DRUG INFORMATION PACK
Item
- Title
- DRUG INFORMATION PACK
- extracted text
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Do Yac Teen hundred — Bus!
«*
The World Health Organisation's Essential Drug List
says:
The world needs only 200 drugs to cure all its ills.
MAKE , BUY '
USE OHLY
The Hathi Committee Report of 1975 says: •
India needs only 116 drugs.
ESSEHTIAL DRUGS
Our drug companies vie with each other to thrust
down our throats 65,000 formulations.
Hippocrates
Father of Medicine
Do Yaa Teen Hun
: .
<^".'r f;
V
■ •
If200 Kaniskhas crashed today
10 million Indians have T.B. 2.5 millions of these
are infectious. More than 50,000 people die of T.B.
every year. This is equal to the population of Simla,
Udhampur, Kodagu, Wayanad, Panna, Khasi Hills,
Kapurthala, Bundi, Dholpur, Sirohi, north Tripura,
South Tripura, Lalitpur and Pithorgarh.
We need every year
for T.B. and leprosy
* DDS (Dapsone) 60T
* Clofazimine
650kg.
* PAS and its salts 250T
* INH
290T
* Thiacetazone
55T
We produced in
1984-85
7.31T
1.47T
19.07T
192.57T
47.19T
We need every year 13.000MU of Tetanus Antitoxin.
We produced in 1984-85 8291.02 MU.
(Source: Indian Drugs Statistics, 1984-85, M&E
Section, Ministry of Chemicals and Fertilisers, Gov
ernment of India).
Our country has signed the Alma Ata Declaration of
"Health for All by the Year 2000". This Declaration
talks of drugs as related to Health. Our country has
pledged itself towards formulating a Rational Drug
Policy at the Summits of the Heads of Non-Aligned
Nations both at SriLanka and at Havana.
Now is your chance to redeem this pledge. The
Third World looks to you for guidance.
Who decides on drug policy?
Every 13 minutes a child goes blind for wantofVitaminA.
We produced in 1984-85 60.58 mmu of Vita
min A when we needed 105 mmu.
(Source: Indian Drugs Statistics, 1984-85, M&E
Section, Ministry of Chemicals and Fertilisers, Gov
ernment of India).
J
If200 Kaniskhas crashed today
Why are medicines expensive?
Each of these contribute to the cost of drugs:
* Packaging
* brand name
* manufacturing company
* advertisements
* medical representatives
* samples
* gifts
* medical journals
* bribes
* research that is not done or done abroad
* five star medical conferences
End this unholy alliance
Most doctors and pharmacists in India do not have
access to continuing education once they leave col
lege. Their only source of information is often the
medical representative of a drug company. As they
have no way of checking the authenticity of his in
formation, they often have no recourse but to ac
cept it as gospel truth, and base their prescribing
practice on this information.
The medical representative gives the doctor a
beautiful brochure, free samples, discounts on
bulk purchases, and gifts.
Many drug
com
panies spend much more on their advertising than
on research and development.
End this unholy alliance
MAKE TAKING OR GIVING OF
INCENTIVES TO DOC
TORS ILLEGAL
Experiments with untruth
■ ■ rce'Importanl. fhev ?.:«life-saving, true.
•. s; all the information yc . ■
on drugs today is
one-sided. Very often this information is untrue.
This information is given to you by the drug com
pany who has every thing to lose if the doctor does
not prescribe their brand. They try their best to con
vince the doctor that their formulation is special,
more effective, and really very necessary. To do
this, they often distort the truth, and even lie.
Similarly, many drugs are sold without inserts.
Again, inserts in developing countries often read
differently than those in developed countries.
Periactin, an antihistaminic, is marketed in the
Third World as an appetite stimulant.
Hydroxyquindline and clioquinol — available in
India as Mexaform and Enterovioform — caused se
vere or partial blindness in over 10,000 patients in
Japan. Ciba-Geigy, makers of Mexaform were
forced to withdraw the brand from the world mar
ket, because of its severe side effects. This drug is
still sold in India, under other names, over the
counter, with warning of ocular toxicity written very
small, and in English, which most people cannot
understan any case.
__________ CD-----------PUNISH ALL WHO SELL
MEDICINES WITHOUT MEN
TIONING ALL SIDE EFFECTS
IN LOCAL LANGUAGES
o
Who decides on drug policy?
Chenifcd Is Mi/i/dh'?’(/■
ind Drug Ind us thy
Do you know that the drug policy is formulated by
the Chemicals and Industry Ministry and not by
the Health Ministry?
The overwhelming concerns that decide the issue
are
"industrial" rather than "health"
"profit" rather than "people".
DRUG ACTION—FACT SHEET
Bangladesh - Drug Policy
Criteria for recommended withdrawal of products from
the Bangladesh market
The Expert Committee constituted by government Order No.
S-DA/D-D-20/82/74 dated 27 April 1982 met at 10.00 a.m. on 28
April 1982 in the office of the Director, IPGMR, Dacca, under the
Chairmanship of Professor Nurul Islam for evaluation of the
pharmaceutical products available in the country and to draft a
National Drug Policy, keeping in view the health needs of the
country.
Consistent with the declared guidelines of Government to
provide basic needs of life to the majority of the people through
austerity, and to improve the economy of the country and pre
vent wastage of foreign exchange, the production and/or import
ation of unnecessary drugs or drugs of marginal value have to be
stopped.
Almost any drug may produce unwanted or adverse reactions.
The combination of two or more active ingredients not only
makes the product costlier, it also increases the possibility of
adverse reaction without increasing the efficacy over a single
ingredient product. Hence, as a general rule, combinations of
similar or disimilar drugs will be prohibited.
Combination drugs could be approved if the drug company
can give definitive, approved scientific proof (ie WHO publi
cations, British National Formulary, British Pharmacopeia,
European Pharmacopeia, USA or other authoritative guide
lines like Goodman’s and Gilman’s “The Pharmacological Basis
of Therapeutics’, “Current Medical Diagnosis and Treatment’,
etc.) of the drugs’ synergistic action and increased efficacy. They
also have to prove conclusively that combining t e e emenis
creates no increase of toxicity or side effects noi insta i i y o
the compound or shortening of the life of the product.,
One of the greatest sources of drainage of the country s un<-ncia
resources is the irresponsible prescribing and marketing and in
appropriate self-use of vitamins. Another great wastage of meagre
resources is cough mixtures, gripe water, alkali preparations,
and digestive enzymes which are of little or no therapeutic value.
It is unanimously decided that the following criteria will serve
as the guidelines in evaluating ail the registered'licensed phar
maceutical products manufactured and/or imported in Bang
ladesh.
i. The combination of an antibiotic with another antibiotic or
antibiotics with corticosteroids or other active substances will be
prohibited.
Antibiotics harmful to children teg Tetracycline) will not be
allowed to be manufactured in liquid form.
ii. The'combination of analgesics in any form is not allowed as
there is no therapeutic advantage and it only increases toxicity,
especially in the case of kidney damage The combination of
analgesics with iron, vitamins or alcohol is also not allowed.
iii. The use of codeine in any combination form is not allowed
as it causes addiction.
iv. In general, no combination drugs will be used unless there
is absolutely no alternative single drug available for treatment
or if no alternative single drug is cost effective for the purpose.
Certain exceptions will be made in the cases of eye, skin,
respiratory and haemorrhoidal preparations, co-trimoxazole,
oral rehydration salts, antimalarial, iron-folic, etc., as well as
certain vitamin preparations, allowing combinations.of more
than one active ingredient in a product.
v. Vitamins should be prepared as single ingredient products
with the exception of B complex. Members of vitamin B complex
with the exception of B12 may be combined into one product.
B12 always has to be produced as a single ingredient injectable
product. Other members of B complex may also be produced as
single ingredient products (eg Bl, B2, B6 etc.). Vitamins will not
be allowed to be combined with any other ingredient such as
minerals, glycerophosphate, etc. It will be allowed to produce
vitamins in tablets, capsules and injectable form only.
' No liquid formswill be permitted because of wastage of finan
cial resources and the tremendous misuse involved. However,
2
paediatric liquid multivitamin (with no Bl2, E. K and/or miner
als) will be allowed to be manufactured in bottles of up to 15 ml.
size with droppers. Paediatric liquid preparations of single i-’gre
dient vitamins will also be allowed to be manufactured in bottles
of up to 15 ml. with droppers.
vi. No cough mixtures, throat lozenges, gripe water, alkalis,
etc. will be allowed to be manufactured or imported as these are
of little therapeutic value and amount to great wastage of our
meagre resources
vii. The sale of tonics, enzyme mixtures/preparations and socalled restorative products flourish on consumer ignorance.
Most are habit-forming and with the exception of pancreatin and
lactase these are of no therapeutic value. Henceforth local
manufacture or importation of such products will be discon
tinued However, pancreatin and lactase will be allowed to be
manufactured and/or imported as single ingredient products.
viii. Some drugs are being manufactured with only a slight
difference in composition from another product but having simi
lar action. This only confuses both patients and doctors. This will
not be allowed.
ix. Products of doubtful, little or no therapeutic value and rather
sometimes harmful, are subject to misuse and will be banned.
x. All prescription chemicals and galenical preparations not
included in the latest edition ofBritish Pharmacopeia or British
Pharmaceutical Codex will be prohibited.
xi. Certain drugs, in spite of known serious side-effects and
possibility of misuse, having favourable risk-benefit ratio may
be allowed to be produced in limited quantity for restricted use.
These will be prescribed by specialists only.
xii The same or cPse substitutes of a drug which is being
produced in the country will not be allowed to be imported, as a
measure of protection for the local industry. However, if local
production is far short of needs, this condition may be relaxed.
xiii. A basic pharmaceutical raw material which is locally
manufactured will be given protection by disallowing it or its
substitute to be imported if sufficient quantity is available in the
country.
xiv. The role of multinationals in providing medicines for this
country is acknowledged with appreciation. In view of the
calibre of machinery and technical know-how which lies in their
hands for producing important and innovative drugs for the
country, the task of producing antacids and vitamins will lie
3
solely with the National Companies, leaving the Multi
nationals free to concentrate their efforts and resources on those
items not so easily produced by smallei National Companies.
