Yash Charitable Trust v. Union of India
“Supreme Court Bars Stem Cell Therapy for Autism as Routine Clinical Service”
TL;DR
The Supreme Court held that stem cell therapy for Autism Spectrum Disorder (ASD) cannot be offered by medical practitioners as a routine clinical service, as it fails to meet the reasonable standard of care mandated under established medical negligence jurisprudence. The Court ruled that such therapy can only be administered within an approved and monitored clinical trial or research setting. It further held that patient consent or autonomy cannot justify unproven treatments, and directed the government to consolidate the fragmented regulatory framework for stem cell research.
The Bottom Line
Clinics and hospitals cannot commercially offer stem cell therapy for autism. Any stem cell use for ASD must be done only within approved clinical trials under strict regulatory oversight. Doctors offering such unproven therapy as a routine service may face professional misconduct charges.
Case Timeline
The journey from FIR to Supreme Court verdict
PIL Filed in Supreme Court
Yash Charitable Trust and others filed Writ Petition (C) No. 369 of 2022 challenging the rampant administration of stem cell therapy for ASD by clinics across India
PIL Filed in Supreme Court
Yash Charitable Trust and others filed Writ Petition (C) No. 369 of 2022 challenging the rampant administration of stem cell therapy for ASD by clinics across India
Matter First Listed Before Supreme Court
The writ petition was first listed before the Supreme Court. Court directed NMC to constitute expert committee.
Matter First Listed Before Supreme Court
The writ petition was first listed before the Supreme Court. Court directed NMC to constitute expert committee.
EMRB Expert Committee Constituted
Pursuant to the Court order, the EMRB of NMC constituted a committee of experts to examine issues related to stem cell therapy for ASD
EMRB Expert Committee Constituted
Pursuant to the Court order, the EMRB of NMC constituted a committee of experts to examine issues related to stem cell therapy for ASD
EMRB-NMC Recommendations Published
The expert committee concluded that stem cell therapy is not recommended for ASD and its use, promotion, and advertisement would constitute professional misconduct
EMRB-NMC Recommendations Published
The expert committee concluded that stem cell therapy is not recommended for ASD and its use, promotion, and advertisement would constitute professional misconduct
ICMR Publishes Draft to Dissolve NAC-SCRT
ICMR published draft seeking inputs on the proposed dissolution of the National Apex Committee for Stem Cell Research & Therapy
ICMR Publishes Draft to Dissolve NAC-SCRT
ICMR published draft seeking inputs on the proposed dissolution of the National Apex Committee for Stem Cell Research & Therapy
DHR Dissolves NAC-SCRT
The Department of Health Research dissolved the National Apex Committee for Stem Cell Research and Therapy, creating regulatory ambiguity
DHR Dissolves NAC-SCRT
The Department of Health Research dissolved the National Apex Committee for Stem Cell Research and Therapy, creating regulatory ambiguity
NMC Approves EMRB Recommendations
The NMC formally approved the EMRB expert committee recommendations dated 06.12.2022 and published them on its website
NMC Approves EMRB Recommendations
The NMC formally approved the EMRB expert committee recommendations dated 06.12.2022 and published them on its website
Supreme Court Delivers Judgment
The Court held that stem cell therapy for ASD cannot be offered as routine clinical service and must be restricted to approved clinical trials
Supreme Court Delivers Judgment
The Court held that stem cell therapy for ASD cannot be offered as routine clinical service and must be restricted to approved clinical trials
The Story
This PIL was filed by Yash Charitable Trust (a Maharashtra-based NGO working with persons with intellectual and developmental disabilities), Dr. Vibha Krishnamurthy (a developmental paediatrician), the Forum for Medical Ethics Society, and Mr. K.S. Ganpathy (a parent whose child received stem cell therapy for ASD in 2011).
The petitioners raised concerns about the rampant promotion, prescription, and administration of stem cell "therapy" for the treatment of Autism Spectrum Disorder (ASD) by several clinics across India. At the core of the petition was the issue of legal permissibility of administering stem cells for palliative and/or curative treatment of ASD.
The petition alleged that although stem cell therapy for ASD is still experimental, it was being touted as a "treatment" and "cure" by various clinics in flagrant violation of the existing legal framework. It claimed that parents and caregivers of individuals diagnosed with ASD, unaware of the scientific and legal intricacies, were placing their implicit faith in such clinics and falling victim to cost-intensive procedures.
The Government (MoHFW) identified 59 entities engaged in offering stem cell therapy but informed that the number of reported cases was not centrally maintained. The petition was filed on 06.05.2022 and first listed before the Supreme Court on 20.05.2022.
