Stem cell therapy for autism only in approved clinical trials: Centre
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 instructed states and Union Territories to ensure that stem cell therapy for autism is only conducted in approved clinical trials. This restriction was included in an advisory released on September 16, reinforcing the existing regulatory framework for stem cell research and therapy. The directive applies to states and territories that have implemented the Clinical Establishments (Registration and Regulation) Act, 2010, following the Supreme Court's ruling on January 30, 2026, in the case of Yash Charitable Trust & Ors. v.
Union of India & Ors. The Ministry emphasized that the therapeutic use of any type of stem cell should be confined to approved clinical trials, as per the National Guidelines for Stem Cell Research, 2017, issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology. The advisory warned against providing stem cell interventions for autism as routine clinical services, unless they have been approved for standard treatment.
This action is prompted by the ongoing use of unproven stem-cell interventions for autism, despite the lack of evidence supporting their efficacy compared to behavioral and supportive therapies. The Ministry has directed states and territories to inform regulatory authorities, clinical establishments, and relevant entities about these instructions.
Non-compliance could lead to penalties, including cancellation of registration and professional misconduct under specific regulations. The Supreme Court's ruling highlights that violations may attract professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations, 2002, and action under Sections 32 and 40 of the Clinical Establishments Act.
The National Medical Commission (NMC) echoed this stance in an advisory on September 5, reiterating that stem cell therapy should only be offered for approved indications. Unauthorised administration or promotion of stem cell therapy beyond these indications would be considered professional misconduct, subject to disciplinary action by State Medical Councils.
Written by urgent.news from The Hindu - Sci-Tech's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
This story
This is one outlet's version. Read the fullest account.
