CHAI ANNUAL MEETING 1984 - TOWARDS A PEOPLE' ORIENTED DRUG POLICY
Item
- Title
- CHAI ANNUAL MEETING 1984 - TOWARDS A PEOPLE' ORIENTED DRUG POLICY
- extracted text
-
RF_DR_22_SUDHA
2^2-. I
FOCUS
The New Drug Policy
What does it have in Store for the People
Dr. Anil Pilgaonkar
EVER since the 1978 Drug Policy was announced, both
the consumer forums and the drug industry have been
seeking changes in that policy, albeit for diametrically
opposite reasons. The drug industry had consistently put
pressure on the government for allowing, a) greater mark
up on the formulations and b) greater freedom from con
trols. The people-i.e. consumer groups, health groups and
science groups had, on the other hand, sought for i)
availability of essential drugs (as drawn by the World
Health Organisation), at very reasonable prices, ii) restrict
ing the drug list to include only the rational drugs and
.exclude all irrational and harmful drugs and iii) the
marketing of drugs and formulations under generic names
only. Further, they had also pressed for people’s participa
tion in the formulation of the drug policy. In fact, many
of the proposals of the Hathi Committee, 1975, were in
consonance with these very demands.
The present New Drug Policy pretends to make an
attempt at pacifying both the groups, though even the
most naive would be able to see through this move and
make out that the policy is very much against the interests
of the consumers and is heavily tilted in favour of the
industry. Virtually all the demands of the people—
drawing out of the essential drugs list, weeding out and
banning irrational and harmful drugs—have been placed
in the hands of the as yet to be constituted National Drugs
and Pharmaceutical Authority (NDPA). This inevitably
means delays and perhaps distortions, depending on the
composition of the NDPA. Secondly, everything that the
drug industry has been pressing for, has been conceded
in ample measure—higher mark-ups and greater freedom
from controls. It is therefore necessary to look into each
of the proposals available from the summary (which is
all that is available at the moment) and see how they would
affect the people on the one hand and the drug industry
on the other.
1) A National Drugs and Pharmaceutical Authority
(NDPA) will be created. This will have representatives
from all concerned agencies, including those from the
industry (emphasis added). While the question of who
these ‘all concerned agencies’ are, is left open, the
summary of the text makes it amply clear that ‘those from
the Industry’ will be represented.
This authority would function as an advisory body on
the development of the pharmaceutical industry. Among
other things, it would go into the question of rationalisa
tion of the existing formulations in the market, including
the banning of harmful formulations and better control
over the introduction of new drugs. While representation
of the industry in NDPA in some matters is under
standable, that in respect of the question of rationalisa
tion of the formulations in the market, including banning
of irrational and harmful drugs is both surprising and
unwarranted as they would have vested interest in this
issue, and this is more than likely to defeat the aim. It
is as ill-conceived as making a quality control manager
report to the production manager, and is therefore
unacceptable to the people.
2) Quality control: It is proposed to give statutory effect
to good manufacturing practices and also to introduce
a certification system under which, recognised institutions
with proven expertise and testing facilities would certify
the adoption by formulators of good manufacturing prac
tices and the quality of the formulations manufactured.
It is common knowledge that these have been the respon
sibilities of the Food and Drug Administration. The ques
tions that therefore arise are: What would be the role of
the FDA vis-a-vis that of this new certification system?
and (b) if these responsibilities are not clearly demarcated,
wouldn’t that allow room for manipulation and the
playing of one authority against the other?
3) Pricing: As against the existing three categories (viz.
category I—40 per cent mark-up, category II—55 per cent
mark-up and category III—100 per cent mark-up) of drugs
and pharmaceuticals, hereafter there would be only two
categories. The first category will consist of drugs
necessary for the national health programme (some 40
drugs) and the second category, of essential drugs.
Formulations of the first category would have a MAPE
(maximum allowable post-manufacturing expense,
virtually the same as ‘mark-up’ used earlier) of 75 per cent,
and those of the second category of 100 per cent. This
implies that the rest of the formulations (and very likely
a very large number of them) would be out of the purview
of price control.
A High-level committee would draw up the list of drugs
to be included in the second category. Who would be in
this high-level committee? What would be the criteria for
deciding the essential drugs? There has been no attempt
to answer these questions—another area of studied
ambiguity.
It will be recalled that after the last (1978) drug policy,
the formulations of the I and II categories were scarcely
available whereas those of the III category and those out
of the purview of price control were in abundance. The
reason forwarded for this situation was that, because the
last two categories were the ones that were profitable, they
were the ones that were manufactured. If this is the case,
and if the intentions of those in authority were to reduce
the drug list to conform with rational drugs only, then
one would expect that the MAPE on formulations not
included in categories I and II should have been even lower
than 75 per cent; but instead, the authorities have left
them out of the purview of price control (which would
mean high margin and high profits). The outcome of this
(continued on page 8)
AIDS: If Slogans were
Vaccines,..
Dr. Merges Mistry
THE dramatic advent of the acquired immunodeficiency
syndrome (AIDS) since 1978, may well have provided to
religious fundamentalists another clue of approaching
Armageddon; however it has had a remarkable effect on
the mobilisation of medical resources and scientific
acumen hitherto unknown.
The vast pool of information gathered on the somewhat
unique tissue tropism of the virus, its molecular structure,
and facets of the immune response towards it, has para
doxically been instrumental in creating a fear psychosis,
since despite the considerable inroads made in the under
standing of the disease, full blown AIDS remains a 100
per cent fatal condition. The treatment is either symptoipatic or hypothetical. The course of events after exposure
(o the virus begin with extremely innocuous symptoms
such as fever, anorexia, weight loss, which, in the absence
of a diagnostic test, would abet the evasion of a correct
diagnosis. Indeed the pattern of immunodeficiency in
AIDS resembles, to varied degrees, patterns noted in
different diseases such as viral infections, malignancies,
Burkitt’s lymphomas, infectious mononucleosis, tropical
splenomegaly, nutritional immunodeficiencies (IDS) and
leprosy. In third world countries therefore, acquired
immunodeficiency syndromes probably exist in vast
numbers but remain unlabelled in the right context.
Little information exists towards the recognition or
measurement of a protective immune response (ImR).
Epidemiological observations bear out that only 10 per
cent of those infected with the virus progress to active
disease, a positive indication that a protective ImR against
the virus exists. Investigators were also elated when it was
computed that homosexual men exhibiting both antibody
positivity (an indication of Human Immunodeficiency
Virus infection) and abnormalities in blood cell numbers
for a prolonged period, reverted to antibody negativity
without exhibiting signs of AIDS related disease. This
disappearance oi
uisappcaianuv
of the
uic virus
viiub uuinuiucu
coincided sigiiiiicanuy
significantly with
wiin a
measurable increase in a critical sub-population of blood
cells termed as suppresser lymphocytes.
In our “vacciphilic” era, it is inconceivable that any
control measures against AIDS would exclude the develop
ment of a viral vaccine to AIDS. At this juncture, only
optimism abounds. Attenuated or live vaccines are
considered too risky for any proposed trial. The favoured
approach lies in isolation and cloning of a viral structure
that may induce the formation of a protective ImR.
Variation in viral structure either through environmental
pressures or genetic mutation provides another obstacle
to the development of a homogenous vaccine. The natural
history of Human Immunodeficiency Virus (HIV) infecI tions in Africa, where the virus is believed to originate,
must necessarily be different from that of other groups.
Adjustment to the virus over generations must play a role
I in natural immunity/tolerance to the virus. This introduces
the question of the-differential response to the vaccine
in various ethnic groups.
With AIDS claiming its first victim in India in 1986,
I
public fear over the disease has descended on this country
as well. This has been compouned by unprecedented
announcements in Parliament, intensive media coverage
and the setting up of an elaborate surveillance network
practicable principally on paper. Nevertheless, because of
the very nature of the superefficient pattern of global
travel and communication prevalent, and the existence of
high risk groups in every society, control of the spread
of infection remains an urgent priority.
IN a special article in a recent issue of the New
England Journal of Medicine, it was reported that
a million new cases of gonorrhoea are reported in
the United States of America every year, despite the
fact that penicillin has been available as a single
shot treatment for several decades. Since there is now
an emergence of resistance to antibiotics, they have
recommended research in recombinant DNA
techniques for developing a vaccine.
China has successfully eradicated sexually
transmitted diseases including gonorrhoea and
syphylis.
This is the result of the revolution which has
changed the social and sexual mores. Penicillin was
only an additional tool to deliver the coup de grace.
The eradication of STD therefore lies more in social
change than in mere medical technology.
Epidemiologists feverishly grapple with “transients”
(anomalies due to the rate of spread of virus and the long
incubation period) to predict estimates for new AIDS
cases in the subsequent,years. Even with a minimum of
pessimism and with a hope that new infections may be
eventually preventable, it is estimated that the epidemic
in countries such as the USA will be five times larger than
the number of cases observed so far.
Because of the identification of HIV as the causative
agent in AIDS and the consequent development of culture
techniques and serologic methods for detecting antibody
to the virus, it is possible to identify both, symptomatic
and asymptomatic infected persons. Paradoxically again,
this very widespread availability of simple, inexpensive and
sensitive screening tests for antibody to HIV has further
complicated the development and implementation of
infection control procedures. The question becomes.,
who to screen. This is a particularly important issue in
health care facilities where frequent and intensive exposure
to infected patients may occur. Protection to health
personnel would also have serious repercussions in clinical
management of AIDS’ patients as well as in early
reporting of AIDS cases.
It is not feasible to identify all infected patients even
with the availability of screening tests. The risk of
nosocomial (relating to a hospital) transmission of HIV
is extremely low even after accidental parenteral innoculainfection control precautions for
tions. iAgain,, special
,
patients known to be infected are not necessary in most
health care settings at least in the developed countries.
The existing guidelines for reducing exposure to blood and
other body fluids will protect workers who care for AIDS
afflicted patients. The procedures recommended to
prevent contact with body fluids would reduce exposure
not only to HIV but also to other sexually transmitted
pathogens.
This is also the general tack of Prof. V. Ramalingaswami,
the former Director General of the Indian Council of
Medical Research, who claims that though sexually
transmitted disease (STD) is widely prevalent, its prevention and control have been largely neglected: “The
opportunity of AIDS should be used to monitor and
prevent STD in general”.
The remarkable mobilisation of scientific resources in
the US towards development of quick and relatively
inexpensive screening procedures was largely due to the
transmission of AIDS through Blood Bank transfusions
to hemophiliacs or to the users of blood products. Even
though they constituted about two per cent of the total
AIDS patient population, their impact on the control
measures was very significant. By a massive screening
million -----units -of
programme, where within 3 years, 20 -------blood were screened, not only for antibody but also for
viral particles themselves, the risk of contracting AIDS
through transfusions in the US was reduced to a minimum
-1.77/1000 units of blood.
Given the prevalent condition of blood banking in this
country, screening for AIDS samples would appear
meaningless when screening for Hepatitis-B or VDRL
for syphilis is still not carried out routinely in a majority
of institutions despite being made mandatory since 1976.
The highest incidence of AIDS is reported to have
_
occured in homosexual
men,, subversion of immune
system probably occuring through the introduction of
sperm through an abnormal route. The recognition of the
L
- contraction
•
heterosexual mode of
of--------AIDS--has been
identified as an important way of introducing the virus
into populations not generally considered at risk. This
single fact may play a key role in the final containment
disease. Slogans such as “Give a Gift—Not Aids”,
«stjcic t0 your partner” are common sights in Western
citjes where generally the level of sexual promiscuity is
sajj t0
and indiscriminate sexual practices, socially
• • Given the relatively
’ •• ’ conser
condoned or even legalised.
vative sexual mores and practices in societies like ours,
4
the likelihood of the problem acquiring
similar dimensjons everyWhere is remote; AIDS cannot be caught easily
from a dirty toilet!
If the trend of incidence continues, a study proclaims,
over 50 per cent of all populations at risk will have con
tracted AIDS by the year 1990. However, persuasive
induction of behavioural change, and accurate public
information have already begun to have an important
impact in markedly reducing the incidence of AIDS long
before a vaccine is available. Far from any sense of
helplessness that may arise from scientific means to
control this affliction, there are a multitude of alternative
levels on which things can be done and multiple cultural
factors that will directly affect the progress of techno
logical advances in hand.
Amniocentesis Update
Dr. Sanjeev Kulkarni
A Committee to study the problem of sex determination
and female foeticide was formed by the government of
Maharashtra, under the chairmanship of Mr. Bhai
Sawant, the Minister for Public Health and Family
Welfare in September 198b. The Committee was formed
as a response to the raging public debate, due to the con
sistent campaign by the Forum against sex-determination
and sex pre-selection, and also because of the private
members’ bill presented in the legislative assembly. The
Secretary to the government of Maharashtra, department
of public health and family welfare, commissioned
Dr. Sanjeev Kulkarni of the Foundation for Research in
Community Health to conduct a short study of prenatal
sex determination tests and female foeticide in Bombay
city.
Some of the important findings of this study are:—
♦
About 84 per cent of the gynaecologists interviewed for
the study are performing amniocentesis for sex
determination tests. These doctors together perform on
an average 270 amniocentesis tests per month.
♦ According to this study, some doctors have been per
forming amniocentesis for 10-12 years. But a majority
of the doctors (over 85 per cent) have started performing
these tests in the last 5 years.
* About 74 per cent of the doctors said that over 50 per
cent of the women who come for the tests are from the
“middle class". More than 85 per cent of the doctors
said that no lower class women had come to them for
sex-determination tests, though the areas selected had
a substantial lower class representation.
* A majority of the women have 2 or 3 daughters when
they come for sex determination tests and the percen
tage of women coming for sex-determination tests when
they have 4 or more daughters is relatively small.
Significantly enough, about 24 per cent doctors said
that in 20 per cent of the cases, the women had only
one daughter, when they came for the sex determina
tion tests.
* About 29 per cent of the doctors said that upto 10 per
cent of the women who come for s.d. tests already have
one or more sons.
A majority of the doctors see the s.d. tests as a humane
service to the women who do not want any more
daughters. Some doctors also feel that s.d. tests are an
important family planning method in our country.
The study also reveals some other interesting features.
For example, one doctor advocates pre-planning of sex
by a method based on the characteristics of the x and ybearing sperms. Another doctor performs s.d. by a nonallopathic, non-ayurvedic, spiritual method.
This report is now ready and is available at the FRCH.
they have access to good education, better health care
Overpopulation and Poverty will
and adequate housing? The honest answer is ‘NO’.
Dr. Ramesh Awasthi
That overpopulation is the root cause of India’s poverty
is an absolute myth. What is the meaning of overpopula
tion? Is it the staggering total figure (1000 million by
2000 AD) that raises a spectre of despair? In that case,
will our reaction be different if India is divided into 25
independent states each having a population of only about
30 million, even less than that of UK or France?
That India supports 15 per cent of the world’s popula
tion with only 2.4 per cent of the world’s total land area
is often cited as a major handicap in solving the problem
of poverty. If population-land ratio is the criteria for
overpopulation, let’s have a look: some of the most
overpopulated countries are also among the richest.
Country
South Korea
Holland
Japan
Belgium
West Germany
U.K.
India
China
Population (Mid 1984)
Million per 100 sq.km land area
4.09
3.51
3.23
3.19
2.46
2.30
2.28
0.01
All these countries have a population-land ratio which is
larger than that of India. On the other hand a large
number of-countries with a favourable population-land
ratio are among the poorest in the world.
Ethiopia
0.345
Zaire
0.127
Thailand
0.973
Indonesia
0.828
Uganda
0.636
Pakistan
1.15
(Source: World Development Report 1986, pp 180-181)
Is poverty a question of there not being enough for so
many people? Let us consider the consumption of
resources or the expenditure on food, health, education,
clothing and housing of the poor vis-a-vis that of the rich.
From the consumption expenditure data .-we know that the
top 10 per cent consume 7-8 times as much as consumed
by the lowest 10 per cent. Hence averting a birth in the
rich families will save 7-8 times the resources that would
be saved by a poor family having 1 child less. Extending
the same logic, if it was a question of limited world
resources, all population control effort should be aimed
at the industrial market economies where, considering on
ly in terms of energy consumption per capita (in kilograms
of equivalent oil) the consumption level in 1984 was 26
times that of India and 13.5 times that of India and China
together.
Another myth harboured by most educated elites is that
the poor remain poor because they have more children.
Without going into the rationale why the poor need to
have more children (high infant mortality, more hands tc
earn the family’s food, lack of illness/oldage security etc),
let us put the question a bit differently—If the poor start
having lesser children, will they be better fed and clothed,
How much the poor will get is determined not by the
number of children they have but by the level of
distributive justice in society. The poor can get more if
they consciously use the power of their numbers to en
force distributive justice.
We are not disputing the need to control the high rate
of population growth in India and in other developing
countries. What we have tried here is to put the relation
between poverty and population straight. We cannot find
excuses for the persistent poverty in high population
growth rate; rather the socio-economic factors have a
stronger bearing on the persisting high rate of popula
tion growth.
Practice of Medicine
Dr. Mukund Uplekar
TOXICITY of vitamin overdose
OUR every day diet contains most of the vitamins that
our body requires. Additional vitamin intake is only
necessary in a very few specific conditions. For these,
single vitamin preparations are necessary—B-l in case of
beri-beri, B-12 for pernicious anaemia. The habit of in
discriminate prescription of multivitamins is unnecessary
and expensive. This habit is based on the false presump
tion that vitamin can only do good but no harm.
However, excessive intake of vitamins can be harmful
and often produces toxic effects.
Vitamin
-
Average Daily Requirement Toxic Effects of Overdoses
cerebral edema resulting in
headache, nausea and vomit
ing. Chronic liver disease.
Skin changes including
dryness, eruption and rash;
fissures, depigmentation,
itching, loss of hair.
Ingrowing toenails resistant to
treatment. Tenderness of
bones.
Psychiatric symptoms.
Peptic ulcer, loss of hair;
itching; liver toxicity, abnor
mal heart beats, hypotension.
A
750 micro grams.
B 3
9-20 mgm.
B 6
2-3 mgm.
Dependency, peripheral sen
sory neuropathy and failure of
muscular coordination.
C
35-60 mgm.
Oxalate stones, possible
teratogenesis and carcino
genesis in very high doses,
multiplicity of minor
idiosyncratic symptoms.
D
400 l.U.
E
5-15 mgm.
Possible mental deterioration
due to excess of calcium,
hypertension, hardening of
organic tissues due to deposi
tion of calcium salts.
Increased anticoagulant action
of Warferin (an oral anti
coagulant drug).
K
100 mgm.
Hemolytic anemia, neonatal
jaundice.
. 4
■COMMUNITY HEALTH CCU
326. V Main, I Sleek
KoramrngMa
*4ngaJ<irt-56OO34
India____________________
ORIGINAL ARTICLE
Drug Prescription Preferences of Medical Officers
— M.K. Vasundhara*
Key words : Prescription survey.
ummary : Study of 47 Medical Officers in
Management of common ailments revealed
Jk-X polypharmacy, violation of standing order and
aggressive treatment of self-limiting disorders. These
practices would contribute towards iatrogenicity.
Introduction : The incidence of iatrogenic disorders is
high ranging from 20 to 30 per cent among in-patients1. It
is indeed tragic to note that the patient who seeks relief
for one disorder leaves with one or more disorders,
probably more serious in nature than the original one.
A study was thus conducted to study the preference of
medical officers for use of drugs in management of
common ailments.
Methodology : A pre-tested schedule was used to elicit
the information from 47 medical officers in government
services about management of common disorders usually
encountered during their practice.
Observations:
It was observed that the "drug pool" tapped for treat
i)
ment of each disorder consisted of 6-23 drugs.
ii) The medical officers preferred to treat the disorders
aggressively including even he self-limiting disor
ders like diarrhoea. Most of them preferred to use 2
to 3 drugs per condition and preference for combina
tion drugs was marked. The "shot-gun" therapy
preferred was more evident in case of fever, urinary
tract infection and pain in abdomen (Table 1).
iii)
iv)
v)
Irrational therapy was suggested for treatment of
common conditions e.g. use of i.v. fluids for fever
and chloramphenicol for treatment of fever and diar
rhoeal disorders (Table 2).
A disturbing feature was the violation of standing
order i.e. "correct drug and correct dose" was of high
order particularly regarding management of convul
sions and diarrhoea (Table 2).
Only a few doctors suggested need for investigations
prior to institution of treatment.
Conclusion:
Though the observations pertain to a small number of
medical practitioners, the findings are shocking regarding
the irrational preference of drugs and likelihood of
resultant iatrogenicity. Polypharmacy, violation of
standing order and aggressive treatment of self-limiting
disorder suggest an alarming situation calling for an
urgent action.
Suggestion:
Introduction of limited drug formulary with drugs
i)
available only under generic names.
ii) Training of medical personnel at ail levels including
undergraduate and post graduate students, interns
and inservice doctors through workshops, seminars
and continued medical education programmes.
Table I
Number of drugs prescribed per doctor for each ailment (n=47)
S.No. Ailment
0
-
1.
2.
3.
4
5.
6.
7.
8.
9.
10.
Fever
Diarrhoea
ARI
Headache
Pain in abdomen
UTI
Convulsions
Insomnia
Backache
Arthritis
6
4
1
Number of Drugs
2
3
7
18
9
12
10
14
18
37
22
11
20
16
20
25
20
17
12
3
18
22
20
5
15
10
15
15
5
4
7
10
4
2
3
2
* Professor and Head of Dept, of Preventive and Social Medicine, Bangalore Medical College - Paper presented at 2nd workshop
on essential drugs organised by National Institute of Public Co-operation & Child Development - June 1990.
AUSHADHI - THERAPEUTICS AND DRUGS, Vol 8, Jan-March 1991.
9
Prescription Survey
Table 2
Doctor v/s standing order
N=47
Standing
SI.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Clinical Condition
Fever
Diarrhoea
Headache
Pain in abdomen
Asthma
Insomnia
Worm infestation
Backache
Scabies
Convulsion
Order
Correct drug
&
Wrong dose
Correct drug
Correct dose
No.
%
No.
%
87.23
44.68
76.59
89.36
76.59
68.05
82.97
82.97
74.46
38.29
6
6
7
5
11
9
4
8
10
19
12.76
12.76
14.89
10.63
23.40
19.14
8.51
17.02
21.27
40.42
41
21
36
42
36
32
39
39
35
18
Status
Wrong drug
No.
%
20
4
42.55
8.51
*
i6
4
12.76
8.57
2
10
4.25
21.27
References:
1. Patel, H., Joshi, V.R. Study of iatrogenic diseases in
a medical acute care unit. Thera, and Drugs Aushadhi, 1985; 1 (1) : 4-9.
2. Singh, J.V. & Dinesh, P. (1990) Review of morbidity
and mortality profile of U.P. (West) and requirement
of Essential Drugs for Primary Health Care-Report
on 2nd Regional Workshop on Essential Drugs in
Primary Health Care; 1990.
BGood leadership consists of motivating people
to their highest level by offering thenr opportunities,
not obligations. That is how’things happen naturally*
Life is an opportunity and not an obligation.”
— Lao Tzu
Rational Use of drugs
Dr Halfdan Mahler, Direcior-General, WHO. WHO Drug hifonnaiion, Vol. 2(2), 1988.
The indivisibility of "care" and "cost" has implications not for industrial interests, but for everyone involved in the
delivery of health care in the public sector. Socioeconomic as well as health-oriented responsibilities impinge at every
level. Standards of individual care must remain sacrosanct, but health care professionals who neglect to provide costeffective treatment are as culpable in their duties as those who fail in their immediate responsibilities to their patients.
10
f
AUSHADHI - THERAPEUTICS AND DRUGS, Vol 8, Jan-March 1991.
DR 7
DRUG PUSHERS OR HEALERS?
"Thu greatest danger to health in India is the over
medicalising of our health care system. Eternal vigilance
is required that the doctor-drug producer axis does not
exploit the people and that the ’abundance' of drugs does
doc
not become a vested interest in health”.
- ICMR/ICSSR study on 'Health for All'
—An alternative Strategy.
The problem of Drug policy and low cost drugs encompasses
a very wide spectrum of issues—multinationalism, industrial
policy, medical advertising, research, drug production,
medical education, price control and so on. The recent
upsurge in interest in this important area of health policy
has led to the publication of numerous reports, books and
papers and many seminars and workshops have and are being
organised. In the final analysis any collective action in
the form of policy, analysis, research or education can.only
result from an individual understanding of the related issues
translated into a prescribing policy to be accepted velunarily
by doctors, nurses, para—professionals and others in
their attempt to contribute to a solution cf the problem.
Readers of this note are requested to think over the
following facts, observations, conclusions taken from WHO,
ICMR, ICSSR, Earthsdan, VHAI, Govt, of India and other
source cf information. Can we collectively accept as many
cf these 9 points as possible?
(1) 15000 branded drugs are on sale in India but a
believes that health needs wculd be met
Government Committ^e^believes
by only 116 drugs. '
There is now an overproduction of drugs (often very costly)
meant for the rich and well to do, while the drugs needed by
the poor people (and these must be cheap) are not adequately
available!
WHO in its report on selection of essential drugs^has
prepared a list of 200 drugs needed for health cure.
The real purpose of an essential drug list must be seen
as taking' drugs to tho.se2whc need them most, not as
reducing the drugs bill.
Could we accept an eseential drug list for, our practice
in which cost would be an important criteria in selection
in addition to efficacy, safety and quality?
(2) All UN agencies and governments involved in preparing
a list cf essential drugs are c nvinced that presegiptions
should be through the generic names of drugs only.
Generic name is not chemical name but official, international,
non—proprietary name eg., not Acetylsalicylic acid but
Aspirin.
Branded named products cost higher because they include
promotional costs and cost of claims of additional ingredients in
f emulation eg.. Librium by Roche is available for Rs.16/per 100 tablets but generic equivalents are available for
Rs.1.50.
A study of UNCT D has shown that bio-availability
argument for branded drugs ie., therapeutic difference^
based on formulation is not very valid for most drugs.
p.t.o... ... 2
°o 2:
Could we accept generic prescribing? ie., Ry Aspirin
not Plusprin, Disprin etc.
(3) In India 60 firms with foreign shares3 accounted for. .
70% of the country's
‘ ; total drug sales in 1973-74. The remaining
30% was shared by 116 large and 2,500
small manufacturing
.,
companies.
Drug industry in India is an offshoot of development of
the industry in the Western World and is in private hands which
produces mainly for profit.
ICMR/ICSSR and the Hathi Corrmission have
the small scale sector, cooperative sector should be encour g .
Hospital and dispensary based formulations should be promoted.
Can we prescribe drugs which are Indian rather than foreign,
Government rather than private industry, small scale and
cooperative sector rather than large 1sector?
(4) "One of the most distressing aspects of the present
health situation in India is the habit of doctors to Prescribe
glamorous and costly drugs with limited medical potentia .
"The drugs required by the poor are not produced on the
main grounds that there is no profitable market ^d adequate
demand for them, while the country continues to be
by plethora of costly and wasteful drugs meant for the
illnesses of the rich and well to do. 1
"Multiple drug combinations often containing drugs in
amounts far in excess of what is required are presently
marketed: ih India. There is a collosal3national wastage
of drugs because of such combinations.
Packaging increases the cost of drugs very greatly
because the trend is to make it attractive and highly^legant
and to add cosmetic embellishments to promote sales..
The drugs Consultative Committee examined 34 categories
of fixed dose combinations and concluded that in the case of
23 categories of these formulations, there was no therapeutic
rationale for their marketing.
The Government of In^ia
issued a notification in July 1983, banning 22 fixed drug
combinations.
Could we stop prescribing drugs whose only additional
advertised values are -
a.
c.
e.
cosmetic embellishment; b. elegant packing;
irrational combination; d. imitative drugs;
inadequate evidence of greater value?
Why were they
Do we know which are these banned drugs?
banned? Can we stop prescribing them?
-3 in 1976
(5) 25% of a total production of Rs.-700 crores
of
the
Planning
Commission
was on
CL/
.
.
as analysed
by a Task force <
tonics,
health
restoratives
and
digestive
enzymes.
vitamins, '-----
An ICMR/ICSSR Study observed that production of INH and
’ f of the minimal
Dapsone are a third and a quarter respectively,
/.
On
the
other
hand,
tonics and
requirements of the country,
alcoholic.preparation
and spin money
vitamins which are mostly <-’
i r*
1
□re produced in wasteful abundance1
\-.Tl
3
°3°
A NIN study on tonics has shown that most of the high potency
or ‘Forte1 preparations of multi-vitamins are a sheer economic
waste.
These are not only a drain on the patients purse but
also help only to vitaminise our sewage systems.
Can we stop this 1 tonic1 and "vitaminl practice?
