DRUG SITUATION IN INDIA
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- Title
- DRUG SITUATION IN INDIA
- extracted text
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THE DRUG SITUATION IN INDIA
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The causes of the problems and the solutions of the presemJ •‘d&yg.
drug situation differs markedly when seen from the eyes of the
drug industry especially OPPI, the Drug Controller, WHO, IMA,
groups and organizations who see everything in terms of what is
socially just or not, and the consumer.
Many significant changes have occurred in the past few years
which are bound to have far reaching effects. It is important
for all of us to be familiar with the problem, with the loop
holes, with the- different versions of the various groups involved.
THE FACT THAT THE SOLUTION OF THE MAJORITY OF THE HEALTH PROBLEMS
IN INDIA DOES NOT LIE IN MORE PILLS, MORE DOCTORS, MORE HOSPITALS,
BUT IN SCCIO ECONOMIC & POLITICAL POWER RELATIONS IN SOCIETY IS W.
WELL ACCEPTED BY MOST OF US HERE .
The need for greater social awareness is not only relevant for
the villager who gets deprived of his right to the least basic
needs, basic health care, but also for those involved in health
work (whether it is in a community health programme, a dispensary,
hospital or even a teaching hospital).
to be
Knowing about drugs is not/limited to their brand names, dosages,
side effects, but also their COST and their AVAILABILITY.
The various factors influencing these need to be analysed.
We will highlight some.of the more important aspects which will
strongly .influence our search for solutions.
Here are sane questions that arise and need answers. How much
is our health budget for the 6th Five Year Plan? and how much of
it goes on drugs as a total percentage and what is the per capita
expenditure on health? (Medical & Public Health & Family Welfare)
a)
b)
c)
1821.05 Crores (1980-85) Centre/State &/Union Territory
Source .: (6th Five Year Plan - Pg. 382)
Traditional System of Medicine - Centre 29 Crores
Source: (Planning Commission - N.D.)
Rs. 15.05 (+ Rs. 1.51 for Family Welfare) in 1977-'78
Source: (Pocket Book of Health Statistics of India 19 80 Pg.37)
What percentage of the Indian population utilizes the benefits
.of modern drugs:
- about 20%; according to some estimates only 10%
How self-sufficient are we in. producing this?
We rtill import 50% of the raw material at stupendous rates inspite
of our Pharmaceutical industry being 33 years old and the biggest
in the Third World.
What.is happening to drug imports?
Our imports tripled between 1963-64 to 1973-74 from Rs. 13.crores
to Rs.37.50 crores ---- within next year it increased to~Rs.47<-crores
this constituted 35% of the bulk drugs utilized in formulations.
According to Dr. S. S. Gotnoskar, the Drug Controller of.India
"The last 3 yrs have witnessed a steady increase in the requirements
of imports*, raw materials by nearly 100 percent. Thus while our
2
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production increased by only 50% from 1976-77 to 1978-79 the expenditure incurred on import of bulk drugs, intermediates,
solvents etc. rose-by nearly' 80%.
The break-up of the drugs in the market is : Foreign Multinationals
.. 78%
Public Sector
Indian Private Sector
. . 6%
. . 16% (Source: Dr. Pankaj
Shah:Link - Aug. '81)
P.g. 12.
In 1978-79 MNC's produced
.. 28% Bulk drugs (Basic drugs)
.. 44% Formulations
(Source: Dr. Thakor - Businss
India, July 1980,Pg.26)
What are the alleqations__against MuItinationals?
According to the Hath! Committee Report in 1975 the Multina.tJ.on.als:
4 block others from producing drugs for a period of 16-20
years by invoking patent production,
- din the brand names into the minds of the medical
profession by employing a large force of medical detailprs,
- resort to high pressure sales techniques, and,
- rig up prices to levels which have no relation to the cost
of manufacture of products or international prices.
what were the Hathi Committee's
major, recommendations.?.
1)
Nationalise the Drug Industry,
2)
Foreign undertakings operating in the country should be
directed to bring down their equity to 40% with
progressive reduction to 26%**
(Under the Nev; Drug Policy it was added that Multinationals
maintain a ratio of 1:5 for production of bulk dru^to
formulations)
**In the US more than 10% share by a foreign undertaking
classifies the company as foreign.
What were the Hathi Committee‘s recommendation reaardina cieneric
d rugs ?
1)
Abolition of brand names in a phased manner, beginning
to be made with 13 single ingredient drugs:
- analgin
- aspirin
- piperazine
- ferrous sulfate
- chlorpromazine
- chlorampheniol
- streptomycin
- Tetracycline
- reserpine
- tolbutamide
- INH
- INH St thiacetazone
Recommendations made in 1975.
In Jan. 17th 1981 decision was
taken to abolish brand names ,f.or
5 classes of drugs:
- analgin
- asprin
- chlorpromazine
- ferrous sulfate
- piperazine
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2)
Production of all new single ingredient drugs to be
under generic names.
On what .were these recommendations regarding generic drugs
- based?
The Committee found that 1) use of brand names led to
unnecessary increase in cost because of costly promotional
activities; 2) medical students were taught pharma/fcology
using generic names.
What are the Drug Industry's objections. against abolishing of
brand names?
1.
It is illegal and discriminatory because it contravened the
protection afforded by the Trade and Merchandise Marks Act
1958 and there was no provision in the Drugs and Cosmetic Act
1945 to empower the government to abolish brand nameg/f : r
drugs.
2.
Since prices are fixed under clearly defined formulae by
the DPCO (Drug Price Control Order 1979), generic names will
not reduce prices.
3.
Standard medical text books use both brand names and generic
names.
4.
Trade marks guarantee ethics in manufacture and in the absence
of brand names, customers cannot be sure of quality.
5.
Generic names will lead to wrong dispensing of drugs with
different pharmacological effects and harm patients’ health.
6.
The ban on brand names for single ingredient new drugs will
completely stop introduction of new drugs in the market.
7.
Drugs sold under brand names often have superior bid- avail
ability than those marketed under generic names. •
8.
The use of generic names takes awy the choice from the
doctor to the chemist.
9.
The general prescription is difficult to remember and repro
duce, lengthy and cumbersome.
10.
The Hathi Committee recommendations would have been quite
different had it observed the results of the Pakistan
experiment.
(Source: S. Viswanathan:
Business India - Sept.28
October 11)
What advantages are seen in having a planned generic policy?
1)
It will eliminate monopolization because of brand names,
and it will encourage healthy competition.
2)
It will curb production of non-essential combination drugs
which only add to the increase in price and have no
additional benefit.
For example.: Aspirin is marketed undea/two generic names:
- acetyl salycilic acid and aspirin
/
- 8 different brand names
'
- 7 brands marketing ASA and Caffeine
/
- 19 brands of ASA and Phenacetin and Caffeine
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Effect on Costs
Manufacturer
Content
Name undej
which drug 1
marketed
Price per
unit(Paise)
Hoechst
Analgin (.5gm)
Novalgin
20.00
IDPL
Analgin (0.5gm)
Analgin (.5gm)
Analgin
18.27
Analgin
Aspro
18.24
Haffkine '
Nicholas
Aspirin (350 mg.)
-(■Caffeine 30 mg.
Sarabhai
Aspirin 350mg.
7.75
Kenalgesic:
22.00
Aspirin 3'00 mg.
Aspirin
3.60
Aspirin 300 mg.
Aspirin
2.84
Source: Indian Pharmaceutical Guide 1980
S ome more examples:
Boots
Haffkine
Anacin
Avedanplus
Aspirin 389mg.
Anae in
Caffeine 16.2mg.
Quinine sulfate 8 mg.
8
Aspirin 350 mg.
8
Acetyl Aminophenol 125mg •
Caffeine 30 mg.
Powe rin
Aspirin 350 mg.
20
Caffeine 65 mg.
Codeine 8.125 mg.
Paracetamol 65 mg.
\
Salicylamide 65 mg.
\
(Analysis 'of Painkillers done by Di?. Anant Phadke
in his paper) Scientific Scrutiny of Over the
Counter drugs)
\
What does WHO Expert Committee on selection of essential drugs
( 1st Report Technical series 615, 1977) recommend? It recommends
Acetyl Salicyclic acid amongst the analgesics beca'use besides
being the cheapest it was therapeutically as effective as analgin
(aspirin is 1/6) APC and multiple.other combinations.
What are the loopholes being made use of in this generic policy
by profit-motivated drug industry?
Since the use of generic named drugs applies only to the 5 single
ingredient drugs it does not touch the COMBINATION DRUGS
which anyway form the majority.
Drug companies will try avoiding the issue by producing more
combination drugs and less single ingredient generic drugs.
Since BRAND NAMES is to be ABOLISHED for ALL NEW SINGLE INGREDIENT
drugs, the drug industry will try introducing new drugs under
BRAND NAMES with more than two ingredients. So not only the cost
will go up because of the use of brand, but also because of
addition of often unnecessary ingredients.
Since the government had emphasised that generic drug names should.
be displayed more prominently than brand names with effect from
■1st August 1981, the drug companies complain of difficulties in
making a long chemical name more prominent on small vials, ampoules
and pleaded of accumulation of stocks inspite of 7 months' notice.
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What are the Drug Companies doing about this?
On 13th March, the industry's delegation met Mr. P.C. Sethi,
Minister ofChemicals and Petroleum, under which the drugs come,
having failed, Hoechst, Cynamid and Pfizer sued the Government
,in the Delhi. High Court against abolishing of : brand names and
have got a stay order.
What is the New Drug Po 1 i c y ?
Three years' debate following the Hathi Committee's recommenda
tion ended with the New Drug Policy. (Presented in Parliament
on the 29th ?iarch 1978 by Mr. Bahuguna, the former Minister for
Petroleum, Chemicals and Fertilizers).
The NDP, the primary objectives were "to develop self-reliance
in drug technology;" to provide leadership role to the public
sector,"to foster and encourage the growth of the Indian sector",
under NDP several limitations were imposed upon foreign sector
drug companies. These included -
-
the gradual reduction of the foreign share holdings of
Multinational Corporations,
- no further expansion of capacity to foreign companies
"engaged in the manufacture of household remedies".
the grant of licences to manufacture formulations to
foreign sector companies to be "linked with the production
of high technology bulk drugs from the basic stage".
- the grant of licences for the manufacture of high technology
bulk drugs to be conditional upon foreign sector companies
supplying 50% of their production to "non-associated
formulators".
(Source: Dilip Thakore - The Ethics of
the Drug Industry Pg. 27
Business India : July 7-20,'80?
Page 29.30)
If a multinational produced, say, Rs. 100/- worth of bulk drugs,
half of it had to be sold to the Indian sector and the remaining
half used for formulating drugs under its own brand. The total
turnover of drugs could not exceed three times the worth of bulk
drugs, if produced, i.e., 100 x 3 = 300 lakhs.
What is the DPCO?
Drug ^rice Control ^rder, an offshoot of the New Drug Policy
passed in 1979 is aimed to restrict prices of the bulk drug and
formulations produced by any pharmaceutical company in the
organised sector.
What are the stipulations under the DPCO?
Bulk or generic drug manufacturing companies are entitled to
12-14% return on net worth (capital + reserves) depending upon
the complexity of the technology utilized in the production
process.
Formulations (i.e. branded drugs) are divided into 4 categories
Category
I - Life Saving Drugs
Category II - )
Category III - ) in between
/
Category IV - Over the Counter Drugs'.
"Mark ups" above the cost of production to the extent of 40%,55%,
100% are permitted by the Ministry of Petroleum, Chemicals and
Fertilizers on Category I, II ant. Ill after a study of the
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production costs to be submitted by the manufacturing company.
What .does the Drug industry have to say about it?
According to Dr. S .K.. Bhattacharya recently elected President of
the Organization of Pharmaceutical Producers of India (OPPI)
(which constitutes of 62 big and 54 medium firms and produces
60% of that total bulk drugs and formulations in the ebuntry),
the present drug shortage of commonly prescribed drugs is because
of the New Drug Policy and the rigid price control and it will
definitely get worse.
Which are the drugs which have had problems regarding availability?
News reports and A.survey done by Medical limes (Glaxo's) Aug.
has revealed a shortage of painkillers
- antiepileptics
- anti TB drugs
‘81
- anti-diabetics
- sera vaccines .
- Cardiac glycosides
- anti hypertensive
*Regarding prescription practices - surveyed by Medical Times
(Glaxo's) use of brand and generic was concerned. Almost all
the doctors seemed to use brand drugs. Reasons:
1)
2)
3)
confidence in the brands
less chance of substitution by chemist
convenience in remembering
Any info what guides prescription practices?
A study done by NIN Hyderabad on drug utilization revealed that
14% of the population surveyed (1800 urban education population)
was taking drugs on the basis of advertisements alone. Only
1.72% gave satisfactory replies on the proper use of drugs.
4 8% a 1lopathy
18% homeopathy
14% naturopathy
11% ayurvedic
2% Unani
63% had erroneous idea about dosage schedules and mode of adminis
tration which could result in bioavailability and therapeutic
problems.
What is OPPI paying to build up public opinion against the
Government policies? OPPI has launched a Rs.24 lakh MEDIA CAMPAIGN
in what is says is a bid to help avert more serious shortages in
the future.
(Source: Vanishing Drugs: Hindustan Times April 27, 19 80)
What is the situation regarding Drug Control?
The Drug Control situation in India is pretty bad. Only 3
(Maharashtra, Gujarat, West Bengal) our of 22 States in India
have machinery to regulate the manufacture, dis-tr.ibuti.on and..
sale of pharmaceuticals.
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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
suops.
(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: Rajcnder Rainer : Delhi Reporder
July 1981:Spurious Drugs dealing in
Death)
At the time of the Hathi Committee Report ( 1975) the- J-'otal drugs
Inspectors in th*: whole of India was 305 . Current estimates are
(Source: The Ethics of Drug Industry: Business
India, July .7-20, 1980 - Pg. 33)
What ..percentage of drugs are considered sub-standard_duKJ±ie_JJi<±Lan.
Market?.
Conservative estimates are 25-30%. The Drug Control authori
ties accept this figure.
(Source: Spurious Drugs: Delhi Recorder,
July 8)
52% drugs are substandard according to a survey quoted by Anil
Aggarwal in Drugs and the Third World. 2% drugs are spurious
(According to the drug control authorities).
What, are the reasons of such a high percen 's.age_of _s ubs.tanda rd_
drugs?
1)
Inadequate drug control.
The centre can only lay down policies, state governments have
con trol over manufacturers, sale and distribution (the inter
state barriers are fully exploited by trade in spurious drgs).
Control, if any, is at the earlier stage of production into#
bulk form or later formulations, improper storage, etc. are not
given that importance.
Shortage of certain brands of popular drugs gives an opportunity
to spurious and substandard drug producers to take advantage
of the situation. Linked to this is high demand of life saving
and other common drugs.
-
easy availability of drugs over the counter without
prescription from a qualified doctor
-
easier availability of drug selling licence
ignorance about drug adulteration and substitution
- the increasingly prevailing habit of chemists to stock drugs
of a company giving them commission in some areas
the desire of the consumer to buy cheaper drugs because of
the high cost of drugs (and his poverty in many cases)
- the buying of drugs by chemists without any bill to avoid
payment of taxes
- only drug control authorities have been associated with
checks and control unlike food adulteration where the consumer
can play a role.
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What can consumers do to deal with this problem of substandard and
spurious drugs?
1)
Buy drugs only from licensed chemists.
2)
Read the drug label carefully, verfy expiry date, price .
and seal before jurchasirig. Check with the price lists of
manufacturers available with the chemists.
'Ask for a cash memo-give the chemist enough time to fill
entries of drugs bought, your address, etc.
Don't swallow all the claims made by the advertisers of the
various drugs.
3)
4)
5)
Avoid self medication by use of patent drugs.
yourself witljAny drug you do not know about.
6)
Follow instructions given by your doctor, pharmacist or on
the medicine label regarding mode of administration of the
drug dosage, frequency, etc., and duration. Check if in
doubt specially if deasling with patent drugs.
7)
Avoid using left-over drugs or drugs that change colour,
taste, or look different. Keep drugs as advised - in a dark
and cool place.
8)
Keep drugs away from children's reach.
separately.
9)
Destroy old cartons, labels, containers to prevent misuse of
spurious drug manufacturers.
10)
If you feel doubtful about the quality of any medicine, contact
the Erug Control Department.
11)
If in Delhi, ring up 22 60 18 be4ween 9 A.M. - 6 P.M..
After office hours and on holidays ring up 63 33 00, 63 40 73
and 63 11 16.
Don't medicate
Keep poisonous drugs
<
The punishment'provided in.Sec. 27 and 27A of the 1940 Drugs and
Cosmetics' Act to safeguard the consumer is maximum imprisonment
of 10 years, increased to life imprisonment by West Bengal.
What constitutes the public sector and how are they faring.-
The public sector constitutes of IDPL
-
Indian Drugs & Pharmaceuticals Limited
HAL
-
Hindustan Antibiotics Limited
SSPL
-
Smith Stanistreet Pharmaceuticals Limited
BE PL
-
Bengal Chemicals & Pharmaceuticals Limited
IDPL and HAL incurred losses of almost 2 crores in 1979. Monthly
losses of IDPL and HAL are 2 crores and 45 lakhs respectively.
