The Supreme Court has delivered a landmark ruling that stem cell therapy for Autism Spectrum Disorder (ASD) cannot be offered as a routine clinical service by private clinics, regardless of parental consent or anecdotal claims of improvement. The judgment firmly anchors medical practice in evidence-based standards and rejects commercial exploitation of vulnerable families seeking hope for uncurable conditions.
Background & Facts
The Dispute
The petition, filed as a Public Interest Litigation, challenged the widespread, unregulated administration of stem cell "therapies" for Autism Spectrum Disorder (ASD) across Indian clinics. These clinics marketed the procedure as a curative or palliative treatment, charging substantial fees to parents of children with ASD, despite the absence of scientific validation. The petitioners, including a charitable trust, a developmental paediatrician, and a medical ethics society, alleged that these practices violated national guidelines, exploited public ignorance, and bypassed regulatory safeguards meant for clinical research.
Procedural History
- 06.05.2022: Writ Petition filed in the Supreme Court seeking regulation of stem cell therapies for ASD.
- 06.12.2022: Ethics & Medical Registration Board (EMRB) of the National Medical Commission issued recommendations declaring stem cell therapy for ASD as professional misconduct.
- 03.03.2024: Department of Health Research (DHR) dissolved the National Apex Committee for Stem Cell Research & Therapy (NAC-SCRT), creating regulatory ambiguity.
- 31.08.2023: Delhi High Court granted interim relief permitting ongoing treatments to continue, citing patient autonomy, pending final adjudication.
Relief Sought
The petitioners sought directions to:
- Prohibit clinics from offering stem cell therapy for ASD as a commercial clinical service.
- Enforce compliance with the National Guidelines for Stem Cell Research, 2017 (NGSCR 2017) and the Evidence Based Status of Stem Cell Therapy for Human Diseases, 2021.
- Clarify the regulatory pathway for any legitimate research involving stem cells in ASD.
- Hold errant clinics accountable under the Clinical Establishments Act and the Drugs Act, 1940.
The Parties' Positions
- Petitioners: Argued that stem cell therapy for ASD is unproven, unethical, and violates the standard of care owed by medical practitioners. Relied on ICMR guidelines, EMRB recommendations, and medical negligence jurisprudence.
- Respondents (Clinics & Parents’ Forum): Contended that autologous stem cell therapy (using patient’s own cells) is a medical procedure, not a "drug," and thus outside the Drugs Act. Invoked patient autonomy under Article 21 and cited Delhi High Court’s interim order permitting continuation.
- Union of India: Acknowledged lack of specific statutory framework for stem cell therapies but maintained that only stem cell-derived products (with substantial manipulation) are regulated as new drugs under NDCT Rules, 2019.
The Legal Issue
The central question was whether medical practitioners can legally offer stem cell therapy for Autism Spectrum Disorder as a routine clinical service, and if not, what regulatory framework governs its permissible use in research or clinical trials under the Drugs Act, 1940 and National Guidelines for Stem Cell Research, 2017.
Arguments Presented
For the Petitioner
The petitioners relied on:
- EMRB-NMC Recommendations (06.12.2022): Explicitly declared use, promotion, or advertisement of stem cell therapy for ASD as professional misconduct.
- ICMR’s Evidence Based Status of Stem Cell Therapy for Human Diseases, 2021: Concluded there is no credible evidence supporting efficacy and that such therapy should not be offered as a standard or routine treatment.
- NGSCR 2017: Stated that any stem cell use outside approved clinical trials is unethical and constitutes malpractice.
- Medical Negligence Jurisprudence: Cited V.P. Shantha, Jacob Mathew, and M.A. Biviji to argue that administering unproven therapies violates the "reasonable standard of care" owed to patients.
- NDCT Rules, 2019: Argued that even autologous stem cells fall under the broad definition of "drugs" under Section 3(b)(i) of the Drugs Act, 1940, and thus require regulatory oversight.
For the Respondent
The respondents (clinics and parents’ forum) contended:
- Autologous stem cell therapy (using patient’s own bone marrow cells) involves minimal manipulation and does not qualify as a "stem cell derived product" under Rule 2(1)(w)(v) of the NDCT Rules, 2019.
- The MoHFW Clarification (09.02.2021) permits procedures limited to rinsing, cleaning, or sizing without triggering drug regulation.
- The DTAB’s 84th Meeting Recommendations (27.08.2019) suggested that non-commercial, in-house therapies fall outside the Drugs Act.
- Article 21 guarantees the right to choose treatment, and informed consent by parents overrides regulatory hesitation.
- The National Ethical Guidelines are non-binding guidance documents, not statutory mandates.
