Central drug regulator creating guidelines for gene therapies, biosimilars: DCGI
Live MintMUMBAI : The Central Drugs Standard Control Organisation 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 Rajeev Raghuvanshi said on Thursday. Raghuvanshi, who was speaking on the sidelines of the Indian Pharmaceutical Alliance’s 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. “You have to give us that opportunity to free up our bandwidth from these operational issues where, at one extreme, we struggle to make people understand how to make paracetamol," Raghuvanshi said. The regulator has earmarked an expenditure of ₹100 crore to develop a digital drug regulatory system, “which would encompass the whole regulatory value chain…bring in every state, manufacturing unit, sales unit…our partner agencies like customs, GST, etc," Raghuvanshi said.
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