Generic Concept Note - Chittorgarh

INDEX
A. Problem Statement 3-4
B. Pharma Scenario in India - Poverty Amidst Plenty 5-13
& How doctors are used as an instrument
1. Prescription by brand name
2. Prescription of non essential drugs
3. Irrational Prescriptions
C. Aggressive Drug Promotion 14-23
1. Influencing Doctors
2. Lack of objective drug information
3. “False” evidence based medical practice
4. Promotion of hazardous, banned and bannable drugs
5. Doctors as Key Opinion Leaders
6. Biased clinical trials
7. Disease Mongering
8. Direct to consumer advertising
9. Influencing Government Policies
D. Implications of unethical promotion 24-25
E. The Solution 26-28
1. Rational use of drugs – Prescription by generic name
– Adoption of Essential Drug List
– Use of standard treatment guidelines
2. Availability of low cost drugs at govt. run medical shops
F. Chittorgarh Model 29-31
G. Concept Note on generic drugs 32-33
H. Frequently Asked Questions 34-35
Annexures
Alphabetical List of 570 low cost generic medicines
Comparative list of 300 low cost ethical drugs
List of 54 IV fluids
List of 142 surgical items
Documentation by
Dr. Samit Sharma
Collector & District Magistrate
Chittorgarh (Rajasthan)
(This also contains excepts from "A Lay Person's Guide to Medicines" by S. Srinivasan)
1

PROBLEM STATEMENT
Huge gap in access to drugs
TOP
With a population of nearly 100 crores, India accounts for 16 per cent of the global
population. Sizeable population lives below the poverty line and 48 per cent of the
people are illiterate. India accounts for huge morbidity & mortality burden due to
large number of deprived & extremely poor people. WHO says that 65% of the
population still lacks regular access to essential medicines. With the rise in health
care cost, over 23 % of the sick don’t seek treatment because they are not having
enough money to spend. A study by World Bank shows that as a result of single
hospitalization 30 % of people fall below poverty line. Over 40% of those
hospitalized, need to borrow money or sell their assets.
Healthcare costs are high and are increasing further. Expenditure on drugs
constitutes about 50 % of the health care cost which increases up to 80 % in rural
areas. (In fact expenditure on health care is the second most common cause for
rural indebtedness in India)
Where does the money for health expenditure (in India) come from
Private out of pocket 79%
expenditure
State govt. 14%
Central govt. 4%
Private investment 3%
Private insurance 0 – 1%
India accounts for 22 per cent of the global illness with only 2 per cent of the global
drug production of which only 0.7 per cent are essential drugs. Yet 1.3 per cent are
non essential, profit-oriented formulations which are highly priced, irrational or
useless. Crores of our people, living in abject poverty, can barely afford a square
meal a day, can they afford to spend on costly medicines.
People are being pushed further into poverty, disability and death because of these
costs. Completely irrational drugs, which do nothing but waste people’s money, are
widely sold. More and more drugs flood our markets every year. There are over
20,000 pharmaceutical units in the country producing over 1,00,000 (one lakh)
formulations of drugs. It is paradoxical that while essential and life-saving drugs
are in short supply, more and more drugs which are not therapeutically more
effective, irrational and may be even dangerous, are being produced and pushed in
the market with absolute disregard to the country's health needs. The problem
becomes more acute in developing countries where resources for the purchase of
drugs are scarce.
In the pharmaceuticals sector, the cost of manufacturing a drug is relatively low,
compared to the price it is sold at. By selling drugs at inflated prices, big
companies and retailers pocket a large share of the money paid out by the
consumer. Retail prices of drugs show complete arbitrary variation between
brands. There are abnormally high trade margins with wasteful, unregulated and
unethical drug promotion. There is a nexus between drug companies, stockists,
retailers, Medical Representatives (M.R.) & some medical practitioners which
disproportionately inflates the cost of medicines & the overall treatment. Each
2

gains down the line, the only loser being the poor patient for whom the drugs
become unaffordable.
TOP
Issue of Research Cost Recovery
The life cycle of a drug has four phases:
1. Research
2. Development
3. Patentee commercialization
4. Generic commercialization
When the product is in the research mode, a research institution invents a new
drug. Then a patent application is filed to preserve rights. When the institution
starts pre-clinical and clinical testing of the drugs, the development phase begins.
In the patentee commercialization phase, the innovator (patent holder) begins
selling in at least one country. In this process, doctors, patients, hospitals, public
health agencies and insurers get involved. Generic commercialization commences
when the patent expires in any given country and generic companies start to sell
the drug at lower prices. Intellectual property is a vital factor for discovery of new
drugs.
Without patents, research and development would be reduced. Without
generics, access to medicine would be impaired. Thus, we have to strike a balance
between encouraging research and development of new drugs and the drugs which
are already discovered should be affordable and accessible to the entire mankind.
All research should be carried out with the intention of improving the health of the
crores of people of this world and not with the intention of getting more and more
money out of their pocket. Studies suggest that the money spent on research is just
2 – 20% of the total turnover, but huge profits are reaped in the name of recovering
research expenditure. During the patent period cost should be such so as to
recover R & D cost and not in form of monopoly pricing. And after the expiring of
patents the cost of generic version should be a reasonable profit added to cost of
manufacturing the drug.
Drugs which are similar to their predecessors are ‘invented’ just by making some
minor change in the original drug chemical and are then patented and aggressively
promoted – Me too drugs (higher priced alternatives of a parent drug without a
clear therapeutic advantage). In contrast to the breakthrough drugs, they have no
significant treatment benefit, but are just created to continue to enjoy the patent
protection (ever greening of patents) and thereby reap huge profits after anyhow
convincing the doctors to prescribe them.
The country where 3 out of 4 children & every other woman are anemic & iron
defensive anemia is the most prevalent public health problem; the drug companies
are free to sell the iron preparation at any cost which comes to about five to ten
times in certain cases.
Do we really want to help our anemic children
So, whether it is about the patented drugs or about the out of patent (generic)
drugs – the story is the same, drug industry is operating with the motive of making
huge profits rather than the intention of serving the sick and the needy. The
ultimate aim of drug production should be, to make drugs affordable and
accessible to all so that people of the world can be cured of their diseases. The
pharma industry has to sub serve human goals of promoting health, and that
industry cannot operate in a manner that just helps the business elite. Should we
allow commercial interests to dominate us so completely
3

Pharma Scenario in India - Poverty Amidst Plenty
TOP
India has a vast pharma market, and is rightly celebrated in international circles
for making medicines very affordable and low-priced. As of 2003, Indian industry
was supplying 20 percent of the world’s drugs and is currently one of the largest
pharma industries in the world. At least 60 manufacturing plants in India have US
Federal Drug Administration (FDA) approval, second only to the Unites States.
Currently a dozen top Indian companies are major suppliers to the US and
European market as well as China. India has one of the best developed
pharmaceutical industries among the developing countries with over 20,000 units
producing between 60,000 to one lakh formulations. The drug industry has a total
annual turnover of approximately Rs 52,000 crores. Nevertheless, the booming
Indian pharma market coming to the rescue of generic world over, especially by
making low priced antiretroviral, is a good part of the story.
The not so good part is that the Indian pharma scenario, as far as the
ordinary poor consumer is concerned, is a failure of the market. As a result of this
extreme market failure of regulation in the absence of well-functioning markets, the
drug (medicines) availability situation in India is one of the poverty amidst
adequacy – there is inadequate access and supply of even essential drugs to the
poor despite adequate drug production. Adding to this misery is the poorly
functioning public health system. While the sales of Indian pharma companies are
increasing steadily, drugs are getting away from the people, more so for the poor.
Share of drugs to total treatment costs can vary from 50 to 80 percent depending
on rural / urban locations and inpatient / out patient treatment. All-India figures
for per capita annual drugs and other medical expenditure (rural) is Rs. 294 out of
Rs. 380 for health as a whole.
Although there are over 20 thousand drug companies & over 1 lac
formulations are sold in the drug market, medicines are out of reach of millions of
people, because they are unaffordable. The large scale production has not had any
significant improvement in the availability of drugs to meet the country's needs.
One of the major reasons for this situation is that, as we have noted before, most of
the formulations produced are unnecessary, unaffordable, irrational and very
costly.
The fact is that the no. of active pharmaceutical ingredients (APIs) is just 550.
When the actual number of ingredients is so small the large numbers of
pharmaceutical products are just to confuse the doctors & exploit the ignorance of
the patients. It has been estimated that barely 20 per cent of the medicines
available today are necessary to treat over 80 per cent of the prevailing diseases.
About 70 - 80 per cent of the output of some major MNCs in India consists of
simple household remedies like cough syrups and vitamin preparations. But lifesaving
drugs account for only 20-30 per cent of the total value of the formulations
sold by these companies.
It is paradoxical that essential & life saving drugs are inaccessible &
unaffordable & newer drugs which have no therapeutic advantages , irrational &
even dangerous are being produces & marketed at very high prices with utter
disregard to country's health requirements.
In 1975, the Hathi Committee which was appointed by the Government of India to
analyze the Indian drug industry, recommended a restricted list of essential drugs
and that measures be implemented to ensure their production, that a gradual shift
4

