SRINAGAR: The Union Health Ministry has directed States and Union Territories to ensure that stem cell therapy is offered as standard clinical care only for disease conditions and indications approved by the ministry.
In an advisory issued on September 17, the Ministry of Health and Family Welfare said the therapeutic use of stem cells for Autism Spectrum Disorder (ASD) must remain restricted to duly approved clinical trials and cannot be offered as a routine, standard or commercial clinical service.
The advisory applies to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010. It follows a January 30, 2026 judgment of the Supreme Court in Yash Charitable Trust & Ors. v. Union of India & Ors.
The ministry said stem cell research and therapy must comply with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research and the Department of Biotechnology, along with other applicable government directions.
States and Union Territories have been asked to circulate the Supreme Court’s directions among State and District Regulatory Authorities and government and private clinical establishments involved in stem cell research, treatment, promotion or administration.
The ministry also warned of regulatory and professional consequences for violations. Citing paragraph 151(xiii) of the Supreme Court judgment, it said non-compliance could attract action for professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, besides proceedings under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for cancellation of registration and penalties.
The National Medical Commission, in an advisory issued on September 5, had also reiterated that stem cell therapy could be provided as standard clinical care only for approved indications.
The NMC said unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct. It advised State Medical Councils to examine alleged violations and take disciplinary action, following due process, where professional misconduct by a registered medical practitioner is established.
