Health ministry curbs unproven stem cell use

The Union health ministry issued an advisory on curbing the unproven use of stem cell therapies in India. The advisory is clear that stem cell treatments can only be offered as standard care for conditions specifically approved by the ministry.

For autism spectrum disorder, a neurodevelopmental condition, the ministry restricts therapeutic use of any type of stem cells to approved clinical trials following the National Guidelines for Stem Cell Research, 2017.

The advisory reiterates the existing framework governing stem cell research and therapy to ensure that therapy is permitted as standard care only for disease conditions included in the list approved by the ministry.

The advisory aligns with a Supreme Court ruling in January that restricted the use of unproven stem cell therapy. The ministry instructed all states and union territories to disseminate the Supreme Court's directions to regulatory authorities and clinical establishments involved in stem cell research and treatment.

Non-compliance with the advisory may lead to serious consequences including professional misconduct, cancellation of registration, and financial penalties under the Clinical Establishments Act. Stem cell therapy has been aggressively marketed in India for conditions like autism, cerebral palsy, and spinal cord injuries despite lacking established clinical evidence, according to an official.

The National Medical Commission has also reinforced the position, advising state medical councils to examine alleged violations and take disciplinary action if misconduct is established.