RATIONAL THERAPEUTICS
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- Title
- RATIONAL THERAPEUTICS
- extracted text
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RF_DR_7_A_SUDHA
PEOPLE IN THE DRUG ACTION
( Paper to be presented at TRICHY WORK SHOP on Drug Problems )
DR . V. BRAHMA REDDY
of drugs
Currently we are dealing with a sensitive subject
which are intended to save the lives, cure the
illness and prevent the disease.
In the historical perspective.
they indeed played an important positive role in the arena
of health.
But this never undermines the crucial role of
immunity and the role of food, water, sanitation, education
and employment
to butress the immunity directly or indirectly.
This immunity continues through ages to be the uanguard to attain
health and prevent and combat disease.
YET»
Drugs is one of the factors in the much bigger problem of
health. But the miracles drugs did in the 1930's and 40s
*
have lead to the emphoria in the people that " there is a
Pill for every ill " and thus a fertile ground has been created
for the indiscriminate use of drugs whether needed or not.
There are diseases that won' t need drug treatment like cold,
mild irritative cough, weakness after heavy work etc., were
also profusely garlanded by drugs. This state of mind of the
people was conveniently exploited by the agency which has
substantial benefit in the form of profit by way of Marketing
drugs. That agency is drug companies. There are Drug
Multi-Nationals, Indian Monopoly Drug Houses, Indian Small Scale,
Mediun scale, Private Drug Industry and Indian Public Sector
Drug Industry. Because of their gagantic economic structure
and advanced promotional leverage, the multi-national Drug
Industry has always got a lion share in the drug sales.
Here again, when we speak about the role of Drugs in the
field of health, there are four agencies that come to interact
with one another. They are the Government, the drug Companies,
the Doctors and the people. We have got the right to request
all the four agencies to stand for the m rational attitude in
the drug situation. But will they oblige us? or not? If so why?
contd..2
P age-2
THE GOVERNMENT*
Let us first approach the Government and requests
After a heated discussion in the Parliament in the
about the role of drug Multinational the Government
early 70s
*
appointed a P ar li an ent ary Committee by nane Hath! Committee in
1974. The Committee submitted its report in April, 1975 with
recommendations like nationalisation of drug multinationals,
till then the equity to be brought down immediately to 40 $ and
later on to 26 % formation of National drug and therapeutics
authority ( NDTA) to monitor the drug issues, abolistion of
brand
names etc.,
That report was kept in attic safely by the G.O.I.
Having known about the recommendations, the drug multinationals
purchased all the copies of Hathi Committee report and destroyed
outright... What the people talked about in those days. Now
the Report is available only with a handfull of individuals
and in a few public libraries. Has the G.O.I. a semblence of
responsibility to reprint the report and make it available to
the Public-
Can I expect this?
In 1978, a new drug policy was announced in the
Parlianent by the then Central Government with the Hath!
IXecommendations in a much diluted and distorted form. Thus
Hathi Committee Report defacto died long before Mr. J aisukhlal
Hathi. The G £) .1 . is an active witness for this episode.
Now to frame the New Drug Policy N.D.P.D.C. has
appointed a steering Commitee and the working groups. The
Chairman for the Steering Committee is Mr. Mahendra Prasad, M .P .,
who has substantial interests in Aristo Pharmaceuticals, a
drug firm.
The Managing Directors of H3ECHST, and EMERCK
drug multinationals are there in the Committee.
When the G.O.I. was asked to include other relevant people
in the Steering Committee, so that it can attain proper representative
character for credibility, the Minister State for Petrolem
and Petro Chemicals retorts that Doctors are not experts, Medical
Representatives are not experts, Druggists, Chemists are not
experts, Pharmacautical Employees are not experts, Scientists
page-3
are not experts, voluntarily organisations that are doing
commendable work in the Drugs issue are not experts to advise
the G.O.I. on New Drug Policy. So who are the experts then?
Mr . M ahendra Prasad, M anaging Directors of E. MERCK and HOECHST .
Inspite of the resistance by a lot of organisations and
individuals, though some of them felt that their efforts stalled
the GJD.I. to introduce the New Drug Policy, the G.O.I. proved
its utter callousness on 18..12.1986 by announcing New Drug
Policy in Press Conference, just after 7 days of Adjournment
of P arliament. Thus not giving a chance even to Parliament members
to discuss on this issue. This New Drug Policy was described
by National Dailies as " Bonanza to the Drug Industry " and
" Christmas Gift to Drug Companies". It contains liberal
pricing, liberal imports, liberal licensing, in nutshell.
Will this Govt, head to Public Openion?
The Drug Companies got stay orders on Brand name
abolition issue, Banned Drug issue like EP Forte and drug
prices issue etc.
To cite an example, HOECHST was selling
Baralgan Ketone at Rs .23,735/- per Kg in India. Somehow,
the G .0 .1. got sufficient information that it costs only
Rs.1810/- per Kg and asked the HOECHST to reduce the Price. The
Company agreed to reduce the Price to Rs .2000/- per Kg. ( Thus
accepting directly that it is over-pricing 12 times its cost )
As the GOI insisted upon its figure, the companies went to
the Court and cited its Fundamental right of Business and
got stay order and enjoying Baralgan at a Cost of Rs .23,735/per Kg. The legitemised right of the Company to cheat the people
was not vacated by the Peoples' Government. Thus the Govt, by
itself is not coming forward to safe guard the people in the
drug issues. Instead steadfast doing things contrary to the
Principle of working for the people. Even the requests of the
aggreived agencies and the people are not cared for. This does
not mean that we should abandon our principled fight against
the GOI to make it oblige to the broader Public Interest.
THE DRUG COMPANIES:
After the arnanents industry, it is the drug industry that
can fetch enormous profits. Hence the Drug Companies concentrate
their might to make people purchase this Commodity called drugs.
page-4
In no other country 60,000 formulations of drugs are available
in the Market, most of them are rather unnecessary, some even
dangerous. Out of roughly Its.2000/- Crores worth drugs sold
here, nearly 500 crore worth drugs are seriously engaged in
enriching the drains rather than the human bodies.
The Drug
Companies are not worried over this.
The Companies in USA have got the capacity to make President
to sign two bills recently • " Drugs which are found harmful in
American Citizens may well be permitted to export to Foreign
Countries” " Drugs which are not tested hitherto in human-beings
mqy also be permitted to export to third world countbies” using
the poor underdeveloped as the Guinesa pigs.
Even a powerful country like USA is Passing on strictures to
Japanese goods to safeguard its companies-but the GOI is
generous enough to import whatever non-sense drug availabile
in the International Market under liberal imports'? The drug
companies are not interested here to scrape the Brand names
’ ecause they get undue leverage in the market hold. Thus an
sprin tablet of 3 ps. cost can be sold at 0.22ps, 25ps even
oops. in different brand names. A Paracetamol tablet of 5ps cost
can be sold at 22ps., 25ps. in different brand names. Even the
companies misuse loan licensing to get their products manufactured
by Smaller Companies.
All this to sustain the " Brand Cult”
To create Brand Cult, they are using profusely the promotional
techniques even spending to the tune of 20-23$ of their total
sales turnover on promotion alone. It is better to speak less
about offering Fritzes, T-Vs., Scooters, Cars etc., to gullible
doctors to get their products prescribed. Equally well it is
true they are never handicapped by conscience in bribing top
people in the Governments to manipulate bulk state orders.
Currently, the Mui tinational' lobby in drug Industry is actively
pressing the GOI to join Paris Convention of drug patents to
prevent Indian Companies to utilise alternate process to manufacture
the same final product.
If once the final drug is reserved, by the
patent right of Paris Convention, we cannot even prepare by
alternate process also. This is to seriously undermine the self-
reliance of Indian Drug Industry— is upto everybody's guess.
.5
«■
p;age-5.'
In. this aspect, the Indian Private drug Industry voiced
by I .DM.A- and the M ultinational Lobby represented by 0 .? .P .1.
are at Logger-heads. Everyone knows that in our country, the
Public Sector Drug Industry has alone effected the reduction of
drug prices and forced the multinationals to start manufacturing
units— a step to self-reliance. Now this component of the drug
Industry is at Peril, running into losses of Crores of Rupees,
working at only 30 % capacity. This is to the rejoice of the
Multinational drug industry. The GOI by way of liberal imports
and delicensing playing silently into the hands of multi-nationals.
At this face, can I expect the 11 Businessmen to behave as
Bishops”?
THE DOCTORS;
Drugs is one commodity where the consumer has no choice in selection
and where the selector won' t pay for its cost.
is Doctor.
Here the selector
Hence the drug companies carefully therew their nets
on them by way of glittering promotion and advertisement.
After several years of coming out of Medical Colleges, most of
the Doctors, lost touch with the current trends in Drug
the
Aapy , thus ultimately, Medical Representatives employed by the
Drug Companies have developed to the stature of " Pharmacology
Professors to the Practising Doctors”, Statistics even in UK
speak this.
Nobody need misunderstand me.
Doctors are systematically lured to prescribe their brands and
illusioned about the relative benefits of a Particular brand.
It is still astonishing that a belief prevails that ” a tonic
improves Strength" , " Bl B6 B12 is necessary in routine weakness
and body pains”
” cough syrups are essential "- etc.
The impact of brand cult is so immense on doctors that they
feel that their independence of treating patients is curtailed by
reducing the nunber of brands available.
Fact is that we want to
reduce the number of un-necessary brands but not the number of
essential drugs. Hence the independence is not curtailed in fact.
instead the burden is lessened by demanding less on the memory
of the Practitioner to remember so many brands for a single drug.
Besides at a given moment an average practitioner can recollect
200 names of drugs.
I f he sincerely feels and makes efforts to
. .6
page-6
rem sober all the 60,000 formulations available in the market,
he will be forced to forget the names of his friends, wife,
children and ultimately his own nane&'.
An established Practitioner by and large might develop the
vested interest in prescribing a particular brand because of
an inwelcome relationship between him and the drug company.
Our experience is sane wherever we go, but relentlessly we
continue our effort to will then over or atleast neutralise
these practitioners when we continue our crusade in the drug
action.
But in the fresh graduates and also in the Practioners who
are to some extent or other committed to social cause but at the
sane time ignorant about the intricacies of the drug situation
our efforts are breeding good results. And this section of the
Practitioners is indeed a strong ally to the people to fight
in this cause.
THE PEOPLE»
\s the people are the ultimate consumers, they are to be aroused
to this cause.
In fact they are in a jungle of problems like poverty, lack of
safe drinking water, lack of shelter, sanitation, illiteracy,
unemployment for which ultimately the people at the helm of
affairs should hold responsibility. They are in fact forced to
organise themselves to fight against these maladies .
Even the
fight for rational picture in drugs, if co-ordinated with their
day to day fight for their liveli-hood, alone will become
successful ultimately.
WHAT ARE WE DO ENG?
a) Io educate the just thinking doctors, we are addressing the
doctor gatherings and IMA General Bodies and requesting them to
co-operate by not prescribing non-essential drugs with-holding
the use of harm-ful drugs, not accepting samples of drugs which
they don't want to prescribe and educating their patients,
prescribing, cheaper, good-quality generics. Ultimately we
request them to follow the WHO essential drug list till a list
is drawn in our country and popularised.
. ..7
page-7
b)
Appeal the intellectuals on these issues and
familiarise therm about the banned and banable drugs
The role of drug multinationals, the role of the
Government by way of slide shows, exhibitions, lectures
and conventions. We conducted this way to Hyderabad,
Kurnool twice, Cuddapah twice, Anantapur twice, Nellore,
Ngae and Khanm an.
We are going to conduct shortly at
Vizag, Vijayawada, Guntur, Tirupati, Rajahnundry,
Nalgonda andWarangal. We hope to cover all the District
Head Quarters of Andhra Pradesh in the near future.
c)
The most inportant section is the rural poor.
We
are drafting the help of teachers and lecturers, students
and youth to go to villages, schools, colleges.
We are
conducting exhibitions and lectures health and drugs
demonstrating the unnecessary, harmful drugs, For this
we are currently engaged in training teachers in these
aspects in some of the District Head Quarters selecting
10 to 15 people from all the sections mentioned above.
We hope the people, intellectuals, voluntary organisations
Druggists Chemists, Scientists, representatives, lawyers,
socially
committed doctors will all come forward unitedly
for the realisation of the just right " Healthy living is
everybody’s right ”•
Essential Drugs
INTRODUCTION
The concept of essential drugs is the focal point of the drugs
issue and of the rational drug policy.
□ur 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 "scientif icity"
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 guided by recommendations of
Committees like the Bhore Committee, 1946, 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 guestions 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-independence 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 co mm 111 ees 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 demand 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
Dave its origins in WHO's Technical Report Series No. 6'15
(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.
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
CHLORAMPHENICOL WITH STREPTOMYCIN
Brand
Manufacturer
1. Basiplon
2. Bichlorphenin
3. Chemistrep
Khandewal
Medinex
4. CHLOROSTREP SUS,
5. Chlorocinstrep
Suprachem
Parke Davis
Jagson Pal
6. Chlorostrep Kapseals
7» Chlorostreptoseal
Parke Davis
8. Chlorsoin
9. Cilastrep
Dolphin
Acila
lO.Contistrep
11.Cooperstrep
Continental
Cooper
12.Chloramphenicol and
Pharma Indiana
INDC
13.Streptomycin
14.
15.
"
IS.Cyperstrep
r.j _ _jci
-----A<! nf oi>'i.aD
ep.
Sarvodaya
H ©Ao
Cyper Pharma
Sunways .
Dynamic
18.Lycos
19.Enterostrep
Deys
20.Glucostrep
21.Glycostrep
Gluconate
Glyco
22.If!strep
23 .Intestostrep
Unique
East India
24.0.Strep
Optho
25oPacim Strep
Fa am
26„Pharmastrep
Pharmaltab
27.Phenistrep
20.Phenistrep
Usan
PCI
29 «Rlieofin
30 ^RsnstrepcoX
Rallis
R A nHaxy
31.Strepcol
32.Strep-C
33.Strepto-Chloramphen
Medochem
34.STBpTO-PARAXIN
35.Streptophenicol
36.Wilstrep
Boehringer-Knoll
Mercury’
Jilichem
Stamac
Dadha
USEDs
for diarrhoea and amoebic dysentry.
COUNTRIES WHERE BANNED, WITHDRAW? OR RESTRICTED
*
Bangladesh, Cyprus, Denmark, Dominican Republic,
Italy, Japan, Nepal, Norway, Philippines, Saudi
Arabia, Sweden, Venezuela, Sri Lanka, Pakistan, and
*
Malaysia
Sarer alternative; for diarrhoea oral rehydration therapy *
,
for amoebic dysentry ~ oral rehydration therapy and
metronidazole *
*
21
Oral rehydration solution j To 1 glass of water
of about 200 cc add 2 fingers pinch’ of salt
*
It should not be more salty than tears.
Taste it.
If it is, throw
it away and make a nex mix with less salt. Add a scoop
of sugar (2 tea spoonful). Try and give one glass of
solution sip by sip after each loose motion.
1
REASON FOR BANNING:
-- ------------- —
pz,
Dangerous : Chloramphenicol can
cause fatal agranulocytosis " and should therefore
be used only when it is specifically indicated (eg, for
typhoid), Of all the drugs that may be responsible for
pancytopenia chloramphenicol is the most common cause,
These reactions may represent an idiosyncratic
reaction to the drug.
The incidence is not related to
dosage, however it seems' to occur more commonly in
individuals who undergo prolonged therapy and especially
in those who are exposed to the drug on more than one
occasion,
Goodman Gillman, 7th Edition, pg,1181
Streptomycin is not useful for treating typhoid - it
is commonly used for tuberculosis. The combination is
therefore not.useful at all, and only leads to the
unnecessary consumption of either chloramphenicol or
streptomycin, so that strains of TB become resistant to
the latter, thus rendering the drug useless for TB,
£i (Chloramphenicol) should never be employed in diseases
readily, safely and effectively treatable with other
anti-microbial agents, or in agents, or in undefined
23
situations”, “
Streptomycin is a drug of choice in the treatment of
tuberculosis and should generally be reserved for this
use because when used in.the treatment of other bacterial
infections resistance has been found to develop within
2 to 3 days,
25
Often serious blood dyscrasias including aplastic anaemias
after both short term and prolonged therapy bone marrow
suppression, grey baby syndrome in infants G,I. upset
optic and peripheral neuritis allergic skin reactions can
be caused by chloramphenicol.
Chloramphenicol may interfere with development of immunity
and it should not be given during active immunization:
Martindale 1992, 2gth Edition, Pg.llBa.
"Resistance to chloramphenicol in S.Typhi has become a
world-wide problem".
The combination of chloramphenicol with streptomycin
was recommended for weeding out by the Subcommittee
of drug consultative Consultative Committee in 1980
for following reason 3 "Fixed dose combinations of
chloramphenicol with streptomycin should not be
allowed. As chloramphenicol is potentially a toxic
drug, its use should be kept restricted to enteric
fever only".
This combination was excluded from the
Banned Drug List by the Drug Technical Advisotry
Board in 1982 and by the Gazette Notification of Drug
Controller of India, 23rd July, 1983 (seepg.33).
The combination has been recommended for being weeded
out again by DCC in 1987,
USBDs
No rational use, but commonly recommenced for
diarrhoea and bacterial infections,
example OF COMBINATIONS; Chlorostrep suspension (Parke
Davis): Chloramphenicol, Streptomycin, Parke Davis
who consider themselves pioneers in sales of this
combination for diarrhoea have in view of the increasing
medicejl evidence against its use have voluntarily
withdrawn their product,
COUNTRIES WHERE BANNED, WITHDRAWN OR RESTRICTED 3
Egypt, Japan, Philippines.
SAFER ALTERNATIVES 3 for diarrhoea oral rehydration therapy
og
for bacterial infections - another anti-biotic.
22.
See glossary
Goodman & Gillman, The Pharmacological Basis of
Therapeutics, 7th edition, 1985, pg.1182
24. ibid, page 1183.
23.
25,
Martindales The Extra Pharmacopoea, 28th edition, 1082
,
p).27
themselves pioneers in sales of this coinbinati on Cor diarrhoea
have in view of the increasing medical evidence against its
use have voluntarily withdrawn their product.
CJ’.’ilTRIdS WHERE 3A;r;ED, V.'ITilDR C-.-.j uH RESTRICTED : Egypt,
Japan,
Philippines.
25
26
SAFER ALTERNATIVES : For diarr'-oea-oral rehydration therary ,
for bacterial infections - another anti-biotic.
Ref- BANNED & BANNABLE DRUGS LIST
VHAI
FIXED DOSE COMBINATION OF STEROIDS
Examples of fixed dose combination of steroids
Contents
Brand
Manufacturer
l.Docabolin
Infar
Nandrolone phenylpro
pionate, desoxycorticoslerone phenylpropio
nate 0
2.Beta3clor
Vilco
Betamethasone, Chlorphea x-L ITS Hid. iTl O Hlclj. - 'ThI'i -
3.Betneton
Glaxo
De tame thasone, Chlorphe
niramine; mal9Soluble Tab.
4.Cortina
Lupin
Chlorpheniramine mal.„
dexamethasone Tab.
5.Costophen
Uniloids
Chlorpheniramine sal.,
dExaioamikan prednisolone
Tab.
S.Histapred
Wyeth
Prednisolone, Chlorph
eniramine mal. Tab.
7.Perideca
Merind
Dexamethasone, Cyproheptadin Tab.
Ref- BANNED & B< NNABLE DRUGS LIST
VHAI
FIXED DOSS COMBINATIOK OF STEROIDS
Reasons for Banning
Fixed- dose combinations of steroids should not be
allowed because; the adrenal suppression accompanying
prolonged steroids therapy leads to symptoms of adrenal
insufficiency, if the steroid is abruptly withdrawn.
It is difficult to titrate the dose of the steroid when
it is present in fixed dose combination with other drugs,
(1) Concurrent administration of corticosteroids will
cause excessive loss of potassium,
(2)»
Also it is impossible to vary the dosage or time schedule
of each drug separately and because if adverse effects
arise it is difficult to know which drug is responsible
for them (3) „
Corticosteroids and androgens affect the protein bound
iodine (4) .
In addition to pituitary-adrenal suppression the principle
complications resulting from prolonged steroid therapy
are fluid and electrolyte disturbances; hyperglycemia
and glycosuria; increased susceptibility to infections
including tuberculosis; peptic ulcers, which may bleed
or periorate; osteoporosis; a characteristic myopathy;
behavioural disturbances; and Cushing’s habitus, consis
ting in “moon face", "buffalo hump", enlargement of
supra clavicular fat pads, ache etc. (5).
Unless considered life saving, systemic administration of
corticosteroid is contaa-indicated in patients with
peptic ulcers, osteoporosis.
I.
Drug Consultative Committee Recommendation 1980,,
2.
Martindale, The Extra pharmacopoeia, 28th ed, 1982,PP.449
3.
Parish Po, Mediciness A Guice for Everybody 5th Ed. 1984
pp.29
4.
5,
Rdverse Drug React. Bull, 1972, June, pp.104.
Goodman LS and Gillman A; The Pharmacological basis
of Therapeutics 7th Edition, 1905.
Double Standard - Steroid
Combination
Before & After the ban on
Steroid Combinations except
for Bronchial asthma
Brand Name
Content
Manufacturer
INDICATIONS
MIMS
MIMS
March 182
October ’85
Betaklor
Betamethasone
Ch1o rphen er ami ne
Maleate
V£lco
Allergies
of all types
AJ1 erg.i c
asthma when
Bronchodila
tors alone
are ineffect ivc.
Betneton
Betamethazone
Chlorpheneramine
Glasco
Allergy
-do-
Cortina
Dexamethasone
Chlorpheneramine
Lupin
Stubborn
allergy
Pood poisonining insect
bites.
-do-
Cortophen
Prednisolone
Uniloids
Chiorpheneramine
Allergic
Disorders
Histacort
Chlorpheneramine SIRIS
Prednisolone
Allergic
Manifeststion
Hlstapred
Prednisolone
Wy e t h
Chiorpheneramine
Allergic
Allergic
Manifestation Asthma
when Broncho
dilators
alone are
ineffective.
Kenamina
friamcinolone
Sarabhai
Allergic
-dodisorders
angioneurotic
oedema Hay
fever, drug
and serum
reactions,
certain
cases of
bronchial
asthma.
Peridecci -
Dexamethozone
Cyproheptadine
MSD
Allergic
disorders
Allergic
Asthma.
-do-
-do-
Please note the steriods combinations were banned by the
Gazette notification July 23, 1983j only allowing steriods
combinations toaiaxH a Lor Bronchial Asthma. The differences
in the indications before and after the ban to escape the ban
is obvious from the above table.
1
psychoses, or severe psychoneurosis and they should be
used only with great caution in the presence of congestive
heart failure in patients with diabetes mellitus
inlections diseases, chronic renal failure and uraemia,
and in elderly persons (6). Empirical use of corticos
teroid. may mask the Symptoms to such an extent that a
true diagnosis becomes extremely difficult to make.(6)„
Countries where banned, withdrawn or severely restricteds
Bangladesh, Turkey, Denmark, Saudi Arabia, Venzuella,
Italy, Australia, Belgium, Greece, Norway, New Zeland,
Singapore, Thailand, USA, India, Nepal, etc.,(7).
Safer Alternatives;
Single steroid drug whenever needed.
The Extra Pharmacopea 1982, pp.450.
6.
N.artindale:
7.
Consolidated list of products whose consumption and/
or sale have been banned, withdrawn, severely
restricted or not approved by the governments.
Prepared by the United Nations Secretarial in
accordance with General Assembly Resolution 37/137,
1924.
Wl ALL INDIA DRUG ACTION NETWORK
. V /
' c-'14 COMMUNITY CENTRE S. D. A. NEW DELHI 110016
RATIONAL DRUG POLICY - STATEMENT
AIDAN
All India Drug Action Network (AIDAN), is a forum, and
coordinating body of organizations, and individuals
all over the country working towards the adoption and
implementation of a people oriented Rational Drug Policy
in India as a part of a Peoples Health Policy. It sets out
the following outline for the Drug Policy :
Health
Policy
and
drugs
Majority of the Indians suffer from the diseases of
poverty and ignorance, i.e. communicable diseases,
diseases due to undernutrition etc. Most of these illnesses
are preventable and curable. In addition, distorted pattern
of industrialisation and urbanisation has led to the deve
lopment of so called diseases of industrialisation. What
we need most is adequate nutrition, adequate and safe
water, universal sanitation, development without damaging
environmental balance and primary medical service,
available to all.
Role
of
drugs
Although drugs constitute only a small part of the overall
health care, they are
most urgent, essential and
hence a priority need in the country where incidence
of death and disability from diseases is high. So long
the basic elements of health care are not made available
universally, medical care will continue to be the priority
service to reduce death and disability and in this context,
drugs understandably assume a vital and priority role.
FTesent
situation
The fact that drugs can save life and relieve sufferings
has been exploited by the drug industry, which is oriented
mainly to profit making, to push all sorts of irrational
druas onto the consumers. The druq industry and the
medical establishment has created a very drug-dependant
health culture which eclipses the much-needed sustainable
solutions to the real health problems. Doctors and non
doctors alike are made to believe that drugs are "cure all"
for all ills. Health is still regarded as basically an individual or personal responsibility and not a product of
social factors.
It is also believed that freedom from diseases could be
obtained by better an< better and more and more drugs.
Such a belief among educated and illiterate alike, has
led
to a universal craze for drugs and
this DRUG
CULTURE has come to dominate the society. In this
situation it is not surprising that drugs provide an oppor
tunity for unlimited profit-making by the drug industry,
since hardly any consumer asks for the necessity, utility,
rationality, price-justifiability and harmful
effects
of a drug. It is not even asked whether a substance sold
as Drug is actually a Drug at all. As a result, about 60%
of the drugs in the market are unscientific or harmful
or substandard; a large number of these are not actually
drugs; many drugs are consumed by those who do not
need it; people die or are disabled from the effects of
harmful drugs; drugs are sold at fantastically high prices;
and most serious of all life saving and essential drugs
are not available to the majority that need them most.
Even 38 years after independence, multinational corpo
rations continue to dominate the drug industry in IndiaFurther, the majority of their production consists of
drug formulations and not bulk drugs. Though, according
to UNIDO, India has the capacity to be self sufficient
in bulk drugs, we still import 40% of our bulk-drug
requirement.
Objectives
of the
Rational
drug
policy
We feel that the Rational Drug Policy objectives should
include the following :A.
ASSESSING THE DRUG-NEEDS
1)
To identify the drug needs in consonance with
the health needs of the people, particularly
those required for primary health care; to
prepare a graded essential and priority list of
drugs for different levels of health expertise
inkeeping with actual health needs of the people.
2)
To eliminate
drugs.
irrational,
useless
and
hazardous
-:3s-
B.
C.
PRODUCTION, PRICE AND QUALITY CONTROL
1)
To make all drugs available at low prices to the
people, particularly the essential & priority drugs.
2)
To ensure quality control of all drugs.
DRUG DISTRIBUTION
To establish a national corporation for the distri
bution of drugs; retailing of drugs through fair
price shops and government's health infrastru
ctures.
D.
DRUG INFORMATION AND ETHICAL MARKETING
1)
E.
F.
To ensure a drug information system for health
personnel and consumers.
2)
To ensure ethical marketing.
3)
To abolish brand names and introduce generic
names for all drugs.
SELF - RELIANCE
1)
To
2)
To foster and encourage the growth of the Indian
Sector and to provide a leadership role to the
public sector.
3)
To aim at quick self sufficiency in the output of
drugs with a view to reducing the quantum of
imports.
develop
self
reliance
in
drug
technology.
RESEARCH AND DEVELOPMENT
To promote research and development for selfreliance and in accordance with the needs of
the Indian people.
G.
LEGISLATION AND ADMINISTRATION
1) To provide comprehensive drug legislation
and administrative support to deal effectively
with and implement all the above aims and
objectives.
2) To ensure smooth Centre-State relations ano
inter-departmental coordination for effective
and relevant drug production, drug control and
drug supply.
H.
HUMANPOWER DEVELOPMENT
To fulfill the needs of the above Rational Drug
Policy, different type of technical personnel
(e.g. druggists, paramedics, etc.) need to be
adequately and appropriately trained in adequate
numbers.
A.
A
ASSESSING THE DRUG NEEDS
1.
Identification of Drug needs and Prioritized Essential Drug List
i)
The National Drug Formulary should be revised and compiled
by an expert multi-disciplinary committee with suitable repre
sentation from all the sections of health professionals. This
committee should draw up the essential priority drug list,
keeping the following criteria in mind * Medico-social justification should act as a primary
criterion keeping in mind - efficacy, safety, cost, ease of
administration, potential for misuse, indigenous production.
* Priority for production has to be given to the drugs
required for diseases causing greater mortality (death),
greater morbidity (illness), severe sequelae (after effects).
* Drugs used in National Programmes e.g. TB, leprosy,
malaria, blindness, goitre control, and immunisation
programmes should get priority.
This list should be revised periodically.
ii)
Selection of the essential and priority drugs would be followed
by preparation of graded drug list for different categories of
health personnel and health institutions. These lists should
form the basic guidelines for bulk purchase procurement and
requisition stocking and dispensing.
-:5:-
An appropriate authority (see section G2) should continuously
assess drug needs and drug production and monitor capacity
utilisation in the industry, drug utilisation patterns, health
needs, changing pattern of diseases, drug requirements, new
information on old drugs, introduction of new drugs, efficacy
of the existing policy of production, distribution and use of
drugs.
A
2.
Withdrawal of hazardous, irrational and therapeutically useless
drugs.
i)
All the drugs in the market should be scrutinised to assess
their rationality on the basis of standard text books of medicine
and pharmacology. All drugs which are not recommended
in these text books should be banned. Those drugs which have
life-threatening or serious side-effects and for which equally
effective alternatives are available should be banned immedia
tely. The rest of these drugs should disappear from the market
within one year.
ii)
No fixed dose combination forms should be allowed to be
manufactured if an alternative single ingredient drug is available
for the purpose, which is therapeutically equivalent and more
cost effective.
iii)
Drug Legislation should be modified to ensure that no stay
order is granted in cases pertaining to banning hazardous
drugs in the interest of public health.
B.
B
PRODUCTION, PRICE AND QUALITY CONTROL
1.
Production and Price Controls
i)
The priority drug list should be a part of much larger essential
drug list based on WHO recommendations as well as those
of our own National Drugs and Therapeutics Authority. In
this essential drug list, life saving drugs and drugs for primary
health care shall be put as category I termed as priority drug
list and the rest of the list shall be put in category II.
ii)
The production of essential drug formulations shall be a minimum
75% of total formulation turnover of each manufacturer now
and shall be brought up to 90% in five years. The priority
drugs shall constitute 60% of the above essential drugs and
shall be raised to 80% of the essential druns in the next 5
years. The above production quota should include all dosage
forms of essential and priority druqs.
iii)
All companies having equity above 26% shall be identified
as foreign companies (as per RBI definition).
iv)
All foreign companies shall produce bulk as to formulation
ratio of 1:5. For other companies the ratio shall be 1:10.
v)
A mechanism should be evolved to provide incentive to those
companies which produce more than the required quota of
essential/priority drugs and deterrent punishment to those
companies which produce less than the required quota as
given above.
vi)
The priority drugs should be made available at low prices.
If required, they may even be subsidized. Before any major
revision in the pricing policy is done, as a policy there should
be an independent study to assess the cost, profitability as
well as availability and price from the point of view of consu
mers. Profit-making should not be the sole basis of the drug
industry. All taxes from priority drugs should be abolished
to reduce the prices of such drugs.
vii)
The trade commission shall be fixed at 20%. However, this
is the total commission which will be paid from the principal
manufacturer to the distributors and the intermediaries. While
the markup under the head of trade commission will be increa
sed, the markup - under the head of sales promotion will be
decreased for essential and priority drugs.
viii)
All drugs including nutritional supplements, except that produced
by small scale sector, shall be under price control.
ix)
The small scale sector can be free from price and production
controls. However, the small scale sector will be defined
as those companies whose turnover is less than 20 lakhs and
not linked to large scale and organised sector units through
ownership, financial participation or marketing arrangements.
2.
Proper Drug Registration and Monitoring
Registration
1:
All pharmaceutical products, both ethical drugs and over-thecounter (OTC) preparations offered for sale should be duly
registered by a competent authority.
2.
Commercially sold indigenous medicines should also be registered
and pharmaceutical products which are not registered should
not be allowed to be marketed.
3.
Pharmaceutical manufacturers and traders must provide the
registration authority with a list of all countries in which the
specific product has not been accepted for registration.
4.
Pharmaceutical manufacturers and traders should inform the
registration authority if a pharmaceutical product already
registered in the country has bee.; removed from the register
of any other country together with the reason for its removal.
5.
Pharmaceutical manufacturers and traders, when applying for
registration of a product, must be made to undertake that
subsequent to the product's registration, they will provide
the registration authority and consumers with all new informa
tions they receive about its effects, adverse reactions and
interactions.
6.
Central Drug Control authorities should have an up-to-date
information about the various drug formulations in the market,
their combinations, their date of licensing, drug information
being given with them by the producers and the latest inter
national medical views on the products.
7.
Drugs which have been banned from sale after being marketed
for some time in one country must not be submitted for clinical
trial or marketing in India. The onus of proving why such
a non-essential drug should be introduced or allowed to continue
in the market should be with the manufacturers.
8.
Whenever a new drug is tested on healthy human subjects
or on patients, the clinical trial must be authorised and moni
tored by a local "Ethical Committee" and must be carried
out only with the full informed consent of the people and
patients concerned.
Medical Audit System
It should be introduced to review the medical costs, the prescription
practices, patient complaints of negligence or financial exploitation
and drug misuse. At least minimal medical/clinical record keeping
should be made mandatory. Medical audit systems should be intro
duced in a systematic manner.
-:8:~
Physicians and pharmacists should be answerable to Rational Thera
peutics Committee of Experts. This could be appointed by Medical
Council or any other academic neutral body. Medical experts involved
in primary, secondary and tertiary medical care, chemists and
consumer organisations should be represented.
C.
DRUG DISTRIBUTION
i)
A National Corporation for distribution of drugs and pharma
ceuticals to retail drug outlets, hospitals and dispensaries
should be established.
ii)
National Drugs and Therapeutics Authority (see section G2)
(or its sub-committee) should look into the drug needs of
the peripheral health units to identify the bottle-necks and
deal with them as a priority and ensure timely drug supply.
iii)
This corporation should look into
-
requirement estimation of various drugs and their dosage
forms;
-
purchasing effective, safe and quality drugs at most
reasonable costs through bulk purchase and other purchase
procedures;
operating an efficient inventory and stock control system;
-
developing an efficient workable system, where drug
needs of the peripheral institutions can be a gauged
and timely drug supplies ensured.
iv)
Adequate drug distribution through the Government's health
service infrastructure should be ensured. Essential drugs in
adequate quantities and at subsidised rates should be available
at PHCs, and their sub-centres.
v)
Quality essential drugs should be made available from Govern
ment fair-price pharmacy shops. These could be handed over
to PHCs and sub-centres.
vi)
Education and relevant material on good pharmacy management
as produced by WHO should be made available to pharmacy
management system.
f)
-:9:-
D
D
vii)
Trained and qualified pharmacists should dispense drugs.
D.
DRUG INFORMATION AND ETHICAL MARKETING
1.
Drug Information
i)
It should be the statutory duty of the drug control .authorities
to inform health personnel and consumers of the WHO's concept
of essential drugs, India's graded essential drug lists, drug
policies and their rationale regarding banning of drugs. Rational
drug policy as a topic should be included in medical and para
medical education.
ii)
Names of the brands banned for manufacture and sales should
be widely publicized in medical journals, magazines, national
newspapers, giving briefly the explanation and rationale of
the ban.
2.
Ethical Marketing
i)
All sales promotion material including package inserts, medical
data sheets by the drug units should be screened by a permanent
National Drug Information body, which will be part of the
National Drugs and Therapeutics Authority. This body should
be responsible for screening as well as ensuring availability
of unbiased drug information to the health personnel and
consumers.
ii)
.Use of audio-visuals for sales promotion on drugs to doctors
in absence of a printed copy (to be kept with the doctor),
of the claims made, should not be allowed.
iii)
All drug promotional literature should contain balanced and
verified scientific information about indication, contra-indications
side effects and drug interaction and antidotes.
iv)
Inadequate and inaccurate information in medical promotional
literature or package insert or worse still of the total commi
ssion of the package insert (as is the trend at present) should
be considered a punishable offence.
v)
Seminars, scientific sessions held by drug companies to present
mainly industry sponsored research studies should be closely
monitored and if need, be restricted as it is associated with
presentation usually only' of favourable results and tend to
create a sense of obligation in the minds of certain medical
personnel towards drug companies for sponsoring .their research.
vi)
Sponsoring of National Conventions of professional medical
and academic societies by drug industry should be discouraged
since consumers have to ultimately indirectly foot the bill
and such sponsorship inevitably introduces bias in favour of
the company and its products. The health ministry should
take up the responsibility for making funds available for such
seminars.
vii)
Advertisement of tonics and food supplements should not
be allowed in the lay-press. OTC sales advertisements making
false or misleading or inaccurate claims should be banned.
Authorities should ensure that adequate consumer caution
is provided to the consumer in regional languages.
viii)
Labelling should be clear. International non-proprietory names
(generic names) should be used. Consumer caution should
be in regional languages.
For food supplements, nutrients, tonics in the consumer caution
in regional languages it should be added that "This is not
a substitute for normal food" and message given pictorially
wherever possible.
D
ix)
"The International Code for Ethical Marketing" as drafted by
the Health Action International should be adopted by India.
3.
Drug Nomenclature
International non-proprietary names should be used for sales, labelling
and prescription writing. This being so because of several advantages:
i)
Generic drug names are used in under-graduate/postgraduate
medical and pharmaceutical education.
ii)
Generic names are used in medical
medical journals and WHO publications.
iii)
All purchases of medicines from international
international markets are based on generic names.
iv)
Use of generic names also ensure production, sale and dispensing
of more rational single ingredient drugs.
v)
Generic name assures clarity by giving information of the
class of drug and thus avoiding confusion arising out of many
dissimilar brand names of one drug.
text
books,
scientific
tenders
and
vi)
Drugs of equal quality are usually cheaper when purchased
by their non-proprietary names than when bought using brand
names.
vii)
Use of non-proprietary names is a valuable aid to memory
as health workers have to learn and remember each drug
by one name only.
E.
E
SELF - RELIANCE
1.
Technological self-reliance
i)
In view of the high importance of achieving the goal of selfreliance in the drug sector, it is imperative that all technology
transfer agreements are made in accordance with the United
Nations Council for Trade and Development draft code.
ii)
Protective mechanisms should be evolved for process that
are being developed in the national laboratories so that techno
logy being developed indigenously does not get aborted as
it has happened in the recent past in case of processes deve
loped at NCL and Central Drug Research Institute.
iii)
While encouraging in house R&D activity through fiscal incen
tives, mechanism should be evolved that the R&D effort
undertaken by different firms is in accordance with the priority
drug needs of the Indian people.
2.
Encouragement to Indian Sector
i)
Make priority drugs, already produced in the country from
basic stage by the public sector and wholly Indian companies,
a reserved category for which companies holding foreign eguity
more than 26% should not be allowed any fresh license.
ii)
Stipulate a strict time limit of five years for all
foreign
companies to start production from basic stage for the existing
already licensed production capacities.
iii)
Ensure implementation of the time limit of two years stipu
lated for foreign companies to undertake production from
the basic stage for fresh license.
No Carry on Business license or production over the license
capacity should be allowed for MRTP, FERA and ex-F
A
companies.
Loan licenses being used by the small scale sector units linked
through ownership, financial participation and/or marketing
arrangements should be cancelled.
Reduction of Imports
The canalisation of all imports snould be streamlined. Open
general licence system should be abolished. There should be
raw material pool in each State to ensure proper pricing and
availability of raw materials.
Import and excise duties should be fixed in such a way that
the landed cost of imported raw materials and bulk drugs
should not be lower than that of indigenous raw materials
and bulk drug production.
F.
RESEARCH AND DEVELOPMENT
Priorities in research should be guided by the health needs
of the people in India. Drugs required in diseases causing
greater mortality, morbidity, serious sequelae should get
priority. Vaccines should get priority over other drugs.
Even 38 years after the cessation of British Colonial Rule
in India, research on non-allopathic drugs continues to get
step-motherly treatment. Hence research on these drugs should
be encouraged. None of these drugs, however, should be allowed
to be produced on commercial scale unless their efficacy
and safety has been proved through scientific research.
Research policy on drugs should be reviewed every ten years
to respond to changing pattern of diseases in India.
All medical research on human beings must be statutorily
required to conform to the 1975 Helsinki (Mark II) Declaration.
All research proposal must be approved by a central authority
before research is started. This should be strictly adhered
to in case of contraceptive research also.
The present policy of giving priority to research on hormonal
contraceptives rather than to barrier methods must be reversed-
-:13:G.
G
1.
DRUGS LEGISLATION AND ADMINISTRATION
Drug legislation should provide for the following:
a system of registration of all medical products (including
traditional medicines)
enforcement of good manufacturing practice
full control of labelling and advertisement
control of prices of finished drugs and therapeutic raw
materials
prescription control of toxic/poisonous and habit forming
drugs
summary trial for violations against the drug policy by
manufacturers and traders in special drug courts
heavy penalties including confiscation of equipments and
properties for the manufacture and/or selling of spurious
and sub-standard drugs.
The legislation should be reviewed, regularly modified and
updated in the interest of the public and they should not
become bottlenecks for implementation of the national drug
policy.
q
2.
National Drug and Therapeutics Authority
i)
The greatest need of the moment is greater public accounta
bility and a greater social control over pharmaceutical industry.
For this, setting up an independent machinery such as a National
Drug and Therapeutics Authority is imperative, which can
scrutinize all the drugs currently marketed in India on an
ongoing basis and be held responsible for the nature of drugs
in the market. This permanent body should have representatives
with medical, pharmacy and management expertise. Repre
sentation being from :
1) drug and health authorities from states
2) Ministry of Chemicals and Fertilzers and Ministry of Finance
3)
medical professional and medical academic bodies
4)
consumer groups and NGOs involved in health work
5)
Trade Unions related to drug industry
6)
chemists and druggists.
The Government should establish National Drug Authorities
(NDA) at the State level also. The Drug Controllers should
be accountable to NDAs.
ii)
The recommendations of the National Drugs and Therapeutics
Authority should be binding on the drug industry.
iii)
Appropriate powers be delegated to Central Drug Controller
and State Drug Control Authorities for the proper implemen
tation of the recommendations of the Drug and Therapeutics
Authority.
iv)
Relationship of NDA with centre and state drug and health
authorities should be clearly defined. Its constitution, function
ing and powers should be aimed at proper implementation
of National Drug Policy. Suitable drug legislation support
should be given to this authority so that its decisions ar'e.
not unnecessarily challenged in the court.
v)
Drugs should be dealt with by this NDA rather than by Ministry
of Chemicals and Fertilizers, to give greater emphasis to
the therapeutic relevance rather than industrial profits and
Government's revenue.
H.
HUMAN POWER DEVELOPMENT
Not merely medical and pharmacology related manpower development
is required, but also development of drug managers, drug inspectors,
quality control technicians, researchers and scientists willing to
do R and D in areas of grater concern to the health of our people.
The training and development should include training of legal personnel
who will be dealing with Food and Drug Courts.
Exposure and training of policy makers to other dimension of drug
issues as experienced by consumers and health personnel in the
field is also relevant.
Drug control mechanism has to be developed in keeping with the
growth of our drug industry and be proportionate to our drug prod
uction and sales.
THE ALL INDIA DRUG ACTION NETWORK (AIDAN)
COORDINATION COMMITTEE CONSISTS OF
(1)
Arogya Dakshata Mandal, Pune.
(2)
Catholic Hospital Association of India, Delhi.
(3)
Consumer Education & Research Centre, Ahmedabad.
(4)
Consumer Guidance Society of India, Bombay.
(5)
Drug Action Forum West Bengal, Calcutta.
(6)
Delhi Science Forum, Delhi.
(7)
Kerala Sashtra Sahitya Parishad, Kerala.
(8)
Locost, Baroda.
(9)
Lok Vigyan Sangathana, Bombay.
(10)
Medico Friends Circle, Pune.
(11)
Voluntary Health Association of India, Delhi.
*»♦»»»♦******««♦
*»♦♦♦
***
AIDAN Coordinator
DR. MIRA SHIVA
c/o VHAI
C-14 Community Centre
S.D.A. New Delhi 110 016.
MB 0ndi@
Aelftem Ng'Sworik
=ABB ABM
OUR DEMANDS
*
availability of essential and life saving drugs (i.e. adequate
production and streamlined distribution to peripheral areas).
*
withdrawal of hazardous and irrational drugs
*
availability of unbiased drug information to health personnel
and consumers (including updating our National Drug Formu
lary), and provision of therapeutic guidelines as in British
National Formulary; provision for consumer caution in
regional languages for problem drugs
*
adequate quality control and drug control so that every
fifth drug in the market is not sub-standard as in at present
according to Government's own figures
*
drug legislation reform to prevent drug companies from
misusing legalistic loopholes against the people.
Printed at IS Bros, A30/1 Naraina Indi. Area Phase-I
New Delhi 110 028
5.
ALL EMDIA DRUG ACTION NETWORK
Lj' C-14 COMMUNITY CENTRE S. D. A. NEW DELHI 110016
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 the
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.
Adeguate production and supply of essential drugs should be ensured.
5.
Adeguate measures should be taken to ensure good guality 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 on their possible side effects in
large print and in local languages.
'The following model list of essential drugs is taken from the WHO Techinical
Report Series 641 (World Health Organisation, Geneva, 1979: "The Selection
of Essential Drugs")
MODEL LIST OF ESSENTIAL DRUGS
EXPLANATORY NOTES
I.
The numbers preceding the drug groups and sub.groups in. the model list
(e.g., 11; 17.6.2) have been allocated, in accordance with the English
alphabetical order, for convenience in referring to the various categor
ies; they have no formal significance.
H.
Numbers in parentheses following the drug names indicate:
1)
Listed as an example of this therapeutic category: choose cheapest
effective drug product acceptable;
2)
Specific expertise, diagnostic precision or special equipment
required for proper use;
3)
Greater potency;
4)
In renal insufficiency, contraindicated or dosage adjustments necessary;
5
)
6)
Special pharmacokinetic properties for purpose ;
7)
Adverse effects diminish benefit/risk ratio ;
8)
Limited indications or narrow spectrum of activity;
9)
For epidural anaesthesia ;
10)
To improve compliance;
Drugs subject to international control under the Single Convention
on Narcotic. Drugs (1961) and the Convention on Psychotropic
Substances (1971).
III.
Letters in parentheses following the drug names indicate the reasons for
the inclusion of complementary drugs:
(A) When drugs in the main list cannot be made available;
(b)
When drugs in the main list are known to be ineffective or inappropriate
for a given individual;
(c)
IV.
For use in rare disorders or in exceptional circumstances.
When the strength is specified in terms of a selected salt or ester, this
is mentioned in brackets; when it refers to the active moiety, the name
of the salt or oster in brackets is preceded by the word "as".
.2
V.
ALL drugs listed in this formulary arc itemized by their generic names
as an aid to encourage the use of generic names in prescribing and
ordering medicines.
Complementary drugs
Main list
1.
Route of administration,
pharmaceutical forms and strengths
ANAESTHETICS
1.1. General Anaesthetics and Ctxygen
ether, anaesthetic (2)
inhalation
halothane (2)
inhalation
nitrous oxide (2)
inhalation
Oxygen
inhalation (medicinal gas)
thiopental (2)
powder for injection, 0.5■ g, 1.0 g
(sodium salt) in ampoule
1.2
Local Anaesthetics
bupivacaine (1,2,9)
injection, 0.25$, 0.5$ (hydrochi ride
ride) in vial
lidocaine (1 )
injection, 1$, 2$ (hydrochloride)
in vial
inj ection, 1 $, 2$ + epinephrine
1 :100000 in vial
topical form 2-4$ (hydrochloride)
2.
ANALGESICS, ANTIPYRETICS, NONSTEROIDAL ANTIINFLALMATORY DRUGS
AND DRUGS USED TO TREAT GOUT
acetylsalicylic acid
tablet, 100-500 mg
allopurinol (4)
tablet, 100 mg
ibuprofen (1)
tablet, 200 mg
suppository, 50-150 mg
indometacin
capsule or tablet, 25 mg
paracetamol
tablet, T00-500 mg
suppository, 100 mg
3.
colchicine (B.C) (7)
tablet, 0.5 mg
probenecid (B.C)
tablet, 500 mg
ANALGESICS, NARCOTICS AND..MRDOTIC ANTAGONISTS
injection, 10 mg (suliate or
hydrochloride) in 1-ml ampoule
morphine (10)
injection, 0.4mg (hydrochloride) in
1-ml ampoule
naloxone
■
pethidine (A) (1,4,10)
Injection, 50 mg (hydrochloride) in
1-ml ampoule
■ 3.
Main, list
Route of administration,
Pharmaceutical forms and strengths
Complementary drugs
4. ANTIAIIERGICS
Antihistamines
tablet, 4 mg (maleate)
Chlorphcnamine (1)
5,. ANTIDOTES
5.1
General
Charcoal, activated
powder
ipecacuanha
syrup, containing 0.14$ ipecacuanha
alkaloids calculated as emetine
5-2
Specific
injection, 1 mg (Sulfate) in 1-ml
ampoule
atropine
deferoxamine
injection, 500 mg (mesilate) in vial
dimercaprol (2)
injection in oil, 50 mg/ml in 2-ml
ampoule
sodium calcium edetate (2)
injection, 200.mg/ml in 5-ml ampoule
Sodium nitrite
injection, 30mg/rnl in 10-ml ampoule
injection, 250 mg/ml in 50-ml ampoule
Sodium thiosulfate
methylthioninium
chloride(c)
(Synonym: methylene
blue)
injection, 10rag/ml in 10-ml ampoule
penicillamine(c) (2) Capsule or tablet, 250 mg
6,
ANTIEPIIEPTICS
diazepam
injection, 5 mg/ml in 2-ml ampoule
ethosuximide
capsule or tablet, 250 mg
phenobarbital (10)
tablet, 50 rag, 100 mg
syrup, 15 mg/5 ml
capsule or tablet, 25 mg, 100 mg
(Sodium salt)
phenytoin
injection, 50 mg (sodium salt)/ial in . 5-rl vial
carbamazepine (B.C) tablet, 200 mg
valproic acid
(B.C) (2,4,7)
tablet, 200 mg (sodium salt)
7.1 Amoebicidcs
tablet, 200-500 mg
m etronidazole
diloxnnide(A)
tablet, 500 mg (furoate)
....4.
-4- Main list
Complementary drugs
Route of administration
Pharmaceutical forms and strengths
emetine (A.B)(1,7)
injection, 60mg (hydrochloride) in
1-ml ampoule
paroncmycin (b)
capsule, 250 mg (as sulfate)
syrup, 125 mg (as sulfate )/5 ml
7.2 Anthelmintic Drugs
tablet, 1 (X) mg
mebendazole
niclosamide
tablet, 500 mg
piperazine
tablet, 500 mg (citrate or adipate)
elixir or syrup (as citrate)
equivalent to 500 mg hydrate/5 ml
chewable tablet, 500 mg
tiabendazole
bephenium hydroxynaphthoate (b) (8)
7.3
ampicillin (1,4-)
granules, 5 g (equivalent to 2.5 g
bephenium)
Antibacterial Drugs
capsule or tablet, 250 mg, 500 mg
(anhydrous)
powder for oral suspension, 125 mg
(anhydrous )/5 ml
powder for injection, 500 mg (as
sodium salt) in vial
benzathine benzylpenicillin (5)
injection, '1.44- g benzylpenicillin
(=2.4- million IU)/5 ml in vial
bonzylpeni cillin
powder for injection, 0.6 g (= 1
mil lion TU), 3.0 g.
(= 5 million Hi) (as sodium or
potassium salt) in vial
Chloramphenicol (7)
capsule, 250 mg
powder for injection, 1 g (as sodium
succinate) in vial
Cl OTariIlin (1 )
capsule, 500 ng (as sodium salt)
powder for injection, 500 mg (as
sodium salt) in vial
erythromycin.
capsule or tablet, 250 rag (as stearate
or ethylsuccinate)
oral suspension, 125 mg
(as stearate or ethylsuccinate )/5nl
powder for injection, 500 ng (as
lactobionate) in vial
gentamicin (4-)
injection, 10 mg, 4-0 ng (as sulfate)
/ml in 2-ml vial
metronidazole
tablet, 200-500 mg
phenoxymethylpenicillin
tablet, 250 mg (as potassium salt)
5.
Main list
Route of administration
pharmaceutical forms and strengths
Complementary drugs
powder for oral suspension, 250 ng
(as potassium salt)/5 ml
Salazosulfapyridine (2)
tablet 500 mg
Sulfadimidine (1, 4)
tablet 500 mg
oral suspension, 500 mg/5 nil
injection, 1 g (sodium salt) in
3 ml ampoule
. Sulfamethoxazole +
trimethoprim (4)
tetracycline (1, 4)
tablet, 100 mg + 20 mg, 400 rag-I80 mg
“
.
capsule or tablet, 250 rag
(hydrochloride)
,.
amikacin (B.C)(1,4) injection, 250 mg( sulf ate )/ml in
2 til ampoule
doxycycline (e)(5,6) capsule or tablet, 100 rag (as
hydrochloride)
injection, 100 rag (as hydrochloride)
nitrofurantcin
(A,B.)(4,7)
tablet, 100 mg
procaine benzy
lpenicillin (A)(7)
7.4
powder for injection, 1 g
(i-1 million IU)
3 g (=3 mi 111 on IU)
Antifilarial Drugs
)
„
die thyl c arb am azine
tablet, 50 ng (citrate)
injection, 1 g in vial
suramin sodium
7.5 Antileprosy Drugs
tablet, 100 mg
dapsone
(b)
rifampicin (b)
clofazimine
capsule, 100 mg
capsule or tablet, 150 rag, 300 mg
7.6 Antimalarials
tablet, 150 rag (as phosphate or
sulfate)
chloroquine (l)
syrup, 50 rag, (as phosphate or
sulfate)/ 5 Bil
primaquine
tablet, 7-5 mg, 15 mg (as phosphate)
pyrirae thiamine
tablet, 25 mg
quinine
tablet, 300 rag (as bisulfate or
sulfate)
injection, 300 mg (as dihydroch
loride )/iH in 2-til
ampoule or 250 mg (as fonaiate)
in 1-ral ampoule
sulf adoxine +
pyrimethamine (B)
tablet, 500 rag + 25 rag
....6.
6
-Hain list
„
,
Complementary drugs
Route of administration
phamaceutical foras
strengths
7.7 Antischistosoraals
. ..
metrifonate. —
tablet, 100 rag
niridaZole (7, 8)
tablet, 100 mg, 500 rag
■ ■ “capsule-, 250 mg
oxaraniquine'
-
-
syrup, 250 ng/5 ral
injection, 60 ng in 1-ral ampoule
antimony sodium
tartrate (b)
sodium stibocaptate
(b) injection, 500'rig
7.8 Antitrypanosoaals
melarsoprol (5)
injection, 3.6% solution
nifurtimox
tablet, 30 rag, 120 ng, 250 rag
pentamidine (5)
powder for injection, 200 rag
(isetionate or mesilate)
suramin sodium
powder for injection, 1 g in vial
7.9 Antituberculosis Drugs
etharihutol
tablet, 100-500 ng (hydrochloride)
isoniazid
tablet, 100 mg-300 mg
rifampicin
capsule or tablet, 150 mg, 300 mg
streptomycin (4)
injection, 1 g (as sulfate)
7.10
Leishmaniacides
pentamidine (5 )
powder for injection, 200 mg
(isetionate. or mesilate)
sodium stibogluconate
injection, 33%, equivalent to 10%
antimony, in 30-nl vifil
7.11 Systemic Antifungal Drugs
injection, 50 ng in vial
amphotericin B
griseofulvin (8)
tablet or capsule, 125 mg, 250 rag
nystatin
■tablet, 5000 Of-
flucytosine(B)
(1,4,8,
8,
ergotamine (2,7)
IU
tablet or capsule, 250 rag
AUTIMIGRAINE DRUGS
tablet, 2 rag (as tartrate)
.7
Main list.
.Complementary drugs
of administration,
pharmaceutical forms and strengths
9. ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE DRUGS
azathioprine (2)
tablet, 50 rag
powder for injection, 100mg (as sodium
salt) in vial
powder for injection, 15 rag (as sulfate)
—in vial
bleomycin (2)
busulfan (2)
tablet, 2 mg
tablet, 15 mg
calcium folinate (2>
injection, 3 rag/ml in 10-ral ampoule
chlorambucil (2)
tablet, 2 mg
tablet, 25 rag
cyclopho spharii de (2)
powder for injection, 500 rag in vial
cytarabine (2)
powder for injection, 100 mg in vial
doxorubicin (1,2)
powder for injection, 10 rag, 5Ong
(hydrochloride) in vial
fluorouracil (2)
injection, 50 ng/ral in 5-ral ampoule
tablet, 2.5 ng (as sodium salt)
methotrexate (2)
injection, 50 ng (as sodium salt) in vial
procarbazine (2)
capsule, 50 i?g (as hydrochloride)
vincristine (2)
powder for injection, 1 rag, 5 rag
(sulfate) in vial
10. ANTIPARKINSONISM DRUGS
levodopa
tablet or capsule, 250 rag
tablet, 2 rag, 5 mg (hydrochloride)
trihexyphenidyl' (1)
levodopa +Carbidopa tahLet
(B) (1,5,6)
100 ng+10 ng, 250 rag + 25 rag
' &
11. BLOOD, DRUGS AFFECTING THE
11.1
ferrous salt (1 )
Anti anaemia Drugs
tablet, equivalent to 60 mg iron
(as sulfate or fumarate)
folic acid (2)
tablot, 1 rag
injection, 1 mg in 1-nil ampoule .
iron dextran
(B) (1, 5)
hydroxocobalanin (1, 2)
injection, equivalent to 50 ng iror/nl
in 2-nl ampoule
inj ection, 1 mg in 1-ral ampoule
* Drug for "rescue therapy" with methotrexate.
,8.
- 8 -
Main list
_
,
,
Complementary
1 ,
J
________ drugs
Route of administration, ,
, . , „
, ,
,.
pharmaceutical forms and strengths
3_______________________
.________
11.2 Anticoagulants and Antagonists
heparin (2)
injection, 1000 Hj/ral, 25000 H/1.1I in
5-ml ampoule
phytonenadione
injection, 10 ng/ml in 5-ml ampoule
protamine sulfate (2)
injection, 10 ng/ml in 5-ml ampoule
warfarin (1,2,6)
tablet, 5 mg (sodium salt)
12. BLOOD PRODUCTS AND BLOOD SUBSTITUTES
12.1 Plasma Substitute
injectable solution, 6%
dextran 70
12.2.Plasma Fractions for Specific Uses
albumin, human normal (2,8)
injectable solution, 25$
antihaenophilic
fraction (c) (2,8) (dried)
(synonym :f actor VTH)
fibrinogen (c) (2,8) (dried)
plasma protein (c)
(2, 8)
injectable solution, 5%
factor IX complex
(dried)
(coagulation factors
n, vn, ix. x,
concentrate)(0)(2, 8),
13. CARDIOVASCULAR DRUGS
13-1 Antianginol Drags
glyceril trinitrate
.tablet (sublingual) 0.5 mg
isosorbide dinitrate (1)
tablet (sublingual) 5 ng
propranolol (1)
tablet, 10 mg, 4-0 mg (hydrochloride)
■injection, 1 rag (hydrochloride) in
1-ml ampoule •
13.2 Antiarrhythmic Drags
lidocaine
procainamide (1)
injection, 20 mg (hydrochloride)
/ml in 5-ml ampoule
tablet, 500 ng (hydrochloride)
injection, 100 rag (hydrochloride )/ml
in 10-nl ampoule
propranolol (1)
-- —tablet, 10 ng, 4-0 mg (hydrochloride)
injection, 1 rag (hydrochloride) in
1-nl ampoule
.9.
- 9 -
Main list
• Complementary drugs
quinidine (A.B)(1)
Route of administration,
pharmaceutical forms and strength:
tablet, 200 mg (sulfate)
13.3 Antihypertensive Drugs
hydralazine (1 )
tablet, 50 mg (hydrochloride)
hydrochlorothiazide (1)
tablet, 50 mg
tablet, 40 mg (hydrochloride^
propranolol (1)
sodium nitroprusside (1,2,8) '
injection, 10 mg/ial in 5-ml vial
methyldopa(A.B)(7)
reserpine
(a)(1,7)
tablet, 250 mg
tablet, 0.-1I..ng, 0.25 mg
injection, 1 mg in 1-nl ampoule
13-4 Cardiac Glycosides
tablet, 0.0625 ng, 0.25 ng
digoxin (4)
oral solution, 0.05 ng/ral
injection, 0.25 mg/ml in 2-ml ampoule
digitoxin (b) (6)
tablet, 0.05 ng, 0.1 ng
oral solution, 1 rag/ml
injection, 0,2 ng in 1-nl ampoule
13,5 Drugs used in Shock or Anaphylaxis
dopamine (2)
injection, 40 ng (hydrochloride )/ml in
5 ml vial
epinephrine
injection, 1 mg (as bitartrate) in
1-ral ampoule
isoprenaline (c)
injection, 1 ng (hydrochloride)/nl
in 2-ml ampoule
14. DERMATOLOGICAL DRUGS
14.1 Antiinfectivc Drugs
neomycin + bacitracin (1)
ointment, 5mg neomycin + 500 ,IU
bacitracin zinc/ g
14 «2 Antiinflammatory Drugs
betamethasone (1,3)
ointment or cream, 0.1% (as valerate)
hydrocortisone (1)
ointment or cream, 1% (acetate)
14.3 Astringents
Aluminium acetate
solution 13% for dilution
.10
- 10 -
Main list <
Complementary drugs
14.4
Route -of administration,
pharmaceutical forms and strengths
Fungicides
+ 3%
benzoic acid + salicylic acid
ointment or cream,
miconazole (1)
ointment or cream, 2% (nitrate)
nystatin
ointment or cream 100 000 H/g
14.5
Kcratoplastic Agents
solution, topical 20%
solution, topical 5%
salicylic acid
14.6
Scabicides end Pediculicides
benzyl benzoate
lotion, 25%
gama benzene hoxachloridc
cream or lotion, 1%
15. DIAGNOSTIC AGENTS
edrophonium (2,8) ■
injection, 10 ng (chloride) in 1-nl
ampoule
tuberculin, purified protein
derivative (PPD)
inj ection
15.1 Ophthalmic
eye drops, 1% (sodium salt)
fluorescein
15.2 Radiocontrast Media
adipiodonc meglumine (1)
injection, 25% in 20 ml vial
barium sulfate (1 )
powder
iopanoic acid (1)
tablet, 500 rag
meglumine amidotrizoate (1)I
injection, 60% in 20-ml ampoule
sodium amidotrizoate (1)
injection, 50% in 20-r.il ampoule
16, DIURETICS
amiloride (1)
tablet, 5 mg (hydrochloride)
furosemide (1)
tablet, 40 ng
injection, 10 mg/ral in 2-nl ampoule
hydrochlorothiazide (1 )
tablet, 50 mg
nannit:!
injectable solution, 10%, 20%
chlortalidone (b)
(6)
tablet, 50 ng.
