Yash Charitable Trust & Ors. v. Union of India & Ors.

Citation: 2026 INSC 96

Court: Supreme Court of India (Original Civil Jurisdiction)

Bench: Justice J.B. Pardiwala and Justice R. Mahadevan Date of Judgment: 30 January 2026

Case Type: Writ Petition (Civil) No. 369 of 2022 (Public Interest Litigation)

Introduction

In Yash Charitable Trust v. Union of India, the Supreme Court of India addressed the unregulated promotion of stem cell “therapy” as a purported treatment for autism spectrum disorder (ASD). The judgment is significant not for expanding constitutional doctrine, but for its interdisciplinary treatment of medical negligence law, drug and clinical trial regulation, and the limits of executive rule-making power. It stands as a strong precedent on patient protection against unproven medical interventions and on the principle that executive action cannot override statutory safeguards.

Facts of the Case

The petition was filed as a Public Interest Litigation by Yash Charitable Trust, a Maharashtra-registered NGO working with persons with intellectual and developmental disabilities, including ASD, along with Dr. Vibha Krishnamurthy, a developmental paediatrician with over two decades of clinical experience in India and the United States.

The petitioners alleged that numerous clinics across India were promoting, prescribing, and administering stem cell “therapy” to children with ASD, marketing it as an effective treatment or even a cure. The petitioners did not object to legitimate scientific research into stem cells; their grievance was that clinics were offering an experimental, unproven intervention as though it were an established form of treatment. Families of children with ASD, often under considerable emotional strain and searching for any available help, were said to be particularly susceptible to being persuaded into costly and scientifically unsupported treatment.

The petitioners relied on the National Guidelines for Stem Cell Research (2017), a 2021 assessment on the evidence-based status of stem cell therapy for human diseases, and recommendations of the Ethics and Medical Registration Board (EMRB) of the National Medical Commission dated 6 December 2022 all of which indicated that stem cell interventions could only be pursued within controlled clinical trials approved by ethics committees, not as routine or commercial treatment.

A further complication arose from a Department of Health Research (DHR) order dated 3 March 2024, which dissolved the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and stated that DHR would no longer play a regulatory role in stem cell research creating a regulatory vacuum at a time when oversight was most needed.

Issues Before the Court

The Supreme Court framed two central issues:

1. Whether doctors, clinics, hospitals, or other medical institutions can offer stem cell “therapy” as a routine healthcare service for ASD.
2. Whether the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trial (NDCT) Rules, 2019 provide an adequate regulatory framework for stem cell research and clinical trials relating to ASD.

A preliminary issue of maintainability was also raised, with respondents questioning whether the petitioners who had no personal or individual grievance could maintain a PIL of this nature.

Contentions of the Parties

Petitioners argued that offering unproven stem cell interventions as routine treatment violated the standard of care owed to patients, exploited vulnerable families, and lacked any scientific or regulatory sanction under existing guidelines. They contended that stem cells fall within the definition of “drugs” under the Drugs Act, 1940, thereby subjecting their use to the clinical trial regime under the NDCT Rules, 2019.

Union of India and National Medical Commission made submissions on the existing regulatory architecture, while the maintainability of the PIL itself was contested on the ground that the petitioners had no personal stake in the matter.

Application of Law

The Court undertook a detailed review of medical negligence jurisprudence to determine whether offering stem cell “therapy” for ASD as a clinical service could attract liability.

On the standard of care, the Court applied the Bolam Test (drawn from the English decision in Bolam v. Friern Hospital Management Committee), as adopted into Indian law in Indian Medical Association v. V.P. Shantha. Under this test, a medical practitioner is not negligent if their conduct aligns with a practice accepted as proper by a responsible and competent body of medical opinion. However, the Court clarified — relying on Jacob Mathew v. State of Punjab and M.A. Biviji — that this protection is unavailable where the practice in question is not recognised as sound and relevant medical practice by authoritative bodies in light of current knowledge. A practitioner’s genuine belief in a technique’s efficacy is no defence unless grounded in reasonable and current medical evidence.

Applying this standard, the Court held that since stem cell therapy for ASD was disapproved by ICMR, DHR, and the EMRB of the NMC, offering it as a routine paid clinical service fell outside the protection of the Bolam standard and amounted to professional misconduct.

On the regulatory framework, the Court held that stem cells fall within the wide definition of “drugs” under the Drugs and Cosmetics Act, 1940, and their therapeutic use is therefore governed by the NDCT Rules, 2019. This confines their use for ASD strictly to approved and monitored clinical trial or research settings, conducted under the supervision of Ethics Committees as mandated under Rules 17 and 18 of the NDCT Rules.

On the 2024 executive order, the Court held that DHR’s order dissolving NAC-SCRT and disclaiming its regulatory role was non est — of no legal effect — because it directly conflicted with the statutory mandate under the NDCT Rules requiring DHR’s oversight of Ethics Committees in biomedical and health research. An executive order cannot dilute or override a statutory scheme; where such conflict exists, the executive instrument simply has no legal existence, rather than merely being voidable.

On maintainability, the Court accepted the PIL as validly instituted, reaffirming that public-spirited litigation to protect the rights of vulnerable groups — here, persons with ASD and their families — does not require the petitioners to demonstrate a personal or individual grievance.

Decision

The Supreme Court held that:

1. Stem cell interventions for Autism Spectrum Disorder cannot be offered as a routine clinical or commercial healthcare service, since such use is not recognised as sound and relevant medical practice on current scientific evidence and stands disapproved by authoritative medical bodies.
2. Such interventions may only be administered within approved, ethics-committee-monitored clinical trial or research settings under the NDCT Rules, 2019.
3. The DHR order of 3 March 2024 dissolving NAC-SCRT’s regulatory role is non est and of no legal effect, as it conflicts with binding statutory rules.
4. The Union Government, through the Ministry of Health and Family Welfare, was directed to clarify and reconstitute an appropriate oversight mechanism for stem cell research — including possibly re-establishing NAC-SCRT or consolidating regulation through dedicated legislation — and to propose a lawful transition pathway for patients currently undergoing such interventions, so that continuity of care is not abruptly disrupted.

Ratio Decidendi

The ratio of the case may be stated as follows:

An unproven medical intervention that is disapproved by authoritative scientific and regulatory bodies cannot be offered as a routine clinical service merely because a practitioner holds a genuine belief in its efficacy; the Bolam standard of care protects only practices recognised as sound by a responsible body of current medical opinion. Further, an executive order that conflicts with a statutory rule mandating regulatory oversight is non est and cannot create a vacuum in patient safety regulation — delegated or executive action cannot dilute the protections established by primary legislation and its rules.

This ratio operates on two independent legal planes — medical negligence/standard of care, and administrative law limits on executive rule-making — both anchored in the constitutional value of protecting vulnerable patients’ right to health and safety under Article 21.

Important Cases Referred

Significance and Conclusion

Yash Charitable Trust v. Union of India is a rare judgment that synthesises tort law (medical negligence), administrative law (limits on executive orders conflicting with statutory rules), and constitutional values (protection of vulnerable patients under Article 21) within a single regulatory controversy. Its most doctrinally significant contribution lies in reaffirming that executive instruments inconsistent with statutory rules are non est, reinforcing the hierarchy of legal norms and preventing regulatory gaps from being created through executive fiat. For medical negligence law, it demonstrates the evolving application of the Bolam Test to modern, scientifically unsettled interventions, clarifying that professional “belief” in a treatment’s value cannot substitute for authoritative scientific consensus. The judgment ultimately serves as both a patient-protection precedent and a governance correction in a rapidly evolving biomedical field.