Government issues advisory on regulation of stem cell therapy

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The Ministry of Health and Family Welfare, Government of India, has issued an advisory to all States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010 regarding the regulation of stem cell therapy.

The advisory reiterates the existing regulations on stem cell research and therapy and seeks to ensure that stem cell therapy is allowed as standard care in routine clinical practice only for diseases/conditions on the list approved by the Ministry of Health and Family Welfare.

In the advisory, with regard to Autism Spectrum Disorder (ASD), it has been clarified that the therapeutic use of any stem cell in autism is prohibited as per the 'National Guidelines for Stem Cell Research, 2017' issued jointly by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) and other applicable Government instructions issued by the Government of India from time to time. To be restricted to only duly approved clinical trials.

The Ministry has requested the States and UTs to give wide publicity to all concerned State and District Regulatory Authorities and government and private clinical establishments involved in stem cell research, treatment, promotion or administration to ensure strict adherence to the applicable regulations.

The consultation also draws attention to the consequences of not following the rules associated with stem cell therapy.  Accordingly, the Ministry has requested the concerned State and District Regulatory Authorities and Clinical Establishments to ensure strict compliance of the Regulations on Stem Cell Research and Therapy.