promotion must be limited to professional journals and to personally
addressed mailings to prescribers; promotion is also permitted in radio
or television progammes addressing exclusively a professionally
trained audience. Promotion material for advertising to health
professionals must include the information required for the scientific
data sheet. In promotional material, this data may be summarised
or abbreviated. In this case attention should be drawn to the scientific
data sheet. All promotional material must be cleared by the drug
registration authority.
9.3
Pharmaceutical products to be distributed by public health officials
may be promoted by them under conditions similar to those outlined
above for medical prescribers. All promotional material must be
cleared by the drug registration authority.
9.4
All promotional material must be modified if registration authorities
request an amendment. Any given promotional item may be banned
by a ruling from the competent public health authorities.
9.5
Pharmaceutical products which may legally be sold only under
prescription may be promoted by medical representatives in ail
countries where medical representatives are allowed to work. Medical
representatives must be adequately trained and possess sufficient
medical and technical knowledge to present complete, accurate and
valid informaion on their company's products. The manufacturer and
his representatives are responsible for all statements made by their
representatives and may be held liable. Governments may prescribe
particular training courses for medical representatives and impose
for health professionals.
8.8
The amounts of the active substance(s) and of auxiliary pharmaceutical
substances contained in a pharmaceutical product will be stated in
package inserts, as well as in information sheets. Only the active
substance(s) and their doses must be stated on the packaging material.
Active substance(s) will be designated by their international non
proprietary names if and when such names exist. Auxiliary
pharmaceutical substances will be designated by names which can
be readily identified by physicians, pharmacists or public health
officials. The grade of purity of active substances and of auxiliary
pharmaceutical substances found in a pharmaceutical product will be
identified by reference to a standard list or internationally recognised
pharmacopeia.
Article 9: Sales Promotion of pharmaceutical products
9.1
Pharmaceutical products that may legally be sold to the public without
a prescription (over-the-counter drugs) may be promoted to the public
through advertisements in the press or displayed publicly or by the
media but not by direct mailings. All promotional texts must
state the non-proprietary names of the pharmaceutically active
substances contained in a pharmaceutical product, the approved
uses, contra-indications and precautions. All statements used in the
promotion must represent strict scientific truth. The texts must be
designed in such a manner as to avoid promoting the use of a drug
by persons who do not need to take the drug and may be quite as
well off without using it. Promotion may suggest the use of one drug
rather than of another but must then state scientifically backed
40
41
examinations or other evaluations of their knowledge and their kills.
Oral statements made by medical representatives must contain the
minimum information required for printed promotional material. The
number of medical representatives working for one company in a given
country must not exceed one representative per promoted
pharmaceutical product per 500 registered physicians or other
p-escribers.
9.6
Article 10: Pricing, sales and distrib Jon
10.1
10.2
Pharmaceutical products to be sold under prescription may be
promoted through the organization of scientific meetings, symposia,
and sessions with congresses. If more than 50 per cent of the total
cost of such meetings is financially supported by a pharmaceutical
manufacturer, this fact must be clearly and visibly stated on all
programmes, invitations or abstracts. The information displayed must
always draw attention to the minimum information required for the
scientific data sheets and must be scientifically accurate and
presented objectively and in good taste. Entertainment and hospitality
offered during promotional meetings must be limited and must be
secondary to the main purpose of the meeting. The level of hospitality
must not exceed the provision of goods or services which the
participants could not afford to buy or might not normally pay for
Samples of pharmaceutical products may be provided free of charge
to prescribers only at their request. All samples must be clearly labelled
as samples in such a manner that they can under no conditions be
sold.
9.8
Drug samples for clinical trials may be supplied by manufacturers
free of charge to physicians only, and only in the framework of a
correctly designed therapeutic trial. The conduct of such a trial must
be approved by an "ethical committee" responsible for the control
of medical experiments on humans in a given institution or region,
or else by public health authorities.
42
In order to encourage indigenous technological development, the
government shall carefully examine and compare the cost of
production of every locally manufactured drug with the landed cost
of a similar but imported drug. If the cost of local production is higher
than the landed cost of the imported drug, the government may,in order to reduce or eliminate the wide discrepancies in the retail
price of these two categories of the same drug, impose a suitable
excise tax on the landed cost of the import drug to bring it closer
to or on a par with the cost of local production.
10.3
Every importer of a drug shall within fourteen days of the import of
a drug make an application to the government in Form 1. (See at
end of Article 10). The government may, after taking into
consideration the information furnished in Form 1 and examining the
cost of production of a similar locally manufactured drug, impose,
if necessary, a suitable excise tax on that drug as mentioned in Article
10.2.
10.4
While fixing the cost of production of a locally manufactured drug
as mentioned in Article 10.2, the government may take into account
the average cost of production of such a drug by an efficient
manufacturer and also taking into consideration material cost, labour
charges, overhead costs,etc. For the purpose of this article, an effi
cient manufacturer means a manufacturer:
in everyday life.
9.7
With a view to regulating the equitable distribution of drugs throuchout
the country, the government of that country may fix the maximum
price at which a druq shall be sold.
(i)
whose production of a drug in relation to the total consumption
of that drug in that country is comparatively large, or
(ii) who employs efficient technology in the production of such a drug.
43
10.5
The government shall fix a maximum retail price for a drug by
specifying the maximum mar!-, up on the cost of production or the
landed cost (if applicable landed ost plus an excise duty as described
in Article 10.3). The mark-up .'.ill include the manufacturers’/importers' margin, transport and distribution costs, promotional ex
10.12
A retail dealer shall main- .in a list of al! drugs available with him anc
their prices; this list should be easily accessible to any person wisninc
to consult the same.
10.13
No importer, whosesaler, or manufacturer shall 'withhold from sale
or refuse to sell to a retail dealer any drug available to him withou'
good and sufficient reasons.
10.14
No retail dealer shall withhold from sale or refuse to sell any druc
available to him to a customer wanting to purchase such a drug foi
which he has a valid prescription or which is sold over the counter.
10.15
An officer authorised by the government may, with a view to securint
compliance with this Article or to satisfy himself that the provision:
of this Article have been complied with:
penses and retailers' commission.
10.6
Every manufacturer, importer or distributor of a drug intended for
sale shall display an indelible print mark on the label of the container
of the drug or the minimum pack thereof offered for retail sale, the
maximum retail price of that drug with the words "retail price not
to exceed" preceding it.
10.7
No dealer shall sell any drug to any person at a price exceeding the
maximum retail price indicated on the label of the container or pack
thereof.
tQ.8
(a)
No dealer shall sell loose quantities of any drug drawn from a
container of such a drug at a price which exceeds the pro rata price of
(b) Seize any drug, along with containers, packages or covering;
in which the drug is found, in respect of which he suspects tha'
any provision of Article 10 has been, or is being, or is about tc
be, contravened.
the drug plus five per cent thereof.
10.9
In order to make a limited number of essential drugs easily accessible
to the poorer sections of the population, the government may fix
a lower mark-up for these compared to the other drugs. For the
purpose of this article, the limited number of essential drugs refer
to those which are so defined and listed by a competent health
authority (eg. Formulary Committee).
10.10
The government may oblige an importer or manufacturer to allocate
a minimum percentage of his total annual turnover to import or locally
manufacture (whichever is applicable) essential drugs described in
enter and search any place;
10.16
When the government, (but not a private trader) imports drugs anc
the landed cost of an imported drug is lower than the cost o
production of a similar drug locally manufactured, the governmen
may purchase the total output from the local manufacturer after fixinc
the cost of production as described in Article 10.4 and allowing hin
a reasonable return on his investment and then fix a common poolet
wholesale, price for both the imported and the locally produced drug
Article 10.9.
10.11
The government may oblige a retail distributor to carry always a suf
ficient inventory of essential drugs referred to in Article 10.9.
44
45
Article 11: Pharmaceutical technology
Form 1
(To be submitted in duplicate by an importer, within fourteen days of the
import, for each imported consignment)
1.
Name of the company
2.
Address of Registered/Head Office/Factory if any
3.
Reference to permission given by the drug registration authority for
The general provisions contained in the draft International Code of Con
duct on the Transfer of Technology being negotiated in UNCTAD shall apply
to all technology transfer transactions in the pharmaceutical sector.
Alternatively this Code should include the following provisions which are
in the UNCTAD draft Code.
11.1
The pharmaceutical technology transferred to a developing country
should be appropriate to the economic and social development ob
jectives of that country.
11.2
Upon request of the technology acquiring party the technology sup
plying party shall make arrangements, as far as possible, to unpackage
the technology in terms of information concerning the various elements
of the technology to be transferred, such as that required for technical
institutional and financial evaluation of the offer.
11.3
Ina technology transfer agreement specific provisions should be made
for the maximum use of locally available resources.
11.4
Technology transfer agreements should not contain restrictive prac
tices which adversely affect the economic and technological develop
ment of the acquiring country. These restrictive practices include,
among others: grant back provisions; restrictions on research; restric
tions on use of personnel; price fixing; restrictions on adaptations; ty
ing agreements; export restrictions; payments and other obligations
after expiration of industrial property rights; restriction after expira
tion of agreement; restrictions on the scope, volume and capacity of
production and field of activity; obligation to use trademarks; require
ment of the acquiring party to provide equity capital or to allow sup
plying party to participate in management; unlimited or unduly lone
duration of transfer agreements; limitations upon the use of importec
technology.
import of the drug
4.
Name of the drug
5.
Specifications of the drug
6.
Country from which the drug is imported
7.
Quantity imported (kg/litres/tonnes, etc)
8.
C.i.f. value in foreign currency
Total
Per unit
local currency local currency
a.
Total c.i.f. paid in local currency
b.
Customs duty paid
c.
Clearing charges with full details
,
Landed cost (a -i- b + c)
(Note: The figures given here should be certified by a practising Cost Ac-
countant/Chartered Accountant)
46
47
11.5
When negotiating, concluding and performing a teclinolc^y transfer
agreement, the parties should observe fair and honest business prac
involved in the transfer of technology transactions shall be
distinctly specified for each item
tices which include among others:
(a)
fair and reasonable terms and conditions
(b)
provisions of all relevant information
(c)
access by the acquiring party during the period of the agreement
to any improvements to the technology transferred under the
(j)
where the acquiring party has no other alternative than to pur
chase goods and/or services from the supplying party, or from
any enterprise designated by it, the prices for such inputs shall
be 'air and not higher than current world prices for goods or ser
vices of the same quality offered on comparable commercial terms
and conditions
(k)
the supplying party shall be liable for the loss of, damage or in
jury to property or persons arising from the technology transfer
red or the goods produced by it, provided that the technology
is used as specified in the agreement, or in the absence of such
specification, in a technically correct manner.
agreement
(d)
the right to cease negotiations if, during the negotiations, either
party determines that a satisfactory agreement connot be reached
(e)
the supplying party shall, to the extent feasible, provide the ac
quiring party, during the period of the agreement, with spare
parts, accessories and raw materials produced by the supplying
party for using the technology transferred, particularly where
11.6
alternative sources are unavailable
(f)
the technology suppliers' guarantee that the technology, meets
the description contained in the transfer agreement
|g)
the technology suppliers' guarantee that the technology, if us
ed in accordance with the description in the transfer agreement,
is suitable for the manufacture of goods as agreed upon by the
If however, some form of protection has to be given, only process
patents should be granted and adequate safeguards aimed at ensur
ing satisfactory working of the patented invention should be provid
ed. These safeguards would be to:
(a)
specify that importation does not constitute working of the
patent;
(b)
provide for an expeditious system of compulsory licensing;
(c)
use forfeiture or revocation of the patent on specific grounds;
(d)
shorten the duration of the parent and use it to ensure satisfac
tory working of the patented invention.
parties and stipulated in the agreement
(h)
the supplying party shall provide adequate training to the per
sonnel of the acquiring party or to the personnel designated by
it, in the knowledge and operation of the technology transfer
red, on the terms stipulated in the agreement
(i)
the prices, charges or other considerations made for all elements
48
I
Patent protection should not be given to pharmaceutical products or i
processes.