e made from brand names to generic names, that price control measures be
effected with the aim of making life-saving drugs and essential drugs affordable,
that public sector play a leading role in drug production and certain drugs be
reserved to encourage the growth of Indian drug companies. The Committee also
recommended elimination of irrational drugs.
The situation assumes menacing proportions when the manufacture, import,
distribution and sale of drugs continue in our country although they are banned,
withdrawn or restricted in other countries, including the country of the parent
company in the case of MNCs. Despite knowledge of the ban, many pharmaceutical
companies continue to market the banned drug, making false claims regarding
their safety and efficacy. For example, the ban order on estrogen-progesterone
drugs was challenged by certain drug companies and a stay was obtained in 1982
on technical grounds. Anabolic steroids were marketed as appetite stimulants for
growing children in the developing countries. Drugs which have a sizeable stake in
our country are not marketed by MNCs in their countries, e.g. cough expectorant,
pain killers, growth tonics, appetite stimulants and anti-inflammatory containing
phenyl- and oxyphenbutazone. Another such drug that has now acquired some
notoriety is analgin and analgin-based drugs like Novalgin, Baralgan, etc. It is
banned in Germany, parent country of Hoecsht, and in several countries of the
West but marketed in India (Baralgan has since been banned in India by an order
of the Supreme Court).
TOP
How doctors are used as an instrument to promote these unhealthy &
unethical practices of pharmaceutical industry
Once their medical education is over, the doctors largely depend on MRs for
information about drugs. MRs knows that for most of the doctors the cure of the
patient is of utmost importance. Thus, doctors are made to believe that although a
particular brand is a bit costly but it is of the best quality and is the most effective
one in the market, which will definitely cure the patient. They are also introduced
to so called latest discoveries which will lead to a magical cure, but which are in
fact minor chemical alterations in the parent drug & are just introduced with the
sole purpose of ever greening of patent and to enjoy monopoly pricing & are non
essential drugs. Similarly with utter disregard to patients health needs drugs which
are neither indicated nor required for a disease are promoted just to increase the
sales figure of the company. Unfortunately most doctors highly depend on MRs for
updation of their medical knowledge and their prescription pattern is largely
influenced by them. Unsuspecting doctors fail to understand that the person
5

coming to them has been hired by a drug company to promote its sale and make
profits.
TOP
Thus, unknowingly doctors help the drug companies and adversely harm the
patients in three different ways.
1. Prescription by brand name
2. Prescription of non essential drugs
3. Irrational Prescriptions
1. Prescription by brand name
In India there are 72 salts which come under drug price control order (DPCO). It
means that the selling price of these drugs is under control & decided by the NPPA
(National Pharmaceutical Pricing Authority). This also means that for all the
remaining drugs, the drug companies are free to decide the selling price (MRP).
Although it is said that in free market economy, market forces will decide the price
to the consumer but in case of drugs it is not so. The reality is that the same salt is
being marketed by different companies under different brand names but the selling
price is to the extent of 10 times to its cost price, which means 1000% profit is
reaped. This is made possible using a marketing strategy of employing Medical
Representatives, who using various means persuade the doctors to prescribe
medicines by brand name of the company & the unsuspecting patient has no
choice except to buy that particular brand even when less costly alternatives are
available in the market. So, due to brand names artificial monopolies are created in
the pharmaceutical market which prevents price competition amongst the same
product and consequently all the brands are sold at high prices.
For example: Amikacin
Drug
manufacturing
company
Name given
by
company
(Brand
Name)
Amistar
500
Salt name of
medicine
(Generic
Name)
Cadila
Amikacin
500 mg
German Amee 500 Amikacin
Remedies
500 mg
Wockhardt Zekacin Amikacin
500 500 mg
Alembic Amikanex Amikacin
500 500 mg
Intas Kami 500 Amikacin
500 mg
Unichem Unimika Amikacin
500 500 mg
Ranbaxy Alfakim Amikacin
500 500 mg
Cipla Amicip 500 Amikacin
500 mg
Rate at which drug
is purchased by the
chemist (Stockiest
price)
One Injection
Rate at which
drug is sold
to the
customer
(Printed MRP)
8.00/- 70/-
8.00/- 70/-
9.90/- 70/-
8.22/- 64.25/
-
8.13/- 60/-
7.80/- 72/-
8.50/- 70/-
7.42/- 72/-
6

For example if doctor has to treat a patient of blood cancer, he may advice the salt
Imatinib by various brand names. If he has prescribed brand Glivec a months
course will cost Rs.1,14,400/- to the patient. Whereas, the same anti cancer drug,
but with a different brand name Veenat costs just Rs.11,400/-. And Cipla supplies
the generic equivalent of this drug (@-imitib) at Rs. 8,000/- only, also Gelnmark
supplies it for Rs. 5,720/-! All these brands contain the same salt Imatinib, in the
same quantity, conform to the same quality standards and are equally effective. TOP
See an example where the same company markets the same salt by different brand
names and use differential pricing policy.
Drug
manufacturin
g company
Name
given by
company
(Brand
Name)
Salt name of
medicine
(Generic Name)
Rate at which Rate at
drug is which drug
purchased by is sold to the
the chemist customer
for 10 Tablets (Printed
(Stockiest price) MRP)
Cipla Alerid Cetrizine 10 mg 28.85/- 37.50
/-
Cipla Cetcip Cetrizine 10 mg 1.88/- 33.65
/-
Cipla Okacet Cetrizine 10 mg 1.84/- 27.50
/-
7

If you don’t believe this then see the list below.
TOP
MRP Printed on the pack
Stockist Price
8

Brand name also violates the right of the patient to choose a product as per his
pocket condition. If doctors prescribe by salt name instead of brand name then
various products can be compared & the one with the lowest price can be offered to
the patients which are at times even 5-10 % of the MRP.
Even oldest of the drugs like paracetamol, iron, etc for which there is no
patent protection and anybody can manufacture and sell it continues to be
marketed at high prices. This is done by appending a brand name to these out of
patent drugs. The same salt is being marketed by different companies under
different brand names but the selling price is to the extent of 10 times to its cost
price, which means 1000% profit is reaped. This happens because the Medical
Representatives of the company persuade the doctors to prescribe medicines by
brand names & the patient has no choice except to buy that particular brand even
when less costly alternatives are available in the market.
BRAND MONOPOLY ELIMINATES PRICE COMPETITION
TOP
There are a number of reasons why the prices of drugs in India, indeed all over the
world, are so high. One of them is the business of branding. In many developing
countries, consumers buy the same drug marketed by several different producers
under different brand names, not realizing that they are all the same product.
Paracetamol, for example, is the generic name, for a painkiller. It is available under
more than 20 brand names -- Crocin, Calpol, Metacin, Pyrin - all of which are
paracetamols. The consumer, however, is not aware of this. Drug companies and
doctors may swear that one particular drug is more effective than the other,
although this cannot be so as they all contain the same ingredient and conform to
the same quality control standards.
Similarly, metronidazole is sold by the name of Amivan, Flagyl, Aristogyl, etc.
The same with different names
Thus, by branding a drug and advertising it, the drug company plays on a
consumer's psyche and brings about an increase in the price of the drug. For
example, it costs around 15 paise to produce one tablet of paracetamol.
Pharmaceutical companies sell the same drug for around 80-90 paise under the
brand name Crocin. That branded drug is sold to consumers through
advertisements; companies spend huge amounts of money on television
advertisements and other kinds of marketing techniques. Brands compete with
each other in the market and the cost is passed on to the consumer. This is the
reason why drugs are so expensive. The pharmaceutical sector thus earns profits at
the cost of the poor and ignorant consumer. The creation of brand names, leading
invariably to high prices, monopolies by big companies and the vulnerability of
consumers, are all aspects related to profiteering in the pharmaceutical sector. This
monopolisation of the market by the drugs industry is one of the main reasons why
drugs are so costly.
9

A look at the growing list of branded drugs also emphasises monopolies in the market. Take
the case of Ciproflaxacin -- an antibiotic used to fight typhoid. Almost half the Ciproflaxacin
sold in the market comes from one company; effectively this drug is the brand leader as well
as the price leader. Being a brand leader, a company, whether it be Cipla, Alembic or Glaxo,
is able to control the market using various marketing strategies and offering huge margins to
retailers and doctors. This way, even if prices are kept high, people will continue to buy the
drug. It is assumed that market forces promote competition. In a free market the
competition results in lowering and more importantly, levelling the prices. But this may be
true in generic drug market but not in proprietary (branded) drug market like that exists in
India. Monopolies are created artificially by means of brand names. In India the
prescription and dispensing of medicines is mostly by brand names. This is in fact the “Trade
Secret” of the pharma business. Different companies manufacture the same salt by different
brand names. The companies allure doctors (via M.R.s ) and induce them to write a particular
brand. The patient has no option but to buy the brand at the M.R.P. which the company has
decided to print. Besides this, the consumers/patients have no choice as they do not select
the medicines like in other consumer goods. The doctors or chemists decide it. Thus, even
when so many companies are manufacturing the same salt there is virtually no price
competition in the market. And all brands are sold at very high rates. The same salt of equal
potency is made by different companies and marketed under different brand names for
different prices (MRP)
2. Promotion of Non essential drugs TOP
There are a total of 354 drugs in the National List of Essential Medicines
(NLEM), which are adequate to take care of the majority of the health needs of the
population. But when we analyze the sales of top 300 brands only 38% of brands
are of the drugs mentioned in the NLEM. The other 62% brands comprise drugs
that are higher priced alternatives without a clear therapeutic advantage and many
are unnecessary, irrational and even hazardous.
Doctor
should act as
FILTER
ESSENTIAL
DRUGS
NON
ESSENTIAL
DRUGS
For the
Patient
10

