The Department of Pharmaceuticals (DOP) has published a voluntary code of marketing practice (DOP code) to prevent Indian pharmaceutical companies from unethically marketing their medicines. The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI code), which is mandatory, has also been amended to restrict medical practitioners in their dealings with the pharmaceutical and allied health sector industry.
Although the DOP code is currently voluntary, if the DOP feels that pharmaceutical companies have not complied with the code, it may consider making the code statutory.
Some of the restrictions and guidelines set out in both the DOP code as well as the MCI code are highlighted below.
The DOP code says that medicines can only be promoted after a drug has been approved by the Drug Controller General of India. The information in the promotion must be accurate, fair, objective, verifiable, and must not be misleading. More importantly, the word “safe” should not be used without qualification. If the drug has been generally available in India for more than 12 months, then the term “new” should not be used.
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Comparisons made between medicines have to be factual, fair, capable of substantiation and should not mislead by distortion, by undue emphasis, omission or in any other way. It is mandatory for companies to include information on the authorization number, the name of the product, its ingredients, the recommended dosage and method of use and adverse reactions or warnings.
Most importantly, pharmaceutical companies are not allowed to give gifts, or to offer or supply any kind of pecuniary benefits to doctors. The free samples that are provided by companies must be supplied only to qualified professionals in response to a signed and dated request from the recipient. The DOP code also ensures that sponsorships and hospitality provided to doctors for medical events and conferences strictly adhere only to the main purpose of the conference and do not support any other leisure or entertainment events which the doctors might attend. Pharmaceutical companies are made responsible for the activities of their employees including medical representatives in the event of any non-compliance by them under the DOP code.
The DOP code also lays down a transparent mechanism to handle complaints under the code by asking each association of pharmaceutical companies to form a “committee for pharmaceutical marketing practices”, to handle all the complaints received by them.
The MCI code has been amended 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 amendment states that a medical practitioner is not allowed to accept any gifts in any form, whether they are monetary or not. Medical companies cannot sponsor any travel facilities inside or outside the country by any means, including rail, air, or ship cruise tickets.
Moreover, any grants or donations for genuine purposes like medical research and study can only be obtained from authorized institutions in a transparent manner. Finally, no medical practitioner is allowed to endorse any product or drug publicly.
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The legislative and regulatory update is compiled by Nishith Desai Associates, a Mumbai-based law firm. The authors can be contacted at nishith@nishithdesai.com. Readers should not act on the basis of this information without seeking professional legal advice.
