Centre directs states to crack down on unproven stem cell therapies

The Union health ministry has instructed states to take action against medical practitioners and clinical establishments that offer stem cell therapies for conditions where such treatment has not been established as effective.

The directive, which draws on a Supreme Court judgment delivered earlier this year, states that doctors found violating the norms may face disciplinary proceedings under the Indian Medical Council's regulations on professional ethics. Clinical establishments offering unapproved therapies could attract penalties and cancellation of licence under the Clinical Establishments (Registration and Regulation) Act.

Enforcement under the Act, however, will apply only in the 19 states and Union Territories that have adopted it, a list that includes Bihar, Uttar Pradesh, Rajasthan, Sikkim and Telangana, among others. The law is yet to be brought into force in the national capital. The Indian Medical Council regulation, by contrast, is applicable across the country.

In a statement, the ministry said it had asked the concerned state and district regulatory authorities and clinical establishments to ensure strict compliance with the framework governing stem cell research and therapy.

Approved indications

Stem cell therapy may be offered only for diseases and conditions specified by the Union health ministry. The approved list covers certain cancers, including acute myeloid leukaemia, B cell lymphoma and multiple myeloma, as well as autoimmune conditions such as multiple sclerosis and aplastic anaemia. In all, the therapy is permitted for 18 conditions in adults and 14 in children.

Autism Spectrum Disorder, the condition at the centre of the Supreme Court case, does not figure on the approved list. Any stem cell therapy for the condition may be administered only within a clinical trial, and only after the prescribed approval process has been followed, the advisory notes.

The communication is intended to sensitise authorities to the Supreme Court case and to the need for action against centres providing unproven therapies. Earlier this month, the National Medical Commission, which regulates the practice and study of modern medicine in the country, reiterated the court's decision and cautioned medical professionals that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would amount to professional misconduct.