Unethical Drug Promotion-An Emerging Threat For The Indian Society

What is drug promotion?

WHO defines drug promotion as ‘all informational and persuasive activities by manufacturers
and distributors to induce/influence the sale and use of medicinal drugs.’[1] Drug promotion has
an important bearing on the rational use of drugs; on drug price-control mechanisms, the
manufacture, availability and use of essential drugs, on equity of drug distribution and the cost of
health care—all making it a central public health issue. Thousands of Indian companies produce
70,000 brands of various drug formulations compared to WHO’s list of 250 essential drugs.
Drugs are sold through chemists and stockists who make a margin on the sale. The private sector
represents 80% of the health expenditure, so a doctor in private practice is an influential
prescriber.

In India apart from registered medical practitioners, un- registered medical practitioners, i.e.
"quacks" play an active role in health care system. In this situation pharmaceutical promotion can
influence not only the use of a product, but also play an active role in our benefit of use of
medicines.. In India, like other countries, the promotional information of prescription drugs and
drugs sold without prescription (OTC-Drugs) is regulated by national legislation. Code of Ethics
for Advertisement of Drugs, is a guideline to regulate the promotion of prescription drugs as well
as OTC drugs marketed in India.

Considering the socio-economic condition in our country there is no way to avoid the situation of
self-medication which is now an important element in Indian health care systems.[2]
Pharmaceutical information is of persuasive value which induces consumers to purchase drugs.
Consumers, Naïve and uneducated consumers fall easy victims to unethical drug promotion
practices.

A health professional obtains information from commercial sources of different pharmaceutical

manufacturers through their sales professionals. Most of the time, pharmaceutical manufacturers
claim that their newly introduced formulation is superior in respect of therapeutic efficacy to the
existing formulation. Sales professionals produce their promotional documents and distribute the
free samples along with eye catching visual-aids to target the increase of sales. The health
professionals are initiated by such misleading documents and information to prescribe the
product without justifying their claims.

In our country, we can take the example of the "Baby Oil" controversy of one multinational
company and two big companies in Maharashtra. Finally, the drug authorities and the
manufacturer settled the matter by deleting the word ``baby''. In fact, advertisements commonly
contain misleading and inaccurate information in case of OTC drugs.[3]

In a literature search on promotional practices undertaken by the Forum for Medical Ethics
Society(FEMS), promotional practices have been grouped under three categories: information,
incentives and trading practices.[4]

Information
Doctors in developed countries have relatively better access to objective sources of information
to offset what the industry promotes. There is not much documentation on drug information
given to doctors in India. Most of the Indian articles deal with the accuracy of product
information as given by medical representatives, package inserts and advertisements in medical
journals. Drug advertisements in Indian medical journals contain less information on safety and
clinical pharmacology than their American and British counterparts do.

Gifts and incentives

Studies suggest that doctors hold a range of views about gifts. However, smaller gifts and those
useful in helping patients are more acceptable. Doctors readily accept gifts that are smaller and
socially more acceptable. But they have double standards, and would frown if a politician
accepted a similar gift. There was also a sense of ‘unique invulnerability’, that only ‘other’
doctors are influenced by gifts. Gifts from modest product samples to exotic cruises turn out to
be a good investment for the companies, which spend huge amount of money because they are
assured of returns. However, patients disapprove of gifts other than samples.

Trading practices
Internationally, it is well known that pharmaceutical firms have aggressive promotional tactics,
but such practices have not been documented within the Indian subcontinent, either from the
point of view of the strategies or the ethics of drug promotion. For example, people often get
medications directly from chemists and retailers, bypassing doctors altogether, and drug
companies exploit this link. The initial findings of the study seem to suggest that the doctor’s
prescription is not so powerful, after all, in the Indian drug market.

In India, at the moment only the Magic Remedies (Objectionable Advertisement) Act[5], 1954
deals with misleading promotion. It has only one relevant clause, Clause 4, on misleading
advertisements which: directly or indirectly gives false impression regarding the true character of
the drug; makes a false claim for the drug, or is otherwise false or misleading in any particular
material.

Where there is an irrational drug, then there is bound to be unethical promotion. Therefore, the
codes which deal with the promotion of drugs need to be looked into:
# International Federation of Pharmaceutical Manufacturers(IFPMA) code of Pharmaceutical
Marketing Practices- updated in 1994
# Criteria for medicinal drug promotion-prepared by World Health Organisation (WHO) in 1988
# Guidelines on IFPMA Code of Pharmaceutical Marketing Practices-prepared by OPPI.
# International Code on Pharmaceuticals-prepared by Health Action International (HAI)

The definition of 'promotion' is vital. WHO has stated, 'In this context, promotion refers to all
informational and persuasive activities by manufacturers and distributors, the effect of which is
to induce the prescription, supply, purchase and/or use of medicinal drugs.'

OPPI has ignored advertising through the electronic media, gifts, literature or display materials
given to wholesalers and chemists, the sponsoring of individuals to attend meetings/conferences,
etc.
The WHO criteria states that training must include updated and continuing training. The training
should also include ethical conduct including training on codes. Also, medical representatives
should not offer inducements to prescribers and dispensers, and prescribers and dispensers
should not solicit such inducements.

The code of conduct restricts many activities including those prescribed by legislation.
Following steps can be brought to ethical code of advertisement and promotion of drugs[6]:-
- Prescription medicine i.e., "Schedule-H drugs" cannot be promoted to the general public
- Manufacturer or traders cannot promote their product for indication that are not listed in the
approved product information.
- Pharmaceutical representative or sales personal cannot promote the product over telephone
unless the promotional material is marked urgent attention.
- Unsolicited reprint of journal articles must be consistent with the product information and the
word "safe" cannot be used unless it is substantiated.

On an analysis of the various laws applicable to the promotion of drugs and the current situation
prevailing, It can be concluded that the same is inadequate to deal with the maladministration of
drugs which is taking place in India and only a thorough review of the same can help in
countering this growing threat which is seemingly getting out of proportion.