India plans strict rules for gene therapy

India plans to bring the new generation of medical treatments involving gene and stem cell therapies under strict governmental control as the market for such treatments grows.

- Priyanka Sharma

The changes are aimed at amending the law to cover therapies like products derived from stem cells, gene therapy and xenografts

The proposed changes are aimed at amending the law to cover therapies such as products derived from stem cells, gene therapy, and xenografts (animal-to-human transplants), according to documents reviewed by Mint.

This will bring manufacturing and licensing of these complex therapies under regulatory processes, ensuring the safety and quality of these cutting-edge biological products, two officials aware of the matter said as the draft is not public yet.