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India Inc Calls For Regulatory Easing; Looks To Biosimilar Launches Including Keytruda

 
• By Vibha Ravi

Speaking of an impending launch of new biosimilars, including pembrolizumab, panelists at a recent event in India asked for regulatory easing from a waiver of Phase III trials for biosimilars to a single body for pre-clinical and trial approvals. The chicken and egg question of VC funding also came up.

IPA 2024 Summit Patient Needs Panel
Left To Right - Ratnesh Jain, MD, Mumbai Biocluster; Ravi Shankara, Sr GM, Sun Pharma; Dhananjay Patankar, former VP, Syngene; Sanjeev Gupta, Sr VP Ipca Labs • Source: Scrip/Citeline

While India has played a salutary role in lowering cost of medicines across the world with generics, it’s time to move on to the next stage of development and that will require an easing of clinical development norms and simplification of regulatory procedures, India Inc feels.

From a waiver of Phase III trials for biosimilars to simplification of regulatory processes for cell and gene therapy development, executives from leading Indian firms Sun Pharmaceutical Industries Ltd

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