NEW DELHI: The centre has issued an advisory to all states to strictly regulate stem cell therapies, stating that only “standard clinical care” is approved.
The advisory by the Union Health Ministry makes it clear that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond the approved indications would constitute professional misconduct.
The advisory, dated September 16, has been issued following the judgment of the January 30 judgment of the Supreme Court on the issue.
It reiterates the existing framework governing stem cell research and therapy and seeks to ensure that stem cell therapies are permitted as standard care in routine clinical practice only for disease conditions/indications included in the list approved by the ministry.
With regard to 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, jointly issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) and other government bodies from time to time.
The ministry has requested the states and UTs to widely disseminate the directions of the SC to all concerned 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.
Citing the SC judgment, the advisory said that the apex court has 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.
In this regard, the ministry 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.
The ministry highlighted that the National Medical Commission (NMC) has also issued an advisory on unregulated stem cell therapies.
In its advisory, dated September 5, the NMC had reiterated that stem cell therapy may be offered as standard clinical care only for the approved indications.
The NMC had further advised State Medical Councils (SMCs) to examine cases of alleged violations brought to their notice and, where professional misconduct by a Registered Medical Practitioner is established after due process, to take appropriate disciplinary action in accordance with the applicable statutory and regulatory provisions.
The advisory has been issued to the states and Union Territories (UTs) that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, regarding the regulation of stem cell therapy.
