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 License 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.

Cell or stem cell derived products e.g. such as stem cell-based regenerative treatments, 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. Xenografts are animal tissue-derived products such as heart valves which can be transplanted into humans. These have use in cardiology and orthopedics.

Since these technologies represent highly complex, specialised and rapidly evolving areas of medical science, they need enhanced regulatory scrutiny to ensure patient safety.

The inclusion of these products under the CLAA framework will facilitate a system of joint oversight by the Central and State Licensing Authorities (C/SLAs), thereby ensuring uniformity in regulatory standards across the country. The amendment will increase regulatory rigor for emerging technologies and reinforcing India's regulatory framework in line with scientific advancements and global best practices.

This initiative reflects the government's continued commitment towards safeguarding public health while promoting innovation and quicker adoption of latest technologies in healthcare and life sciences sectors.