Overall functions of the PMC Division

PMCD is responsible for ensuring the quality, safety and efficacy of medicinal products after it is in the Bhutanese market for consumption. It ensures public safety by monitoring product defects and adverse drug reactions, control of drug advertisements and dissemination of drug information through sensitization workshops, trainings and public notifications.

Roles of different units under the Division

There are four units under the PMC Division with separate roles.

Defective Products Control and Testing Unit

• This unit handles and manages defective products and laboratory testing of medicinal products using risk based sampling of the products.

Pharmacovigilance Unit

• This unit deals with the monitoring of adverse drug reactions (ADRs) by being the apex body for collecting adverse drug reports from the health facilities across the country. It is also responsible for performing causality assessment of the received ADRs and then reporting these assessed reports to Uppsala Monitoring Center (UMC) using vigi-flow.

Control of Drug Advertisement Unit

• This unit controls the advertisements of drugs including drug promotions in the market.

Drug Information Unit

• This unit serves as a centre for the drug information. It is responsible for information dissemination through notifications and publications of DRA newsletter. They also coordinate for the development and revision of Bhutan National Formulary, ADR guidelines and many other materials related to drug safety.