.11
11
Main list
Complementary drugs
Route of administration
pharmaceutical foms and strengths
17, GASTROINTESTINAL DRUGS
---
■
17.1 Antacids (nonsystemic )
aluminium hydroxide
tablet, 500 mg
magnesium hydroxide
oral suspension, equivalent to 550
mg magnesium oxidc/10 ml
oral suspension, 320 ng/5 ml
calcium carbonate (A.B) tablet, 600 ng
17.2
Antiemetics
tablet, 10mg, 25 mg (hydrochloride)
promethazine (1)
elixir or syrup, 5 mg (hydrochloride)
/ 5 ml
injection, 25 mg (hydrochloride)/
ml in 2 ml ampoule
17.3
Antihacmorrhoidals
local anaesthetic, astringent
and antiinflammatory drug (1)
17.4
ointment or suppository
Antispasmodics
tablet, 1 mg (sulfate)
atropine (1 )
injection, 1 mg (sulfate) in 1 ml
ampoule
17.5
Cathartics
tablet, 7.5 mg (sennosides)
senna (l)
17»6 Diarrhoea
17.6.1
codeine (1,10)
Antidiarrhoeal
tablet, 30 mg (phosphate)
17.6.2 Replacement Solution
oral rehydration salts
(for glucose-salt solution)
For 1 litre of water:
(sachet)
sodium chloride (table salt)
3.5 g, Na+
90
sodium bicarbonate
(baking soda)
2.5g, HCO3~
30
mnO |/1
potassium chloride
1.5 g K +
20
glucose (dextrose)
20.0 g, glucose
111
.12
n :| id -
Main list
Route of administration,
pharmaceutical forms and strengths
Complementary drugs
18, HORMONES
18.1
Adrenal Hormones and Synthetic Substitutes
tablet, 0.5 ng, A mg
dexanethasone (1 )
injection, 4 ng (sodium phosphate) i:
1
—ml ampoule
powder for injection, 100 mg (as
sodium succinate) in viol
hydrocortisone
prednisolone (1)
tablet, 5 ng
fludrocortisone (c)
18.2
Androgens
injection, 200 mg (enantate)in 1 -ml
ampoule
,
testosterone (2)
tablet, 0.1 ng (acetate)
injection 25 mg (propionate) in 1-ral
ampoule
18,3
Estrogens
tablet, 0.05 mg
ethinylestradiol (1)
18.4
Insulins
compound insulin zinc suspension(l)
injection, 40 lU/nl in 10-nl vial,
80 lU/ml in 10-nl viol
insulin injection
injection, 40 Xl/ml in 10-nl viol,
80 lU/nl in 10-nl vial
18.5
Oral Contraceptives
ethinylestradiol + levonorgestrel
(1)
tablet, 0.03 ng + 0.15 ng, 0.05 ng+
0.25 ng
ethinylestradiol + norethisterone
(1)
tablet, 0.05 ng + 1.0 mg
norethisterone (b)
>■
norethistermc (1)
tablet, 0.35,ng
18.6 Progestogcns
tablet, 5 ng
18.7 Thyroid Homoncs and Antagonists
levothyroxine
tablet, 0.05ng, 0.1ng (sodium salt
potassium iodide
tablet, 60 ng
propylthiouracil (1)
tablet, 50 ng
.13
- 13 -
Main list
Complementary Drugs
Route of administration,
pharmaceutical forms & strengths
18.8 Ovulation Inducer
clomifene (c)(2,8)
tablet, 50 mg (citrate)
19. IMMUNOLOGICALS
19.1
Sera and Immunoglobulins
anti-D immunoglobulin (human)
injection, 0.25 mg/ml
antirabies hyperimmune serum
injection, 1000 IU in 5-ml ampoule
antivenom sera
inj ection
injection, 10000 IU, 20000 IU in vial
diphtheria antitoxin
immunoglobulin, human normal
(2)
inj ection
injection, 50 000 IU in vial
tetanus antitoxin
19.2 Vaccines
19.2.1 For Universal Immunization
-BCG vaccine (dried)
injection
diphtheri a-pertus si s-tetanus
vaccine
injection
diphtheria-tetanus vaccine
injection
measles vaccine
injection
poliomyelitis vaccine
(live attenuated)
oral solution
smallpox vaccine
multiple puncture
tetanus vaccine
injection
Jill vaccines
should comply
with the
WHO roquf.roments for
Biologic 1
substances. ':'
19.2.2 For Specific Groups of Individuals
influenza vaccine
injection
meningococcal vaccine
injection
rabies vaccine
injection
typhoid vaccine
injection
yellow fever vaccine
20. MUSCLE! RELAXANTS (PERIPHERALLY ACTING) & CHOLINESTERASE INHIBITORS
neostigmine (1)
tablet, 15 mg (bromide)
injection, 0.5 mg (metilsulfatc) in
1-ml ampoule
suxamethonium (2)
injection, 50 mg (chloride )/ml in
2-ml ampoule
>■■■■■
'
■■■
' :
f
i* Requirements for specific vaccines and tticir-dtandards
are nvm‘1 abl p. in various WHO Technical Reports, available on request from
the WHO, Geneva.
....1'4.
- 14 Main list
Route of administration
pharmaceutical foms and strengths
Complementary drugs
injection, 10 ng (chloride)/ml in
1.5-ml ampoule
tubocurarine (1,2)
tablet, 60 mg (bromide)
pyridostigmine
(b)(2,8)
injection, 1 rag (bromide) in 1-nl
ampoule
21. OPHTHALMOLOGICAL PREPARATIONS
21.1 Antiinfactive
silver nitrate
solution (eye drops) 1$
sulfacetamide
eye ointment, 10$ (sodium salt)
solution (eye drops), 10$ (sodium
salt)
eye ointment, 1$
(hydrochloride)
21.2 Antiinflammatory
eye ointment, 1$ (acetate)
hydrocortisone (2, 7)
21.3 Local Anaesthetics
solution (oye drops), 0.5$
hydrochloride)
tetracaine (1)
21.4
Kotics
solution (eye drops), 2$, 4$
(hydrochloride or nitrate)
pilocarpine
21.5
Mvdriqtics
.
solution (eyo drops), 2$ (hydrobromide)
han atropine (1 )
epinephrine (A,B)(2)
solution (eye drops),2$ (?•”
(as hydrochloride)
21.6
Systemic
tablet, 250 mg
acctazolaraide
22. OXYTOCICS
ergometrine (1)
tablet, 0.2 mg (maleate)
injection, 0.2 ng (maleate) in
1-ml ampoule
injection, 10 IU in 1-nl ampoule
oxytocin
23. PERITONEAL DIALYSIS SOLUTION
intraperitoneal dialysis solution
(of appropriate composition)
parenteral solution
.15.
Main list
Route of administration,
pharmaceutical forms and strengths
Complementary drugs
24. PSYCHOTHERAPEUTIC DRUGS
amitriptyline (l)
tablet, 25 mg (hydrochloride)
chlorpromazine (1 )
tablet, 100 mg (hydrochloride)
syrup, 25 ng (hydrochloride)/ 5 ml
injection, 25 mg (hydrochloride )/ml
in 2-nil ampoule
diazepam (1)
tablet, 5 mg
fluphenazine (1, 5)
injection, 25 mg (decanoate or
enantatc) in 1-ml ampoule
haloperidol (1)
tablet, 2 mg
injectio, 5 mg in 1-til ampoule
capsule or tablet, 300 ng
lithium carbonate (2,4,7)
25. RESPIRATORY TRACT, DRUGS ACTING ON THE
25.1
Antiasthmatic Drugs
aninophyllino (1)
tablet, 200 ng
epinephrine
injection, 1 ng (as'hydrochloride) in
1-ral ampoule
salbutamol (1 )
tablet, 4 rag (sulfate)
injection, 25 mg/ml in 10-nl ampoule
oral inhalation (aerosol), 0,1 mg
(sulfate) per dose
syrup, 2 mg (sulfato)/ 5 ml
beclonctasone
(b) (8) oral inhalation (aerosol), 0.05 ng
(dipropionate) per dose
cromoglicic acid
(B) (2, 8)
oral inhalation (cartridge), 20 rag
(sodium salt ) per dose
tablet, 30 mg (as hydrochloride)
ephedrine (A)
elixir, 15 mg (as hydrochloride )/5 ml
injection, 50 ng (sulfate) in ,1-ml
ampoule.
25.2
Antitussivc s
tablet, 10 ng (phosphate)
codeine (10)
26.
SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE DISTURBANCES
26.1 Oral
for composition, see 17.6.2
replacement solution
oral rohydration salts
(for glueose-salt solution)
potassium chloride
'
26.2
compound solution of sodium
lactate
oral solution
Parenteral
injectable solution
....16.
- 16 -
Main list
Complementary drugs
Route of administration,
pharmaceutical form's and strengths
glucose
injectable solution, 5$ isotonic ,
50$ hypertonic
glucose with sodiun chloride
injectable solution,+4$ glucose, 0.18$
sodiun chloride (Na 30 nmol,
CL-' 30 mol/1)
potassium, chloride
injectable solution
sodiun bicarbonate
injectable solution, 1.4$ isotonic
(Naj67 ninoJ/1,
HCO' j 167 nnol/1)
sodiun chloride
injectable solution, 0.9$ isotonic
(Na + 154 nnol/1, CL~ 154 mo 1/1)
water for injection
in 2-ral, 5~nl, 10-ral ampoules
27.
SURGICAL DISINFECTANTS
clilorhcxidinc (1 )
solution, 5$ (gluconate) for dilution
iodine (1 )
solution, 2.5$
28.
VITAMINS AND MINERALS
ascorbic acid
tablet, 50 ng
ergocalciferol (1 )
capsule or tablet, 1 .25 ng (5'0000 IU)
nic otinanidc (l)
tablet, 50 ng
oral solution, 0.25 ng/ml (10000 Hi)
pyridoxine
tablet, 25 rag (hydrochloride)
re tinol
capsule or tablet, 7.5 ng (25000 Hl),
60 rag (200000 IU>
oral solution, 15 ng/nl (50000 IU)
riboflavin
tablet, 5 ng
sodiun fluoride
tablet, 1.1 ng
tablet, 50 rag (hydrochloride)
thiamine
-
cnlciun gluconat<
(c) (2,8)
injection, 100 ng/nl in 10-;-.~. ampoule
sFor use in the treat.ant of xcr-phthr_L--.ia with a. sin lo d'-sc, not to be
rope~.tcd before 4 ninths have elapsed.
17.
A handout urenared as. guidelines for exploration of the theme with the
participants of the health Care Administration Course at St. John's
liedioal College Hospital, Bangalore.
A Rational Drug Policy (issues and prospects)
1 .
"Eternal vigilance is required to ensure that the health care system
does not get medicalised, that the doctor-drug producer axis does not
exploit the people and that the abundance of drugs does not become
a vested interest in ill-health".
- ICMR/lCSSR
2.
Health for All Report, 1981
Understanding Irrationalities of the present situation
i.
45000 formulations available in India while WHO says 200 are
essential and Hathi^ Committee in India says 116 are essential.
ii.
Twenty percent of drugs are substandard and spurious.
iii.
The formulations available include:
- irrational combinations
- hazardous drugs
- banned drugs and bannable drugs
- costly drugs
iv.
Inadequate drug legislation and drug control
v.
Shortages and non-availability of essential drugs and life
saving drugs
vi.
Non-availability
vii.
Unethical medical advertising and drug company sponsored mis
information.
viii.
Irrational prescribing practices of medical profession induced
by doctor-drug producer axis
of unbiassed drug information.
ix.
Tonics, vitamins and enzymes are in excess whereas anti-TB
and anti-leprosy drugs and Vit. A are in short supply.
x.
Drug policy is an industrial policy not a health policy.
xi.
Increasing prices or inadequate price control.
xii.
Drugs as a substitute for caring - new medical culture.
2
2
Sono issues
a.
Brand vs. Generic names
b,
Drug/business - dumping
transfer pricing
profit orientation
mis-information
corrupting control systems
doctor-drug producer axis
(one of the biggest and most profitable business in the world
today)
c.
Inadequacies in Medical/Nursing education and health team training
d.
Consumer Awareness/consumer protection forums
e.
Absence of health personnel's continuing education
f.
Floor moppers to Tap turners off
- the increasing role of preventive/promotive health care.
Components of a Rational Drug Policy
i.
Drug availability^roduction in consonance with health neods of
the people.
ii.
Elimination of irrational, useless and hazardous drugs
iii.
Low cost drugs in adequate quantities particularly essential/
priority drugs.
iv.
Adequate quality control and drug control.
v.
Availability of unbiassed drug information and ethical market
ing of drugs.
vit
Drug legislation'reform
vii.
Generic prescribing,
viii.
Technological self reliance.
lx.
Increase drug availability through fair price shops
ment health infrastructure.
,
and govern
».
z.
Training of health personnel in Rational therapeutics and
rational drug policy.
What_can Managers_£f Eo.spitals do?
i.
Educate yourselves on rational drug policy and rational thera
peutic issues.
ii.
Share and disseminate information to all staff and colleagues
in-hospital and associated centres.
...3
3
6’
iii.
Adopt essential drug list using cost, efficacy, safety and
quality as criteria.
Evolve a hospital formulary and purchas
and stock drugs in accordance with this.
iv.
Adopt *
'generic
concept during purchasing, prescribing and
dispensing drugs.
v.
Weed out the following types of drugs from the hospital
pharmacy:
a.
banned and bannable drugs
b.
irrational combinations
c.
imitative or me-too
d.
costly drugs with cosmetic embellishments and elegant
packaging.
e.
drugs with inadequate evidence of greater value.
drugs
vi.
Avoid injection and tonic practice.
vii.
Avoid drug industry linkages - gifts, sponsorship, unethical
trade discounts and other forms of inducement.
viii.
Adopt bulk purchasing and or supports co-operative purchasing
and production ventures.
ix.
Evolve a system of health education on drugs (use, misuse and
overuse) for patients and also a continuing education for
hospital personnel.
x.
Join and participate in groups at local/regional/state/
&
national level who are interested in rational therapeutical/
rational drug policy/consumer awareness issues.
xi.
Seek information on other forms of treatment. Adopt open
policy to rationally tested non-allopathic systems and non-di
therapies and incorporate in work.
xii.
Promote 'Health for All' priorities:
a.
simple home remedies;
b.
health education;
c.
community health initiatives;
d.
development programme;
e.
community organization and awareness pro
^HSgestions_for_Reading
1.
A Rational Drug Policy (All India Drug Action Network and Volunt
ary Health Association of India publication, Rs. 20)
2.
Banned and Bannab]e drugs, Health Action Series 2, VHAI publi
cation, Rs.10.
J.
Towards a People Oriented Drug Policy (Medical Service, Vol. 41,
No. 9, Oct.-Nov. 1984 and Vol. 42, No. 1, January 1985, CHAl)
...4
4
4.
Drugs-Fact, Fallacy and Fraud, (The Journal of Christian Medical
.Association of India, Vol. LX, September 1983, No. 9)
5.
Getting Essential Drugs to People (CONTACT, No, 63, August 1981 )
6.
Strengthening & Regulating the Supply, Distribution and Production
of Basic Pharmaceutical Products (CONTACT, No. 75, June 1983)
7.
The Use of Essential Drugs, WHO
8.
ionics, How Much an Economic Waste, Kanala Jaya Rao, Medico Friend
circle bulletin, November 1976.
9.
The Dangerous Drug List, Claude Alvares, Illustrated Weekly of
India, 12 July 1987.
10.
Formulary and Therapeutic Guide, Kurji Holy Family Hospital,
January 1983.
Tech Report Series 722 (1988)
Items 1,2, 7, 8, 10 available from VHAI, 40 Institutional Area, South
of IIT, Now Delhi 110016.
******
41st Annual Convention of the Catholic Hospital Association of India
Workshop on; TOWARDS A PEOPLE-ORIENTED DRUG POLICY
23-25 November 1984 : St John's Medical College and Hospital
Objectives
WHAT IS THE PROBLEM
1.
To create an awareness of
a.
the health situation in India
b. the role of drugs in health care
, the pattern of drug production in India vis a vis the
c.
people's health needs
2.
3.
d.
the dynamics of. the drug industry
e.
the patterns of drug distribution/availability in the
hea 1 th sys tem
f.
the national drug policies and laws.
To create an awareness of the
growing -
a.
irrational use
b.
over use
c.
misuse of drugs by health personnel
To look at the above issues within the context of the
CHURCH HEALTH SERVICES
4.
To try and understand the problem from the people's point
of view.
HOW/WHY THE PROBLEM?
5.
At the broader level to discover the social, economic,
political, cultural and other factors responsible for
this problem.
6.
At personal level to discover how all of us are part of the o
problem atthe individual and the institutional levels.
WHAT TO DO TO TACKLE THE PROBLEM?
7.
To consider the various responses at the national/international
levels by groups/institutions/governments in the areas of a.
b.
consumer awareness and people's movements
continuing professional education
c.
pressure groups on policy makers
P.t.o...2
2
8.
d.
search for low cost alternatives
e.
individual/group action
f.
institutional policy changes
To discuss ways and means by which participants can
respond to this problem ata.
b.
individual
institutional and
c. regional/national levels
and identify ways and means by which follow up action
will be taken in this growing commitment.
;
11.00 am
Preparatory Workshop for Faciliation Team
17th November 1984
St John's Medical College, Bangalore
11.00 am
Introduction of team/theme and details of
PROGRAM
the prog.’, .mme
11.20 am
Group Gi.cussion;
a. What are the different dimensions of
the drug policy and prescribing issues
in India?
V
b. What information would we like to have
to further understand and analyse this problem'
12.40 p.m.
Pie''pt/ session;
Listing out what we would like to know
1.00 pirn.
LUNCH
2.00 p.m.
Information check list
3.30 p.m.
Tea
4.00 p.m.
Planning the group discussion and the
facilitation
5.00 p.m.
Video presentation on the theme.
5
DRUG ISSUES
Information check list
A. Drug Industry
Output
Profits
Type
Pattern of production
Structure
Drug Policy
Prices
Quality control
Research and Development
Consumption of :Drugs
B. Drug Policy Issues (Problems)
Plethora of formulations
Mark up
Braid names
Net worth returns
Fixed drug combinations
Transfer pricing
Bio-availability argument
Sales promotion
Dumping
Samples
Me-too drugs
Advertising
Drug controls
C.
Policy Issues (solving Problems)
Essential drug list
Formulary (level of use)
Generic prescribing
Bulk Drug formulation
Price control
Bulk purchasing
Labelling
Quality control
Low cost production
Cooperatives
Herbal gardens
Pharmaceutical code
Physicians code
Counter advertising
D.
-s_'R-':; orts
Consumer Awareness
D. Drug Laws/Policjes/Reports
Drugs and cosmetics Act
Drugs & Magic Remedies Ac€
The Pharmacy Act
Hathic Committee Report
p.t^o.^.
National Drug Policy
Drug Price Control Orders
Health for All Report
Govt. Ban of 22 drugs
Irrational Drug use/prescribing types
TyPe 5
Extravagant
Overprescribing
Incorrect
Multiple
Under-prescribing
z
Causes
Inadequate basic training
Lack of continuing education
Lack of supervision
Inappropriate desire for p
prestige
Drug company sales
promotion
Drug company misinformation
Heavy patient load
Patient presssure
Panic/fear inc ■
.
induced prescription
Incorrect generalisations
Lack of patient
awareness
Doctor-Drug producer axis
Problem Drugs
Specific
Analgin
Amidopyrin
Ancdloxin/
Bromides ■
Chloral hydrate
Cloquinols
Dipyrone
E-P Forte
Ergot
Gripe water
Kaolin
Lomotil
Methapyrilene
Nialamide
Oxyphenbutazone
Phenylbutazone
Phenacetin
Practolol
Penicillin
Quinine
Sulphonamides
Strychnine
Yohembine
bt'O $
Groups
G.
H.
I.
Antibiotic combinations
Anabolic steroids
Analgesics
Antidiarrhoeals
Enzymes
Fixed dose combinations
Placebos
Steroids
OTC Drugs
Unani/Ayurvedic drugs
Church Health Services (context)
Institutional response
New vision/option
Community response
Humanisation
Holistic healing
Issues of social justice
People's Point of view
Availability
Accessibility
Cost
Cross-cultural conflicts
Mystique of injections
Communication failures
Self prescribing
Low cost home remedies
Initiatives
Meetings and workshops
Newsletters/bulletins
Books/journals
Professional awareness
Continuing education
Consumer awareness
Signature campaign
Memorandum to policy makers
Public interest litigation
Low cost drug production
Bulk/central purchasing
Cooperatives
Herbal gardens
Formularies
Codes
J*
Case studies
Bangladesh Ban
Operation Medicine
VHAI Cell
Drug Action Network
IOCU HAI
Social Audit
mfc Rational Drug Policy
Cell
Vincents Case
Ankuran
KSSP
Lok Vidnyan Sanghatana
LOCOST
Bangarapet Tablet Industry
Kurji formulary
State Forum (AP/WB)
mfc ms
THE DRUG INDUSTRY IN INDIA
What our experts say.
THE INDUSTRY
The total output of the industry increased hundredfold - from
Rs.100 million in 1947 to Rs.10.500 million in 1978-79. This was
due to expanded production, especially of an ever-increasing number of
sophisticated drugs, and rising prices
The drug industry has enjoyed a higher man-average profitability
so that investment therein has increased substantially from Rs.240 million
in 1952 to Rs.4,500 million in 1977.
There are about 125 large and medium factories and nearly 3,000
small scale sector units engaged in this industry which provides
employment to about 100,000 workers.
PATTERN OF DRUG PRODUCTION
There is now an overproduction of drugs (often very costly)
meant for the rich and the well-to-do while the drugs needed by
the poor people (and these must be cheap) are not adequately
available. This skewed pattern of drug production is in keeping
with our inequitous social structure which stresses the production
of luxury goods for the rich at the cost of the basic needs of the poor.
Out of a total production of Rs.700 crores in 1976, 25 percent is
taken away by vitamins, tonics, health restoratives and enzyme digestants,
mostly consumed by the relatively well-fed urban population. Twenty
percent is covered by antibiotics, only 1.3 percent by sulphonamides
2
2
(a very cheap and useful anti-infective) and 1.4 percent by
anti-tuberculosis drugs......
PATTERN OF PRESCRIBING
One of the most distressing aspects of the present health
situation in India is the habit of doctors to over-prescribe
glamorous and costly drugs with limited medical potential. It is
also unfortunate that the drug producers always try to push doctors
into using their products by all means—fair or foul. These basic
facts are more responsible for distortions in drug production and
consumption than anything else.
STRUCTURE OF THE INDUSTRY
The existing drug policy rightly emphasises the attainment
of self-sufficiency in the production of drugs, in increasing the share
of the Indian producers and in giving a more significant role to
public sector.
The foreign companies account for about 40 percent of the total
drug production in the country; their share in the production of
basic drugs was about 28 percent and that in formulations, 44 percent
(1978-79). This is still high.
PRICE CONTROL
The drug prices are high and continue to rise. In some instances,
Indian prices are even higher than the international ones.
Packaging increases the cost of drugs very greatly because the
trend is to make it attractive and highly elegant and to add cosmetic
embellishments to promote sales....
There may indeed be a glut of applications for the introduction
of 'Me-too Drugs' which will not attract new legislation for
3
another five years in regard, to price control
Genuine ’breakthrough' research has declined in recent
times.
Existing prices of drugs including those of essential drags
of everyday use is highly inflated. For example, the cost of analgin
sold over the counter is 30 times the cost of production.
Prices are often inflated by the use of brand names.....
Very often, prolonged controversy over the price of a
drug has resulted in stopping its production.
The bill for import of bulk drugs, intermediates, solvents
etc., has
jumped from Rs.53.77 crores in 1976-77 to about
Rs.119 crores in 1979-80.
QUALITY CONTROL
The standards prescribed are unrealistic...are mechanically
copied from books.... and not uniformly enforced in all parts of
the country.
CONSUMPTION OF DRUGS
At present the supplies of drugs to urban and rural institutias
HI within the health care system is very uneven. In an urban
hospital, for instance, the drug cost is Rs.6 per patient per year
while in a Primary Health Centre, it is about 40 paise per patient
per year.....
4
AN OVERVIEW
We recognise the value and significance of drugs in the
health care system. We fully support the policy that all the
essential drugs should be produced in the country, preferably
in the Indian sector, and that they should be made available
to the people at reasonable prices. To realize-these objectives,
it is essential to lay down and vigorously implement a national drug
policy which will ensure that the pattern of drug production in the
country (barring drugs meant for export) should be geared to its
actual needs. While the supply of drugs should be adequate, eternal
»
_=---
vigilance is required to ensure that the health care system does _not
get medicalized, that the doctor-drug-producer axis does not exploit the
people, and that the 'abundance
*
of drugs does not become a vested
interest in ill-health.
Source;
Health for All - An alternative Strategy
::
report of a study
group set up jointly by the Indian Council of Social Science Research
(ICSSR) and the Indian Council of Medical Research (ICMR).
10
DRUG COMPANY SPONSORED MISINFORMATION OF DOCTORS.
In countries with less well-organized drug control mechanisms, studies
have shown that the same drug manufactured by the same multinational
company is sold for more indications
with less contra-indications
less side effects
as compared to the information provided in U.S.A.
The following example of two drugs bears this out only too well.
IFTHERE ARE NO SIDE EFFECTS, THIS MUST BE ARGENTINA
Drug:
Tetracycline (Antibiotic used against various infections; Lederle
Laboratories)
U.S.A.
Caution Against Use
(1)
Adverse reactions publicized
(2)
By infants, children; during
Vomiting, diarrhoea, nausea,
pregnancy: Liver or kidney
stomach upset, rashes, kidney
impairement (latter can be
poisoning, can poison fetus.
fatal) or if overly sensitive
to light.
MEXICO
BRAZIL
ARGENTINA
By infants, children;
Vomiting, diarrhoea, nausea,
during pregnancy or
if overly^ensitive to light.
stomach upset.
By infants, children,
Vomiting, nausea, stomach
during pregnancy.
upset, rashes.
None
None
2
Drug:
Ovulen (birth control pills: GD Searle Co.) in US used for
contraception only. In some Latin countries, Searle recommends
it also for regulating menstrual cycles, premenstrual tension,
menopausal problems.
U.S.A.
Caution against use
Adverse reactions publicized
If patient has tendency
Nausea, loss of hair,
to blood clot, liver
nervousness, jaundice, high
dysfunction, abnormal
blood pressure, weight change,
vaginal bleeding,
headaches.
epilepsy, migrain,
asthma, heart problem.
MEXICO
If patient has tendency
Nausea, weight change.
to blood clot, liver
dysfunction.
BRAZIL
If patient has tendency to
None
blood clot.
ARGENTINA
If patient has tendency
to blood clot.
None
(Taken from the Mother Jones, Courtesy—Health and Society, also mfc
bulletin 73-4, Jan-Feb 1982).
2
Drug : IMIPRAMINE (Anti-depressant, Ciba Geigy)
In U.S. used for depression only. In some Latin American
countries, Ciba Geigy recommends it also for senility,
chronic pain and alcoholism
U.S.A
MEXICO
BRAZIL
Caution against use
Adverse reactions publicized
If patient has heart disease,
Hypertension, stroke,
history of urinary retention,
stumbling, delusions, insomnia
history of seizures, manic
disorder or is on typhoid
numbness, dry mouth, blurred
vision, constipation, itching,
medication. Nofrecommended for
nausea, vomiting, loss of
children or during pregnancy
appetite, diarrhea
During first trimester of
Dry mouth, constipation
pregnancy
itching, c~a sweating
If patient has heart disease.
not recommended for children
None
or during pregnancy
ARGENTINA
May exaggerate response to
None
alcohol
(Taken from the Mother Jones, Courtesy—Health and Society, also mfc
bulletin 73-4, Jan-Feb 1982.)
What Can We Do?
1. Educate ourselves
We should make an effort to availourselves
of all the available, materials on drugs.
We should purchase some of the books and
subscribe to some of the journals and bulletins
mentioned in^widening horizons
tyt
*
% to keep
ourselves upto date.
2. Share and Disseminate,!: We should circulate all the information end
information
resources to all our staff and to other colleagues
and centres through all possible channels of
communication. We could share our own initiatives
and experiences.
3. Adopt essential
drug list
We should draw up an essential list for our
institution in which cost, efficacy, safety and
quality will be important criteria (refer to
*
WHO
s suggested list)
We could purchase and stock drugs in accordance
with this list.
4• Adopt generic
prescribing
5. Stop Irrational
prescribing
We could use/adopt the generic drug concept
during purchasing, prescribing or dispensing drugs
Could stop prescribing drugs whose only
advertised values are ia. cosmetic embellishments
b. elegant packing
c. irrational combinations
*
d. imitative drugs
2
2
e. inadequate evidence of greater value
We could weed out ‘banned drugs
*
as well as
restricted drugs.
We could stop ’injection and tonic
*
practice.
6. Avoid Drug
We could refuse to take gifts and physician samples
Industry’-
We could avoid allowing drug companies to sponsor
Linkages
events/meetings
We could beware of unethical trade discounts or other
forms of inducement
7.
Adopt Rational; We could adopt bulk purchasing
Drug Purchase
Support cooperative purchasing or production
endeavours
Produce drugs in pour hospitals/dispensaries.
8.
Adopt open
We should be open to other forms of treatment
policy to
Seek information and be willing to incorporate it
non-allcpathic
systems and non-
drug therapies
in our work
[
Share our experience with others
Send our staff for training in these forms of
treatment if necssary.
9.
Support
networks/
organization/
Find out about all such groups at local, regional,
state level or national level
Support and participate in their activities.
consumer
movements
taking up
drug issues.
•••••3
3
10.
Promote ’Health for all’
We should actively promote
priorities.
the following in our work:
a.
simple home remedies
b.
herbal remedies and herbal gardens
c.
health education and patient awarene
d.
training of village level workers
e.
community health initiatives
f.
development programmes
g.
awareness building.
1
3
often receive no information at all. In Mexico, for example, upto
70% of pr scription drugs are sold without prescription. Yet the
packaging of these medicines generally contains no information about
use, dosage, or risks.
8.
Health Workers not adequately informed.
In spite of the tremendous
amount of self-medication in most countries, many programs still do
not teach health workers much about the use - or misuse — of
commonly self-prescribed medicines. As a result, many health workers
to meet popular demand, secretly purchase and administer a wide
range of medicines they know little about.
9.
Use of medicine to gain prestige and power.
Another reason for
medicine overuse is that many professionals use their ability
to medicate as a sort of magic to make people grateful and dependent.
This way they gain special privilege and power. In the same way,
health workers may be tempted to give injections or expensive drugs
when home remedies or kindly advice would cost less and do more good.
From Helping Health Workers Learn
David Werner and Bill Bower
mfc ms
Some reasons for widespread misuse and overuse of medicines.
HEALTH WORKERS SHOULD DISCUSS THESE FACTS
AND HELP MAKE EVERYONE AWARE OF THEM
1.
Big business.
The production and marketing of modern medicines is one
of the biggest, most profitable businesses in the world. Drug
companies are continually inventing new products to increase their
sales and profits. Some of these medicines are useful. But 1 atleast
90% of medicines on the market today are unnecessary. Doctors prescribe
them and people buy them, because the drug companies spend millions
on advertising.
2.
False advertising.
Especially in poor countries, much of the
advertising, and even the information published in ’pharmaceutical
indexes’, is misleading or false. Information on dangerous side
effects is often not included. Risky medicines are frequently recommended
a
for illnesses less dangerous than the medicines. (For example
chloramphenicol has often been advertised as a treatment for minor
diarrhea and respiratory infections).
3.
Dumping.
Drug companies in wealthy countries sometimes produce
medicines that do not sell well in their homelands. Or the use of
certain medicines is restricted or prohibited because they have been
proved unsafe. It is a common practice for drug companies to 'dump'
these medicines on poor countries—often with a great deal of false
advertising. For example, several years ago the U.S. government
restricted the use of Lincocin (lincomycin) because it proved more
dangerous, more costly, and generally less effective than penicillin.
The following year, thanks to massive advertising, Lincocin became
the best selling drug in Mexico!
2
2
4.
Lack of adequate controls.
Poor countries, especially, have
inadequate laws controlling the production and sale of medicines.
As a result, many poor countries sell up to 3 times as many
different medicines as rich countries do. Most of these medicines
are a waste of money. Many are completely unreasonable combinations
of drugs, yet they are widely prescribed by doctors. For example,
in both Latin America and Asia, a popular injectable medicine is
tetracycline combined with cJh loramphenicol. This is a senseless
combination because the two drugs are ’incompatible
*
and should
never be used together.
5.
Bribes and corruption.
Drug companies in rich countries pay millions
in bribes to officials in poor countries so that governments
will buy their products. (A major US pharmaceutical company recently
admitted to having spent millions of dollars on bribes to advance
its products in poor countries.)
6.
Sale of prescription medicines without prescriptions.
This is
common in many countries (partly because poor people cannot afford
*
doctors
fees).
Most people who •self-medicate' try to use the
medicines well, so they follow the patterns set by doctors.
Unfortunately, this often leads to incorrect use. For example,
in Latin America atleast 95% of doctors’ prescriptions for
Vitamin B12 injections are among the most widely used self-prescribed
medicines in Latin America—at a cost of millions to a people
too poor to eat welll
7.
People not adequately informed.
Neither doctors nor the people
are adequately informed about the correct use of medicines.
Most doctors rely on the information given in misleading 'blurbs'
supplied with sample medicines, while villagers who self-prescribe
3
IRRATIONAL DRUG USE Pff £SC ?2) ©.‘
Occurs if a drug is prescribed when:
Extravagant
Prescribing
* a less expensive drug would provide compa
rable 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
prescribing
* the drug is given for an incorrect diagnosis
* the wrong drug is selected for the indication
* 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
IRRATIONAL DRUG USE
CAUSES
In brief, the main causes identified by those who have studied
prescribing behavior are the following:
1.
Inadequate training in clinical pharmacology - Despite
the daily use of medicines in clinical pra ictice, 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 considered 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 nn
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.
Pear-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.
S.
Incorrect generalisation 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 overproscribe 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.
Drug Utilisation Survey Report
This survey was conducted by the National Institute of Nutrition
(NIN) in cooperation with the Directorate of Drug Control Administration
and AP Chemists and Druggists Association, Hyderabad in the
twin cities of Hyderabad and Secunderabad covering 10% of the 330
retail pharmaceutical shops.
Some of the findings of the survey are as follows:
-
self medication rate was an alarming 46%.
-
27% of the doctors
*
prescriptions were for 3 to 4 drugs
Only 4.3% of prescriptions were for more than 4 drugs.
-
the maximum number of pres riptions were for Nutritional
Products (tonics, enzymatic preparations and vitamins), then
antiinfectives (antibiotics and sulfas) and then analgesics.
-
58% of the self medicated drugs were schedule *L
and *H
drugs which can ot be sold without prescription, nor should be
consumed without medical supervision, because of the associated
major side effects and toxicity.
-
amongst self administered drugs analgesics, nutritional
products and antibiotics topped the list.
Analgesics, antipyretics and anti-inflammatory drugs:
-
30.2% of the self prescribed analgesics, antipyretics- and
anti-inflammatory agents were scheduled drugs. These were
mainly analgin, phenylbutazone (with or without corticosteroids)
and ibuprofen.
—
an earlier survey by the CERF (Consumer Education and Research
Centre, Ahmedabad) hud shown that of 13 over-the-counter brands
of these drugs, 11 did not provide any information. The 44 doctors
interviewed reported s-eing on an average 8 to 10 cases of drug
...... 2
2
drug poisoning per month.
Vitamins and Tonics:
-
only 31% persons surveyed had a correct concept regarding
nutritional supplements. The majority held the erroneous view
that daily consumption of tonics was essential for healthl
The credit for this false belief goes to advertising pressure
as well as doctors' prescription practices.
-
16% of the doctors had pr scribed simultaneously more, than
one vitamin preparation having the same ingredientsin various
dosage forms.
-
iron deficiency anemia, B2 deficiency, were the commonest
deficiencies in the population but sales of B Complex
z
(Bl, B2, B6 1312) combinations and other vitamins topped
the list of sales figures.
Antibiotics:
-
over 30% of the doctors’ prescriptions contained antibiotics.
-
approximately 12.8% of self-prescribed drugs were antibiotics.
-
most antibiotic prescriptions were for sulfa and trimethoprim
combinations, tetracyclines and penicillin, in that order.
-
tetracycline, sulfa-trimethoprim and penicillin were the
most popular self-prescribed
—
drugs.
30% of the antibiotics purchased for self medication were for
less than a day. Only 18% were purchased for a full course of
five days. Only 40% of prescriptions for antibiotics were bought
for five days.
3
3
The findings of the NIN and CERC surveys indicate the urgent need for
public education where disease and drugs are concerned.
Sources The Drug Action network; Newsletter of the Low Cost
Drugs and Rational Therapeutics Cell, VHAI, Nev; Delhi.
Learning to use antibiotics wisely,
First guidelines
1.
Use an antibiotic that kills bacteria rather than one that
just slows them down. This usually gives quicker results,
and prevents the infection from becoming resistant to treatment,
2.
Use an antibiotic that causes fewer side effects and is less
risky. For example, if the person is not allergic, it is
safer to use penicillin or ampicillin rather than an
antibiotic like erythromycin that can cause poisoning.
3.
When possible, use a narrow-range antibiotic that attacks
the specific infection rather than one that attacks many
kinds of bacteria. Broad-range antibiotics cause more
i
o
h
problems—especially diarrhea and thrust—because they attack
good bacteria along with the bad. i'he good bacteria
prevent the growth of harmful things like moniliasis
(fungutfs that can cause diarrHea, thrush, etc.)
4.
Use a broad-range antibiotic only when no other will work,
or when several kinds of bacteria may be causing the infection
(as with infections of the gut, peritonitis, appendicitis,
some urinary infections, etc.)
Additional guidelines for further learning
5.
Use antibiotics only for bacterial infections. Do not use
them for viral infections, because antibiotics do nothing
against viruses (common cold, measles, chicken pox etc.)
2
6.
Be careful never to give more than the recommended dose of a toxic
(poisonous) antibiotic. However, it is usually not dangerous
to give higher doses of an antibiotic that is not poisonous
(penicillin or ampicillin). For example, it is all right to
use penicillin for months or even years after|it has expired,
and to increase the dose to allow for any loss of strength. (But
tetracycline becomes more poisonous when old. It should never
be used beyond the expiration date or in more than the recommended
dose.)
7.
Do not use an antibiotic that slows down bacteria together with
an antibiotic that kills them, ‘^'he combination is often less
effective than one alone. (Once the bacteria are captured or
slowed, they stay hidden where the other antibiotics cannot
kill them.)
For example, never use tetracycline in combination with
chloramphenicol.
8.
Whenever possible, avoid using a toxic medicine for a person
with diarrhoea or dehydration. A dehydrated person’s body
cannot get rid of poisons as quickly in the urine. Even normal
doses of a toxic medicine may build up and poison the person.
0
(Sulfas are especially riskly for treating diarrhea. Unless
the person is making a lot of jhirine, sulfa can form crystals
in the kidneys and cause damage.)
9.
Do not use toxic medicines during pregnancy—especially during the
first three months.. Some medicines can cause severe birth defects.
10.Use a medicine the family can afford. When choosing between
medicines, always consider the relative cost, and weigh^ this with
other advantages and disadvantages.
—Helping Health Workers Learn
David Werner and Bill Bower
IG
41st ANNUAL CONVENTION
CATHOLIC HOSPITAL ASSOCIATION OF INDIA
23-26 NOVEMBER 1984
Qo
OO
Eternal vigilance is required to
ensure that the health system
does not get medicalised, that the
doctor-dwg producer axis does
not exploit the people and that
the abundance of drugs does not
become a vested interest in ill-health
-- ICMR/ICSSR Health for All Report.
Venue: ST JOHN'S MEDICAL COLLEGE, BANGALORE 560034
2
SIGNIFICANCE OF THE THEME
THE Workshop is to help participants understand the
issues relevant to drug prescribing, drug distribution
and pharmacy policy in our institutions in the context
of the ICMR/ICSSR warning and to challenge them to
participate in the growing national response to
the problem.
WHAT does the ’abundance of drugs' mean to the millions
of the poor in our country who struggle in life to
make both ends meet? Can they ever have access to the
modern health care system which has become a business
today, rather than remaining at the service of humanity
at large? Do they have essential and life saving drugs
at their reach within a price range they can afford?
IS our drug policy today more profession-oriented, drug
industry-oriented rather than patient-oriented? Whose
interests are we serving in our institutions?
HOW can \;e move towards a more people and patient-oriented
drug policy?
THESE are some of the QUESTIONS which we shall respond to
in our Workshop.
ooooooooooooooooooooooooooooooooooo
"Community Health is a process
of enabling people to exercise
collectively their responsibi
lities to maintain their health
and to demand health as their
right. Thus it is beyond mere
distribution of medicines,
prevention of sickness, and
income generating programmes".
—CHAI new vision
OOOOOOOOOOOOOOOOCOOOOOOO0OOOOOOOOOO
OBJECTIVES
1.
3
TO CREATE AN AWARENESS OF?. =
the health situation in India, the role of drugs
in health care, the pattern of drug production
in India vis-a-vis the people's health needs, the
dynamics of the drug industry, the pattern Of drug
distribution and availability in the health system,
the national drug policies and laws.
2.
TO CREATE AN AWARENESS OF 8 =
irrational use, over use and misuse of drugs by
health personnel.
3.
TO DISCOVER
the social, economic, political, cultural and
other factors responsible for this problem.
4.
TO DISCOVER
how all of us are part of the problem at a
personal level.
5.
TO CONSIDER
the various responses at national/regional levels
in the areas of s— consumer awareness and people's
movements; continuing professional education;
pressure group on policy makers; search for low cost
alternatives; individual/group action; institutional
policy changes.
6.
TO DI®COVER
ways and means by which we can respond to this
situation at individual, institutional and
r^gional/national levels.
4
PROGRAMME HIGHLIGHTS
jjjSessions ons
Understanding the problem
Drugs and the healing ministry
Towards rational therapeutics
What to do to tackle the problem
Some initiatives in the country
The people's medicine
i:Group discussions on;
What/why the problem in our health institutions?
What can we do to tackle this problem?
'^Liturgy
Reflecting on our calling and the faith dimension
of our response
:;^Exhibition ons
Socio-political dimensions of Health and Drugs
Rational Drug Therapy
Home remedies and Herbal medicines
::iStudies on:
Drugs for a Community Health Center
Understanding the injection/tonic culture
Use/misuse of drugs in surgery
Drug situation in small rural hospitals
Cost of treatment
i:^Cultural Programme
Understanding the problem from the poor man's
point of view.
5
SYMOPSIS OF PAPERS
Drugs for Primary Health Care (c M Francis)
An integral part of our commitment to primary health care is
the provision of essential drugs to all those who need
them, in adequate quantity and quality and at affordable
prices wherever the person is. The various aspects of
the drug problem, needing our attention include production,
what drugs are required, choice of drugs, National Drug
Policy, selection of drugs, drug production and procurement,
logistics of supply, quality control, regulating the drug
trade, drugs for immunization, drugs for cure, drugs for
symptomatic relief, search for new drugs, drug information
and the need for evaluation of the efficacy of primary
health care including drugs.
The Ten Commandments of the Drug Industry (Augustine Veliath)
1.
Thou shalt have tens of thousands of drugs
2.
Thou shalt not question the price of a drug
3.
Thou shalt not tamper with nature’s garden
4.
Thou shalt respect they doctor more than thyself
5.
Thou shalt betray thy people and thy nation for petty rewards
6.
Thou shalt not covet, court, or subscribe to any other
system of medicine
7.
Thou shall never reveal company secrets
8.
Thou shall first seek remedies for fashionable ailments
9.
Thou shalt be a'dumping ground for banned drugs
10.Thou shalt be a guinea pig for new and untried drugs.
6
The Ethics of Prescribing (George Lobo, sj)
Discusses reasons for the unfortunate situation related to
drugs prevalent today, viz., technological model of
health care leading to manipulation of the patient,
search and demand for instantaneous cure of symptoms,
mystification of medicine, profit motive and 'free
enterprise' of the pharmaceutical industry, a deep
rooted cultural alienation from the people, exploitation
of dependent developing countries, decreasing emphasis
being given to preventive medicine and other systems
of medicine.
The use of drugs should be regulated by the principles of
totality (overall good of the patient) and of double
effect (the good effect overriding any harmful effect).
It suggests remedies for the development of a personcentred and holistic approach to health care.
Professionals in the Church - an introspection (George Joseph)
Serious questions have been raised about the institutional
witness of the church in India, particularly its
relevance in the social context of today. In the case of
the Healing Ministry there is urgent need to critically
look at our priorities and commitment and our style of
functioning in the light of the gospel. The role- of the
professionals have to be reassessed as part of an
overall -effort to bring back the true spirit of 'Diakonia'
into this ministry.
The vzhole issue regarding the need for evolving a 'rational
drug policy' has to be seen in this perspective.
7
What is Rational Drug Therapy? (Mira Shiva)
Rational drug therapy means practice of socially
conscious, relevant, concerned and yet scientifically
sound medicine. It recognizes the non-role of drugs
in certain conditions, the role of alternative systems
of medicine and recognizes the limitations of Western
Medicine in our social context.
It emphasises selective use of drugs based on essentiality,
efficacy, safety, easy availability, easy administration,
quality drugs preferably of indigenous production.
Rational Drug Therapy recognizes the concept of essential
drugs and the concept of graded essential drug lists for
different levels of health personnel. It recognizes the
right of health personnel and consumers to drug information
and'its effective communication.
It is taking of a conscious decision to boycott certain
drugs and use others only when needed. It means
prescription with awareness, to avoid as far as possible
— iatrogenesis (drug induced problems, drug interactions,
adverse drug reactions and emerging drug resistance).
It is understanding the role of drugs and rational drug
therapy in the emerging health movement.
What can be done at a pharmacy level (Alan Cranmer)
(a)
Management of Pharmacy Services include involving the
users of the service; the Pharmacy Committee - its
constitution and functions, viz., implementation of
hospital policy, selection of medicines, sources of
medicines, cost versus quality, basic drugs and formula
tions, medicines banned in India and abroad, medicines
from other systems; stock control; prescribing
discipline and pharmacy discipline.
(b)
Good dispensing services involve need for good
professional service to patients, proper presentation
of patient's medicines, preparation of medicines in
the pharmacy compared to purchase, medicines in the
pharmacy and at clinic level.
contd
.8
(c)
Relationships with suppliers, ie., with representatives
in the pharmacy and an assessment of products offered
and their sources.
(d)
Educational requirements - basic courses, legal
requirements, course content, continuing education for
pharmacists.
(e)
Relationships with hospital colleagues.
9
INITIATIVES IN THE COUNTRY
(1)
Arogya Dakshata Mandal, Pune has been raising awareness
about drug related issues among medical professionals
and the lay public since the past 3 years. They publish
a monthly—'Pune Journal of Continuing Health Education' —
on drug issues and are also bringing out a book
'Rational Drug Therapy' in December 1984.
They launched a movement called 'Operation Medicine' in
1977 against irrational prescription cf vitamins, tonics
and tinned foods.
(2)
All India Drug Action Network; A number of groups have
been working in the field of drug related issues at
various levels during the past 3-4 years. They have
been in contact with each other and have been working
informally together sharing information, putting forward
a memorandum (demanding a Rational Drug Policy),
participating in campaigns, lobbying with government etc.
In August 1984, they felt the need to have a more organized
base and have formed the All India Drug Action Network.
CHAI is also a member of the Network.
(3)
Lok Vioyan Sanghatana, Maharashtra, or the People's Science
Movement have launched campaigns about anaemia and
irrational anti-anaemia.drug preparations end also about
over the counter drugs. They organize jathas, hold district/
town seminars, write in the mass media etc.
(4)
Kerala Sastra Sahitya Parishad is a voluntary non-government
organization consisting of sci ntists, doctors, engineers,
social scientists, teachers, students, workers, peasants,
technicians who arc committed to popularising science and
channelising it for social revolution. The KSSP has recently
decided to take up the Drug issue and initiate a big campaign
to expose the anti-people and exploitative tactics of the
Multinational Drug Companies. The questions of essential
versus non-essential and dangerous drugs, the inadequacy
of drug safety control measures, the- rising prices of
life saving drugs and the non-implementation of the Hath!
Committee' recommendations are the highlights of the
programme.
10
(5)
LOCOST or Low Cost Standard Therapeutics is a collective
voluntary enterprise for rational therapeutics. LOCOST
aims to promote low cost, scientifically tested medicine
under generic names. LOCOST is a response to a growing
demand and challenge of the voluntary health sector to
meet the needs of the deprived sectors of the society
for not only low priced but also good quality medicine.
LOCOST includes procurement, quality testing and control,
distribution and educational efforts, and is located in Gujarat
(6)
Bangarapet Mission Tablet Industry in Karnataka is a
successful small scale venture providing low cost, good
quality formulations to some mission hospitals in the
country.
(7)
Low Cost drugs and Rational Therapeutics Cell of the
Voluntary Health Association of India, New Delhi, has
been instrumental in bringing together various groups in
India on the issue of drugs. They have been providing
informational backing to these groups, organizing meetings,
informally coordinating some actions etc.
(8)
medico friends circle is a group of socially conscious
individuals, interested in the health problems of our
people. Through their monthly bulletin, they discuss
drug issues among others. They have formed a Rational
Drug Policy Coll and have launched a campaign on antidiarrhocals.
(9)
The Kurji Holy Family Hospital Formulary is the result
of the accumulated experience of the hospital over the
last 10 years. It gives a comprehensive, list of drugs
to treat 98% of the hospital admissions. It also gives the
generic name, dosage, indications, contra-indications
and side effects of these drugs. Information about
comparative cost of treatment is also provided.
li
do)
State Forums; During the past year drug action forums
have been active in Andhra Pradesh and West Bengal.
Drug Action forums are also being initiated in Gujarat
and Orissa.
(11)
The Pharmacology Department.of_ the Post-Graduate Institute
of Medical Education and Rosearch, Chandigarh, provide
unbiased technical information on drugs and therapeutic
through a monthly publication 'The Drugs Bulletin'.
(12)
Others?
The following organizations have also been
involved in drug related issues and are part of the
All India Drug Action Network?
Consumer guidance Society of India, Bombay
Consumer Education Research Centre, Ahmedabad
Federation of Medical Representatives
Association of India
Health Services Association, Calcutta
Delhi Science Forum, New Delhi
People's Participation in Science and Technology,
Madras/Bangalore
Centre for Science and Environment, Delhi
Centre of Social Medicine and Community Health,
N University, New Delhi
J
W h a t
w o
can
do ?
— Support them
— Join them
Keep them informed about what you are doing
12
RESOURCE .MATERIALS
iii
People.. Pills and Prescriptions,, column in MEDICAL
SERVICE since May-June 1984.
iii Objectives of the Workshop,
a handout.
iii Understand ,iq the Drug situation in our Hospitals,
a check list,
iii Towards a People-Oriented Drug Policy,
Special
Convention Issue of MEDICAL SERVICE (October-Novembe
1934) and a supplement to this issue will be
distributed during the Workshop.
iii Drugs awareness and Action,
mfc BULLETIN Special Issue
No,107 November 1984.
iii DECCAN HERALD Supplement on the Workshop.
'What people really need,
first
and foremost is clean drinking
water, latrines,
school and
land, not urban hospitals with
their wonder drugs".
•— Planning Commission
0 0 00000000000000000 0 00'’ ooooocoooooooooo
AN INSPIRATION
13
Reading
The story of the sickman
at the pool of Bethsaida
•John 5s 1-9
Reflection
'
The action of Jesus in bypassing the pool is an
invitation to us to look more critically at
our own health care system. Thanks to our
emphasis on curative health care, we have grown
accustomed to thinking solely in terms of the
health needs of the individual rather than addressing
ourselves to the community as a whole. While
concentrating on the symptoms, we have failed
to take into account the environment and other
social factors. Poor sanitation, polluted water
supply, the- superstitious beliefs and taboos
of the community are also related to sickness and
disease.
Further, the miraculous pool in its ineffectiveness is
a symbol of our own ineffective health care system
despite the highly qualified doctors and nurses,
well equipped private and public hospitals, medical
research centres and multinational drug industry.
The poor man in the gospel story lived very close to
the pool, yet he was helploss because of his
poverty. In like manner the poor in our midst
remain helpless in the shadow of an expensive,
curative health care system that is geared
exclusively to the service of the rich.
Source; The Bible; Aspirin or Dynamite
by Cedric Rebello s.j.
Integrated
' hilosophy of
Health
n
Dr. Karan Singh
Minister of Health and Family Planning,
Government of India
Text of the Inaugural Address at the XXIX Session of the WHO Regional
Conference for South-East Asia, Srinagar (India), September 14, 1976
It is a genuine pleasure for me to be with you on this occasion, not only
because of the very great importance that the Government of India attaches to the
work of the World Health Organisation but, in addition, because of the personal
reason that this Conference is being held in my home State and, even more, in
the very home where I grew up as a boy and spent some of the happiest years
of my life. I,therefore,look upon it not only as a professional but as a personal
privilege to be with you on this occasion. Kashmir provides an ideal venue for
national and international conferences and conventions. The beautiful surroun
dings have already been referred to in poetic terms by Dr. Gunaratne. My only
hope is that the beauty of Kashmir will inspire and not distract the delegates
who have gathered here.
The World Health Organisation is a unique organisation. It is perhaps
the best example we have of international cooperation for mutual benefit, an
example of the way in which the benign uses of science and technology can be
harnessed for furthering the welfare of the vast millions of people on this
planet. WHO has done remarkable work in many fields; the eradication of
smallpox is only one of the more dramatic of these achievements. In a
great number of fields of communicable-disease control projects, research,
manpower training and so on, WHO is doing continuing service to the world
community. The South-East Asia Region, to which we belong, is particularly
important. It has almost a billion people now - 950 million by the last count which is over 23% of the entire population of the world. Therefore, the deli
berations of this Regional Committee are of very special importance not only
because of the numbers involved but also because it consists of ten developing
nations, nations which are grappling with the problem of trying to provide
acceptable health services to the people.
I would like at the outset to commend the work of the Regional Director,
Dr.Gunaratne, his staff and office. I find that they have brought a good deal of
dedication and imagination to bear upon the problems of this Region, to pro
mote and develop expertise within the Region, the setting up of a Regional
Advisory Committee on Medical Research and the furthering of inter-country
cooperation. I hope that the Regional Committee will continue to strengthen
and deepen its efforts in all these fields.
The theme for your conference this year is Nutrition Programmes
and Health, and this leads straight to the heart of the new health philosophy
that we are moving towards in this country and in other countries. Dr. Mahler,
the enlightened and dynamic Director-General of the World Health Organisation,
in his message has rightly pointed to the importance of accepting certain
social goals, and it is in furtherance of these social goals that the new health
philosophy is beginning to develop. I would like to take the opportunity this
morning, Mr. Chairman, to say a few words upon what we think are the broad
lines on which this philosophy should develop, revolving around the basic
concept of integration.
If the philosophy is to be summed up in a single phrase I would call
it an integrated philosophy of health; and I would like to spell out, rather
briefly, what I mean by this integration. The integration takes place on
several levels. First, the very concept of health itself must be widened
much more than it has so far. There are three very clear aspects of health.
There is the promotive and preventive aspect, there is the curative aspect,
and there is the rehabilitative aspect. So far health has been considered
to be co-terminus with the curative aspect. When you talk of health, people
usually think only of hospitals, in other words of ill-health. It seems to
me that ours are more ministries of illness than ministries of health. We
have got to move into a larger, broader definition of health. Health is not
merely morbidity or its absence. Health is a positive concept which implies
the promotive aspect of health, community health, preventive health, the
restructuring of medical education in order to give necessary importance
to community health. We produce very good specialists but, unless we are
able to prevent morbidity, we can convert our whole nation into vast hos
pitals, and still never be able to meet the health needs of our people.
We have got to fight the enemy on his ground, and this requires a
re-orientation of our entire approach. All the plums of health today go to
the brilliant clinicians. What about the public health man? What about
the person who is working in the villages and slums ? He hardly ever gets
any recognition. It is important,therefore,that the promotive and pre
ventive aspects of health receive much higher importance and priority
than they have done so far; this includes, of course, the whole gamut of
health education, starting from the primary school level, the involvement
of the community and of the voluntary agencies in the work of health edu
cation and promotion and a general national campaign of physical fitness,
because unless we are able to build up the bodies of our younger generation
it will not be possible for them to develop the resistance to disease that
is required.
Along with preventive and promotive health, of course, our
massive campaigns against communicable diseases have got to continue
with increased vigour, whether it is malaria or filariasis, leprosy,
tuberculosis, sexually transmitted diseases or any other. I think we can
learn a great deal from the experience of the smallpox eradication campaign,
both as far as the methodology is concerned and the general organisational
pattern. Therefore,the first aspect is the preventive and promotive side
of health.
Then there is the curative aspect and here we are moving towards
a three-tier system. The first is the primary health centre downwards.
As you know, in our country the primary health centre is our rural hos
pital, our rural outreach. Each primary health centre has at least two,
if not three, M. B. B. S. doctors, and an input of X-ray machine and
dentist's chair and various other operative equipment. Each primary
2
health centre has 6 to 8 sub-centres which will now be manned by a new cadre
of Health Assistants which we are developing. Below that, we go to t e vi lage
level, where we have a national programme now to involve not only the village
school teacher, but also the village postman, the traditional village midwife
and the gram sewak or the agricultural extension worker. We see o mvo ve
these four categories of functionaries at the village level so that our outreach
is able to cover the rural areas where the vast majority of our population
lives. I am sure that in each one of the ten countries represented in this
South-East Asia Region, the vast majority of population lives in rural areas,
and it is only by developing an effective rural outreach that we will be able
to cover their problems. The first tier goes upto the primary health centre,
beyond that are the 30-bed referral hospitals, the district hospital and the
medical college hospitals; and finally on top are the metropolitan hospitals
and the super-speciality institutions. This three-tier system of curative
health is what we are now trying, with our limited resources, to develop.
Then we come to the rehabilitative aspect, both the mentally and the
physically handicapped. So far all we do is to treat them and to send them
back to the community without any follow-up, without any way of ensuring
that they can go back as useful and creative members of the society. You
can cut off a limb, you can cut off an arm or a leg and then you just send the
person back, and sometimes he is so badly off after he gets back to the com
munity that one wonders whether it would not have been kinder to let the man
die earlier rather than to make him a cripple and to send him into the com
munity with no follow-up. In leprosy, in orthopaedic cases, in various other
types of physical and mental handicaps, this is a tremendous lacuna in our
system and I think the time has come when we have got to give some thought
to the rehabilitative aspects of health.
So the first level of integration is in promotive, curative and re
habilitative health. The second level of integration is the combined package
of health, family planning and nutrition that we are attempting to take to the
doorstep of every citizen. Health I have already covered. Over-population
is one of the major problems in this region, and in fact is very often the
cause of low living standards, of morbidity and mortality, particularly of
child mortality. Therefore,in countries like ours over-population itself
constitutes a major health hazard. In order to meet this we have come
out with a remarkably inclusive and integrated National Population Policy
which will be circulated at this meeting and could be of some value perhaps
to other countries in the development of their policies. This National
Population Policy lays special emphasis upon maternal and child health
because child mortality is a direct cause and a direct function of over
population. It is only when we can cut down child mortality and morbidity
drastically, that our population rate of growth will also come down
3
Then there is nutrition. Nutritional inputs, particularly to pregnant
and lactating mothers, to infants and to small children are absolutely essential
if their welfare is to be ensured. The first 3-5 years, including the period of
pregnancy, are the most critical in the development of the mind and body of the
child, and if a child is deprived of adequate nutritional inputs in this period,
his body and mind will remain warped for the rest of his life. It is a tragedy
and a disgrace to all of us that in our countries millions of children do not get
adequate nutritional inputs. How are we going to build the world of our dreams
if we cannot ensure to our children at least the minimum inputs that are necessary
for the body and the mind to grow? This, therefore, is a problem which has
got to receive the highest priority, and I am happy that it has been chosen as the
theme of technical discussion at your meeting. This will involve a change of
eating habits and cooking methods. A lot of nutritive value is wasted simply
because of ignorance and because of wrong methods of preparing foods. There
is this question, for example, of white bread. If I had my way I would ban white
bread totally and force people to have brown bread, it is so much more delicious
and so much more nutritive. And yet we polish the nutrients out of our bread.
We polish the nutrients out of our rice and we polish the nutrients out of our
sugar. We have some fixation about whiteness which I do not understand. We
must have white rice, white sugar and white bread - all three of which are
systematically and scientifically deprived of their nutritive value before they
are given to our children and to our people. I think we need a revolution here
also. We must break away from the mode of behaviour that we have inherited
as a result of a long period of colonial exploitation, and begin to develop our
own insights into these problems and see that the eating habits and the cooking
habits of our people are creatively adapted in order to ensure greater nutritive
input.
Then, of course, there are the special feeding programmes that are
required because, howsoever well and scientifically we may cook, there are
vast number of people who simply do not have the wherewithal to get the
minimum nutritional inputs. The UNICEF Representative is here; they are
doing valuable work as are various other organisations - UNDP for example
and others - but very much more needs to be done. The feeding programme,
ideally, should be based upon locally available food. This whole syndrome
of elaborately-packaged baby foods also, if I may submit, is something which
may suit a developed and an affluent society, but which will never have
massive application as far as the countries in our Region are concerned. We
have got to develop locally available foods and we have to develop a system
whereby these can be given to the most vulnerable sections of our society.
Malnutrition is a major cause of morbidity and of mortality, and it is indeed
ironic that while there are millions in this world who are under-fed, there
are hundreds of thousands who die of over-eating. This once again highlights
the unacceptable maldistribution of global resources, particularly in such
basic and essential commodities as food and nutritive inputs. This,therefore,
is the second level of integration - between health, family planning and
nutrition. These have got to be integrated into a package and delivered to
the most remote rural areas.
4
A third level of integration resolves around the modern system of
medicine and the traditional systems of medicines. The WHO now is begin
ning increasingly to appreciate the importance and value of traditional
systems of medicine. There was a time when it was thought that the only
system of medicine that worked was the so-called allopathic system, but
that particular stage of arrogance has now passed. Certainly the achieve
ments of modern medicines have been nothing short of fantastic - the
development of antibiotics, the advanced surgical techniques and so on.
Nobody wishes to denigrate them, but it is also clear that there are a lot
of insights in the traditional systems of medicine. We do not want to moves
on to an over drug-oriented, over surgery-oriented system. You remember
Ivan IHich's thesis on iatrogenic disease, disease caused by doctors. I do
not want to go into that particular controversy because there are so many
distinguished doctors present this morning, but the fact remains that over
drugging and unnecessary surgery have become increasing features of the
affluent society, and in our country we simply cannot afford this. It is,
therefore, useful and valuable if we are able to get the insights of the tradi
tional systems of medicine.