This indicates that contrary to what is advocated by WHO & as adopted in our
national health policy, the drugs which are most useful & cost effective for the
treatment are not being prescribed & the non costlier & irrational drugs are sold
more often (The government of Rajasthan has directed that at least 85% of the
drugs prescribed should be from EDL)
TOP
Top 300 Brands and their Relation to the National Essential Medicines List
The moving annual total (MAT) from the retail sales of top 300 brands alone is Rs.
18,000 crores.
Some of the top-selling Brands in India as per ORG-Nielsen Retail Audit
Brand name Uses and Remarks
Moving Annual Total
in rupees crore (Oct
2003)
Corex Cough suppressant. Abused as drug of
88.18
addicition because of presence of codeine
Becosules Multivitamin, unnecessary preparation 79.74
Liv-52 Ayurvedic liver preparation 62.67
Neurobion Irrational Multivitamin preparation 60.27
Nise Hazardous drug for pain relief 58.31
Dexorange Irrational preparation for anemia 57.65
Top – Selling Drugs Outside the NLEM include:
(i) Higher priced brand of either the same drug or a higher priced alternative to a
lower cost essential drug
Example: Cifran brand of ciprofloxacin is the largest selling antibiotic, whereas it is
the costliest among the ciprofloxacins. Other brands of ciprofloxacin (e.g. Zoxan)
although three times cheaper, sell five times lesser than Cifran.
(ii) Irrational combinations of drugs, which only add cost but are of no therapeutic
value, are touted as effective remedies and promoted aggressively. In our country
about 75 % of the children & 50 % of the women suffers from Anemia and iron
deficiency anemia is responsible for 1/3 of all maternal deaths. But the most
popular prescription is of fancy multivitamin formulations instead of iron and folic
acid preparations.
The sales figures reflect the fact that in India, drugs which are not considered
essential sell more than rational & essential drugs, that costlier drugs most often
sell more than cheaper alternatives (even
those made by well known
manufacturers), and downright irrational
and hazardous drugs are among the topsellers.
The majority of sales are coming
from the sales of drugs not considered
relevant by experts for inclusion into an
essential medicines list, and not
considered important by the government
for regulation of their price.
Brief analysis of the top 300 brands
suggests that the Indian doctors are
prescribing drugs without adequate
11

concern for evidence of their efficacy, safety and cost. This is because of poor
access to unbiased information on drugs, aggressive and often misleading drug
promotion by the drug industry. The result is increased health care costs, irrational
use of drugs and exposure of patients to the risk of unsafe drugs.
Vitamins and Tonics
These are some of the most highly selling and highly priced products in India.
Vitamin and tonics are in many cases a mixture of Vitamin B-complex or vitamins
in solutions of sugar and alcohol. Among the top-selling 25 medicines in India are
Becosules, Neurobion and Dexorange; the first two are irrational and / or
unnecessary multivitamin preparations and the last is an irrational iron “tonic”.
Vitamins deficiency should be treated with specific vitamins in dry tablet form.
Tonics are hazardous when substances like caffeine, leptazol, are combined with
vitamins. Regular intake of Vitamin A and D can be excessive and hence
hazardous. Bangladesh had banned tonics, enzyme mixture / preparations and
restorative product because such products “flourish on consumer ignorance…and
of no therapeutic value. The United Kingdom does not recognize tonics as drugs.
The production of the high-potency or “Forte” preparations of multivitamins is a
sheer economic waste. It is a drain on the consumers and government
dispensaries. High-potency preparations are also a drain on the country’s foreign
exchange as most of the raw materials have to be imported.
The table below shows that the sale of these rarely required tonics is in hundred of
crore rupees.
TOP
S.N. Brand Name Moving Annual Total (rupees crores)
1 Becosules 79.74
2 Revital 47.64
3 Polybion 40.85
4 Zincovit 32.26
5 Cobadex Forte 26.10
6 Methycobal 21.87
7 Zincovit 21.65
8 Neogadine 21.52
9 Riconia 20.78
10 R.B. Tone 20.21
11 A to Z 19.07
12 M2tone 18.22
13 Supradyn 15.25
14 Becadexamin 14.63
15 Raricap 13.89
16 Becosules-Z 12.03
17 Optineuron 11.97
Total 437.68
It shows: According to the Pharmaceutical Industry, Most Common Public Health
Problem of India is Not Anemia, but B-Complex Deficiency!
12

3. Irrational Prescriptions TOP
Ideally use of drugs should be only when there is an appropriate indication, but
this is not in the interest of the drug industry which is more interested in sales
promotion. Higher the sales, higher the profit. Therefore doctors under constant
persuasion of MRs sometimes follow what is being promoted by the brochures of
drug companies instead of prescribing what they have read in their standard
medical text books. For example:
-> A one year old with low body weight for age is seen in the OPD, because the
parents noticed a pot belly. This is due to under nutrition. The family is poor but
the child has not been weaned and given solid foods. Should the child receive
advice on feeding or an alcohol-based 'multi-vitamin tonic'
-> A computer professional has low-backache because of long hours of sitting at
the desk in a faulty posture on a faulty chair. Should he receive long term painkillers
like indomethacin, valdecoxib, tramadol, etc (all of which have well known
serious side effects) or advice on posture, exercise and a proper chair which
supports lower back
-> A chronic smoker comes with cough off and on, especially in the morning. There
is no shortness of breath. The clinical examination is normal. Should he receive a
cough suppressant, an antibiotic or advice and support for stopping smoking
Reasons for Irrational Prescribing:
1. The MR said so.
2. The latest is the best (latest antimalarials, antibiotics, analgesics, etc.)
3. Costlier the drug, the better it is.
4. The more I write the more I earn.
5. Availability of Irrational Drugs in the Market
6. The patients demand it (or, I will lose my practice…).
Aggressive Drug Promotion:
There are more than 100,000 formulations (at five products per company for the
estimated 20,000 manufacturing units India) in the Indian market, many of which
are similar except for different brand names or for a few unnecessary additional
ingredients. Pharmaceutical companies therefore indulge in aggressive marketing to
promote the sale of their brands. Sometimes, it results in unethical marketing
practices.
As pharmaceutical business is very profitable, it is hardly any wonder that
pharmaceutical companies spend at least 20 percent of their sales revenue on
promoting their products. Drug promotion is carried out by means of heavy
advertising, frequent visits to private medical practitioners by the medical
representatives of pharmaceutical companies with literature on their drugs, free
sample of drugs, and even gifts like diaries, posters, calendars, pens and
sometimes also invitations to medical conferences held in five-star hotels. The
companies also encourage articles in newspapers and magazines, television and
radio programs, release promotional materials as news stories about latest
developments in medical field and sponsoring television programs. Thus, drug
promotion is a comprehensive attempt to influence the doctors to suspend their
critical judgment and prescribe what is profitable for the manufacturer.
13

1. Influencing Doctors to prescribe
irrational, non essential drugs by brand
name
Companies prefer to spend more on drug
promotion because they recover their
expenses by pricing the drug highly. Doctors
are influenced into prescribing a particular
brand which is often more expensive. The
Hathi Committee in its report, made this
observation about the multinational drug
industry: "High pressure sales techniques
coupled with distribution of medical samples on a liberal scale to the medical
profession was their (MNC's) forte". According to David Jones, former vice president
of Public Affairs for Abbott Laboratories, and former Executive Director of Public
and Professional Affairs for Ciba-Geigy, "Prescription drugs are marketed as if they
are candy. Claims are made beyond what the product will do. Demand is inflated
beyond the medical need. Uses are promoted that are neither healthy nor wise"
World over, and in India specially, medicines are promoted by all means fair and
foul. Drug industry treats doctors as prescribers and not cares givers.
2. Lack of Objective Drug Information TOP
It is doubtful whether the majority of doctors in India are in the habit of regularly
referring to standard textbooks or standard medical journals. In Britain, all
practicing doctors are supplied every six months with a copy of the British National
Formulary (BNF) which contains reliable, updated information including costs on
the preparations on sale in the UK.
In the absence of objective information on new drugs, doctors in many Third World
Countries, are fully dependent on drug information supplied by the pharmaceutical
companies. And owing to the profit-oriented nature of the drug companies, the
information provided in its literature is bound to be in favor of the drug.
The prescribing information in most publications cannot be relied upon. Some of
these journals bring out "Review of New Drugs", which are actually based on
unreliable information. These publications even bring out pseudo-scientific reviews
of irrational drugs!
Doctors in India usually rely on information supplied by medical representatives
and drug companies which can be very biased and selective. Also, doctors are led to
believe a lot of new products are being marketed every day. Many of these are not
new discoveries, which radically alter the course of treatment.
3. “False” Evidence-based medical practice: The practice of medicine based on
scientific evidence is more talked about and less practiced. Some times evidence is
selectively quoted or false evidence is produced to promote a drug. For Example:
• Glaxo Laboratories cited the authority of a British medical journal, the
Lancet to promote its sales of Ostocalcium B-12 even though there was no
such endorsement of the product in the Lancet.
14

