The Union Ministry of Health and Family Welfare has directed states and Union Territories to strictly regulate stem cell therapy, making clear that the treatment can be offered as routine clinical care only for diseases and conditions approved by the government.

The advisory, issued on September 17, follows a January 30, 2026, Supreme Court judgment in Yash Charitable Trust & Ors. v. Union of India & Ors., W.P. (C) No. 369 of 2022 [2026 INSC 96].

According to the advisory, stem cell therapy is to be “permitted as standard care in routine clinical practice only for disease conditions/indications included in the list approved by the Ministry of Health & Family Welfare.”

The ministry has asked all states and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, to circulate the Supreme Court’s directions among State and District Regulatory Authorities and government and private clinical establishments involved in stem cell research, treatment, promotion or administration.

Autism treatment restricted to trials

The ministry has specifically clarified the position on the use of stem cell therapy for Autism Spectrum Disorder (ASD).

Such treatment, it said, “is to remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017.”

The guidelines were issued jointly by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).

The clarification means that stem cell therapy for autism cannot be offered as routine clinical treatment outside an approved clinical trial.

Violations can lead to action

The advisory also draws attention to the consequences of failing to comply with the regulatory framework.

Referring to Para 151(xiii) of the Supreme Court’s January 30 judgment, the ministry said the court “held that non-compliance with the statutory mandate must attract consequences, including professional misconduct under Regulation 7.22 of the IMC Regulations, 2002.”

The judgment also provides for action “under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for cancellation of registration and penalty.”

The ministry has “accordingly requested the concerned State and District Regulatory Authorities and clinical establishments to ensure strict compliance with the applicable framework governing stem cell research and therapy.”

NMC warns against unauthorized use

The advisory also refers to a separate communication issued by the National Medical Commission (NMC) on September 5, 2026.

The NMC “reiterated that stem cell therapy may be offered as standard clinical care only for the approved indications.”

It further warned that “unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond the approved indications would constitute to professional misconduct.”

The NMC has also advised State Medical Councils “to examine cases of alleged violations brought to their notice and, where professional misconduct by a Registered Medical Practitioner is established after due process, take appropriate disciplinary action in accordance with the applicable statutory and regulatory provisions.”

The Health Ministry has asked regulatory authorities and clinical establishments to ensure that stem cell research and treatment are carried out within the approved legal and scientific framework.

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