49
Article 12: Research and Development
12.1
innovation.
12.2
WHO and UNCTAD -hall, on request, provide technical support to.
countries preparing national legislation or regulations or taking other
appropriate measures in implementation and furtherance of the rainciples and aims of this Code.
13.3
Monitoring the application of this Code lies with the governments of
the countries acting individually and together with WHO and UNC
TAD. Pharmaceutical manufacturers and traders, appropriate non
governmental organizations, professional groups and consumer
organizations should collaborate with governments to this end.
13.4
Independently of any other measures taken for implementation of this
Code, pharmaceutical manufacturers and traders should regard
themselves as responsible for monitoring their marketing practices,
according to the principles and aims of this Code and for taking steps
to ensure that their conduct at every level conforms to them.
13.5
Non-governmental organizations, professional groups, consumei
organizations and individuals concerned should also undertake to draw
to the attention of pharmaceutical manufacturers and traders activities
which are incompatible with the principles and aims of this Code, sc
that they can take appropriate action. The appropriate governmem
authority should also be informed.
13.6
Pharmaceutical manufacturers and traders should appraise eacf
member of their marketing personnel of the principles and aims o
this Code and of their responsibilities under it.
13.7
WHO and UNCTAD should provide fora for consultations, discussion
and exchange of views between countries on matters related to thi
Code, in particular to its application and greater harmonisation an.
the experience gained in its operations.
Pharmaceutical manufacturers, if they are not engaged in research
and development activities themselves, and pharmaceutical importers,
shall set aside an agreed parcentage of their total turnover for research
and development. This money may be credited to the state sponsored
research institutions.
12.3
13.2
Since the national pharmaceutical industry in most developing coun
tries is still in its formative stages, governments shall enter the area
of research and development by setting up special research and
development institutions and linking their activities to production and
Pharmaceutical manufacturers and traders may be allowed tax relief
on their contributions to research and development.
12.4
The governments shall, in view of the requisite manpower and facilities,
the small volume of total research effort, and the low research capabili
ty in most developing countries, set up appropriate organizations to
define the priorities and problems needing research and coordinate
the entire research activities between the specialised institutions set
up by the government, universities, and institutes of technology.
Article 13: Implementation and monitoring
13.1 Countries which have accepted the Code should take appropriate steps
at the national level to meet their commitment to the Code, including
the adoption of national legislation, regulations or other suitable
measures. National policies and measures, including laws and regula
tions, which are adopted to give effect to the principles and aims of
the Code should be publicly stated, and should apply on the same
basis to all those involved in the manufacture and marketing of phar
maceutical products.
50
Article 14: Review procedure
WHO and UNCTAD shall submit a report in four years to the World
Health Assembly and the United Nations Conference on Trade and
Development, reviewing all the aspects of the Code with proposals
for the improvement and further development of the Code.
52
T’ntrod u’c Eion"
Dear Friends,
The work of the Gonoshasthay a Kendra (People 's Health
Centre) of Bangladesh under the leadership of
Dr Zafarullah Chowdhury is well known, soon after independence
the Gonoshasthaya Kendra was established in Bangladesh and
it went ahead step by stepto organise the Community Health
Program, the women's vocational Centre (Nari Kendra), the
People's workshop (Gono shilpalaya), the People's shoe
Factory (Gono Paduka), the People's School (Gono Patshala),
the People's Farm (Gono Krishi Khamar) and the now famous
Gonoshasthaya Kendra Pharmaceuticals. During these years,
the Kendra also organised training programmes for the
para-medics of savor, and health workers (IRDP & UNICEF) and
field programmes for undergraduate medical students and post
graduate doctors. Since 19b2, the GK Project has been exploring
the possibilities of evolving an alternative medical curriculum
more suited to the health, socio-political and cultural
realities of countries like Bangladesh. In March 1963, there
was a special conference held in Dacca entitled "People and
Health" organised by the Kendra and Jehangir Nagar University
(Bangladesh) at which recommendations for a more people and
health oriented curriculum were made.
1962 has also witnessed in Bangladesh the government's
bold decision to ban 1707 hazardous and irrational drugs,
fix fees for doctors, stop construction of eight new medical
colleges and enforce a five year compulsory rural work
before permanent registration of doctors--all these steps
hopefully towards a more people-oriented! health service.
Dr zafarullah Chowdhury will be visiting India (Pune,
Bombay, Trivandrum, Bangalore, Delhi and Culcutta)
from. 24 Nov to 4 Dec 19o3 in response to invitations by
the Indian Academy of Paediatrics, voluntary Health
Association of India, Medico Friend circle, Lok vidnyan
Sanghatana (Maharashtra), Kerala Sastra sanitya Parishad,
NISTADS, FMRA.I and other organizations.
He will be in Bangalore on 1st Dec 1963 and will deliver
two public lectures here (st John's Medical College 9 am to 9.45 am) and Indian Institute of science (2.30 pm
to 4.30 pm) apart from having group discussions with
medical teachers and health and development activists and
trainers. This file has been prepared as a background
resource material for all those who arc- keen to know
more about the GK Project, the GK Pharmaceuticals and.
the Bangladesh Drug Policy, we arc grateful to OXFAM
South India Office for their assistance in preparing
this file.
i
Materials and information here may be reproduced
freely in media/handouts for public awareness giving
specific sources (mentioned in each article) due
acknowledgement, we hope this file- will help in focussing
the relevance of such effort for the Indian situation as
well.
medico friend circle
Indian Social Institute
Science Circle (Indian Institute of science)
Bangalore
I
GONOSHASTHAYA KENDRA
(PEOPLE'S HEALTH CENTRE)
DACCA, BANGLADESH
OBJECTIVES
1.
To provide adequate health service in the rural area of
Savarthana
2.
to increase the independence and bargaining power of
women, and
3.
to bring about a 'change in the infrastructure and thereby
allow for the economic and social development of poor
villagers, i.e., 90 percent of the population of Bangladesh
*
ACTIVITIES
1.
2.
A health programme which encompasses
a.
training of paramedical workers, basic health workers,
medical students and doctors in' rural health care
delivery,
b.
curative care through a system of sub-centres which
are staffed by paramedical workers and backed by a
main centre which is staffed by doctors, technicians
and paramedics, and which offers OT, sick-room,
pathology, x-ray, and dental care facilities,
c.
preventive care including immunization programmes,
mother/child’clinics, pre-, and post-natal care,
nutrition, hygiene, and basic health education carried
o,i+ through regular programme of v51 age visiting,
d.
family planning which provides contraceptives (pills
and injection), sterilizations, and abortions, while
carrying out a programme of motivation and follow-up,
e.
an insurance scheme for users of the health care services,
f.
pharmaceutical plant which manufactures drugs under
their generic names (this is in the initial stages
of operation), and
g.
publication and distribution of literature to assist
medical practitioners in effective health care delivery
in rural areas.
A vocational training programme for villagers in which both
men and women are instructed and employed in all of the
following areas:
a.
b.
c.
.agriculture,
jute handicraft manufacture for export,
shoe manufacture and sale,
.../2
2
d.
e.
f.
3.
4.
metal work including welding, etc.,
woodworking and finishing, and
management of canteen which caters to a sizable
public clientele.
Education
a.
classes in literacy and conscience-raising for village
women and staff members, and
b.
experimental school for children of landless combining
practical training with formal study.
Credit unions providing loans for marginal and landless
farmers.
CRITICAL ANALYSIS
1. Health Programme. "Some success of the primary service
have been ascertained by surveys of sample villages and also
by more random observation of disease incidence. Thus, there
has been a dramatic fall in incidence of serious diarrhoea
with dehydration. This is probably due to our intensive
teaching of oral fluid therapy to mothers of small children,
who now give the 'shortbut' to their infants as soon as they
notice the first symptoms of diarrhoea. Since diarrhoea in
children is still the commonest cause of death in Bangladesh
as a whole, our success with preventing serious cases may
well account for the lower overall death rate in our area
which has been established by a sample survey (12/1,000 as
opposed to the national average of 17/1,000). There has also
been a marked decrease in scabies and other forms of skin
diseases. Care of at-risk pregnancies, especially of women
with symptoms of pre-eclampsra, has resulted in nil maternity
deaths for the last year in the area fully covered by our servic
2. Women. "Out of a total project staff (including subcentres)
of 114, forty six are female; and on the health side, women
outnumber men. Apart from nightguard duty, there is no single
task which women have not been engaged in on equal terms and
On equal pay with their male colleagues, it the daily ,
agricultural labour, health work, welding in the technical
workshop, teaching, or office work. In the vocational
training programme women are taught blacksmithing, carpentry,
whitewashing, and varnishing ....
"A much talked-about event occurred on May 1, 1977, when 23
women from the project cycled all the way to Dacca to demons
trate solidarity with women's movement all over the world ....
"While behavioral changes and increased self-confidence made
possible by economic independence and experience of work out
side the home is most striking in the women closely connected
with the project, there has also been a discernible change
in the attitudes of women in our area in general. Burkas
(veils) have almost vanished from sight among patients both at
.../3
- 5 the main centre and the subcentres, recruitment of female workers
for those types of work and training which do not require much
school education, no longer poses a problem; indeed, we have
to send many home for lack of places, and during our recent
procession to the Shimulia suboentre to commemorate the firs «
death anniversary of Nizam (see below), many village women,
as well as men, joined the ranks of the project staff.
"Nationwide, our work with women has contributed to Government
decisions to recruit women for village work in family planning
and as female primary school teachers."2
However, though as individuals there is a noticeable liberation
among women, with certain barriers having come down, as a group,
they yet remain unorganized.
3. Infrastructure. "Nizam was 25 years old. He had been with
the project as a paramedic since its inception, and when a
paramedic subcentre was to be set up at Shimulia he was the
one arranging the final details of rhe land. He knew the coming
of the centre to Shimulia would threaten the fraudulent practices
of a good many people, including illegal possession of government
lands, smuggling and selling health centre drugs. Among those
involved in the illegal activities was the'only qualified
physician in the area, who was making a handsome profit by
over-charging patients. Nizam did not realize just how great
a threat the new centre was. In collaboration with local
officials, i.e.-, the union chairman and a union member, the
physician hired a group of thugs to have Nizam murdered, confident
that he could make.the necessary payments to the proper people,
allowing him to continue his illegal work, along with his cohorts,
and ensuring that the centre would not become a permanent fixture
in Shimulia. Nizam lost his "1ife, and now an almost incredible
struggled ^or simple justice seems to be availing nothing.
