Stem Cell Therapy for ASD Supreme Court Judgment: Regulation, Ethics & Legal Impact

Case Summary

• Case: Yash Charitable Trust & Ors. v. Union of India & Ors., W.P. (C) No. 369 of 2022 (2026 INSC 96)

• Date of Judgment: 30 January 2026

• Bench: Honourable Justice J. B. Pardiwala; Honourable Justice R. Mahadevan

• Leading Advocates/Counsel appearing: Mr Siddharth Nath (for petitioners); Mr Vikramjit Banerjee, Ms Aishwarya Bhati (Additional Solicitor Generals for Union of India); Mr Prateek Bhatia (for National Medical Commission); Mr Utkarsh Sharma (for Neurogen Brain & Spine Institute Pvt. Ltd.); Mr Nikilesh Ramachandran (for Reelabs Pvt. Ltd.); Ms Swarupama Chaturvedi (for Saffron Naturele Products Ltd.); Mr Nitesh Ranjan (for Parents’ Forum)

• Principal statutory provisions and instruments considered: Drugs and Cosmetics Act, 1940 (Section 3(b)); NDCT Rules, 2019 (Rule 2(1)(w)(v), Rules 15–25, Rule 52, Rule 74, Rule 91, Rule 100); Section 33P direction (MoHFW clarification dated 09.02.2021); National Medical Commission Act, 2019 (Sections 16, 27, 57, 61(2)); Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (Regulation 7.22); National Guidelines for Stem Cell Research (NGSCR 2017); Evidence Based Status of Stem Cell Therapy for Human Diseases (EBSSCT 2021); National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017; Clinical Establishments (Registration and Regulation) Act, 2010 (Sections 32 and 40)

• Notable authorities and precedent: Bolam v Friern Hospital Management Committee; Indian Medical Association v. V.P. Shantha (1996); Laxman Balkrishna Joshi v. Trimbak Bapu Godbole; Jacob Mathew v. State of Punjab (2005); Kusum Sharma v. Batra Hospital (2010); M.A. Biviji v. Sunita & Ors. (2024); Samira Kohli v. Dr Prabha Manchandra (2008); Common Cause v. Union of India (2018) (Chandrachud J. concurring); Chimanlal Jagjivan Das Sheth; Ishwar Singh Bindra; State of M.P. v. G.S. Dall & Flour Mills; Jaiveer Singh v. State of Uttarakhand

Judicial Examination of Stem-Cell Therapy Regulation in India

Analysis for Legal Professionals in India

The Supreme Court’s judgment in Yash Charitable Trust is a careful attempt to reconcile competing concerns: the desperate hopes of parents of children with Autism Spectrum Disorder (ASD), the emerging but inconclusive science around stem-cell interventions, and the need for coherent regulatory oversight. The Bench sets out a two-fold analytic trajectory: (i) whether stem-cell therapies for ASD can be offered as routine clinical services; and (ii) if not, what regulatory pathway governs ethically permissible research and clinical trials.

The Court’s starting point is well-founded in medical negligence jurisprudence. Applying Bolam and its Indian refinements (V.P. Shantha, Jacob Mathew, Kusum Sharma, and the recent M.A. Biviji), the Bench reiterates the central test: a practitioner’s conduct must conform to a practice accepted by the medical profession of that day, judged by the knowledge available at the time. The consequence is direct: where an intervention is unproven and authoritative bodies advise against its routine clinical use, offering it as a paid treatment will ordinarily fail the standard of care.

The judgment gives substantial weight to expert guidance—principally the ICMR/DHR publications (NGSCR 2017 and EBSSCT 2021) and the EMRB (NMC) recommendations of 06.12.2022. The Court emphasises that these documents, though some are guidelines rather than statutes, are authoritative indicators of the contemporary scientific and ethical baseline. In particular, the judgment quotes the EMRB’s conclusion that: ""Stem cell therapy is not recommended as a treatment for Autism Spectrum Disorder (ASD) in clinical practice,"" and records that promotion of such therapy for ASD would be treated as ""professional misconduct.""

Statutory Interpretation and Regulatory Framework

Legal Classification of Stem Cells and Drugs Law

Two technical but critical statutory readings follow. First, the Court construes ‘stem cells’ as falling within the broad statutory definition of ""drug"" in Section 3(b) of the Drugs Act, 1940, as a ""substance intended to be used for... treatment"". Second, it unpacks the NDCT Rules, 2019 categorisation: only ""stem-cell derived products"" that have undergone ""substantial or more than minimal manipulation"" are perpetually treated as ""new drugs"" and hence regulated as such. Autologous cells used intra-operatively with minimal manipulation fall outside that sub-category but nonetheless remain ""drugs"" for many regulatory purposes.

This nuanced separation matters for the regulatory route. For stem-cell derived products, the full NDCT clinical-trial regime (ethics committee registration, Central Licensing Authority approval, trial safeguards, compensation regimes) applies. For minimally processed autologous cells, the Court reads the statutory and ethical framework to require that such uses are conducted only in clinical trial/research settings governed by the National Ethical Guidelines and NDCT Chapter IV (biomedical and health research), with institutional ethics committees and IC-SCR oversight. The Court therefore rejects the thesis that autologous use automatically renders the therapy outside statutory control.