During the proceedings, multiple significant documents were released including the EMRB-NMC recommendations dated 06.12.2022 which found no evidence for stem cell therapy in ASD, the ICMR draft to dissolve NAC-SCRT dated 31.05.2023, and the DHR order dated 03.03.2024 dissolving the NAC-SCRT. Respondent No. 9 (Neurogen Brain and Spine Institute) and Respondent No. 13 (Parents Forum for Stem Cells in Autism and Cerebral Palsy) opposed the petition.
Legal Issues
Click each question to reveal the Supreme Court's answer
Arguments
The battle of arguments before the Supreme Court
Petitioner
Vihaan Kumar
Stem cell therapy for ASD is illegal and violates NDCT Rules, 2019
The petitioners argued that stem cell therapies are being administered commercially in contravention of the NDCT Rules, 2019, without permission from the Central Licensing Authority and without Ethics Committee approval for clinical trials. Rule 2(1)(w)(v) includes "stem cell derived products" and therefore stem cell therapies must follow clinical trial rules.
ICMR and NMC conclude stem cell therapy for ASD is not recommended
The NGSCR 2017 and the Evidence Based Status of Stem Cell Therapy for Human Diseases, 2021 both conclude that stem cell therapies should not be offered as standard or routine procedure to ASD patients. The EMRB recommendations dated 06.12.2022 state that its use, promotion, and advertisement constitute professional misconduct.
Patients lack the protections available to clinical trial subjects
Since stem cell therapies are being undertaken as commercial ventures and not as clinical trials, subjects are not protected by the safeguards under Chapter VI of the NDCT Rules, 2019, including compensation in case of injury, disability, or death.
Regulatory grey area is being exploited for commercial gain
The failure of respondent nos. 1-8 to enforce the existing regulatory framework has created a regulatory grey area that is being exploited by clinics and hospitals for commercial gain at the expense of vulnerable ASD patients and their families.
Respondent
State of Haryana
Distinction between stem cell "product" and "procedure"
Respondent No. 9 (Neurogen) argued that stem cell therapy delivered as a "procedure" (doctor takes cells from patient and administers them back) is different from a "product" (manufactured and sold). Only the Drugs Act covers products/drugs, not procedures. Autologous bone-marrow derived cell therapy uses the patient's own body part and thus does not fall within the definition of "drug".
DTAB recommendations support non-regulation of routine stem cell practices
The DTAB in its 84th meeting dated 27.08.2019 recommended that routine practices/therapies involving stem cells undertaken by doctors for treatment of their own patients, without intention to commercialise outside their hospitals/clinics, would fall outside the purview of the Drugs Act, 1940 and NDCT Rules, 2019.
NGSCR 2017 is only a guidance document, not binding
Respondent No. 9 argued that the NGSCR 2017 guidelines are merely a guidance document and have no statutory force. An RTI reply dated 16.08.2020 confirmed this position. Further, ICMR had withdrawn from regulatory matters pertaining to stem cell research via public notices dated 31.05.2023 and 03.03.2024.
Right to life includes right to choose medical treatment
Respondent No. 13 (Parents Forum) argued that Article 21 contains the fundamental right of the patient to choose any available treatment. Medical records including brain scans were placed showing improvements. The potential of risk or lack of guaranteed efficacy cannot deny a patient a therapy to which they have given explicit consent.
EMRB recommendations lack binding force
Respondent No. 9 submitted that the EMRB report does not have the force of law since the EMRB is merely an autonomous board and its recommendations are not declaratory or binding, especially without explicit acceptance by the NMC.
Court's Analysis
How the Court reasoned its decision
The Court conducted a comprehensive analysis across multiple dimensions: maintainability of the PIL, the nature of stem cell therapies in ASD, whether medical practitioners can offer them as a clinical service, the interplay of consent and patient autonomy, whether stem cells fall within the definition of "drugs" under the Drugs Act 1940, and the regulatory pathway for clinical trials. The Court applied the Bolam test and standard of care jurisprudence to determine that offering unproven stem cell therapy as a routine service fails the reasonable standard of care. It rejected the argument that patient consent can justify scientifically unvalidated treatments, and found that the existing regulatory framework under the NDCT Rules 2019, though fragmented, does cover stem cell research through the clinical trial pathway.
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.
Para 70
This is the central holding -- stem cell therapy for ASD as a commercial clinical service violates the duty of care standard established in Indian medical negligence law.
A medical practitioner cannot be said to meet the standard of reasonable care if they administer 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.
Para 63
Establishes the principle that treatments rejected by authoritative medical bodies cannot constitute reasonable medical practice.
