Government brings stem cell, gene therapies under Central licensing ambit

2 min readNew DelhiUpdated: Jul 3, 2026 06:04 AM IST

Xenografts are animal tissue-derived products, such as heart valves, which are being used in cardiology.(Credit: Unsplash)

The Central government on Thursday amended the Drugs Rules, 1945, bringing stem cell derived products, gene therapeutic products and xenografts under the ambit of the Centrally Licensed Approving Authority (CLAA) framework to enhance regulatory oversight of new and emerging therapies.

Under the Drugs and Cosmetics Act, certain drugs and biological products are under joint regulatory supervision of the Central and State regulators. These include vaccines, large volume parenterals and r-DNA based medicines.

With this amendment, this set is being expanded to cover additional emerging technologies, the health ministry said in a statement.

Cell and genetic therapies are complex and rapidly evolving fields with several cutting-edge cancer treatments, including the Chimeric Antigen Receptor T-cell therapy (CAR-T). With high costs of the patented therapies, many Indian companies are making their own immunotherapy to treat blood cancer.

Genetic therapies are used to treat genetic disorders and various types of cancers. Xenografts are animal tissue-derived products, such as heart valves, which are being used in cardiology.

“Since these technologies represent highly complex, specialized and rapidly evolving areas of medical science, they need enhanced regulatory scrutiny to ensure patient safety,” the health ministry said in a statement. This will help in quicker adoption of newer technologies, it said.