(Source: Policy Pitfalls: Ranjana Kaul:
“industan Times, April 27, 1980)
Why are they running at a loss?
The reasons given are mismamagement, inefficiency, poor-coordina
tion, under-utilization of capacity, corruption, frequent machine
breakdowns.
Probably, one acceptable reason is the refusal of the MNC and
other private companies to go into production of essential and
life-saving drugs of Category I & II which allow mark-up of only
40 and 55% respectively (as they can make up to 100% profit on
non-essential over t ie counter drugs) and the public sector
having to take on the burden.
4
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According to Mr. D.B. Telang, Financial Manager of the company
for every kilo of streptomycin produced, a loss of Rs.25 is
incurred. The more esssential drugs are produced the more are
the losses incurred. Losses are due to increase in the price of
raw materials, inflation - 35-40%; packaging 30%, power 30%, cost
of transportation. A,, this in the presence of fixed drug prices
apparently has caused the ever increasing losses in the public
drug sector. 1DPL, HAL, IDRI were instituted to break foreign
monopolization and produce a reasonably cost essential drugs for
the Indian public. But even today, 33 years we still import drugs
for Kalazar, malaria, leprosy, diphtheria, TB. Losses can be made
up by raising production or by asking government to alter the
pricing structure.
How self sufficient are we regarding production of drugs? What
.do the MNC's and OPPI have to say about production of essential
drugs?
of
saYs "We are business concerns. Why
Twhich actually meins less profits)^ CaUSG incurrence of loss."
What is C.P.C.?
Chemicals & Pharmaceuticals Corporation is for channelizing drugs
and regulating their availability in the country. The Corpora
tion has had problems regarding availability and prices of
imported ingredients. There are reports of essential bulk drugs
not being lifted from the C.P.C. by the drug company on account
of low profitability. On December 1, 1979, CPC had 4 crore worth
of canalized bulk drugs in stock. These included essential drugs
like tetracycline, streptomycin, doxycyclin.
Drug
Company
Licensed capacity
in million^ tons
Actua L produc
tion in mil
lion tons
56.06
135.82
PAS
3) Biological Evans
b) Warner Hmndustan
120
300’
INH
a) Biological Evans
b) Ghas. Pfizer
c) Wamer: Hindustan
10
1.6
90
0.13
0.06
6.08
What are the objectives of C.P.C.. ■?
The basic objectives of CPC in canalizing import of drugs is as
follows:
1.
Bulk purchase for all manufacturing units gave bargaining
power in world market so that concessional or low prices
could be secured.
2.
To prevent disturbance of indigenous production of drugs with
a certain therapeutic value - introduce and regulate imports
of newer, sophisticated drugs in a planned manner.
3.
To protect the indigenous production of drugs, especially when
the production is inadequate to meet internal demand.
4.
To ensure the equitable supply of raw materials at uniform
prices, eliminating middleman's profits,, so that formulations
from this are priced at a fixed uniform level.
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5.
To help the small scale sector of the industry whose require
ments are small and who would otherwise find it uneconomic
and impractical to import.
6.
To regulate the import of drugs whose indigenous production
is substantial enough to warrant their being given protection
so that their growth and utility are ensured with a view to
achieving ultimate self-sufficiency.
7.
To secure those drugs which have very few world manufacturers
and monopolies at reasonable prices.
■
8.
To regulate the import of drugs whose imports can cause public
health problems, eg., addiction forming drugs, etc.
Loopholes points 4 and 5 were to avoid middlemen but unfortunately
since small units have to give their REQUIREMENTS AND ADVANCE
PAYMENT several months prior to time of supply (promptness of which
is not assured), the -small scale agencies are unable to take full
advantage and it is the MIDDLEMEN who lift the STOCK, HOARD it and
sell it at 25-30% higher than the usual rate.
10% foreign firms have not utilized 3 industrial licences and
7 letters of intent for the manufacture of 16 bulk drugs.
40 firms in the Indian private sector failed to implement the
investment proposals with 31 industrial licenses and 27 letters
of intent.
Of 32 items of bulk drugs covered by 13 licenses, 21 items were not
produced by Glaxo laboratories for the last 5 years.
(Source: J.S. Mazumdar: Drug Industry
Instruments of Policy)
And with all this, useless non-essential drugs are"pumped into the
market while essential drugs are not produced. Very obviously,
profit is the motive of the drug production industry and not ful
filling of the country's need as is often alleged.
The small scale sector feels itself financially ill-equipeed to
undertake any undue losses or profits and therefore also opts for
non-essential drugs.
What does the Sth Five Year Plan require regarding drug production?
From Present
Bulk 226 crores
By 1984-85
to
665 crores
Formulation Rs.1150 crores
2450 crores.
VIth PLAN aims at:
1)
Developing self-reliance in technology,
2)
Ensuring availability of drugs with reasonable prices and
inadequate amount
3)
Dominant role of the public sector in the industry.
What's the situation?
Growth rate of bulk drugs has fallen from 13% to 6% and for formula.
tions from 10% to 4%.
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IN THE FIRST YEAR OF THE PLAN, the foreign and big Indian
companies are not interested in manufacturing the drugs that yield
low profit margin. In fact, by cornering the already sanctioned
licenses and letters of intent they are out to blackmail the
-government in order to secure substantial price rise - by starving
the market of these drugs.
(Source: MNC 's Fatten, Indian Die:
Dr. Pankaj Shah: Link, Aug. 2, 1981,Pg.10)
The Multinationals give the high prices because of the 'research1
they apparently finance. What all constitutes research?
- basic research
- product development
- toxicity tests.
- research on formulations
- mass production methods
- clinical trials, etc.
it also includes studies on colour design of product, its packaging
to promote sales, general market studies, purchase of international
patents, solely to extend the company's monopoly position abroad.
It includes
(Source:
Link, Aug. 2, 1981, Pg.11
Dr. Pankaj Shah)
What percentage of their sales do they put into research?
what percentage in publicity?
and
Glaxo in 1979-8Q spent Rs.1.52 crores on publicity - .. percent
on tropical diseases.
Amount MNC's spend on research is <^3% of their sales turnover
compare! to 14-15% in Developed countries. Even so research acti
vities are seldom in tropical diseases but in diseases like cancer
hypertension etc.
What are the country's health requirements based on priorities set
by Alternative Strategy: ICMR/ICSSR Study
Measures against
-
Communicable Diseases
-
Nutritional deficiencies
Family Planning. Fertility rate,
Basic health care
Some of the figures that indicate the seriousness of the problem
*IMR in 1976 129/1000 live births (when Sri Lanka's is 45:1 in'72
( pg . 129) )
*Maternal mortality 163 in 1976 (Percentage Distribution
( pg. 125)
/
*Birth rate - 33.3?(per thousand per annum in 1978 (Pg.13)
Health Budget set' aside for the VIth Five Year Plan - 1821.05
Crores
50% of the Health budget earlier has been spent on curative cai®-.x
40% in construction and capital expenditure
and only 10%. on. preventive health care(Health Statistical
Intelligence Report)
/
50% of under fives and pregnant mothers are found to be anaemic
6.0...80..% are clinically malnourished.
5 0% of Indian children get
the calories -that they require.
40,000 children become blind each y«--ar because of Vitamin A
defiency.
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*27,08,222 get malaria every year and 147 die of malaria in 1979
( Pci 82)
Incidence of T.B. is 2%, i.e., 8 million people. About
y*
2 million have open TB.
*Incidence of leprosy is 25,59,566 cases on Record - Mar.'80 i
21,58,822 cases under treatment
jPg.89)
on Record - Mar.'80 J
(India harbours 1/3 of the world's leprosy, malaria cases).
(*Source; Pocket Book of Health Statistics
'80, CBHI, New Delhi)
The incidence of malaria - even Falciparum - Filaria, polio,
Kalazar, Japanese ‘Becephalitis has shown an increasing trend.
The above becomes extra significant when, we focus on the percentage
of people below or bordering the poverty level - a figure that is
also showing a rising trend. 60% Indians are below poverty line
(assessed in relation to average caloric requirement).
|
What is the production of drugs like in relation to the.se health
requirements:
Out of Rs. 636.9 crores of drugs sold in 1980
19% were anti-biotics
10.21% vitamins
4.41% tonics
4.241% anti-anaemic preparations
4.71% cough and cold (increase in growth within
the last 5 years has been
70%) .
Talking in absolute figures 137 crores worth of vitamins were sold
in the year 1980.
Break-up of the above available in Dr. A. Patwardhan's paper
•1,2, and 3;
All modern drugs are available to economically well off 5%.
Hasic 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 po'ulation will be 950 millions.
Amount required for drugs with inflation, increasing prices of
raw material, etc, etc., will be
Our National Formulary has over 60,000 drugs and chemicals.
(15,000 brand drugs)
68% are obsolete and useless (only about 5000 are useful and 2500
of marginal use)
’The Hathi Committee has identified 117 as essential drugs and WHO
about 200' drugs which would take care of the 90% of the EXISTING
HEALTH PROBLEMS.
D-10:343
MS:k:5.1.82
: 13 :
Regarding essential drugs production what is happening?
Out of Rs. 1260 crores worth of drugs manufactured in 1979-80
essential and life saving drugs accounted for Rs.350 crores only the rest were tonics, digestive enzymes, formulations of medicines
with marginal benefit.
MANY VITAL BULK DRUGS IN HUGE QUANTITY HAVE BEEN WASTED WHICH
COULD HAVE BEEN UTILIZED FOR MANUFACTURE OF ESSENTIAL DRUGS.
(Source: Drugs : Industry Instruments of Policy
- J.S. Majumdar)
1977
1978
Production
Installed Produc
Ins tailed
Tonnes
capacity
capacity
tion
Anti-T.B. Drugs
bonnes
j-'onnes
tonnes
INH
509
57
5 39
94
PAS and its salts
1170
56
1290
558
Theacetazone
153
25
153
13
Streptomycin
Anti-Leprosy
DDS and its derivatives
257
194
257
225
26
17
38
17
Anti-filaria
DEC citrate
56
18
56
23
Anti-typhoid
Chloramphinicol
128
95
128
95
An ti-Dysentery
Halogenated
Quinolines
Metronidazole
Anti-malaria Is
5 87
137
157
16
590
170
195
156
34
176
45
Chloroquin
Pfizer Ltd.
Licensed capacity
55
INH
80 metric tonnes
Production during
1978
19 79
5 2 MT
45 MT
PAS and its salts
Terramycin
Protienex
110
14
90 MT
5 3 MT
54 MT
269 MT
290 MT
Burrough's Welcome
Licensed annual capacity
Production 19 80-81
26 million tablets
187 million tablets
Products
Septran
110
u
54 MT
Similarly, Glaxo's production of Betamethazone has been increasing
while production of antibiotics - penicillin, streptomycin, serra
and vaccines is much below licensed capacity.
Make-up of Drug Industry at a glance?
*5000 pharmaceutical units
*3500 manufacuring units
*1500 units based on loan
* 118 companies in the organised
license system
sector
*45 Multinational drug companies* Of the 20,000 formulations in tire
which have foreign equity
market - 78% formulations in the
more than 40%
hands of Multinationals, 16%
.*****
a.
Indian Private Sector, 6%sPu£i ic
; ANGAi-Or>E - 560 001
DRUGS
IN
INDIA
1500 BRANTED DRUGS ARE ON SALE IN INDIA.
PUT A GOVEFNMENT COMMITTEE BELIEVES HEALTH
NEEDS WOULD PE MET DY ONLY
116 DRUGS.
IN INDIA, 60 FIRMS WITH FOREIGN SHARES
ACCOUNTED FOR 70% OF THE COUNTRY’S TOTAL
DRUG SALES IN 1973-74. THE REMAINING 30%
".'AS SHARED DY 116 LARGE AND 2500 SMALL
MANUFACTURING COMPANIES.
IN INDIA'THE CONSUMPTION OF MODERN DRUGS IN
1973 WAS ONLY 6 FUPEES PER PERSON AND ONLY
20% OF THE POPULATION USED THEM.
THIS IS
DESPITE THE FACT THAT INDIA HAS THE MOST
SOPHISTICATED DRUG INDUSTRY IN THE THIRD WORLD.
THE PRICES OF MANY DRUGS SOLD EY WESTERN DFUG
COMPANIES TO DEVELOPING COUNTRIES LIKE INDIA
ARE OFTEN HIGHER THAN THE PRICES AT WHICH THEY
AFE SOLD AT HOME. E.G., BRITAIN PAID U.S. FIRMS
£2.40 PER Kg. OF VITAMIN - C IN 1973,
INDIA
HAD TO FAY NEARLY £ 10.
TETRACYCLINE ANTIBIOTICS WHICH COST £24-30 IN
EUROPE, WERE DEING SOLD TO INDIA FOR £ 100-270.
IN INDIA FOREIGN DRUG COMPANIES HAVE USUALLY
SHOWN THE HIGHEST PROFITS OF ANY FOREIGN MANUFACTURER
\
COMMUNITY HEALTH CELL
rj /rst^oor)St. Marks Road
' vAN3.-iO .E-56DOO1
"THE GREATEST DANCED TO HEALTH IN
INDIA IS THE OVED MEDICALISING OF
OUF HEALTH CARE SYSTEM. ETERNAL
VIGILANCE IS REQUIRED THAT THE
DOCTOR-DRUG PRODUCER AXIS DOES
NOT EXPLOIT THE PEOPLE AFP THAT
THE ’APUNDANCE' OF DRUGS DOES
NOT BECOME A VESTED INTEREST IN
ILL HEALTH".
<7
MULTIPLE DRUGS COMBINATIONS OFTEN
CONTAINING DRUGS, PARTICULARLY
VITAMINS, IN AMOUNTS FAR IN EXCESS
OF WHAT IS REQUIRED ARE PRESENTLY
MARKETED IN INDIA.
THERE IS A
COLOSSAL NATIONAL ’VASTAGE OF DRUGS
BECAUSE OF SUCH COLP INAT IONS.
- HATHI COMMITTEE REPORT-1975
© © @ @ @ @
CANGAlO.;^ - 560 00'3
ALTEP NATE
DRUG
POLICY?
THERE IS NEED FOR A CLEARCUT DRUG POLICY AND
A NATIONAL DRUG AGENCY TO IMPLE1MENT IT.
THE PATTERN OF DRUG PRODUCTION SHOULD BE
ORIENTED TO THE DISEASE PATTERN, WITH AN
EMPHASIS ON THE PRODUCTION OF ESSENTIAL
AND BASIC DRUGS (ESPECIALLY THOSE NEEDED
BY THE POOR AND UNDERPRIVILEGED GROUPS)
WHICH SHOULD' BE PRODUCED IN ADEQUATE
QUANTITIES AND SOLD AT CHEAPEST POSSIBLE
PT. ICES.
THE DOMINATION OF THE FOREIGN SECTION IN
DRUG PRODUCTION SHOULD BE REDUCED FURTHER
ANT PRICE CONTROL MADE MORE EFFECTIVE BY
REDUCING OVED HEADS AND PACKAGING COSTS AND
ADOPTION OF GENERIC NAPES.
THERE SHOULD BE STRICT QUALITY CONTROL,
SUPPLY OF ADEQUATE DRUGS TO THE RURAL
SECTOR AND A MOVE IN THE DIRECTION TO
MAKE THE CLIENTS PAY FOR THE COST OF DRUGS.
RECOMMENDATIONS OF STUDY GROUP OF ICSSR/ICMR
ON
HEALTH FOR ALL - AN ALTERNATIVE STRATEGY
coWNRJNITY■
PATTERN GF DRUG PRODUCTION
(INDIA)
WHAT DRUGS ARE PRODUCED AND FOR WHOM ?
* THERE IS NOW AN OVERPP.ODUCTION OF DRUGS (OFTEN
VERY COSTLY) LEANT FOR THE RICH AND WELL TO DO.
WHILE THE DRUGS NEEDED DY THE POOR PEOPLE (AND
THESE MUST BE CHEAP) APE NOT ADEQUATELY
AVAILABLE. THIS STEWED PATTERN OF DRUG
PRODUCTION IS IN KEEPING WITH OUR INEQUITOUS
SOCIAL STRUCTURE WHICH STRESSES THE PR.ODUCTION
OF LUXURY COOLS FOP. THE RICH AT THE COST OF
THE BASIC NEEDS OF THE POOR .
* DRUG INDUSTRY IN INDIA IS AN OFFSHOOT OF
DEVELOPMENT OF "HE INDUSTRY IN THE WESTERN
WORLD
DRUG INDUSTRY IN INDIA IS IN PRIVATE HANDS
WHICH PRODUCES MAINLY FOR PROFIT
THESE TWO FACTORS I ESULT IN A SITUATION WHERE
THE DRUGS REQUIRED BY THE POOR ARE NOT PRODUCED
ON THE MAIN GROUND THAT THERE IS NO PROFITABLE
MARKET AND ADEQUATE DEMAND FOR THEM, WHILE THE
COUNTRY CONTINUES TO BE FLOODED RY A PLETHORA
OF COSTLY AND WASTEFUL DRUGS LEANT FOR THE
MINOR ILLNESSES OF THE RICH AN? WELL TO DO ?
C^'
^7
£."660 00''
DRUG
PRODUCTION
J^B/ICSSR P.ECOI.'jYENTATIONS
The small scale sector needs to be encouraged,
subject to strict quality control
It would be desirable to introduce- the cooperative
sector.
