lawyers in India

Unethical Drug Promotion - Drug laws - International Code on Pharma

Written by: Shubhang Setlur - 2nd Year Law Student of Gujarat National Law University
Patent Law in India
Legal Service
  • 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, Na´ve 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]

    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.

    [1] (13th March 2007)
    [2] (13th march 2007)
    [3] Supra Note 2
    [5] (13th march 2007)
    [6] Ibid

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