The Health Ministry has directed states and UTs to ensure stem cell therapy for Autism Spectrum Disorder is offered only through duly approved clinical trials.
Routine stem cell treatment is permitted only for disease conditions and indications included in the ministry’s approved list.
The advisory cites a January 2026 Supreme Court judgment and warns of professional misconduct proceedings, registration cancellation and other penalties for regulatory violations.
The Union Health Ministry has directed states and Union Territories to strictly enforce existing regulations governing stem cell research and therapy, making it clear that stem cell treatment for Autism Spectrum Disorder (ASD) can be offered only as part of duly approved clinical trials.
In an advisory dated September 16, the Ministry of Health and Family Welfare said stem cell therapy can be used as standard care in routine clinical practice only for disease conditions and indications included in the ministry’s approved list. Unapproved interventions, including those promoted for autism, cannot be offered as routine, standard or commercial clinical services.
The advisory follows a January 30, 2026, Supreme Court judgment in Yash Charitable Trust and Others vs Union of India and Others.
Stem Cell Therapy For Autism Restricted To Clinical Trials
The Health Ministry said therapeutic use of any type of stem cell for autism must remain restricted to duly approved clinical trials.
Such trials must 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, along with other applicable government directions.
The ministry has asked State and District Regulatory Authorities and clinical establishments involved in stem cell research, treatment, promotion or administration to ensure strict compliance with the regulatory framework.
The advisory seeks to prevent interventions that have not been approved for routine clinical use from being presented or marketed as standard treatment.
NMC Warns Of Professional Misconduct
The National Medical Commission (NMC) had also issued an advisory on September 5 reinforcing the regulatory position.
According to the NMC, stem cell therapy may be offered as standard clinical care only for approved indications. Unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond those indications would amount to professional misconduct.
The NMC has advised State Medical Councils to examine complaints of alleged violations and take appropriate disciplinary action where professional misconduct by a registered medical practitioner is established following due process.
The Health Ministry's advisory also highlights potential legal and professional consequences for violations. Citing the Supreme Court's January 30 judgment, it said non-compliance with the statutory framework must attract consequences, including professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations, 2002.
The advisory also refers to action under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, including cancellation of registration and penalties.
The ministry has consequently asked state and district authorities as well as clinical establishments to ensure that stem cell research and therapy remain within the approved regulatory framework.
