New Delhi: The Centre has amended the Drugs Rules, 1945 to bring advanced cell and stem cell-derived products, gene therapies and xenografts under the Centrally License Approving Authority (CLAA) framework, strengthening regulatory oversight of emerging medical technologies.
The Ministry of Health and Family Welfare said the move aims to ensure uniform regulation of cutting-edge therapies across the country through joint supervision by Central and State drug regulators.
The expanded CLAA framework will now cover stem cell-based regenerative therapies, CAR-T cell treatments for blood cancers, gene replacement and gene-editing therapies for genetic disorders and cancers, as well as xenografts, including animal tissue-derived products such as heart valves used in cardiology and orthopaedics.
The government said these rapidly evolving technologies require enhanced regulatory scrutiny because of their complexity and specialised nature. Bringing them under the CLAA framework will help maintain uniform safety and quality standards nationwide while aligning India’s regulatory system with global best practices.
According to the ministry, the amendment strengthens patient safety, promotes responsible adoption of advanced medical technologies and reinforces India’s regulatory framework as innovation in healthcare and life sciences accelerates.
The revised rules expand the list of products already regulated under the CLAA framework, which includes vaccines, large-volume intravenous solutions and recombinant DNA-based medicines.
