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Informist, Friday, Jan. 30, 2026

 

NEW DELHI – The Supreme Court Friday held that stem cell therapy for treatment of autism outside an approved clinical trial is unethical and shall be considered as malpractice, since there is a lack of reliable and conclusive research on the efficacy and safety of such procedures. If a medical practitioner chooses to offer stem cell therapies for autism spectrum disorder, outside of an approved clinical trial, then such practitioners would be considered as having failed to act in accordance with the reasonable standard of care, the top court said.

 

The Bench of Justice J.B. Pardiwala and Justice R. Mahadevan said that stem cell therapy for autism spectrum disorder cannot continue as a commercial endeavour in the form of routine clinical treatment. However, the court does not wish to leave the patients who are already undergoing the therapy in any apprehension that discontinuing it may prove detrimental to their well-being, the bench said. The court directed the secretary of the Ministry of Health and Family Welfare, in consultation with the officials of AIIMS and the National Medical Council, to provide the best possible solution in this regard so as to ensure that such patients are able to continue receiving the therapy till the time they can be rerouted to the institutions that are conducting clinical trials.

 

It is unfortunate that the Centre has allowed the matter to worsen without timely intervention, the top court said. Such inaction has led to several parents and guardians seeking an unproven method of treatment for their children suffering from autism spectrum disorder, incurring huge financial costs, the court said.

 

It cannot be denied that various clinics, in flagrant violation of the statutory mandate, continued to recommend and perform stem cell therapy as a routine clinical treatment for autism spectrum disorder because there was a lack of executive action against the same, the court said. The court asked the Centre to consolidate and clarify the position of law to enable better implementation and insisted on the creation of a dedicated authority for the regulatory oversight of stem cell research across the country. In this regard, the top court suggested enacting legislation to clarify issues that plague stem cell research.

 

Even though the patient may have voluntarily opted for such a procedure, such a choice does not constitute valid consent to undergo the treatment due to the lack of adequate information on which to base it, the court said. It clarified that one would still have the liberty to participate in an approved and regulated research or clinical trial involving stem cell therapy for autism spectrum disorder.

 

The top court noted that Rules 15 and 16(4) of the New Drugs and Clinical Trial Rules, 2019, by giving binding effect to the National Ethical Guidelines, mandate that any research involving stem cells must be undertaken as a clinical trial. The natural corollary of this stipulation is that the therapeutic use of such stem cells cannot be offered as a medical treatment for autism spectrum disorder, the court said.

 

The apex court was hearing a public interest litigation by Yash Charitable Trust and others on concerns relating to the rampant promotion, prescription and administration of stem cell therapy for the treatment of autism spectrum disorder by several clinics across the country. The petitioners said that although stem cell therapy could be said to be still at an experimental stage, the same was being touted as a treatment and cure for autism spectrum disorder by various clinics and hospitals in flagrant violation of the existing legal framework and guidelines. 

 

The individuals diagnosed with autism spectrum disorder and their parents and guardians are unaware of the scientific and legal intricacies and unsuspectingly place their implicit faith in such hospitals in the hope of there being a miraculous cure and fall victim to cost-intensive procedures such as the present one, the petitioners said. Stem cell therapy for autism spectrum disorder is illegal and does not provide for safety nets that are available to the subjects of clinical trials under the present regulatory framework, the petitioners said.  End

 

Reported by Surya Tripathi

Edited by Saji George Titus

 

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