Stem cell therapy for autism cannot be offered as a clinical service outside an approved and monitored trial, the Supreme Court has reiterated, directing the Centre to issue a public protocol on the regulatory regime within six weeks.
New Delhi: The Supreme Court on October 13, 2026 directed the Union Ministry of Health and Family Welfare to issue, within six weeks, a comprehensive protocol on the regulatory regime for stem cell research and clinical trials relating to autism spectrum disorder (ASD), reiterating that stem cell therapy for ASD cannot be offered as a clinical service outside an approved and monitored research or trial setting, while permitting patients who started therapy on or before January 30, 2026 to continue, as a strictly temporary arrangement, subject to registration on a portal [Yash Charitable Trust and Others v. Union of India and Others].
A Bench of Justices J.B. Pardiwala and R. Mahadevan passed the order in Writ Petition (Civil) No. 369 of 2022. Additional Solicitor General Aishwarya Bhati appeared for the Union of India, Senior Advocate Neeraj Kishan Kaul for Respondent No. 13, the Parents’ Forum for Stem Cells in Autism and Cerebral Palsy, and Prashant Bhushan was also heard. Some individuals present in Court, who said their children or wards are undergoing the therapy, were heard in person as well.
How the case reached here
The petition challenged the promotion and administration of stem cell therapy for ASD by clinics. In its judgment of January 30, 2026, the same Bench held that the therapy cannot be demanded as of right or offered as a routine or commercial clinical service, and that its therapeutic use is permissible only within approved and monitored clinical trials. It also directed the Health Ministry, with AIIMS and the National Medical Commission, to devise a mechanism to move patients already undergoing therapy into approved trial institutions rather than ending treatment abruptly. On September 1, 2026, the Court asked the Union to report whether regulators, treating institutions and caregivers were taking genuine steps in that direction.
The Union’s compliance affidavit of September 28, 2026, affirmed by Dr. Tushar Karmarkar, Deputy Secretary in the Department of Health Research, recorded that a National Stem Cell Research Regulation Committee had been constituted on March 24, 2026 to oversee research on minimally manipulated stem cells, and listed the letters and advisories issued by the Department of Health Research, the National Medical Commission and the Health Ministry since the judgment.
It stated that neither the Central Drugs Standard Control Organisation, the Department of Health Research nor the Indian Council of Medical Research had received any application to conduct a trial or research on stem cell therapy for ASD. It also proposed a multicentre randomised controlled trial at two tertiary care sites, one in North India and one in South India, within six months, with ICMR funding.
The legal position
The Court recorded that the competent regulator depends on the degree of manipulation of the stem cells. Where they have undergone more than minimal manipulation, research is regulated by the Central Drugs Standard Control Organisation under the New Drugs and Clinical Trials Rules, 2019. Where they have undergone minimal or less than minimal manipulation, it is regulated by the Department of Health Research, and the trial must also be approved by the National Stem Cell Research Regulation Committee.
What the Court said
The Bench began by clarifying that it was not evaluating the efficacy of the therapies, since the question before it is one of law. It then restated the position:
“Under the existing regulatory framework, stem cell ‘therapy’ for ASD cannot be offered as a clinical service outside an approved and monitored research/clinical trial setting. In such circumstances, the individuals diagnosed with ASD, or their parents/guardians/caregivers cannot demand that such a form of procedure be permitted to be administered as a clinical service.”
The Court added that liberty to take part in an approved and regulated trial remains, but that participants must not labour under a “therapeutic misconception”, that is, a belief that a trial exists to treat them rather than to conduct research. It also made clear that the bar is not permanent:
“It does not amount to an immutable prohibition against any future development in this field.”
The Court found that the failure to curb the illegal administration of the therapy, and the lack of readily accessible information on the legal position, had allowed clinics offering it to proliferate, and that a “labyrinth of rules, regulations, office orders and advisories” left room for dubious elements to exploit the public.
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The directions
Within six weeks, the Health Ministry must issue a step-wise protocol identifying the permissions needed, the timelines, the competent authority and the statutory basis for each step, with a flowchart where practicable, and must publicise on its website and those of the DBT, ICMR, CDSCO and NMC, and through hospitals and patient support organisations, that the therapy is not permitted as a clinical service outside an approved trial. Within four weeks, the Union must set up an online portal for views and suggestions to the National Stem Cell Research Regulation Committee, which may be used by Respondent No. 13 and any other interested person.
Within six weeks, it must set up a dedicated portal to record the particulars of patients who began therapy on or before January 30, 2026, their treating practitioners and the intervention given, with safeguards for confidentiality; registration will then be mandatory before the intervention continues.
Until the proposed tertiary care centres begin functioning, such existing patients may continue at their current clinics as a strictly temporary arrangement, which the Court said is not recognition of the therapy as a permissible clinical service. It added:
“We reiterate that no new patients shall be inducted for stem cell ‘therapy’ for ASD outside a duly approved and monitored research or clinical trial setting.”
On the proposed randomised trial, the Union must clarify at the next hearing its eligibility criteria, and in particular whether randomisation could leave some participants, including those already undergoing therapy, excluded from the intervention under study. If so, it must place a plan for their continued monitoring and medical supervision. The matter will be heard next on December 14, 2026 at 2 pm.
Why the order matters
The order turns a ban on paper into a compliance exercise. It puts the burden on the Centre to make the rules legible to parents and doctors, creates a registry of existing patients so that the temporary arrangement can be monitored, and holds the line on new patients. It also keeps open the possibility of future approval if rigorous, regulated research establishes safety, efficacy and ethical acceptability. The Court has not ruled on the scientific merits of the therapy, and its concern for families already on treatment is visible in the questions it has asked about the design of the proposed trial.
Case Title: Yash Charitable Trust and Others v. Union of India and Others [Writ Petition (Civil) No. 369 of 2022]
Bench: Justice J.B. Pardiwala and Justice R. Mahadevan, Supreme Court of India
Date of Order: October 13, 2026
Next Date: December 14, 2026, 2 pm
Appearances: Additional Solicitor General Aishwarya Bhati for the Union of India; Senior Advocate Neeraj Kishan Kaul for Respondent No. 13; Prashant Bhushan, counsel, and individuals in person.