Health Ministry Restricts Stem Cell Therapy to Approved Diseases

NEW DELHI, Sept 17: 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, follows a Supreme Court judgment delivered on January 30 in Yash Charitable Trust and Ors v Union of India and Ors.

The Ministry reiterated that stem cell therapy can be permitted as standard care in routine clinical practice only for diseases or indications included in the list approved by the Ministry of Health and Family Welfare.

For Autism Spectrum Disorder (ASD), the advisory states that therapeutic use of any type of stem cell must remain confined 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 (ICMR) and Department of Biotechnology (DBT), along with other applicable government instructions.

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 advisory also warned of consequences for violations of the regulatory framework. The Supreme Court had held that non-compliance could attract professional misconduct proceedings and action under the Clinical Establishments Act, including cancellation of registration and penalties.

The National Medical Commission, in an advisory dated September 5, also reiterated that stem cell therapy may be offered as standard clinical care only for approved indications. Unauthorised administration, prescription, promotion or advertisement beyond approved indications would constitute professional misconduct. (Agencies)