Stem cell interventions that have not been approved for routine clinical use, including those offered for autism, should not be provided as routine, standard or commercial clinical services, the advisory said.
The Union Health Ministry has asked 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, with its use for Autism Spectrum Disorder (ASD) restricted to duly approved clinical trials.
In an advisory issued on September 16, the Ministry reiterated the existing regulatory framework governing stem cell research and therapy. The advisory was issued to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, following a January 30, 2026, judgment of the Supreme Court in Yash Charitable Trust & Ors. v. Union of India & Ors.
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For ASD, the Ministry said therapeutic use of any type of stem cell must remain confined to duly approved clinical trials in accordance with the National Guidelines for Stem Cell Research, 2017, issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology.
Stem cell interventions that have not been approved for routine clinical use, including those offered for autism, should not be provided as routine, standard or commercial clinical services, the advisory said.
The move comes against the backdrop of the continuing use of stem-cell interventions for autism despite the lack of established evidence supporting them as a standard treatment. An ICMR review has said that available evidence does not support stem cell therapy over behavioural and supportive therapies for ASD and recommended that such therapy be restricted to approved clinical trials.
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The Ministry has asked States and Union Territories to disseminate the Supreme Court’s 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 advisory also draws attention to the consequences of non-compliance. The Supreme Court, in its January judgment, said violations of the statutory framework could attract consequences including professional misconduct under Regulation 7.22 of the erstwhile Indian Medical Council Regulations, 2002, as well as action under Sections 32 and 40 of the Clinical Establishments Act, including cancellation of registration and penalties.
The National Medical Commission (NMC), in an advisory issued on September 5, has separately reiterated that stem cell therapy may 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 allegations of violations and, where professional misconduct by a registered medical practitioner is established after due process, take disciplinary action under the applicable provisions.
