Supreme Court lens on stem cell therapy for autism

The Court asked for details of all approved or proposed clinical trials for stem cell therapy for ASD, the institutions involved and their patient capacity. The Supreme Court has sought a detailed account of clinical trials for stem cell therapy for Autism Spectrum Disorder (ASD), asking the Centre to disclose whether any applications for such trials have been received since its January judgment and what steps have been taken to move patients already undergoing the controversial treatment into a regulated research framework.Supreme Court had previously ruled that stem cell therapy for autism cannot be offered as a routine clinical service or commercial treatment. (AFP/Representational)A bench of justices JB Pardiwala and R Mahadevan also directed the Centre to place before it details of all approved or proposed clinical trials for stem cell therapy for ASD, the institutions involved and their capacity, if any, to accommodate patients who were already receiving the therapy when the court delivered its judgment on January 30.The order assumes significance as the court had in January ruled that stem cell therapy for ASD cannot be offered as a routine clinical service or commercial treatment and must be undertaken only within an approved and monitored clinical trial or research setting.Also Read I Chandigarh administration intensifies crackdown on misuse of habit-forming drugsNot approved for routine treatmentAs per the ministry of health and family welfare, stem cell therapy is not approved as routine treatment and it is only permitted for research purposes in certain conditions listed by the ministry, with autism not being one of them. In an order issued in March, the Indian Council of Medical Research (ICMR) said, “Stem cell therapies in routine practice shall be permitted only for disease conditions specified in the list of MHoFW approved indications as standard care… Other than the approved indications, stem cell therapy is permissible only in the context of research.”The United States’ Food and Drug Administration (FDA) has also approved stem cell therapy only for blood stem transplantation that is meant to treat blood cancers, and certain blood and immune system disorders. For all other conditions, it is experimental.Courts asks government for regulatory mechanismThe court said the government had yet to clearly place on record how such patients were proposed to be regulated or transitioned into an appropriately approved research or clinical-trial framework. It therefore directed the Union government to disclose in its compliance affidavit whether any application had been made to the competent regulatory authority for approval or permission to conduct research or a clinical trial involving stem cell therapy for ASD. If so, the Centre has been asked to give the number of applications, dates of receipt, names of applicant institutions and the present status of each.Also Read I AstraZeneca Breast-Cancer Drug Misses Goal in Late-Stage TrialThe scrutiny does not stop with the government. The court has directed the Parents Forum for Stem Cells in Autism and Cerebral Palsy, the institutions and clinics administering the therapy, and parents, guardians or caregivers of patients to place on record whether they too have taken steps since the January judgment to bring the ongoing treatment within the framework of a duly approved and regulated clinical trial.The bench has listed the matter for further hearing on September 29.Utkarsh Anand is the National Legal Editor at Hindustan Times, where he leads the newspaper's coverage of the Supreme Court, constitutional law, the judiciary and the Union law ministry. He joined Hindustan Times in 2020 after stints at Press Trust of India (PTI), The Indian Express and CNN-News18, and has over two decades of experience reporting on law, governance and public policy. His work has focussed on some of India's most consequential constitutional and legal developments, including the Supreme Court's judgments on Article 370, marriage equality, decriminalisation of homosexuality, the Babri Masjid dispute, electoral reforms and judicial appointments. He specialises in making complex legal proceedings and judgments accessible to readers while examining their wider social and political impact. Beyond daily reportage, Utkarsh has led investigative projects and enterprise reporting that have shaped public debate and prompted institutional responses. His work has received several journalism awards, including the Ramnath Goenka Excellence in Journalism Award. As National Legal Editor, he has also played a key role in expanding Hindustan Times' legal journalism footprint, mentoring reporters and strengthening coverage across platforms. A Chevening South Asia Journalism Programme Fellow, Utkarsh regularly writes analyses on the judiciary and constitutional issues, and his reporting is widely followed by lawyers, judges, policymakers, academics and readers seeking clarity on India's evolving legal landscape.Read MoreAutismIcmrStem CellGet the latest India News, breaking headlines and real-time updates from across the country. Stay informed about politics, government policies, crime, weather major national developments and Karnataka Bandh LIVE.