India’s Ministry of Health and Family Welfare has issued an advisory stating that stem cell therapy should be used as standard care only for diseases or indications approved by the Ministry.The advisory reiterates the existing regulatory framework governing stem cell research and therapy.What Does The Advisory Say?The advisory directs that stem cell therapy for Autism Spectrum Disorder (ASD) be restricted to approved clinical trials.This aligns with the National Guidelines for Stem Cell Research, 2017, issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT), along with other applicable government instructions.The advisory also says unproven stem cell interventions, including those for ASD, should not be offered as “routine, standard or commercial clinical services.”“All States and Union Territories must adopt the Clinical Establishments (Registration and Regulation) Act, 2010, regarding regulation of stem cell therapy,” the Ministry said.The directions apply to government and private clinical establishments involved in stem cell research, treatment, promotion or administration.The Supreme Court had earlier ruled against the use of stem cell therapy for autism outside approved clinical trials. The National Medical Commission (NMC) has also warned doctors and hospitals against offering it as routine treatment for ASD.Also read: Autism Care Begins Early: Why the First 1,000 Days Matter Most, Says AIIMS Expert Action Against ViolationsThe Ministry has asked States and Union Territories to ensure that hospitals, clinics and other establishments involved in stem cell research or treatment comply with the regulatory framework.The Supreme Court, in its January 30, 2026 judgment, said violations can lead to professional misconduct proceedings, as well as action under the Clinical Establishments Act, including cancellation of registration and penalties.NMC: Stem Cell Therapy Only For Approved UsesRead More: Could Tylenol Taken During Pregnancy Affect Girl Child’s Future Reproductive Health? Study Raises ConcernIn its September 5, 2026 advisory, the National Medical Commission (NMC) said stem cell therapy can be offered as standard clinical care only for approved indications.Unauthorized administration, prescription, promotion or advertising of stem cell therapy beyond approved indications may amount to professional misconduct, it said.State Medical Councils have been asked to examine alleged violations and take disciplinary action where professional misconduct by a registered medical practitioner is established after due process.Which Diseases Can Be Treated With Stem Cells?Earlier this year, ICMR Director-General Dr Rajiv Bahl told the NMC that stem cell treatment could be used in regular medical practice only for 32 government-approved diseases.These include:Acute myeloid leukemiaThalassemiaMultiple myelomaAplastic anemiaMyelofibrosisGerm cell tumorsThe ICMR DG asked doctors not to offer stem cell therapy for diseases outside the approved list. Current international guidelines also do not recommend stem cell therapy as a treatment for ASD.What Did The Supreme Court Say? In January, a Supreme Court bench comprising Justice JB Pardiwala and Justice R Mahadevan said stem cell therapy lacks “scientific support” and has not been recognized as a sound medical practice backed by empirical evidence.The Bench ruled that “every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.”The Court said stem cell therapy can still be studied through monitored clinical research trials, and patients can participate in approved and regulated trials.What Is Stem Cell Therapy?Stem cell therapy, also called regenerative medicine, uses stem cells to repair or replace damaged tissues.While stem cell therapy is used for certain blood cancers and blood disorders, there is no established scientific evidence supporting its use as a treatment for autism.Stem cell therapy remains vastly unregulated in India, and some private labs have been making money by promising treatment for autism, according to experts.