India Moves to Regulate Cell and Gene Therapies Under Drug Licensing Rules: A Landmark Step in Biomedical Governance

In a decisive move to strengthen regulation of advanced medical therapies, the Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Drugs Rules, 1945, bringing cell- and gene-based therapies—including stem cell products and xenografts—under India’s formal drug licensing framework. The draft notification, published in the Gazette of India on October 16, 2025, aims to ensure these rapidly evolving technologies meet the same safety, quality, and efficacy standards as recombinant DNA (r-DNA) derived drugs by requiring prior approval, licensing, and compliance with Good Manufacturing Practices (GMP) .

Expanded Oversight of Advanced Therapies

The draft Drugs (Amendment) Rules, 2025, mark the most significant update to India’s biologics regulation in a decade. The proposed rules amend Rules 75, 75A, 76, and 76A of the Drugs Rules, 1945, to explicitly include “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts, etc.” in all references that currently apply to recombinant DNA-derived drugs .

This change means that manufacturers and importers of such advanced therapies must now obtain licensing and adhere to strict regulatory oversight by the Drugs Controller General of India (DCGI) before marketing their products. Importantly, these regulations would also extend to laboratory-developed and hospital-based therapies that use patient-derived cells, closing a long-standing regulatory gap.

Regulatory Rationale and Context

India’s biotechnology sector has seen rapid growth, especially in regenerative medicine and genetic therapies, creating a pressing need for ethical and safety governance. Until now, therapies involving cell and gene modification often operated in a patchwork regulatory landscape, sometimes escaping the stringent approval process required of conventional pharmaceuticals.

According to regulatory experts, these amendments will align India’s framework with those of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), both of which already treat cell and gene therapies as “biological drugs” requiring full premarket authorization. “This move will ensure accountability and scientific robustness in treatments that have life-altering potential but carry complex risks,” said Dr. Rohit Sinha, Professor of Pharmacology at the All India Institute of Medical Sciences (AIIMS), not affiliated with the drafting process.

Public Consultation and Next Steps

The Ministry has invited public comments and objections within 30 days of publication, which must be addressed to the Director (Drugs Regulation), MoHFW, at Nirman Bhavan, New Delhi, or via email to [email protected] . After the consultation period, the MoHFW is expected to finalize the rules for publication in the Official Gazette, which will specify the enactment date.

Once implemented, manufacturers of cell- and gene-based therapies will need to apply for new drug licenses under Forms 27D, 27DA, 28D, and 28DA, newly modified to encompass these advanced biologics.

Implications for Public Health and Industry

For patients, the proposed amendment promises greater safety assurance. Gene therapies—which directly alter genetic material to treat diseases like muscular dystrophy or sickle cell disease—carry the risk of immune responses, insertional mutagenesis, and other serious side effects. Regulatory vetting will help standardize preclinical studies, clinical trials, and long-term monitoring, limiting unsafe or unproven offerings in the market.

For the biopharma industry, this move could both elevate standards and increase compliance responsibility. According to the Association of Biotechnology-Led Enterprises (ABLE), India’s gene therapy market could exceed US$ 600 million by 2030, driven by collaborations between academia, startups, and global partners. Formal regulation could stimulate investor confidence and ensure alignment with international clinical trial protocols.

At the same time, experts caution that smaller firms and research institutes may face challenges adapting to new compliance costs. “A phased transition and support from regulators will be critical,” observed Dr. Kavita Menon, a clinical researcher in translational medicine at the National Institute of Immunology. “India must balance innovation with patient safety and equitable access.”

Ethical and Scientific Responsibility

The expansion of regulatory oversight reflects a broader shift toward ethical governance in biotechnology. India has witnessed sporadic controversies over unauthorized stem cell therapies offered by private clinics lacking clinical validation. The proposed rules will help clamp down on unregulated or experimental treatments, particularly in the field of regenerative medicine and cancer immunotherapy.

Moreover, aligning cell and gene therapies with the Drugs and Cosmetics Act, 1940, ensures that safety assessments, manufacturing practices, and post-market surveillance mirror those of conventional pharmaceuticals. The inclusion of xenografts—tissue or organ transplants derived from another species—further demonstrates the government’s preparedness to manage newer cross-species biomedical innovations.

Limitations and Counterpoints

While broadly welcomed, some regulatory scientists note potential implementation challenges, such as the availability of expertise within licensing authorities to assess novel therapeutic modalities. Moreover, updating infrastructure for GMP certification of cell-based facilities may require significant investment.

Bioethicists also warn that excessive bureaucratic delay could hinder legitimate research. “Oversight should not become overreach,” said Dr. Prateek Banerjee, a bioethicist at the Indian Council of Medical Research (ICMR). “Proportionate regulation—one that differentiates between clinical trial research and commercial production—is key.”

A Broader Step Toward Biomedical Accountability

India’s decision to formally govern emerging therapies under a structured licensing framework represents a critical milestone in healthcare regulation. By treating gene, cell, and tissue-based therapies with the same rigour as biologic drugs, the government signals a commitment to scientific responsibility and patient safety in an increasingly complex medical frontier.

Such frameworks will not only enhance global credibility for India’s biotechnology ecosystem but also protect consumers from pseudo-scientific or premature interventions marketed under the guise of innovation. For patients and practitioners alike, this regulatory evolution emphasizes that progress in medicine must advance hand-in-hand with ethical precision and effective oversight.

Medical Disclaimer:
This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.

References

1. Ministry of Health and Family Welfare. Draft Drugs (Amendment) Rules, 2025, Gazette Notification G.S.R. 758(E), October 16, 2025.

2. Medical Dialogues Staff Report. “India to Regulate Cell and Gene Therapies Under Drug Licensing Rules.” Medical Dialogues, October 2025.