The Court's Analysis
The Court undertook a comprehensive doctrinal analysis, beginning with the foundational duty of care owed by medical practitioners. It reaffirmed the principles from V.P. Shantha and M.A. Biviji: a doctor’s conduct must conform to the "practice acceptable to the medical profession of that day," judged by the knowledge available at the time of treatment. The Court held that administering an intervention lacking credible scientific evidence, and expressly disapproved by authoritative bodies like ICMR and EMRB, cannot satisfy this standard.
"If a treatment is characterised by the relevant scientific community or regulatory authorities as unproven, experimental, obsolete, or lacking justification, such a treatment cannot be defended as an exercise of due care and reasonable judgment by a medical practitioner."
The Court examined the regulatory architecture under the Drugs Act, 1940 and concluded that while autologous stem cells do not qualify as "new drugs" under the NDCT Rules, 2019, they fall squarely within the broader statutory definition of "drugs" as "substances intended to be used for... treatment" under Section 3(b)(i). This classification subjects them to the Act’s protective framework, even if not subject to the full clinical trial regime for new drugs.
The Court then turned to the National Ethical Guidelines, 2017, which, though not statutory instruments themselves, were made legally enforceable through Rule 15 and Rule 16(4) of the NDCT Rules, 2019. Clause 7.9.1 of the Guidelines mandates that any use of stem cells in human participants (except for haematopoietic transplants) must be conducted as a clinical trial. This binding effect, the Court held, transforms ICMR’s ethical guidance into a statutory imperative.
The Court rejected the respondents’ reliance on the DTAB’s 84th meeting recommendations and the purported MoHFW "list" of clinical options, noting these were never formally adopted or published. The dissolution of the NAC-SCRT by the DHR through an executive order was held to be in direct conflict with the statutory oversight mechanism under Rules 17 and 18 of the NDCT Rules, 2019. The Court invoked the principle from Jaiveer Singh that executive instructions cannot supplant statutory rules.
On the issue of consent, the Court distinguished between "choice" and "consent." Citing Samira Kohli, it held that valid consent requires adequate information - information that simply does not exist for ASD stem cell therapy due to the absence of reliable data on safety and efficacy. The Court warned against "therapeutic misconception," where patients mistake experimental research for proven treatment.
"Consent is an informed authorisation, grounded in adequate disclosure... Where the requisite information is unavailable, a choice cannot mature into a valid consent."
The Court concluded that while patients may participate in approved clinical trials, offering stem cell therapy as a commercial clinical service is unlawful, unethical, and constitutes professional misconduct.
The Verdict
The petitioners succeeded. The Supreme Court held that stem cell therapy for Autism Spectrum Disorder cannot be offered as a routine clinical service by any clinic or medical practitioner. The only permissible avenue is within an approved and monitored clinical trial, governed by the National Ethical Guidelines and subject to oversight by Ethics Committees and the Department of Health Research. The Court directed the Union to ensure continuity of ongoing treatments for affected patients while transitioning them to legitimate research settings.
What This Means For Similar Cases
Clinical Trials Are the Only Legal Pathway
- Practitioners must cease offering stem cell therapies for ASD (or any unproven condition) as a fee-based service.
- Any research involving stem cells in humans must be registered as a clinical trial under the NDCT Rules, 2019, with approval from an Ethics Committee and adherence to ICMR guidelines.
- Clinics must not advertise or promote such therapies as cures or standard treatments.
Consent Is Not a Shield for Unproven Treatments
- Informed consent requires disclosure of scientific uncertainty - not just risks.
- Parents or patients cannot demand unproven therapies as a right under Article 21.
- Medical professionals who proceed without credible evidence risk disciplinary action under Regulation 7.22 of the IMC Regulations, 2002.
Regulatory Gaps Must Be Closed by Legislation
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The current framework is fragmented, relying on non-statutory guidelines made binding through rules.
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Practitioners must now document and justify the degree of stem cell manipulation to determine applicable regulatory pathway (new drug vs. biomedical research).
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State Medical Councils must initiate disciplinary proceedings against clinics violating the judgment.
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The Union must urgently establish a dedicated regulatory authority for stem cell research to prevent future exploitation.
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Action Point: Lawyers representing patients or clinics must now verify whether any stem cell intervention is part of a registered clinical trial with EC and DHR oversight.
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Action Point: Regulatory bodies must audit clinics offering stem cell services and initiate action under the Clinical Establishments Act, 2010.
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Action Point: Law students and practitioners must treat ICMR guidelines as binding in medical ethics cases, especially when incorporated into statutory rules.
