Government Amends Drug Rules to Regulate Advanced Cell and Gene Therapy

New Delhi, July 2: The central government has amended the Drugs Rules of 1945 to enhance the regulation of modern medical technologies such as advanced cell and gene therapy. This amendment includes products derived from cells or stem cells, gene therapy products, and xenografts under the purview of the Central Licensing Approving Authority (CLAA).

The government states that this move will help implement a uniform regulatory framework for these modern medical products across the country, ensuring patient safety.

According to the government, monitoring of certain essential drugs and biological products is already conducted by licensing agencies from both central and state governments under the Drugs and Cosmetics Act. This includes vaccines, intravenous (IV) solutions exceeding 100 milliliters, and recombinant DNA-based drugs. Now, the scope of this system has been expanded to include new medical technologies.

The government has noted a rapid increase in the use of cell and stem cell-based products in modern treatments such as regenerative therapy and CAR-T cell therapy. These are utilized in treating blood cancers like leukemia and lymphoma. Meanwhile, gene therapy products are employed through techniques like gene replacement and gene editing to address genetic disorders and various types of cancer.

Additionally, xenografts are medical products made from animal tissues, including heart valves, which are used for transplants in cardiology and orthopedics.

The government emphasizes that these technologies are rapidly evolving and quite complex. Therefore, stringent monitoring is essential to ensure their safe use and protect patients. Bringing these products under the CLAA’s jurisdiction will foster better coordination between central and state licensing agencies, ensuring adherence to uniform regulatory standards nationwide.

The government believes that this amendment will strengthen India’s regulatory framework to meet global standards. It will also promote innovation in the health and life sciences sector, facilitating the safe adoption of modern medical technologies. A detailed gazette notification regarding this has already been issued.