New Delhi, Sept 17: The Union Health Ministry has directed states and Union territories to ensure that stem cell therapy is provided as standard clinical care only for approved disease conditions and indications.
The advisory, issued on September 16, applies to states and UTs that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010. It follows a Supreme Court judgment delivered on January 30 in the case of Yash Charitable Trust and Others v Union of India and Others.
Under the directions, stem cell based interventions may be offered as part of routine clinical practice only for conditions included in the list of indications approved by the Ministry of Health and Family Welfare.
The ministry has specifically clarified the position concerning Autism Spectrum Disorder (ASD). The therapeutic use of any type of stem cell for autism must remain limited to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research and the Department of Biotechnology.
The guidelines, along with other instructions issued by the government from time to time, form the regulatory framework for research and therapeutic applications involving stem cells.
States and Union territories have been asked to circulate 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 ministry has also highlighted the consequences of violating the applicable regulatory provisions. According to the Supreme Court’s January 30 judgment, non-compliance can attract action for professional misconduct under Regulation 7.22 of the IMC Regulations, 2002.
Further action may be taken under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, including cancellation of registration and imposition of penalties.
The National Medical Commission had also reinforced the regulatory position through an advisory issued on September 5. It stated that stem cell interventions can be offered as standard clinical care only for approved indications.
The NMC further clarified that unauthorised administration, prescription, promotion or advertisement of such interventions beyond approved indications would amount to professional misconduct.
State medical councils have been advised to examine complaints or cases involving alleged violations. Where professional misconduct by a Registered Medical Practitioner is established following due process, appropriate disciplinary action may be taken under the applicable statutory and regulatory provisions.
The latest directions are aimed at ensuring that clinical establishments and medical practitioners follow the established framework governing stem cell research and therapeutic use, while preventing unauthorised applications outside approved indications and clinical trials.