New Delhi

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 remains restricted to duly approved clinical trials.

The advisory, issued on September 16 to states and UTs that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010 regarding the regulation of stem cell therapy, follows a Supreme Court judgment delivered on January 30 in Yash Charitable Trust and Ors v Union of India and Ors.

The advisory reiterates the existing framework governing stem cell research and therapy and seeks to ensure that stem cell therapy is permitted as standard care in routine clinical practice only for disease conditions/indications included in the list approved by the Ministry of Health and Family Welfare.

For Autism Spectrum Disorder (ASD), the advisory stipulates that the therapeutic use of any type of stem cell in autism is to remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by 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.

The ministry has requested states and Union territories to disseminate the Supreme Court’s directions to all state and district regulatory authorities and government and private clinical establishments involved in stem cell research, treatment, promotion or administration, for strict compliance with the applicable framework.

The advisory also draws attention to the consequences of non-compliance with the framework governing stem cell therapy.

The Supreme Court, in its judgment dated 30 January, 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 ministry has accordingly requested the concerned state and district regulatory authorities and clinical establishments to ensure strict compliance with the applicable framework governing stem cell research and therapy.

Reinforcing the regulatory position, the National Medical Commission, in its advisory dated 5 September, reiterated that stem cell therapy may be offered as standard clinical care only for the approved indications.

The advisory further states that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond the approved indications would constitute professional misconduct.

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The NMC has 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 in accordance with the applicable statutory and regulatory provisions.