The Union Health Ministry has updated the Drugs Rules, 1945 to include cell and stem cell products, gene therapies, and xenografts under the Centrally Licence Approving Authority. This step addresses a previous gap in oversight of advanced medical treatments in India.
The change does not grant automatic approval or reduce prices right away, according to a ministry official. Companies must still demonstrate safety, quality, and effectiveness, obtain clinical trial and marketing clearances, and follow the Drugs and Cosmetics Act. Both central and state authorities will now share responsibility for supervision.
The update responds to reports of clinics offering expensive and unverified stem cell procedures for conditions such as autism and spinal cord injuries. It creates a single regulatory system for these items.
Previously, the central system applied only to certain high-risk biologics like vaccines and recombinant drugs. Stem cell products were treated as new drugs since 2018 but lacked specific licensing forms. The revisions to relevant rules and forms correct this issue.
The framework now covers regenerative medicine, CAR-T therapies for cancers like lymphoma, gene editing products for genetic diseases, and animal-derived items such as heart valves.
India’s regulatory system has focused mainly on generic medicines, which does not fit well with these novel therapies. Recent approvals, including the first domestic CAR-T treatment, occurred without a standard process. Several companies and research bodies are developing similar products.
While the rules may limit unproven treatments, experts warn they could extend review times and increase expenses for smaller firms. Issues like manufacturing capacity and skilled staff shortages continue.
