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Introduction to the Pharma & Healthcare Podcast Series [PODCAST]

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.

Nishith Desai Associates 2023. All rights reserved.National Law Review, Volume X, Number 353

About this Author

Dr. Milind Antani Lawyer Nishith Desai Assoc. India-centric Global Law Firm

Dr. Milind Antani, a renowned surgeon turned lawyer, leads the Pharma & Healthcare practice at multi-skilled, research-based international law firm, Nishith Desai Associates where he represents high net-worth clients in matters allied to JVs, M&As, VC and Private Equity investments, Collaborations, Regulatory advice, IP, Licensing and Commercialization. He also leads the Social Sector Practice and represents various global and national foundations in India. He continues as an active participant in helping frame national policies on key impact areas, within the...

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