Yash Charitable Trust v. Union of India 2026 INSC 96 - Stem Cell Therapy - Autism Spectrum Disorder
Stem Cell ‘Therapies’ For ASD Cannot Be Offered As A Clinical Service By Doctors: Supreme Court
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Drugs Act, 1940 - Stem cell “therapy” for the treatment of Autism Spectrum Disorder (ASD) cannot continue as a commercial endeavour in the form of routine clinical treatment– Stem cell therapy is required to be undertaken in a clinical trial format. Although, the stem cells administered for therapeutic use in ASD are characterised as “drugs” under the Drugs Act, 1940, yet the same by itself is not determinative of the fact that it is permissible to be administered as a clinical service - Stem cell ‘therapies’ for ASD cannot be offered by medical practitioners as a clinical service, outside an approved and monitored clinical trial/research setting (Para 151,153)
Medical Profession - Every medical practitioner owes to his patient a duty to exercise a reasonable degree of care, skill, and knowledge expected of a prudent practitioner in the same field. A medical practitioner cannot be said to meet the standard of reasonable care if he administers an intervention that lacks credible scientific evidence of safety and efficacy, or where authoritative medical bodies unequivocally state that such form of treatment is not recommended. if an intervention is characterised by the relevant scientific community or regulatory authorities, as unproven, experimental, obsolete, or lacking justification, such an intervention cannot be defended as exercise of due care and reasonable judgment by a medical practitioner. (Para 151)
Medical negligence - Experimental treatment - A medical practitioner who administers speculative, unproven, or experimental treatments even when credible professional bodies have expressly advised against the use of such an intervention, may be held liable on count of professional misconduct. The administration of such a treatment would fail to satisfy the standard of reasonable care necessitated under the established medical negligence jurisprudence in India. The only circumstance in which an experimental treatment may be provided is when it is administered within an approved research or clinical trial setting. (Para 151)
Medical Treatment- Essentials of informed consent: (i) First, consent obtained by a medical practitioner must be real and valid. It is imperative that the following three conditions are met for a patient’s consent to be valid: • the patient should have the capacity and competence to consent; • consent should be voluntary; and • consent should be on the basis of adequate information, concerning the nature of the treatment procedure, so that the patient knows what the consent is for. (ii) Secondly, “adequate information” about a procedure or treatment must necessarily consist information about • the nature and procedure of the treatment; • its purpose and benefits; • its likely effects and complications; • any alternatives, if available; • an outline of the substantial risks; and • adverse consequences of refusing the treatment.
Legislation- Executive Instructions - instructions can only supplement a statute to address areas that are within the statute’s purview but have not been covered thereby. However, in no situation can such instructions run contrary to statutory provisions or whittle down their effect. (Para 137)
Case Info
Case name: Yash Charitable Trust & Ors. v. Union of India & Ors.Neutral citation: 2026 INSC 96
Coram:Justice J.B. Pardiwala and Justice R. Mahadevan
Judgment date:30 January 2026 (New Delhi)
Statutes / laws referred:Drugs and Cosmetics Act, 1940 (including Sections 3(b), 18, 27(d), 33P, 38)New Drugs and Clinical Trial Rules, 2019 (NDCT Rules), especially Rules 2(1)(w), 6–8, 11, 14, 15–18, 20–22, 25, 52, 74, 91, 100Drugs Rules, 1945National Medical Commission Act, 2019 (Sections 16, 27, 30, 57, 61)Indian Medical Council Act, 1956 (repealed, but saved via NMC Act)Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, especially Regulations 7, 7.22, 8National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 (referenced in principle)Clinical Establishments (Registration and Regulation) Act, 2010 (Sections 32, 40)Right to Information Act, 2005Constitution of India – Article 21 (right to life, patient autonomy)Government of India (Allocation of Business) Rules, 1961
Guidelines / policy documents discussed:National Guidelines for Stem Cell Research, 2017 (NGSCR 2017) – ICMR/DHREvidence Based Status of Stem Cell Therapy for Human Diseases, 2021 (EBSSCT 2021) – ICMRNational Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 – ICMRRecommendations of Ethics & Medical Registration Board, NMC, on Stem Cell Use in ASD – 06.12.2022 (EMRB‑NMC recommendations)Order dated 03.03.2024, Department of Health Research (DHR), dissolving NAC‑SCRTMoHFW clarification letter dated 09.02.2021 under Section 33P, defining “stem cell derived product”Minutes of the Drugs Technical Advisory Board (DTAB), 84th Meeting, 27.08.2019
Case law and citations referred:Indian Medical Association v. V.P. Shantha & Ors., (1996) 86 Comp Cas 806 (SC) – adoption of Bolam test, standard of careBolam v. Friern Hospital Management Committee, (1957) 1 WLR 582 (QB) – classic Bolam testLaxman Balkrishna Joshi v. Trimbak Bapu Godbole, 1968 SCC OnLine SC 260 – duty of care of doctorsJacob Mathew v. State of Punjab, (2005) 6 SCC 1 – medical negligence, standard for criminal/civil liabilityKusum Sharma v. Batra Hospital, (2010) 3 SCC 480 – principles on medical negligenceM.A. Biviji v. Sunita & Ors., (2024) 2 SCC 242 – restatement of standard of care, “sound and relevant medical practice”Samira Kohli v. Dr. Prabha Manchanda & Anr., (2008) 2 SCC 1 – informed consent, “adequate information”Common Cause (A Regd. Society) v. Union of India & Anr., (2018) 5 SCC 1 – Chandrachud J.’s opinion on consent and patient’s inability to demand a specific treatmentChimanlal Jagjivan Das Sheth v. State of Maharashtra, 1962 SCC OnLine SC 16 – wide meaning of “drug” and “substances”Ishwar Singh Bindra & Ors. v. State of U.P., 1968 SCC OnLine SC 98 – “drug” under Section 3(b), reading “and” disjunctivelyState of M.P. v. G.S. Dall and Flour Mills, 1992 Supp (1) SCC 150 – executive instructions cannot override statutory rulesJaiveer Singh v. State of Uttarakhand, (2024) 15 SCC 227 – reiteration that executive orders cannot supplant rulesAbhishek Agarwal & Anr. v. Union of India & Anr., W.P.(C) 5147/2019 (Delhi High Court, order dated 04.09.2019) – interim permission to continue certain stem cell treatments pending regulatory clarityDalip Kaur & Anr. v. Union of India & Anr., WP(C) 6850/2023 (Delhi High Court, interim order dated 31.08.2023) – continuation of ongoing stem cell treatment in ASD at patients’ own risk