April 14, 2016

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Pharmaceutical Industry And Self-Regulation

- Vineet Chaudhary, Sr. Manager – Legal [ Wockhardt Ltd ]


The amended MCI regulations for doctors coupled with notified DOP Code for the entire pharmaceutical industry should make financial transactional relationship between physicians and the pharmaceutical industry in India clean and transparent

The Indian pharmaceutical industry has been witnessing remarkable growth over the past few years. It currently tops the charts amongst India's science-based industries with large ranging capabilities in the complex field of drug manufacture and technology. A highly organised sector, the Indian pharmaceutical industry is estimated to be worth $4.5 billion, growing at about 8 to 9 percent annually.

India is now among the five pharmaceutical emerging markets. There will be new drug launches, new drug filings, and Phase II clinic trials which are expected in the upcoming years. The domestic pharmaceutical market is expected to register a strong double-digit growth of 13-14 per cent in the coming times. Due to rapid growth of the pharmaceutical industry, marketing has also become an important determinant of the survival and growth of various pharmaceutical companies, amidst increasing competition faced by them.

In the present article, we enlist the key features and efficacy of statutes and various codes regulating the Indian Pharmaceuticals Marketing Practices.

Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954

Advertisements of drugs and pharmaceuticals should ideally be strictly regulated and the legislation should not allow advertisement of prescription medicines in any form in any kind of media. However, apart from restraint on advertising of prescription drugs, and making claims to provide prevention or cures of certain diseases under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, there are as such no legal constraints on advertising. The Act basically prohibits advertisements about diagnosis, cure, mitigation or prevention of 54 diseases and listed disorders such as cancer, diabetes, epilepsy, leucoderma, paralysis, sexual impotence etc. However, as a matter of fact, in the present scenario, the law is somewhat out modelled and outdated. While it prohibits misleading health claims in the print media, it has no provision to tackle the advertisements that may appear on television or internet. The billboards in Delhi, the local train railway compartments in Mumbai, advertisement pages of newspapers and now, electronic media are in constant breach of the Act. As such, there is an immediate need not only to formulate a strict law but also for strict vigil on the various claims made by unscrupulous practitioners about their claims for curing different ailments and punish defaulters accordingly.

Uniform Code Of Pharmaceuticals' Marketing Practices

Keeping in view growth of the pharmaceutical sector and with the intention to provide a uniform code with respect to pharmaceutical marketing practices, a uniform code of Pharmaceuticals marketing practices ("DOP Code") has been introduced by the Department of Pharmaceuticals, Government of India, on December 12, 2014, which became effective from 1 January, 2015. It is expected to encourage good marketing practices by pharmaceutical companies. This DOP Code prohibits companies from paying cash or monetary incentives to any healthcare professional under any pretext and restricts pharmaceutical companies from providing free samples of drugs to any person, not qualified to prescribe such product.

It has been described in the DOP Code that the information about medicinal products must be accurate, balanced, fair, and objective and also must not mislead either directly or by implication. It is necessary to declare clear information about medicinal products because it may somehow cause danger to consumers. Pharmaceutical companies are not allowed to use brand names of products of other companies in comparison unless the prior consent of companies concerned has been obtained. All the adverse reactions and precautions for use of all medicinal products must be mentioned so as to protect the consumers from any danger that the product can cause.

Further, as per the DOP Code, the basic ingredients are very important to be mentioned on all the products with all the do's and don'ts on it. The DOP Code declares that the entire medicinal product shall consist of the date of manufacturing of the product and also the date of expiration so that the public is aware of when to and when not to consume the product.

Promotional material such as mailings and journal advertisements of the medicinal products are not allowed to be designed as they disguise their real nature. If the pharmaceutical company pays for or otherwise secures or arranges the publication of promotional material in journals, the material must not match the editorial matter. The promotional material should not contain the names or photographs of healthcare professionals. Advertisement of the product is allowed but the companies should anyway try not to mislead the public. The free samples of medicinal products shall not be supplied to any person who is not qualified to prescribe such product. It must be supplied directly to a person qualified to prescribe such product or to a person authorised to receive the sample on their behalf. The person qualified to prescribe such product must be experienced in dealing with that kind of product. A person shall not supply a sample of a medicinal product which is an anti-depressant, hypnotic, sedative or tranquilliser.

