Stem Cell Therapy Not Allowed As Routine Treatment For Autism, Permitted Only In Clinical Trials: Supreme Court
Kiran Raj
The Supreme Court Division Bench of Justice J.B. Pardiwala and Justice R. Mahadevan, on January 30, held that offering stem cell treatment as a routine clinical service for Autism Spectrum Disorder is not permissible, as it is not recognised as a sound medical practice and lacks adequate scientific support and empirical evidence. The Court said that any use of stem cells for ASD outside an approved and monitored clinical trial is unethical and amounts to malpractice, while clarifying that stem cell interventions may be undertaken in a regulated research or clinical trial setting. It directed the Health Ministry, in consultation with AIIMS and the national medical regulator, to propose a workable arrangement for patients already receiving the therapy to continue until they can be transitioned to trial institutions, with submissions to be filed within four weeks.
The petitioners, including a registered trust and a developmental paediatrician, filed a Public Interest Litigation raising concerns regarding the promotion and administration of stem cell therapy for Autism Spectrum Disorder (ASD) by various clinics. The petitioners contended that such therapies are unproven, experimental, and offered in violation of the New Drugs and Clinical Trial Rules, 2019 (NDCT Rules) and the National Guidelines for Stem Cell Research, 2017 (NGSCR). They argued that stem cell therapy for ASD lacks established safety and efficacy and should only be conducted within controlled clinical trials.
The Union of India submitted that while "stem cell derived products" are regulated as new drugs under the NDCT Rules, therapies involving minimally manipulated autologous stem cells do not fall under the definition of "stem cell derived products" per a 2021 clarification. Private clinics and parent associations argued that autologous stem cell therapy, which uses a patient’s own cells, is a procedure rather than a drug and cited patient autonomy and anecdotal improvements.
The core dispute involved determining whether these therapies constitute a "drug" under the Drugs and Cosmetics Act, 1940, and if offering them as routine clinical services constitutes professional misconduct.
The Bench framed two issues for consideration.
On the first issue—whether doctors, clinics, hospitals or institutions can legally offer stem cell “therapy” for ASD as a routine healthcare service—the Court examined the EMRB-NMC recommendations (06.12.2022) alongside the EBSSCT, 2021, the NGSCR, 2017 and the National Ethical Guidelines issued by the ICMR, and recorded that these materials do not support therapeutic use of stem cells for ASD as routine clinical treatment. It noted that the therapy is not recognised as a sound medical practice because scientific support and empirical evidence of efficacy are lacking, and that any such use is contemplated only within approved and monitored clinical trials intended to advance research.
It concluded: “Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice. Therefore, medical practitioners who offer such stem cell therapy as a routine clinical service and not in a research/clinical trial setting, could be said to be failing to meet the reasonable “standard of care” owed by them towards the patients as expounded by this Court in M.A. Biviji (supra) and V.P. Shantha (supra).”
On patient autonomy and consent to an unproven treatment, the Court stated: “we are of the considered view that a treatment cannot be demanded by a patient as a matter of right. This Court's dictum in Samira Kohli (supra) underscores that adequate information as regards a particular treatment, is the bedrock and the consent thereto should be on the basis of such adequate information. It is undisputed that stem cell therapy for treatment of ASD does not fulfil the essentials of 'adequate information'. The validity of consent stems from the nature and information available about the treatment. In the absence of such knowledge, the patients may remain under therapeutic misconception and anticipate such results from an unproven treatment as may be expected from routine treatment and care.”
On the second issue—whether the Drugs Act, 1940 and the NDCT Rules, 2019 provide a regulatory framework for research in stem cell therapies used for ASD—the Court proceeded on the basis that even if autologous stem cells used in such interventions may not meet the criteria of a “new drug” under the NDCT Rules, they may still fall within the broader definition of “drugs” under the Drugs Act.
It recorded: “We say so because all stem cells fall within the purview of “drugs” as 'substances' under Section 3(b)(i) of the Drugs Act, 1940. Therefore, there is no gainsaying that the scheme of the Drugs Act, 1940 envisages providing protections being available in respect of stem cell therapy for ASD. We find that Chapter IV of the NDCT Rules, 2019, which relates to Biomedical and Health Research, provides such safeguards and the necessary regulatory pathway in respect of stem cell therapy for ASD.”
The Court then set out the regulatory position, distinguishing between stem-cell derived products (attracting the clinical trial framework for “new drugs”) and minimally manipulated stem cells (to be governed as biomedical and health research under Chapter IV of the NDCT Rules). In that context, it stated: “In such circumstances, any research involving such stem cells is to be governed by the regulatory framework in place for “biomedical and health research” under Chapter IV of the NDCT Rules, 2019. Rules 15 and 16(4) respectively, thereof provide binding effect to the National Ethical Guidelines, which in turn provides in Clause 7.9.1 that any use of stem cells involving human participants (except for haemopoietic stem cell transplantation for haematological disorders) shall be undertaken as a clinical trial. Furthermore, Clause 4.2.4 of the National Ethical Guidelines mandates that review of proposals for research in stem cells must be in accordance with the NGSCR, 2017. Since, Rules 15 and 16(4) respectively, of the NDCT Rules, 2019 make the National Ethical Guidelines legally enforceable, we are of the considered view that all stem cell research involving human participants must necessarily be in a clinical trial setting.”
“Non-compliance of the aforesaid statutory mandate must attract consequences viz. professional misconduct under Regulation 7.22 of the IMC Regulations, 2002 as well as action under Sections 32 and Section 40 respectively, of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for the cancellation of registration and penalty”. The Court also clarified that “any entity that intends to undertake even a part of the processing of stem cells, would be required to obtain necessary prior approvals which are to be undertaken for biomedical and health research, or clinical trial, depending on the degree of processing involved”.
Regarding patients currently undergoing treatment, the Court directed, “we direct the Secretary, 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 re-routed to the institutions that are conducting clinical trials”. The Secretary was further directed to “file submissions in compliance with this direction within a period of four (4) weeks from the date of pronouncement of this judgment”.
Case Title: Yash Charitable Trust & Ors. v. Union of India & Ors.
Neutral Citation: 2026 INSC 96
Case Number: Writ Petition (C) No. 369 of 2022
Bench: Justice J.B. Pardiwala and Justice R. Mahadevan
