It has come to the notice of the Drug Regulatory Authority that many Health Supplements including tea which are manufactured and imported into the country claim or imply to prevent, treat or cure certain diseases. As per Section 27 of the Medicines Act of the Kingdom of Bhutan 2003 and Section 182(a) of the Bhutan Medicines Rules and Regulations 2012, such claims require prior approval from the Bhutan Medicines Board. The products should not be boastful of the therapeutic properties and certain ingredients are prohibited in Health Supplements. Therefore, the Authority hereby notifies all the individuals or firms to refrain from manufacturing or importing Health Supplements with such claims in the label.

Prior to import or manufacture of such products, a sample of the product label should be submitted to the Authority for necessary clearance and if one desires to manufacture or import Health supplements with claims on medicinal properties, listing of the product with the Authority is mandatory. This shall require submission of product/label samples and documents of scientific evidence supporting the claims. Further, individuals and firms are also cautioned to report any adverse reactions associated with the use of Health Supplements.

The Authority shall take actions against any individual or firm contravening the provisions of the Medicines Act of the Kingdom of Bhutan 2003 and the Regulation thereunder.

Please click on the link below to view the notification:

Regulatory Notification on Health Supplement: 19/DRA/DC/Notification/2018-19/117