Direct To Consumer Advertising Of Medicines And Medical Devices — A Call For Action!

Dr Milind Antani, Anay Shukla and Darren Punnen from Nishith Desai Associates, give an insight on the scope of laws that regulate direct to patient advertising in India.

Direct-to-Consumer(DTC) advertising is key to any business. However, DTC advertising has always been a challenge for pharmaceutical and medical device companies in India. Any marketing professional from either of these industries, will admit that there is an instinctive hesitation to advertise medicines and medical devices before the end consumers. This begs for the question - what is the basis of this hesitation? Do laws in India stop DTC advertising of medicines and medical devices? In the paragraphs below, we have explored the scope of laws that regulate direct to patient advertising in India.

In India, the business of medicines is regulated by the Drug and Cosmetics Act, 1940 (DCA) and the Drugs and Cosmetics Rules, 1945 (DCR). Until 2015, the DCA and DCR did not regulate DTC advertising except for the content that appeared on the label of the product. The DCR now prohibits the manufacturers of medicines identified in Schedule H, H1 and X of the DCR from indulging in any form of advertisement. The language used to prohibit DTC advertising makes it amply clear that ‘public interest’ is not a cushion any longer to advertise medicines.

Unfortunately, the language of the prohibition under the DCR sheds no light on the following crucial aspects of DTC advertising:

1. What is the scope of the expression ‘advertisement’? Does spreading knowledge and awareness of facts such as the results of successful clinical trials before patients amounts to an advertisement? Do patient testimonials constitute an advertisement? Can the presence of facts and testimonials on the global website of a pharmaceutical company amount to an advertisement of the drug in India?