The Ministry of Health and Family Welfare has issued an advisory to States and Union Territories regarding the regulation of stem cell therapy, reiterating that stem cell treatments can be offered as standard clinical care only for approved disease conditions and indications. The advisory was issued on September 16, 2026, in the context of the Supreme Court judgment dated January 30, 2026, in Yash Charitable Trust & Ors. v. Union of India & Ors. The Ministry has directed concerned authorities and clinical establishments to ensure compliance with the existing regulatory framework governing stem cell research and therapy.
According to the Health Ministry, stem cell therapy as standard care in routine clinical practice should be permitted only for disease conditions or indications included in the list approved by the Ministry of Health and Family Welfare. The advisory reinforces the existing regulatory framework and seeks to ensure that stem cell-based interventions are provided in accordance with applicable government guidelines and regulatory requirements.
A significant aspect of the advisory relates to the use of stem cell therapy for Autism Spectrum Disorder (ASD). The Ministry has stated that the therapeutic use of any type of stem cell for autism should remain restricted to duly approved clinical trials. Such clinical trials are required to comply 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), along with other applicable government instructions. This means that unproven stem cell interventions for autism should not be offered as routine, standard or commercial clinical services.
The Ministry has also requested States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, to widely disseminate the Supreme Court's directions to State and District Regulatory Authorities. Government and private clinical establishments involved in stem cell research, treatment, promotion or administration have been asked to comply with the applicable regulatory framework.
The advisory further highlights the consequences of non-compliance with the regulatory requirements. The Supreme Court, in paragraph 151(xiii) of its January 30, 2026 judgment, stated that non-compliance with statutory requirements may 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. Depending on the applicable provisions and circumstances, regulatory action may include cancellation of registration and penalties.
The National Medical Commission (NMC), through its advisory dated September 5, 2026, has also reiterated that stem cell therapy may be offered as standard clinical care only for approved indications. The NMC has stated that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct. State Medical Councils have been advised to examine complaints concerning alleged violations and, where professional misconduct by a Registered Medical Practitioner is established following due process, take appropriate disciplinary action under the applicable statutory and regulatory provisions.
The latest advisory therefore reinforces the distinction between approved clinical use of stem cell therapy and experimental interventions. For autism specifically, the Ministry has reiterated that therapeutic use of stem cells should currently remain within properly approved clinical trials and under the applicable research and regulatory framework.
