Authority: Supreme Court of India

Order Date: 13 October 2026

Case Overview

  • Petitioners: Yash Charitable Trust & others; Respondents: Union of India & others.
  • The matter concerns the legality of administering stem‑cell therapy for Autism Spectrum Disorder (ASD) as a clinical service.
  • The Court previously issued a Judgment & Order on 30 January 2026 clarifying that such therapy is not recognised as sound medical practice outside an approved research or clinical‑trial setting.
  • Hearings on 01 September 2026 and 13 October 2026 featured submissions from Ms. Aishwarya Bhati (Additional Solicitor General for the Union), Mr. Neeraj Kishan Kaul (Senior Counsel for Respondent No.13 – Parents' Forum for Stem Cells in Autism and Cerebral Palsy), Mr. Prashant Bhushan, and several individuals appearing in‑person to voice concerns.
  • The Court reiterated that the issue is one of law, not of scientific efficacy, and that the prohibition is based on current scientific evidence and regulatory standards.

Regulatory Background Presented

  • The Union filed a compliance affidavit dated 28 September 2026, affirmed by Dr. Tushar Karmarkar, Deputy Secretary, Department of Health Research (DHR), Ministry of Health & Family Welfare.
  • The affidavit references Office Order No. M‑11019/5/2026‑CG dated 24 March 2026, which constituted the National Stem Cell Research Regulation Committee (NSRC) to oversee research on minimally manipulated stem cells.
  • NSRC composition: representatives of the Department of Biotechnology, Department of Health & Family Welfare, CDSCO, Chairman of the National Medical Commission (rank not below Joint Secretary), seven permanent experts, rotating subject‑expert members from 13 specialties, and an ICMR‑DHR Secretariat.
  • Documents issued to implement the 30‑Jan‑2026 judgment:

1. D.O. Letter No. M‑11019/5/2026‑CG dated 10 March 2026 (Secretary DHR to Chairman NMC).

2. Advisory No. CDN‑20011/105/2026‑COORDINATION‑NMC dated 25 March 2026 (National Medical Commission).

3. Advisory No. R‑13014/28/2022‑Ethics dated 05 September 2026 (Ethics & Medical Registration Board, NMC).

4. Advisory No. C.18018/13/2026‑MS dated 16 September 2026 (Department of Health & Family Welfare to state health secretaries and clinical‑establishment officers).

  • The Union reported that no applications for ASD stem‑cell research or clinical trials have been received by CDSCO, DHR, or ICMR.
  • A multicentre randomised controlled trial (RCT) is proposed at two tertiary care sites (one in North India, one in South India) within six months, with funding support from ICMR.

Court Directions

1. Protocol Development – Within six weeks, the Ministry of Health & Family Welfare must issue a comprehensive, step‑wise protocol explaining the regulatory regime for stem‑cell research and clinical trials in ASD, including timelines, duties, statutory bases, and responsible authorities; a flowchart should be included.

2. Public Awareness – The Ministry shall publish the protocol on its website and on the websites of DBT, ICMR, CDSCO, and NMC; it must also disseminate the information through hospitals, medical institutions, professional associations, and patient‑support organisations, clearly distinguishing approved treatments from experimental interventions.

3. Online Portal for Suggestions – Within four weeks, an online portal must be created for the public and interested parties to submit views and suggestions to the NSRC; the Committee will consider these, provide a hearing where necessary, and decide in accordance with law.

4. Online Portal for Patient Records – Within six weeks, a dedicated portal must be established to maintain medical records of patients who began stem‑cell therapy for ASD on or before 30‑Jan‑2026, capturing practitioner details, intervention specifics, and other clinical data, with confidentiality safeguards. Registration on this portal will be mandatory for both patient/caregiver and treating doctor/clinic before any further intervention.

5. Temporary Continuation for Existing Patients – Patients who started therapy before 30‑Jan‑2026 may continue the procedure at existing clinics, provided they register on the portal and comply with monitoring and reporting requirements. No new patients may be inducted outside an approved research/clinical‑trial setting.

6. RCT Eligibility Clarification – The Union must, on the next hearing date, clarify the eligibility criteria for the proposed multicentre RCT and outline a plan for monitoring participants who might be excluded from the intervention, ensuring ethical and medical safeguards.

7. Further Hearing – The matter is listed for further hearing on 14 December 2026 at 2.00 p.m.

Final Outcome

  • The Supreme Court reaffirmed that stem‑cell therapy for ASD cannot be offered as a clinical service outside regulated research or trials.
  • It mandated the Ministry to create and widely disseminate a clear regulatory protocol, establish two online portals for stakeholder input and patient record‑keeping, and ensure temporary monitoring of existing patients while prohibiting new clinical‑service administrations.
  • The Court also sought clarification on the design and eligibility of the proposed multicentre RCT and allowed interested parties to submit representations to the NSRC.

Topics: Regulatory Framework; Stem Cell Research; Autism Therapy