NEW DELHI — The Union Ministry of Health and Family Welfare issued an amendment to the Drugs and Cosmetics Rules, 1945, on Tuesday, introducing a “uniform regulation” framework for advanced cell‑based and gene‑therapy products, officials said. The change expands the legal definition of “new drug” to expressly cover cell‑based and gene‑based products and sets out a dedicated pathway for clinical‑trial approval, marketing authorisation and post‑marketing surveillance. The amendment will be notified in the official Gazette and will require manufacturers to obtain a licence from the Central Drugs Standard Control Organisation (CDSCO) before conducting trials or marketing any such product in India.
What happened
The revised rules, announced by a health‑ministry spokesperson, create a new regulatory category for products derived from stem cells, regenerative‑medicine approaches and chimeric antigen receptor T‑cell (CAR‑T) therapies. Under the amendment, a specialised expert committee will be constituted to evaluate safety and efficacy data for these advanced therapies. Health ministry spokesperson Dr Rohit Kumar told reporters that the move addresses a “regulatory lacuna” that has allowed some cell‑based products to operate without consistent scrutiny. He added, “India is witnessing a surge in the development of cell and gene‑based interventions. It is imperative that we have a robust, science‑based framework that protects patients while encouraging innovation.”
Industry reaction was mixed but generally positive. The Indian Biotech Association (IBA) welcomed the regulatory certainty the amendment provides, while cautioning that the approval process must be streamlined to avoid delays that could impede patient access.
Why it matters
Cell‑based and gene‑therapy products have moved from experimental status to clinical use in recent years, particularly for blood cancers such as leukaemia and lymphoma. CAR‑T therapies, which re‑engineer a patient’s own T‑cells to target cancer cells, are among the most high‑profile examples. The amendment aims to close gaps in oversight that could expose patients to untested or inadequately monitored treatments. By bringing these products under a clear, uniform regulatory regime, the government seeks to ensure that safety and efficacy data are rigorously reviewed before patients receive them, and that post‑marketing surveillance mechanisms are in place to track adverse events.
Background and context
Globally, the market for cell‑based therapies is expanding rapidly. A 2023 report from the International Society for Cellular Therapy noted that worldwide sales of CAR‑T therapies exceeded US$5 billion in 2022, with analysts projecting continued growth. In India, several tertiary hospitals have already begun offering CAR‑T treatments under clinical‑trial protocols, but the absence of a dedicated regulatory pathway has raised concerns about uniform safety standards and consistent post‑treatment monitoring.
Historically, the Drugs and Cosmetics Rules, 1945, have governed a broad spectrum of pharmaceuticals, but they have not explicitly addressed the unique characteristics of advanced therapies that involve living cells, genetic manipulation, or complex manufacturing processes. The amendment therefore represents the first formal inclusion of such products within India’s drug‑regulatory architecture.
Competing claims and uncertainty
While the ministry frames the amendment as a necessary step to protect patients and foster innovation, industry stakeholders have highlighted potential downsides. The IBA’s call for a streamlined process reflects fears that additional regulatory layers could increase compliance costs and lengthen time‑to‑market for domestic biotech firms. Critics argue that prolonged approval timelines may reduce India’s competitiveness in a sector where multinational companies dominate and where speed to market can be critical for patient outcomes.
Conversely, patient‑advocacy groups, not quoted in the source but historically active on safety issues, are likely to view the move as a positive development, given past instances where unregulated cell‑based interventions have led to adverse events in other jurisdictions. The balance between rigorous oversight and maintaining an innovation‑friendly environment remains an open question, pending the operational details of the expert committee and the CDSCO’s capacity to evaluate complex biologics.
What to watch next
The amendment’s effectiveness will hinge on several forthcoming developments:
1. Gazette notification and rule implementation – The official publication in the Gazette will trigger the legal force of the amendment. The timeline for the rollout of the new licensing and trial‑approval procedures will be closely monitored.
2. Composition and mandate of the expert committee – Details on the committee’s membership, expertise criteria and decision‑making timelines have not yet been disclosed. Transparency in its operations will be essential to gauge whether it can deliver timely reviews without compromising scientific rigour.
3. CDSCO capacity building – The CDSCO will need to augment its technical and staffing resources to assess cell‑based and gene‑therapy dossiers, which often involve extensive pre‑clinical data, manufacturing controls and long‑term follow‑up plans.
4. Industry response and filing patterns – Early applications for licences under the new framework, especially from Indian biotech firms, will indicate how the sector adapts to the revised requirements.
5. International alignment – As regulators in the United States, Europe and elsewhere have introduced dedicated pathways for advanced therapies, observers will watch whether India’s rules facilitate cross‑border collaborations, joint clinical trials or market access for Indian‑developed products.
Conclusion
The amendment to the Drugs and Cosmetics Rules, 1945, marks a decisive policy shift aimed at bringing advanced cell‑based and gene‑therapy products under a uniform, science‑based regulatory umbrella. By expanding the definition of “new drug” and mandating CDSCO licences for trials and marketing, the government seeks to close a regulatory gap that has left some high‑cost, high‑complexity biologics without consistent oversight. While industry groups welcome the clarity, they caution that procedural delays and rising compliance costs could hinder domestic innovation and patient access. The true impact of the amendment will depend on how swiftly and transparently the expert committee and CDSCO operationalise the new framework, and whether the rules can balance rigorous safety standards with the need to keep India competitive in a fast‑growing global market for cell and gene therapies.
Sources
– “Centre amends Drugs Rules, 1945 to ensure uniform regulation of advance cell and gene therapies,” The Hindu (National), July 3 2026. https://www.thehindu.com/news/national/centre-amends-drugs-rules-1945-to-ensure-uniform-regulation-of-advance-cell-and-gene-therapies/article71174882.ece
Story synopsis gathered from: The Hindu – National — source
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