Govt issues advisory on stem cell therapy: What doctors cannot offer as routine treatment

The Union Health Ministry has tightened oversight of stem cell therapy, saying it can be offered as standard clinical care only for approved medical conditions and that its use to treat autism must be limited to authorised clinical trials.

In an advisory issued on September 16, the ministry reiterated the existing regulatory framework governing stem cell research and therapy and directed authorities to ensure that unproven stem cell interventions are not offered as routine, standard or commercial clinical services.

The advisory has been issued to states and UTs that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, in view of a Supreme Court judgment in a case involving Yash Charitable Trust and others, the ministry said.

The ministry said stem cell therapy could be permitted as standard care in routine clinical practice only for disease conditions or indications included in the list approved by the Ministry of Health and Family Welfare.

On Autism Spectrum Disorder (ASD), it said therapeutic use of any type of stem cell would remain restricted to duly approved clinical trials.

Such trials have to be conducted in accordance 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.

"Unproven" stem cell interventions, including therapies offered for autism, should not be provided as routine, standard or commercial clinical services, it added.

The ministry has asked states and UTs to widely disseminate the Supreme Court's directions among state and district regulatory authorities as well as government and private clinical establishments involved in stem cell research, treatment, promotion or administration.

The Supreme Court held in its January judgment that non-compliance could attract consequences including professional misconduct proceedings under the Indian Medical Council regulations, as well as action under the Clinical Establishments Act, including cancellation of registration and penalties, the ministry said.

The advisory comes days after the National Medical Commission (NMC), in an advisory issued on September 5, reiterated that stem cell therapy can be offered as standard clinical care only for approved indications.

The NMC said unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct.

It also advised state medical councils to examine complaints of alleged violations and, where professional misconduct by a registered medical practitioner is established after due process, take appropriate disciplinary action under applicable statutory and regulatory provisions.