Centre amends Drugs Rules, 1945 to ensure uniform regulation of advanced cell and gene therapies

The Central Government has amended the Drugs Rules, 1945 to bring cell or stem cell-derived products, gene therapeutic products and xenografts under the ambit of the Centrally Licence Approving Authority (CLAA) framework, marking a significant regulatory step towards strengthening oversight of advanced therapies and emerging medical technologies.

The amendment expands the list of products that require joint oversight by the Central and State licensing authorities, ensuring uniform regulatory standards for complex biological products across the country. Until now, the CLAA framework covered specified categories such as vaccines, recombinant DNA (r-DNA)-based medicines and large-volume parenterals exceeding 100 ml.

With the latest amendment, advanced therapies including stem cell-based regenerative treatments, gene therapies and xenografts will now also be subject to central licensing approval alongside state-level regulation.

According to the government, the move is aimed at enhancing regulatory scrutiny of rapidly evolving technologies that are increasingly being used in the treatment of complex diseases.

Cell or stem cell-derived products, including CAR-T cell therapies, have emerged as promising treatment options for blood cancers such as leukaemia and lymphoma. Gene therapeutic products, including gene replacement and gene-editing therapies, are being developed for the treatment of inherited genetic disorders and several types of cancers. Xenografts, which involve the transplantation of animal tissue-derived products such as heart valves into humans, have found applications in cardiology and orthopaedics.

Given the complexity and specialised nature of these therapies, the government said enhanced regulatory oversight is necessary to ensure patient safety while supporting the adoption of innovative treatment modalities.

The inclusion of these products under the CLAA framework is expected to facilitate coordinated regulation between the Central and State Licensing Authorities, leading to greater consistency in licensing decisions and regulatory compliance across the country. The government said the amendment would strengthen India’s regulatory framework for emerging healthcare technologies while aligning it with evolving scientific developments and global best practices.

The move comes as India witnesses growing research and clinical interest in advanced therapy medicinal products, particularly in areas such as regenerative medicine, cell and gene therapies, and precision medicine. By bringing these products under a centralised licensing mechanism, regulators aim to ensure that quality, safety and efficacy standards keep pace with technological advancements.

The amendment also underscores the government’s broader efforts to modernise the country’s regulatory ecosystem to support innovation without compromising patient safety. Officials said the initiative reflects the government’s commitment to fostering the development and adoption of advanced healthcare technologies while maintaining robust regulatory safeguards.