A September 16 advisory reiterates that stem cell therapies may be offered as routine care only for approved indications and says any therapeutic use for Autism Spectrum Disorder must occur inside duly approved clinical trials under existing national guidelines and court directions.
Therapeutic use of any stem cell for autism is restricted to duly approved clinical trials governed by the 2017 National Guidelines for Stem Cell Research (ICMR–DBT) and other applicable rules.
States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010 must circulate the Supreme Court’s January 30, 2026 directions and enforce compliance.
Violations can attract disciplinary action including professional misconduct under Indian Medical Council Regulations 2002 and cancellation or penalties under Sections 32 and 40 of the Clinical Establishments Act.
Territories that follow the Clinical Establishments (Registration and Regulation) Act, 2010. The advisory reiterates that stem cell therapy may be provided as standard clinical care only for indications that are explicitly approved. It states that any therapeutic use of stem cells for Autism Spectrum Disorder (ASD) must be confined to duly approved clinical trials.
The advisory cites a Supreme Court judgment delivered on January 30, 2026 (Yash Charitable Trust and Others v. Union of India and Others). That judgment set out consequences for non-compliance with statutory requirements governing stem cell work. The Ministry's note reminds state and district regulatory authorities, and both government and private clinical establishments involved with stem cell research or treatment, to circulate the Court's directions widely and to follow the existing regulatory framework.
The advisory refers specifically to the National Guidelines for Stem Cell Research, 2017, jointly issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT). It also points to other applicable government instructions and the Clinical Establishments Act framework adopted by many States and Union Territories.
The advisory highlights legal and professional consequences for breaches. The Supreme Court judgment refers to professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations, 2002. It also references Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, which provide for cancellation of registration and penalties. The Ministry has urged state regulators and clinical establishments to ensure compliance and to take action where rules are violated.
National Medical Commission advisory
Separately, the National Medical Commission issued an advisory on September 5 restating that stem cell therapy should be offered as standard clinical care only for approved indications. The NMC said unauthorized administration, prescription, promotion, or advertisement of stem cell therapies beyond approved indications would amount to professional misconduct. It advised State Medical Councils to investigate alleged violations and to take disciplinary action where due process establishes misconduct.
What this means for patients and providers
Patients seeking stem cell interventions for autism should expect that such treatments must be part of approved clinical trials. Providers and clinics offering stem cell therapy for ASD outside trial settings now face regulatory scrutiny, possible disciplinary proceedings by medical councils, and administrative penalties under the Clinical Establishments Act. States and district regulators have been asked to circulate the direction and enforce it.
State and district-level health and medical authorities will need to communicate the advisory to registered clinical establishments and to monitor compliance. Clinical teams that wish to study stem cell approaches for autism must follow trial approval processes and the 2017 ICMR–DBT guidelines.
The advisory also draws attention to the consequences of non-compliance with the framework governing stem cell therapy
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