The Ministry of Health and Family Welfare has issued an advisory to all States and Union Territories on the regulation of stem cell therapy. The advisory states that under the existing regulatory framework, stem cell therapy can be used as standard treatment in routine clinical practice only for diseases and conditions included in the list approved by the Ministry.
The advisory further clarifies that the therapeutic use of any form of stem cell for autism must remain limited to properly approved clinical trials. This is in line with the National Guidelines for Stem Cell Research, 2017, which were jointly issued by the Indian Council of Medical Research and the Department of Biotechnology.
The advisory applies to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010. The Ministry has also asked the relevant State and District Regulatory Authorities, along with clinical establishments, to ensure strict adherence to the applicable rules governing stem cell research and therapy.