Health Ministry Orders State Bodies to Regulate Unproven Stem Cell Therapies; Warns Clinical Professionals

September 21: The advisory by the Union Health Ministry has made it clear that unauthorized administration, prescription, promotion or advertisement of stem cell therapy beyond the approved indications would constitute professional misconduct.

The advisory has been issued following the January 30 judgement by the supreme court. It reiterates the existing guidelines to ensure that stem cell therapies are permitted as standard care in routine clinical practice only for disease conditions/indications included in the list approved by the ministry.

The centre  requested the state bodies and Union Territories to circulate the directions of the 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 ministry specifically mentioned that for people with Autism Spectrum Disorder (ASD) the therapeutic use of any type of stem cell should remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, jointly issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) and other government bodies from time to time.

A similar advisory was issued by the National Medical Council (NMC) on September 5 on unregulated stem cell therapies.

The Union Ministry strictly highlighted that non-compliance with the statutory mandate will have 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. 

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.

Approved Stem Cell Therapy Indications for Adults in India

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 (This is flagging plagiarism, however I took it from an official statement issued by the Govt. of India)

14. Constitutional Severe Aplastic Anemia

15. Aplastic Anemia/Paroxysmal hemoglobinuria

16. Germ Cell tumors

17. Multiple Sclerosis

18. Systemic Sclerosis

Approved Stem Cell Therapy Indications for Children in India

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

Also Read: Stem Cell Therapy Reverses Type 2 Diabetes in China

According to reports, patients have occasionally been harmed by uncharacterized treatments received at stem cell clinics. 

These include suffering significant bacterial infection,loss of movement or feeling in the lower half of the body and loss of vision in both eyes.

The difference between clinical trials and medical treatments lies in the purpose and certainty of these treatments.

Clinical trials are uncertain because the medical drug/device/procedure being tested is still under evaluation. Clinical trials test and discover new medical possibilities. 

However, medical treatments have already undergone a thorough trial phase and are proven effective.

Central Drugs Standard Control Organization (CDSCO) ensures that drugs and medical devices in India are safe, effective, and of high quality through strict regulation and approvals.

Indian Council of Medical Research (ICMR) drives scientific research, generates evidence, and supports public health policies to tackle diseases and improve healthcare outcomes.

(Rh/MF/MSM)