Various categories of medicinal products are registered with theDrug Regulatory Authority on the basis of medical indications and uses after review of the evidences submitted. Prescribing or dispensing medicines beyond the approved indication is not allowed under the provisions of the Medicines Act of the Kingdom of Bhutan, 2003.

Therefore, all medical and health professionals are requested to adhere to this provision to avoid unnecessary regulatory actions.

For further information and clarifications, please contact Office of the Drug Controller, Drug Regulatory Authority at 337074/337075 during office hours.

Please click here to view the:Notification on prescribing or dispensing medicines beyond the approved indication.