Multinationals will, however, be allowed to produce injectable
vitamins as single ingredient products.
xv. No foreign brands will be allowed to be manufactured
under license in any factory in Bangladesh as this leads to
unnecessary high prices and payment of royalties. In the light of
this policy, all existing licensing agreements should be re
viewed.
xvi. No Multinational Company without their own factory in
Bangladesh will be allowed to market their products after
manufacturing them in another factory in Bangladesh on toll
basis.
- After approval of these recommendations by Government,
the licensing authority for drugs (Director, Drug Administration)
will have to issue necessary orders withdrawing/cancelling the
licensing/registration of the products, with the provision of a
maximum period of six months grace for using up the present
stock of corresponding raw materials. Henceforth no raw
materials should be allowed to be imported for the manufacture
of these products. All future licensing/registration should be
given after evaluation of the products on the basis of the above
criteria.
Reprinted By : VHAI - New Delhi
VOLUNTARY HEALTH ASSOCIATION OF
INDIA
C-14 Community Centre
Safdarjung Dev. Area
New Delhi-110016
As Part Of Rational Drug
Policy Campaign
4
DRUG ACTON—FACT SHEET
WHO - Esseoifeil Drugs
Policies for providing essential drugs
The selection of essential drugs. Technical Report Series 615;
WHO, 1977. Excerpt.
“While drugs alone are not sufficient to provide health care,
they do play an important role in protecting, maintaining and
restoring the health of people. In recent years, there has been a
tremendous number of pharmaceutical products marketed;
however, there has not been a proportionate improvement in
health.
Many pharmaceutical products are marketed with little con
cern for the differing health needs and priorities of individual
countries. Promotional activities of the manufacturers have
created a demand greater than actual needs. Since up to 40% of
the total health care budget in developing countries may be
spent on drugs, the result has been an increase in the cost of
health care or a reduction in funds available for other health
services. The cost has affected even the affluent • ations, and
their governments are increasingly worried by the rising ex
penditure on pharmaceutical products. In developing countries,
the problem is magnified by limited economic resources, short
age of trained health personnel, and lack of organised drug
policies. In the least developed countries, where communicable
diseases and lack of elementary health care are the major medi
cal concerns, large segments of the population are in urgent
need of essential drugs.
It is clear that for the optimal use of limited financial re
sources the available drugs must be restricted to those proven to
be therapeutically effective, to have acceptable safety and to
satisfy the health needs of the population. The selected drugs
are here called ‘essential’ drugs, indicating that they are of the
utmost importance, and are basic, indispensable and necessary
for the health needs of the population.
Drugs included in such a list would differ from country to
country depending on many conditions, such as the pattern of
prevalent diseases, the type of health personnel available,
financial resources, and genetic, demographic and environ
mental factors.
Because of the great differences between countries, the prep
aration of a drug list of uniform, general applicability and
acceptability is not feasible or possible. Therefore, each country
has the direct responsibility of evaluating and adopting a list
of essential drugs, according to its own policy in the field of
health.
The list of essential drugs based on the guidelines put for
ward in this report is a model which can furnish a basis for coun
tries to identify their own priorities and to make their own
selection.
The notion that the number of necessary drugs is relatively
small is supported by experience. Several developing countries
that have adopted limited drugs lists report good aceptance, as
well as favourable medical and economic results. Lists and for
mularies with a limited number of drugs are also successfully
used in many developed countries.
A limited list may not provide for the needs of every person but
certainly should meet those of the vast majority. Whether or not
drugs or pharmaceutical products outside the list are available
in the private sector should be a local decision.
Limited drug lists have several advantages:
1. Reduction in the number of pharmaceutical products to
be purchased, stored, analysed, and distributed;
2. Improvement in the quality of drug utilisation, manage
ment, information, and monitoring;
3. Stimulation of local pharmaceutical industries;
4. Assistance to the least developed countries in urgent
need of high-priority drug programmes to solve their primary
health care problems.
An effective programme of drug selection coupled with
appropriate information and education may help to improve
attitudes regarding the role of drugs in health and disease.”
General principles for establishing a list of essential drugs
The following principles were considered by the Expert Com
mittee to be a foundation on which to establish a list of essential
drugs:
1. Adoption of a list of essential drugs is part of a national
health policy. This implies that priority is given to achieving
the widest possible coverage of the pop-ulation with drugs of
proven efficacy and safety, in order to meet the needs for
prevention and treatment of the most prevalent diseases.
2. Only those drugs for which adequate scientific data are
available from controlled studies should be selected.
3. Each selected pharmaceutical product must meet adequ
ate standards of quality, including when necessary bioavaila
bility.
4. Concise, accurate and comprehensive drug information
drawn from unbiased sources should accompany each list of
essential drugs.
Reprinted By : VHAI - New Delhi
VOLUNTARY HEALTH ASSOCIATION OF
INDIA
C-14 Community Centre
Safdarjung Dev. Area
New Delhi-110016
As Part Of Rational Drug
Policy Campaign
3
Primary Health Care is the key to health for all
Tn a world in which four-fifths of the population has no
[y access to any permanent form of health care, and in
which millions more are disenchanted with the service
provided by conventional health systems, primary health
care is the key to achieving an acceptable level of health for
all. The international Conference on Primary Health Care,
held at Alma-Ata in the USSR from 6 to 12 September 1978,
drew up the fundamental principles of this far-seeing
concept and embodied them in The Declaration of AlmaAta. Urgent national and international action is needed
now to translate these principles into dynamic, practical
programmes.
WORLD HEALTH ORGANIZATION • UNITED NATIONS CHILDREN'S FUND
■
Declaration of Alma-Ata
The International Conference on Primary Health Care, meeting in
Alma-Ata this twelfth day of September in the year Nineteen
hundred and seventy-eight, expressing the need for urgent action
by all governments, all health and development workers, and the
world community to protect and promote the health of all the
people of the world, hereby makes the following Declaration:
I
rhe conference strongly reaffirms that
health, which is a state of complete phys
ical, mental and social wellbeing, and not
merely the absence of disease or infirmi
ty, is a fundamental human right and
that the attainment of the highest pos
sible level of health is a most important
world-wide social goal whose realization
requires the action of many other social
and economic sectors in addition to the
health sector.
II
The existing gross inequality in the
health status of the people, particularly
between developed and developing coun.tries as well as within countries, is politi
cally, socially and economically unaccep
table and is, therefore, of common
concern to all countries.
Ill
Economic and social development,
based on a New International Economic
Order, is of basic importance to the ful
lest attainment of health for all and to
the reduction of the gap between the
health status or me cteveloping ano
developed countries. The promotion and
protection of the health of the people is
essential to sustained economic and
social development and contributes to a
better quality of life and to world peace.
IV
The people have the right and duty to
participate individually and collectively
in the planning and implementation of
their health care.
V
Governments have a responsibility
fcr the health of their people which can
be fulfilled only by the provision of ade
quate health and social measures. A
main social target of governments, inter
national organizations and the whole
world community in the coming decades
should be the attainment by all peoples
of the world by the year 2000 of a level ot
health that will permit them to lead a
socially and economically productive
life. Primary health care is the key to at
taining this target as part of development
in the spirit of social justice.
VI
Primary health care is essential health
care based on practical, scientifically
sound and socially acceptable methods
and technology made universally acces
sible to individuals and families in the
community through their full participa
tion and at a cost that the community
and country can afford to maintain at ev
ery stage of their development in the spi
rit of self-reliance and self-determina
tion. It forms an integral part both of the
country's health system, of which it is the
central function and main focus, and of
the overall social and economic develop
ment of the community. It is the first
level of contact of individuals, the family
and community with the national health
system bringing health care as close as
possible to where people live and work,
and constitutes the first element of a con
tinuing health care process.
sate water and basic sanitation; maternal
and child health care, including family
planning; immunization against the
major infectious diseases, prevention and
control of locally endemic diseases; ap
propriate treatment of common diseases
and injuries; and provision of essential
drugs;
4. involves, in addition to the health sec
tor, all related sectors and aspects of
national and community development,
in particular agriculture, animal husban
dry, food, industry, education, housing,
public works, communications and other
sectors; and demands the coordinated ef
forts of all those sectors;
5. requires and promotes maximum
community and individual self-reliance
and participation in the planning, organ
ization, operation and control of pri
mary health care, making fullest use
of local,, national and other available
resources, and to this end develops
through appropriate education the
ability of communities to participate;
VII
6. should be sustained by integrated,
functional and mutually-supportivc
referral systems, leading to the progres
sive improvement of comprehensive
health care for all. and giving priority to
those most in need;
Primary health care:
1. reflects and evolves from the eco
nomic conditions and socio-cultural and
political characteristics of the country
and its communities, and is based on the
application of the relevant results of
social, biomedical and health services
research and public health experience;
7. relies, at local and referral levels, on
health workers, including physicians,
nurses, midwives, auxiliaries and com
munity workers as applicable, as well as
traditional practitioners as needed, suit
ably trained socially and technically to
work as a health team and to respond to
the expressed health needs of the com
munity.
2. addresses the main health problems
in the community, providing promotive,
preventive, curative, and rehabilitative
services accordingly;
3. includes at least: education concern
ing prevailing health problems and the
methods of preventing and controlling
them; promotion of food supply and
proper nutrition; an adequate supply of
VIII
All governments should formulate
national policies, strategies and nlans of
action to launch and sustain primary
health care as part of a comprehensive
national health system and in coordina
tion with other sectors. To this end. it
will be necessary to exercise political will.
to mobilize the country's resources and
resources
and in particular to the acceleration of
social and economic development of
which primary health care, as an essential
part, should be allotted its proper shSte.
