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.
What did the Supreme Court say on stem cell therapy for autism?
The Supreme Court, in its judgment dated January 30, had ruled that stem cell therapy for autism spectrum disorder cannot be offered as a commercial medical treatment outside approved and monitored clinical trials. In the case of Yash Charitable Trust v Union of India, the top court bench declared that using stem cells for autism outside of strict research is unethical and amounts to medical malpractice.
The top court had held that non-compliance with the statutory mandate must attract consequences, including professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, as well as action under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for cancellation of registration and penalty. The court further clarified that parents, guardians and caregivers cannot demand that stem-cell therapy be administered as a clinical service.
What did the National Medical Commission say?
Reinforcing the regulatory position, the National Medical Commission (NMC), in its advisory dated September 5, reiterated that stem cell therapy may be offered as standard clinical care only for the approved indications.
The advisory further stated that unauthorised administration, prescription, promotion or advertisement of stem cell therapy would constitute professional misconduct. The NMC had further advised state medical councils to examine cases of alleged violations brought to their notice and, where professional misconduct by a registered medical practitioner is established after due process, take appropriate disciplinary action.
