Supreme Court orders autism patients on stem cell therapy to register on Centre’s portal

The Supreme Court ordered the Union government to create a dedicated online portal for people who had begun stem cell therapy for Autism Spectrum Disorder on or before January 30, 2026. The portal must be launched within six weeks of the October 13 order. It is meant to bring these patients into a monitored, regulated framework while a proposed clinical trial is prepared.

The information duty is broad. Patients, their parents, guardians and caregivers must register and submit details. Treating medical practitioners and clinics administering the therapy must also maintain the required database. This creates one common record instead of scattered or unavailable information.

The Court also ordered safeguards for confidentiality and medical-data security. Registration does not approve stem cell therapy as an ordinary service. It is part of a temporary arrangement for existing patients while the Centre develops a research pathway and issues clearer regulatory guidance.

Stem cell therapy is a medical intervention that uses stem cells, which can develop into or support different types of cells, to try to repair, replace or influence body tissue. The article does not describe a proven stem-cell treatment for autism. It discusses the therapy as an intervention being offered to some ASD patients.

The Supreme Court’s January 30 order prohibited its use as a routine clinical service. The therapy may be undertaken only within an approved and monitored clinical trial or research setting. This distinction matters because ordinary clinical care can be offered as an accepted service, while research must follow regulatory oversight and defined procedures.

The Court said the public must be clearly told that stem cell therapy for ASD is not permissible outside such an approved setting. It also gave the Centre six weeks to explain the regulatory regime, including requirements for different levels of stem-cell manipulation.

The portal must collect patients’ medical records and identify the medical practitioners treating them. It must also record the nature and course of the intervention administered. These details are intended to show what therapy was given, by whom and over what treatment course.

The Court further allowed the portal to require other clinical details specified on the system. Patients, parents, guardians and caregivers must provide information, while treating practitioners and clinics must maintain the corresponding database. This shared record can help authorities identify existing patients and understand their treatment histories.

The information is not meant to create approval for the therapy. The Centre must protect confidentiality and medical security. The records will support the temporary continuation of treatment for eligible existing patients and help move them into a regulated research framework when the proposed trial is established.

The Supreme Court gave the Centre six weeks from the October 13 order to establish the dedicated portal. It gave the same six-week period to issue a comprehensive protocol explaining the regulatory regime for ASD-related stem-cell research and clinical trials. The information must be clear enough for stakeholders to understand the requirements.

The proposed clinical trial is a multicentre randomised controlled trial. It is planned at two tertiary-care sites: one in north India and another in south India. The Indian Council of Medical Research will fund it, and the Centre’s affidavit said it was proposed to be set up within six months.

The Court found that the proposal did not yet specify eligibility criteria for patients already receiving therapy. It also lacked a uniform platform for patients and caregivers to submit information. The portal and protocol are intended to address those gaps while the trial is developed.

Patients who had commenced stem cell therapy for ASD on or before January 30, 2026, may continue treatment after registering on the new portal. The Court described this as a strictly temporary arrangement. It applies only to patients already undergoing therapy by that date.

The continuation lasts until the proposed randomised controlled trial is established. The Centre’s affidavit proposed a multicentre trial at two tertiary-care sites, supported by the Indian Council of Medical Research. The Court ordered the existing patients to be shifted into a regulated research framework, but noted that the proposal lacked eligibility criteria for them.

This permission is narrow. The Court expressly said it must not be treated as recognition or approval of stem cell therapy for ASD as a permissible clinical service. New patients cannot rely on the arrangement to begin routine treatment outside an approved and monitored trial or research setting.

The Supreme Court said many patients and families pursued stem cell therapy because easily accessible information about its use for ASD was lacking. Without a clear public explanation, people could not readily determine whether a clinic’s offer was legally permitted or part of approved research.

The Court criticised authorities for failing to curb the malpractice. It said the absence of a public, accessible source explaining the regulatory position had tacitly enabled clinics and doctors to offer the prohibited intervention as a clinical service. Clearer information could help families identify the difference between regulated research and ordinary treatment.

The Centre must therefore place clear information in a dedicated, easily identifiable section of the Health Ministry’s official website. It must explain that stem cell therapy for ASD is not permissible outside approved, monitored research or trials, and publish the applicable regulatory requirements.

A randomised controlled trial is a structured research study in which eligible participants are assigned by chance to different groups. Researchers compare outcomes under defined conditions. Random assignment helps reduce the influence of personal or clinical differences when the groups are assessed.

That differs from an ordinary clinical service. In routine care, a clinic offers an intervention to patients as treatment, rather than enrolling them under a research design with specified eligibility, monitoring and comparison. A trial must follow an approved protocol and regulatory oversight. Its purpose is to generate reliable evidence about safety or effects.

The article says a multicentre RCT was proposed for ASD stem cell therapy at two tertiary-care sites. However, the Court found that the proposal did not state eligibility criteria for patients already receiving therapy. Until the trial is established, those existing patients may continue only under the Court’s temporary arrangement.