All countries should cooperate in a
spirit of partnership and service to en
sure primary health care for all people
since the attainment of health by people
in any one country directly concerns and
benefits every other country. In this con
text the joint who/unicef report on pri
mary health care constitutes a solid basis
for the further development and opera
tion of primary health care throughout
the world.
The International Conference on Pri
mary Health Care calls for urgent and ef
fective national and international action
to develop and implement primary
health care throughout the world and
particularly in developing countries in a
spirit of technical cooperation and in
keeping with a New International Eco
nomic Order. It urges governments, who
and unicef, and other international or
ganizations, as well as multilateral and
bilateral agencies, non-governmental or
ganizations, funding agencies, all health
workers and the whole world community
to support national and international
commitment to primary health care .and
to channel increased technical and finan
cial support to it, particularly in develop
ing countries. The Conference calls on all
the aforementioned to collaborate in
introducing; developing and maintain
ing primary health care in accordance
with the spirit and content of this
Declaration.
a
to use available
rationally.
external
IX
X
An acceptable level of health for all
the people of the world by the year 2000
can be attained through a fuller and bet
ter use of the world’s resources, a consid
erable part of which is now spent on ar
maments and military conflicts. A
genuine policy of independence, peace,
detente and disarmament could and
should release additional resources that
could well be devoted to peaceful aims
Voluntary Health Association of india
C-14, Community Centre,
S.D.A. (Opp. I.I.T. Main GateJ.
New Delhi-110016
Our Concern About Drugs
Inspite of the green revolution, white revolution, industrialization,
modernization and development, the country's increase' in GNP
(Gross national Profits), most of these things have not touched
that man who hangs helplessly below the poverty line. The
irony of all our great development is that the number of such
people who are becoming destitutes is increasing.
From 27 we can now boast of over 200 medical colleges. According
to WHO's recommendations our doctor population ratio is above
the requirement. Our Pharmaceutical Industry is amongst the
best in the Third World. The state spends Rs. 9 per person
per year on health. Why then do we still have such a high
incidence of malnutrition?
High infant mortality?
Why are
there still 10 million TB patients when we have crores being
spent on the National TB Programme ? Why do 27 million Indians
get Typhoid every year ? 6 out of 100 children are in potential
danger of becoming blind with Vit. A deficiency. Why is it
that the great majority of our population has no access to
basic health care? 80% of our doctors and our health budget
cater to-the needsof a small minority.
Drugs costs represent 40-60% of the total health care expenditure
in the developing countries (compared with 10-20% in the
developed ones).
The rural urban disparity when it comes to health man-power
allocation, expenses on drugs, vaccines and other health services
is in simple words UNJUST. Only a very meagre percentage
of Rs. 9 alloted per person for 'health expenditure reach him,
who forms our 'Millions'.
VHAI believes in making health care available to those who
need it most. A prescription written with the high medical
standards in mind, may be highly inappropriate in a social context
where the patient cannot afford to buy the drugs, or where
buying these drugs for the family members means being in
: 2 :
and out of debt with money lenders. Education and awareness
as to how to avoid disease and then how to handle it appropriately
at the lowest possible cost is the crux of oui approach in low
cost appropriate health care.
*DRUGS:
The marketing of most brand named drugs specially by the
multinational in the Third World works against the Health of
the poor : (1) Most critically - because Health Care priorities
are distorted by pressure to buy expensive inappropriate drugs,
which cream off limited resources, and (2) Drugs freely promoted
in the absence of distribution controls can be dangerous-
1)
The effect of promoting the expensive, branded drugs
for which generic equivalents are available at a fraction
of the cost (sometimes as low as 10%), is to drain limited
Health Budgets unnecessarily.
Third World countries spend a disproportionate amount
on Drugs, often as much as 55% of the total health budget
(compared to 11% of NHS budget on drugs in Britain).
Bearing in mind the very limited effectiveness of drugs
and curative medicine in general in tackling the major
health problems - malnutrition, infectious and parasitic
diseases - public funds would be far better spent on preven
tive health measures and the basic Primary Health Care
infrastructure. For this, WHO estimate that 200 generic
drugs v/ould be more than adequate to meet Health needs.
the promotional practices of drugs companies, aimed at
maximising profits, run directly counter to the health
needs of the poorest. Drug company salesmen (Glaxo has
500 in India alone) concentrate their promotion on encoura
ging doctors to prescribe the most expensive, latest patented
drugs, claiming they are great improvements on far cheaper,
well-established drugs. When Beecham's and Wellcome's
antibiotics and antimalarials are Drescribed at public expense,
instead of penicillin
and chloroquine, the drug budget
is rapidly exhausted. Because of existing imbalances in
the health services, reinforced by marketing, the brunt
: 3 :
of wasteful spending invariably falls on the poorest, as
the rural dispensaries fun short of vital life-saving drugs.
-
Apart from promotion of unnecessarily expensive, but
necessary drugs, doctors are also encouraged into wasteful
overprescribing of non-essential
tranguilisers, symptonallaying drugs, and tonics. Once again, the indirect effect
on the poor, is that Valium being doled out in hospitals
on public funds, can mean shortages of first line drugs
in the village dispensaries. Where medicines have to be
paid for, (particularly when the doctor is remunerated
for prescribing rather than consultation) - sales talk
may lead him to prescribe unnecessary drugs e.g. several
courses of antibiotics and vitamins for a sick child, costing
anything up to a months wages.
Drugs freely promoted in the absence of distribution controls
can be dangerous
2)
-
The trickle down effects of uncontrolled drug marketing
in the absence of an adeguate health infrastructure, trained
health workers and controls on over-the-counter sales
can seriously endanger the health of the poor. They are
most vulnerable through ignorance of dangers and the
misconception' that a medicine - any medicine - will do
the trick.
-
When under attack for unethical marketing practices in
the Third World, the drug companies argue that they stick
to the letter of the law. Quite true - But, they demonstrate
a total lack of social responsibility in promoting potent,
potentially dangerous drugs, in countries where they know
they will be freely available over-the-counter, prescribed
by local practitioners and traders with little knowledge
of medicine - let alone sophisticated drugs. (Whilst deaths
from adverse drug reaction go unreported in the Third
World - in the USA they are estimated at 30,000 per
year.)
-
the net effect is that the poor are encouraged to buy
drugs for totally inappropriate uses and irrational self-
: 4 :
medication — particularly of antibiotics — leading to
serious problems of drug resistance. First line antibiotics
given to children with diarrhoea could mean they will
die later if they get TB, because there will be no way
of obtaining or paying for a second line drug.
Other Activities to decrease health care costs :
Training of different levels
be able to handle common
and as cheaply as possible.
of health personnel to
problems as effectively
Investigate role of health insurance schemes in different
parts of India and their feasibility.
Preparation of recommended
and material related to low
care.
reading list of books
cost appropriate health
Formation of linkages » with groups working on the
same lines e.g. :MFC, Centre of Science and Environment.
Collaborating with groups to do scientific field studies
on local remedies, their utility value and optimum
methods of preparation (Solidarity, SIRTDO, Ranchi).
This background paper is for discussion.
: 5 :
APPENDIX
1
Distribution of Essential drugs in Developing Countries
Drug distribution was identified as a critical factor in health
care and the accomplishment of a comprehensive national drug
policy at the consultation and WHO Technical Discussion in 1978.
It appeared that the types of distribution systems or patterns
depend largely on the political and economic system and the
administrative system under which the Govt, is operating.
(Effective distribution of resources depends on nation's political
will).
Following were the relevant factors
system of distribution of drugs :
to be considered for any
1.
Health Care System, Demography, Health Indiactors
2.
Morbidity pattern
3.
List of essential drugs and medical equipment
4.
Adequate storage facilities
5.
Administration, personnel forecasting and inventory control
6.
Transportation facilities and maintenance service
7.
Packaging material standardization and labelling
8.
Quality surveillance and inspection
9.
Education and regular training of staff
10.
Drug utilization studies.
: 6 :
APPENDIX
The Primary
Committee
purposes
a.
Advisory
b.
Educational
the
of
Pharmacy
and
2
Tnerapeutics
Functions and Scope
The following list,
is often as a guide :
which
is
not
necessarily
comprehensive,
A.
To serve in an advisory capacity to the medical staff
and hospital administration in all matters pertaining to
theuse of drugs.
B.
To serve in an advisory capacity to the medical staff
and the pharmacist in the selection of choice of drugs
meet the most effective therapeutic quality standards.
C.
To evaluate objectively clinical data regarding new drugs
or agents proposed for use in the hospital
D.
to prevent unnecessary
drug or its combinations.
of
the
same
basic
E.
To recommend additions and deletions
drugs accepted for use in the hospital.
from
the
or
F.
To develop a basic drug list or formulary of accepted
drugs for use in the hospital and to provide for its constant
revision.
G.
To make recommendations concerning drugs to be stocked
in hospital patient units or services.
H.
To establish or plan suitable educational programmes
for the professional staff on pertinent matters related
to drugs and their use.
duplication
list
: 7 :
I.
To recommend policies regarding the safe use of drugs
in hospital, including a study of such matters as investiga
tional drugs, hazardous drugs, apd others.
J.
To study problems involved in proper distribution and
labelling of medications for inpatients and out patients.
K.
To study problems
medications.
L.
To review reported adverse reactions to drugs administered.
M.
to evaluatate
drug therapy.
related
periodically
to
medical
the
administration of
records
in
terms
of
Reprinted By : VHAI-New Delhi
VOLUNTARY HEALTH ASSOCIATION OF
INDIA
C-14 Community Centre
Safdarjung Dev. Area
New Delhi-110016
As Part Of Rational Drug
Policy Campaign
Our Concern About Drugs
Inspite of the green revolution, white revolution, industrialization,
modernization and development, the country's increase ' in GNP
(Gross national Profits), most of these things have not touched
that man who hangs helplessly below the poverty line. The
irony of all our great development is that the number of such
people who are becoming destitutes is increasing.
