The Union Ministry of Health and Family Welfare has tightened its rules and regulations regarding stem cell therapy. An advisory has been issued to all states and union territories to ensure strict compliance with the existing legal and regulatory framework governing stem cell research and therapy.
The Ministry said that stem cell therapy can be offered as standard care in routine clinical practice only for disease conditions and indications included in the list approved by the Ministry of Health and Family Welfare.
The advisory has also addressed the use of stem cell therapy for Autism Spectrum Disorder (ASD). It underlined that therapeutic use of any type of stem cell in autism must remain restricted to duly approved clinical trials. "Such treatment should not be offered as routine, standard or commercial clinical services without the required regulatory approvals.
According to the Health Ministry, stem cell therapy is permitted as standard clinical care only for specific disease conditions on the Ministry’s approved list.
This mandates that all clinical facilities conducting stem cell research, treatment, or administration adhere to the approved regulatory framework. The Ministry has urged State and District authorities to ensure strict compliance.
Regarding stem cell therapy for autistic patients, the advisory stated that the trials must follow the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research and the Department of Biotechnology, along with other applicable government instructions issued from time to time.
The advisory makes it clear that unproven stem cell interventions, including stem cell therapy for ASD, should not be offered as routine, standard or commercial clinical services.
The advisory follows the Supreme Court's January 30, 2026 judgment, which held that non-compliance with the statutory mandate must attract consequences. These include professional misconduct under Regulation 7.22 of the IMC Regulations, 2002.
The advisory also refers to action under Sections 32 and 40 of the Clinical Establishments Registration and Regulation Act, 2010. These provisions provide for cancellation of registration and penalties.