Drug production by village communities for
thc-ir own use (e.g. through cultivation of herbs)
should be encouraged.
COMMUNITY HEALTH CE1I.
•;-r)St. MarkSjRoctf
'■ H '
'■ j - 560 001 :
PRICE
CONTROL
I C M F./I C S S R
RECOMMENDATIONS
PACKAGING INCREASES TIE COST OF DRUGS VERY ®EATLY
BECAUSE THE TREND IS TO MAKE IT ATTRACTIVE AND
HIGHLY ELEGANT APT TO ALL COSMETIC EMBELLISHMENTS
TO PROMOTE SALES. THIS SHOULD BE DISCOURAGED.
PACKAGING SHOULD ENSURE UNDAMAGED TRANSIT,
FREEDOM FROM IMPURITY ® ADULTERATION! AND’
PREVENTION OF DETEFIORATION BY EXPOSURE TO
AMBIENT TEMPERATURE APT MOISTURE. ALL THESE
CONDITIONS CAN ED FULFILLED WITH EXCESSIVELY
INCREASING THE COST. IT SHOULD ALSO BE POSSIBLE
TO SUPPLY DP-UCS TO HOSPITALS ETC., IN BULK
PACKAGES TO REDUCE COST.
DRUGS BANTED IN OTHER COUNTRIES SHOULD NOT BE
ALLOWED IN INDIA.
IT IS IMPORTANT TO ENSURE THAT THE PRICES OF
ESSENTIAL DRUGS ARE KEPT DOWN TO THE EXTENT
POSS IDLE.
A LIST OF ESSENTIAL DRUGS SHOULD THEREFORE BE
DRAWN UP.
ALL ESSENTIAL DRUGS SHOULD GO GENERIC.
THE PROLIFERATION OF DRUGS BY MIN® VARIATIONS
IN COMPOSITION SHOULD DE TOTALLY DISCOURAGED.
COMMUNITY HL’ALTH CELL
$7/1’(First Hoor)St. Marks Hoad
BANGAlOBE - 560 007
■........ ... ; ' ;...... =
A NATIONAL DRUG POLICY SHOULD FIRST AND
FOREMOST EE LINKED TO A HEALTH STRATEGY
WHICH MEETS THE TEAL HEALTH NEEDS OF
THE PEOPLE.
THE PEAL PURPOSE OF AN ESSENTIAL DRUG
LIST, FOR INSTANCE, MUST BE SEEN AS
TAKING DRUGS TO THOSE WHO NEED THEM
MOST, NOT AS DEDUCING THE DRUGS BILL.
ANY ATTEMPT TO MOVE TOWARDS A RATIONAL
DRUG POLICY IS LIKELY TO BE OPIOSED BY
THE LOCAL MEDICAL ESTABLISHMENT AND
THE INTERNATIONAL DRUG AND MEDICAL
EQUIPMENT INDUSTRY.
_1L__......
..
irhtV health cel?»
COMNlVN-T5/
^ks Ro*d
ANDY CHETLEY
Operation Sidestep
Export licences have recently been granted for 236
drugs that were to be destroyed in September, accord
ing to Bangladesh government officials. The drugs
were considered potentially harmful by an Expert Com
mittee which drafted a new national drugs policy for
Bangladesh earlier this year.
This concession was granted following application
by atleast three of the pharmaceutical companies in
volved to export the products to Europe for relabelling
and shipment to other developing countries.
The matter was then passed on to the Industrial
Ministry. On 6 October, export licences were granted
for these products and an additional 233 drugs
scheduled for destruction.
An ICI spokesperson in the UK confirmed that the
company was considering of sending its drugs to other
markets, but noted that details had not been finalised
and that the drugs may yet be destroyed in Bangla
desh.
The industry now appears to be attempting to side
ICI wanted to send Imperacin, a tetracycline syrup step some of the provisions, rather than attack the
which has potentially harmful side-effects when given policy directly. Companies have been given upto 18
to children, back to the UK and then on to market in months to run down on the banned list. Several
Saudi Arabia. Organon planned to send its anabolic . companies have attempted to force a loophole in this
steroid drops, Orabolin, via Europe to Saudi Arabia p-ovision by arguing that they need to import one parti
and Africa. May and Baker intended sending banned cular ingredient in order to use up existing stocks.
drugs via West Germany to markets in West Africa.
Organon, for example, has told the government
that it has 2 million Taka worth (approx. US S100,000)
of capsules for decadurabolin, an anabolic steroid.
They claim that they need to import a few kilograms
of the hormone to put in the capsules.
Similarly, Squibb has applied to import two tonnes
of alum hydroxide gel in order to complete the ingre
dients needed for an antacid preparation.
The companies approached Bangladesh Health
Secretary S. Rahman two days before the drugs were
due for destruction. He responded favourably, how
ever, the Bangladesh Drug Administration refused to
give permission. The only way the Drug Administra
tion was prepared to allow the drugs out of the
country was if they were labelled that they should
have been destroyed on 12 September.
Andy Chetley, International Health Campaigner,
Want, recently toured Bangladesh.
HEALTH EOR THE MILLIONS/DECEMBER 1982
War on
To date, the Drug Administration has refused these
requests, recognising that allowing the imports would
mean the continued production and sale of products
deemed to be unnecessary. The object of the policy
is to remove those drugs from the market as quickly
as possible.
Another method of attacking the policy has been
for companies to apply for permission to continue
manufacturing a particular drug on the grounds that
it meets a special need. Pfizer has used this technique
successfully with its Heptuna Plus—an iron and vita
min preparation.
Despite these attempts to undermine the policy,
observers in Bangladesh feel the policy is having some
impact. Professor Nuru! Islam, Chairman of the Expert
Committee which drew up the policy, and Director of
the Institute of Post Graduate Medicine and Research
in Dacca, said recently that people in Bangladesh were
"becoming more conscious" of the banned drugs.
"Now when people are given prescriptions they are
asking the doctors if any of the drugs are on the bann-
5
An estimated one-third of the country s US 8 68
million annual expenditure on drugs, goes on these un
necessary products. This was a major concern for the
Bangladesh government in designing the policy, in
order to "protect the consumers from being hood
winked into spending their scanty resources on useless,
unnecessary and (at times) harmful drugs.
ed list," said Islam. "Some of my patients have stop
ped using cough syrups because they realise they are
of no use. And the policy has changed the prescrib
ing habits of doctors. Some doctors used to make
every prescription out for six or eight drugs—two anti
biotics, two types of vitamins, two enzymes and other
drugs. Now they are putting down fewer medicines."
One of the major arguments used by the phar
maceutical industry against the policy is that it will not
necessarily benefit people. The industry has sugges
ted that there may now be shortages of some impor
tant drugs, and that what is required is a better distri
bution system for drugs.
According to Islam, "The criticism is absolutely
wrong. Of course the policy will be beneficial. Firstly,
for the first time, people have been made aware that
some drugs are useless. And secondly, if you want
to make good medicine reach the people, you must
take away the bad medicine. The policy has educated
the people and given them safety. At the same time,
it has guided the pharmaceutical companies in the
country to produce useful medicines."
That guidance, appears to be long overdue. As
part of the policy, 150 drugs were identified as "essen
tial for most therapeutic purposes in Bangladesh." Yet
the Expert Committee noted that 90 of those drugs
were not being produced in Bangladesh.
In its report, the Expert Committee commented :
"Though the multinationals have all the technologies
and know-how to produce sophisticated essential
drugs and basic pharmaceutical raw materials, in
Bangladesh these companies are engaged mostly in
formulation of simple diugs including many useless
products such as vitamin mixtures, tonics and gripe
water."
6
Although slow to respond to the policy, the World
Health Organisation (WHO) has expressed its support
for the efforts of Bangladesh to rationalise its drug
situation. Speaking ata WHO South East Asia Re
gional Committee meeting held in Dacca during Sep
tember, WHO Director General Dr Halfdan Mahler
said : "I take this opportunity of congratulating our
host country on its courage in starting to put its drug
house in order along the licences recently endorsed by
the World Health Assembly."
Mahler was referring to a resolution passed earlier
this year which urged WHO member states, to concen
trate on ensuring a supply of essential drugs as part of
an action programme. The pharmaceutical industry
has expressed willingness to act in partnership with
governments on th:s matter.
Michael Peretz, vice-president of the International
Federafon of Pharmaceutical Manufacturers Associa
tions (I FPM A), was also present at the Dacca meeting
and told delegates that 53 companies had agreed to
provide a total of 140 essential drugs at "favourable
prices". He defines favourable prices as "non-commercial prices", but did not offer any specific examples.
Peretz added that the international pharmaceutical
industry "does not take a negative approach to the
essential drugs programme.”
If appears, however, that the IFPMA is not totally
committed to the concept of essential drugs, nor are
all of its member associations. Earlier this year, the
Pharmaceutical Products Association of Thailand
(PPA), comprised of "foreign corporations" (TNCs)
operating in the country, lodged a protest with the
Thai government over a p-oposed drugs policy was
to include a priority purchase list of 300 essential
drugs, based on WHO's own essential drugs list.
The PPA submission referred to an IFPMA critique
explaining why WHO's essential drugs list was "un
wise and should not be followed". The PPA added,
"We see the establishment of an essential drugs list
in its present form as a regressive step in the efforts
to continue the improvement of the health care system
in Thailand."
HEALTH FOR THE millions/DECEMBER 1982
and distribution of the Technical Report series No. 641
(Essential Drugs) would be an important step. We
approached the WHO office in Dacca for permission
in respect of this request and, if possible some finan
cial assistance for the project. We were informed that
WHO in Bangladesh has no funds to support such a
request. Then followed eight months of lengthy corres
pondence, at the finish of which we were informed
that since Gonoshasthaya Kendra is not a government
organization, permission could not be granted for us
to translate, publish and distribute on our own. (We
and it provides an easy entry to vast third world
markets for multinational corporations—in this case
the pharmaceutical industry. In the past decade, drug
companies have increased their influence on WHO
through participation in three new programmes :
human reproduction, tropical disease research, and
essential drugs for primary health care. The drug
industry's penetration is indicative of WHO's conti
nuing reliance on technological and industrial ap
proaches to problems that are economic, social and
political. Rather than promoting 'Health for AH', isn’t
WHO furthering the medicalization of underdevelop
ment ?"
Furthermore, the politically neutral attitude of
WHO prevents it from directly denouncing various
forms of domination such as colonialism and neo
colonialism which are at the root of many health
problems. Trushen and Thebaud have rightly pointed
out, "WHO's technocratic approach is a refuge : It
permits the organisation's doctors to identify a disease
and describe it scientifically without calling into ques
tion the economic, political and social mechanisms
that ensure its development and transmission."
And that very approach prevents 'essential drugs
for the poor' from becoming a reality. Establishment
of rights of the oppressed is always an up-hill
struggle.
later learned that there is no need for any permission
asWHO publications are not subject to any copyrights).
This is a vital document which should have wide dis
tribution in all third world countries, yet little has been
done by WHO in Bangladesh to see doctors, phar
macists, etc, informed about the guidelines, they them
selves have established to help us reach the goal of
'HEALTH FOR ALL by 2000', in fact, when the Expert
Committee was sitting earlier this year and requested
eight copies of the booklet, it could not be found in
the country and had to be sent for (by which time the
Committee had already submitted its report).
HEALTH FOR ALL
if
farffustry
permits
Relevant here is an article which appeared in the
Monthly Review (December 1981) by Trushen and
Thebaud who argued, "...medical aid, like food aid, is
a weapon of foreign policy wielded by donor nations,
HEALTH FOR THE
millions/december 1982
11
DRUG NEWS
MIRA
Drugs Workshop at Jaipur
The two-day drug workshop held on August SO31 at Jaipur, an MFC-VHAI collaborative effort—was
a part of the on-going work related to drugs. The 26
participants who took Part in tha workshop, are involved
in health work, consumer activities and jounalism.
The focus was on hazardous drugs, many of which
have already been banned in numerous other countries.
Some of the specific drugs discussed were : Ami
dopyrine's, aminopyrines, dipyrones (analgin-like drugs),
paediatric tetracyclines, anabolic steroids, antidiarrhoeals (e.g. Lomotil, Chloromycetin—streptomycin
combinations), female hormonal preparations used in
pregnancy and clioquinols (mexaform, enterovioform).
Comprehensive papers reviewing the medical
liferature to focus on the significance of the hazardous
nature of these drugs and their limited therapeutic
value were shared. The criteria for selection of alter
native drugs was discussed too.
The present situation regarding the banning of cer
tain drugs was discussed. The Bangladesh Drug ban
of 1707 drugs, the pressure by the multi-nationals and
the role of individual organisations involved in health
work were also discussed. It was decided that indivi
dual organisations and groups would independently
indicate their support of the ban or express concern
regarding the issue.
Drug Combinations Banned
The Kerala High Court on November 19, banned
indefinitely the sale of three drug combinations,
according to the Indian Express.
The fixed dose combinations are phenacetin,
anidipyrine and halogenated hydroxyquinolene. Out
of these combinations, a number of preparations can
and are being made and marketed.
The Drugs Technical Advisory Board and the drugs
consultative committee of the Government of India had
recommended even in October 1981, a ban on the
manufacture and sale of these combinations, because
they were found to be injurious to public health.
12
The need for demanding an ethical code of mar
keting piactices by the drug companies and ethical
functioning by the health personnel is being felt by
more and more people. Guidelines as to what to do
when exposed to spurious or banned drugs were
shared by Dr. Kabra, a medical journalist and lawyer.
Action plans were drawn up on individual res
ponsibilities of work which were voluntarily taken up.
The campaign against hormonal pregnancy tests in
which Dr. Sathyamala is playing an important part and
the campaign against the misuse of anti-diarrhoeals,
continues in collaboration with Medico Friend Circle.
Regarding shortages of anti-TB drugs in the
field, a very valuable contribution was made by
Mr. J.S. Majumdar, General Secretary of the Federation
of Drug Representatives of India. This emerged as an
area needing intense work.
The follow-up work continues zealously as this
informal network of concerned individuals becomes
bigger. Those desirous of sharing their efforts of
building an unbiased information network are reques
ted to get in touch with VHAI.
The drug related papers and the workshop report
are available from VHAI for the nominal sum of Rs. 20
plus postage. This is to ensure continuation of this
work without having to depend on outside sources.
The Health Ministry of the Government of India
had, accordingly banned the manufacture and sale of
18 fixed dose combinations, including these three.
The ban on the sale of these combinations was to
have been effective from November 1, this year.
However, the Government of India gave an extended
life to those acknowledgedly injurious drugs fill March
31, 1983, on the basis of the representation received
from the Indian Drug Manufacturers Association.
This was challenged by the general secretary of the
Public Interest Law Service Society, Mr Vincent Panikulangara, in the High Court through a writ petition.
Justice K. K. Narendran had earlier stayed the
Government of India's order giving extended life to
the drugs for two weeks from November, 1.
HEALTH FOR THE
MILLIONs/dECEMBER 1982
Tosrfcs : How Mwi Ann Economic Waste
KAMALA S. JAYARAO*
MONG the pharmaceutical preparations that are
indiscriminately prescribed are the vitamins, parti
cularly those of the B-complex group. “ Probably
no single class of drugs (Sic ) has been the target
of as much quackery, misunderstanding, misrepresen
tation and misuse as the vitamins......... ’’’. There are
however a number of reasons for this, some in my
opinion condonable.
A
may be needed. Hence, we are probably not in a
position to recognize all situations which may respond
to vitamin therapy, though severe deficiencies of single
vitamin have been well characterized in most cases.
The trouble arises with the dose that is prescribed.
The physician should realise that in such undefined
situation, the therapy is purely empirical. The burden
rests on him to know whether he is prescribing the
right amount, less or more. This brings us to the
Patients often come with vague symptoms which
question of what the right amount is. Here we must
can be correlated to no known disease. The comp
laints may be genuine or psychosomatic, but the patient
defferentiate between vitamins taken as nutrients to
expects treatment. For example, a common complaint
ward off deficiency and taken for therapeutic purposes,
is pain in the back or pulling sensation in the legs.
in established deficiency. The latter dosages are not
Or, it may be a simple complaint of general fatigue
'based on as careful a scientific scrutiny as the former.
or loss of appetite due to no organic cause. What Is
They are prescribed for acute and severe, single defi
one to do ? One usually prescribes a multivitamin or
ciency states like beri-beri, pellagra, keratomalacia etc.
a B-complex preparation. This may be done for three
Since water-soluble vitamins are considered to be
reasons. The physician may sincerely believe that
relatively innocuous, the amounts prescribed are very
vitamins will help the patient or he may feel compelled
high; the main aim being to tide over the acute situation.
to prescribe something. Thirdly, the patient himself
On the other hand, we have these various unde
may demand some medicine, generally a ‘ tonic ’.
fined situations which we attribute to vitamin deficie
What does a tonic mean, anyway ? In' general parley
ncies or anaemia. These are neither acute nor proven
it has come to mean a liquid preparation. However
states of deficiency. If the condition is due to a
we do come across advertisements of ‘ nervous tonics ’
nutrient deficiency, the deficiency is probably chronic
‘tonic for muscle strength’ ‘for energy’ etc.. This
and marginal or moderate in nature. Here the impli
is pure baloney. One of the definitions given by the
cation probably is that the individual is unable to
Webster Dictionary for tonic [is ‘ something that
meet his nutrient requirements. This is perhaps a
invigorates, restores, stimulates or refreshes ’. Could
justifiable premise since the prevalence of B-comlex
it be the generous quantity of alcohol in these prepa
deficiency in our country is relatively high. According
rations ?
to certain surveys the prevalnce rate is 5 per cent in
pre-school children and 17.8% in pregnant women
If the physician believes that B-complex would be
( assessed by the presence of angular stomatitis and
beneficial, even if he has no scientific evidence or the
glossitis )2. The percentage of those with less severe
rapeutic basis, he need not in my opinion be casti
gated. We still do not know all the-metabolic-functions—• — deficiency .is. .exp.ec.ted. to .be. higher.
for which one or more members of the B-complex
* National Institute of Nutrition, Hyderabad-500 007
What is a nutrient-requirement ?