From 27 we can now boast of over 200 medical colleges. According
to WHO's recommendations our doctor population ratio is above
the requirement. Our Pharmaceutical Industry is amongst the
best in the Third World. The state spends Rs. 9 per person
per year on health. Why then do we still have such a high
incidence of malnutrition?
High infant mortality?
Why are
there still 10 million TB patients when we have crores being
spent on the National TB Programme ? Why do 27 million Indians
get Typhoid every year ? 6 out of 100 children are in potential
danger of becoming blind with Vit. A deficiency. Why is it
that the great majority of our population has no access to
basic health care? 80% of our doctors and our health budget
cater to-the needsof a small minority.
Drugs costs represent 40-60% of the total health care expenditure
in the developing countries (compared with 10-20% in the
developed ones).
The rural urban disparity when it comes to health man-power
allocation, expenses on drugs, vaccines and other health services
is in simple words UNJUST. Only a very meagre percentage
of Rs. 9 alloted per person for Health expenditure reach him,
who forms our 'Millions'.
VHAI believes in making health care available to those who
need it most. A prescription written with the high medical
standards in mind, may be highly inappropriate in a social context
where the patient cannot afford to buy the drugs, or where
buying these drugs for the family members means being in
Essential Drugs
INTRODUCTION
The concept of essential drugs is the focal point of the drugs
issue and of the rational drug policy.
Dur focussing on essential drugs does not mean that by ensuring
production and supply of essential drugs, the health care status
of our people will dramatically improve. We are focussing on
it to highlight the fact the majority of our people are not merely
deprived of health care facilities, but whatever they are given
by way of health care does not necessarily have their interest
in mind. The kind of health care facilities, medical technologies
and drugs being promoted under the garb of "scientificity"
and "modern advances" and as "latest break through" usually
serve the interest of the "medical industry" i.e. the drug industry
and the medical establishment. Some of these modern myths
and superstitions have to be demolished, e.g. Myth I - medicine
is a noble profession brimming with selflessness, putting patients
interest and welfare, above self interest. Myth II - The drug
industry produces 'pills for every ill' and is fighting an unselfish
battle against death and disease. If it wasn't for them, lots
of us would be sick and suffering if not dead. Myth III - India
is a welfare state, signatory of the Alma Ata Charter giving
priority to Primary Health Care, and that our health policies
are oeoole oriented and are quided by recommendations of
Committees like the Bhore Committee, 1^46, Hathi Committee
1975, "Alternative strategy Health for All - ICMR-ICSSR Report
1981" and even the last year "National Health Policystatement",
all of which emphazise that the health needs of the majority
have to take priority over sophisticated, centralised, costly,
high technology medical servics meant for the minority with
the purchasing power.
The concept of essential drugs - questions the health personnel
who are supposed to safeguard the health of the -people; it
questions why their prescriptions include irrational, inessential,
: 2 :
costly combinations and often hazardous drugs. It questions
the medical establishment for not demanding bans on bannable
drugs, nor attempting to ensure and implement such bans. It
focusses the attention on the present day medical servicesprivate and government; the prescription patterns; the gross
lack of accountability to the public or to any medical council.
Myth II - The drug industry is there not to serve, but safeguard
its own interests. The performance of multinationals in decreasing
production of essential and life saving drugs, and the double
dealing in giving biased drug information; their ensuring the
purchase of their drug by gratifying doctors with samples,
gifts and sponsored medical conferences. With loan licensing,
products of many of the big name companies are produced
by small scale drug outfits with as much quality control as
most other small-scale drug companies.
Myth III - The third myth of course is that our health policy
is geared to fulfil the health needs of the majority.
The health budget has steadily decreased. It may have been
broken up under different heads but with increasing population
and increased need for health services, health budget should
be going up much more rapidly.
How has the money been spent ? What are the disparities existing?
What has been the role of the policy makers? What has happened
to the various recommendations mentioned earlier? The perspective
should have been set when we attained independence. The direction
being pursued now hasn't changed verymuch from the pre-inde
pendence period. The public has had no say in deciding the
kind of doctors it wants trained with its money and what kind
of health facilities and drugs it needs.
The issue of essential drugs focuses on the role the experts,
the committees and policy makers have played in the past
(many of whom are known to have been bought and sold). It
focusses on the role of consumers and on their demana for
participation in decision making as a majority, for the benefit
of the majority.
: 3 :
Demand for essential and life saving drugs as a priority is an
exercise in demystifying medicine; it is an exercise in public
education, an exercise in ensuring that public needs guide and
influence decision making. This demand is also an exercise
in learning to boycott drug decisions and policies which are
thrust down peoples throats against their will and against their
interest.
It is part of a slowly emerging consumer movement, people's
science movement and also people's health movement. It is
an integral part of a larger process and not a piece-meal demand
of a minor rectification.
COURAGEOUS EFFORTS
A Brief Review
The concept of essential drugs list is nothing new nor did it
have its origins in WHO's Technical Report Series No. 615
(1977) as many believe. Many efforts had been made prior to
this. We just mention few.
CHILE :
As far back as 1973, the Chilean Medical Commission comprising
of Dr. Salvador Allende had believed in limiting the drugs to
those that had demonstrable therapeutic value and thus "scale
down the pharmacopea". Allende during his short tenure as
President quite successfully compelled the medical profession
to serve "basic" rather than profitable needs. He proposed to
ban drugs not prescribed for clients in North America or Europe.
SHRI LANKA :
In 1971 under the guidance of Seneka Bibile, Sri Lanka had
formed the State Pharmaceutical Committee to launch its people
oriented new Drug Policy. The number of drugs in the market
were slashed down from 2100 to 600 and made available mostly
under generic names and obtained by calling international tenders.
: 4 :
Within six months there were savings of about 40% in relation
to expenditure incurred earlier.
INDIA :
In 1975, the Hathi Committee in India recommended a restricted
essential drug list of 116 drugs which were to be sold under
their generic names. There was no dramatic opposition to the
recommendations. They were just very effectively ignored.
So much so that today for interested healthand consumer groups
no copies of the Hathi Committee recommendations are available,
from the health ministry. These recommendations are shrouded
in cob-webs. The difference between the Indian experience
withessential drugs and that of others is that the demand for
them did not emerge from enlightened medical professionals
and has till recently remained an official exercise.
MOZAMBIQUE :
After its liberation from Portuguese rule in 1975 the Mozambique
government took some drastic decisions regarding its health
and drug policy. Health was nationalized and private practice
banned within one month of independence. The number of drugs
were decreased to 430 medicines in 1977. Essential drug list
was revised in 1980 and contained only 343 drugs. ONLY THESE
DRUGS COULD BE PRESCRIBED.
The result of streamlined contracts was that the drug prices
of many essential drugs came down to 1/3 of their orginal
prices. The essential drugs 'became available, to more people
in remote areas, not just to the privileged few. This could
be done with the drug import costs the same as they were
10 years ago because the selection was more sensible.
WHO
The WHO Expert Committee on Essential Drugs in Technical
Report Series 615 gave the criteria for selection of essential
drugs and a model of such a list. Another report in 1979 was
followed bythe Technical Report Series 685 which dealt with
: 5 :
the "Use of Essential Drugs'’ and gave the essential drug list
for emerqencysituations and primary health care.
BANGLADESH :
In June 1982 Bangladesh's Military regime under General Ershad,
promulgated a Drug Policy based on WHO recommendations.
1742 drugs were banned because of their hazardous and irrational
nature. This of course had been preceded by educational campaigns
about rational drug use by some of the individuals involved
in pushing the National Drug Policy. The January 1982 interna
tional conference on Health and Pharmaceutical Policies was
one such attempt organized by Gonoshasthya Kendra. Dr. Zafrullah
Chowdhury admits that the Hathi Committee and its recommen
dations held great inspiration for evolving and for implementation
of the Bangladesh drug policy. In Bangladeshthe restricted drug
list constitutes of 150 drugs. The grading of 150 selected essential
drugs has also been done based on location of utilization and
level of potential users. There is also list of 76 supplementary
drugs for restricted use.
ZIMBABWE :
Zimbabwe's Government has selected 376 essential drugs to
be used in the public health system. The Government will not
make foreign exchange available for importing drugs outside
this list.
Reprinted By : VHAI-New Delhi
VOLUNTARY HEALTH ASSOCIATION OF
INDIA
C-14 Community Centre
Safdarjung Dev. Area
New Delhi-110016
As Part Of Rational Drug
Policy Campaign
Hazardous, Bannable and Dumped Drugs
The issue of dumped drugs has been in the news for the past
few years. The drug companies involved in the manufacture
and sales of such drugs have received their due share of condem
nation. Foreign governments
policies, which provided scope
for exports of such hazardous products have been also condemned,
e.g., the Clayton Amendment Act and the U.S. Regulation.
It is well known that sales of medical technologies and drugs
is a commericai enterprise, the motivation being profit rather
than "service" or "welfare work".
Realising all this, the question arises as to how much can we,
as citizens of India, expect our drug control authorities to
safeguard our interests. The pressure from the drug industry
is immense. In spite of knowing this, our expectations from
the drug control authorities is high. After all our pharmaceutical
industry is the most developed in the Third World. According
to UNIDO, it belongs to Category V — developed enough to
be self-sufficient.
We have demanded that our imports, production and sales should
give priority to essential, life-saving drugs over irrational and
hazardous drugs, as per WHO's guidelines for Essential Drugs.
The drug industry and its supporters allege that the concept
of essential drugs is only for struggling, less developed countries
of the Third World and not for a country like India, with its
well-developed industry and its 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. The lobby claims that
consideration of hazards over efficacy, is a luxury which we
cannot afford.