(6) A WHO report notes that drug advertising and contacts with
representatives of pharmaceutical firms are often the main source
of informaticn for a physician on drugs and sometimes thecnly
one. Such6information is largely influenced by commercial
interest.
Drugs are often being prescribed by doctors not because
they think a particular one is best suited for the situation but
atY
from free samples (often sold in practice), pens, calendars,
1/6
diaries, teas, lunches, travel and conference attendance costs.
Medical training in colleges dees not train future physicians
to judge a preparation critically. ......nor does it include
conscious immunization against the half truths of persuasive
industrial advertising., CAN WE STOP ACCEPTING PHYSICIzljS
SAMPLES AND OTHER FORMS OF INDUCEMENT FROM MEDICAL COMPziNIES^
---- (7) Many medicinal herbs and roots that are used by
grandmothers, local dais and village medicine men have been
scientifically tested and researched and known to have therapeu
value. Theirgdescriptions in journals collect dust in reference
libraries. '
Herbal medicines and home remedies are not only low cost
and easily available but their popularisation will help in
breaking the doctcr-clrug producer axis for over 80% of the
common minor ailments which are now being overtreatecl.
China has integrated over 50 herbal medicine and home
remedies in their armamentariums not only as a drug policy 2/6
but as an expression of local participation in health care.
Can wc propagate simple home remed.ics and locally available
herbaTmedicine after studying their efficacy?
(8) A very large number of techniques of healing are being
researched today in which diseases are tackled and cured without
drugs. Non-drug therapies include Yoga, Pranayama, Meditatin,
Accupuncture, Acupressure and Chiropractice among others.
Traditional systems of Medicine such as Ayurveda, Unani,
Homeopathy which use drugs but of a different sort are being
researched in various places and the therapeutic effectiveness
of many of their products are being discovered and documented.
Can we adopt a more open policy of enquiry and introduce
use of t;aditicnal medicine and non-drug therapies in our
practice after.scientific enquiry?
(9) Health Care is becoming increasingly a quest for
priorities. ’’Clean water before anti—biotics, Toed before
vitamin pills, vaccination before kidney machines, mothers
milk before powdered baby foods mixed with dirty water, health
for villagers and slums before more^hospitals for the
affluent suburbs of capital cities.
0.0.4
E
s4s
ur preoccupation with Drug Prescribing
In spite of our
ourselves to ether more importan
pclicyz could we commit
c .
Health Core Priorities?
ravi narayan
background paper , mfc Annual Meet 1982
References
strategy - ICMR/ICSSR
1. Health for all - an alternative and
Pharmaceuticals
Report (1980) Chapter on Drugs
2
3.
i
Drucs and the Third World, Anil Aggarwal, Earthscan
Earthscan
publication, 10 Percy Street, London W1PODR (1978)
HAthi Committee; Report of the,,Committee on Drugs and
Pharmaceutical Industry, Ministry of Petroleum an_:
Chemicals, Govt, of India (1975)
an mfc bepk containing reprints
4. In Search of aDiagncsisz
from its bulletin
Committee/
5. The Selection of Essential Drugs, WHO Expert
'
'(1979)
.
--------WHO~TRS No.615 (1977) and 641
6. Medicincs as if people mattered - Health for the Millions
.283, April-June 1981.
TVHAI Bimonthly) Vol .VII Nc <7
CONSUMER ALERT—CONSUMER ACTION*
ravi narayan
The problem
The Indian Council of Medical Research (ICMR) and the Indian
Council of Social Science Research (ICSSR) have, in.a joint study
group report entitled ’Health for All — An alternative Strategy
warned that ’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 drug does not become a vested interest iri illhealth* . This warning is a serious indictment of the drug
industry and the medical profession in the country. It
confirms the growing evidence that drugs are being pushed
on an unsuspecting public by devious methods which masquerade
as ’sales promotion’ of drug companies and ’professional
prescribing practice’ by doctors.
A spate of reports have been appearing in our newspapers
and periodicals of late, on drug—related issues and a review
of these highlight that m^ny of the following practices are
not at all uncommon in India?
i) Sale of drugs banned in other countries eg? Lomotil
and Clioquinol preparations.
ii) Sale of irrational combinations and formulations
eg.,z Hathi Committee has suggested weeding cut of
atleast 23 such preparations.
iii) Sale of druc,s without adequate precautionary
product information
• — • - costs
•
iv) Sale of drugs at highly inflated
eg?? it is
reported that Analgin is being sold at 20 to 30
times the cost of production.
v) Promotion of drugs! for indications that are not
clinically proved and arc often potentially dangerous
eg? Promotion of EP forte combinations for pregnancy
testing and induction of abortion. There is well
documented scientific evidence that the risk of
foetal deformity is increased by the use of these
hormonal preparations.
vi) Sale of spurious, adulterated or po r quality drugs
eg?. Turmeric powcler in tetracycline capsules and
poor quality and reaction producing intravenous
fluid prcparati< -fis have been reported.
vii) Sale of old, expired and unused drugs. There is
the double danc .:r of effects of denatured drugs
as also of inadequate dosage,.
viii) Over—pre scrip t.iQn and misuse of tonics, high—protein
foods, hormonail
hormc n.'al preparations and baby f..ods
f. ods that are
both superfluous and a drain on the family economy.
ix) Sale of drugs over the counter without doctor1 s
prescriptioris or the necessary statutery checks.
x) Production of drugs for profits rather than health
needs of people - eg? The ICMR/ICSSR report highlights
that drug# for diseases like leprosy and tuberculosis
which aff.cct millions arc produced at one-third
Bull. Scs. Vcl..l No. 2 Dec83—Jan84
page 11-15.
2
o 2®
and one-fourth of the actual requirements while tonics,
vitamins and high protein substitutes are being
produced in wasteful abundance.
It is evident then, that what is needed in the country today
is a consumer awakening and awareness building process that
will sensitise people to the realities of the drug industry,
mobilise public opinion, sensitise policy makers, confront
the medical establishment and challenge the drug industry.
This process will have to lead to the initiation, promotion
and sustenance of consumer action to ensure that the drug
policy in India is more 'people' and 'health' oriented. Is
there any evidence of such an awareness?
Consumer ■■lert and action
Beginning in the late seventies, there is an increasing
number of organisations, associations, projects and action
groups who have begun to create an awareness of drug-related
policy issues. These groups are predominantly if not exclusively
urban-based, consisting of young•professionals and intellectuals
from different ideological backgrounds.
Since the Medical Profession is the 'instrumental consumer'
ie., they prescribe the drugs, many of these groups have directed
their efforts particularly towards them. Many others are health
or development associations, science popularising movements
and consumer associations who are increasingly taking up drug
issues as one of their many activities. The list of groups
which makes interesting reading are -’
- Voluntary Health Association of .India (VHAI), New Delhi
- medico friend circle (mfc) Pune
- Arogya Dakshata Mandal (AIM), Pune
- Delhi Science Forum (DSF), New Delhi
- Society of Young Scientists (SYS), New Delhi
- Lok Vignyan Sangathana (PSM), Maharashtra
- Kerala Sastra Sahitya Parishad (KSSP)
- Concern for Correct Medicine (CCM), New Delhi
- Consumer Action Front (CAF), New Delhi
- Consumer Education and Research Centre (CERC), Ahmedabad
- Centre for Education Development (CED), Bombay
- Federation of Medical Representatives Association of
India (FMRA)z Patna.
All India Women's Conference (AWC) and so on. It is
impossible to document all the efforts of these groups but
the main types of action they have been involved ini ares1. Publications
mfc published two anthologies of the.ir bulletin articles
‘In Search of Diagnosis' (1977) and 'Health Care Which Way
to go' (1982) which included many articles on drug policy
»3
e Q
o^o
related issues. VHAI’s special issue of the.bi-monthly.
’Health for the Millions’ was entitled ’Medicines, as if
people mattered’ (1981). It covered many aspects of drug use
-md abuse and tried to stimulate voluntary initiatives from
the public and the medical profession. CED published an
exhaustive, well-researched report on "Aspects of Drug Industry
in India" (1982) to stimulate further interest.
2. Meetings
These were organised by many of the groups to bring together
people interested in the problem to share views and discuss
action plans. The Drug Industry and the Indian People (DSF,
SYSZ FMRA and others/ November 1981)t Drug Issues and Feasible
Alternatives (VHAIZ Pune/ Jan *82)/ Drug use and Abuse (mfc,
Tara/ Jan ’82) were three such meetings. The Seminar on
National Health Policy (New Delhi/ VHAI/ AIWC/ CCM, April 1983)
also discussed drug issues and stressed j:.he need for information
dissemination and consumer action.
3. Educational Campaign through letters and media
AIM launched a movement called ’Operation Medicine' in July
1977 with letters to medical practitioners and articles in the
press requesting for a stop in prescription of fortevitamin
preparaticns, irrational B—complex formulations, tonics and
tinned foods and boycotting of certain drugs being sold at
inflated costs.
in Marcia 1982 (International Women’s
VHAI launched a campaign
<
Day) against the misuse of hormonal preparations for pregnancy
testing. Letters were sent to doctors and chemists informing
them about the dangers and requesting them not to misuse these
products. Articles were published in leading newspapers and.
periodicals. The movement snowballed and the government decided
to ban EP forte combinations. The movement continues to challenge
government action which has given a lag period of six months
to drug companies to move stock before ban becomes effective.
mfc launched a campaign early this year about the rational
management of diarrhoeas in children with a hope to prevent
misuse of various available preparations.that do not have
much therapeutic value. Press releases, informative articles
and letters to drug controllers have been major constituents
of this campaign.
4. Newsletters/Bulletins
One of the best examples of continuing education of doctors
on drug issues is the Pune Journal of Continuing Health Education
published by AIM. This bulletin sensitises its subscribers to
the half-truths of medical advertising apart from providing
reliable information on latest drugs. The Drugs Bulletin of
Pharmacology Department of Post-Graduate Institute/ Chandigarh,
is another example, mfc bulletins have also regularly featured
articles on drug issues.
5• Information net-work among voluntary
■action groups
To maintain this growing interest, VHAI has set up a
special cell on ’Low Cost Drugs and rational Therapeutics'.
This Cell has been keeping groups all over India informed about
new problems and follow up action of campaigns. Other groups
have also initiated infopmal network exchanges.
4
s 4"
6 o Low Cost Druc£ Ventures
The Bangarapet Medical Mission Tablet
keen a
very successful small scale venture in gliding 1
hospital^
good quality formulations to a.limitec group o
in the country. Recently in Gujar
c - Voluntary endeavour for
has been initiated. This is a collective volunt^, quality/
rational therapeutics through p-.
dimension of the project
generic named medicines. An ii o
d tc the voiuntary sector
S^mSiX^Tof^Sg^^the sccio^concxnic implications of
irrational therapeutics.
7. Drug Iss21£g„in__S£icncc- Movements
with the growing interest on drug
^ps^njj^also
science movements In the jamg
campaigns.
2sTs:X"i”^
—’the
following four components.
a.
b.
Ban on EP Forte combinations
drug companies being
To oppose the wrong arguments of
to
lift ban order on these
used tc pressurise government
comb in ati on s.
Irrational anti-anaemic
Campaign about Anemie in Women and
PSM
Maharashtra included
drug preparations in the market»
it as a topic for their yatra in May 1983.
c.
d.
coincide with the annual Jatha of KSSP and to mate peop
XSo of the role of multinational corporations in Indra.
Towards a people 1 s movement
an the above efforts are small steps towards a much more
pSle^reTet7tid°-Ollne and w^n more thanks p^rcen^of
SlSr^r^^nS^n^rmStSd
1 “X “ be
off Irom the needs and aspirations of the majority.
beSr= ^s:ig£s£c^^og«^ss favour for
UqSidate ^norance'^poJlS^and"unemployment" .
drug production and availability lies "hat Ivan 11lionhas
-mtlv described as "Socialiatrogenesis - re., health poiici
SmS" Industrial organisation which generates rll-health .
■
Voluntary He3kfi
C-14, Comniunft.. c
D-10:343
MS : k : 5.1.82
Delhi-110016.
DR. 2-2--d>
1 'fi >n of Indi,a
e,,t;e. S.D.a.,
THF DRUG SITUATION IN INDIA
L,v '
/ '
^..01
M a.
illvuai
Co^p..
5.
r;ie''apeaf-
i
'°a
5^4
of the present
y
groupsnand oraanizatk117 °bPI' the DrUg
ler, WHO,
Drug Control
Controller,
WHO, IMA,
--
sSrs
everything in terms of what
o"LXsee
see
everYm"g “
«
consumer.
in the
wShSaS1boMttCohSS£have
a‘rreaoccurred
”hS”-ffecS
e
t
far reaching
for all of us to be familiar
with ?he effects.
r
“
1S lmPortant
problem,
with
the loop
holes, with the different versions of the various
-------- 5 groups involved.
A
I
™AJ
SOLUTION OF THE mjORITY OF THE HEALTH PROBLEMS
• IN INDIA DOES NOT LIE IN MORE PILLS, MORE DOCTORS, MORE HOSPITALS
BUT IN SOCIO ECONOMIC tP0FTiCAL pOWER RELATIONS IN SOCIETY isl,'
WELL ACCEPTED BY MOST OF US HERE .
greater
social awareness
relevant for
for
the villager X
glts^mv^c
—35 is not only' relSVant
of his right to the least basic
w!rkS( whltherhfrlth Care' bUt alS° fOr those Invol^d
health
hospl^o?^
- inaio
wsaiy.
t o be
Knowing about drugs is not^limited
• to their brand names, dosages,
side effects, but also their COST <
and their AVAILABILITY.
The various factors influencing these need
to be analysed.
We will Highlight
] *
’ ■
some.of the
z
more important aspects which will
strongly ,influence
-------- > our search for solutions.
Here are sone questions that arise and need answers
is our
c
health budget for the 6th Five Year plan?
How much
it goes on drugs as a total percentage and what isand how much of
expenditure on health? (Medical & Public Health & J the per capita
Family Welfare)
a)
1S21.05 Crores (1980-85) Centre/state 8/unlon Territory
Source :
(6th Five Year Plan - Pg.382}
b)
Traditional System of Medicine - Centre 29 Crores
Source-: (Planning Commission - N.D.)
c)
Rs.15.05 (+ Rs. 1.51 for Family Welfare) in 1977 • no
octree,
(rocket Book of H^lth
Mie .
(.Pocket Book of Health
1980 Pg.37)
What percentage of the Indian
population utilizes the benefits
.of. modern drugs :
- about 20%; according to
some estimates only 10%
• -11QW self-sufficient ire we _in__producinq this?
I
We rtill import 50% of the —
-■
5^
at stupendous rates
—I
of our Pharmaceutical industry
inspite
being 333 years old and the
in the Third World.
-bo biggest
■ i
What is happening to drug imports ?
Our imports tripled between 1963
~
“6vear I?73"74 fr°!?
13.1.7 crores
to Rs. 37.5 0 crores -- within'next
year
it
increased
to
Rs. 4 7^'crores
this constituted 35% of the bulk <
drugs utilized in formulations
According to Dr. S. s. Gothoskar,
lhe last 3 yrs have witnessed a <.qSLDrVg ControHer of India
i^the ^quiromente
of imported raw materials by nearly So
..
100 percent.
Thus while our
i.
D-10:-‘ 343
MS : k ; 5.1.82
: 3 z
2)
Production of all new single ingredient drugs to be
under generic names.
"based?^7g_re^anmenbatjons regarding generic drugs
unnecessar^ino011116 that
USG °f brand names led to
activiS? “ medlcai^rr
°f C°Stly Promotional
using gene Ac namet
taught pharmacology
brand names?
Students
I
Dr“C industry's obiections aaainst abollShing__of
1.
b
contravened the
I
-- > Act
195S and there was no provision In the Drugs
and
Cosmetic
Act
to emP°wer the government to abolish brand
Cl GJ S. •
i
—T nameg/fr
2.
th^DRvWn8
fiXerd under clearly defined fouuulaA by
the DPCO (Drug Price Control Order 1979), generic
naI1Mn'vd n
not reduce prices.
y
3.
Standard medical text books use both brand names and generic
names.
4.
Trade marks guarantee ethics in manufacture and in the absence
of brand names, customers cannot be sure of quality.
5.
Generic names will lead to wrong dispensing of drugs
different pharmacological effects ~
J 5 with
and harm patients* health.
6.
The ban on brand names ffor single ingredient new drugs will
drugs will
completely stop introduction
ofnew drugs in the market.
----
7o
Drugs sold under brand r.-.-.L.
names often have superior bid- avail-'
ability than those marketed
---d under generic names.
8.
The use of generic names takes aw-.y the choice from the
doctor to the chemist.
.1
9 o
The general prescription is difficult to ’lojnoml
duce, lengthy and cumbersome.
j
10.
t
.iirl
repro-
•
1
5
I
»'
| •
The’ Hathi Committee r
i
recommendations
would have been quitedifferent had it observed
the results of the Pakistan
orvod the
experiment.
(Source: SQ Viswanathan:
Business India - Sept.28
Oc tobe r 11)
i- '
Wlga t advantages are seen in having a planned generic policy?
1)
2)
It will eliminate monopolization because of brand names
and it will encourage healthy competition.
; •
It will curb production of inon-essential
---- -.re
Li
combination drugs
which only add to the increase in
price
4" yJ-u and have no
additional benefit.
For example,: Aspirin is marketed unde^/two generic names:
i
- acetyl salycilic- acid and aspirin
- 8 different brand names
- 7 brands marketing ASA and Caffeine
/
19 brands of ASA and Phenacetin and C-affeine
7
i.
,1
D-10:343
MS:k:5.1.82
: 4
Effect on Costs.:
Manufacturer
Con tent
Name under
which drug is
marketed
Price per
unit( Paise)
Hoechst
Analgin (.5gm)
Novalgin
20.00
IDPL
Analgin
18.27
Analgin
18.24
As pro
7.75
Kenalges ic
Boots
Analgin (0.5gm)
Analgin (.5gm)
Aspirin ( 350 mg.)
+Caffeine 30 mg.
Aspirin 350mg.
Aspirin 3'0*0 mg.
22.00
Aspirin-
Haffkine
3.60
Aspirin 300 mg.
Aspirin
Haffkine ;
. Nicholas
.Sarabhai
i‘
2.84
Source: Indian Pharmaceutical Guide 1980
Some more examples:
Anae in:
Aspirin 389mg.
Anaein
Caffeine 16,2mg.
8
Quinine sulfate 8 mg.
Avedanplus
Aspirin 350 mg.
8
Acetyl Aminophenol 125mg.
Caffeine 30 mg.
Powerin
i
Aspirin 350 mg.
20
Caffeine 65 mg.
Codeine 8.125 mg.
Paracetamol 65 mg.
Salicylamide 65 mg.
\
(Analysis of Painkillers done bV Dr. Anant Phadke
in his paper) Scientific Scrutli.ny of Over the
Counter drugs)
\
i'
jj
4
teL_ages_WHO Expert Committee on selection of eksentia1 druos
sentjal drugs
Te<7hnical seties 615, 1977) rec amend? 1
1 "recommends
It
recommends
|cetyl Saiicyclic acid amongst tile-analgesics' because
besides
being the cheapest it was therapeutically as effective as analm’n
(aspirin is 1/6) APC and multiple other combinations.
9
jjhat are .the loopholes being made use of in this generic oolicv
by prorit-motivated drug industry?
----- - ---------- a------
Since the use of generic named drugs applies conly to the 5 single
ingredient drugs it does not touch the COMBINATION DRUGS
which anyway form the majority.
Drug companies will try avoiding the issue by producing more
combination drugs and less single ingredient generic drugs.
Since BRAND names fis to be ABOLISHED for ALL NEW SINGLE INGREDIENT
drugs, the drug industry will try introducing[ new drugs under
BRAND NAMES with more than two ingredients. :So not only the cost
will go up because of the use of brand, but also because of
addition of often unnecessary ingredients.
Since the government had emphasised, that generic drug names should
bg.. Q4§.PI^Ygd_^Qre__Prpm.inently than brand names with effect from
1st August 1981, the drug companies complain.of'difficulties in
making a long chemical name more prominent on small vials, ampoules
and pleaded of accumulation of stocks inspite of 7 months * notice.
>
P-10 343
MS:k:5.1.82
: 5
What are the Drug Companies doing about this?
Minister ^FChlndustry ’s delegation met Mr. P.C. Sethi,
hJino
aemacal1s and Petroleum, under which the drugs come
in SI dSm '
Cynamid and Pfiz^ s^d the GovSn^n?'
invr;o”ers\a/Xr!Urt a9ai"!,t abolish1^ of.brand
What is the New Drug Policy?
Three years ’ debate following the Hathi Committee’s recommendation ended with the
Pp1^CV° (Presented in Parliament
6n the 29th narch
Mr.
Bahuguna, the former Minister for
Petroleum, Chemicals and Fertilizers).
-tnreuer ror
the
unde, NDP several.
drug companies..
■
Sp^oS^sSo?"'
foreign simm h°idi"'’s of
~ XnaIaedrihThnSi°n % caPacity to foreign companies
ngaged m the manufacture of household remedies".
foredln"! °f licences to manufacture formulations to
foreign
sector
h 92 f
ector companies to be "linked with the production
ofi- high
ugh technology"bulk
technology bulk, drugs
drugs from the basic stage".
- ^,,11
the grant of----------licences
—for the manufacture of high technology
Pnlk^drugs
to
supplying350? be
o? conditional
^°nditional iu?on foreign sector compands'’
production to "non-associated
fomulatorsproduction
non-associated
I
I
(Source : Dilip Thakore - The Ethics of.
the Drug Industry Pg. 2 7
Business India : July 7-20, *80|
Page 29.30)
half S^i^had^^be^l^to the' TR3:100/~ worth of bulk drugs,
sector
half used for formulating di-nrrc:
2
sectOr and
and the
the regaining
its own brand.
rugs, if produced, i.e., 100 x 3 = 300 lakhs. the worth of bulk'
What is the DPCO?
passed in levg^^imed^o^estrfo?^ °f thS
Drug Policy
formulations produced bv an
prices °f the bulk drug and
organised secJo?.
?
Y Pharmaceutical company in the
What are the ^stipulations under the DPCO?
Bulk or generic drug
m?nU5a?turing companies are entitled to
12-14% return
“ net worth
-n c
on
■ Feserves) depending upon
.
, (capital
, ■. "**
the complexity of the technology
hnology utilized
utilized ’in the production
process.
Formulations (i. e. branded drugs) are divided into 4 categoric
Category
I - Life Saving Drugs
Categor y II Category III - ' in between
/
Category IV — Over the Counter Drugh o
"
cost of production to the —
extent o
of
100% are p
f 40%,55%
I, iFa^
Chemicals and '
Fertilizers
rs on Category
Category
u ^-y I, u
u and
and IIZ
in after
after a study of the
!
i
D~1Q:343
MS:k:5 ol.82
<
6
production costs to be submitted by the manufacturing company.
r
-Ulet„dpe^__th^Drug industry have to say about it? ‘
Dr° S’K"' Bhattacharya recently elected President of
of
fwhioh9^12:^^ °f Pharmaceutical Producers of IndiaPresident
(OPPI) '
607 of lha"
big and 54 m£dium f™ and produces
i-hY % th% total bulk dibgs and formulations in the country)
of thf%en%arUgpS't?°rtage Of commorily- prescribed drugs is because
Which are the drugs which have had problems
regarding availability?
Newsreports and A survey done by Medical limes (Glaxo's) Aug. '81
has revealed a shortage of painkillers
- antiepileptics
- anti TB drugs
- anti-diabetics
- sera vaccines
- Cardiac glycosides
- anti hypertensive
prescription practices - surveyed by Medical Times
(Glaxo s) use
use of
of brand
brand and
and generic
generic was concerned, Almost all
the doctors seemedC to
-J use
use brand
brand drubs
drugs.. Reasons:
1)
2)
3)
confidence in the. brands
less chance of substitution by chemist
convenience in remembering
Any info what guides prescription practices?
study done by NIN Hyderabad
Hyderabad con drug utilization revealed that
iaA°
"1 b .
Population
’
---1 surveyed
surveyed ( (1800
ISOoUrban^education
urban education population)
Y
%??
S
.°
n
.
the
basis
of
advertisements
alonef Only
1
79°/ rratrA
x:
a
-----------v c;-»CS a lOHC .
1./z^ gave satisfactory replies on the proper use of drugs.
48% allopathy
18% homeopathy
14% naturopathy
11% ayurvedic
2% Unani
63% had erroneous idea about dosage schedules
and mode of adminis—
tration which could result in
bioavailability
and
therapeutic
problems.
What is OPPI paying to build up public opinion against the
i„ xr?:
the future
the future.
? te.2?
hn
1 to.h';-lp avert more serious shortages in
(Source: Vanishing Drugs: Hindustan Times April 27,
1980)
What is the situation regarding Drug Contro1?
The Drug Control situation in
b, India
Lidxc is pretty bad. Only 3
(Maharashtra, Gujarat, West Bengal)
) our of 22 States in India
have machinery to regulate the
manufacture
z distribution- and
sale of pharmaceuticals.
f
H
D-1Q:343
MS:k:5.1.82
I
». 7 :
In Maharashtra, acknowledged to have the most effective drug
control administration, there are only 96 drug inspectors and
1 drug testing laboratory for over 2000 manufacturers and 15, 000
shops.
(Source; Dr. S.K. Bhattacharya of OPPI in
Medical Times - August 1981)
In Delhi for 5 million population there are 20 drug inspectors.
In Uttar Pradesh for 100 million population there are only 24 drug
inspectors.
'Source: Rajender Rainer : Delhi Reportr
July 1981:Spurious Drugs dealing in
Death)
?
!
At the. time of the Hathi Committee Report ( 1975) the- I'otal drugs
Inspectors in the.-- whole of India was 305 • Current estimates are
5 :0'
(Source: The Ethics of Drug Industry: Business
India, July 7-20, 19 80 - Pg. 33')
What percentage .of drugs, are considered .sub-standard in .the., Indian
Conservative estimates are 25-30%. The Drug Control authorities accept this figure.
(Source: Spurious Drugs: Delhi Recorder/
July 8)
5 2% drugs are substandard according to a survey quoted by Anil
Aggarwal in Drugs and the Third World. 2% drugs are spurious
(According to the drug control authorities).
Wha_t are.
drugs?
1)
Laa<oaa_jQt__Jsj4^
rd
Inadequate drug control.
centre can only lay down policies/ state governments have
control over manufacturers, sale and distribution (the inter
state barriers are fully exploited by trade in spurious drgs).
Control/, if anyz is at the earlier stage of production .into#
bulk form or later formulations, improper storage, etc. are not
given that importance.
Shortage of certain brands of popular drugs gives an opportunity
to spurious and substandard drug producers to take advantage
of the situation. Linked to this is high demand of life saving
and other common drugs.
easy availability of drugs over the counter without
preseription from a qualified doctor
- easier availability of drug selling licence
- ignorance about drug adulteration and substitution
- the increasingly prevailing habit of chemists to stock drugs
of a company giving them commission in some areas
the desire of the consumer to buy cheaper drugs because of
the high cost of drugs (and his poverty in many cases)
- the buying of drugs by chemists without any bill to avoid
payment of taxes
- only drug control authorities have been associated with
checks and control unlike food aditeration where the consumer
can play a role.
I
D-l0:343
MS;k:5.1.82
: 9.:
/'
According to Mr. D.B. Telang, Financial Manager of the company
for every kilo of streptomycin produced, a loss of Rs.25 is
incurred. The more esssential drugs are produced the more are
the losses incurred. Losses are due to increase in the price of
raw materials, inflation - 35-40%; packaging 30%, power 30%, cost
of transportation. A/z this in the presence of fixed drug prices
apparently has caused the ever increasing losses in the public
drug sector. IDPL, HAL, IDRI were instituted to break foreign
monopolization and produce a reasonably cost essential drugs for
the Indian public. But even today, 33 years we still import drugs
for Kalazar> malaria, leprosy, diphtheria, TB. • Losses can be madeup by raising production or by asking government to alter the
pricing structure.
How self sufficient are we regarding production of drugs? What
do the MNC’s and QPPI have to say about production of essential
'drugs?
/
Dr. Bhattacha.rya
—
”We are business
1__
of OPPI says "We
concerns. Why
should we prpd
: CmelnFlesi
’ly
profitsCaUSe
cause incurrence
incurrence of loss."
I which actua11
What
is CeP.Co?
Chemicals & Pharmaceuticals Corporation is for channalizing drugs
and regulating their availability in the country. The Corpora
tion has had problems regarding availability and prices of
imported ingredients. There are reports of essential.bulk drugs
not being lifted from the C.P.C. by the drug company on account
of low profitability. On December 1, 1979, CPC had 4 crore worth
of canalized bulk drugs in stock, These included essential drugs
like tetracycline, streptomycin. do^ycyc lin.
