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[The Viewpoint] Decoding the legality of Stem Cell Therapy in India

The first attempt to regulate stem cell activities was made in 2007 when the CMR and the Department of Biotechnology (DBT) jointly issued a set of Guidelines for Stem Cell Research and Therapy. The document laid down the “general ethical principles for research and processes for formal committee approval of stem cell activities”. The guidelines stipulated that the clinical use of stem cells was not permitted unless clinical trials were conducted and approved by relevant ethics committees and the Central Drugs Standard Control Organisation (CDSCO). Subsequently, the guidelines were revised in 2013 and 2017, and the word “therapy” was removed from the title of the guidelines. This was done to emphasise that “stem cells are still not a part of the standard of care; hence there can be no guidelines for therapy until efficacy is proven.”

While this sends a strong message, the guidelines lack statutory backing, due to which they cannot be enforced. Furthermore, both ICMR and DBT have no jurisdiction over clinicians to compel them to follow the guidelines. The ICMR is a research institution under the Ministry of Health and Family Welfare, and its role is limited to “formulation, coordination and promotion of biomedical research.”

In contrast, the DBT comes under the Ministry of Science and Technology and is created to promote biotechnology in India with no enforcement abilities over clinics. Both the ICMR and the DBT are aware of their inherent inability to regulate unproven stem cell therapies. However, the guidelines highlight the role of other bodies and legislation to regulate this field. While several bodies and departments have been created to overlook the development of stem cell activities in India, there is no unequivocal answer to the question, “Who regulates stem cell activities in India?”

Source: Barandbench

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