Stem cell therapy for Autism Spectrum Disorder (ASD) can only be used as part of duly approved clinical trials and cannot be offered as routine or commercial treatment, the Union Health Ministry said in an advisory issued to states and Union Territories.

The advisory, issued on September 16, reiterates that stem cell therapy can be permitted as standard clinical care only for disease conditions or indications included in the list approved by the Ministry of Health and Family Welfare.

For autism, the ministry said the therapeutic use of any type of stem cell must remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).

The ministry has also directed states and Union Territories to widely disseminate the Supreme Court's directions to state and district regulatory authorities as well as government and private clinical establishments involved in stem cell research, treatment, promotion, or administration.

The advisory comes in view of the Supreme Court judgment of January 30, 2026, in Yash Charitable Trust & Ors. v. Union of India & Ors.

The Health Ministry has warned that unproven stem cell interventions, including stem cell therapy for autism, must not be offered as routine, standard, or commercial clinical services.

Also Read: Supreme Court Bars Stem Cell Therapy For Autism: Why The Ruling Matters

The advisory also highlights consequences for violations of the regulatory framework. According to the ministry, the Supreme Court held that non-compliance with the statutory mandate can attract consequences including professional misconduct under the applicable medical regulations, as well as action under the Clinical Establishments (Registration and Regulation) Act, 2010, including cancellation of registration and penalties.

Separately, the National Medical Commission, in an advisory dated September 5, reiterated that stem cell therapy may be offered as standard clinical care only for approved indications.

The NMC said unauthorised administration, prescription, promotion, or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct. It has asked State Medical Councils to examine alleged violations and, where professional misconduct by a registered medical practitioner is established after due process, take appropriate disciplinary action.

The Health Ministry has accordingly asked regulatory authorities and clinical establishments to ensure strict compliance with the existing framework governing stem cell research and therapy.

Read More: What Is Stem Cell Therapy? Here's How Much It Costs For Conditions It Can Actually Cure



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