Stem cell therapy: NMC issues advisory for medical colleges to comply with Supreme Court directions

New Delhi: In compliance with the Supreme Court of India judgment on the use of stem cell therapy, the National Medical Commission (NMC) has notified that medical colleges and institutions can undertake stem cell therapy in routine practice only for diseases listed by the Ministry of Health and Family Welfare, while research beyond this is permitted strictly as part of an approved clinical trial.

The Apex medical commission issued the advisory after the Indian Council of Medical Research (ICMR) requested Dr Abhijat Chandrakant Sheth, Chairman of NMC to specify to all the medical colleges that stem cell therapy in routine practice is restricted only to approved indications listed in the Indian Council of Medical Research (ICMR)/Department of Health Research (DHR)/MoHFW guidelines and that research beyond this is strictly conducted in compliance with ICMR Ethical Guidelines and with prior approval of either CDSCO or DHR, depending on the level of manipulation of stem cells.

The top court, in its 30th January, 2026 judgment, clearly held stem cell therapy is not approved for conditions like Autism Spectrum Disorder (ASD) since therapeutic use of stem cells in ASD, outside an approved clinical trial is unethical and shall be considered as malpractice, as there is a lack of reliable, conclusive research on the efficacy and safety of such procedures.

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.

In compliance with the top court direction, the ICMR wrote to the NMC Chairman, urging him to issue an advisory to all the medical colleges and institutions in this regard.

In the communication on March 10, 2026, the ICMR referred to the top court's judgment in Yash Charitable Trust & Ors. vs Union of India & Ors. and highlighted that stem cell therapy in routine practice shall be permitted only for disease conditions specified in the list of MoHFW-approved indications as standard care.

"This has reference to the judgment (D. No. 14452/2022/SEC-X dated 3rd February 2026) of Hon’ble Supreme Court of India in the matter of Yash Charitable Trust & Ors. versus Union of India & Ors. (W.P. (C) No. 369 of 2022), concerning issues related to the use of stem cell therapy for the treatment of Autism Spectrum Disorder (ASD). This judgement has important implications for giving stem cell therapy in India. The following is being conveyed to ensure compliance with the directions of the Hon’ble Court. Stem cell therapies in routine practice shall be permitted only for disease conditions specified in the list of MoHFW approved indications as Standard Care (enclosed herewith)," the letter stated.

It further clarified that any use beyond the approved indications is permissible only in the context of research. Depending on the level of manipulation of stem cells, such research would require prior approval from either the Central Drugs Standard Control Organisation (CDSCO) or the Department of Health Research (DHR).

"If stem cells have undergone more than minimal manipulation, the research will be regulated by CDSCO. If stem cells have undergone less than minimal manipulation, research will be regulated by DHR, and in this case, in addition to the recommendations of the Institutional Ethics Committee (IEC) registered with DHR, the trials will have to be approved by the National Stem Cell Research Regulation Committee. The levels of manipulation for stem cell therapy have been defined by CDSCO," the communication added.

ICMR also emphasised that stem cell research shall be permissible only as part of an approved clinical trial and will be required to comply with all ICMR ethical guidelines, including written informed consent, no cost to the patient and provision of compensation in case of injury or death.

Further, any stem cell treatment not included in the list of standard care indications, or not approved by CDSCO or DHR, shall be deemed illegal and liable to action in accordance with law. “It is reiterated that biomedical research can only be approved by IEC registered with DHR,” the letter stated.

Following this, the ICMR requested NMC to issue an advisory stating that "firstly, Routine practice should be restricted ONLY to the approved indications listed in ICMR/DHR/MoHFW guidelines. Secondly, beyond the approved list of disease conditions, Stem cell research needs to be conducted in compliance with ICMR Ethical Guidelines and with prior approval of either CDSCO or DHR depending on the level of manipulation of stem cells. This advisory may be circulated to all registered medical practitioners, medical colleges, and affiliated institutions under the jurisdiction of the Commission to ensure strict compliance."

ICMR warned that any deviation from the above shall be liable to regulatory and legal action in accordance with law.

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/Paroxysmal hemoglobinuria

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

**For details, refer to Hematopoietic Cell Transplantation Guidelines 2021 (Annexure IStandard of Care only)

Referring to this communication, the Policy and Coordination Division of NMC on March 25, 2026 issued an advisory addressing Dean and Principal all the Medical Colleges and Institutions saying, "A D. O. letter no. M - 11019 / 5 / 2026 - CG dated the 10 th March, 2026 with respect to Judgement (D. No. 14452 / 2022 / SEC-X dated 3rd February, 2026) of the Hon'ble Supreme Court of India in the matter of Yash Charitable Trust & Ors. versus Union of India & Ors. (W.P. (C) No. 369 of 2022) concerning issues related to the use of stem cell therapy for the treatment of Autism Spectrum Disorder (ASD) is attached. All Medical Colleges / Institutions are requested to ensure compliance with the directions of the Hon'ble Supreme of India."

To view the advisory, click on the link below:

Also read- Stem cell therapy for autism outside approved clinical trial is medical malpractice: Supreme Court