India tightens regulatory oversight for advanced cell and gene therapies

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. This move aims to strengthen regulatory oversight of advanced and emerging medical technologies.

Under the Drugs and Cosmetics Act, certain critical drugs and biological products—such as vaccines, large volume parenterals (IV solutions over 100 ml), and r-DNA based medicines—are jointly regulated by central and state authorities. The amendment expands this list to cover additional emerging technologies, according to a Ministry release issued on July 2, 2026.

Cell or stem cell-derived products, including stem cell-based regenerative treatments and CAR-T cell therapies, have seen increased use in treating blood cancers like leukemias and lymphomas. Gene therapeutic products, such as gene replacement and gene-editing therapies, are used for genetic disorders and various cancers. Xenografts—animal tissue-derived products like heart valves—are used in cardiology and orthopedics for transplantation into humans.

The Ministry stated that these technologies are highly complex, specialised, and rapidly evolving, requiring enhanced regulatory scrutiny to ensure patient safety. Including these products under the CLAA framework will establish a system of joint oversight by central and state licensing authorities, ensuring uniform regulatory standards across the country. The amendment increases regulatory rigour for emerging technologies and aligns India's regulatory framework with scientific advancements and global best practices.