The requirement for
a specific nutrient is defined as the smallest amount
cf that nutrient that will ensure a good state of health.
This will however, vary from person to person.
Therefore, nutrient requirements are set down as reco
mmended dietary allowances ( RDA ). These levels
are believed to * meet the known nutritional needs of
almost every healthy person. ’ By experimental pro
cedures, the highest requirements in a population are
assessed, some further allowances are added and the
RDA for each nutrient is fixed. Thus for many
individuals the RDA will be higher than their actual
requirement. No person need take more than the
suggested RDA. The RDA for various nutrients have
been fixed by international organizations like the
FAO and WHO3 and by various national bodies
including the Indian Council of Medical Research4.
In the process of this search, I came across an
interesting or disturbing feature, depending on how
you wish to perceive it. Many advertisements do not
say what ingredients the preparation contains, leave
alone their quantities. Many inform you that the
preparation is a unique formulation of generous
amounts of vitamins or that it is a vitalizer with
balanced amounts of vitamin ( Incidentally, IDPL is
one of them ). The advertisement merely proclaims
the efficacy of their product -in specified condition.
There is one advertisement by a leading company,
which reveals nothing about the formula but claims
that it is good for memory ! It contains nothing but
vitamins Bi, Bs and Bic. The companies are pro
bably cocksure that the physician will rely more on
their advice than on his own judgement ( and they
are dead right ).
I was interested to know how some of the comm
only available vitamin preparations fare when compar
ed to the RDA suggested by the ICMR. Table I
shows the RDA for some nutrients, for various
physiological groups. For specific reasons, 1 have
not taken the RDA for infants and children but in
absolute terms these values will be less than those for
adults. In Table II, 1 have presented the quantities
of various vitamins purported to be present in each
commercial preparation. It is however not the complete
formula of the preparation. 1 have taken only some
important vitamins into consideratoin. The list is by
no means exhaustive. I culled them from some recent
issues of the Journal of the Indian Medical Associa-;
lion. They are marketed by leading pharmaceutical
companies.
This lack of needed information is one of the
reasons why Table II does not have more preparations
listed. But this is ample for what I have to say.
There is also no reason to believe that those which
escaped inclusion would be any different.
The RDA for any nutrient is the amount which
if taken regularly will ensure that a deficiency state
of that nutrient will not develop.
For example if a
sedentary, house-wife takes 1.0 mg riboflavin daily,
she is expected not to develop riboflavin deficiency.
As 1 said earlier, 1.0 is the highest level and most
can afford to live on lesser amounts.
The situations
which are under discussion now, are considered to be
deficiency states of mild or moderate degree. The
individual might have depleted levels of the nutrient
and may need higher amounts than the RDA. What
Recommended Daily Allowances*
Table-I
Thiamine
( Bj ) mg
Riboflavin
( B2 ) nlg
N cotinic acid
nig
Man :
Sedentary
Moderate
Heavy work
Pyridoxinef
( B6 ) mg
Folic acid
mg
Vitamin B.?
mcg
1.2
1.4
2.0
1.3
1.5
2.2
16
19
26
—
1.4
—
0.1
0.1
0.1
I
1
1
1.0
1.1
1.5
1.0
1.2
1.7
13
15
20
—
2.0
—
0.1
0.1
0.1
1
1
1
1.1-1.3
1.1-1.5
1.2-1.4
J.2-1.7
N-17
14-21
1.6
1.8
0.1
0.1
0.5-1
0.5-1
1.2-1.7
1.4-1.9
1.2-1.9
1.4-2.1
15-2218-25
2.5
2.5
0.15-0.3
0.15
1.5
1.5
Woman :
Sedentary
Moderate
Heavy work
Adolescents :
13-15 yrs
16-18 yrs
Piegnancy
(Second half)
L'ctation
c- Taken from reference 4
t Taken from RDA of Food and Nutrition Board, U.S.A. 1968.
per the above mentioned schedule they supply 2-4
times the RDA, and it was argued above that double
the RDA should be enough in moderate or doubtful
deficiency states. We must also remember that when
a diet is considered to be low in a nutrient, it is not
totally lacking in that nutrient. The average diets of
the low socio-economic groups provide 0.5 to 0.8 mg
each of Bi and Bz.
Items 7-9 provide about 5-25
times the RDA in a single dose.
If even such pre
parations are prescribed thrice a day, the intake
would be 15-75 times the RDA. Item 8 in a single
dose supplies thiamine in a quantity prescribed for
the whole day in beri-beri ? Moreover in beri-beri
it is not necessary to prescribe very large amounts of
other vitamins. Thus preparations like 8 and 9 are
not necessary at all.
should this higher level be ? For acute and severe
states like beri-beri or keratomalacia text-books
prescribe doses, empirically arrived at and found to
bring quick relief. These are usually much higher
than what would be required even for that degree of
amelioration.
Table III shows the prescribed thera
peutic doses, as obtained from various standard books
on nutrition and medicine.
For chronic, moderate deficiency states or for
situations where vitamins are prescribed empirically,
we may assume that levels much lower than the
therapeutic doses and slightly higher than the RDA
should be enough. Let us be generous and double
the RDA, remembering that the patient does receive
a certain amount from his diet too.
With this
information 1 would like you to critically compare
Table II with Tables 1 and III.
Much of the time drugs are not prescribed
according to any therapeutic schedule.
They are
usually prescribed as ‘ 1 dose or 1 tablet, three times
a day ’. Items No. 1-4 in Table II are close to the
RDA with respect to vitamins Bi and Ba. Given as
Table-II
An argument may be put forward that since
water-soluble vitamins are harmless compounds there
is no necessity to raise a hue and cry about the
dosages prescribed.
This is no doubt true but,
‘ such practice is economically wasteful and in some
instances, causes financial hardship ”.
Composition of some multivitamin and haeniatinic preparations available in India.
1
Capsule
Vitamin Bi mg
Vitamin Ba mg
Vitamin Be mg
Niacin mg
Vitamin B12 mcg
Folic acid mg
Vitamin C mg
Iron
( Type of salt ) mg
1
0.5
0.6
4
2
2
2
2
1
50
Sulp.
150
timed
release
Vit. A. I.U.
Vitamin D. I.U.
3
5 ml.
4
5 ml.
5
Cap.
6
Cap.
7
Cap.
1.0
0.75
0.15
7
0.45
1.6
0.8
0.8
4.0
2.5
3.0
1.0
0.5
30.0
5.0
10
10
5
100
5
F.A.C
185
Gluco.
35 '
5
?
I
10
5
1
50
Sulp.
200
Cap.
250
90
200
Sulp.
41
8
Cap.
50
25
10
100
5
0.5
300
9
Cap.
20
5
2.5
100
5
1.0
100
10000
1000
25000
1000
Table-II ( Contd)
10
5 ml
Vitamin B, mg
Vitamin B.. mg
Vitamin B,; mg
Niacin mg
Vitamin B|2 mcg
Folic acid mg
Vitamin C mg
Iron (Type of salt)
mg
Vitamin A
Vitamin D
11
Cap.
12
Cap.
13
Cap.
14
5 ml.
15
5 aml.
16
Cap.
io
25
2.5
Colloidal
oxide
100
25
2.0
200
Fuma
rate
350
15
150
Fuma
rate
350
50
2.5
100
Fuma
rate
300
7
1.75
15
2
25
2.5
Colloi
dal ox.
500
Fuma
rate
125
Fuma
rate
'250
17
3. mll.M.
18
5ml. I.M
100
100
27.5
25
1000
500
It must also be remembered that water-soluble
vitamins cannot be stored in large amounts unlike
the fat-soluble ones. This of course is one of the
factors underlying their low toxicity. ‘ In prescribing
thiamine it should be remembered that the healthy
human body contains only about 25 mg of the
vitamin. Furthermore, it has no means of storing
any excess taken in the diet; the excess is lost rapidly
in the urine.
The human body is certainly an
effective machine for dissolving thiamine pills and
transferring the solution to the urinal ’5.
Moreover
it has been shown, atleast for riboflavin that intestinal
absorption is limited by saturability and that higher
the dose, smaller the fraction absorbed. This is no
case in favour of parenteral administration either,
because higher the amount in circulation greater the
excretion in urine.
Thus, most of the ‘ high-potency ’ or ‘ Forte ’
preparations of multivitamins are a sheer economic
waste. It is a drain on the patients’ purse and the
onus is on the doctor because he is making the
patient buy a specific preparation.
If bought by
goverment or public sector dispensaries, it is a
national waste. If preparations with smaller and yet
adequate quantities were bought, for the same money
more tablets could be purchased and a greater number
of patients benefitted. Manufacture of such ‘ highpotency ’ preparations must also use up an unnecessary
amount of the scarce foreign exchange resources,
since quite a few, and probably all vitamins ( raw
materials ) are imported.
Thus it is not proper if one merely prescribes’
B-complex tablets and avoids brand name because he
is a ‘ conscientious objector ’ to brand names. As long
as there is no uniformity in the dosage employed in.
various preparations, it is necessary to know which
brand supplies or claims to supply requisite quantities
of vitamins. Also, there is no need to blindly follow
Table-Ill
Suggested doses of vitamins for single, acute and
severe deficiency
Condition
Vitamin
Beri-Beri
B,
Riboflavin deficiency B,
Megaloblastic anaemia Folic acid
Bl 2
Megaloblastic amentia
of pregnancy
Folic acid
Corneal xerosis
Bitot’s spots
Vifamin A
Rickets
Vitamin D
»
Dose (Oral)
10-25 mg bid
or tds
5-10 mg
5-10 mg
5-10 mg
10 mg
5000-10,000 I.U
1000-5000 I.U.
the ’ one t.d.s. ’ schedule. How much and how
frequently, should be decided on the merits of the case.
1 also wish to draw your attention to one or
two additional points. There is a widely held belief
that a combination of vitamins B, Ba and B12 is
good for neuropathies and other nervous disorders.
I don’t think this is based on any solid therapeutic
evidence. The reason the three are combined, I think
is because each one has been shown to be effective
in a specific disorder of the nervous system. Hence
the triad is used as a short-gun therapy, indiscrimina
tely. In fact, the brand names of certain such prepa
rations incorporate Greek terms like ‘ encephalo ’,
‘ neuro ’ etc. The manufacturers of one preparation
even ciaimi ts efficacy in improving memory.
‘ It (thiamine) may be given, though without
expectation of dramatic results, in cases of nutritional
neuropathy. There is no reliable evidence that it is
useful in any other disorder of the nervous system.
The prescription of synthetic thiamine, either alone or
in combination with other vitamins, as a general tonic
or appetiser, is supported by no scientific evidence
and is now discredited. ’5
‘ Vitamin therapy is often given to patients with
polyneuropathy, although it is clear that polyneuro
pathy is not due to deficiency of vitamin Bi, B12 or
any other known vitamin. Such treatment has a
placebo value and probably no other, but is not to
be decried... .’s.
For reasons mentioned right at the beginning
I too do not decry the use of the combination as
I do the dosage in such preparations. Items 17 and
18 in Table-II are two classical examples. Both are
meant for parenteral use, another characteristic of
this triple combination, probably because of the
presence of vitamin B12. The conventional prescri
ption by physicians for parenteral B-complex is ‘ 2 ml
M.
I.
once a day or once on alternate days ’.
Assuming the patient receives 6 ml in a week, he is
given 600 mcg to 2 mg of vitamin B12 ! What a
collossal waste considering that vitamin B12 is an
expensive substance. The prescribed dose even for
pernicious anaemia is 2 mg weekly, even those who
may argue that unlike the other B-complex vitamins,
vitamin B12 is stored to a certain extent in the body
may note that with each 1 ml goes 20-33 mg thiamine.
Many of the oral preparation too contain unnece
ssarily high amounts of Bl5. The RD A for this
vitamin is 1.0 mcg and in pregnancy and lactation, 1.5
mcg. Even conceding that a majority of the popu
lation cannot afford animal foods and hence many
may suffer from vitamin B12. deficiency, I see no
reason why any preparation should contain more
than 2 mcg. and at the most 5 mcg vitamin Bl2.
This criteria is met by only 7 of the 16 oral prepa
rations listed. If dle preparations are haematinics
combined with iron, they have to be prescribed three
times a day. In which case the preparation should not
contam more than 2 mcg Biz . Items 10-13, 15 and
16 must be very expensive and those who really
suffer Irom B12 deficiency can ill-afford then. 1 also
wish you to note that mixed haemanitics-iron prepa
ration containing vitamins and minerals, are condcmed
by authorities in the field of anaemia. “ Recovery
of the patient with uncomplicated iron-deficiency
anaemia is not helped by vitamin supplements or
minerals’'. In our experience vitamin B,._. and folic
acid are not needed till haemoglobin levels come upto
11 gms. % or more.
Let us now consider the vitamin A content of
these preparations. The prescribed dose of vitamin A
for corneal xerosis and Bitot’s spots is 1500-3000 nig
( 5000-10,000 l.U ). daily8,9.
The RDA during
lactation, the maximum suggested for any group, is
3500 l.U. Notice the vitamin A content of items 7
and 9.
Who needs 25,000 l.U. vitamin A daily ?
Severe cases of deficiency like keratomalacia are not
to be treated with oral preparations9,10.
Those who
really develop xerosis can never afford a pharma
ceutical like 7 or 9, whose price is further raised due
to presence of other nutrients.
Imagine to what
extent the price can be reduced simply by bringing
down the vitamin A content, even to 5000 I.U.,
which itself is a high amount.
Then, there is the practice of adding glycero
phosphates to liquid, multivitamin preparations. I do
not know of what therapeutic value these compounds
arc. They are not mentioned in any standard text
book of pharmacology and therapeutics. As far as
1 know (see any pharmacopoea) they only form basic
ingredients of syrups, possibly for flavour. However,
a widespread misunderstanding is that they are
’ energy givers ’ or
tonics . Some brand names
carry a prefix or suffix of phospho’ and the advertise
ment says ‘energy givers’, vitalizer etc. This in my
opinion is a fraud perpetuated by the drug companies
and worse still, an unpardonable ignorance on the
part of the doctor. The vitamins atleast, despite the
excess and the wastage, do some good. I see no
nutritive or therapeutic value for the glycerophos
phates. Their presence is needed for syrup preparation
but its name should not be included in the brand
name and no claims should be made for its therape
utic efficacies.
One of the nutrients commonly added to multi
vitamin preparations is iron. Witness that out of the
16 listed items, only 4 do not contain iron. It is
well-known that ferrous compounds are better absor
bed than the ferric, and it is heartening to note that
most are ferrous salts.
A preplexing form is the
colloidal iron oxide (items 10 and 14) which finds
no mention in any book on pharmacology or iron
metabolism. Since it is a colloidal preparation I doubt
if the iron in it is easilly available to the body.
Of the various ferrous salts, ferrous sulphate is
the least expensive and should be the treatment of
choice, yet only 3 preparations contain it. It is said
that contrary to popular thinking and claims,
gastrointestinal intolerance to iron preparations depends
on the total amount of elemental iron in the gut and
on psychological factors;
it is not a function of
the form in which iron is administered.1,7 Thus claims
made for compounds other than ferrous sulphate,
of increased tolerance or decreased toxicity, are not
genuine.
Also, sustained - release ( timed-release )
compounds ( no. 2 ) take the compound beyond the
duodenum and proximal jejunum and thus reduce
iron absorption. Therefore it is wasteful to prescribe
such preparations.
The RDA for iron ranges from 20-40 mg per day
depending on age, sex, physiological state etc. This
of course is for food iron and for free inorganic
salts would be less. The therapeutic dose, on the
other hand, is 60 mg elemental iron, thrice a day.
Ferrous sulphate, fumarate and gluconate contain 20%.
33% and 12% elemental iron respectively. Items
11-13 and 16 are probably meant for iron deficiency
anaemia. Prescribed twice a day they supply 250-350
mg elemental iron which is higher than the thera
Thus taken,
13 supplies 150 mcg
peutic dose.
vitamin B12. On the other hand, no. 7 supplies only
8 mg elemental iron per capsule. One may argue
that this may be used as for prophylaxis and not
treatment. Have a second look and tell me the
situation where in an individual is grossly deficient
in every vitamin one can think of and is yet not
deficient in iron ? This is a pure commercial gimmick
to claim haematinic value for the preparation.
As
early as 1936 Strauss said “shot-gun therapy is to be
deplored for a number of reasons. Most mixtures of
substances fail to contain enough of any one ingredient
to give maximal effects. The patient must pay not
only for the material he needs but also for the nonessentials ” (cited from ref. 1).