• Boehringer-Knoll quoted UNICEF and used their logo to promote the use of
streptomycin-chloramphenicol combination for diarrhoea treatment,
whereas UNICEF promotes simple ORT for most diarrhoea.
• Franco-Indian Laboratories misquoted Goodman and Gilman to promote
their tonic, whereas Vitamin B-12 has no role in ordinary anaemia.
• S.G. Chemicals (Indian subsidiary of Ciba-Geigy) misquoted Goodman and
Gilman and Martindale to promote a combination of two dangerous drugs
analgin and oxyphenbutazone, whereas in fact the texts warn against this
dangerous combination.
• There also exist double standards in the information given on drugs by
MNCs in the developed and developing countries. In the developing
countries, warnings about the side-effects or contraindications are not given;
drugs are recommended when their efficacy is not proven and even when its
safety is not established fully. For instance, oral contraceptive drugs are not
recommended in U.S.A. and Britain for premenstrual tension, menstrual
cramps, and menopausal problems and in dysfunction of the female
reproductive system.
TOP
Opinions of International Panel on Drugs Advertised in Indian Edition of
BMJ
Trental 400 (pentoxifylline): “The advertisement makes unsubstantiated claims
of improvement in mental function.” (This drug is marketed only for peripheral
vascular disease in America and Britain; in India it is indicated for
cerebrovascular disease as well)
Relaxyl (diclofenac): “The claim ‘gentle on the gastrointestinal tract’ is not in
accord with the reported high incidence of gastrointestinal side effects (up to
30% in Australian approved product information).”
4. Promotion of Hazardous, Banned and
Bannable Drugs
Internationally, a whole group of "block
buster" drugs have been in serious
trouble. These include rofecoxib ("Vioxx"),
valdecoxib ("Bextra"), celecoxib
("Celebrex"), atoravastin ("Lipitor"), etc. as
of writing there is enough evidence to
doubt the safety of a host of cyclooxygenase
(COX) -2 inhibitors.
(i) The case of Rofecoxib shows how a leading MNC drug company with a block
buster does anything to ensure its continued presence in the market, how research
studies are reported and interpreted selectively and how meta-analyses can be
used to support contrary positions, and how the US FDA acts ever so haltingly and
indecisively.
Rofecoxib was first marketed by Merck in 1999. The following year, a
randomized trial revealed increased rates of adverse cardiovascular events. Merck
15

aggressively defended rofecoxib's safety with a series of meta-analyses and
retrospective studies, and spent hundreds of millions of dollars marketing rofecoxib
to physicians and consumers. Merck's eventual decision to withdraw -effective
September 30, 2004 from the market was based on an increased risk for heart
attacks and strokes. US FDA analysts estimated that Vioxx caused between 88,000
and 139,000 heart attacks, 30 to 40 per cent of which were probably fatal, in the
five years the drug was on the market.
TOP
(ii) Valdecoxib was eventually withdrawn on April 7, 2005 after a US FDA request
asking Pfizer to voluntarily remove Bextra (valdecoxib) from the market, a decision
based on an incidence of severe skin reactions and evidence of increased risk of
cardiovascular malfunction.
(iii) Celecoxib is the only COX-2 inhibitor still available. It now carries a boxed
warning regarding cardiovascular and gastrointestinal risks. The Drug Controller
General Of India (DCGI) has asked drug companies to carry a warning on the label
of selected Cox-2 inhibitors. "This drug should be used with caution in patients
from Coronary Heart Disease (CHD) / Cardiovascular Disease.
(iv) Atorvastatin. Pfizer misled consumers into using its anti-cholesterol drug
brand Lipitor despite the absence of evidence from clinical trials that the drug or
others in its class are of any benefit to large segments of the population, according
to a consumer class action lawsuit filed against the world’s largest maker.
Lipitor is in the class of cholesterol lowering drugs and it is the best selling
drug in the world, with sales in 2004 of more than $10 billion. “The idea that
lowering cholesterol always reduces the risk of heart disease had become the
conventional wisdom, which drug companies like Pfizer have taken great pains to
promote. But for women under 65 and people over 65 with no history of heart
disease or diabetes, the evidence isn’t just there. Millions of women and seniors are
spending huge sums to take Atorvastatin every day despite a lack of proof that it’s
doing anything beneficial for them, and may actually be harming the elderly with
its side effects.
(v) Thalidomide: most women experience nausea during pregnancy which is a
physiological condition, but interestingly a drug was invented to cure it and blindly
propagated with the sole purpose of making money. It is another example where a
drug was pushed into the market without adequate evaluation of its safety.
Unfortunately above 8,000 mothers who unsuspectingly took the drug bore
children without arms and legs, the condition which is known among doctors as
phocomelia (seal like limbs).
16

(vi) Clioquinol a widely used over the counter drug to treat diarrhoea and marketed
as Entero-Vioform, Mexaform, etc. It damages the central nervous system resulting
in paralysis, blindness (Subacute myelo-optic neuropathy, SMON). About 11,000
people in Japan were victims of these side effects caused by the drug. The Swiss
drug company, Ciba-Geigy, was found guilty of marketing this drug without
revealing its hazards.
TOP
(vii) Nimeuslide was discovered by an American Company, 3M Pharmaceuticals,
but never got approval for use in the US, Canada, Britain, Australia, New Zealand
and 140 other countries around the world. It was banned in Spain and England in
2001 on reports of its hepatotoxicity. Even in Sri Lanka and Bangladesh, it is not
allowed to be marketed. In August 2003, the European Medicine Evaluation Agency
(EMEA) had banned the use of nimesulide in all the 25-member countries. Its use
for fever is not permitted.
Numerous studies have established the life-threatening adverse events with
nimesulide such as hepatotoxicity, renal toxicity, severe skin reactions including
fixed eruptions, gastrointestinal toxicity, potentiation of seizures, potentiation of
colitis in passive cigarette smoking. There is no reason for selecting nimesulide as
the first drug of choice for fever or pain.
In India, marketing approval for the drug was granted in 1994 for painful
inflammatory febrile disorders but unfortunately due to huge profit potential it is
being promoted as first line antipyretic therapy. Despite of serious side effects and
its indication for specific clinical conditions, there is abundance of Nimesulide
Formulations in our country. Pharmabiz.com reports that, “...200 nimesulide
formulations are marketed without the approval of Drug Controller General of
India. Out of these 200 products, 70 are nimesulide suspensions and the
remaining 130 are fixed dose combinations of nimesulide with a number of other
drugs. Combinations of nimesulide and paracetamol, numbering 50, are the largest
segment in this group. Top selling brands in
all the three categories are being marketed
by major pharmaceutical companies in the
country…”
Studies have shown that nimesulide
should not be used as the primary mode of
treatment as an antipyretic or analgesic,
especially in children, for whom much better
and safer choices are available. But there
are over 70 brands of pediatric suspensions,
including Nise of Dr. Reddy’s Labs and
Nimulid of Panacea Biotec. Two account for
more than 50 per cent of the market. And the nimesulide market is around Rs. 700
crores with profit percentage over 1500%.
When a PIL was filed in Delhi High Court seeking a ban on nimesulide, it was
informed by DCGI that on the basis of an “opinion poll” among just 50 doctors of
the over 4,00,000 doctors, the Indian Medical Association (IMA), Delhi branch, has
come to the conclusion that nimesulide was “safe and effective for all age groups
starting with day one to over 60 years”. In the wake of media reports the Indian
Academy of Pediatrics (IAP) also advocated use of nimesulide by Indian children. It
is indeed disturbing that while the leading countries of the world have not allowed
/ banned or withdrawn the drug, the opinion of a mere 50 private doctors has tilted
17

the scale towards allowing the drug to continue to be marketed in India, because of
the vested interests of the powerful pharma industry lobby.
TOP
(viii) Depo Provera is an injectable contraceptive for use by women manufactured
by the American multinational, Upjohn. This drug is not allowed for use as
contraceptive in USA. Yet the drug is sold in the Third World for contraceptive use.
The drug is associated with breast and endometrial cancers and lowered resistance
to infection. The drug causes severe birth defects if a woman who is unaware of her
pregnancy, take the drug.
(ix) Dexorange: An outstanding example of a patently irrational drug is that of
Dexorange. This formulation is used for treatment of one of the most common and
serious health problems of people, anemia. It is one of the top selling preparations
in India with a Moving Annual total in retail sales of Rs. 57 crores. Till 2000 this
company, for over a decade and a half, was adding minute amounts of hemoglobin
obtained from slaughterhouses under unhygienic conditions to its otherwise
irrational formulation of iron. The amount of hemoglobin added to the preparation
was such as to provide a meager additional 2-3 mg of iron per 15 ml.
Finally, the Government banned hemoglobin. But, the addition of
hemoglobin of animal origin to an iron preparation is without parallel in the
pharmaceutical sector worldwide. No other formulary mentions it, and no other
country ever allowed it. This particular preparation still contains an iron salt,
which is less efficiently absorbed, in a concentration that is low, and is still
marketed at a price that is extravagant. The cost of treating iron deficiency anemia
with this preparation can be up to Rs. 600 per month, against the cost of a simple
iron-folic acid preparation that should cost Rs. 9 per month. The case of the
consistent marketing success of Dexorange is not a mere example but stands as a
damning indictment of the state of affairs in the pharmaceutical sector, the
government and the prescribers. It has put the interests of the voiceless patient /
consumer in the background.
(x) Cisapride: Causes acidity, constipation, etc. Reason for ban: Irregular
heartbeat. But continues to be marketed by brand name: Ciza, Syspride, etc. even
as suspensions for our children.
5. Doctors as Key Opinion Leaders:
Key Opinion Leaders (KOLs) are influential specialists in their fields such as
doctors at teaching hospitals, senior consultants, authors etc. An endorsement by
a KOL in favor of new products or new uses of old products is a top priority for
pharma companies. Aggressive, often highly unethical, tools are employed to
capture KOLs.
Consider the following actions of drug companies and their KOLs.
1. Sun Pharmaceuticals sponsored over a dozen “educational seminars” all over
India to advocate Letrozole’s use in infertile young women. KOLs were paid
up to Rs. 30,000 per lecture to endorse the new indication. It is illegal to
promote any drug for unapproved indications.
2. According to one KOL of Jammu, he has already prescribed cisapride to
40,000 patients. Another KOL from Jammu says the same thing in the same
language and he too has prescribed for 40,000 patients and from 1990 at
that when the drug was not even marketed! Another KOL says it is okay to
give it to infants for pain in abdomen when it is prohibited for use in
18

