New Delhi, September 17 (Daily Kiran) : The Indian government announced on September 17, 2026, that it has released an advisory aimed at regulating stem cell therapy. According to the advisory, this therapy can only be employed as standard care for diseases or conditions approved by the Ministry of Health.
Specifically regarding Autism Spectrum Disorder (ASD), the advisory states that the use of any form of stem cells for treating autism will be restricted to approved clinical trials, in line with the “National Guidelines for Stem Cell Research, 2017.”
Dated September 16, the advisory has been sent to all states and union territories that have adopted the “Clinical Establishments (Registration and Regulation) Act, 2010,” which pertains to the regulation of stem cell therapy. It reiterates existing rules surrounding stem cell research and therapy.
The advisory also emphasizes the consequences of failing to comply with these regulations. The Supreme Court, in a ruling on January 30, 2026, indicated that legal actions should follow non-compliance, referencing professional misconduct under the IMC Regulations, 2002, and provisions for registration cancellation and fines under the Clinical Establishments Act.
The Ministry has urged state and district regulatory authorities and clinical establishments to ensure strict adherence to the rules regarding stem cell research and therapy.
Additionally, the National Medical Commission (NMC) reiterated its advisory that stem cell therapy should only be provided as standard clinical care for approved conditions. Offering, prescribing, promoting, or advertising stem cell therapy for unapproved conditions will be deemed professional misconduct.
The NMC has also advised state medical councils to investigate reported violations. If professional misconduct is established after due process, appropriate disciplinary actions will be taken in accordance with relevant legal and regulatory provisions.
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