Centre amends Drugs Rules, 1945 to ensure uniform regulation of advance cell and gene therapies
The Hindu – National
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Subscribed with another email? Logout and Login with that one. Account subscription benefits alongside Premium Stories, Editorials, Opinions and more. Unlock these with Subscription Updated - July 02, 2026 11:34 pm IST - NEW DELHI Aimed at strengthening regulatory oversight of advanced and emerging medical technologies, the Central government has amended the Drugs Rules, 1945 to bring stem cell derived products, gene therapeutic products, and xenografts under the ambit of the Centrally Licence Approving Authority (CLAA) framework. Under the Drugs and Cosmetics Act, certain specified categories of critical drugs and biological products are under the joint regulatory supervision of the Central and State regulators. These include vaccines, large volume parenterals (IV solutions > 100 ml) and r-DNA based medicines. This set is being expanded with this amendment to cover additional emerging technologies, said a release issued by the Ministry on Thursday (July 2, 2026). Cell or stem cell-derived products such as stem cell-based regenerative treatments and CAR-T cell therapies have seen increasing use in treatment of blood cancers such as leukemias and lymphomas. Gene therapeutic products such as gene replacement and gene-editing products have found use in treating genetic disorders and various types of cancers. The amendment will increase regulatory rigour for emerging technologies and reinforcing India’s regulatory framework in line with scientific advancements and global best practices,’’ the Ministry said in its statement.
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Cell or stem cell-derived products such as stem cell-based regenerative treatments and CAR-T cell therapies have seen increasing use in treatment of blood cancers such as leukemias and lymphomas; the Centre’s move is aimed at strengthening regulatory oversight of such advanced and emerging medical technologies
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