Drug
PAS
INH
Company
a) Biological Evans
b) Warner - Hiiindustan
Licensed capacity
in million^ ‘tons
Actua L produc
tion in mil
lion tons
120
56.06
135.82
300
a) Biological Evans
b) Ghas. Pfizer
c) Warner Hindustan
10
1.6
90
0.13
0.06
6.08
What are the objectives of C.P.C.?
The basic objectives of- CPC in canalizing import of drugs is as
follows:
1.
Bulk purchase for all manufactuning units gave bargaining
power in world market so that concessional or 'low prices
could be secured.
2.
To prevent disturbance of indigenous production of dru^with
a certain therapeutic value - introduce and regulate imports
of newer, sophisticated drugs in a planned manner.
3.
To protect the indigenous production of drugs ^ "especially when
the production is inadequate to meet internal demand.
4.
To ensure the equitable supply of raw materials at uniform
prices, eliminating middleman’s profits,, so that formulations
from this are priced at a fixed uniform level.
. . ' i.
1
r-lQ:343
MS ?k:5.1.82
10:
5.
To help the small
scale sector of the industry whose reouirements are small and
who would otherwise find it uneconomic
and impractical to import.
.6.
To regulate the import of drugs i :
indigenous ]_production
is substantial• enough to warrant whose
their
• being given
so that their <
achieving atimlST—^ ^ility are ensured with i protection
a view to
se If ‘“Sufficiency.
To secure those <drugs
’
which have very few world
and monopolies at- reasonable prices.
manufacturers
7.
8.
To regulate C._
the import of drugs
health problems,/ eg., addiction whose imports can cause public
forming drugs, etc.
Loopholes points 4 and 5 were to avoid middlemen
since small units have
but unfortunately
Payment several months to give their REQUIREMENTS AND ADVANCE
prior to time of rsupply (promptness of which
alzanhaSSUr!db the ^allTcale'
<,pn $age and it is the MIDDLEMEN agencies are unable to take full
sell lt at 25-30% higher than the who
usuallift the STOCK, HOARD it and
--CUL1 rate.
7 lettert9offi™In^aforn^ <mali-ed 3 industrial licences
intent for the manufacture of 16 bulk drugs. and
40 firms in the Indian private sectorinvestment proposals with n •
F ^aile<i to implement the
of intent.
Wlth 31 lndustrial licenses and 27 letters
Of 32 items Of bulk drugs covered by 13 licenses
produced by Glaxo laboratories for the lastTyears^
nOt
(Source: J S. Mazumdar: Drug Industry
Instruments of Policy)
market^hMe esteAtiH^s°^ssential.^ugs
Pimped
into the
are not produced. are
Very
obviousl?,
- ---- 1 industry and not ful■ as is often alleged.
The small scale sector feels itself
undertake any undue losses
„ill*ecJuiPee<i to
or profits and therefore
non-essential drugs.
--------- ; also opts for
what does the 6th Five Year
Plan require
From Present
Bulk 226 crores
By 1984-85
to
VI th PIAN aims at:
665 crores
regard in
dru<
reduction?
Formulation Rs. 1150 crores
2450 crores.
1)
2)
Developing self-reliance in
technology^
Ensuring availability
of drugs with reasonable prices and
inadequate amount
3) Dominant role of the public
sector in the indus try •
What‘s the situation?
Growth rate <of7 bulk drugs has
fallen from 13% to 6% and #Gr formula
tions from 10% to 4%#
0-10:343
MS :ki5.1.82
: 11
IN THE FIRST YEAR Ct THE
-- -PLAN, the foreign and big Indian
companies are not interested
low profit margin. In fact,
licenses and letters <Ox intent they are out to blackmail the
government in order to
substantial price rise - by starving
the market of these C Liy o •
io» pooflt
g SPSS'S?
(Source: MNC's Fatten, Indian Die:
Dr. Pankaj Shah : Link, Aug.
2y 1981,Pg.10)
The Multinationals al
< ‘ Ye the:-hiqh trlces because of the -research'
of the
they apparently finance.
—~ - *---- What all constitutes research?
It includes
?
- basic research
- product development
- toxicity tests
- research on formulations
- mass production methods
- clinical trials,j etc •
studies c
Jo
O£
general market studies,
stents, solely t0%xte-J
„d the
(Source:
itS
Link, Aug. 2, 1981, Pg H
Dr. Panka£ Shah)
What percentage of their sales do
what percentage in publicity?---- they put into research?
and
Glaxo in 1979-8Q spent Rs.1.52 crores on
publicity - .o percent
on tropical diseases.
Amount MNC 's spend on research is <^3°/ of
their sales turnover
Compaq to 14-15% in Developed countries
s^xSoriS1 in ferop,icai diseases but
Even so research actiin diseases like cancer
What .are the country's health requirements based
on priorities set
Strategy
by Alternative
----------------- ICMR/ICSSR Study
Measures against
Communicable Diseases
Nutritional deficiencies
Family Planning, Fertility ra te ,
Basic health care
Some of the figures that indicate the
seriousness of the problem
*IMR in 1976 129/1000' live births (when
Sri Lanka's is 45:1 in 172
(pg-129) )
*Maternal mortality 163 in 1976 (Percentage Distribution
(pg. 125)
*Birth rate - 33.3%per thousand
per annum in 19 78 (Pg.13)'
Health Budget set aside for the VIth Five Year Plan - 1821.05
50% of the Health budget earlier ,
_
Crores
has been spent on curative cai^-.
40% in construction and capital expenditure
and only 10% r~
.
on y_preventive
health care(Health StajhLsticol
Intelligence Report)
/
50% of under fives and pregnant mothers
are found to be anaemic
6.Q»%8.0. o% are clinically malnourished.
50% of Indian children get \ the calories that they rcguire.
defiency^ildrCn b'3COmu: blind each
because of Vitamin A
D-IO:343
MS:k:5.1.82
12 ;
f
*27/08/222 get malaria every year and 147 die of malaria in 1979
Incidence of T.B. is 2%, i.e.
i.e.,z 88 million
million people.
people. About (p9’82)
2 million have open TB.
*Incidence of leprosy is 25,59/566 cases on Record - Mar.'80
’2'1/58/822 cases under treatment
Pg. 89)
on Record - Mar. ' 80
(India harbours 1/3 of the world’s leprosy, malaria cases).
(^Source: Pocket Book of Health Statistics
'80/ CBHI, New Delhi)
The incidence of malaria - even Falciparum - Filaria, polio,
Kalazar,
-j uapanese ’Becephalitis has shown an increasing trend.
The above becomes extra significant when we focus on the percentage
of people below or bordering the poverty level - a figure that is
also showing a rising trend. 60% Indians are below poverty line
(assessed in relation to average caloric requirement).
What is the production of drugs like in relation to these health
requirements:
Out of Rs.636.9 crores of drugs sold in 19 80
19% were anti-biotics
10.21% vitamins
4.41% tonics
4.241% anti-anaemic preparations
4.71% cough and cold (increase in growth within
the last 5 years has been
70%) .
Talking in absolute figures. 137 crores worth of vitamins were sold
in the year 1980.
Break-up of the above available in Dr. A, Patwardhan’s paper
1/2/ and 3.
All modern drugs are available to economically well off 5%.
basic drugs available to another 20%.
Percentage of people denied availability of essential modern drugs
is 75%.
This is when our population is 65 million.
With annual expenditure of 636.9 crores.
By 2001 the population will be 950 millions.
Amount required for drugs with inflation/ increasing prices of
raw material/ etc, etc., will be
Our National Formulary has over 60/000 drugs and chemicals.
(15/000 brand drugs)
68% are obsolete and useless (only about 5000 are useful and 2500
of marginal use)
The Hathi Committee has identified 117 as essential drugs and WHO
about 2 00' drugs which would take care of the 90% of the EXISTING
HEALTH PROBLEMS.
j
D-10:343
MS :k:5.1.82
: 13 :
Regarding essential drugs production what _is happening?
Out of Rs. 1260 crores worth of drugs manufactured^in 19 79-80
essential and life saving drugs accounted for Rs.350 crores only the rest were tonics, digestive enzymes, formulations
£--- 1 ‘-1— of
" medicines
~
with marginal benefit.
Ulf- 7DRUGS
----> IN HUGE QUANTITY HAVE BEEN WASTED WHICH
MANY VITAL BULK
UTILIZED FOR MANUFACTURE OF ESSENTIAL DRUGS .
COULD HAVE BEEN
]
Drugs : Industry Instruments of Policy
- J.S, Majumdar)
1978
19 77
Production
Installed
Installed Produc
Tonnes
capacity
tion
capacity
^'onnes
tonnes
^'onnes
(Source :
Anti-T.B. Drugs
INH
5 09
57
5 39
94
PAS and its salts
1170
56
1290
558
Theacetazone
15 3
25
153
13
Streptomycin
257
194
25 7
225
DDS and its deriva
tives
26
17
38
17
Anti-filaria
DEC citrate
56
18
56 .
23
Anti-typhoid
Chloramphinicol
17 8
95
128
95
5 87
137
157
16
590
170
19-5
55
156
34
176
45
Anti-Leprosy
Anti-Dysentery
Metronidazole
An ti-ma1aria Is
Chloroquin
PfizerLtd,
Products
Licensed capacity
Production durinq
1978
19 79
45 MT
52 MT
INH
80 metric tonnes
PAS and its salts
110
ii
ii
90 MT
54 MT
Terramycin
14
ii
ii
5 3 MT
54 MT
Protienex
110
ii
■I
26'9 MT
290 MT
Burrough1s We1c ome
Septran
Licensed annual capacity
26 million tablets
Product ion 1980-81
187 million tablets
Similarly, Glaxo’s production of Betamethazone has been increasing
■
'
* , serra
while production of antibiotics - penicillin, streptomycin,
and vaccines is much below licensed capacity.
Make-up of Drug Industry at a glance?
*3500 manufacuring units
*5000 pharmaceutical units
*
118 companies in the organised
*1500 units based on loan
sector
license system
*
Of
the
20,000
formulations
in -ffe
*45 Multinational drug companies
market
78%
formulations
in
thg
which have foreign equity
hands
of
Multinationals,
16%
more than 40%
Indian Private Sector, 6%gP}^ljic
-Jr w -fr
■i
... 0
. Ji;': -
^Cliahges 111 drug
©
f.
. .
new modifications being made in the policy are 73 from the present 142 and the span of con
of the rules made thereunder, would also be
as follows:
trol to about 50 per cent from the present 70
'responsible for monitoring standard practices
1. Industrial licensing for all bulk drugs and per cent.
in drug promotion and use and to clearly iden
Over the years, through the successive drug their formulations, and for intermediates
The Government will keep a close watch ox. tify those which are acceptable and prohmit
policies, the Goveminent has sought to meet stands abolished, .xcept for (i) five identified the prices of medicines which are taken out oi
those which are unethical and against the con
? the requirements of medicines for catering to bulk drugs reserved for the public sector, (ii) price control. In case the prices of these med
sumers
interest. NPA would prepare and pu
drugs
involving
use
of
recombinant
DNA
tech
. the Le-dth needs of the people. The existing
icines rise unreasonably* the Government blish a rrarranal formulary ahcT a iso the
dvug jx lioy was fu.-iiiulatcd in 1986. Imple- nology and (iii) specific cell/tissue targeted for would take appropriate measures, including formularies relcVcrnt~td various levels (like dis
. rnenidtion cf the main policy provisions has mulations. .
reclamping of price control.
trict hospital, community centre, primary
2. Companies with foreign equitv’ up to 51
t ven through the I (DSR) Act in regard to the
5. A uniform maximum allowable post-ma health centre) foL-lhe-guidance of consumers
indiwtriJ li. ensing expects and through the per cent would be at par with wholly Indian nufacturing expense of 100 per cent will be as well as doctors.
Drugs (Piices Control; Orders under the Essen companies. Automatic approval would be gi allowed in all cases of drugs under price con
tial Commodities Ad for giving effect to the ven for foreign technology’ agreements, as per trol.
10. Besides the need to undertake upgradapricing mechanism. Ihe drug policy has also the industrial policy for all products except
6. To achieve uniformity in prices of widely tion and augmentation of the existing infras
provided the policy homework in regard to those produced by the use of recombinant DNA used formulations there would be ceiling prices tructural facilities. in terms of drug testing
quality control and rationul use of drugs. En- technology.
for commonly marketed standard pack sizes of laboratories and enforcement staff under tne
3. In the case of manufacture of drugs from price controlled formulations and it would be Central and State organisations, there is need
for? fnci.t of quality and standards in mediviucs i,- dune thrmi-di the provisions contained the tyasic stage, a rale of return higher by’ 4 per obligatory for all. including small-scale units, for establishing more zonal and sub-zonal offic
in the Driigs and Cosmetics Act which is ad- cent over the existing rales which are 14 per to follow the prices so fixed.
es under the Central Drug Standard:. Control
rri.: a- lew 1 by the Ministry of Health and Fami cent on net worth or 22 per cent on capital
as well -as.............
additional regional
7. Special emphasis will be laid on encourag- Organisation
-----.cmunax
employed would be allowed in fixation of prices ing R & D in the pharmaceutical sector. Apart
ly Welfare.
testing laboratories. The implementation ’
for drugs under price control.
from existing incentives available for R & D, lof these
l,hese proposals
Proposals would require additional =
' In vLw of the experience gained over the ,
4. It has been decided to keep the drugs hav including tax incentives, an inier-ministerial punds
Vunds which
"’hich are |proposed to be mobilised bv '
ytars. the Government had felt the need to
cf b.{ir cent
— on
... production
p.uduvHun of'
modify the existing drug policy, 1986. so as to ing un unnuul turnover of Rs. 400 lakhs or committee will be set up under the chairman- lev-vb>g a cess of
I
b.ing ii in consonance with the industrial pol more under price control. HowevenTRe mono ship of the Secretary, Department of Chemicals dru8s and pharmaceutic^s-bvsx-ipcci<hieeisia- j
poly-situation
in
the
cases
of
drugs
with
com
and Petrochemicals, to go into the question of tion t0 be Piloted by the Ministrv of Health and (
icy, 1 99 I. and the present LXIM policy as also
paratively lower turnoverr has
.. also been
- Providing further incentives and impetus for R'
Welfare. The funds mobilised tiirou”h r
c> remove the anomalies/aberrations observed
decided
to
be
kept
in
view,
f
.
.
’
.L
r
...
r
For this purpose, if & D in .his sector within a set time frame.
l"e cess would be utilised also for encouraging
in its woH ing.
encouraging
for any bulk drug having an annual .turnover
-------- —"
8. The Government would set up an inde- research and development in the drug; sector.
°
Am., having considered the. viewpoints of of Rs. 100 lakhs or imore- there
’___ 1______
is a single for- pendent body of experts, to be called the Nan T
.. . ,
the varioas interest groups, viz. consumers and mulator having 90 per cent or more market
r^r
tional Pharmaceutical Pricing Authority
’ j pr0Vlde setter focus to the develop- r
voluntary health asrxKiations, the medical pro share in the retail trade
(as per ORG).
mono XNTPATToTKuhUT^^^^ ^^ndpromotionofayurvedic.unani.sidd-----...
a monofession, trade and industry associations, in poly situation would be considered as existing. HWtd-Take
woxitd-Take decisions on the applications of T ho™copathic and other traditional svstems
cluding small-scale manufacturers, and after Drugs m which there is sufficient market com- price approvals within a set time limit of two °r
a separate department, to look
broad-based discussions at various levels, in S flTlPVn« W ?aS‘ 7e bU k drUg prokducer!; r*
;!'rr rrand four
four months
months for
t* 'ib
yr ff -rmulations
-rmulations and
for ^7“ 1 mtatters rre'atwi 10 lhe development c
cluding discussions in the consultative com- “
and atk™
least,d
10
fonnulators
and
none
having
bulk
u..“tgs.
d Prdrnotion of these systems of medicine,
0.n
™U a'?rS ar
ld n
?ne havi
P8 bu
“- gs- iihe
!le NPPA
XPI’A would also oversee the
miiicc. the standing committee on petroleum more than the 40 per cent market share in the enforcement of the provisions of DPCO
W0.ube ^ated under the Ministry of Health r
enforcement
of
the
provisions
of
DPCO.
F
and chemicals in the Rajya Sabha and Lok retail trade (as per ORG) may be kept outside
9.
9. In
In order
order to
to nrovidp
provide aa n,nr
moreP efficient me- and FamilT Welfare,
Sakha, the Government has finalised the mod- tiie puce control. However, a strict watch
12.'An inter-ministerial coordination com- &
iuc-iiij.m, required to hr made in the drug pol- would be kept on the movement of prices as it is chanism for ensuring quality control and rai'h5' a,
Na,"onal Dru8 rPlttee will be set up under the chairmanship of 2
i^V- 1986.'"Hie iiiaiu objectives of the drug expected that their prices would be kept in Amf
A t "f p Jh-b,“>up by a separate the
the Secretary
Secretary,
Department of
of Chemicals.
Chemicals,‘for
for F
policy continue to aeate conditions for adeq check by the forces of market competition.
’, Department
ol larliam^.JND.A, in
addition to the monitoring
monitoringareas
areasof
ofkey
kevconcern
concernand
andfor
fortaking
tik mo n
uate a . aJubdity of medicines of good quality at
With these measures tk_ _number
...Mt’ ofridrugs au
implementation of
of the
the effective
effective and
and timely
timely action
action m
in respect
respect of
of issues
issu-s d
live implementation
reasonable prices. The salient features of the under price control will get reduced to about iv.rk related to c., .tjve
------ 1 Provisions of the Brigand Cosmetics Act and facing
pharmaceutical industry'.
industry.
” n
facing the
the pharmaceutical
.X-
..
.
THE following b the text of the official reon the modifications eflected in the ding
3
d
V
f
DANGEROUS PROFITERING
-Dr.GOPAL DABADE
and SHARADA GOPAL
The pioneers in e stablishing the drug industry in the country were
P.C. Ray and T.K.Gujjar. At the time of Independence, the total
pharmaceuticals sale was Rs. 10 Crore.
Over the years, the multinationals have gained strong roots in the
Indian drug omdustry and repatriate huge amounts out of this country.
For example, Glaxo, which during 1975-76 had remittances of Rs.62.84
lakh built their empire to Rs.1 20.82 lakh in 1 978-79.
□n the whole, the contribution of these drug manufacturing units
towards producing life-saving and essential drugs has been very little
ihe Indian drug industry floods the market with about 70,000 formu-ations, yet 40,000 children‘go blind every year because of Vitamin
deficiency. H-ardly has the industry anything to contribute to
preventive medicine.
The Hathi Committee has commented that the firms have reduced life
to disease, "to be cured in those countries by their sales propa
ganda technique”. What are these 70,000 formulations that our drug
industry is producing?
Most of these drugs produced are unessential and many of them have
been banned in developed countries. The Government regularly
receives information regarding banning of drugs from the World
Health Organisation.
Recently, the US Senate sub-committee passed a bill that permits
export of drugs which are not approved by that country’s Food and
Drug Administration, The laws of the European Economic Community
also do not prevent export of hazardous drugs banned in their
countries•
The Indian Government had hardly taken note of this until serious
concern was expressed in and outside Parliament, when it took steps
to ban the production and s.ale of certain i rugs. The Drug Technical
Advisory Board recommended banning of 10 fixed-dose combination
drugs and accordingly, the Drug Controller of India issued a notifi
cation banning their manufacture from September 30, 1982, and sale
from April 1,1963.
Bjt a stay was brought by by the Retail and Dispensing Chemists1.
Association of Bombay,in iherBambbycHigh Court, which ordeiedfthai
ibe; li'atnof the drugs banned should be published in the gazette as
per the Drugs and Cosmetic Act.
Another drug company, Boehringer Knoll, challenged the order and got
an interim stay restraining the Drug Controller from publishing it
in the gazette.
Ultimately, the Ministry of Health and Family Welfare issued a
notification banning some drugs, which are listed below. But it
will be disheartening to note that the drug companies have found
lacunae even in some of these bans, as will be mentioned later.
Under section 26(a) of the Drugs and Cosmetic Act G.S.R 578(e) dated
23/7/1983 (as amended by G.S.R. 1057(e) dated 3/11/86 - the
following drugs have been banned in the country.
. . .2
1• Amidopyrine.
2. Fixed-dose combinations of vitamins with anti-inflammatory agents
and transquilise.xs.
3. Fixed—dose combinations of Atropine in analgesis and anti
pyretics.
4 • Fixed-dose combinations of strychnine, and caffeine in tonics.
5. Fixed-dose combinations of strychnine and yohimbine with
testosterone and vitamins,
6. Fixed-dose combination of sodium bromide/Chloral.hydrate with
other drugs.
7. Fixed-dose combinations of iron with strychnine, arsenic and
yohimbine.
8. PhenaSetin.
9. Fixed-dose combinations of anti-histaminics with analgesics.
10. Fixed-dose combinations of Pencx-lin with sulphanamides.
11. Fixed-dose combinations of vitamins with analgesics.
12. Fixed-dose combinations of tetracycline and Vitamin C.
13.
I 3. Fixed-dose combinations of Hydroxyguinoline
Hydroxyguinolin group of drugs,
except preparations which are used in the treatment of diarrhoea
and dysentry and for external use only.
14. Fixed-dose combinations of certicosteroids with any other drug
for internal use, except combinations of steroids with other
drugs for treatment of Asthma.
15. Fixed-dose combinations of chloramphenicol with any
f
other drug
for internal use, except combinations of chloramphenicol and
Streptomycin.
16. Fixed-dose combinations of Ergot.
17. Fixed-dose combinations of vitamins with anti-TB drugs, except
combinations of isonizid with pyridoxine hydrochloride (B6).
18. Pencillin skin eye ointment.
19. Tetracyiine liquid (oral) preparations.
20. Nialamide.
21 . Practolol.
22. Methapyrilene as salts (G.S.R.49(c) 3/5/84).
23. Methaqualone (G.S.R. 322(e) 3/5/84).
24. Oxytetracycline (oral) preparations.
25. Democlocycline liquid (oral) preparations (G.S.R. 86(e) 22/11/85).
26. Combination of anabolic steroid with other drugs (G.S♦R.700(e)
15/6/88).
27. Fixed-dose combinations of oestrogen and progestin (other than
oral contraceptives) containing pertablet estrogen content of
more than 50 mg and of progestin of more than 3 mg.
28 « Fixed-dose combinations of corticosteroids with any other drug
for internal use.
29. Fixed-dose combinations of Chloramphenicol with any other drug
for internal use.
But drug manugacturing companies have found adequate loopholes in
in these notifications*
. .3
‘iv.
Mahufactures of fixed-dose combinations of oestrogen and progestin,
for example, were given a notice on June 13, 1982, saying that the
production of the drug should be banned from Dec.31, 1982 and sale
from June 30, 1983. The order was challenged by Organon, Cibageigy
and Unichem, and they obtained a stay from Calcutta and Bombay High
Courts.
This drug was advocated for ban as it was known to produce congental
deformity of the unborn child. The drug had already been banned in
the TCPs in Europe, America and Australia,
The ICMR had recommended
that the drug be banned.
The Supreme Court urged the Government to take action in six months
and deplored the lack of interest in the issueoby IMA, the Medical
Council of India, and Drug Controllers of various States, as they had
shown complete lack of interest in public health and welfare*
Ultimately, a public hearing was conducted, as a result of which the
Drugs Controller banned it again on June 15, 1988. However, the
'drug was sold in several places in Karnataka and Maharashtra even
after the ban, as evident from the receipts of purchase.
The companies producing the drug had mischievously interpreted this
ban order as one which appliej to the tablet form only and not in
jections. The drug companies continue to enjoy profits, at the cost
of the health of people.
Tetracycline syrup has been banned on the groung that it cani cause
permanent'damage to teeth and bone marrow. fSo also oxytetracycline
and demeclocyline syrups.
But the injection form of the same dru<g does not even carry a warn*
ing, that the drug should not be injected in children, Even though
syrups have been banned, so that children below 14 years do not
concume it, the same is injected into the body.
Tetracycline (which is an essential drug) combination with Vitamin C
is also banned. But pfizer, a leading drug company, now combines
oxytetracycline with Vitamin €.
Oxytetracycline is pharmacologically no different from tetracycline.
Hence, pfizer enjoys defying the ban, right under the nose of the
law.
Atropine combination with analgesics and antipyretics are banned but
the drug company, IDPL, uses the same combination. Instead of
atropine, it uses homatropine, which has the same action and effect
in the body.
Fixed-dose combination of steroids has been banned,but the drug
company, Roussell, has already brought a stay order for its products,
Cortasmy. So has another drug company, Lyka.
The scientific facts remain in the text books of medicine that such
combination of drugs have nd role to.play, and that they can-be
dangerous.
Inspite of the ,fact that the Drug Controller has issued
ban orders on these, the drugs still find place in the market.
There are several drugs that should be banned, or their availability
restricted.
. . .4
* ■•-t
<
nenylbutazone or Oxy phe.nbut az one is a drug that is restricted for
use as per the circular by the Drug Controller and Directorate
General of Health Services (dated 20 May, 1988, No.12-4-04-DC) , but
many drug companies
flaunt
.
- ----j theIn circular,
fact, :his circular
dated 20 May, ’88 states that none of the companies insert cautionary
printed statement as per an earlier circular.
This drug has been banned or restricted for use in several countries,
but in our country it continues to be prescribed even for any injury.
Such restrictions on drugs have no use at all.
In fact, in a recent
issue of a guide book for professional medical world, the drug
phenylbutazone is advocated by several drug companies for children.
Analgin is another notorious drug which is indiscritoinately used in
our country.
It is difficult to convince our doctors about dangerous
side effects of analgin.
Prof.B.C.Mehta, a leading haematologist
from Bombay, has estimated that, in India, one person develops analgin
induced agranulocytosis per day.
Agranulocytosis is a serious condition wherein the white blood cells
(the defensive mechanism of body) loses its function, hence the
btpdy becomes susceptable to any infection.
Analgin is available in
every pan shop of our country and Baralgan, which also contains
Analgin, is used by college girls to suppress menstrual pains.
Cliquinols or enteroyioform tablets are another illustration,
They
were Iknown to produce SMON (Subacute Mayelo Opti c Neurophathy) in
Japan in 1969, where "2,340
“’3 cases were reported.
After a hard fought
litigation in that coiuntry Ciba Geigy ultimately withdraw the drug
from the world market.
But in our country, the production of this group of drugs rose from
230 tonnes in 1982-83.
Third World countries are (easy prey to the dangerous drugs, os they
do not have strict regulations5 on drug control.
The range of unessential drugs flooding the Indian market is very
wide, ranging from Gripe water mixture and baby food to cough- syrups
arid combination drugs,
At the outset, it may seem that these drugs
produce no harm to the body.
But the economic waste is huge.
For example,pfizer’s Becosules, the
second ranked product with retail sale in 1 985 worth Rs. 1’1.93 crore ,
is- an unessential drug.
India is fortunate enough to be a country that possesses the techno
logy for production of all essential drugs, as’ certified by UNIDO.
According to) a survey, the total sale of drugs in 1 985 was Rs.1.777
crore.
Of this, essential drugs were worth Rs.632 crore (53.12%)
of non-essential drug s was Rs. 552 crore (46.68%).
and sales
An artificial demand for these non-essential drugs has been created
by the multinationals for over a decade. They earn fabulous profits
and are desperate to maintain the market.
Unlike other commodities in the market for which the market is open
ano common through the mass media, the drug companies main concern
are doctors, wholesalers and retail chemists.
. . .5
It is obvious that the drug companies use high pressure marketing
techniques, and thus non-essential drugs are sold. An analysis
shows that 52 multinationals in 1978-79 spent only Rs.1.56 crore on
research, but Rs.15.34 crore was spent for marketing.
Though the drug companies approach the doctors through medical re
presentatives, they extensively advertise in professional medical
journals also.
The Indian Council of Medical Research and the Indian Council of
Sci^l Sciences Research set up a joint study group to study the >
health situation in India and in the report have rightly said,
’’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”.
Regarding the drug-pushing strategy of drug companies, the ICMR and
IC55R study states, "It is 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”.
After having known about banned drugs, bannable drugs, unessential
drugs and the promotional techniques of drugs companies, let us see
what our drug policy has to offer. The following observations are
worth not&ng.
1 • The drug .policy of our country is prepared by the Ministry of
Petroleum and Chemicals, and the Health Ministry is in no way involved.
2. The policy announced as on January 3, 1986, did make a brief
mention about banning of drugs, But no thought had been given to
the ban orders.
