Govt tightens stem cell therapy rules, bars routine use for autism

For autism, the ministry has specifically said that therapeutic use of any type of stem cell will remain restricted to duly approved clinical trials

The Union Health Ministry has advised states and union territories to ensure that stem cell therapy is offered as standard clinical care only for approved disease conditions, while its use for autism spectrum disorder (ASD) remains restricted to duly approved clinical trials.

In an advisory dated September 16, the ministry reiterated the existing regulatory framework for stem cell research and therapy and asked states to ensure that unproven stem cell interventions are not offered as routine, standard or commercial clinical services.

For autism, the ministry has specifically said that therapeutic use of any type of stem cell will remain restricted to duly approved clinical trials. Such trials will have to comply with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT), along with other applicable government instructions.

Stem cell therapy is a medical treatment that uses stem cells to replace, repair or regenerate damaged or diseased cells, tissues or organs. Stem cells have the ability to self-renew and, depending on their type, develop into different types of specialised cells.

The ministry has also asked states and union territories to disseminate the Supreme Court's directions to all state and district regulatory authorities and government and private clinical establishments for strict compliance with the applicable framework.