One can go on endlessly in this manner.
My
intention in writing this is to bring to the notice of
MFC members the fact that all multivitamin and
hieittatinic preparations are not same.
Them is no uniformity in dosage employed.
There is no authority to lay down criteria for
The:e is no authority to check whether the
claimed doses are actually present.
4.
Doctors prescribe these preparations with total
ignorance of or indifference to principles of
nutiition and therapeutics.
5. High-potency preparations should be available
separately for single vitamins.
Multivitamins
need not contain amounts much higher than
RDA. They are economically wasteful.
6. The false claims made for improvement of
unspecified and unproven conditions are perpetua
ted due to the ignorance or compliance of the
doctors.
7. Most of the companies have foreign collaboration.
Most of the raw ingredients tuc to be imported.
Could this be one of the reasons for the high
dosages employed ?
1 ; m sure you will find asking yourself many
more such questions.
I.
2.
3.
References
1.
2.
The Pharmacological Basis of Therapeutics. ( L. S. Goodman
and A. Gilman, cds.). Fourth cdn. MacMillan Co.,
London. 1970.
Nutrition Atlas of India ( C. Gopalan and K. V. Raghavan
cds.) National Institute of Nutrition. Hyderabad, 1971.
3.
Energy and Protein Requirements. WHO Tech. Rep. scr.
No. 522. 1973; Requirements of vitamin A, Thiamine,
Riboflavine and Niacin. WHO Tech. Rep. scr. No. 362,
1967, WHO Geneva.
4.
Dietary Allowances for Indians ( C. Gopalan, B. S. N. Rao)
Indian Council of Med. Research, Spl. Rep. Ser. Mo. 60, 1968.
5.
D. Davidson, R. Passmore, J. F. Brock and A. S. Truswcll.
( 1975 ). Human Nutrition and Dietetics, Sixth cdn. Churchill
Livingstone. Edinburg and London.
6.
W. G. Bradley (1975 ).
Practitioner 215: 452.
7.
T. H. Bothwell and C. A. Finch ( 1962) Iron Metabolism.
Little, Brown Co., Boston.
8.
S. G. Srikanlia ( 1975) Human vitamin A deficiency. Wld.
Rev. Nutr. Diet. 20: 184.
Reddy, V. ( 1969) vitamin A deficiency in children. Indian
J. Med. Res. Suppl. to vol. 57, p. 54.
M. F. C. Bulletin 8, August, 1976.
9.
10.
The treatment of polyneuropathy.
Reprinted from :
Medico Friend Circle Bulletin, November, 1976
Published monthly from 21 Nirman Society, Vadodara-390 005
rT>P-' 2-o
DRUG SITUATION JN .INDIA
DANGEROUS
PROFITEERING
•’MY IDEA OF A BETTER ORDERED
WORLD IS ONE IN WHICH MEDICAL
DISCOVERIES WOULD BE FREE OF
PATENTS AND THERE •WOULD BE NO
PROFITEERING FROM LIFE OR DEATH'’.
- Indira Gandhi
at World Health Assembly (1981)
The pioneers in establishing the drug industry in the
country were
P.C.Ray and T.K.Gujjar.
At the time of Indepe
ndence, the total pharmaceuticals sale was Rs.10 crore.
Over the years, the multinationals have gained strong
roots in the Indian Drug Industry and repatriate huge amounts
out of this country.
On the whole, the contribution of these
drug manufacturing units towards producing life-saving and
essential drugs has been very little.
The Indian drug industry
floods the market with about 70,000 formulations, yet 40,000
children go blind every year because of Vitamin A deficiencv.
Most of drugs produced ire unessential and many of them
have been banned in developed countries.
Unlike other commodities in the market for which the
market is open and common through the mass media, the drug
companies’ main concern are doctors, wholesalers and retail
chemists.
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 representatives, they extensively advertise in profes
sional medical journals also.
The Indian Council of Medical Research and the Iridian
Council of Social Sciences Research set up a joint study
group to study the health situation in India and in the report
2
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 ICSSR 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 drug
companies, let us see what our drug policy has to offer.
The
following observations are worth noting.
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 loopholes in the ban orders.
3.
No attempt has been made by the policy about abolition of
brand names and introducing generic names.
4.
5.
No attempt was made to make a list of essential drugs.
The 1986 drug policy increases the cost of essential drugs.
The Increase in price is even one hundred percent for some
products.
6.
w
The policy encourages more formulations by delicensing
certain drugs and also its formulations.
7.
The drug policy makes no mention about restrictions that
need to be put on the promotional material of drug 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.
dations .
1.
2.
The following are the highlights of the recommen
All multinational companies should be nationalised.
Generic names should be used, instead of using trade
names, brand names.
- 3 -
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.
Distribution of drugs being an important factor, a
National Drug Authority of India (NDA) should be
set up.
7.
A list of 117 essential drugs were drawn up by the
committee >
8.
The Indian sector of drug industry should be helped
to obtain self-sufficiency.
Former judge of the Supreme Court Justice Krishna
Iyer is on record as stating.
"Government is allergic
to the Hathi committee report and dithers, delays,
shies and even retreats, allowing the hefty drug indu
strialists to hold to ransom people's health. Pharma
ceutical imperialism practised by covert and overt dis
information, trade terrorism and brainwashed professionalism
is a menace to a patriotic drug policy".
In the context of the entire drug issue, a lesson
has to be learnt from a small neighbour, Bangladesh.
In fact, the country took up the entire idea, of a drug
policy from the Hathi Committee.
The Indian drug industry should cease to exist as a
profit - making industry and the concern should be for
health of the people.
Drugs have a role to play in the
health care system, and people will have to raise their
voice to claim it.
SHOWS. THE' .. WAY
BANGLADESH
A small developing country has taken a big, bold step in
Bangladesh has banned 1707 drugs dealing
the right direction.
with 4140 drug products. Multinational companies and their
governments have expressed great resentment and resistance to
this move.
That is expected because they control 80% of the
drug sales in Bangladesh and their market in developing
countries runs into many, many millions of dollars.
The multinational and national companies affected, succeeded in
pressurising the Bangladesh government to review and postpone
the* ban.
These few months are therefore very crucial- because
all kinds of pressures are being exerted to dilute the ban.
This is where all of us in India concerned with drug issues,
have a vital role.
issue.
We need to study all information on this
We published in the last issue the criteria adopted
by the Bangladesh Government for the ban.
In this issue,
there are articles by Zafrullah, Susanne Chowdhury and Andy
Chetley.
Other related informations are available with VHAI.
Thanks to the work of Mira and Sathya.
And then act.
Write to the Bangladesh
Write to newspapers.
Health Minister (C/o Bangladesh High Commission, 56 Mahatma
Gandhi .Hoad, Lajpat Nagar III, Nev; Delhi - 110024).
'Write to
Zafrullah Chowdhury, expressing solidarity and support.
need it.
They
-With lack of international support, a bold step is
likely to bo backtracked by the Bangladesh Government under
multina- ional pressure.
There ar . some who believe that supporting the ban means supp
orting a military Government.
On the contrary, it means supp
orting people like Zafrullah Chowdhury and his.friends people
who are working hard to promote social justice and equality in
health. Supporting the ban means supporting a major decision
i:. 1-vou
of the poor.
We need to d,° even better. We have to stop similar irrational
and dangerous practices.
We have to demand a similar ban rom
our own Government.
Write to the Drugs Controller of India,
Nirman Bhavan, New Delhi - 110011.
It is a tough struggle to
promote justice and fight oppression.
But if Bangladesh, a
small country which is more dependent on foreign aid for its
drugs and development than India can do it,
why can't we i?
Bangladesh has shown us the way.
by S. SRINIVASAN
Need versus Supply of Drugs
Ana nt R Phadke
•
«
Reprinted from Economic and Political Weekly, Vol XXX, No 39, September 30. 1995
Pagination as in original
Need versus Supply of Drugs
Anant R Phadke
It is not primarily inadequate expenditure on drugs that is responsible for the unmet drug needs of the people, but
the use of irrational and unnecessary drugs and the irrational use of radonal drugs. A study of drug expenditure in
Satara district of Maharashtra bears this out.
IT is often pointed out that the per capita
drug consumption in a developing country
like India is quite low as compared to that
in the developed countries The drug
companies want drug consumption in India
to increase from the current estimated Rs
7,000 crore to Rs 15,000 crore by the year
2000 AD. But this estimate is not derived
from any study of the actual needs of the
Indian people based on the prevalent rates
of all the diseases in India. We therefore
decided to make such a need-based estimate
of drug requirement for Satara district
(Maharashtra) as an example. We are unaware
of any study which has estimated the drug
needs at district level or above in a systematic
Hanner on the basis of estimated morbidity
^^atara district was selected for the
following reasons. We look into
consideration
its
socio-economic
development, size of the civil hospital
(number and beds), existence of cottage
hospitals, expenditure on drugs and logistic
convenience for undertaking a study there.
ThcCcntre for Monitoring Indian Economy’s
Index for district socio-economic
development was taken to classify districts
in Maharashtra as highly developed,
averagely developed and underdeveloped.
The districts falling in the averagely
developed class were selected for application
of other criteria. From the Performance
Budget of the Government of Maharashtra
1990-91. information on the sanctioned beds
in the civil hospital and expenditure for
drugs were obtained for the averagely
developed districts. Before doing the final
selection, the logistical convenience to study
the district from Pune city whereour research
was located was kept in mind. Satara
:t in the western part of Maharashtra
ed the above criteria belter than other
districts. Table 1 shows its characteristics.
We carried out thus exercise of estimating
drug needs of Satara district in two stages.
We first estimated the drug needs for curative/
symptomatic care if the patients coming to
PHC-OPD were to be treated rationally and
adequately. This need was compared with
the average drug supply to PHCs for curati ve/
symptomatic care during 1991 -92 in Satara
district.
In the second stage of our exercise, we
estimated the drug needs for Satara district,
if all the patients in Satara district were to
be adequately and rationally treated and if
all children and mothers in Satara district
were to be given adequate preventive
medication in a maternal and child health
S
2454
(MCH) programme. This need was compared
with the total sale of drugs of Rs 21.28 crore
during 1991-92 in Satara district.
The first step in this exercise was to
calculate the number of ill persons who
come to PHC-OPD for medical relief. This
was done as follows.
In the first phase of the study, drug supply
data of nine PHCs (out of 69) were collected.
Out of these nine PHCs, we wanted to select
six PHCs for this study; two each from
average, backward and developed areas. But
only two out of these nine were in the
averagely developed area and one of them,
the Bawdhan PHC, had a very low OPD
attendance. One PHC from backward area
was selected to replace the Bawdhan PHC.
The Pimpode PHC from developed area was
also excluded due to low OPD turn-out and
the Aundh-PHC from backward area was
dropped because of very poor records in that
PHC. The final selection was as follows:
PHCs from backward area - Khatav, Mayani,
Vaduz; PHCs from average area - Bhuinj;
and PHCs from developed area - Indoli,
Undale.
The average annual OPD attendance in
these PHCs in Satara district is 7,774. To
get a minimum average sample of more than
100 cases, an approximate 5 per cent sample
was taken, i e, every 20th case-paper from
the case-papers of 1991-92 was selected.
starting from a random number. Thecondition
for which treatment wis sought during the
last visit as noted on the case-paj^r along
with the age of the patient was noted down
by the pharmacist-investigator. Analysis of
these data gave us the estimated disease
wise frequency of patients coming to PHCOPD. Since overall aim of this exercise was
to estimate drug-needs of this morbidity
load, the patients were grouped into three
age-groups - 0-5 years. 6 to 12 years and
above 12 years. In order to calculate the cost
of an adequate and rational drug treatment
for all the cases coming to PHC-OPD.
standard prescriptions were prepared on the
basis of Indian medical text books, with the
help ofconcerned experts for the92 common
conditions encountered in these prescriptions.
Then the costs of drug treatment for these
92 common conditions were worked out on
the basis of rate contract prices.
The detailed standard drug treatment cost
estimates for each type of disease reported
at each of the six PHCs selected for study
were worked out. Table 2 gives the summary
of these results. Table 3 gives the details
of this exercise for one PHC (Bhuinj) by way
of example. (Table 3 contains, by way of
example, only the first five and the last five
items from the original (able.) This estimate
excludes cost oi drug-therapy for TB and
leprosy because the PHC-OPD routine case
paper records do not contain a record of TB
and leprosy patients. These records are kept
separately.
Table 2 shows that the average drug
requirement for curalive/symptomatic care
for patients seeking treatment at PHC-OPD
during 1991 -92 was Rs 67,418 per PHC for
these six PHCs; Rs 11.68 per patient. As
mentioned earlier, we have not included here
the drug cost for treatment of tuberculosis
and leprosy. But this small deficiency would
not materially affect the argument given
below about the drug needs of patients coming
to PHC-OPD.
We have also worked out as an example
the requirement of different important,
commonly used drugs for Bhuinj PHC and
have compared this with the actual supply
to Bhuinj PHC during 1991-92. The
category wise (as per categories of Essential
Drug List of WHO) requirement and supply
for Bhuinj PHC has been given in Table 4.
This table illustrates in a very concrete way
the categorywise shortfalls and imbalances
in the supply of drugs to a PHC. (Table 4
contains by way of example the first four
and last four items from the original table.)
^ShoiAfall at PHC
Let us compare the need of Rs 67,418 per
PHC fordrugs forcurati ve/symplomatic care
with the drug supply to these six PHCs as
worked out in the first part of the larger
Table 1 Criteria for Selection of District
Maharashtra Satara
Average
The CMlEindcx
(All India = 100)
163
Average no of beds in
non-teaching Civil
Hospital-Ch (1990-91)
239
Average OPD attendance
per day (CHs) (1990-91)
631
Average daily expenditure
on drugs per OPD patient
(Civil Hospital)
(1990-91) (Rs)
4.47
Average no of Indoor
Patients per day (CHs)
(1990-91)
251
Average daily expenditure
on drugs per Indoor patient
(CHs) (1990-91) (Rs)
22
Distance from Pune kins
-
Economic and Political Weekly
93
235
350
7
233
20
70
September 30, 1995
study, for the year 1991 -92.lt was an average
of Rs 37,134.38 per PHC. We have excluded
the supply of anti-tubercular drugs for these
six PHCs, since the estimate of the need
excluded anti-tubercular drugs. These supply
data are based on drug supply to PHCs from
all sources. (PHCs do not get only Rs 15,000
to Rs 20,000 as mentioned in the Annual
Report 1991-92 of the Zilla Parishad; more
drug supply comes under various schemes.)
Thus there is a shortfall of Rs 30.284 per
PHC.
This shortfall must be met by additional
supply The average recurring expense per
PHC during 1991 -92 as given in the 199192 Annual Report of Satara Zilla Parishad
was Rs 0.363 million. The additional drug
supply required would be only 8.34 per cent
of this expenditure. Today PHCs do not cater
adequately to the fell needs of the people
for curative/symptomalic care. If this is done
by a mere 8.34 per cent increase in the PHC
budget for recurring expenses, an important
acutely felt need of especially those poor
people in rural area who seek medical care
at PHCs would be fulfilled. Secondly, it
would increase the esteem for the public
health system and thereby increase people’s
co-operation in public health programmes.
Increased drug supply to PHCs would
need a change in the overall official attitude
and policy towards health care. It is true that
prevention is better than cure. But it docs
not mean neglect of ailments which arc
already there. The official policy
conveniently makes precisely this mistake
of neglect of curative/ symptomatic needs
of the people, leaving it to the private sector.
This attitude must change. A government
which collects huge taxes and docs not spend
even a minimum 5 per cent of GNP (as per
recommendations of the Health For All
Strategy of the Alma Ata Conference) has
no right to ask people to go to private
practitioners for their curative/symptomatic
needs. At least primary health care needs
must be necessarily met.
The need of Rs 67,418 per PHC per year
as calculated above is only a small part of
the total drug needs of all the people in Satara
district. This is because only a small
proportion of patients go to the PHC. The
^BTable 2: Morbidity Load at the PHC OPD and Standard Cost of Treatment at Rate
Contract Prices (1991 -92) for Six PHCs
Name of
h-il
Adult (above 12 yrs)
No
Total
of
Cost
Cases (Rs)
Bhuinj
5420 89125
3460 29390
Indoli
4680 87544
Khatav
Mayani 3680 6661 1
2780 28981
Undale
Vaduz
5140 54948
25160 356599
Toial
Average 4193 59433
Child (6-12 yrs)
Child (0-5 yrs)
Total
Cost/ No Toial
Case
of
Cost
(Rs) Cases (Rs)
Cost/ No
Total
Cost
Case of
(Rs) Cases (Rs)
Total
Cost
(Rs)
Cost/
Case
(Rs)
16.44
8 49
18.71
18 10
10.42
10 69
14.17
14.17
5.49 1000
96472
1635 1.64 7460
32115
2.38 580
533 0 92 4960
93016
5.50 420
633 1 51 5980
75795
5 89 840
2582 3 07 5640
31741
6 41 260
836 3 22 3340
75370
9.72 1040 9917 10.28 7260
6.02 4140 16136 3 90 34640 404509
6.02 690 2689.3 3 90 5773. 67418.16
12.93
6.47
15.55
13.44
9 50
10.38
1 1 68
1 1 68
1040
5712
920
2192
880
4839
1120 6602
1924
300
1020 10505
5280 31774
880 5295.6
Cost/ No
Case of
(Rs) Cases
rest go to private practitioners. The drug
needs for curative/symptomatic care of the
total population has been worked out in
Table 5. For this we needed community
based morbidity data. In India community
based morbidity data for some diseases have
been recorded. But to our knowledge
comprehensive morbidity data for all major
and common diseases in India are not
available. However, some estimates of
overall morbidity load in India are available
[Park 1987, Duggal 1994]. We used these
estimates in Table 5 for Satara district, since
these data for Satara district arc not available.
