New Delhi: The Union Health Ministry has issued an advisory to States and Union Territories reiterating that stem cell therapy can be offered as standard clinical care only for approved medical indications, while its therapeutic use for Autism Spectrum Disorder (ASD) must remain restricted to duly approved clinical trials.
The advisory, dated September 16, was issued to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, in view of a Supreme Court judgment delivered on January 30, 2026.
The Ministry said stem cell therapy must not be offered as routine, standard or commercial clinical services for conditions not included in the list of approved indications.
With regard to autism, the advisory states that the therapeutic use of any type of stem cell must be 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), along with other applicable government instructions.
The Ministry has asked States and Union Territories to widely circulate the Supreme Court’s directions among State and district regulatory authorities, as well as government and private clinical establishments involved in stem cell research, treatment, promotion or administration.
It has called for strict compliance with the existing regulatory framework.
Action against violations
The advisory also highlights the consequences of violating the rules governing stem cell therapy.
The Supreme Court, in paragraph 151(xiii) of its January 30 judgment in Yash Charitable Trust and Others v. Union of India and Others, held that non-compliance with statutory requirements must attract consequences, including professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations, 2002.
The judgment also referred to action under Sections 32 and 40 of the Clinical Establishments Act, which provide for cancellation of registration and penalties.
The Ministry has accordingly urged regulatory authorities and clinical establishments to ensure compliance with the applicable framework.
NMC reiterates restrictions
The National Medical Commission (NMC), in an advisory dated September 5, also reiterated that stem cell therapy may be offered as standard clinical care only for approved indications.
The NMC stated that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct.
It has advised State Medical Councils to examine alleged violations brought to their notice and take appropriate disciplinary action against registered medical practitioners where professional misconduct is established after due process.
