The advisory, dated September 16, 2026, outlines the regulatory framework for stem cell therapy in autism, restricting its use to approved clinical trials according to the National Guidelines for Stem Cell Research, 2017.
On September 17, 2026, the Ministry of Health & Family Welfare issued an advisory to all states and union territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010. The advisory concerns the regulation of stem cell therapy in light of a January 30, 2026, Supreme Court judgment in the case of Yash Charitable Trust & Ors. v. Union of India & Ors. The advisory reiterates the existing framework governing stem cell research and therapy, stating that stem cell therapy is permitted as standard care only for disease conditions/indications approved by the Ministry of Health & Family Welfare. Autism Spectrum Disorder (ASD) is mentioned specifically in the advisory as a condition where the therapeutic use of any type of stem cell remains restricted to duly approved clinical trials, according to the National Guidelines for Stem Cell Research, 2017. The Ministry has requested states and union territories to widely disseminate the directions of the Hon’ble Supreme Court to all concerned State and District Regulatory Authorities and Government and private clinical establishments involved in stem cell research, treatment, promotion or administration, for strict compliance with the applicable framework. Non-compliance may result in professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, and action under Sections 32 and 40 of the Indian Medical Council Act, which provide for cancellation of registration and penalty. The National Medical Commission (NMC) has also reinforced this regulatory position, stating that stem cell therapy may be offered as standard clinical care only for approved indications.
The advisory dated September 16, 2026, further draws attention to the consequences of non-compliance with the framework governing stem cell therapy. The Hon’ble Supreme Court, in Para 151(xiii) of its judgment dated January 30, 2026, held that non-compliance with the statutory mandate must attract consequences, including professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, as well as action under Sections 32 and 40 of the Indian Medical Council Act. The NMC advisory dated September 5, 2026, advises State Medical Councils to examine cases of alleged violations brought to their notice and, where professional misconduct by a Registered Medical Practitioner is established after due process, take appropriate disciplinary action in accordance with the applicable statutory and regulatory provisions.
Source:
Press Information Bureau
