Authority: Supreme Court of India

Order Date: 01-09-2026

Case Overview

  • Petition: Writ Petition (Civil) No. 369/2022 filed by Yash Charitable Trust & Ors. against Union of India & Ors.
  • Bench: Hon'ble Mr. Justice J.B. Pardiwala and Hon'ble Mr. Justice R. Mahadevan.
  • Prior Judgment: The Court delivered its judgment on 30 January 2026, directing the Government to strengthen the regulatory framework for stem‑cell therapy in Autism Spectrum Disorder (ASD) and to ensure that patients already receiving such therapy are not left without medical supervision (see paragraph 153).
  • Subsequent Developments: The Government issued an advisory through the Department of Health Research (DHR) and updated the list of disease conditions where stem‑cell therapy is approved/recommended, following an expert consultation chaired by the Secretary, DHR and involving CDSCO, DBT, NMC, AIIMS New Delhi, Tata Memorial Centre, and King George Medical University.
  • Current Hearing: On 01 September 2026 the Court sought a compliance report on the steps taken since the 30 January 2026 judgment.

Court Directions

1. The Union of India must file a compliance affidavit disclosing:

  • (i) Whether any application for approval or permission to conduct stem‑cell research/clinical trial for ASD has been received by the competent regulatory authority after the judgment.
  • (ii) If such applications exist, the number of applications, dates received, identity of applicant institutions, and present status of each.
  • (iii) Details of any clinical trials on stem‑cell therapy for ASD that are approved or under consideration, including the institutions conducting them and their capacity to accommodate patients already under treatment.
  • (iv) If no applications have been received from institutions currently administering therapy, whether the Government has investigated the reasons, in light of paragraph 153.
  • (v) The steps the Union proposes to facilitate transition of existing patients into duly approved clinical trials while maintaining regulatory safeguards.

2. Institutions/clinics presently providing stem‑cell therapy for ASD, and the parents/guardians or caregivers of such patients, must also disclose:

  • (i) Any steps taken post‑judgment to bring ongoing treatment within a regulated clinical‑trial framework, including approaches to competent authorities.
  • (ii) Whether any application, proposal, or request has been made by the institution/clinic or by a parent/guardian to any competent authority, medical or research institution, or clinical‑trial centre for initiation of or participation in an approved trial.
  • (iii) If such steps have been taken, the particulars – date of application/request, authority or institution approached, response received, and present status of the proposal.

3. The disclosures are intended to ascertain the present position of patients already receiving therapy and to evaluate whether the Court’s directive in paragraph 153 is being implemented.

4. The compliance affidavit and accompanying disclosures are to be filed by 29 September 2026 at 2.00 PM.

5. The order was recorded by the Assistant Registrar‑cum‑PS Court Master (NSH) – Chandresh, with Pooja Sharma as ASTT.

Final Outcome

  • The Union of India is mandated to submit a detailed compliance affidavit covering applications, trial statuses, and transition plans for existing ASD patients.
  • Relevant treatment institutions and caregivers must also report any actions taken to align ongoing therapy with the regulated clinical‑trial framework.
  • The Court will review these disclosures to determine whether the regulatory safeguards and patient‑supervision requirements outlined in its earlier judgment are being effectively implemented.

Topics: Stem Cell Therapy, Autism Spectrum Disorder, Regulatory Compliance