However, consumers anywhere in the world have the right to
expect that irrational and hazardous drugs are not issued licences
and that licences of banned drugs should be withdrawn as soon
as possible, the ban implemented, and that all drugs in the
market are quality - controlled. We have 20 per cent substandard
drugs . One out of every five drugs will not be effective.
With the incereasing number of spurious
drugs floating in
the market, the problem is beginning to take on dangerous
proportions.
: 2 :
Since 1980 we've been concerned about
and hazardous drugs.
SOME
BANNABLE
DRUGS —
this
issue of
dumped
WHAT IS THE POSITION NOW
Under Section 23 P of the Drugs and Cosmetic Act
of 1940, the Central government has the power to
issue such directions to the State Governments as
required to execute the Drug Act. under Section
18 of the Act the State Government has the power
to prohibit manufacture, distribution and sale of
drugs by a gazette notification.
The sub-committee of the Drugs Consultative Committee,
in its 1980 report, recommended the banning of 23 combinations
of drugs, giving their reasons for such banning, 16 categories
of these drugs were recommended for immediate
weeding
and seven of the categories were to be weeded out over a
specified time. Over 500 brand drugs would be thus affected.
This report was presented to the Durg Consultative Committee
at a special meeting on 10.10.81, and later to the Drug Technical
Advisory Board (DTAB) and the Ministry of Healtn and Family
Welfare accepted it in 1981.
The DTAB, a Statuatory Body under Section 5 dtf the Drugs
and Cosmetics Act of 1940 recommended banning of 18 fixed
dose combinations. These drugs were randomly selected from
the Pharmaceutical Guide. Out of the 350 brand names affected,
44 were marketed by the foreign sector, 8 by public sector,
and 298 by private sector. Mnst of these drugs were being
produced by national companies According to the authorities,
"the purpose was to give time limit to firms who may already
have purchased the bulk drugs form manufacturing the formula
ties". What compassion and consideration for the drug companies!
SOME BATTLES
Halogenated Hydroxyquinoline
Ban of fixed dose combinations of halogenated hydroxyquinoline
: 3 :
was to be effective from 1.11.82. The date of the ban was
extended to 31.3.83 through DO No. X19013/8/81-D dated 13.8.82.
High Doses of EP Drugs
Through another DO. No. 12-48/79 DC dated 26.6.82, the Drug
Controller of India directed the State Drug Controllers to ban
the manufacture of high dose Estrogen-Progesterone combinations
from 31.3.83 and their sales from 30.6.83.
M/s. Unichem Labs, Bombay (OP 2927/82 of writ petion 2928/82), M/s. Nicholas Labs, Bombay and M/s. Organon (now known
as Infac (India) Ltd., Calcutta filed writ petitions in Bombay
and Calcutta high courts challenging the ban. Their contention
was that the Central Government has no powers to ban the
drugs. The High Court of Bombay and the High Court of Calcutta
have granted stay orders against the ban. Now these products
are available in the market.
Section 10A and 26A of the amended Drugs and Cosmetics
Act (April 1982) empower the Central Government to prohibit
import, manufacture and sale of any drugs considered harmful/
toxic or irrational, etc. Since the matter was in court during
the gazette notification of 23.7.83, this combination of drugs
has not been included in it.
What is absolutely objectionable is the fact that — inspite
of the act of the Drug Controller of India's ban of the production
and sale of EP drugs, M/s. Organon have managed to obtain
extension of licences to manufacture these products for another
two years.
Paediatric Tetracycline
Although this drug is banned in its oral liquid from to discontinue
its being prescribed for children because of its often serious
side-effects, it is being manufactured today as a tablet of
30mg. for children — an example of how a company can follow
the letter of law and yet disobey it without any legal
consequences.
: 4 :
Aspirin and Vitamin C
In October 1982, M/s. Nicholas Labs, Bombay filed a writ petition
in the Bombay High Court against the decision to ban the fixed
dose combinations of Aspirin with Vitamin C. The Court ruled
that the State Drug Controller has no -power under Section
18 of the Drugs and Cosmetics Act to stop the manufacture
and sales of this product. However, it would be open to the
respondents as and when the law has been enacted, to pass
any fesh order as it is considered necessary in accordance with
the law after following procedures prescribed by the Government.
Subsequent to the Drug Amendment Act of 1.2.83, the manufac
turers have again gone to court challenging the
Central
government and Sections 26 A and 10A on the grounds of "lack
of objective criterion for such ban".
This has resulted in the FDA — Maharashtra (which is supposed
to be having the best drug control mechanism in India) informing
the Drug Controller of India 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 question". (Letter dated 9.6.1984
ov the Drug Controller of India to the Voluntary Health Associa
tion of India).
Gazette Ambiguities
It is not ciear from the DO letter banning 22 drugs, whether
some drugs like strychnine and yohimbine, and caffeine are
banned only in some combinations, or in all combinations :
any drug containing yohimbine, or strychinine would be
banned (as neither of the two were considered to have
any therapeutic value and infact could lead to serious
side effects).
or the ban was applicable to drugs containing both yohimbine
and strychnine.
or to yomhimbine
vitamins
and
strychnine
with
testesterone
or
: 5 :
or ONLY to drugs which contained all four : yohimbine,
strychine, testesterone and vitamins.
Bangladesh banned 1742 drugs in June 1982. The time period
given to the drug companies to withdraw these products from
the market, to destroy these products was three to nine months,
depending on the product. They were strictly prohibited from
exporting these products to other countries. But we failed to
ban even a few hundreds, let alone 1742 drugs. The time period
given to drug companies was to complete the manufacture
of their formulation and sell off their stocks.
WHO IS MORE IMPORANT
THE CONSUMER ??
THE
DRUG
COMPANY
OR
The drug policy is now on the anvil. It is now that we can
assume the responsibility for putting people's health before
the health of the industry. If Indian people have to become
healthy, Indian Drug Policy needs to be rational. The choiqe
is ours — and we must make a decision now.
ALL .TOLA DRUG ACTION NETWORK
C-H COMMUNITY CENTRE S. D. A. NEW DELHI 110018
Dear Member of Parliament
As you know the Drug Policy of our country is being formulated in this session
of the Parliament. Drugs and health are very closely related. It is unfortunate
that today, drugs-their prioritization and manufacture are under the Chemical
and Industry Ministry. We are concerned that drugs, being what they are, should
be looked at from the people's health point of view, and not the industry's health.
The WHO list of eassential drugs says only 200 drugs can cure all illnesses of
the world. Today India produces more than 60,000 drugs. Majority of them are
useless. Many of them are banned abroad. Some, which are banned here, are still
being sold.
The prices we pay for these drugs is very high. Often many of these drugs are
substandard. There are also a large number of spurious drugs in the market.
You are the people's chosen representative. They chose you over others to safeguard
their interests. Health is one of the people's interest - a very large one. We,
the people who have elected you wish you to stand up for us at this crucial juncture.
The new drug policy, which you will shortly be formulating should -
1.
Restrict the number of drugs based on the criteria laid down by
World Health Organization and Hathi Committee Report of 1975.
2.
The new rational drug policy should be in keeping with Government of
India's Health Survey and Development Committee (BHORE COMMITTEE)
Report, 1946 and the Health Survey and Planning Committee (MUDALIAR
COMMITTEE) Report 1959-61.
3.
All Hazardous drugs should be banned or severely restricted.
4.
Adequate
5.
Adequate measures should be taken to ensure good quality drugs both
with brand names and generic names. Interational nomenclature (generic
names) should preferably be used. Marketing in spurious or substandard
drugs should be considered on par with trafficking in narcotics and
psychotropic drugs.
6.
All drugs should contain information
large print and in local languages.
production
and supply
of
essential
on
their
drugs
should
possible side
be
the
ensured.
effects
in
:: 2 ::
India has signed the Alma Ata Declaration of ''Health for All By the Year 2000".
India has pledged to formulate a rational drug policy at the fifth and sixth summits
of the Heads of Non-Aligned Countries both in Sri Lanka (1976) and in Havana
(1979).
India is considered as a leader of the Third World and of Non-aligned countries.
They look to us for guidance. Can we make this leadership concrete ? Can we
redeem our pledge now ?
Can we formulate a drug policy where people matter more than profits.
It depends on you .... now.
Signed by the citizens of India
and
All India Drug Action Network
The World Health Organization says:
it A
few ©u
which are ©ff
no value and are even dangerous, are often given
t©
tom® are
wasted m their ms®b55So ...
who ws uowni
has NO VALUE?
LOMOTIL (diphenoxylate/? :: .; I;. r:
by the I-'.multinational drug comt;. ..? . :;... :.
and
promoted to physicians e’. ■: -.••>.• t world in terms
such as “established su<■■ ■ ■ .< "good tolerance”,
“excellent value" and ‘ seal for every situation" Thi
leaflet — prepared and published by Social Audit Ltd.,
and friends* — calls into question these claims.
LOMOTIL may be of value in giving symptomatic relief
for non-specific “travellers' diarrhoea” in adults. But
experts sefy Lomotil — and other products like it2 —
have little or no place in the treatment of young
children — especially in developing countries, where
infective diarrhoeas are the major cause of death in
children aged under three.' Lomotil’s limitations
include:
(»ARkE c
SCARCE
POTENTIAL BASTOEKS
“Lomotil, which is widely used in the
treatment of diarrhoea in the paediatric age
group, is dangerous and unwarranted . . .
we urge that all physicians treating infants
and children avoid the potentially dangerous
use of Lomotil for the treatment of
diarrhoea.”
(Clinical Notes [1974])3
“Lomotil can relieve the symptoms of acute
gastroenteritis in children, but it can also
mask the signs of dehydration and cause
fatal toxic reactions . . . use of this
combination for treatment of diarrhoea in
children is hazardous.”
(The Medical Letter [198Q])“
“Lomotil is a dangerous combination of
drugs contra-indicated for children under 2
years of age and probably never indicated in
childhood diarrhoea.”
