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

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.

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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.

Operational fixes

The regulator has been working on fixing operational issues, including easing exports and setting up a digital system.

Raghuvanshi, who got an extension of one year to his tenure as DCGI starting 28 February, emphasised that these need to be fixed so the regulator can focus on new innovation-led technologies.

“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.

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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.

“It is in the final phases of [government] approvals, then we will float the tender,” Raghuvanshi said, adding that it could take two years to roll this out.

The regulator is also considering easing export no-objection certificates (NOCs) and test licences, he said. This would ease the administrative burden on the department.

"I am giving NOCs for making this product for this [specific] customer and this quantity only. If the same customer gives a repeat order, you have to come again and apply again…now we are changing it based on history…suppose in one year you have exported 10 crore tablets. I will give you a blanket NOC for 10 crore tablets, not specific to a customer,” he said.

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This would reduce the number of NOCs issued from an estimated 15,000 annually to less than 5,000, the DCGI said.