Supreme Court Holds Stem Cell Therapy For Autism Not A Routine Clinical Service; Allows Research Only In Approved Trials

A bench of Justices J.B. Pardiwala and R. Mahadevan heard a public interest writ petition challenging the widespread promotion, prescription and administration of stem cell “therapy” for Autism Spectrum Disorder (ASD). The petition, filed by Yash Charitable Trust and others, questioned whether clinics could offer stem cell interventions for ASD as routine commercial clinical services and sought directions for enforcing the existing regulatory framework under the Drugs and Cosmetics Act, the New Drugs and Clinical Trials (NDCT) Rules, and ICMR guidelines.

The Court held that therapeutic use of stem cells for ASD could not be offered as a routine clinical service outside an approved and monitored clinical trial or research setting. It relied on the consolidated scientific and ethical position reflected in the ICMR’s National Guidelines for Stem Cell Research, 2017 and the Evidence Based Status of Stem Cell Therapy for Human Diseases, 2021, and on recommendations of the Ethics & Medical Registration Board (EMRB), National Medical Commission (NMC). The Court noted that the EMRB had concluded “Current Status: Stem cell therapy is not recommended as a treatment for Autism Spectrum Disorder (ASD) in clinical practice” and that “use of Stem cell in ASD, its promotion and advertisement will be considered as professional misconduct.” The Court, in its reasoning, observed: “Therefore, we arrive at the conclusion that, since therapeutic use of stem cells in ASD is not recognised as ‘a sound and relevant medical practice’ as per the knowledge available at present, the medical practitioners who offer the same as a clinical service, outside of an approved and monitored research/clinical trial, fail to meet the reasonable standard of care owed by them towards their patients.” The Court further recorded that ICMR documents stated that “based on the review of available scientific evidence, stem cell therapy should NOT be offered as a standard or routine therapy to patients with Autism Spectrum Disorder.”

Background The petition alleged rampant, commercialised administration and promotion of stem cell therapy for ASD despite its experimental status and absence of proven safety and efficacy. Petitioners pointed to the NDCT Rules, 2019 (which treat “stem cell derived products” as new drugs) and to ICMR guidelines that restricted therapeutic use to approved clinical trials. Respondent Union of India and the NMC maintained that certain processed cell products fell within the NDCT regime while unprocessed autologous procedures might not amount to “stem-cell derived products”; the MoHFW clarification of 09.02.2021 on the meaning of “stem cell derived product” and the DTAB minutes of 27.08.2019 featured prominently in arguments. Several clinics and industry respondents contended that autologous procedures were treatments or procedures, not manufacture of new drugs, and relied on earlier interim orders of Delhi High Court (notably Dalip Kaur v. Union of India) which permitted continuation of ongoing therapies pending adjudication, observing that “medical advancements often encompass, both known and unforeseen risks, and individual autonomy in making informed decisions about treatment options is the cornerstone of patient rights.”

The Court reviewed ICMR’s EBSSCT 2021 chapter on ASD and the NGSCR 2017, which described non‑trial use of stem cells (other than established haematopoietic indications) as “investigational” and stated that use outside approved clinical trials “is unethical and shall be considered as malpractice.” The bench held that, in light of established medical negligence jurisprudence requiring a treatment to be a “practice acceptable to the medical profession of that day,” offering stem cell therapy for ASD as routine care would fall below the standard of reasonable care. The Court also examined regulatory lacunae, including dissolution of the National Apex Committee for Stem Cell Research & Therapy (NAC‑SCRT) by a DHR order of 03.03.2024, and directed the Secretary, Ministry of Health & Family Welfare, in consultation with AIIMS and NMC, to file proposals within four weeks to ensure continuity of care for patients currently receiving treatment and to clarify the regulatory oversight and pathway for stem cell research and trials. The matter was kept part‑heard for final directions after the Union’s response.

Case Details: Case No.: 2026 INSC 96; Writ Petition (C) No. 369 of 2022 Case Title: Yash Charitable Trust & Ors. v. Union of India & Ors. Appearances: For the Petitioner(s): Mr. Siddharth Nath (Advocate) For the Respondent(s): Mr. Vikramjit Banerjee, Mr. Aishwarya Bhati (ASGs) for Union of India; Mr. Prateek Bhatia (for NMC); Mr. Utkarsh Sharma (for Respondent No.9); Mr. Nikilesh Ramachandran (for Respondent No.10); Ms. Swarupama Chaturvedi (for Respondent No.11); Mr. Nitesh Ranjan (for Respondent No.13).