(Pediatrics [1980])5
@UESTO©NABLE USEFULNESS
“The use of Lomotil as an antidiarrhoeal
agent in children is difficult to justify . . . we
doubt if it has any place in the treatment of
diarrhoea in children.”
(Arch, of Dis. in Child. [1979])6
“A diarrhoea that needs 4 such tablets to be
cured would probably have been cured
without it too. A more prolonged diarrhoea
needs proper investigation and specific
therapy rather than a blindly harmful
stopcock.”
(Leb. Med. J. [1974])7
ECONOMIC WASTE
Lomotil costs up to 25 times more than other
widely-used symptomatic treatments for
diarrhoea.
(AMREF[1980])8
“Lomotil (no value).” (WHO [1976])' '
HOW USEFUL...
“The management of acute diarrhoea in
childhood is essentially dietary . . .
Unnecessary drug prescription for these
chidren should be vigorously opposed.”
(The Lancet [1976])9
. . . Against Dehydration?
“The cause of death in diarrhoea is
DEHYDRATION . . . Diarrhoea is the most
common cause of death in children under
three years of age . .
(WHO [1976])’
LOMOTIL is not a treatment for dehydration. It
may reduce the loss of fluid from the body but
can also allow fluids to accumulate in the
paralysed gut.
“LOMOTIL can mask fluid losses without
diminishing them, and the drug itself can
cause fatal adverse effects . . . there is no
evidence that reduced motility diminishes
the loss of fluid and electrolytes into the
lumen of an inflamed intestine.”
(The Medical Letter [1975])“
The accumulation of the body’s vital fluids within
the intestine can be just as dangerous as the
more obvious dehydration:
“In diarrhoea, life-threatening situations
are reached ... so long as fluid and
electrolytes are excessively lost into the
lumen whether they are expelled from the
lumen to the outside of the body or not...”
(J. of Singapore Ped. Soc. [1976])’0
Small feeds of water (or a weak electrolyte
solution) given frequently by mouth is the only
first-line treatment against serious childhood
diarrhoea. If this fails after 24 hours, intravenous
therapy and hospitalisation may be needed.
... Against Infection?
“Acute diarrhoea in children is usually
Infective, but antibiotics and anti-diarrhoeal
drugs rarely help.”
(Drug and Ther. Bulletin [1978])''
LOMOTIL is widely and often successfully used
by adults as a symptomatic treatment of
bothersome, non-specific “travellers’ diarrhoea’’
(which is rarely serious). But in children infective
diarrhoea is serious. LOMOTIL prevents the child
from getting rid of the infective agent and may
prolong the period of infection.’2
“In patients with infect?*;-. o>asr?so®a, tbs
use of constipating sgos-'f::
eaw’h
state last longer by stezs,:';-. •
nanism
from being excreted.”
(AM REF [1980])“
A comparison between LOMOand a placebo
in treatment of an infective dlarrl
reported
that:
“Febrile volunteers receiving Lomoiil
alone experienced over a day more fever
than those in other treatment groe-jss,”
suggesting that “drugs that retard gut
motility may facilitate intestinal
infection...”
(JAMA [1973])’3
HOW SAFE?
“Because of its depressant effects it is no
longer recommended for children.”
(Brit. Med. J. [1976])’4
LOMOTIL poisoning in children can include
atropinism, respiratory depression, coma, and
even death. Symptoms can appear even at near
therapeutic doses:
“Lomotil ingestion is a cause of serious
poisoning in young children, especially those
aged under five. It is always hard to assess
the dose in patients suffering from
poisoning, but it seems that young children
may develop pronounced symptoms after
taking only one to five tablets.”
(Brit. Med. J. [1977])’5
The difference between therapeutic and toxic
dose is unpredictable:
“We were unable to find a correlation
between the severity of symptoms and the
dose ingested. Because of this it Is not
possible to predict what dose will be toxic in
children, and while some may have only the
mildest symptoms with relatively large
doses, others develop severe toxicity on
ingesting an amount near the normal dose.”
(Arch, of Dis. in Child. [1979])6
“There is a very narrow range between
allegedly therapeutic and toxic dosages, and
many cases of toxicity in children have been
reported.”
(Pediatrics [1980])5
“The narrow margin between therapeutic
and toxic doses, and the high incidence of
atrojsine hypersensitivity, make Lomotil a
potentially dangerous therapeutic agent.”
(Ciinicai Notes [1974])3
“Th® dangers of this drug to children have
not been well recognised. The narrow range
between therapeutic and toxic doses, and
also the possibility of a child being
abnormally sensitive ... may account for the
severe toxicity sometimes seen with low
dosage.”
(Ciinicai Pediatrics [1973])’6
DESPITE THE DANGEROUSLY VARIABLE
RESPONSE, SEARLE’S RECOMMENDED DOSES
FOR INFANTS AND CHILDREN AND THE
PACKAGE WARNING INFORMATION VARY
AROUND THE WORLD.
In the US, LOMOTIL is contra-indicated for
children under two years old.
“This warning by the manufacturer is not
because there has been inadequate
paediatric testing of the drug but rather
because severe life-threatening reactions
(which are not rare) occur in this age group.”
(Am. Fam. Phys. [1976])’7
In Britain, however, the makers recommend it for
one-year-olds; and in Hong-Kong, Thailand, and
the Philippines it is offered for infants of three
months old.
Special circumstances in developing countries
compound the potential danger of treating
infants with Lomotil in this way. In developing
countries:
• children are relatively lighter than those of the
same age elswhere;
• the amount of medical supervision is greatly
lower;
• typically, no adverse reaction reporting systems
exist; and
• drugs such as LOMOTIL (available only on
prescription in the West) are in practice freely
available over the counter.
HOW EXPENSIVE?
The cost of the smallest available size of
LOMOTIL would for many people in developing
countries be equivalent to at least one day’s
income. Other effective preparations for
symptomatic treatment of diarrhoea’8’’9 cost
much less.
According to the African Medical and Research
Foundation (AMREF), the cost of treatment with
LOMOTIL is about twice the cost of treatment
with codeine syrup orcodeine phosphate.
Treatment with a kaolin mixture, which may also
give relief20, costs about 25 times less.8
LOMOTIL WITH NEOMYCIN (an antibiotic)
is recommended by Searle for the treatment
of "diarrhoea of bacterial origin." This is
unacceptable:
“Antibiotic and sulphonamide
preparations should be avoided for the
treatment of diarrhoea even when a
bacterial cause is suspected because
they may prolong rather than shorten
the time taken to control diarrhoea and
carrier states.”
(BNF[1981])2’
“Neomycin not only can cause renal
damage, but also it makes diarrhoea,
dehydration, and nutritional losses
worse and could interfere with oral
rehydration therapy.”
(Population Report ,1980)22
“Medicines which should not be used
In the treatment of diarrhoea:...
Neomycin...”
(WHO [1976])’
Treatment with LOMOTIL plus NEOMYCIN
costs about three times more than
treatment with LOMOTIL alone.
REFERENCES:
1 World Health Organization: Treatment and Prevention of Dehydration in Diarrhoeal Diseases (A Guide for
Use at the Primary Level) (Geneva: WHO, 1976). LOMOTIL is one of 9 treatments not recommended.
2 The same preparation is sold by Janssen Pharmaceutical Ltd. and known as “Reasec”. Other proprietary
names: Diarsed (Fr.); Retardin (Swed.). (Source: Martindale’s Extra Pharmacopoeia, 27th Edition).
3 Drake M E, & Drake M E Jr.: “Lomotil Intoxication in Pediatric Patients" (in) Clinical Notes (June 1974)
pp. 501-2.
4 "Lomotil for Diarrhoea in Children” (in) The Medical Letter (iss. 25,1975) p. 104.
5 “Delayed Cardiopulminary Arrest after Lomotil Ingestion” (in) Pediatrics (Jan 1980) pp. 157-8.
6 Curtis J A, & Goel K M: “Lomotil Poisoning in Children” (in) Archives of Disease in Childhood (iss. 54,
1979) pp. 222-5.
7 Uthman S M: “Some Complications of Diphenoxylate Hydrochloride with Atropine” (in) Lebanese
Medical Journal (iss. 27/5,1974) pp. 521-2.
8 Upunda G, Yudkin J, and Brown G: Therapeutic Guidelines (A manual to assist in the rational purchase
and prescription of drugs) (Nairobi: African Medical and Research Foundation, 1980) p. 96.
9 "Drugs for Acute Diarrhoea in ChikJ!
’ (in) The Lancet (Nov. 20,1976) p. 112.
10 Wong Hock Boon & Michael : ■ •'
omotil Poisoning” (in) The Journal of the Singapore
Pediatric Society (April 1970•. .
11 “Diarrhoea in Children” (in) L ?
: L-:\Jan 6,
;
12 Pittman F E, “Adverse Effects
. mvr- ■' rtter tc .-.ditor
.
v:
iogy (Iss. 67/2,1974) pp. 408-9.
13 Dupont H L, & Hornick R B:
of Lomotil Therr-r r Viuceiiosis” (in) Journal of the
American Med. Assoc.iL--?
i525-8.
14 Bell D R: “Diseases
: -. '
...
g-y
id/t) p. 1240.
15 Penfold D, and Volar? GN: ? " ...
i Lomotil’ (in
J. 1977) pp. 1401-2.
16 Snyder R, Mofenson :\ ■ ;. L
, ...'
' Toxicity
;
i'.i J.CiJ Viirfiatrics (Jan 1973)
pp. 47-9.
17 Wasserman G S: “Lomotil <.:ge•••.tr.-:-’ (iwtier to editor in).. £•«!.. . .-J: ,J ; Jet 1976) pp. 27-8.
18 Smits B J: "The Irritable Bowei
(>r>) Preet .-me.- . ; ■■
19 Collins CD: “Lomotil in Treatr-em
PostVagotomy Diarrhoea' /i;:.:'- ?? .:. • «’.J. (Sept3,1966)
pp. 560-1.