The morbidity rate for this average district
is unlikely to be quite different from the all
India average. It will be seen from this table
thatdrug requirement forOPD level curative/
symptomatic care (excluding TB and leprosy)
for the total population in Satara district is
in the range of Rs 92.97 to Rs 208.96 million
with an average of Rs 151.02 million. To
this is to be added the cost of treating all
cases of TB and leprosy.
In calculating the cost of adequate and
rational treatment for all the cases coming
to PHC-OPD, we had deleted the cost of
drug therapy for TB and leprosy, since the
data for the same were not available in the
PHC-OPD routine case paper records. But
in estimating the total drug needs for Satara
district forOPD level curative/symptomatic
care, we have to add the cost of drug therapy
for these two diseases for all patients in
Satara district . To estimate this cost, we need
prevalent rate of TB and leprosy in Satara
district. No such data are available. We
therefore used the prevalent rate of 2 per cent
forTB as found in various surveys in India
[Park 1990:132] and a prevalent rate of 6.37
cases of leprosy per thousand population in
Maharashtra state. The agewise break-up of
the Satara population (0-5 years, 5-12 years.
Table 3: Prevalence of Diseases Reported at Primary Health Centre OPD
and Standard Cost of Treatment at Rate Contract Prices. 1991-92
Bhuinj PHC
S No Names of
Diseases
1
2
1 Abcess
2 Abdominal pain
3 Acid peptic
4 Allergic rash
5 Allergic rhinitis
58 Stomatitis
59 Tonsilitis
6IURTI
62 UT1
Total
Costing for
Costing for
Cost of
Adult Cases
Child Cases
Treat(12 Yrs or More)
(5-11 Yrs)
ment Per
No
No
Adult
A as Cost A as
No
B as Cost B as
Per
of
Per
of
Per
of
Per
of
of
Case
Adult Cent Adult Cent Child Cent Child Cent Child
(Unit
Cost) Cases Total Cases Total Cases Total Cases Total Cases
(B) Cases in Rs Cost
(C)
(A) Cases in Rs Cost
(Rs
7260 (bi
7260
(a)
(Rs
96473)
96473)
5
4
9
7
3
6
8
10
12
11
8.95
0.28
171.00
0 18
1.62
4.28
8.94
7.36
42.50
0.19
0 28
179
34
1.65
0.03
1.10 13680 14.18
0.01
0.83
11
0.00
0.00
0.83
257
0.27
536
0.56
0.83
1 1.02 5888 6.10
0.83 2550 2.64
20
120
80
60
60
60
800
60
5420
Economic and Political Weekly
Rs
89125
September 30, 1995
180
1040
0 00
0.00
0.00
0.00
0.00
0.00
0.00
2.48
0.00
662
Rs
5712
0.00
0 00
0.00
0.00
0.00
0.00
0.00
0.69
0 00
60
40
140
1000
Costing for
Costing for
Child Cases
All Cases
(Below 5 Yrs)
Grang Total
Cas Cost Cas
No T as Cost
T as
Per
Per
of
of
of
Per
Per
Cent Child Cent Total Cent Total Cent
Total Cases Cost Cases of Cases Total
Cases in Rs (Rs
A+B Total in Rs
Cost
(Rs
7260
(c) 96473) +C Cases a+b+c
96473)
= T 7260
14
17
15
16
18
19
13
0.00
0 83
0.00
0.00
0 00
55
0.00
1.93
0.00
6
57
343
Rs
1635
0.00
0.01
0.00
0 00
0 00
0.06
0.00
0.36
0.00
0.28 179
2.48 39
1 10 13680
0.83
11
0.00
100 1.38 314
60 0.83 536
1 120 15 43 6894
60 0.83 2550
20
180
80
60
0.19
0.04
14 18
0.01
0.00
0.33
0.56
7.15
2.64
7260
Rs 1100.00
96473
2455
above 12 years) is required to calculate cost
per case for these age groups. But such a
break-up for Satara district is not available.
We therefore used the data for India, since
such demographic data do not vary much
within India. For cost calculations, we used
the cost of treating these diseases as worked
out in our main study.
It will be seen from Table 6 that if all cases
of tuberculosis and leprosy in Satara district
were to be adequately and rationally treated.
in 1991-92 it would cost Rs 27.31 million
and Rs 2 42 million respectively, i c. a total
of Rs 29.73 million. Thus the total drug cost
of treating all OPD level cases (including
TB and leprosy Jin Satara district in a rational
and adequate manner in 1991-92 would be
Rs 151.02 m + Rs 29.73 m = Rs 180.75 m.
To this is to be added the drug cost of
indoorcases. As per lhe performance budget
of government of Maharashtra for 1993-94,
lhe drug cost of indoor cases in the civil
hospital and in the Karad cottage hospital
was Rs 1.37 million and Rs 0.25 million,
respectively, i e. a total of Rs 1.62 million.
These two hospitals account for most of the
indoorcases in the publicsector. The number
of indoor cases in the private sector is not
10 times that in lhe public sector as in the
case of outdoor cases. But let us make a
liberal assumption that the number of indoor
cases in private sector is 10 times that in the
public sector and hence the expenses for
private indoorcases would be Rs 16.2 million;
and the total for both the sectors together
would be Rs 17.82 million. To this is to be
added the cost of preventive medication.
Drug Cost MCH Programme
The next step in estimating the total drug
needs of Sataradistrict is to estimate the drug
needs for prevention. Preventive medication
is mostly immunisation of children and
women and giving iron-calcium tablets to
pregnant women. Thus, it means that all
children and pregnant women are covered
in the maternal and child health programme.
To get the cost of preventive medication for
all children and pregnant women, we first
worked out the cost of immunisation per
child for primary and secondary
immunisation and the cost of drugs for ante
natal care per pregnant woman. This cost
multiplied by the total number of children
and pregnant women in need of preventive
medication gave us the cost of comprehensive
preventive medication for the maternal and
child health programme.
The cost of this preventive medication has
been estimated for Satara district in Tables
7 and 8. In this calculation we have assumed
that all children would be covered by
immunisation, whereas only 85 per cent
coverage is adequate for herd-immunity. But
on the other hand, we have not made any
allowance for wastages. The extra 15 per
cent vaccine that we have taken would take
care of the wastages during transport and
administration, etc.
Table 4 Categorywise Comparison of Supply versus Need of Some Important Drugs •N ACCORDANCE WITH STANDARD DRUG TREATMENT GUIDELINES.
for Cases coming to PHC-OPD. 1 991-92
Bhuinj PHC
S WHO Name of
No Ess!
Drugs
Drug Required
Cal
12
3
4
28
29
30
31
3
4
Total
Total
Unit
Adult 12 yrs Child 5-12 y Child 0-4 yrs Government Total
Doses ------------------------------------------------------------------Rates
Amount Cost of Amount Cost of
Required Total Drug Total
Drug Total
Drug
(Rate
of Drug
Drug Supplied Drug
Per
Cases Req- Cases Req- Cases ReqContract) Required Required During Supplied
Case
uired
uircd
uired
in Rs
1991-92
5
6
7
8
9
10
II
12
13
14
15
16
Abcess
9
20
180
0
0
0.05
180
Arthritis
Contusion
Infected
wound
30
21
180
60
5400
1260
0
0
0
0
0.5
0.05
5400
1260
9
Total
Tb Paracetamol Tonsilitis
9
500 mg
Pyoderma
9
(NSAID)
Dogbite
9
Body ache
9
Sinusitis
9
Boils
9
Pharyngitis
9
Cold cough
9
Otitis-media
9
Pyrexia/Fever 9
Bronchitis
9
Total
2.1 Tb Ibuprofen
Caries
15
400mg
dental
(NSAID)
(infected)
Total
2.2 Tb Codeine
URTI
4
lOmg
Cold cough
6
(Opoid
analgesic)
Total
25.1 Tb Salbutamol
4 mg
Bronchitis
1
27 Cp vitamin A
50.000 i.u.
Night blindness
10
27 Tb Multivitamin
ANC
15
Total
27 Tb Bcomplex
Giddiness
14
Total
Grand Total
400
3600
60
180
60
20
220
560
220
120
240
120
40
420
60
540
180
1980
5040
1980
1080
2160
1080
360
3780
540
100
0
0
0
0
0
300
0
180
120
300
120
0.05
0.05
0.16
0.16
0.16
0 16
0.16
0.16
0.16
0.16
0.16
0.02
0.16
0.16
4480
11320
540
180
2430
5040
1980
1650
2520
1440
480
4440
450
21450
80
0
0.40
1350
I
2
Name of
Diseases
2.1
Tb Aspirin
300mg
(NSAID)
2.1
140
700
566.00
25500
1275.0
3432.00
13500
2160.0
80
20
0
0
450
0
0
270
360
180
0
360
90
1200
20
150
180
40
360
120
140
60
187
120
1350
3747
960
NS
3200
720
0.40
0.20
0.20
540.00
800
120
0.2
4707
941.33
NS
60
60
20
10
4y
13.333
0.06
83
4 98
100
60
80
40
60
40
100
40
20
200
0
0
0.68
280
190.40
200
WOO
0
0
0.15
0.15
0.07
0.07
450
730
140
1167
450.00
640.40
9.80
81.69
74763.62
0
20
140
25432.5
NS - Not Supplied
2456
Economic and Political Weekly
September 30, 1995
To calculate the total number of children
and pregnant women in need of preventive
medication, we needed agewise break-up of
the Satara district population. But this break
up is not available. We therefore used the
figures for Maharashtra state. For this
purpose, instead of the census data, we used
the more reliable data and estimate of a
recent study [Balsubramanyam etal 1994].
It will be seen from Table 8 that the cost
of this comprehensive preventive medication
for the maternal and child health (MCH)
programme in Satara district is only Rs 6.86
million.
The total drug needs of Satara district in
1991-92 would thus be as in Table A.
Table A
(In Rs million)
For curative care at OPD level
excluding TB and Leprosy
For all cases of TB and Leprosy
For preventive medication in
MCH programme
For indoor cases
Total
151.02
29.73
6.86
17.82
205.43
Total Drug Needs versus Supply
The total drug sale in 1992-93 in Satara
district from reliable sources (audited
accounts of drug distributors) was Rs 26.6
crore. Weestimatethat thedrugsalcin 199192 would be 20 per cent less, i e. Rs 21.28
crore. Add to it the drug supply of Rs 5.6
million to the public sector, thus yielding a
total drug supply of Rs 21.84 crore.
Compared to this, the total drug requirement
as seen above for OPD level curative/
symptomatic care and preventive care as
well as for indoor care in 1991-92 was Rs
20.61 crore. Thus the drug expenditure in
Satara district in 1991-92 was adequate to
take care of all the drug needs of the total
population of Satara district. As is well
known, a substantial part of the money spent
by patients on medicines is wasted due to
irrational prescriptions. We have estimated
such wastages in Satara district as part of
our larger study. We found that in a random
sample of 152 prescriptions from 30 clinics,
in the private and public sector respectively,
54 per cent and 69 per cent of the money
spent on drugs was a waste. If this wastage
Table 5’ Annual Drug Requirement of Satara District for Curative/Symptomatic
Care at PHC-OPD Level. 1991-92
Estimate
- 1*
Estimate
-11** r
Estimated
Rate of
Morbidity
Load **•
Annual
Morbidity
for Satara
District
(Popn 2.45m)
Drug
Requirement
Per Case
(as per Table G-I)
in Rs
Total Drug
Requirement
for Satara
District
in Rs million
3.25 illness
episodes/
capita/year
2 per cent morbidity
per day
3.25 x 2.45
= 7.96 million
11 68
92.97
2 x 365 x 2.45
11.68
208.96
100
= 17.89 million
12.93 million
151 02
Average
11.68
—d———
*
BasedPark (iOth edition). We have taken the average of the range given by Park of 2.6
to 3.9 illness episodes per capita per year. r
•* Duggal 1994. . .
*#’ Since the estimate of rate of morbidity load for Satara district is not available, we have used
the available estimated rate of morbidity for India.
Ta4£e 6: Estimated Cost of Treatment of all TB and Leprosy Cases in Satara District.
1991-92
Aj^lrbup
NoofTB
Cost
No of
Total
Cost
Total
No of People
Patients
Per Case
Cost
Leprosy Per Case Cost
(Per Cent of
in that Agein that
(Rs) (Rs Millio n) Patients
(Rs
Population in
Group in
in that
Million)
that Age-group) Satara District Age-group
(Thousands)
Age-group
(Million)
(C)
(D)
(E)
(F)
(A)
(B)
(G)
(H)
0-5 years
0.368
(15 per cent)
5-12 years
0.539
(22 per cent)
Above 12 years
1.544
(63 per cent)
Total (100 percent) 2.451
7.35
235.2
1.73
2344
60.58
0.142
10.80
352.8
3.80
3433
90.88
0.312
30.90
705.6
21.78
9835
181.75.
1.788
49.05
—
27.31
15612
—
2.42
Notes: A: Estimated from Park 1990; p 266. Table 6 Since demographic data required for this table
a<^ not available for Satara district, we have used available rales for Maharashtra/lndia.
for this table.
B: Satara district population in 1991-2.45 million.
C: Estimated pmvatence rate of 2 per cent (Park 1990; p 132, Table 2).
D and G: As peritwr co. Jn5 in Ann^xure I of our main study. [Phaclke l995]7Please see item nos
56 and ©2 respectively in Annexurc I.
F: Estima|^prevalence rate of 6.37 per thousand population (Park 1990; p 211. Table I).
Economic!I.Weekly
September 30. 1995
is eliminated, the current drug expenditure
in Satara district would be sufficient to cater
to all the drug needs of the people in the
district. It may be pointed out that while
estimating drug needs for various diseases,
we have assumed that drugs are given in
sufficient quantity for adequate duration.
Based on limited data for a year from six
PHCs in Satara district, we cannot draw
general conclusions. But the estimate from
the current study in Satara district of the total
drug needs may be compared with the actual
experience of the Munnar project. This
project caters to all the OPD level and indoor
level curative and preventive medical needs
of a well demarcated population of 1,00,000
in tea estates in Kerala. It has been reported
that the annual per capita recurring health
expenditure in this project was Rs 120 out
of which 25 per cent i e. Rs 30 was spent
on drugs [Chenan 1993]. In our study, the
total drug need for Satara district for 199192 was Rs 205 million, for a population of
2.45 million, i c. Rs 84 per capita. Thus we
have not underestimated the drug need for
Satara district.
Drug Needs for India
This drug need of Rs 84 per capita, if
projected to the Indian population of 84.6
crore in 1991, works out to be Rs 7,106
crore. If we compare this need with the
estimated production of drug formulations
in India of Rs 6.900 crore in 1993-94
[Banerjee 1994], we find that the present
level of drug production in India would
roughly meet al l the drug needs of the 1 ndian
people for rational and adequate medication.
In any case, the argument of lhedrug industry
to increase the present drug production to
Rs 15.000 crore by 2000 A D is clearly
untenable.
Our estimation of drug needs for OPD
level care is an underesti mate. This is because.
(i)
Our estimation of morbidity load is based
on reported morbidity. This does not include
morbidities like gynaecological infections
Table 7: Cost of Primary Immunisation
Per Child (1992 Prices)
Type of
Vaccine
BCG
Oral Polio Vaccine
DPT (Triple) Vaccine
Measles Vaccine
Total
Cost
No of ■Cost
Per Dose Doses (Rs)
NA
1.88
1.07
4.43
5
3
_
9 40
3.21
4.43
17.04
Note: Except for the measles vaccine, the costs
of vaccines have been taken from the
1992 price-list of the Haffkine Bio-Phar
maceutical Corporation (Bombay), the
public sector undertaking, which sup
plies vaccines to the Maharashtra gov
ernment. Measles vaccine is not supplied
by Haffkine and hence for measles vac
cine. price as given tn IPG 1991-92 has
been used. Prices for biggest available
vial have been used as they are used in
inass-vaccination. Price of BCG vaccine
is not available since it is supplied by the
central government.
2457
which arc generally not reported, (ii) Our
csimatc of Rs 11.68 of drug cost per ease
is based on PHC-morbidity data which
generally do not adequately represent chronic
diseases like diabetes, hypertension, etc.
Despite this underestimation, we feel that
the estimate ofthe drug industry of Rs 15,000
crore (more than Rs 150 per capita) for the
year 2000 A D is too high.
