The Union ministry of health and family welfare on Thursday announced it has issued an advisory for states to ensure that stem cell therapy is offered as standard clinical care only for approved disease conditions. Also, its use for autism still remains restricted to clinical trials approved by the authorities concerned.
“…the advisory has been issued in view of the judgment dated 30 January 2026 of the Hon’ble Supreme Court in Yash Charitable Trust & Ors. v. Union of India & Ors., W.P. (C) No. 369 of 2022. 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 and Family Welfare,” read the health ministry statement.
For Autism Spectrum Disorder (ASD), the advisory stipulates that the therapeutic use of any type of stem cell in autism 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 Department of Biotechnology (DBT), and other applicable government instructions issued from time to time.
The ministry has requested states and Union territories to disseminate the Supreme Court’s directions to all 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.
{{/usCountry}}The ministry has requested states and Union territories to disseminate the Supreme Court’s directions to all 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.
{{/usCountry}}The advisory also draws attention to the consequences of non-compliance with the framework governing stem cell therapy.
The Supreme Court, in its judgment dated January 30, 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, in its advisory dated September 5, 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.