3. No attempt has been made by the policy about abolition of brand
names and introducing generic names.
4. No attempt was macle to make
a list of essential drugs.
5. The 1986 drug policy increases the cost of essential drugs. The
increase in price is even one hundred percent for some products.
6. The policy encourages more formulations by delicensing certain,
drugs and also its formulations.
7 • The drug policy makes no mention about restriction that need to be
put on the promotional material of drugs companies.
In short, the drug policy is more a pricing policy than making it a
people’s policy.
A committee set up under the guidance of Jaisukhlal Hathi made
certain useful recommendations. None of these has been fully
implemented. The following are the highlights of the recommendations.
1. All.multinational companies should be nationalised.
2. Generic names should be used, instead of using trade names/brand
names.
3. Production of single drugs.
4. Elimination of irrational drug combinations.
5. Indian National Formulory must be revised in order to keep the
medical profession well informed.
. . .6
.
—• ■■
■I
6. Distribution of drugs being an important factor,a National Drug
Authority of India (NDA) should be set up.
. A list of 117 essential drugs were drawn up by the committee,
3 . The Indian sector of drug industry should be helped to obtain
self-sufficiency.
rormcr judge of the Supreme Court Justice Krishna Iyer is on record
sis stating: ’’Government is allergic to the Hothi Committee report ..
and dithers, delays, shies and even retreats, allowing the hefty drug
industrialists to hold to ransom people’s health. Pharmaceutical
imperialism practised by covert and overt disinformation, trade terror'ism and brainwashed professionalism is a menace to a patriotic drug
policy”.
Ih the context of the entxre drug issue, a lesson has to be learnt
'from a small neighbour, Bangladesh. In fact, the country took up
tne entire idea of a drug policy from the Hathi Committee.
"he Indian drug industry should cease to exist as a profit-making
industry and the concern should be for health of the people. Drugs
lave a role to play in the health care system, and people will have
raise their voice to claim it*
India has committed itself to ’’Health for all” by 2000 AD.
But to
•shink of health as being deliverable by drugs and doctors is for from
^cing practical.
Despite the rise in the number of medical colleges,
• Hospitals, doctors, paramedics and drug production; Malnutrition,
mortality and disease rates in the country continue to evade a solu*!
lion.
However, since drugs form only a part of the health programmes,
ihis aspect is usually ignored. GOPAL DABADE and SHARADA GOPAL take
look at the Indian drug scene, and the continuing use of harmful
ctugs.
riioni
DRUG ACTION FORUM-KARNaTAKA
579 Tejeswinagsr
DHARWAD-58D 002.
1
r«z
COVER STORY
Drug situation Comparative study of India
and Bangladesh
OR thousands of years, mankind has
devised and employed a variety of ways to
deal with diseases, each suitable to the
climatic and social conditions prevailing.
In all societies there have been people to advise on
how to deal with disease and its consequences.
■'
■
I
I
Unlike those trained in the allopathic system,
traditional healers, at least in India, have treated
body, mind and social relations as an indivisible
unit. Allopathic system gained importance and
spread in the Third World countries during the
colonial period, but was generally limited to a very
small group usually the white population residing
in cities. In the countryside, traditional medicines
largely remained the only source of treatment. In
later years, however, both the systems began to be
used at the same time.
Now-a-days, physicians applying the traditional
system of curing disease, are employing to an in
creasing extent modern allopathic drugs in their
therapies to attract patients. This can be a cause
for concern, because these healers have no training
in the use of pharmaceuticals, their information
regarding drug indications, contraindications and
side-effects. Their knowledge is mostly devised
from informal non-medical sources or from drug
retailers having extremely limited knowledge.
Wide consumption gap
I
Despite this, the gap in per capita consumption of
drugs between the developed and developing na
tions, which was already very considerable
continued to grow in subsequent years. While in
terms of value, each inhabitant of a developed
country consumed in 1976, on an average, 8.5 times
as many drugs as an inhabitant of a developing
country, in 1985 he consumed drugs costing 11.5
times as much.
This worsening of the situation is due to both the
slower growth of drug consumption in developing
APRIL 16, 1991
ES 4
When a Drug Policy and supplementary Drug
Legislation were promulgated in neighbouring
Bangladesh after 1962, much was written in this
country about the pragmatic approach of the neigh
bour and it was even suggested that India should
learn from its neighbour how to administer a drug
policy. It was overlooked that the drug situation in
India with its enormous size as compared with Bangaladesh and its large population was far more
complex and that no single and simple policy was
suitable for all countries.
countries and the faster growth of population.
Whereas the growth rate of the population in
developing countries reached 201 per cent per year
in the period 1976-85, in developed countries it was
less than one per cent.
The pattern shows the low effective demand in
developing countries for drugs of the highest health
priority for the majority of the population, namely,
those for tropical infections and parasitic diseases,
and a relatively high demand for drugs that do not
meet the basic needs and are chiefly consumed by
a small segment of the population. This is so be
cause, whether in developed or developing
countries, medical personnel, other prescribers,
and the public are not rational in their use of drugs.
Drug industry
Many developing countries have a substantial drug
industry, but it is largely made up of the local
affiliates of foreign companies and employs the
production of active ingredients and the develop
ment of new products taking place elsewhere. Thus
in most of international trade in drugs the develop
ing countries play only a marginal role while the
transnational corporations generally play the
dominant one. Their share of the market ranges
S FORTUNE INDIA
HU
.
ft
COVER STORY
from 30 per cent in Egypt, 50 in Argentina, 70 per
cent in India, 78 in Brazil and 90 in Ecuador, to
nearly 100 per cent in many African countries.
Subsidiaries of the major pharmaceutical com
panies may or may not have national capital
participation, depending on the law of each country,
generally they produce pharmaceuticals developed
by the parent firms and buy the raw materials also
from them. In some cases, for reasons of taxation
and profit, it is in the interest of the companies to
sell the active ingredients to the subsidiary at a
high price, thus increasing the cost of production.
This practice is called transfer pricing.
A large number of domestically owned phar
maceutical firms, engaged mainly in formulation
and packing, compete for the remaining share of
the market. These may be privately owned or state
owned but because they are not equipped to carry
out research and development, often market a wide
range of drugs which are combination or duplicate
products.
precedence over health priorities.
The situation is further confounded by allowing the
responsibility for the development of the phar
maceutical sector to be shared by two different
ministries at the Centre. The Department of
Chemicals and Petrochemicals, Ministry of In
dustry deals with the new drug policy, prices and
profits technology and other matters while the Min
istry of Health and Family Care deals with such
matters as registration of units, quality controls
and others.
I
!
Hathi Committee
With the advent of independence, the government
planned an orderly integrated growth of the phar
maceutical industry. .The 1956 Industrial Policy
Resolution set the tempo for industrialisation, with
Indian paradox
In 1977, the World Health Organisation published
the first model list of essential drugs and in 1981
an Action Programme on essential drugs was
launched. Since then a large number of countries
have adopted an essential drugs policy to
31*
- make effective, safe, low cost drugs available to
meet the needs for essential drugs of the entire
population.
- ensure that drugs are used rationally, and
- develop, where economically and technically pos
sible, national pharmaceutical production that will
support economic growth and the overall develop
ment strategy of a country.
=
*
India provides a paradoxical example where over
production of non-essential drugs is allowed to
co-exist with shortage of essential drugs for curing
major diseases. This is all the more pitiable because
the country does have a strong pharmaceutical
industry capable of manufacturing nearly all the
drugs needed and according to UNIDO, falls in
category 4 of countries technologically developed
enough to be totally self-reliant, with research
capabilities for the discovery of new chemical en
tities.
Attempts were made by the Hathi Committee to
elaborate a policy geared to meeting the health
needs of the people. The policy has not, been fol
lowed completely however, and economic and
political priorities have often been allowed to take
APRIL 16, 1991
Q 5
emphasis on self -reliance. On the basis of some of
the recommendations made by the Hathi Commit
tee in 1975, a national drug policy was proclaimed
in 1978 with the objectives of developing selfreliance in drug technology; according a leadership
role to the public sector; achieving self sufficiency
in the production of 117 essential drugs and thus
reducing the level of imports; encouraging the
growth of the domestic sector; ensuring that drugs
are available in abundance and at a reasonable
price to meet the health needs of the people, main
taining high standards of production and
promoting research and development.
Among other measures it was decided that imports
of the necessary raw material would be carried out
on behalf of drug manufacturers by the State Trad
ing Corporation (STC), a process known as “drug
£3 FORTUNE INDIA
:
£
I'
!
—
mm*,*,
iu.
COVER STORY
canalisation’' and the pooled stock of imported raw In the absence of any specific requirement that
materials was to be distributed among the I essential drugs should be produced, companies con
manufacturers in both the public and the private centrated on the more profitable non-priority end
sectors. The objectives of canalisation were to of the market. As a result, essential drugs are in
prevent transfer-pricing and to ensure a reliable short supply in many parts of the country and in
supply of raw materials to indigenous manufac 1980 they constituted 16.8 per cent of the total of
turers at a fair price.
drugs consumed. Tonics, vitamins, restoratives,
Since the report of the Hathi Committee in 1975 and enzyme preparations constitute 25 per cent of
and the promulgation of the*drug policy in 1978, the drugs in the market.
there have been significant changes in the pharmaceutical industry. The production of finished N6W drug policy
products has reached a value of Rs.20 billion in
1985-86, and that of bulk drugs to Rs.four billion
rupees. A cumulative growth of 19.6 per cent from
1971-72 to 1978-79 in formulations and 22 per cent
in bulk drugs has taken place, imports of finished
formulations (tablets, injections, and so on readypacked for retail sale) have been virtually
eliminated, and exports have increased. All this has
produced net savings in foreign exchange.
I
L
To set up production in general and give a boost to
stagnating drug exports, the goverment adjusted
its policy in 1986. Among the changes brought
about were the introduction of a new comprehen- .
sive pricing system; changes in licensing policy;
decanalisation of imported new materials and in
termediates, and the maximum priority to making
essential drugs available.
Requirements for the registration of new drugs
were to be revised and the marketing of new drugs
was not to be allowed unless they could be
demonstrated to possess distinct advantages over
existing products. However, because of the com
plexity of implementing national drug policies,
although India has strict and comprehensive legis
lation on the import, manufacture and sale of
drugs, much remains to be done to implement the
reforms.
To improve the availability of essential drugs,
measures to regulate prices have previously been
taken by the government, culminating in the Drug
Price Control Order (DPCO) of 1970. However,
pharmaceutical firms took advantage of some
aspects of the Order and increased the prices of
unregulated drugs to compensate for the control.
Policy failures
However, the 1978 policy has not achieved all the
intended results. Between 1952 and 1983 the num
ber of production units grew three-fold, investment
24-fold, and bulk drug production 18-fold. Yet, the
production of essential drugs in 1980 accounted for
only Rs.3.5 billion of an overall total production
worth Rs. 12.6 billion. Imports of bulk drugs, mostly
essential, reached a record Rs. 1.78 billion in 198485, about half of the indigenous production. In the
five years between 1978-79 and 1983-84 the
industry’s sales of essential drugs with the lowest
price mark-up actually dipped from Rs. 554.7 mil
lion to Rs. 493.5 million, while sales of other drugs
for which the government permits higher mark-ups
grew by over 25 per cent from Rs. 1544.4 million to
Rs 1983.8 million.
APRIL 16, 1991 0 6
To remedy the situation, a new order was issued in
1979, dividing formulations or finished products of
37 bulk drugs into three categories according to
their “essentiality”, with a different price mark-up
for each category .Unfortunately the policy led to
the adoption of price control measures that proved
difficult to implement in practice.
With the 1986 Drug Policy, all bulk drugs and their
formulations have been freed from price control
except for a priority list of 166 bulk drugs, which
fall into two price-control categories. The mark-up
on finished drugs in controlled categories ..is to in
crease from 40 per cent to 75 per cent for drugs in
Category I and from 55 per cent to 100 per cent for
Category II drugs of their manufacturing costs.
Small units with a turnover of under Rs five milE3 FORTUNE INDIA
.
A
i,____
_ ______________ -
COVER STORY
lion will continue to be exempt from price control.
Finished drugs in Category II, produced by com
panies with investments totalling less than Rs. 3.5
million, are also exempt from price control. All
single- ingredient formulations sold under generic
names have also been freed from price control.
Production for these drugs and their formulations
should subject to government monitoring, account
for 20 per cent of the total output in value of every
manufacturer in India. The new Drug Prjce Control
Order was issued in August 1987.
As for the critical question of ensuring the prices
are under control, a monitoring system, National
Drug and Pharmaceutical Authority (NDPA), will
be set up, but is not likely, to be functional for at
least a year and at best will be only an advisory
body. The new pricing policy could improve the
availability of essential drugs, though at a higher
cost - anything from 0.43 to 13 per cent above
current prices. Some sources though predict a pos
sible increase in cost of 50-300 percent.
On the other hand, the argument has been put forth
that a differential mark-up for finished products
combined with price controls for a selected few
(leaving the rest to be sold in the open market
without strict price control) will encourage the in
dustry to produce more non-essential drugs and
also increase their prices.
Harmful formulations
As well as the lack of the most basic drugs for entire
groups of the population, there is a proliferation on
the market of formulations without adequate
therapeutic rationale. Concern has been expressed
in several Indian newspapers regarding harmful
and/or ineffective formulations, in particular com
bination drugs such as antibiotics plus vitamins,
penicillin plus streptomycin, chloramphenicol plus
stremptomycin, and various cough syrups contain
ing ingredients with opposing effects.
More than 20,000 combination drugs are in the
market. The indiscriminate use of antibiotics has
led to the development of bacterial drug resistance,
thus multiresistant Salmonella typhimurium in
fection has spread all over India, causing serious
outbreaks in hospitals and nurseries.
Conflicting goals
However, towards the end of 1987, the Drugs Tech
nical Advisory Board, a statutory body established
under the Drugs and Cosmetics Act, recommended
that the Central Government ban a large number
of these irrational formulations. It is understood
that government has now effetively done so, an
action that is likely to weed out a large number of
harmful and hazardous combinations.
Already, prior to the new Drug Price Control Order,
the prices of all drugs showed a 30 per cent mark-up
and drug company shares were selling at high
premia. This was despite the fact that the drug
controllers were instructed to ensure that there
was no price increase before the issuance of the
Order.
i'
Although drug prices have not risen as much as the
prices of other commodities in India, the increase
has been substantial. The drug price index rose
from 135.2 in 1979-80 to 167 in 1982- 84. Thus,
despite price control and the phenomenal growth of
the drug industry during the last three decades, the
availability of modern drugs was still very low.
For example, in 1984 only five to six per cent of the
population were able to afford or procure the
modern drugs they needed; another 25 per cent had
limited access to essential drugs. A majority of the
people living in rural areas and urban slums, the
main victims of endemic and epidemic diseases,
had no or very little access to modern drugs. With
the predicted increase in the cost of drugs, the
problems are likely to be accentuated.
APRIL 16, 1991 SI 7
I
i -^3
Consumer organizations, under the auspices of the
All India Drug Action Network, are growing in
strength and are distributing drug information
packets to doctors. In most instances however, com
panies instances, howver, medical information
from representatives of pharmaceutical companies
D FORTUNE INDIA
—1- A a
is the only source of information to prescribers in ! guidelines, out of a total of about 4000 brands of
remote areas.
I registered allopathic drugs, the registration or
From this brief description of what has happened licence of 1701 brands of locally manufactured1 or
in India in the last twenty years it is evident that imported drugs was cancelled. This procedure took
it is not always possible to reconcile economic and longer than planned because of the pressures put
health goals. Although attempts have been made on the government by a number of interested par
by the Hathi Committee to elaborate a policy ties. A list of 150 essential drugs by generic name
geared to meeting the health needs of the people, was drawn up for the national health system. A
this policy has not been followed completely and supplementary list of 100 was established for
economic priorities have often taken precedence restricted use by specialists.
over health priorities. The new policy is an attempt As a result of the new policy, in 1984 over 80 per
cent of the country’s requirements for drugs were
produced locally but almost all raw materials were
imported. About 2300 locally manufactured
products and 1600 foreign products were registered
and authorised for marketing. Only drugs approved
L
and registered by the Bangladesh Drug Ad
ministration could be imported into the country.
'
*>•------ X
I
Saving foreign exchange
to redress the situation and ensure availability of
essential medicines for everyone. It is, however, too
early as yet to assess its impact.
On to Bangladesh
i
In Bangladesh in 1982, a new drug policy and
supplementary drug legislation (the Drug Control
Ordinance, 1982) were promulgated to provide
inter alia, administrative and legislative support
for ensuring the quality and availability of essen
tial drugs, reducing the price of drugs and raw
materials, eliminating useless, non-essential and
harmful drugs from the market, promoting local
production, and developing a drug monitoring and
information system.
One of the objectives of the drug policy was to save
foreign exchange previously spent on the import of
irrelevant, dangerous, or overpriced products. This
was achieved by removing certain products from
the market, purchasing products in the world
market at competitive prices, and carrying out
careful investigation of requests for registration of
imported drugs by pharmaceutical companies.
The total cost of imports of raw materials in local
currency appoximately doubled between 1981 and
1985, from 451 to 982 million taka (approximately
22.5 million US dollars to 32.7 million dollars) but
the average price paid inrl986 for a number of raw
materials was lower than in 1981. For instance, the
price of ampicillin was 75 dollars per kg. in 1985
against 120 dollars. In 1981, doxycycline cost was
175 dollars instead of 1500 dollars, rifampicin 230
dollars against 473 dollars and mebendazole 52
dollars against 287 dollars. Thus far more drugs
were produced per dollar spent on imports. Imports
of finished products (284 million taka in 1981 and
337 million in 1985) did not rise as fast as raw
materials, and more products were manufactured
locally.
A committee appointed by the Ministry fo Health
developed a set of guidelines to evaluate all
registered/licensed
pharmaceutical
products
manufactured in or imported into Bangladesh.
In 1982 the market was dominated by eight multi
Nearly all combination products and harmful drugs national companies producing about 75 per cent of
were to be withdrawn, unless there was absolutely the market share, followed by 25 medium-sized
no alternative single drug available for treatment. companies producing 15 per cent while other com
The sale of tonics and of some duplicate drugs was panies accounted for the remaining 10 per cent. The
to be prohibited. Drugs and raw materials produced government today has a larger share in the phar
in Bangladesh were not allowed to be imported and maceutical industry, as full or part owner. The
multinational companies were not to be allowed to share of production by Bangladeshi corporations
produce antacids and vitamins. Under these I rose from 35.3 per cent of total local production in
APRIL 16, 1991
H8
FORTUNE INDIA
. ..
COVER STORY
1981 to 54.2 per cent in 1985. Production of first 45 tern under the thana health complexes, but sup
essential drugs doubled between 1981 and 1983 | plies are irregular, and even the health complexes
and represented 56 per cent of total local production are frequently short of essential drugs. An essential
in 1983 as against 30 per cent in 1981. The share drugs programme has been established in one
ofthis production by national companies was 80 per | province, with DANIDA support, and will be ex
cent.
tended to larger areas.
The remaining 90 per cent of drugs are sold by
’s
14000 retailers. The Drug Ordinance states that all
The monopoly existing in certain therapeutic clas retail sales of drugs must be under the supervision
ses was to a certain extent broken by the new drug of a pharmacist, but owing to the lack of phar
policy. When many of the most profitable drugs macists and the understaffing of the drug
were banned, the multinational companies were administration this has proved difficult in practice.
forced to compete in terms of both prices and The maximum retail price of drugs is decided by the
products. The restriction imposed on the manufac government under the Essential Commodities Act.
ture of vitamins and antacids by the multinational But the enforcement of the Act is weak. However,
companies provided an opportunity for local com despite the pressure of inflation, the market price
panies.
of some essential drugs has been reduced since the
Following initial reservations, the national phar
maceutical companies now have a more positive
attitude towards the new drug policy, as reflected
in an article by the Bangladesh Association of Phar
maceutical Industry in the newspaper New Nation,
detailing the benefits the industry has reaped from
- .. e .
the policy. A letter from the Association in 1986
approved ratification of the Drug Control Or
;S><"
dinance.
Industry welcome
■-
Nor have the multinational companies suffered
drastically from the new policy. Their output has
not declined, and some firms have actually
benefitted. In all, 170 drugs produced by the multi
nationals were banned by the Ordinance, but
several new drugs produced by them have been
approved and others reformulated; more than 136
of these new products are now on the market. The
attraction of the pharmaceutical market in
Bangladesh has not declined: local companies have
expanded, while at the same time the entire phar
maceutical market has grown, thus leaving ample
room for the multinational companies too. Since the
new drug policy was introduced one more multina
tional company has entered the market, and there
have been no reports of companies intending to
leave.
Progress insufficient
Although there has been remarkable progress in
the production of essential drugs, it is still insuffi
cient. Between 70 and 80 per cent of the population
are without access to even basic essential drugs
and, while antibiotics may be available, other fun
damental drugs are not. About 10 per cent of drugs
are distributed free of charge in the public sector.
Only small amount of drugs reach the health sysAPRIL 16, 1991
I
E3 9
.(a;-'-"
U -. . 'Z—->
!
new policy came into force because of increased
competition, control of prices of raw materials, and
the prohibition of the manufacture of a drug by a
company under another company’s brand name.
Even so,prices are still too high for the majority of
the population, whose annual income is less than
100 dollars per capita. The average spending on
pharmaceuticals was 1.25 dollar per capita in 1985
one of the lowest in the world.
Only the wealthier 20 per cent of the population
have easy access to drugs and health care.
Polypharmacy is widespread, the average number
of drugs on each prescription being four.
Doctors’knowledge of drugs still often depends on
information provided by companies and their rep
resentatives; loyalty to brand-name products is
strong and prevents essential drugs, especially
generic ones, from being used more widely.
S FORTUNE INDIA
A
A&a*
a
,.,k .
__
_
—
iik___ a.
COVER STORY
Areas of concern
Although some experts estimate that 75-85 per cent
of all the new chemical entities currently awaiting
Two other areas are of concern in Bangladesh
approval by the FDA belong to the imitative
namely quality control and traditional medicines.
Quality control capacity is very limited and the category, advances m the biological and biochemidrug administration is too understaffed to exercise ! cal sciences in recent years are likely to foster the
development of major new therapeutic agents
^equate control. Drug sample tests in 1983 and
1900 showed some improvement in the quality of more specifically the product of what some have
products, 18.6 per cent of the samples being unac called the “second pharmacological revolution”,
They include neurotransmitters, mood-altering
ceptable m 1983 as against 10.75 per cent in'1985
drugs,
prostaglandis,
andr-—
productsto treat the
Nevertheless, the number of substandard products .
- ---is htgh. DANIDA with WHO assistance, is support health problems of the elderly (the fastest-growing
population group in the major world markets.)
ing the Ministry of Health in this field.
Before the introduction of the new drug p'olicy,
traditional medicines were uncontrolled. Under the Newer technology
ordinance, a large number of these medicines were
Many of the drugs of the future will also be products
banned, but enforcement of the policy on Ayurvedic of recombinant DNA technology. Until now, genetic
and Unani drugs was postponed several times be| engineering has mainly offered-ways of making and
cause the Ministry of Health had only slight control
improving old products (e.g.human insulin)but new
over the producing companies. As a result the
products are on the way, though their appearance
manufacture of traditional medicines have become
on the market may take longer than expected.
an attractive investment proposition and the num
ber of units manufacturing Unani and Ayurvedic Novel drug dehvery systems and techniques for
drugs increased from 151 in 1978 and 1981 to 336 carrying agents to specific receptor sites will also
m 1986 This has led to the production of drugs of be a new field for expansion and one of the respon
doubtful efficacy, several of which are claimed to ses of research and development firms to the
threatening growth of the generic producers. The
have the same curative potential as banned drugs
Evmence shows that some of these drugs have been goal will be to replace current “peak and
packaged and marketed in such a way as to appear trough”dosmg systems with ones that provide the
medicinal effect when and where needed.
to be substitutes for the banned drugs.
Future concerns
In conclusion, the Bangladesh drug policy has in a
lew years permitted several steps forward to be
taken m lowering prices, controlling transfer pric
ing, increasing essential drug production,
stimulating local companies and removing
dangerous drugs from the market, However, the
government still faces a number of obstacles to the
success of the policy.
While it is making efforts to ensure that essential
drugsloi-are made available to the
majority
--------j—of
vx the
ghc
J*\ /"X VX'* "I 4-^
.
—.
populataon, the government realises that it needs
... .........and,
..... ....
.. .
to strengthen the health sector
in particular
the drug administration, including quality control
there is also an awareness of the need to improve
control of the production of. traditional medicines.
Attempts^ to overcome the various obstacles are
„ th.
Both the cost of research and the time required to
transfer a drug from the laboratory to the market
have increased in the last 15 years. In 1963 in the
United Kingdom, according to industry analysts, it
nok about three years and two to three sterlings to
develop and market a new drug but now it is es
timated to take seven to ten years and 50 million
pounds sterling .
When we talk of Health For All by 2000 A.D, I feel
we in India shall have to put a lot of endeavour to
encompass a wide variety of activities, such as developing a system of primary health care that
1'eaches the whole population and promoting the
health of mothers and children; combating mah
nutritionjcontrolling
malaria
and
other
communicable diseases including tuberculosis and
leprosy, promoting mass immunization against a
£ zs
government. In the 1UtUr
futuree research and development are likely to continue to become more
complex, time-consuming and costly. Greater em
phasis is now being put on research efficiency.
. all categories
. i>uPPue®> aM
training health-----------personnel, of
------------- and con
cern for health care by the government as well as
people at large. -,Y
— L.K.ACHARYzk
APRIL 16, 1991 s 10
□ FORTUNE INDIA
•r-
1:
I
I
RU
.EOI
;j »n (MM _
Ltjm
■
:"<
'
!■"'
;
■w<4!'n
"
Public Folicy Division
Voluntary Health Association of India
40 Tara Crescent
(Fhcne C68071/72)
■'■.•• ■74^-r-i
COVER STORY
Drug situation Comparative study of India
and Bangladesh
TF"^|OR thousands of years, mankind has
■ J| 1 devised and employed a variety of ways to
B 'I deal with diseases, each suitable to the
■BLm
climatic and social condition^ prevailing.
In all societies there have been people to advise on
how to deal with disease and its consequences.
;
I
Unlike those trained in the allopathic system,
traditional healers, at least in India, have treated
body, mind and social relations as an indivisible
unit. Allopathic system gained importance and
spread in the Third World countries during the
colonial period, but was generally limited to a very
small group usually the white population residing
in cities. In the countryside, traditional medicines
largely remained the only source of treatment. In
later years, however, both the systems began to be
used at the same time.
Now-a-days, physicians applying the traditional
system of curing disease, are employing to an in
creasing extent modern allopathic drugs in their
therppies to attract patients. This can be a cause
for concern, because these healers have no training
in the use of pharmaceuticals, their information
regarding drug indications, contraindications and
side-effects. Their knowledge is mostly devised
from informal non-medical sources or from drug
retailers having extremely limited knowledge.
Wide consumption gap
Despite this, the gap in per capita consumption of
drugs between the developed and developing na
tions, which was already very considerable
continued to grow in subsequent years. While in
terms of value, each inhabitant of a developed
country consumed in 1976, on an average, 8.5 tithes
as many drugs as an inhabitant of a developing
country, in 1985 he consumed drugs costing 11.5
times as much.
This worsening of the situation is due to both the
slower growth of drug consumption in developing
APRIL 16, 1991 ■ 4
When a Drug Policy and supplementary Drug
Legislation were promulgated in neighbouring
Bangladesh after 1962, much was written in this
country about the pragmatic approach of the neigh
bour and it was even suggested that India should
learn from its neighbour how to administer a drug
policy. It was overlooked that the drug situation in
India with its enormous size as compared with Bangaladesh and its large population was far more
complex and that no single and simple policy was
suitable for all countries.
countries and the faster growth of population.
Whereas the growth rate of the population in
developing countries reached 201 per cent per year
in the period 1976-85, in developed countries it was
less than one per cent.
The pattern shows the low effective demand in
developing countries for drugs of the highest health
priority for the majority of the population, namely,
those for tropical infections and parasitic diseases,
and a relatively high demand for drugs that do not
meet the basic needs and are chiefly consumed by
a small segment of the population. This is so be
cause, whether in developed or developing
countries, medical personnel, other prescribers,
and the public are not rational in their use of drugs.
Drug industry
Many developing countries have a substantial drug
industry, but it is largely made up of the local
affiliates of foreign companies and employs the
production of active ingredients and the develop
ment of new products taking place elsewhere. Thus
in most of international trade in drugs the develop
ing countries play only a marginal role while the
transnational corporations generally play the
dominant one. Their share of the market ranges
■ FORTUNE INDIA
COVER STORY
I
I
from 30 per cent in Egypt, 50 in Argentina, 70 per
cent in India, 78 in Brazil and 90 in Ecuador, to
nearly 100 per cent in many African countries.