We have come face to face with the village. We have reached,
it seems, our limit. Do we carry on with our small struggle or
are we sustaining a system that would (and should) crumble,
sooner without our gallant efforts„ And even if we choose to
work on, can Gonoshasthaya Kendra last in its present form?
How viable can a body remain when it is alien to thesystem in
which it operates?"^
REFERENCES
1.
Gonoshasthaya Kendra Progress Report No. 6. Dec., 1977,
p. 8, par. 2.
2.
Gonoshasthaya Kendra Progress Report No.6. p. 1, par. 3,
and 4, p.2, par. 2 and 3.
3/
Basic Service Delivery in "Underdeveloping" Countries: A
View FrommGonoshasthaya Kendra, by Dr Azfrullah Chowdhury,
published by UNICEF.
SOURCE:-
Towards a People's Science Movement
Kerala Sastrasahitya Parishad
*X- -X- -X- -X- -X- *X- -X- -X- -X- -X- -) $■ "X- -X- -X- -x-
.,./4
II
THE PARAMEDICS OF SAVAR: AN EXPERIMENT IN
COMMUNITY HEALTH IN BANGLA DESK
INTRODUCTION
The People's Health Centre (Gonoshasthaya Kendra) is situated
at Savar, some JO miles from Dacca. The centre at Savar has
gained an international reputation as an example of integrated
development; none of the familiar problems (health, family
planning, food, even poverty) are dealt with an isolation.
Health, however, dominates the activities of the Centre. Most of the Centre's 44 paramedics are women. One of the Centre's
founders was Dr Zafrullah Chowdhury. Chowdhury's team has
achieved remarkable success as well as deserved recognition.
But it has not been without its setbacks. In 1976, a key
paramedic was murdered in one of the local villages - illus
trating the kind of opposition to pioneering health that exists
among the wealthy elite, not least among the quack doctors,
in the villages. Here Dr Zafrullah Chowdhury describes the
work of the Centre.
The poor health in our rural areas is a consequence of under
development. Malnutrition is a problem not for the physician,
but for the agronomist, the teacher and the community organizer.
A strictly medical approach cannot produce a healthy community,
and without the involvement of the community, anything that is
produced will have a questionable value.
Originally, the Bangladesh Hospital came into being during the
war of liberation in 1971- At the- close of the war it moved
into the rural area of Savar thana, which had no health centre.
Health services for the heavily populated rural areas are
virtually non-existent. It was on remedying’this that the
Bangladesh Hospital, now name1 Gonoshasthaya Kendra, set its sight-.
When we came to Savar in 1972, we held numerous meetings both
with villagers and students in the area, to try to determine
the. best methods for bringing service to-the people. We
decided upon a centre base, which would act as referral point
for a number of subcentres. Initially we recruited 100 parttime volunteers from among the students, to carry out the
vaccination and health education programmes.
From the beginning, we made efforts to ensure that GonoshasthayaKendra would be a People's Health Centre, rather than a
'community death and disease centre.'- Preventive programmes
were emphasized and integrated with other areas of life that had
a bearing on health, such as nutrition, agriculture and family
planning.
■THE PARAMEDIC:
In time, we discovered that the part-time volunteer workers
were not able to fulfil the demands that the project work was
making on them. We came to realize that a full-time paid
worker was needed.
.. ./5
- 5 It was at this time, in 1973, that we developed the concept
of the paramedic. This has continued to evolve, although we
still define the paramedic as 'a worker who brings community
development services to his own village.' From the beginning,
wemrealized that a majority of girls would be needed if we were
to reach tne women of rhe area. The paramedics are drawn from
the area which the project serves, so they are working in a
familiar locality where communications are at their best. They
range from 17 to 25 years. Their training is carried out in
the field, where they take part in the delivery of services,
carefully supervised and supported by the doctors. Some
theoretical classes are given in the evenings, but the greatest
strength of the paramedic is his or her closeness to the village,
its unspoken needs, its wisdom and its ways.
Paramedics must show understanding and sensivity to the life
of the village. They do not preach vitamin A capsules, but
rather local green vegetables. They do not ask the mothers to
go (usually some distance) to a tubewell for bathing, but they
are pleased if the tubewell water is used for cooking and
drinking. Unlike the doctor who doled out two to six large
piperazing tablets to be taken at home, the paramedic had the
child take the required treatment in front of her. She is aware
that a mother would hesitate to give a large dose of medicine to
a child at one time.
It was also the paramedics who questioned the wisdom of the
antenatal clinics. Among the people being served in one sub
centre area (15,000 to 20,000) there would be approximately
800 pregnancies in a year. Out of this number, no more than
15 to 20 percent would be 'risk' pregnancies. Gathering all
the women and having them sit unnecessarily was neither an
efficient use of their time nor of the clinic's. An alternative
was to ha_'e the paramedics pey regular visits to those
pregnant •..•omen who are most Likely to have difficult labour
or other pregnancy problems, and give them the necessary
examination and instruction. The result is that we have had
no maternal deaths in the area.
The selection of the paramedics involves the villagers, which
leads to a greater responsibility for the programme on both'
sides. Members of the community chosen to interview the new
recruits are older villagers, but from among the poorer class.
If the delivery of the service, distance is always a problem.
We sought to overcome it by the use of bicycles. Though quite
acceptable for boys, girls on bicycles was a revolutionary step.
It took little time to win over the villagers, but the more
'educated' and 'religious' leaders balked at the idea. Never
theless, the plan went ahead - and not only does it solve the
problem of transportation, but it is also a definite step
forward in the liberation of the women.
The degraded social position of the. women in the villages was
what first moved us into the field of education. We felt that
if they could receive some training which would provide them
with a marketable skill, they would eventually gain a certain
. ../6
■f,
economic independence and respect.
FAMILY PLANNING:
Demand and Obstruction
When we smarted our project, we became aware Ghat demand for
family planning services existed in the villages. The source
of supply was lacking. So we began to offer a family planning
service, but always within an integrated programme. Without
real efforts at assuring parents that their young children would
reach adulthood, we felt we could not with justice deny them
the right to sons and daughters of their own. The programme
has therefore made efforts to provide the needed health care,
educating the parents in birth control methods and fami ~l y
planning to motivate them properly. Once the method has been
chosen, clients are visited at home regularly.
The dai has also been successfully incorporated into our
programme. Remaining in the village, she works on a part-time
basis, distributing pills, checking for side-effects, assisting
where possible and referring to tne centre or sub-centre where
needed. She is also taught to spot pre-eclamptic patients and
other possible labour and birth difficulties and to instruct
the-mothers in regard to child care. Because the dais are
village based, their drop-out rate is lower than that of the
paramedics,
Since the beginning cf the programme in 1972, we have noticed
a steady pattern of clients moving towards a more permanent
method of contraception; once family planning has been a
accepted. In 1974 we began to offer female ster^ization,
performed by the paramedics, and found that a relatively large
demand existed for this method. The sterilizations are-per
formed under local anaesthesia. Paramedics, having been trained
to perfor"1 these operations, ’??7e proved themselves to be quire
skilled. The villagers prefer the female paramedic to the male
physicians, and it has been noted that the infection rate for
the paramedics is lower than that of the doctors. The reason
for this may be that the doctor is usually an occasional
operator, and there is doubtless a tendency for him to assume
the more difficult cases.
Advice on menstrual regulation and abortion are offered at the
clinic. More advanced stages of abortion are performed by the
doctors, but the government attitude to abortion is somewhat
ambiguous. A survey conducted in Bangla Desh regarding
attitudes towards legalization of abortion found that, with
the exception of engineers, physicians were the. most conservative.
Sixty two percent of the physicians surveyed opposed the
legalizing, of abortion. Being far from the village reality,
they cannot or will not, accept it.
THE WATER:
Ths Problem of Pumps
They have no king, the rivers of Bangla Desh. At whim they rise
and fall, and carry the fate of 80 million people in their
course. They bring destruction, drought, dehydrated bodies,
disease in a myriad forms, to green fields, fish, fertile soil.
Water is the first authority in the land to whom poor and rich
alike make their appeal. For want of water, or because of flood,
the lands lie idle, yielding nothing.
However, this need not be. Bangla Desh has a farm labour force
of approximately 19 million men, but only 12 million of them
are employed. If land was used to its maximum advantage,
rather than only producing just over one crop a year, there
would be shortage of labour. Sixty seven percent of the land
in Bangla Desh, however, requires irrigation. One deep tube
well irrigates an area of atleast 100 acres.
Yet there are numerous instances where four of five such wells
are installed within the radius of a mile. Often, this results
in too rapid use of ground water and local handpump wells go dry.
UNICEF has also paid attention to the problem of water, and
admirably put in efforts into supplying handpump tubewells.
But generally the pump has been situated close to, or within,
the compound of the wealthy man, the man with power and influe
nce. UNICEF's aim has been to supply one pump for every 200
people. Our suggestion was to make an initial payment of 25
paisa for each person using the pump. This would ensure that
it was placed in a position advantageous to all members of the
village. UNICEF did alter its original scheme, and decided
after three years to make a charge for the pumps ... 250
taka for each pump installed, with no further payment required.
Any one individual could make ibhis payment of 250 taka. So,
now the rich man could establish his full rights over the water.
No only installation but also real availability of water and
latrines for general use will contribute to the better health of
the community, cutting down intestinal and diarrhoeal diseases
and skin conditions. The incidence of disease is decreased by
the provision of water, irrespective of the quality, and an
uncared for latrine has no appreciable effect on community
health. What we need is a simple construction, that can be
cared for as necessary and is convenient for use.
(courtsey - Development Dialogue 1978, No. 1)
mfc bulletin : September I960
**************** * * * *
.../8
Ill
LEARNING FROM THE SAVAR PROJECT
Abhay Bang
(The last issue contained a brief overview of the Savar-project.
This one gives a more detailed information from close quarters
and raises very interesting questions.)
As the car was passing from Dacca airport to the Gonoshasthya
Kendra of Savar, the landscape of Bangla Desh was unfolding
before me. A decade ago while working as a medical volunteer
in the refugee camps during the liberation war, I had seen a
few glimpses of Bangla Desh by occasional infiltration. My
interest in Bangla Desh dates back to that experience. The
news of political upheavals and natural disasters kept on
disturbing one about Bangla Desh for last one decade, but at
the same time some interesting, rather sensational news of the
community health work started in Bangla. Desh by a group of young
doctors led by Dr Zafrullah Chowdhary, their paramedic programme,
paramedics doing tubectomies etc. had created a curiosity in my
mind. And here was I today heading towards the famous Gono
shasthya Kendra (G. K.), passing through the main land of
Bangla Desh, seeing both her beauty and ugliness.
BEAUTIFUL AND UGLY
Beautiful because of the natural greennery and abundance of water.
Ugly because of the poverty, the worst I have ever seen. The
per capital yearly income for Bangla Desh is 560 Rs; one of the
lowest in the world. There is gross disparity even in this
small average income and the lower 50% of the population has
per capita yearly income of Rs.225 or less. Population
density in this country of 85 millions is one of the highest
in the world (1375 persons per sq.mile). 91% of the population
lives in the rural area. 50% of the total population has either
no land or less than half acre of land. Literacy rate is 20%,
but for women it is less than 10%.
