Big NMC Warning on Stem Cell Therapy: Doctors will face Professional Misconduct action, if going beyond approved use
New Delhi: Through a recent notice, the National Medical Commission (NMC) has 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.
The Commission has 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.
"All RMPs, medical institutions, SMC(s) and other stakeholders are, therefore, again advised that Stem Cell Therapy may be offered as standard clinical care, ONLY for approved indications as listed in ICMR/DHR/MoHFW guidelines. Any unauthorized administration, prescription, promotion or advertisement thereof, beyond such approved indications, shall constitute professional misconduct," NMC mentioned in an advisory dated 05.09.2026.
"All State Medical Councils shall examine individual cases of such alleged violation brought to their notice and, where misconduct by a RMP is established after due process, appropriate disciplinary action in accordance with applicable statutory and regulatory provisions, shall be taken," it further added.
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.
Referring to the top court's order, NMC mentioned in the advisory, "In view of the aforesaid order and the applicable regulatory framework governing Stem Cell research and therapy, it is hereby reiterated that Stem Cell Therapy for use as standard care in routine clinical practice shall be permitted only for such disease conditions/indications which are included in the list approved by the Ministry of Health and Family Welfare (MoHFW)."
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.
ICMR's letter to NMC and Consequent Directions:
In compliance with the top court direction, the ICMR wrote to the NMC Chairman, Dr. Abhijat Sheth, urging him to issue an advisory to all the medical colleges and institutions in this regard and 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.
ICMR warned that any deviation from the above shall be liable to regulatory and legal action in accordance with law. Consequently, in March, 2026, NMC issued an advisory and notified the medical colleges and institutes in this regard.
Once again, NMC on 05.07.2026 reiterated its directions and warned the stakeholders against unauthorized administration, prescription, promotion, or advertisement of Stem Cell Therapy.
In this connection, NMC also referred to the following related sections of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002:
i. "1.9 Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating the practice of medicine and shall also not assist others to evade such laws. He should be cooperative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotroріс substances Act, 1985; Medical Termination of Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental Health Act, 1987; Environmental Protection Act, 1986; Pre-natal Sex Determination Test Act, 1994; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal Opportunities and Full Participation) Act, 1995 and Bio-Medical Waste (Management and Handling) Rules, 1998 and such other Acts, Rules, Regulations made by the Central/State Governments or local Administrative Bodies or any other relevant Act relating to the protection and promotion of public health."
ii. "7.22 Research- Clinical drug trials or other research involving patients volunteers as per the guidelines of ICMR can be undertaken, provided ethics considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct."
iii. "8.2 It is made clear that any complaint with regard to professional misconduct can be brought before the appropriate medical council for disciplinary action. Upon receipt of any complaint of professional misconduct, the appropriate medical council would hold an enquiry and give opportunity to the registered medical practitioner to be heard in person or by pleader. If the medical practitioner is found to be guilty of committing professional misconduct, the appropriate medical council may award such punishment as deemed necessary or may direct the removal altogether or for a specified period, form the register of the name of the delinquent registered practitioner. Deletion from the Register shall be widely publicized in local press as well as in the publications of different Medical Associations/Societies/Bodies."
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
To view the NMC notice, click on the link below:
https://medicaldialogues.in/pdf_upload/2026/09/07/nmc-advisory-05092026-474464.pdf
