Ø
Stem Cell Therapy as Standard Care to be Permitted
Only for Disease Conditions/Indications Included in Ministry-Approved List
Ø
Therapeutic Use of Stem Cells for Autism Spectrum
Disorder (ASD) Restricted to Clinical Trials with Necessary Regulatory
Approvals
Ø
Unproven Stem Cell Interventions, Including Stem
Cell Therapy for ASD, Not to be Offered as Routine,
Standard or Commercial Clinical Services
·
MoHFW advisory: Ministry of Health & Family Welfare
issued an advisory dated 16
September 2026 to States/UTs that have adopted the Clinical Establishments (Registration
and Regulation) Act, 2010.
·
Supreme
Court judgment: The
advisory follows the Supreme Court judgment dated 30 January 2026 in Yash Charitable Trust & Ors.
v. Union of India & Ors., W.P. (C) No. 369 of 2022 [2026 INSC 96].
·
Standard
clinical care: Stem
cell therapy may be used as standard
care in routine clinical practice only for disease conditions/indications
included in the list approved by MoHFW.
·
Autism
Spectrum Disorder (ASD):
Therapeutic use of any
type of stem cell for autism is to remain restricted to duly approved clinical trials.
·
Applicable
guidelines:
ASD-related stem cell research/therapy must comply with the National Guidelines for Stem Cell
Research, 2017, issued jointly by ICMR and DBT, along with
other applicable Government instructions.
·
Regulatory
dissemination:
States/UTs have been asked to circulate the Supreme Court's directions to State and District Regulatory
Authorities and Government/private clinical establishments
involved in stem cell research, treatment, promotion or administration.
·
Professional
misconduct: The
Supreme Court held that non-compliance with the statutory framework may attract
consequences, including professional
misconduct under Regulation 7.22 of the IMC Regulations, 2002.
·
Clinical
Establishments Act:
Action may also be taken under Sections
32 and 40 of the Clinical Establishments (Registration and Regulation) Act,
2010, including cancellation
of registration and penalties.
·
NMC
advisory: The National Medical Commission (NMC),
through its advisory dated 5
September 2026, separately reiterated that stem cell therapy
can be offered as standard clinical care only
for approved indications.
·
Unauthorised
activities: The
NMC stated that unauthorised administration,
prescription, promotion or advertisement of stem cell therapy
beyond approved indications would constitute professional misconduct.
·
State
Medical Councils: State
Medical Councils have been advised to examine alleged violations and, where
professional misconduct by a Registered Medical Practitioner is established
after due process, take appropriate disciplinary
action.
Effect
of the advisory: Stem
cell therapy remains permissible as routine clinical care only for MoHFW-approved indications,
while its therapeutic use for autism
is confined to approved clinical trials. The advisory
reinforces regulatory action against unauthorised treatment, promotion and
advertising.
The Ministry
of Health & Family Welfare has issued an advisory dated 16 September 2026
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 has been issued in view of the
judgment dated 30 January 2026 of the Hon’ble Supreme Court in Yash
Charitable Trust & Ors. v. Union of India & Ors., W.P. (C) No. 369
of 2022 [2026 INSC 96].
The advisory
reiterates the existing framework governing stem cell research and therapy and
seeks to ensure that stem cell therapy is permitted as standard care in
routine clinical practice only for disease conditions/indications included in
the list approved by the Ministry of Health & Family Welfare.
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, issued jointly by Indian Council of Medical
Research (ICMR) and the Department of Biotechnology (DBT) and other applicable
Government instructions issued by the Government of India from time to time.
The Ministry
has requested the States and Union Territories to widely disseminate the
directions of the Hon’ble Supreme Court to all concerned State and District
Regulatory Authorities and Government and private clinical establishments
involved in stem cell research, treatment, promotion or administration, for
strict compliance with the applicable framework.
The advisory
also draws attention to the consequences of non-compliance with the framework
governing stem cell therapy. The Hon’ble Supreme Court, in Para 151(xiii) of
its judgment dated 30 January 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.
Reinforcing
the regulatory position, the National Medical Commission (NMC), in its advisory
dated 5 September 2026, 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.
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.