Central drug regulator creating guidelines for gene therapies, biosimilars: DCGI

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Subscribe to enjoy similar stories. MUMBAI : 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 Department of Biotechnology and Indian Council of Medical Research. So, for cell and gene therapy, we are creating regulator’s guidance…how to develop, how to get approval, etc," he said.

This is likely to be out in two months, he added. For biosimilars, the CDSCO is updating the regulatory framework since it first came out in 2018, to align it with global standards. Cell and gene therapies, which involve the transfer of genetic material or cells into a patient for treatment, have been on the rise in India.

So far, the regulator has two approved CAR-T cell therapies, used to treat certain types of cancers. “There are many more in the pipeline, being reviewed," Raghuvanshi said. The regulator has been working on fixing operational issues, including easing exports and setting up a digital system.