Centre Amends Drugs Rules, 1945 to Ensure Uniform Regulation of Advanced Cell and Gene Therapies
In a significant step towards strengthening the regulatory oversight of advanced and emerging medical technologies, 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 fou...