Govt issues advisory to regulate stem cell therapy

  The government has issued an advisory tightening regulation of stem cell therapy, allowing standard clinical use only for approved indications. Stem cell treatment for autism remains limited to approved clinical trials, with unauthorised use, promotion or advertising attracting professional misconduct and disciplinary action 

New Delhi: The government on Thursday said it has issued an advisory to regulate stem cell therapy, saying the therapy is permitted as standard care in routine clinical practice only for disease conditions or indications included in the list approved by the Health Ministry.

With regard to Autism Spectrum Disorder (ASD), the advisory stipulates that the therapeutic use of any type of stem cell in autism is to remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017.

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The advisory, dated September 16, has been sent to all states and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, regarding regulation of stem cell therapy. The advisory reiterates the existing framework governing stem cell research and therapy.

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, 2026, 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,” the statement said. Moreover, the National Medical Commission (NMC), in its advisory, 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 to professional misconduct.

According to the statement, 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.