Subsidiaries of the major pharmaceutical com
panies may or may not have national capital
participation, depending on the law of each country,
generally they produce pharmaceuticals developed
by the parent firms and buy the raw materials also
from them. In some cases, for reasons of taxation
and profit, it is in the interest of the companies lo
sell the active ingredients to the subsidiary at a
high price, thus increasing the cost of production.
This practice is called transfer pricing.
A large number of domestically owned phar
maceutical firms, engaged mainly in formulation
and packing, compete for the remaining share of
the market. These may be privately owned or state
owned but because they are not equipped to carry
out research and developipent, often market a wide
range of drugs which are combination or duplicate
products.
precedence over health priorities.
The situation is further confounded by allowing the
responsibility for the development of the phar
maceutical sector to be shared by two different
ministries at the Centre. The Department^ of
Chemicals and Petrochemicals, Ministry of In
dustry deals with the new drug policy, prices and
profits technology and other matters while the Min
istry of Health and Family Care deals with such
matters as registration of units, quality controls
and others.
,
Hathi Committee
: ■
With the advent of independence, the government
planned an orderly integrated growth of the phar
maceutical industry. The 1956 Industrial Policy
Resolution set the tempo for industrialisation, with
Indian paradox
In 1977, the World Health Organisation published
the first model list of essential drugs and in 1981
an Action Programme on essential drugs was
launched. Since then a large number of countries
have adopted an essential drugs policy to
- make effective, safe, low cost drugs available to
meet the needs for essential drugs of the entire
population.
- ensure that drugs are used rationally, and
- develop, where economically and technically pos
sible, national pharmaceutical production that will
support economic growth and the overall develop
ment strategy of a country.
India provides a paradQxical example where over
production of non-essential drugs is allowed to
co-exist with shortage of essential drugs for curing
major diseases. This is all the more pitiable because
the country does have a strong pharmaceutical
industry capable of manufacturing nearly all the
drugs needed and according to UNIDO, falls in
category 4 of countries technologically developed
enough to be totally self-reliant, with research
capabilities for the discovery of new chemical en
tities.
Attempts were made by the Hathi Committee to
elaborate a policy geared to meeting the health
needs of the people. The policy has not, been fol
lowed completely however, and economic and
political priorities have often been allowed to take
APRIL 16, 1991 H5
emphasis on self -reliance. On the basis of some of
the recommendations made by the Hathi Commit
tee in 1975, a national drug policy was proclaimed
in 1978 with the objectives of developing selfreliance in drug technology; according a leadership
role to the public sector; achieving self sufficiency
in the production of 117 essential drugs and thus
reducing the level of imports; encouraging the
growth of the domestic sector; ensuring that drugs
are available in abundance and at a reasonable
price to meet the health needs of the people, main
taining high standards of production and
promoting research and development.
Among other measures it was decided that imports
of the necessary raw material would be carried out
on behalf of drug manufacturers by the State Trad
ing Corporation (STC), a process known as “drug
■ FORTUNE INDIA
:<■
t
i
COVER STORY
canalisation” and the pooled stock of imported raw
materials was to be distributed among the
manufacturers in both the public and the private
sectors. The objectives of canalisation were to
prevent transfer-pricing and to ensure a reliable
supply of raw materials to indigenous manufacturers at a fair price.
Since the report of the Hathi Committee in 1975
and the promulgation of the drug policy in 1978
there have been significant changes in the phar
maceutical industry. The production1 of finished
UCtS has reached a va^e of Rs.20 billion in
1985-86, and that of bulk drugs to Rs.four billion
rupees. A cumulative growth of 19.6 per cent from
1971-72 to 1978-79 in formulations and 22 percent
in bulk drugs has taken place, imports of finished
formulations (tablets, injections, and so on readypacked for retail sale) have been virtually
eliminated, and exports have increased. All this has
produced not savings in foreign exchange.
In the absence of any specific requirement that
essential drugs should be produced, companies con
centrated on the more profitable non-priority end
of the market. As a result, essential drugs are in
short supply in many parts of the country and in
1980 they constituted 16.8 per cent of the total of
drugs consumed. Tonics, vitamins, restoratives,
and enzyme preparations constitute 25 per cent of
the drugs in the market.
New drug policy
Tb set up production in general and give a boost to
stagnating drug exports, the goverment adjusted
its policy in 1986. Among the changes brought
about were the introduction of a new comprehen
sive pi icing system; changes in licensing policy;
decanaiisation of imported new materials and in
termediates, and the maximum priority to making
essential drugs available.
Requirements for the registration of new drugs
were to be revised and the marketing of new drugs
was not to be allowed unless they could be
demonstrated to possess distinct advantages over
existing products. However, because of the com
plexity of implementing national drug policies,
although India has strict and comprehensive legis
lation on the import, manufacture and sale of
drugs, much remains to be done to implement the
reforms.
lb improve the availability of essential drugs,
measures to regulate prices have previously been
taken by the government, culminating in the Drug
Price Control Order (DPCO) of 1970. However,
pharmaceutical firms took advantage of some
aspects of the Order and increased the prices of
unregulated drugs to compensate for the control.
To remedy the situation, a new drder was issued in
1979, dividing formulations or fihished products of
37 bulk drugs into three categdries according to
their essentiality”, with a different price mark-up
for each category .Unfortunately the policy led to
the adoption of price control hibasures that proved
difficult to implement in practice.
Policy failures
However, the 1978 policy has not achieved all the
intended results. Between 1952 and 1983 the numo!rr0LPr°duCti0n
grew
investment
24-fold, and bulk drug production 18-fold. Yet, the
production of essential drugs in 1980 accountecl for
only Rs.3.5 billion of an overall total production
worth Rs. 12.6 billion. Imports of bulk drugs, mostly
essential, reached A record Rs. 1.78 billion in 1984- With the 1986 Drug Policy, all btilk drugs and their
85, about half of the indigenous production. In the formulations have been freed from price control
five years between 1978-79 and 1983-84 the except for a priority list of 166 bulk drugs, which
industry’s sales of essential drugs with the lowest fall into two price-control categories. The mark-up
price mark-up actually dipped from Rs. 554.7 mil on finished drugs in controlled categoriesJs to in
lion to Rs. 493.5 million, while sales of other drugs crease from 40 per cent to 75 per cerit for drugs in
for which the government permits higher mark-ups Category I and from 55 per cent to 100 per cent for
grew by over 25 per cent from Rs. 1544.4 million to Category II drugs of their manufacturing costs.
Rs 1983.8 million.
Small units with a turnover of under Rs five milAPRIL U, 1991
6
■ FORTUNE INDIA
COVER STORY
Harmful formulations
lion will continue to be exempt from price control.
Finished drugs in Category II, produced by com As well as the lack of the most basic drugs for entire
panies with investments totalling less than Rs. 3.5 groups of the population, there is a proliferation on
million, are also exempt from price control. All the market of formulations without adequate
single* ingredient formulations sold under generic therapeutic rationale. Concern has been expressed
names have also been freed from price control. in several Indian newspapers regarding harmful
Production for these drugs and their formulations and/or ineffective formulations, in particular com
should subject to government paonitoring, account bination drugs such as antibiotics plus vitamins,
for 20 per cent of the total output in value of every penicillin plus streptomycin, chloramphenicol plus
manufacturer in India. The new Drug Prjce Control stremptomycin, and various cough syrups contain
Order was issued in August 1987.
ing ingredients with opposing effects.
As for the critical question of ensuring the prices More than 20,000 combination drugs are in the
are under control, a monitoring system, National market. The indiscriminate use of antibiotics has
Drug and Pharmaceutical Authority (NDPA), will led to the development of bacterial drug resistance,
be set up, but is not likely, to be functional for at thus multiresistant Salmonella typhimurium in
least a year and at best will be only an advisory fection has spread all over India, causing serious
body. The new pricing policy could improve the
outbreaks in hospitals and nurseries.
availability of essential drugs, though at a higher
cost - anything from 0.43 to 13 per cent above
current prices. Some sources though predict a pos However, towards the end of 1987, the Drugs Tech
sible increase in cost of 50-300 percent.
nical Advisory Board, a statutory body established
On the other hand, the argument has been put forth under the Drugs and Cosmetics Act, recommended
that a differential mark-up for finished products that the Central Government ban a large number
combined with price controls for a selected few of these irrational formulations. It is understood
(leaving the rest to be sold in the open market that government has now effetively done so, an
without strict price control) will encourage the in action that is likely to weed out a large number of
dustry to produce more non-essential drugs and harmful and hazardous combinations.
also increase their prices.
Conflicting goals
Already, prior to the new Drug Price Control Order,
the prices of all drugs showed a 30 per cent mark-up
and drug company shares were selling at high
premia. This was despite the fact that the drug
controllers were instructed to ensure that there
was no price increase before the issuance of the
Order.
A.
-
Although drug prices have not risen as much as the
prices of other commodities in India, the increase
has been substantial. The drug price index rose
from 135.2 in 1979-80 to 167 in 1982- 84. Thus,
despite price control and the phenomenal growth of
the drug industry during the last three decades, the
availability of modern drugs was still very low.
For example, in 1984 only five to six per cent of the
population were able to afford or procure the
modem drugs they needed; another 25 per cent had
limited access to essential drugs. A majority of the
people living in rural areas and urban slums, the
< main victims of endemic and epidemic diseases,
’ had no or very little access to modern drugs. With
the predicted increase in the cost of drugs, the
problems are likely to be accentuated.
APRIL 16, 1991 B7
Consumer organizations, under the auspices of the
All India Drug Action Network, are growing in
strength and are distributing drug information
packets to doctors. In most instances however, com
panies instances, howver, medical information
from representatives of pharmaceutical companies
■ FORTUNE INDIA
* <
COVER STORY
is the only source of information to prescribers in
remote areas.
From this brief description of what has happened
in India in the last twenty years it is evident that
it is not always possible to reconcile economic and
health goals. Although attempts have been made
by the Hathi Committee to elaborate a policy
geared to meeting the health needs of the people,
this policy has not been followed completely and
economic priorities have often taken precedence
over health priorities. The new policy is an attempt
?
" ■ /’I
- ^4
guidelines, out of a total of about 4000 brands of
registered allopathic drugs, the registration or
licence of 1701 brands of locally manufactured or
imported drugs was cancelled. This procedure took
longer than planned because of the pressures put
on the government by a number of interested par
ties. A list of 150 essential drugs by generic name
was drawn up for the national health system. A
supplementary list of 100 was established for
restricted use by specialists.
As a result of the new policy, in 1984 over 80 per
cent of the country’s requirements for drugs were
produced locally but almost all raw materials were
imported. About 2300 locally manufactured
products and 1600 foreign products were registered
and authorised for marketing. Only drugs approved
and registered by the Bangladesh Drug Ad
ministration could be imported into the country.
Saving foreign exchange
to redress the situation and ensure availability of
essential medicines for everyone. It is, however, too
early as yet to assess its impact.
On to Bangladesh
In Bangladesh in 1982, a new drug policy and
supplementary drug legislation (the Drug Control
Ordinance, 1982) were promulgated to provide
inter alia, administrative and legislative support
for ensuring the quality and availability of essen
tial drugs, reducing the price of drugs and raw
materials, eliminating useless, non-essential and
harmful drugs from the market, promoting local
production, and developing a drug monitoring and
information system.
A committee appointed by the Ministry fo Health
developed a set of guidelines to evaluate all
registered/licensed
pharmaceutical
products
manufactured in or imported into Bangladesh.
Nearly all combination products and harmful drugs
were to be withdrawn, unless there was absolutely
no alternative sipgle drug available for treatment.
The sale of tonics and of some duplicate drugs was
to be prohibited. Drugs and raw materials produced
in Bangladesh were not allowed to be imported and
multinational companies were not to be allowed to
produce antacids and vitamins. Under these
APRIL 16, 1991 S 8
One of the objectives of the drug policy was to save
foreign exchange previously spent on the import of
irrelevant, dangerous, or overpriced products. This
was achieved by removing certain products from
the market, purchasing products in the world
market at competitive prices, and carrying out
careful investigation of requests for registration of
imported drugs by pharmaceutical companies.
The total cost of imports of raw materials in local
currency appoximately doubled between 1981 and
1985, from 451 to 982 million taka (approximately
22.5 million US dollars to 32.7 million dollars) but
the average price paid in 1986 for a number of raw
materials was lower than in 1981. For instance, the
price of ampicillin was 75 dollars per kg. in 1985
against 120 dollars. In 1981, doxycycline cost was
175 dollars instead of 1500 dollars, rifampicin 230
dollars against 473 dollars and mebendazole 52
dollars against 287 dollars. Thus far more drugs
were produced per dollar spent on imports. Imports
of finished products (284 million taka in 1981 and
337 million in 1985) did not rise as fast as raw
materials, and more products were manufactured
locally.
In 1982 the market was dominated by eight multi
national companies producing about 75 per cent of
the market share, followed by 25 medium-sized
companies producing 15 per cent while other com
panies accounted for the remaining 10 per cent. The
government today has a larger share in the phar
maceutical industry, as full or part owner. The
share of production by Bangladeshi corporations
rose from 35.3 per cent of total local production in
H FORTUNE INDIA
«■
.
' J
COVER STORY
1981 to 54.2 per cent in 1985. Production of first 45
essential drugs doubled between 1981 and 1983
and reputsented 56 per cent of total local production
in 1983 as against 30 per cent in 1981. The share
ofthis production by national companies was 80 per
cent.
Industry’s welcome
The monopoly existing in certain therapeutic Mas
ses was to a certain extent broken by the new drOg
policy. When many of the most profitable drugs
were banned, the multinational companies were
forced to compete in terms of both prices and
products. The restriction imposed on the manufac
ture of vitamins and antacids by the multinational
companies provided an opportunity for local com
panies.
Following initial reservations, the national phar
maceutical companies now have a more positive
attitude towards the new drug policy, as reflected
in an article by the Bangladesh Association of Phar
maceutical Industry in the newspaper New Nation,
detailing the benefits the industry has reaped from
the policy. A letter from the Association in 1986
approved ratification of the Drug Control Or
dinance.
Nor have the multinational companies suffered
drastically from the new policy. Their output has
not declined, and some firms have actually
benefitted. In all, 170 drugs produced by the multi
nationals were banned by the Ordinance, but
several new drugs produced by them have been
approved and others reformulated; more than 136
of these new products are now on the market. The
attraction of the pharmaceutical market in
Bangladesh has not declined: local companies have
expanded, while at the same time the entire phar
maceutical market has grown, thus leaving ample
room for the multinational companies too. Since the
new drug policy was introduced one more multina
tional company has entered the market, and there
have been no reports of companies intending to
leave.
1 •
I
Progress insufficient
Although there has been remarkable progress in
the production of essential drugs, it is still insuffi
cient. Between 70 and 80 per cent of the population
are without access to even basic essential drugs
and, while antibiotics may be available, other fun
damental drugs are not. About 10 per cent of drugs
are distributed free of charge in the public sector.
Only small amount of drugs reach the health sys
APRIL 16, 1991 ■ 9
tem under the thana health complexes, but sup
plies are irregular, and even the health complexes
are frequently short of essential drugs. An essential
drugs programme has been established in, one
pipvince, with DANIDA support, and will be ex
tended to larger areas.
'
The remaining 90 per cent of drugs are sold by
14000 retailers. The Drug Ordinance states that all
retail sales of drugs must be under the supervision
of a pharmacist, but owing to the lack of phar
macists and the understafilng of the drug
administration this has proved difficult in practice.
The maximum retail price of drugs is decided by the
government under the Essential Commodities Act
But the enforcement of the Act is weak. However,
despite the pressure of inflation, the market price
of some essential drugs has been reduced since the
'r; '’’’TTBHi
Vi
t i
new policy came into force because of increased
competition, control of prices of raw materials, and
the prohibition of the manufacture of a drug by a
company under another coihpany’s brand name.
Even so,prices are still too high for the majority of
thfe population, whose annual income is less than
100 dollars per capita. The average spending on
pharmaceuticals was 1.25 dollar per capita in 1985
one of the lowest in the world.
Ohly the wealthier 20 per cent of the population
have easy access to drugs hnd health care.
Polypharmacy is widespread, the average number
of drugs on each prescription being four.
Doctors’knowledge of drugs still often depends bn
information provided by companies and their rep
resentatives; loyalty to brand-name products is
strong and prevents essential drugs, especially
generic ones, from being used more widely.
■ FORTUNE INDIA
Areas of concern
Two other areas are of concern in Bangladesh
namely quality control and traditional medicines.
Quality control capacity is very limited and the
drug administration is too understaffed to exercise
adequate control. Drug sample tests in 1983 and
1985 showed some improvement in the quality of
products, 18.6 per cent of the samples being unac
ceptable in 1983 as against 10.75 per cent in 1985.
Nevertheless, the number of substandard products
is high. DANIDA with WHO assistance, is support
ing the Ministry of Health in this field.
Before the introduction of the new drug policy,
traditional medicines were uncontrolled. Under the
ordinance, a large number of these medicines were
banned, but enforcement of the policy on Ayurvedic
. and Unani drugs was postponed several times be
cause the Ministry of Health had only slight control
over the producing companies. As a result the
manufacture of traditional medicines have become
an attractive investment proposition and the num
her of units manufacturing Unani and Ayurvedic
drugs increased from 151 in 1978 and 1981 to 336>
in 1986. This has led to the production of drugs of
doubtful efficacy, several of which are claimed to
have the same curative potential as banned drugs.
Evidence shows that some of these drugs have been
packaged and marketed in such a way as to appear
to be substitutes for the banned drugs.
Future concerns
In conclusion, the Bangladesh drug policy has in a
few years permitted several steps forward to be
taken in lowering prices, controlling transfer pric
ing, increasing essential drug production,
stimulating local companies and removing
dangerous drugs from the market. However, the
government still faces a number of obstacles to the
success of the policy.
While it is making efforts to ensure that essential
drugs are made available to the majority of the
population, the government realises that it needs
to strengthen the health sector and, in particular
the drug administration, including quality control.
There is also an awareness of the need to improve
control of the production of traditional medicines.
Attempts to overcome the various obstacles are
hampered by the scanty resources available to the
government. In the future research and develop
ment are likely to continue to become more
complex, time-consuming and costly. Greater em
phasis is now being put on research efficiency.
APRIL 16, 1991 ■ 10
Although some experts estimate that 75-85 per cent
of all the new chemical entities currently awaiting
approval by the FDA belong to the imitative
category, advances in the biological and biochemi
cal sciences in recent years are likely to foster the
development of major new therapeutic agents,
more specifically the product of what some have
called the “second pharmacological revolution”.
They include neurotransmitters, mood-altering
drugs, prostaglandis, and products to treat the
health problems of the elderly (the fastest-growing
population group in the major world markets.)
Newer technology
Many of the drugs of the future will also be products
of recombinant DNA technology. Until now, genetic
engineering has mainly offered ways of making and
improving old products (e.g.human insulinlbut new
products are on the way, though their appearance
on the market may take longer than expected.
Novel drug delivery systems and techniques for
carrying agents to specific receptor sites will also
be a new field for expansion and one of the respon
ses of research and development firms to the
threatening growth of the generic producers. The
goal will be to replace current “peak and
trough”dosing systems with ones that provide the
medicinal effect when and where needed.
Both the cost of research and the time required to
transfer a drug from the laboratory to the market
have increased in the last 15 years. In 1963 in the
United Kingdom, according to industry analysts, it
took about three years and two to three sterlings to
develop and market a new drug but now it is es
timated to take seven to ten years and 50 million
pounds sterling
When we talk of Health For All by 2000 A.D, I feel
we in India shall have to put a lot of endeavour to
encompass a wide variety of activities, such as
developing a system of primary health care that
reaches the whole population and promoting the
health of mothers and children; combating malnutrition;controlling
malaria
and
other
communicable diseases including tuberculosis and
leprosy, promoting mass immunization against a
number of other preventable diseases, improving
mental health, providing safe water supplies, and
training health personnel of all categories and con
cern for health care by the government as well as
people at large.
— L.K.ACHARYA
■ FORTUNE INDIA
(
HfflC;......
■/I
H
a jic
.....
g
108 ifeigay.
Ktwi
WWO
sy ' '.>1 . .< -
'W
W^';,w
W
Owl
a. i®
■
ib
■•’I
111Kfe
1
Rs. 6
MARCH. 1991
f
..
•
■
‘
;•■■;"■■''■'
.■
'•>"
•„
■•
j
■
■■
•
.
■
ARE
YOU
K*
BEING DRUGGED
ft."
wS
IsH!
,
.
.
a'
-'■•'•
■.
■
•
'.,’■•■■■' 'j
'
-
■
•
'
••.■'•-
’..
,■
A
; '
,
.
‘
s? ■
■ hBt=
'■i£^ ■
H #
3
.^/■■.
rv:\.?c
'■■ 4fe
Hi
1 h
•’
■
Public Policy Division
Volur.tr. ry 11 cal th Association of In^g
<0 Tara Crescent
K:\y I. r.i.41C0l6.
'■WW’^
■BV
k
KA-'
.
BB'-: •
h-'-
<••
k
■
iH
IB'
IP
P? ’■’
B
I
k
?V>»t yTOygSyl
s
.
"x-?.1 ' -’i
'
-- ^^F«KSSi
• . _ x'^Z ’
* * fUTJm
tas*
r
’A
1
■*
'*
.=■
■ ■
■ I' ~‘--
1
J'-’
IOK c. .
:
■'^U'’-
'
injOaMI
'*'^4
_ ■ ••.•.
-■J’ 4;.'’ ■
tfefrg1
$£a$K
R^?>
* ■
■
r cr
&»»>>»
A
,
PUi-c cao71/72)
;
■
-rt*'.;
/■ OSHK
^W«SSS
8,^^ 5
Ap'
..''\’:‘'>z“ "
«<ya
yw|y -.
O'-
■ ?z.
E»if&4«b®Wsa
COVER STORY
MEDICAL FORMULATIONS
ARE YOU
BEING
w »R1JG(>E» TO
DEATH?
L •
'■■ ■ ■* A../.
There are 60,000
to 75,000 drug for
mulations available
on the Indian markht,
many of them haz
ardous, most of them
irrational.
Do you know
what's being pre
scribed?
Does your Doctor?
J n an age of aggressive maiketing
1 End sales strategies, the consumer
seldom knows what »s hidden behind
the well nackaged product he's
saddled with. But where the product
is as important, and as complex, as a
prescribed, even life saving drug, user
ignorance is intensified by the levels
of expertise needed to understand
the significance or the suitability of a
particular combination. Depend
ence on expert, and sometimes
pseudo-expert opinions is absolute,
the latter particularly in case of sup
posedly harmless across-the-counter
drugs for a plethora of minor ail
ments.
In such a situation, it is assumed
that the law would be sufficiently
effective to ensure that an appropri
ate number of standardised drugs,
under various brandnames, are made
available to the hapless consumer,
already burdened by the distress of
his illness
The fact, however, is that the
prevailing situation relating to sub
standard, hazardous and irrational
drugs available on the Indian market
is absolutely scandalous. The journal
of the Voluntary Health Association
of India (VHAI) notes, "It is possible
to go into your local chemists shop
today, looking for something to treat
a simple headache, a remedy for diarrohea, something for rheumatism, a
tonic and a pregnancy test - and
come out with one drug that can
blind and paralyse you for life, an
other which can deform your baby
still in the womb, one more which
can make your young daughter g*ow
a moustache, and another couple
which can give you a serious and
often fatal blood disease,”
Today, it is officially acknov 1
edged that one out of every five phar
maceutical products in the country
are either sub-standard or spurious
Lest this create the impression that
there is a vast sub-terruinian network
of criminal drug manufactv rvs
churning out these drugs, it is impor
tant to note that not ail such sub
standard products corne from indis
tinguishable back-room laboratories,
or even from the small-scale sector.
In What can only be described as acts
of heartless negligence and proffer
ing, it has been found that some of
the most reputed multinational
companies are also actively palming
"It is possible to go into your local chemists shop today,
looking for a remedy for diarrohea...and come out with a
drug that can blind and paralyse you for life..."
L
'
off substandard drugs on
the market. For Instance, a
survey conducted in 1981
revealed that out of a total
of 218 samples collected,
135 sub-standard products
were manufactured by
rhultinational companies. Dr Mira
Shiva of the Voluntary Health Assoelation of India (VHAI) notes, ’It Is
always alleged that the small scale
sector does not have its own quality
control. That the small scale sector is
rpbbish, and the large companies are
good. But the large sector is exten
sively using the small sector through
lease licensing agreements, and is
merely packaging and marketing
what the small sector produces.’
’It is not only the small scale
sector that is involved," adds Amit
Sen Gupta of the Delhi Science Fo
rum, "Most of the major companies
have at some point or the other been
indicted for using substandard drugs.
There are reports*/ if you talk infor
mally to the drug control authorities,
that if a big company is caught, a lot
of pressure is put on them. And by the
time they can do any-
»
Learning About The Dangers
* Public consciousness of the inherent dangers from drug use came into being
dramatically with the Thalidomide disaster, the first major drug induced
disaster in the world, which resulted in the birth of some forty thousand
children with severe physical deformities. The case of Thalidomide induced
teratogenesis is the classic example of how ingestion of a seemingly safe drug
during a shor period of gestation can lead to sever structural defects in the
offspring. Infants exposed in tdero-were born with phocomelia (total absence
of limbs or the presence of flipperlike or shortened limbs) and other devel
opmental abnormalities Involving the face and ears.
* This was followed by the SMON disaster in Japan, where hydroxyquinoline
drugs (such as Mexaform and Enterovioform) crippled, maimed and blinded
over 11,000 victims, and are said to have affected over 30,000.
* Subsequently, the teratogenic effects (causing congenital malformations
when taken during pregnancy) of DES (Diethylstilbaestrol), the negative ef
fect of anabolic steroids on children, and the efect of amidopyrine on white
cells and bone marrow, each, in turn, underlined the fact that drugs can be
dangerous too.
Unfortunately, a large number of drugs that have been widely demonstrated
. to be dangerous continue to be sold across the counter in India. For instance,
over 130 brands of hydroxyquinoline deravitives, the drug responsible for
the SMON disaster in Japan, are easily available, even in rural dispensaries
with the most rudimentary facilities, in India.
The World Health Organisation
(WHO) List of Essential Drugs con
sists of 250 drugs and contains only
seven combinations. In India there
are presently over
20,000 pharmaceutical
L
p
?.
r
h
cuIar
The
lack
of
unbiased
case, a lot of those drugs
units producing be
drug information to tween
have already been sold.
60,000 and
T^iey send an order say- doctors, health Offick 75,000 drug formula
ing that such and such
ers and consumers tions, manyofthem ir
batch should be with
and some ex
precludes even lhe rational,
drawn from the market,
tremely toxic and haz
bijt it takes 3 months possibility of rational ardous. A large number
before the order actually
among these are
prescriptions
reaches the market, and
dumped in India, as in
by that time most of the drugs have other Third World countries, by First
sold.
already been sold."
Wotld manufacturers who are not
The problem, however, is not re- allowed to sell such combinations in
stricted to substandard and spurious
thler own countries.
dribgs alone, but extends to a very
The outcome is that, not only are
large number of 'irrational* drug
dangerous and irrational formula
combmations which are quite legally tions passed off as life-saving drugs,
available in the market. Irrational resulting in enormous loss of life, but
drug combinations are those that are. the lack of unbiased drug informa
known to be either quite useless for
tion to doctors, health officlers and
their declared purpose, or to have consumers precludes even the possi
specific harmful effects that out bility of rational prescriptions. The
weigh whatever limited benefits they
only information available on some
may have. An estimate of the extent of the latest drugs and medical trends
to which such 'irrational' drug com is from manufacturers and suppliers
binations pervade the market is avail who exploit the situation to their
able from a very simple set of facts.
own advantage, thriving on conceal-
men-t and disinformation.
The department of health, how
ever, is not particularly perturbed by
the proliferation of brands. Dr Prem
K Gupta, Drug Controller of India,
responding to queries by SURYA
observes, "Since India is self-suffi
cient in drug formulations and since
there are many pharmaceutical
units, there are bound to be a large
number of formulations moving in
A German victim of the Thalidomide Di&aster
Surya India, March 1991
.....
II
COVER STORY----
The Politics of Medicine
ThA overwhelming power cf the vested Interests In the drug
mdu^ woXTnXtly and surreptitiously, are seldom
Sgsss
PharmaceuticalUenited,
hya Kendra, were bund down, resultingin a
takas. This was one among several attempts on Dr
Choudhury’s life. The Magasaysay Award winnet
been implicated in a case of murder and has been forced to fie
f
<4
:
underground.
and pressures may be generated.
