Drugs Rules, 1945 Amended for Central Licensing of Stem Cell and Gene Therapies

Key facts

• The Central Government amended the Drugs Rules, 1945 to bring cell or stem cell derived products, gene therapeutic products, and xenografts under the Centrally License Approving Authority (CLAA) framework.
• The amendment was announced by the Ministry of Health and Family Welfare (MoHFW) to ensure uniformity in regulatory standards nationwide for evolving medical technologies.
• The Drugs and Cosmetics Act already provides joint regulatory supervision by central and state authorities for vaccines, large-volume parenterals, and r-DNA based medicines.
• Cell or stem cell derived products, such as stem cell-based regenerative treatments and CAR-T cell therapies, are used in the treatment of blood cancers including leukemias and lymphomas.
• Gene therapeutic products include gene replacement and gene editing products for genetic disorders and cancers, while xenografts are animal tissue-derived products, such as heart valves, used in cardiology and orthopedics.