children and yet another has determines that the side effects of cisapride are
to be found in 0.0001% of the patients whereas the US FDA says it is about
5 percent! TOP
3. Professional associations endorse products: Delhi branch of the Indian
Medical Association endorsed nimesulide and in its so-called survey for the
purpose, the sample of adults to children taken if extrapolated results in the
number of children of India being more than the population of India!
4. The Journal of Indian Medical Association has a “Research Analysis
Section” that in effect provides a platform to Pharma companies to market
their products.
Example: JIMA (Volume 99, No 3, July-Sep 2001) published two articles in a
span of a few months. Both promoting iron polymaltose (IP) preparations
claiming superiority of IP over ferrous fumerate and then quotes the
publication of these papers in marketing Mumfer, its brands of IP!
A further and more blatantly unethical form of manufacturing “consent” is
by ghostwriting research papers. Estimates suggest that almost half of all articles
published in journals are by ghostwriters. While doctors who have put their names
to the papers can be paid handsomely for ‘lending’ their reputations, the
ghostwriters remain hidden. They, and the involvement of the pharmaceutical
firms, are rarely revealed.
6. Biased Clinical Trials
The medical fraternity believes in evidence based medicines but many times: trials
are sponsored, evidence is created and favorable results are arrived at. Research
that is sponsored by a drug manufacturer is more likely to yield a positive result for
the company’s product.
Examples of Methods for Pharmaceutical Companies to get the Results they want
from Clinical Trials:
1. Conduct a trial of your drug against a treatment known to be inferior.
2. Trial your drugs against too low a dose of a competitor drug
3. Conduct a trial of your drug against too high a dose of a competitor drug
(making your drug seem less toxic)
4. Conduct trials that are too small to show differences from competitor drug
5. Do multi centre trials and select for publication results from centers that are
favorable.
6. Conduct subgroup analyses and select for publication those that are
favorable.
7. Present results that are most likely to impress.
When we talk of scams involving drug trials in India, none can forget unethical
trials of G4N which was discovered in USA but was unlawfully tested on oral
cancer patients at Regional Cancer Center in Kerala.
Drug companies, driven by economic pressure conduct often post-approval studies.
Merck and Pharmacia did extensive post-approval studies to show that their
arthritis pain medications, Vioxx and Celebrex, were easier on the stomach.
Merck’s study, involving 8000 adults, showed Vioxx causes fewer stomach
complications but also found it increases the risk of heart attacks. Despite that
only the advantages were selectively revealed, intentionally hiding the life
threatening side effects. In fact, it is better to kill a new hazardous drug which is
19

ought into the market without adequate clinical trials rather than to kill many
unsuspecting patients.
TOP
7. Disease Mongering: “Corporate Construction of Disease”
One of the important ways drug companies make money is by telling people they
are sick, even when they are passing through one of life’s many normal transitions.
This “Disease Mongering” suits the medical profession too, as it helps medicalising
problems.
1. In India, piractecam is being promoted for vague conditions like
“intellectual decay”, “social maladjustment,” “lack of alertness,” “change of
mood,” “ deterioration in behavior” and “learning disabilities in children
associated with the written word.” The recommended duration of treatment
for the last indication is “entire school year” in dose of “3g per day” i.e. 7-8
capsules of 400mg daily. If the drug is administered for the entire school
year as recommended, it will mean parents buying at least 2700 capsules at
a cost of Rs. 12,775 year after year. The unending claims of the drug’s
efficacy include the treatment of sickle cell anaemia, stroke and vertigo. In
Britain, piracetam (Nootropil) is permitted for use in just a single indication,
a rare disorder called cortical myoclonus, that too only as an adjunctive
therapy. While in India, the drug is being promoted for use in young
children, in Britain its use is contraindicated for adolescents under the age
of 16 years. If the Indian company marketing piracetam is to be believed, the
drug is nothing short of nectar. It has no contraindications; no need to
observe any precautions and no adverse drug reactions. In Britain, the drug
is contraindicated in hepatic and renal impairment, during pregnancy and
lactation. It is not marketed in USA.
2. Buclizine (brand Longifene in India) is being promoted as appetite
stimulant while the drug itself is not commercially available in the US and
is restricted worldwide for treatment of migraine in combination with
analgesics. Internationally reported adverse effects include: drowsiness,
blurred vision, diarrhoea, difficulty in passing urine, dizziness, dryness,
tachycardia, headache, nervousness, restlessness, hallucinations, skin rash
and upset stomach. Bottles of Longifene, the only brand of buclizine being
sold in Indian do not contain either the package insert or the patient
information leaflet.
3. Warner Lambert invented a condition called “halitosis” which makes
ordinary bad smell in the breath sound serious. Sales of Listerine rose from
US $ 100,000 to US $4 million in six years.
4. In the 1980s Glaxo needed to expand their market for ranitidine (brand
Zantac). They again created a condition called “gastro-oesophageal” reflux
disease (GERD)” which is a serious sounding name for heartburn, an age-old
complaint. The companies also setup a platform called the Glaxo Institute
for Digestive Health, which in due course led to a PR exercise called
Heartburn Across America. Annual sales of Zantac peaked at US $2 billion.
5. “Capturing impotence in an acronym”: During the 1990s Pfizer had to create
a market for sildenafil citrate (“Viagra”) and it ended up calling the broader
condition of impotence as “erectile dysfunction” (ED). Calling impotence
20

ED caused probably less embarrassment to shy patients as they could now
discuss a medical problem called ED with their doctors.
TOP
6. “A legendary example of this condition (called) branding strategy was the
development of Xanax (alprazolam) for panic disorder. A conference then
published diagnostic criteria for panic disorder and how best to treat it. Of
course, Xanas was the first to receive an exclusive indication, thereby
maintaining its leadership in anxiety disorders.
7. In Australia, baldness in men was medicalised by merck to sell its hairgrowth
drug finasteride (Propecia).
8. Manufactures of fluoxetine as a marketing strategy eulogized premenstrual
syndrome which is a routine physiological hormonal transition.
9. Roche started promoting its antidepressant Aurorix (moclobemide) as a
valuable treatment for “social phobia”. Its press release says more than one
million Australians suffers from this “soul-destroying condition”.
Where most of the drug research is funded by the pharmaceutical industry,
truthful reporting is unlikely to occur.
8. Direct to consumer advertising (DTCA)
Some products which should be taken under medical guidance are marketed
through advertisements using electronic & print media. Tall claims are made about
the results they will bring about but they are silent on the side effects which will
occur. Thus medicines are promoted like any other consumer item just to increase
the sales. For example
Oral emergency contraceptive pill: Unwanted 72 and I-Pill
Cough Syrups
Cough Syrups and expectorants are mixtures of drugs which stimulate coughing
(ammonium chloride, ipecac) as well as those which suppress coughing (codeine,
noscapine) and antihistamines that dry the secretions (some common brand names
are Benadryl Expectorant, Piriton Expectorant, Avil Expectorant).
Prolonged use of cough syrup is habit-forming, it may cause stomach upsets,
reduce food intake and cause drowsiness. Coughing is a protective activity of the
body. It should not be suppressed except in certain conditions. Simple steam
21