An estimate of the vested interests that arise In the entire
drug trade can be had from the financial stakes o he top
multinational companies whose turnovers often outstrip *e
In Sri Lanka, Dr Senaka BibUe recognised the econontfc ex
ploitation occurring in the name of medlcln^anidatternptal t
G„„
w
-a comparison ofgrowin
evolve a ration ^eadingpharmaceutiealcom^^
companies (in $ million).
Company or country
down.
DrSalvadorAUendeofChllealsosoughttocurbthecontrol
before his assassination. Among the first ta lx
ass^tedhim in ^f^at1on °fa
^drug policy in the interest of his people and country.
nr 7*frullah Choudhury, the Director of the Gonosasthya
s-xr—
formally adopted on June 7, 1982, and the ordinance promul-
8ate<Immedlately the US Government attacked the ordinance,
and S S multinationals expressed resentment and
''P^multaMOUsly, the British Dutch and German Embassies
a»
1
committee of 6 military doctors. Based on the e e
tee Report, a Drug Control Ordinance amendment was an
^“^r^Hafden^Mahler^DlrKmr^e^e^ral WHO, congratubted
Bangladesh on “its courage in starting to P^^15
order along the lines endorsed by the Wordl Health
With Ershad’s demission frorarthe Presidentship, and the
political turmoil in Bangladesh the field is once again consld-
Average yearly
1986
Turnover/GNP change(%)83-86
_
Costa Rica
Bolivia
Yemen
Uganda
Merck Sharp & Dohmc(USA)
Honduras
Cyprus
Hoechst (F?-G)
Mozambique
Afghanistan (estimated 1984-6)
Lebanon (estimated 1984-6)
Ciba-Gelgy (SWI)
Bayer (FRG)
Senegal
Nicaragua
Iceland
Albania (estimated 1984-6)
Papupa New Guinea
American Home Products (USA)
Nepal
Madagascar
Haiti
Pfizer (USA)
Sandoz (SWI)
Glaxo (UK)
Ell Lilly (USA)
Roche (SWI)
Zambia
Abbott (USA)
Warner Lambert (USA)
Guinea (estimated 1986)
Bristol-Myers (USA)
Jamaica
Smith Kline (USA)
Upjohn (USA)
Rwanda
Congo
<
Johnson £< Johnson (USA)
Takeda (Jpn)
Wellcome (UK)
Niger
Boehrlrtger Ingelheim (FRG)
Mongolia (estimated 1984-6)
Schering-Plough (USA)
Barbados
Mali
3,996.0
3,900.0
3,850.0
3.680.0
3,441.0
3,330.0
3,052.0
3,042.6
3,003.0
2,924.0
2,889.0
2,851.2
2,787.5
2,772.0
2,686.0
2,682.0
2,604.0
2,592.0
2,560.4
2,535.0
2,369.0
2,244.0
2,203.0
2,155.1
2,143.2
2,119.8
2115.0
2,070.0
2,057.0
2,041.0
1,984.0
1,961.7
1,932.0
1,896.0
1,863.0
1,827.0
1,782.0
1,731.7
1,700.0
1,675.7
1,638.0
1,616.9
1,560.0
1,557.6
1,545.0
1,494.0
"A
13.9
6.7
4.0 1
4.4 I
10.9 |
6.2
5.3 I
4.7 j
-4.1 i
6.2
1.2
9.1
3.5
-0.2
-0.8
8.1
2.2
3.0
0.3
-/.7
5.4
5.3
11.5
17.5
7.9
9.8
-20.3
8.0
I
|
i
11.5
7.4
8-4
-15.8
8.2
10.7
5.5
-5.5
12.0
3.8
12.0
V
8.2
3.4
12.0
7.7
5.0
Table: Andrew Chelley, A Healthy Business?
World Health and the Pharmaceutical Industry.
Surya India, March 1991
10
1
I
*
L
COVER STORY
the market. For example, if slonally hazardous combi
100 pharmaceutical units nations) of chemicals that
manufacture approxi find no place on the WHO
mately 300 drugs given in list. What is more, with the
0
the WHp essential list un total absence of reliable and
der different brand names, easily accessible informa
the tptal number of formu tion, Doctors often fall to
lations woutyd be 300x100=3,000. In understand what they and
India there ?re about 20,000 pharma their colleagues are prescrib
ceutical units. Including about 200 ing, with possibly drastic
big DGTD registered units." From results for their patients.
this point of view, presumably, the •The number of combinaDrug. Controller would not beJ un- tlons available on the piarduly aviated even if the number of ket is so large/ observes Dr
tformulations on .Ithe market went up
Shiva, "that neither
to 20,000x300=6,000,0001 1.
Doctors nor Chemistscan be
’ But the argument is non sequiter. completely familiar with
It shifts imperceptibly from citing them. There is compelte
the WHO essential drug list to the In chaos. I don’t know what
numerable brands of garbage avail your favurite drug is — and
USE SAFER
able on the market The fact, how when the patient comes in
ALTERNATIVES
ever, is that, despite the proliferation half dead to the hospital, 1
of brands, India has a chronic short can't make sense of your
age of essential drugs. Says Sen prescriptions. You just don't
Gupta, "We have about one-third of know the ingredient. No
ORAL REHYDAATION
total leprosy patients in the world body thinks ingedient. They
tbday. We have about 500,000 think brands."
deaths due to Tuberculosis every
The situation, feels Dr
year. And the production of anti-TB Shiva, has arisen at least
VHAI campaiffn affainst Quinol derivatives
and anti-leprosy drugs is under 50 partially because of the pric
per cent of the target every year. The ing structure. Drugs needed for the drugs for which they can charge what
Government has consistently failed National Health Programme, and they please."
to compel the industry tb produce other life saving and essential drugs
At a 75 per cent markup for Cate
essential drugs. The 1978 Drug Pol are all listed by the Government as gory I drugs and a 100 per cent
icy, based on the Hathi Commissions Category I and Category II drugs, and markup for Category II drugs, the
recommendations, had a stipulation their prices are fixed by the Govern drug industry claims that it is being
that 20 per cent of turnover of any ment, All other formulations are driven to sickness due to low profits.
company was to be made up of essen decontrolled. "So manufacturing The industry claims an overall prof
tial drugs. This recommendation was units prefer to produce decontrolled itability of barely 5 to 7 per cent (this
never implemented, and finally, In
the 1986 Policy, that clause was
Useless Drugs
scrapped
totally."
•
Another point, missed out quite
* Protein powders and liquids: an adult need 60 gm of Protein a day and a child
completely by the Drug Controllers
3-4 grams of protejn/kg a day. If a child consumes protein from protinules, the
obtuse alibi, is that the formulations
cost would be Rs ib/day and if protone liquid, Rs 35/day. 100 grams of protein
available on the market are largely
from wheat, gram, groundnut and jaggery would cost about Rs 4/- day.
irrational combinations (and occas* G1 ucose powder: e.g., (iiucon D costs Rs 9.50 for 200 grams. 250 grams of sugar
cost about Rs 1.25. You ^pend more only to inflate the industry.
Harrassedt
* Red injections of Vitamen Bt, B6, Bia. Anemia due to Bu deficiency is very rare
Hounded, Driven
in India.
out: Dr Zqfrullah
Chowdhury, the
* Vitamin E preparations: the anxiety of Infertile couples Is being exploited by
man behind drug
drug manufacturers.
;
policy rationali*
* Placcntrex (An extract from the placenta): is not mentioned In any standard
sadon In Bangla
desh.
medical textbook.
* Encephabol and Hydergine are expensive and cannot regenerate destroyed
nerve cells.
* Stryptics (stypobion, styptochrome, styptindon, botrapasc, etc.) have no
■t'4 .7
proven efficacy in the treatment of bleeding.
®
8
I
I
t
!
i
r
r
i'i
■ Wr
!
J
___ >
91
11
Irrational Drugs
COVER STORY
MM Includes profits from decontrolled drugs), and argues
that manyunits are already
on the verge of closure. They
r,
have consistently been produring much less than the
requirement of essential and
Categorised drugs, although the
number of decontrolled brands is
multiplying constantly on the mar
ket.
The Industry's assertions on
profitability are a little hard to swal
low, though it Is equally difficult to
incontrovertlbly prove the contrary
in the absence of any data. The ab
sence of data, however, is largely a
consequence of the industry’s un
willingness to provide reliable
Information, and this suggests
that there is a great deal to hide.
"IMs almost impossible to find
actual levels of profits in the
industry,” asserts Sen Gupta,
"The Bureau of Industrial Cost
Pricing (BICP) is supposed to de
termine costs and suggest suit
able prices for all drugs. But
BICP officials tell us that they
have actually been physically
cheaper substitutes are available. Examples are.
; sssssssa;
included in the WHO essential drugs list.
♦ Fixed dose combinations of:
Tetracycline with analgin or Vitamin C
m Chloramphenicol with Streptomycin
Penicillin and Streptomycin
More than one anti-histamlne
Antihistamine with tranquillizer
Analgesics and Vitamins.
Pain killers like codeln, caffeine and phenacctin.
.
T
Illness becomes a dreaded night
mare, with the possibilities of
contaminated drugs everpresent
Hazardous Drugs
- „
with a clearlv high and
and unfavourable
unfavourable benefit/risk
benent/nsK ratio
iauv and
«*>«
Th
' “X SXt
S“->« ■»" ■te
bJ’k' °.h'.
course, wa
ab
number of hazardous drugs still available on th
diffiCUlty in getting data, and in
.na
S”“
.hi .hey W
cm p,od„„ sub,„„
market, especially in India
* Halogenated clioquinoline^ —). 130 brands are available on the Indian
myelo optic neuropathy (SMON).
22RSpm’w S w
I
1
assaulted when they have gone
to the vnits for surveys. The
industry just refuses to give
data. However, the NCAER
(National Council for Applied
Economic Research) did a study
to find the breakeven markups,
ai>w they came up with a figure of 53
per cent. This Study was sponsored by
the Organisation of Pharmaceutical
Producers in India (OPPI), that’s the
multlnational lobby in India. And
t"------ -------- 7“
«« o'"””*'
c,n
■ SESSSSi—
The NCAER did a study to find
the breakeven markups, and
the companies.
Nonetheless, if a markup of S3
per cent was evaluated asbeingremunerative in an industry sponsored
study, it is hard to understand how H
could be going sick at a markup of 75
per cent for Category I and 100 per
cent for Category II drugs, especially
when the combined production of all
such listed drugs is barely 10 per cent
Surya India, March 1991
i
%
•e;.
i
Lying For Sales
COVER STORY
The killing competition between the over 60,000 formulations in a small
market of just 20 per cent of the population who can afford them results in a
resort to a variety of unethical marketing practices. These could number in the
thousand, but a few examples can suffice to indicate the extent to which
pharmaceutical companies will go to fish into the pockets of hapless patients.
* Glaxo Laboratories cited the authority of the enormously respected
medical journal Lancet to promote its sales of Ostocalcium B-12, even
’ though there was no such endorsement of the product in the journal.
* Boehringer-Knoll quoted UNICEF and used their logo to promote the use
of streptomycin-chloramphenicol combination for diarrhoea treatment,
whereas UNICEF actually promotes simple oral re-hydration therapy for
most common diarrhoeas.
* Franco-Indian Laboratories misquoted Goodman and Gilman (a stan
dard pharmacology textbook) to promote their tonic as beneficial for
anaemia, whereas Vitamen Ba has no role in ordinary anaemia.
* SG Chemicals misquoted Goodman and Gilman, and Martinadale (a
standard pharmacopia) to promote a combination of two dangerous
drugs, analgin and oxyphenbutazonc, whereas, in fact, the texts warn
against the use of this dangerous combination.
It required an eight year long legal
battle, resisted all the way by the
drug industry, to get the hazard
ous Estrogen Progesterone combi
nations banned
of the industry's annual turnover
of Rs 3,500 crores.
Expert^, however, suggest
that a few units may, in ^act, be
going through some difficulties,
not as a result of price controls,
but rather due to the absolutely
distorted, indeed absurd, direc
tion in which the industry is
growing. "The Industry is now
caught in a loop," argues Sen
Gupta, They are targeting at a
very middle class market which
constitutes lOto 15 percentof the
Indian population. That's the
kind of people who can shell out
^’Advertising plays a very small
^ple in essential drugs. It’s only
U? forzIrrational and useless
products that you are Incurring
../ .those expenses."
<
the money to buy their drugs. To get
to that market, the amount of pro
motional expense they are incurring,
that is a spiralling expense for the
industry. All this is their own fault.
With certain essential drugs, they
wouldn't even have to put up one
chit ofpa per to sell. Advertising plays
a very small role in essential drugs.
You don't have to promote an anti-
Surya India, March 1991
leprosy or anti-TB drug. It's only for
irrational and useless products that
you are incurring those expenses."
Even so, the plea of sickness is
somewhat incredible, particularly in
an industry that has, on occassion,
imposed a price markup of right upto
1000 per cent for some of its products
(Baralgan Ketone, produced by
Hoechst, for instance).
Whatever the case, the result is
that the total growth in the drug
market today is artificially pumped
up with advertising hype, and far
more money is going into advertising
than into research and development,
and none at all into clinical and con
firmatory studies regarding the side
effects of various (especially con
troversial) drugs. "The drug indus
try often claims it's doing a lot of
innovation. But the maximum in
novation it's doing is in the field
of advertising. Finding out mar
kets which have no use except for
getting them higher revenues."
Whatever the case may be,
the current situation is one of
medical anarchy, with the hapless
patient a vulnerable, and totally
uninformed victim of an insensi
tive, profit oriented industry.
The comprehensive failure of
the government to check this fla
grant abuse of public trust, and
the assault on the health and lives
of the people that it constitutes, is,
at least partly, a consequence of
the information lacuna, on the
Double Standards
Multinational companies do not promote many drugs in their own countries
or in any developed country, but dump these drugs on India and other Third
World nations. Some examples of such drugs, available in India, but banned
in their country of origin, are;
Name of Drug
Company
Country of Origin
Avil Expectorant
Soventol Expectorant
Hoechst
Boehirnger
Knoll
Glaxo
Merind (MSD)
Glaxo
Pfizer
Hoechst
Hoechst
CI BA Giegy
FRG
Piriton Expectorant
Periactin
Ostocalcium B12
Amebiotic
Novalgin
Baralgan
Suganril
FRG
UK
USA
UK
USA
FRG
FRG
Swiss
COVER STORY
I
these systems has been wrongly
taken advantage of by innumerable
manufacturers, who are selling all
sorts of formulations, many of which
have no basis in the literature of
traditional medicine, as ayurvedic or
unani products. Unfortunately, in
—Dr Shakeel-ur-Rahman,
doing this they are not violating, but
Minister for Health and Family Welfare
only skirting the law. Often, by add
ing or identifying a single herbal
ingredient in their product, they seek
In India there are owr20,000phar to a rationalisation of drug policy in
India.
to avoid pricing and other controls.
maceutical units producing approxi
It is an officially accepted fact that There is an urgent need to review all
mately 63,000 drug formulations. The
WHO List ofEssential Drugs consists of one out of every five pharmaceutical such formulations, in fact, to review
all drug formulations in the market,
250 drugs and just seven combinations. products^ are substandard or spurious,
What measures have your undertaken to and that many of these are manufac to correctly determine their efficacy,
bring the situation on standardisation of tured by large and multinational compa and to see that the consumer is not
drugs in conformity with international nies. What steps have been undertaken cheated through unethical advertis
by you to attack this problem?
ing and marketing practices.
norms of safety?
The testing of standards is the re
This is a tremendous exercise,
I can only agree with you that
and the resources required are not
the situation relating to the prolifera sponsibility of the States, and there Is
immediately available. However, we
tion of brands is causing great con little we can do on a day to day basis.
cern. However, the interests in per However, the Health Ministry moni are certainly going to initiate a
phased review in the immediate fu
petuation of the system are en tors the activities of the various Drug
ture. Also, I feel that a strong con
trenched. Over 15 years have elapsed, Control Authorities in the States.
The present machinery to monitor sumer movement, and efforts at
since the recommendations of the
consumer education can help
Hathi Commission were accepted as drug production and to test finished
products
is
completely
inadequate.
counter the trends to mislead and
the correct direction in which drug
What measures do you plan to improve cheat the consumer. The ministry is
policy in the country must evolve,
planning to coordinate its efforts
the situation?
but none of the recommendations
It is proposed that both the
with those of various NGOs and
have actually been implemented.
consumer groups active in this field.
The Health Ministry had, in the monitoring and testing facilities
Why have the rec
should
be
expanded.
The
past, attempted to nationalise the
ommendations of the
situation at least in terms of bringing difficulties here are fi
"I personally
Hathi Committee not
most essential drugs under price nancial, as the burden of g stand totally
been implemented till
establishing
testing
fa
control after the drug policy was
^committed
to
now? What are the plans
cilities
in
the
States
announced In 1986. We had sug
relating to their imple
■■'a
rationalisa-,
*
where
they
are
lacking
of
gested the Inclusion of some TOO
mentation?
tion of drug
essential drugs in the list of Category inadequate, would be
Successive Gov
I drugs. Eventually, however, only 27 enormous.
policy in
ernments
have failed
At least for testing of
were included.
India."
to
Implement
the
drug
standards,
the
existi
■
|
The problems here are that the
Hathi
Committee
re
ing
infrastructure
of
vari
Ministry of Health alone is not in
volved. The Industries Ministry, the ous research and educational institu port, despite a theoretical acceptance
Ministry for Petroleum and Chemi tions may be utilised. We are working of its findings. The only reason I can
discover is an absence of the neces
out the logistics of this at present.
cals, they play the defining role in
Formulations of traditional medi sary political will, and the enormous
drug policy. This itself is an anomaly,
and needs to b£ seriously looked into. cal systems often make exaggerated and clout the drug lobby exercises over
As Minister, I have been apprised unsubstantiated claims of effectiveness the political executive.
Speaking for myself, I can say
of the immerise problems relating to fora variety ofills. What steps have you
that the political will is now not lack
taken to standardize such medical for
hazardous and irrational drugs, and I
ing. We have not had sufficient time
realise the necessity and urgency of mulations?
to take action, and the issue is com
The
traditional
medical
and
drastic refbrm in this field. We are
homeopathic systems are respond plex, involving more than one minis
currently appraising the situation
try’. Action has already been Initi
ing to the same market forces that are
and seeking to coordinate action
with the Other ministries involved. I creating havoc In the allopathic drug ated, however, and we shall defi
nitely show results soon.
market. Our policy’ of encouraging
personally stand totally committed
".I
“Enormous Clout of the Drug Lobby53
14
Suiya India, March 1991
COVER STORY
f- ■
'
“Bungling and Corruption”
—Rasheed Masood, mp (jd),
Despite a very brief tenure of five months as Minister of State for Health and Family Welfare,
Rasheed Masood insists that he had already initiated moves for a overhaul of the Government's
practices relating to substandard and spurious drugs, and had demanded the whole issue of drug
policy be placed under the Ministry of Health, Excerpts from an interview:
* In my opinion, not only drug policy, but tht; entire
Health Ministry is very wrongly placed. The responsibil
ity for implementation is cent per cent that of the State
Governments, but the Central Government is answerable
for what they do. The result is that, in most matters we
find it impossible to defend our failures in the House. We
keep writing to the States, but no one pays any attention.
* There must be a single cell involving both Central and
State representatives, to monitor the entire drug scenario.
* Interestingly, the Health Ministry has nothing to do
with the drug policy. It comes under the Ministry of
Chemicals. But we are answerable again. Quality Control
is our problem. Production is under them. I had written
during my tenure that the entire drug policy formul ation
and implementation must be brought under one minis
try.
* There is enormous bungling and corruption in the
listing of Category I and Category II drugs. They are no
experts on the Committee that draws up these lists. In
fact, let me tell you something amazing that happened
while was in charge. I directed the Secmtary Health to give
me details of the nominees of the Committee of experts
for deciding Category I ?nd II drugs. I was away for a few
days, and when I returned, I asked the Secretary what had
happened in that matter. He told me he had already
finalised the list of 150 drugs and sent it to the Ministry
of Chemicals, He completely bypassed me. I sent for the
file again, but it wasn't brought back while I was there. Of
course, our ministry fell a little later.
* 1 feel that all manufacturers of substandard drugs should
be blacklisted in perpetuity. And not only should the
companies be blacklisted, their owners should also be
balcklisted, so that they can't set up a new company and
restart manufacture.
* I agree that our drug policy is irrational...
* There is no sentiment of service in the industry. It's just
a question of making profits - that is the one point
programme of the manufacturers. And that is precisely
why these fellows under us, these bureaucrats, yeh kahte
hain aurgadbad hoti chali jaati hai (they take bribes and
this hanky panky continues).
* 1 think there should be a review of our drug policy in its
entirety. A central committee should be formed and
should also go into the question of hazardous and irra
tional drugs. We can reduce the total number of formula
tions to 200 or 250. We intended doing this. Unfortu
nately, the very little time our Government had made this
impossible.
* Even if you don't go so far as to remove the multination
als, you will definitely have to place restrictions on them.
They are blocking indigenous development.
Tonics - A Waste Of Money
Common Brands: Bayer's, BG PHos,Neogadine Elixer, Orheptal, Ranbaxy’s,
Santevinl, Dexorange, toniazol, Hepatoglotin, etc.
Used and Propagated for: Debility, Chronic diseases, loss of appetite, restora
tive, weight loss, fatigue, etc.
Why^Irrational: What is needed in the above cases is an adequate mixed diet
and not tonics which are mixtures of B-complex vitamins in solutions of
sugar and alcohol. None of the above cases can be cured by vitamins.
Morever, if vitardln deficiency occurs, it is to be treated by supplying the
specific vitamin tohich is deficient, and should be taken in dry tablet form.
No medical textbook recommends the use of tonics.
Why Irrational: Consumption of B-Complex vitamins as tonics may not be
hazardous as such, but other substances like caffeine, strychnine, Leptazol,
etc, present along with it are potentially harmful. Regular intoke of excess of
vitamin A and D are hazardous.
Tonics and health restoratives are banned in Bangladesh.
The plea of sickness Is
somewhat Incredible,;
particularly Inan
industry that has, on
occasslon, imposed a /
price markup of right ;
upto 1000 per cent tor .x
some of Its products
(Baralgan Ketone,
produced by Hoechst,
15
COVER STORY
one hand, and the absence
of adequate facilities to
gather required informa
tion, on the other. Various
health activists representS ing voluntary’ agencies insist that government follow
WHO guidelines and international
standards, banning all drugs that are
currently banned in the Western na
tions. There is, however, a certain
degree of conflict on this count as
well, as no universal norms arc fol
lowed throughout Europe and Amer
ica. Furthermore, official experts in
sist that local conditions vary, and so
do the effects of the drugs. Thus,
speaking of entroquinol, a drug
banned in many Western countries,
the Health Minister, replying to
questions raised in the Parliamentary
Consultative Committee Meeting
held on 26.7.90, stated that, "The
drug entroquinol, a hydroxyquino
line derivative, is not banned all over
the world. It is marketed in many
countries, particularly where Amoe
bic diarrohoea is very prevalent. The
drug is marketed In 34 countries in
cluding Austria, Canada, France,
Germany and Mexico. The drug was
banned in Japan due to a topical ad-
tion (sic)." The result is that the drug
is freely available for use in India as
an across the counter remedy.
However, the 'expert opinion'
expressed in this case, as in other
cases, goes little beyond intelligent
guesswork. There are few, if any field
studies, virtually no research or data
MOWO
&"You cannot have the >e double standards: you introduce a drug
Kased.onjttudles Jn the West, but ae not prepared to ban a drug on
similar studies” • ; ■
■
■
j
Peddling Placebos
Cough Syrups/Expectorants
Common Brands: Avil, Benadryl, Cadistin, 5heS?n'DuOreXl?Op?°tnn
Cosome, Deacos, Dilosyn, Driostan, Grilincutus, Kanaka, Phensedyl,.
n,
Tixylix, Zeet, etc.
Why StFonSirough sy^up^are mixtures of drugs which stimulate
coughing (Ammonium chloride. Ipecac, Etc), as well as those that suppress
coughing (codeine, noscapine, etc.) and antihistamines that dry the secre
tions (Benadryl, Piritone, Avil, etc). Coexistence of such drugs in a syrup is
abslolutely unscientific and irrational. Coughingis a protective activity of the
body. It should not be suppressed except in certain conditions. In these cases,
single ingredient cough suppressants (codeine, dextromethorphan, etc.)
WhyH^aXus: Prolonged use of cough syrups is habit forming; may cause
stomach upsets; reduce food intake; cause drowsiness. Chloroform preset in
many of these cough syrups may damage the liver and may even cause cancer.
Bangladesh has banned all cough syrups and combinations. No cough syrup
or cough lozenge has been included in the WHO essential drug list.
verse reaction seen in Japanese popu
lation suspected due to administra
tion of the drug. Adverse reaction
started with skin reaction, peripheral
neuritis and finaly leading to a syn
drome of eye disease called SMON.
The Opthalmologists and expert
bodies like ICMR were consulted and
commented that drugs like entroqui
nol is cheap and essential for the
treatment of Amoebic diarrohoea
and they have not come across such
edverse reaction in Indian populaliving as they do. at ths very edge
cf despair, a vast majority qf our
fopulation lacks access to even
the most essential and life saving
drugs, while the markets are
.flooded udth expensive garbage.
j
1
collection, and no clearly directed ef
fort to confirming or disproving the
allegations relating to a particular
drug. It is only when a major tragedy
draws media attention to a particular
formulation that some action is
taken. More often than not, the drug
soon reappears on the market, with
some minor changes, under a differ
ent brand name.
There is, however, a major flaw
in the offical argument. Tn many
cases," observes Sen Gupta, "there is
evidence of unacceptable risks asso
ciated with particular drugs. Mainly,
these are reported from outside India
because we have a very weak surveil
lance system, and there is no moni
toring of adverse drug reactions. In
Surya India, March 1991
1
Cures or Trips?
the West, they have fairly elaborate
systems of monitoring drug reac
tions. Whenever the question arises
of banning a drug in India because of
reports outside India regarding the
hazards of its use, the official plea
given for continuing these drugs is
that these reports are not Indian re
ports. The point is that, one, there
are no Indian reports. And, secondly,
when these drugs are introduced in
India, the studies quoted are Western
studies. You cannot have these
double standards: you introduce a
drug based on studies in the West,
but are not prepared to ban a drug on
similar studies."
This widespread availability of
hazardous drugs is thus largely con
sequent upon the absence of an ade
quate mechanism to monitor drug
quality and reaction. The possibility
of effective preventive measures by
Government is completely pre
cluded by the fact that there is, rela
tive to the need, almost a total ab
sence of testing facilties. Only four
A staggering 62 formulations have Alcohol listed as one of their major
ingredients. These include a vast array of combinations ranging over:
Tonics (BGPhos)
Mouthwashes (Dettolin)
Expectorants (Eskold)
Nasal Drops (Dristan)
Sedative Syrups for babies (Vallergan forte Syrup)
Remedies for toothaches (Gelosa)
There is no rationale to this, except that the effects of alcohol as a depressant
of the Central Nervous System are evidenced. This is completely unrelated to
the symptoms or disease these 'tonics' and formulations are supposed to cure.
Quality testing facilities (above)
ait severely inadequate, as both
large and small manuj'aeturers (be
low) produce substandard drugs.
| N'imeofCo.
Country
No. of substandard
Samples
| BAYER
OTS
-ROUHS WELLCOME
A GEIGY
ERCK
XO
CHS!
IND (MSB)
ER
CHE
FRG
UK
UK
SWITZERLAND
FRG
UK
FRG
USA
USA
SWITZERLAND
13
9
8
4
2
10
7
11
9
5
States in the country have fullfledged drug quality testing laborato
ries, and 10 states have facilities to
test only non-bilooglcal drugs; most
of these laboratories have inadequate
equipment and manpower to per
form their tasks satisfactorily. With
over 60,000 combinations, it is obvi
ous that this situation is unaccept
able. Barely 26,000 samples are tested
every year as against millions of
batches of drugs turned out by thou
sands of geographically dispersed
manufacturing units. Worse still, fa
cilities to test adverse drug reactions
are virtually non-existant.
The situation relating to field
inspection of drug units and retail
outlets is similarly abysmal. Ther are
just about 800 drug inspectors, as
against 2,689 recommended by the
Health Minlstery Task Force.
The result is that a large number
of hazardous drugs continue to be
marketed in the country, and the colection of evidence is virtually impos
sible. Less than 10 per cent of prose
cutions against manufacturers of
spurious and sub-standard drugs re
sult in convictions.
