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.

In this episode, Dr. Milind Antani, head of the pharmaceutical and life sciences practice at NDA, provides an overview of the pharmaceutical and medical device industry in India. India has a well-established and predictable pharmaceutical and medical device regulatory framework. The clinical trials, manufacture and sale of drugs and medical devices have been regulated under the same parent legislation since 1940, which has been amended from time to time as necessary. Additionally, various ancillary legislations also apply to the drug and medical device industry which regulate the advertisement, marketing and pricing of drugs. In recent times, digital health and med-tech is also slowly being regulated as India has started to adopt digital health technologies to increase the quality and reach of healthcare services. Dr. Antani provides an overview of these and various other subjects intended to be covered during the course of the podcast series, including:

• Manufacture, import and sale of drugs (including vaccines and biologics) and medical devices.

• Advertisement and marketing of drugs and medical devices.

• The nature and process of drug price regulation.

• Intellectual property issues in the pharmaceutical and medical device industry.

• Importance of digital health technologies such as telemedicine and online pharmacies, and other emerging technologies in the healthcare sector.

• An overview of healthcare law and policy in India including the way forward.

Listen to Dr. Milind Antani's introduction below.

The first episode of the podcast can be downloaded here.