In India, for example, we have Ayurveda the science of life, which
is a system going back at least to 5000 years, and is incorporated in a number
of texts in this country which has some remarkable effects; there is Siddha
which is the Tamil version of Ayurveda and which also has got a lot of very
interesting approaches; there is the Unani system named after the Greeks
but which came to us through the Arab world though, I think it has disappeared
from the Arab world.
In India we are still actively encouraging it; we have hospitals and
dispensaries for all these systems. There is homoeopathy, which was born
in Germany but which was banished from the continent of its birth; that also
came to India and today thousands of people are deriving benefit from it.
There is naturopathy and there is our new attempt through naturopathy, in
coordination with other systems of medicine, to have a combination therapy,
and there are several health aspects of yoga. All these constitute a tremen
dously valuable cultural heritage. I would urge that our Region should take the
lead in trying to develop a working relationship between these various systems
of medicine; ultimately all systems of medicine must be based around the
concept of human welfare, and there is no reason whatsoever why we should
give up insights that have been developed in our nations for centuries.
The final element of integration that I would like to talk about is the
integrated approach to the human being - the human body, the human mind
and, if you like, the human spirit. Man is more than simply a body; there
are physical, there are mental and there are spiritual aspects of the human
-,
personality. One of the weaknesses of the western approaches so far has
been the artificial dichotomy that has been imposed, trying to make a distinction
between the body and the mind. I would submit that what is required is a holistic
approach, an integrated approach to the human being. You cannot disassociate
the body, the mind and the spirit; you have to deal with the entire human being
in his cultural milieu within his intellectual background, with his hopes, his urges
and his aspirations. Human beings can no longer simply be looked upon as
interesting clinical material. They are more than that. They are human beings,
they are people of flesh and blood with fears and hopes and aspirations. There
fore,any system of medicine, and any approach of an enlightened body like the
World Health Organisation, has got to realize these dimensions of the human
personality. This brings me, in passing, to a subject which is of particular
interest to me, and that is this whole field of consciousness research. So far
we have assumed that consciousness is static and that everything happens within
its own base of a firm screen of consciousness. It is now becoming increasingly
realized that consciousness itself is dynamic, is kinetic, and this opens up a
totally new field of enquiry into the functioning of the human mind and the spirit.
We are on the threshold of exciting developments, as exciting as the latest
scientific work in unravelling the mysteries of the cosmos or the structure of
the RNA and the DNA molecules. This also is another level upon which our
approach has got to be integrated.
These are some of the levels of integration which are essential if we
are to have a comprehensive global health policy. In the developing world in
particular, Mr.Chairman and friends, in the developing nations in Asia, Africa
and South America, we have only one enemy and that enemy is poverty.
Malnutrition, disease, ignorance, iHiteracy, over-population, unemployment —
these are all aspects of poverty, and the time has come when our people are no
longer satisfied with remaining within the poverty barrier. This is a battle
which has now been joined; it is a battle which has got to be taken to a successful
conclusion, not in another 1000 years but in our very lifetimes before the end of
the century. It is unacceptable to the millions of people living in the developing
countries that they should be deprived ad infinitum of at least the basic essentials
of life, and in this tremendous adventure the health :nput is absolutely crucial.
Education is important, clothing is important, shelter is important, but health
perhaps is the most important of all; because you can have a beautiful house, you
can live in a palace, you can eat 20 different dishes, but you wiH not be able to
enjoy anything without good health. Health ultimately is the parameter of social
progress and of the status of any people. And, therefore, the WHO has a very
special role to play in this crucial moment in the destiny of the human race.
Mankind today is at a crossroad. Science and technology has given man the
power, if used wisely, to abolish poverty, want, ignorance, disease and illiteracy
from the face of the earth. If the same power is misused it can destroy not only
the human race but all life on this planet. We, who are working in the field of
wealth, are privileged because we are on the side of the forces of harmony, the
orces of progress. We must have before us a glowing vision of humanity, a human
•ace in which every single child born into this world, regardless of nationality or
colour or creed or religion or any other category, is ensured the minimum inputs
that are necessary for a healthy development of the body, the mind and the spirit.
It is dedicated to this broader vision of the future of humanity that I have greatest
pleasure in inaugurating this Conference.
6
5
thThnJ h’+k11 ^n^e®ra'"e<^ aPPr°ach to the human being. You cannot disassociate
y, the mind and the spirit; you have to deal with the entire human being
in 1S. C U.1
within his intellectual background, with his hopes, his urges
and his aspirations. Human beings can no longer simply be looked upon as
interesting clinical material. They are more than that. They are human beings,
t ey are people of flesh and blood with fears and hopes and aspirations. Therefore,any system of medicine, and any approach of an enlightened body like the
World Health Organisation, has got to realize these dimensions of the human
peisonality. This brings me, in passing, to a subject which is of particular
interest to me, and that is this whole field of consciousness research. So far
we have assumed that consciousness is static and that everything happens within
its own base of a firm screen of consciousness. It is now becoming increasingly
realized that consciousness itself is dynamic, is kinetic, and this opens up a
totally new field of enquiry into the functioning of the human mind and the spirit.
We are on the threshold of exciting developments, as exciting as the latest
scientific work in unravelling the mysteries of the cosmos or the structure of
the RNA and the DNA molecules. This also is another level upon which our
approach has got to be integrated.
ion
Stic
These are some of the levels of integration which are essential if we
are to have a comprehensive global health policy. In the developing world in
particular, Mr.Chairman and friends, in the developing nations in Asia, Africa
and South America, we have only one enemy and that enemy is poverty.
Malnutrition, disease, ignorance, illiteracy, over-population, unemployment these are all aspects of poverty, and the time has come when our people are no
longer satisfied with remaining within the poverty barrier. This is a battle
which has now been joined; it is a battle which has got to be taken to a successful
conclusion, not in another- 1000 years but in our very lifetimes before the end of
the century. It is unacceptable to the millions of people living in the developing
countries that they should be deprived ad infinitum of at least the basic essentials
of life, and in this tremendous adventure tire health input is absolutely crucial.
Education is important, clothing is important, shelter is important, but health
perhaps is the most important of all; because you can have a beautiful house, you
can live in a palace, you can eat 20 different dishes, but you wiH not be able to
enjoy anything without good health. Health ultimately is the parameter of social
progress and of the status of any people. And, therefore, the WHO has a very
special role to play in this crucial moment in the destiny of the human race.
Mankind today is at a crossroad. Science and technology has given man the
power, if used wisely, to abolish poverty, want, ignorance, disease and illiteracy
from the face of the earth. If the same power is misused it can destroy not only
the human race but all life on this planet. We, who are working in the field of
■ealth, are privileged because we are on the side of the forces of harmony, the
trees’of progress. We must have before us a glowing vision of humanity, a human
•ace in which every single child born into this world, regardless of nationality or
colour or creed or religion or any other category, is ensured the minimum Inputs
that are necessary for a healthy development of the body, the mind and the spirit.
It is dedicated to this broader vision of the future of humanity that I have greatest
pleasure in inaugurating this Conference.
/
6
Uppsala County and, the organization for the mentally retarded.
Uppsala County has about 200.000 inhabitants.
It is divided in 5 primary-communes among whi-chitjie city of
Uppsala and its surroundings are the greatest with about 110.000
persons.
The County Council is by a law from 19&8 responsible for organiza
tion and finances for education, training and care of the mentally
retarded. There is in every county a special committee "Omsorgsstyr-
elsen", though which the County Council has to organize the aktivities
for the mentally retarded.
Education and training (special schools).
Number.
A.
Preschool^ (kindergarten)
24
.4 groups for only mentally retarded
children in Uppsala and Enkoping
(not integrated). In some places
there is also a single child who
is integrated in groups for normal
children.
B.
GroundspecialschooIs (7-17)
126
In Uppsala and Enkoping and two
other places. This type of classes is
generally integrated in schools for
normal children. There are three special
schoolclasses in each normal school..
C.
Training school (7 - 17)
5&
New form of schools in Sweden (from
1968). At present there is only one
training school in the county. It is
at Rickombergaschool in Uppsala and
consists of 6 classes. Many of these
pupils live in boarding home during
the schoolweeks.
D.
Individual training (7 - 17)
Many of the children at The Childrens
Home of Care in Rickomberga (severe
mentally retarded children) get
29
Number
individual training or training in small
groups. There are also many children who
are living in their parents home and are
unable to come and train in the schodls.
They get training at home.
E.
Vocational training schools (18 - 21 year)
77
Are also a compulsory form of school. The
vocational training has very varied pro
grammes. Some pupils are able to be rather good
in easy manual industrial therapeutics. A part of
these pupils lives in group home or at an institution.
Most of them live in ..arents home.
Where the mentally retarded children live.fo - 21)
A.
Children who live at their parents or at another
families (20 of them get only individual training)
B.
"
C.
220
Grouphome in Uppsala
10
5
in Enkoping
At Rickombergaschool in Uppsala
Boarding home for small children
"
"
15
belongs to ground
specialschool and trainingschools 40
Hostel for severe mentally retard
ed children "Childrens Home of
Care'.'
39
B. Pupils from this county in other special
4
schools.
In these varies forms of schools 300 children and youths will be
educated and trained in the County-. If they are in need of continued
help in any way after 21 they will be recorded as adult mentally
retarded and the organization for the adults takes over.
Where the mentally retarded adults live (22 -)
Belong to
the "open
care"
• * With their parents
121
•
Homes of themselves
61
•
At homes of other peoples
41
•
Group home
45
In institutions
HSgaby cottages
"
residential homes
84
64
Group homes within H^gaby
10
Alby residential homes
51
Special hospitals (mentally
retarded + mentally ill +
complicated handicapped)
34
Institutions in other counties
36
What do the mentally retarded adults do?
Open market
(factories etc)
Sheltered workshops
67
36
Therapeutics within our insti
tutions (inclusive 30 persons
who live outside)
131
At present without therapeutics
98
Special hospitals + private
institutions
34 + 22
MEDICATION AS A SUBSTITUTE FOR CARING
Perhaps the biggest reason for overuse of medicines, however,
is that doctors and health workers often find it easier to hand out
medicine than to give the time and personal attention that people need.
About 4 out of 5 illnesses are self-limiting. This mean people'
get well whether they take medicine or not. Most health problems can be
better managed without any medication. What often will help people
most is friendly advice and understanding support.
However, many doctors and health workers get into the habit
of giving everyone medicine—for any and every problem they have.
The less curable the problem, the more medicines they give!
At the same time, people have come to expect medicine every
time they visit a doctor or health worker, •‘■'hey like to believe that
"there is a medicine for everything". They are disappointed if the
doctor or health worker does not give them any, even when medicines
will do no good and the health worker carefully explains why.
So a 'vicious circle' results in which the doctor always
gives medicine because the 'patient' always expects (or demands)
it, because the doctor always gives it. ihe prescribing of a medicine
becomes both the symbol and the substitute for human caring. This
problem is especially common in places where doctors nurses, and
health worker.-, are overworked, ^he result is not only a costly
overusedof medicine, but a failure to meet human needs on human terms.
—Helping Health Workers Learn
David Werner and Bill Bower.
News & Views
TATA PHARMA I MAKING
RAPID STRIDES | . i '
The new pharmaceutical ven
ture of the houseioj jTatasTATA PHARMA—a division of
Lakme Limited (see CIMS
Volume-11), recently com
menced marketing a! range of,
5 ethical and very mqderi) for
mulations.
Tata Pharma hav6 already
acquired land in Patalganga, a
notified backward area in
Maharashtra, apd are in the
process of setting up a bulk
drug plant for manufacture of
cetrimide, chloroquine di
phosphate, ethambutol and
some important drug interme
diates
MAY & BAKER DILUTING
EQUITY AND EXPANDING
May & Baker India Ltd. has
announced an expansion and
diversification programme
involving additional invest
ment of Rs.120 million to
increase production of exist
ing bulk drugs and to intro
duce their two new drugs —
KETOPROFEN (anti-arthritic)
and ACEBUTOLOL (anti
hypertensive).
The Chairman of May &.Baker
India Ltd , Mr. C.C. Chokshi,
recently announced that the
company would dilute its
foreign equity from 60% to
40% under the FERA.
LUPIN LAUNCHING MAJOR
EXPANSION AND DIVERSI
FICATION
Based on a technology agree
ment with the International
Minerals & Chemical Corpora
tion (USA), Lupin Laboratories
have promoted a joint venture
with the Gujarat Industrial
Investment Corporation (GIIC)
for the manufacture of
racemic 2-aminobutamol and
ethambutol. This Rs.75 mjlllon
project will be located at
Ankleshwar in Gujarat.
Lupin's new and modern
Rs.17 million formulations
facility at Aurangabad will help
raise the company's annual
turnover beyond the project
ed Rs.300 million by 1984-85.
Lupin is already manufactur
ing and exporting pharmaceu
tical machinery.
18
estrogen-progesTOGEN FIXED DOSE COM
BINATIONS OTHER THAN
ORAL CONTRACEPTIVES
BANNED
The Office of the Drugs Con
troller (India) has announced
a ban on fixed dose combina
tions of oestrogens with progestogens. other than those
used as oral contraceptives in
low doses.
The medical experts in the
country taking note of the mis
use of these preparations and
the action taken in many coun- .
tries to ban these prepara
tions, recommended their ban
in India. The experts have
pointed out that there are
substitutes available in the
country for the management
of secondary amenorrhoea
and similar gynaecological
disorders.
The ban becomes effective on
January 1. 1983 for manufac
ture and July 1, 1983 for
marketing these preparations.
14.
Hydroxyquinoline group
of drugs except those
used for diarrhoea and
'
dysentery.
15.
Prophylactic vitamins with *
anti-TB drugs except
combination of INH’with
Vitamin Ba.
16.
17.
18.
Amidopyrine.
Phenacetin.
Ergot except those of
ergotamine with caffeine.
The ban takes effect from
October 1. 1982 for manufac- •
turing and April 1,1983 for sale.
MANUFACTURE AND SALE
OF CERTAIN FIXED DOSE
COMBINATIONS
MADE
CONDITIONAL
|he Drugs Controller, India.
has released a statement of
certain categories of drug
combination. the manufacture
and sale of which will be sub
ject to certain conditions:
. 1. Combinations of caffeine
with anti-spasmodic drugs
provided caffeine is in
therapeutic dose
2.
Combinations of tetracyc- ■
line/oxytetracyciine in antiamoebic preparations, pro: vided the quantity of tetra
cycline is 125mg7dose
3.
Combinations of analge
sics. antipyretics and antihistaminics provided the
1.
Vitamins
with
antiformulation contains mini
inflammatory agents and
mum pharmacopoeal dose
tranquillisers.
of each.
2 Atropine in analgesics
4.
Combinations of antacids
and antipyretics.
with only those enzymes
3.
Strychnine and caffeine in
which are stable in pH over
tonics.
5 and where both such
4.
Yohimbine and strychnine
drugs are compatible in the
with testosterone and vita
same pH.
mins.
5.
Combinations of enzymes
5.
Iron with strychnine.
containingeitheronly those
arsenic and yohimbine.
stable in acid medium or
6.
Sodium bromide and
those stable in alkaline
chloral hydrate with other
medium.
drugs.
6.
Combinations of metroni
7.
Ayurvedic. Unani drugs
dazole with methylpolysilo
with modern drugs.
xane provided the dose of
8.
Anti-histaminicswithantithe latter is not less than
diarrhoeals.
25mg/dose.
9.
Penicillin with sulphona 7.
Combinations of pharma
mides.
copoeal drugs if they are
10.
Vitamins with analgesics.
already existing and only if
11.
Tetracycline with Vitamin
they are rational and hav
C.
ing minimum official dose.
12.
Steroids for internal use
unless evidence of syner
except those in combina
gism is available, backed
tion with other drugs for
by data
the treatment of asthma.
13.
Chloramphenicol except The State Drugs Controllers
have
been directed to n? . :^
those of chloramphenicol
and streptomycin
18 CATEGORIES OF FIXED
DOSE DRUG COMBINA
TIONS BANNED
The Drugs Controller of India,
based on the recorr)mendations of the Drugs Technical
Advisory Board. tia£ issued
directives for ban of the follow
ing:
Fixed dose combinations of:
j
- ------------- —»
ESTROQEN-PROGESTOGEN FIXED DOSE COM
BINATIONS OTHER THAN
ORAL CONTRACEPTIVES
BANNED
TATA PHARMA ! MAKING
The Office of the Drugs Con
RAPID STRIDES
’
troller (India) has announced
The new pharmaceutical ven
a ban on fixed dose combina
ture of the house of Tatas —
tions of oestrogens with proTATA PHARMA—a division of
gestogens, other than those
Lakme Limited (see CIMS
used as oral contraceptives in
Volume-11), recently com
low doses.
menced marketing a range of, The medical experts in the
5 ethical and very maderrj for
country taking note of the mis
mulations.
use of these preparations and
the action taken in many coun
Tata Pharma havd already
tries to ban these prepara
acquired land in Patalganga, a
tions, recommended their ban
notified backward area in
in India. Tho experts have
Maharashtra, and are in the
pointed out that there are
process of setting tip a bulk
substitutes available in the
drug plant for manufacture of
country for the management
cetrimide. chloroquine di
of secondary amenorrhoea
phosphate, ethambutol and
and similar gynaecological
some important drug interme
disorders.
diates.
News & Vjews
MAY & BAKER DILUTING
EQUITY AND EXPANDING
May & Baker India Ltd. has
announced an expansion and
diversification programme
involving additional invest
ment of Rs. 120 million to
increase production of exist
ing bulk drugs and to intro
duce their two new drugs —
KETOPROFEN (anti-arthritic)
and ACEBU1OLOL (anti
hypertensive).
The Chairman of May 8 Baker
India Ltd., Mr. C.C. Chokshi.
recently announced that the
company would dilute its
foreign equity from 60% to
40% under the FERA
LUPIN LAUNCHING MAJOR
EXPANSION AND DIVERSI
FICATION
Based on a technology agree
ment -with the International
Minerals & Chemical Corpora
tion (USA), Lupin Laboratories
have promoted a joint venture
with the Gujarat Industrial
Investment Corporation (GIIC)
for the manufacture of
racemic 2-aminobutamol and
ethambutol. This Rs.75 million
project will be located at
Ankleshwar in Gujarat.
Lupins new and modern
Rs.17 million formulations
facility at Aurangabad will help
raise the company’s annual
turnover beyond the project
ed Rs.300 million by 1984-85.
Lupin is already manufactur
ing and exporting pharmaceu
tical machinery.
18
The ban becomes effective on
January 1, 1983 for manufac
ture and July 1, 1983 for
marketing these preparations.
Hydroxyquinoline group
||
of drugs except those
*
used for diarrhoea and
?
dysentery.
15.
Prophylactic vitamins with ”
anti-TB drugs except
combination of INH’with
Vitamin Ba.
14.
16.
Amidopyrine
17.
Phenacetin.
18 Ergot except those of
ergotamine with caffeine.
The ban takes effect from '■
October 1. 1982 for manufac- \
turing and April 1.1983 for sale. ’
MANUFACTURE AND SALE
OF CERTAIN FIXED DOSE
COMBINATIONS
MADE
CONDITIONAL
|he Drugs Controller, India,
has released a statement of
pertain categories of drug
combination. the manufacture
and sale of which will be sub
ject to certain conditions:
Combinations of caffeine
with anti-spasrnodic drugs
provided caffeine is in
• therapeutic dose
2,
Combinations of tetracycline/oxyletracycline in antiamoebic preparations, pro
vided tiie quantity of tetra- ;
cycline is 125mg/dose.
3.
Combinations of analge
Fixed dose combinations of:
sics, antipyretics and anlihistaminics provided the
1.
Vitamins
with
anti
formulation contains mini
inflammatory agents and
mum pharmacopoeal dose
tranquillisers.
of each.
2.
Atropine in analgesics
4.
Combinations of antacids ’
and antipyretics.
with only those enzymes ■
3.
Strychnine and caffeine in
which are stable in pH over
tonics.
5 and where both such
4.
Yohimbine and strychnine
drugs arc compatible in the
with testosterone and vita
same pH.
mins.
5.
Combinations of enzymes
5.
Iron with strychnine.
containingeitheronly those
arsenic and yohimbine.
stable in acid medium or
6.
Sodium bromide and
those stable in alkaline
chloral hydrate with other
medium
drugs.
6.
Combinations of metroni
7.
Ayurvedic. Unani drugs
dazole with methylpolysilo
with modern drugs
xane provided the dose of
8.
Anli-histaminics with antithe latter is not less than
diarrhoeals
25mg/dose.
9 Penicillin with sulphona
7.
Combinations of pharma
mides.
copoeal drugs if they are
10. Vitamins with analgesics.
already existing and only if
1 I. Tetracycline with Vitamin
they are rational and hav
C.
ing minimum official dose.
12.
Steroids for internal use
unless evidence of syner
except those in combina
gism is available, backed
tion with other drugs for
by data.
the treatment of asthma.
13.
Chloramphenicol except The State Drugs Controllers
those of chloramphenicol
have been directedto iinr-Je-.
and streptomycin-'
18 CATEGORIES OF FIXED
DOSE DRUG COMBINA
TIONS BANNED
Tho Drugs Controller of. India,
based on the recommenda
tions of the Drugs Technical
Advisory Board, fiai issued
directives for ban of the follow
ing:
1.
LOCOST
Low Cost Standard Therapeutics Project
( a collective voluntary endevour for rational therapeutics
through promotion of low cost, quality, generic-named medicine )
Our Ref No.
Your Ref No.
P/0AMIL PVT. LTD.
K G. P. 0 Box 7,
i
BARODA-390 001.
6
I
Dear
All of us involved in voluntary health services
have felt the need for the introduction of rational
theraputics and having low cost standard generic
drugs. However, the issue has po far remained a
laudable theoretical study and Critique. The hard
option of practical experiments to make it a reality
is still unattended. The present project is
planned and started to fill ip this gap.
For the last five year? VHAI and GVHA (Dr.Doshi
and Dr. Ashvin Patel) were -joying with the idea of
starting a project under voluntary sector to
provide low cost quality drugs for rural and deprived
mass of the society. You ?iave already received
communication.regarding LQDOMP project which has
finally shaped into LOCOS? (Low Cost Standard Theraputics).
Bangladesh has taken lead in this field by starting
'Gonoshasthya Kendra1 under low cofit health care
voluntary sector. The unit manufactures and supplies
low cost generic rational drugs to the masses.
In India we have sufficient expertise to plan
such project but to get involved people and evolve
a group with vision of community health, management
capabilities, undettered commitment and honesty is
extremely difficult. Fortunately the idea has
progressed tremendously in last few months. We
have now a group of individuals who are committed to
make this project a top priority in their activities.
We are ready with LOW COST STANDARD THERAPUTICS
(LOCOST) Project.
’The project proposal is worked out in detail
with precision. We are approaching international
funding agencies to help this endeavour. We are
confident to have sufficient financial aid within
six to eight, months. In the mean time, it is decided
-2-
to keep the group together and march forward
with funds generated in the form of deposits or
loans from friends and partners. The initial
deposits of Rs.30,000.00 is already arranged and
the project has started functioning from 1st August,1983.
We plan to supply your ordered drugs from
1st October, 1983. At this stage of project,
we plan to.procure quality drugs and get them
tested at approved standard laboratory, stock
these tested drugs at a unit which is committed to
work for LOCOST project without any commercial
consideration of profits and dispatch them to our
valued partners.
Our limitation for first few months will be
availability of finance. We request you all
partners to come forward with your cooperation in
any of the following forms 1.
2.
3.
4.
Interim loan to the LOCOST for six months
Donations
Advance towards your orders •
Immediate payment of your ordered goods
In the beginning we shall provide only -21drugs which we shall gradually increase to -69- total'
selected drugs. Our LOCOST representative will visit
you as soon as possible to explain our work conditions
and obtain your cooperation.
Thanking you,
Yours truly
LOCOST PROJECT
Dear Sir,
We request you to fill in your order for the
understated drugs with the time of delivery after
2nd October, 1985
Sr. Name of drug
No.
Form
1.
Ampicillin
Cap,
2.
Aspirin
Ohioremphenicol
Tab.
Cap.
Chlorpheneramine
meleate
Ohiorphromazine
Tab.
3.
4.
5'.
6. , Chloroquin
7.
8.
Co-trimoxazole
Di-iodohydroxyquinolin
Tab.
Tab.
Tab,
Tab.
9.
10.
Ephedrine
Ethambutol
Tab,
Tab
11 .
Ferrous Sulphate &
Folic Acid
Tab,
12.
Frusemide
Tab
13.
14.
Mebendazole
Metronidazole
15.
16.
Nitrofurantoin
Tab
Tab
Tab
Paracetamol
Penicillin V
Sulphadiazine
Tab
Tab
Tab
Tetracycline
Cap
Rifamicin
Vit.A
Cap
Cap
17.
18.
19.
20.
21 .
Qty.
Period of
ordered delivery
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 :
: 3 :
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 ous approach in low
cost appropriate health care.
of wasteful spending invariably falls on the poorest, as
the rural dispensaries run 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 tranquilisers, 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:
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 would 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 prescribed 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
2)
Drugs freely promoted in the absence of distribution controls
can be dangerous
- The trickle down effects of uncontrolled drug marketing
in the absence of an adequate 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-
: 2 :
: 3 :
and out of debt with money lenders, t-ducation 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.
of wasteful spending invariably falls on the poorest, as
the rural dispensaries Tun 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 tranquilisers, 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:
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 would 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 orescribed 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
2)
Drugs freely promoted in the absence of distribution controls
can be dangerous
- The trickle down effects of uncontrolled drug marketing
in the absence of an adequate 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 reading list of books
and material related to low cost appropriate health
care.
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).
Followirig were the relevant factors to be considered for any
system of distribution of drugs :
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 2
The Primary
Committee
purposes
a.
Advisory
b.
Educational
the
of
Pharmacy
and
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 meoical 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.
E.
To recommend additions and deletions from the list ot
drugs accepted for use in the hospital.
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
of
the same
basic
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
to
periodically 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-11001 6
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 commerical enterprise, the motivation being profit rather
than "service1' 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 this issue of dumped
and hazardous drugs.
SOME BANNABLE DRUGS - 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 D.rug Technical
Advisory Board (DTAB) and the Ministry of Health 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. Most 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 formulatios". 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
uv the Drug Controller of India to the Voluntary Health Associa
tion of India).
Gazette Ambiguities
It is not ciear rrom 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 choice
is ours — and we must make a decision now.
at-
Third World Network
87 Cantonment Road, Penang, MALAYSIA.
M-139 Goa Housing Board Colony, Alto-Betim 403 112, INDIA.
Date: 6th November 1985.
Dear Friends
The TWN would like to bring to your attention the following
'Action Alert' from D. Rajeandran, Secretary of Sahabat Alam
Malaysia (SAM) and Coordinator of the Asia-Pacific People's
Environment Network (APPEN).
a£'ERT:
UN consolidated list of products
This is in response to an urgent request for support from
the Coordinating Committee on Toxics and Drugs in the United
States with regard to the United Nations Consolidated List
of Products Whose Consumption and/or Sale Have Been Banned,
Withdrawn, Severely Restricted or Not Approved By Governments.
On the 10th of April this year, we had circulated an action
alert to you all calling for support of this important
campaign which concerns all of us.
Unfortunately, we had not
heard from-a number of you, but we hope that this time you
will all respond towards this -crucial matter in the., spirit
of solidarity.
Remember that it costs us a lot of time and
money to circulate more than 1,000 copies around the world.
If we ourselves are not concerned, then nobody will be on
the fate of the earth and mankind.
Yes, coming back to the Consolidated List, we are sure you
all are aware that it contains- critical information on regu
latory decisions, restrictions and bans taken by national •
governments on more than 500 hazardous products.
It has
just been revealed that trade names and manufacturing data
will most likely not be part of the 1986 version.
The trade
name index which is so useful to NGOs will thus disappear.
With reference to the 1986 edition of the Consolidated List,
the actual collection, screening and processing of the
relevant data will now be carried out by the World Health
Organisation for pharmaceuticals while the United Nations
Environment Programme will be concerned with pesticides and
industrial chemicals. What is interesting to note is that
the UN Centre on Transnational Corporations, which was
actively involved in the previous two editions of the
Consolidated List, is not included in the multi-agency
negotiations.
Other substantial changes include the deletion of all
pharmaceuticals that have been banned because they are
useless.
There are other changes as well, most of which
we feel appear to cater more to industry's wishes th.an to
address consumer, health and environmental concerns.
In
pure political terms, the LIST is more vulnerable now as
the United States, the primary opponent of the LIST has
significantly more control and influence over the multi
agencies .
2
We need your undivided and continued support for the
Consolidated List which may otherwise be considerably
weakened.
WHAT YOU CAN DO:
Write to the UN Program Planning and Coordination office
in support of the LIST, but also to introduce yourself
to the new director, Mr Luis Gomez.
Ask the office to
continue to include trade data as it is mandated to do
by the original 1982 UN resolution, "Protection against
products harmful to health and the environment."
The address is
1.
Mr Luis Gomez
Assistant Secretary General
United Nations
DIESA - Program Planning and
Coordination Office
DC 2, 18th Floor
New York, NY 10017
USA
2.
■
Write to the UN Centre -on Transnational Corporations
to express your support for their efforts.
Send any
trade data (that you have not sent previously) directly
to the UNCTC to assist them in their work.
Urge your
government officials as well to submit trade data
directly to the UNCTC, Thejaddress is
Mr Peter Hansen
Executive Director
UN Centre on Transnational Corporations
DC 2, 12th Floor
New York, NY 10017
USA
3.
Continue to send all official information on bans and
restrictions of pesticides, pharmaceuticals, industrial
chemicals and consumer products to the United Nations
Program Planning and Coordinating Office in New York.
The UN office will then mail your information to the
appropriate agency, but we feel that it will be -wiser
for us as NGOs to continue the practice of going through
one central office, to effectively monitor what is being
sent.
The address is
Ms Eileen Nic
Project Coordinator
Coordinating Committee on Toxics and
Drugs
Natural Resources Defence Centre
122 East 42 St
New York, NY 10168
USA
4.
As the World Health Organisation and the United Nations
Environment Program are playing a new, p i votal role
this year with respect to the LIST, we must let them
know that NGOs support a readable, comprehensive
document.
By writing to them to explain that you have
been following the work,on the CONSOLIDATED LIST and
that you will continue to be helpful and supportive,
you can make it clear that we are taking our mandate
very seriously.
The addresses of those agencies are
Mrs Inger Brugen'ann
Director of External Coordination
World Health or3an;i-sation
20 Avenue Appia
1211 Genova
3
Mr Jan Huismans
Director
IRPTC/UNEP
Palais des Nations
1211 Geneva 10
SWITZERLAND
5.
Many governments may not know the agreement to delete
trade data from the 1986 version of the LIST or that
other changes have been made.
If possible, speak with
or write to government officials to express your con
cern about the new arrangements.
If your country is
supportive of the LIST, ask that it make that support
known through the UN mission or directly to the Program
Planning and Coordination Office and request that it
also provide data on bans, withdrawals and severe
restrictions to the United Nations.
6.
If you know of any case where use of the UN CONSOLIDATED
LIST has resulted in new regulations on pesticides,
pharmaceuticals or consumer products or has actually
saved lives, prevented injury or resulted in some
positive change in your country, please let the Coordi
nating Committee on Toxics and Drugs and
ted
Nations know about it.
The information is /
Qto coun
ter allegations that the LIST serves no role for
governments.
7.
As postage by air to all organisations is exorbitant,
we will bo grateful if you can reproduce this APPEN
ACTION ALERT and circulate it to all concerned groups
in your country.
8.
Finally, do keep us informed of your activities and
don't forget to
send us copies for our follow-up
reference.
We thank you and hope that we dan continue to work together
in future campaigns of
.interest.
Note; Please send carbon copies of all your letters and
cables to 3
THIRD WORLD NETWORK
M-139, Goa Housing Board Colony,
Alto-Betim 403 112, Goa.
for transmission to Malaysia and follow up action.
Carbon copies on air-mail (thin) paper preferred.
FEDERATION CF MEDICAL REPRESENT AT IVES 1 ASSOCIATION CF INDIA.
372/2, Russa Road. (East)
Calcutta - 700033
Nate on the Brand. .List of Banned Drugs
In pursuance of the brand list of banned drugs as prepared
and circulated by VHA.I following list is prepared after investiga
tion in the market of Eastern India. It was surprisingly observed
that most of the companies have either withdrawn their products ex
changed the formulations without any official information. Active
sales promotion of all these products except the steriods have
been stopped.
Details of the drugs of Class I is enclosed.
Class II
0/0/4 Tonizal — Caffine has been withdrawn from the drug
Vitahest:
Hoechst - is to be added in this group.
13/9/8
-
Phenacetinin has been withdrawn fran all the
drugs enlisted.
15/0/0
-
Bistrapen, Bistrapen Forte, Crys- 4, Qnnymycin
are available. Other drugs are not marketed
7/0/0
-
Analgin of all brands and combinations are
available.
14/0/0
-
Rans-trepcol - withdrawn. A leading brand
'Strepto Parasin
*
of Boerhringer Knoll is to
be included in the list.
-
E.P. Drugs, Clioquinols, Phenyl butaone, Qxyphen .
butazone and Analbolic Steriods are all available.
-
Amitava Guha
Si. No.
Brand / Comp,any !
Not |
marketed'
Available'
To,be added
in the list
Changed
1
1
2/1/1
7
Alergin
Aristopyrin
7
„._L
7
Cibalgin
!
Nee-spnsmindon
7
y
Esgipyrin
7
Dolorindon
v
Opt al in on
7
7
Qripyrin
Pyrindon
7
Spasmindon
7
Uni-S pasm
7
S pasmo-C lb algin
\/
Veganin
Dolviron
7
Codopyrin
-7
Apidin
v
Trevpel
5/2/2
x/
Placid in
S pasmo- Pc oxivon
J
SudhinolrM-C
'■/
Tylinol
i
Wai ages ic
V
Diligan
7
*Duodil
J
Equagesic
7
J
Spndmolysin
7
i ,
1
Prydonal
1
Art is pasmin
f
6/3/3
NEWSLETTER OF THE LOW COST DRUGS
AND RATIONAL THERAPEUTICS CELL
VOLUNTARY HEALTH ASSOCIATION OF INDIA C14 COMMUNITY CENTRE SDA NEW DELHI 110016
NEW DELHI Oct
23
1983
A With this issue of what was so
far simply the "Drugs Newsletter"
we introduce a new, and we hope
more attractive format for the
humble two page leaflet that
served as our forum for exchange
of news and views.
We have been painfully aware of
the irregularity of its appear
ance and this is one of the
shortcomings that we are deter
mined to overcome. So that at
least once in two months there
is a review and sharing of the
activities of the network.
One of the reasons for giving
the newsletter this shape and
style is to try and reach more
people through the efforts of
the existing networkers, who
will hopefully circulate it to
their friends - in fact we can
send extra copies on request or
directly to individuals or groups
whose names and addresses you
send us.
•
And so for those who have just
come into the network, the story
so far :
What we have called today,rather
tentatively "The Drug Action
Network" began for most of us
with an informal and exciting
three day meeting in Pune in
January 1982 where 28 partici
pants representing various
interest groups already involved
in drugs and health met to pool
their efforts in discussing pro
blems and finding solutions to
them. The individuals and groups
included doctors, pharmacologists,
consumer education groups, jour
nalists, documentation centres,
management experts and other
professionals.
Problem areas were defined and
action plans drawn up. It was
decided to launch a concerted
nationwide campaign against the
widely misused high dosage
estrogen-progesterone combina
tion drugs on March 8, 1982,
International Women's Day. It was
in a sense, a test balloon for
the network. The campaign was a
success both in terms of public
awareness as well as the response
from the government, which finally
banned the drugs. The scene of
this battle has now shifted to
the courtroom with the drug
companies challenging the ban in
the High Courts. xSee "The Case
Against EP Forte")
Drug Workshop I ( Pune ) was
followed by Drug Workshop II at
Jaipur in August 1982. The issues
selected for the workshop inclu
ded
- follow up of EP Forte
campaign
- misuse of anti-diarrhoeals ,
anabolic steroids,
clioquinol,
ped. tetracycline.
- banning of drugs
- need for a code of ethical
marketing for the companies'
- the events in Bangladesh,
the new drug policy,etc.
within the network. We hope that
the present attempt will rein
force these efforts.
It has been suggested that the
drugs network should be given
a proper name by which it can
be identified. This would be one
way of emphasising the collective
character of our action plans,
which should not appear to be
diffused as the efforts of indiv
idual do-gooders.
What do you think of this
suggestion? If you agree, what
would you suggest for a name?
Or is "Drug Action Network"
good enough?
Various members of the network
again assumed responsibility for
different facets of the follow
up action.
Please write in your feedback.
Together with news from your
point of view.
Since then the "Drugs Newsletter"
and various cyclostyled papers
on different issues from members
of the network have been the
chief means of communication
That's what this newsletter
is all about, anyway.
network rnows
l&Ms Kapila Hingorani who has
been working on some of the legal
aspects of health issues has got
a group of NSS students from
Delhi involved in the drugs issue
as part of their project work.
Shebani and her friends from
Lady Sriram College have been
compiling and collating inform
ation on the banned drugs.
afe-Aspi Mistry who was formerly
with the Centre for Education
and Documentation in Bombay and
one of its founder-members has
joined VHAI since July 1983. He
is based in Dehradun with the
Low Cost Drugs and Rational
Therapeutics Cell and will be
working with Mira Shiva from
there. For all future corres
pondence their address is :
4^-Vincent Panikulangara1 s writ
petition in the Supreme Court
was due to come up in October for
hearing. In this petition (No.3492
of 1983) he had asked for a writ
of mandamus directing the govt.
105 Rajpur Road
D ehradun
U.P. 248 001
Tel : 23374
2
Xth MFC ANNUAL MEET
As announced in the last issue, the Xth MFC Annual Meet will
take place in January-end 1984. The dates and the venue have been
finalised-27th to 29th January, 1984 at the Child In Need Institute
(CINI) at Calcutta, West Bengal. We are thankful to Dr. Samir
Choudhary, the Director of CINI for offering to help organize the MFC
Meet at CINI. There are many socially conscious medicos in W. B.
But so far we never had an Annual Meet in that region. By arranging
the Meet near Calcutta, we hope to contact other socially conscious
medicos in West Bengal.
Theme fur discussion : The first two days of the meet will be
devoted to the discussion on “ Why alternative medical education is
necessary?’’ The Third-day will be reserved for the Annual General
Body meeting of MFC. There has been a strong feeling among MFCmembers and like-minded people that the existing medical education
is inappropriate. Tn fact, one of the founding inspirations of MFC has
been the realization of the irrelevence of the medical education to the
needs of the rural poor. But we have not so far discussed systematically
and in detail, as to what is exactly wrong with the existing medical
education, why an alternative is necessary ? 1 he aim of the two days ’
discussion at the coming Annual Meet would be to build a strong
case for an alternative medical education by showing in some
depth the inappropriateness of the existing medical education.
As usual, some background material and the discussion-papers
would be circulated well in advance. There will be a special double
issue of MFC-Bulletin containing 1) Survey of history of evolution of
medical education in India during last 150 years, 2) An article
pointing out the gap between the health-needs of the people and the
health-facilities available-this will lead us to what system of medical
care do we need and what should be the role of the doctor in it and
accordingly what should be the training he/she should receive.
3) A survey of different experiments done in different countries about
alternative medical education.
After the last Annual Meet at Anand, some of us stayed back for
one day to discuss alternative medical education. Some MFC members
had been invited for a workshop at Dhaka on alternative medical
education. The discussion at Anand had been mainly organized as a
preparation for the Dhaka Conference. This time, however, the focus
will be different—to argue out in the first place, the inappropriateness
of medical education.
Travel arrangements etc : As usual, participants will have to
pay for their own travel. Since participants outside West Bengal
would have to spend considerable amount on travel, attempts arc
being made to subsidize food. The exact extent of subsidy is
yet undecided. Those who cannot afford to pay will be exempted.
Those of you who want to attend this Meet, are requested to
write to me so that I can send
all further details and also the
background—papers...etc. as they get ready.
—Anant Phadke, Convenor, MFC.
( Published as supplement ro the November- 1983 issue. )
Just released
Management Process
in Health Care
S. Srinivasan, (ed) pages 534,
1982,
Rs. 58
This is a book on management of health care institutions. Written
by a team of paople with training and experience in administration, this
book is meant for the manager and those interested in the art of manage
ment. This book will interest all who are interested in organising for
health—be it in a hospital, a dispensary, a community health programme
or a special care home for the handicapped.
The book is meant as a guide. It can be used as a text-book or a
reference for basic principles and practices. The book seeks to put to
gether notes, cases and aiticles and present the Indian experience of
health care management. This book focuses more on the process of
planning, activating and reviewing. There is less emphasis on the tools
and techniques of management. But it would give you an idea of the
availability of these tools and techniques, and the situations where they
could be appplied.
Edited by S. Srinivasan of the Health Care Management team of
VHAI, the book is a beautiful example of the team effort it advocates.
To order (add Rs. 8/- postage), write to VHAI.
*
*
*
19 going on 59
I
H
1,000 Illustrations
pages 500
Rs. 19/-
If you still do not have the Hindi version of Where There is No
Doctor, this is the time to order. Thanks to a well wisher. We are able to
offer another 3,000 copies at Rs. 19+postage Rs. 7 instead of the usual
29/- -i-postage. Order your copies now. Till stocks last.
*
*
Health Care: Which Way to Go
Abhay Bang and Ashwin Patel
Pages 272
Rs. 10
This is the second anthology of the Medico Friend Circle.
Probing articles on
Doctors- Prescriptions-Khesari Camp-Women-Nutrition
Nurses-Curses-Mass Vaccine-Diarrhoea-Rehydration
Health Politics-Liberators-Rural Health-Health Workers
Dais-Directions etc.
Illustrated, humorous, thought provoking.
(To order (add Rs. 3/- Postage) Write to VHAI.
*
A Letter from a Friend
on Drugs
Dear Renu
*
.............. The holistic seminar group is still very en
thusiastic. I am very happy about it. The latest news
is that the medical representatives are a bit worried.
They were asking me about the posters that we have
put up in the OPD. "Who gave you the ideas", they
asked. I handed over to them a Black copy of the drugs
issue of Health for the Millions and also the article
'Drugging the Indian.' I guess that I was the first
woman who challenged them. They did not stay very
long in my office after that. I have asked all of them
to go and have a chat with VHAI staff. Then, if they
feel like coming, they are welcome. Lots to tell
you. Love and prayers.
Dated 30-9-82
Sr. Agnes
Administrator,
Holy Family Hospital,
Mandar.
*VHAI staff member
Expensive, yes, but the doctor says, you have got
to take a couple of these pills—we will have to
put off paying the house rent, the grocer, the
milkman —I
THE VICIOUS CIRCLE THAT LEADS
TO THE OVERUSE OF MEDICINE
For private circulation only
is buying a lot more drugs for its money, simply by
not wasting money on useless and dangerous drugs,
on fancy packets, and on well known trade names."
The Mozambique experience and the efforts of
Bangladesh and Thailand are significant initiatives on
the part of developing countries to decrease dependence
on the transnational pharmaceutical industry. With
TNCs looking to developing countries to provide about
one-third of their sales turnover by the end of the
next decade, the importance of these initiatives be
Drug Prices Are Falling
comes apparent.
Drug prices in Mozambique are dropping. Some
Bangladesh has given permission to WHO to
basic antibiotics and pain killers now cost one-third circulate its new drugs policy to all WHO member
less than they did three years ago. Useless and states. If this is done, and other countries begin
dangerous drugs have largely been taken off the to implement similar measures, the pattern of drug
market. And for the first time, according to a WHO usage may be radically altered in the coming years.
evaluation report, most rural health posts have enough We may be witnessing the beginnings of a revolution
basic drugs.
in drugs therapy—a revolution no less significant than
One commentator in Mozambique has noted: "Drug the development of antibiotics a few short decades
imports in Mozambique today cost the same as they ago—and a revolution that may have tremendous
did 10 years ago: about US 81 per person. Mozambique impact on people's health.
There is very little evidence to substantiate the
criticisms made by the industry in either Thailand or
Bangladesh. By way of contrast, in Mozambique, a
country which has successfully implemented a restric
ted drugs list based on the WHO model, coupled with
competitive bulk buying and an education pro
gramme to transform prescribing habits, the evidence
shows a positive improvement in health care which
meets people's needs.
Doctors PptiiorD
Before the Ban
After the Ban
Dr. Abdul Khan M.B.B.S.
Dr. Sheela Abdul Khan M.B.B.S.
FATIMA CLINIC
285, Bose Road, Mujeeb Nagar-5
Phone : 47946
Dr. Abdul Khan M.B.B.S.
Dr. Sheela Abdul Khan M.B.B.S.
FATIMA CLINIC
285, Bose Road, Mujeeb Nagar~5
Phone : 47946
X
r rj>sx3<^>
TIX XF^
bo -/I -'gj
FOR EMERGENCY
Please ring up to 674321
HEALTH FOR THE MILLIONs/dECEMBER 1982
FOR EMERGENCY
Please ring up to 674321
7
ZAFRULLAH & SUSANNE CHOWDHURY
Gonoshasthaya Pharmaceuticals
Gonoshasthaya Kendra (People's Health) Charitable
Trust's original objective of establishing a preventive
and primary health care service in a rural area of
Bangladesh gradually developed into a broader com
munity 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, (Gonoshasthaya Pharmaceuticals Ltd.) GPL is
designed to supply 15-20% of the present Bangladesh
market in essential drugs. It aims to 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 sub
ject like any other company, to the usual customs,
taxes and ot'her duties. Unlike other companies, how
ever, 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, Bangla
desh 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 avoid
ing 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 Interna
tional Dispensary Association (Holland) who helped
to organise additional training for managers and pro
cured machinery
and raw materials. Professor
J. Polderman, Expert Committee Chairman of the Euro
8
pean Pharmacopeia has been sponsored by NOVIB as
our Production 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 establish a high technology project in
an underdeveloped country will suffer from lack of
infrastructure and problems arising from having to im
port much of the necessary equipment. Our main
problems here were in the lines of architecture, elec
trical 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 Bangla
desh due to migration to the Middle East where wages
are much higher. Unskilled labourers, we were deter
mined 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 educa
tion was necessary before the women could begin
working in the 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 dollars 2.62 million
OXFAM (U.KJ
„
CHRISTIAN AID (U.K.)
„
„
0-22
COMMUNITY AID ABROAD
(Australia)
M
n
g g3
0 33
EUROPEAN ECONOMIC COMMUNITY
(through Novib)
H
ggg
Bangladesh Shilpa Bank, GK Trust
and Others
M
u
4 5g
(this is strictly a loan to GPL)
US dollars 4.92 million
HEALTH FOR THE MILLIONs/dECEMBER 1982
The social and political climate
CONTRAST IN DRUGS PRICES
cannot be ignored either, when Syrup1Liquid
CapsulelTablet
Product’s Name
Company
Name
beginning a new industry in a
Price
Price
country like Bangladesh.
The _
1. Ampicillin
government's policy is to encourage
Tk. 1.69/cap
*
Tk. 23.80/60mls
Penbritin
Fisons
industrial development, especially
Amblosin
1.80
23.80
Hoechst
in such a thing as essential drugs.
1.70
Ampicin
21.00
Square
Amplin
1.70
23.80
K.D H.
However, anyone who intends to
21.00
Am pi ci I
1.70
Pioneer
produce or market in Bangladesh
Aldapen
1.30
Albert David
G-Ampicillin
24.00/100mls
1.00
G.P.L.
has to cope with the corrupt prac
tices which pervade the industrial
2. Amoxicillin
and commercial life of the country.
Amoxil
3.00/cap
32.00/60mls
Fison
For those who have 'been in the
Amolin
2.47
25.00
K.D.H.
G-Amoxicillin
2.25
G.P.L.
business,' GPL's conditions for
doing business come as a surprise
3. Tetracycline/Oxytetracycline
which they often cannot fully un
Teracin
0.90/cap
Pioneer
Oxalin
derstand, since everyone knows
0.97
Pharmadesh
Hostacycline
0.90
Hoechst
bribery is part and parcel of the
Aldacycllne
1.00
Albert David
way of life in this country.
0.98
Sumycin
Squibb
Imperacin
1.05
l.c.l.
G-Tetracycllne
0.50
G.P.L.
Then of course, there is the
problem of moving into an already
4. Sulphamethoxazole & Trimethoprim
well-established market.
Consi
Septrin
2.30/tab
28.00/60mls
Burrough Wellcome
dering that our aim is to supply
Cotrim
Square
1.98
22.00
Therapeutics
Theratrim
1.80
22.00
quality drugs at the lowest possi
Chemotrim
Opsonin
1.75
16.00
ble price, we knew trouble would
Sephtazol
1.90
Pioneer
G-Cotrimexazole
G.P.L.
1.25
21.00/100mls
be waiting—just how much trouble
has only come in bits and pieces,
5. Paracetamoi
but it has come, especially in the
Paracetamol
0.25/tab
BPI (May & Baker)
Cetamol
field of pricing and marketing.
Square
0.25
We believe that for the proper
information of the consumer, all
pharmaceuticals should be obliged
to give details of their pricing 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 pro
ducts being manufactured and
marketed in Bangladesh.
It should be noted that as a 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
Hoechst
Fisons
Nicholas
G.P.L.
Pyralgin
Fltamol
Paratan
G-Paracetamol
0.27
0.25
0.25
0.15
Flagyl
Amodis
Metazol
Metril
G-Metronidazole
Tk.0.78/tab
0.70
0.60
0.50
0.40
Metronidazol
6.
BPI (May & Baker)
Square
Pioneer
Opsonin
G.P.L.
Aspirin (300mg)
7.
K.D.H.
Fisons
G.P.L.
Aspirin
Genasprln
G-Asplrin
0.12/tab
0.10
0.75
Sedll
Easium
Sudex
Sedalin
G-Diazepam
0.30/tab
0.25
0.20
0.30
0.125
Avlocld
Antacil
Nutracll
G-Antacid
0.45
0.25
0.20
0.20
Diazepam (5 mg)
8.
Square
Opsonin
Peoples
K.D.H.
G.P.L.
8.
Antacid
•I.C.L
Squibb
K.D.H.
G.P.L.
HEALTH FOR THE MILLIONS/DECEMBER 1982
Tk.23.00/225mls
15.20/228mls
16.00/228mla
14.00/200mls
• 2 Bangladesh Taka^= Approximately One Indian Rupee.
9
Frusemide (40 mg)
10.
Hoechst
G.P.L.
An Indian Low Cost Drugs Project
Lasix
G-Frusemide
1.30/tab
0-60
Oral Rehydration Salt Sachet (27.5 gm)
11
Pioneer
Oralite-D
10 00
G P.L.
Labon Jaler Sarbat
(O.R.S.)
2.50
Ferrous Fumerate with Folic Acid
12.
Fisons
G P.L.
Folte Tab
G-lron with Focid Acid
0 06
0.05
important or whose use we wish to discourage.
For example we make a 6.57% profit on ampicillin
and 3.2% on paracetamol (which are below our over
all profit margin of 10-15%) and make it up with a
36.6% profit on diazepam and 85-6% on frusemide.
GPL hopes to market about 60-70% of its produc
tion to government, government agencies and chari
table 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 in
volves 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 Bangla
desh National Formulary and often the product infor
mation leaflets are very different in content in 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 dissemi
nate 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 Albert David 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 93 paisa, basing our calculation
10
A meeting of Abhay Bhang and Ashwin Patel
of Medico Friend Circle, Dilip Desai of SewaRural (Jhagaria, Gujarat) and S. Srinivasan of VHAI,
took place on October 20, 1982 at Delhi. The pur
pose of the meeting was to finalise action plans for
a low cost drugs project. The project involves en
suring a rigid quality control check on the products
of low cost drug manufacturers. Initially, partners
(user institutions, groups) for this project are being
sought in Gujarat and Maharashtra only. The drugs
envisaged for distribution will be generic formula
tions along the lines of the WHO essential drugs
list and the Hathi Committee list. For details, con
tact: Dr. Dilip Desai, SEWA-RURAL, Jhagadia—
393110, District Bharuch, Gujarat.
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 have 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-selling national 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 their '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
health for the millions/december 1982
NEWS
Manila Declaration
Anwar and Alternative Nobel
Stepped-up activities and more organized action
to promote breastfeeding in Asia are in the offing. This
is a direct result of a seminar held in Manila from
September 27-30, 1982.
awarded the 1982 Alternative Nobel Prize by the Right
to Livelihood Foundation for founding Consumer Inter
The Asian regional seminar for the promotion of
breastfeeding, organised by IOCU with support from
UNICEF, was attended by representatives of consumer
groups, women's and health organizations, and key
social action groups from 12 countries.
The local host was the National Coalition for the
Promotion of Breastfeeding.
During the highly successful seminar, a number of
workshops, evaluative and planning sessions were
held. The framework for a regional programme of
action was drawn up. At the end of the four days of
lively and stimulating discussions, participants unani
mously adopted a declaration calling on all govern
ments, health professionals and consumers to promote
breastfeeding.
Noting that milk companies continued to violate
the provisions of the WHO/UNICEF Code, they
stressed the need to formulate national codes of
marketing to restrict excessive promotion of artificial
baby milks. Consumer groups and other people’s
organizations were urged to expose such violations.
Augustine Veliath who represented NANI and
India, ended his country report with the following
prayer:
Lord's Prayer a la Amul
Amul Father who art in Anand give us this day
Amulspray (or Balamul if you prefer)
but before that
Give us clean, running water constantly and fuel
to boil that water so that we may fol low the instructions
on your tin.
Give us a fridge to keep the feed safe
and above all
Give us lands and jobs so that
we may pay for Amulspray.
Forgive us our poverty but do not lead us
into the temptation of diluting your formula.
May the WHO/UNICEF Code be always with you
Utterly, butterly Amen.
health for the millions/december 1982
The president of IOCU, Anwar Fazal, has been
pol. He shares the US $ 50,000 prize with : Petra
Kelly, leader of the West German ‘'GREENS", the
rapidly growing environmental and peace movement
which has transformed the German political scene;
Sir George Trevelyan, a pioneer of adult education in
Britain and founder of the Wrekin Trust, which brings
together scientists and mystics, doctors and healers
etc., in order to bring about "an evolutionary leap in
human consciousness"; and the Participatory Institute
for Development Alternative (PIDA), a group working
to multiply grass root self-reliant development in rural
Asia.
The annual prize was started three years ago by a
Swedish stamp dealer, Jakob
von Uexkull, to
''support those working on practical solutions to the
real problems in the world today". Von Uexkull be
lieves that Nobel Prizes today reward "the wrong
kind of knowledge which is often irrevelant and irres
ponsible". The new 'Alternative Nobel' award is pre
sented in Stockholm on the day before the official
Nobel Prize ceremony. The Right to Livelihood Award
winners are chosen by an international panel which
includes Robert Muller, Assistant Secretary General of
the United Nations.
Anwar Fazal in the early 1970s was to Malaysia
what Ralph Nader was to the US. His decision to
become a fulltime consumer activist (which required
him to give up his Nos. 2 position in the city govern
ment) came about when he led a group of citizens to
oppose the building of a bridge that was to have
connected his native Penang to the mainland for eco
logical and socio-economic reasons. "There was con
flict of interests" was how the 41 year-old Fazal ex
plained his decision. After nearly a decade of being in
the forefront of his country's consumer action move
ment, Fazal was elected president of the International
Organization of Consumers Union (IOCU)—the first
from a Third World country to assume the position.
13
Health Workers’ Convention
—D. Rayanna reports from Hyderabad.
The first ever Andhra Pradesh State VHWs con
vention was concluded at V R 0, Pedakakari, Guntur
on October 25, 1 982. The three day convention was
organised by A.P. Voluntary Health Association.
200 delegates from 20 districts participated in this
convention.
The whole programme was geared to the VHWs
themselves through groups sessions for sharing of
their experiences and through opportunities for
discussion.
On the first day at the inauguration of the conven
tion, the lighting of the lamp was done by a VHW,
the inaugural address was given by Dr. C. Savithri,
principal, Guntur Medical College, and the Presidential
Address by Dr. Lakshman Rao, Superintendent, Govt.
General Hospital, Guntur.
Welfare, Govt, of A.P., Hyderabad, and featured also
Dr. Kunhinani, D.M. & H,O. Guntur, Professor Widney,
Director, V R 0 and also five'of the VHWs giving their
impression of this convention.
Handbook for VHW Trainers
in Telugu
The APVHA is preparing a handbook for the
trainers in Telugu mainly for those who are working
or planning to initiate village health workers pro
gramme. This guide deals with selection, training,
supervision of VHWs teaching methods, teaching aids.
It also includes a simple course outline for VHWs &
evaluation framework.
For copies (Rs. 12 plus postage Rs 3/- on single
copies Rs 6/- for units of 4 copies)
Write to : Andhra Pradesh Voluntary Health Asso
ciation, 10-3-311 /7/2 Vijayanagar Colony,
Hyderabad-500457.
Another highlight of the convention was the parti
cipants' programmes where health themes were
presented in various media (skits, dramas, songs
dances, Burakhatha etc.)
The Ban is Coming
David Werner, the author of WHERE THERE IS
NO DOCTOR, then on a visit to India, was the centre
of attraction on the second day. He was welcomed by
the VHWs and happily shared the morning session
with them as they discussed the problems in working
and living in the villages.
patriot.
In the afternoon, Werner presented his personal
experiences in Piaxtla, a rural health project in
Mexico, through an excellent slide show emphasising
traditional medicine as they have discovered and
utilised in Mexico. That presentation was followed by
a discussion period.
Amruthavani
(Communications
Centre) from
Secunderabad, presented an excellent open session on
health teaching media such as puppet shows and films.
On the concluding day, Amruthavani presented
health related skits. This was followed by a group
discussion on these themes by VHWs. Various health
songs were compiled by the VHWs and were either
written down or tape-recorded.
Amruthavani's final presentation covered low cost
teaching aids. The valedictory session was chaired by
Dr. Y.R. Reddy, D.M. & H.S. Health and Family
14
The Government proposes a total ban on advertise
ments of baby milk powder as a substitute to breast
feeding and restriction on advertisements of weaning
foods for infants up to the age of 18 months, reports
A legislation, which is in an advanced stage, is
expected to go before the Cabinet shortly, Social
Welfare Secretary, Mir Nasrallah told newsmen in
Delhi on November 9, 1982.
The proposed legislation is intended to promote
breast-feeding. It will also discourage doctors from
prescribing these foods as a substitute for breast
feeding and put restrictions on physician's samples.
Mr. Nasrullh, however said that a total ban on the
sale of baby milk foods may not be possible for various
reasons.
While there were no problems in the rural areas
where mothers had no alternative to breastfeeding,
most working mothers in metropolitan and other
cities turned to tinned food which was to be dis
couraged.
Mr. Nasrullah said his ministry was trying to create
greater awareness among the people in a big way by
propagating that "investment in child is an investment
in future,"
HEALTH FOR THE
MILLIONs/dECEMBER
1982
Critique of Amendment
Basically the Bangladesh government cannot be
criticised for its final report. The items reinstated under
Schedule I can easily be taken care of at the time of
renewal of licence (if the policy survives). Oddities,
discrepancies begin to appear in Schedule II. Heptunaplus, manufactured by Pfizer, USA, was 'lobbied' for
by the country's gynaecologists (headed by Professor
Feroza Begum, President of the Bangladesh Medical
Association and a shareholder and member of the Board
of Directors of Pfizer). This capsule, containing Iron,
folic acid, multi-vitamins and minerals was claimed a
necessary ante-natal drug, pleading the general under
nourished, anaemic condition of so many pregnant
women in the country. The problem now is—other com
panies,' products of similar formulation remain banned.
Naturally they have appealed to the Drug Controller and
if the government succumbs, the door is wide open for
further manipulation. No time beyond the previous
six months limit was necessary for companies to sub
mit their reformulation recipes. Extending this limit
to 12 months merely prolongs the hope that change
can still come.
The major coup for withdrawal/banning under
Schedule III was, of course, allowing third party/
under licence products to continue to be manufactured
until expiry of the present contracts, thus 'honouring
international agreements, or the more aptly phrased,
succumbing to international blackmailing by imperia
list countries'. However, in this respect the govern
ment has not lost entirely in that. It also allows no
further import of raw mater ials for these items.
A definite conflict is now arising in this area,.
The Drug Controller (who is the actual authority in
this matter) is an honest, but weak person directly
under the Secretary of Health who is a very clever
individual, said to have connections with a number
of multinationals. Ten companies have already applied
for excipients (most products contain 1-2 active ingre
dients and 3-5 excipients) to be imported to use up
on-hand, active ingredients. Squibb on the other hand,
has all the excipients but has applied for two tonnes of
alum hydroxide gel (active ingredient) for antacid manu
facture. Organon has two milion capsules and some
vials for their hormonal preparation decadurbolin and
they want to import a few kilos of the active ingredient
for this product. Herein lies the danger—the Drug Con
troller has rejected application for active ingredients
but has become soft about allowing excipients. If
one item is allowed, the cycle will continue with no
HEALTH FOR THE MILLIONs/dECEMBER 1982
hope of effective control and actual implementation of
the new policy regulations. These applications are all
naturally in the name of 'saving foreign exchange,
by allowing the items on hand for manufacture to
be used up rather than destroyed.
Support/Lack of Support
To open cut hero
URGENT
Class of Telegram
TELEGRAM
1.10.1982
(booking
Timo of it
^Receipt
2.10.1982
Office of origin
i
INDIA
Ento
’
1-10-1982
Number of words
i
12
X 1110
N
Address:
To
THE
PEOPLE OF BANGLADESH
BANGLADESH
First Fold
- I0U
21*
DEL -
HAVE FOUND
PEOPLE OF
INDIA J 6
J7
THE RIGHT PRESCRIPTION
WELL DONE
PEOPLE OF INDIA
Those concerned with the survival of the new
drug policy have been tremendously encouraged by
the support the policy has received world over
through various nongovernmental, voluntary organi
zations; scientists, academics, journalists, etc. Their
cables to the Chief Martial Law Administrator and
Health Minister, their news media exposes and anti
pressure, and questioning of various governments'
(especially USA) interference has most certainly
played a major role in keeping the policy alive.
It cannot be questioned that Bangladesh or any
other third world country is in need of this support
system if they are to implement any policy of
this nature for the good of their countries.
Conspicuous has been the lack of support, (Please
also see page 6,—Ed, Hfm) from the campaigners of
'Health for all by 2000) the World Health Organization
(WHO). One wonders how directly this is tied to
the fact that 25% of WHO funds come from the
USA. Dr. Halfden Mahler, Director General of WHO,
in Dacca mid-September for meetings, lauded the
advancement being made in health services in the
country (where actually under 10% receive adequate
health care) and assured his co-operation in this
3
APPEAL
matter. Asked specifically whether he appreciated the
national drug policy, he avoided a direct reply saying,
"governments announce policies for
people."
Dr. Cohen, also of WHO, when questioned on the sub
ject by South magazine is reported to have replied,
"How would you like WHO to ask the government of
Bangladesh to make comments on your magazine ?".
Multinationals have done their utmost to discredit
voluntary agencies supporting various health/pharmaceutical/consumer education works in Bangladesh.
