Codes to curtail unethical means of drug marketing

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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.

Labelling_medicine_bottleSome 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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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.

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