Stem Cell Therapy For Autism: Supreme Court Directs Govt To Clarify Regulatory Framework

The Supreme Court has reiterated that stem cell therapy for autism spectrum disorder (ASD) cannot be offered as a clinical service outside an approved and monitored research or clinical trial setting, while directing the Union government to put in place a clear protocol explaining the regulatory framework governing such interventions.

A Bench of Justices J B Pardiwala and R Mahadevan said the absence of readily accessible information about the regulatory position had enabled clinics and doctors to offer stem cell interventions for ASD under the guise of legitimate medical treatment.

Stem cell therapy uses stem cells, which can develop into different types of cells, to repair or replace damaged tissues. This therapy is being marketed to families of children with autism as a possible treatment, but there is no convincing scientific evidence that it effectively treats the core features of autism.

A clear protocol on stem cell therapy for ASD

Court said regulatory authorities must provide a clear and accessible protocol to stakeholders to ensure compliance with the law and prevent malpractice. It directed the Ministry of Health and Family Welfare to issue a comprehensive protocol explaining the regulatory regime governing the use of stem cells in research and clinical trials relating to ASD, and to create awareness about the existing framework.

Court gave the Ministry six weeks to undertake the exercise and clearly inform the public that stem cell therapy for ASD is not permissible as a clinical service.

The Bench noted that research involving stem cells that have undergone more than minimal manipulation is regulated by the Central Drugs Standard Control Organisation (CDSCO) under the New Drugs and Clinical Trial Rules, 2019. Research involving minimal or less than minimal manipulation is regulated by the Department of Health Research under the oversight of the National Stem Cell Research Regulation Committee.

The Bench thus differentiated the applicable regulatory framework based on the level of manipulation of the stem cells.

Stem cell therapy for ASD not recognised as sound medical practice

Court reiterated that the therapeutic use of stem cells for ASD is not recognised as "sound and relevant medical practice" by the concerned authorities, in light of the scientific knowledge and regulatory standards prevailing at present.

Consequently, it said medical practitioners offering such interventions as a clinical service, outside an approved and monitored research or clinical trial setting, fail to meet the reasonable standard of care owed to their patients.

"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 Bench said.

Court, however, clarified that individuals remain free to participate in an approved and regulated research or clinical trial involving such interventions.

It cautioned that participants in such trials must not suffer from any "therapeutic misconception", meaning a belief that the purpose of a clinical trial or research is to provide treatment rather than conduct research. Potential participants, the Bench said, should be mindful of this distinction.

Does the Court's ruling permanently prohibit stem cell therapy for ASD?

No. Court clarified that its January 30, 2026 judgment does not foreclose the possibility of such an intervention becoming permissible in the future.

"The prohibition on administering stem cell ‘therapy’ for ASD as a clinical service is founded upon the state of scientific evidence and the prevailing regulatory framework as on date. It does not amount to an immutable prohibition against any future development in this field," the Bench said.

It said that if further rigorous scientific research, undertaken in a duly regulated manner and in accordance with applicable scientific and ethical standards, establishes the safety, efficacy and ethical acceptability of such an intervention, the competent regulatory authorities would remain free to consider whether it can be permitted and, if so, subject to what conditions and safeguards.

What did the government propose for patients already undergoing the therapy?

The directions came in a writ petition filed by Yash Charitable Trust and others. On September 1, 2026, the Court had asked the Union government to ascertain whether reasonable and genuine steps were being taken by regulatory authorities, treating institutions and caregivers to move existing patients, wherever appropriate, towards a duly regulated research or clinical trial framework.

Additional Solicitor General Aishwarya Bhati, appearing for the Union of India, highlighted the steps already taken and those proposed to be taken in compliance with the Court's January 30, 2026 judgment and order, which had ruled that stem cell therapy for ASD cannot be offered as a routine clinical service.

In its affidavit, the Union government recognised the need to provide a duly regulated avenue for patients already undergoing such therapy. It proposed a multicentre randomised controlled trial (RCT) at two tertiary care sites, one in North India and one in South India, within six months, with funding support from the Indian Council of Medical Research (ICMR).

Court directed the Union government to clarify on the next date of hearing the eligibility criteria proposed for participation in the RCT, including whether randomisation could result in some participants, particularly those already undergoing the therapy, being excluded from the intervention under study and consequently being unable to avail of its potential benefits.

What did Supreme Court direct for existing patients?

For patients who had commenced stem cell therapy for ASD on or before January 30, 2026, Court directed the Union government to establish a dedicated online portal to maintain their medical records.

The portal will include details of the treating medical practitioners, the nature and course of the intervention administered and other clinical details prescribed by the competent authority. The Court said appropriate safeguards must be put in place for the confidentiality and security of patients' medical information.

The portal is to be created within six weeks.

As a strictly temporary arrangement, such patients may continue the ongoing procedure at their existing clinics or institutions, subject to registration on the portal and compliance with monitoring, reporting and other safeguards prescribed by the competent authority.

Court made it clear that this arrangement is confined to existing patients and cannot be treated as recognition or approval of stem cell therapy for ASD as a permissible clinical service.

No new patients can be inducted outside approved trials

The Bench also allowed interested individuals to place their views and suggestions before the National Stem Cell Research Regulation Committee. The Union government was directed to establish a dedicated online portal for submission of such views and suggestions within four weeks.

Court said the need for a step-wise procedure to be widely disseminated had become urgent because the failure of authorities to effectively curb the illegal administration of the prohibited intervention as a clinical service had resulted in the proliferation of clinics and doctors offering such services.

"The lack of readily accessible information, which the public could consult to ascertain the legal position, has tacitly enabled such malpractice to continue," the Bench said.

It added that the labyrinth of rules, regulations, office orders and advisories, unless presented in a clear and coherent manner, leaves room for malpractice and enables dubious elements to exploit the lack of public awareness.

The Court accordingly reiterated that no new patients can be inducted for stem cell therapy for ASD outside a duly approved and monitored research or clinical trial setting.

The matter has been listed for further consideration on December 14, 2026.

Case Title: Yash Charitable Trust & Ors Vs Union of India & Ors

Bench: Justices J B Pardiwala and R Mahadevan 

Date of Judgment: October 13, 2026