Advanced Therapies Under Centrally Licensed Approving Authority (CLAA) Context: The Central government 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. Objective: To strengthen regulatory oversight of advanced and emerging medical technologies by ensuring uniform regulation across the country through the Centrally Licensed Approving Authority (CLAA) framework. Expansion of Regulatory Scope Stem cell-derived products: Regenerative medicine products, including CAR-T cell therapies used for treating leukaemias and lymphomas, have now been brought under the CLAA framework. Gene therapeutic products: Gene replacement and gene-editing therapies developed for genetic disorders and cancers are now covered under the revised rules. Xenografts: Products derived from animal tissues, such as heart valves used in cardiology and orthopaedics, have also been included within the expanded regulatory ambit. Legal Basis The amendment has been made under the Drugs and Cosmetics Act and the Drugs Rules, 1945. Earlier, the CLAA framework covered critical products such as: Vaccines Large volume parenterals (intravenous solutions exceeding 100 ml) Recombinant DNA (r-DNA)-based medicines The latest amendment extends this regulatory framework to advanced cell- and gene-based therapies. Significance The amendment strengthens India's regulatory framework for emerging medical technologies by bringing advanced therapies under a uniform central approval mechanism. It aligns the country's regulatory standards with global best practices while enhancing oversight, quality, safety, and consistency in the approval of innovative medical products. Marine Products Export Development Authority (MPEDA) Context: Recently, the Marine Products Export Development Authority (MPEDA) organised the second edition of the National Skill Olympiad on Seafood Value Addition during Seafood Expo Bharat 2026 held in Kochi. About MPEDA Nature: A statutory body responsible for promoting the export of marine products from India. Establishment: Constituted under…