Some supporting agencies have written to various
presses in protest, others have been weak in this fight.
Little of this protest has appeared in print and the
time seems appropriate for the maligned agencies to
take their comments to the Bangladesh Press Council
and demand hearing via the printed media.
Similarly, when local multinational opposition has
gone to the press with their advertisements, these
have been refused by all the larger papers. If a news
paper won't take money for advertising, the natural
assumption is, that they are being paid by someone
else NOT to take it.
Dr. Zafrullah Chowdhury
Gonoshasthaya Kendra
P.O. Nayarhat, Via Dharmrai
District Dacca
Bangladesh.
Dear Readers,
I kindly appeal to you to send for our informa
tion, any newspaper/magazine clippings which you
may come across
dealing with new drugs,
ban of drugs in any country,
the Bangladesh drug policy and
any other information of a similar nature.
I would also be pleased to receive any articles
on the subject which you may personally write.
Thank you for your kind cooperation.
Yours sincerely,
Dr. Zafrullah Chowdhury
Project Coordinator
Conclusion
The Bangladesh Government has taken a major
step to curb exploitation of their people by multina
tional and national drug companies/manufacturers, but
the battle is far from over. The policy still has to be
implemented in the face of continuing opposition and
pressure.. A vigorous doctor/consumer education
campaign needs to continue in the country to coun
teract the deliberately planned confusion which has
been created in respect of the drug policy. We there
fore need the continued support of concerned groups
and individuals outside bringing this matter to the
attention of the people of their own countries. We
also need the continued support of pharmacologists,
pharmacists, medical professors, etc. to feed our
medical knowledge so our people will be the
recipients of quality, low-cost medicines which meet
their specific needs.
I
To
Gonoshasthaya Kendra
P.O. Nayarhat via Dhamra:
District Dacca
Bangladesh
Course in Community Health and Development
The International Nursing Services Association will
conduct 10-week course in Community Health and
Development for medical and para-medical workers
involved in community health and interested in train
ing village health workers.
4
Courses begin on January 13,1983 and June 13,
1983. (Applications due for the second Course—
April 10, 1983), Contact
Programme Director,
INSA/INDIA, Rural Health and Development Pro
gramme, 2 Benson Town, Bangalore 560 046.
health for the millions/december 1982
ZAFRULLAH & SUSANNE CHOWDHURY
Gonoshasthaya Pharmaceuticals
Gonoshasthaya Kendra (People's Health) Charitable
Trust's original objective of establishing a preventive
and primary health care service in a rural area of
Bangladesh gradually developed into a broader com
munity 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, (Gonoshasthaya Pharmaceuticals Ltd.) GPL is
designed to supply 15-20% of the present Bangladesh
market in essential drugs. It aims to 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 sub
ject like any other company, to th3 usual customs,
taxes and other duties. Unlike other companies, how
ever, 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, Bangla
desh 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 avoid
ing profit motives.
pean Pharmacopeia has been sponsored by NOVIB as
our Production 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 establish a high technology project in
an underdeveloped country will suffer from lack of
infrastructure and problems arising from having to im
port much of the necessary equipment. Our main
problems here were in the lines of architecture, elec
trical 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 Bangla
desh due to migration to the Middle East where wages
are much higher. Unskilled labourers, we were deter
mined 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 educa
tion was necessary before the women could begin
working in the 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 dollars 2.62 million
OXFAM (U.K.)
CHRISTIAN AID (U.K.)
„
„
„
„
u.33
0.22
„
M
0.05
EUROPEAN ECONOMIC COMMUNITY
(through Novlb)
,,
,,
q 2q
n
4 59
(Australia)
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.
Bangladesh Shilpa Bank, GK Trust
and Others
Technical expertise was provided by the Interna
tional Dispensary Association (Holland) who helped
to organise additional training for managers and pro
cured machinery
and raw materials. Professor
J. Polderman, Expert Committee Chairman of the Euro
8
’’
COMMUNITY AID ABROAD
„
(this is strictly a loan to GPL)
US dollars 4.92 million
health for the millions/December 1982
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 with the corrupt prac
tices which pervade the industrial
and commercial life of the country.
For those who have 'been in the
business,' GPL's conditions for
doing business come as a surprise
which they often cannot fully un
derstand, 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.
Consi
dering that our aim is to supply
quality drugs at the lowest possi
ble 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 be obliged
to give details of their pricing 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 pro
ducts being manufactured and
marketed in Bangladesh.
It should be noted that as a 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
CONTRAST IN DRUGS PRICES
Company Name
1.
2.
Ampicillin
Fisons
Hoechst
Square
K.DH.
Pioneer
Albert David
G.P.L.
health for the millions/december 1982
32.00/60mls
25.00
Teracin
Oxalin
Hostacycline
Aldacycline
Sumycln
Imperacin
G-Tetracycllne
0.90/cap
0.97
0.90
1.00
0.98
1.05
0.50
Septrin
Cotrim
Theratrlm
Chemotrim
Sephtazol
G-Cotrimexazole
2.30/tab
1.98
1.80
1.75
1.90
1.25
Paracetamol
Cetamol
Pyralgin
Fitamol
Paratan
G-Paracetamol
0.25/tab
0.25
0.27
0.25
0.25
0.15
Flagyl
Amodis
Metazol
Metrll
G-Metronidazole
Tk.0.78/tab
0.70
0.60
0.50
0.40
20.00/60mls
22.00
22.00
16.00
21.00/100mls
Aspirin
Genasprln
G-Aspirin
0.12/tab
0.10
0.75
Sedll
Easium
Sudex
Sedalin
G-Diazepam
0.30/tab
0.25
0.20
0.30
0.125
Avlocld
Antacil
Nutracll
G-Antacid
0.45
0.25
0.20
0.20
Diazepam (5 mg)
Square
Opsonin
Peoples
K.D.H.
G.P.L.
8.
Amoxil
Amolin
G-Amoxicillin
Aspirin (300mg)
K.D.H.
Fisons
G.P.L.
8.
3.00/cap
2.47
2.25
24.00/100mls
Metronidazol
BPI (May & Baker)
Square
Pioneer
Opsonin
G.P.L.
7.
Tk. 23.80/60mls
23.80
21.00
23.80
21.00
Paracetamol
BPI (May & Baker)
Square
Hoechst
Fisons
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.
SyruplLiquid
Price
Tetracycline/Oxytetracycline
Pioneer
Pharmadesh
Hoechst
Albert David
Squibb
I.C.l.
G.P.L.
4.
Penbritin
Amblosin
Ampicin
Amplin
Ampicil
Aldapen
G-Ampicillin
Capsule/Tablet
Price
Amoxicillin
Fison
K.O.H.
G.P.L.
3.
Product’s Name
Antacid
I.C.l.
Squibb
K.D.H.
G.P.L.
• 2 Bangladesh Taka = Approximately One Indian Rupee.
Tk.23.00/225mls
15.20/228mls
16.00/228ml»
14.00/200mls
10.
Frusemide (40 mg)
Hoechst
G.P.L.
11
1.30/tab
0.60
Oral Rehydration Sait Sachet (27.5 gm)
Pioneer
G P.L.
12.
An Indian Low Cost Drugs Project
Lasix
G-Frusemide
Oralite-D
Labon Jaler Sarbat
(O.R.S.)
10.00
2.50
Ferrous Fumerate with Folic Acid
Fisons
G P.L.
FolteTab
G-lron with Focid Acid
0 06
0.05
important or whose use we wish to discourage.
For example we make a 6.57% profit on ampicillin
and 3.2% on paracetamol (which are below our over
all profit margin of 10-15%) and make it up with a
36.6% profit on diazepam and 85.6% on frusemide.
GPL hopes to market about 60-70% of its produc
tion to government, government agencies and chari
table 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 in
volves 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 Bangla
desh National Formulary and often the product infor
mation leaflets are very different in content in 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 dissemi
nate 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 Albert David 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 93 paisa, basing our calculation
10
A meeting of Abhay Bhang and Ashwin Patel
of Medico Friend Circle, Dilip Desai of SewaRural (Jhagaria, Gujarat) and S. Srinivasan of VHAI,
took place on October 20, 1982 at Delhi. The pur
pose of the meeting was to finalise action plans for
a low cost drugs project. The project involves en
suring a rigid quality control check on the products
of low cost drug manufacturers. Initially, partners
(user institutions, groups) for this project are being
sought in Gujarat and Maharashtra only. The drugs
envisaged for distribution will be generic formula
tions along the lines of the WHO essential drugs
list and the Hathi Committee list. For details, con
tact: Dr. Dilip Desai, SEWA-RURAL, Jhagadia—
393110, District Bharuch, Gujarat.
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 have 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-selling national companies had a meeting
before the tender. We did not win the tender. Jt 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 their '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
HEALTH FOR THE MILLIONs/dECEMBER 1982
NEWS
Manila Declaration
Anwar and Alternative Nobel
Stepped-up activities and more organized action
to promote breastfeeding in Asia are in the offing. This
is a direct result of a seminar held in Manila from
September 27-30, 1982.
awarded the 1982 Alternative Nobel Prize by the Right
to Livelihood Foundation for founding Consumer Inter
The Asian regional seminar for the promotion of
breastfeeding, organised by IOCU with support from
UNICEF, was attended by representatives of consumer
groups, women's and health organizations, and key
social action groups from 12 countries.
The local host was the National Coalition for the
Promotion of Breastfeeding.
During the highly successful seminar, a number of
workshops, evaluative and planning sessions were
held. The framework for a regional programme of
action was drawn up. At the end of the four days of
lively and stimulating discussions, participants unani
mously adopted a declaration calling on all govern
ments, health professionals and consumers to promote
breastfeeding.
Noting that milk companies continued to violate
the provisions of the WHO/UNICEF Code, they
stressed the need to formulate national codes of
marketing to restrict excessive promotion of artificial
baby milks. Consumer groups and other people’s
organizations were urged to expose such violations.
Augustine Veliath who represented NANI and
India, ended his country report with the following
prayer :
Lord's Prayer a la Amul
Amul Father who art in Anand give us this day
Amulspray (or Balamul if you prefer)
but before that
Give us clean, running water constantly and fuel
to boil that water so that we may fol low the instructions
on your tin.
Give us a fridge to keep the feed safe
and above all
Give us lands and jobs so that
we may pay for Amulspray.
Forgive us our poverty but do not lead us
into the temptation of diluting your formula.
May the WHO/UNICEF Code be always with you
Utterly, butterly Amen.
HEALTH FOR THE MILLIONS/dECEMBER 1982
The president of IOCU, Anwar Fazal, has been
pol. He shares the US $ 50,000 prize with : Petra
Kelly, leader of the West German ‘'GREENS'', the
rapidly growing environmental and peace movement
which has transformed the German political scene;
Sir George Trevelyan, a pioneer of adult education in
Britain and founder of the Wrekin Trust, which brings
together scientists and mystics, doctors and healers
etc., in order to bring about "an evolutionary leap in
human consciousness"; and the Participatory Institute
for Development Alternative (PIDA), a group working
to multiply grass root self-reliant development in rural
Asia.
The annual prize was started three years ago by a
Swedish stamp dealer, Jakob
von Uexkull, to
''support those working on practical solutions to the
real problems in the world today". Von Uexkull be
lieves that Nobel Prizes today reward "the wrong
kind of knowledge which is often irrevelant and irres
ponsible". The new 'Alternative Nobel' award is pre
sented in Stockholm on the day before the official
Nobel Prize ceremony. The Right to Livelihood Award
winners are chosen by an international panel which
includes Robert Muller, Assistant Secretary General of
the United Nations.
Anwar Fazal in the early 1970s was to Malaysia
what Ralph Nader was to the US. His decision to
become a fulltime consumer activist (which required
him to give up his Nos. 2 position in the city govern
ment) came about when he led a group of citizens to
oppose the building of a bridge that was to have
connected his native Penang to the mainland for eco
logical and socio-economic reasons. "There was con
flict of interests" was how the 41 year-old Fazal ex
plained his decision. After nearly a decade of being in
the forefront of his country's consumer action move
ment, Fazal was elected president of the International
Organization of Consumers Union (IOCU)—the first
from a Third World country to assume the position.
13
Health Workers’ Convention
—D. Rayanna reports from Hyderabad.
The first ever Andhra Pradesh State VHWs con
vention was concluded at V R 0, Pedakakari, Guntur
on October 25, 1982. The three day convention was
organised by A.P. Voluntary Health Association.
200 delegates from 20 districts participated in this
convention.
The whole programme was geared to the VHWs
themselves through groups sessions for sharing of
their experiences and through opportunities for
discussion.
On the first day at the inauguration of the conven
tion, the lighting of the lamp was done by a VHW,
the inaugural address was given by Dr. C. Savithri,
principal, Guntur Medical College, and the Presidential
Address by Dr. Lakshman Rao, Superintendent, Govt.
General Hospital, Guntur.
Welfare, Govt, of A.P., Hyderabad, and featured also
Dr. Kunhinani, D.M. & H,O. Guntur, Professor Widney,
Director, V R 0 and also five of the VHWs giving their
impression of this convention.
Handbook for VHW Trainers
in Telugu
The APVHA is preparing a handbook for the
trainers in Telugu mainly for those who are working
or planning to initiate village health workers pro
gramme. This guide deals with selection, training,
supervision of VHWs teaching methods, teaching aids.
It also includes a simple course outline for VHWs &
evaluation framework.
For copies (Rs. 12 plus postage Rs 3/- on single
copies Rs 6/- for units of 4 copies)
Write to : Andhra Pradesh Voluntary Health Asso
ciation, 10-3-31117/2 Vijayanagar Colony,
Hyderabad-500457.
*
*
Another highlight of the convention was the parti
cipants' programmes where health themes were
presented in various media (skits, dramas, songs
dances, Burakhatha etc.)
The Ban is Coming
David Werner, the author of WHERE THERE IS
NO DOCTOR, then on a visit to India, was the centre
of attraction on the second day. He was welcomed by
the VHWs and happily shared the morning session
with them as they discussed the problems in working
and living in the villages.
patriot.
In the afternoon, Werner presented his personal
experiences in Piaxtla, a rural health project in
Mexico, through an excellent slide show emphasising
traditional medicine as they have discovered and
utilised in Mexico. That presentation was followed by
a discussion period.
Amruthavani
(Communications
Centre) from
Secunderabad, presented an excellent open session on
health teaching media such as puppet showsand films.
On the concluding day, Amruthavani presented
health related skits. This was followed by a group
discussion on these themes by VHWs. Various health
songs were compiled by the VHWs and were either
written down or tape-recorded.
Amruthavani’s final presentation covered low cost
teaching aids. The valedictory session was chaired by
Dr. Y.R. Reddy, D.M. & H.S. Health and Family
14
*
The Government proposes a total ban on advertise
ments of baby milk powder as a substitute to breast
feeding and restriction on advertisements of weaning
foods for infants up to the age of 18 months, reports
f\ legislation, which is in an advanced stage, is
expected to go before the Cabinet shortly, Social
Welfare Secretary, Mir Nasrullah told newsmen in
Delhi on November 9, 1982.
The proposed legislation is intended to promote
breast-feeding. It will also discourage doctors from
prescribing these foods as a substitute for breast
feeding and put restrictions on physician's samples.
Mr. Nasrullh, however said that a total ban on the
sale of baby milk foods may not be possible for various
reasons.
While there were no problems in the rural areas
where mothers had no alternative to breastfeeding,
most working mothers in metropolitan and other
cities turned to tinned food which was to be dis
couraged.
Mr. Nasrullah said his ministry was trying to create
greater awareness among the people in a big way by
propagating that investment in child is an investment
in future,"
HEALTH FOR THE
MILLIONs/dECEMBER
1982
- 34 ’ r e'^ing" 1 i^t"7Sn"''3~’r ug~Issues
Banglad esh situ ation
^Soui^cu/Available at
1. Gonushasthaya Kendra
- a program. report
LINK Vol.l, No.l, May “June
19csl (Asian Community Health
Action Network Newsletter)
2. Goncshasthay a Kuner a
- a progress report
(Aug, 19 oO)
Handout available from
VHAI, New Delhi
3. Bangladesh finds the
right proscription
Health for the Millions
(VHAI Bimonthly) Vol.VIII,
No.6, Liecumber 19u2 SPECIAL
ISSUE.
4. Drugs in Bangladesh
LINK Vo1.2, No.3, Aug-Sept
198 2 (Asian Community Health
Action Network Newsletter)
5- In Support of Bangladesh
Drug Policy
Handout of VHAI Cell on
Low Cost Drugs and Rational
Therapeutics.
6. The war against Bangladesh
- Claude Alvaros
A Rustic/vHAI publication
7 . Bitter Pills—Medicine
and the Third world Poor
- Dianna Melrose
OXF7J4 publication 19o2.
Indian situation
1. Report of Committee on
Drugs & Pharmaceuticals
Industry (Hath! 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,
New Delhi, April-June 1981.
3. Aspects of Drug Industry
. in India - Mukaram Bhagat
Center fur Education and
Development, Bombay
4.
Insult or Injury
- Charles Medawar
Social Audit, England,
1979
PMA argued that blockin j the flow of drugs from its
member companies could open the market in Bangladesh to
uncertified and potentially impure drugs from their sjurce
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 appreciable
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 INDIAN- ’EGRESS” of 21.6.82
’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
out through regular programme of village 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 whic'h 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 'shorthut' 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-eclampsia, has resulted j_n nil maternity
deaths for the last year in the area fully covered by our service?
2. Women.
"Out of a total project staff (including subcentres^^
of 114, forty six are female; and on the health sidd, 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 fxom sight among patients both at
.../3
<I98S>
ALPHABETICAL LIST OF ESSENTIAL DRUGS
(Fourth Revision)
WHO Technical Report Series 722
A
□cimetidine
coal tar
□codeine
colchicine
cromoglicic acid
cyclophosphamide
cytarabine
amodiaquine
amphotericin B
□ampicillin
anti-D immunoglobulin (human)
antihaemophilic fraction (see
factor VIII concentrate)
antihaemorrhoidal preparation:
local anaesthetic, astringent and
antiinflammatory drug
antirabies hyperimmune serum
antiscorpion sera
antivenom sera
. ascorbic acid
□atropine
16.
□azathioprinc
B
□bacitracin + □neomycin
D
dactinomycin
dapsone
deferoxamine
dchydroemetine
depot medroxyprogesterone
acetate
□dexamethasone
□dextran 70
□diazepam
diethylcarbamazine
digitoxin
digoxin
diloxanide
dimercaprol
G
□gallamine
gentian violet'
□gentamicin
□glibenclamide
glucose
glucose with sodium chloride
glyceryl trinitrate
griseofuivin
H
□haloperidol
diphtheria antitoxin
diphtheria-pertussis-tetanus
vaccine
diphtheria-tetanus vaccine
dopamine
□doxorubicin
barium sulfate
BCG vaccine (dried)
beclometasone
benzathine benzylpenicillin
benzoic acid + salicylic acid
benzyl benzoate
benzylpenicillin
□betamethasone
□biperiden
bleomycin
□bupivacaine
doxycycline
halothane
heparin
□homatropine
□hydralazine
□hydrochlorothiazide
□hydrocortisone
□hydroxocobalamin
24,
E
ephedrine
epinephrine
□ergocalciferol
□ergometrine
C
1
16, 23, 29,
ergotamine
erythromycin
ethambutol
ether, anaesthetic
□ethinylestradiol
□ethinylestradiol 4- ^levonorgestrel
□ethinylcstradiol + □norethislerone
□calamine lotion
calcium carbonate
calcium folinate
calcium gluconate
carbamazepine
□carbidopa + levodopa
charcoal, activated
□chloramphenicol
□chlorhexidine
□chloroquine
□chlorphenamine
□chlorpromazine
chlortalidone
’ Also known as crystal
methylrosanilinium chloride).
factor IX complex
(coagulation factors II, VII,
IX, X) concentrate
ferrous salt
ferrous salt + folic acid
flucytosine
fludrocortisone
fluorescein
fluorouracil
□fluphenazine
folic acid
folic acid + □ferrous salt
□furosemide
cisplatin
clofazimine
clomifene
□cloxacillin
acetazolamide
acetylsalicylic acid
albumin, human
allopurinol
aluminium acetate
aluminium hydroxide
□amiloride
□aminophylline
□amitriptyline
ethionamide
ethosuximide
etoposide
ipecacuanha
□iron dextran
isoniazid
isoniazid + thioacclazone
isoprenaline
□isosorbide dinitrate
F
(international
Nonproprietary
imipramine
immunoglobulin, human normal
indomctacin
influenza vaccine
insulin injection, solution
insulin, intermediate acting
intraperitoneal dialysis solution
□iodine
□iohexal
iotroxalc
□iopanoic acid
factor VIII concentrate
violet
□ibuprofen
Name:
p
K
paracetamol
penicillamine
pentamidine
□pethidine
ketamine
L
levodopa
levodopa 4- □carbidopa
□levonorgestrel 4- □ethinylcstradiol
levothyroxine
□lidocaine
15.
lindane
lithium carbonate
M
magnesium hydroxide
magnesium sulfate
mannitol
measles vaccine
□mebendazole
meglumine amidotrizoate
melarsoprol
meningococcal vaccine
mercaptopurine
methotrexate
methyldopa
methylthioninium chloride
metoclopramide
melrifonatc
□metronidazole
□miconazole
□morphine
procaine benzylpenicillin
procarbazine
□promethazine
□propranolol
propyliodone
□propylthiouracil
17,
protamine sulfate
protionamide
pyrantel
pyrazinamide
pyridostigmine
pyridoxine
pyrimethamine 4- sulfadoxinc
N
Q
naloxone
□neomycin + □bacitracin
□neostigmine
□nicotinamide
□quinidine
quinine
niclosamide
□mfurtimox
nitrofurantoin
nitrous oxide
□norethisterone
22,
solution
sodium nitrite
□sodium nitroprusside
□sodium stibogluconate
sodium thiosulfate
spcctinomycin
spironolactone
streptomycin
sulfacetamide
1 ’sulfadimidine
sulladoxinc t pyrimethamine
f Sulfamethoxazole f trimethopri
suramin sodium
suxamethonium
tamoxifen
testosterone
tetanus antitoxin
tetanus antitoxin, human
tetanus vaccine
□tetracaine
□tetracycline
thiamine
thioacetazone -I- isoniazid
thiopental
tiabendazole
□timolol
trimethoprim 4- □sulfa
methoxazole
trisodium citrate dihydrate
tuberculin, purified protein
derivative (PPD)
typhoid vaccine
R
26,
norethisterone enantate
norethisterone + □cthinyleslradiol
nystatin
19
rabies vaccine
□reserpine
valproic acid
f ^verapamil
retinol
riboflavin
rifampicin
vinblastine
vincristine
W
O
S
oral rehydration salts (for
glucose salt solution)
oxamniquine
oxygen
oxytocin
19.
phenobarbital
phcnoxymelhylpenicillin
phenytoin
phytomenadione
pilocarpine
piperazine
podophylline
poliomyelitis vaccine
potassium chloride, oral
solution
26,
potassium chloride, parenteral
potassium iodide
praziquantel
17,
□prednisolone
16, 21,
primaquine
probenecid
□procainamide
sodium amidotrizoate
sodium bicarbonate
sodium calcium edetate
sodium chloride
sodium chloride with glucose
sodium fluoride
□sodium lactate, compound
26
salazosulfapyridine
□salbutamol
salicylic acid
salicylic acid 4- benzoic acid
□senna
silver nitrate
□warfarin
water for injection
Y
yellow fever vaccine
Reproduced from The Use of Essential Drugs, Second Report of the WHO
Expert Committee, WHO Technical Series 722, WHO, Geneva, 1985
18,
4W ALPHABETICAL LIST OF ESSENTIAL DRUGS
(Fourth Revision)
WHO Technical Report Series 722
A
□cimetidine
cisplatin
clofazimine
clomifene
□cloxacillin
acetazolamide
acetylsalicylic acid
albumin, human
allopurinol
aluminium acetate
aluminium hydroxide
□amiloride
□aminophylline
□amitriptyline
factor IX complex
(coagulation factors II, VII,
IX, X) concentrate
ferrous salt
ferrous salt 4- folic acid
flucytosine
fludrocortisone
fluorescein
fluorouracil
□fluphenazine
folic acid
folic acid 4- Dferrous salt
□furosemide
coal tar
□codeine
colchicine
cromoglicic acid
cyclophosphamide
cytarabine
amodiaquine
amphotericin B
□ampicillin
anti-D immunoglobulin (human)
antihaemophilic fraction (see
factor VIII concentrate)
antihaemorrhoidal preparation:
local anaesthetic, astringent and
antiinflammatory drug
antirabics hyperimmune serum
antiscorpion sera
antivenom sera
. ascorbic acid
□atropine
16.
□azalhioprinc
B
□bacitracin 4- □neomycin
diethylcarbamazine
digitoxin
digoxin
diloxanide
dimercaprol
G
□gallamine
gentian violet1
□gentamicin
□glibenclamide
glucose
glucose with sodium chloride
glyceryl trinitrate
griseofulvin
H
□haloperidol
diphtheria antitoxin
diphtheria-pertussis-tetanus
vaccine
diphtheria-tetanus vaccine
dopamine
□doxorubicin
barium sulfate
BCG vaccine (dried)
beclometasone
benzathine benzylpenicillin
benzoic acid 4- salicylic acid
benzyl benzoate
benzylpenicillin
□betamethasone
□biperiden
bleomycin
□bupivacaine
doxycycline
halothane
heparin
□homatropine
□hydralazine
□hydrochlorothiazide
□hydrocortisone
□hydroxocobalamin
24,
E
ephedrine
epinephrine
□ergocalciferol
□ergometrine
C
I
16, 23, 29,
ergotamine
erythromycin
ethambutol
ether, anaesthetic
□ethinylestradiol
□ethinylestradiol + □levonorgestrel
□elhinylcstradiol + □norethisterone
□calamine lotion
calcium carbonate
calcium folinate
calcium gluconate
carbamazepine
□carbidopa + levodopa
charcoal, activated
□chloramphenicol
□chlorhexidine
□chloroquine
□chlorphenamine
□chlorpromazine
chlortalidone
1 Also known as crystal
methylrosanilinium chloride).
D
dactinomycin
dapsone
deferoxamine
dehydroemetine
depot medroxyprogesterone
acetate
□dexamethasone
□dextran 70
□diazepam
ethionamide
ethosuximide
etoposide
ipecacuanha
□iron dextran
isoniazid
isoniazid 4- thioacetazone
isoprenaline
□isosorbide dinitrate
F
(International
Nonproprietary
imipramine
immunoglobulin, human normal
indomclacin
influenza vaccine
insulin injection, solution
insulin, intermediate acting
intraperitoneal dialysis solution
□iodine
□iohexal
iolroxatc
□iopanoic acid
factor VIII concentrate
violet
□ibuprofen
Name:
P
K
paracetamol
penicillamine
pentamidine
□pethidine
ketamine
L
levodopa
levodopa 4- Dcarbidopa
□levonorgestrel + □ethinylestradiol
levothyroxine
□lidocaine
15.
lindane
lithium carbonate
M
magnesium hydroxide
magnesium sulfate
mannitol
measles vaccine
□mebendazole
meglumine amidotrizoate
melarsoprol
meningococcal vaccine
meicaptopurme
methotrexate
methyldopa
methyllhionimum chloride
metoclopramide
melrifonatc
□metronidazole
□miconazole
□morphine
primaquine
probenecid
□procainamide
procaine benzylpenicillin
procarbazine
□promethazine
□propranolol
propyliodone
□propylthiouracil
17,
protamine sulfate
prolionamide
pyrantel
pyrazinamide
pyridostigmine
pyridoxine
pyrimethamine + sulfadoxine
N
Q
naloxone
□neomycin 4- □bacitracin
□neostigmine
□nicotinamide
□quinidine
quinine
niclosamide
□nifurtimox
nitrofurantoin
nitrous oxide
□norethistcrone
22,
solution
sodium nitrite
□sodi urn nitroprusside
□sodium stibogluconate
sodium thiosulfate
spcctinomycin
spironolactone
streptomycin
sulfacetamide
1 sulfadimidine
sulfadoxine I pyrimethamine
1 'sulfamethoxazole r trimethopri
suramin sodium
suxamethonium
tamoxifen
testosterone
tetanus antitoxin
tetanus antitoxin, human
tetanus vaccine
□tetracaine
□tetracycline
thiamine
thioaectazone + isoniazid
thiopental
tiabendazole
' 'timolol
trimethoprim 4 □sulfa
methoxazole
trisodium citrate dihydrate
tuberculin, purified protein
derivative (PPD)
typhoid vaccine
R
26,
norethisterone enantate
norethisterone 4- □ethinylestradiol
nystatin
19
rabies vaccine
□reserpine
retinol
riboflavin
rifampicin
'verapamil
vinblastine
vincristine
W
O
S
oral rchydration salts (for
glucose salt solution)
oxamniquinc
oxygen
oxytocin
19.
phenobarbital
phcnoxymethylpenicillin
phenytoin
phytomenadione
pilocarpine
piperazine
podophylline
poliomyelitis vaccine
potassium chloride, oral
solution
26,
potassium chloride, parenteral
potassium iodide
praziquantel
17,
□prednisolone
16, 21,
sodium amidotrizoate
sodium bicarbonate
sodium calcium edetate
sodium chloride
sodium chloride with glucose
sodium fluoride
□sodium lactate, compound
26
salazosulfapyridine
□salbutamol
n
•
u-warlarm
water for injection
salicylic acid
salicylic acid 4- benzoic acid
□senna
silver nitrate
yellow fever vaccine
Reproduced from The Use of Essential Drugs, Second Report of the WHO
Expert Committee, WHO Technical Series 722, WHO, Geneva, 1985
4ftt ALPHABETICAL LIST OF ESSENTIAL DRUGS
(Fourth Revision)
WHO Technical Report Series 722
^cimetidine
cisplatin
clofazimine
clomifene
□cloxacillin
acetazolamide
acetylsalicylic acid
albumin, human
allopurinol
aluminium acetate
aluminium hydroxide
□amiloride
□aminophylline
□amitriptyline
factor IX complex
(coagulation factors II, VII,
IX, X) concentrate
ferrous salt
ferrous salt + folic acid
flucytosine
fludrocortisone
fluorescein
fluorouracil
□fluphenazine
folic acid
folic acid 4- □ferrous salt
□furosemide
coal tar
□codeine
colchicine
cromoglicic acid
cyclophosphamide
cytarabine
amodiaquine
amphotericin B
□ampicillin
anti-D immunoglobulin (human)
antihaemophilic fraction (see
factor VI11 concentrate)
antihaemorrhoidal preparation:
local anaesthetic, astringent and
antiinflammatory drug
antirabics hyperimmune serum
antiscorpion sera
antivenom sera
. ascorbic acid
□atropine
16,
□azalhioprinc
B
□bacitracin 4- □neomycin
diethylcarbamazine
digitoxin
digoxin
diloxanide
dimercaprol
G
□gallamine
gentian violet1
□gentamicin
□glibenclamide
glucose
glucose with sodium chloride
glyceryl trinitrate
griseofulvin
H
□haloperidol
diphtheria antitoxin
diphtheria-pertussis-tetanus
vaccine
diphtheria-tetanus vaccine
dopamine
□doxorubicin
barium sulfate
BCG vaccine (dried)
beclometasone
benzathine benzylpenicillin
benzoic acid 4- salicylic acid
benzyl benzoate
benzylpenicillin
□betamethasone
□biperiden
bleomycin
□bupivacaine
doxycycline
halothane
heparin
□homatropine
□hydralazine
□hydrochlorothiazide
□hydrocortisone
□hydroxocobalamin
24,
E
ephedrine
epinephrine
□ergocalciferol
□ergometrine
C
1
16, 23, 29,
ergotamine
erythromycin
ethambutol
ether, anaesthetic
□ethinylestradiol
□elhinylestradiol 4- ^levonorgestrel
□ethinylcstradiol + Dnorethisterone
□calamine lotion
calcium carbonate
calcium folinate
calcium gluconate
carbamazepine
□carbidopa 4- levodopa
charcoal, activated
□chloramphenicol
□chlorhexidine
□chloroquine
□chlorphenamine
□chlorpromazine
chlortalidone
1 Also known as crystal
methylrosanilinium chloride).
D
dactinomycin
dapsone
deferoxamine
dehydroemetine
depot medroxyprogesterone
acetate
□dexamethasone
□dextran 70
□diazepam
ethionamide
ethosuximide
etoposide
factor VIII concentrate
(International
Nonproprietary
imipramine
immunoglobulin, human normal
indomctacin
influenza vaccine
insulin injection, solution
insulin, intermediate acting
intraperitoneal dialysis solution
□iodine
□iohexal
iolroxatc
□iopanoic acid
ipecacuanha
□iron dextran
isoniazid
isoniazid -f thioacclazone
isoprenaline
□isosorbide dinitrate
F
violet
□ibuprofen
Name:
K
paracetamol
penicillamine
pentamidine
□pethidine
ketamine
L
levodopa
levodopa 4- Dcarbidopa
□levonorgestrel -I- □ethinylestradiol
levothyroxine
□lidocaine
15,
lindane
lithium carbonate
M
magnesium hydroxide
magnesium sulfate
mannitol
measles vaccine
□mebendazole
meglumine amidolrizoate
melarsoprol
meningococcal vaccine
meicaptopurine
methotrexate
methyldopa
methylthioninium chloride
metoclopramide
melrifonate
□metronidazole
□miconazole
□morphine
primaquine
probenecid
□procainamide
procaine benzylpenicillin
procarbazine
□promethazine
□propranolol
propyliodone
□propylthiouracil
17,
protamine sulfate
protionamide
pyrantel
pyrazinamide
pyridostigmine
pyridoxine
pyrimethamine 4- sulfadoxinc
N
Q
naloxone
□neomycin 4- abacitracin
□neostigmine
□nicotinamide
□quinidine
quinine
niclosamide
□nifurlimox
nitrofurantoin
nitrous oxide
□norethistcrone
22,
solution
sodium nitrite
□sodium nitroprusside
□sodium stibogluconate
sodium thiosulfate
spcctinomycin
spironolactone
streptomycin
sulfacetamide
1 'sulfadimidine
sulfadoxinc I pyrimethamine
f 'sulfamethoxazole E trimethopri
suramin sodium
suxamethonium
tamoxifen
testosterone
tetanus antitoxin
tetanus antitoxin, human
tetanus vaccine
□tetracaine
□tetracycline
thiamine
thioacctazone 4- isoniazid
thiopental
tiabendazole
timolol
trimethoprim 4 □sulfa
methoxazole
trisodium citrate dihydrate
tuberculin, purified protein
derivative (PPD)
typhoid vaccine
R
26,
norethisterone cnantate
norelhisterone + uethinyleslradiol
nystatin
19
rabies vaccine
□reserpine
valproic acid
□verapamil
retinol
riboflavin
rifampicin
vinblastine
vincristine
W
O
S
oral rehydration salts (for
glucose salt solution)
oxamniquine
oxygen
oxytocin
19.
phenobarbital
phenoxymethylpenicillin
phenytoin
phytomenadione
pilocarpine
piperazine
podophylline
poliomyelitis vaccine
potassium chloride, oral
solution
26,
potassium chloride, parenteral
potassium iodide
praziquantel
17,
□prednisolone
16, 21,
sodium amidolrizoate
sodium bicarbonate
sodium calcium edetale
sodium chloride
sodium chloride with glucose
sodium fluoride
□sodium lactate, compound
26
salazosulfapyridine
□salbutamol
salicylic acid
salicylic acid 4- benzoic acid
□senna
silver nitrate
□warfarin
waler for injection
Y
yellow fever vaccine
Reproduced from The Use of Essential Drugs, Second Report of the WHO
Expert Committee, WHO Technical Series 722, WHO, Geneva, 1985
Wd ALPHABETICAL LIST OF ESSENTIAL DRUGS
(Fourth Revision)
WHO Technical Report Series 722
A
□cimetidine
cisplatin
clofazimine
clomifene
□cioxacillin
acetazolamide
acetylsalicylic acid
albumin, human
allopurinol
aluminium acetate
aluminium hydroxide
□amiloride
□aminophylline
□amitriptyline
factor IX complex
(coagulation factors II, VII,
IX, X) concentrate
ferrous salt
ferrous salt 4- folic acid
flucytosine
fludrocortisone
fluorescein
fluorouracil
□fluphcnazinc
coal tar
□codeine
colchicine
cromoglicic acid
cyclophosphamide
cytarabine
folic acid
folic acid 4- □ferrous salt
□furosemide
amodiaquine
amphotericin B
□ampicillin
•
anti-D immunoglobulin (human)
antihaemophilic fraction (sec
factor VIII concentrate)
antihaemorrhoidal preparation.
local anaesthetic, astringent and
antiinflammatory drug
antirabies hyperimmune serum
antiscorpion sera
antivenom sera
. ascorbic acid
□atropine
16,
□azathioprinc
B
□bacitracin 4- □neomycin
G
□gallamine
gentian violet1
□gentamicin
□glibenclamide
glucose
glucose with sodium chloride
glyceryl trinitrate
griseofulvin
H
□haloperidol
doxycycline
halothane
heparin
□homatropine
□hydralazine
□hydrochlorothiazide
□hydrocortisone
□hydroxocobalamin
24,
E
ephedrine
epinephrine
□ergocalciferol
□ergometrine
C
1
16, 23, 29,
ergotamine
erythromycin
ethambutol
ether, anaesthetic
□ethinylestradiol
□ethinylestradiol 4- □levonorgestrel
□ethinylestradiol 4- □norethisterone
□calamine lotion
calcium carbonate
calcium folinate
calcium gluconate
carbamazepine
□carbidopa 4- levodopa
charcoal, activated
□chloramphenicol
□chlorhexidine
□chloroquine
□chlorphenamine
□chlorpromazine
chlortalidone
1 Also known as crystal
mcthylrosanilinium chloride).
diethylcarbamazine
digitoxin
digoxin
diloxanide
dimercaprol
diphtheria antitoxin
diphtheria-pertussis-tetanus
vaccine
diphtheria-tetanus vaccine
dopamine
□doxorubicin
barium sulfate
BCG vaccine (dried)
beclometasone
benzathine benzylpenicillin
benzoic acid 4- salicylic acid
benzyl benzoate
benzylpenicillin
□betamethasone
□biperiden
bleomycin
□bupivacaine
•
D
dactinomycin
dapsone
deferoxamine
dchydrocmetine
depot medroxyprogesterone
acetate
□dexamethasone
□dextran 70
□diazepam
ethionamide
ethosuximide
etoposide
isoniazid
isoniazid 4- thioacelazone
isoprenaline
□isosorbide dinitrate
factor VII1 concentrate
(International
Nonproprietary
imipramine
immunoglobulin, human normal
indomclacin
influenza vaccine
insulin injection, solution
insulin, intermediate acting
intraperitoneal dialysis solution
□iodine
□iohexal
iotroxatc
□iopanoic acid
ipecacuanha
□iron dextran
F
violet
□ibuprofen
Name:
P
K
paracetamol
penicillamine
pentamidine
□pethidine
ketamine
L
levodopa
levodopa -I- □carbidopa
□levonorgestrel + □ethinylcstradiol
levothyroxine
□lidocaine
15.
lindane
lithium carbonate
M
magnesium hydroxide
magnesium sulfate
mannitol
measles vaccine
□mebendazole
meglumine amidotrizoate
melarsoprol
meningococcal vaccine
mercaptopurme
methotrexate
methyldopa
methylthioninium chloride
metoclopramide
metrifonate
□metronidazole
□miconazole
□morphine
primaquine
probenecid
□procainamide
procaine benzylpenicillin
procarbazine
□promethazine
□propranolol
propyliodone
□propylthiouracil
17,
protamine sulfate
prolionamide
pyrantel
pyrazinamide
pyridostigmine
pyridoxine
pyrimethamine + sulfadoxine
N
Q
naloxone
□neomycin + □bacitracin
□neostigmine
□nicotinamide
□quinidine
quinine
niclosamide
□nifurtimox
nitrofurantoin
nitrous oxide
□norethisterone
19.
phenobarbital
phenoxymethylpenicillin
phenytoin
phytomenadione
pilocarpine
piperazine
podophylline
poliomyelitis vaccine
potassium chloride, oral
solution
26,
potassium chloride, parenteral
potassium iodide
praziquantel
17.
□prednisolone
16, 21,
22,
sodium amidotrizoate
sodium bicarbonate
sodium calcium edetate
sodium chloride
sodium chloride with glucose
sodium fluoride
□sodium lactate, compound
solution
sodium nitrite
□sodium nitroprusside
□sodium stibogluconate
sodium thiosulfate
spcctmomycin
spironolactone
streptomycin
sulfacetamide
1 ’sulfadimidine
sulfadoxine I pyrimethamine
□sulfamethoxazole F trimethopri
suramin sodium
suxamethonium
tamoxifen
testosterone
tetanus antitoxin
tetanus antitoxin, human
tetanus vaccine
□tetracaine
□tetracycline
thiamine
thioacctazonc + isoniazid
thiopental
tiabendazole
□timolol
trimethoprim I- □sulfa
methoxazole
trisodium citrate dihydrate
tuberculin, purified protein
derivative (PPD)
typhoid vaccine
R
26,
norethisterone enanlate
norcthisterone + □cthinyleslradiol
nystatin
19
rabies vaccine
□reserpine
valproic acid
1J verapamil
retinol
riboflavin
rifampicin
vinblastine
vincristine
O
oral rchydration salts (for
glucose salt solution)
oxamniquine
oxygen
oxytocin
26
salazosulfapyridine
□salbutamol
salicylic acid
salicylic acid + benzoic acid
senna
silver nitrate
waler for injection
yellow fever vaccine
Reproduced from The Use of Essential Drugs, Second Report of the WHO
Expert Committee, WHO Technical Series 722, WHO, Geneva, 1985
18,
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 commerical 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, o.ur 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 — develooed 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 this issue of dumped
and hazardous drugs.
SOME BANNABLE DRUGS — 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 Health and Family
Welfare accepted it in 1981.
The DTAB, a Statuatory Body under Section 5 of 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 foreiqn sector, 8 by public sector,
and 298 by private sector. Most 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 formulatios". What compassion and consideration for the drug companies!
SOME BATTLES
Halogenated Hydroxyquinolme
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.
Reprinted by : VHAI—New Delhi
VOLUNTARY HEALTH ASSOCIATION OF INDIA
40, Institutional Area, South of l.l.T.
New Delhi -110016
As Part of Rational Drug
Policy Campaign
RESailFEES
HA I Clearinghouse
Resource Sheet #3
March 1982
This list covers articles on drugs published since 1975 in a major consumer magazine.
DRUGS AND DRUG INDUSTRY
K
Les consommateurs au banc de la defence, in 50 Millions de Consommateurs,
Consommation (France), No. 49, Jan. 1975, p. 6.
4
Industries pharmaceutiaues, de drole de m&thodes, in 50 Millions de Consoimateurs, I ns ti tut National de la
Consommation (France), No. 50, Feb. 1975, pp. 48-49.
4
Medicaments et medicine en question, in Liaisons Cooperatives, Federation Nationale des Cooperatives de
Consommation (France), No. 185, Mar. 1975, pp. 61-8.
I ns ti tut National de la
in Le Cooperateur de
4
L'Industrie pharmaceutique reconnait le droit a I'information des consommateurs,
France, CDF (France), No. 638, 14 June 1975, p. 4.
4
Medicaments: des silences calcules,
July/Aug. 1975, p. 31.
4
A qui profits la maladie? (Who profits out of illness?), in Test Achats, Association des Consommateurs
(Belgium), No. 161, Oct. 1975, pp. 4-5.
4
Hvem misbruger medicinen ? ([/ho is misusing medicine?),
1976, pp. 2
*6-31.
4
Drug Companies and the Third World, in Asia/Pacific Consumer, I0CU (Malaysia), No. 9, Oct. 1976, pp. 3-7
and 29.
4
Drugs and Cosmetics, in Asia/Pacific Consumer, I0CU (Malaysia), No. 9, Oct. 1976, pp. 10-14.
4
Les remedes brevetes. Faut etre malade pour acheter ca!, in Le Reveil du Consommateur, I nstitut de
Promotion des Interets du Consommateur (Canada), Vol. 4, No. 7, 1976, pp. 12-24.
4
Questions-reponses apropos des medicaments, in J'achete mieux, Federation Romande des Consommatrices
(Switzerland), No. 68, March 1977, pp. 30-31.
4
Stop dem Tablettenmissbrauch! (Stop the misuse of tablets!),
(Switzerland), No. 2, Mar-Apr. 1977, pp. 3“7.
4
"Tag familien med!" (Bring your family!), in Taenk, Forbrugerradet (Denmark), No. 4, June 1977, p. 2.
(Edi torial about the sales techniques of drug companies and the fact that there are too many drugs on
the market.)
4
Sbandardarzncimittel kosbendampfend,
27 Sept. 1977, pp. 2-3.
4
Le sucre et les medicaments, in Le Reveil du Consommateur, L'lnstitut de Promotion des Interets du
Consommateur (Canada), Sept. 1977, PP. 35-36.
4
Un paso contra el abuso de medicinas, in Ciudadano, Ciudadano S.A. (Spain), No. 73, Feb. 1978, pp. 54-55.
in Test Achats, Association des Consommateurs (Belgium), No. 159,
in Taenk, Forbrugerradet (Denmark), No. 5, June
in Pruf Mit, Konsumentinnenforums
in Verbraucher Politische Korrespondenz, AgV (Germany), No. 39,
in L 'Impatient, L1Impatient (France), No. 6, April 1978, pp. 20-21.
4
Les medicaments essentials,
*
Aliments et medicaments interagissent,
No. 120, May/June 1978, p. 32.
4
Indignation:
4
Medicamentos esenciales,
4
Rom the FDA rates prescription drugs, in Consumer Reports, Consumers' Union (USA), Oct. 1978, pp. 578-581.
4
Alkoholkennzeichnung fur Arzneimittel dringlich,
No. 46, 14 Nov. 1978, pp. 6-7.
4
L'effet "placebo", in Le Cooperateur de France, FNCC (France), No. 720, 2 Dec. 1978, p. 34.
4
La Consommation pharmaceutique: une escalade difficile a controler,
OrGeCo (France), 31 Dec. 1978, pp. 2-3.
4
Dishwashing Machines in developing countries, in Asia/Pacific Consumer, IOCU (Malaysia), Jan. 1979,
pP. 18-20.
(On drug companies and the Third World.)
4
Les multinationales pharmaceutiques et le tiersmonde,
pp. 14-151.
4
Serocytol: des precisions....,
4
Rew drugs and their side effects,
March-April 1979, p. 7-
in Bulletin d'Information, Laboratoire Cooperatif (France),
le gaspillage des medicaments,
in Que Choisir?, UFC (France), No. 130, June 1978, p. 16.
in Ciudadano, Ciudadano S.A.
(Spain), No. 76, June 1978, pp. 36-37 + 40-41.
in Verbraucher-politische Korrespondenz, AgV (Germany),
in Information Consommation,
in L 'Impatient (France), No. 15, Feb. 1979,
in Consommateurs Actualite, INC (France), No. 191-192, 30 Mar. 1979, p.ll.
in Case Consumer Bulletin, Consumers' Association (Singapore),
4
Les escrocs du serocytol,
in 50 Millions de Consommateurs, INC (France), No. 100, April 1979, pp. 3-7.
4
Serocytol:
les reactions,
in 50 Millions de Consommateurs, INC (France), No. 191, May 1979, pp. 10-11.
4
Serocytols:
ce qu'on ne vous a pas dit,
4
Medicaments: des remedes antigaspillage, in Le Cooperateur de France, FNCC (France), No. 734, 16 June
1979, PP. 10.11.
4
Pour un meillure usage des medicaments,
PP. 2-3.
in L 'Impatient (France), No. 18, May 1979, pp. 7-8.
in Consommateurs Actualite, INC (France), No. 202, June 1979,
defense de chasser le gaspi, in L 'Impatient (France), No. 20-21, July Aug.
4
Medicaments:
*
Remedes contre les abus,
in 50 Millions de Consoimateurs, INC (France), No.
’
10^, Aug. 1979, P
*
Los medicamentes y los paises en desarrollo, in Guia del Consumidor, Consumer Protection
*
Arzneimittel und Verbraucher (Drugs and the consumer),
(Mexico), No. 92/Nov. 1979, pp. 3^”35.
in Verbraucher Rundschau, AgV (Germany), No. 5,
1979, pp. 2-5.
*
Fairs du "patient" europeen un consommateur de sante,
*
Drug advertising and marketing in the Third World,
in Que Choisir?, UFC (France), No. 1, 1979, PP- 30 35.
in Sri Lanka Consumer Quarterly, Consumers
Association,
(Sri Lanka), No. 1 , Jan-Apr. 1980, pp. 26-30.
*
Vanlig at folk misforstar, in Forbruker Rapporten, Forbrukerradet (Norway), Feb. 1980, pp. 12 13-
IOCU (Netherlands), No. 90, May 1980, pp. 1-6.
*
The voice of the consumer, in I0CU Newsletter,
*
Questions for the doctor,
*
Consumerisme et Industrie pharmaceutigue,
4
Les petits cadeaux entretiennent I’amitie, in L'Impatient (France), No. 32-33, Jul-Aug. 1980, pp. A4-^6.
4
Gesundheitsschutz,
4
Illness as a business,
4
Ansat afsldrede kemikoncem - fik penge af EF,
4
Cadeaux empoisonnes,
4
Dangerous medicines pushed by drug companies,
(Malaysia), Dec. 198b, p. 11.
4
Alkoholhinweis bei Arzneien fehlt immer noch, in Verbraucher-politische Korrespondenz, AgV (Germany),
No. 5, 3 Feb. 1981, p. 7.
in Consumers' Research Magazine, Consumers1 Research Inc.
(USA), Jul. 1980, p.4l.
in Cooperation, Distribution, Consommation, FNCC (France),
No. 7-8, Jul-Aug. 1980, pp. 19-23.
in Verbraucher-politische Korrespondenz, AgV (Germany), No. 38, 16 Sept. 1980, pp.7-8.
in Berita FOMCA, FOMCA (Malaysia), Sept. 1980, p.h.
in Taenk, Forbrugerradet (Denmark), No. 8, Oct.
1980, p. 15.
in 50 Millions de Consommateurs, INC (France), No. 118, Oct. 1980, pp. 13-15.
in Utusan Konsumer, Consumers' Association of Penang
March 1981,
4
Lembaga informasi obat, in Warta Konsumen, Yayasan Lembaga Konsumen (Indonesia), No. 8
*4,
pp. 3“^•
(The Indonesian Information Centre on Medicines.)
4
Sante et Medicaments,
4
Reflexions sur un proces, in 50 Millions de Consommateurs, INC (France), No. 127, Jul. 1981 , p. 9.
(On Serocytol.)
4
The WHO essential drugs programme, in I0CU Newsletter (Netherlands), No. h, 1981, pp. 5-6.
DRUGS:
4
in Information Consommation, Orgeco (France), No. 87, 15 Apr. 1981 , pp. 1-A.
ADVERTISING
Publicite des produits medicaux, in Consommateurs Actualite, Institut National de la Consommation (Francel
No. 104, 16 Sept. 1976, pp. 8-9.
A
La publicite pharmaceutigue,
PP- I-1*.
in Que Savoir?, Union Federale des Consommateurs (France)
No. 5 & 6, 1976,
4
C.C.C. et publicite sur les produits pharmaceutigues,
30 June 1978’, p.X
4
ba publicite reconforte plus gue des mediccaments,
Oct. 1978, pp. 5-6.
in Le Reveil du Consommateur
Heilmittelwerbung ist keine Gesundheitserziehung,
No. 45, 7 Nov. 1978, pp. 2-3.———
in Verbraucher-politische Korrespondenz, hg\J (Germany),
in Consommateurs Actualite, INC (France)
IPIC (Canada)
No. 158,
No. 3,
Du ser inte reklamen - men den paverkar dig, (Patients don 't see the publicity - but it affo^-a
them),
in Rad <S Ron, Konsumentverket (Sweden), No. 6, Aug. 1979, pp. 14-17.
J
97% P°T m adVerti3in? fOr
*
4
Das Heilmittelwcrbegesetz, in Verbraucher Rundschau, AgV (Germany), No. 5, 1979
4
Drug advertising and marketing in the Third World, In Sri Lanka Consumer Quarter! „
Association (Sri Lanka), No. 1, Jan-Apr. 1980, pp. 26-30.
Health hazards of drug advertising,
Il etait une fois un dccret....,
pp. 12-13.
16
p
onsumers.
in Sri Lanka Consumer Quarterly, No. 1, Jan-Apr. 1980, pp. 21-26.
In 50 Millions de Consommateurs, INC (France), No. 123, Mar. 1981
28 Mar
La publicite des medicaments, in Le Cooperateur de France, FNCC (France), No. 777
1981 , pp. H-15.
Grundlagsskyddad bluff, i n Konsumentratt & Ekonomi, Konsumentverket (Sweden), No
1
1981
PP- 2-5.
DRUGS:
LABELLING
4
Du nouveau pour la regiementation des medicaments,
March 1975, p. 2.
4
Neuvos simbolos en los medicamentos, in Cuidadano, Cuidadano SA (Spain), No. 44, April 1976, pp. 38.
In la Cooperate de France, C.O.F.
(France), No. 632
('onsonma'i'eur8 Aetualite, I ns ti tut National de la Consommation (France),
No. 140, Feb^
gtfre besked om medicin,
in Taenk, Forbrugerradet (Denmark), No. k, May 1978, p. 5.
Concurncr^pfLf^i^
nie^ccfne,ltos peligrosos y el etiquetage inadecuado,
consumer Protect .on Assoc.ation (Mexico), No. 104, Nov. ig8o,~pp. 10-16.
Tun.g?98^a<‘p'a'l?3 ^'n8er1'--f
DRUGS:
'n
in Guia del Consumidor,
of the Consumer, Consumer Protection Association, Ohio (USA), No. 4,
PRESCRIPTIONS
—to pay less for prescription drugs, in Consumer Reports, Consumers Union (USA), Jan. 1975, pp. 48-53.
zu wenig auf die Praise, in Verbraucher Politisehe Korrespondenz, AgV (Germany), No. 8,
reo. 19/0, pp. 6-7.
Dae Drez-Milliarden-Ding der Arzte, in Test, Stiftung Warentest (Germany), No. 2, Feb. 1978, pp. 14-20.
Consumismo farmaceutico,
In UNC Notizie, UNC (Italy), No. 259, 31 Jan. 198O, p. 2.
Ifedicine^—how to read your drug prescription, in Canadian Consumer, Consumers' Association (Canada),
Vol. 11, No. 3, Jun. 1981 . pp. 37-39.
DRUGS:
*
PRICES
Mere om Apotekerpriser (More about the price of drugs), in Taenk, Forbrugerradet (Denmark)
1975, pp. 16-18.
----------- ---------
Waar bligft het paardemzddel tegen dure plllenslikkerig?,
(Netherlands), No. 7, July 1976, pp. 10.12.
No. 3, April
in Koopkracht, Stichtung Konsumenten Kontakt
How the drug companies operate,
in Asia/Pacific Consumer, IOCU (Malaysia), No. 9, Oct. 1976, pp. 1-2.
The price of pill-popping....,
in Asia/Pacific Consumer, IOCU (Malaysia), No. 9, Oct. 1976, pp. 8-9.
Wig betalen onze medieignen duur Prigzen van geneesmiddelen internationaal vergeleken, i n Consumentengids ,
Consumentenbond (Netherlands), No. 12, Dec. 1976, pp. 543-6.
in Verbraucher-politische Korrespondenz, AgV (Germany), No. 2,
4
Arzneimittelpreise erstmals durchleuchtet,
11 Jan. 1977, PP- 2-3.
4
Prig everschillen medieignen, in Consumentengids, Consumentenbond (Netherlands), Feb. 1977, p- 84.
*
Medicinpriser,
4
Drug Price Comparison, in AFCO Quarterly, Australian Federation of Consumer Organizations (Australia),
No. 7, Apr. 1977, pp. 8-10+11.
4
En international sammenligning af medicinpriser (International comparison of prices of medicaments),
Taenk, Forbrugerradet (Denmark), No. 5, July 1977, pp. 16-18.
4
Les aleas du tiers-payant, in 50 Millions de Consommateurs , Institut National de la Consommation (France),
No. 80, Aug. 1977, pp: 17“l8.
in Taenk, Forbrugerradet (Denmark), No. 2, Mar. 1977, p. 2.
in
in Consumentengids, Consumentenbond (Netherlands), Nov. 1977, p. 487.
*
Valium en librium nog steeds te duur,
*
C/Caisse M&dico-Chirurgicale Mutualiste,
(Luxembourg), No. 5, 1977, pp. 6-8.
*
Bittere Pille fur deutsche Patienten (Bitter pills for German patients),
(Germany), No. 1, Jan. 1978, pp. 10-17•
*
Das Drei-Milliarden-Ding der Arzte,
•+
[)ne surveillance indispensable, in J’Achete Mieux, La Federation Romande des Consommatrices (Switzerland),
No. 75, May-June 1978, pp. 38-39-
*
Qnze geneesmiddelenprigzen,
4
ez precio de los medicamentos,
4
yjele Listen - kein Durchblick, in Test, Stiftung Warentest (Germany), No. 4, Apr. 1980, pp.
4
Loco’s in plaats van specialties: dezelfde working, lagere prigs,
(Netherlands), May 1980, pp. 223-225.
4
[^s multinationales et le prix des medicaments,
20 June 1980, pp. 11-12.
4
boycott des pharmaciens,
4
medicaments:
4
in de Konswnent, Union Luxembourgeoise Des Consommateurs
in Test, Stiftung Warentest
in Test, Stlftung-Warentest (Germany), No. 2, Feb. 1978, pp. 14-20.
in Consumentengids, Consumentenbond (Netherlands), No. 2, Feb. 1979, pp.74-77.
in Ciudadano (Spain), No. 95, Apr. 1980, pp. 20-21.
18-20.
in Consumentengids , Consumentenbond
in Consommateurs Aetualite, INC (France), No. 250,
in 50 Millions de Consommateurs, INC (France), No. 118, Oct. 198O, pp. 10-12.
que coutent-ils?,
in J'Achete Mieux, FRC (Switzerland), No. 91, Jan-Feb. 198l,pp.7-9.
Scheinheiliges Stabilitatsversprechenj In Verbraucher-politische Korrespondenz, AgV (Germany), No. 17,
28 Apr. 198'1, PP- 3-^-
DRUGS:
SAFETY
4
Rezeptfreie Sehmcrzmittel (Painkillers not on prescription),
(Switzerland), No. i"7 1975, pP• 18-21.
4
pn miracle a la tragedie,
4
you
In Pruf Mit, KonsumentInnenforum
in Le Consommateur, Federation Beige des Cooperatives (Belgium), May/Jun. 1976,p. 10.
and your health - Medicines,
pp. 2O1-3T
in Consumer, Consumers'
Institute (New Zealand), No. 131, August 1976,
1
St les medicaments?, in Ufidec, Ufidec (Belgium), No. 123, Sept. 1976, PP- 2-1'-
»
Aleool £ Elixirs, in J’achite mieux, Federation Romande des Consommatrices (Switzerland), No. 70, July '77, p. kO.
*
Piramidon muss sofort yom Markt, in Verbraucher-politische Korrespondenz, AgV (Germany), No. 33,
*
Tons les medicaments ne sauvent pas, in Ufidec, Ufidec (Belgium), No. 132, Aug. 1977, P- 7(Danger of
cl ioquinol - 1000 deaths & 30,000 handicapped people In Japan - fami lies asking for compensation from CIba-GeigyJ
*
Medicament dangereux:
(Colouring in Medicines.)
1(j August 1977, PP- 2-4.
prudence necessaire!,
In Bulletin d' information, Laboratoire Co-operatif d'analyses
et de recherche, No. 117, Nov-Dec. 1977, PP- 24-26.
*
Qu est la difference entre ces 2 flacons de medicaments? (What is the difference between these two
bottles of medicine?), in Que Choi sir, UFC (France) , No. 124, Dec. 1977, PP- 3
4.
*
4
Sachez bien utiliser vos medicaments, in Le Cooperateur de France, Federation Nationale des Cooperatives
de Consommateurs (France), No. 705, 8 April 1978, pp. 23“26.
in Test Achats, Association des Consommateurs (Belgium), No. 189, Apr. 1978, pp. 35-
*
Dans noire guide....,
*
Protection du consommateur, in Information Consommation, L'Orgeco (France), No. 28, May-June 1978, p. 12.
*
Des medicaments deconseilles aux automobilistes, in L 'Impatient, L'Impatient (France), No. 9, July 1978,
PP- 19-20.
*
Vous avez le droit de savoir, in 50 Millions de Consommateurs,
*
Missbildungen durch Douggnon,
1 Aug. 197'6, pp. 2-3-
4
Zentrale Erfassungsstelle fur Duoggnon-geschadigte Kinder,
(Germany) , No. 37, 12 Sept'. 1978, pp. 2-3-
INC (France), No. 91, July 1978, pp. 38-39-
in Verbraucher-politische Korrespondenz , AgV (Germany), No. 31,
in Verbraucher-politische Korrespondenz, AgV
in Canadian Consumer, Consumers' Association (Canada), Oct. 1978, pp. 56-57-
4
Drugs and Diet,
4
Les medicaments contre-indiques avec I 'aleool, in L’Impatient, L'Impatient (France), No.11, Oct. '78, pp. 27-28.
4
Picolez...nous ferons le reste!,
4
AgV unterstiitzt Verbot von "Clofibrat" (AgV supports ban on "Clofibrat"),
Korrespondenz, AgV (Germany), No. 52, 27 Dec. 1978, p. 4.
*
Notre demands de retrait des 3 medicaments,
*
Kan vi stole pa legemiddelindustrien? (Can we rely on the pharmaceutical industry?),
Rapporten, Forbrukerradet (Norway),No. 7, 1978, pp. 44-47.
*
Alkoholhinweis auf Arzneimitteln kommt, in Verbraucher-politische Korrespondenz, AgV (Germany), No. 2,
9 Jan. 1979, P- 6.
in Le Cooperateur de France, FNCC (France), No. 718, Nov. 1978, p. 40.
in Verbraucher-politische
in Que Choisir ?, UFC (France), No. 135, Dec. 1978, p. 23.
in Forbruker
in Asia/Pacific Consumer, I0CU (Malaysia), Jan. 1979, pp. 23-29.
*
Developing a register of "problem drugs",
*
Die heimlichen Verfuhrer (The secret seducer),
PP- 17“19(Alcohol in medicines.)
4
muss ein Arzneimittel verboten warden? (When should a drug be banned?), in Verbraucher-politische
Korrespondenz, AgV (Germany), No. 6, 6 Feb. 1979, pp- 2-3.
4
Clofibrate:
*
Une ordonnance ca s'evalue.. .nous aligns le faire,
4
Les medicaments dangereux pour les enfants,
la fin d'une illusion,
in Test, Stiftung Warentest (Germany), No. 1, Jan. 1979,
in L 'Impatient (France), No. 15, Feb. 1979, pp. 12-14.
in L'Impatient (France), No. 16, March 1979, p. 31.
in L'Impatient (France), No. 18, May 1979, pp. 4-6.
4
Drug/alcohol interactions,
in Choice, Consumers' Association (Australia), June 1979, pp- 187-188.
