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 Authority |
| Overrules / Affirms | Affirms existing regulatory scheme (Drugs Act, NDCT Rules, ICMR Guidelines) |
| Type of Law | Health/Administrative Law |
| Questions of Law |
|
| Ratio Decidendi | The Court held that therapeutic use of stem cells for ASD lacks sufficient scientific validation and is not a “sound and relevant medical practice” under established Bolam‐based standards of care. It upholds ICMR’s NGSCR 2017, EBSSCT 2021 and NMC‐EMRB’s December 2022 recommendations as binding on practitioners via the NDCT Rules and IMC/NMC regulations. The Drugs Act’s broad definition of “drug” encompasses stem cells, but only “stem-cell derived products” undergo the NDCT new‐drug pathway; other stem cell uses must follow Chapter IV (biomedical research) and National Ethical Guidelines, entailing clinical trial approval, ethics‐committee oversight and DHR monitoring. Executive orders (e.g., dissolution of NAC-SCRT) cannot override statutory rules. Any offering of stem cell “therapy” for ASD outside approved clinical trials constitutes professional misconduct and must attract disciplinary action. |
| Judgments Relied Upon | Bolam v. Friern Hosp. Mgmt. (1957) 1 WLR 582; V.P. Shantha (1996) 86 COMP 806; Jacob Mathew (2005) 6 SCC 1; M.A. Biviji (2024) 2 SCC 242; Samira Kohli (2008) 2 SCC 1 |
| Logic / Jurisprudence / Authorities Relied Upon | Standard of care: Bolam test and Indian cases on medical negligence; Drugs Act 1940 definition of “drug”; NDCT Rules 2019 (Rule 2(1)(w), Ch VI, Ch IV); IMC Regs 2002 Reg 7.22; NMC Act 2019 Secs 27, 57, 61; ICMR’s NGSCR 2017, EBSSCT 2021, National Ethical Guidelines; EMRB‐NMC recommendations; DTAB minutes and MoHFW clarifications; DHR order dissolving NAC-SCRT. |
| Facts as Summarised by the Court |
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Practical Impact
| Category | Impact |
|---|---|
| Binding On | All subordinate courts; medical practitioners |
| Persuasive For | High Courts, policy-making bodies |
| Follows | NDCT Rules 2019 clinical trial framework; ICMR’s NGSCR 2017 and National Ethical Guidelines; NMC-EMRB recommendations |
What’s New / What Lawyers Should Note
- The Court affirms that stem cell “therapy” for ASD lacks proven efficacy and is not a standard treatment.
- Offering or advertising ASD stem cell interventions outside approved clinical trials amounts to professional misconduct under IMC/NMC regulations.
- ICMR’s NGSCR 2017 and EBSSCT 2021, and EMRB’s Dec 2022 recommendations are binding via NDCT Rules 2019 and IMC Regs 2002.
- Autologous stem cells (no substantial manipulation) fall under Chapter IV (biomedical research) not the NDCT new‐drug pathway, mandating EC and DHR oversight.
- Executive orders cannot override statutory rules; MoHFW’s dissolution of NAC-SCRT is ultra vires NDCT Rules requiring DHR monitoring of ECs.
- Consent for unproven therapies cannot satisfy “adequate information” standard; therapeutic misconception must be guarded against.
- Urgent need for a consolidated statutory framework and dedicated regulator for stem cell research and banking.
Summary of Legal Reasoning
- Standard of Care (Bolam Test): A medical practitioner must act according to practices accepted by a competent body of medical opinion (V.P. Shantha, Jacob Mathew, M.A. Biviji). Unproven, experimental treatments fail to meet the “reasonable standard of care.”
- Evidence‐Based Position: ICMR’s EBSSCT 2021 and NGSCR 2017 find insufficient evidence for ASD stem cell therapy, deem it unethical outside clinical trials. EMRB‐NMC expert committee (06.12.2022) disapproved its use and classified promotion as misconduct.
- Statutory Framework: Drugs Act 1940 defines “drug” to include all substances for treatment. NDCT Rules 2019 treat “stem-cell derived products” as perpetual new drugs (Rule 2(1)(w)), requiring license and clinical trial approval. Other stem cells (minimal manipulation) must follow Chapter IV (biomedical research) and National Ethical Guidelines (Rules 15, 16(4), 17, 18).
