Dr. Milind Antani, Darren Punnen and Shreya Shenolikar of Nishith Desai Associates have analysed the key regulations applicable to the Indian pharma, medical device and health-tech industry in a multi-part podcast series. The series starts off with the basics of pharmaceutical and medical device regulation and subsequently delves deeper into the regulation of various aspects of the industry. Each episode begins with an overview of applicable regulation, how the regulation applies to the industry and ends by providing some practical inputs on how stakeholders should approach this space. 

Episode Introduction: As with all jurisdictions, India also struggles to ensure that ethical marketing practices are followed by pharmaceutical and medical device companies when promoting their products to healthcare practitioners. While the restrictions on promoting to healthcare practitioners are not as narrow as those for direct-to-consumer advertisements, there are some general guidelines that advertisers are required to follow. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRA) is the primary legislation that governs the advertisements of drugs and medical devices in India. The DMRA applies to both advertisements made to the general public as well as healthcare practitioners. For guidelines on marketing to healthcare practitioners, one must look to the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). The UCPMP is a voluntary code of conduct to be adhered to by pharmaceutical companies and enforced by industry associations. 

As a corollary to the above, there are restrictions on healthcare practitioners under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 against accepting gifts, travel facilities, hospitality, cash and monetary grants from pharmaceutical and medical device manufacturers and suppliers.

In this podcast, Darren Punnen deals with regulatory framework applicable to promotion of drugs to healthcare practitioners. More specifically, he covers:

• The rules and guidelines applicable to marketing drugs and medical devices, including the DMRA and the UCPMP.

• The rules and guidelines applicable to healthcare practitioners vis-à-vis marketing of drugs and medical devices. 

• Permissible ways to market drugs and medical devices to healthcare practitioners. 

• Special restrictions on marketing to healthcare practitioners affiliated with government institutions.