Financial Wastage
It may be pointed out here that though the
current level of production of drugs would
roughly meet the rational drug needs ofthe
Indian population, today the majority ofthe
Indian people arc deprived of proper drug
treatment because of poverty and paucity of
medical services in the rural area. The drug
industry focuses on selling drugs mainly to
the middle and upper classes. They are lured
into or cheated into (i) consuming drugs of
doubtful or no scientific value (so-called
digestive, appetite stimulants, brain tomes
or sex tomes, etc); (ii) unnecessary
consumption of rational drugs (multivitamin
preparations in well-nourished patients or
antibiotics in viral infections), (iii)
Consumption of irrational combination of
two to five urugs when only one of the
conslitu-' ..s is adequate. Addition of other
unnecessary ingredients merely increases the
price of the drug (cough and cold mixtures,
iron tonics, pain-killer drug combinations,
etc); and (iv) buying well advertised brands
when good quality, cheaper alternatives are
available.
All this is possible because the drug policy
allows manufacture of all kinds of irrational
drugs or irrational drug combinations and
majority of doctors prescribe these either
due to ignorance or social insensitivity or
plain bribery from the drug industry in the
form of samples, gifts or sometimes even
direct financial incentives.
Every study that has analysed a particular
type of drug combination (anti-diarrhoea,
multivitamins, iron tonics, over the counter
drugs, etc) has found that almost all the drug
combinations studied were irrational (seven
to 11). A lot of money is wasted due to the
undesirable, wasteful forms of drug
consumption mentioned above (use of
useless, unnecessary and irrational drugs).
We have estimated this wastage in the Satara
distict study. For this purpose, we chose a
systematic random sample of 68 and 84
prescriptions from a stratified, purposive
sample of 19 and 30 private and public
outdoor clinics respectively, from the three
socio-economic zones of the district. The
drug cost of these prescriptions calculated
at retail prices, minus the drug cost of
‘standard prescriptions’ gave us the financial
wastage due to these prescriptions. It was
found that 69 per cent and 55 per cent of
the money Spent on these 68 private and 84
public prescriptions was a waste, with an
average of 64 per cent [Phadke 1995:66].
This wastage affects not only the well-todo, but also the poor.
This wastage of Rs 4.76 and Rs 2.08 per
prescription in public and private sector
respectively was projected to the Satara
district morbidity data with the help of public
sector outdoor clinic attendance data for
Sataradistrictandestimatednumbcrof illness
episodes during 1991-92 (as estimated in
Table 5. This exercise led to an estimation
of wastage of Rs I7.70croreon irrationalities
in prescriptions in Satara district in 199192 {Phadke 1995.67]. Compare this with the
drug supply of Rs 21.84 crore to Satara
district as estimated above. It will be thus
seen that though the existing drug supply to
Satara district in 1991-92 was roughly
adequate to cater to the rational drug needs
of the district, most of this drug expenditure
was wasted due to irrationalities in
prescriptions.
of money through irrational prescriptions.
(ii)
The total drug needs of Satara district
inclusive of rational treatment of all outdoor
and indoor patients and inclusive of total
coverage in MCH programme would be Rs
20.54 crore in 1991-92.
(iii)
Most of thedrug expenditure in Satara
district is wasted due to irrationalities in
prescriptions.
If the money presently being spent on
drugs in Satara district is not wasted on
irrational and unnecessary drugs and
irrational use of rational drugs and instead
if it were spent on rational drug treatment,
the current drug expenditure of Rs 21.84
crore is more than adequate to take care of
all OPD and indoor cases as well as for
preventive care. Thus, today, it is not
primarily lack of dmg expenditure that is
responsible for the unmet drug needs of
people in Satara district, but its irrational
use.
(This study is part of our larger study, ‘A Study
of Supply and Use of Pharmaceuticals in Satara
District’ This is a modified version of Chapter
XI of my forthcoming book. Drug Supply and
Use under the Microscope based on our^^eycar FRCH study of Supply and l^Bof
Pharmaceuticals in Satara District. I am thankful
lo N H Antia for his encouragement, research
associates Audrey Fernandes and L Sharda for
their sincere work, the medical officers in PHCs
in this study for (heir co-operation and Sham
Ashtekar for comments on an earlier draft. We
are thankful to Sanjeevani Mulay fordrawing our
attention to their study.]
References
Balsubramanyam. K ct a I (1994): National Family
Health Survey 1992-93. Maharashtra:
Population Research Centre. Gokhale Institute
Conclusion
of Politics and Economics. Pune. Tables 3.1.
5.1. 5.5.
On the basis of the exercise carried out
Cherian. T K (1993): ‘Rural Development
above, we conclude that:
through Total Health Care’ in People's
(i) The rational drug requirement at PHCHealth in People's Hands, N H Antia and
OPD level for curalivc/sy Diplomatic care
Kavita Bhatia. FRCH. Bombay.
can be met in Satara district by increasing
Desai. S V (1990): ’Anaemiaand Oral Haematinic
the health budget for recurring expenses by .
Preparations’, Drug Disease Doctor. Vol 3.
about 8.4 per cent and stopping the wastage
No 2.
Table 8: Estimated Cost of Preventive Medication in Satara District 1991-92
Desai, S V and R S Desai (1991): ‘Rational
Cough Mixtures: Analysis of Prop^^ry
Type of Preventive
Population in This Category
Cost Per Total
Preparations’, Bulletin ofSocietyfor RcMKal
Medication
in Satara District
Person Cost in
Therapy. Vol 3. No 5
As Per Cent
Absolute Nos
in (Rs) million
Duggal, Ravi (1994): ‘Fora New Health Policy:
of Population in Millions in
(Rs)
A Discussion Paper’. Medico Fnend Circle.
of Satara
Satara District
Bombay.
District
(Pop 2.45 million)
Jaya, Rao (1977): ‘Tonics — How Much an
Primary immunisation for all children
Economic Waste’, In Search of Diagnosis.
up to 1 year
2.4
.0588
17.04*
1.00
Medico Friend Circle.
One booster dq.se eao.h. of polio, triple and
Modak, Shishir (1985): Rationality Analysis of
measles vaccine for all children between
Anlidiarrhoeal Preparations. Medico Friend
1 to 2 years
2.4
.0588
7.38
0.43
Circle, Pune.
One booster dose each of polio and DT vaccine
Park. J E (1987): Textbook of Preventive and
for all children between 5-6 years of age
2.5
.0613
2.76
0.17
Social
Medicine. II th edition. 1987. p 26.
Two doses of typhoid vaccine for all children
Phadke. Anant (1985): ‘Scientific Scrutiny of
of 2-3 years of age
24
.0588
1.24
0.07
Over the Counter Drugs’. Medical Service.
Iron. Calcium supplementation and tetanus
Ocober-November.
immunisation for all pregnant women
3.0
.0735
70.58**
5.19
Phadke. Anant. Audrey Fernandes. L Sharda.
Total
.2663
6.86
Amar Jesam (1995): A Study of Supply and
Note: * As per Table 7.
Use of Pharmaceuticals tn Satara District,
** As per the cost of Standard Drugs Treatment Regimen, worked this study, in Annexure
Foundation for Research in Community
A-I of the main study.
Health. Bombay.
2458
Economic and Political Weekly
September 30. 1995
II
I
Sr. Disease
79
Stomatitis
III
No.
of
Drugs
2
V ’J
IV
Treatment
Drugs
Tb.Bcomplex
• Glycerine
*Tb.Folic acid 5mg
Dosage
Ibd x 7dys
100ml L.A
lod x lOdys
VII
VI
Total
Unit Cost
Total No
Of
Tablets Govt. Rate
Pvt. Rate Adult
1/2
14
bottle
.10
Tonsilitis
2
Tb.Penicillin V
Tb.Paracetamol SOOmg
Iqids x 5dys
ltds x 3dys
20
9
Tubectomy
82
Tuberculosis
4.80
•2.40
■ 2.43
13.68
8.34
’
4.20
;o.27
2.80
' ’ ;o.i8
15.00
‘ 2.25«
7.50
1.13
‘
8.94
4.47
•
2.98
17.25
8.63
• 5.83
0.35
20.00
10.00
2.21
^0;48
,0:30
-0.15
’‘4 .’28
3.64
8.40 i
’ 0.54
3.00
|
|
’
'-
2
Ij. PPF
Tb.Aspirin 300mg
1/day x Sdays
ltds. x 7days
5
21
3.5
0.05
4.00
0.21
17.50
'1.05
• - - « Z/S
0.53
18.55
-
9.28
6.18
24.41
12.21
4
Cp.Rifampin 450mg
Tb.Isoniazid Hyd. 300mg
Pyrazinamide
Cap. Rifampin 450 mg
Tb. Isoniazid 300 mg
lod x 120dys
lod x 120dys
ltds x 60dys
lod x 120 dys.
lod x 120dys
120
120
180
120
120
2.66
0.05
1.21
2.66
0.05
3.90
0.24
1.34
3.9
0.24
319.20
6 00
217.8
319.2
6.00
159.60
3.00
- 108.9
159.6
3.00
106.40
2.00
72.6
106.4
/ 2.00
468.00
28.80
241.2
468.00
28.80
234.00
14.40
120.6
234.00
14.40
705.60
352.80
235.20
986.40
493.20
Tb.Co-trimoxazole d.s
Tb.Chlorpheneramine 4mg
Tb.Paracetamol SOOmg
Ibds x Sdys
sos
ltds x 3dys
10
0.65
0.02
0.16
1.48
0.08
0.25
6.50
0.08
3.25
0.04
- 0.72
• 2.17
0.03
0.48
14.80
0.32
2.25
• 7.40
0.16
1.13
4.01
A-----•'C-. 2.67
Total
Upper Respiratory Tract
Infection (Bacterial)
^0.10
0.03 :
Total
83
■2.94
3.00
-0.49
Total
81
5.88
' 3.00
1
•'0.98>
' '3.00 J
0.75
0.25
|6-12yrs [below S yrs
*0.33
’ 2.00
0.42
.6.00
0.42
0.06
Total Cost at Private Rate
16-12 yrs 1 below 5 yrs Adult
0.07
6.00
Total
80
VIII
Cost at Govt. Rate
9
A
Total
8.02
104
-1.96
"\2.00
"1.60
8.69
5.00
0.75
•'5.75
■
-
-
- 6.67
;i.4.7
•
8.14
156.00
.9.60
80.4
156.00
9.60
328.80
......
4 93
0.11 .
0.75 ■
A
17.37
.5.56
...................
' ' 5.79
PR
VI
HAZARDOUS AND IRRATIONAL DRUGS
There are about 8,000 pharmaceutical units in India, which are producing
approximately 60,000 drug formulations.
many ci
these formulations are
known to be irrational and even hazardous.
MOST DRUG COMBINATIONS ARE IRRATIONAL
•
they increase cost unnecessarily
*
they increase chances of drug interaction
•
they make quality control difficult
*
they make drug pricing and price control difficult
♦
they make monitoring of adverse drug reactions difficult
•
they confuse consumers and medical practitioners alike.
The WHO List of Essential Drugs which consists of 250 drugs contains
only seven combinations.(Technical
Report Series 722, 1985)
In 1980, the Drug Consultative Committee, a statutory body constituted
under Section 7 ci the Drugs and Cosmetics Act (Act 23 of 1940), nominated
a sub-committee of
experts to study the rationality of
fixed dose combination drugs.
34 categories of
This sub-committee was to recommend to
the DCC whether these combination drugs should be allowed or withdrawn.
The sub-committee formulated norms to allow combinations of drugs.
These were :
a)
if there is synergistic action
b)
where there is corrective action
c)
when two or more drugs are normally prescribed together and
taken by the patient simultaneously
c!
when the dosage of each of the drugs need not be individualized.
e'
where
a
fixed-dose
combination
would
ensure
compliance due to convenience of administration
57
better
patient
2_tj
f)
wnere two or
more drugs, prescribed separately
non-ingestion of one of
may
lead
to
the drugs, thus adversely affecting the
health of the patient
Conversely,
norms for NOT allowing fixed dose combinations were
formulated as follows :
a)
b)
where adverse interactions may occur
the' combined drugs becomes
when one oi
toxic or prolonged
use
c)
when abruspt withdrawal of one of the drugs may cause withdrawal
symptoms
d)
if
sub-therapeutic doses are used in the absence of clinically
demonstrable synergism
e)
when pharmacokinetic behaviour of the individual agents is grossly
different.
and on the basis of
34 categories of combination drugs were evaluated
these criteria, the sub-committee recommended a
ban on 23 combination drugs and gave reasons for recommending the ban.
Sixtten categories of
recommended
these drugs were
immediately, while 7 cf
to be weeded out
the categories were recommended to be weeded
out over a specified period.
The list of 23 combinations to be weeded out is given on pg.
The
sub-committee
submitted
Committee on the 10 October 1981.
its
report
to the
Drug
Consultative
It was also presented to the Drug Techni
cal Advisory Board, and to the Ministry of Health and Family Welfare, which
accepted these recommendations
in
1981.
The Drug Technical
Advisory
Board (a statutory body constituted under Sections of the Drugs and Cosmetics
Act of 1940) recommended banning of eighteen fixed dose combination drugs.
It decided to prohibit the manufacture of fixed dose combinations of broncho
dilators, ant ihistaminics
and
tranquilizers with corticosteroids as early as
October 1980.
By some incomprehensible logic, the Drug Technical Advisory board,
consisting of exactly the same members reversed its decision on December
31, 1981 and allowed the sale of the products which it had earlier considered
58
to be dangerous.
At this point of time, it claimed that it was necessary
to obtain wider medical opinion.
The Editor of MIMS in his editorial in the issue of February 1982 (Voi.
2 No.3) on the "somersault on steroids" said that "they must have had very
extraordinary reason to
reverse their own earlier decision
ignore the advice of the Drug Consultative Committee
consider the opinion of the whole battery of eminent and distin
guished medical specialists from research institutions as inadequate
so as to ask for further details and wider medical opinion."
The
so know
consumer
who is exposed to these hazardous drugs is entitled
the reason/s
for the
This
volte-face.
has, however, not been
‘ *>r thcoming.
KI .COMMENDATIONS
FOR WITHDRAWAL
OF HAZARDOUS, IRRATIONAL
AND THERAPEUTICALLY USELESS DRUGS
*
All existing drugs available in the Indian market should be screened
by an appropriate, impartial authority, such as the National Drug
Authority recommended by the Hathi Committee.
*
Those drugs which have life-threatening or serious side-effects,
and for which safe alternatives are available should be banned
with immediate effect.
*
No fixed dose combinations should be allowed if an alternative
single ingredient drug
is available,
except
in accordance
with
the norms laid down by WHO.
*
Information
regarding
the
action
taken
by
other countries
to
ban hazardous and irrational drugs, and their reasons for doing
so (together
with supporting
be made available t-> rhe public.
59
medical/research evidence) should
The criteria for the withdrawal of
drugs
hazardous and/or irrational
which have an unacceptably high risk factor, which are
prepared
in
sub-therapeutic
do-es,
or
which
are
marketed
in
irrational combinations, should be widely publicized for the benefit
of
medical practitioners and the general public.
The criteria
used by the Scandinavian countries,Sri Lanka,Bangladesh,Mozambique
etc. can be used as guidelines (see Appendix)
Once a decision is made that a particular drug or drug combination
is hazardous or irrational or useless, immediate steps must be
taken to destroy all existing stocks and-to stop further production
immediately.
Legislation should
be suitably
modified to ensure
that Courts
do not grant stay orders against decisions to destroy existing
stocks of hazardous drugs, or to stop further production of such
drugs forthwith.
This is necessary in the interest of public health.
After screening by the proposed National Drug Authority, only
those
drugs
which
are
approved,
should be
re-registered
with
the Government. All other products should be withdrawn from
the
market, and further production banned.
In line with the
practice followed by other countries, it should be made mandatory
for all drugs to be re-registered periodically e.g. every five years.
60
.DRUG S.ITUATI0I4 IN INDIA
DANGEROUS ..PROFITEERINS.
MY IDEA OF A BETTER ORDERED
WORLD IS ONE IN WHICH MEDICAL
DISCOVERIES WOULD BE FREE OF
•
y
PATENTS AND THERE WOULD BE NO
PROFITEERING FROM LIFE OR DEATEJ’-i.
- Indira'Gandhi
at World Health Assembly (1981)
The pioneer., in establishing- the drug industry in the country
were P.O.Ray and T.K.Gujjar.
At the time of Independence,
the total pharmaceuticals sale was Rs.10 crore.
Over the ye^rs, the multinationals have gained strong roots
in the Indian Drug Industry and repatriate huge amounts out
of this country. On the whole, the contribution of these
drug manufacturing units towards producing life-saving and
essential d^ugs has been very little, The Indian drug
industry floods the market with about 70,000 formulations,
yet 40,000 children go blind every year because of
Vitamin A Deficiency.
Most of dru.js pi'oduccd are uaesscntj al and many of them
have been banned in developed countries.
Unlike othe,. commodities in the market for which the market
is open and; common'^through tfte mass media, the drug companies'
main concern are doctors, wholesalers and retail chemists.
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 representatives, they extensively advertise in
professional medical journals also.The Indian Council of Medical Research and the Indian
Council of Social 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 ,! vested interest in ill-health”.
Regarding iiie drug-pushing strategy of drug companies,
the ICMR a:,d ICSSR study states.
”lc 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,
unvr.sr'silia i drugs and the promotional techniques of
dr'K: c- :'., -:. or, let us see what our drug p..n..r i.-.c
The tGliowj..ig ooservations are worth noting.
uffer.
1.
me 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 mo thought had
been giygn to the loopholes in the ban orders.
