Govt expands central licensing rules to cover gene and stem cell therapies
New Delhi, July 2 (IANS/WISHAVWARTA) The Central Government has amended the Drugs Rules, 1945 to bring cell or stem cell derived products, gene therapeutic products and xenografts under the Centrally License Approving Authority framework, a statement said on Thursday, adding that the move strengthens the regulatory oversight of advanced and emerging medical technologies.
The move expands the set of critical drugs and biological products that receive joint regulatory supervision by central and state authorities under the Drugs and Cosmetics Act, which already covers vaccines, large‑volume parenterals and r‑DNA based medicines.
Through the new amendment the government expanded the Centrally License Approving Authority (CLAA) Framework to include Cell and Stem Cell-derived Products, gene therapeutics and xenografts.
The amendment aims to ensure uniformity in regulatory standards nationwide for rapidly evolving medical technologies, the statement from the Ministry of Health and Family Welfare said.
The amendment will increase regulatory rigour for emerging technologies and reinforcing India’s regulatory framework in line with scientific advancements and global best practices, the ministry said.
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 are used 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 used in cardiology and orthopedics.
As these technologies represent highly complex, specialized and rapidly evolving areas of medical science, they need enhanced regulatory scrutiny to ensure patient safety, the ministry said.
“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,” the statement noted.