Consent, Autonomy and Limits of Patient Choice

The judgment is firm on consent and patient autonomy. Drawing on Samira Kohli and Common Cause, the Court holds that autonomy does not convert into a right to demand an unproven treatment. ""Consent gives an individual the ability to choose... But consent does not confer on a patient the right to demand that a particular form of treatment be administered."" In practical terms, where adequate scientific information is lacking, so too is the capacity to provide the ""adequate information"" necessary for valid informed consent.

Structural Regulatory Gaps Identified by the Court

Two governance deficits underpin the Court’s recommendations. First, the fragmentary nature of the regulatory architecture—rules, guidelines and ad hoc Executive orders—creates ambiguity that has been exploited. Second, the dissolution of the NAC-SCRT (03.03.2024 Order) and the Ministry’s direction carving the DHR out of regulatory oversight have produced a regulatory lacuna. The Bench correctly holds that executive instructions cannot supplant statutory rules and that Rule 17–18 NDCT (DHR oversight of ethics committees) cannot be rendered ineffective by administrative fiat.

Practical Consequences for Medical Practice and Institutions

Practical consequences for practitioners and institutions are stark. Until robust evidence is produced through approved clinical trials, offering stem-cell therapy for ASD as a routine paid clinical service risks disciplinary action under professional regulations and statutory penalties (Clinical Establishments Act; suspension or de-registration of ECs). The Court calls for reconstitution of a dedicated national authority (NAC-SCRT) or otherwise clear statutory consolidation—suggesting legislative reform and tighter licensing, consent, inspection and redress mechanisms.

Key Judicial Quotations

• Stem cell therapy is not recommended as a treatment for Autism Spectrum Disorder (ASD) in clinical practice. (EMRB recommendations endorsed by the Court)

• Consent gives an individual the ability to choose... But consent does not confer on a patient the right to demand that a particular form of treatment be administered. (Chandrachud J., Common Cause — relied upon)

• Any stem cell use in patients outside an approved clinical trial is unethical and shall be considered as malpractice.(NGSCR 2017 / EBSSCT 2021 summarised)

Implications for litigation, regulation and clinical practice

• Legal risk: Hospitals and practitioners offering commercial stem-cell therapy for ASD face exposure to professional misconduct complaints (Regulation 7.22 IMC Regulations 2002/NMC transitional provisions) and to regulatory action under the Clinical Establishments Act and Drugs Act.

• Regulatory priority: The judgment compels the Union to clarify the regulatory pathway and to restore a national apex oversight mechanism; institutions must ensure ECs with requisite stem-cell expertise and robust, documented consent procedures.

• Research design: Investigators and sponsors must act through the NDCT/EC route; sponsors cannot convert treatment into commerce by labelling interventions as ‘‘therapy’’ outside properly approved trials. Stringent informed consent, prohibition on charging participants for experimental interventions, and compensation mechanisms must be respected.

Conclusion

This judgment marks a principled recalibration: it protects vulnerable patients from commercialisation of unproven interventions while preserving space for ethically regulated research. For practitioners and institutions, the takeaway is clear — stem-cell interventions for ASD must proceed only within approved research protocols and under unambiguous regulatory oversight; otherwise, they invite professional, administrative and criminal censure. The Court’s invitation to legislative consolidation should be heeded urgently to eliminate the present regulatory fragmentation.

Authorised passage on ethics oversight and standard of care

The EMRB is constituted by the Central Government as an Autonomous Body under Section 16(d) of the NMC Act, 2019. As per Section 27(1)(b), the EMRB has the power to regulate professional conduct and promote medical ethics in accordance with the regulations framed under the NMC Act, 2019. Moreover, as per Section 27(2) of the NMC Act, 2019, the EMRB may, in the discharge of its functions, make such recommendations to, and seek such directions from, the NMC, as it deems necessary. Sections 27(1)(b) and 27(2), respectively, read thus:

27. Powers and functions of Ethics and Medical Registration Board.- (1) The Ethics and Medical Registration Board shall perform the following functions, namely:- (b) regulate professional conduct and promote medical ethics in accordance with the regulations made under this Act: Provided that the Ethics and Medical Registration Board shall ensure compliance of the code of professional and ethical conduct through the State Medical Council in a case where such State Medical Council has been conferred power to take disciplinary actions in respect of professional or ethical misconduct by medical practitioners under respective State Acts; (2) The Ethics and Medical Registration Board may, in the discharge of its duties, make such recommendations to, and seek such directions from, the Commission, as it deems necessary.

The EMRB is a statutory body under the NMC Act, 2019, responsible for regulating professional conduct and promoting medical ethics; therefore, its recommendations, once approved by the NMC, serve as authoritative guidance on what constitutes ethical and professionally acceptable conduct for medical practitioners in India. The EMRB’s recommendations expressly state that stem cell therapy for ASD is not recommended, for lack of adequate evidence, and that its use or promotion amounts to professional misconduct.

In such a view of the matter, could it be said that the administration of stem cells for therapeutic use in ASD constitutes a "sound and relevant medical practice" or a "practice acceptable to the medical profession of that day" when "judged in the light of the knowledge available at the time of the incident"? In light of this Court’s dictum in M.A. Biviji and V.P. Shantha, our answer to this question must be an emphatic ‘No’. There is no manner of doubt left in our minds that if any medical practitioner offers such stem cell therapy in ASD as a clinical service, he/she would fail to meet the reasonable standard of care which the law requires a medical practitioner to discharge.