- The Drug Regulatory was formally established on 14 June, 2004 as per the Medicines Act of the Kingdom of Bhutan 2003 passed by the 81st session of the National Assembly of Bhutan.
- The most dynamic, reliable and client-centric model regulatory organization.
- Promoting availability of quality, safe, and efficacious medicinal products for consumers.
- Core Mandate
- Authorizing for manufacture, import, export, sale, distribution and storage of the medicinal products including blood and blood products.
- Registration of medicinal products which are manufactured within as well as imported into the country.
- Monitoring the competency and skills of personnel involved in the import, storage, manufacture and sale of the medicinal products.
- Inspection/monitoring of premises for manufacture, sale, distribution and storage of medicinal products including blood and blood products.
- Providing up-to-date information in form of Bhutan National Formulary and Drug Safety information.
- Monitoring the trends and cases of adverse effects resulting from medicinal products.
- Informing the public on the use and harmful effects of medicinal products.
- Promoting the policies for improved access to cost-effective quality medicinal products.
- Conducting research on pertinent issues related to medicinal products.
- Delivering the regulatory services to the public in a cost effective and efficient manner.
- Core Values
- Honesty and Integrity
- We are always open and honest at work.
- We express our ideas and concerns honestly.
- We respect each other and alternative views.
- We uphold confidentiality in exercising our duties.
- Professionalism and Excellence
- We do things in a systematic manner.
- We always strive for quality and excellence.
- We always strive to enhance knowledge and learn new ways.
- We promote learning culture in our organization.
- Team work and Unity
- We value everyones role in the organization.
- We believe in strength of our unity and work as a team.
- We make decisions in a consultative and collaborative manner.
- We support each other in times of need.
- Commitment and Ownership
- We belong to the organization.
- We work hard to achieve our goals.
- We are committed and responsible for our job.
- We are accountable for our own actions.
- Our clients believe and value our services.
- We provide services to our clients efficiently.
- We consider the feedback received from our clients positively.
- Key Strategies
- Formulate policy briefs and promote effective laws for the regulation of the medicinal products.
- Develop standard operating procedures, guidelines and standards.
- Enforce the regulations for sale, manufacture and storage of medicinal products.
- Coordinate with other law enforcement agencies and regulatory bodies. .
- Conduct public advocacies and awareness programs.
- Mobilize resources required for the implementation of strategies.
- Management and Organizational Structure
- The Authority reports to the Bhutan Medicines Board for policy directives. The Drug Technical Advisory Committee (DTAC) and Blood Technical Advisory Committee (BTAC) provide the technical advice to the Authority. The Authority has three technical Divisions viz., Registration Division, Inspection Division and Post Marketing Control Division and is supported by the Administration and Finance Section.
- Performance Goals
- Availability of quality and safe medicinal products both in the private and public health facilities.
- Minimal incidences of adverse events from medicinal products.
- Positive feedback from the clients in terms of delivery of services.
- No complaints related to corruption.
Key words that shall define the Authority as a Regulator:
|R||Reassuring, relevant, responsive|
|E||Efficient, effective, energetic|
|U||Unambiguous, united, up-to-date|
|L||Learned, lawful, legitimate|
|A||Agile, able, accessible, assertive|
|R||Respectable, resourceful, role model|