New Delhi, 17 September (H.S.): The Union Ministry of Health and Family Welfare has issued an advisory to states and Union Territories on the regulation of stem cell therapy. The Ministry has clarified that stem cell therapy may be used as a routine and standard treatment only for diseases and conditions that have been approved by the Ministry.

In the advisory issued by the Ministry on September 16, it stated that any form of stem cell therapy for the treatment of Autism Spectrum Disorder (ASD) may, for the time being, be administered only as part of a duly approved clinical trial. Such trials must comply with the 2017 ICMR-DBT National Guidelines for Stem Cell Research, as well as other government directives issued from time to time.

The Ministry has directed states and Union Territories to widely disseminate the Supreme Court’s directions among all concerned state and district regulatory authorities, as well as government and private clinical institutions. In particular, institutions involved in stem cell research, treatment, promotion or use will be required to comply with these regulations.

The advisory makes it clear that unproven stem cell therapies, including stem cell treatment for autism, cannot be offered as a routine, standard or commercial clinical service.

The advisory was issued following the Supreme Court’s judgment dated January 30, 2026, in the case of Yash Charitable Trust and Others versus the Government of India. The court had stated that failure to comply with the applicable regulations could invite legal and regulatory action, including proceedings for professional misconduct.

The Ministry said that doctors found violating the regulations could face action for professional misconduct. In addition, provisions under the Clinical Establishments (Registration and Regulation) Act, 2010, include measures such as cancellation of an institution’s registration and imposition of penalties.

Meanwhile, the National Medical Commission, in its advisory dated September 5, 2026, has also reiterated that stem cell therapy may be provided as a standard medical service only for approved diseases and indications. The unauthorised use, prescription, promotion or advertisement of stem cell therapy beyond the approved scope may be treated as professional misconduct.

The Commission has also directed state medical councils to investigate complaints concerning violations of the regulations and, where a violation is established following due process, take appropriate disciplinary action against the concerned doctor in accordance with the applicable rules.

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Hindusthan Samachar / Jun Sarkar