3.
No attempt has been made by the policy about abolition of
brand na^es and introducing generic names.
4.
No attempt was made to make a list of essential drugs.'
5«_JThe 1986,drug policy increases the cost of essential drugs.
The increase in price is even one hundred percent for some
products".
6t The policy encourages more formulations by delicensing
certain jjrugs and also its formulations.
7. The drugfpo 11 cy makes no mention about, jv-tiictions that
to bo put on the pvoin-'l.i
1 m.-itorial of drug v'-.Hij-.-m
.
In short, tge drug pS'l.icy is nip re a pricing policy than making
it a peoplejs policy.
'1
>0
A committee set up under the Guidance at Jaisukhlal Hath! made
certain usei u 1 ro*
■1 iens .
None of these has been f ully
implemented,
'me following are the highlights of the recommen
dations.
1.
All multi nat.i anal companies should be nationalised.
Generic games should be used, instead of using trade names,
brand na.jjes. ,
3.
Production of single drugs.
2.
4.
Elimination of irrational drug combinations
5.
Indian National Formulory must be revised in order to keep
the medjeal profession will informed.
6.
Distribution of drugs being an important factor, a National
Drug Authority of India (NDA) should be set up.
7.
A list -,-j 117 essential drugs were drawn up by the committee.
8.
The Indian sector of drug industry should be helped to
obtain self-sufficiency.
Former judge of the Supreme Courpt Justice Krishna Iyer is on
record a; stating. "Government is allergic to tne Hathi
committee report and dithers, delays, shies and even retreats,
allowing the hefty drug industrialists to hold to ransvm
people's health. Pharmaceutical imperialism practised by
covert and overt disinformation, trade terrorism and brainwa<i?c professionalism is a menace to a patriotic drug policy".
In -I.he context of the entire drug issue, a lesson has to be
learnt from a small neighbour, Bangladesh.
In fact., the country
took up thj entire idea cf a drug policy from the Hathi committee.
Th. Indian, drug industry should cease to exist as a profit mailing ind-istry ano tne concern should be for health of the
ce.’ole.
have a role to olay in the health cars svs+nm.
RATIONAL DRUG uSE
Drugs are the pallmark of Modern Medicine. The 'healing
professions' throughout the ages have always used 'natural'
or 'synthetic* products for their medicinal value, to
treat various pommon ailments of people. Drugs, however,
have never in the past dominated the medical scene as
they have done in the second half of this century. Today,
the ’pill for every ill' culture is well established.’ It
has ensured that we are probably the most 'drugged
generation* of all times. Not a very healthy thought!
Throughout the centuries, philosophers, social activists and
concerned doctors have warned against the dangers and
problems of overuse or misuse of drugs by doctors and the
people.
The Indian Situation
The Indian Council of Medical Research and the Indian
Council of Social Sciences Research set up a joint study
group to study the health situation in India and evolve
an alternative strategy for our commitment to 'Health for
All by 2000 AD). This high powered expert committee had
some very interesting things to say about the present
situation of drugs and prescribing practices, in their
Report published in 1981.(1)
"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 doctor^ into using their products by all means - fair
or foul. These basic tacts are more responsible for
distortions in drug production and consumption than anything
else. **
Irrational Drug Use - Some dimensions
To understand the principles of Rational Drug Use, one needs to
first identity’and appreciate the elements of irrationality in
the present situation. A spate'of reports appearing in our
newspapers and periodicals high-light these elements. Of all
of them, however, the report of the recent 'Lentin Commission’
and its shocking findings are the most telling.
Irrationality m drug use arises out of three sets of factors:
A.
Irrationality in drug production, marketing and
availability.
B,
Irrationality in prescribing practices of doctors and
health workers.
C.
Irrationality in drug use by the consumber public.
All-these taken together result in the situation we find
ourselves today.
A.
Irrationality in drug production, marketing and availability.
* Industrial Policy
Drug policy continues to be part of the industrial policy and
not part of the-health policy. Industrial growth and profit
margins determine the policy and not health needs of the
people.
/
* Over abundance
. '
There is a plethora of drugs produced in the country. The
Hathi Committee-recommended 116 as essential and the WHO
says 200 are necessary. At -present there are over 70,000
formulations in.the country.
* Quality of drygs
Twenty percent yf the drugs available in the country are
substandard and"spurious. Many are adulterated. Many are
old and being spld atter the expiry dates are over.
Turmeric powder in tetracycline and poor quality intravenous
fluids have beey'reported. The substandard ’glycerol’ in
J.J.Hospital highlighted by the Lentin report is another
example.
* Unwanted drug^
The formulation^ available include the following:
i.
ii.
Banned drug$; Drugs which have been banned in many
countries sych as Lomotil and Clioquinol.
Irrational combinations:
Formulations which .have combinations that are antagonistic
or irrational. The* Hathi Cqmmitte^ had suggested weeding
out of atle^st 23 such groups of preparations. These were
finally banped by a gazette notification in July 1983 but
continue tobe available.
iii.
Hazardous or Bannable drugs: Hazardous drugs which should
not be available without prescription or adequate medical
supervision'. Preparations containing analgin, oxyphenbuta
zone and cgrtico-steroids are the commonest examples
(Refer A to Z of Drug use - page 31)
iv.
Drugs promoted for indications that are not clinically
proven or are potentially dangerous, eg., promotion of
EP Forte combinations for pregnancy testing and induction
of abortion"even when there is well documented evidence
that risk of foetal deformity is increased by the use of
these preparations.
(now banned since 1988 June 30)
v.
Costly Drugs: Drugs which are inflated in cost by
inclusion of costly, additional, often unnecessary ingredients
or by cosmetic embellishments in manufacture and packaging.
Tonics and tjigh protein foods especially baby foods are
good examples.
3
* Wrong Priorities
There is over-production of unimportant drugs or drugs for
the rich while drugs for some common health problems are in
short supply. Tonics, vitamins, horomne preparations and
high protein substitutes are being produced in wasteful'
abundance while drugs for leprosy and tuberculosis (two
major public health problems) are produced at one third and
one fourth of actual requirements. Similarly Vitamin A and
many vaccines urgently required for child care programmes
are frequently in short supply.
* Over-the-counter sales
Sale of drugs oyer-the-counter without doctor’s prescriptions
or the necessary statutory checks are not at all uncommon.
This results from inadequate drug legislation and even more
inadequate drug/'controls. Over-the-counter unauthorised sales
of prescription drugs which now-a-days do not even have the
precautionary product information make the situation even more
hazardous.
* Escalating Prices
Price control policies have been both inadequate and ineffective
and hence the cost of drugs has been constantly escalating.
With liberalization policies of the present government this is
bound to increase further. The purchasing power of majority of
our patients is,;7limited. With increasing prices, patients are
forced to buy £nly patt of a prescription or go in for sub
standard alternatives promoted by the drug shops.
B.
Irrational Drug Prescribing
Doctors, nurses^ and health workers often prescribe or administer
drugs irrationally. The types of irrational drug prescribing
has been classified as follows: (4)
Type of irrational drug use
1.
Extravagant prescribing
Occurs if a drug is prescribed
when:
a less expensive drug would provide
comparable efficacy and safety
Symptomatic treatment of mild
conditions divert funds from
treating serious illness
A brand name is used where less
.expensive equivalents are available.
2.
Overprescribing
The drug is not needed
The dose is too large
The treatment period is too long
The- quantity dispensed is too
great for the current course of
treatment
4
Type of irra.ional drug use
3.
Occurs if a drug is prescribed
when:
The drug is given tor an incorrect
diagnosis
Incorrect prescribing
The wrong drug is selected for
the indication
/
The prescription is prepared
improperly
Adjustments are not made for
co-existing medical, genetic,
environmental or other factors.
4.
Two or more medications are used
when one or two would achieve
virtually the same effect.
Several related conditions are
treated when treatment of the
primary condition will improve
for cure the other conditions.
Multiple prescribing
5O Under prescribing
(
-
•
.»
Needed medications are not
prescribed
d
Dosage is inadequate
■Length of treatment is too brief.
There are many background factors which lead to such prescribing
practices.
a. Inadequatu training
Doctors, nurses, pharmacists and health workers may be inadequately
trained in the use of drugs. The training may be theoretical and
not geared tg the practice of prescribing in the real life situa
tion. Technical minutiae may be stressed at the cost of inform
tion on cost’, social context and hazard.
b.
Inadequate continuing education
The doctor, pharmacist, nurse or health workers in field practice
are inadequately supported by a process of continuing education
by their professional associations and training institutions.
Once graduation is over, there is little opportunity to refresh
one's knowledge of drugs and medical matters through unbiased
sources of iuformation.
c.
Unethical^medical advertising
Medical advertising of drugs has been more often than not,
found to be full of unproven claims of efficacy. In addition,
promotional literature all over the world by the same company
for the same^drug has been found to be vastly different. Facts
are withheld or modified. Statistics are used in a biased manner.
Drug company sponsored misinformation is not uncommon.
d. Prescribing for prestige/power
Doctors especially often prescribe extravagantly as a sign of
’prestige' a nd 'power'. In India people often consider a good
doctor to be one who gives a long, costly prescription, in
keeping with'his list of degrees. Many doctors succumb to
this cultural status symbol. A vicious cycle is maintained
thereby.
e. Busy outpatients
z
Many of our institutions are understaffed especially those
run by the government. The queues at the out-patient clinic
are long and-tnere is a heavy rush. Lack of time to make a
good clinical judgement often results in an irrational
prescription/including drugs for all eventualities.
f.
Inducements by medical companies
Misinformation is not the only method by which doctors are made
to prescribe irrationally by medical companies. Bales promotion
includes a host of practices-such as unethical trade discounts,
bribes, gifts, sponsorship for conferences and travel. The
commercial proposition induces' many doctors to prescribe
unethically.
g. Unauthorised prescribing
Health workers and practitioners of other non-allopathis systems
of medicine are often by virtue of their training unauthorised
to prescribe all the drugs in the medical armamentarium. Health
workers may be trained to prescribe only a few drugs. Too often
they get a larger number of drugs and dispense them to get the
community's approval and get greater prestige. Many traditional
medicine practitioners, dispense allopathic drugs with little
background training or knowledge.
ho Drugs as a substitute for caring
Drugs have become, a symbol of the new medical culture, where
treatment is primarily drug oriented and all other aspects of
'caring' and pursing of the patient are relegated to the back
ground. Wheij simple home remedies like hot water gargles and
nursing procedures can provide relief to many symptoms of the
patients, doctors prefer tb prescribe symptomatic drugs
instead, thus increasing drug consumption irrationally.
i.
Drug use by Consumer Public-irrational dimensions
i. Self-mqgication.
Medication by patients themselves is not an uncommon problem.
Either they are too poor to consult doctors or because of the
easy availability of urugs they medicate themselves, encouraged
by the pn^rmacists, advertisements, peer group information or
advice of family members. A survey conducted by the National
Institute pf Nutrition in the twin cities of Hyderabad and
Secunderabad covering 10 percent of the 330 retail Pharmaceuti
cal shops showed that self-medication rate was an alarming
46 percent.
ii.
Use of unutilized drugs.
It is a vei y common habit among the consumer public to take
a medicine, not as the doctor has directed by just enough to
feel better. This is often the case with antibiotics and
particularly for children. Unused medicine is kept in the
home pharmacy and given to one or other of the children or
family member who gets the same symptoms, next. Unused or
unutilized portion of prescribed medicine is often kept
beyond expiry date. If proper storage precautions are not
taken, it 'jiiay also get denatured. Use of such medicines
is a major?cause of untoward reactions.
iii.
Inadequate labelling or storage of medicine.
Medicines prescribed by doctors are often-inadequately
labelled by the dispensing pharmadist. Storage instructions
are not very clearly explained to the patient. The medicine
cupboard is often a source of irrational drug use. Children
may have Recess to it and this may lead to accidential
poisoningj
iv.
Peer jroup exchange
-
Consumers of drugs often advise relatives, friends and
neighbours about the benefits a particular prescribed drug
has given them. They are advised totake these drugs for
what is thought to be a similar complaint or disease. This
peer group exchange is often the cause of much irrational
drug use by the lay public.
v.
Status symbol drugs
Capsules', injections and tonics have become status symbol
drugs. Ihey are thought to be more effective and also
being coatilier are considered to be of greater prestige
value, patients often demand or pressurise their doctors
to prescribe one or more of these and doctors often comply
with the; request to retain the patient and family in their
practice,
vi. Multiple consultations
Patients often go to many doctors seeking quick relief of
their symptoms. The doctors are not often aware that
consultation with them is one of many such concurrent
events.? Oeneralists and Specialists may both be consulted.
Practitioners of different systems may be consulted
.simultaneously. Different medicines given by different
doctors "''are then consumed with the hope of getting relief.
When relief does occur it is not easy to decide which
medicine brought it about.
Multiple prescriptions then become a way of life when
symptoms recur. Many drugs may potentiate one another.
Others 'may work at cross purposes. When the consultation
is of plural systems the contusion is worse,
;
- 7 -
vii.
Inadequate Consumer Awareness
Probably jne of the key factors for irrational drug use by
consumers-is the absence of awareness of drug use, misuse
and the effects of overuse. Consumer education is next to
absent in India. Due to loopholes in the existing laws,
precautionary product information is not supplied with the
medical pj-oducts. The media, the medical profession, the
educational system and the social welfare agencies
concentrate on tt^e misuse of psychotropic substances and
drug abus#. Misuse, overuse or §buse of commonly
prescribe^ drugs is not considered to be an adequately
serious problem for consumer education. The problem is
further compounded by a large illiterate population and
the need pf such efforts to be in multiple languages when
they do g$t organized.
Rational Drug Use
♦ Means practice of socially conscious, relevant and
scientifically!'sound medicine.
*
Emphasises the selective use of drugs based on
- Essentiality
- Efficacy
- Safety
- Easy availability
- low cost
- Ease of administration
- Adequate Quality
- Preterably of indigenous production
* Recognises the concept of essential drugs and the concept of
graded lists fyr dilierent levels of health personnel.
* Recognises tlje non-role of drugs in certain conditions and the
role of alternative systems of medicine in some other conditions.
* Accepts a conscious decision not to use certain drugs which are
hazardous or b^nnable or banned and use all others only when they
are really needed.
* Means prescription with awareness, to avoid as far as possible
iatrogenesis wfeich includes
- drug induced problems,
- drug interactions,
- adverse drug reactions and
- emerging dru^ resistance.
* Recognises the rights of health personnel and consumers to
unbiased drug information and its effective communication.
Drugs have alloyed pain and suffering over the centuries. They
have helped mapy live more comfortable, productive and meaningful
lives. All of us committed to the health movement must ensure that
drugs should continue to play their limited but useful role in
medical service.
And it will only t>e if
- The public;
Governments;
drug industries;
planners;
health professionals;
medical colleges;
pharmacy college^;
nursing colleges;
drug controllers;
pharmacists;
[
'
journalists and jjiedia
and
*
teachers and educators;
X
.
'■
i
Commit themselve^ to promoting a Rational Drug Use.
Ref erences:
1.
ICMR/ICSSR (1981)
Wealth for A|1 Analternative Strategy
2.
VHAI (1986)
Banned and Bunnable drugs
3.
Shiva Mira (1985)
Rational Drug Therapy
Medical Service, Vol. 42, No.1, January 1985
4.
Management Sciences for Health (1982)
Managing Drug Supply, Boston, Masachusetts, USA
5,
Narayan Ravi (1984)
Consumer" Al art - Consumer Action
Medical Servj.ee, Vol. 41, No.9 October-November 1984
6.
Werner David & Bower Bill (1982)
Helping Health Worker’s Learn Hesperian Foundation, USA.
1
OVfcR-MEDICALISATION
* While production of drugs should
be
adequate,
excessive
production has its own dangers:
the
doctor
and
the
drug
producer join hands to over
medicalise Health care.
should be prevented.
HEALTH FOR ALL
- An alternative strategy
ICSSR/ICMR 1981
This
* Most distressing aspect...habit of
doctors to overprescribe or to
prescribe glamorous and costly
drugs
with
limited
medical
potential. It is unfortunate that
drug producers always try to push
doctors into using their products
by all means - Fair or Foul.
HEALTH FOR ALL
- An alternative strategy
ICSSR/ICMR 1981
DOCTOR-DRUG PRODUCER AXIS
* Eternal
vigilance
is
required
to ensure 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....
HEALTH FOR ALL
- An alternative strategy
ICSSR/ICMR 1981.
Hathi Committee Report, 1974
0 Too many inessential drugs - combination
0 Shortage of essential drugs
0 Poor quality control
0 Technology to produce essential drugs available
0 MNCs doing only Formulation activity
0 Brand names - Double Standards
0 Aggressive Sales Practice
0 R & D Activity
Recommendations
♦ Essential drugs for Primary Care
♦ Generic Names
♦ Distribution of quality control
♦ Equity of Foreign participation, Phasing out of MNC's
♦ Bulk drug production
Self reliance
♦ Communication with health professionals, researchers and
planners
♦ NDA
♦ Result - WHO Essential Drug List, Bangladesh Drug Policy
♦ 1985 Rajiv Gandhi's New Economic Policy
♦ 1986 New Drug Policy - Bonanza for MNCs
♦ 1 994 NDP to suit DDT - WTO
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