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.
Union of India & Ors. 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. 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.
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. 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.
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.