4
Arzneimittelnebenwirkunaen,
in Verbraucher Rundschau, hg\J (Germany), No. 5, 1979, pp. 9-10.
4‘ Drug safety - monitoring: WHO,
in Consumer Review,
IOCU (Netherlands), Vol. X, No. 4, 1979, pp. 295-297.
4
Chloramphenicol and olioquinol, in IOCU Newsletter,
4
Attention: contre-indications , in 50 Millions de Consommateurs, INC (France), No. Ill, Mar. '80, pp. II-13.
4
Diflurex:
4
Food
interactions, in Consumer Comment, Consumers' Association of Victoria (Australia)
No. 3
Sect. 1980. dd. 10-11.
’
'
’
IOCU (Netherlands), No. 91, Jun. 198O, p. 5.ii.
on est perplexe, in L 'Impatient (France), No. 28, Mar. 1980, p. 22.
La controversia de las mediementos veligrosos y el etiquetaje inadecuado,
Consumer Protection Institute (Mexico), No. 104, Nov. 1980, pp. 10-16.
Death by prescription pad,
Am Beispiel Duoggnon,
in Guia del Consimidor
in Caveat Emptor Consumers Bulletin (USA), Dec. 1980, p. 7.
in Verbraucher-politische Korrespondenz, AgV (Germany), No. 4, 27 Jan. 1981
Pillren gor dig trafikfarlig (Medicine can make you a dangerous driver),
(Sweden), No. 1, Jan. 1981, pp. 4-5.
pp 6-8
in Had d Ron. Konsumentverker
Drug interactions:—a potehtial health threat, in Consumers' Research Magazine, Consumers' Research Inc
(USA), Feb. 1981, pp. 30-31.
nesearen inc.,
in Utusan Konsumer, Consumers Association of Penang (Malaysia), Mar. 1981, p
4
Alcohol in children's tonics,
4
Alkohol in Arzneimitteln (Alcohol in drugs), in Verbraucher-politische Korrespondenz AqV (Germanv)
No. 14, 7 Apr. 1981, pp. 3-4.
’ a
3
in Keemat, Consumer Guidance Society (India), No. k, Apr. 1981, pp. 6-7
*
Food and drugs,
*
Mon oar anti-biotique,
*
faod and
may alter the effect of drugs,
Education Research Center (USA), May 1981 , p. I5!.
in SO Millions de Consommateurs, INC (France), No. 12k, Apr. 1981
pp
In Caveat Emptor Consumers' Bulletin
15-16
Consumer
consumer
(S.2/2/82)
OCTOBER. 9, 1.9
*6
THE BANG LADES H TIMES
There is perhaps no denial
of the fact that the Drug Con
trol Ordinance 1982, came as
a big jolt for the entire indus
try. Changing an entire indus
trial sector from their exist
ing direction to a new direc
tion overnight, demanded a
great deal of the industry’s
capability and flexibility to ad
just to such
*changes.
'The ini
tial despair and frustration was
the result of this adjustment
crisis.
What the ordinance propos
ed and obviously accomplished
to a large extent today. w?ulc?
have perhaps evolved natural
ly, incourse of a long time, as
a result of the growing public
and industry conscience in fav
our of such change in direction.
What was a probability in
future was made by the ordin
ance into a reality over night.
Perhaps every such revolu
tionary change has a cost
which initially makes its po
tential benefits less obvious.
Needless to mention 'hat the
pharmaceutical industry of the
country paid that cost in term
*
of substantial loss of turnover,
*
low-'
’ ^rowth oi even negative
growth in some instances In
the years following the ordin
ance, wastage of resources, and
finally in redundancies of man
power.
Nevertheless,
despite
this initial experience, today.
four years after the ordinance
came into c fleet many of its
beneficial aspects have become
vivid, some of which are worth
the initial negative consequ
ences.
CONCEPT OF ESSENTIAL
DRUGS:
The single most important
benefit of the Drug Control Or
dinance was its emphasis cn
the concept of essential Drugs.
The concept emanated from
the realisation that although
every ‘drug’ is essential for
people who may require it.
sortie drugs are required more
often and by many Survey of
the disease prevalence in our
country would show that ab
out 150 drugs can cover almost
all major ailments affecting
the general mass. Pharmaceu
tical Industry’s approach to the
market did not overlook this
fact totally since, it is obvious
that the industry being basic-
Pharmaceutical Industries View
of Drug Control Ordinance 1982.
A. K. M- SHAH1DULLAH.
Secretary Genet al,
ally business enterprises can
not ignore products which have
mass demands. However, gov
ernment emphasis on the essen
tial drugs as enumerated in the
Drug Control Ordinance 1932,
was a
powerful motivating
force for the industry to treat
the essential drugs in higher
order of priority than before.
The result is well evident,
today the industry commits
64% of its total production
capacity to the essential drugs.
compared to 30% in 1931. This
does not only help people, as
larger output of these much
needed products results into
the deeper penetration of the
same into the mr;u market,
but also Hie industry. ft
is
Bangladesh ^ushad Siiilpa.
easy to appreciate that the in
dustry is based on much stron
ger toundation than before as
they thrive on products need
ed by the mass and such need
is only likely to grow and not
diminish for any reason what
soever, be it commercial or re
gulatory.
REDUCED DEPENDANCE
ON IMPORTED PRODUCTS:
One of the fundamental ob
jectives of the ordinance was
to encourage local production
of import-substitute.
Clearly,
before the promulgation of the
ordinance there were fixed ide: a
in the minds of all concerned
that there were many products
which were beyond the abili
ties of the local industry 1o for
mulate. That, this was
myth.
obvious by successful
Sanuty,
Heal market by unit, is per
haps as low as 5-7% today.
INCREASED AWARENESS
OF THE GENERAL PEOPLE:
Before the ordjft?.nce, Drug
v.as a subject which did not
concern the general population.
The wide-spread impact of the
ordinance on the general peo
ple stimp'ated their overall, in
terest on this subject which
they realised' was vitally con
nected to ‘.heii overall welfare.
The ordinance greatly boosted
the realisation of the mass that
their health e.t <
needs are as
vital as other needs of cheir
life, such as food, clothing and
housing. This increased their
health consciousness and re
sulted into expension of the
pharmaceutical
market,
as
more people sought medical at
tention than ever before. This
is a welcome sign for the in
dustry as well as for the coun
try in generaL
QUALITY CONTROL MUST
FOR SUCCESSFUL IMPLE
MENTATION OF ORDINANCE
It would be wise to sound a
note of cp’-u on that
r-rh-
leving greater production of
essential drugs at lower prices
is the main objective,
ho
cost standard of quality bt.
compromised. A certain scctr-r.
who would deliberately like
to foil this objective are divert
ing attention Iron this vital
aspect of drug manufacture.
Emphasis must be given L-y
the Government and the Re
gulatory Authorities on main
taining the highest quality of
products regardless of the size
or capability of the manufac
turer. Also at the time of im
port of raw materials due con
sideration to origin and quality
must be made. Lastly but most
were foiled, due to the eupho
ria of its Immediate gains
which its main objectives got
lost. While all of us feel quite
satisfied of >be achievements,
we must be careful of not los
ing sight of the main, objec
*
tives of The ordinance, which
were to make available, qua
lity produces, in enough quan«
titles,
at
reasonable
prices.
While working with these ob
jectives it has to be ensured
that the quality of pharmaceu
tical product is the most Im
portant fundamental require
ment and the same vtn not be
compromised for quantity Or foi
price.
important,
testing
facilities
must be further strengthened
so that this extremely import
ant function can be and is pro
perly discharged on a nation
wide basis.
of success,
CONCLUSION:
keep the main essence of the
As the history will
many
revolutionary
testify
efforts
• The nation's efforts to acnieve health for all by the year
2000, will have a better chance
if
all
ordinance in mind while tak
ing their Individual actions
PRODUCTION OF ESSENTIAL DRUGS AS COMPARED TO THE
TOTAL LOCAL PRODUCTION.
formulation of many of the
import-substitutes by local in
dustries during the four. ^qai^.
period following the orciihrmcW;;
Before the ordinance, it re
quired years of efforts by
local industries to secure pro
tection for their locally formu
lated import substitute. Import
substitutes received no priority
treatments In registration.
Today import substitutes nr-:
prioritised over other produces
in registrafon, they receive
preferential considerations fit
price fixation. Sometimes, the
licencing authority even takes
the initiative to reco.-r mend co
(he manufacturers to take up
production of certain high vo
lume import-substitutes, Indus
*
try citvo not hr-ve to move
tariff protection
any more.
They are consulted before for
mulation of the import policy
and their recommendations on
import restriction of products
arc viewed more seriously than
before.
All these wore possible be
cause of the serious re-biasing
of the attitude of all concerned
which includes of course the
regulatory authorities.
The result is obvious from
the reduction In the quantum
of imported products since 1981.
By value the imported pro
ducts share of the total drug’
consumption came down from
15% in 1981 to 10% in 1985. ]f
IMPORTED PRODUCT SHARE OF THE TOTAL NATIONAL
CONSUMPTION OF PHARMACEUTICAL PRODUCT.
we take Into account the dep
reciation of Taka against the
various currencies it will an'
pear that the imported product
-*are
of the total pharniaceu-
1984
YEAR
concerned
1985
The following is the text of the new tariat. ft is expected that the author termediates related to bulk drugs
drug policy.
ity would be set up within a period of which are delicensed.
three months.
The scheme of delicensing would
2. Quality control: It is proposed to be available to non-FERA and nonV XT ^TH a view to ensuring abunV V dam availability of drugs and give statutory effect to the good MRTP companies only. However, a
manufacturing
practices
arid
also
to
phased
manufactunng programme
pharmaceuticals at reasonable prices,
the Government has taken some me introduce a certification system would be presenbed for all com
asures for rationalisation, quality under which recognised institutions panies in order lo encourage Indigecontrol and growth of pharmaceutical with proven expertise and testing nisation. To encourage introduction
industry. The Hathi Committee facilities would certify the adoption of new drugs, it is proposed to bnng
which is a milestone in the develop by formulators of good manufactur all new bulk drugs and related for
ment of drug and pharmaceutical ing practices and the quality of for mulations developed in the country
under the scheme of delicensing To
industry in the country gave ns re mulations manufactured.
3. Pricing: In order to increase give a fillip to R&D activities within
commendations in 1975 on the basis
of which a Drug Policy was production which will lead to ulti the country, this scheme would be
mate
lowering
of
prices
of
drugs,
it
is
available
to all companies.
announced in 1978.
To further encourage production
There has been a considerable proposed to reduce the existing span
change in the situation in the phar of price control over drugs and phar and availability of drugs, it is prop
maceutical sector in the country since maceuticals. However, a very strong osed to extend the scheme of broad
the announcement of the policy of monitoring system will be evolved. banding to 31 groups of bulk drugs
1978 and it was considered necessary As against the existing three categor and formulations.
that the new thrust and direction ies of drugs and pharmaceuticals
Over the course of the last decade.
should be given in the policy frame to hereafter, there will be two category
Penicillin has come to be an essential
subserve the objective of growth of ies The first category will consist of
drug intermediate going into the pro
pharmaceutical industry in the de drugs necessary for the national
duction of such life-saving and essen
sired areas. The Government expects health programme and the second
tial broad spectrum antibiotics iike
that new measures which are being category that of other essential drugs.
ampicillin, amoxycillin, cephalexin
announced would help in the growth Formulations oF The first category
etc. Its production has been stagnat
of the industry in conformity with the would have a MAPE (Maximum
ing and imports have increased". To
health needs of the country. These Allowable Post Manufactunng Ex
increase production, to curtail im
measures also cover other important penses) of 75 per cent and those of
areas like quality control, rationalisa the second category that of 100 per ports and to save foreign exchange, it
is
proposed to allow all non-FERA
cent.
tion of use of drugs, standardisation
A High-Level .Expert Committee pharmaceutical companies in the
of packaging, banning of non-.
essential and harmful drugs etc. In would draw up a list of drugs to be country to produce penicillin The
included in the second category. same facility is being extended in
short, new measures aim at
(a)
ensuring abundant availability.However, the existing Drug Price respect of Polio Vaccine also.
To encourage export production.
at reasonable prices of essential life Control Order (DPCO) will continue
ail companies would have total flex
saving and prophylactic medicines of to be in force till a new one has been
announced after the finalisation of ibility io produce any products within
good quality;
their existing facilities.
(b)
strengthening the system ofdrugs in these two categories.
The existing ratio parameters be
The Government would retain the
quality control over drug production
and promoting the rational use of right to bring within the ambit of tween the value of production of bulk
drugs
and formulations are proposed
control any drug in the decontrolled
drugs in the country;
whenever considered neces to be revised as under:
(c)
creating an environment conducategory
(a) For FERA companies, ratio
sary.
Prices
of
drugs
in
the
decontrol
cive to channelising new investment
into the pharmaceutical industry, to led category would be constantly and parameters would now be 1.4 in place
encouraging cost-effective produc closely monitored and an effective of the present 1:5 in respect of value
ol production of bulk drugs to for
*
tion with economic sizes and io intro monitonmg system developed for
mulations.
ducing new technologies and new these.
(b) The ratio parameter
*;
for com
Drug prices Equalisation Account
drugs, and
(d)
strengthening the indigenouswould be abolished; but all accruals panies other than the FERA com
capability lor production of drugs. that have taken place to the account panies have been proposed on a
The salient features of the new or are likely to take place as a result graded basis depending upon the
of action in the past would be pro turnover, upto Rs 10 crores the ratio
measures are:
tected. Protection to indigenous in will be i:10; for production in excess
of Rs 10 crores and upto Rs 25
]. A National Drug & Phar dustry would be provided where crores, the ratio would De 1.7; and
necessary
through
the
tariff
maceutical Authority will-be created.
for production in excess of Rs 25
This authority will be an apex body mechanism.
crores, the ratio would be 15.
which will have representation from LICENSING
To provide effective co-ordination
all the concerned agencies including
The system of delicensing would be between the Health. Industry and
those from the industry. This author progressively extended subject to the other related Ministries, a Commit
ity would function as an advisor)’ following criteria:
tee would be set up in the Depart
body on matters of development of
(a) Bulk drugs whose imports are ment of Chemicals and Petrochemic
pharmaceutical industry. Among allowed on Open General Licence; als with Secretary, Chemicals and
other things, it would go into the
(b) Bulk drugs, whose production Petrochemicals as Chairman and con
question of rationalisation of existing is limned to three producers or less in sisting of Secretary, Ministry of
formulations in the market including the organised sector;
Health and other officials of Health
the banning of formulations of harm
(c) Bulk drugs whose formulations and other concerned Ministries as
ful nature and better control over are of essential and mass consump members to co-ordinate the proposed
introduction of new drugs. The au tion nature; and
measures and to monitor the prog
thority will have a permanent secre
(d) Formulations and drug in ress.
",,anc'a' Express, Wednesday, Decer
‘OrugSSSjS' ThelWp?ranh
D ™8
7"
1( ieie8rdPn rise alarmingly
6
manufacturers’
wa
o
financial Express Bureru
MONDAY 22 DECEMBER 1986 VOL. V NO. 163
=
2 §
£ 3
6 = a[’;bt>
'ins s
"Medina ,
a
-
^}i^y ^h,ch
,Jedh- had
A half-baked policy
jKlSSSaSj-a
New n
?5-i I
ethambutol
manufactured
•
ethambutol
manufactured
by
Wockhardt costs Rs 15.08 now.
After
the nhike,
most probably
probably in
in
£
“CI u,c
.,KC. most
February, it will be priced bed- io
r->_
tween Rs
18 —
and> Rs
‘eTSM is■
NEW nnm n.. on
A
L DELHI. Dec 20: Asnarp escalation in the prices of
essential drugs is feared following
an anti-tuberculosis drug. The
the announcement of the new price of streptomycin, another
drug policy on Thursday.
*
• Avila, P
pIlXS
,us
drug used in treating tuberculosis,
a reduction in categories
It will also reduce the level of will shoot up to Rs 6 for a one
icenemn
.. •' « There is hardly anything new for the people in the
self reliance already achieved in gramme vial.
' “new” drug policy announced last week by the Union
the production of drugs and give
Also threatening to crons the
’ government. Except the multinationaJr^rH^e policv may not
rise to intense Joying by drug
Rs 20 mark are medicines used in
please many. It talks loftily of givilg A/^w thrust and
the
manufactur&sx-uo keep their pro the treatment of leprosy. One
direction to the pharmaceutical in du\i‘v\imk5t riving for
certain drugs.
ducts out o£ the/pprt^contro!led particular brard, Arzide manu
the fulfilment of the objectives of etaisur.’ng'sbundant
category.
X
)
factured by Albert David, may
Scienc\ For/Tnyrah orgaavailability of drugs at reascramkle prices, Mp^onalisation,
cost Rs 24 if the prices rise to the
quality control and growth.
there is s^nnuch of P’-DbOTpf youn^cn^nistyned by
maximum allowed mark up of 75
confusion, lack of foc^a-tuid hazrrie^s tha\ affl that the new C
aPPr\lenlX>hat the per cent for essential drugs, as
policy may achieve i/a premfcdtat\inbu-easb'zin the prices of
"'^-™ieV^py will SfcXit up by 50 specified in the policy.
drugs. The policy is Y^ot
c^mpjehensively thought
Xi tent.
■» The minimum prescribed treat
h>vesJr
’i ■*! ’> : by The Sunday
out action pl^n\The^nde pAch-racked about ideal of
*
ment period for tuberculosis is
ushering inim eZi of getaeXZ drugs appears to hav&4&ceA Observerr y ealed that a ten- one year and for those who just
*
VbleWu
^of ET-800. a brand of
given a qui^t bwnrtTKThene is also no talk of reducing 1^4
number of unnecessary RQj^nulations, numbering
’bey is at “cst enced"?ren UC °f sfll,®’8e of '’Ped-
’^on^
compulsory on ,hc
e-wnnal drugs point hke
by Kuldeep Kumar and
Nirupama Subramanian
^Ith takes
seas
e health needs
alone and
rike move against
f^ew dhug poh’ey is ‘antikpeophr
i ? o s •;
TTA\
The CITU president. Mr B. T. Ranadive cal- des\ri
led the policy as a “bonanza for “multinaIn\
tionals". which control an estimated 78 per cent areas,
outbid the Ind
of the Indian drug industry. Some 16 per cent is even ;
which will be up
under the monopoly private sector and only six
l,i_«.
u.uo.u .
worin -o
per cent with the public sector.
drug pu
A . .ational convention representing v.rf.
a
qThe drug industry in Bombay has welcomed
This ord
the entire spectrum of
"fl
the hike in maximum allowable post-manufac
ire ___
into ______
actual
provi_
»-_______
turing expenses (MAPE) for essential drugs ly
practice. The/policy seeks to eake the pressure of price
and the reduction in the number of drugs under
regulation thSmg^lT" jr ra^pR-ups
’
to allow for postprice control. —PTI
T^jpdrk-ups will range bemanufacturing a^pen;
t^l lOOXerk^...
________
_____________
_______
rX)ne
consequence
of this
could
waila^lity
of/ssential
drugs,
admittedly at
be a/beuerTv
T, aim . , ,
^EW DELHI. Dec. 20
prices wkh c
J 1 • up/tfy 13 to 43 per cent. At present,
The AH I'Kbe India,, Drgus and Pharmaceuti
.. Anant vna
„f i w
fiftm
the population is able to afford
iweuiaw
By nr'
cals Ltd. Karngni Federation today described no
drugs.Vf dru)
go up, the number of those who •
own •
tl>e new drug policy announced by the Govern
•nremuch-n^S^^
ment on Friday as a gift for multinationals' that cannot VuCxtkugs is likely to increase. Reduction in
will birther erode the role of the public sector in controls in lerorrm of expansion of deiicensing may not
..Jblem because the pharmaceutical market is
the drug industry and threatened to launch an solve thApn|known to
* )e/subject to the monopolistic behaviour of the
agnation if the same was not withdrawn.
decontrol"In a statement issued here the federation said bigger companies. The new policy also talks of a national
0
0
°
T1
v.w -v-i
drug and pharmaceutical authoritv that would monitor the
disupP»inl- Unnecessary
AVqO
industry. But it will only be an advisory body and,
> therefore, will have little clout. The inadequate homework
The
Sot®:
fra’avyvCTp.
? done by those who framed the policy also shows up in the
the fact that no proper list has been policy" aspects related
*
to" the effects fact that a high level expert committee is vet to be set up
drawn up to define high-technology of-drugs had been ignored.
"
'
r
’
*
to prepare a list of drugs to be included in the second
drugs, and given the record of foreign
n
—•«-'----Besides
the forum,
many drugs category. And last, but not the least, if the list is not ready,
companies in not bringing any new specialists and scientists contend that if the new drug prices control order is not ready, what was
technology, meant “virtually opening there are many more drug formula the hurry to come our with a half-baked policy? Again,
is, mis
n
be
Surpr><®B' - >' jcclinB. cotn®"" p b
teu>u®- cn u
lhe ead
Lav®
the doors for entry of foreign capital
tions in the country. It is estimated critics of the government are bound to make some capital
nes issues dtrectW
aceon^
ptom
into the market."
out of the fact that although the policy has a bearing on the
The forum said the Government that about 20,000 formulations are
had "totally capituated to the un marketed in the country. And scien vital public issue of health, the government chose to
reasonable demands of the phar tists say most of them are “irrational” announce it so soon after the recent session of Parliament
and marketed only for industrial was over.
maceuticals industry”.
The policy had been announced profit.
Mr Sharad Yadav’ MP and Gener
just a week after the end of the
winter session of Parliament and cal al Secretary, Lok Dal has dubbed the
led this "a clear attempt to bypass the new drug policy as “pro-capitalist
and against the poor ailing con
people's representatives.”
sumer’ .
It expressed surprise that while
Mr Yadav said the 35 per cent
concessions had been made to the .........
.............
—
increase
in life-saving
drugs will "crutial P®'
industry by “rushing through the cify the public sector.”
«
NEW DELHI. Dec. 20
c
The Indian Medical Association (IMA) has
E described the new drug policy as "pro-industry
E and anti-people".
The prices of medicines will go up from 60
£ per cent to 300 per cent wih the implementation
i of this policy." Dr. J. J Sood. General Sccretary. IMA. told PTI.
E
This policy would not ensure abundant availa£ bility of essential and useful drugs at reason
able prices, he said and added that this would
■ help the drug formulalors.
;'
The CPI in a press statement condemned the
•. decision to decontrol non-essential drugs and
; \ progressively delicense the drug industry and
: said This is nothing but an extension of the
; policy of so-called liberalisation and privatisa, tion of the drug industry.”
J
The CITU and the Delhi Science Forum, a
• body of scientists and science students said the
p-policy sought to appease the pharmaceuticals
industry and multinational companies.
*-fe
U-
DWB P°'“ twent
Drug policy criticised * ~
NEW___
_________
DELHI,
Dec 20_____
(UNI), — — will shoot up drug prices much
The Delhi Science Forum of Scien more than the 12 to 15 per cent the
tists and Science Students, on Friday Government envisages.
“Given a situation where only 20
condemned the new drug policy,
saying it sought to appease the phar per cent of the people in India can
maceuticals industry at the cost of the afford to buy drugs, the new policy
would lead to even less people being
nation’s health.
The forum, whose President Mr P. able to afford modern drugs”, the
N. Haksar, said in a statement here forum said.
The scientists also criticised the
that the two principal formulations of
policy — one reducing the number of decision to expand the delicensing
price-controlled drugs from three to scheme and to make licensing
and the other expanding the scheme arrangements for MRTP and FERA
of delicensing — would have "dis companies
to
produce
hightechnology'drugs.
astrous consequences”.
The first decision, the forum said.
It said the decision to cut down the
categories of price-controlled drues would allow the foreign sector to
with mark-up of 75 per cent and 1(50 enter the market more aggressively.
The second decision, coupled with
per cent — against 50 per cent earlier
disappo®1®
‘Gift for multinationals’
•8 - ■-..... — • ——- -
i , ® “^^ ‘ ' , ;
S ssSj,Ss
No Dru^Pobcy
fVJARKPT
The new drug policy is certain to disappoint al! those
who expected a balanced and rational policy orientation to
emerge after four long years of vacillation on the issue in
New Delhi. Not only consumers, but even large numbers
I
W
I
'---------------- " ^ril j
~
T O fl fl
V Win II
of indigenous producers of drugs, will feel let down by the
new package. It has only one feature that may seem
A uulj
3K
J
Indian Expt-es
tran
UiJtXLN miew VlQOIir
v
ILiilL
somewhat positive: the raising of the mark-up (the dif“
fcrence between the cost of production and final selling
price) on a small number of essential drugs from the rather
unattractive levels to a profitable 75 to 100 per cent.
By Dei
Looked at in isolation, this measure could improve the
availability of some essential drugs, albeit at a higher cost . 1
waning u c^cr
. than 1(V>
A
drug policy, uhich had rc— anything from 13 to 43 per cent above current prices.
The policy package also involves price decontrol for the
overwhelming majority of formulations on the market.
Hopefully prices of drugs should not skyrocket. But the
...
drugs market is marked by powerful marketing monopolies n<:
cxpccicd
and free competition may nut stabilise prices at least in the
near future.
'1 he new policy also discomages the development of
indigenous manufacturing capabilities. First, it allows for
the delicensing of bulk drug production even in areas where
Indian-owned
companies
have established
their
capabilities. And secondly, it abolishes the dnig price
equalisation fund, which has offered a degree of necessary
protection to domestic producers. Infirmities in the draft
ing of the policy are evident elsewhere also. The package
specifics parameters for the ratio of bulk drugs to for
mulations produced by a company; it also provides for a
mechanism to monitor drug prices. But such ratios and
mechanisms have never worked and cannot be legally
5
c<£
C
)
BOMBAY, Jan
said (he drug
...
Dr Zaftullah CboMghury. who
All-India Drug Actio., ixuworK aimed at promoting the interests ol played a major role in drafting a
(AIDAN) has described the new the piofit-bascd pharmaceutical in- consumer-oriented drug policy in
drug policy statement released by the dustry and not the health of people Bangladesh in 1982. said since the
centre as ’anti-health, anti-people “It is an unfortunate imbalance that ban on the manufacture of nonand pro-industry’ and said that it there is a short supply of essential essential drug> by multinationals in
'eutica/5in/'1 that
p,i!country
>dd a . the quality of drugs had
defeats the Government’s aim of drugs for malaria and tuberculosis
achieving health for all by 2.000 A.D. (he country but a plethora of tonics greatly improved and the total proAt a news conference organised and vitamins which arc consumed duction of essential drugs had gone
nere on Thursday by the Association mainly by the rich.” he said.
up and become available at cheap
for Consumers Action on Safety and
Dr Antia said although the World prices
Health (ACASH), an AIDAN mem- Health Organisation (WHO) list of
Bangladesh’s national drug policy
c her. eminent doctor expressed con- essential drugs of 1985 had said that a stipulates the manufacture of only
cern over the fact that the policy total of 258 drugs covered all the single incredient drugs, a ban on
statement had been formulated with- needs of all the people in the world, addictive drugs except in restricted
out PU^I,C debate and discussion with “we have somewhere in the region of formulations reduction of alcohol
‘ The
consumer
and health
professionals. medically
40,(XX)-60.000
formulations
. Even
contentoffrom
to fiveto
per
cent and
de-licensing
and broad-banding
advanced
country ’like
Nor-a refusal
loan40
mcence
companies
c6^\£,!N)so
01 tiru"
drugs
as only
announced
theStrangstatewould
increaseinthe
-o'vv mem
k€=\ -
way had
only 2.000due
formulations
said.
Complications
eV lehold of multinational
andh"
big
J '
rease"
,c Ind
s'"'e-
’
A
- ■
»<•.»•••■
which di-’ not have a factory in the
-...v bans multinationals iron
which are most profitable to them
producing antacids and vitamins
""'ch did
>outnrv
enforced. And as for the critical question of weeding out
. harmful or useless drugs and of promoting the rational use
; of essential drugs, the policy has delegated the task to a
J proposed national drugs and pharmaceuticals authority.
.s Such an authority will, however, only have an advisory
5 role. Even worse, since it will include representatives from
% all interest groups and is likely to be dominated by the
^TURDay dec
^5, industry, it can safely be expected to be ineffectual and
2°. 7986
~ ■ incoherent, much as the national drugs and pharmaceutical
No
development council proved to be. The problem of
icgulating the use of drugs has never been solved in this
.
new drug
r
,
5 c way anywhere. 3 he new' policy simply evades the vital, in theC
m C,n„„®
f Cy’,ornu',;Hed after Innn ri„ru
c § issue as it does the much-debated
issue of
the use
Ov<
1Aleualea tssue
o, me
use of
ot brand
orana so-giantJ^'XVa'°
bb^
Times
/AIPDR.Janun
and.least useful for the people, he
said
•'Banelack
•vhere inc r
drugs and their formulations should be : ■ multinational
banned These were not only ' superflu-1 The nine
• ii- icccntlv-announced drug ous" but harmful too Only seven of. .
policy is under fire for omnunc these comomaiions. added to the list o., ,
,K
- be,ng
,n -single compound drugs were sum
”le000
^rcdrU8S
?lopnine
thema
hst'keicd
of about
cicnt tor the national nealili. the " HO
h°V.orse still the total number of"i Onh I
'ourths
of D'these
are stated
to be PU|
oscs
a Problem
f *" founl
More
than threeugsmanufactu
•
no"-essenttal and useless
tioncr. No Doc.„
drugs
manufactured tn the country.also
•XTca^rv
0^"^"?'
O issue as n uoes me >”“<■"
lhat yet another commUtee-ad economic- philosophy ofb hesurpns«- Given the
w!’°?as also
been pr“'; noses a problem to the medical praclithati;yet
another committee>ad
econwould beCO7n
"S names. Finally, it is surprising
surpn
bf
c» mn
mere
an Pani
at,
' l/le ‘atler, it was inevitable A™ of he ,ndl;ln nh'”-----uoncr No Doctor can be said to have
§
should have
been
set-up
to
finalise
the
second
list
oft
there
n
°
m
’
c
P^ilosonhv^/^
no
,
,
licm
oer
of
the
nations.
have hrrn cel-.m m Gn
wholly IStrV This ha,. , L" a‘,emP'>>dS
at reducing
°"trCof
" the -v
Pharmac
no
surprises.
. itCOntr^
zwas
....Given
Siant(and
the Pcongress
dent
Indian
Phan""”“ d! f 5rag
Min
'T^^^Vand^.
'polAas
s‘Sr'a half months
before
S
new
sophy
of the
latter,
inevitable
and the
Pha'™o
announced.
Hethe
said
m
, aPtteyvntpt
controls
on the
.... Jf S
’ o P—
J ■§ essential drugs. In the light of past experience it is wholly--woulH
■'at reducing
?
unrealistic to expect it to complete its job in three months.
nonths. gones in
?ken.
forms.
_a" interview nere to
?were a W^‘ch fonnulation (tablets T ’ ,be numbcr of-^-Jhc overwhelming m.norm
-
Were d,v'ded have tulation
been (tablets, 'compounds
ontpounds add the
been red.— reduced from four to two. On
. ...<v in
; drug prices
-
1
cs
New policy seeks to
Our Special Correspondent
rices of all drugs needed for the
because of this that the prices are likely
National Health Programme
to go up further. However, Mr Jai
will register a steep hike of 12 to
25 per cent under the new drug policy
Chandra Singh assured newsmen that
announced by the Government on
the Government would evolve a very
Thursday.
strong monitoring system.
The much-awaited policy seeks to
Referring to the salient features of
lessen controls, allow market forces a
the policy, the Minister said the exist
P
C3
e a
icosen controls
ing three categories of drugs and phar
maceuticals were being henceforth be-
t---------------- ’
would I
pmsent. the country
, ^X'spend more than Rs. lOcrores
to reduce druo- ”ISmqmre an mtotnietun- worth
forinulations
'nd^°DroB Acdon1'??' 9 (PT',:
Alt
I inThe ’w’drugs (price control) order
l,as demanded °dNe'"'ork 'AIDAN;
"TOlations ,^thc Ura'°n of dreg forProsen, 0>."‘ [from the
.^mended by rhe u/°.750, as a‘cfcanisauon (WHO). U°f d Hc2,lh Or-
identified IS1 drugs and their fori mulations as •■essentia!
hnnpJ"6
them under the purview of ths order
it placed them in the first two of ths
four categories of drugs. Following
" a'ro«nnagnmaB,imnhpr0Up volunl«rs !
pnee control order, the multinationl
(FERA) companies shifted their pnJld 'he net dn.„ a,y on Thuroday
oritv from production of essential
Cduci'ng non-c«8 1X5 ,Cy ,nslead of I drugs to the non-essential drugs, which
"dad -he f"°0
^,,al dru'^
d™-“ only
cniy
.promisedP^^^imates,
...genual
m
them huge profits, as nonthey
K|,at?ofn’sh h treated
t’he | es^.al dru^pnecs - as much as 30
*-rm
and other
Pharmaceutical industry as another
Xdrug ^oh^mvolves deconcnemtcal industry, where proms and
The new orugt
>
r.-ccssary
aa ?no'"cr
not health was the mainZconcern.
'^'^“"tmnli health programme and
"'nd
All leading health action groups felt
the new drug policy was heavily lilted
in favour of multinationals under the
Organisation of Pharmaceutical Products of India (OPPi). who sold 50 per
cent of the drugs in the Indian market.
I
■ThenewCd™g°rproduc'fion.1
--
the essential drugs. According to _t e
,Union
'rolofa||dn,?/
W,c
>"tor
,voh
minister of
state
cnemicais
.f?r'^na,mna
u^?''^neceS":
and
fertilisers. eMr.
this would ensure abundan
. ■
ability of drugs”, and would help inc . ■
country meet the rather ditlicui i target ■
5
UJ 1
of production of medicines worth Rs. I •
5
16.000 crores by 2001.
DR<. OLLE HANSSON’S DAY - BAN HAZARDOUS DRUGS DAY
ooooooeo
Oooooooo
oooooooo©
It was on 23rd May 1985 that Dr, Olle Hansson passed away
in a hospital in Stockholm,
He was just 49,
For almost
272 decades this paediatric neurologist by profession had
faught a long lonely battle against the multinational gi ant
Ciba Geigyo
He was instrumental in getting Ciba to with
draw its products mexaform and entrovioform from the
world market.
Not merely did he contribute to the Academic world by being
the first to show the association of optic neuMis (blind-
ness) with consumption of this drug way back in 1965 but
he also challenged the incorrect facts promoted by the
manufacturer that the drug was not absorbed from the gut o
Through various tests conducted by him he showed that the
drug was absorbed., metabolized, in the body and its meta
bolites excreted in the urine.
This information was
critical in being able to associate the neurological side
effects with the consumption of the drug.
It was due to his extensive research, writing and work on
clioquinols that led the Japanese SMON victims to invite
him as an expert on their behalf, in their fight for
compensation,
(SMON i,e, sub acute rayeln- optic neuropathy
left over 11000 people crippled, blinded or with loss
of Bladder control over the discharge of urine and stools.
For eight years in Tokyo High Court a legal battle for
compensation was faught by the victims themselves with the
help of socially conscious lawyers, doctors, and experts
like Dr, Olle Hanssop, and ultimately won, A
major international conference on Drug induced suffering
was organised later at Kyoto at which Dr, Olle Hansson
spoke emphatically about the consumers ’Right to Information
The clioquinol tragedy next to the Thalidomide disaster was
the second major drug induced tragedy.
Even though the
s2s
manufacturers faught tooth and nail in trying to prove that
SMON was caused by virus and had some genetic etiology, It
was only due to a concerted effort on part of the victims
and the professionals this case could be faught and won.
Dro Olle Hansson was not satisfied Just seeing the victims
compensated, he continued his tight to see that such a
thing did not recur in any other country where the drug
was being consumed in large amounts by the uninformed publico
In 1976 he initiated a boycott which in Sweden vzas joined by
over 2000 doctors who refused to prescribe any Ciba Geigy
W
product till it withdraw these potentially hazards and
therapeutic doubtful drugs from the world market, and
the company lost 75 million kroners in Sweden i.eo their
entire turnover in 1980o Doctors from Norway, Finland,
and Denmark joined the Boycott,,
By November 1982 the sales
of Ciba Geigy fell by 73 rd and it was this which forced
Ciba Geigy to withdraw
mexaform and Enterovioform from
the world market proving once again that the only argu ment
that seems to make sense to the industrial houses is with
economic
argument linkec^ Today a number of western
countries as well as Bangladesh, Pakisthan, Nepal, Sri
^with loss,,'
Lanka, Malaysia have banned the clioquinols in their
marketso
In India over 150 brands are freely available„
Stricken with Cancer from his hospital bed he faught for
withdrawl of yet another hazardous drug Ciba Geigy’s Tandril,
(Oxyphenbutazone)o
This was following receipt of incri
minating internal documents, where over 1036 deaths due to the
drug had been documented - while only 200 had been reported
to the drug regulatory authoritieso
The product while
allowed in India only for acute goutyarthritis and cervical
spondylosis continues to be used extensively for prolonged
periods for diverse indication from arthritis, dental pain,
post operatively. It is given to the elderly and the
..3..
:38
children,.
of Oxyphenbutazone
Hundreds of combination'wi th analgin exist and
are widely consumed„
These are sold without warning
and if any warning is given it is in a medical jargon no consumer caution is given,,
Ciba Geigy subsidiary
Suhrid Geigy continued to sell oxyphenbutazone product
suganril stating that it was an Indian company and the
marketing policies of the International Head Quarters
did not bind them,
In India over 100 brands of oxyphen
butazone and Phenylbutazone are freely soldo
Dr, Olle Hansson continued his work right till his deatho
He had all the elements of a great health campaigner
scientifically sound facts, persistence, perseverance,
honesty, integrity coupled with humility, The moral support
and inspiration that he provided to the drug activists across
the globe is unimaginable,.
On this day he is remembered with
respect, love and gratitude for all his selfless efforts,
for being such a inspiring teacher, a role model and a
dependable friendo
There can be no greater tribute that we
can pay than for us to be able to continue fighting the
battles for safeguarding peoples health against profit
oriented vested interest more effectively against,.
Like every year the health and drug activists commemorate
Dr, Olle Hanssons death anniversary as “Ban Hazardous Drugs
Day”, For the past two years the focus was on high dose
EP combination because of the EP case.
This year the two
drugs in question are the fixed dose combinations of
chloramphenicol streptomycin and of steroids.
Way back in 1980 the Drug Consultative Committee had recommended
their IMMEDIATE withdraw!,
It was only on 3rd November
1988 that the fixed dose combinations of the above therapeutic
category was banned after the matter was reviewed by the
Drug Technical Advisory Board,
cation attached).
(PLease see Gazette Notifi
It is with a sense of dismay that it was
..4,.
s4s
found out that the manufacturers have as in the EP case
appealed for a stayorder against the ban and a stay has
been granted,
Chloramphenicol-Streptomycin is a combination of two anti-
microbial agents greatly misused in diarrhoea, when over
60% of the diarrhoeas are viral in origin, not requiring
any antibiotic.
Chloramphenicol while considered, useful in Typhoid is not
recommended for simple diarrhoea because of the association
of serious almost fatal toxicity of the drug leading to
Agranulocytosis fall of white cell count which are required
for fighting infection and sometimes total bone marrow
shut down.
Extensive misuse of antibiotics like chloramphenicol has
led to emergence of drug resistance as was evident in
Mexico when over 3000 people died of Typhoid before emergence
of resistance to chloramphenicol was detected.
Emergence
of drug resistance to Typhoid has been reported from
different parts of the country.
Furthermore, the use of Streptomycin in a combination for
diarrhoea when adequate amount its single ingredient pre
paration for TB is not available is unwarranted. This is
specially so when its therapeutic role is marginal and when
better antimicrobials for specific conditions eg. Shigella
dysentry, amoebiasis, giardiasis, and anti helminthics for
worms.
Gross over use of a potentially hazardous combination
for non specific diarrhoea is not Just a matter of misuse
it is bad medicine.
Unfortunately in India as in many other
developing countries these drugs have been promoted for
precisely such trivial condition®
AIDAN and its member organisations call for implementation
of the ban (It had taken over 7 years in the case of high
..5..
dose EP)o
Academic Bodies ego XM?0 IMA have also made
their stand on the above drug adequately clear and called
for their removal®
Increasing medical evidence against
the combination and pressure for medical professionals eg®
medical lobby against unethical marketing has led to a company
like Parke Davis^-zithdrawing its popular Chloramphenicol
Streptomycin combination.Chloro Strepafrom the
marketo
world
A large number of other manufacturers continue to
produce and sell these products (List attached)o
Having been deeply involved with the entire EP case AIDAN
feels that the ban orders will continue to be flaunted and
stay orders continue to be granted unless drug legislation
reforms are brought about, specially ensuring that the onus
of proof of safety lying on the manufacturers0 other than
the onus of providing lack of safety lying on the drug
control authoritieso
It is a shame that with the New Drug Policy of 1986 which
after 4 years of "policy formulation" was presented to the
nation as "measures" for Rationalization for the Growth
of the Pharmaceutical Industry"0 except for the increase in
drug prices^no other measures eg. ensuring availability of
essential life saving drugs of good quality, with adequate
information was ensured,,
Of the three combinations,(1) High Base EP (2) Chloramphenicol^
Streptomycin (3) Steroid combination, drugs banned = stay
orders were granted to all three drugs0
There is absolutely no alternative left to the people but to
register their protest at such shameful behaviour by boy
cotting such companies which are challenging the orders of
the highest Drug Control Authority in the country i.e® Drug
Controller of India. It is obvious that these manufacturers
6
s 6:
in the interest of profit are keen to sell their products
even when they have been recognised as potentially hazardous
and legally banned,,
The companies who have obtained stay orders are Lyka
and Deys Chemical, Roussel and Indocoo
It is hoped that the manufacturers will implement the ban„
Till then socially conscious doctors are requested not to
prescribe their products and people should request their
doctors not to prescribe any products of the above
manufacturers and prescribe an alternative.
People must
have a say in what cannot get pushed down their throats
in the name of medicine,, Since it is not possible for the
authorities to ensure the ban orders the people must do so
in the interest of their own health and the health of
their family members.
DR. MIRA SHIVA MD
COORDINATOR, AIDAN
40 INSTITUTIONAL AREA
SOUTH OF I.I.T.
NEW DELHI 110 0016
Inside ('" i b a Geigy
Olle Hansson
"This volume has not been written in honour of CIBA-GEIGY. It is an account offacts
which those in responsible positions within CIBA-GEIGY are reluctant to talk about, preferr
ing to conceal, distort, deny or keep them secret.
Confidential internal material, that has been acquiredfrom individuals working inside the
company. will as a result, be discussed openly for the first tune. One conceivable outcome is
that CIBA-GEIG Y’s reputation and financial standing may be affected. .4s a doctor I have no
choice in the matter. The primary duty of a doctor is not to cause harm. This necessarily
implies that I must not keep silent about knowledge which may prevent suffering”.
These arc the opening words of Dr Olle Hansson’s book which exposes some of the
unconscionable operations of the pharmaceutical giant CIBA-GEIGY.
r
•
’
The book itself is in three parts. The first part is the story of a drug, clioquinol, which
ruined thousands of people’s lives. The story is told by Olle Hansson who, early on, became
deeply involved in the tragedy and did more than anyone else to bring it towards a conclusion.
It is a dramatic and horrifying story, but also raises the question, ‘Could it happen again?’
In the second part of the book, more recent examples of drug marketing by CIBAGEIGY and other transnational companies are examined. The picture is very’ disturbing.
Olle Hansson himself died before he could finish the book, so the final part was written
by an associate and describes the events that followed Olle Hansson’s long struggle with CIBAGEIGY.
Penang, Malaysia • The Hague, Netherlands • Montevideo. Uruguay
INSIDE CIBA-GEIGY: ISBN: 967-9973-26-3,© IOCU, 1989,
ca. 230 pp. 140 mm x 216 mm, US$7.95 pb.
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MCKTKJtKO NO. I). (».N.) iZ7
tf. tfi. (<rt-<pr.)-l27 ,
'
-xti iu I <v.i
EXTRAORDINARY
hut II—3—g’f-’mr (*1
PART II—Section 3—Sub-section (i)
snftraiT H srarftrar
PUBLISHED BY AUTHORITY
sr^nfann:,3, 19 88/RnfaT 12, i9io
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No. 5751
NEW DELHI, THURSDAY, NOVEMBER 3, 1988/KARTIKA 12, J910
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THE GAZETH-OF INDIA : EXTRAORDINARY
2
•
h-t tt qt-Ti-q ?ran~, nfafir hr a-qw-i ’.rrmfr
qi:-23) T?r irn 2631 7Rf SRvT TlfaCTCTT
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15-0-1988
3
MINIS FRY OF HEALTH AND FAMILY WELFARE
New Delhi, du: 3rd Nos ember, 1988
NOTIFICATION
G.S.R. 1057 (E) .—Whereas the Central Government is now satisfied that
knur terms use of steroids in fixed dose combinations dings for treat
ment of asthma is likely to involve, risk to human beings and such foimulation' do not have therapeutic justification :
\nd whereas the Cential Government is no"' also satisfied that fixed
do-e (ombinations ol chloramphenicol lor internal use is likely to involve
1 isk to human beings :
And. whereas the Central Government is satisfied that it is necessary and
expedient in public interest to prohibit the manufacture and sale of the
drugs aforesaid.
qra ur ’rsriv: qqiur'.’i
\---------- "/•"/'.....
-------- • - -
3
-
7
Now, therefore, in exercise of powers conferred by section 26A <.f,t'.-:
Drugs & Cosmetics Art, 19-10 (23 of 1919) rhe Cential Govciinnent lidicby
makes the following further tuncndnicnls in the notification of the Govern
ment of India, in the Ministry of Health and Family Welfare No. G.S.R.
578 (E), dated 23rd of July, 1983 namely
In the Table under the said notification Im items rl and 15 the follouing items shall be substituted namely
"1-1. Fixed dose combination of corticosteroids with any other drug lor
internal use.
15. Fixed dose combinations of Chloramphenicol with any other ding Im
internal use."
[No. X-l ID1-I 2,.'M HMSAl'l AJ
SMT. V1N1-.ETA RAI, Jt. So .-.
Note : Government of India Ministry of Health & Family Welfare Notiluetion No. G.S.R. 578(E), dated 23rd July, 1983 was amended In th?
following notification published in the Gazette
of India, l-.xtraordinary, Part II, Section 3(i), namely
J. G.S.R. -19(E), dated 31-1-198-1.
2. G.S.R. 322(E), dated 3-5-1984.
3. G.S.R. 803(E), dated 22-11-1985.
■1. G.S.R. 709 (E), dated 15-0-1988.
t’linlcd 'ry lire Mnnrincr, Govt, of India Press, Ilinr. Road, New Delhi-110064
rind published by the-Controller of I'ubficalions, Delhi-110054, 1044
HA I Clearinghouse
Resource Sheet #6
August 1982
RESOURCES
PUBLICATIONS RECEIVED BY THE HA I CLEARINGHOUSE
0
The Health of Nations, by Mike Muller.
Price: £7.95, Faber paperback: £3-95-
Published by Faber & Faber.
This book raises some fundamental questions including: * Is the positive
contribution of the multinational drug companies towards Third World health
care outweighed by the damage they do?; * Do 'eminently respectable drug
companies' promote the consumption of certain drugs that are not only
inefficacious but also dangerous?; * Is the Third World the centre of the
pharmaceutical market place of the future?; * What should be the role of
the World Health Organization in securing 'health for all'?; * What has
been the drug companies' response to the growing criticism towards their
practices?; * Is there a real chance of 'health for all' by the year 2000?
For further information about the author and the book, contact Greg Hunt at
Faber and Faber, 3 Queen Square, London WC1 (tel: 01-278 6881)
0
Pills, Pesticides and Profits - The International Trade in Toxic Substances.
Edited by Ruth Norris.
Contributors: A. Karim Ahmed, S. Jacob Scherr and
Robert Richter.
Published by North River Press, Inc.
This book traces briefly the historical development of the trade in toxic
substances and deals with several specific areas - pesticides, pharmaceu
ticals, industrial hazards, hazardous wastes and infant formula.
It also
looks into possible solutions to the problem at the international, national
and community levels.
Also included is the transcript of the Public
Broadcasting Service documentary film, 'Pesticides & Pills:
For Export Only.'
For additional copies of this book, write to North River Press, Inc., Box
241 Croton-on-Hudson, NY 10520.
For information concerning a student edition
and other educational materials related to the book, write to the Council
on International and Public Affairs, 777 United Nations Plaza, New York,
NY 10017For information on rental or purchase of the films whose
transcripts appear in the book, write to Robert Richter Productions, 330
W. 42nd Street, New York, NY 10036-
The Pharmaceutical Industry in ASEAN countries.
Edited by C. Sepulveda
and E. Meneses.
Published by UN - Asian and Pacific Development Institute
in cooperation with UNIDO. UNAPDI Health Technical Paper #36/PHI 15
The following books also deal with the pharmaceutical
industry in Asean
Proceedings of the Consultation, 19-23 May 1980, Bangkok.
Edited by
C. Sepulveda and P. Bumrungcheep.
Published by ESCAP (Economic and
Social Commission for Asia and the Pacific).
Programme on Health and
Society Health Technical Paper #^42/PHI 21, November 1980.
Preliminary Production Programme Considered for Local Formulation:
Essential Drugs Selected for Basic Production: UNIDO, by E. Meneses
Published by UNAPDI in cooperation with UNIDO.
UNAPDI Health Technical
Paper #37/PHI 16.
Case studies:
Indonesia.
Edited by S. Prawirosujanto.
Published by
UNAPDI, Faculty of Pharmacy, Pancasila University, Jakarta.
Philippines.
Edited by Q.L. Kintanar.
Published by UNAPDI.
National Institute of Science & Technology, Manila.
Singapore.
Edited by A.S.C. Wan.
Published by UNAPDI,
Department of Pharmacy, University of Singapore, Singapore
Malaysia.
Edited by M. Musa.
Published by UNAPDI,
School of Pharmaceutical Science, Universiti Sains Malaysia.
Penang.
(S.2/8/87?
Excerpts from
hAi
THE RATIONAL AND ECONOMIC USE OF DRUGS
IN THE THIRD WORLD
millMJIlllMLIIIILlIllimB
A Health Action International briefing paper on
the Bangladesh Drug Ordinance of 12 June, 1982
On L2 June 1982, the Bangladeshi Ministry
of Health published a New Drug Ordinance,
prohibiting the future sale of over 1,700
drugs. The Ordinance implemented the
recommendations of a National Expert
Committee on Drugs and Drug Policies,
whose report had been published very
shortly before.
The Bangladeshi Government's initiative
is extremely important. Nationally and
internationally it could have far-reaching
effects on the health of consumers.
It
will certainly affect the policies and
practices of the international pharmaceu
tical industry.
And it can be expected
to influence governments' drug policies
and regulation of the pharmaceutical in
dustry, throughout the world.
This HAI briefing paper summarises the
arguments and findings of the Bangladeshi
Government's Expert Committee; and out
lines in general terms what the wider
implications of this initiative are likely
to be.
Need for a drug policy in Bangladesh
On 27 April 1982, the Bangladeshi Ministry
’of Health set up an eight-man Expert Com
mittee '...to evaluate all the registered/
licensed pharmaceutical products presently
available in the country and to formulate
a draft National Drug policy in consist
ence with the health need of the country.'
The Committee identified the following as
the main weakness of the national health
policy:
o
Poor laws, poorly enforced.
•
Exploitation of consumers.
o
Undesirable foreign domination.
•
Waste of national economic resources.
Drug policy objectives
The Expert Committee proposed a national
drug policy and proposed the introduction
of new drug laws; and recommended the
setting up of a greatly strengthened Drug
Administration. The Committee also made
specific proposals relating to the ration
al and economic use of drugs.
The Committee suggested first, that action
be taken to identify 'a limited list of
150 essential drugs considered adequate
for most therapeutic purposes.' The Com
mittee also envisaged the need for 'a list
of another about 1OO supplementary drugs
needed for the tertiary level of health
care by specialists.’
Secondly, the Committee proposed annual
reviews of all drugs on the market, to
take account of their 'usefulness, essen
tiality and cost-effectiveneps in the
light of up to date available information.'
It also proposed to grant licences to new
products only when these were 'considered
essential and relevant to (the) health
needs of the country.'
Thirdly, the Committee called for 'the
elimination of all unnecessary, useless
drugs and drugs of doubtful efficacy from
the market.'
Guidelines for drug evaluation
The Expert Committee unanimously agreed
on 16 criteria to be used as guidelines
for evaluating drugs on the market in
Bangladesh.
(These guidelines are
summarised in the booklet - in some cases,
with notes and examples outlining their
significance.)
metlico friend circle
[organization & bulletin cffircl
326. V Main, 1st Block
Koramangala, Bangaioio.560 634
HEALTH ACTION INTERNATIONAL (HAI) is an informal network of consumer, professional, develop
ment action and other public-interest groups working on pharmaceutical issues. A clearinghouse is main
tained at IOCU Regional Office for Asia and the Pacific, P.O.Box 1045, Penang, Malaysia. CableINTEROCU PENANG Telex: MA 40164 APIOCU Tel: (04) 885072.
General significance of the Bangladesh
initiative
The importance of the Bangladeshi ini
tiative, as health policy, is obvious. In
particular, the rationalisation of the
national drug list represents a substan
tial commitment to public health.
As the
Expect Committee says:
'At present, not
more than 20 per cent of the population
have access even to the most essential
drugs for their health needs and yet the
market is flooded with hundreds of useless
or non-essential medicinal products.'
Limitations of national initiatives
Another reason for closely watching what
happens in Bangladesh is that events
there may give some clue about how other
developing countries could rationalise
their drug lists - inevitably in the
face of opposition from drug suppliers
and drug-producing countries, and
probably from the medical profession and
high-income consumers as well.
Is there
a 'right' or 'wrong' way to go about
this?
International initiatives:
Bangladesh.has done what any health
conscious nation should do
It is worth saying that the Bangladesh
Initiative is also in line with the
domestic drug policies of the major drug
producing nations.
In the US and the UK,
for example, a purging of undesirable
products from the national List began
about 15 years ago, following the
thalidomide scandal.
a role for
WHO?
This question arises not because the
World Health Organization (WHO) has great
authority over the collective will of
the member nations of the World Health
Assembly.
The question arises because
the WHO speaks for the Assembly in pro
moting "Health for all by the year 2000"
as a formal and attainable objective.
The politics of .the Bangladeshi initiative
A distinction must be made between the
sense of the Bangladesh New Drug Order as
health policy - and the national and
international politics of the thing. The
difference in this case is fundamental.
"The rational and economic use of drugs in the
Third World," 14 pp, published by Health Action
International in August 1982, is available from:
HAI clearinghouse
P.O. Box 1045
Penang, Malaysia.
Price available upon request.
(S.1/8/82)
HAI Clearinghouse
Resource Sheet #4
April 1982
I40
RE5DUREE5
PUBLICATIONS RECEIVED BY THE HAI CLEARINGHOUSE
o
Trade Union Action against the Transnational Pharmaceutical Companies .
Proceedings of the International Trade Union Conference, November
11-13, 1981, 30 pp, price not known.
It contains, among others, two main reports:
(a) the impact of the
activities of pharmaceutical transnational corporations on the health
of the population and health policies of different countries,
particularly of developing countries; action by trade unions for a
democratic health policy satisfying the needs of the population and
aspirations of working people;
(b) the situation of workers in the
pharmaceutical industry, their struggles and actions against trans
national corporations and for relations corresponding to a new inter
national economic order between industrialised and developing countries.
The conference was held in Moscow from November 11-13, 1981.
Available from:
o
Alain Covet, 1068 Bp, Benezurn 45, Budapest, Hungary.
Documentation about the International Trade with Blood Plasma, by Buko
Pharma-Kampagne. 39 pp, price 4 DM.
This booklet is a short introduction to the problem containing an
article in English and the rest in German.
Available from:
Dritte Welt Hauz, August-Bebel-Str. 62, D-4800
Bielefeld 1, Federal Republic of Germany.
o
'Examination of the Economic, Commercial and Developmental Aspects of
Industrial Property in the Transfer of Technology to Developing
Countries: Trade Marks and Generic Plames of Pharmaceuticals and
Consumer Protection, by UNCTAD Secretariat.
TD/B/C.6/AC.5/4, UNCTAD,
UN, 15 December 1981.
CASE STUDIES ON PHARMACEUTICALS:
TRANSFER OF TECHNOLOGY, UNCTAD
o
Major Issues in Transfer of Technology to Developing Countries: A
case study of the pharmaceutical industry, by Lail, Sanjaya, Dr.
TD/B/C.6/4, UNCTAD, UN, 8 October 1975, 63 PP-
«
Technology Policies in the Pharmaceutical Sector in Cuba: A case
study, by Medico-Pharmaceutical branch of the Ministry of Public Health,
Cuba. UNCTAD/TT/33, UNCTAD, UN, 16 December 1980, 49 pp.
•
Case Studies in the Transfer of Technology: The Pharmaceutical
Industry in India, by Jawaharlal Nehru University and the Indian Council
of Scientific and Industrial Research. TD/B/C.6/20, UNCTAD, UN,
11 October 1977, 49 pp.
\
S.3/4/82
Technology Policies in the Pharmaceutical Sector in Nepal: A case
study, by Suwal, P.N. Dr. UNCTAD/TT/34, UNCTAD, UN, 27 October 1980,
32 pp.
Techno logy Policies in the Pharmaceutical Sector in the Philippines,
by Bautista, Esteban and Clemente, Wilfredo.
UNCTAD/TT/3&, UNCTAD, UN,
24 October 1980, 30 pp.
Case Studies in Transfer of Technology: Pharmaceutical Policies in
Sri Lanka, by UNCTAD Secretariat.
TD/B/C.6/21, UNCTAD, UN, 27 June
1977, 32 pp.
Technology Policies in the Pharmaceutical Sector in the United
Republic of -Tanzania, by National Development Corporation, Dar-esSalaam, Tanzania.
UNCTAD/TT 35, UNCTAD, UN, 29 October 1980, 32 pp.
further heading
1 • HATGX CUHWITTLEt KLrHlfiF L>F M UDH/.XTTLE QU DOUGS ..ND PHARMACEUTICAL
INDUSTRY
Ministry of Petroleum & Chemicals, Government of India: April 1975
(Rs.17.00)
2.
MEDICINE aS IF PEOPLE MASTERED
Special Issue of HEALTH FOR THE MILLIONS.
Voluntary Health Association of India
New Oolhi
April-Dune 1981 (Ro.6.00)
3.
ASPECTS OF THE DRUG INDUSTRY IN INDIA
Mukarram Bhagot
Centro for Education and Document
Bombay
February 1982 (Rs.
4.
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HEALTH CAIIE-UHILH bl.'iY TU CO
Medico Friend Circle (Anthology) 1982 (fto.10-00)
Available from Voluntary Health Association of India, Nevi Delhi.
5.
HEALTH FO; ALL—AN ALTERNATIVE STRATEGY
ICMpyiCSSR Study Group
Indian Institute of Education, Puno (ICSSR, 1981).
Available at Voluntary Health Association of India, New Delhi.
6.
INSULT OR IN3LIRY
Charles Redawar
Social Audit, England: 1979
(Rs.
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Available from Indian Social Institute, Now Delhi.
.....2
s2i
7.
DRUGS AND THE THIRD WORLD
Anil Aggarwal
Earthscan, 10 Percy Street
London U1 PO DR
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1970
8,
POOR HEALTH, RICH PROFITS
Tom Heller
Spokesman Books
Bertrand Russel Peace Foundation Limited
Gamble street, Nottingham, England
1977 (
9.
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DRUGS DISINFORFATIOH
Charles Medauar
Social Audit Ltd
England
1980
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BITTER PILLS? MEDICINE AND THE THIRD WORLD POOR
Dianna Melrose
OXFAM, 274 Banbury Road
Oxford 0X2 7DZ
U.K. (£4.95)
11.
DRUG DIPLOMACY
Charles f-todauar & Barbara Freeso
Social Audit Ltd
PO Box 111, London NX18XG
1982
12.
(£3.95)
PRESCRIPTION'S FOR DEATH? THE DRUGGING OF THE THIRD WORLD
Milton Silverman ot al.
University of California Prsa
2223 Fulton Street, Berkeley CA 94720
1982
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DRUGS THAT *DOM
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WORK
SidneyunlFe, Christopher Colely and Health Research Group t 1980
Available From Public Citizen Health Research Group, Dept AC 2000
P Street N.W., u&ohington DC 20036, USA.
,3
|3»
14.
M Problem Drugs - a csnauaior action and g source kit on pharmaceuticals
Hay 1981.
International Organization of Consumers' Union Registered Office for
Asia and Pacific
PO Box 1045, Penang, Malaysia.
c^LC^J-^vd'
-T^t
CO&^]
ru^J" rxUJL^7—
cT^^z
For further Information please contact:
1. Medico Friend circle
50 LIC Quarters
University Road,
Pune 411016
2. voluntary Health Association of India
C-14 Community centre, Safdarjung Development Area
New Delhi 110016
3- Low Cost Drugs & Rational Therapeutics Cell (VHAI)
105 Raj pur Road
Dehrad un 246001
4. Arogya Daks hat a Hand al
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5. Delhi science Forum
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6. Society of Young Scientists
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Ansari Nagar, New Delhi 110016
7• Concern for Correct Medicine
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9. Centre for Education and. Documentation
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. .contc
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11. Federation o£ Medical Representatives Association of India
J.S. Majumdar, General secretary,
l-E, Rajendra. Nag ar
Patna 800016
INFANT
FORMULA
PROMOTION
/
The marketing of milk powder based products as breast milk substitutes
Please use this form to file a report whenever you witness any infant formula promotion,
or give copies to any local person (project holder etc.) who is interested in the issue
and might wish to file a report.
Plea'se attach copies of photographs of relevant materials where you can or texts, slogans
or gists of texts where appropriate.
i)
The monitoring applies to breast milk substitutes or bottle fed supplements,
not to weaning foods, (which are foods usually cereal based and given after
G months of age).
ii)
Infant formulae are in general prepared with a good deal of care.
They are
good alternatives to breast milk when the latter is unavailable.
In poor
communities, however, it is extremely difficult to use the products safely
and so are to be regarded as last resorts.
It is the active promotion of
these products in such situations which is wrong.
iii)
The use of feeding bottles may provide a useful indicator to infant formula
promotion (N.B. if formulas are used they should be via cup and spoon)
iv)
Not all parts of the questionnaire will apply.
v)
Increasingly companies are using the facilities of the health service to
promote infant formulae (with implied medical endorsement) rather than
direct advertising.
This is more difficult to observe.
Sections B, C and
D, then, are most relevant but are likely to need a small amount of
research to complete, rather than a chance witnessing as in A.
vi)
"Mother-craft nurses" are company employed sales staff working within or
alongside the health service.
These may be dressed in a uniform which
resembles local hospital uniforms.
Ignore if not applicable.
OXFAM staff member.
_ __ —--------Product Name.
_ Company name and Parent
Date Witnessed
Location
Date of issue of promotion (if known)
________________ _ _ ——
PROMOTION THROUGH MEDIA
PROMOTION MEDIUM
Newspaper Advert
Magazine
"
Radio
"
T.V.