A passage from Dacca to G. K. offers sights of sharp contrast;
tall buildings of American architect mushrooming on t>he expansive
periphery of Dacca juxtaposed to and even engulfing the
collapsing huts of the surrounding villages. It must be
mentioned here that the ijost vulgur display of affluence is not
only by the plethora of 'ad' agencies UN, World Food, US Aid
and so on.
But as we moved away from Dacca, the poverty of the rural area
started showing and soon the car turned to the right to enter
into the headquarters of G. K. The first to strike you are the
buildings-two-storey hospital cum office building and a fourstorey hostel residence for paramedics and other staff of the
G. K. Total buildings cost in GK is 9 lac Rs. "Was it so
essential?" one starts questioning in the mind. But same is
the feeling of Zafrullah Choudhary, who later on said, "For
initial 14 year we were living in tents and temporary shades.
Had no money for buildings. An armed robbery, heavy rains and
inconvenience to the patients and the staff created a need for
buildings. Therefore, when we received generous foreign aid
offers for buildings, we were enamoured. We did the mistake of
accepting the offer and within next twb years these incongruous
. . ./gr
edifices stood up.
But what is more impressive is the simplicity and the austerity
of the living style of the staff and the equality in relation
ship. I rust admit that when I met Choudhart for the first time,
I mistook him for a PA or typist of Zafrullah. Except for a
few families with children, all other workers live in the same
huilding in similar accommodation. From the gate keeper to
Zafrullah, all take the same, very ordinary food in a common
mess. G. K. has a novel rule-reminding me of Gandbiji's Ashram
in his time (not now)-everybody in the project works for 1J hour
in the morning on the farm. "This not only helps us to become
self-sufficient in our food requirements, but also builds up
a healthy equal relationship among us, an identification with
the manual labourers of rural areas and also helps to screen
and eliminate the elitists among the new recalls." All these
things must have contributed in the creation of the warm,
friendly and family relationship which exists in the whole team
of G. K.
I shall not describe the history and all the activities of G.K.
as these things have already been published in the MFC Bulletin
(Paramedic of Savar: issue No 57) Instead, after a brief
description of the activities, I shall try to discuss some
questions and inferences from their experiences and some, of the
recent experiments at G. K.
THE PARAMEDICS
G.K. started in 1972. With only 2500 doctors working for the 75
million people in the rural area of Bangla Desh (1 doctor for
30,000 population) and with only 700 trained nurses in the whole
country, the Western health model was irrelevent. "The purpose
of our project is to evolve some system by which the medical
care of the whole population of a particular area can be under
taken efficiently and effectively with the minimum benefit, with
the employment of limited medical manpower." (from the original
project proposal, Feb. 1972)
In the last eight years, G. K. has been able to develop such
a system with the paramedic as its main health workers. There
is a central 30 bedded hospital withi.X'ray, pathology and
operative facilities. Office and training centre is attached to
this hospital. The headquarters and its’4 subcentres together
try to deliver primary health care to the 91,000 population of
100 villages of Savar thana.
There are in total 4 doctors and 64 paramedics at present
(39 females and 25 males) - 16 paramedics in the headquarters
hospital and clinic, 15 stay at the headquarters and cover the
surrounding 40 villages, moving on bicycles. (Because of the
high population density a large number of villages are packed
in small area). Other 20 stay at 4 subcentres (5 at each) and
each subcentre covers 15 villages. 13 paramedics (mostly
, males) are village based-living, in their own villages and
serving them.
Each paramedic (except village based) cover about 2500 population
(2 to 5 villages-depending up on the size of the villages.) The
■ -' \
/io
' .
10
The sub-centres have a weekly OPD when a doctor from the head
quarters visits but offers emergency services all the seven
days. Some subcentres, managed entirely by paramedics, have
small indoor also. The head quarter hospital runs twice a week
OPD. Most of the cases are seen and treated b'r the paramedics.
Doctors mainly work as a referral persons, as trainers and as
administrators.
A paramedic is usually 7th standard to SSC pass unmarried girl
almost all recruited from the outside area because of the lack
of educated women in the Savur area. They are given about one
year's inservice training, contents being similiar to AM training.
in India. They are full time workers of GK Drop out rate is 50%.
Salama, the paramedic with whom I went to a village on bicycle to
see her routine village visit covers 4 villages. So she visits
each village about once a week, sometimes twice; goes house to
house, covering about 25 houses in one visit, thus usually the
same house is again visisted once in a month. The main assigned
jobs are 1) Treatment of minor illnesses. 2) Immunisation - BCG,
& Triple to all children and tetanus toxoid to all the women in
child bearing ages. 5) ANC check up. 4) motivation for IT and
distribution of oral pills 5) Health education 6) Detection and
referring complicated cases, specially among pregnant women and
children to the doctor at subcentre OPD or at head quarters.
The sincerity and the efforts put by Salama were worth seeing;
but the response of the people and the health status didn't seem
good, The causes of low health status were also obvious in the
village - terrible poverty, poor sanitation (water, mud and flies
everywhere), ignorance and a resultant apathy. The paramedic was
struggling against these odds with her small health kit and fighting
spirit. Of course, the pictures of health might have been still
worse without GK or without Salama.
I accompanied Dr Kamal, to a subcentre. That was the OPD dayfor
the subcentre. 3 girls and 2 boys paramedics, all unmarried,
stayed at that subcentre - must be a sensation in the rural Muslim
community of Bangla Desh. The OPD was overflowing with patients.
One could observe that neither the subcentre paramedics nor the
doctor were overusing antibiotics or the injections. Same
experience at the OPD at the headquaryers.
GK has innovated some unorthodox methods. Diarrhoea and cholera
are very common in Bangala Desh. When Cholera Research laboratory (CRD) of Dacca evolved oral rehydration therapy with the
electrolyte mixture, GK field workers, while applying it in the
field conditions, modified it to "Lobon-Gur" that is salt and
Jaggery mixture.
Jaggery is easily available in every house,
it is cheap, and provides sucrose and potassium. CRD later on did
field trials on this "Lobon-Gur" mixture and found it almost
equally effective.
Paramedics doing tubectomies at GK is famous, and now about 85%
of the tubectomies are done by the paramedics with very low
complication rate. Even more bold is the OPD method of tubectomy.
.../Il
1
Patient is discharged within two hours and spends the post
operative period at home. This has been found to be safe and
also prefered by the patients who apprehended and avoided
tubectomies because of 7 days, hospitalisation.
WHAT BO PEOPLE WANT?
The study of the coverage and health impact of G. K. activities
raises some questions which offer useful lessons.
What is the coverage of the population by the project?
The total visits by patients to the curative services offered by
G. K. are about 60,000 in a year. It has been estimated that if
cost and distance are not the barriers, each individual seeks
curative service on an average 3 times a year. So the 1,000,00
population in the project area should be seeking help 3,000,00
times. It means that 60,000 visits cover 20% of the total
curative requirements of the population. Remaining 80% are
either unmet or met by other health agencies (Quacks' mostly)
what is the reason for this behaviour of the people?
But even more interesting is the analysis of these 60,000 visits
In the year 1975-76 the OPBs (at headquarter and subcentres)
treated 4-8,000 patients while the paramedics in their village
rounds treated only 6000 cases.
We all speak hoarse on behalf of the 'dumb' poor people of the
villages and advocate a decentralised, simplified, deprofesionalised, cheap medical care, for them. But in the GK experience
when a fairly well trained (approx. 1 year) woman paramedic is
going to the door step only few' people are availing her curative
services and the majority are preferring to walk a longer distance
to the subcentre or to the headquarter.
There are 2 possible reasons which could be,discovered during
the discussion 1) People still felt that the curative services
offered at subcentre or headquarters are superior to the services
of paramedic. The mystification about doctors, indoor buildings
and injections influences their choice. 2) Paramedics are all
ill-equiped in their curative powers. They don't have chemoth
erapy beyond sulfas. This has acted as an impediment in her
showing good curative results to the village people which in turn
diminishes their co-operation to her in the preventive activities.
These lessons should help others in planning the curative services
and understanding what people want.
THUS FAR ANB NO FURTHER
What is the impact of G. K. health activities on the health
status of the people?
Though comprehensive statistices are not available, the one
offered by G. K. shows that the infant mortality rate in GK
area is about 120 as against 140 in Bangla Besh and the birth
rate is 29 as against 44 in Bangla Besh. The impact is definitely
.../12
12
there but a point of stagnation has come, beyond which further
improvement in health indices has become difficult.
I felt that whatever improvement G. K. could achieve is mainly
because of cheap, effective, widely availabl. curative services.
A cure at an early stage is a major preventive force. Some
improvement is attributable to lower birth rate because of
family planning, oral rehydration therapy in the cases of de
hydration and tetanus toxid to mothers. But probably all these
measures have reached their saturation point. Some further
improvement might occur if the curative powers of the paramedic
are increased and if her acceptibility increases. But poor
paying capacity of the people will limit their utilisation of
curative services at some point. Further significant improvementt,
will not occur unless poverty, illiteracy and poor environmental
factors are changed. Improving environmental factors is a
difficult thing in Bangla Desh, where most of the land is under
water for 6 months in an year. Huge inputs will be necessary
to change this situation, which people can't afford.
So GK offers a good case, demonstrating to what extent the health
status can be improved by the health measures alone and then how
an impasse comes because of socio-economic factors acting as
bottle neck. Such conclusions are possible because though GK
has a comprehensive vision and has economic and educational
programmes also, they are too small to effectively influence the
whole population and hence the main force is still the health
activity.
WHAT ABOUT PEOPLES- PARTICIPATION?
In GKs experience it is very difficult to achieve active community
participation for health purpose. The health volunteers from
the villages were inadequate. The health co-miittees formed in
the villages almost never functioned effectively. The villages
are factioned and health is not the priority. The paramedics of
GK mostly are recruited from outside the GK area and being un
married girls, they stay together in the. domitary rather than in
the villages. The community health programme of GK is in the
Director Dr Qasem's words, "village oriented but not village
based."
In Jamkhed (MFC Bulletin No 49, Jan. 1980) VHWS are from the
same villages. But what about the apparent active participation by the villagers in the programmes at Jamkhed, the respect and the
response the VHW seems to get there in her preventive and
educative activities as compared to the not so active co-opera
tion by the villagers to the GK paramedic? Probably the peoples
co-operation at Jamkhed is not because of the health work (in
fact GK paramedics are better trained than Jamkhed VHWs) but
because of the massive feeding programme and the food for the
work programme. If these big economic inputs are eliminated
probably people won't have much enthusiasm to participate only
for 'a health programme' at Jamkhed also.
G. K. has tried to achieve economic self reliance by a health
insurance scheme. But the maximum they have been able to
. . .13
13
achieve is 50$> economic self reliance. This was in spite- of the
fact that the project got vaccines and FP supplements at no
cost. The main impediments are poverty and hence the poor
paying capacity of the people (specially in Bangla Desh) and
the project not adopting unethical curative measures to satisfy
people arh complete with the quacks.
Some of the conclusions thus drawn may seem negative. But these
are the hard facts of community health work and anybody jumping
into this field would better learn these lessons from the G. K.
experiences rather than having illusions about massive people's
mobilisation through health work, economic, self reliance and
improving health by health measures alone. I have found friends
at GK very open and honest in accepting and discussing their
limitations also. This is a rare quality in a successful pfoject
and this increases the educative value of GK very much.