81 survey showed 135 substandard products out of 218 samples collected,
ufactqred by 23 multinational companies. This table lists the major
ufaetdred
•lets.
17
Do Doctors Know?
1 t
That only 20 per cent of our people have access to modern medicine.
That 50 per cent of drugs are sold over the counter without prescription?
That medical students are taught about drugs, but not the economics
behind drugs?
That after the medical student graduates all his subsequent education is
taken over by the drug representatives?
That generic names are taught In medical colleges but the prescriptions are
all in trade names?
Out of 218 cases of substandard production of drugs, 135 were from 23
multinational companies?
That vitamen A is in short supply while 40,000 children in India go blind
each year?
That the bulk of the drugs produced and sold are tonics, cough syrups and
pain killers, while drugs for leprosy, tuberculosis and malaria are in short
supply?
t
The 60 million people in India suffer from endemic goitre for want of
iodized salt?
The drug policy is formulated by the Ministry of Chemicals rather than the
Ministry of Health?
w
I
1{
I
i '.
i
i
I
other states.
jk
Conversely, through anotfijj
order, the Drug controller direct^
the State Drug Controllers to banlw
manufacture of high dose estrogen
and progesterone combinations
from March 31,1983, and their sales
from 30 June 1983. Three drug com
panies obtained stay orders from the
High Courts of Calcutta and Bombay
on the grounds that the Central Gov
ernment has no powers to ban the
manufacture and sale of drugs. An
other fact that emerged from these
cases is that one of the multinational
companies Ms Organon [known in
India as Infar (India) Ltd] is prohib
ited from manufacturing and selling
the product in its parent country,
Source VHAI
Netherlands.
Thus, through various court
orders,
it appears that neither the
The
impotence
of
these
legal
The existing legislation on the
State
Governments
nor the Central
subject, furthermore, presents a sce provisions is evident in the case of
Government
is
dd
facto
empowered
nario of contradictions and inade the attempts to ban amidopyrine.
to
ban
dangerous.or
irrational
drugs.
quacy. Currently, drug quality con The Drug Controller of India directed
It
was
only
after
an
eight-year
legal
trol comes under the Drugs Cosmet the State Drug Controllers to ban the
battle
that
the
Hydroe&trogen-Proics Act of 1940 (Amended in 1955, fixed dose combinations of arfiidopgesterone combinations were
1960, 1962, 1964, 1972, 1984); The yrine with effect from February 1982.
Drugs and Magic Remedies (Objec When the Maharashtra Dru£ Con banned. And these were extremely
troller issued orders for the b&n, sev hazardous drugs. "These were being
tionable Advertisement) Act, 1955;
the Dangerous Drugs Act, 1930; and eral multinational drug companies marketed as pregnancy fest kits with
the Poisons Act, 1919. These Acts obtained a stay order from tht Bom out a warning to the another that
they could cause severe congenital
give apparently sweeping powers to bay High Court o.n the ground that
these drugs were allowed to be sold in abnormalities," points out Dr Shiva,
the Central government for the conrecalling the protracted
trol of drug quality and
legal battle in this case, "In
marketing, as well as to
the West, women were us
ban Import and manufac
felt appears,ihat neitter:the State Governments nor
ing these drugs to find out
ture for sale of such drugs
Sthe.Ceiitral;Go¥ernment
is de'•--------facto empowered to
at the earliest if they were
T'
...................
as are therapeutically irra
pregnant, in ordrer to ter
tional or which involve
minate pregnancy. In In
risk to human beings and
dia,
however, women who
animals. Rules framed
If Health for All U to be taken as a
wanted to have a baby
serious programme, manufacturers
under these Acts also pro
must be compelled to produce ade
were using these kits to
vide for the banning of
quate supplies of essential drugs.
confirm pregnancy. It was
drugs, the manufacture,
really criminal. Especially
sale or distribution of
since we found that Or
which is prohibited in the
^EST BENGAL STATE RUM* .WmwlM ganon wasn't allowed to
i
coutry of origin. .
....................
sell the drug in the Nether
Despite these laws, a
lands. Yet, only after a
wide range of drugs
41- 4i$ i
great hue and cry, was the
banned, in the country of
l
obile
drug eventually with
origin are being dumped
drawn from the market in
in India, and the manufac
- ( 1988."
ture, import and sale fo
The fight ban a single
therapeutically irrational
drug,
on which an elabo
and hazardous drugs con
rate data base of clinical
tinues unabated.
&
-Sl
*»
,
'
''
_W
-
♦_
2
*
P
... A —
r.-:
_ - a.
a. —?
A —.
-*’_________ »-»“k_______
i * 'OMM
M
f
it
18
Ro
Surya India, March 1991
I
HI trials already exists, can
|i thus be totally exhausting.
I Where such completely in
fl controvertible evidence is
W not in existence, or where
M there Is even a little controil versy In medical circles re
garding the possibility of its efficacy,
all the efforts of government and vol
untary agencies would prove worth
less against the legal quibblings of in
dustry lawyers. The result is that the
Drug Controller of India and the
State Drug Controllers are rendered
totally ineffective, and drug manu
facturers continue to produce these
harmful drugs with impunity.
Interestingly, the Government's
initiatives to promote traditional
medeicine systems (such as Ayurveda
and Unani) and homeopathy has
had its own unfortunate fallout, add
ing to the already chaotic medical
remedies scenario. These systems do,
of course, offer cheap, and perhaps
safe, alternatives to the allopathic
system in many cases. Unfortu
nately, the trade in these medeicines
is almost completely out of the
Government's control, concentrated
as it is in the hands of unregistered
practitioners, and often of quacks,
who are marketing untested and sub
standard combinations with claims
of miraculous cures for a wide range
of aliments from the common cold to
cancer.
Some of the larger producers,
such as Dabur and Maharishi Ayur
veda are now aggressively marketing
brands of specific combinations for a
range of ailments, including paracctamols, antacids, asthama cures,
and liver treatments. Virtually noth
ing is known about the composition
of these formulations, and there is, of
course, no available data on clinical
trials.
"Take, for Instance, Liv 52, a
Hamdard product," observes Sen
Gupta, "For years it has consistently
been one of the top ten selling
brands. It has a total turnover of
something like Rs 15 crores annually.
Uptll.now, I have yet to see a study
where it has been. conclusively
shown that Liv 52 acts in any condi-
Surya India, March 1991
Anti Drug-price rise rally at Calicut
tion. Yet, if you have jaundice, and
go to a Doctor, nine times out of ten
doctors will prescribe Liv 52. I can
challenge you that none of the Doc
tors know what the ingredients of Liv
52 are, what their actions are, what
their side effects are. That's the kind
of thing advertising builds up."
The unregulated administra
tion of such Treatment* has a double
danger: In the first place, these 'cures*
may actually be harmful; secondly,
even where they are no more than in
effective, they cause undue delay In
the administration of scientifically
tested therapy, often taking the gul
lible patient over the brink before he
is taken to a recognised hospital or
medical practitioner.
The gravity of the situation relat
ing to the unregulated traditional
medicines bazaar can be estimated by
the fact that almost 70 per cent of the
population (primarily the poor) is
still dependent on locally available
traditional skills. ^The market In
duced distortions, consequent upon
the 'herbal remedies fad* have furthermagnified the problem, unloading
hundreds of brands, most of them
? "None of the Doctors know what the Ingredients of Liv 52 are, what
the,r actions are, what their side effects are. That's the kind of thing
advertising builds up"
7
The Hath! Committee
Main Recommendations;.
Nationalisation of Multinatirial Drug Companies.
Establishment of a National Drug Authority.
Priority Production of 116 Essential Drugs.
Abolition of Brand Names and introduction of Generic names.
*
Revision and updating of the Indian National Formulary.
*
Strengthening of quality control.
*
Elimination of irrational 4rug combinations.
The Committee on Drugs and Pharmaceuticals (commonly known as the
Hathi Committee), appointed by tne Ministry of Petroleum and Chemicals,
submitted Its report In April 1975.
The Report provided the inspiration for the formulation of Bangladesh's
National Drug Policy, the most radical policy in the Third World.
Not a single recommendation of the Hathi Committee has been imple
mented in India.
*
*
*
Source: AIDAN/VHA1
'
COVER STORY
i
garbage, of 'authentic and
Akw safe herbal remedies’ for
J just about everything. Their
ran8e vades from toffees
with high sugar content, laf'JRn belled 'Ayurvedic digestive
LZS&J drops' (e.g. Swad, which is
97 per cent sugar), to high alcoholcontent preparations (medicines
which contain more than 24 per cent
alcohol, e.g. Mrit-sanjecvani sura)
which are commonly sold as liqueur
substitutes in dry areas.
Dr Unnlkrishnan of the VHAI
writes, "From a study of the range of
ayurvedic products sold, it emerges
that the main emphasis is on the pro
duction of cosmetics and tonics
which have nothing to do with the
basic needs of the people. Of the Rs
150 crore annual sales of Dabur India
Ltd, 80 per cent is from just 24 of its
products, most of which arc nonessential. Yet this company has a bur
geoning growth rate of 25 per cent
every year, its turnover doubling
every three years."
Comparison Of Expenditures on R&D and Marketing by 52
Multinational Companies
R&D
Year
Marketing
1975- 76
1976- 77
1978-79
In Lakhs of Rs.
107
136
156
1317
1462
1534
Source: M Bhagat, Aspects of Drug industry in India
drugs, like 30 Plus and
Another reason for
Vicks Vaporub con- other tonics, you can
the explosive growth of
get to the consumer
the herbal remedies mar ■ ialns Menthol. The
diretly. You don't have
ket Is that they are com1986 drug policy
pletley outside price brought Menthol under to go to the Doctor.’
most signifi
control. The result is
price control. Over cantThe
problem in this
that, even traditionally
night. Vicks Vaporub scenario of chaos is the
allopathic drug produc
ingcompanies are jump began to call Menthol lack of coherence in the
ing onto the ayurvedic/ by Its Ayurvedic name overall policy perspec
unani bandwagon. "You
and became a herbal tive. Perhaps the most
significant reason for
can charge just any
remedy this is the Ministerial
thing," notes Sen Gupta,
"as soon as you call your medicine an breakup of responsibility., with the
Ayurveic product. Take an interest entire drug policy being determined
by the Ministry of Industries and
ing example, the case of Vicks
Dr
Olle
Vaporub. Vaporub contains Chemicals, while the Ministry of
Hansson- one
Health is supposed to be responsible
Menthol, and the 1986 drug
of the pioneers
for
implementation, and has noth
policy brought Menthol under
in the struggle
ing
to
do with policy formulation. As
price
control.
Overnight,
Vicks
to protect the
consumer
a matter of fact, as must be clear by
Vaporub began to call Menthol
from hazard
now, the Health Ministry can do
by its Ayurvedic name, and
ous drugs, who
started claiming to be an Ayur little by way even of implementa
died recently
tion, except in the Union Territories
of cancer.
vedic product. So overnight
and in the CGHS schemes, since,
they came out of price control."
Qncc again, implementation of drug
He adds, "With Ayurvedic
quality control norms is a State
subject, and the States have been
notorious for thier unwilling
ness to take a hard line against
the drug lobby.
One of the critical reccom
mendations of the Hath! Com
mittee, and one that has been
repeated at every Parliamentary
consultative committee meet
ing, seminar and discussion, is
for the formation of a centrally
controlled National Drug Au
thority, responsible for all as
pects of policy formulation and
Dr Zqfrullah Chowdhury (centre),
Dr Mird Shiva (Right), and the late
Mrs Tara All Baig at a raiional
drug policy meet.
Surya India, March 1991
/
COVER STORY v
implementation in connec
tion with drugs. The consti
tution of such a body would
have gone a long way to
wards bringing order to the
$ reigning madness of the
market. Despite the passage
of over 15 years, however, such an
Authority is nowhere nearer consti
tution.
The absence of the necessary
1
*
of its own insecurities. The impact of
a rationalisation of drug policy does
not necessarily imply declining reve
nues. Indeed, when Bangladesh dras
tically cut down its drug list to a bare
160 essential drugs, the revenues of
the major companies, far from
shrinking, continued to grow. It
would, therefore, not be to the detri
ment of the drug industry if It aban
doned the route to chaos that it is
political will to implement this deci
sion in the face of opposition from
the drug lobby is largely responsible
for this failure. The drug industry has
been the single largest beneficiary of
the of the confusion that prevails,
and feels it has a vested interest in
sustaining current levels of disinfor
mation, and in resisting all efforts at
a rationalisation. It has fought tooth
and nail against every effort to Im-
“Government AcUon On Hazardous arid Substan_d^d DruSs
No. Found
Spurious
Prosecutions
Launched
Convictions
Obtained
3,687
31
639
265
27,696
3,987
56
611
281
26787
3,539
35
541
174
Year
No. Of
Samples Tested
No. Found
Substandard
1987-88
26,545
1988-89
1989-90
Source: Drug Controller (India)
currently pursuing, and ceased to be
an obstacle to public health.
Given the complex situation,
furthermore, it is evident that the
current drug policy requires more
than a marginal reform; it requires an
overhaul. Comprehensive screening
of all drugs and remedies on the mar
ket, stringent penalties for substan
dard and spurious drugs, adequate
testing and evaluation fa
cilities, and a National
!i would not be to the detriment of
Drugs Control Authority
the drug Industry If It abandoned
(as recommended as far
A ■ the route to chaos that It Is pursuback as 1975 by the Hath!
am rmri
iA Wfi AR OhSAflClfi
Committee), and tighter
■ • h'JIng,
la and
(BUM ceased to be an obstacle
'
legislation can only be aft
-•
v to public health,
liealth. g
-J------- ——------------------- -— beginning in what promises to be an ardous journey towards
tory of the country. The strike.
public safety in medical treatment.
eventually, failed to materialise,
but certain concessions were The responsibility for initiating these
announced by Government a reforms rests with whatever govern
little later suggesting that a ment that presently holds power at
the Centre, irrespective of the politi
'deal' had been worked out.
To the extent that the drug cal imperatives it may face. Govern
ment and Industry must unequivo
industry has adopted this attltude, it appears that it isa victim cally accept that slogans of liberalisa
tion cannot be permitted to become
excuses for exploitation. The liberali
Increasing testingfacilities U aflrst
sation of drug policy is inextricably
Imperative (above left); and VHAI
campaign for standard Isa Hon of
linked to its rationalisation.
pose controls of any kind. In
deed, the limited efforts by gov
ernment to control at least the
price of essential and life saving
drugs have been resented by the
industry to such an extent that,
in August last year, the entire in
dustry threatened a two day
strike, perhaps the first such
incident in the industrial his-
//
I
i
‘I
Oral Rehydration Therapy Sachets
(lefl)
Ajai Salmi
21
72) rz 7-2.. i o
^elephone i 630091
“Hari Bhari", C-46, East of Kailash-I, New Delhi-l 1 DOSS
Name of the Paper
:
THE ECONOMIC TIMES
: NEW DELHI
Published at
Speculation rife on US hand
in drag policy
------- - past few years. US firms
have been ommendation for price cut. BICP
BCXEj* 12 MARCH
------------declined to do so on the basis of
very critical about
IS TH£RE zz American hand n!lT
ab°Ul Indian
lndian patent
■
the
information offered. The gov
rules
and
----behind me government's policy of I?
and, Were amon? those
disafioumg remunerative prices to s
S lntoping
.plat:,n? india
Indiaunder
under ernment can, of course, cut the
pnee suo moto as it has been
the pnannacemxal industry, fort>
kclause'. 'Many
—‘r Indiani doing.
mg many unns to stop manufac- nc^ have been Penetrating the
Xr"
““
|„ 0„in!
CUtsannouncing
are in lhe °ffing.
A notification
reduc-
« increasingly being talked about Pe'fochemicaJs smack of a cor) azole is being8
d H
current price is around Rs. 325
m the industry. There is no shred Sp,r.Ky ‘^n^ the industry, a- per
kg.
° eytcience to back the allegation. ?Ordln8 10 s°tne industry leader
At the same uae. many in the
A temporary fall in the open
This is a leading item in
mdustry say that . -'deliberate, ^et pnee of a bulk drug on a ’ndia's export basket. As in the
^tematic undermining" of the
“ ^ediauly “se of some other drogs good
tn^try by smxessive governfollowed up by a P™' realisation abroad and comgovern- ^ lOnd
cidenreClnnOt * *
coin" Some ltS.not,r,cd Price, they said. Petition in the home market has at
i C Un,ls which have reeeivrf «>“« led to market prices £
b^hlf^T'1” “ aiS0 supponed c aims under Drug Price Equally- ^'o* the notified price
8
^‘b'^'hatveryfewAmencan allon Account (DPEA) in
’
P
compares have a significant pres- nionl,’s “X there are horrendous
Ibuprofen, metronidazole and
ence m the Indian drugs industry miscaIeulations some of which ap.
an undertmnmg of the Inditm
deliberate rather than a£ amox)’cillin have been other drues
whose pnces were similarly cut in
J tfdustry's profitabd.ty, therefore, cidental.
recent months. The first two are
"ill not hurt the Americans much
TUI recently, the department has again among top export earners.
say industry sources. .
India has become a name to
reducing prices as rec At least in the case of ibuprofen, a
reckon with m global market for ommended by BICP, but ignoring reduction in the domestic price
many drags, affemmg the market ns recommendations for price u; mH benefit American drug comshare of leading western com- creases based on its own cost panitt, which are major players inPMiK. Ethyl Corporation of Unit audits. In a recent instance, it this drug in the world markets,
ed States has been lobbying went one step further by prefer this is particularly so because
against imports of cheap but high ring information on an imponed importers of drugs from India nor
drug and requesting for a rec mally negotiate prices using the
domestic price as a benchmark.
r
ANNEXIJRE.II
EJnigs and Pharmaceuticals (Monitored Bulk Drugs) Prducticn Targets and Achievements (Organised Sector)
Name of lhe Drug
' A/c
Unit
1
2
1987-88
(Actual)
3
Production .
1988-89
Targeti
Actual
4
1989-90
Target
5
6
I. ANTIBIOTICS
•:(7 :
1. Penicillin (excluding 1st crystal)
MMU
304.83
500
330.47
520.00 •
2. Streptomycin
T
248.32
270
243.79: i
270.00
3. Chloramphenicol Powder**
T
94.64
300.00
92.84
300.00
4. Chloramphenicol Palmitate**
T
1.93
5. Tetracycline
I
210.22
400.00
184.33
420.00'
6. Oxyletracsclinc
T
120.62
190.00
164.49
200.00
7. Ampicillin*
rr
235.19
500.00
272.34
580.00'
8. Erythromycin
T
41.50
80.00
40.72
90.00
‘k Amoxicillin
r
48.67
130.00
53.68
145.00
10. Doxycycline
T
17.94
10.00
9.25
11.00
II. Gentamycin
Kg.
345.00
2310.00
884.00
2660.00
12. Framycetin
Kg.
3890.00
4400.00
4000.00
13. Rifampicin*’
T
80.96
•73.67
93.10
14. Ampicillin Sodium
T
♦
15. Cioxacillin
T
>3
16. Cephalexin
T
17.
MMU
♦
n.a.
n.a.
4'
♦
26.65
29.20
I. Sulphamethoxazole**
T
688.00
620.00
1445.56
720.00
2. Sulphadimidinc
T
475.36
800.00
465.72
850.00
3. Sulphacctamidc
T
49.50
85.00
48.09
90.00
4. Phlhalyl Sulphalhiazole
T
305.00
13.57
320.00
5. Sulphadiazinc
T
135.00
10.05
140.00
Plienoxymclhylpcnicillin
IS. Griscofuhin
14.50
n.a.
n.a.
15.95
’
i
n.a.
10.72
n.a.
45.84
17.54
II. SULPHA DRUGS
78.99
0 It was not monitored during 1987-88.
Substantial production from small scale units also
n.a. Not Available
1DMA Bulletin (XXI) 18
289
I
2
3
4
5
6
6. Sulphamoxolc
T
42.39
135.00
92.90.
140.00;
7. Sulphaphcnazolc
T
25.60
90.00
2.49
90.00:
8. Sulphaguanidine
T
183.04
285.00
219.56
285.00
9. Sulphasomidine
T
24.61
80.00
45.74
85.00
16. Sulphanilamidc
T
10.24
30.60
12.57
30.00
11. Sulphamcthizolc
T
4.00
4.00:
12. Sulphadoxinc
T
n.a.
n.a.
HI. M l AMINS
1. Vitamin A
MMU
76.10
185.00
74.24
210.00
2. Vitamin Bl
T
64.35
180.00
75.25
190.00
3. Vitamin B2
T
21.52
7.00
25.74
80.00
4. Vitamin B12
Kg.
53.00
101.63
580.00
5. Vitamin C
rr
831.26
115.00
868.77
1210.00
6. Vitamin D3
Kg.
404.00
530.00
249.00
580.00
7. Vitamin E
T
72.83
20.00
101.59
20.00
8. Vitamin K
T
9. Vitamin P
1'
2.47
4.50
1.84
4.50
10. Folic Acid
T
7.5*5
13.00
9.26
H. Nicotinic Acid**
15.00
T
6.48
420.00
8.74
12. Nicotinamide**
470.00
T
89.14
13. Vitamin B6
T
❖
14. Calcium Pantothenate
T
2.68
2.81
115.95
70.00
27.32
35.00
80.00
40.00
IV ANALGESICS & ANTIPYRETICS ETC.
1. Analgin**
T
274.90
1000.00
271.80
1000.00
2. Aspirin
T
1512.49
2490.00
1582.50
2740.00
3. Oxyphenbutazone**
T
5.11
190.00
0.19
220.00.
4. Phenyl Butazone**
T
40.21
100.00
30.04
100.00
5. Paracetamol**
T
5780.00
2.39
6650.00"
6. Pethidine
Kg.
1600.00
515.00
1760.00,
478.00
It was not monitored during 1987-83.
Substanthl production from small scale units also
n.a. Not Available
1DMA Bulletin (XXI) 18
290
2
J
3
4
5
6
91.66
120.00
125.35
140.00
7. Ibuprofen
T
8. Probenecid
T
n.a.
6.80
n.a.
9. Baralgan Ketone
T
n.a.
2.82
n.a.
10. Dcxtropropoxyphenc HC1
T
11. Methyl Salicylate
T
n.a.
12. Piroxicam
T
n.a.
*
19.00
17.00
410.51
n.a.
n.a.
V. CORTICOSTEROIDS
1. Dexamethasone
Kg.
228.00
1390.00
. 343.00
1600.00
2. Betamethasone
Kg.
858.00
1620.00
932.00
1600.00 -
3. Prednisolone
Kg.
2157.00
5010.00
1923.00
6390.00
4. Hydrocortisone
Kg.
n.a.
11.00
n.a.
VI. AMT T.B. DRUGS
1. PAS & Its Salls
T'
68.77
250.00
74.48
250.00
2. INH
T
57.84
400.00
140.29
450.00
3. Thiacctazonc
T
39.58
80.00
24.69
85.00
4. Ethambutol
T
345.31
370.00
407.99
450.00
5. Pyrazinamidc*
f. n
—
.
VII. AMT MALARIALS
T
27.71
32.50
3.87
35.00 ’
1. Chloroquin
T
140.10
450.00
141.16
470.00
2. Amodiaquin
T
19.81
44.00
20.16
47.00
3. Pyrimethamine
T
n.a.
n.a.
VIH. AMTDYSENTERY DRUGS
1. Metronidazole* *
T
444.93
480.00
436.27
572.00
2. Tinidazolc
T
37.98
73.00
44.20
84.00
3. Diloxanidc Furoate
T
5.95
48.00
15.06
53.00
4. lodochlorohydroxyquinolinc
T
197.12
416.00
204.87
460.00
5. Di-iodochlorohydroxyquinolinc
T
4.89
145.00
6.08
160.00
f-' It was not monitored during 1987-88.
Substantial production from small scale units also
. n.a. Not Available
1DMA Bulletin (XXI) 18
291
I •
2
3
4
T
*
205
T
*
n.a.
1. Chlorpropamide
T
54.50
44.00
50.09
2. Tolbutamide
T
36.86 ’
40.00
132.88
3. Glybenclamide
T
2.05
1.42
1.43
6. Triamterene
7. Lepe ram id c
5
6
225.00
n.a.
IX. AN'I’l DIABETICS
4. Insulin
49.00
404)0
1.56
4
MU
3148.00
4080.00
2846.00
‘ 4480.00
1. Caffeine**
T
7.36
135.00
27.32
140.00
2. Nikethamide
T
0.07
6.00
0.42
7.00
1. Frusemidc
T
6.89
14.00
10.25
16.00
2. Acclazolamidc
T
n.a.
1.79
n.a.
3. Hydrochlorothiazide
T
7.09
22.16
7.80
4. Spironolactone
T
n.a.
0.48
n.a.
5. Amiloride
T
n.a.
n.a.
6. Triamterene
T
n.a.
n.a.
X. CNS STIMULANTS
XI. DIURETICS
*
XII. ANTI ASTHAMATICS
1. Ephedrine
T
28.68
70.00
35.50
77.00
2. Salbutamol
Kg.
4158.00
2660.00
2736.00
2930.00
3. Terbutaline
Kg.
448.00
390.00
362.00
430.00
1. Propranolol
T
10.70
13.80
1.10
15.96
2. Xanthinol Nicotinate
rr
11.26
19.00
15.83
20.00
3. Digoxin
Kg-
11.32
35.00
6.97
39.00
4. Methyl Dopa
T
75.07
59.00
60.49
68.00
5. Dihydralazine
T
n.a.
15.20
n.a.
XIII. CARDIOVASCULAR DRUGS
)
* It was not monitored during 1987-88.
c*
Substantial production from small scale units also
n.a. Not Available
1DMA Bulletin (XXI) 18
292
2
3
4
5
6
/ 6.94
I 7.98
T
n.a.
n.a.
9. Quinidine
T
n.a.
n.a.
10. Reserpine
T
n.a.
n.a.
11. Verpamil
T
n.a.
n.a.
12. Dipyridamilc
T
6.47
(>. Glyceryl Trinitrate
T
7. Isosorbide Dinitrate
T
8. Isoprcnaline
*
7.44
i
XIV. ANAESTHETICS
1. Lignocainc/Xylocaine
T
8.14
70.00
7.52
80.00
2. Procaine
T
42.25
94.00
54.35
98.00
1. Cyproheptadine
T
*
n.a.
2. Pheniramine Maleale
T
21.75
28.00
3. Chlorpheniramine Maleale
Kg.
4. Diphenhydramine
T
5. Mebhydrolinc
T
X V. ANTI HISTAMINES
n.a.
24.48
1900.00
15.57
31.00
2100.00
35.00
7.90
39.00
n.a.
19.15
n.a.
3.85
270.00
11.10
280.00
42.03
57.00
I8.ll
63.00
♦
16.00
!
XVI. ANTI IIELMINTICS
I. Piperazine and Salts**
r
2. Mebendazole’*
..n
3. Bephenium Hydroxy Napthoatc
T
* 4. Tctramisolc
T
5. Pyrantel
T
n.a.
T
n.a.
6. Levamisolc
4
17.00
13.11
35.00
31.33
n.a.
n.a.
XVH. TRANQUILIZERS & SEDATIVES
1. Phcnobarbilonc
T
10.76
47.00
5.12
49.00
2. Diazepam
T
10.33
5.00
7.22
5.00
3. Triflupcrazinc
T
♦
3.54
4. Jmipramine
T
♦
3.51
3.90
0.41
3.87
<! It was not monitored during 1987-88.
Substantial production from small scale units also
n.a. Not Av. liable
I
IL\M/\ Bulletin (XXI) 18
293
4
2
I £
3
4
6
5
5. Lorazepan
T
n.a.
6. Nitrazepan
Kg.
T
n.a.
90.00
n.a.
n.a.
0.28
n.a.
89.00
7. Prochlorperazine
n.a.
HI. z\NH FILAR1ALS
1. Diethyl Carbamazine’*
(D.E.C. Citrate)
T
.7.15
81.00
17.17
T
23.54
40.00
23.55
Kg.
2.07
4000.00
1.45
3000.00
1. Triple Vaccine
KL
13.04
32.2
10.40
33.3
2. Tetanus Anti Toxin
MU
7071.00
13000.00
7700.00
13000.00
3. Diphtheria Anti Toxin
MU
136.00
800.00
219.00
800.00
4. Hepatitis B Vaccine
MU
160.00
99.56
190.00
n.a.
20.40
n.a.
5.00
3.25
5.00
0.24
n.a.
XIX. AMI LEPROTICS
1. Dapsone
2. Clofazaminc
i
80.00
XX. IMMUNOLOGICAL AGENTS
n.a.
