Centre issues advisory on stem cell therapy for autism, following directions of SC

New Delhi, Sep 17 (UNI) The Ministry of Health and Family Welfare has issued an advisory to all States and UTs that have adopted the Clinical Establishments Act, 2010, on the regulation of stem cell therapy.

The advisory, issued on Wednesday, reiterates the existing legal framework and states that stem cell therapy as standard care in routine clinical practice is permitted only for conditions included in the list approved by the ministry.

The advisory was issued in view of the Supreme Court judgment dated January 30, 2026, in Yash Charitable Trust & Ors vs union of India & Ors [2026 INSC 96]. In the public interest litigation, the petitioners had flagged rampant promotion, prescription, and administration of stem cell "therapy" for Autism Spectrum Disorder (ASD) by several clinics across the country.

The plea alleged that although stem cell therapy is still at an experimental stage, it is being touted as a treatment or cure for ASD in violation of the existing framework. It claimed that persons with ASD and their parents or caregivers, unaware of the scientific and legal aspects, place faith in such clinics, hoping for a miraculous cure and fall victim to cost-intensive procedures.

The petition also alleged that stem cell therapy for ASD is illegal and lacks safety nets available to subjects of clinical trials, and that despite a regulatory framework, enforcement was lacking. Regarding ASD, the advisory stipulates that therapeutic use of any type of stem cell in autism shall remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT), and other applicable instructions issued by the government from time to time.