Mumbai, Feb. 27 -- The Central Drugs Standard Control Organisation (CDSCO) is in the process of creating guidelines to regulate cell and gene therapies and upgrading the framework to regulate biosimilars, as the Indian industry moves towards innovations in the space, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said on Thursday.

Raghuvanshi, who was speaking on the sidelines of the Indian Pharmaceutical Alliance's (IPA) Global Pharmaceutical Quality Summit 2025, said that while the country's top drug regulator had been focusing on operational efficiency, it's also looking closely at newer areas.

"CDSCO currently does not have guidance for cell and gene therapies. The applicants work on guidance which is issued by the Depa...