If poster or
calendar, etc.,
was this:-
Billboard
X
Baby Show
Poster, Calendar etc.
Other (point of sale
display, tee shirts,
feeding bottles, baby
book etc - give details)
In a hospital
In a clinic
Product Labels (Please send if possible)
Is the product described as "humanised" or "maternalised"
[YES I N0~]
Is it made clear that breast feeding is superior
EEsznsn
Is the label written in a local or national language
|YKS~T~NCT1
B)
PROMOTION THROUGH HEALTH PERSONNEL
PROMOTER
PROMOTION METHOD
WHERE WITNESSED
Mothercraft nurse
Doctor
M i dwi f<>
Official nurse
Other
( p I ease spec, i fy )
Giving free sample _
Giving bottles
Other gifts
(please specify
_
Suggesting product
as most appropriate
food
Other
(please specify)
_
(examples may be
using company wrist
bands weight cards or
brochures)
In hospital
Clinic
Mothers Home
Elsewhere
(please specify)
Docs the promoter receive any inducements (commission,gifts etc. ) [YES I NO]
Can you spec i f y_______________
~_—----------If Company employee, does"premoter wear a uniform
|YfcS I NO]
If YES does this resemble a
'
|YES I CONSIDERABLY I SLIGHTLYTTO
hospital nurses’ uniform
PROMOTION IN INSTITUTIONS
C)
Institution name
(hospital / cl in ic/other)
__ ____________ __ ____
Does the institution automatically give newborns infant
formula
Is there a cheap infant formula sales point (milk bank)
|YES I N0~]
Is the mother offered infant formula at a lower- price than
local shops
When infant formula is used, does the institution recommend:
feeding bottles/cup and spoon
|YES I NO~1
lYES I NO~I
lYES I NO~I
ADDITIONAL INFORMATION The following details would be useful to have
but might prove difficult to obtain and so are not essential.
It
might be that there is an appropriate local person - interested in
this issues, who would research this.section.
Company name and Parent----------------Name of institution.
_ . __ . _
_
(village/town/country wide)
Product Name
Date Witnessed
Location
D)
PROMOTION TO HEALTH SERVICE (HEALTH PERSONNEL)
(i.e. promotion to rather than promotion by doctors)
PROMOTION METHOD
TO
Free sample for distribution
Free sample for personal use by health
personnel
Commission on sales
High discount for monopoly product use
Gifts or grants (please give details)
Hospital
Clinic
E)
Doctor
Nurse
Midwife
Pharmacist
Administrator
COMPANY SALES PERSONNEL
In the country, how many ’mother care nurses' does the company
emp1o y_________________
Are there ex-nurses and if not do they receive appropriate
training
Are mother care nurses' wages significantly higher than
hospital nurses'
(YES I NO]
Do Company Sales Personnel earn commission on sales
lYES I NO]
Are there other company sales staff
Do sales staff have contact with:
hospital - administrators
Do sales staff work in:
|YES | NO]
Numbers
doctors/nurses/midwives/pharmacists/
hospitals/clinics/mothers home/other----------
What local laws govern sales promotion personnel-----------------------Other Comments: ( Please write seperately and attach to this form.) Such as results of
medical studies on the prevalence of bottle feeding, or on the health status of bottle vs
breast fed babies.
Details of breast feeding promotion programmes.
Availability of
infant formula and cost relative to average wage of a poor family.
Marketing of products
other than infant formula (such as sweetened condensed milk) as a breast milk substitute.
The World Health Organization says:
A number of medicines, which are of
n© value and are even dangerous, are often given
to treat diarrhoea. Money and time are
wasted in their use.HSo...
WHO says LOMOTIL
taS NO VALUE
*
LOMOTIL (diphenoxylate/atropine) is made by the US
multinational drug company, G.D. Searle; and
promoted to physicians all over the world in terms
such as “established success”, “good tolerance”,
“excellent value” and “ideal for every situation”. This
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 say 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:
POTENTIAL DANGERS
“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 [1980])4
“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
QUESTIONABLE 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])’
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])’
medico friend circle
[organization & bulletin cfflflef
326, v Main, 1st Block
Koramangala, Bsngaloi^.&^e
Lomotil
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 infective diarrhoea, the
use of constipating agents make the carrier
state last longer by stopping the organism
from being excreted.”
(AMREF [1980])8
A comparison between LOMOTIL and a placebo
in treatment of an infective diarrhoea reported
that:
“Febrile volunteers receiving Lomotil
alone experienced over a day more fever
than those in other treatment groups,”
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
atropine hypersensitivity, make Lomotil a
potentially dangerous therapeutic agent.”
(Clinical Notes [1974])3
“The 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.”
(Clinical 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])'’
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.3
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.
i
!
REFERENCES:
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.
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 Childhood" (in) The Lancet (Nov. 20,1976) p. 112.
10 Wong Hock Boon & Michael Toh Ho Sing: “Lomotil Poisoning” (in) The Journal of the Singapore
Pediatric Society (April 1976) pp. 34-7.
11 “Diarrhoea in Children” (in) Drug and Ther. Bulletin (Jan 6,1978) p. 2.
12 Pittman F E, “Adverse Effects of Lomotil” (letter to editor in) Gastroenterology (Iss. 67/2,1974) pp. 408-9.
13 Dupont H L, & Hornick R B: “Adverse Effect of Lomotil Therapy in Shigellosis” (in) Journal of the
American Med. Assoc. (Dec 24-31,1973) pp. 1525-8.
14
Bell D R: “Diseases of the Alimentary System” (in) British Med. J. (Nov 20,1976) p. 1240.
15 Penfold D, and Volans G N: “Overdose from Lomotil” (in) British Med. J. (Nov 26,1977) pp. 1401-2.
16 Snyder R, Mofenson H C, & Greensher J: “Toxicity from Lomotil” (in) Clinical Pediatrics (Jan 1973)
pp. 47-9.
17 Wasserman G S: “Lomotil Ingestions” (letter to editor in) Am. Fam. Physician (Oct 1976) pp. 27-8.
18
Smits B J: “The Irritable Bowel Syndrome” (in) Practitioner (July 1974) p. 43.
19
Collins C D: “Lomotil in Treatment of Post-Vagotomy Diarrhoea” (in) British Med. J. (Sept 3,1966)
pp. 560-1.
20 Portnoy B L, et al: “Antidiarrhoeal 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.
1
2
* 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 — 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 LONDON W1V3DG
© Social Audit Limited 1981
PILLS, POLICIES
AND PROFITS
The majority of Bangladesh's 100 million people suffer from chronic ill-health. Most
cannot afford to buy the few essential drugs they need, drugs which are already in short
supply.
In 1982, following World Health Organisation recommendations, Bangladesh enacted
laws to control the import, manufacture and marketing of the “dangerous, useless and
irrational” drugs which flooded the market and cost the country dearly in scarce foreign
exchange, at the expense of essential drugs. 1700 pharmaceutical products were
banned.
The eight multinational pharmaceutical companies with factories in Bangladesh, and
which controlled three-quarters of the total market, have tried hard to prevent
implementation of the new law.
'Pills, Policies and Profits' examines commercial, political and professional reactions to
Bangladesh's Drug Policy, both within the country and internationally. It explainsthe
ways in which the Policy has been obstructed and the difficulties of trying to improve the
health of the majority in a poor, Third World country.
ORDERFORM
PILLS, POLICIES
AND PROFITS
By Francis Roll Published by War on Want
Price £2.95 + Postage (40p. in UK, 6Op. to Europe, £1.50 outside Europe)
Please send me
I enclose £
copies of'Pills, Policies and Profits'.
(UK cheques/POs or International Money Orders payable to War on Want).
Name
Address
Please return this form to War on Want, 467 Caledonian Road, London N7 9BE up until March
1985. After April 1st 1985 please return the form to Three Castles House, 1 London Bridge St.,
London SEI. Copies are also available fromThird World Publications, 151 Stratford Rd.,
Birmingham Bll 1 RD 021-773 6572
A WAR ON WANT PUBLICATION:
ISBN 0 905990 22 6
ABC
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Horizons : on Drug issues
IL
Periodicals
1. Pune Journal of Continuing Health Education
Presents scientific information and opinion on drugs and health
issues to stimulate thought and further investigation.
Annual subscription Rs.10.00 or a five year subscription for Rs.45.00
from Arogya Dakshata Mandal, 1913, Sadashiv Peth, Pune 411030
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Annual subscription Ks.l0.00 from Dr VS Mathur, Professor,
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health care system, medical education, drug issues etc., from
the point of view of relevance to the needs of the majority in our
country.
Annual subscription Rs.15.00
Write to Convenor, medico friend circle, 326, V Main I Block,
v Koramangala, Bangalore 560034.
4.
©
HAI News
A very informative bimonthly of the Health Action International
(HAI), covering world drug news of special relevance for the
third world.
is an informal network of health consumer
and development oriented associationsand professionals
concerned with health and pharmaceutical issues, particularly those
that adversely affect the poor.
2
Annual subscription s US$10.00 from HAI Clearinghouse,
regional office for Asia and the Pacific, International
Organization of Consumer Unions (IOCU), PO Box 1045,
Penang, Malaysia.
A number of journals have brought out special issues on
drugs. These may be available
Sbm). on request
for back issues.
1. Contact! from Christian Medical Commission,
World Council of Churches, 150 route de Ferney,
1211 Geneva 20, Switzerland or VT'AT, Nev; Delhi.
a. August 1981 No.63: 'Getting Essential Drugs
to the People' with a model list of essential
drugs.
b. June 1983, No.73: ' Strengtheningjand r gulating
the supply, distribution and production of
basic pharmaceutical products'.
2.
Health for the Millions
From Publications Department, Voluntary Health
Association of India, '"-14, Community Centre,
SDA, New Delhi 110016.
a.
Medicines as if people mattered - April-June 1981
b. Special Issues on diarrhoea and tuberculosis
3.
The Journal of the Christian Medical Association
of India
From: T^e CMAI Office, Christian Council Lodge,
Nagpur 1, Maharashtra.
Sept 1983, Vol LX, No.9, Drugs—Fact, fallacy and fraud
3
3
4.
World Healths The magazine of the World Health
Organization, Avenue Appla, 1211 Geneva 27, Switzerland.
July 1984,
Essential drugs for the World.
WIDENING HORIZONS - on DRUG ISSUES
■-tf ,
Books
1. Hath! Committees Report of the Committee on the Drugs and
Pharmaceutical industry.
Ministry of Petroleum and Chemicals, Govt of India,
April 1975, Rs.17.00.
The essential drug list suggested here could
provide the foundation for a demand for a
Rational National Drug Policy.
2.
Health for All - an Alternative Strategy
ICSSR & ICMR, 1981, Rs.18.00 Available from VHAI.
In focussing on a comprehensive national policy of health and
a new operational strategy, the report is intended to be
a basic document to initiate a nation wide debate on the
subject as well as positive action towards certain radical
changes to correct the present imbalances in our health
caresystem. Has a very comprehensive chapter on drugs and
pharmaceuticals.
3.
Aspects of the Drug Industry in India.
Mukarram Bhagat, Feb 1982, Rs.19.00
From Centre for Education and Documentation (CED),
3,
4.
Suleman Chambers, Battery Street, Bombay.
Insult or Injury
Charles Medawar, 1980, Rs.18.00, 139 p.
Social Audit, England. Available from : Indian Social Institute,
Lodi Road, New Delhi 110003. Highlights marketing and sales
of British drugs and food products. Illustrated easy reading.
.2
' 2
5.
Health Care Which Way to Go
Medico Friend Circle Anthology II, 1982,
Rs.10.00
from : medico friend circle office, 326, 5th Main, I Block
Koramangala, Bangalore 560034
Raises relevant issues regarding peoples health. Questions why is
there a lack of political will to solve pressing health problems
of the country. How detrimental is the alliance between
medical professionals and the drug industry to people’s health.
6.
Under the lens; health and medicine
III Anthology of medico friend circle is due shortly and will
be available; from VHAI and mfc office (above).
7.
Kurji Holy Family Hospital; Formulary and Therapeutic Guide.
January 1983, Rs.12.00
Available from VHAI.
It is the result of the accumulated experience of
senior medical staff of the hospital over the last 10 years. It gives
a comprehensive list of drugs to treat 98% of hospital admissions -
it also gives the generic name, dosage, indications, contraindications
and main side effects in the same page. Information about comparative
cost of treatment is also provided.
8.
Drugs and the Third World
Anil Agarwal, 1978, $5.00
From Earthscan, 10 Percy Street, London W1 PO DR
A very comprehensive overview of the drug situation in the third
world and the problems and causes.
3
3
9.
Prescription for change
Health Action Internationals guide to rational health projects,
Virginia Beardshaw, November 1983, 85pp
US$10.00
from Heelth Action International Clearing House
PO Box 1045, Penang, Malaysia.
Gives more than 40 ideas for action research projects on drugs :
- a summary of the main elements of the rational health issues
and suggestions about how to campaign on it;
~ advice on how to talk to drug companies and the powers that be
- a reference section that lists the main materials you need to
research on drugs.
10.
Pill-fering the poors Drugs and the third world.
An information/action pack on drugs and the third world from
Interfaith Center on Corporate Responsibility, International
Health Programme, 475 Riverside Drive, Room 566, New York, NY 10115.
US$4.00 plus postage surface mail $2.70/air mail $4.70.
It provides an overview of the problems related to drug marketing
in the third world. It contains articles on the need for essential
drugs, on the suffering wrought overseas by some US made drugs
and on the high price the third world poor have to pay for their
medicines. ihis package includes an extensive annotated bibliography
basic fact.- and figures about the transnational drug industry and an
outline of suggestions for action on how you can get more involved in
helping to stop abuses.
11.
Therapeutic guidelines: A manual to assist in the rational
purchase and prescription of drugs.
Upunda, Yudkin et al 1981, pp. 166, Rs.35.00 African Medical and
Research Foundation. Available from VHAI.
4
4
An excellent guideline for rational therapeutics, giving special
emphasis on drug cost as criteria for choice of drug diagramatico
format.
12.
Managoent schedules for dispensaries: A manual for rural health
workers
Peter Petit,
1983,
Rs.35.00
African Medical and Research Foundatioh.
Available from VHAI.
13.
44 problem drugs: a consumer action and resources kit on
pharmaceuticals,
I0CU, May 1981.
Available from HAI Clearing House (see 9)
Gives information about 44 problem drugs, Along with articles
by some of the gleading drug compaigners.
14.
A number of interesting papers to keep you upto date
about the drug issue is availabb from Low Cost Drugs and
Therapeutics Cell, VHAI, C-14, Community Centre, Safdarjung
Development Area, Nev; Delhi 110016.
(write to them for a list)
‘Publicise info on banned drugs’
______ By Our Staff Reporter
BANGALORE. Aug 21
Doctors and consumer activists
today made a strong case for
widely publicising names of ban
ned drugs to check the exploita
tion of consumers by manufacturs.
They also stressed the need for
ihanced consumer awareness on
e use of drugs at a symposium
on “Health, Drugs and Con
sumers" here, organised by the
Consumer Rights Education and
Awareness Trust (CREAT), a
voluntary agency.
Participating in the symposium,
Dr Shiradi Prasad of Community
Health Cell regretted that the Gov
ernment was weak-kneed before
the powerful drug lobby and,
hence, even banned drugs were
able to survive in the market. It
was an irony of sorts that a drug
like "analgin", banned in several
countries, was freely used in In
dia.
Even priorities for drug manu
facture in the country were totally
misplaced. There was less produc
tion of drugs in common use,
while a higher investment was
made on "elitist" drugs. If the
Government could provide clean
drinking water and environment
over 80 per cent of the diseases
could be prevented, he noted.
Pointing out the negative influ
ence of advertisements and medi
cal representatives on drug use,
Dr (Ms) Chanda Kulkarni, Assist
ant Professor of Pharmacology, St.
John's Hospital, expressed con
cern over the inaccurate informa
tion propagated through these two
media. However, doctors should
"prescribe rationally and not
fashionably" and patients should
avoid self-medication, she ad
vised.
Regretting that research on es
sential drugs was minimal she
said that there was an absolute
dearth of funds and trained man
power to carry out research.
Whatever little information avail
able with the Government on ban
ned and bannable drugs was not
being adequately advertised, she
said.
Ms Niraja of the Voluntary
Health Association of India said
the Government was unable to an
nounce the new drug policy even
after its promise to that effect
made four years ago. The Hath!
committee report, submitted in
1979 with an alm to evolve a better
drug policy, was implemented
only in parts.
Opposing the move to include
doctors within the ambit of Con
sumer Protection Act, Indian
Medical Association President Dr
Nanjundaiah described it as a
populist move of the Government,
which was not advisable in the in
terest of the public. The process
of medical treatment would be
unnecessarily delayed with gen
eral practitioners shoving the
buck on specialists at every stage.
Stating that such legislation did
not exiJt anywhere in the world,
he said medical science was not
“as exact as mathematics" and a
minor mistake can ruin a doctor’s
career. However, the reckless
money-mongering attitude among
doctors should be controlled, he
admitted.
Strongly opposing the entry of
multinationals on the drug front,
Dr Prakash Rao maintained that
indigenous drug industries would
suffer a lot if past experiences
were any indication. He said 20 to
40 per cent drugs in the Indian
market were spurious. Consumer
awareness was the only cure to
the problem.
APPEAL: Earlier inaugurating
the symposium, State Assistant
Drugs .
Controller
G.B.
Prabhakumar
appealed
to
voluntary agencies to bring spuri
ous, harmful and defective drugs
to his notice so that action could
be initiated against errant indus
tries after due analysis.
Referring to blood banks, he ex
pressed his happiness over the
growing popularity of voluntary
blood donation. AIDS test has
been made mandatory in all blood
banks, he clarified.
__ IN THECITY TODAY
Indian Institute of Science: Union Minister for Environment Kamal Nath inaugurates
International conference on 'Biodiversity of Aslan Regions,' Chief Minister Molly
chief guest, Dr C V Raman Road, 10 a.m.
Main road, Gandhinagar, 9.30 a.m.
GENERAL
O Rotary Club of Bangalore
O Karnataka Forest Department:
Indiranagar: Lecture on 'Why Polio
Union Minister for Environment
Plus’, 2143,16 E main, HAL II Stage,
Kamalnath unveils forest martyrs'
Indiranagar, 7 p.m.
memorial, Chief Minister Moily
• The Bangalore Social Science
Forum: Lecture on Gandhi-Indian
presides, Forest Minister Vishwanath
National Movement, National College,
chief guest, Aranya Bhavan,
Basavangudl, 6 p.m.
Malleswaram, 9.30 a.m.
• Alpine Robotics Limited:
• Sri R Gundu Rao Mlthra Koota:
Dcmonstratlon of Educational
Observance of first death aimiversary
Programme of 4 Axis Robotics Arm,
• Sathsanga Goshthl: 203rd Geetha
Gnana Yagna by H N Ramatheertha,
Sri Uma Maheshwara Temple
premises, K R Road, 11 a.m. and 6.30
p.m.
© Basava Samithi: Discourse on
Nuliya Chandiaiah, Basava Samithi,
Sri Basaveshwara Circle, 6 p.m.
© Sri Raghavendra Seva Samithi:
Aradhana Celebration and Pooja, 6/CA,
13th main road, 4th T block, Jayanagar,
7.30 a.m.
Sri Gururaja Association: 323rd
Aradhana Mahotsava of Sri
Doctors’ strike
hits hospitals
By Our Staff Reporter
BANGALORE. Aug 21
The indefinite strike of junior doc
tors in the State entered the thin
day today, affecting medical ser
vices at several hospitals.
The doctors struck work in sup
port of their demands, includin
the one on bringing admissions t
PG medical courses within th
purview of a Supreme Com
verdict on professional courses.
The authorities at major hosp
tals in the City, includin
Bowring Hospital and Victori
Hospital, claimed, however, tha
services had not been affected, a
patients were being attended b
assistant professors and lecturer
Operations had been conducted i
all emergency cases.
Chain snatched
from woman
By Our Staff Reporter
BANGALORE, Aug 21
Two unidentified persons snatc
ed a gold chain, valued at arour
Rs.11,600, from a woman as si
was walking on Link Road, 5
Main, in the Madivala police st
tion limits on Saturday. The I
lice have registered a case and a
investigating.
THEFT: Dr. S.P. Padma, a reside
of
1st
Cross,
2nd
Sta.
Banashankari, has in a compla
with the police alleged t!
unidentified persons broke b
her house on Saturday night a
decamped with gold omame
and Silver articles and cash, in
valued
at
around
Rs.33, t
BAnashankari police are inve
gating.
In a similar case Bhadraial
resident
of
Unasamarah;
Toachex-’s
Colony.
in
■Io
S p. TTia'^.
New Drug Policy
Betrayal of Consumers’ Interest
The following is a statement issued by the Voluntary Health Association of India on the new drug policy. It
was issued on September 16, 1994.
— Editor
he Voluntary Health Association of India
(VHAI), New Delhi, a federation of more than
3000 organisations involved in community health,
has noted with great concern the announcement of
the new drug policy. The policy was announced at a
press conference on September 15, 1994 We are
shocked that the policy is totally in the interest of
the industry and the consumers basic needs are
neglected. We are dismayed at the ' callous
indifference of the government towards the health
needs of the people. Even the way the government
chose to announce the drug policy (which has farreaching implications as far as the health and life of
millions of people are concerned) through a press
conference rather than after a proper discussion .in
Parliament itself is undemocratic.
Drug prices will shoot up because the number of
drugs in the price control range has been brought
down to 73 from 142. Increasing the profitability
ceiling for bulk drugs will directly further worsen the
situation as far as the prices are concerned.
The rationale for allowing price decontrol, can in
no way be justified if the figures for the last few
years are studied. There has been a steady
increase in sales, profits and dividends of the drug
companies. It is sad that the government has
‘bought’ the drug industries' argument that drug
production is not profitable and drafted the policy
accordingly.
The total liberalisation will further worsen the
existing anarchic situation in drug production. In the
absence of a mechanism to ensure the production
of essential drugs, its acute shortage will hit
all national health programmes. Its implications
are far-reaching as it will lead to further proliferation
of hazardous and irrational drugs The argument
of the industry that trade is a fundamental right
should not be at the cost of the public’s health and
life.
The present policy as such will open the gates
for the multinationals. High priced, useless and
hazardous drugs will be pushed down the throat of
the gullible Indian consumer. Increased dependence
or imports, higher prices and proliferation will
happen due to the policy which allows companies
with 51 per cent equity participation to be treated on
par with Indian companies. This policy will further
hit the Indian industry resulting in import and
increasing prices.
It is further disappointing that there has been no
reference to the irrational and hazardous drugs
which are still being sold.
The neglect towards such an important issue
where thousands of products keep the life of the
public at stake is very critical. These products will
pose a continued threat as far as safety is
concerned because the new drug policy does not
address this critical issue.
Even in developed countries where the industry
has been enjoying a "free-hand” it is under criticism
of late. The spiralling costs in health care in the
USA is just an example. Recent studies from
different parts of the world point out that competition
by market forces need not bring down prices. For
example, the Office of Technology Assessment in
the US was forced to study the costs and profits of
pharmaceutical manufacturers because of the ever
spiralling drug costs.
The OTA report dated Februray 25, 1993 tells
why drug prices in the US are high and it also
shows that competition simply does not work in the
market for prescription drugs which are becoming
unaffordable even in the US. The OTA report states
that to reduce prices there is room to reduce profits,
advertising costs, unimportant research while leaving
breakthrough drugs intact and leaving industry a
generous profit.
These lessons of failures of such liberalisations
and Structural Adjustment Programmes initiated in
those countries, instead of being taken as an eyeopener, are being ignored.
The drug companies have proved in the past that
September 24, 1994 ■ MAINSTREAM
their organised sales promotion propaganda with
advertising and marketing strategies will leave no
chance for the medical, profession to make a free
decision.; Furthermore, drug: is not a substance
which- an ordinary-'iconsumer/patient can decide
The government is giving a “false hope’ to the
public that if required the government will bring back
decontrolled drugs to the price-control category. But
lessons from past experiences show that giving
even a chance for overcharging for drugs by drug
companies has never benefited the consumer.
The VHAI urges the government to reconsider
the policy. We urge that a “rational drug policy"
which will ensure the concerns of the consumers
[namely, (a) availability of essential and life-saving
drugs, (b)--withdrawal of hazardous and irrational
drugs, (c) adequate quality control and drug control,
(d) technological self-reliance] is to be formulated in
a democratic process by discussions at various
levels, like with professional bodies, health groups,
rational drug groups, consumer groups, voluntary
organisations, people’s organisations and in the
Houses of Parliament.
■
Allround Decadence and Ray of Hope
NIKHIL CHAKRAVARTTY
hile there is no doubt a lot on which to attack
those in authority for their dereliction in
running an orderly system of governance, one has
to ask at the same time why there has been such
an appalling deterioration in social conscience in
most of our public activity. In other'•words, the
corrosion of values in public life is not confined to
Ministers and top bureaucrats, but has become allpervasive, the pollution of morals seem to choke
out public service.
If we look around," there is undoubtedly a
widespread feeling of being let-down by those in
power, those who have been assigned the mandate
to rille by the public that has elected them and
placed: them on the position of authority. It is
precisely because of this reason-that the Chief
Election Commissioner has suddenly become a
phenomenon—applauded by the public that expects
him to weed out corrupt practices from the business
of election, while he is the target of attack largely by
those who feel that their citadel of vested interests
in the business of vote-collecting is being invaded
by Seshan’s attempt at weeding out irregularities in
the running of the election machinery. Khairnar
might be reckless in his charges against Sharad
Pawar, but the fact that he, a minor fry in the
bureaucratic- set-up, could brace up to make such
charges of corruption against the Chief Minister,
who is patently on the defensive, shows that in the
_public mind Pawar’s reputation cannot smother out
MAINSTREAM ■ September it. 1994
such a critic from inside the very government over
which he presides. And quite likely there are many
more Khairnars waiting to be counted in the months
to come. Obviously the ministerial standing for
probity has plummetted so much that it cannot
make short shrift of critics from within the
bureaucracy itself.
• If we look back on the immediate past, we find
that in the last ten years corruption has become a
by-word in pur public life and is having a deleterious
effect on the stability of the government. The fact
that criminalisation of politics has become a serious
item of concern for responsible people in politics
irrespective of party labels—and not just the
exaggerated outburst of some chronic critics of the
establishment—shows the dangerous deterioration
in our public life. All this has begun to stir the public
in general. The shock of the scam, that nobody in
authority is prepared to take the responsibility for,
has contributed in no small measure towards the
sapping of public confidence in the government.
But the government apart, the callous irrespon
sibility of people at different stations of public life is
now becoming an issue of intense comment and
concern all over the country. The scandal of the
capitation fees for entry into educational institutions—
and the angry objections at any ban being imposed
on this vicious practice—has been widely commented
upon, and one would not be surprised if this
touches off violent protests. It is not merely the
Tonies : How Much An Economic Waste
KAMALA
MONG the pharmaceutical preparations that are
indiscriminately prescribed are the vitamins, parti
cularly those of the B-complex group. “Probably
no single class of drugs ( Sic ) has been the target
of as much quackery, misunderstanding, misrepresen
tation and misuse as the vitamins......... ’’’. There are
however a number of reasons for this, some in my
opinion condonable.
S.
*
JAYARAO
may be needed. Hence, we are probably not in a
position to recognize all situations which may respond
to vitamin therapy, though severe deficiencies of single
vitamin have been well characterized in most cases.
A
Patients often come with vague symptoms which
can be correlated to no known disease. The comp
laints may be genuine or psychosomatic, but the patient
expects treatment. For example, a common complaint
is pain in the back or pulling sensation in the legs.
Or, it may be a simple complaint of general fatigue
or loss of appetite due to no organic cause. What is
one to do ? One usually prescribes a multivitamin or
a B-complex preparation. This may be done for three
reasons.
The physician may sincerely believe that
vitamins will help the patient or he may feel compelled
to prescribe something. Thirdly, the patient himself
may demand some medicine, generally a ‘ tonic ’.
What does a tonic mean, anyway ? In general parley
it has come to mean a liquid preparation. However
we do come across advertisements of ‘ nervous tonics ’
‘tonic for muscle strength’ ‘for energy’ etc.. This
is pure baloney. One of the definitions given by the
Webster Dictionary for tonic {is ‘ something that
invigorates, restores, stimulates or refreshes ’. Could
it be the generous quantity of alcohol in these prepa
rations ?
If the physician believes that B-complex would be
beneficial, even if he has no scientific evidence or the
rapeutic basis, he need not in my opinion be casti
gated. We still do not know all the metabolic functions
for which one or more members of the B-complex
The trouble arises with the dose that is prescribed.
The physician should realise that in such undefined
situation, the therapy is purely empirical. The burden
rests on him to know whether he is prescribing the
right amount, less or more. This brings us to the
question of what the right amount is. Here we must
defi'erentiate between vitamins taken as nutrients to
ward off deficiency and taken for therapeutic purposes,
in established deficiency. The latter dosages are not
based on as careful a scientific scrutiny as the former.
They are prescribed for acute and severe, single defi
ciency states like beri-beri, pellagra, keratomalacia etc.
Since water-soluble vittynins are considered to be
relatively innocuous, the amounts prescribed are very
high, the main aim being to tide over the acute situation.
On the other hand, we have these various unde
fined situations which we attribute to vitamin deficie
ncies or anaemia. These are neither acute nor proven
states of deficiency. If the condition is due to a
nutrient deficiency, the deficiency is probably chronic
and marginal or moderate in nature. Here the impli
cation probably is that the individual is unable to
meet his nutrient requirements. This is perhaps a
justifiable premise since the prevalence of B-comlex
deficiency in our country is relatively high. According
to certain surveys the prevalnce rate is 5 per cent in
pre-school children and 17.8% in pregnant women
( assessed by the presence of angular stomatitis and
glossitis )2. The percentage of those with less severe
deficiency is expected to be higher.
*
National Institute of Nutrition, Hyderabad-500 007
What is a nutrient-requirement ? The requirement for
a specific nutrient is defined as the smallest amount
of that nutrient that will ensure a good state of health.
This will however, vary from person to person.
Therefore, nutrient requirements are set down as reco
mmended dietary allowances ( RDA ). These levels
are believed to ‘ meet the known nutritional needs of
almost every healthy person. ' By experimental pro
cedures, the highest requirements in a population are
assessed, some further allowances are added and the
RDA for each nutrient is fixed. Thus for many
individuals the RDA will be higher than their actual
requirement. No person need take more than the
suggested RDA. The RDA for various nutrients have
been fixed by international organizations like the
FAO and WHO3 and by various national bodies
including the Indian Council of Medical Research4.
In the process of this search, I came across an
interesting or disturbing feature, depending on how
you wish to perceive it. Many advertisements do not
say what ingredients the preparation contains, leave
alone their quantities. Many inform you that the
preparation is a unique formulation of generous
amounts of vitamins or that it is a vitalizer with
balanced amounts of vitamin ( Incidentally, IDPL is
one of them ). The advertisement merely proclaims
the efficacy of their product in specified condition.
There is one advertisement by a leading company,
which reveals nothing about the formula but claims
that it is good for memory 1 It contains nothing but
vitamins Bi, Be and B12. The companies are pro
bably cocksure that the physician will rely more on
their advice than on his own judgement ( and they
are dead right ).
1 was interested to know how some of the comm
only available vitamin preparations fare when compar
ed to the RDA suggested by the ICMR. Table I
shows the RDA for some nutrients, for various
physiological groups. For specific reasons, 1 have
not taken the RDA for infants and children but in
absolute terms these values will be less than those for
adults. In Table II, I have presented the quantities
of various vitamins purported to be present in each
commercial preparation. It is however not the complete
formula of the preparation. 1 have taken only some
important vitamins into consideratoin. The list is by
no means exhaustive. I culled them from some recent
issues of the Journal of the Indian Medical Associa
tion. They are marketed by leading pharmaceutical
companies.
This lack of needed information is one of the
reasons why Table Il does not have more preparations
listed. But this is ample for what I have to say.
There is also no reason to believe that those which
escaped inclusion would be any different.
Table-I
Recommended Daily Allowances
*
Thiamine
( Bj ) mg
Man :
Sedentary
Moderate
Heavy work
Woman :
Sedentary
Moderate
Heavy work
Adolescents :
13-15 yrs
16-18 yrs
Pregnancy
( Second half)
L elation
The RDA for any nutrient is the amount which
if taken regularly will ensure that a deficiency state
of that nutrient will not develop.
For example if a
sedentary, house-wife takes 1.0 mg riboflavin daily,
she is expected not to develop riboflavin deficiency.
As I said earlier, 1.0 is the highest level and most
can afford to live on lesser amounts.
The situations
which are under discussion now, are considered to be
deficiency states of mild or moderate degree. The
individual might have depleted levels of the nutrient
and may need higher amounts than the RDA. What
Riboflavin
( b2 ) mg
N cotinic acid
mg
Pyridoxinef
( B6 ) mg
Folic acid
mg
Vitamin B.o
mcg
I
1
H 1
1.2
1.4
2.0
1.3
1.5
2.2
16
19
26
_
1.4
—
0.1
0.1
0.1
1.0
1.1
1.5
1.0
1.2
1.7
13
15
20
_
2.0
—
0.1
0.1
0.1
1
■ 1 -1
1
1.1-1.3
1.1-1.5
1.2-1.4
1.2-1.7
14-17
14-21
1.6
1.8
0.1
0.1
0.5-1
0.5-1
1.2-1.7
1.4-1.9
1.2-1.9
1.4-2.1
1 5-22
2.5
2.5
0.15-0.3
0.15
1.5
1.5
18-25
* Taken from reference 4
t Taken from RDA of Food and Nutrition Board, U.S.A.
1968.
.
should this higher level be ? For acute and severe
states like beri-beri or keratomalacia text-books
prescribe doses, empirically arrived at and found to
bring quick relief. These are usually much higher
than what would be required even for that degree of
amelioration.
Table III shows the prescribed thera
peutic doses, as obtained from various standard books
on nutrition and medicine.
For chronic, moderate deficiency states or for
situations where vitamins are prescribed empirically,
we may assume that levels much lower than the
therapeutic doses and slightly higher than the RDA
should be enough. Let us be generous and double
the RDA, remembering that the patient does receive
a certain amount from his diet too.
With this
information I would like you to critically compare
Table II with Tables 1 and III.
Much of the time drugs are not prescribed
according to any therapeutic schedule.
They are
usually prescribed as ‘ I dose or I tablet, three times
a day ’. Items No. 1-4 in Table II are close to the
RDA with respect to vitamins Bi and B2. Given as
Table-II
per the above mentioned schedule they supply 2-4
times the RDA, and it was argued above that double
the RDA should be enough in moderate or doubtful
deficiency states. We must also remember that when
a diet is considered to be low in a nutrient, it is not
totally lacking in that nutrient. The average diets of
the low socio-economic groups provide 0.5 to 0.8 mg
each of Bi and B2.
Items 7-9 provide about 5-25
times the RDA in a single dose. If even such pre
parations are prescribed thrice a day, the intake
would be 15-75 times the RDA. Item 8 in a single
dose supplies thiamine in a quantity prescribed for
the whole day in beri-beri ? Moreover in beri-beri
it is not necessary to prescribe very large amounts of
other vitamins. Thus preparations like 8 and 9 are
not necessary at all.
An argument may be put forward that since
water-soluble vitamins are harmless compounds there
is no necessity to raise a hue and cry about the
dosages prescribed.
This is no doubt true but,
‘ such practice is economically wasteful and in some
instances, causes financial hardship
Composition of some multivitamin and haematinic preparations available in India.
Vitamin Bi mg
Vitamin Bs mg
Vitamin Be mg
Niacin mg
Vitamin B1S mcg
Folic acid me
Vitamin C mg
Iron
( Type of salt ) mg
3
5 ml.
4
5 ml.
5
Cap.
1
1.0
0.75
0.15
7
0.45
1.6
0.8
0.8
4.0
2.5
3.0
1.0
0.5
30.0
5.0
50
Sulp.
150
timed
release
F.A.C
185
Gluco.
35
Capsule
Cap.
1
0.5
0.6
4
2
2
9
9
Vit. A. I.U.
Vitamin D. I.U.
6
Cap.
7
Cap.
5
10
10
5
100
5
9
I
10
5
1
50
Sulp.
200
250
90
200
Sulp.
41
8
Cap.
50
25
10
100
5
0.5
300
9
Cap.
20
5
2.5
100
5
1.0
100
10000
1000
25000
1000
Table-II (Contd)
10
5 ml
Vitamin B, mg
Vitamin B_. mg
Vitamin B,: mg
Niacin mg
Vitamin B:; mcg
Folic acid mg
Vitamin C mg
Iron (Type of salt)
mg
Vitamin A
Vitamin D
11
Cap.
12
Cap.
13
Cap.
14
5 ml.
15
5 ml.
16
Cap.
17
3. ml I.M.
100
io
25
2.5
Colloidal
oxide
100
25
2.0
200
Fumarate
350
15
9
150
Fumarate
350
50
2.5
100
Fumarate
300
7
1.75
15
2
Colloidal ox.
500
Fumarate
125
25
2.5
Fumarate
250
18
5ml. I.M
100
27.5
25
1000
500
It mtist also be remembered that water-soluble
vitamins cannot be stored in large amounts unlike
the fat-soluble ones. This of course is one of the
factors underlying their low toxicity. ‘ In prescribing
thiamine it should be remembered that the healthy
human body contains only about 25 mg of the
vitamin. Furthermore, it has no means of storing
any excess taken in the diet; the excess is lost rapidly
in the urine.
The human body is certainly an
effective machine for dissolving thiamine pills and
transferring the solution to the urinal’s.
Moreover
it has been shown, atleast for riboflavin that intestinal
absorption is limited by saturability and that higher
the dose, smaller the fraction absorbed. This is no
case in favour of parenteral administration either,
because higher the amount in circulation greater the
excretion in urine.
Thus, most of the ‘ high-potency ’ or ‘ Forte ’
preparations of multivitamins are a sheer economic
waste. It is a drain on the patients’ purse and the
onus is on the doctor because he is making the
patient buy a specific preparation.
If bought by
goverment or public sector dispensaries, it is a
national waste. If preparations with smaller and yet
adequate quantities were bought, for the same money
more tablets could be purchased and a greater number
of patients benefitted. Manufacture of such ‘ highpotency ’ preparations must also use up an unnecessary
amount of the scarce foreign exchange resources,
since quite a few, and probably all vitamins ( raw
materials ) are imported.
Thus it is not proper if one merely prescribes
B-complex tablets and avoids brand name because he
is a ‘ conscientious objector ’ to brand names. As long
as there is no uniformity in the dosage employed in
various preparations, it is necessary to know which
brand supplies or claims to supply requisite quantities
of vitamins. Also, there is no need to blindly follow
Table-IH
Suggested doses of vitamins for single,
severe deficiency
acute and
Condition
Vitamin
Dose (Oral)
Beri-Beri
Bi
10-25 mg bid'
or tds
5-10 mg
5-10 mg
5-10 mg
Riboflavin deficiency B,
Megaloblastic anaemia Folic acid
Bia
Megaloblastic an: emia
Folic acid
of pregnancy
Corneal xerosis
Vitamin A
Bitot’s spots
Vitamin D
Rickets
10 mg
5000-10,000 I.U
1000-5000 I.U.
the ' one t.d.s. ’ schedule. How much and how
frequently, should be decided on the merits of the case.
I also wish to draw your attention to one or
two additional points. There is a widely held belief
that a combination of vitamins Bi Ba and Bi ; is
good for neuropathies and other nervous disorders.
I don’t think this is based on any solid therapeutic
evidence. The reason the three are combined, I think
is because each one has been shown to be effective
in a specific disorder of the nervous system. Hence
the triad is used as a short-gun therapy, indiscrimina
tely. In fact, the brand names of certain such prepa
rations incorporate Greek terms like ‘ encephalo
‘ neuro ’ etc. The manufacturers of one preparation
even claimi ts efficacy in improving memory.
‘ It ( thiamine ) may be given, though without
expectation of dramatic results, in cases of nutritional
neuropathy. There is no reliable evidence that it is
useful in any other disorder of the nervous system.
The prescription of synthetic thiamine, either alone or
in combination with other vitamins, as a general tonic
or appetiser, is supported by no scientific evidence
and is now discredited. ’5
‘ Vitamin therapy is often given to patients with
polyneuropathy, although it is clear that polyneuro
pathy is not due to deficiency of vitamin Bi, B'2 or
any other known vitamin. Such treatment has a
placebo value and probably no other, but is not to
be decried... ,’6.
For reasons mentioned right at the beginning
I too do not decry the use of the combination as
I do the dosage in such preparations. Items 17 and
18 in Table-II are two classical examples.
Both are
meant for parenteral use, another characteristic of
this triple combination, probably because of the
presence of vitamin Bia. The conventional prescri
ption by physicians for parenteral B-complex is ‘ 2 ml
I.M. once a day or once on alternate days ’.
Assuming the patient receives 6 ml in a week, he is
given 600 mcg to 2 mg of vitamin Bls 1 What a
collossal waste considering that vitamin B)2 is an
expensive substance. The prescribed dose even for
pernicious anaemia is 2 rag weekly, even those who
may aigue that unlike the other B-complex vitamins.
vitamin B)2 is stored to a certain extent in the body
may note that with each 1 ml goes 20-33 mg thiamine.
(
Many of the oral preparation too contain unnece
ssarily high amounts of Bia. The RDA for this
vitamin is 1.0 mcg and in pregnancy and lactation, 1.5
mcg. Even conceding that a majority of the popu
lation cannot afford animal foods and hence many
may stiller from vitamin B,... deficiency, I see no
jk
J
reason why any preparation should contain more
than 2 mcg. and at the most 5 mcg vitamin B12 .
This criteria is met by only 7 of the 16 oral prepa
rations listed. If the preparations are haematinics
combined with iron, they have to be prescribed three
times a day. In which case the preparation should not
contain more than 2 mcg B12 . Items 10-13, 15 and
16 must be very expensive and those who really
suffer from B12 deficiency can ill—afford then. 1 also
wish you to note that mixed haemanitics-iron prepa
ration containing vitamins and minerals, are condemcd
by authorities in the field of anaemia. “ Recovery
of the patient with uncomplicated iron-deficiency
anaemia is not helped by vitamin supplements or
minerals’7. In our experience vitamin B13 and folic
acid are not needed till haemoglobin levels come upto
11 gms. % or more.
Let us now consider the vitamin A content of
these preparations. The prescribed dose of vitamin A
for corneal xerosis and Bitot’s spots is 1500-3000 mg
( 5000-10,000 LU ). daily8,9.
The RDA during
lactation, the maximum suggested for any group, is
3500 LU. Notice the vitamin A content of items 7
and 9.
Who needs 25,000 LU. vitamin A daily?
Severe cases of deficiency like keratomalacia are not
to be treated with oral preparations9,10.
Those who
really develop xerosis can never afford a pharma
ceutical like 7 or 9, whose price is further raised due
to presence of other nutrients.
Imagine to what
extent the price can be reduced simply by bringing
down the vitamin A content, even to 5000 LU.,
which itself is a high amount.
Then, there is the practice of adding glycero
phosphates to liquid, multivitamin preparations. I do
not know of what therapeutic value these compounds
are. They are not mentioned in any standard text
book of pharmacology and therapeutics.
As far as
1 know (see any pharmacopoea) they only form basic
ingredients of syrups, possibly for flavour. However,
a widespread misunderstanding is that they are
‘ energy givers ’ or ‘ tonics ’. Some brand names
carry a prefix or suffix of ‘phospho’ and the advertise
ment says ‘energy givers’, ‘ vitalizer ' etc. This in my
opinion is a fraud perpetuated by the drug companies
and worse still, an unpardonable ignorance on the
part of the doctor. The vitamins atleast, despite the
excess and the wastage, do some’ good.
I see no
nutritive or therapeutic value for the glycerophos
phates. Their presence is needed for syrup preparation
but its name should not be included in the brand
name and no claims should be made for its therape
utic efficacies.
One of the nutrients commonly added to multi
vitamin preparations is iron. Witness that out of the
16 listed items, only 4 do not contain iron. It is
well-known that ferrous compounds are better absor
bed than the ferric, and it is heartening to note that
most are ferrous salts.
A prcplexing form is the
colloidal iron oxide (items 10 and 14 ) which finds
no mention in any book on pharmacology or iron
metabolism. Since it is a colloidal preparation I doubt
if the iron in it is easilly available to the body.
Of the various ferrous salts, ferrous sulphate is
the least expensive and should be the treatment of
choice, yet only 3 preparations contain it. It is said
that contrary to popular thinking and claims,
gastrointestinal intolerance to iron preparations depends
on the total amount of elemental iron in the gut and
on psychological factors;
it is not a function of
the form in which iron is administered.1'7 Thus claims
made for compounds other than ferrous sulphate,
of increased tolerance or decreased toxicity, are not
genuine.
Also, sustained - release ( timed-release )
compounds ( no. 2 ) take the compound beyond the
duodenum and proximal jejunum and thus reduce
iron absorption. Therefore it is wasteful to prescribe
such preparations.
The RDA for iron ranges from 20-40 mg per day
depending on age, sex, physiological state etc. This
of course is for food iron and for free inorganic
salts would be less. The therapeutic dose, on the
other hand, is 60 mg elemental iron, thrice a day.
Ferrous sulphate, fumarate and gluconate contain 20%.
33% and 12% elemental iron respectively. Items
11-13 and 16 are probably meant for iron deficiency
anaemia. Prescribed twice a day they supply 250-350
mg elemental iron which is higher than the thera
peutic dose.
Thus taken,
13 supplies 150 mcg
vitamin B12. On the other hand. no. 7 supplies only
8 mg elemental iron per capsule.
One may argue
that this may be used as for prophylaxis and not
treatment. Have a second look and tell me the
situation where in an individual is grossly deficient
in every vitamin one can think of and is yet not
deficient in iron ? This is a pure commercial gimmick
to claim haematinic value for the preparation. As
early as 1936 Strauss said “ shot-gun therapy is to be
deplored for a number of reasons. Most mixtures of
substances fail to contain enough of any one ingredient
to give maximal effects. The patient must pay not
only for the material he needs but also for the nonessentials ” (cited from ref. 1).
One can go on endlessly in this manner.
My
intention in writing this is to bring to the notice of
MFC members the fact that all multivitamin and
haematinic preparations are not same.
I.
2.
3.
Theie is no uniformity in dosage employed.
There is no authority to lay down criteria for
There is no authority to check whether the
claimed doses are actually present.
Doctors prescribe these preparations with total
ignorance of or indifference to principles of
nutrition and therapeutics.
5. High-potency preparations should be available
separately for single vitamins.
Multivitamins
need not contain amounts much higher than
RDA. They are economically wasteful.
6. The false claims made for improvement of
unspecified and unproven conditions are perpetua
ted due to the ignorance or compliance of the
doctors.
7. Most of the companies have foreign collaboration.
Most of the raw ingredients ate to be imported.
Could this be one of the reasons for the high
dosages employed ?
1 am sure you will find asking yourself many
more such questions.
4.
References
1.
The Pharmacological Basis of Therapeutics. ( L. S. Goodman
and A. Gilman, cds.).
Fourth cdn. MacMillan Co.,
London. 1970.
2.
Nutrition Atlas of India ( C. Gopaian and K. V. Raghavan
cds.) National Institute of Nutrition. Hyderabad, 1971.
3.
Energy and Protein Requirements. WHO Tech. Rep. scr.
No. 522. 1973; Requirements of vitamin A, Thiamine,
Riboflavinc and Niacin. WHO Tech. Rep. scr. No. 362,
1967, WHO Geneva.
4.
Dietary Allowances for Indians ( C. Gopaian, B. S. N. Rao)
Indian Council of Med. Research, Spl. Rep. Ser. No. 60, 1968.
5.
D. Davidson, R. Passmore, .1. F. Brock and A. S. Truswell.
( 1975 ). Human Nutrition and Dietetics, Sixth cdn. Churchill
Livingstone, Edinburg and London.
6.
W. G. Bradley (1975 ).
Practitioner 215: 452.
7
T. H. Bothwell and C. A. Finch (1962) Iron Metabolism.
Little, Brown Co., Boston.
8.
S. G. Srikantia ( 1975 ) Human vitamin A deficiency. Wld.
Rev. Nulr. Diet. 20: 184.
Reddy, V. ( 1969) vitamin A deficiency in children. Indian
J. Med. Res. Suppl. to vol. 57, p. 54.
M. F. C. Bulletin 8, August, 1976.
9.
10.
The treatment of polyneuropathy.
Reprinted from :
Medico Friend Circle Bulletin, November, 1976
Published monthly from 21 Nirman Society, Vadodara-390 005
COVER STORY
RATIONAL DRUG THERAPY
A to Z of Drug Policy Issues
and
A to Z of Problem Drugs
Chloral Hydrate
Advertising
diarrhoeas need only ORT, antibiotics
are needed only when specific orga
nisms have been detected as in amoebiasis, giardiasis, cholera etc.
is one of the mam tools of drug compa
nies to create a need for their products.
Includes appeals for status, modernity,
even unnecessary uses and cosmetic
embellishments.
B=
Analgin
Bulk Purchasing
Clioquinol
is a potentially toxic drug and may
cause agranulocytosis. Fixed dose
combinations (FDC) with any other
category of drug in oral dosage forms
are considered harmful.
Buying of drugs in bulk by competitive
buying of generic drugs in the interna
tional market. It does away with brand
names and private importers.
Amidopyrin
This implies fundamental and innovational process or product research. A
necessary step to prevent dependence
on foreign companies.
or hydroxyquinohnes have been popu
larly used for prophylaxis and treatment
of gastro-ententis, amoebiasis and tra
veller's diarrhoea. Ever since the report
of its association with SMON (sub
acute myeloptic neuropathy), its use
has been restricted or banned in many
countries. In India they are supposed to
be prescription drugs but are obtaina
ble over the counter A warning in Eng
lish small print, is given on the product
but it hardly succeeds in warning
consumers.
A=
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 with renal tubular necro
sis (Banned in July 1983)
Ancoloxin
a widely used anti-nausea drug,
reported to have teratogenic potential
and hence is a hazard to pregnant
women. Sold in India without warning.
Anabolic Steroids
are synthetic derivatives of male sex
hormones which have an androgenic
and anabolic (body building) effect. It is
chiefly indicated for treatment of senile
and post-menopausal bone disorders
and aplastic anemia. In India it is advised
for malnutrition, as appetite stimulant
and for increasing growth. All these are
foolish especially in the light of irreversi
ble harm it can have on children's
growth and sexual development. After
much publicity of these side effects,
CIBA Geigy has withdrawn Dianabol,
one of the commonest available. Many
more preparations continue to be mar
keted in India.
Basic Research
Bio-Availability
This means that the same chemical
ingredient, may be therapeutically dif
ferent because of the way of formula
tion. A common but unconvincing
argument against generic prescribing
by drug companies.
Bromides
used as a hypnotic; has been found to be
an imta’nt of the gastnc mucosa caus
ing nausea, vomiting, flatulence and epigastnc distress. It can also cause
hepatic or renal damage. It should no
longer be used as a hypnotic. (Banned in
July 1983)
D=
On prolonged administration, they
replace chloride ions in the body.
Cumulative poisoning manifests as con
junctivitis, gastro-intestinal symptoms,
dermatitis and mental disturbances. It
was commonly used as a hypnotic of
low potency but unreliable (Banned in
July 1983)
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.
c=
Government orders to control prices of
drugs and profits issued in 1963,1966,
1970,1979 and 1987.
Consumer Alert And Consumer
Action
Anti-Diarrhoeals
An important and growing need in the
formulation &. the implementation of a
safe drug policy.
Have no value in the treatment of diar
rhoea. but are commonly available as
over-the-counter drugs. Non-specific
A pharmaceutical product containing
mgre than one active ingredient.
Combination Drug
Dumping
□ rug Price Control Orders
Dipyrone
is the sodium sulphonate of amidopy
rine having similar properties and
adverse effects particularly fatal agra
nulocytosis. The incidence and risk of
this hazard far outweighs any benefit
that can be derived from its use.
HEALTH ACTION AUGUST 19B8 •
COVER STORY
Essential Drug List
A list of medicinal products of proven
efficiency, acceptable safety and suita
bility to satisfy the health needs of the
majority of the population.
Expiry Date
The date appearing on a drug product
and established by the manufacturer,
beyond which the manufacturer will not
guarantee the potency, purity, unifor
mity, or bio-availability of the product.
EP Forte
High dose estrogen-progesterone
combinations which are dangerous for
use in pregnant women because of
associated fetal malformation. In spite
of the banning of production and sale of
these drugs by the Drug Controller in
March/June 1983 they continue fan
stay orders) to be misused for hormo
nal pregnancy tests and for induction of
abortion. (Banned on June 30, 1988)
Enzymes
A very wide range of enzyme prepara
tions are available in India as digestives.
Though by themselves they are not
harmful, their production in large
amounts along with tonics, vitamins
and health restoratives are an indica
tion of our irrational durg policy at the
cost of larger social needs. These are
mostly consumed by the relatively wellfed urban population.
Ergot
is an alkaloid effective in the treatment
of migraine. However fixed dose combi
nations with drugs like paracetamol,
prochlorperazine etc., have no thera
peutic advantage and hence are irra
tional (FDCs of ergot are banned since
July 1983)
F=
Formulations
are finished products which are directly
consumed and contain in addition to the
active drug compound other ingre
dients such as diluents, binders, flavour
ing/ colouring agents, gelatin shells,
chemical bases, waxes and preserva
tives.
RATIONAL DRUG THERAPY
tioner or a group of medical and scien
tific professionals or a hospital for the
purpose of a specific medical practice
or supply system, e.g., St. Martha’s
Hospital Formulary.
which include lodochlor-hydroxyquinoline, Proxyqumolme, halquinol, di
iodohydroxyquinoline, chlorqumaldol,
chiniofon). For hazard see clioquinol.
FDC or Fixed Drug combinations
Estrogen-progesterone
combina
tions 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 these tests should no longer
be done. The Drug Controller had
issued a directive to strengthen
warning on packages (March 1982)
and banned manufacture (Dec 1982)
and sale (June 1983). Due to legal
controversy, and professional and
consumer ignorance it still continues
to be used. (Banned on July 3,1988)
are formulations where two or more
drugs are combined for the following
reasons: (a) synergistic action; (b) cor
rective action; (c) two or more drugs
normally presenbed together and taken
by patient simultaneously; (d) when
dosage of each drug need not be indivi
dualised; (e) where combination ensures
better patient compliance due to con
venience of administration. Conversly
FDCs are irrational and should not be
permitted if a) adverse interactions
occur; b) when one of the combined
drugs becomes toxic on prolonged use;
c) When abrupt withdrawal of one
causes withdrawal symptoms; d) if subtherapeutic doses are used in the
absence of clinically demonstrable syn
ergism; e) when pharmacokinetic behav
iour of individual agents is different. (22
FDCs were banned in July 1983-refer
Government order)
Gr=
Generic Prescribing
Prescription of drugs using the official,
international, non-propnetary name and
not trade or brand names eg. aspirin,
not Aspro or Plusprin.
Gripe Water
These 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. Des
pite toxicity and side effects gripe
water does a thriving business through
medical and consumer ignorance
(Banned in Bangladesh in June 1982).
H=
Hathi Committee Report
Formulary
An exhaustive report of far-reaching
importance, by the Committee on
Drugs and Pharmaceutical Industry,
Government of India, published in April
1.975.
A list of approved or recommended
drugs compiled by an individual practi
or halogenated oxyquinoline derivatives
Hydroxyquinolines
Hormonal Pregnancy Tests
1=
international Codes
These are codes of quality or safety
of products or business procedures
eg. Code of Ethical Marketing Prac
tices of Health Action International.
An important step in pressurising
multinationals to stop exploiting the
Third World.
Injectable Contraceptives
DEPO-PROVERA and NET-EN are
examples of long acting injectable
hormonal contraceptives which have
and are being introduced into Third
World countries. Animal experi
ments and human use show toxic
side effects. They have been banned
in many countries.
Irrational Prescribing
Extravagant prescribing, over pres
cribing, incorrect prescribing, multi
ple prescribing or under prescribing
of medications, as compared to good
standards of treatment.
Injections
have played a very important role in
modern medicine and form one of its
most distinctive features. 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 temp
tation of the medical practitioners to
pander to this need and use it for
their own economic gain.
HEALTH ACTION AUGUST 1980 •
COVER STORY
J=
‘Junk Drugs’
are newer drugs in the market whose
only additional value are cosmetic
embellishments, elegant packing and
irrational combinations, all of which help
to increase its cost.
K=
“What people really
need, first and fore
most is dean drinking
water, latrines, school
and land, not urban
hospitals with their
wonder drugs".
- Planning Commission
Know-how
An important requirement for the
technical improvement of the drug
industry. Often controlled by patents,
royalty rules and monopoly of foreign
companies.
Kaolin
is hydrated and purified aluminium
silicate, a common addition in antidiarrhoeal mixtures. Along with pectin
and bismuth salts, it forms a group
called absorbents, astringents and bind
ing agents. These drugs may cause loss
of electrolytes by preventing absorbtion
through gastrointestinal tracts. If at all,
they are of cosmetic value and may
actually mask the seventy of disease.
Me-Too Drugs
These are products of research using
molecular manipulation which are pro
fitable but not necessarily a scientific
advance.
Mark Up
Is the hike in the pnce above the basic
production cost. It is presently fixed by
government orders. The less essential
the drug formulation the higher the
mark up allowed in India.
Methapyrilene
and its salts (Banned in July 1983)
Net Worth Returns
Labelling
Is an expression of the profit potential Of
a drug company and is one of the high
est in the chemical industry in India.
Nialamide or Niamid
an MAO inhibitor used in the treatment
of depressive disorders (Banned in July
1983)
Level of Use
A classification of drugs according to
the medical practitioners who use
them and the clinical facilities at which
they are used.
0=
Lomotil
or over-the-counter drugs. These are
drugs that are available to consumers
without prescription and are mainly
painkillers, anticold preparations, cough
mixtures, tonics, food substitutes and
protein powders. Many of them are
cdstly compared to the benefits they
render, have some ingredients which
are unnecessary or useless but help to
push up costs and are widely advertised
with false claims to push up sales. Their
or diphenoxylate and Loperamide are
drugs whose nsks of treatment out
weigh their benefits especially in child
ren. Used in diarrhoeas. Dangers of
paralytic ileus and toxaemia if asso
ciated with gut infections. Especially
dangerous in pediatric practice. Their
use for children under six has been
banned in India. In most other countries
its use is banned altogether.
scientific scrutiny is a need as also a
systematic campaign against their
irrational ingredients or claims.
Oxyphenbutazone
A group of non-steroidal antiinflamma
tory drugs which also have mild antipy
retic and analgesic properties. The
dangers associated with its use are
bone marrow toxicity and liver toxicity.
They are a widely used/overused/misused group of drugs, there is great need
for building professional awareness and
consumer alert on this group of drugs.
Recently these drugs have been
banned in UK.
ORT or Oral Rehydration Therapy
N=
Placing wntten 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.
RATIONAL DRUG THERAPY
OTC Drugs
A very important need in the rational
management of diarrhoeas in children
and its popularity will prevent use of
many anti-diarrhoeals that have doubt
ful therapeutic value.
p=
Public Sector
Includes drug manufacturing compa
nies owned by the Central Government.
These have pioneered the production of
bulk drugs in the country. The Govern
ment policy attempts to give it a leader
ship role
Patents
Exclusive rights given to manufacturers
for fabrication of a specific product, use
of a specific process, or application of a
product or process in a specific way.
Phenacetin
was a commonly used analgesic/antipyretic agent which has been reported
to cause kidney damage and failure and
haemolytic anemia. Fixed dose combi
nations containing it are considered
hazardous. These have been recom
mended for weeding out by the Hathi
Committee.
Phenylbutazones
Another group of non-stenodal anti
inflammatory drugs which give only
symptomatic relief and in no way alter
the course of the illness. Its main indica
tions are for ankylosing sponlitis 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
severiy restricted. Its present availabi
lity - freely over the counter - should be
HEALTH ACTION AUGUST 1988*
'
COVER STORY
RATIONAL DRUG THERAPY
drastically controlled and its deadly
combinations with amidopynn, analgin
paracetamol, diazepam, vitamin B, dextrapropoxyphene,
acetaminophen
should be banned or adequate warnings
in labels instituted.
Practolol
(Banned in July 1983)
Pencillin
Still an important constitutent of anti
bacterial therapy in spite of the risk of
anaphylactic reaction and allergic reac
tions (Its combination with sulphonam
ides and its preparations as skin/eye
ointments are banned from July 1983)
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 competi
tions, samples and give-a-ways.
Samples
Strychnine
Commonest method by drug compa
nies to woo doctors. Other methods
are advertising in medical journals, leafleting, sponsoring medical events, hos
pital and providing gifts.
This was. a drug formerly used as an
appetiser' Its use in tonics can induce
convulsions particularly in susceptible
individuals As obsolete drug! (FDCs of
strychnine with caffeine, yohimbine,
testosterone and vitamins are banned
since July 1983)
Shelf Life
Q=
The length of time a material may be
stored without affecting the usability,
safety, punty or potency of the item.
The testing of drug samples against
specific standards of quality A very
important step in manufacture and dis
tribution of drugs, in India this is orga
nised by the Drug Controller
A system for providing written instruc
tions for patients using sketches and
other graphic representations.
Quality Control
Quinine
Was the sheet anchor of anti-malana
treatment till safer 4 ammoquinolmes
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 some
times in cerebral malaria.
Symbolic Labelling
Sulphonamides
These have an important role to play in
the treatment of infections. The combi
nation with pencillins is undesirable
because of the antagonism of antibac
terial effect when bacteriostatic and
bacteriocidal drugs are given together.
(FDCs of sulphonanamides and penicil
lins are banned since July 1983)
Streptomycin
R=
Research and Development
A much neglected area in the drug
industry. A very necessary requirement
for a country to evolve its own indigen
ous drug policy
Rational Drug Therapy
is the art/science of prescribing the
best suited drugs to individuals who
need them. It takes into account fac
tors like efficiency, safety (low incidence
of side effects), cost and ease of admini
stration. It scrupulously avoids extra
vagant prescribing over or under pres
cribing, multiple prescribing or incorrect
prescribing.
Resistance
of organisms to various antibiotic drugs
are on the increase due to irrational and
unnecessary prescribing. It necessi
tates tne use of second line drugs
which have more side effects and are
more expensive.
• HEALTH ACTION AUGUST 1988
suppression. It is a life saving drug to be
used in special circumstances. Their
doses should be adjusted to the mini
mum that can produce the effects.
Fixed dose combinations with other
drugs are irrational and objectionable
since individualization of the dose can
not be done. (FDCs of steroids for inter
nal use except for treatment of asthma
are banned since July 1983)
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 combina
tion with penicillins is undesirable since
its use in small doses promotes deve
lopment of resistance.
Steroids
One of the most misused drugs in
general practice because of quick
effects. Patients are exposed to a wide
range of toxic cumulative effects and
adrenal' insufficiency due to adrenal
Helpful
Nurse, showing a new patient to
his room: "Now, we want you to be
happy and enjoy yourself while you
are here, so if there's anything you
want that we haven't got, let me
know and I'll show you how to get
along without it."