inhalation is advised. If it is necessary to use drugs, use only a single ingredient
cough suppressants such as codeine, dextromethorphan. There is no scientific
basis for using cough suppressants and cough stimulants together. The WHO List
of Essential Drugs does not include cough syrups and lozenges. Bangladesh has
banned them on the grounds they are "of little or no therapeutic value and
amounts to great wastage of meager resources"
TOP
9. Influencing Government Policies
Multinational companies (MNCs) are complex, highly technical structures, with
economic and political clout often exceeding that of the governments of the
countries where they operate. In a bid to expand their markets internationally,
MNCs resort to business practices which may be unethical. They are known to take
advantage of the economic weaknesses of the host countries to conduct operations
of a nature which have deep adverse effects on the host country's economy, human
health and environment.
The companies repeatedly and illegally influence policy makers, to keep the essential drugs
out of price control and to keep on utilizing pharmaceuticals that have been banned in
developed countries and dumped on the Third World. All in all, the abuses and false promotion
of needless, costly, and irrationally combined medications have reached alarming and healththreatening
proportions, particularly in India.
HISTORY OF DRUG PRICE CONTROL IN INDIA
India being a socialistic country, decided to control the prices of medicines. Two
important policy interventions had helped keep drug prices from spiralling. One,
the 1970 Patents Act and the other, the Drug Prices Control Order (DPCO). The
former did so by making process patents valid in India for pharmaceuticals. This
dramatically brought down the prices, facilitating local bulk drug manufacture at
costs one-tenths of international drug companies. The latter is issued under
Essential Commodities Act,1955 which empowers the central govt. to keep a check
(ceiling) on drug prices by issuing Drug Price Control Order (DPCO).
In 1979, 347 essential drugs were under control. Subsequently drug companies,
national and multinational, had their way, and have succeeded in persuading the
government to reduce the basket of price controlled drugs from 347 in 1979 to 142
drugs in 1987. In 1995 this came down to 76 and at present only 74 out of over
500 commonly used drugs are under statutory price control. It means for all the
remaining drugs the companies are free to charge any price from the patient, as
there is no ceiling on M.R.P. This is an irony that most of the essential drugs and
their formulations are outside the PRICE CONTROLLED DRUGS LIST. This means
that for all other drugs, the companies are free to fix MRP of their choice , which
could be 5 to 10 times the actual production cost (even at the cost of many lives).
22

Implications of Unethical Promotion and
Irrational Use of Drugs
TOP
THE SUFFERING
The consequences of this widespread uncontrolled misuse are devastating:
1. MEDICINES BECOME UNAFFORDABLE.- Suffering and deaths Profiteering
and huge expenditure incurred on marketing & commissions by drug companies
inflates the cost of medicines many times. By selling drugs at inflated prices, big
companies and retailers pocket a large share of the money paid out by the
consumer. In low and middle-income countries including India, public medicine
expenditure does not cover the basic medicine needs of the majority of the
population. In these countries, patients pay for 50-90 per cent of the medicines
from their own pockets. Consequently, many families are driven into debt. Many
Indian families shift below poverty line, annually due to health expenditures.
Many patients spend their lifetime savings to procure them. Many who have no
savings have no option, but to die without treatment. WHO estimated in 1999
that the percentage of Indian population had sustainable access to essential
drugs was in 0-49 range, categorized as very low access country. This is the most
unfortunate part of the story. It is important to remember that consumers of
pharmaceutical products are extremely vulnerable. They are in no position to
reject or postpone buying medicines, even if the medicines are expensive. If a
doctor prescribes a particular drug, the patient has to buy it. Drug companies
exploit this vulnerability, especially in India where drug consumers are
fragmented and unrepresented, unlike in the West. In the West, people either get
themselves insured or are insured by their employers. The insurance company
buys the patient's medicines. Expenditure on health is also responsible for APL to
BPL shift, rural indebtness & failure to rise above poverty line.
Let’s take an example. A doctor has prescribed an injection (Amikacin 500) for
pneumonia which bears MRP of Rs. 70. In India there are many patients who have
just Rs. 10 in their pocket and hence are not able to purchase injection Amikacin
as it is sold in the market at Rs.70 (MRP). Therefore, many poor patients are forced
to die for want of medicines. Although, the actual cost is less than Rs. 10. In our
country where millions live below poverty line, many poor people die like this,
every day, in this criminally exploitative and brutally unjust system. If, the
injection which actually costs Rs. 8 could be supplied at Rs. 10 instead of Rs.70
(printed MRP), many more patients could afford treatment and many more lives
could be saved.
2. INAPPROPRIATE MEDICATION Approximately 4 million children die each
year from diarrhea-related causes, primarily dehydration, according to the WHO.
Many of these deaths can be prevented through oral rehydration therapy, which is
simply the replacement of fluid and mineral losses caused by the diarrhea with a
mixture of clean water, salt and sugar. Yet, according to WHO appropriate
treatment "often remains the exception rather than the rule”. A large number of
pharmaceutical agents of dubious efficacy and potential toxicity are widely
used. Tragically, many spend their scant savings on medicines that are ineffective,
23

worthless and sometimes even harmful.
delays or replaces appropriate treatment.
The inappropriate use of drugs often
TOP
Many drugs eg. protein powders, vitamins, health tonics, etc which are not
required for the patient are prescribed, virtually regardless of the condition being
treated, just to increase the sale of a particular brand and draw commissions from
this sale. Side effects are inevitable in such cases. Also, indiscriminate use of
antibiotics could lead to resistance.
3. CIRCULATION OF BANNED DRUGS. Drugs banned or withdrawn in Europe
are widely available in the Third World. Right now, 85 types of drugs, considered
hazardous and therefore banned in the West, are being sold in India . The majority
of the drugs on the list are analgesics and antibacterials, for which there are
several safer alternatives that appear on the World Health Organization essential
drugs list. Many such drugs are available in India, for eg. Analgin, Cisapride,
Droperidol, Furazolidone, Nemisulide, Nitrofurazone, Phenopthlein,
Phenylpropanalamine, Oxyphenbutazone, Piperazine, Quinodochlor.(source: MIMS)
4. EXTRA BURDEN ON GOVT. EXCHEQUER. The govt. hospitals indent and
receive medicines by generic name. Thus, medicines written by brand name are
usually not available in hospital supply. Therefore, pensioners and other govt.
servants buy these overpriced branded medicines from private chemists, and claim
medical reimbursement from the govt. This leads to a heavy burden on the govt.
exchequer. This money can be saved very easily by generic prescribing and making
low cost drugs available to the patients and this money, can be used to treat more
patients.
5. DRAIN ON FOREIGN EXCHANGE. ‘Importation of pharmaceuticals is one of
the fastest growing drains on hard foreign currency for developing countries’,
explains WHO. The Third World pays the rich world an estimated nine billion
dollars a year for drugs. And prices are rising: four times as fast as GNP in many
poor countries. In fact, some health ministries are spending over 50 per cent of
their budgets on drugs alone. Poorer countries waste limited currency on
unnecessary drugs.
6. RISK OF ADVERSE EFFECTS: All drugs carry the risk of side - effects, e.g.
majority of the pain killers carries the risk of side - effects on the stomach. The
unnecessary use of drugs exposes patients to the risk of side effects. About 4% to
10% of hospital in-patients suffer an adverse drug reaction in developed countries.
This is the fourth to sixth leading cause of death in the US.
7. RISK OF TRANSMISSION OF DISEASES THROUGH UNSAFE INJECTIONS:
An average Indian receives 2.9-5.8 injections per year. The safety of such injections
was abysmal with 62.9 per cent of injections being adjudged as unsafe and nearly
32 percent were considered to be capable of transmitting serious blood borne viral
infections. A proof of the hazard of unsafe injections has been in outbreaks of
hepatitis B with high fatality. Unsafe injections contributes to 80,000-1,60,000 HIV
infections, 2.7-4.7 million Hepatitis C virus infections, and 8-16 million Hepatitis B
virus infections globally every year.
8. RISK OF ANTIMICROBIAL RESISTANCE: Globally there is a rise in the
resistance to antibiotics and a major cause is the wrong use of these medicines.
24

E. The Solution
1. Rational use of Drugs TOP
(i). Generic Prescribing: Generic drugs play an important role in health care and
the prescription and availability of generic drugs eliminates the monopoly of the
drug companies. WHO calculates that generic prescribing of essential drugs could
save 70 per cent of the drugs bill in rich countries alone. In poor countries benefit
to the patients will be much more.
A generic medicine provides the same quality, safety and efficacy as the original
brand name product and undergoes strict scrutiny before it is licensed and given
market approval by the authorities. A generic medicine is typically 20% to 80% less
expensive than the brand-name original. In addition, the availability of lower-priced
generic medicines brings down the price of originator drugs through market
competition.
Advantages of having a generics-only policy
Ensure production, sale and dispensing of more rational single ingredient
drugs.
Quality drugs are much cheaper when purchased under their generic
names rather than their brand names.
Ensure clarity and avoids confusion arising out of many dissimilar brand
names of the same drug.
Curtail the heavy promotion of brands and their high cost.
(ii) Adoption of essential drugs list WHO points out
that a selection of just few drugs are needed to treat the
majority of diseases i.e. Essential Drugs. But there are
over 1,00,000 available in India. The govt. of Rajasthan
acknowledges that “high profits in pharmaceutical
industry has led to a large number of drugs and
medicinal products under various brand names and
number of them have been reported to be irrational
combinations as per WHO criteria”. Thus to promote
rational use of drugs on basis of suitability and cost
effectiveness, the state govt. has adopted an essential
drug list (EDL) which includes about 350 medicines.
The govt. hospitals have been directed to spend 85
percent of their budget to procure medicines from EDL
and the govt. doctors shall prescribe medicines out of
EDL as far as possible. The need of the hour is to give
effect to these govt. orders.
(iii) Adoption of Standard Treatment Guidelines to
discourage “Luxury drugs” WHO believes that
expenditure on preparations which are not in EDL is a
criminal waste of resources. Many health tonics,
vitamins, antioxidants, etc. are promoted by
companies just to increase sales and reap profits. Any
new product, including a new analgesic or antibiotic,
generates enthusiasm in physicians, which is
multiplied many times through the persuasive
25

