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The Ministry of Health and Family Welfare issued an advisory dated 16 September 2026 to all States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010.
It follows the Supreme Court judgment of 30 January 2026 in Yash Charitable Trust and Others v. Union of India and Others, W.P. (C) No. 369 of 2022, reported as 2026 INSC 96.
Stem cell therapy may be offered as standard care only for disease conditions and indications on the list approved by the Ministry.
Therapeutic use of any type of stem cell in Autism Spectrum Disorder is confined to duly approved clinical trials under the National Guidelines for Stem Cell Research, 2017.
Non-compliance can attract professional misconduct proceedings and action under Sections 32 and 40 of the Clinical Establishments Act, covering cancellation of registration and penalty.
Registers and regulates clinical establishments in States and UTs that adopt it. Section 32 allows cancellation of registration; Section 40 is the residual penalty provision.
Issued jointly by ICMR and DBT on 11 October 2017. They sort research into permissible, restrictive and prohibited categories and require an Institutional Committee for Stem Cell Research registered with NAC-SCRT.
Regulation 7.22 is the professional-misconduct route the Supreme Court pointed to.
Notified 19 March 2019 in place of Part XA and Schedule Y of the Drugs and Cosmetics Rules, 1945; they govern the trials to which stem cell use in autism is now confined.
Lists Autism Spectrum Disorder among its specified disabilities, defined as a neuro-developmental condition typically appearing in the first three years of life.
Apex body for biomedical research; co-author of the 2017 stem cell guidelines
Monitors stem cell research nationally; institutional committees register with it
India's National Regulatory Authority for drugs, cosmetics and medical devices; clinical-trial ethics committees register with it
Regulates medical education and practice; issued the parallel 5 September 2026 advisory
A therapy becomes standard care only after trials establish that it works for a named indication. An unproven intervention sold as routine treatment skips that step, charges the patient for it, and drops the safety monitoring a trial carries.
GS Paper 2 > Governance > Issues Relating to Development and Management of Health
General Awareness > Indian Polity and Current Affairs
A condition listed in the Schedule to the Rights of Persons with Disabilities Act, 2016, which covers 21 such conditions including Autism Spectrum Disorder.
The institution-level body that approves and monitors stem cell research, and must register with NAC-SCRT.
A treatment accepted for routine clinical use for a named indication, as against an intervention still confined to research.