Summary
| Category | Data |
|---|---|
| Court | Supreme Court of India |
| Case Number | W.P.(C) No.-000369 – 2022 |
| Diary Number | 14452/2022 |
| Judge Name | HON’BLE MR. JUSTICE J.B. PARDIWALA |
| Precedent Value | Binding on medical practitioners, ethics committees, clinical establishments |
| Overrules / Affirms | Affirms established standards on medical negligence and clinical trial regulation |
| Type of Law | Regulatory Law / Medical Negligence Law |
| Questions of Law |
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| Ratio Decidendi | The Court held that unproven experimental interventions lacking credible evidence and disapproved by authoritative bodies do not satisfy the reasonable standard of care owed by medical practitioners. Stem cell administration for ASD, not recommended by ICMR guidelines or EMRB-NMC recommendations, cannot be offered as a routine clinical service. Such interventions may only be administered within an approved and monitored clinical trial or research setting under the Drugs Act and NDCT Rules, 2019. Consent based on “adequate information” is impossible when safety and efficacy are unestablished, making routine provision of therapy unethical and professionally misconduct. |
| Judgments Relied Upon |
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| Logic / Jurisprudence / Authorities Relied Upon by Court |
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| Facts as Summarised by the Court |
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Practical Impact
| Category | Impact |
|---|---|
| Binding On | All registered medical practitioners, institutional Ethics Committees, clinical establishments |
| Persuasive For | High Courts, State Medical Councils, National Medical Commission |
| Distinguishes | Non-binding internal DTAB recommendations versus published statutory guidelines |
| Follows | Indian Medical Association v. V.P. Shantha (Bolam standard), Jacob Mathew v. State of Punjab (medical negligence thresholds) |
What’s New / What Lawyers Should Note
- Supreme Court holds stem cell “therapy” for ASD cannot be offered as routine clinical treatment; must be confined to approved clinical trials or research.
- Affirms that ICMR’s NGSCR 2017, EBSSCT 2021 and EMRB-NMC Recommendations (06.12.2022) are authoritative benchmarks of sound medical practice.
- Clarifies that under Section 3(b) of Drugs Act 1940, all stem cells qualify as “drugs”; but autologous cells not meeting NDCT Rules’ “stem-cell derived product” threshold remain subject to clinical research regulation.
- Reinforces that valid informed consent requires “adequate information” on safety and efficacy—absent in unproven therapies—invalidating routine administration.
- Warns medical practitioners administering stem cell interventions outside trials face disciplinary action for professional misconduct under IMC/NMC regulations.
Summary of Legal Reasoning
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Standard of Care
- Relied on Bolam/Shantha, Jacob Mathew, Kusum Sharma, M.A. Biviji: medical negligence requires conformity with accepted professional practice judged by contemporaneous scientific knowledge.
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Authority of Guidelines
- EMRB-NMC (06.12.2022) and ICMR publications (NGSCR 2017, EBSSCT 2021, Ethical Guidelines 2017) unanimously advise against routine use of stem cells in ASD and classify unapproved use as unethical/malpractice.
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Statutory Framework
- Drugs Act 1940 defines “drug” broadly; NDCT Rules 2019 classify processed stem-cell products as “new drugs” requiring CDSCO licensing and clinical trial approval.
- Unprocessed (autologous) cells fall under NDCT Chapter IV “biomedical and health research”—mandatory EC review, clinical trial conduct, DHR oversight.
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Informed Consent & Patient Autonomy
- Samira Kohli: valid consent demands disclosure of nature, purpose, benefits, risks, and alternatives—impossible for unproven ASD therapies, creating “therapeutic misconception”.
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Regulatory Gaps & Oversight
- ECs must register under NDCT 2019 and follow ICMR ethical guidelines; dissolution of NAC-SCRT by DHR Order (03.03.2024) conflicts with NDCT Rules’ oversight scheme—calling for legislative clarity and reconstitution of apex committee.
Arguments by the Parties
Petitioners
- Stem cell “therapy” for ASD is experimental and unapproved—offered commercially in violation of NDCT Rules 2019 and ICMR NGSCR 2017.
- Clinics lack CDSCO licence and Ethics Committee approval; patients lack clinical trial safeguards.
Respondent No. 1 (Union of India)
- “Stem cell derived products” regulated under Drugs Act/NDCT Rules only if cells undergo substantial manipulation.
- Minimal manipulation autologous therapies fall outside “new drug” regime; however, no provisions exist to regulate unapproved therapies.
Respondent No. 2 (National Medical Commission)
- Based on EMRB committee, no evidence supports safety/efficacy; professional misconduct to offer, promote, or advertise.
- Disciplinary action via State Medical Councils under Professional Conduct regulations.
Respondent No. 9 (Neurogen Brain & Spine Institute)
- Distinguish between ‘product’ (regulated) and ‘procedure’ (autologous minimal manipulation outside NDCT).
- Claimed EC approval and State Health Ministry permission; reliance on DTAB minutes and MoHFW internal list (not formally adopted).
Respondent No. 10 (Reelabs Pvt. Ltd.)
- Engaged in cord blood banking; no advertisement of ASD therapy; compliance with NGSCR 2017 and NDCT Rules 2019 for approved indications.
Respondent No. 11 (Saffron Naturele Products)
- Supplier of processed cells only; end-use regulation lies with hospitals/doctors; contends no binding law governs stem cell therapy.
Respondent No. 13 (Parents’ Forum)
- Autologous therapy improved children’s conditions; right under Article 21 to choose treatment; risks assumed voluntarily; challenge to EMRB recommendations pending before Delhi HC.
Factual Background
By PIL, petitioners challenged commercial promotion and administration of experimental stem cell “therapies” as ASD cure. No proven ASD cure exists; stem cell use remains at research stage. Regulatory framework spans Drugs Act 1940, NDCT Rules 2019, ICMR NGSCR 2017; EMRB-NMC issued recommendations on 06.12.2022; NAC-SCRT dissolved on 03.03.2024 by DHR; Delhi HC granted interim continuance of therapy in Dalip Kaur (pending).
Statutory Analysis
- Drugs Act 1940: Section 3(b) defines “drug” to include substances for treatment; “manufacture” broadly defined.
- NDCT Rules 2019: Rule 2(1)(w)(v) deems “stem-cell derived products” as perpetual “new drugs” requiring CDSCO licensing and clinical trial approval. Chapter IV binds all stem cell research to ICMR Ethical Guidelines via Rules 15 & 16(4).
- IMC/NMC Regulations: Regulation 7.22 makes breach of ICMR research guidelines or consent standards professional misconduct.
- ICMR NGSCR 2017 & Ethical Guidelines 2017: Mandate all non-hematopoietic stem cell use in patients only within approved clinical trials; classified outside-trial use as malpractice.
Alert Indicators
- ✔ Precedent Followed – Affirms Bolam/Shantha and clinical trial jurisprudence
- 🔄 Conflicting Decisions – DHR’s dissolution of NAC-SCRT conflicts with NDCT Rules’ oversight scheme