HOW ETHICAL IS THE PHARMACEUTICAL
INDUSTRY IN INDIA
When one talks of ethics, the pharmaceutical
industry in India often proffers Good Manufacturing
Practice (GMP) as an example of their good behavior. The
various state Food and Drug Administrations (FDA) and the
Drugs Controller General of India have laid down minimum
GMP requirements to qualify for drug manufacturing
license. These requirements are far less stringent than
international GMP guidelines, including those recommended
by the World Health Organization (WHO). Even then, the
controlling authorities do not have adequate staff to
monitor the practices followed by the licensed
manufacturers and see that they conform to GMP norms.
Taking advantage of the situation manufacturers, both
small and big, frequently flout norms.
The FDA in Maharashtra ordered a nation-wide recall of
the antibacterial drug COMSAT FORTE, a brand of
co-trimoxazole, of Boehringer-Mannheim (India) Limited
when it was found to contain the antidiabetic ingredient
glibenclamide as a result of mix-up in raw materials on
the shop floor of the manufacturing plant. Rather than
cure infections, the tablets caused a drastic fall in
blood sugar and blood pressure, and 62 people turned
critical after using it at an eye camp in Ahmednagar on
August 16, 1996. Although the deadline for recall expired
on September 5, the drug claimed 2 lives in Kolar,
Karnataka, five days later. The company’s Managing
Director left India for Canada. The Maharashtra FDA has
been reported to have opined that the multinational
company is over 125 year old and that its reputation had
to be considered before taking any precipitate action. Is
this ethical?
In 1992, during a raid on the premises of one scrap
dealer Barkat Ali, rejected materials and labels in bulk,
both coded and uncoded, of Glaxo India Limited were
recovered. Further investigations followed and the
revelations shocked medical and pharmaceutical circles in
the country. The scrap dealer confessed to selling
rejected medicines to an enterprising Gujarati
businessman operating from a cubby hole in Ahmedabad. On
February 14, 1994, the Mumbai High Court upheld the
closure orders of Glaxo India Limited given to it by the
state FDA. The company opined "we feel we were being
singled out although there were other pharmaceutical
companies which were found to be violating the
rules". Glaxo was referring to violation of rules
done by Boots and German Remedies Limited. These are all
multinational drug companies. It was only Mr. Arun
Bhatia, an upright officer of the FDA, who insisted on
the act being implemented. He paid the price. He took
over as FDA commissioner on March 23, 1993, and was made
to hand over the charge on October 21, 1993. That
established the nexus between politicians and the drug
manufacturers so beautifully explained by Justice B.
Lentin in the Lentin Commission Report. Is use of
political clout ethical?
Between January 21 and February 7, 1986, 14 patients died
in J.J. Hospitals in Mumbai from a cause totally
unrelated to the diseases that brought them there. They
died of poisoning by the adulterated glycerol given to
them. The toxic adulterant was diethyl glycol which was
present in a concentration of 18.5% - over three times
the lethal dose. Rapid necrosis of the kidneys took place
and the unfortunate victims succumbed to acute renal
failure. This adulterated glycerol, meant for industrial
consumption, was sold by Kailash Company to Alpana
Pharma, with the former knowing that it was to be used
for medicinal purpose. This was not a mistake, nor an act
of carelessness. It was an extremely conscious act
motivated by greed for more profits. What about ethics?
The licensing authority, the drug testing laboratory, the
tender committee, the pharmacology department and the
highest authorities in J.J. Hospitals, and the Health
minister were indicted. What has been the track record of
action taken against the guilty? The non-implementation
of the judgments makes statutes like the Drugs &
Cosmetics Act a farce. Loopholes continue to be used
against the people by vested interests. Can a voluntary
code of ethics put an end to such acts of omission and
commission?
Drug manufacturers argue that high drug prices are need
to fund research and development of new pharmaceutical
products which they contend, is a very expensive, risky
and uncertain business. However, high prices, profits and
tax subsidies, are producing many more slick and
expensive marketing campaigns than they are leading to
breakthrough drug products. The drug marketing practices
in India are most unethical and the government has no
control over the marketing gimmicks.
The International Federation of Pharmaceutical
Manufacturers’ Association code of pharmaceutical
marketing practice states that the detailers (medical
representatives) must be adequately trained and possess
sufficient medical and technical knowledge to present
information on their company products in an accurate and
responsible manner. However, in India, doctors and their
patients could be better off if the detailers paid them
fewer visits. Often they are poorly trained and are
ill-informed. Generally they use flip charts (instead of
a detailed literature) bearing colorful pictures of the
drug and list of indications in bold print. Even the
composition of a combination product is not given, leave
alone the side effects and contraindications. The
practice of distributing samples and gifts has
degenerated into a rat race amongst the drug
manufacturers.
The issue of drug promotion cannot be separated from the
products that pharmaceutical companies choose to sell.
Irrational drug combinations or products with ingredients
that are of no scientific value are being sold. The All
India Drug Action Network, Karnataka Drug Forum and other
voluntary health activists have filed a writ petition in
the Supreme Court for banning of all drug combinations,
excepting the few recommended by WHO. It was through
untiring efforts of drug and health activists that the
government of India has banned over 64 drugs and drug
combinations covering thousands of branded products.
These products were marketed unethically.
Double standards by multinational drug companies poses a
further problem. Frequently, the information provided to
Indian doctors is a lot different from that given to
physicians in advanced countries. The range of
indications for use of a drug is expanded and fewer
adverse drug reactions, warnings and contraindications
are given.
Evidence indicates that doctors rely heavily on drug
companies for their drug information. The ayurvedic,
homeopathic, unani and other doctors practicing in
indigenous or traditional systems of medicine have no
access to independent information on drugs they prescribe
and for them education in clinical pharmacology is the
unchallenged province of ill-trained detailers. It is no
wonder if maximum unethical practices are employed by the
pharmaceutical industry to win over the support of these
doctors. Introduction of a pharmaceutical product to a
person not trained or educated in pharmacology, is in
itself, an unethical practice.
Unethical, uncontrolled pharmaceutical promotion is
obviously one of the many problems in health care in the
Third World. It is not a trivial problem as the
pharmaceutical industry tries to suggest. When physicians
rely on information provided by drug companies, they tend
to prescribe expensive branded products. It thus become
the moral responsibility of the drug manufacturer to give
nothing but the correct information. Is this
responsibility being ethically discharged? Wishvas Rane
Recent additions to
our library:
Reynolds
JEF, editor. Martindale: The Extra
Pharmacopoeia. 31st ed. London: The Royal
Pharmaceutical Society; 1996.
Public-Private
Roles in the Pharmaceutical Sector:
Implications for Equitable Access and
Rational Drug Use [Health Economics and
Drugs, DAP Series No. 5]. Geneva: World
Health Organization; 1997.
Werner D,
Sanders D, Weston J, Babb S, Rodriguez B.
Questioning The Solution: The Politics of
Primary Health Care and Child Survival.
Palo Alto, California: Healthwrights;
1997.
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