The Supreme Court has directed the Centre to create a dedicated online portal for patients undergoing stem cell therapy for Autism Spectrum Disorder (ASD) within six weeks. The court also made it mandatory for such patients, their parents, guardians, caregivers and also the treating medical practitioners and clinics administering such therapy to maintain an extensive database.
The order, passed on October 13 and uploaded on Friday, comes in the backdrop of the court’s January 30 order prohibiting the use of stem cell therapy as a routine clinical service, directing it only to be undertaken only within an approved and monitored clinical trial or research setting.
A bench of justices JB Pardiwala and R Mahadevan said, “As regards patients who had already commenced stem cell therapy for ASD on or before January 30, 2026, we direct the Union to establish a dedicated online portal…Such online portal is to be created within a period of 6 weeks from the date of this order.”
The particulars to be given on the portal included the medical records of such patients, including the particulars of the treating medical practitioners, the nature and course of the intervention administered, and such other clinical details as specified on the portal. The bench directed the Centre to ensure appropriate safeguards for the confidentiality and security of the patients’ medical information.
Last month, the court had directed the Centre to disclose how many applications for clinical trials were received pursuant to its January 30 order. It further asked the Centre to indicate steps being taken to shift those ASD patients already undergoing stem cell therapy as of January 30 into a regulated research framework.
The Centre filed an affidavit on September 28 which said that pursuant to January 30 no application for a clinical trial had been received. Regarding the other issue, the Centre stated that a multicenter randomised controlled trial (RCT) has been proposed to be set up at two tertiary care sites – one in north India and another in south India, within a period of six months. This will be funded by the Indian Council of Medical Research (ICMR).
After reviewing the response, the court found that the proposed RCT does not lay down any eligibility criteria for patients already undergoing stem cell therapy for ASD. Further, there was no uniform platform for such patients or their caregivers to provide their information.
After registering on the portal, the court said that until the RCT is established, patients who commenced stem cell therapy for ASD on or before January 30 will be permitted to continue therapy, as a “strictly temporary arrangement”.
“This arrangement shall be confined to existing patients and shall not be construed as recognition or approval of stem cell therapy for ASD as a permissible clinical service,” the court added.
The court further noted that the lack of easily accessible information about the use of stem cell therapy for ASD is a prime reason for many patients and their families to pursue such treatment.
It granted the Centre six weeks to issue a comprehensive protocol clearly explaining the regulatory regime governing the use of stem cells in research and clinical trials relating to ASD. “The objective is to ensure that no stakeholder is left to navigate a labyrinth of regulatory instruments without being able to ascertain the precise requirements applicable to them,” the order said.
The court directed the Centre to clearly inform the public that stem cell therapy for ASD is not permissible as a clinical service outside a duly approved and monitored research or clinical trial setting. Such information was ordered to be put out in a dedicated and easily identifiable section of the Ministry of Health’s official website in a clear and accessible language.
“The need of the hour is to clearly explain the existing regulatory framework applicable to research/clinical trial corresponding to different levels of manipulation of stem cells for ASD,” the bench said. It was critical of the Centre and various authorities concerned in this field for failing to curb this malpractice due to a lack of readily accessible information to the public.
“The failure of the authorities to effectively curb the malpractice of illegally administering a prohibited form of medical intervention as a clinical service has led to 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 court said.
The bench allowed the Parents’ Forum for Stem Cells in Autism and Cerebral Palsy to make their suggestions to the Centre while formulating the proposed design of the RCT. It also asked the Centre what mechanism will be available for those patients excluded from receiving the intervention under RCT as they too are continuing the treatment as per the present arrangement.
The order required the Centre to deliberate upon this issue and place a comprehensive plan for the continued monitoring and medical supervision of such participants, including appropriate follow-up, assessment of their clinical condition and such further measures as may be necessary to safeguard their health and well-being.
The court further clarified its January 30 order to suggest that the prohibition is on the use of stem cell being administered as a “therapy” for ASD based on the availability of scientific evidence and the prevailing regulatory framework in the country. However, “It does not amount to an immutable prohibition against any future development in this field,” it added.
The court sought compliance report from the Centre before the next date of hearing on December 14.