XXL OTHER ANTI BACTERIAL
1. Trimethoprim**
1'
2. Nalidixic Acid
T
3. Nitrofurantoin
T
84.72
*
XXII. AN 11 CONVULSANT
1. Carbamazopinc
T
*
n.a.
2. Phenytoin
T
*
n.a.
3. Valproic Acid
T
n.a.
n.a.
3.36
n.a.
1
XXHI. GASTRO INTESTINAL
'I'
*
n.a.
24.96
n.a.
T
♦
n.a.
1360.30
n.a.
♦
n.a.
224.00
n.a.
2. Heparin
Kg.
MU
*
n.a.
9186.00
n.a.
3. Chlorpromazine
T
♦
n.a.
2.66
n.a.
4. Atropine
T
♦
n.a.
1.72
n.a.
5. Iron Dextran
KL
♦
n.a.
29.16
n.a.
T
♦
n.a.
17.62
n.a.
7. Silver Nitrate
T
$
n.a.
n.a.
8. Warfarin
T
n.a.
n.a.
9. Oxytocin
T
n.a.
n.a.
10. Metoclopramide
T
n.a.
n.a.
I. Ranitidine
2. Aluminium Hydroxide
XXIV. OTHER DRUGS
1. Hyd.alazinc
6. Menthol
:l It was not monitored during 1987-88.
** Substantial production from small scale units
also n.a. Nut Available.
ID.MA Bulletin (XXI) 18
294
' 1^POLITIKEN SOENDAG, Sunday 5 March 1 989
Developing Countries Victims in Rover Struggle
The Pharmaceutical industry Governs WHO
by Niels Stensgaard
Authority and responsibilities vere cut bit by bit from Ernst Lauridsen’s job. An
effective, bureaucratic "salami technique" vhich finally made it impossible for
him to continue as director at the WHO. Under a nev leadership, deceit and
sabotage became the norm. As head of the World Health Organisation’s global
campaign against unnecessary and expensive drugs he had long been unpopular in
pharmaceutical industry circles. "1 submitted my letter of resignation, and
nobody urged me to withdraw it."
The 51-year old physician returned to Denmark this veek to a job as consultant
to DAM1DA after six years as director of the WHO’s Essential Drugs Programme
(DAP). Ernst Lauridsen reveals for the first time hov he vas forced from the
extensive, but controversial Programme.
The Industry Man
The campaign vas launched in 1 982 after the WHO resolution on health for all and
provision of essential drugs. Halfdan Mahler, Director General at the time, vas
the architect. During the term of this highly respected Dane, no-one dared touch
the Programme, vhich vas considered to be close to his heart. But no sooner that
Mahler announced his departure last year, than the noose began to tighten around
Ernst Lauridsen. It is common knovledge in the WHO that Mahler vas very
skeptical about his successor, the Japanese Hiroshi Hakajima. In addition to his
career with the WHO, Hakajima has a past in a multinational pharmaceutical
concern, and his candidacy vas strongly supported by Japan, the second largest
producer of pharmaceutical products.
Nakajima’s name vas first mentioned in January 1988 and ve in the Programme
became avare that his possible election would entail considerable changes in the
pharmaceutical area (of the organisation's activities). He is known as a
conservative who has always been "in" with the industry. After his election last
May, I knew that my days vere counted, because even before the election,
Hakajima had offered my post to someone else. This despite the fact that I still
had three years left on my contract and our Programme vas reaffirmed every year
by the General Assembly. Hakajima clearly favoured a candidate with a different
outlook and conviction than mine. The candidate vas American, and he confirmed
to me that he had been asked if he would come to Geneva to assume my post.
Nothing ever came of it, maybe because the nev Director General got cold feet
when several of the progressive countries declared that they thought it unwise to
have a director from the USA, a country vhich has always been critical of the P
programme.
'l
/ .
J
Pensioner In Seat Of Povef
A few days after Hakajima/s arrival, I requested a meeting with him in writing
with a view to discussing the future of the Programme and my own role in it. To
my great surprise he refused to see me. An unheard of situation in the UN system:
that a director is denied access to upper management. A few days later I was
informed that DAP was to be "reorganised”. After five year’s directorship, I was
to be moved down two steps in the hierarchy--in addition to which an "advisor”
was named and inserted between upper management and myself. An interesting
phenomenon: one of Nakajima’s old friends and confidant, a conservative
pensioner of almost 70, was to review all my decisions . This "advisor" was in
fact a controller whose mandate was to make nry life so difficult that I would
either go mad or disappear. As a former WHO director he was all too familiar
with the bureaucratic game, and he was now to attempt to satisfy the
pharmaceutical industry and the critics of the Programme.
I do not knov if 1 might have been able to accept the situation. But I was really
shaken vhen this retired gentleman denied me permission to travel to the
Philippines, whose Minister of Health had specifically requested my presence for
the purpose of developing a new drugs policy. And the justification...that this
policy was controversial. It is indeed true that the industry had distanced itself
from the new government’s wishe3--but we are talking about a policy developed
in accordance with the guidelines and drug programme of the WHO. I pursued the
matter and was told that the WHO should refrain from taking sides. My argument,
that by doing nothing we would be adopting a position, was met with the incredible
reply: "That is not so, because if we do not go there, nobody will know which side
we might have chosen"...The perspective is frightening: by ett^mpting to avoid
conflict, the WHO may be subjected to coersion.
No Support to Developing Countries
Towards autumn it became increasingly clear that we were no longer able to
continue the previous technical and moral support to the drug action programmes
of the developing countries. This was emphasized one day when I was summoned by
the advisor who just wanted to inform me that, my contract not withstanding, I
should feel no obligation to continue working at the WHO. That was strong stuff
for a United Nations director with a clean record, so I complained internally. The
reply was that our conversation had been off the record and that nothing concrete
had been said. As if anyone is summoned to a private conversation during working
hours...
I had no further doubts: I was through if I intended to do any meaningful work.
My authority was gradually undermined to the point where I could no longer
maintain an illusion of leadership. I was stripped of everyday executive
functions, such as decisions on budgetary and mission matters, which now had to
be approved by other authorities. Every bureaucrat knows how to cow others.
The only thing left was for me to write my own resignation, which I did in
November. Nobody urged me to reconsider, and no sooner had I left to spend my
accumulated leave than the retired advisor was installed in my chair with the
title of interim director.
Regression
When the Director General had addressed the World Association of Pharmaceutical
Companies the previous month, I vas only able to interpret his statements to
mean that the organisation vas to regress ten years. The advances accomplished
by Programme vith the blessing of the WHO General Assembly nov has to be
brought dovn to the level of the 1970s. During the development of the Drug
Action Programme,ve have been threathened repeatedly: The international
pharmaceutical industry had protested vehemently in defence of a market vith an
annual vholesale turnover of about US$100 billion, presumably US$200-300
billion retail value. The (drug action) campaign has resulted in numerous legal
processes and threats to curtail (industry) investments. We (DAP) maintained
our position that unbelievable quantities of superfluous, useless, and even
hazardous drugs vere introduced onto the market. This is vhy ve vere never
accepted by the multinationals. DAP’s philosophy has been to suggest a selection
of drugs carefully adapted to the need, enabling reduction in prices and vider drug
distribution. We have been able to depress the prices of the most essential drugs.
We have elaborated lists of about 250 drugs vhich cover the needs of developing
countries, many of vhich vere formerly flooded vith up to 40,000 different
drugs. The decisive question nov is: vho vill be molding the future drug policy
of the third vorld? Will it conform to WHO guidelines or to industry’s vishes?
WHO has promoted the goal of health for all by the year 2000. What I have
experienced close up during the past year is possibly the last ideological struggle
vithin the health care system before the turn of this century.
I
T) p.
'e
DRUG ACTION FORUM-KARNATAKA
Workshop : Rational Drug Policy and Rational Therapy
- Understanding issues and evolving perspectives.
Dates : 8-10th June 1989
Venue : Vidyadeep, 128/1, Ulsoor Road, Bangalore 560042
T ime
: The Workshop will be a residential one and the
timings of session will be evolved through a
participatory discussion with the participants
on the 8th morning.
(Tentatively there are possibilities for a short
post breakfast session, a longer forenoon session,
a post lunch till tea session, two short
pre-supper and post-supper sessions. Adequate
time will be available both in the sessions and
after the sessions for small group interactions)
OBJECTIVES
The Workshop has arisen out of a felt need by DAF-K
contacts to explore all aspects of the ’Drug Issue* so that they
are better informed for project level/local/regional action.
The specific objectives of the Workshop will be:
WHAT IS THE PROBLEM
1. TO-Understand^Drugs ’ in their overall context
a. Health situation in India
b. Role of drugs in health care
c. Pattern of drug production in India vis-a-vis health needs
d. Dynamics of drug industry
e. Patterns of drug distribution/availability
f. National drug policies and laws.
2. To understand the irrational/overuse/misuse of drugs by
2
2
health personnel focussing particularly
on banned/bannable
and hazardous drugs.
io try and understand the role and problem
of drugs from
the peoples point of view.
how/uhy the problem
4. At a broader level to discover the Social/Economic/Political/
Cultural factors responsible for this problem.
5* At a micro level to discover
the factors responsible for
actual overuse/misuse by health teams and the people.
UHAT TO DO Tu TACKLE THE P^ODLEm
6. To consider the various r--responses to the problem at
local/regional/national/international
---- level by various
groups/projects/institutions/g
overnment in the areas of :
a* Consumer awareness and movements
b. Updating/iniorming health personnel
c. Pressure group on policy makers
d* Search for low cost alternatives
s* Individual/gro'jp action
f. Project policy changes.
7. To explore ways and means by which the workshop
participants
can respond to this problem at individual/project level.
METHODOLOGY
The workshop will explore the above issues in a variety
of ways using more participatory and group learning experiences
keeping 'didactic input' sessions to a minimum
3
3
A tentative list of possible components to the programme are
as follows.
1. Getting to know each other sessions
(pulling in information on both individual and project
experiences)
2. ’Expectations from Workshop’ and ’Participatory Planning’
session.
3. Exploring all aspects of the Drug issue using Tonics as a
case study
4. Two sessions on Banned, Bannable and Hazardous drugs.
5. Screening of videos, produced by:
a. Voluntary Health Association of India, New Delhi
b. Institute For Cultural Research and Action, Bangalore
c. International Organisation of Consumer Union, Malaysia
6. Slide shows:
a. Drug Policy in India - Ramakka’s Story (CNFCE/CHAl)
b. Tonics and Health (DAF-K)
c. The Bangladesh experiance (CDC)
7. Exploring issues and perspectives through a poster/chart
exhibition.
8. Interviews/meetings with:
a. Drug Controller
b. Representatives of Drug Industry
c. Doctors
d. Medical Representatives
e. Pharmacists
f. Consumers
- understanding the issue from the point of view of each group
9. Reviewing actions/initiatives by members of All India Drug
Action Network.
.... 4
4
10. A Cultural programme on Drug issues
a. Drug issues through art
b. A street theatre
11. fiuestion-Answers sessions
12. A planning Future Action session.
Participants
The workshop will be for a email group not exceeding 15
apart from a few resource persons. As of 1st April wo haws
received confirmation from participants in XRVPt Srujana* DEED*
OAKSHETHEf I0St People’s Trust, Grahaka Jagruti, Samstgra Vikas,
Ashwini Hospital, SMEHAKUH3A and CHC.
The above objectives and outline hav£? arisen out of a
questionnaire sent to participants as well as a ccre-group
interaction in Bangalore on 27th March 1989. Participants are
welooma to send any more suggestions to modify/imprave the
programme after perusing this note.
Sone reading materials will be sent to all th® participants
in early Ray* Hora will bo distributed at the ti^e of ths
meeting, If particio^nts/organis^ticns would like to distribute
some materials of their ownt they ar® requested to bring 20
copies of each.
/
1 If there are no side effects, this must be Argentina
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 comparison of promotional literature for three drugs bears this out
only too well.
Drug :
Tetracycline (Antibiotic used against various infections; Lederle Loboratories)
Caution Against Use
Adverse reactions publicized
U.S.A.
By infants, children; during
pregnancy : Liver or kidney
impairement (latter can be
fatal) or if overly sensitive
to light.
Vomiting, diarrhoea, nausea, stomach
upset, rashes, kidney poisoning, can
poison fetus.
Mexico
By infants, children; during
pregnancy or if overly sensi
tive to light.
Vomiting, diarrhoea, nausea, stomach
upset.
Brazil
By infants, children, during
pregnancy.
Vomiting,
rashes.
Argentina
None
None
Drug :
nausea,
stomach upset.
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.
Caution against use
Adverse reactions publicized
U.S.A.
If patient has tendency to
blood clot, liver dysfunction,
abnormal vaginal bleeding,
epilepsy, migrain, asthma, heart
problem.
Nausea, loss of hair, nervousness,
jaundice,
high
blood
pressure,
weight change, headaches.
Mexico
If patient has tendency to
blood clot, liver dysfunction.
Nausea,
Brazil
If patient has tendency to
blood clot
None
weight change.
(Contd. to page 30)
22
Medical Service
f
(Contd. from page 22)
Argentina
If patient has tendency to
blood clot.
Drug : imipramine (Anti-depressant, Ciba Geigy)
None
In U.S. used for depression only. In
some Latin American countries, Ciba Geigy recommends it also
for senility.
pain and alcoholism
Caution against use
Adverse reactions publicized
U.S.A.
If patient has heart disease,
history of urinary retention,
history of seizures, manic
disorder or is on typhoid
medication.
Not recom
mended
for children
or
during pregnancy.
Mexico
During first
pregnancy
Brazil
trimester
of
If patient has heart disease;
Hypertension,
stroke,
stumbling,
delusions, insomnia, numbness, dry
mouth, blurred vision, constipation,
itching, nausea, vomiting, loss of
appetite, diarrhoea
Dry mouth,
sweating
constipation
itching.
None
not
recommended
for
children or during pregnancy
Argentina
May exaggerate response to
alcohol
None
(Taken from the Mother Jones, Courtesy-Health and Society, also mfc bulletin 73-4,
Jan-Feb 1982).
30
Medical Service
D V2_
Medication as a Substitute for Caring
Perhaps the biggest reason for over
use 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 limi
ting. This means people get well whether
they take medicine or not. Most health
problems can be better managed with
out medication. What often will help
people most is friendly advice and
understanding support.
However, many doctors
and health
workers get into tne 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. They 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. The
prescribing of a medicine becomes both
the symbol and the substitute for
human caring. This problem especially
common in places where doctors, nurses, and
health workers are overworked. The result
is not only a costly overuse of medicine, but
a failure to meet human needs on human
terms.
—Helping Health Workers Learn
David Werner and Bill Bower.
. The Physician who sets about to treat a disease without knowing anything about it
is to be punished even if he is
- -o a qualified physician; if he does not give proper treatment, he is to be punished
imna;
u m°re s®vere,y' and if by his treatment the vital functions of
the patient are impaired, he must be punished most severely."
—Koutilya Arthashastra
12
Medical Service
The Crazy World of Tonics
Mukarram Bhagat
'Health' tonics are a craze with the afflu
ent in the cities with their supposedly hectic,
energy-consuming life-styles. Feeling tired?
Pop a pill or gulp down a spoonful and it will
keep you going (nobody knows where!)
The most commonly used tonics are
multi-vitamin preparations with highly exce
ssive quantities of vitamins.
Incremin C, the famous growth tonic with
the Giraffe logo, contains an important amino
acid lysine which the human body cannot
synthesise by itself. However, a teaspoon
of Incremin contains only about 300 millig
rams of lysine when just a handful of peas
contains about 1800 milligrams of lysine.
The advertising slogan that Incremin turns
"extra eating into extra growth" is medically
unsubstantiated and at best a half-truth.
The quantities of vitamin constituents of
Incremen are absurd: 10 times more vitamin
B1, 25 times more vitamin Bl 2, 2 times
more vitamin B6 than required by the body
daily.
(1)
The daily requirement of the human body
of vitamin C is about 50 milligrams, of
vitamin Bl one milligram and some others
in minute quantities of a few micrograms.
Against these well established norms, most
tonic preparations contain between 10 to 50
times the minimum requirements (2) which
are simply excreted away by the body—a
colossal waste of valuable nutrients in a poor
country. Further, most vitamins are needed
, in small amounts to stimulate the processes
of normal metabolism, they are not energy
giving in themselves.
28
It is almost certain that the high-potency
multivitamin formulations consumed by the
well-fed are almost wholly rejected by the
body. For example, the daily requirements
of vitamin C can be obtained from a single
fruit or a salad helping. Vitamin A, supplied
by green, leafy vegetables, is stored in large
amounts by the body for proper vision.
Vitamin D is naturally synthesised by the
skin from daily sunlight. Despite all these
simple facts, the craze for 'health tonics
continue unabated. (2).
Why ? Manohar S Kamath in his article
in THE DAILY MAGAZINE provide the ans
wers :
"The real culprits behind the 'tonic craze
are the manufacturers of such formula
tions. The principal reason for their hard
selling of such products that the tonics
and vitamins fell in 'category four' of the
Drugs Price Control Act, which means
that there is no limit on profits made on
these preparations. With easy pickings and
a readymade market, no wonder then that
every new company entering the pharma
ceutical world wants to market its own
brand of tonic rather than any life-saving
drug;" (2)
Explaining how the 'tonic craze' is the
result of systematic campaigns of the large
companies, he says :
"The first part of the plan was the mount
ing of an intensive sales campaign to
influence doctors on the need for tonics
in their day to day practice. This was
followed by free sampling" (2)
Medical Service
"The other part of the marketing gimmic
kry in selling tonics was by directly adver
tising in the mass media, to catch the
public eye. Slogans like "Do you feel tired
at the end of the day? You need..." or "A
woman needs iron every day" gradually
made a deep impact on the people until
many were psyched into believing that
they could not do without a tonic."(2)
r
that this tonic stimulates appetites and builds
bodies. But chemical analysis has revealed
that it has 10% alcohol content which is the
real appetite-stimulant: (1),
We have noted that these tonics are not
consumed by the poor but mainly by the
relatively rich whose ordinary diet adequately
meets their vitamin and other requirements.
In recent years,’evidence has grown that the
excessive vitamins may not simply be dis
charged by the body but may even cause
severe disorders. Prolonged consumption of
excessive viramin C may form kidney stones,
excessive vitamin A may cause diseases of
the hair, skin and liver and vitamin D in
excess may cause disorders of the kindneys
and bones. (2)
1
!
Waterbury's Yellow Label Tonic, a
brand leader in the Indian 1tonics markets,
contains only 3 milligrams of iron
—i per teaspoon just 1/10 of which may be absorbed
by the body. The Indian Council of Medical
Research (ICMR) recommends at least 10
milligrams for women. The producer claims
Take this further example from South East
Asia. In the U K., Sanatogen is marketed
as a 'nerve tonic' for old women who
believe in its doubtful ability to tranquilise. But Sanatogen Powder is marketed to
stuoents in Malaysia who believe in its
ability to stimulate their minds. "Worried
about exams?" says the advertisement. San
atogen will give you "Greater energy and
concentration . Can a drug both stimulate
and sedate? (3)
| A person who eats well does not need extra vitamins. |
THE BEST WAY TO GET VITAMINS:
These
are
better
than
these.
These
are
better
than
this.
This
is
better
than
this.
I
Thus, the sheer irrationality and deliber
ate exploitation of consumers through this
sinister "tonic racket" is obvious. The fact
that many such, rackets' continue unabated
is a measure of the enormous influence and
power of the large pharmaceutical corporat
ions not only in India but in many other
countries, particularly the developing ones.
More than 20 years ago, the following
words were spoken before the Kefauver
Committee hearings on drugs in the U.S.A.:
"The incidence of disease cannot be
manipulated and so increased sales volume
must depend atleast in part on the use of
drugs unrelated to their utility or need, or in
other words, improperly prescribed. Human
frailty can be manipulated and exploited and
this is fertile ground for any one who wishes
Source-. Aspects of the Drug Industry in India
C E D.
to increase profits. The enormous sales of socalled tranquillisers are only a small part of
the crop reaped from this ground. The phar
maceutical industry is unique in that it can
make exploitation appear a noble purpose "
(4)
References:
1.
Health for the Millions, VHAI, AprilJune 1981
2.
"Some Boost, and at what price?".
The Daily Magazine, 7 May 1981.
3. The Impact of multinational corpor
ations on Health in Developing Countries, by
Charles Medawar, Seminar on Health, Food
and Nutrition, Consumers Association of
Penang, Malaysia, 15-20 Sept 1977.
4.
Drugs and the Common Man, Science
Today, November 1970.
Drug Utilisation Survey Report
This survey was conducted by the National Institute of Nutrition
(NIN) in cooperation with the Directorate of Drug Control Adtministration
and AP Chemists and Druggists Association, Hyderabad in the
twin cities of Hyderabad and Secunderabad covering 10% ol 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 doctors1 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 ’L1 and •E’
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 brand:?-
of these drugs. 11 did not provide any information. The 44 aoctors
interviewed reporte d s ein-
or: an average 8 to 10 cases of drug
2
2
drug poisoning per monthe
Vitamins and Tcnlcst
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 health!
The credit for this false belief goes to advertising pr ssure
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
(Bl, B2, B6 B12) combinations and other vitamins topped
the list of sales figures.
Antibioticst
over 30% of the doctors1 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 NXN and CERC surveys indicate the urgent need for
public education where disease and drugs are concerned.
Sources The Drug Action networks Newsletter of the Low Cost
Drugs and Rational Therapeutics Cell, VHAI, New Delhi,
<
PR
Prescribing Drugs
Questions to ask yourself before writing a prescription.
1.
Need
Is this drug really necessary ?
Is it being given to make the patient feel that something is
being done ?
2.
Aim
What aim is to be achieved by this drug ?
What disorder of function is to be corrected ?
What symptom/s have to be relieved ?
3.
Knowledge
What is the approved or generic name ?
What class does it belong to ?
What are its characteristics ?
Do I have the requisite experience or knowledge to use it ?
Have I weighed the potential toxic
benefit ?
against the
effects
4.
Route and Dosage
By what route, in what dose and at what intervals is 1'
the drug
to be given and why ? In what form/s does the drug come ?
5.
Alternatives
Have I selected the best agent available for this particular
purpose ?
What other remedies might have been chosen ?
How do these compare in efficacy, safety, cost ?
6.
Duration
For what period of time, days, weeks or months will it be
advisable to continue therapy ?
When and how could a decision be made to stop ?
7.
Observations
What observations can be made to judge whether the aim has
been achieved ?
When should they be made and by whom ?
What laboratory
assessment ?
8.
Elimination
investigation
if any would
help
in
this
How is the drug eliminated ?
Will the patients illness change the usual pattern of distri
bution, effects or elimination of the drug ?
9.
Unwanted effects
What are the side effects or toxic effects of the drug ?
Are they acceptable ?
How frequent are they ?
How can they be modified/managed ?
14
Medical Service
10.
Have I checked for the following :
Precautions
a.
possible allergic risks
b.
possible idiosyncratic reactions
c.
patients drug diet which may interfere with the drug
What precautions can I take to ensure continuation of therapy.
11.
Are there any conditions in which this drug is contraindicated ?
Contraindications
Are these 'absolute' or 'relative' ?
Are there any drugs which should
be avoided when
the
patient takes this treatment ?
Which and why ?
12.
Patients point of view
What does the patient believe about the drug ?
What has he been told about it ?
And what has he remembered ?
Does he need additional information ?
13.
Does his relative need additional information ?
Patient reliability
Is the patient reliable for this type of therapy ?
Will he need/get proper supervision by relatives or attendants ?
Is the drug the cheapest drug of that type ?
If not could a cheaper drug do the job as well ?
14.
Cost
15.
Finally is there anything else
I need to know about this drug ?
Adapted from :
i.
ii.
A Herxheimer :
The Lancet II 1186-1 187, 27th Nov 1976
Formulary and Therapeutic guide—Kurji Holy Family Hospital
Prescribing drugs - MNAMS Handout, Dept of Pharmacology, St John's Medical
iii.
College, Bangalore
15
October-November 1984 (Suppl)
Du T-U-. I
i
What Can We Do ?
i.
Educate ourselves
We should make an effort to avail ourselves of all
available materials on drugs.
the
We should purchase some of the books and subscribe to some
of the journals and bulletins mentioned in 'widening
horizons' to keep ourselves upto date.
2.
Share and
Disseminate
information
We should circulate all the information and 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
We could use/adopt the generic drug concept during pur- J
chasing, prescribing or dispensing drugs.
5.
Stop Irrational
prescribing
Could stop prescribing drugs whose only advertised values
are :—
a.
cosmetic embellishments
b. elegant packing
c.
irrational combinations
d.
imitative drugs
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 gifs and physician samples
Industry Linkages
We could avoid allowing drug companies to sponsor events/
meetings
We could beware of unethical trade discounts or other forms
of inducement
7.
16
Adopt Rational :
We could adopt bulk purchasing
Drug Purchase
Support cooperative purchasing or production endeavours
Produce drugs in your hospitals dispensaries.
Medical Service
Adopt open
policy to nonallopathic systems
and non-drug
therapies
8.
We should be open to other forms of treatment. Seek informa
tion and be willing to incorporate it in our work
Share our experience with others
Send our staff for training in these forms of treatment if
necessary.
9.
Support networks/
organization/
consumer
movements taking
up drug issues.
10.
Promote 'Health for
all' priorities.
Find out about all such groups at local, regional, state level
or national level
Support and participate in their activities.
should actively promote the following in our work .
We
a. simple home remedies
b.
herbal remedies and herbal gardens
c.
health education and patient awareness
d.
training of village level workers
e.
community health initiatives
f.
development programmes
g.
awareness building.
Reporting in 1956 on the excessive amount of space taken up by advertisements in
Indian newspapers, the Indian Press Commission commented :
- ■ • f
objectionable advertising which we feel should be put down
"The largest field of
is of drugs and proprietary medicines
The volume of advertising of such
by law i_
commodities ranks next only to the volume of advertising of cosmetics.
—Use and Misuse of the Media
Sumanta Banerjee, World Health, Feb-March 1983
October-November 1984 (Suppl)
17
Misuse and overuse of medicines—Why ?
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!
Some Reasons
1.
2.
3.
8
Big business The production and
marketing of modern medicines is
one of the biggest, most profitable
business in the world. Drug compa
nies are continually inventing new
products to increase their sales and
profits. Some of these medicines
are useful. But
atleast 90% of
medicine on the market today are
unnecessary.
Doctors
prescrible
them and people buy them, because
the drug companies spend millions
on advertising.
False advertising
Especially in
poor countries, much of the adver
tising, 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 for illnesses
less dangerous than the medicines.
(For example chloramphenicol has
often been advertised as a treatment
for minor diarrhoea and respiratory
infections).
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 un
safe. 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
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 medi
cines are a waste of money. Many
are completely unreasonable combi
nations of drugs, yet they are widely
prescribed by doctors. For example,
in both Latin America and Asia, a
popular injectable medicine is tetra
cycline combined with chlorampheni
col. This is a senseless combination
because the two drugs are 'incom
patible' 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
recenty
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 medi-
Medical Service
cines 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 well!
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 often receive no
information at all. In Mexico, for
example, upto 70% of prescription
drugs are sold without prescription.
Yet the packaging of these medicines
generally contains no information
about use, dosage, or risks.
8.
Health Workers nqjt adequately
informed In spite of the tremen
dous 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 pur
chase 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 pro
fessionals 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
This rare Himalayan herb will cure your headache. If it doesn't I'll give you a
pill prepared by a famous multinational drug house.
October-November 1984
11
The Drug Industry in India—
What our experts say
The Industry
Pattern of Prescribing
The total output ofthe 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...
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.
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.
Structure of the Industry
There are about 125 large and medium
factories and nearly 3, 000 small scale sector
units engaged in this industry which pro
vides
employment to
about 100,000
workers.
The existing drug policy rightly emphasi
ses 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.
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 pat
tern 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 enzy
me digestants, mostly consumed by the
relatively well-fed urban population. Twenty
percent is covered by antibiotics, only 1.3
percent by sulphonamides (a very cheap and
useful anti-infective) and 1.4 percent by anti
tuberculosis drugs...
6
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 another
five years in regard to price control...
Medical Service
has
per year while in a Primary Health Centre, it
is about 40 paise per patient per year.
Existing prices of drugs including those
of essential drugs of everyday use is highly
inflated. For example, the cost of analgin
sold over the counter is 30 times the cost of
production.
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 imple
ment 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.
Genuine
'breakthrough'
declined in recent times.
research
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, inter
mediates, 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 institutions within the health care
system is very uneven. In an urban hospital,
for instance, the drug cost is Rs. 6 per patient
October-November 1984
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).
7
- Media
RF_DR_22_SUDHA.pdf
Position: 1302 (4 views)