T=
Transfer pricing
Importing of raw materials from parent
companies by multinational sub
sidiaries, very often at rates higher than
the prices in the international market
thereby transfering costs to the local
consumer.
Tetracyclines
One of the most commonly misused/
overused broad spectrum antibiotics
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 in child
ren. Fanconi syndrome (if outdated,
degraded drug is used) and liver dam
age in pregnant women have put it on
the list of hazardous drugs. It should not
be used in paediatric practice and in
pregnant mothers. Its manufacture is
supposed to be banned from January
1982.
Tonics
Apart from being an economic waste,
most tonics in the market contain alco
hol, which is the mam appetite stimulant
and also vitamin and mineral constitu
ents in amounts greater than the phy
siological absorptive capacities of aver
age Gl tracts. Their overuse mainly
helps to vitaminise our sewage
systems!
Fast drivers get everywhere a
little sooner - even the cemetery.
\ /Q C
jstA.'A •")
w=
UN Agencies
These include UNIDO, UNCTAD, UNI
CEF. AN of these are gearing up to help
developing countries evolve relevant
drug policies.
Unani and Ayurvedic drugs
These are difficult to standardise since
official standardisation methods are
not available FDCs of these with allopa
thic drugs have no therapeutic rationale
or justification or proven efficacy. (FDCs
of ayurvedic and unani drugs with
modem drugs have been banned since
July 1983)
v=
Voluntary Action
Only voluntary action and initiative can
tackle many drug policy issues. The .
Gonoshasthya Kendra and GK Pharma
ceuticals are one example of such an ,
initiative.
Vitamins
Misused/overused group of agents
especially as combinations and tonics.
They are essential nutritional require
ments but most people get adequate
amounts in a balanced diet Specific and
separate preparations are required for
specific deficiency states or as
adjuncts to therapy. (Their FDCs with
analgesics, tetracyclines, anti-inflammatory drugs, tranquilisers have no
proven therapeutic effects and have
been banned since July 1983)
SOURCEl
Health Action
World Health Organization
Their expert committee reports and
working group reports are providing :
technical back up for the evolution of a
more health oriented policy in member
nations.
Waterbury's compound
is one of the brand leaders in the tonic
market whose main effects, if any, are
because of the 9-10°/o alcohol content.
It contains an insufficient amount of
iron, and creosates and guaicols whose
role in man has not been definitively
established. Uke incremin, phosphomin
hermphos their advertised claims far
surpass their actual chemical content
Advertisements of such tonics are the
most symbolic of the high pressure,
half-truth gimmicry of medical
advertising.
Y=
Yohimbine
a drug often combined with strychnine,
vitamins, testosterone, arsenic, iron
and vitamins has been found to pene
trate the CNS and cause central exci
tation including rise of blood pressure.
heart rate, hyperexcitability and trem
ors (its use especially in such combina
tions is banned since July 1983)
Compiled by
Community Health Cell
Bangalore
Vol. 1
No.8,
1988
-a. /<?- /-B
COVER STORY
Rational
Drug use
□r Ravi Narayan, MBBS MD DIH
Community Health Cell Bangal
CJ
rugs are the hallmark of Modern
Medicine. The 'healing professions’
throughout the ages have always
used 'natural' or 'synthetic' product^^
for their medicinal value, to treat var-^5
ious common ailments of people.
Drugs, however, have never in
past dominated the medical scene
as they have done in the second half
of this century. Today, the 'pill for$&
every///'culture is well established. It 1
has ensured that we are probably
the most 'drugged generation' of all
times. Not a very healthy thought!
Throughout the centuries, philo
sophers, social activists and con
cerned doctors have warned again^.
the dangers and problems of-pyei
otoyeroseu
__
or misuse of drugs by doctors and
the people.
The indiai^ituatitfti 3?.
doctors to over-prescribe glam of irrationality in the present situa
orous and costly drugs with
tion. A spate of reports appearing in
limited medical potential. It is also our newspapers and periodicals high
light these elements. Of all of them,
unfortunate that the drug pro
ducers always try to push doc however, the report of the recent
tors into using their products by 'Lentin Commission' and its shocking
all means - fair or foul. These findings are the most telling.
basic facts are more responsible Irrationality in drug use arises out of
for disj^ions in drug production three sets of factors:
and consumption than anything
A Irrationality in drug production,
else.
marketing and availability
Eternal vigilance is required to
' B Irrationality in prescribing practi
ensure that the health care sys
ces of doctors and health
tem does not get medicalised,
workers
that the doctor-drug-producer
axis does not exploit the people C Irrationality in drug use by the
anQ
t>al.lct; u(
ug&
consumer public.
and tnat
that tne
the duutl
abundance
of ur
drugs
All these taken together result in
does not become avested inter
pc). in .iihp^ir h "
the situation we find ourselves today.
w^Bngs are a serious
nt of the medical profession A Irrationality in drug produc
“There are two types
of physicians - those
who promote life and
attack diseases; those
who promote diseases
and attack life."
- Charaka Samhita
The Indian Council of Medical
ResearpKaod the Indian .Council of
Social Sciences Researcn set up a
joint study group to study the health
situation in India and evolve an alter
native strategy for our commitment and the drug industry in the country.
to ‘Health for All by 2000 AD." This It confirms the growing evidence
high powered expert committee had that drugs are being pushed on an
some very interesting things to say unsuspecting public by devious
about the present situation of drugs methods which masquerade as
and prescribing practices, in thei&.
Bl!e& sa'es promotion' of drug companies
pHr and 'professional prescribing pracReport published in 1981. (1)
by doctors and health workers.
★ “There is now an over-production
M(|pf ajs who are committed to
of drugs (often very costly) meanfc
'HealtWjeed
to be concerned about
. for the rich and well-to-do whil^j
the drugs needed by the poor this.sitwpon. The promotion of a
people (and these must be cheap) 'RationaEQwg Use'by the medical
are not adequately available. This profession^pd health workers and
skewed pattern of drug produc ultimately by the consumers - the
tion is in keeping with our inequi- patient community and the public, is
■ tous .social structure which an important item on the agenda of
stresses the production of luxury HEALTH ACTION.
. igood&Ter the rich at the cost of Irrational Drug Use - some
the basic needs of the poor.:....
★, Cine of the most distressing
. aspects of the present health
. 'situation in India is the habit of
RATIONAL DRUG THERAPY
dimensions
To understand the principles of
Rational Drug Use, one needs to first
identify arid appreciate the elements
tion, marketing and availa
bility
Industrial Policy
Qcug policy continues to be part
.of the industrial policy and not
^part of the health policy. Indus
trial growth and profit margins
determine the policy and not
heqiBh needs of the people.
r Overabundance
f There is a plethora of drugs pro
ceed in the country. The Hathi
Committee recommended 116
as es$rffential and the WHO says
2D(S&re necessary. At present
there are over 60,000 formula
tions in the country.
k Quality of drugs
Twenty percent of the drugs
available in the country are sub
standard and spurious. Many are
adulterated. Many ; Sold and
being sold after the< nry dates
are over.
Turmeric powder ,WP?etracycline capsules andjroor quality
intravenous fluid; ____
been
reported. The substandard ’gly
cerol’ in J J Hospital highlighted
by the Lentin report is another
example.
k Unwanted Drugs
The formulations available include
the following:
i Banned drugs: Drugs which
r have been banned in many
countries such as Lomotil and
Clioqujnol.
'
; O'? 1
HEALTH ACTION AUGUST 1988 •
x /3S
COVER STORY
(j-orAS,- 'y
RATIONAL DRUG THERAPY
ii Irrational
combinations:
Formulations which have
combinations that are anta
gonistic or irrational. The
Hathi Committee had sug
gested weeding out of atleast
23 such groups of prepara
tions. These were finally
banned by a gazette notifica
tion in July 1983 but continue
to be available.
iii Hazardous or Bannable
drugs: Hazardous drugs
which should not be available
without prescription or ade
quate medical supervision.
Preparations containing anal
gin, oxyphenbutazone
and
cortico-steroids
are
the
commonest examples (Refer
A to Z of Drug use - page 31)
iv Drugs promoted for indica
tions that are not clinically
proven or are potentially dan
gerous, eg., promotion of EP
Forte combinations for preg
nancy testing and induction of
abortion even when there is
well documented evidence
that risk of foetal deformity is
increased by the use of these
preparations, (now banned
since 1988 June 30.)
v Costly Drugs: Drugs which
are inflated in cost by inclusion
of costly, additional, often un
necessary ingredients or by
cosmetic embellishments in
manufacture and packaging
Tonics and high protein foods
especially baby foods are good
examples.
★ Over-the-counter sales
Sale of drugs over-the-counter
without doctor's prescriptions or
the necessary statutory checks
are not at all uncommon. This
results from inadequate drug leg
islation and even more inade
quate drug controls. Over-thecounter unauthorised sales of
prescription drugs, which now-adays do not even have the pre
cautionary product information
make the situation even more
hazardous.
“The physician who
sets about to treat a
disease without know
ing anything about it is
to be punished even if
he is a qualified physi
cian; if he does not give
proper treatment, he
is to be punished more
severely; and if by his
treatment the vita!
functions of the pati
ent are impaired, he
must be punished most
severely."
- Koutilya
Arthashastra
Wrong Priorities
There is over-production of un
important drugs or drugs for the
rich while drugs for some com
mon health problems are in short
supply. Tonics, vitamins, hormone
preparations and high protein
substitutes are being produced in
wasteful abundance while drugs
for leprosy and tuberculosis (two
major public health problems) are
produced at one third and one
fourth of actual requirements.
Similarly Vitamin A and many
vaccines urgently required for
child care programmes are fre
quently in short supply.
• HEALTH ACTION AUGUST 1S8B
★ Escalating Prices
Price control policies have been
both inadequate and ineffective
and hence the cost of drugs has
been constantly escalating. With
liberalization policies of the pre
sent government this is bound to
increase further. The purchasing
power of majority of our patients
is limited. With increasing prices,
patients are forced to buy only
part of a prescription or go in for
sub-standard alternatives pro
moted by the drug shops.
B Irrational Drug
Prescribing
Doctors, nurses and health
workers often prescribe or adminis
ter drugs irrationally. The types of
irrational drug prescribing has been
classified as follows: (4)
Type of
Occurs if a drug is
irrational
prescribed when:
drug use
1 Extravagant - A less expensive
prescribing
drug would pro
vide comparable
efficacy and
safety
symptomatic
treatment of
mild conditions
divert funds from
treating serious
illness
a brand name is
used where less
expensive equi
valents are
available.
2 Over
the drug is not
prescribing
needed
the dose is too
large
the treatment
period is too long
the quantity
dispensed is too
great for the
current course
of treatment
3 Incorrect
the drug is given
prescribing
for an incorrect
diagnosis
the wrong drug
is selected for
the indication
the prescription
is prepared
improperly
adjustments are
not made for co
existing medical,
genetic, envir
onmental or
other factors.
4 Multiple
two or more
prescribing
medications are
used when one
or two would
achieve virtually
the same effect.
COVER STORY
- several related
conditions are
treated when
treatment of the
primary condition
will improve or
cure the other
conditions.
5 Linder
- needed medicaprescribing
tions are not
prescribed
- dosage is
inadequate
- length of treat
ment is too brief.
Drug:
Tetracycline (antibiotic used against various
infections; Lederle Laboratories)
U.S.A.
Mexico
Brazil
How does such prescribing take
place?
There are many background fac
tors which lead to such prescribing
practices.
Argentina
Caution against use
Adverse reaction
publicized
By infants, children;
during pregnancy: liver
or kidney impairement
(latter can be fatal) or
if overly sensitive to
light.
By infants, children,
during pregnancy or if
overly sensitive to
light.
By infants, children,
during pregnancy
Vomiting, diarrhoea,
nausea, stomach
upset, rashes, kidney
poisoning, can poison
fetus.
None
b Inadequate continuing
education
The doctor, pharmacist, nurse or
health workers in field practice
are inadequately supported by a
process of continuing education
by their professional associations
and training institutions. Once
graduation is over, there is little
opportunity to refresh one's
knowledge of drugs and medical
matters through unbiased sour
ces of information.
-K-cUnethical medical
advertising
Medical advertising of drugs has
been more often than not, found
to be full of unproven claims of
efficacy. In addition, promotional
literature all over the world by the
same company for the same drug
has been found to be vastly dif
ferent. Facts are withheld or mod
ified. Statistics are used in a
biased manner. Drug company
Sponsored misinformation is not
uncommon.
vomiting, diarrhoea,
nausea, stomach
upset.
vomiting, nausea,
stomach upset,
rashes
None
Courtesy: Mother Jones, USA
a Inadequate training
Doctors, nurses, pharmacists
and health workers may be
inadequately trained in the use of
drugs. The training may be theo
retical and not geared to the
practice of prescribing in the real
life situation. Technical minutiae
may be stressed at the cost of
information on cost, social con
text and hazard.
RATIONAL DRUG THERAPY
"Physicians prescribe
medicine of which they f
know little, to cure
diseases of which they
know less, in human
beings of which they
know nothing."
- Voltaire
18th century
time to make a good clinical
judgement often results in an
irrational prescription including
drugs for all eventualities.
Inducements
companies
by
medical
Misinformation is not the only
method by which doctors are
made to prescribe irrationally by
medical companies. Sales promo
tion includes a host of practices
such as unethical trade dis
counts, bribes, gifts, sponsorship
for conferences and travel. The
commercial proposition induces
many doctors to prescribe
unethically.
Unauthorised prescribing
Health workers and practitioners
of other non-allopathic systems
of medicine are often by virtue of
their training unauthorised to
prescribe all the drugs in the med
ical armamentarium. Health
workers may be trained to pres
cribe only a few drugs. Too often
they get a larger number of drugs
and dispense them to get the
community's approval and get
greater prestige. Many tradi
tional medicine practitioners,
dispense allopathic drugs with lit
tle background training or
knowledge.
d Prescribing for prestige/
power
Doctors especially often pre
scribe extravagantly as a sign of
‘prestige’ and 'power'. In India
people often consider a good
doctor to be one who gives a long,
costly prescription, in keeping
with his list of degrees. Many
doctors succumb to this cultural
status symbol. A vicious cycle is
maintained thereby.
e Busy outpatients
Many of our institutions are
understaffed especially those run
by the government. The queues
at the out-patient clinic are long
and there is a heavy rush. Lack of
"
□rugs as a substitute for
caring
Drugs have become a symbol of
the new medical culture, where
HEALTH ACTION AUGUST 1388 •
COVER STORY
take a medicine, not as the
doctor has directed but just
enough to feel better. This is
often the case with antibio
tics and particularly for child
ren. Unused medicine is kept
in the home pharmacy and
given to one or other of the
children or family member
who gets the same symp
toms, next. Unused or unuti
lized portion of prescribed
medicine is often kept beyond
expiry date. If proper storage
treatment is primarily drug
oriented and all other aspects of
'caring' and nursing of the patient
are relegated to the back ground.
When simple home remedies like
hot water gargles and nursing
procedures can provide relief to
many symptoms of the patients,
doctors prefer to prescribe
symptomatic drugs instead, thus
increasing drug consumption
irrationally.
i
Commercialisation of
medical profession
the
There was a time not so long ago
when the doctors’ profession
was a vocation. Aspirants to the
profession saw service to the
sick and ailing as more important
than the financial rewards they
would get, if at all, from their
grateful patients. Today the
situation has changed drastically.
Parents are willing to pay lakhs to
get their children into medical
school. No such investment
would be made if the returns
were not equally rewarding. Aspi
rants today therefore see medi
cine as a business investment. In
such a social ethos 'irrational
prescribing' for pecuniary bene
fits would not at all be frowned
upon. In fact it may even be seen
as a stepping stone to success.
c Drug use by Consumer Pub
lic - irrational dimensions
i Self-medication
Medication by patients them
selves is not an uncommon
problem. Either they are too
poor to consult doctors or
because of the easy availabi
lity of drugs they medicate
themselves, encouraged by
the pharmacists, advertise
ments, peer group informa
tion or advise of family
members. A survey con
ducted by the National Insti
tute of Nutrition in the twin
cities of Hyderabad and
Secunderabad covering 10
percent of the 330 retail
Pharmaceutical shops sho
wed that self-medication rate
was an alarming 46 percent.
ii
Use of unutilized drugs
It is a very common habit
among the consumer public to
Children may have access to
it and this may lead to acci
dental poisoning.
Peer-group exchange
iv
Consumers of drugs often
advise relatives, friends and
neighbours about the benefits
a particular prescribed drug
has given them. They are
advised to take these drugs
for what is thought to be a
similar complaint or disease.
.This peer group exchange is
often the cause of much irra
tional drug use by. the lay
public.
v
"The incidence of dis
ease cannot be manip
ulated and so increa
sed sales volume must
depend at least in part
on the use of drugs
unrelated to their uti
lity or need or in other
words improperly pre
scribed. Human frailty
can be manipulated
and exploited and this
is fertile ground for
anyone who wishes to
increase profits.”
- Kefauver Committee
Hearing on Drugs,
USA
vi
Multiple consultations
Patients often go to many
doctors seeking quick relief of
their symptoms. The doctors
are not often aware that con
sultation with them is one of
many such concurrent events.
Generalists and Specialists
may both be consulted. Prac
titioners of different systems
may be consulted simultane
ously. Different medicines
given by different doctors are
then consumed with the hope
of getting relief. When relief
does occur it is not easy to
decide which medicine brought
it about.
Multiple prescriptions then
become a way of life when
symptoms recur. Many drugs
may potentiate one another.
Others may work at cross
purposes. When the consul
tation is of plural systems the
confusion is worse.
Inadequate labelling or
storage of medicine
Medicines prescribed by doc
tors are often inadequately
labelled by the dispensing
pharmacist. Storage instruc
tions are not very clearly
explained to the patient. The
medicine cupboard is often a
source of irrational drug use.
Status-symbol drugs
Capsules, injections, and
tonics have become status
symbol drugs. They are
thought to be more effective
and also being costlier are
considered to be of greater
prestige value. Patients often
demand or pressurise their
doctors to prescribe one or
more of these and doctors
often comply with the request
to retain the patient and fam
ily in their practice.
precautions are not taken, it
may also get denatured. Use
of such medicines is a major
cause of untoward reactions.
iii
RATIONAL DRUG THERAPY
vii
Inadequate Consumer
Awareness
Probably one of the key fac
tors for irrational drug use by
HEALTH ACTION AUGUST 1980* I
COVER STORY
RATIONAL DRUG THERAPY
consumers is the absence of
awareness of drug use, mis
use and the effects of over
use. Consumer education is
next to absent in India. Due to
loopholes in the existing laws,
precautionary product infor
mation is not supplied with the
medical products. The media,
the medical profession, the
educational system and the
social welfare agencies con
centrate on the misuse of
psychotropic substances and
drug abuse. Misuse, overuse
or abuse of commonly pre
scribed drugs is not consi
dered to be an adequately
serious problem for consumer
education The problem is
further compounded by a
large illiterate population and
the need of such efforts to be
in multiple languages when
they do get organized.
Rational Drug use - Principles
The irrationalities and predispos
ing factors promoting unsafe drug
use in our country have been des
cribed. The challenge that faces all of
us today is: How to counter this
phenomena9 Health for All by 2000
AD would be an empty slogan if we
did not join and participate actively in
a'consumer and professional move
ment to tackle the 'irrational drug
use' problem. In the absence of
prompt efforts in this direction, we
would probably arrive at a situationover abundant drugs and ill-health for
all by 2000 AD.
What could be our prescription for
action?
A thorough understanding of the
situation would lead us to appreciate
the following principles. (3)
Rational Drug Use
* means practice of socially con
scious, relevant and scientifically
sound medicine
★ emphasises the selective use of
drugs based on
- essentiality
- efficacy
- safety
- easy availability
- low cost
- ease of administration
- adequate quality
- preferably of indigenous produc
tion
• HEALTH ACTION AUGUST 1988
* recognises the concept of essen
tial drugs and the concept of
graded lists for different levels of
health personnel
★ recognises the non-role of drugs
in certain conditions, the role of
alternative systems of medicine in
some other conditions and recog
nises the overall limitations of
allopathic medicine in our eco
nomic, social and cultural context.
★ accepts a conscious decision to
boycott certain drugs which are
hazardous or bannable or banned
and use all others only when they
are really needed.
* means prescription with aware
ness, to avoid as far as possible
iatrogenesis (doctor induced dis
ease) which includes - drug induced problems
- drug interactions
- adverse drug reactions
- emerging drug resistance
* recognises the rights of health
personnel and consumers to un
biased drug information and its
effective communication.
★ understands the role of drugs in
the emerging health movement.
For all of us concerned about the
increasing medicalismg of health
action and the ‘over abundance of
rfrugs'becoming a 'vestedinterest in
ill health’ there is a phenomenal
challenge in making the above
principles of Rational Drug use
- common knowledge
- common practice
- commom commitment.
In conclusion, drugs have allayed
pain and suffering over the centuries
They have helped many live more
comfortable, productive and mean
ingful lives. All of us committed to the
health movement must ensure that
drugs should continue to play their
limited but useful role in medical ser
vice. However, the use of drugs know
ingly and unknowingly, to make profit
out of human health must stop.
And it will only if
Governments:
drug industries;
planners;
health professionals;
medical colleges;
pharmacy colleges;
nursing colleges;
drug controllers,
pharmacists;
journalists and media persons;
teachers and educators;
social development activists;
consumer groups;
and
the public
commit themselves to promot
ing a Rational Drug Use.
References
1
2
3
4
5
6
ICMR/ICSSR (1981)
Health for All-An alternative
Strategy.
• VHAK1986)
Banned and Bannable drugs
Shiva Mira (1985)
Rational Drug Therapy
Medical Service, Vol. 42. No. 1.
January 1985.
Management Sciences for Health
(1982)
Managing Drug Supply
Boston, Masachusetts, USA
Narayan Ravi (1984)
Consumer Alert - Consumer
Action
Medical Service, Vol 41, No. 9,
October-November 1984
Werner David S. Bower Bill
(1982)
Helping Health Worker's Learn
Hesperian Foundation, USA.
MEDICAL EDUCATION RE-EXAMINED
women, scheduled castes and tribes, non formal education,
continuing education, univcrsalisation of elementary
education geared to the dis-advantaged of the present system.
On the other hand it is also committed to pace-selling schools,
computer literacy, modern communication technologies and
electronic audio-visual equipment to help the ‘haves’ school
keep up with the rest of the world.
The government had promised to follow up this policy
statement with a separate one on Higher Technical Education
but none has been announced so far. In the absence of such a
statement one has to study the Educational Policy and derive
pointers towards new directions in Medical Education and
Health policy for the 90’s.
An indepth review of the statement brings out the following
issues as of relevance :
RECENT INITIATIVES
management and health manpower training
Promotion of autonomy/freedom of educational centres
with accountability.
Improvement of pedagogical skills of teachers at all
levels.
■
Examination reform.
’
Curbing commercialisation of technical and professional
education and preventing emergence of substandard
institutions.
♦
Regular review of curriculum to phase out obsolescence
and introduction of new dimcnsions/disciplincs.
*
Overhaul in management of education with promotion
of perspective planning, decentralisation, autonomy,
people’s involvement, greater role to women and
accountability.
*
Increasing role of communities in school education and
greater role for NGOS/Voluntary agcncics/Social
activist groups in educational efforts.
A commitment of human values and social justice
Equal access to education of comparable quality to all
irrespective of caste, creed, location or sex
A core curriculum promoting common India heritage,
democracy, secularism, egalitarianism, equality of
sexes, protection of environment, removal of social
barriers, small family nonn and scientific temper.
Future thrust to ‘open’ and distance learning and
continuing education.
Strengthening National Councils like UGC, MCI, ICMR
etc., and promoting integrated planning and functional
linkages.
Explore and operationalise health-related vocational
courses by interlinking health planning, health service
It is clear that Medical Education reform cannot occur in a
vacuum in 1990’s and will be affected by the above changes
in orientation if ‘political will’ can actually sec it through,
beyond 'he paper phase. Though three years have already
passed since the policy statement, this ‘political will’ is yet to
be perceived.
5) Some Disturbing Trends"The National Health and Education Policies have clearly
defined their overall options for social justice and reducing the
disparities in standards and opportunities and the ‘haves’ and
COMMUNITY HEALTH
'microscopic research' are such
'baloonist researchers' available for
the task?
FROM INTRACELLULAR TO
SOCIETAL RESEARCH
NGO Research Centres in Community
Health: Some Profiles
* Foundation For Research in Commu(Maharashtra),
Estb: 1975
The development of NGO health
Non-government research centre
research units keeping in tune with
and exploring in depth issues arising which undertakes conceptual as well
out of the emerging Community as field level research to study,
Health movement are few but these analyse and wherever possible
influence the cultural, economic and
are atleast positive signs.
political factors that affect the
The Foundat.on for Research in
health of the people.
Community Health (Bombay) the
Initiatives and studies include
Action Research in Community
evolution
and study of low cost
Health, Mangrol (Gujarat), Society
community
based heaitn systems in
for Education Research and Training
m Health, (SEARCH) Gadchirole Uran and Mandwa. Socio-economic
study
of
rural transformation;
(Maharashtra). Community Health
Women's work fertility and access
Cell (Bangalore) are examples.
to health; PHCs in Maharashtra;
A few of the larger NGO Health Health Service projects (NGOs in
Projects like CHOP, Pachod, (Maha Maharashtra) Health Financing in
rashtra) SEWA-Rural (Gujarat). CINI India, Stigma against leprosy,
(Calcutta). Jamkhed (Maharashtra) Alternative school health project,
and RUHSA (Tamilnadu) have also
Facilitation of ICMR-ICSSR Joint
begun to take up some key research study group on Health' for All an
issues but this whole interest is still
alternative strategy.
in a nascent state.
The Research and Research Centres given below is a sub-section
of the July TSSS's Cover Story "Community Health Scene in India’ i nity Health, Bombay,
The new approaches to Commu
nity Heaitn evolving in tne country
have shown that a very important
but negiecteo area is research into
socio-economic-poiiticai-cultural fac
tors tnat affect health and disease
and Determine the nature of health
care development as well as the
response of the people.
Medical research in India has been
preoccupied as m other parts of the
world with intracellular or molecular
biological roots of disease and much
of the research efforts sponsored by
iCMR and other national and
regional, government and private
research centres nas seen in this
direction. Most of it has been
imitative research, we toonave done
it ,n India' sort of focus and there is
the continued myopic view that the
future of nealtn m tne country will be
determined by the discovery of ii lew
more vaccines ana maybe the odd
drug or contraceotive. This techno
logical focus has bunoea us to the
fact tnat tne word- over health care
action initiators are proving again
ana again that tne clue to health of
tne people is in greater societal
problems in the 'wider social reality
ana to study them in a socioepiaemioiogical context to determine
bottlenecks and to evolve creative
innovations is the need of the hour
Some ICMR institutions like the
National Institute of Nutrition in
Hyderabad. National Tuberculosis
Institute m Bangalore and the
Vector Control Researcn Centre in
Pondicherry have treaded the path of
societal research and made unique
contributions to Primary Health
Care and Community Health but
these are the exceptions to the
overriding rule.
Have the NGO Health action
initiators fared better9 Is anyone
interested .n heaitr. related societal
researcn ,n tne country9
The Social Medicine and Commu
nity Health Department at JNU is
the only other national centre which
is undertak.ng societal research
relevant to Health Care and Health
policy issues. The medico friend
circle's efforts in providing counter
research expertise in the Bhopal
disaster and its aftermath was also
a beginning cf this new trend.
Much neecs to be cone by both
governmental and non-govemmental
groups, if the emerging 'Community
Health' approach and movement has
to be put on a sound researched
social and epidemiological basis. But
this needs people who see Research
as an important need. It also needs
innovative 'researchers' who will be
willing to leam existing health' care
research methodologies and then
creatively adapt it through interac
tive, participatory approaches to
study the dynamics of Community
Health care and the evolving
movement.
With the preoccupation with
* Action Research in Community
Health — (ARCH) Mangrol, (Gujarat),
Estb: 1378
A group of individuals of diverse
background got together to establish
this centre in the eastern tribal belt
of Gujarat to study the developmen
tal process using the health of
children and women of the poorer
sections of society as the guiding
thread.
The approach was to get involved
in the complex process of develop
ment (ACTION) and to study
critically the health of the community
and the processes which results in ill
health (RESEARCH).
Field based strategies evolved
were programmes to attack preva
lent diseases, methods and skills of
community diagnosis and interven
tion, training of health assistants and
part time community health workers,
non-formal school and finally a just
and human rehabilitation policy for
tnbals displaced by an ambitious
irrigation project in the area.
r-EALTH ACTION AUGUST 1S8S • 47
| COMMUNITY HEALTH
t Society for Education, Awareness
and Research in Community Health
(SEARCH), Gadchiroli (Maharashtra)
Estd:1984
This Society has aoopted Gadchi
roli district, a predominantly tribal
district in Maharashtra, for its
education, awareness building and
research activities. Presently they
have long term projects on the study
of Active Respiratory Illnesses in
children: and a study of women's
health focussing on the community.
The Society also seeks to evolve
methods of intervention which will be
at the level of the multipurpose
workers of the government PHC.
Due to its increasing community
involvement the Society has also
begun to explore the dynamics of
women's health and other related
issues, the forest issues affecting
tribal and the illicit liquor issue in its
community context. It has also tried
to modify the health care/medical
practices at the District level to
make it more responsive to the
needs of the people's situation.
Facilitation of ICMR-ICSSR joint
study group on Health for All an
alternative strategy.
★ Action Research in Community
Health - (ARCH) Mangrol, (Gujarat),
From page 40
V
Medical Ethics & Human Rights
38
Medicine at Risk: Doctor as human
rights acuser and vict-m
by Amnesty International
Estb: 1978
A group of individuals of diverse
background got together to establish
this centre in the eastern tribal belt
of Gujarat to study the developmen
tal process using the health of
-children and women of the poorer
sections of society as the guiding
thread.
The approach was to get involved
in the complex process of develop
ment (ACTION) and to study
critically the health of the community
and the processes which results in ill
health (RESEARCH) Field based
strategies evolved were program
mes to attack prevalent diseases.
methods and skills of community
diagnosis and intervention, training
of health assistants and part time
community health workers, non
formal school and finally a just and
humane rehabilitation policy for
tnbals displaced by an ambitious
niGG (Non-Governmental Organiza irrigation project in the area.
tions) Research Centres in Community
* Society for Education, Awareness
Health: Some Profiles
and Research in Community Health
(SEARCH) Gadchiroli (Maharashtra)
* Foundation For Research in Commu
Estb:1984
nity Health, Bombay (Maharashtra),
The society has adopted Gadchiroli
Estb:1375
district, a predominantly tribal
Non-govemment research centre
district in Maharashtra, for its
which undertakes conceptual as well
education, awareness building and
Radical iciumal of Health
September — Decemoer 1988 P 35-39
39
They Condone torture
by Cesar A Cheiala
World Health
April 1989 P 24-25
40
Health Ethics and the law
by Sasan Scholls Connor and Hernan L
Fuenzalidapuelma
World Health
April 1989 P 10-13
41
Ethics and Health
by Zbigniew Bankauski
World Health
April 1989 P 2-6
42
Genetics. Medcne and Ethics
by Zbigniew Sankowski
2001
May 1989 P 43-44 and 83
VI Environmental Issues
43
Another Morvi in the Making
by Dems Rodrigues
Economic & Political Weekly
April 8,1989 P 714-715
Defenders put
Eucalyptus
South
June 1989 P 79
45
the
case
for
the
Water-Logging in Kosni river proiect
by Mukul
The Othersxie
March 1989 P 37-39
46
Fuelwood Famine in Inca
May 1989 P 40-44
as field level research to study, research activities. Presently they
analyse and wherever possible
have long term projects on the study VII Consumer Issues
influence the cultural, economic and
of Active Respiratory Illnesses in
political factors that affect the
children; and a study of women's
health of the people.
health focussing on the community.
Initiatives and studies include
The society also seeks to evolve
Evolution and study of low cost- methods of intervention which will be
community based health systems ini at the level of the multipurpose
Uran and Mandwa,
workers of the government PHC.
Socio-economic study of ruralI
Due to its increasing community
transformation.
involvement the society has also
Women's work fertility and accessi begun to explore the dynamics of
to health:
,-. women’s health and other related
issues, the forest issues affecting
PHCs m Maharastra;
Health service projects (NGOs in(
Maharashtra);
Health financing in India;
Stigma against leprosy;
Alternative school health project;
48 • HEALTH ACTION AUGUST 1S8S
tribal and the illicit liquor issue and its
community context. It has also tried
to modify the health care/medical
practices at the District level to
make it more responsive to the
needs and the people's situation.
47
Legal Status of a Telephone owner
by KD Gaur
Apcl-May 1989 P 13-14
Healing Presence of The Church
by
Thomas Sebastian
Panachickavayalil OFM Cap
Published by
Good Tidings Publications
8/4 MT. Main Road. Mathikere
Bangalore 560 054
Also available at
CHAI
PB 2126 Secunderabad-3
DRUG UPDATE
Safer analgesics —
alternatives to Analgin
Dr Wishvas Rane
^Analgin is known to cause
agranulocytosis
circulatory shock
gastric irritation, bleeding and
dyspepsia
significant increase in liver toxity,
and skin reactions.
Because of the known serious
adverse reactions, most of the
advanced countries have banned
analgin, wherever it is used, the use is
restricted to terminal cases only.
The following countries, among
others, have banned its use:
Great Britain and Canada — 1960
Australia
—1965
Sweden
— 1974
Norway
— 1976
USA
—1977
Ireland and Singapore
— 1979
Denmark
—1979
Malaysia
—1986
Should Indians continue to be
exposed to the great risks posed by
analgin ana its combinations? Should
we not join with the progressive
countries and protect our people9
Sometimes arguments are put
forward that analgin is required
because there are not enough, safer
alternatives readily available. The
continued use of this dangerous drug
is promoted by stating that its use is
necessary m patients with post
operative pain, cardiac pain, and
biliary and renal colic It must be analgesics that is not necessarily
remembered that none of the true in chronic pain. The simplest
standard textbooks mention analgin clinical guideline is that where pain
as a pain killer or as an anti occurs in a numb area (e.g.
spasmodic in above referred dysaethesia) or in non-existent areas
conditions.
(phantom limb pain) conventional
What are the safer alternatives9 analgesics are unlikely to be helpful.
In the Oxford Regional Pain Relief
The Management of pain:
Unit, approximately one-third of
Whereas most pain occurring patients with either malignant or
immediately after trauma or opera non-malignant pain show a poor
tion responds to conventional response to conventional analgesis.
Table 1
Analgesics
Conventional analgesics
Acetyl salicylic acid (aspirin)
Paracetamol
□ihydrocodeme
Non-steroidal anti-inflammatory
drugs
Levorphanol (dromoran)
Phenazocine
Strong
Morphine
Other agonist opioids
Buprenorphine
Other partial agonist opioids
Phenazocine
□ RUG UPDATE
Unconventional analgesics
Antidepressants
Anticonvulsants
Tricyclics
{
Benzodiazepines
Other
<1
Amitriptyline
Dothiepm
Clobazam
Nomifensine
Mianserin.
Sodium valproate
Clonazepam
Phenytoin
As in other branches of medicine
. the concept of a ladder, with the mild
|| peripherally acting analgesics at the
bottom rungs and strong narcotics
at the top, is helpful (Table 1), The
major limitations in implementing the
ladder for non-malignant pain is the
problem of using 'strong opiate
analgesics with their potential for
dependence.
The use of antidepressants in
chronic pain management is wide
spread. but with little support from
controlled studies. The dosage used
(e g. amitriptyline 25 mg nocte) do
’ not result in plasma concentrations
■ required for treatment of depres' sion, any benefit is unlikely to be from
measurable antidepressant effect.
Despite the uncertainties over mode
of action, m post-herpetic neuralgia,
this is the single most effective
k treatment.
The use of anticonvulsants is best
known from the prescribing of
carbamazepine in trigeminal neural
gia. Sodium valproate and clonaze
pam are probably the commonest
anticonvulsants used in the manage
ment of chronic pain, and it is
encouraging that this unconventional
approach is now being recognised by
the major pharmaceutical compa
nies as it is likely that the
breakthrough will come in this
group1.
Biliary colic (acute cholecystitis):
Conservative treatment: Oral
feeding is stopped. Intravenous
fluids, and analgesia with pentazocin
or pethidine and atropine are
administered. Antibiotics are given
to all but the most mild cases;
tetracycline, ampicillin, or a cephalo
sporin are satisfactory for general
use2.
Myocardial infarction
Clinical Management
Geheral measures
Pain relief
Rapid and effective analgesia is the
mam requirement of most patients in
the early stages of myocardial
infarction. The opiates, morphine,
and diamorphine, are most effective
for this purpose. When given by slow
intravenous injection, either mor
phine, 10-15 mg, or diamorphine 510 mg, result in rapid pain relief The
emetic effect of both drugs results in
unwanted circulatory stresses but
may be lessened by the routine
intravenous use of cyclizine 50 mg.
Among alternative drugs are
pethidine, methadone, and pentazo
cine. Pentazocine has been a source
of some concern because, following
its administration a rise in pulmonary
artery pressure has been observed
in several studies. This finding has
been associated with an elevation of
left ventricular end-diastolic pres
sure in one study; This has not,
however, been a uniform observation.
In any event, pentazocine, although
an effective analgesic in doses of 3060 mg intravenously, is probably
best avoided because of its tendency
to produce hallucinations. Some
patients require a second' or third
dose of analgesic during the first 2448 hours of admission; others are
anxious and benefit from sedation
with a benzodiazepine, e.g. diazepam
2-5 mg thrice daily. When potent
analgesics may not be available, a
period of prolonged pain and distress
can be avoided by the use of a 50 per
cent nitrous oxide/oxygen mixture,
which can also be used during
transport to hospital. The analgesic
effects are -apidly reversed, which
allows the patient to provide a
history free from sedative effects of
analgesia3
Renal and ureteric colic:
Atropine and’ other anti-cholinergic agents, narcotic analgesics,
papaverine hydrochloride, amyl ni
trite, glyceryl trim trite are effective4.
□ysmenorrhoea:
Aspirin and other similar analge
sics, hyoscme butylbromide, papavanne hydrochloride and sex hormones
are useful5.
Hyoscine butylbromide is a quaternary
ammonium anti-cholinergic agent.
The peripheral effects are similar to
those of atropine, but weaker and of
shorter duration. Hyoscine butyl
bromide is used in the treatment of
conditions associated with gastro
intestinal spasm. The usual dose is
20 mg intramuscularly or intra
venously, repeated after 30 minutes
if necessary It is also given by mouth
in doses of 20 mg four times daily,
and is claimed to be of value in
spasmodic dysmenorrhoea®.
Flavoxalate hydrochloride counter
acts smooth muscle spasm of the
urinary tract. It is indicated for
symptomatic relief of dysuria,
urgency, nocturia, suprapublic pain,
frequency and incontinence as may
occur in cystitis, prostatitis, urethri
tis, urethrocystitis/ urethrotrigonitis.7
Dicyclomine hydrochloride is an
anticholinergic agent with peripheral
effect similar to but much weaker
than those of atropine, it also has
direct antispasmodic action and a
local anaesthetic action. It is used in
biliary, gastrointestinal or urinary
tract spasm and is given with
antacids in the treatment of gastric
and duodenal ulcer8. Dicyclomine is
indicated in functional bowel/
irritable bowel syndrome (irritable
HEALTH ACTION MAY 1989 • 33
DRUG UPDATE
colon, spastic colon, mucous colitis)
and acute enterocolitis. It is contra
indicated in obstructive uropathy,
(for example bladder neck obstruc
tion due to prostatic hypertrophy);
obstructive disease of the gastro
intestinal tract (as in achalasia,
pyloroduodenal sterosis), paralytic
ileus, intestinal atony of the elderly or
debilitated patients, unstable cardio
vascular status in acute haemorrhoage; severe ulcerative colitis, toxic
megacolon, complicating ulcerative
colitis; myasthenia gravis9
Phenazopyridine hydrochloride is usefulTor the symptomatic relief of pain,
sense of burning, frequency, urgency,
and other discomforts arising from
irritation of the lower urinary tract
mucosa. Its topical analgesic action
may reduce or eliminate the need of
systemic analgesics or narcotis. It is
contra-indicated in renal insuffici
ency. A yellowish tinge of the skin or
sclerae may indicate accumulation
due to impaired renal excretion and
the need to discontinue therapy10.
□ extropropoxyphene
hydrochloride
(Propoxyphene hydrochloride) is a
centraiiy acting narcotic analgesic
agent. It is structurally related to
methadone. The potency of propoxy
phene hydrochloride is from twothirds to equal that of codeine. Do
not prescribe propoxyphene for
patients who have suicidal tenden
cies or are accident prone. Prescribe
propoxyphene with caution for
patients taking tranquillisers or anti
depressant drugs and patients who
use alcohol in excess. Tell your
patients not to exceed the
recommended dose and to limit their
intake of alcohol11. Prolonged use of
higher doses of dextropropoxyphene
may lead to dependence of the
morphine type. Liability to abuse is
reported to be a little less than for
codeine12.
Pentazocin is a potent analgesic
which when administered orally is
approximately equivalent, on a mg for
mg basis, in analgesic effect to
codeine. The respiratory depressant
effects of pentazocin and its
potential for elevating cerebrospinal
fluid pressure may be markedly
exaggerated in the presence of head
34* HEALTH AC'ION MAY 1!1H9
injury13. For the relief of moderate to
severe pain, 30 mg of pentazocin
intramuscularly is reported to be
equivalent to about 90-100 mg
pentazocin by mouth, about 10 mg of
morphine subcutaneously or intra
muscularly, or 50 to 100 mg of
pethidine intramuscularly14. Penta
zocin 60 mg intravenously appeared
to be a suitable analgesic for patients
with a recent myocardial infarction.
Unlike morphine, its use was not
generally followed by hypotension, an
increase in the respiratory deadspace/tidal volume ratio or an
increase in the difference between
alveolar and arterial oxygen tensions.
It was suggested that pentazocin
should be used in preference to
morphine as an analgesic in patients
with myocardial infarction15. Dimorphme might be considered to be the
analgesic of choice in a situation
where rapid relief of pain was
References:
1
2
essential but pentazocin with its low
addiction potential and lower inci
dence of blood pressure reduction
might be the most suitable
treatment;,of pai.p in patients with a
suspected cardiac infarction16.
Drugs available in India
Amitriptyline Hcl: 10,25,75 mg tab
Buprenorphin as Hcl: 0.3 mg per ml
Carbamazepine: 100,200,400 mg
tab
Dicyclomine Hcl: 20 mg tab
□extropropoxyphene: Available only
in combination form with other
analgesics like aspirin, paracetamol
etc.
Flavoxalate Hcl: 200 mg tab
Glyceril nitrate. 0 5 mg tablet
Hyoscin-N-Butylbromide: 10 mg tab
Pentazbcin: 30 mg per ml inj.
Phenazopyndme Hcl: 100 mg tab
Sodium Valproate. 200 mg tablet
9
Oxford Text Book of Medicine: 1987
21.27
PDR 1982. 36th edn: 1291
10
PDR 1982 36th edn. 1469
11
Oxford Text Book of Medicine: 1987'
12
12 202
PDR 1982 36tn edn 1097
Martindale. The Extra Pharmacopoeia
27th edn- 956
3
Oxford Text Book of Medicine 1987
13
13 172
4
Martindale. The Extra Pharmacopoeia 14
27th edn 1889
Martindale. The Extra Pharmacopoeia
27th edn 978
5
Martindale. The Extra Pharmacopoeia 15
27th edn 1891
6
Martindale. The Extra Pharmacopoeia
16
27th edn- 239
S.Lal et al, Lancet, i/1969, 379 &. 381
per Martindale. The Extra Pharma
copoeia 27th edn: 979
7
8
PDR 1982 36th edn. 1819
PDR 1982 36th edn 2036
ME Scott and R Orr Lancet i/1969
1065 per Martindale, The Extra
Pharmacopoeia 27th edn: 979
Martindale. The Extra Pharmacopoeia
27th edn 235
® ■=-
-
-
■
Says the company's young manag
ing partner Deepak Bhandari, "Our
plan is to ultimately stop the 15°/o
import of herbs we require. We are
encouraging farmers in Ooty to raise
nurseries.of herbs - vitex negundo,
strychnos nux vomica messua ferrea etc. The temperate climate in
Ooty is conducive to the growth of
these herbs"
Thp enmnanv is exporting its pro
ducts to west Asia and South East
Asia and by 1991-92 expect to
reach an export figure of 15°/o to
25°/o. The race has begun
With the growing interest in alter
native medicine, the Government of
India too has decided to set up a
Medicinal Plant Board. Its functions
will include assessment of herb
requirement, organised cultivation,
distribution and export. The demand
for herbal products is growing fast
Let us hope that the government and
more private companies will soon
enter the national and international
market and provide people with a
safe and sure cure for many of the
ailments that plague us today.
— Hindustan Times
Reprinted from Current Therapeutic Research, VoL 32, No. 4, October 1982.
CLINICAL COMPARATIVE STUDY OF INTRAVENOUS
AMPICILLIN AND AMOXYCILLIN AT HALF THE DOSAGE
IN THE TREATMENT OF INFECTIONS
OF THE LOWER RESPIRATORY TRACT
Y. MOUTON, G. BEAUCA1RE, M. BRION, R. MBELEPE, A. FOURRIER,
AND M. CAILLAUX
Unit for Reanimation of the Regional Department of Infectious Diseases
(Pr. Agr Y. Mouton/,
C.H. Tourcoing, 59208, France
CURRENT
THERAPEUTIC
RESEARCH
VOL. 32. NO. 4. OCTOBER, 1982
CLINICAL COMPARATIVE STUDY OF INTRAVENOUS
AMPICILLIN AND AMOXYCILLIN AT HALF THE DOSAGE
IN THE TREATMENT OF INFECTIONS
OF THE LOWER RESPIRATORY TRACT
Y. MOUTON, G. BEAUCA1RE. M. BRION. R. MBELEPE. A. FOURR1ER,
AND M. CA1LLAUX
Unit for Reanimation of the Regional Department of Infectious Diseases
(Pr. Agr. Y. Mouton),
C.H. Tourcoing. 59208, France
ABSTRACT
The results obtained in this study in 19 patients with essentially bron
chopulmonary infections treated at 50 mg/kg/day amoxycillin
intravenously were identical with those obtained in 19 patients receiving
twice as much ampicillin, i.e. 100 mg/kg/day intravenously. This similar
ity of clinical and bacteriological results has to be seen in context with
the hope of reduced dosage of antibiotics — often hoped for in theory’ but
rarely possible. It can be achieved w’ith amocycillin.
INTRODUCTION
The object of our study was to compare the efficacy of amoxycillin
intravenously at a dose of 50 mg/kg/24 hours in the treatment of pulmonary
or lower respiratory tract infections, with that of ampicillin intravenously in
a dose of 100 mg/kg/24 hours. The daily doses of each antibiotic was given
as 6 rapid intravenous injections (1 injection every 4 hours).
Amoxycillin is a semi-synthetic penicillin, the anti-bacterial spectrum
of which is identical to that of ampicillin,4 but the bactericidal activity of
which is more rapid.13 ‘ This rapidity of bactericidal action is explained by a
preferential binding of amoxycillin to Penicillin Binding Protein la (PBP
la) on the target membrane of the bacteria, whilst ampicillin preferentially
binds to PBP 2 and 3.6
The intravenous administration of 500 mg amoxycillin produces con
centrations giving therapeutic activity for a duration of 4 hours and the bio
availability of amoxycillin is 2 times greater than that of ampicillin s
©
Received for publication on May 13, 1982. Printed in U.S.A.
1982, Therapeutic Research Press, Inc. Reproduction in whole or part is not permitted.
Y. MOUTON. G. BEAUCAIRE. M. BR1ON, R_ MBELEPE. A. FOURRIER. AND M. CAILLAUX
PATIENTS AND METHODS
Type of Trial
This was a comparative controlled trial of amoxycillin against the reference product am
picillin. Two groups of subjects received either amoxycillin or ampicillin, the treatment being
allocated according to a randomisation table.
Patients
The patients were adults, of either sex suffering from pneumonia, broncho-pneumonia, or
bronchopathies caused by bacteria assumed to be or identified as sensitive to ampicillin, in the
Intensive Care Unit of the Regional Service of Infectious Diseases (Prof. Agr. Y, Mouton).
Criteria of Exclusion
The following were excluded from the study: patients with allergy to penicillins or
cephalosporins; patients who had received a combination of antibiotics; and patients with in
fectious mononucleosis.
Bacteriological Examinations
Bacteriological examinations were carried out by the Bacteriological Laboratory of the
Hospital Centre of Tourcoing (M. Caillauxl. After isolation and identification of the bacteria
responsible for the infection, a quantitative analysis was carried out where possible. The sen
sitivity to amoxycillin and to ampicillin was established by the agar-diffusion method. The ex
aminations were repeated on Lhe 2nd day and 5th day and at the end of the treatment
Evaluation Criteria of Efficacy
Clinical assessment — Cure: the complete disappearance of the majority of the clinical and
radiological signs. Considerable improvement, the disappearance of most clinical signs but in
cluding fever and notable regression of any radiological signs. Failure: the presence or per
sistence of clinical signs or their aggravation.
Bacteriological assessment — Success: disappearance of the bacteria responsible for the infu
sion. Failure: persistence of the bacteria, and-or development of other pathogenic flora Indeterminte: if no bacteriological control was carried out.
Assessment of Tolerance
Clinical tolerance was monitored, in particular any local reaction on the skin and veins
Biological tolerance was evaluated by systematic examinations of the blood to include: all
causes and differential platelets, urea, creatinine, transaminases, alkaline phosphatase,
Coombs test, tests for proteinuria and glycosuria and radiography of the thorax. These ex
aminations were carried out on the 1st and 2nd day of treatment and repeated at the end of
treatment.
Analysis of the Comparability of the Groups
It is essential to test the randomisation of the 2 groups to receive either ampicillin or
amoxycillin at half dosage in order to determine the comparability of the groups. The use of
( 611 ]
AMPICILLIN AND AMOXYCILLIN IN INFECTIONS OF THE LOWER RESPIRATORY TRACT
Table I — Demographics of the two groups of patients
Ampicillin Group
Amoxycillin Group
19
19
75.99 87.86.63 74.
64.39.90.60.70 62.
56 60,57.58.87.56
50.60.58.65.78.67.
68 63.53.75.70 48.
60.60.110.70.61.
57.67
6648lo 110
NUMBER OF CASES
WEIGHT (Kg).
Average & Range
39 to 99
70 13
6
11
8
AGE (yrs).
85.62.83 80.70.83
74.76.40.35.19.57.
55.2..60.57.87.83.
57
62.31910 85
81 79 66.70 77 36
43.65 87 34 81.77.
70.72.73 89.83.29
INITIAL CONDITION.
Good
Moderate
Critical
TYPE OF INFECTION
Pneumonia
Bronchooneumoma
Bronchitis
Pure septicaemia
Pyelonephritis
3
7
9
Mann & Whitney
NS
NS
NS
SEX. Mate
Female
Average & Range
Test & Result
Mann & Whitney
NS
f)
36 to 87
66 8 -
3
9
7
8
6
6
2
3
3
BACTERIA
Streptococcus pneumoniae
Streptococcus alpha-haemolytic
Streptococcus Group D
6
1
0
Haemopmlus
Escnerichia coh
Salmonella
3
5
0
7
1
6
8
6
2
9
the Mann & Whitney Test showed no statistically significant difference in the parameters of
entry into the study of these 2 groups which consequently may be compared, (of Table I)
f)
RESULTS
Results of Treatment with Ampicillin 100 mg/kg/24 hrs.
Clinical Results
In the 19 patients treated with ampicillin we noted:
— 11 cures (6 pneumonia including 2 with pneumococcus-positive blood
cultures; 2 bronchopneumonia; 1 bronchitis; 2 pure septicaemia). Four
of these patients were in a ciitical condition and 5 were moderntelv ill
— 2 improvements (1 bronchopneumonia and 1 bronchitis) both in a
critical condition and mechanically ventilated.
1 612 ]
Y. MOUTON. G. BEAUCAlRB. M. BR10N. A. MBELEPE. A. rOLTUUEa. AND M. CA1LLAUX
—
6 failures (2 pneumonia; 1 bronchopneumonia with positive pneumo
coccal haemocultures; 1 bronchitis: 1 pyelonephritis, and 1 septicaemia.
both due to sensitive Escherichia coli). Three of these patients were in a
critical condition and 2 were in a moderate condition.
Bacteriological Results
Out of 15 bacteria isolates before treatment we noted:
— 5 cures
— 4 failures of which 2 were superinfections (sensitive pneumococcus
replaced in a mechanically ventilated patient by a resistant
Acinetobacter; a sensitive pneumococcus replaced in a patient by an
Acinetobacter and a resistant Pseudomonas aeruginosa.
Tolerance
There was one phlebitis and a moderate eosinophilia evaluated at 452 mm'.
which recovered after cessation of treatment. No other undesirable effects
were detected.
Results of Treatments with Amoxycillin 50 mg/kg/24 hrs.
Clinical Results
In the 19 patients treated with amoxycillin we noted:
— 13 cures (3 pneumonia; 3 bronchopneumonia, including 1 with a positive
pneumococcus haemoculture; 4 bronchitis: 1 urinary tract infection, and
2 septicaemia caused by Escherichia coli). Two of these patients were in
a critical condition and 7 in a moderate state.
— 2 improvements (1 bronchopneumonia and 1 bronchitis).
— 4 failures (1 pneumonia due to Haemophilus and 3 bronchopneumonias.
all 4 in a critical condition).
Bacteriological Results
Of 15 bacteria isolated before treatment we noted:
— 9 cures
— 4 failures of which 3 were superinfections (a sensitive pneumococcus
replaced by a resistant Enterobacte’- in two mechanically ventilated
patients; the appearance of a resistant Escherichia coli septicaemia in a
patient with bronchopneumonia with positive haemocultures to
pneumococcus).
f 613 J
AMPICILLIN AND AMOXYCILLIN IN INFECTIONS OF THE LOWER RESPIRATORY TRACT
Table II — Comparison of clinical results
Group Troatod Wrtti
AMPICILLIN
100 mg/kg/24 h.
Group Treated With
AMOXYCILLIN
50 mg/kg/24 h
19
19
6
2
Number ot cases
Cures
Pneumonia
Broncnooneumoma
Bronchitis
Septicaemia pure
tnteciion urinary
Improvements
Bronchopneumonia
BrcncWis
Failures
Pneumonia
Broncnopnt umonic
Bronchitis
Pyelonephritis
Septicaemia to Escnericnia col
Secondary Ehects
Pmec-t'S
Eosinophilia
2
3
3
4
2
11
13
1
1
1
~2
2
i
3
1
"e
4
1
1
1
A
~2
3
Table HI — Comparison of bacteriological results
*BEFM TREATMENT
No ot bactf'ic
isoiatec petore treatmen:
(see Tabie i.
Nc o* cases with
inoete-minate ’tore
*
AFTEK TREATMENT
Cure
*
Fauure
*
Supenntections
Supenntecimg bacteria
Group Treated With
AMPICILLIN
100 mg/kg/24 h
Group Treated With
AMOXYCILLIN
50 mg/kg/24 h
15
15
4
4
5
9
2
3 (2 Acineiobacter R.
1 Pseudomonas R)
3
3
• lack ol Dactenoiogicat control
•• tanure — aue io persistence ol bacteria anfl/or development ot other pathogenic Hora
[ 614 ]
(2 Entefooacier R
1 Escnericnta coi‘ Ri
e
Y. MOUTON. C BEAUCAIRE. M BRION. R MBELEFE. a. FOURRIER. AND M. CAILLAUX
Tolerance
We noted 3 moderate cases of eosinophilia at the end of treatment (520, 460,
355/mmJ). No other undesirable clinical or biological effect was detected.
Comparative Results (Cf. Table II and III)
In Table II and Table III the data describing the clinical results and the
bacteriological results are presented.
DISCUSSION
Ampicillin and amoxycillin are similar antibiotics in their antibacterial
spectrum, their pharmacokinetics, their antibacterial activity, and their
tolerance. However, they differ in the speed of their bactericidal action and
their site of membrane fixation.
We wished to verify whether the benefit noted in favour of oral
amoxycillin in comparison with an identical dose of oral ampicillin1 would
also be found after the intravenous administration of these products. With
this object in mind we have taken two groups of patients who were com
parable as regards:
— their diagnosis (pneumonia, bronchopneumonia, bronchitis, sep
ticaemia, urinary infectionsl and their initial condition
— the bacteria responsible
— the weight, sex. age of the patients and the duration of treatment.
These patients received, by drawing lots from a randomisation table.
either 100 mg'kg'daily of ampicillin intravenously or 50 mg kg daily of
amoxycillin intravenously. The results obtained in the 2 groups were com
parable although amoxycillin at the beginning had to compensate for the
handicap of a dose only half that of ampicillin. This similarity of clinical
results is similar to that obtained after oral administration by other
authors.1 ’
Bibliography:
1.
2.
Anderson. G.. Jariwalla. A.G.. and Saour. J.: A comparison of ampicillin in acute and
chronic bronchitis. Thorax 59:814-816. 1979.
Anderson. J.D., Johnson, K.R., and Aird, M.Y.: Comparison of amoxycillin and
ampicillin activities in a continuous culture model of the human urinary bladder.
Antimicro. Ag. Chemo. 17:554-557, 1980.
3.
Bergan, T., and Carlsen, I.B.: Bacterial kill rates of amoxycillin and ampicillin at
exponentially diminishing concentration simulating in uiuo conditions. Infection &S1.
103-108, 1980.
I 615 ]
AMPICILLIN AND AMOXYCILLIN IN INFECTIONS OF THE LOWER RESPIRATORY TRACT
4.
Duval J. et Soussy, C.J.: Activity antibact^rienne et pharmacocm6tique de I’Amoxycilline. Comparaison avec 1’Ampicilline. Med. MaL Infect. 5:525-531, 1973.
5.
Leng, B.M.. Saux, M.C. et Latrille, J.: Pharmacocin&tique de 1’Amoxycilline chez le sujet
normal. Med. MaL Infect. 9:77-82. 1979.
6.
Neuman. M.: Acquisitions r¢es sur le mode d’action des beta-lactamines. Gaz. Med.
Fr 57:2635-2638, 1980.
7.
Puchelle, E., Sobradillo, V., Aug. F. et Sadoul, F.: Amoxycilline et ampicilline chez le
bronchiteux chronique. Nouv. Pres. Med. 4:2449-2452, 1975.
8.
Rolinson. G.N.: Etude compare de 1’activiU bactericide de 1’Amoxycilline et de
1 ampicilline. Med. MaL Infect 4:651-662, 1974.
I S16 ]
/
ANALG-IN-—A STUDY
1 . The Drug
A class of chemicals called PYRAZOLONES have been used
as medicines for over ninety years. Pyrazolones include
drugs like Antipyrine, Aminopyrine, Phenylbut zone,
oxyphenbutazone, sulfinpyrazone and a derivative of
aminopyrine called dipyrone or analgin. The pyrazolones
share similar pain killing, fever reducing, inflammation
reducing and also toxic properties. Analgin being more water
soluble is amenable to use in injections and liquid oral
preparations (for children). They are rapidly absorbed in the
stomach and intestine and spread in various tissues of the
body in proportion to their water content. While 30 to 40%
of the drug is altered in the liver and eliminated in the urine,
5% is eliminated unaltered. The fate of a significant fraction
is not known.
The range of actions of Pyrazolones is similar to that of
Salicylates (Aspirins) except in reducing fever in diseases
like Hodgkins' disease and Periarteritis nodosa, whore aspirins
are not completely effective.
The most important and potentially fatal adverse effect
of Pyrazolones (Analgin) is Agranulocytosis. This is a
condition where the Granulocytes which form the major part
of the white blood cell population and are the first line
of the body's defence against infection are destroyed.
It is an allergic reaction and can occur suddenly even after
a fraction of a dose in any person who has been previously
taking Analgin with no bad effects. Within 6 to 24 hours,
the white blood cell count fall and granulocytes disappear
from the blood. They start reappearing 5 to 10 days after
the drug is discontinued and rapid recovery occurs.
The incidence of agranulocytosis has been variously estimated
from 0.01% to 0.86%. If infection occurs now, it starts
as a sore throat of sudden onset, high fever and prostration,
which even on proper treatment carries a mortality of
20 to 50%.
The other adverse effects of Analgin documented in a study
are: skin rashes, dyspepsia, fever, analphylactic shock
and broncho spasm. Analgin can aggravate a bleeding tendency
and produces a serious fall in body temperature when given
along with Chlorpromazine. Liver cancer in mice has also
been reported by Japanese.
. . .. 2
2
Even now—
a.
the mode of action is not known;'
b.
which arc the metabolites which cause agranulocytosis
and how is not known;
-c.
basic pharmacological data, like potential for
causing cancer, congenital malformations, kidney
and liver damage ano damage in el 'erly patients
are not known;
d.
interactions with other drugs for diabetes,
hypertension etc., hav
not been investigated
because pyrazolones were introduced in the
pre-Thalidomide era when registration was easy.
2. History and _p_resent stat_us
1897
Aminopyrine was first introduced and became very
popular in 1920s for pain killing and fever. By 1930s
its use was world wide.
1922
Agranulocytosis was first described by U.
1922
Dipyrone or Analgin was introduced by Hoechst. Not
being recognised as a derivative of Aminopyrine,
it gained popular use.
Schulz
1933
Madison and Squier established a causal relation
. between Amidopyrine and agranulocytosis.
1935
Kr.acke and Parker established its relationship to
.agranulocytosis beyond doubt'
1938
O.T.C.
19551959
The American Medical Association Registry on
Adverse Reactions recorded only 10 reports of
leucopenia (fall in UBC count) and none, in children.
19601964
18 cases reported (7 children).
An increase in the import into USA of dipyrone
from nil in 1958 to 18,879 lbs in 1962 was noticed.
1964
American Council of Drugs—Section One: adverse
reactions: studied the case of Dipyrone (Analgin)
and questioned the justification of continued use
of this drug.
sale in U.S.A,
was prohibited.
. . .3
3
1960
Groat Britian and Canada revoked the licence of
Dipyrone
1965
Australia and Neu Zealand issued an import ban
on dinyronc
1974
Sueden revoked Dipyrone licence
1976
Noruay revoked Dipyrone licence
1977
USA revoked Dipyrona licence
Oapan banned free O.T.C. sale
1978
Ireland and Singapore revoked licence of dipyrone
1979
Denmark revoked licence of Dipyrone
19801984
An international study for agranulocytosis and
aplastic anaemia was done in Europe—called the
Boston Study, since coordination and data analysis uas
done at the Drug Epidemiology Unit at Boston.
This uas primarily financed by Hoechst, and the results
published in the DAMA of Oct 1986.
1983
The Government of India banned the manufacture and
sale of Amidopyrine
1986
Malaysia banned dipyrohe.
ERG banned OTC sale
In Netherlands, Dipyrone use is only alloued
for uncontrollable fever.
Eollouing reports of anaphylactic shock, Italy, Egypt and
Saudi Arabia have prohibited manufacture of injectible
preparations.
3• The Issues
i.
