By: IPP Bureau
Last updated : July 03, 2026 7:24 am
The move expands the list of critical drugs and biological products subject to joint regulation by the Central and State licensing authorities
The Central Government has amended the Drugs Rules, 1945 to bring cell and stem cell-derived products, gene therapeutic products, and xenografts under the Centrally License Approving Authority (CLAA) framework, strengthening regulatory oversight of advanced and emerging medical technologies.
The move expands the list of critical drugs and biological products subject to joint regulation by the Central and State licensing authorities. Until now, the CLAA framework covered products such as vaccines, large-volume parenterals and recombinant DNA (r-DNA)-based medicines.
The amendment extends this oversight to next-generation therapies, including stem cell-based regenerative medicines, CAR-T cell therapies for blood cancers, gene replacement and gene-editing therapies for genetic disorders and cancer, and xenografts, such as animal tissue-derived heart valves and orthopedic implants used in human transplantation.
According to the government, these products represent highly specialized and rapidly evolving areas of medical science that require enhanced regulatory scrutiny to ensure patient safety and product quality.
Bringing these therapies under the CLAA framework will enable uniform regulatory standards across the country through joint oversight by the Central and State licensing authorities.
The amendment is expected to strengthen India's regulatory framework, align it with global best practices, and facilitate the safe adoption of cutting-edge healthcare technologies.
The government said the initiative reflects its commitment to safeguarding public health while promoting innovation and accelerating the adoption of advanced therapies in India's healthcare and life sciences sectors.