The Union Health Ministry has directed states and union territories to permit stem cell therapy as standard clinical care only for Ministry-approved conditions, restricting its use for autism to approved clinical trials in line with a Supreme Court verdict.

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• The Ministry of Health and Family Welfare issued an advisory dated 16 September 2026 to all states and union territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010.
• The advisory permits stem cell therapy as routine standard clinical care only for disease conditions and indications included in the Ministry’s approved list.
• It specifically restricts the use of stem cells for Autism Spectrum Disorder to properly approved clinical trials, barring its offer as a routine or commercial service.
• The move follows the Supreme Court’s judgment of 30 January 2026 in Yash Charitable Trust and Others versus Union of India, delivered in W.P. (C) No. 369 of 2022.
• The Court had held in that judgment that non-compliance with the statutory framework must attract consequences, including professional misconduct proceedings and penalties.
• The National Medical Commission had already issued a reinforcing advisory on 5 September 2026, restating that stem cell therapy may be offered as standard care only for approved indications.
• Unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications is classified as professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations, 2002.
• Non-compliance also invites action under Sections 32 and 40 of the Clinical Establishments Act, 2010, which allow for cancellation of registration and monetary penalty.
• The advisory draws a clear distinction between established treatments, such as haematopoietic stem cell transplantation for certain blood disorders, and experimental therapies that remain unproven for other conditions.
• State and district regulatory authorities and clinical establishments have been asked to ensure strict compliance with the existing framework governing stem cell research and therapy.
• The directive addresses long-standing concerns about unregulated clinics offering unproven stem cell treatments as commercial services outside the approved regulatory pathway.