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: Direct to consumer advertisements of drugs and medical devices are heavily regulated in India. While not completely prohibited, the regulation places restrictions on the diseases/disorders in respect of which advertisements may be made and the claims that such advertisements may make. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRA) is the primary legislation regulating the advertisements of drugs and medical devices in India. The DMRA has been rarely amended since its enactment in 1954 and is therefore losing relevance. While certain amendments have been proposed to the law, they do too little too late. 

In addition to the DMRA, the drug general drug regulatory framework i.e. the Drugs and Cosmetics Act, 1940 (D&C Act) also places restrictions on the advertisements of drugs.  In this podcast, Shreya Shenolikar simplifies the drug advertisement framework and covers the following:

• A brief overview of the DMRA i.e. the primary regulatory framework governing drug and medical device marketing.

• The types of diseases in respect of which advertisements may not be made.

• The manner in which advertisements claims may be made in respect of drugs and medical devices. 

• Proposed changes in the drug advertisement regulation.

• The restrictions on drug and medical device marketing under the D&C Act.

• The importance of relaxing the regulatory framework to help patients make informed decisions. 

• Recommendations in which the regulatory framework should be amended that ensures drug advertisements are accurate.