Consent is a mode of exercising patient autonomy. Since consent does not confer on a patient the right to demand a particular form of treatment, patient autonomy cannot be stretched to seek an entitlement to subject oneself to a clinical procedure that is scientifically unvalidated, ethically impermissible, and outside the bounds of reasonable medical practice.
Para 96
Distinguishes between "consent" and "choice" -- patient autonomy does not extend to demanding unproven treatments.
The therapeutic use of stem cells in ASD falls in such a category of treatments as there is a dearth of established scientific evidence on its efficacy and safety. As a result, the doctors do not have "adequate information" to provide to their patients in the first place.
Para 94
Links the lack of scientific evidence to the impossibility of obtaining valid informed consent.
The legal framework pertaining to stem cell research is fragmented and spread out across legislations with little harmony. This makes both compliance and enforcement an uphill task. The obscurity in the legal regime also enables manipulation of patients' vulnerabilities by errant medical practitioners.
Para 148
Identifies the fundamental problem with the existing regulatory framework and urges legislative consolidation.
The Verdict
Relief Granted
The writ petition was partly allowed. The Court declared that stem cell therapy for ASD cannot be commercially offered as a routine clinical service. It ordered the MoHFW to arrange for transition of existing patients to clinical trial settings within 4 weeks, declared the DHR order removing its regulatory role as non est, and suggested comprehensive legislative reforms for stem cell regulation. The matter was kept part-heard pending the Union's compliance submissions.
Directions Issued
- Stem cell therapy for ASD cannot be offered by medical practitioners as a routine clinical service; it can only be administered in an approved and monitored clinical trial/research setting.
- Medical practitioners who offer stem cell therapy for ASD as a routine clinical service outside of approved clinical trials fail to meet the reasonable standard of care and may face professional misconduct charges under Regulation 7.22 of the IMC Regulations, 2002.
- Action against errant clinics/organisations must be taken by the appropriate authority under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010.
- Clause 2(vi) of the DHR Order dated 03.03.2024 removing regulatory role of DHR in stem cell research is declared non est as it conflicts with Rules 17 and 18 of the NDCT Rules, 2019.
- Secretary, Ministry of Health and Family Welfare, in consultation with AIIMS and the NMC, shall provide the best possible solution for patients currently receiving stem cell therapy so they can continue receiving therapy through institutions conducting clinical trials.
- The Secretary, MoHFW, shall file submissions in compliance within four (4) weeks from the date of the judgment.
- The Registry shall circulate one copy of the judgment to all the High Courts and to the Secretary, Ministry of Health and Family Welfare.
- The NAC-SCRT should be reconstituted to ensure proper and coherent monitoring and regulation of stem cell research.
- The government is urged to enact a consolidated legislation on stem cell clinical trials and research.
Key Legal Principles Established
Medical practitioners owe their patients a duty to exercise a reasonable degree of care, skill, and knowledge (Bolam test). Offering treatments that lack credible scientific evidence of safety and efficacy violates this standard.
The only circumstance in which an experimental treatment may be provided is within an approved research or clinical trial setting.
ICMR publications, though not binding by themselves, serve as authoritative indicators of what constitutes sound medical practice, and can be relied upon to assess whether a practice is "acceptable to the medical profession of that day".
Patient autonomy and consent cannot be stretched to demand unproven treatments. Valid consent requires "adequate information," which cannot exist where scientific evidence on efficacy and safety is absent or inconclusive.
EMRB-NMC recommendations, once approved by the NMC, serve as authoritative guidance on what constitutes ethical and professionally acceptable conduct for medical practitioners in India.
Executive orders/office memorandums cannot operate in contravention of statutory rules. The removal of DHR regulatory role via executive order conflicting with NDCT Rules 2019 is non est.
All stem cells fall within the purview of "drugs" as "substances" under Section 3(b)(i) of the Drugs Act, 1940, regardless of whether they are stem cell derived products or minimally manipulated cells.
Non-compliance with the statutory mandate regarding stem cell research attracts professional misconduct under IMC Regulations and action under the Clinical Establishments Act, 2010.
Key Takeaways
What different people should know from this case
- Stem cell therapy for autism cannot be offered as a routine commercial treatment by any clinic or hospital in India.
- If a clinic is advertising stem cell therapy as a "cure" or "treatment" for autism, it is likely acting in violation of medical ethics and the law.
- Even if you consent to stem cell therapy for autism, that consent is not legally valid because there is insufficient scientific information to base it on.
- Stem cell therapy for autism may still be available through approved clinical trials, but participants should not be charged for the treatment and should receive compensation protections.
- Parents and caregivers of children with ASD should be wary of predatory marketing and false claims about miraculous cures through stem cells.
