Industry Odisha Bureau, Sept 19: The Union Ministry of Health and Family Welfare has issued an advisory to all States and Union Territories directing authorities and clinical establishments to strictly follow the regulatory framework following the regulatory framework governing stem cell research and therapy.
The advisory, dated Sept 16, 2026, states that stem cell therapy can be offered as standard care in routine clinical practice only. This too, only for disease conditions and indications included in the list approved by the Health ministry.
The government has also specifically addressed the use of stem cell therapy for Autism Spectrum Disorder (ASD). As stated, therapeutic use of any type of stem cell for autism must remain restricted to duly approved clinical trials.
Such treatment cannot be offered as routine, standard or commercial clinical services without the necessary regulatory approvals.
Autism treatment restricted to approved clinical trials
The Health Ministry said clinical establishments involved in stem cell research, treatment, promotion, or administration must comply with the applicable regulatory framework. State and District Regulatory Authorities have also been asked to ensure that the requirements are followed.
For autism, clinical trials involving stem cell therapy must follow the National Guidelines for Stem Cell Research, 2017. Notably, issued jointly ICMR and the Department of Biotechnology (DBT).
The National Medical Commission (NMC) has separately reinforced the position through an advisory dated September 5. It said stem cell therapy can be offered as standard clinical care only for approved indications. Unauthorized administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct.
The NMC has asked State Medical Councils to examine complaints of alleged violations. They’ve urged to take disciplinary action where professional misconduct by a Registered Medical Practitioner is established after due process.
The Health Ministry advisory also points to legal consequences for non-compliance. The Supreme Court judgement noted that violations of the statutory requirements can attract action. This includes professional misconduct under Regulation 7.22 of the IMC Regulations, 2022.
Action may also be taken under Sections 32 and 40 of the clinical Establishments (Registration and Regulation) Act, 2010, including cancellation of registration and penalties.
The Ministry has therefore directed authorities and clinical establishments to ensure that stem cell therapies are provided only within the approved regulatory framework.
