Stem Cell Therapy: Health Ministry directs states, UTs to ensure regulatory compliance, warns of action
New Delhi: In compliance with the Supreme Court's directives, the Union Ministry of Health and Family Welfare has recently issued an advisory to all States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, regarding the 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].
Issuing the advisory, the Ministry has reiterated 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.
Regarding 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.
Advisory from the Union Health Ministry comes after the National Medical Commission (NMC) issued a similar advisory on September 5, 2026, and reiterated that stem cell therapy may be offered as standard clinical care only for the approved indications.
Medical Dialogues had earlier reported that through the advisory dated 05.09.2026, the Apex Medical Commission had warned against unauthorized administration, prescription, promotion, or advertisement of Stem Cell Therapy, warning that it would constitute professional misconduct on the part of doctors, medical institutes, SMC(s), and other stakeholders.
NMC had also advised the stakeholders that while Stem Cell Therapy may be offered as standard clinical care, it should be ONLY done for approved indications as listed in ICMR/DHR/MoHFW guidelines.
Further, the Commission had 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.
The Apex Medical Commission has issued this advisory following the Supreme Court order dated 30.01.2026 in the case of Yash Charitable Trust & Ors. vs. Union of India & Ors. regarding the Regulation of Stem Cell Therapy for the treatment of ASD as Clinical Practice. In this order, the Apex Court observed that Stem Cell Therapy for the treatment of ASD cannot be offered as routine commercial medical treatment outside the regulatory framework of clinical trials.
Supreme Court's Order:
Medical Dialogues had previously reported that the Supreme Court disapproved of the use of Stem Cell Treatment (SCT) for Autism Spectrum Disorder (ASD) as regular clinical treatment.
"If a medical practitioner, in blatant disregard of such authoritative guidelines choose to offer stem cell therapies for ASD, as a clinical service, outside of an approved clinical trial, then such medical practitioner would be considered as having failed to act in accordance with reasonable standard of care," held the top court bench comprising Justice JB Pardiwala and Justice R Mahadevan.
The bench concluded that since therapeutic use of stem cells in ASD is not recognised as ‘a sound and relevant medical practice’ as per the knowledge available at present, "the medical practitioners who offer the same as a clinical service, outside of an approved and monitored research/clinical trial, fail to meet the reasonable standard of care owed by them towards their patients."
"Hence, until there is further research which establishes this as a sound and relevant medical practice, stem cell ‘therapies’ for ASD cannot be offered by medical practitioners as a clinical service, outside an approved and monitored clinical trial/research setting," held the bench.
List of MOHFW Approved Disease Conditions for Stem Cell Therapy as Standard Care:
Only safe and appropriately performed hematopoietic stem cell transplantation is recommended as Standard of Care for the following indications** Mesenchymal stem cell transplantation is not recommended for any disease condition.
Adults:
1. Acute Myeloid Leukemia
2. Acute lymphoblastic leukemia
3. Chronic Myeloid Leukemia
4. Myelofibrosis
5. Myelodysplastic syndromes
6. Chronic lymphocytic leukemia
7. Diffuse Large b cell lymphoma
8. Follicular lymphoma
9. Mantle cell lymphoma
10. Peripheral T cell lymphoma
11. Hodgkin's Lymphoma
12. Multiple Myeloma
13. Acquired Severe Aplastic Anemia
14. Constitutional Severe Aplastic Anemia
15. Aplastic Anemia/Paroxysmalhemoglobinuria
16. Germ Cell tumors
17. Multiple Sclerosis
18. Systemic Sclerosis
Pediatrics:
1. Acute Myeloid Leukemia
2. Acute lymphoblastic leukemia
3. Chronic Myeloid Leukemia
4. Myelodysplastic syndromes/ Juvenile myelomonocytic leukemia
5. Non-Hodgkin Lymphoma
6. Hodgkin lymphoma
7. Primary immunodeficiency diseases
8. Mucopolysaccharidoses
9. Thalassemia/ SCD
10. Osteopetrosis
11. Acquired Severe Aplastic Anemia
12. Inherited Bone Marrow failure syndromes
13. Ewings Sarcoma
14. Neuroblastoma
