NEW DELHI, SEPT 17: The Union Health Ministry has asked states and Union territories to ensure that stem cell therapy is used as standard clinical care only for officially approved diseases and indications.
The advisory, issued on September 16, also clarified that the use of stem cells for Autism Spectrum Disorder (ASD) must remain limited to duly approved clinical trials.
The directions apply to states and UTs that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010. The advisory follows a Supreme Court judgment delivered on January 30 in the case of Yash Charitable Trust and Others vs Union of India and Others.
According to the Health Ministry, stem cell therapy can be provided as routine clinical care only for disease conditions included in the list of indications approved by the Ministry of Health and Family Welfare.
For autism, the ministry said therapeutic use of any type of stem cell must be restricted to approved clinical trials 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).
States and UTs 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 legal and professional consequences of violating the regulatory framework.
The Supreme Court had held that non-compliance with the statutory requirements could attract action, including professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, along with provisions of the Clinical Establishments Act that allow for cancellation of registration and penalties.
The National Medical Commission (NMC), in its advisory dated September 5, also reiterated that stem cell therapy may be offered as standard clinical care only for approved indications.
The NMC further stated that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would amount to professional misconduct.
State medical councils have been advised to examine complaints of alleged violations and take disciplinary action against registered medical practitioners where professional misconduct is established following due process.