(To be concluded)
mfc bulletin: October 198.
-X- * * -X- * -X- -X- * ** -X- -X- * ** *
••./14
14
IV
ESSENTIAL DRUGS FOR THE POOR : MYTH AND REALITY
Ilf BANGLADESH
*
by
Z. & ,.S. CHOWDHURY
The drug scene (controversy) has been headline news in Bangla- •
desh for the past five months. The supply of medicine in this
country has for years been characterised by high prices, making
drugs unavailable to the poor, by the sale of unnecessary and
“
useless drugs and by the continued marketing of drugs identified
as harmful and banned elsewhere.
Most people would agree that TOO's list of essential drugs (1)
covers most diseases afflicting the world, but the fact remains,
these are not the drugs being produced in quantity - in
Bangladesh or elsewhere in the Third World.
In India, a big drug producing as well as consuming nation, tonics,
vitamins, "health restoratives" and enzyme digestives (most cf
hich are alcoholic preparations), "spin" money and account for
three-quarters of drug production there,' leaving scant resources
for "essential" drugs (2). With tuberculosis and leprosy major
health problems in that country, the Indian Council of Social
Science Research had to report in 1981 that the production of
anti-tubercular drugs was only one-third the minimal requirement,
while that of anti-leprotic drugs was only one-fourth the
minimal requirement (3).
An excellent example of demand being stimulated for non-essential
drugs in ycor countries is the case of Vitamin B12. Used in
developed countries for the treatment.of pernicious anaemia and
similar B12 deficiencies, in Bangladesh the same B12 is advertised
to doctors by Glaxo (UK) as useful in a wide range of treatments ..
including "poor appetite", "poor growth" and "sterility" (6).
While 8 formulations containing B12 are listed in the UK MIMS, ,
there are 126 on sale in India and 160 on the Brazilian market (7).
106 of the preparations available in Brazil range in dose from
5,000 to 30,000 micrograms per mililitre (2 of these formulations
are sold by British Glaxo). In Britain, the highest recommended
dose of injectable B12 is 1,000 micrograms per mililitre (8).
Most third world countries are now doubling their expenditure on
drugs every four years while their Gross National Product (GNP)
doubles only every 16 years and, according to WHO, "... for
developing countries, importation of pharmaceuticals is one of
the fastest growing drains on hard foreign currency" (9).
*The article is the abridged version of one part of a paper
presented by the authors at the Primary Health Care Symposium
No. 3 in Liverpool, UK in April 1982.
.../15
- 15
The Bangladesh scene before June 1982 and the new policy guide
lines :-A waste of resources
In 1981 Bangladesh spent an estimated 1250 million taka on
allopathic drugs (approximately 63 million IS dollars). Only
a negligible portion of this was available free of cost at
Government Health Centres. The rest was sold commercially. In
a country with one of the lowest per capital incomes in the
world (70 US dollars per year), this means that after food,
clothing and shelter, medicines are a major part of the re
maining expenditure. Often a little medicine is bought in
extreme need, but not enough to cure the illness. The. public
are left in ignorance as to the detrimental effects of breaking
off treatment prematurely and the drug companies thrive on the
need for repeated prescriptions. Most important, due to poverty
and the high cost of drugs, only 15% of the population at a
maximum estimate, ore able to buy modern medicine.
Inadequate information and the common habit of self-prescription
(because doctors are unavailable or too expensive and all drugs
can b,e easily bought over the counter) have led to a situation
where 70% of the annual drugs sales are on drugs 'described as
useless or therpeutically insignificant by the British National
Formulary, the National Research Council (USA) or the Federal
Drug Administration (USA). An apt example is seen in two
British companies manufacturing in Bangladesh - Glaxo and Fisons.
The Glaxo Bangladesh Limited Medical Reference List of March
1980 listed 51 products, of which only 17 are available in
Britain according to the UK MIMS of February 1980. Only onethird of Glaxo's products on the market in Bangladesh appear on
WHO's list of essential drugs. In the UK'MIMS of January 1982,
Fisons had only five drugs listed out of the 31 products available
in Bangladesh and 17 of these 31 were combinations of vitamins
and minerals. The "hottest" item of the Wert German manufacturers,
Merck or the local market has been Neuobior ( a combination of
vitamins Bl, B6 and B12). This one item alone accounted for over
68% of the total market in neuro-tropic preparations and their
1980 Marketing Plan stated:
"Our objective will be to achieve
at least 75% of the market share by intensifying our promotional
effort". They were, also concerned that Government could prove
a threat and so instructed their company in Bangladesh to "....
maintain a very good relations with Government officials in
Health and Commerce Ministry to guarantee importability of our
products" (11).
Drugs worth an average of 150 million taka are imported
annualy into Bangladesh by local firms as well as voluntary and
UN organizations. The remaining medicines, worth about 1100
milll°n taka are produced in the country. 890 million.taka
worth, or 80% of the drugs produced in Bangladesh are manufact
ured by 8 multinational companies. The "rest is shared by 22 of
the larger local companies, with or without third party licens
ing arrangements with multinationals.
The Expert Committee, set up by the Government on 27th April
1982 to evaluate all the registered/licensed pharmaceuticals
then available in the country, found about 4170 brand name drugs
.../16
16
containing over 150 different active ingredients. Only about 250
of these (less than 1%) are therapeutically significant or
essential. The rest have been promoted solely for the purpose of
financial gain. In a country like Bangladesh the situation is
acute because it diverts desperately scarce ■'-esources and many
people will deny themselves fond in the hope that some aggress
ively advertised, but useless tonic will do them more good. Bui
lt is not only a confidence trick - substances which have actually
been identified as harmful and banned in developed countries
have continued to be manufactured and marketed in Bangladesh.
Mr A Wahid, Managing Director of Pisons (Bangladesh), sums
up well when he says, "we are businessmen first. First of all
we went profit ..... we are oversensitive about reports from
j
WHO. Restrictions on drugs and pesticides imposed in the US and
Canada should not be applied in our country because our people
are ethnically and biologically different'from others" (15).
<
Quality Control and price Fixation
Up to this point in time, manufacture and marketing of medicine
has been regulated by the Ministry of Commerce and Industries
and the Ministry of Health. Drug Administration, a department
of the Ministry of Health, tests the quality and composition of
drugs produced and imported. Each drug and its price has to be
approved by this body. On paper this sounds very good and this
formal machinery is cited by drug companies to argue that nothing
much can be wrong with their practice under such "stringent" a
system. However, to perform their vast task, which includes test
ing every drug on the market in Bangladesh as well as inspecting
160 pharmaceutical Companies and Thousands of registered and un
registered pharmacies and 7 inspectors. It is clear that
supervision and control of manufacturers and retailers can exist
only on paper with a system of this sort. In this connection,
the Expert Committee which, after reviewing The drug market,
formulated the new drug policy, recommended, that the Director
ate of Drug Administration be expanded and adequately staffed
with experts in medical and pharmaceutical sciences. They furTher
recommended that all drug control laboratories be brought under
the control of Drug Administration and that a properly
staffed and equipped National Drug laboratory with appellate
facilities be set up as soon as possible.
The maximum retail price (MRP) of each drug is fixed by the
Director General of Prices, Supplier and Market Intelligence,
Ministry of Commerce at about 200% of the cost and freight (C & F)
value of the drug'which includes the value of raw and packaging
materials. This mar-up on C & F price includes 20% for
insurance, bank charges, etc .., 30% for distributors and
retailers and only about 15/20% profit for the manufacturer.
In actual fact, it is estimated that the real profit has been
between 70/100%. One manner of obtaining this excessive profit
is to buy raw materials at prices higher than international
competitive rates. Pfizer, for example has a binding clause
in.its agreement with Government that its head office in the
US will have to approve of any raw materials that it purchases.
This allows Pfizer (Bangladesh) to buy raw materials at
exhorbitant prices from its sister companies abroad and thereby
.../17
17
transfer profit out of Bangladesh in the name of production
costs. Many other companies have similar clauses in one form
or another. Nationals as well as multinationals are out for
table profit. Two local as well as the transnational company
Glaxo are all buying from the same source, yet all quote
different prices. It is interesting that 3 years later (1982),
in spite of tremendous inflation, GPL was able to buy from'a
West German firm at a price less than that paid, by any other
company in Bangladesh. It would also be false to claim that
Pliva Pharmaceuticals (Yugoslavia) is of questionable quality
since Pliva products have been approved by Federal Food and Drug
Authority of the US as being of standard quality and usuable
in the US.
Packaging to increase profit:
The mystique of the name is supported by other promotional
features, especially packaging. Consumers naturally tend to
identify brand name tablets, capsules and syrups by their dist
inctive bottle or packeting. Packaging is promoted with reference
to better hygiene and customer appeal. Foil-wrapped products
offer much more to visual perception than the same product which
comes out of a bulk tin and is wrapped in a twist of paper or
non-descript container. In a country like Bangladesh where
something like foil must be imported, there is a ready-made excuse
for increasing the price of the product since the MRP allowed
by the Government is two and one-half times the cost of raw
and packaging materials.
Fortunately the new drug policy has taken steps to curb these
practices also. All manufacturing companies must now
purchase their raw materials at competitive international prices
so this will automatically bring down the prices in this area
for a number of companies. The mark-up price, previously done
on a basis of 100/150$ cn raw materials and nackaging should be
curtailed so that the mark-up is only the price of the raw
materialsand no mark-up allowed on the actual cost of packaging
materials. The immediate effect of this would be a much more
even-scale price range for similar products manufactured by
different companies.
* * * * * * -x- -x * * -x- * * * *
. ../18
GOhOSHASTHAYA PHARi-UCEUTICALS
Gonoshasthaya Kendra (People's Health) Charitable Trust original
objective of establishing a preventive and primary health care
service in a rural area of Bangladesh gradually developed into
a broader community development programme and not surprisingly,
we began to consider how to provide our service area with quality
and inexpensive medicine.
A project of the Gonoshasthaya Kendra Charitable Trust (Gonoshas
thaya Pharmaceuticals Ltd), GPL is designed to supply 15-20%
of the present Bangladesh market in essential drugs. It aims to1
produce high quality, essential and generic drugs only, at the
lowest possible price through responsible marketing practices.
GPL is registered with the Joint Stock Companies under the
Companies Act of 1913 and as such, is subject like any other
company, to the usual customs, taxes and' other duties. Unlike
other companies, however, there are no private shareholders.
The entire stock is owned by the Trust which, by its charter,
limits profits to 10-15% after payment of duties and bank charges,
About 50% of the profits must be ploughed back into the factory
and' 50% spent for research and charitable purposes.
The Board of directors has nine members - five from GK Trust
and the rest representatives from the Ministry of Health,
Directorate of Industries, Bangladesh Shilpa (industrial) Bank
and NOVIB, a Dutch non-government organisation. This structure
was adopted with the hope that GPL would combine the advantages
of private industry with its freedom of decision making for
management with the character of a public enterprise oriented
to the consumer and avoiding profit motives.
Funding came in good part through foreign voluntary organisation
donations directly to the GK Trust for this (GPL) project. A
break-down is shown at the end of the second column.
Technical expertise was provided by the Interhaational Dispensary
Association (Holland) who helped to organise additional training
■for managers and procured machinery and raw materials. Professor
J Polderman, Expert Committee Chairman of the European Pharmacopeia
has been sponsored by NOVIB as our Producting Advisor. All
managers of the factory are Bangladeshi.,
Establishment of GPL, needless to say, met with problem areas.
