India restricts stem cell therapy for autism to approved trials

India's Union Health Ministry has issued a national advisory restricting the use of stem cell therapy for autism to approved clinical trials only, warning of disciplinary and legal consequences for non-compliance. The advisory, dated September 16, 2026, was sent to states and union territories that have adopted the Clinical Establishments Registration and Regulation Act, 2010. The directive follows a January 30, 2026, Supreme Court judgment in the case of Yash Charitable Trust versus the Union of India. The court held that violations of the statutory framework for stem cell research and therapy could attract penalties, including professional misconduct charges against practitioners and the cancellation of registration for clinical establishments. The Health Ministry's advisory clarifies that stem cell therapy may be offered as standard clinical care only for specific, pre-approved conditions. It lists 18 approved indications for adults and 14 for children, which include certain cancers and autoimmune diseases. Autism Spectrum Disorder (ASD) is not on this list.