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: India has been increasingly focusing on adopting digital health technologies to increase access to healthcare. Telemedicine and online pharmacies are the most prominent examples of digital health technologies that have become ubiquitous in Indian society. In this podcast, Darren Punnen discusses the exponential growth of online pharmacies and telemedicine in India. He covers the reasons for the success of the digital health industry in India and deals with how digital health tools can be used to increase the access to and quality of healthcare service delivery in India. 

Darren also covers in detail the regulation applicable to e-pharmacies (and the controversy surrounding such regulation) as well as the Telemedicine Practice Guidelines (TPG) which were notified in March of 2020 in light of the COVID-19 pandemic.  More specifically, the podcast covers:

• How online pharmacies and telemedicine is defined in India. 

• The importance of online pharmacies and telemedicine in the Indian context.

• An overview of India’s data protection regulatory framework as generally applicable to digital health technologies. 

• The lead up to the enactment of the TPG and how the COVID-19 pandemic sped up the adoption of digital health technologies in India. 

• An overview of the TPG and the improvements that can be made in future editions of the guidelines.   

• The controversy surrounding online pharmacies in India and the steps taken so far to regulate the space.