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 addition to common digital health tools such as e-pharmacies and telemedicine, India’s private sector is increasingly looking into emerging health-tech such as AI and 3D Printing. While these technologies are not specifically regulated as of yet, there is an ad-hoc regulatory framework that applies to them. 

At present, the biggest hurdle to the adoption of AI for healthcare purposes is the lack of infrastructure to maintain electronic health records. Nonetheless, there also various initiatives in the pipeline to increase the adoption of digital health technologies in general. 

In this podcast, Darren Punnen discusses the challenges in making AI and 3D Printing enabled tech a reality in India and the steps taken so far to overcome those challenges. This includes an in-depth discussion of the various digital health policies sought to be implemented in India and the impact of such policies. 

Darren also covers the scope and potential of 3D Printing in India, including the different applications this technology may have in the manufacturing of personalised medicine and medical devices. 

The podcast specifically covers:

• The potential for AI in India and the hurdles towards AI becoming a reality in India. 

• The need for adopting electronic health records in India. 

• The initiatives taken by the government to encourage the adoption of digital health technologies in India e.g. National Health Stack and the National Digital Health Blueprint. 

• The regulation of 3D Printing under India’s existing drug and medical device regulatory framework.