New rules to bring stem cell, gene therapies under Central licensing net close regulatory gap

The Union Ministry of Health recently amended the Drugs Rules, 1945 to bring cell and stem cell products, gene therapies, and xenografts under the Centrally Licence Approving Authority (CLAA) framework, closing a long-standing regulatory gap in India’s oversight of advanced therapies.

The amendment does not amount to automatic approval of these therapies, nor will it immediately make them cheaper or more accessible, a Health Ministry official clarified on Saturday (July 4, 2026). Manufacturers will still have to prove safety, quality and efficacy, secure clinical trial and marketing approvals, and comply with the Drugs and Cosmetics Act. The change lays the regulatory groundwork for safer, more reliable access to advanced treatments over time, with both Central and State licensing authorities now jointly overseeing these products, the official said.

The move comes against the backdrop of clinics across India offering costly, often unproven stem cell treatments for several conditions, including autism and spinal cord injury.

The amendment brings such products under a uniform framework for the first time, addressing a regulatory grey zone that had let some clinics market dubious “stem cell” cures while charging patients large sums, Mandeep Singh Malhotra, director, surgical oncologist at C.K. Birla Hospital, Delhi, said.

Until now, the CLAA system covered only specific high-risk biologics — vaccines, large-volume parenterals, and recombinant DNA-derived drugs — which needed manufacturing licences from State Licensing Authorities with CLAA approval. Stem cell and cell-based products had been classified as “new drugs” since 2018, requiring regulatory clearance for clinical use, but the Rules had no dedicated provision (Forms 27D, 27DA, 28D, 28DA) for issuing manufacturing licences to these categories. The amendment fixes this by revising Rules 75, 75A, 76, and 76A along with the relevant licensing forms.

The updated framework will cover regenerative treatments and CAR-T cell therapies for blood cancers, including lymphoma, gene replacement, and editing products for genetic disorders and cancers, and animal-tissue-derived products, including heart valves used in cardiology and orthopaedics.

Experts note that India’s drug regulatory architecture has traditionally been built around its generics industry, which evaluates equivalence to already approved drugs — a model ill-suited to novel cell and gene therapies. The gap became apparent in 2023, when ImmunoACT won approval for NexCAR19, India’s first indigenous CAR-T therapy, only after regulators and the company worked out evaluation standards during the process itself. Since then, firms including Immuneel Therapeutics and Dr. Reddy’s Laboratories, have advanced their own CAR-T programmes, while Council of Scientific and Industrial Research - Institute of Genomics and Integrative Biology (CSIR-IGIB), and the Serum Institute of India are developing BIRSA-101, a CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)-based gene-editing therapy for sickle cell disease — all previously assessed case-by-case without a formal pathway.

Analysts caution that while the new framework should curb unregulated and unproven therapies, the added compliance layer could lengthen approval timelines and raise costs, especially for smaller biotech firms. Broader constraints — limited manufacturing infrastructure, a shortage of specialised workforce, and constrained clinical research capacity — remain unaddressed.