20 Portnoy B L, et al: “Antidiarrhoea! Agents in the Treatment of Acute Diarrhoea in Children” (in) Journal of
the American Med. Assoc. (Aut 16,1976) pp. 844-6.
21 British Medical Assoc. & The Pharmaceutical Soc. of G.B., British National Formulary 1981, No. 1,
(London: The Pharmaceutical Press and the BMA, 1981) p. 40.
22 The Johns Hopkins University, "Oral Rehydration Therapy (ORT) for Childhood Diarrhoea” (in) Population
Reports (Issues in World Health) (Nov/Dec 1980) p. 54.
* SOCIAL AUDIT ATO METOS
SOCIAL AUDIT Ltd is an independent non-profit making action-research unit, concerned with
improving government and corporate responsiveness to the public generally. Its concern applies to ail
corporations and to any government, whatever its politics. Social Audit has reported and campaigned
on a wide variety of public interest issues. Its interest in multinational drug companies and in
development is reflected in this leaflet — with hopefully others to follow — and also in the
publication of Insult or Injury? (An enquiry into the promotion of British food and drug products in the
third world, 1979); and Drug Disinformation (What British and other multinationals tell doctors about
their products at home and abroad, 1980).
This leaflet — for which Social Audit is wholly responsible — could not have been prepared and
published without the generous support given by:
War on Want, 467 Caledonian Rd., London N7 9BE, and The International Organisation of
Consumers Unions, Regional Office for Asia and the Pacific, PO Box 1045, Penang, Malaysia.
SOCIAL AUDIT LIMITED 9 POLAND STREET po box hi undonNwi bxg
© Social Audit Limited 1981
Reproduced by
VOLUNTARY
HEALTH
ASSOCIATION
OF
INDIA
C-14, Community Centre, S. D. Area,
New Delhi - 110016
AS PART OF THE RATIONAL DRUG POLICY CAMPAIGN.
BAD INFORMATION
MEANS
BAD MEDICINE...
Dear
ctor
So many different brands of clioquinol recommended
for the prevention or treatment of non-specific
diarrhoeaso
How does a doctor choose between them?
A brand of clioquinol from an unknown local firm?
Or Mexaform or Entero-Vioform - world leading brands
from a trusted Swiss name, CIBA?
The choice is immaterialo
This is because all
brands have this in common: In the t,re_a.tm_ent of nonspecific diarrhoeas, their benefits have not been
proveno
Their dangers clearly have0
Whatever the brand - with clioquinol there is no
choice.
Thank you for not prescribing it0
Yours faithfully,
SO WHY AREN'T THERE MORE
'DEAR DOCTOR1 LETTERS
LIKE THIS?
This ‘Dear Doctor’ leaflet
puts patients first. It was prepared and is published by
Social Audit and friends*.
—W BEK9TS OF CLIOQUINOL: UNPROVEN NMI
The CIBA-GEIGY products Entero-Vioform and
Mexaform are among the many brands of
clioquinol that have long been promoted1 for the
prevention and/or treatment of a wide variety of
non-specific/travellers’ diarrhoeas — e.g. for
‘summer diarrhoea', ‘food intolerance', ‘non
specific diarrhoeal disorders' — and even for ‘all
forms of gastro-intestinal disorders'.
But authoritative, independent assessments
have concluded that the evidence for such claims
is trivial. The evidence that has been offered has
been described in terms such as: ‘inadequate',
‘scanty’, ‘unconvincing’, ‘insubstantial’ and ‘non
existent’. For example:
‘The claims for the value of clioquinol in
the prevention and treatment of that
nebulous ragbag “travellers’ diarrhoea” do
not withstand critical examination.’
(The Lancet [1977])2
‘There is no evidence to suggest clioquinol
(is) effective in the prophylaxis of travellers’
diarrhoea.’
(British National Formulary [1981 j)3
‘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 this claim”.’
(Pharmaceutical Journal [1977])“
*. . . in 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’ diarrhoea,
whereas one other prospective study has
shown it to be no more effective than a
placebo.’
(JAMA editorial [1972])5
This lack of evidence has not deterred CIBAGEIGY, BAYER and other drug manufacturers
from vigorously promoting their brands of
clioquinol for the treatment of non-specific
diarrhoeas. If there has been less emphasis
recently on such promotion, it has been largely
the result-of successful legal action against
CIBA-GEIGY and other firms — and of
government regulation.
But, for the future, is it sufficient merely to delete
any reference to ‘non-specific diarrhoeas’ in the
prescribing literature? No:
‘A quiet change in the indications is not
enough. Drug regulatory authorities,
manufacturers and distributors . . .should
now emphasise to the public that these
drugs should no longer be used for
travellers’ and other non-specific
diarrhoeas.’
(The Lancet [1978])6
Other uses for clioquinol
Ciba-Geigy and the law
Clioquinol is used in the treatment of intestinal
amoebiasis — though other effective and safer
drugs are available for treatment of both the
symptomatic and carrier state of this disease.16
In 1978, after 8 years of litigation over the claims of
Japanese victims of SMON, the Tokyo District
Court reached two decisions — the first of several
similar rulings. The Court found first that clioquinol
caused SMON. Secondly, it was found that CIBAGEIGY et. al. were liable, in failing to pass on
information about the dangers of clioquinol.
Clioquinol has been used in the treatment of the
rare childhood skin condition, acrodermatitis
enteropathica. It has been established since 1973
that treatment with zinc salts is more effective and
safer.”
Clioquinol is of no value in the treatment of acute
cholera.18
Since then, the SMON victims and their
representatives have put CIBA-GEIGY under
considerable pressure, if not to withdraw its
clioquinol products, then to include appropriate
instructions and warnings with them. In defending
its position the Company has argued: ‘It is,
however, not possible to achieve complete
uniformity of the information for the doctors and
patients because in different countries there are
different rules which are usually laid down by the
local health authorities.’19 Though this is true, any
implication that such regulatory requirements
would prevent a company from including more
than the minimum warnings required is wholly
unacceptable.
EZZZJ ©ANGERS OF CLIOQUINOL: PROVEN >HBi
The benefits of using clioquinol against diarrhoea
have not been proved. But the dangers have —
and they clearly compare with the thalidomide
catastrophe in severity.
Clioquinol has caused thousands of cases of
SMON — subacute myelo optic neuropathy — a
condition involving continuous pain, paralysis,
blindness and, in extreme cases, death.
from England, Australia, Switzerland,
Sweden, Denmark, the Netherlands and the
US have described patients who developed
neurologic symptoms while taking (these
compounds). The clinical symptoms of these
patients were like the ones that
characterised SMON.’
(JAMA [1973])’
In Japan, cases of SMON reached epidemic
proportions — affecting an estimated 10,00030,000 people — before the drug was banned
there, in 1970. But what of the situation
elsewhere?
Incapacitating neurological damage has been
associated with high doses of clioquinol in
prolonged treatments. But limiting the dose or
duration of treatment is not necessarily an
appropriate response:
. the companies deny that the
neurological damage from clioquinol is a
serious risk outside Japan. This denial is
unconvincing because cases of clioquinol
damage have been observed outside Japan,
and identical abnormalities of the nervous
system have been reproduced in animals.’
(The Lancet [1976])7
‘In fact, since it now seems almost certain
that large doses of (clioquinol) produce
severe, clinically obvious neurological
damage, it must be suspected that the
accepted smaller dose schedules may cause
sub-clinical neurological damage.’
(Pediatrics [1974])9
‘The absence of epidemics in other
countries does not invalidate the conclusion
that (clioquinol) is neuro-toxic. Clinicians
IS THIS DRUG CLIOQUINOL WORTH THAT
ADDITIONAL RISK?
MH CONTROL OF CLIOQUINOL: INADEQUATE ■■
Several governments have concluded — as the
World Health Organisation has stated — ‘that the
risks of treatment outweigh the potential
benefits’.'0 In some countries — they include the
United States, Japan, New Zealand, Sweden,
Denmark and Norway — clioquinol has been
withdrawn or altogether banned. Other
governments have.restricted the availability or
applications of this drug."
But in many developing countries, and
elsewhere, clioquinol is still widely available:'2
‘Worldwide, these preparations are still
available in at least 1OO countries and, in
some instances,- on a scale comparable to
that existing in Jar •< at the height of the
SMON epidemic.’
(World Health Organisation [1977])'3
A survey of 107 samples of clioquinol obtained
from 34 different countries (International
Organisation of Consumers Unions [1975])'“
established that ‘Clioquinol is widely available as
an over-the-counter drug for the prophylaxis and
treatment of travellers’ diarrhoea’. The
investigators reported serious inadequacies in
the prescribing information supplied, with ‘wide
variation in the doses, duration of treatment,
contraindications, side effects and warnings
listed’.
In a more recent survey (IOCU [1980])'? an
examination was made of the instructions given
with twelve brands of clioquinol sold in
Indonesia, Malaysia, the Philippines and
Thailand. Of the 20 samples obtained:
• all but one was bought without a prescription
• four contained no instructions for use
• eleven recommended, use for ‘non-specific
diarrhoeas’
• ten omitted any warning to stop using the
product immediately on the first signs of
neuritis, damage to nerves.
The need for control is underlined by the fact that
products containing clioquinol cannot readily be
recognised as such. There is not only a
multiplicity of brand names — but many
products are also identified only by a confusing
chemical name, such as 'iodochlorhydroxyquinoline’ or‘5-Chloro-7-iodo-8-quinoline’.
BAD INFORMATION. IT MEANS BAD MEDICINE.
‘Do you think a big multinational company
would continue sales of a compound, of a
product, if this would mean a danger to human
lives?’