The first of these was infrastructure. Any attempt to establisha high technology project in an underdeveloped country will
suffer from lack of infrastructure and problems arising from
having to import much of the necessary equipment. Our main
problems here were,in the lines of architecture, electrical
supply and assembling and maintenance of machines/equipment.
The second area of concern was personnel. Skilled workers in
all categories, but especially maintenance technicians are
extremely difficult to hold in Bangladesh due to migration to
the Middle East where wages are much higher. Unskilled labourers,
we were determined to recruit from among the really needy, main
taining the emphasis of the whole of Gonoshasthaya Kendra on
developing women's skills. Since this was our objective, a good
deal of basic functional education was necessary before the
..../19
- 19
women could begin working in factory. For most of our recruits,
it, meant functional literacy classes as well as learning
pharmaceutical terminology and familiarisation with the machinery
they would be using.
NOVIB (Holland)
US
OXFAM (UK)
n
H
CHRISTIAN AID (UK)
ii
H
COMMUNITY AID ABROAD
(Australia)
EUROPEAN ECONOMIC COMMUNITY
(through Novib)
2.62
0.33
0
0.22
II
0.05
11
II
0.20
II
II
1.50
II
1!
II
Bangladesh Shilpa Bank, GK 'Trust
li •
and Others
million
(this is strictly a loan to GPL)
US
dollars
4.92
million
The social and political climate cannot be ignored either, when
beginning a new industry in a country like Bangladesh. The
government's policy is to encourage industrial development?,
especially in such a thing as essential drugs. However, anyone
who intends to produce or market in Bangladesh has to cope wit'h
the corrupt practices which pervade the industrial and commercial
life of the country. For those who have been in the business,
G-PL's conditions for doing business come as a surprise which they
often cannot fully understand, since everyone knows bribery is
part and parcel of the way of life in this country.
Then of course, there is the problem of moving into an already
well-established market, Considering that our aim is to supply
.quality drugs at the lowest possible price, we knew trouble
would be waiting - just how much trouble has only come in bits
and pieces, but it has come, especially in the field of pricing
and marketing.
We believe that for the proper information of the consumer, all
pharmaceuticals should he obliged to give details of their pric
ing policy. The table "Contrast in Drugs Prices" though not a
break-down in details of pricing, compares some of GPL's prices
with those of similar products being manufactured and marketed
in Bangladesh.
It should be noted that as new company, as well as due to our
insistence on very high quality control and social benefits for
our workers, our overheads are very high. Older companies whose
machines are fully depreciated will have much lower overheads.
We intentionally make higher profits on drugs we consider less
.../20
20 CONTRAST IN DRUGS PRICKS
Company Name
1
Tk. 23.8O/6Omls
23.80
21.00
23.80
21.00
Amoxil
Amolin
G-Amoxicillin
3-00/cap
2.47
2.25
32.00/60mls
25.00
24.00/100mls
Teracin
Oxalin
Hostacycline
Aldacycline
Sumycin
Imperacin
G-Tetracycline
0.90/cap
0.97
0.90
1.00
O.98
1.05
0.50
Septrin
Co trim
Theratrim
Chemotrim
Sephtazol
G-Cotrimexazole
2.30/tab
1.98
1.80
1.75
1.90
1.25
Paracetamol
Cetamol
Pyralgin
Pitamol
Paratan
G-Paracetamol
0.25/tab
0.25
0.27
0.25
0.25
0.15
26.00/60mls
22.00
22.00
16.00
2.100/100mls
Paracetamol
BPI (May & Baker)
Square
Hoechst
Pisons
Nicholas
G.P.L.
6
Tk. *
1.69/cap
1.80
1.70
1.70
1.70
1.30
1.00
Sulphamethoxazole & Trimethoprim
Burrough Wellcome
Square
Therapeutics
Opsonin
Pioneer
G.P.L.
5
Penbritin
Amblosin
Ampicin
Amplin
Ampicil
Aldapen
G—Ampicillin
Tetracycline/Oxy te tra cycline
Pioneer
Pharmadesh.
Hoechst
Albert David
Squibb
I.C.I
G.P.L.
4
Syrup/Liqtia
Price
.Amoxicillin
Pison
K.D.H.
G.P.L.
3
Capsule, Tablet
Price
Ampicillin
Pisons
Hoechst
Square
K.D.rl.
Pioneer
Aloert David
G.P.L.
2
Produce's Name
Metronidazol
BPI (May & Baker)
Square
Pioneer
Opsonin
G.P.L.
Glagyl
Amodis
Metazol
Metril
G-Metronidazole
Tk. 0.78/tab
0.70
0.60
0.50
0.40
•
- 21 -
Product's Name
Company Name
7
0.30/tab
0.25
0.20
0.30
0.125
Avlocid
Antacil
Nutracil
G-Antacid
0.45
0.25
0.20
0.20
Lasix
G-Frusemide
1.30/tab
0.60
Tk. 23,oo/225irJs
15.20/228mjs
16.00/228mls
14.OO/2OOm2s
Oral -dehydration Salt Sachet (27.5 pm)
Pioneer
G.P.L.
12
Sedil
Easium
Sudex
Sedalin
G-Diazepam
Frusemide (40 mg)
Hoechst
G.P.L.
11
0.12
0.10
0.75
Antacid
I.C.I.
Squibb
K.D.H.
G.P.L.
10
Asprin
Genasprin
G-Asprin
Diazepam (5mg)
Square
Opsonin
Peopled
K.D.H.
G.P.L.
9
Syrup/Liquid
Price
Asprin/ 3C0mg)
K.D.H.
Fisons
G.P.L.
8
Capsule/Tablet
Price
Oralite-D
Labon Jaler Sarbat
fiO.R.S.)
10.00
2.50
Ferrous Fumerate with Folic Acid
Fisons
G.P.L.
Folte Tab
G-Iron with Focid Acid
0.06
0.05
* 2 Bangladesh Taka = Approximately One Indian Rupee.
important or whose use we wish to discourage. For example we make a 6.575®
profit on ampicillin and J.2y0 on paracetamol (which are below our overall
margin of 10.15)°) and make it up with a 36.670 profit on diazepam and 85.67b on
frusemide.
GPL hopes to market about 6O-7O/0 of its production to government, government
agencies and charitable health services in bulk supply. This is deemed the
safest, quickest way to channel the benefits of cheap drugs to people most
in need.. The remaining 30-40% will be sold on the open market but this involves
a system of education (most, including doctors, believe the higher the cost, the
better the drug) and distribution. It is difficult for even doctors to come
by unbiased drug information since there is no Bangladesh National Formulary
and often the product information leaflets are very different in content in
.../22
22
third, world countries than they are in first. The only way
then for doctors to keep, abreast of pharmaceutical developments
is through foreign medical journals, etc. and most don't have
access to the foreign currency necessary for purchase of these.
In this respect, we have used our Bengali language health bulletin
'Monthly Gonoshasthaya' to disseminate various information in
relation to the baby food issue, abuse and exploitation in the
drug market and other vital health-related topics.
Bid for Government Tender
Each year, the government calls for a large tender for medicines.
for rural health centres. In 1978-79, the government after
proper calculation, put pressure on the government-owned AlbertDavid company to sell them their ampicillin at a price of 95
paisa/capsule. In 1979-80, Albert David management contended
that due to rising costs they couldn't supply lower than 99 paisa.
In 1981, GPL bid for the tender of 10 million ampicillin capsule
at 95 paisa, basing our calculation on the raw materials price
cited by one of the leading trading houses and considering our
high overheads. The day after submitting the bid, we were
informed by the Trading Company that they could now quote a
better raw material price. The previous one had been 95-120
US dollars per kg, the new one was 89-100 US dollars,. This
cheaper price would ha.ve resulted in a lowering of 5-17 paisa
per capsule. We later learned that the Trading House in Question
is owned by the wives of the Managing Directors of three large
pharmaceutical companies, one multinational and two national.
Still later, we learned that some multinational and top-sellingnational companies had a meeting before the tender. We did not
win the tender. It went to a national company which had bid
at 80 paisa per capsule. The retail price of the same company's
ampicillin is 159 paisa. For the government, this was the
cheapest ampicillin they had ever purchased and giving credit
where credit is due, some officials thanked us, requesting us to
keep up the good work.
Role of UNICEF and WHO
UNICEF is the main supplier of drugs for primary health care in’
the rural health centres of Bangladesh, largely through tneir
'Drug and Diet Supplement' (D &DS) kits. The drugs are purchased
through a general tender, mainly from East and West European
countries, packaged in Copenhagen and then shipped to the recipient
countries. We are pleased to say that UNICEF is now considering
GPL as a supplier for the Bangladesh rural health scene.
Since one of our aims is to encourage the sale of generic drugs,
we thought the translation, publication and distribution of the
Technical Report series No 641 (Essential Drugs) would be an
important step] We approached the WHO office in Caeca for
permission in respect of this request and, if possible some
financial assistance for the project. We were informed that
WHO in Bangladesh has no funds to support such a request. Then
followed eight months of lengthy correspondence, at the finish
. . ./25
23
of which we were informed that since Gonoshasthaya Kendra is not
a government organisation, permission could not be granted for
us to translate, publish and distribute on our own. (We later
learned that there is no need for any permission as WHO public
ations are not subject to anv copyrights), rhis is. a vital
document which should have wide distribution in all" third world
countries, yet little has been done by WHO in Bangladesh to see
doctors, pharmacists, etc, informed about the guidelines, they
themselves have established to help us reach the goal of
'HEALTH FOR ALL by 2000', in fact, when the Expert Committee
was sitting earlier this year and requested eight copies of the
booklet, it could not be found in the country and had to be sent
for (by which time the Committee had already submitted its
report).
Relevant here is an article which appeared in the Monthly
eview (December 1981) by Trushen and ^hebaud who aruged,
medical aid, like food aid, is a weapon of foreign policy wielded
by donor nations, and it provides an easy entry to vast third
world markets for multinational corporations - in this case the
pharmaceutical industry. In the past decade, drug companies have
increased their influence on WHO through participation in
three new programmes: human reproduction, tropical disease
research, and essential drugs for primary health care. The drug
industry's penetration is indicative of WHO's continuing
reliance on technological and industrial approaches to problems
that are economic, social and political. Rather than promoting
'Health for All', isn't WHO furthering the medicalization of
underdevelopment?"
Furthermore, the politically neutral attitude of WHO prevents it
from directly denouncing various forms of domination such as
colonialism and neocolonialism which are at the root of many
health problems. Trushen and Thebaud have r_ghtly pointed cut,
"WHO's technocratic approach is a refuge: It permits the
organisation's doctors to identify a disease and describe it
scientifically without calling into question the economic,
political and social mechanisms that ensure its development and
transmission."
And that very approach prevents essential drugs for the poor'
from becoming a reality. Establishment of rights of the
oppressed is always an up-hill struggle.
* ** ************** ** *
.../24
24-
VI
THE BANGLADESH BAN ON HAZARDOUS AND IRRATIONAL
, MSM ’
D-9/334.(J:l)
21.10.1982
Its Review and tne present Status
28th April 1982:
An 8-member expert committee commissioned
to evaluate all the pharmaceutical
products in Bangladesh and draft a
rational Drug Policy - met for the first ’
time.
