Center amends Drugs Rules, 1945 to ensure uniform regulation of advanced cell and gene therapy

To strengthen regulatory oversight of advanced and emerging medical technologies, the central government amended the Drugs Rules of 1945 to bring stem cell-derived products, gene therapy products and xenografts under the purview of the Central Licensing Authority (CLAA).

Under the Drugs and Cosmetics Act, certain specified categories of critical drugs and biological products are under the joint regulatory oversight of central and state regulators. These include vaccines, large-volume parenterals (IV solutions > 100 mL), and r-DNA-based drugs. This set is being expanded by this amendment to cover other emerging technologies, the ministry said in a release on Thursday (July 2, 2026).

Cellular or stem cell-derived products, such as stem cell-based regenerative treatments and CAR-T cell therapies, have seen increasing use in the treatment of blood cancers such as leukemias and lymphomas.

Gene therapy products, such as gene replacement and gene editing products, have found applications in the treatment of genetic disorders and various types of cancer. Xenografts are products derived from animal tissue, such as heart valves, that can be transplanted into humans. They are used in cardiology and orthopedics.

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As these technologies represent highly complex, specialized and rapidly developing areas of medical science, they need increased regulatory scrutiny to ensure patient safety, the ministry added.

“The inclusion of these products under the CLAA framework will facilitate a system of joint oversight by central and state licensing authorities, thereby ensuring uniformity in regulatory norms across the country. The amendment will enhance regulatory rigor for emerging technologies and strengthen India’s regulatory framework in line with scientific progress and global best practices,” the ministry said in a statement.

Published – 02 Jul 2026 23:33 IST