Published Mar 26, 2026 | 7:15 PM ⚊ Updated Mar 26, 2026 | 7:15 PM
Autism. (iStock)
Synopsis: It clarified that “only hematopoietic stem cell transplantation is recognised as standard care,” while mesenchymal stem cell therapy, widely marketed by private clinics for autism and other disorders, “has not been approved for any disease condition.”
The National Medical Commission (NMC) has declared stem cell therapy illegal for the treatment of Autism Spectrum Disorder (ASD), issuing a nationwide advisory in line with a recent judgment of the Supreme Court of India.
In its 25 March advisory to medical colleges, hospitals and registered practitioners, the NMC stated that stem cell therapy “can now be used only for 32 approved disease conditions,” all of which are haematological or oncological in nature.
It clarified that “only hematopoietic stem cell transplantation is recognised as standard care,” while mesenchymal stem cell therapy, widely marketed by private clinics for autism and other disorders, “has not been approved for any disease condition.”
The advisory follows the Supreme Court’s 30 January, 2026 ruling in Yash Charitable Trust vs Union of India, where the bench categorically held that stem cell therapy for ASD “cannot be offered by medical practitioners as a clinical service, outside an approved and monitored clinical trial/research setting.”
The petitioners had flagged what they described as the “unrestricted marketing and commercialisation of stem cell therapy,” alleging that clinics were operating in “flagrant violation of the existing legal framework” without regulatory approvals or ethics committee oversight.
Taking note, the court directed the Union government to “consolidate and clarify the position of law” and ensure better enforcement.
The court’s ruling rests on a consistent scientific position taken by regulators and expert bodies over the years.
The Ethics and Medical Registration Board (EMRB) of the NMC had concluded that there is “insufficient and inadequate scientific evidence on efficacy of the stem cell therapy in ASD.” It further warned that “the use of stem cell in ASD, its promotion and advertisement will be considered as professional misconduct.”
This view was reinforced by the Indian Council of Medical Research (ICMR), which stated in its 2021 review that available evidence does not support stem cell therapy “over and above the behavioural and supportive therapies for ASD.” The ICMR also acknowledged that “many Indian patients with ASD have been offered different types of stem cell therapies as a standard treatment option” outside approved trials.
The National Guidelines for Stem Cell Research, 2017, go further, stating that “any stem cell use in patients outside an approved clinical trial is unethical and shall be considered as malpractice.”
The Supreme Court also rejected the argument that parental consent could legitimise the therapy.
It held that “where scientific evidence is absent or inconclusive, the pre-requisite of disclosure of adequate information to obtain a valid consent cannot be satisfied.” In such a situation, the court said, consent itself becomes legally and ethically untenable.
Clarifying the limits of patient autonomy, the bench added that “consent does not confer on a patient the right to demand that a particular form of treatment be administered,” particularly if it is “scientifically unvalidated, ethically impermissible, and outside the bounds of reasonable medical practice.”
The judgment paints a stark picture of how stem cell therapy has been commercialised in India.
It noted that clinics were offering the treatment “as a routine clinical treatment for ASD,” leading families to incur “huge financial cost” in pursuit of unproven interventions. The court described this as “therapeutic misconception,” where patients believe experimental therapies are equivalent to established medical care.
Warning against such practices, the bench observed: “To lead patients and their guardians to put faith in treatments wherein this substructure itself is absent is… wholly unethical and against the tenets of medical jurisprudence on informed consent.”
Regulators have similarly flagged “predatory marketing practices” that create “false hopes” and “unrealistic expectations,” with earlier government data indicating dozens of entities offering such therapies.
Going forward, the NMC and ICMR have made it clear that any use of stem cell therapy outside the 32 approved indications will be treated as illegal unless conducted within a properly approved clinical trial.
In a communication accompanying the advisory, the ICMR stated that “any stem cell treatment not included in the list of standard care indications, or not approved by CDSCO or DHR shall be deemed illegal.”
The regulatory pathway distinguishes between levels of manipulation. Where stem cells are more than minimally manipulated, oversight will fall under CDSCO; where manipulation is minimal, regulation will be under the Department of Health Research along with the National Stem Cell Research Regulation Committee.
Crucially, patients enrolled in such trials “cannot be charged” and must be compensated in case of injury or death.
The NMC has warned that practitioners who administer, promote or advertise stem cell therapy for ASD outside permitted settings will face action for professional misconduct under medical ethics regulations.
Errant clinics could also face cancellation of registration and penalties under existing laws.
The Supreme Court, meanwhile, has called for the reconstitution of the National Apex Committee for Stem Cell Research and Therapy and urged Parliament to enact a dedicated legal framework, including provisions for penal consequences where patient safety is compromised.
(Edited by Sumavarsha)