Important outcome:
4140 products in the market were evaluated,
16 criteria were laid down for evaluation..
(12 criteria selected on scientific
grounds) .
Based on these, 1707 products were re
commended to be banned. These were divi
ded into 3 categories or Schedules as
follows:
Schedule I - This included 265 locally
manufactured and 40 imported drugs re
garded as positively hazardous to be
banned immediately.
Schedule II - included 134 drugs which
required reformulation and were to be
banned after a period of 6 months.
Schedule III - included 742 locally
manufactured and 526 imported drugs. Thesdrugs either had little or no proven
therapeutic value or could easily be
manufactured by local drug companies instead of the multinationals -producing
them at higher costs, thereby depleting
the country of much needed foreign exchange
12th May 1982:
The Expert Committee submitted its reporr
to the Government.
29th May, 1982:
The Chief Martial Lav/ Administrator and
his Council of Minister approved it. The
date of the ban of Schedule I was changed
from 1 to 3 months and the banning dates
of Schedule III drugs from 6 to 9 months.
7th June 1982':
Formal declaration of the new policy was
made.
12th June 1982:
The Drug Control Ordinance was promulgated.
June 1982:
Reported pressure exerted on the Government
by the Bangladesh American Ambassador on
behalf of the US multinationals to have
.../ 25
_ 2 5-
D-9/334-(J:l)
21.10.82: a
the policy amended. The negative stand of
the USA regarding WHO.'s International Code
against unethical marketing practices of
milk food is well .known.
The British, Dutch ano the German Embassies
.'joined to exert pressure on the government.
The anti-government campaign having failed.
the focus then turned to the Expert Committee which had recommended and pushed the
drug policy
July 1982
The 4-member Expert Scientific Committee
of various pharmaceutical manufacturing
companies was brought by the US Embassy to
further pressurize the government to
reconsider the ban.
19th August 1982:
In Washington Post it was reported that the
US State Deportment spokesman had acknow
ledged: "that the Pharmaceutical Manufac
turers Association, a trade organisation
the drug industry, asked it to bring
pressure on the Bangladesh government to
delay implementing the law pending discussio
ions with the manufacturers-"! He added:
"The State Department has a statutory
responsibility for assistir,g..American
interests‘abroad. In this particular case,
the US Government is also concerned that
these regulations may inhibit further
foreign investment in Bangladesh's US S 30
billion market in the developing countries
would be at stake if other countries follow
ed SUIT.
. . .
12th August 1982:
Report submitted by the Review Committee
constituting of 6 military doctors set up
to re-examine the matter in view of the
pressure mounted by the multinationals and
their respective governments.
6th September 1982:
The Drug (Control) Ordinance Amendment
announced by the Government after studying
the Review Committee's Report.
AMENDMENTS
SCHEDULE I:
Ban lifted from only 1 item of imprtanct Imodium (an anti-diarrhoeal).
Six other misused/abused dental remedies
reinstated.
TOTAL BAN OF SCHEDULE I'DRUGS will remain EFFECTIVE 3 month
period as decided earlier all harmful
drugs to be destroyed by 12th September 1982.../2 C
D-9/334-(J:1)
SCHEDULE II
-26-
4 eye preparations containing anti-biotic
and steroid combinations allowed (contra
dictory to the Expert Committee's
recommendation).
Heptuna plus a capsule containing iron folic
acid, Multivitamins and minerals produced
by pfizer (very strangely) allowed to remain.
Ban withdrawn of total 7 drugs in Schedule If-.
Time limit extended according to the
*
amended ordinance from 6 months to 12 months
for the drugs listed in Schedule II.
Lobbying for this so called necessary ante-natal drug for the
under-nourished anaemic pregnant woman was done by the country's
gynaecologists headed by the President of Bangladesh Medical
Association, shareholder and member of the Board of Directors of
Pfizer, Begum Peroza.
Pacts about the Bangladesh Drugs Scene in Brief:
-
-
Bangladesh is the third poorest country in the world with
a per capital income of US Si 70 a year.
That 70% of annual drug sales are of drug described as
useless or therapeutically insignificant by the British
National Formulary, the National Research Council, USA and
the Federal Drug Administration, USA.
Out of 51 products of Glaxo available in Bangladesh market
in 1980, only 17 are available in the UK and only | are
present in WHO's list of essential drugs.
Of 31 products of Fisons available in Bangladesh, 17 were
combination of vitamins and minerals. And only 5 of thescdrugs were available in the UK. 60% o^ Bangladesh's health
budget is spent on drug®
In 1981 about 1250 million taka was spent on a lopathic
drugs in Bangladesh, but due to poverty and the high cost
of drugs less than 15% of the population was in a position
to buy modern medicines.
SCHEDULE III -
28 drugs (manufactured under the third party •
licence) were allowed to remain. Time limit
extended from 9 months to 18 months effective
from 12th June 1982 - date of promulgation of ‘
drugs.
SCHEDULE
Under this new schedule, 88 balms and vapours
of small national companies were to be allowed
to be manufactured for 18 months with effect
from 12th June 1932.
IV -
WHAT'S NEW?
All hazardous drugs of Schedule I were to be completely
destroyed by 12th September 1982.
There is a move on by the drug companies to apply for.
-.../2 7
D-9/334-(J:l)
"
“
licence to export them to Saudi Arabia, Western Africa, etc,
via Europe. These applications were made on 10th September
with the support of Secretary of Health. The Erug
Controller has refused and the matter has now been taken
up with the industrial "iinistry. The Drug Controller has
recommended that if this move should g~ through, all these
products should be previously labelled saying the drugs was
recommended to be destroyed in Bangladesh: by 12th September
1982.
The failure of Sri.uLanka and Pakistan to have a progressive
drug policy has been quoted by the multinationals to sub
vert the attempts of Bangladesh Government to ban hazardous
drugs.
What is probably the most humiliating comment on the social
consciousness of Indian health personnel is that our drug
policy is being quoted by the multinationals to criticize
condemn the Bangladesh ban. Here it would not be out of
place to quote from a medical journal from Bangladesh,
6th September 1982.
In India, 43606 drugs are registered and sold. Even these
have not upset their possibilities of further industriali
zation in spite of their technological advance and
pverty . . . . " (sic).
The above information is based on newspaper reports from Bangla
desh and elsewhere and the personal communications from socially
concerned health personnel in Bangladeshnlike Dr Zafrullah
Chowdhury.
Availability of supply of essential life-saving drugs for the
majority at reasonable cost, should come before profits of the
drug companies. If these profits derive from the sale of hazar
dous and irrational drugs or drugs with little therapeutic value,
they need to be curtailed, and policies which allow drug compan
ies to continue producing them need to be seriously questioned,
We want a rational, people-oriented drug policy, and any effort
in this direction anywhere has our support.
As mentioned in our handout "In Support of Bangladesh Ban" we
repeat "Sabotage of this ban at this stage by the application of
pressure or by money power will be a blow to all those who since
rely believe in socially relevant and socially just health care.
Consequently, this is not a question of Bangladesh's fighting
a 'Bangladesh problem'. It is in fact a question of a higher
premium being placed on profits than on the welfare of human
beings - if the ban is withdrawn under duress. This is therefore^.
a move against which the public opinion of all nations, particulrf
the developing countries should be raised. It is a cause worthy of
global support specially from those involved in health work.
What would we do if we knew that the sale of hazardous and irrat
ional drugs would continue because of the pressures and marketing
strategics of the Drug companies? Would we continue stocking them
in our pharmacies and prescribing them? We request our'readers to
boycott such hazardous products, because a Government ban on them
may come too late, or never come because of vested interests.
SOURCE:-
Low Cost Drugs & Rational Therapeutics.
* -X- -X- * -X- * * -X * -X * * -X- * * -X
28 -
CURBING DRUG MULTINATIONALS
Will_India follow Bangla example?
- by Sumanta Banerjee
Little Notice has been taken here of a momentous
decision taken by the Bangladesh Government recently.
In a sweeping new drug policy, the Government has clamped
an immediate ban on 237 largely harmful medicines, and has
recommended the removal of another 1500 unnecessary drugs
by the end of 19d2.
Quite predictably, multinational drug manufacturers have
taken umbrage at the decision, and have succeeded in
pressurising the US Government to ask Bangladesh to “reconsider"
the new national drug policy. Apart from inhibiting their
future foreign investment in Bangladesh in particular, they
fear that other developing countries might follow Bangladesh's
example, world wide drug sales to developing countries
by these companies exceed ifi>30 billion a year. It is no
wonder that they are unhappy at the Bangladesh decision.
The new drug policy of Bangladesh bears important
lessons for other developing countries and India in particular
which shares in common with Bangladesh a number of problems
pertaining to the pharmaceutical industry and people 's
health. Accordin'./ to Bangladesh's Health Minister,
Maj Gen shamsul Huq, the Government had to adopt the new
policy because ’’incomplete transfer of technology, restrictive
business practices, and purchase of raw materials by the
multinationals at inflated prices from tied sources"
were
1 etriment al to our national, economy”.
.......
The stakes which the multinationals have in the
Bangladesh drug market can be measured by some figures.
The Experts ’ Committee which drew up the new drug policy
revealed that 75 percent of the Bangladesh market was
controlled by just eight multinational companies—Fisons
Glaxo, ICI, May and .Baker, Pfizer, Hoechst, squibt? and
Organon. Pfizer dominated the market with more than
%>10 million in sales in 19ol, while Squibb sold around 4i>5
million in the same year. Nineteen Pfizer drugs appeared
on the list of drugs to be banned immediately including
its stericol capsules which contain Clioquinol. Among
the 22 Squibb products listed are Quizaline tablets and
suspensions, both of which also contain clioquinol.
- 29 -
The Chairman of the Experts Committee, Prof. Nurul
Islam, noted that banning of these products would help
to improve health care and added : 'Nobody will die because
of the want of medicines in the country if we stick to
only 250 essential drugs, including 100 life-saving
medicines '. In fact this conforms to the WHO report of
1979 which identified about 237 basic drugs and about
303 single ingredient formulations of these drugs which
were considered as most needed for health care of the
majority of the population.
(However, at the request of the US administration,
Bangladesh has since revised the law by removing 41 drugs
from the list of 237 harmful ones and extending for 18
months the production, sale and distribution of 71 others).
The reaction of the foreign multinationals is significant.
The Pharmaceutical Manufacturers Association (PMA), a trade
organisation for the drug industry of the US has described
the new drug policy of Bangladesh as "precipitous" and
pre-judicial to public health. It has warned that blocking
the flow of drugs from its member companies could open the
market in Bangladesh to uncertified and potentially impure
drugs from other sources.
How far is the fu.ar justified? The Bangladesh Government
has announced, while banning these drugs, its policy to
encourage local industries to achieve self-sufficiency in
the manufacture of essential drugs. The multinationals
are expected to move out of the production of the simpler
preparations and use their technology and resources to
provide the more complex and innovative drugs which may
be necessary.
A local organisation, Gonoshastya Kendra (People's Health
Centre) has already established a limited company, Gonoshasthya
Pharmac. uticals Limited, which in 1981 began production with
two of the 33 most essential drugs for primary health care-ampicillin and paracetamol. By 19a2, they were producing
six more drugs. It is essential that more and more such
local industries are encouraged to manufacture drugs to
replace the ones sold by the multinationals.
