The advisory has been issued as per the January 2026 judgment of the Supreme Court in ‘Yash Charitable Trust’ Case to curb unregulated commercial Stem cell therapy trials in the country.
Key Highlights of the Advisory
- Approved List Only: Stem cell therapy is allowed as standard care only for conditions on the Ministry-approved list.
- Autism Restriction: Stem cell treatment for Autism Spectrum Disorder is limited to approved clinical trials only.
- Strict Enforcement: Unapproved use can result in registration cancellation, fines under the Clinical Establishments Act 2010, and professional misconduct under IMC Regulations 2002.
What is Stem Cell Therapy?
- Definition: Stem cell therapy (or regenerative medicine) uses stem cells to replace, repair, or regenerate damaged, diseased, or dysfunctional body tissues.
- Stem cells are the body's "master cells" or unspecialized foundation cells which can copy itself and transform into specialized cell types (such as blood, bone, muscle, or nerve cells)
- Types of Stem Cells:
- Embryonic (From 3–5 day-old embryos);
- Adult (Found in tissues like bone marrow and umbilical cord);
- Induced pluripotent (From adult cells such as skin, reprogrammed in the lab).
- Key Benefits: Proven for blood cancers/disorders (via transplants); helps repair cartilage, heart muscle, etc.
- Risks: Unapproved clinics risk infection, permanent harm (e.g., blindness), etc.
- Other issues: High cost; ethical concerns with embryonic cells, etc.