influence of M.R.s who claims this costly new drug is more effective. Tragically,
millions of poor spend their scant savings in medicines that are worthless and
sometimes even harmful. Though they can be easily treated with help of essential
drugs. Thus, curbing the marketing of useless or harmful drugs is equally
important. This can be done by putting Standard Treatment Guidelines (STG)
into practice. This will prevent the doctor from prescribing useless drugs
unnecessarily.
2. Availability of Low cost drugs. TOP
I. Drug procurement by generic name through open tender system: The
prerequisite for such a system is identification of required drugs by generic
name. Drugs are then procured by a two stage transparent tender system.
This ensures that only those companies that are capable of supplying
products of adequate quality receive orders. The tender process is limited to
companies that fulfill the "quality" criteria. Through a two stage tender system
(technical bid and price bid), it is ensured that the purchases are made from
companies complying with the good manufacturing practices. The prices
offered by pharmaceutical companies to the Government during quality
conscious bulk procurement are only to the tune of 2 – 20 % of the retail price
(MRP). The Tamil Nadu model and Delhi Model of centralized procurement are
being followed by many other states in the country. This has enhanced the
supply of prescription drugs in the hospitals, besides causing a substantial
reduction in drugs procurement cost.
II. Distribution of Low cost drugs through govt. drug counters.
The drugs procured through centralized procurement system or manufactured
by PSUs costs very low. It is not enough to supply these in govt. hospitals, but
they should be made available to all the patients at govt. run drug counters at
low cost. For example tab. Diazepam is being supplied to govt. hospitals at 90
paise per 10 tabs. However, the same drug is available to the patients by the
brand name of Valium, for Rs. 19.50. A mechanism needs to be devised to
provide all the commonly used medicines at their actual costs to all citizens.
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The possible drug counters could be:
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1. Life-line drug stores (run by RMRS)
2. Co-operative Medical Stores
3. Kray Vikray Sahakari Samiti (KVSS)
4. Medical shop runs by Red Cross societies
5. Jan Aushadhi Kendra
In Rajasthan the life-line fluid stores run by RMRS in govt. hospitals are
already providing cheap injections and IV fluids. In 2004, the govt. instructed to
upgrade these fluid stores to life-line drug stores i.e. apart from fluids they will
also sell other drugs as well but these drug stores have come up only in few cities.
Moreover, these are procuring and supplying medicines by brand names which are
costly. If such stores are opened in all govt. hospitals and they procure and
provide all essential drugs by generic name, then it will improve the supply of
low cost medicines to the patients. Rates must be displayed prominently outside
the stores. If these low cost generic medicines are made available at govt. stores
counters the cost of medicines can be reduced to more than half in most cases and
this price fall will come down to the extent of one tenth of the prevailing market
rate in certain cases, like cetrizine and nimesulide. Once choice of low cost drugs is
available to the consumer, market competition will ensure that private medical
shops also reduce their prices.
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LOW COST MEDICINES INITIATIVE – CHITTORGARH
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DISTRICT LEVEL INTERVENTIONS – THE MODEL
We knew that the actual cost of most of the drugs is very low. But, these were not
available to patients at low rates because of three obstacles:
1. The doctors prescribe medicines by brand name of a particular drug company.
This prevents competition and creates monopoly in the drug market and
enables the drug company to put a very high MRP.
2. As very high MRP is printed on the drugs, the chemists charge the same
amount from the patient.
3. Consumers are not aware that the actual cost of production of most of the
drugs is very low. Moreover, once doctor has prescribed a particular brand, the
patient has got no option, but to buy it, even when other low cost brands are
available in the market. For example if doctor has prescribed a brand Glivec to
a patient of blood cancer, a months course will cost Rs.1,14,400/- to the
patient. Whereas, the same anti cancer drug, but with a different brand name
Veenet costs just Rs.11,400/-. And Cipla supplies the generic equivalent of
this drug (imitib) at Rs. 8,000/- & Gelnmark supplies it for Rs. 5,720/-!!!!!
So, the district administration adopted the following strategy to provide low cost
medicines to the patients. Generic medicines are on an average 5 times less the cost
of branded medicines. We broke the monopoly of drug manufacturers by pursuing
doctors to prescribe by the salt name and we made arrangements to sell medicines
below the MRP at govt. drug counters and made consumer aware. This was done in
three steps: -
1. Ensuring that doctors prescribe drugs by generic (salt) name, as directed
by the state govt.
The state govt. has issued various circulars/ orders, which directs all govt.
doctors to use generic names, instead of brand names.
1. Circular No. P13 (108) M.E/gh1/98 dated 03.09.05
2. Circular No. P4/PMF/2005/20VBOT/5892-0037 dated 26.09.05
3. Circular No. P31(108) M.E./gh1/98 dated 18.08.05
4. Circular No. F.22(1) M.R./96 dated 24.05.96
5. Circular dated 24.04.02
6. Circular dated 04.12.04
7. Circular No HA/MR/ Circular05/10 dated 19.07.05
8. Circular No chi/pra/05/MR/1802-1887 dated 01.09.05
9. Circular No P(193)(a) RPMF/2005/6041-6107 dated 13.10.06
10. Rule 32 of Raj.C.S.Medical (Attendance) Rules, 1970.
The following issues were addressed before the project could take off.
A. Quality
A team of doctors was constituted to suggest the companies, which they
believe, produce good quality drugs. Only these were procured and supplied
at co-op. stores.
B. Combination preparations
Commonly used combination generic drugs were made available at co-op.
stores.
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C. Chemists will give brand of his choice and will charge the printed MRP
If the patient gets medicine from hospital supply or is educated to buy low
cost drugs from co-op. store, the problem is no more. Once, patients
understand that the same drugs are available at co-op. store at much
cheaper rate, market competition ensures that the chemists also sell at
lower rates. Eventually the patient benefits.
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D. Govt. can put a ceiling on MRP
This cannot be done at the state govt. level. Central govt. can do it using the
provisions of Essential Commodities Act and Drug Price Control Order.
Doctors were convinced that by the time a ceiling on MRP is put by the
central government they should not wait and start helping their patients,
specially the poor.
2. Govt. Cooperative Medical Stores and Life-line drug stores (run by RMRS)
provide low cost medicines of well reputed companies.
Medicines which are commonly used by the patients and prescribed by
Doctors were listed after discussions with various medical specialists.
A committee of doctors was consulted which recommended that drugs of
reputed companies like Cipla, Cadila, Ranbaxy, German Remedies,
Alembic, etc. can be purchased . (Initially 22 and now 57 companies are
approved)
Finally, the tender was floated for these medicines. The tender included
564 generic medicines and more than 100 surgical and I.V. fluids.
Cooperative store invited bids to purchase the drugs of these companies
from the local stockists at competitive prices, after preparing comparative
statement and finding out the most economical company (L1).
The medicines are then sold at 20% profit margin to the patients. This
money goes to the coop. deptt. and will make the project self sustainable.
Thus, medicines of reputed drug manufacturers (which are unthinkably
cheap) were made available at government co-op. medical stores for sale.
Pricelists are displayed outside the coop. stores to advertise the rates and
educate the patients.
Once choice of low cost drugs is available to the consumer, market
competition will ensure that private medical shops also reduce their prices.
3. Awareness generation. Doctors were sensitized by organizing discussions.
Training of co-op. pharmacists was carried out. The consumers were made
aware by displaying boards showing comparative price lists and positive use of
local electronic and print media.
Quality control and Audit:-
The quality control Officer is Dr. Dinesh Vaishnav who is assisted by drug
Inspector Sh. Jain. This team ensures that the drugs of the companies approved by
the committee of doctors only are available. So far 33 samples of generic drugs
from various shops have been tested and all of them have been found to be of
standard quality.
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THE IMPACT: many human lives saved
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1. Medicines are available at unbelievably low prices, at govt. co-op. store, much
below the printed market rate i.e. MRP. See the (illustrative) list.
Generic Name of Drug
Chittorgarh
Bhandar Rate*
(Rs.)
Unit
MRP Printed on
pack / strip (Rs.)
Albendazole Tab IP 400 mg 1.37 1 tablet 25.00
Alprazolam Tab IP 0.5 mg 1.75 10 tablets 14.00
Arteether 2 ml Inj 11.72 1 Injection 99.00
Amlodipine Tab 5 mg 3.12 10 tablets 22.00
Cetrizine 10 mg 1.50 10 tablets 35.00
Ceftazidime 1000 mg 64.90 1 Injection 370.00
Atorvastatin Tab 20 mg 22.59 10 tablets 170.00
Diclofenac Tab IP 100mg 2.75 10 tablets 25.00
Diazepam Tab IP 5 mg 1.90 10 tablets 29.40
Amikacin 500 mg 8.67 1 Injection 70.00
2. Treatment cost of most illnesses falls sharply.
3. Increase in number of patients getting free drugs from hospital supply.
4. Decrease in expenditure from Rajasthan Pensioners Medical Fund (RPMF), so
more patients can now be benefited.
This can be made possible if two things happen simultaneously:
Rational Prescription
(by Doctor )
1. Prescription of drugs by
generic (salt) name.
2. Prescription out of essential
drugs list.
3. As per Standard Treatment
Guidelines.
Low cost drugs made
available
(at govt. medical shops)
1. Transparent procurement
through open tender system.
2. Distribution of Low cost
drugs through Life Line/ Coop.
Store.
3. Display of Rates
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THE ULTIMATE SOLUTION: Statutory price control for all essential drugs TOP
It is the government, which can provide medicines at an affordable cost and
improve medicine accessibility. In India, an effective price control mechanism is a
must, failing which the medicine accessibility will become less and lesser as most of
the countrymen pay for medicines from their own pocket. The need is that Central
Government should introduce a more effective drug pricing policy that would bring
down the high profit margins for the pharmaceutical trade and make medicines more
