Authority: Supreme Court of India
Order Date: 30-07-2026
Case Overview
- Petitioners: Yash Charitable Trust & Others; Respondents: Union of India & Others.
- Bench: Hon. Justice J.B. Pardiwala and Hon. Justice R. Mahadevan.
- The Court revisited compliance with its earlier judgment dated 30‑01‑2026 (Writ Petition (Civil) No.369/2022).
- A short affidavit was filed by the Department of Health Research, Ministry of Health and Family Welfare, affirmed by its Director Shri Murari Lal Sharma, addressing only Para 153 compliance.
- Ms. Aishwarya Bhati, Additional Solicitor General, indicated that the Union must file a comprehensive compliance report covering all directions.
- The Court granted the Union four weeks to file a detailed status report, outlining how the judgment has been examined and how each direction will be implemented.
- Interlocutory Application (IA) No.9 by Neurogen Brain and Spine Institute Pvt. Ltd. was noted; the Court directed Ms. Bhati to consider its suggestions and any expert body inputs.
- Senior Counsel Mr. Shyam Divan appeared on behalf of the Parents Forum for Stem Cells in Autism and Cerebral Palsy (Respondent No.13), representing parents of children undergoing stem‑cell therapy; he requested to await the Union’s exhaustive report.
- The Court scheduled a further hearing on 01‑09‑2026 to consider the IA of Respondent No.13.
Related Writ Petition (Civil) No.731/2026
- The matter was heard on a partial court working day.
- On 12‑06‑2026, the Court observed that letters dated 10‑03‑2026, 11‑03‑2026 and advisory dated 25‑03‑2026 were issued in compliance with the directions of W.P. (C) No.369/2022.
- The Court ordered the petition to be tagged with W.P. (C) No.369/2022 and reiterated that all directions of that judgment must be complied with.
Society of Regenerative Sciences Petition
- The Society sought multiple reliefs, including:
1. Quashing of the Impugned Letter (D.O. No. M‑11019/5/2026‑CG dated 10 Mar 2026) issued by the Department of ICMR.
2. Quashing of the Impugned Letter‑II (dated 11 Mar 2026) issued by the Department of Health Research through NECRBHR.
3. Quashing of the Impugned Advisory (dated 25 Mar 2026) issued by the National Medical Commission.
4. A mandamus declaring that Autologous Cell Procedures (ACP) involving minimal manipulation by Registered Medical Practitioners in a single sitting for their own patients, not for commercialisation, fall outside the purview of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019, referencing the statutory clarification dated 09‑Feb‑2021 (Section 33P) and DTAB recommendations (84th meeting, 27‑Aug‑2019).
5. A mandamus declaring that Respondents No.2, 3 and 4 lack statutory mandate or legislative competence to regulate, restrict, prohibit, or declare ACP illegal.
6. A mandamus directing Respondent No.1 (Department of Health Research) to constitute an expert committee to examine the functioning of Respondents 2‑4, especially any nexus with private companies manufacturing stem‑cell‑derived products.
7. Formation of a Court‑appointed expert committee to evaluate scientific publications, granting hearing rights to stakeholders, including patients benefitting from autologous cell procedures and representatives of the petitioner society.
8. A stay on the operation, implementation, and enforcement of the impugned letters and advisory pending final disposal, and a direction that no coercive or disciplinary action be taken against any Registered Medical Practitioner or Society member under those communications.
9. Any further orders the Court deems fit and proper.
- The Court noted that the Medical Council of India had issued advisories in line with the earlier Yash Charitable Trust judgment; the petitioner challenges the legality and validity of those advisories.
- Although the bench had earlier ordered the petition to be tagged with W.P. (C) No.369/2022, the Court directed the Registry to place the petition before the Chief Justice of India for appropriate orders.
Final Outcome
- The Union of India was ordered to submit a comprehensive compliance status report within four weeks.
- The Court will consider the IA of Neurogen Brain and Spine Institute and the Parents Forum for Stem Cells on 01‑09‑2026.
- Writ Petition No.731/2026 was tagged with W.P. (C) No.369/2022, and compliance with its directions was reaffirmed.
- The Society of Regenerative Sciences’ extensive reliefs were recorded, with the Court reserving further consideration and directing that the matter be placed before the Chief Justice of India.
Topics: Compliance Reporting, Stem‑Cell Therapy Regulation, Court‑Ordered Expert Committee