Short answer: for a small, defined list of indications, yes. For everything else, only inside an approved clinical trial. And since early 2026, the consequences of getting that wrong are explicit.
What changed in 2026
The Supreme Court of India, in Yash Charitable Trust & Others v. Union of India (W.P.(C) No. 369 of 2022), held that stem cell therapy for Autism Spectrum Disorder cannot be offered as a routine clinical service, on the grounds that the scientific evidence does not support it.
Following that judgment, the Director General of ICMR wrote to the National Medical Commission in March 2026 enclosing a list of 32 disease conditions in which stem cell therapy may be used as standard care. The letter stated that any stem cell treatment outside that list, and not approved by CDSCO or the Department of Health Research, is to be deemed illegal and actionable in law. The NMC then issued an advisory to all medical colleges, hospitals and registered medical practitioners giving effect to that position.
The two lawful routes
Route one — an approved indication
The approved list is dominated by haematological conditions treated with haematopoietic stem cell transplantation: acute myeloid leukaemia, acute lymphoblastic leukaemia, chronic myeloid leukaemia, lymphomas, multiple myeloma, thalassaemia, aplastic anaemia, myelofibrosis, osteopetrosis and germ cell tumours among them. Limbal stem cell transplantation for defined corneal disease has also long been treated as established practice.
Route two — an approved clinical trial
Everything else. That means compliance with ICMR ethical guidelines, ethics committee approval, prior approval from CDSCO or DHR depending on the level of manipulation, registration on the Clinical Trials Registry - India, written informed consent, no cost to the participant, and provision for compensation in the event of injury.
How your product is classified
Under the New Drugs and Clinical Trials Rules, 2019, a stem cell-based biological product is treated as a new drug unless it is autologous, minimally manipulated and used for a homologous purpose. Once it is a new drug, it needs clinical trial approval from CDSCO and, ultimately, marketing authorisation before it can be sold as a therapy. The three questions that decide your position:
- Autologous or allogeneic?
- Minimally manipulated, or culture-expanded and processed?
- Homologous use, or a different function from the tissue of origin?
Where PRP and bone marrow aspirate concentrate sit
Autologous PRP is a blood product prepared and returned to the same patient in a single procedure, and is generally treated differently from a manufactured cell product. Bone marrow aspirate concentrate sits closer to the line and depends on the degree of manipulation. On request
What this means for your clinic
- Do not advertise stem cell therapy for any indication outside the approved list
- Do not describe an investigational treatment as a cure, a treatment, or established
- If you are working outside the approved list, you are conducting research, and it must be structured, approved and registered
- Consent must state plainly that the intervention is investigational
- Review your website and consent forms against the 2026 advisory now — historic marketing copy is the commonest source of exposure
Sources
- NMC advisory (nmc.org.in)
- ICMR communication to the NMC, March 2026
- Supreme Court judgment, Yash Charitable Trust v. Union of India
- ICMR-DBT National Guidelines for Stem Cell Research (2017)
- New Drugs and Clinical Trials Rules, 2019
Last reviewed August 2026. This article is general information about the regulatory framework and is not legal advice.