All the Indian Pharmaceutical Manufacturer Associations are under obligation to upload the Code on their websites. All the details as how the complaint shall be lodged should also be declared on the website. The present status of the complaint and what action has been taken on the complaint should remain uploaded for three years.

The Code also provides that in case a pharmaceutical company is not member of any association or member of more than one association, in such cases, the complaint shall be handled by the Pharma Industry Association to whom the complainant has addressed the complaint.

Every association is required to have a committee for handling complaint named as "Ethics Committee for Pharma Marketing Practices (ECPMP)" which shall consist of 3 members. The Code also provides provision of a review committee for handling the review of decisions of ECPMP and such committee is named as Apex Ethics Committee for Pharma Marketing Practices (AECPMP) which shall consist of 5 members. The complaints that are lodged must be in writing and also the Complainant should identify himself, identify the company, give the details of breach of code, and also supporting evidence.

Code of Pharmaceutical Marketing Practices by OPPI

The Organization of Pharmaceutical Producers of India had issued a Code of Pharmaceutical Marketing Practices 2010 (the "OPPI Code"). The OPPI Code has set out specific standards for the promotion of pharmaceutical products ethically to doctors. It is based on the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code that has been in practice for the last two decades. However, the OPPI Code is a matter of self-regulation and self-discipline on the part of member companies.

Medical Council (Professional Conduct, Etiquette and Ethics) Regulations

Specific provisions relating to restrictions on benefits to be procured by doctors have also been incorporated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Code). Registered medical practitioners in India are required to adhere to the MCI Code, issued by the Medical Council of India, under the provisions of section 20A read with section 33(m) of the Indian Medical Council Act, 1956. In a recent amendment, the MCI Code has put restrictions on doctors in their dealings with the pharmaceutical and allied health sector industry. The Medical Council of India has amended the MCI Code to include specific restrictive provisions for doctors and professional associations of doctors in their relationship with the pharmaceutical and the allied health sector industry. The MCI Code has imposed the following restrictions on doctors:

  • A medical practitioner shall not receive any gift from any pharmaceutical or allied healthcare industry and their sales people or representatives;
  • A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme etc. as a delegate;
  • A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext;
  • A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purposes in individual capacity under any pretext. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed;
  • A medical practitioner may carry out, participate in or work on research projects funded by pharmaceutical and allied healthcare industries, after taking necessary clearances and fulfilling certain conditions;
  • A medical practitioner shall not endorse any drug or product of the industry publicly.

In case of violation of these provisions by the medical practitioners, the MCI Code provides for disciplinary action. In the recent past, in view of the restrictions imposed, a practice of entering into consultancy arrangements with pharmaceutical companies has developed. Under the MCI Code, a medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacity.

At present, the DOP Code is voluntary, but the MCI Code is mandatory. After six months, if the DOP Code is incorporated as a statutory code, then pharma companies are likely to face prosecution or penalties in case of violation. A review of the global practices seems to indicate that in some respects, the DOP Code and the MCI Code may be more restrictive than the codes / regulations in other jurisdictions. However, there are certain other aspects that are covered in other jurisdictions that are still not covered in the Indian codes. Further, some of the provisions under the MCI Code are more onerous than that of the DOP Code. E.g., while the DOP Code permits companies to provide assistance for travel and events within India, the MCI Code prohibits doctors from accepting the same. Hence, the government should, once again, take a look at both the codes, and re-align the same for more cohesive implementation.


In all countries and India is no exception, pharmaceutical companies, by and large, have been articulating that they try to follow the legal ways and means to maximise turnover of their respective brands. Many of them do follow transparent and admirable stringent self-regulations, stipulated either by themselves or by their industry associations.

'Self-regulation with pharmaceutical marketing practices' and 'voluntary disclosure of payment to the physicians' by some leading global pharmaceutical companies are laudable steps to address this vexing issue. However, the moot question still remains, are all these good enough for the entire industry in India?

The amended MCI regulations for the doctors coupled with the notified DOP Code for the entire pharmaceutical industry should make the financial transactional relationship between the physicians and the pharmaceutical industry in India clean and transparent.

The popular dictum, especially used by the healthcare industry, "patients' interest comes first", should not be misused or abused by some unscrupulous elements and greedy profiteers, to squeeze out even the last drop of financial resource from the long exploited population of ailing patients.

Disclaimer - The views expressed in this article are the personal views of the author and are purely informative in nature.

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