NEW DELHI: The Union health ministry has asked states and Union territories to act against unauthorised stem cell therapy, reiterating that it can be offered as routine treatment only for disease conditions or indications approved by the ministry.In an advisory issued on September 16, the ministry said stem cell therapy for autism spectrum disorder (ASD) must remain restricted to duly approved clinical trials. It must not be offered as routine, standard or commercial clinical treatment.The advisory follows the Supreme Court judgment of January 30, 2026, in which the court issued directions on the use of stem cell therapy for ASD. The ministry has asked states and UTs to circulate the directions to state and district regulatory authorities as well as government and private clinical establishments involved in stem cell research, treatment, promotion or administration.The ministry has also flagged the consequences of violations. Citing the Supreme Court’s directions, it said non-compliance can attract professional misconduct, besides action under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, including cancellation of registration and penalties.The National Medical Commission (NMC), in an advisory issued on September 5, also reiterated that stem cell therapy can be offered as standard clinical care only for approved indications. It said unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct.The NMC has asked State Medical Councils to examine alleged violations and, where professional misconduct by a Registered Medical Practitioner is established after due process, take appropriate disciplinary action.
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The health ministry has also reiterated that the regulatory framework governing stem cell research and therapy must be followed, including the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research and Department of Biotechnology.The latest advisory puts the focus on enforcement by state and district authorities. It directs authorities and clinical establishments to ensure that unproven stem cell interventions, including those for ASD, are not offered outside the permitted regulatory framework.
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