The Health Ministry has directed all states and UTs to regulate stem cell therapy, permitting it as standard care only for approved indications. The advisory, based on a Supreme Court verdict, warns of strict action for non-compliance.
The Ministry of Health and Family Welfare has issued a comprehensive advisory to all States and Union Territories regulating the use of stem cell therapy, directing that it can be offered as routine standard clinical care only for approved indications, in strict compliance with a recent Supreme Court verdict.
The directive, issued on September 16 to all states and UTs that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, comes in the wake of the Supreme Court’s judgment delivered on January 30, 2026, in Yash Charitable Trust & Ors v Union of India & Ors.
Specific Guidelines and Compliance
According to a press release issued by the Ministry, the advisory reiterates the existing framework governing stem cell research and therapy and seeks to ensure that stem cell therapy is 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.
With regard to Autism Spectrum Disorder (ASD), the advisory stipulates that the therapeutic use of any type of stem cell in autism is to remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) and other applicable Government instructions issued by the Government of India from time to time.
The Ministry has requested the States and Union Territories to widely disseminate the directions of the Supreme Court to all concerned State and District Regulatory Authorities and Government and private clinical establishments involved in stem cell research, treatment, promotion or administration, for strict compliance with the applicable framework.
Penalties for Non-Compliance
The advisory also draws attention to the consequences of non-compliance with the framework governing stem cell therapy. The Supreme Court, in its judgment, held that non-compliance with the statutory mandate must attract consequences, including professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, as well as 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.
Reinforcing the regulatory position, the National Medical Commission (NMC), in its advisory dated September 5, 2026, reiterated that stem cell therapy may be offered as standard clinical care only for the approved indications. The advisory further states that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond the approved indications would constitute professional misconduct.
The NMC has further 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. (ANI)
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