HOW ETHICAL IS

THE
PHARMACEUTICA
L 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 HealthOrganization (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
thatpharmaceutical 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 healthactivists 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?