Groundless fear
Besides, contrary to the fear propagated by the multi
nationals that a drug scarcity is round the corner in
Bangladesh, it must be emphasised that the Government has
not banned all foreign manufactured drugs, but only those
considered harmful and unnecessary. Alternatives are
available for each of the drugs that have been banned ,
including cough or pain relievers.
-jo
lt has to be admitted at the same time that' the new
drug policy in Bangladesh-goes only some way towards
strengthening the local industry, and still leaves many
questions unanswered. In a developing country like
Bangladesh (which is the third poorest country in the
world, with the lowest per capita income, the lowest life
expectancy and the highest infant mortality of all the
developing countries), more curative measures however
indigenous and inexpensive that might be are not enough.
A preventive approach that will aim at removing the basic
causes of diseases (poverty and malnutrition) forms the
basis for primary health care in such a situation.
One still ought to recognise that the Bangladesh
Government has taken an important first step curbing the hold
of the multinationals and seeing to it that resources are
not wasted on inessential drugs. One wishes that our
government takes courage in both hands and at least implements
the .recommendation made by the Drugs Consultative- Committee
to weed out 22 fixed dose combinations as an immediate step,
and narrow down the number of drugs to 116 (as recommended
by the Hath! Committee).
extracts "from DECCAN 'HE RALEH3 at’cxT’TS • 9' .’1%’2
- 31 -
POL ICY UNDER; U. S . PRE8.SUE
US asks Bang!a to relax ban on drugs
- by T.v. PARASURAM
Express News Service
Washington Aug 20:
The United states has urged Bangladesh to reconsider
a new national policy designed to ban hundreds of drugs,
though 70 percent of the banned drugs are considered by
the us Federal Drug Administration and its counterparts
in Europe to be dangerous or worthless.
The state Department acknowledged Wednesday that its
intercession with Bangladesh was in response to an appeal
from several multi-national drug companies which fear
that other developing countries will follow the lead of
Bangladesh and this could undermine their 30 billion
dollar world market.
Bangladesh is playing it in a low key. The economics
attache of the Bangladesh embassy in Washington said
the Bangladesh law was a good step forward, but the
review requested by the state Department "is normal and
not important". The US consumer groups do not share this
benign view of the US government 's intervention and have
blasted the administration-
The Washington Post noted in a front page despatch
that among the drugs Bangladesh wants banned are several
that are not permitted in the US, including clioquinol, a
chemica1 that is known to cruse serious damage to the
nervous system.
A Stat- Department spokesman acknowledged that the
Pharmaceutical Manufacturers Association of the United
States (EMA), a trade organisation of the industry, asked
the department to brj.ng pressure on Bangladesh to delay
implementing the law, pending discussions with the manufact
urers. The spokesman defended the US intercession by saying
'the state Department has a statutory responsibility for
assisting /American interests abroad. In this particular
case, the US government is also concerned that these
regulations may inhibit future foreign investments in
Bangladesh.
The Carter Administration had drugs or pesticides
banned in the USA would not be allowed to be exported
abroad. One of the first acts of the Reagan administration
was to overturn that rule with the result that drug
- 32 -
companies can now export from the US any item banned.
here. There was never any ban on the manufacture of such
drugs abroad .
Thu US action has been condemned by several international
and US charity and consumer groups. About rhe latest State
Department action requesting Bangladesh to review the
ban on certain drugs, a spokesman for War on Want said in
London, 'encouraging this review is certainly not helping
the people of Bangladesh1.
The Public Citizen Health Research Group, a Washington
based organisation in a letter to Secretary of stage
George- Shultz called the j department's action 'unconscio
nable'. it said: 'Perhaps you are unaware that many of the
US based multinational drug companies are foisting on
innocent people in the developing countries drug which our
own medical authorities consider worthless and unnecessary '
The group expressed dismay ' that the state Department had
allowed itself to be used by the giant multinational drug
companies to promote and protect their exploitation of the
impoverished citizens of underdeveloped countriesThe Bangladesh government announced the new law, prohibi
ting the sale of over 1700 drugs and immediately banning
237 products which are considered dangerous, in June. Among
the US drugs affected are some made by Merck, Pfizer, Squibb,
Searle and Upjohn.
According to the members of the committee that drew up
the new Bangladesh policy, eight multinational companies
including Pfizer and Squibb share 75 percent of Bangladesh's
1OO million dollar a year drug market. Pfizer dominates the
market with over 10 million dollars in sales in 1961. Squibb
sold five million dollars uurth the same year.
Nineteen Pfizer drugs are on the list of drugs banned
in Bangladesn immediately. They include stericol capsules,
which contain clioquinol. Anong the 22 Squibb products
affected are quixaline tablets and suspension (Q and S caps),
both of which also contain clioquinol. Neither Pfizer nor
Squibb would comment on the new Bangladesh law or the drugs
named in it. They obviously prefer to deal with the matter
through the state department.
However j a spokesman for the industry 's Pharmaceutical
Association, which recently led a delegation to Bangladesh
in an unsuccessful effort to secure reconsideration of the
law, described the new law as precipitous and prejudicial
to public health.
PMZi argued that blackin.i the flow of drugs from its
member companies could open the market in Bangladesh to
uncertified and potentially impure drugs from their sources.
Approximately 60 percent of Bangladesh's health budget
is devoted to the purchase of drugs compared to less than
10 percent in the USA. Because of that Bangladesh is eager
to bring its drug outlays under control and to begin to
produce some of the less complex drugs immediately.
The Bangladesh committee acknowledged "with appreciation"
the role of the transnationals but urged them to devote
their “machinery and technical know-how" to producing
important and innovative drugs and leave the production of
simple and cheap drugs to the domestic companies.
sources
EGRESS'’o^ 3T7d.82
- 54 ” re acfing" Tr st drT’cl’r ug"Iso ues”
Bangladesh situation
! So urce/Av ail abl e_ at
1. Gonoshasthay a Kendra
- a program- report
LINK Vo1.1, No . 1, May-June
19ol (Asian Community Health
Action Network Newsletter)
2= Gonoshasthay a Kendra
- a progress report
(Aug, 19o0)
Handout available from
VHAI,' New Delhi
3. Bangladesh finds the
right prescription
Health for the Millions
(VHAI Bimonthly) vol.VIII,
No.6, December 19<j2 SPECIAL'
ISSUE.
4. Drugs in Bangladesh
LINK Vol.2, No.3, Aug-Sept
198 2 (Asian Community Health
Action Network Newsletter)
5> In Support of Bangladesh
Drug Policy
Handout of VHAI Coll on
Low Cost Drugs and Rational
Ther apeutic s.
6.
The war against Bangladesh
- Claude Alvares
A Rustic/vHAI publication
7
. Bitter Pills—Medicine
and the Third world Poor
- Dianna Melrose
0XF71'1 publication 19 o 2.
Indian situation
1. Report of Committee on
Drugs & Pharmaceuticals
Industry (Hathi Report)
Ministry of Petroleum and
Chemicals, Government of
India, April 1975.
2- Medicine-as if people
mattered
Special Issue of Health
for the Millions, VHAI,
Nev? Delhi, April-June 1981.
3.
Aspects of Drug Industry
in India - Mukaram Bhagat
Center for Education and
Development, Bombay
4.
Insult or Injury
- Charles Medawar
Social Audit, England,
1979
- 55 -
5.
Health for all - an
alternative strategy
6 . Health Care Which way
To Go
7.
Bulletin of sciences—
Special Issue on Drug
Policy
ICMR/lCSSR group
VHAI, New JXlhi
medico friend circle,
VHAI, NGW Delhi
Science Circle, Indian
Institute of science,
December 1983, New Delhi.
for further in form ata o n" corit act -
1. Gonoshasthaya Kendra
P.O. Nayarhat
Via Dhamrai
Dacca, Bangladesh
2. Low Cost Drugs & Rational
Therapeutics Cell
Voluntary Health Association
of Ind ia
C-14, Community Centre, SDA
New Delhi 110016
3. medico friend circle
4.
50 Lie Quarters
University Road
Pune 411016
Asian Community Health
Action Network (ACHAN)
Flat 2A, 144 Prince Edward
f8>ad, Kowloon, Hongkong
- 36 DRUG ACTION NETWORK NEWS
1)
Drug Action Network is a growing informal network of people,
professional groups, projects, consumer education groups and
activists who are keenly interested in drug use and misuse and
dng policy issues in India.
Members of the network have been and are involved in various
drug issues including campaign against EP forte' preparations;
misuse of anti-diarrhoeals, anabolic steroids, >clioquinol,
paediatric tetracyclines; banning of dangerous drugs; need for
a code of eithical marketing for companies; popularising event
in Bangaladesh including new drug policy, anti-TB drug shortages
and so on.
For m re information please write to:
Low Cost Drugs and Rational Therapeutics Cell,
Volunt ry Health Association of India
C-14, Community Centre. Sardarjnng Development Area,
NEW DELHI 110 016
November 1983 is Drug Campaign Month
Various individuals and groups, part of the Drug Action Network
and others in India will be launching a concerted campaign this
month on Drug and Drug policy issues. For further information
contact:
.
.
a)
Medico friend circle,
50 LIC Quarters
University Road
PUNE 411 016
c)
Arogya Dakshata Mandal
2127 Sadashiv Peth
PUNE 411 030
e)
Centre for Education .and
Documentation
3 Suleman Chambers
4 Battery Street
BOMBAY 400 039
g)
Kerala Sastra Sahitya Parishad
Parishad Bhavan
Trivandrum 695 001
*******
b)
Centre for Science and
Environment
807 Vishal Bhavan
95 Nehru Place
NEV/ DELHI 110 019
d)
Consumer Education and
Research Centre
Near Law College
Ellis Bridge
AHMEDABAD 380 016
f)
Lok Vidnyan Sanghatana
People's Science Movene nt
18 A Jcfejivan Nivas
Behind Arora Talkies
Matunga
BOMBAY 400 019
h)
Federation of Medical
Representatives Association
of India
General Secretary
IE Rajendra Nagar
PATNA 800 016
- 57 -
0?3?AM publication on drug'TLssue’s
Bitter Pills: Medicines and the Third world Foor
Dianna Melrose
OXFAM Public Affairs Unit
October 1982
£4.95
Medicines can cost the poor many times their
daily wage. Many people do not have access to
drugs which could save their lives. Yet in
Third world countries sale of tonics and
multi-vitamin preparations are high.
This report examines the relationship between
health problems and the sale of medicines. It
produces evidence from Oxfams field experience
and calls for greater international control of
pharmaceutical sales and promotion.
The Great Health Robbery
Baby Milk and medicines in Yemen
Dianna Melrose
OXFAM (PAU), 1981
£1.50
A study of the tragic, frequently Fatal, effects of
the marketing of baby foods and medicines in the Yemen
Arab Republic. The Yemen case illustrates a problem
which exists throughout the Third World where Western
manufacturers exploit new markets without consideration
of the context in which their products will be used.
To get publications
Send current rupee equivalent of the cost of book/s
by MO to OXFAM, South India Office, 59 Miller Road
Benson Town, BANGALORE 560 046 - alongwith order.
- Media
RF_DR_4_SUDHA.pdf
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