Series Introduction: 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: In this podcast, Darren Punnen, senior member of the pharmaceutical and lifesciences practice at NDA, provides an overview of how every aspect of the pharmaceutical and medical device industry is regulated. This includes the clinical trial, manufacture, import, packaging and sale of medical devices. He also covers ancillary drug regulation such as the drug price control legislation, the drug advertisement legislation and the regulations applicable to healthcare practitioner in so far as they impact pharmaceutical and medical device companies. Some of the legislations covered include:

• Drugs and Cosmetics Act, 1940 which governs the clinical trial, import, manufacture, labelling and sale of drugs and medical devices.

• The Legal Metrology (Packaged Commodities) Rules, 2011 which govern the labelling of medical devices.

• Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 which regulates the marketing of drugs and medical devices.

• The Uniform Code of Pharmaceutical Marketing Practices which regulates the manner in which pharmaceutical and medical device companies may market their products to healthcare practitioners.

• The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 which regulates how allopathic practitioners interact with pharmaceutical and medical device companies.

• Drugs (Prices Control) Order, 2013 which regulates drug pricing.

• Proposed legislation to regulate digital health technologies in India.

Darren also provides a brief overview of the enforcement authorities responsible for administering the above-mentioned legislations.