- Professional Misconduct: IMC Regs 2002 Reg 7.22 and NMC Act 2019 Sec 27 empower disciplinary action for violating ICMR/ethical guidelines or offering unapproved therapies.
- Executive vs. Statute: DHR’s 03.03.2024 order dissolving NAC-SCRT and removing DHR oversight conflicts with NDCT Rules 2019—executive instructions cannot override statutory regulations.
- Consent & Autonomy: Valid consent requires “adequate information” about nature, risks and benefits (Samira Kohli). Absence of reliable data on ASD stem cell therapy defeats informed consent; choice does not confer a right to demand unvalidated treatment (Common Cause).
Arguments by the Parties
Petitioners
- Stem cell therapy for ASD is experimental, unproven and illegally offered as routine service.
- Clinics lack Central Licensing Authority permission and EC-approved protocols under NDCT Rules 2019.
- Patients are deprived of clinical‐trial safeguards (injury compensation, monitoring).
- ICMR and EMRB documents conclude these interventions should not be standard treatment.
Respondent no. 1 (Union of India)
- Only “stem-cell derived products” (substantial manipulation) are regulated under NDCT Rules; minimal‐manipulation therapies fall outside.
- Drugs Act 1940 has no direct provisions for therapies, only for medicinal products.
- MoHFW clarification (09.02.2021) defines “stem-cell derived product” and exempts autologous minimal‐manipulation procedures.
Respondent no. 2 (NMC)
- EMRB’s Dec 2022 expert report (approved by NMC) finds insufficient evidence, disapproves ASD stem cell use and classifies promotion/advertising as professional misconduct.
Respondent no. 9 / no. 13 (Clinics & Parents’ Forum)
- Autologous stem cell procedures are “surgical procedures” not “drugs” under NDCT Rules.
- DTAB 84th meeting minutes and MoHFW “clinical option” list supposedly permit such therapies.
- Patients and families, fully informed of risks, have seen benefits; autonomy under Article 21 includes the right to choose available treatments.
Factual Background
Petitioners, comprising a charitable trust, medical experts and a parent, filed a PIL challenging the widespread commercial offering of stem cell “therapy” for Autism Spectrum Disorder, alleging it violates the Drugs Act 1940, NDCT Rules 2019 and ICMR guidelines and lacks enforcement by authorities. Clinics across India advertise unproven interventions as cures, leading vulnerable patients and guardians to incur high costs without clinical‐trial protections. During the proceedings, EMRB (NMC) issued December 2022 recommendations rejecting ASD stem cell use; ICMR drafted inputs on dissolving NAC-SCRT; and MoHFW’s March 2024 order formally dissolved the NAC-SCRT, creating regulatory ambiguity over stem cell research.
Statutory Analysis
- Drugs Act 1940 Sec 3(b): Broad definition of “drug” includes substances intended for treatment.
- Drugs Act 1940 Sec 33P & MoHFW Clarification (09.02.2021): Defines “stem-cell derived product” by degree of manipulation.
- NDCT Rules 2019 Rule 2(1)(w)(v): “Stem-cell derived products” are perpetual new drugs; Rule 74–91: licensing & clinical trial requirements. Chapter IV (Rules 15–18): “Biomedical and health research” binding ICMR Ethical Guidelines, EC registration and DHR oversight.
- ICMR NGSCR 2017: Investigational use only in approved trials; unethical outside clinical trials.
- ICMR National Ethical Guidelines 2017 Clauses 4.2.4, 7.9.1: Stem cell studies must follow NAC-SCRT, EC, clinical trial pathway.
- IMC Regs 2002 Reg 7.22: Violations of ICMR guidelines constitute professional misconduct.
- NMC Act 2019 Secs 27, 57, 61: EMRB powers and transitory continuation of IMC Regs.
- Clinical Establishments Act 2010 Secs 32, 40: Penalty and cancellation for unregistered establishments.
Alert Indicators
- ✔ Precedent Followed – Affirms Bolam standard and regulatory framework for drug approval and medical ethics.
- 🔄 Conflicting Decisions – DTAB minutes and MoHFW orders conflict with NDCT Rules; dissolution of NAC-SCRT conflicts with statutory oversight.