affordable for the common man.
Liberalisation has nothing to do with a price protective mechanism in a sector
as vital as healthcare. The medicines under national list of essential drugs must be
kept under price control domain and the provision to control of newer necessary
medicines useful in public health should be made.
Supreme Court in its interim order dated, March 10, 2003 in Gopi Nath case
has directed the central government to ensure that essential and life saving drugs
are kept under price control. The fact that Karnataka High Court and subsequently
Supreme Court stayed the implementation of pharmaceutical policy 2002
questioning the stand of Government over the exclusion of many essential drugs
under the ambit of price control speaks the importance of price controlled essential
drugs in India. This is yet to be complied with.
At present only 74 drugs have ceiling prices. If SC orders of 10 Mar.03 are
complied with, it would result in control on ceiling prices (ie control on MRP) of about
350 Essential Drugs and many other life saving drugs as well. Even if these drugs
could be provided at affordable prices many more human lives could be saved.
CONCEPT NOTE ON GENERIC DRUGS:
COST EFFECTIVE ALTERNATE TO BRANDED DRUGS
A Generic Drug is a copy that is the same as a brand name drug in dosage,
safety, strength, how it is taken, quality, performance and intended use. Generic
simply means that the drug is not sold as the brand name, but it has the identical
strength, dosage and route of administration and the same active ingredients as
the brand-name drug. The use of generic drugs is now widely accepted and they are
commonly prescribed by physicians and dispensed at hospitals. While
manufacturing generic drugs, the drug companies use the same active ingredients
and are shown to work the same way in the body, they have the same risks and
benefits as their brand name counterparts. Also, generic drugs have the same
quality, strength, purity and stability as brand name drugs. It is seen that Generic
Drugs work in the same way and in the same amount of time as branded drugs.
The generic drugs are less expensive as compared to branded drugs as generic
manufacturers do not have the investment costs of the developer of a new drug.
New drugs are generally developed under patent protection. The patent protects
the investment and the associated expense, viz. research, development,
marketing and promotion. When patents are nearing expiration, manufacturers
usually approach the Government/Drug Control Department to sell generic
versions. In the process, the consumers get genetic drugs at substantially lower
costs. Both branded and generic drugs are manufactured by conforming to
International standards. Brand name drugs are usually given patent protection
for 20 years from the date of submission of the patent. This provides protection
for the innovator of such drugs to make good the initial costs incurred by him,
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viz., research development and marketing expenses, to develop the new drug.
Many drug companies start manufacturing generic drugs once the patent
license expires for a branded drug. The physician plays a vital role to determine
whether his patient needs a branded drug or generic drug.
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Patients should become assertive and insist upon the doctors to prescribe
generic drugs if available, so that the patient would get the product at the best
possible price. Pharmacists also play a vital role in educating the doctors about
the availability of generic drugs. Thus the right medication could be given to the
patients at the best possible price. Generics are as good as branded drugs. Thus
if generic drugs are bought by the patient, the patient may not lose money by
going in for branded drugs, which are too costly. Health care costs continue to
rise. Therefore, consumers, providers and policymakers need to assess the best
way to keep health care affordable without adversely affecting access to quality
care. With prescription drug (branded drug) costs serving as a major contributor
to cost escalations,
Generic drugs offer an important tool for reducing the rate of growth in
overall health expenditure. Generic drugs play an important role in health care
and the availability of generic drugs reduces the monopoly and oligopoly powers
of the patent holder. The Government may also impose compulsory licensing so
as to make available the much needed generic drugs. It is seen that many
countries do not have the technological capability for manufacturing and
supplying generic drugs even if the laws of those countries permit them to do
so. It has also been found that prices fall substantially once the drugs are off
the patent, if there are generic producers. When more generic producers enter
the market, more is the fall in the prices.
Differences between a Brand name Drug and a Generic Drug:
• The innovator of a branded drug does research to discover the new
biochemical substances that eventually become new drugs.
• This research is essential for finding new and better treatments for various
diseases. This process is expensive.
• The expense incurred by a pharmaceutical industry for coming out with a
branded drug is passed on to the consumer, but most of the money is
ploughed back into research and development of new products.
• In America, FDA grants the innovator company a patent of exclusivity making it the
only company able to produce and sell the drug. The patent expires 20 years from the
commencement of drug development to drug marketing. When it does, generic
companies are then allowed to manufacture and sell the drug.
• Generic drugs offer significant savings to consumers. The cost of generic
drugs averages 40 to 60 per cent below the cost of the innovator or brand
name drug.
• It may be noted that the generic company’s version of the drug has the same
active ingredient with the same chemical purity as the brand name drug.
Obviously this results in cost savings for the generic as it does not involve
doing research as was done by the original inventor. Also, it would cost less
for the generic company to market its drugs and thus the savings passed on
to the patient.
• Generic drugs are regulated like band name drugs. Consequently, both are
safe and effective when properly used.
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• Generic drugs today are manufactured by branded drug manufacturers also
employing the same technology and processes. The only differences are the
labeling, tablet or capsule design and the price.
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• A generic drug is pharmaceutically and therapeutically equivalent to brand
name drug
Frequently Asked Questions about Generic Drugs
1. Are generic drugs as safe as brand-name drugs
Yes, since generics use the same active ingredients and are shown to work
the same way in the body, they have the same safety and benefits as their
brand-name counterparts.
2. Are generic drugs as strong as brand-name drugs
Yes, generic drugs to have the same quality, strength, purity and stability as
brand-name drugs. The standards of quality, laid down in the
pharmacopoeias are the same for branded and generic drugs.
3. Do generic drugs take longer to work in the body
No. Generic drugs work in the same way and in the same amount of time as
brand-name drugs.
4. Why are generic drugs less expensive
Generics cost less than brand-name drugs, mostly because manufacturers
of generic drugs do not have the expense of research, development,
advertisement and marketing related to a new drug. New drugs are
developed under patent protection. The patent protects the investment by
giving the company the sole right to sell the drug while it is in effect. As
patents near expiration, other manufacturers can apply to sell generic
versions. Because those manufacturers don't have the same development
costs, they can sell their product at substantial discounts. Also, once generic
drugs are approved, there is greater competition, which keeps the price
down. Today, in U.S. almost half of all prescriptions are filled with generic
drugs. Generic drugs save consumers an estimated $10 billion a year at
retail pharmacies. Even more billions are saved when hospitals use
generics.
5. Are brand-name drugs made in more modern facilities than generic
drugs
No. Both brand-name and generic drug facilities must meet the same
standards of good manufacturing practices. Drug authorities won't permit
drugs to be made in substandard facilities. Inspections are conducted to
ensure that prescribed standards are met. Generic firms have facilities
comparable to those of brand-name firms. In fact, brand-name firms are
linked to an estimated 50 percent of generic drug production. They
frequently make copies of their own or other brand-name drugs but sell
them without the brand name.
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6. Does every brand-name drug have a generic counterpart
No. Brand-name drugs are generally given patent protection for 20 years
from the date of submission of the patent. This provides protection for the
innovator who laid out the initial costs (including research, development,
and marketing expenses) to develop the new drug. However, when the patent
expires, other drug companies can introduce competitive generic versions,
but only after they have been thoroughly tested by the manufacturer and
approved by the FDA.
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7. Is my generic drug made by the same company that makes the brandname
drug
It is possible. Brand-name firms are responsible for manufacturing
approximately 50 percent of generic drugs.
8. Why do medicines have more than one name
Medicines will often have more than one name:
a generic name, which is the active ingredient of the medicine
a brand name, which is the trade name the manufacturer gives to the
medicine.
The generic name is the official medical name for the active ingredient of the
medicine. The brand name is chosen by the manufacturer, usually on the
basis that it can be recognized, pronounced and remembered by health
professionals and members of the public. An example would be Viagra - this
is the well-known brand name given by Pfizer to the generic medicine
sildenafil. (Brand names are capitalized; generic names are not.)
9. How does this affect me
When a doctor is writing a prescription, or a consumer is buying an overthe-counter
medicine, they may have a choice between a branded medicine
and the generic version of that medicine. Generic medicines are mostly
cheaper than brand-name medicines, but the active ingredient (the
ingredient that produces the therapeutic effect of the medicine) is the same
in both. If your doctor has prescribed a medicine by its brand name, your
pharmacist must dispense that brand. However, if a medicine has been
prescribed by its generic name, your pharmacist can dispense whatever
version of the medicine they have available, because each version will have
the same therapeutic effect.
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