- You can file complaints against clinics offering unauthorized stem cell therapy with the State Medical Council or under the Clinical Establishments Act, 2010.
Legal Framework
Applicable laws and provisions
Constitutional Provisions
Article 21
Constitution of India
“No person shall be deprived of his life or personal liberty except according to procedure established by law.”
Relevance: Respondent No. 13 invoked Article 21 to argue the right to choose medical treatment. The Court held that patient autonomy under Article 21 does not extend to demanding unproven treatments that are scientifically unvalidated and ethically impermissible.
Article 32
Constitution of India
“Right to move the Supreme Court for enforcement of fundamental rights.”
Relevance: The PIL was filed under Article 32 seeking directions against rampant administration of unproven stem cell therapy for ASD.
Statutory Provisions
Section 3(b)
Drugs and Cosmetics Act, 1940
“"Drug" includes all medicines for internal or external use of human beings and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings.”
Relevance: The Court held that all stem cells fall within the definition of "drugs" as "substances" under Section 3(b)(i), bringing them under the regulatory purview of the Drugs Act regardless of the degree of manipulation.
Rule 2(1)(w)(v)
New Drugs and Clinical Trial Rules, 2019
“Definition of "new drug" includes "stem cell derived products".”
Relevance: Stem cell derived products (those substantially manipulated) are governed by the clinical trial framework for new drugs under the NDCT Rules 2019.
Chapter IV (Rules 15-18)
New Drugs and Clinical Trial Rules, 2019
“Provisions governing biomedical and health research, including Ethics Committee requirements and DHR oversight.”
Relevance: Minimally manipulated stem cells not qualifying as "new drugs" are still governed by Chapter IV for biomedical research. Rules 15 and 16(4) make National Ethical Guidelines legally enforceable.
Section 27(1)(b) and 27(2)
National Medical Commission Act, 2019
“EMRB has power to regulate professional conduct and promote medical ethics. It may make recommendations to, and seek directions from, the NMC.”
Relevance: The EMRB recommendations against stem cell therapy for ASD, once approved by NMC, serve as authoritative guidance on ethical conduct for medical practitioners.
Sections 32 and 40
Clinical Establishments (Registration and Regulation) Act, 2010
“Provisions for cancellation of registration and penalty for errant clinical establishments.”
Relevance: The Court directed that action against errant clinics offering unauthorized stem cell therapy must be taken under these provisions.
Regulations 7 and 8
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
“Provisions regarding professional misconduct by medical practitioners.”
Relevance: Medical practitioners administering, promoting, or advertising stem cell therapy for ASD outside clinical trials can be proceeded against for professional misconduct under these regulations (continuing in force under Section 61(2) of NMC Act 2019).
Related Cases & Precedents
Indian Medical Association v. V.P. Shantha & Others
cited(1996) 86 COMP 806
Three-Judge Bench judgment that adopted the Bolam test in Indian medical negligence jurisprudence, establishing the standard of care required from medical practitioners.
Jacob Mathew v. State of Punjab
cited(2005) 6 SCC 1
Recognized the standard of care as requiring a medical practitioner to exercise a reasonable degree of care, skill, and knowledge expected of a prudent practitioner in the same field.
M.A. Biviji v. Sunita & Others
cited(2024) 2 SCC 242
Reaffirmed that a line of treatment undertaken should be regarded as "sound and relevant medical practice" and "should not be a discarded or obsolete category in any circumstance."
Samira Kohli v. Dr. Prabha Manchandra & Another
cited(2008) 2 SCC 1
Three-Judge Bench judgment that established principles of informed consent, requiring "adequate information" to be furnished by the doctor for valid consent.
Common Cause (A Registered Society) v. Union of India & Another
cited(2018) 5 SCC 1
Chandrachud J.'s concurring opinion clarified that consent does not confer on a patient the right to demand a particular form of treatment.
Bolam v. Friern Hospital Management Committee
cited(1957) 1 WLR 582
Landmark English case establishing the Bolam test: a medical practitioner is not negligent if they act in accordance with a practice accepted as proper by a responsible body of medical opinion.
Kusum Sharma v. Batra Hospital
cited(2010) 3 SCC 480
Laid down comprehensive principles for determining medical negligence, including that a doctor is not negligent merely because a more skilled doctor would have chosen differently.
Dalip Kaur & Anr. v. Union of India & Anr.
citedWP(C) No. 6850/2023 (Delhi HC)
Delhi High Court order permitting continuation of stem cell treatment for ASD patients in the spirit of patient autonomy, whose interim order was discussed but ultimately not followed by the Supreme Court.
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