According to Hoechst, approximately 25 tonnes or
18.5
million doses of Novalgin are used uorld uide
everyday. With most of the developed nations banning
or restricting its use, it is obvious that it is sold
mainly in third uorld countries.
The countries uhich have banned Dipyrone have been
managing pain uithout Dipyrone by using equally
effective and safe analgesics.
4
The 'Boston Study' generated a lot of controversy..
since Hoochst used the results even before publication
for a misleading advertisement campaign showing the
occurrence to be 1 per million. The hearing of
the German Federal
Health Office finally confirmed
the assumption of T per 30,000 to 60,000 to be
nearer the mark, or one tablet per 70,000 consumed
could cause agranulocytosis based on this same study.
ii.
The limitations of this study are that-a.
it excludes all patients
i.
ii.
who die of agranulocytosis without
receiving medical aid;
who die without having a white cell count; and
who
iii.
have undiagnosed agranulocytosis and
recover from it.
iii.
b.
it does not look into other side effects
of dipyrone, like shock, fall in BP, Urticaria
etc.
c.
the data presented in the intermediate and final
reports are inconsistant
J
d.
whereas 400 cases of agranulocytosis were
registered to a sess risk properly, only 221
cases were analysed in the final report; "
e.
there is extreme variability in data between
different countries and even within the same
country; and
f.
some data wore seen to ba clearly unreliable.
The finnings of the controversial 'Boston Study' is being
utilised by Hoechst the largest manufacturer of
Analgin for sales promotion in Germany, Eastern Bloc
countries and the Third World. Unethical propaganda
practices with different types of promotional literature
in different countries is being practiced. Even claims
of anti-spasmodic action which is not scientifically
substantiated is being made. Any source of detailed
scientific literature is virtually non-existant beyond
the literature supplied by the drug companies.
references contd...from page 6
9.
4
Drug marketing in the Third World: Beneath
the Cosmetic Reforms, Lancet, 7 Jan 1986,
Trisha Greemhalgh.
.............. 5
|
5
iv.
Since 1985, Dipyrone (finalpin) has not found mention
in any standard modical text books, except for naming
it as a drug which can cause agranulocytosis.
v.
Even in our country, medical, student' do not learn
about analgin while doing their Pharmacology.
n I ndia
4•
i.
In 1983, the Government of India banned the manufacture
and sale of amidopyrine but not dipyrone. The Drugs
Consultative Committee had recommanded ban on FDCs
of dipyrone also but this seems to have slipped from
the banned list.
ii.
The government is the largest manufacturer of dipyrone
in this country.
iii.
Analgin is among the largest selling analgesics in the
country with sales figures accounting for Rs 70 million.
There are approximately 200 formulations containing
Analgin, including inj?ctibles and drops for newborns
and infants for colic.
iv.
Analgin is available as OTC in spite of its being a
Schedule H drua in our country and the attitude of
the proscribing doctors as per a study (Lancet 86)
was “if I prescribe it 30 times a day and it is
available over the counter, it must be safe'1. In a
field study (Lancet 86) it was seen that the pyr'zolones
made up the majority of both GP prescriptions and OTC
sales of analgesics. One more of these drugs were given
to over 50% of patients reguesting an analgesic.
v,
Drug action groups have initiated a campaign on Analgin
especially at ACASH, Bombay, OAF-West Bengal and AIDAN,
Neu Delhi.
vi.
Analgin induced agranulocytosis does occur in India,
especially if one looks for it systematically as a
Bombay haematologist BC Mehta has done. He reports
12-15 cases of agranulocytosis a year, of which 10-12
are caused by Dipyrone- or Dipyrone containing drugs.
Evan by the risk estimation of the Boston Study, in
India, one person develops analgin induced agranulocytosis
per day by. other reasonable estimates, it could be
15 times this figure.
references from page 5 contd..
• .... 6
Dangerous and Inappropriate Drugs, Lancet,
28 Dune 1986, MOS Langman.
11.
A BUKO Campaign-~A Drug Campaign Newsletter, mfc
Rational Drug Policy Coll, 1985.
12.
The Hoechst Medical Bulletin, Issue No.8.
10.
6
5 • liLi de r_ J.ssues
Developing countries like ours are ill placed to afford
expensive apd useless health care products arid definitely
not the frankly dangerous ones.
We have unsophisticated consumers and poorly developed
regulatory and advisory systarns—this is fertile ground
for pharmaceutical companies to indulge in unacceptable
practices.
The. vast majority of rur°l doctors working in professional
isolation have no access to independent information on
drugs they prescribe. Hers, the representative of the
pharmaceutical company who is ill-informed himself and
paid by commission on drug sales becomes an id^al tool to
promote, the interests of the Pharmaceutical company.
Thus, it appears that the consumer is at the mercy of drug
A
manufacturers. Other than an appeal to the Food and Drugs
Administration, the Central Government and the NRTP
Commission the consumer is virtually without recourse to
&ny independent body such as the judiciary. The 00 Hospital
Commission (Lentin Commission) enquiry reveals the ineffective
ness of those agencies. The Consumer Protection Act of 1986 is
expected to offer some hope.
In effect only a public outcry by the consumer can force
voluntary withdrawal by or reform by drug companies.
--S P TEKUR, Community Health Cell
47/1 St (lark's Road, Bangalore 560001
References, 2
1. The Pharmacological Basis of Therapeutics,
Goodman and Gillman, 5th Ed., 1975.
g
*
"
Oaustz, Goldfien,
2.
Review of nodical Pharmacology, neyers,
6th Ed., 1978.
3.
Agranulocytosis induced by Dipyrone, a Hazardous
antipuretic and analgesic, Charles n Huguley Or.,
DAnA 21 Sept 1964.
4.
Risks of agranulocytosis and aplastic anaemia-—A first
report of the International Agranulocytosis and Aplastic
Anaemia study, 0AnA 3 Oct 1986.
Analgin...Pain Killers or nan Killers? Indian Express
24 Oct 1987
Why analgin should be banned—a bit of history, Anant Phadke
Counterfact on Analgin (an untold story), Drug Disease
Doctor Vol 3, No.4, 1988—Arun Bal and Anil Pilgaonkar
Dipyrone, Hoechst and the Boston Study, mfc Bulletin
Dec 1986, Wilber-t Bannonberg.
5.
6.
7.
8.
—references contd....page 5
Health Maintenance
Rational Therapeutics
Dr. Shirdi Prasad Tekur
Community Health Cell, Bangalore
The most rational approach to a rational drug
policy is rational prescription
*
"The flood of new drugs in recent years has
provided many dramatic improvements in therapy,
but it has also created a number of problems of equal
magnitude. Not the least of these is the "therapeutic
jungle", the term used to refer to the combination of
the overwhelming number of drugs, the confusion
over nomenclature and the associated uncertainty of
the status of many of these drugs."
Policies
Policies determine the availability of medicines in
terms of production patterns, distribution, marketing,
pricing and ultimately, drug usage. To be rational,
availability should match the need - but does it? See
box 1 for some realities in our context.
People
Peoples/Patient behaviour in diseases is
governed by numerous variables based on their cul
ture, traditions, socio-economic status, access to
medical aid, life-styles and imperatives of their daily
existence. The bottom-line is a lack of awareness of
factors affecting health and disease.
This leads to
- self-medication in an empirical manner, based
on: experience, peer group advice, high pressure ad-
- Goodman and Gillman, 7th Ed. 1985
Drugs play an useful role in treatment of disease
and alleviation of symptoms. Optimal and rational
use of drugs is an obvious but imprecisely defined
pre-requisite of good medical practice.
An understanding of the pressures operating at
the levels of Policy, People and Practitioner could
clarify present irrationalities.
Box 1
- There are 20,000 pharmaceutical units producing over 60,000 formulations. The Hathi Committee in
1976 recommended 116 drugs as essential and the WHO says about 250 are necessary!
- Every 5th drug tested is sub-standard due to lack of good manufacturing practices. Also, the drug
controlling and inspecting apparatus is grossly inadequate. .
-Almost 50% of drugs are sold over-the-counter (O.T.C.) without proper prescription.
- The bulk of drugs produced and sold are tonics, cough syrups and pain-killers, while drugs for
diseases like TB, Leprosy and Malaria are in short supply.
- The drug policy is formulated by the Ministry of Chemicals rather than the Ministry of Health and the
Drug control policy is limited to a drug pricing policy.
Physicians Update
169
Vol III, No 4
Health Maintenance
vertisements, etc., with the attendant hazards (NIN
study-46% in Secunderabad and Hyderabad);
- inordinate fear of the medical system and its
processes; promoting self-manipulation of drug
therapies against advise;
- cross consultations and alternating different
systems of medicine; e.g. Ayurveda, Unani,
Homeopathy etc. whose understanding and treat
ment methods of disease processes differ at a fun
damental level. This gives conflicting signals to the
consumers, compounding their confusion and com
plicating the outcome. The prescription of allopathic
medicines by unauthorised personnel and a faith in
Ionics’ and other nutritional supplements add to the
problems.
These practices are based on the flawed belief
that There Is A Pill For Every Illi
Practitioner
The Practitioner is considered to be in a position
to understand rationality by virtue of training. The first
fact faced is a training in pharmacology in 'generic’
names of drugs, while practice means choosing from
a plethora of 'brand' names. Not having learnt the
economics of drug prescribing leads to easy
manipulation by pharmaceutical producers as part of
their promotional and marketing strategies.
Continuing education from unbiased sources of
information on rational therapy is not available to a
majority of practitioners.
The pressures of practice and patient expecta
tions leading to:
- emulating and competing with peer-groups and
'specialist' and consultant behaviour in prescriptions,
leads to:
extravagant prescribing, over-prescribing, under
prescribing and incorrect prescribing.
- accepting patient behaviour patterns listed ear
lier, or condemning them without rational discussion.
- erosion of clinical skills instead of honing them,
while high-tech diagnostics of limited utility are relied
upon more and more.
- not appreciating the high incidence of iatrogenic
disease, adverse drug reactions and the limited role
of drugs in treatment.
Physicians Update
- succumbing to marketing strategies, induce
ments and biased information provided by phar
maceutical companies.
It means substituting ‘medicine' for ‘caring and
acquiring of 'experience' which 'justified'. Is this
'rationalisation!, rational?
What does all this mean?
1. We do not have a Rational Drug Policy at the
National Level (see box 1). The Hathi Committee
Report (1976) universally considered as the most
authentic and exhaustive study of Indian Phar
maceutical Industry, is largely ignored.
2. The plethora of drugs available in our country
do not match our health needs.
3. Drugs banned elsewhere in the world are free
ly available in our country (e.g., Analgin, Clioquinols,
Oxyphenbutazone etc.)
4. Irrational combinations of drugs are in plenty,
while very few combinations are considered rational
(see Table 1);
____________________________________ Table 1
Rational Combinations
Fixed dose comblnallons Included In the WHO list
Ferrous sulphate
+ Folic Acid (anti-anaemic)
Isoniazid
+ B6 (anti-tuberculosis)
Sulphamethoxazole
+ Trimethoprim (anti-infective)
Ethinylestradiol
+ Levonorgestral (Contraceptives)
Ethinylestradiol
+ Norethisterone (Contraceptives)
L Dopa
+ Methyl Dopa (Anti-parkinsonism)
Neomycin
+ Bacitracin (Anti-infective
dermatological ointment)
5. Tonics (multiple combination), Cough syrups
(containing sedatives and expectorants) and Nutri
tional supplements, flood the market. These are sold
170
Vol III. No 4
i
Health Maintenance
' at exorbitant costs, and cannot be considered ration
public through publications like Drug-Disease-Doctor
al in our socio-economic millieu.
and ’Health Action’; and,
6. The practitioner has a greater responsibility in
- reaching the consumer to create awareness
questioning the present trends and consciously
through many of the above, including the KSSP
promoting rationality.
(Kerala Shastra Sahitya Parishad), AIPSM (All India
Peoples Science Movement), DSF (Delhi Science
Attempts at rationalisation
Forum) and other such fora.
The World Health Organisation and Health Ac
The practitioner can contribute towards rational
tion International have been drawing attention to
therapeutics by
rationality at the international level.
- being aware and supporting attempts at
At the national level, the Indian Academy of
rationality.
Paediatrics and Indian Medical Associations at some
- ’auditing’ his/her own prescriptions and prac
regional levels have started activity in this direction.
tices. Actively looking out for iatrogenic problems.
The Voluntary sector has been particularly active
Updating knowledge from unbiased sources. - believ
in
ing that the patient's ri^ht to information and a firm
adherence to medical ethics is the basis or
- promoting rationalisation at hospital levels in
developing Hospital formularies (CHAI-CMAI and
rationality.
Holy Family Hospital formularies);
- deciding that if drugs are the appropriate
- starting ADR (Adverse Drug Reaction) reporting
therapeutic option. GIVE THOUGHT TO THE IM
"cells to monitor drug reactions;
PLICATIONS OF THIS DECISION.
- promoting quality drug manufacture and dis
References/suggested reading
tribution at low cost through agencies like LOCOST,
1.
The use of essential drugs, W.H.O. TRS-770, 1988
etc.;
2.
A decade after Hathi Committee - KSSP, 1988.
- sensitising professional groups and lobbying
3.
Drug Industry and the Indian People - DSF, 1986.
with the Government through bodies life the m.f.c.
4.
W.H.O. Drug Information, Vol.1, No.1, 1987.
5.
Drug Disease Doctor - DAG-WB, Vol.3, No.4, 1990
(medico 'riends circle) AIDAN (All India Drug Action
6.
Health Action - Vol.1, No.8, August 1988.
Network) and DAF-K (Drug Action Forum - Kar
7.
Research and Development for Production of Es
nataka) and DAF-WB (Drug Action Forum - West
sential Drugs in India - NISTADS, 1984
8.
Banned and Bannable drugs - VHAI, May 1989.
Bengal);
9.
The Rational use of Medicines - VHAI, 1988.
- creating awareness among professionals and the
I.M.A. Rohtak
Statement regarding the ownership and other particulars of
PHYSICIANS UPDATE (See Rule 3)
1. Place of publication :
Bangalore
2. Periodicity of publication :
Bi-monthly
3. Publisher's Name :
Mr. R. Rajashekar
Whether a citizen of India :
Yes
Address :
81, Mosque Road, Fraser Town, Bangalore- 560 005.
4. Printer’s Name :
Mr. Arun Kaujalji
Whether a citizen of India :
Yes
Address :
Brindavan Publishers and Printers (Pvt) Ltd
No.12/13, Lalbagh Fort Road, Bangalore.
Physicians Update
5. Editor’s Name :
Mr. R. Rajashekar
Whether a citizen of India :
Yes
Address ;
81, Mosque Road, Fraser Town, Bangalore-560 005.
6. Names and Addresses of Individuals
who own the newspaper and partners or
shareholders holding more than one percent
of the total capital:
Mr. R. Rajashekar, 81, Mosque Road
Fraser Town, Bangalore-560 005.
I, Mr. R. Rajashekar, hereby declare that the
particulars given above are true to the best
of my knowledge and belief.
(Sd) Mr. R. Rajashekar
Signature of publisher
171
Vol III, No 4
DRUG PATENTS COVER STORY
Drug Divide
Drug cocktoils hove reduced AIDS
deaths in the West by 75%. In poor
countries victims die in six months or
less because of high cost of drugs.
95% patients arena poor nations
Africa is only one area
of conflict; in the Americas,
a more crucial battle is under
way. The US has taken Brazil to
the disputes settlements body of
the WTO over what it claims is a
violation of the TRIPs agree
ment. The Americans want
Brazil to drop the compulsory li
censing provisions in its patent
laws, provisions that the latter
claims are fully in line with
the letter and spirit ofTRIPs. The
battle is over Article 31 of
tire TRIPs agreement.
This is a test case that is be
ing watched with as much concern in Delhi as in Brasilia. It’s
not merely on account of the burgeoning collaboration on
health and pharma issues between the two countries. Brazil
and India, it is generally accepted, will be facing the brunt of the
legislative assault from the rich countries because both have a
well-developed domestic industry. The Aurangzeb Road em
bassy of Brazil is thus a focal point for officials and pharma in
dustry executives.
The confrontation with Brazil has major implications
for TRIPs and the drug MNCs who are losing face — and key
patent battles. Soon after they caved in on the price issue, the
pharma giants conceded defeat on a more substantive issue.
On 19 April, a coalition of leading pharma companies drop
ped a landmark suit against a South African law enacted in
1997 to help it fight the AIDS epidemic. The coalition was
set on preventing the i
mentation of the law
would have allowed
South Africa to im
port cheaper ver
sions of patented
AIDS drugs or the
manufacture of ge
neric versions of
these high-cost for
mulations.
The withdrawal of
the case may have
been a tactical retreat.Or it may have
■
I
heading lights of the scientific community, economists and
non-governmental organisations are calling for a rethink on
the issue by policy makers. Even if faint, there is an echo in min
isterial chambers where two major policies are being formu
lated: tire national health policy and the drugs and pharmaceu
ticals policy. For the many organisations and individuals
involved in the TRIPs battle, the more important document is
the Patents (Second Amendment) Bill 1999 which has been
sent to the joint parliamentary committee.
Udyog Bhavan, headquarters of the commerce ministry, is
being inundated with representations — accompanied by vast
documentation — from different quarters. Among those beat
ing a path to the commerce minister's office is the Indian
pharma industry, which fears that unless the regulatory safe
guards are in place — particularly the Patents Bill — the out
look would be rather grim. Four years down the line, India will
have to accept product patents instead of just process patents
as is the case today.
Elsewhere, earnest confabulations are taking place to put
together a strategy that will help developing countries adopt
the right strategies to outflank the MNC lobby. There's a sense
of urgency as a top-level MSF delegation arrives in Delhi for a
series of meetings with officials and NGOs involved in the
TRIPs campaign.
These are turbulent times for the global pharma industry.
The most serious fallout of the patent regime Is the
increasing gap between those who can buy medicines and
those who cannot. For the most vulnerable population in
poor countries, essential drugs are becoming far too costly
MAGAZINE OFTHE NEW ECONOMY
BUSINESSWORLD 25 JUNE 2001
COVER STORY DRUG PATENTS
Industry Prescription
The I PA has its own views on what the patents bill should contain
B.K. Raizada, senior
vice-president, Ran
baxy: the TRIPs expert
LATHA JISHNU
F there are still
many bureaucrats
in the commerce
ministry
have
not
heardwho
of Arti
cles 7, 8, 30, 31 — in
fact, the entire gamut of
regulations — of the
WTO agreement on
TRIPs, it would be sur
prising. In recent
months, the Indian
Pharmaceuticals Al
liance (IPA) has been
producing a steady
stream of representations and docu
ments in the emerging issues on the
patent battle.
The IPA brings together the big
I
names in domestic pharma: Ranbaxy, Dr
Reddy’s Labs, Cipla, Cadila Healthcare,
Alembic, Lupin Laboratories, Nicholas
Piramal India, Sun Pharma, Wockhardt,
Unichem Laboratories and Torrent
Pharmaceuticals. They account for 30%
of the domestic market, a similar share
of the exports, and almost the entire
(92%) Rs 255-crore R&D spend.
Dilip G. Shah, IPA's secretary-gen
eral, says that the forum’s primary agen
da is to help bring in a patent regime that
will conform to TRIPs but will primarily
serve the national interest. Although it is
lobbying actively to whittle down the
price controls on drugs, IPA's focus is the
Patents (second amendment) Bill 1999
that is now before the joint select com
mittee of Parliament.
Its worry: several amendments pro
posed in the bill would have a serious
impact on the domestic industry. For
starters, there’s the issue of patentability.
Given the trend in the US of extending
the patent life without the involvement
of any new technology, the IPA has
warned policy makers that product
patentability should extend only to new
chemical entities and not to their formu
lations or usage.
The omissions are equally grave.
Foremost among them is compulsory li-
censing for local work
ing of a patent. Al
though TRIPs allows
flexibility on compul
sory licensing to ad
dress urgent issues and
national healthcare
concerns, the proposed
| Indian legislation has
| been timid on this
i score. To remove this
a lacuna — experts like
James Love of the US
based Consumer Project on Technology
believe it could severely affect develop
ing countries—the IPA has been beefing
up its arsenal of arguments.
The association has been bombard
ing the ministry with laws enacted in
other countries to provide for compul
sory licensing under different circum
stances. The IPA — and NGOs — believe
this is an effective instrument for keep
ing healthcare costs down. Brazil has
demonstrated this, but it appears that
the US case against the South American
country has given bureaucrats cold feet
on the issue. The IPA’s efforts have thus
been directed at showing that the US it
self has resorted to this measure time
and again.
The abuse of monopoly is another
worry for the IPA—the
bill has failed to specify
what would constitute
abuse. Countries such
as Brazil, Israel and
China have provisions
saying that inadequate
production at afford
able prices would qual
ify as abuse. Strong de
terrents must be in
place to prevent abuse,
say IPA members.
Dilip G. Shah,
secretary-general,
IPA: industry voice
MAGAZINE OF THE NEW ECONOMY
The moving force behind the patent
initiative is B.K. Raizada, senior vicepresident, Ranbaxy, who is the acknowl
edged expert on TRIPs. "We’re missing
the point on many issues. On data exclu
sivity, the Bolar exception in particular,"
warns the executive, who examines
TRIPs issues with a fine toothcomb.
What's at stake is the right of a country to
undertake R&D.
The Bolar exception is intended to
allow pre-patent expiry work leading to
the development of products. The In
dian amendment has enunciated a fixed
period of just three years before the
patent elapses when research and devel
opment can begin. “This is surprising,
since no country, not even America, has
included such restrictions in its regula
tion. This would seriously impede the
development of science and technology,” warns Raizada.
For an association that believes the
pharmaceuticals industry is always up
against a hostile government, the IPA
has been rather effective in persuading
the authorities of the critical role it can
play under a more stringent patent
regime. It has managed to secure a Rs
150-crore funding from the finance min
istry to advance R&D as part of its grand
strategy’ of moving to an R&D spend of
Rs 1,500 crore by 2005. The IPA is clearly
making its voice heard in the corridors
of power.
But whether it will succeed in getting
the drug control order
relaxed is another mat
ter. This, claims Shah, is
a major impediment to
the growth of pharma
companies and would
leave them far too weak
to take on the MNCs.
Currently, the govern
ment is in litigation
with over 100 drug
companies for over
pricing. “How do you
expect a strong pharma
industry when th-.
CEOs are all busy w 1 court battles?’’
BUSINESSWORI.D 25 JUNE 2001
DRUG PATENTS COVER STORY
been a secret deal struck with tire South
Africa government to keep cheap imports in
return for cut rate AIDS medicines by the
patent holders. Whatever the reasons, the
backing down by the giants has opened up
the familiar arguments about TRIPs.
The most serious fallout of the patent re
gime, according to its critics, is tire increasing
gap between those who can buy drugs and
those who can’t. As MSF points out, two dif
ferent worlds exist in healthcare. In industri
alised nations, there is a huge choice of med
icines. But for the world’s poorest and the
most vulnerable lot (one-third the total pop
ulation), essential drugs are too expensive or
aren't available. In the impoverished parts of
Asia and Africa, the drug divide is sharper:
half the population doesn’t have access.
Is TRIPs to blame? Research compiled by
campaigners worldwide would appear to re-
60% Of New Drugs Approved By FDA In 1990-1999
Contained Existing Active Ingredients
NEW FORMULATIONS: New dosage or
new formulation of active ingredients for
drugs already on the market
NEW MOLECULAR ENTITIES: New
compound which has never been sold in
the US market
NEW MANUFACTURERS: Company
creating product with the same active
ingredients or formulations as marketed by
another manufacturer
NEW COMBINATIONS: Drug containing
two or more compounds which have been
marketed before, but have not been
marketed together in a product
OTHERS
Source FDA/Center for Drug Evaluation and Research 2000
R&D Is Not The Big Tab
(1999 data, as percentage of sales)
R&D
Marketing & administrative
Bristol-Myers Squibb
9.1%
34.6%
Eli Lilly
17.8%
27.6%
Glaxo-Wellcome
14.6%
35.2%
Merck
6.3%
15.9%
Pfizer
17.1%
39.2%
9.7%
46.1%
SmithKline Beecham
Source- Consumer Project on Technology (based on company SEC 10K filings and annual reports)
Pharma Industry Profitability Is Soaring
Profitability gap between pharma firms and Fortune 500 firms is growing
20
iyeu
iyoo
iy/u
iy/3
iyou
iyoo
iyyu
iyyo
zuUO
Source: Prime Institute 1999, Stephen Schondelmeyer, data from Fortune 1958-2000
The Cost Of Patents (Rs)
All countries, except India, have product patent; India recognises only process patents
Drugs/brands
Patent holder
India
Pakistan
Indonesia
UK
US
Ranitidine (Zantac)
150 mg X 10s
Times costlier
GLAXO
7.16
127.08
142.68
339.45
739.60
(17.75)
(19.93)
(47.41)
(103.30)
Diciofenic (Voltaren)
50 mg X 10s
Times costlier
CIBAGEIGY
69.38
47.96
132.86
505.68
piroxicam (Dolonex)
20 mg X 10s
Times costlier
PFIZER
5.64
24.64
(12.30) .-(8-50)
97.23
61.32
(23.56)
(89.66)
254.04 1,210.88
(3.95)
(10.31)
(2.49)
(49.14)
inforce the claim that the patent regime,
which is intended to stimulate innovation
and give access to new medications, has only
‘conferred multiple and additive protection
to prescription (branded) drugs'. The result:
delayed entry of cheaper generic drugs. This
is the finding of the National Institute for
Health Care Management (NIHCM) Founda
tion, a Washington-based NGO seeking im
proved medicare for Americans.
It warns that efforts to increase patent
protection will go up as manufacturers try to
protect the $20 billion worth of drugs going
off-patent over the next five years. The foun
dation’s concern is not about access to medi
cines for the impoverished of the world;
its agenda is the rising cost of healthcare in
the US, which it believes is on account of the
laws passed by the US Congress to prolong
the effective patent life enjoyed by prescrip
tion drugs.
The pricing power provided by patent
protection has certainly given the pharma
industry an enviable position. It is the most
profitable. According to a Fortune 500 prof
itability analysis, pharma posted 14.7% net
profits as a percentage of assets while net
profits were as high as 18.3% on revenues
(1999 figures). The nearest competitor was
the beverages industry with 11.1% and
10.1%, respectively.
As for the most common argument that
patent protection is vital for drug breakthr-
0f the 1,223 new drugs developed
between 1975 and 1996, only 11 are
for the treatment o' tropical
diseases. Several have become
orphan drugs because the drug compmiies don't iWd th ct yrditable
Source US (Red Book 98); UK (MIMS June 98); Pakistan (Pharmaguide Mar 98); Indonesia (UMS No. 1,98); India (Drug Index 98)
MAGAZINE OF THE NEW ECONOMY
IlJSXLjLi
BUSINESSWORLD 25 JUNE2001
COVER STORY DRUG PATENTS
and believes that implementation of TRIPs
should take into consideration the health con
cerns of different nations. The sharpest indict
ment was made by a sub-committee of the UN
Commission on Human Rights which noted
that the TRIPs agreement is a contravention of
the international human rights law.
R.A. Mashelkar, one of India’s top scientists,
is not surprised at the groundswell of support
for reviewing the TRIPs provisions relating to
Yusuf K. Hamied,
pharma. Mashelkar, director-general of the
Council for Scientific & Industrial Research
chairman & MD, Cipla
(CSIR), is a member of the Committee for Inteloughs and innovation, the scepticism is mounting. On the one j lectual Property Rights set up by the U K government to exam
hand is the break-up of expenditure: Fortune's analysis is that ine the working of TRIPs. Such a move by a developed country
R&D accounts for a significantly low proportion of costs in which is home to some big pharma companies (GlaxoSmith
curred by drug firms in launching new products in the market Kline Beecham and AstraZeneca), he believes, is a signal that
(see ’R&D Is Not The Big Tab’). It’s promotional costs that add there are growing and serious concerns over TRIPs.
heavily to the tab.
These concerns relate primarily to the price and accessibil
Besides, studies show that most drugs were developed at ity of drugs. Increased patent protection can, and does, mean
public expense. A World Bank study puts R&D expenditure cur higher costs for consumers and governments (see ’The Cost Of
rently at an estimated S70-90 billion. Half of this is funded by Patents'), and it keeps life-saving and essential drugs out of the
the taxpayer. For instance, the AIDS drug stavudine was discov reach of vast sections of the population in impoverished coun
ered in 1966 by Yale University on a grant given by the govern tries. Other worries are:
ment. So were four other AIDS drugs.
■ Local manufacturing will be put under controls and remove
If these are known arguments, what has changed? In the I a vital source of generic, innovative drugs that poor countries
early 90s, the anti-TRIPs lobby did not count
for much. It comprised scattered NGOs, and
We should use this
little-known activists. Today's campaigners
may belong to the same genre but they cannot momentum to prise open
be taken lightly. MSF has a Nobel Peace Prize
tag (1999) and in the last two years it has trans the TRIPs agreement, and
formed itself into a formidable lobbyist. question the issue of pat
Aligned with it are outfits like the Consumer ents on drugs. It must not
Project on Technology (CPT), a non-profit re
search and advocacy organisation set up by be reduced to a quibble'
legendary consumer activist Ralph Nader.
There are half-a-dozen other heavyweights Amit Sen Gupta, secretary,
NCCDP
among the campaigners.
Moreover, a host of UN organisations are
taking a humanitarian view on the patent debate. The UN it- | depend upon. India is a prime example of this.
self, following tire new gloves-off approach adopted by secre ■ There is no incentive to encourage research on diseases that
tary-general Kofi Annan, is encouraging the wider use of afflict the poor, such as tuberculosis and malaria. It is estimated
cheaper generic alternatives to branded drugs in the fight that 97% of the deaths from communicable diseases occur in
against HIV/AIDS. Annan has also praised Brazil for its exem developing countries and the burden it imposes on their
plary public health campaign against AIDS — a campaign that economies is devastating.
relies on generic drugs and mandatory local manufacture. And,
All this is happening when old diseases are re-appearing
Unaids — the agency set up to fight the scourge — is backing and are proving resistant to existing drugs. Amidst such con
MSF and Oxfam in their anti-MNC stance.
cerns, are sinister new threats. Not from new diseases but from
The issue has overshadowed discussions in other forums the pressure that the developed world is putting on developing
too. The World Health Organisation (WHO) strongly favours countries to implement stricter patent legislation than is re
policies that encourage the production of generic medicines quired under TRIPs. The new TRIPS-plus legislation is lethal for
poor countries. It excludes safeguards such as
compulsory licensing or parallel imports (shop
There should be a
ping globally for the cheapest source of
patented products) that are available inTRIPs to
clear-cut correlation
between the health policy offset the negative impact of patents. In western
Africa, the stringent legislation was forced upon
(people) and the drugs
15 countries, most of whom are least developed
policy (domestic industry) countries!
TRIPs-plus is not the only threat. There is die
with the patent laws'
problem of evergreening, a strategy used
drug
firms to increase the patent on a moLvule
B.K. Keayla, convenor,
by deriving new products from compou; ; • r
NWG on patent laws
introducing a ‘purified’ form of the dru;-z. : o
You can't have the
same rules for all. There
must be a TRIPs North for
the developed world and
TRIPs South for the devel
oping countries'
MAGAZINE OF THE NEW ECONOMY
BUSINESSWORLD 25 JUNE 2001
DRUG PATENTS COVER STORY
Brazil Shows The Way
This country sets an example by giving free drugs to AIDS patients
LATHA JISHNU
OSE Serra is something of a hero
here — and, one imagines, in
most parts of the developing
world. The Brazilian health min
ister has come to symbolise the
doughty spirit of a poor country that has
taken on a big bully (the US) and the
might of drug multinationals. Since Jan
uary, when the US took the South Amer
ican country to the disputes settlement
body of the World Trade Organisation
for alleged violation of the TRIPs agree
ment, Serra has gone on a diplomatic of
fensive. He has taken the issue to the
World Health Organisation and the UN
Human Rights Commission and got
their backing for the right of poor countries to access cheap medicines.
Brazil’s rallying cry — and one that
has worsted MNCs like Merck — is that
the price of a drug should not determine
whether people live or die. When the
AIDS crisis erupted in the 90s, it was one
of the countries most at risk with the
fourth-highest number of HIV/AIDS pa
tients. The WHO forecast that it would
have a total of 1.2 million patients by
2001. But an exemplary public health
care programme (cost: $300 million last
year) has kept the figure to just 531,000.
The death rate has been cut by half and it
has saved $472 million in hospital costs.
At the core of Brazil’s success is its
ability to supply drugs free to AIDS pa
tients. By locally manufacturing drugs at
a fraction of the cost charged by MNCs,
the country was able to cut costs by $200
million a year. It also imports drugs at
the best price going and has bought sub^stantial quantities from India.
With a $ 10-billion market for pharma
products, the fifth-largest in the world,
Brazil is a lucrative proposition for
MNCs. But its vibrant public sector ma
kes it a tough market to crack. After these
firms began generic production of the
anti-retroviral drugs that keep AIDS pa
tients alive, the prices of equivalent br
anded products fell by as much as 80%.
But the WTO case which was initi
ated in May last year has put a question
J
mark over Brazil’s healthcare
and drugs policy. The US be
lieves Article 68 of Brazil's
patent law — it provides for
compulsory licensing and
local manufacture of a
patented product if it is not
made within three years of a
license being issued to the
patent holder — violates
TRIPs. Washington insists
the dispute is not about
healthcare or access to drugs
but about a discriminatory
regulation.
No developing country,
least of all Brazil, is buying
this. An indignant Serra says
what's bothering the US is his
country’s policy of produc
ing generic drugs. And the
fact that it keeps a strict con
trol on drug prices. Brazil’s
patent laws are completely
TRIPs-compliant, explains Brazilian health minister Jose Serra believes that
VeraBarrouin Machado, am poor nations have a right to cheap drugs
bassador to India. “The WTO
case has become a showpiece conflict compulsory licensing you simply can
because it undermines what is possibly not fight a government that's decisive.
the best AIDS programme in the world.’’
Brazil is clearly that or you wouldn’t have
In a response to the US trade repre seen Merck drop prices so sharply."
sentative, Serra points out that Article 68
Indian industry is also betting on a
sets two conditions for compulsory li favourable outcome for Brazil. B.K.
censing: one, if production of a drug has Raizada, senior vice-president of Ran
not taken place after a period of three baxy, which was the first Indian com
years, and two, when prices of certain pany to set up shop in Brazil, believes
patented drugs are considered an abuse that the US will back off for two reasons.
of monopoly. Brazil has not resorted to Apart from the fact that the US also re
the use of either proviso so far. It's only sorts to compulsory licensing, a bill was
the generic production that has pro introduced in the US House of Repre
mpted the US action.
sentatives on 3 May. to provide for com
Besides, the US itself has a provision pulsory licensing of certain patented
for compulsory licensing and has used it products relating to health. In short, the
as a remedy for anti-competitive prices, US position is untenable.
specially in the case of mergers in the
Raizada says Brazil's example has to
pharma industry. At a recent seminar in be emulated on another count: it has a
Delhi, legal experts from the US were of proper healthcare system in place and a
the opinion that Brazil would win its I public sector that has to face global
case because the TRI Ps rules allow the I competition. This is what gives the
use of compulsory licensing under Arti- I country an edge in coping with the kind
cle 31 although it does not specifically j of emergency it faced on AIDS. Which
use the term. Jerome Reichman, profes might explain how Brazil has the stren
sor of law at Duke University, says: "On ' gth to take on a superpower.
Si
MAGAZINE OF THE NEW ECONOMY
■lrB
BUSINESSWORIJJ 2SJUNE2001
COVER STORY DRUG PATENTS
Preduction of eflornithine, a drug
patent law that would ensure the safe
US. not surprisingly, has taken the lead
guards embodied in the TRIPs agree
in this case.
used to treat sleeping sickness, was
ment. The domestic industry, which is
For countries like India and Brazil,
as unhappy with TRIPs as the devel
stopped in 1995 because it wasn't
with a large domestic industry, the
oping
world although for different
pressures are expected to mount. Brazil
making a profit. The active ingredi
reasons, is seeking a regulatory frame
is on firmer ground because of wellent
is
now
used
in
a
vanity
product
work
that
will encourage local pro
considered regulations ('Brazil Shows
meant for removing facial hair
duction, support exports to global
The Way'), whereas India, with none of
markets, ensure equity in pricing reg
the critical laws and policies in place, is
on a stick}' wicket. Among the worries: the patent law doesn't ulations and provide incentives for R&D.
Such a strategy has the backing of economist James Love,
have a provision for compulsory licensing for local working of a
patent which is critical for maintaining an affordable health who works for CPT. He insists that TRIPs “is actually fairly lib
eral in terms of government decisions to authorise third parties
system. Nor does it address the issue of data exclusivity.
Cipla's Harrtied believes the solution is to seek renegotiation to use patents without the permission of patent owners." The
ofTRIPs. “There must be aTRlPs North for the developed world moot point is national legislation to cover this eventuality. But
and its 600-million population and a TRIPs South for the over what TRIPs permits and what countries actually do are two dif
3-biIlion population of the developing countries. You can’t ferent things. Ultimately, it is national law and practice that will
have the same rules for the two worlds." Hamied takes a rather be decisive, both in terms of providing access to inventions,
extreme stand: if renegotiation ofTRIPs doesn’t work to India’s and in establishing the legal framework in which TRIPs rules
will be interpreted. Love’s tip: “No developing country should
advantage, it should quit the WTO.
Few would go along. The domestic drug industry is con have statutory public use provisions that are weaker than
vinced it would be suicidal for India to seek the reopening of American, German, Irish or UK provisions."
This is exactly what the newly-formed Indian Pharmaceuti
TRIPs. The strategy, instead, should be to have in place a strong
cal Alliance (1PA), which clubs 11 of the
top R&D-based drug manufacturers, is
seeking to do. Dilip Shah, secretary-gen
eral of 1PA, believes that the forum is lob
bying for a balanced policy (see 'Industry'
Prescription’) on patents. “Opening up
O EACH according to his or her need. This dictum has rarely been tried in
the whole gamut ofTRIPs negotiation
healtltcare, much less in the pricing of drugs. Patented drugs, especially, are
would subject the developing countries
priced exorbitantly, thus keeping them out of reach of the common man in
to more intense pressure from the devel
poor nations. Differential pricing is an effort to do away with uniformity and in
oped world for doing away with the pre
troduce prices according to the purchasing power of the people in that country’.
sent safeguards,” warns Shah, who
Sensible as it may sound, differential pricing is far from easy. Research shows
worked in Pfizer India for three decades
that those who can least afford to pay for drugs out of their pocket pay the most.
before setting up his own pharma con
Public spending on healthcare in developing nations is poor. Just to take some
sultancy.
examples, the public share of healthcare spending is 95% in the UK, 45% in the
On this issue at least, the IPA shares
US and 78% in Japan. This is compared to 20% in Vietnam, 15% in Pakistan, and
common ground with the MSF which
20% in Nigeria. It’s a paltry 10% in India.
believes that TRIPs should be harnessed
Such lopsided spending has an effect on the health of the people in these
to serve development goals. So, while
countries, where two-thirds of the children under 15 die from seven prevent
MSF will push for implementation of the
able communicable diseases, for which treatment also exists. One of the rea
existing safeguards in the agreement, it
sons for this is the high-priced drugs, the others being lack of rational selection
will pin its hopes on public funding for
and use, sustainable financing, and a reliable health and supply system. High
drug R&D to meet public health require
prices have an impact on household expenditure in poor nations. Drugs form
ments of poor countries.
the main component of a household’s healthcare spending. WHO research
James Orbinski, former president of
shows that in poor nations, 50-90% of a household’s health expenditure is on
MSF, who is currently spearheading its
drugs. To take two extreme examples, 85% of an Indian's health expenditure is
efforts to find drugs for forgotten dis
on drugs, while it’s less than 5% in the UK. But one of the problems is that drug
eases, advocates a global health security
development is almost entirely in the hands of private firms, who write the
tax to fund R&D. This will entail a multi
entire project cost into the price of a drug. Also, they price the drug in a way
lateral treaty to tax drug sales in the richdrat they recover the project costs in four to five years, which gives them
est markets (the US, the European Union
another eight years of profits before the patent expires. So what is the way out?
and Japan) to provide funds for ThirdA WTO-sponsored workshop on differential pricing held last April offers
World diseases.
some solutions.The participants discussed mechanisms like financing,
MSF is creating a not-for-profit fund
concentration of demand through pooled procurement arrangements and
of SI million (70% from public funding
elimination of tariffs and taxes, etc. Drug companies agreed that differential
and tlie rest from private NGOs) for drug
pricing was necessary' but they had reservations. Says Mike Rance, senior vicedevelopment. It is also pushing for a
president (corporate affairs), AstraZeneca: “Our biggest worry is the diversion
treaty on burden-sharing of neglec
of the drugs from the low-income countries to the developed markets."
■
ted diseases to stimulate R&D. This
means that the cost of research and ca ■
P. HAR1
pacity-building will be shared equitably
on researching diseases prioritised ac
cording to public need.
This Pricing Task Will Work
T
MAGAZINE OF THE NEW ECONOMY
BUS1NESSWOHI.D 25 JUNE 2001
COVER STORY DRUG PATENTS
For A Human Cause
The AIDS epidemic in Africa forces drug firms to rethink their strategies
P. HARI
HEN tile TRIPs agreement
was signed in 1994, it was
considered to be the final nail
in the coffin
ofyears,
developing
countries.
In 10
TRIPs
would have brought IPR laws in all sig
natories to the same level, and put the
drug firms in charge of their products.
The year 2005 is nearing, but the out
come is far from final.
The trigger is the AIDS epidemic in
Africa, which is rewriting conventional
approaches to disease control. There are
drugs that reduce mortality and infec
tion, but cost $12,000 per patient a year.
Drug firms which made these drugs
owned the patents as well, and charged
whatever they liked. There was only one
way out. Reduce drug prices. ,
Take the case of South Africa. The
South African Patents Act 1978 afforded
full patent protection to new drugs. In
1997, the government decided that it
wanted to make medicines more afford
able, which wasn’t possible without am
ending the laws. The government pass
ed the Medicines & the Related Sub
stances Amendment Act No. 90. It had
many controversial provisions — one
was very interesting. In English, it meant
that the health minister had the power to
override patents and give anybody the
right to make drugs or import them from
sources other than the patent holder.
The country’s pharma sector was the
first to protest. For months it tried to per
suade the department of health to cha
nge the amendment, failing which it fil
ed a petition in the Pretoria High Court.
The petition claimed that the amend
ment violated the country's obligations
to TRIPs. South African courts decide
fast in such matters, but the case was
postponed sine die.
In 1998, the US placed South Africa
on the Special 301 watch list. This was in
response to representations by the
pharma industry saying that South
Africa didn’t comply with TRIPS. But this
was probably the last measure that the
US took against the South Africans. Sym-
W
statement, which meant that develop
ing nations had the option of using this
mechanism to dramatically cut drug
prices. The letter read: "If the Thai gov
ernment determines that issuing a com
pulsory license is required to address its
healthcare crisis, the US will raise no ob
jection, provided tine compulsory licen
se is issued in a manner fully consistent
with the WTO Agreement on TRIPs.”
On 10 May 2000, came another sig
nificant order, called executive order
1355. The order speaks for itself: 'The
United States would not seek, through
negotiation or otherwise, the revocation
or revision of any intellectual property
law or policy of a beneficiary sub-Saha
ran African country, as determined by
the President, that regulates HIV/AIDS
pharmaceuticals or medical technologies if the law or policy of the country: (1)
promotes access to HIV/ AIDS pharma
ceuticals or medical technologies for af
fected populations in that country; and
(2) provides adequate and effective in
There's still hope for patients in the
tellectual property protection consistent
developing nations
with the TRIPs Agreement. The US shall
encourage all beneficiary sub-Saharan
pathy for AIDS patients began rising, African countries to implement policies
and there were several signals that even designed to address the underlying
the US government sympathised with causes of the HIV/AIDS crisis by, among
the South African action.
other things, making efforts to encour
On 1 December 1999, president Clin age practices that will prevent further
ton announced that the United States transmission and infection and to stim
Trade Representative (USTR) and the ulate development of the infrastructure
Department of Health and Human Ser necessary to deliver adequate health
vices (HHS) would develop a coopera services, and by encouraging policies
tive approach on health-related intellec that provide an incentive for public and
tual property matters to help poor private research on, and development
countries gain access to affordable med of, vaccines and other medical innova
icines. He also promised to ensure that tions that will combat the HIV/AIDS epi
the application of US trade law related to demic in Africa’.
intellectual property, such as Special
Even the pharma industry felt some- V
301, remained sufficiently flexible to re thing had to be done. Pfizer, for instance,
spond to legitimate public health crises. said that it would distribute medicines
It was a major statement and a sign that free in South Africa. Five drug firms in
the US recognised the importance of a cluding Merck agreed to cut AIDS drug
different approach to AIDS.
prices for African nations. The biggest
On 27 January 2000, the US sent a let surprise came from Cipla, which said it
ter to Thailand saying they would supp would provide AIDS drugs for $350 a
ort the Thai use of compulsory licensing year. And the best news came on 19 April
(overriding of patents) to increase access this year: all the pharma firms withdrew
to AIDS drugs. It was another major their petition against the government.
MAGAZINE OF THE NEW ECONOMY
BUSINESSWORLD 25 JUNE 2001
DRUG PATENTS COVER STORY
mentioned in it have disappeared. Nor does
the country have a drug policy or even a list of
what it considers essential drugs. According to
indications from the ministry of health, a draft
national health policy is almost ready and is ex
pected to be circulated shortly.
B.K. Keayla, a retired bureaucrat who has
been spearheading the campaign for a fairer
implementation of TRIPs through the forma
tion of the National Working Group on Patent
James Orbinski, director,
Laws (NWGPL), says India has failed to protect
Medicins Sans Frontieres
its national interest because it has not under
stood the correlation between the health and
Is any of this feasible? Orbinski, who was president when the drugs & pharma policies and the patent laws. The two, he
MSF was awarded the Nobel Prize, is convinced that “the clear argues, should be in place before enactments or amendments
moral argument that appeals to human dignity and human to patent laws are made to make them TRIPs-compliant.
values” will ensure the success of the access campaign. He
But one should not be carried away by anti-TRlPs rhetoric,
finds that the three factors that propelled the campaign against cautions Zafar Mirza, a doctor working with an Islamabad
landmines to victory are present in this case too: a strong coali based NGO. Mirza, who is in India to share Pakistan’s experi
tion, a morally-compulsive argument and the political oppor ence post-TRIPs, says blaming TRIPS for each and every' prob
tunity for wresting a bargain.
lem is passing the buck. The executive coordinator of Pakistan's
Orbinski's calculations may err on the side of naivete. Network for Consumer Protection points out: “TRIPs is an im
Ranged against the access campaign and developing countries portant factor in the health mess in developed countries, but
is a formidable opponent: an industry that makes no bones there are hundreds of others. Government failure, for starters.
about its profit motive and its determination to increase those We should not let our policy makers get away by blaming an in
profits at all costs. This is not an accusation but a statement of ternational agreement for all the ills of our health system."
intent that comes from the pharma industry it
self. Its most influential spokesman is Philip
The costs of drugs can
Brown, publisher of the highly-regarded Scrip
magazine, which reflects the views of the R&D- be brought down if the
based pharma industry.
In a recent issue of Scrip, Brown says wither- drug development process
ingly that “treating Third World illnesses is not shifts from developed
the core business of die international pharma countries to the develop
ceutical industry'." He points out that for the in
dustry, the market is the developed world where ing countries'
patent protection gives it "rights to charge the
prices needed to sustain its activities." More im R.A. Mashelkar, directorportant, its agenda is to treat die diseases of the general, CSIR
western world — cardiovascular, neurological
For most crusaders though, the important issue now is
diseases, cancer and problems associated with the western ,
lifestyle. AIDS, he argues, is a disease which spans both rich and I to stay focused on the agreement. It isn't as if die MNCs have gi
poor countries and, hence, the problem. But primarily ven up the fight. NGOs say the pharma giants will be putting
"pharma companies are businesses and not charities”, says pressure on their governments, most of all the US, to make
Brown. Thus, around 1.5 billion people benefit from its R&D: it extremely difficult, if not impossible, for developing count
4.5 billion people do not. Blunt and unpalatable as Brown's ries to use the exclusions and other safeguards in TRIPs. There
views may be, there’s no debate on his most caustic observa fore, 'the tremendous evocative appeal of the access campaign',
tion: "The pharma industry is not a substitute for a country's should be used to delegitimise TRIPs. Their fear is drat the
pharma industry'will try a damage-limitation exercise by mak
national health service.''
This is specially true of India. The government is yet to set ing the AIDS campaign an exception; other essential medica
out its public healdi priorities; tire last policy was enunciated in tion would thus be left to the mercy' of the patent regime.
Rapidly, however, the air is growing thick with talk of .Article
1983 under Indira Gandhi's premiership and some diseases
8.31, and the handful of TRIPs regulations that
will be tested soon. It’s the outcome of these le
What TRIPs permits
gal battles that will determine the future of the
global patent regime. Sen Gupta says there's no
and what countries
time to be lost. "The pharma industry has
actually do are two differ never been so defensive as it is now. Never be
ent things. Ultimately, it is fore has public perception been so hostile to
it, and never before has such a wide global
national law and practice
unity' been forged on the issue. Can ■ e seize
that will be decisive'
the moment?"
Can we indeed?
Intellectual property
rights in principle seeks to
protect, promote and
reward innovation. But
it's skewed towards
investment interest'
James Love, director
Consumer Preset on Tech.
MAGAZINE OF THENEW ECONOMY
,',’T .
: liHad)
COVER STORY DRUG PATENTS
AstraZeneca Steps Up
The first MNC to set up an R&D centre in India for a Third World disease
search programme: '"What we need is a
drug which can reduce the dme of treat
ment from the present six months to
HE last thing you would associ
ate the lush, tree-lined campus
about two months.”
The TB bacillus is smart. It lies inside
with is danger. But tucked away
in
a corner
the AstraZeneca
a type of cell called macrophage (it’s sup
R&D
centre of
in Bangalore
is one
posed to defend us from intruders), whi
of the most dangerous places on earth.
ch drugs can't reach easily. It isn't just in
In a small building next to the main one.
side the macrophage, it is inside a part of
scientists wear special suits and oxygen
it called the vacuole. Since vacuoles are
masks while working. What's cooking?
present inside most cells, it’s a challenge
In one of the rooms here, researchers
to make a drug that can penetrate the va
spray die air with tuberculosis bacilli:
cuole, yet be non-toxic to everything ex
the idea is to infect rats with TB of
cept theTB bacteria.
the lung. The sick rats become in
There are other challenges.
valuable models to study the dis
The bacterium divides every’ 23
ease. AstraZeneca has invested
hours,
unlike 20 minutes for
$10 million in this facility, and
most other bacteria. This means
plans to invest $5 million every
that
the
drug has to be present in
year.
the body for a longer time. Most
This is the first R&D centre set
drugs
have
a half-life (the time it
up by a pharma multinational in
takes for 50% of the drug to be
India to develop drugs for a dis
eliminated)
of an hour, which is
ease of the developing world. Pri
not adequate in this case. But a
vate companies have made some
drug
that
is
present in the body
efforts on TB, the most notable
for a longer time has to be less
being Glaxo Wellcome's Action
toxic.This means that we need a
TB initiative, where it pledged
drug which kills rather than in
$32 million (to be spent in the
hibits the bacterium but works at
UK, South Africa and the US) to
very small concentrations. The
develop a drug at an early stage of
< drug researcher has to cleverly
clinical trials by 2003, with a
5 use cutting-edge science to take
back-up molecule. But these are
| care of all these variables. To
small efforts compared to the bil
i complicate matters, these efforts
lions of dollars spent on diseases
may not make the researcher
of the developed world. Hardly T.S. Balganesh, head of research at the R&D centre:
much money, as the market is
any company has set up an R&D joining the fight against the killer disease TB
highly subsidised.
centre in a developing country
AstraZeneca’s lab in Banga
foraThird World disease.
pany
invest
so
much?
lore
has
earlier developed diagnostic kits
In the next few years, about 60 scien
Yet, the world urgently needs a new for TB and malaria. So, when the compa
tists here will use cutting-edge technol
ogy to study the TB bacteria. They will TB drug. The disease is the leading cause ny’s management in the UK asked the
use information from the TB genome of deadi due to a single infectious organ lab to work on a developing country’ dis
(sequenced recently) to identify targets ism in the world. There are 8-10 million ease, it immediately chose TB. The
to attack in the bacterium. They will new active cases of TB each year and ap Level-4 facility also helped. Most facili
ties in the world use injections rather
screen thousands of candidate mole proximately two million deaths. Onecules, using state-of-the-art, high- third of the world’s population (1.7 bil than aerosol sprays, and the rats develop
throughput techniques. The aim is to lion individuals) harbours the TB of the spleen instead of the lung.
generate a few candidate drugs by 2005. bacterium, although not everyone de Since humans usually get TB of the
Says T.S. Balganesh, AstraZeneca vice- velops the disease. TB is treatable, but lungs, using aerosol is a better way of
president and head of research at the world rates of tuberculosis are predicted studying the disease. In fact, observers
R&D centre: "The drug discovery’ to increase by approximately 50% each say that the AstraZeneca facility is the
process forTB is very old. We want to op decade. Says Ashok Rattan, director of place to watch for the development of
microbiology at Ranbaxy’s new drug re next anti-TB drug. Lets.
S
P. HARI
T
timise it and get some new targets soon.”
An unfortunate paradox exists in
drug research on TB, and it probably ex
tends to any’ disease of the Third World.
For a big multinational, developing new
TB drugs do not make much commer
cial sense. The World Health Organisa
tion estimates die TB drug market to be
about $200-300 million. Most best-sell
ing drugs have markets of a few billion
dollars. The cost of developing a new
drug can run into several hundred mil
lion dollars. Why should a private com
MAGAZINE or THE NEW ECONOMY
BUSINESSWORLD 25 JUNE 2001
VQtC & S____ _______________ CnMMt; AH CArttw
trfx 77 A/n 3 ■/<?<?.
The New Drug Policy
n August 1992 the Government, Department of Chemicals and Petrochemicals,
Ministry of Chemicalsand Fertilisers circulated a note to members of parliament
regarding proposed changes in the 1986 Drug Policy. This was interpreted as an
introduction to the New Drug Policy and was used by the industry to focus on its
demands to fewer controls and higher margins of profitability. After more than two
years the Government has finalised the draft for a new policy and has clearly
decided to go along with demands of the industry.
With absolutely no change in the number of hazardous drugs in the market, no
effort at ensuring unbiased drug information on ethical marketing practices and no
improvement in quality control or drug legislation, the Drug Action Forum,
Karnataka, All India Drug Action Network and National Campaign Committee for
Drug Policy have felt the need to file a petition in the Supreme Court of India on
behalf of all drug consumers of India. By this, the petitioners seek to enforce the
fundamental rights of drug consumers under Article 21 of the Constitution for being
protected against hazardous drugs and for information about hazardous drugs
which are being manufactured and sold in India.
The petitioners have prayed to the court that it must give appropriate directions
to the respondents to ensure that banned and harmful drugs are not manufactured
or sold in India and that the consumers are properly informed and educated about
them. The following are the details of the petition:
I
Petition
*
*
issue appropriate writs and directions to the Respondents
directing the union of India and the Drug Controller of India to make
appropriate rules to ensure that the chemists and druggist prominently exhibit
the list of banned drugs;
* directing the union of India and the Drug Controller to ensure that manufactur
ers of drugs print and attach with the product in vernacular language the caution
statement and contraindications of the product;
* directing the Union of India and the Drug Controller to ensure that publishers
of Current index of Medical Specialities (CIMS) and Monthly Index of Medical
specialities (MIMS) publish the trade names of banned drugs and do not
recommend banned drugs, and publish along with the products particulars and
caution statement and contraindications;
* directing the Drug Controller of India to send all Medical Centers and Medical
colleges in India notifications of banned drugs and caution statement and
contraindications of such drugs notified by the Drug Controller;
* directing the Union of India to ensure that the electronic media such as TV and
Radio broadcast periodically and as often as necessary information regarding
banned drugs in generic names and in brand names;
* directing the Drug Technical Advisory Board to meet regularly to review and
recommend the banning of drugs and make their reports public;
* directing the Union of India and the Drug Controller to implement the ban
orders and prosecute those persons responsible for flouting the orders in a time
bound manner;
* directing the Union of India to take immediate steps to get vacated any stay
orders in other courts which is impleading the implementation of the ban orders
of the Government;
• pass any other or further order/s as this Hon'ble Court may see fit and proper.
November 17 '94 hearing
The Bench comprising Mr.Justice J J Verma and Mr.Justice K S Paripooman
indicated that the court would like to appoint an expert committee of eminent and
credible specialists to go into the whole question and make a report to the court.
The next hearing has been fixed for the 9th of January '95. The proposed commission
consists of Dr.N H Antia, Dr.Naresh Bannerjee and Dr.Nityanand.
Drug Action Forum, Karnataka
lauuinivnti avpcuaiv vignanw wn Snouiu ia UvdiCU liiiuCi
l>l'Ug OOniiOi liiaviiHiviy iv Waivn Cjuriiiiy Ci
medicines.
Irrational and Hazardous Druss:
.All irrational and hazardous drugs should be withdrawn Registration system needs to he revamped. All drugs
J r’.’itlura o rorr
*
>Jo*• rr>» r«rirol Frxr r'cF'.iI'U'cbrrtrr rte’??- ?r-!/'’,or>rn it to v"ih<te,.
GhOUld
Research and Development:
Govt, should involve the research establishments of its own with adequate fund and encourage them for developing
cost effective process technology Any private company which develops new molecules should be encoiUMged for
Third Tarty Licenses:
The Govt, should abolish Loan/Third Party License system.
Ail thugs under EDL shall be pnee vuiniulicd. Cuniiui uf price ui outer drugs should also be covered and
mark up shall be kept low based on the annual turnover.
Providing of cost data by the manufacturers should be mandatory, Any violation of price fixed shall be entitled
l<> sever Ui.iriishrnent
medicines may draw inoie duties than indigenously produced drugs.
Wholesale and retail margins should be determined by the Govt, which should be strictly followed. Like over
pricing, under pricing should also he disallowed Incentive, trade bonus should only he allowed in such a manner that
would finally reduce nriees to the consumers.
Setup like hrPA shouid be strengthened with sufficient staff and statutory power.
Pharmacy Act:
pharmacists for granting license to open retaii chemist shops
inOiiitOiiiig i'cScai'Cli, WithuiaWal Oi drugs. iiliS Cuijuiiiucc shuulu iuCiudc experts ii'Ofu incuiCcu pi’aCtiiiOilci'S, iiiuuSiiy,
consumers, academics
Community Health Ccii
From:
To:
Sent:
EmkAI" <fmrai(g)vsni.net>
"Janswathya Abhiyan" <pha-ncc@yahoogroups.com>
Thursday, July 22, 2004 5.58 PM
vuujcvu
[pi ia-1 twj
Dear aii
Giving below a scetch aboout our position on the drug policy which may be presented before the Ministry. This is a pruned
thinking which may be remodelled based on the suggestions of JSA meeting and then it may be made specific on each
points. This is being proposed for discussion in the JSA meeting at Bhopal.
Pharmaceutical I’oiicy:
f ast couple of years Govt. has taken executive decisions in rapid successions for which the first Drug Policy.
1978 h.qg been thoroughly changed The political good will under which Drug Po
*i°'
’ 107^ woe Hmrr'iQrmr? nnnwi
away iuokiilg tlxc buSiv tciiain Ot tuc puiiCy i'cuuijuaiit. r icSeiit Statu 5 Oi iiic pOUCy icficviS Virtually SCaiit GuVi. COiitFOi
anti add ro this unwillingness of rhe past NDA Govt to implement whatever left in the policy has created an anarchy in
the pharmaceutical field. It is, therefore needed to prepare and adopt anew policy in the new global regime keeping
interest of the people in the foreground
Responsibility;
Excepting industrial part di the policy, all other area should come under the purview of the Health Ministry.
Selection of drugs of National Essential Drag List (EDI.). quality assurance. Drug Laws etc., should he the exclusive
responsibility of the Health 'viir.isiry. Issues like drugs prices may be the concurrent responsibility of the ivlinirtn7 of
Production:
the Govt, should monitor
Govt. used io monitor production of 93 bulk druns. In order io ensure
*
.11 .1— . ...
i.' ,i
...
1... ...
i rm
au tiii.ittb Wiuvii whik. uhuii nauvjicu
r>... < ..L...11
,i.t:..t.
j.
<
run
1
. 1
,
uuvi anon pUunon piuuuvuvn StdiiiS ui an uit'Sv iiFUgS at ivdSi OjivC ili a
year. Govt, should also establish a ceii to estimate need of aii the drags under EDL and should explore shortfall in
indigenous production to determine import requirements or expansion of indigenous production. Public sector
pharmaceutical units should be given priority for production and a policy to revive this sector should be developed.
National Essential Drug List:
The EDI, shops should be prepared by an expert committee every after three years Experts from different
The list should be popularised with a guideline of use Standaid Ticatiiieni Guideline) among the users. Ils use
should be mandatory among Govt., Public sector units and for use in reimbursement or for insurance coverage Drugs
under the list should be priced low. Industry should be given incentive for production of these drags. Prescription of
Ihesrt (Ith’-'s shaiitit be nwllr in lrene.TU.’ Harries.
Quality Control:
Drugs <S Cosmetics Act should be amended to ensure quality control. Stringent punishment should be enacted
for violation of quality norms. Drag testing laboratories should be established by the Govt, in each states Consumers
ilieiilcineS.
Ii'r2tiOuciI uHC« JH2Z2rd0”s Dri-^s:
Research and Development;
Govt, should involve the research establishments of its own with adequate fund and encourage them for developing
cost effective process technology Any private company winch develops new molecules should lie encouraped for
7/23/04
Page 2 of2
i hirti Tarry Licenses;
The Govt, should abolish Lcan/Third Party License system.
Au uiugs undci HDL shall be pnvc uuiniuiicu. Cunliui of puce oi olhei uiu.gs siiuuki also be cuvvicu and
mark up shall be kept low based on the annual turnover.
Providing of cost data by the manufacturers should be mandator/. .Any violation of price fixed shall be entitled
hi sever nnrjivrirrienf
medicines may draw niuic duties than indigenously produced drugs.
Wholesale and retail margins should be determined by the Govt. winch should be strictly followed. Like over
pricing. under pricing should also be disallowed Incentive, trade bonus should only be allowed in such a manner that
would fmallv reduce nrices to the consumers.
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X 11UVO U1 lllVVUVillVO OUUU1U MV 11VI VI IOAV3 LLUVl OlllUt UU UllJlVllll till VW1 11IX. VUIIHUJ.
Setup iikelvPPA should be strengthened with sufficient staff and statutory power.
pharmacists for granting license to open retail chemist shops.
Pharmaceutical A ?! t horily t
j'nviiitOi'iiig icScafCh, WnhuiaWai OiunigS. fihS COiiiinuicc sliOuld liivhiwC CXpciiS iiOiTi incut Citi pi’dCiniOjivi5. industry,
consumers, academics
- Media
RF_DR_7_A_SUDHA.pdf
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