(Ciba-Geigy representative [198O])20
REFERENCES:
1 CIBA-GEIGY has stated (letter to Social Audit dated 6 May, 1981) that ‘the indication "non specific
diarrhoea" was recommended for elimination from the package leaflets for these drugs in 1978. This
policy has been implemented worldwide, with the exception of one European country’. However, see
section on ‘Controls' in this leaflet, and references 14 and 15.
2 ‘Clioquinol;Time to Act' editorial in The Lancet (28 May, 1977, p. 1139).
3 Joint Formulary Committee: British National Formulary (London: British Medical Association and the
Pharmaceutical Press, 1981). p. 40.
4 Pharm. J. (30 July, 1977) p. 597.
5 JAMA editorial (10 April, 1972) p. 273.
6 The Lancet (2 September, 1978) p. 519.
7 The Lancet editorial (28 May, 1977) p. 596.
8 JAMA (23 July, 1973). p 296.
9 Pediatrics (1 July, 1974) p. 339 (b).
10 ‘Clioquinol and SMON’ (in) WHO Drug Information Bull. October-December 1977. p. 12.
11 For instance, in France, Switzerland and other countries, clioquinol is available only on prescription. In
Venezuela and Australia, use of clioquinol is restricted to severe cases of amoebic dysentery and
acrodermatitis enteropathica.
12 CIBA-GEIGY (in a letter to Social Audit dated 6 May, 1981) stated that its clioquinol brands were available
in over 100 countries.
13 World Health Organisation. Op. Cit.
14 International Organisation of Consumers Unions: Clioquinol: Availability and Instructions for Use. (The
Hague: IOCU, 1975).
15 IOCU Regional Office for Asia and the Pacific: Clioquinol in South East Asia (Penang, Malaysia: IOCU,
1980).
16 Symptomatic intestinal amoebiasis may be successfully treated with metronidazole and the carrier stateof amoebiasis responds to diloxanide furoate. See: American Medical Association: AMA Drug
Evaluations 4th Edition (New York: Wiley & Sons, 1980) Chapters 58 and 82.
17 Martindale: The Extra Pharmacopoeia 27th Ed. (London: The Pharmaceutical Press, 1977) pp. 74, 222.
Spencer PS & Shaumberg HH: ‘Clioquinol’ (in) Experimental and Clinical Neurotoxicology (Baltimore:
Williams and Wilkins, 1980). p. 397. Berggren L and Hansson O.: ‘Treating Acrodermatitis Enteropathica'
(in) The Lancet (1 January, 1966) p. 52.
18 Martindale. Op. Cit. p. 74.
19 Dr. J. Sobotkiewicz. Statement at Geneva press conference on SMON. Proc, of 28 April, 1980. p. 34.
20 Dr. J. Sobotkiewicz. Ibid. p. 23.
* SOCIAL AUDIT AND FRIENDS
SOCIAL AUDIT Ltd is an independent non-profit making action-research unit, concerned with
improving government and corporate responsiveness to the public generally. Its concern applies to all
corporations and to any government, whatever its politics. Social Audit has reported and campaigned
on a wide variety of public interest issues. Its interest in multinational drug companies and in
development is reflected in this leaflet — the second in a proposed series — and also in the
publication of Insult or Injury? (An enquiry into the promotion of British food and drug products in the
third world, 1979); and Drug Disinformation (What British and other multinationals tell doctors about
their products at home and abroad, 1980).
This leaflet — for which Social Audit is wholly respdnsible — could not have been prepared and
published without the generous support given by: The International Organisation of Consumers Unions
(Regional Office for Asia and the Pacific), PO Box 1045, Penang, Malaysia. IOCU and Social Auditare
affiliates of Health Action International.
SOCIAL AUDIT LIMITED
PO Box III London N W I 8 X G
© Social Audit Limited 1981
Reproduced by
VOLUNTARY
HEALTH
ASSOCIATION
OF
INDIA
C-14, Community Centre, S. D. Area,
New Delhi-110016
AS PART OF THE RATIONAL DRUG POLICY CAMPAIGN.
DRUG
ACTION
FORUM,
KARNATAKA
57, "SONI" Tejaswinagar, Dharwad-580002
Date 5 Jan 1993.
KARNATAKA INDIA
PLEASE REPLY TO
Dr Benjamin V, Tel no 569087.
©Dr Tekur SP,
Tel no 531518.
Dr Saraswathy Ganapathy Tel no 630463.
/Dr Vanaja Ramprasad Tel no 644963.
Dr Prakash Rao C, Tel no 369016,
Mr Gebastain MA, Tel no 575852.
P-r Philip Goerge, Tel no 22 3229.
i.s Ammu "Joseph, Tel no 541875.
Dr Arun K, Tel no 569 527.
Dr Sudarshan H,
:’r Natraj DR,
Dr Gopal Dabade,
Khan’s building,
Sanmati Marg,
Dharwad 580001.
■ar friends.
Wish you all a happy new year.
December 1992 has left several scars on us.When the whole country
was shaken and tattered by Ayodhya issue, we at Kittur had to face uphills.
The Kittur landlord filed a police canplaint on sane of us and the villagers.
u'e really had to struggle and strive to cane out of it.To cut the long story
short, we came out ultimately with flying colours, but that meant one and half
month intense stratagesing and organising.! hope you will excuse me for not
being able to communicate to you.And amidst all this we have shifted to our
our new house at Dharwad.Note change in address.
So let us get back to our work. Drug Action Forum-Kamataka will
meet on 12th Jan 1993 at 3.30 pm at SCM House, Ban galore. Agendas for discussion
l)Future action and reorganising of DAF-K.
2)Natraj's study and how DAF-K will use it.
Hoping to meet you on 12th Jan.
Yours Sincerlyi
(Dr Gopal Dabade)
Remember Gandhi
When you formulate the Drug Policy, remember
Gandhiji's words:
"Recall the face of the poorest and the most
helpless man whom you may have seen and askyourself if the step you contemplate is going to
be of any use to him."
5. ENSURE QUALITY
4. USE GENERIC NAMES
3. PRODUCE AND SUPPLY ADEQUATELY ESSEN
TIAL DRUGS
2. BAN HAZARDOUS AND IRRATIONAL DRUGS
I. ASSESS DRUG NEEDS
NOT MARKET DEMAND
ENSURE IMPLEMENTATION
OF BAN
\
The Drug Controller of India's DO Pio. X 1 1014/7/83
banned liquid preparations of oral tetracycline so
that its misuse in children could be prevented. This
issue was side stepped by the production of Ledermycin tablets of 30mg. for children.
Most doctors, particularly in smaller towns and
rural areas, do not know about the ban. The ban
ned drugs are availabe, and the doctors prescribe
them.
...
.
„__ __ _ ______ ____
Murder in the name of medicine
147721} Gi
i'or health and energy
fyr ihe Sam? price
One teaspoon of Waterbury's Compound gives you
5 mg. of iron and 8-9.5% v/v alcohol.
A child needs daily 15 to 20mg of iron — at feast 5
teaspoons of Waterbury's compound or 100g.
methi (fenugreek leaves)
An adult needs daily 20 to 30mg. iron — at least 7
teaspoons of Waterbury's compound, or 200mg. of
methi leaves daily.
neither need the alcohol.
Most gripe waters given to infants contain large
amounts of alcohol. More than 20 years ago, the
Kefauver Committee on drugs in USA reported:
"The incidence of disease cannot be manipulated
and so increased sales volume must depend on at
least in part on the use of drugs unrelated to their
utility or need, or in other words, improperly pre
scribed. Human fraility can be manipulated and
exploited and this is fertile ground for anyone who
wishes to increase profits."
A
1
Liquor is cheaper than tonic
_____________ ________
Two tears for quality control
__ __________ CL------ --------------■
•
Japan, considered to be the seat of small-scale in
dustry, has 1000 drug manufacturing units.
USA with 16 percent of the drug market has 700
units.
India with just 1 per cent of the drug market has
over 8000 formulators.
5 quality control laboratories and 600 drug inspec
tors attempt to maintain quality control of over
60,000 drugs.
20 per cent of the drugs available in the Indian mar
ket are substandard. That is, 1 out of every 5
medicines you buy is uneffective.
India has numerous spurious drugs in the market,
and their number is increasing. This is due to the
high profit margin there is in drugs. The spurious
drugs are naturally not quality controlled.They can
even cause death.
I
t-----
1
Two tears for quality control
30 YEARS R.I. OR RS. 3 LAKHS
FINE OR BOTH FOR DEALING IN
SUBSTANDARD AND SPURIOUS
DRUGS
Loopholes in the law
There are numerous instances where the laws have
provided enough loopholes for manufacturers of
hazardous and irrational drugs to escape.
When the Drug Controller of India banned highdose estrogen-progesterone combinations, be
cause they were being used for pregnancy testing
and could harm the unborn babies, the manufac
turers managed to get a stay order against the ban.
When the Drug Controller of India banned paediat
ric tetracycline in liquid oral preparations, the man
ufacturers are making tablets of the same for chil
dren.
Every time the drug control authorities have made
a decision favouring health of the people over the
drug industry, the industry has managed to find
enough loopholes in the law to escape. Today, you
can do something.
Something for the public whose interests you have
promised to safe guard. And health is one of those
interests.
Steps for survival
YOU HOW HAVE A RATIONAL DRUG POLICY
10. PLUG LEGAL LOOPHOLES
9. PROMOTE INDIGENOUS RESEARCH AND DE
VELOPMENT
8. ENSURE REASONABLE PRICE
7. ENSURE ETHICAL MARKETING
6. ENSURE CORRECT INFORMATION
Availability of essential and life saving drugs
Withdrawal of hazardous and irrational drugs
Availability of unbiased drug information
Adequate quality control and drug control
Drug legislation reform
,
Use
of generic
names ■
\ •
) .■
'
vV;< ■
■
ALL INDIA DRUG ACTION NETWORK
Position: 1207 (7 views)