In order to control and regulate medicinal products in the Kingdom, the 81 session of the National Assembly passed The Medicines Act of the Kingdom of Bhutan, 2003 on 5th August 2003. Further, knowing that the medicine regulation demands the application of sound knowledge and skills and operates within a legal framework, Drug Regulatory Authority (DRA) was established in June 2004 (as per Chapter III section 10 of the Act). It was then under the umbrella of Ministry of Health. DRA regulated not only regulates human medicines but also the veterinary medicines.
While the Bhutan Medicines Board instituted as per Chapter II of the Medicines Act issues policy directives, Drug Technical Advisory Committee makes technical recommendations related to medicines to the Board and DRA. The health Minister is the Chairperson of the Bhutan Medicines Board while the Secretary, Ministry of Agriculture and Forest is the Vice Chairperson.
The 1st Edition of the Bhutan Medicines Rules and Regulation was developed in 2005 and second edition in 2008. Since 11th November 2012, we are enforcing 3rd Edition of regulation viz., Bhutan Medicines Rules and regulation 2012.As per 351st Coordination Committee Meeting (CCM) of the council of Ministers held on July 10 2007, the government approved establishment of the Drug Regulatory Authority as an autonomous agency and in July 2008, DRA was delinked from Ministry of Health.
DRA was started with 2 technical staff in 2004 and in 2008 it has 10 staff (5 Drug Inspectors and 2 Regulatory Officers, 2 OA and 1 messenger). After its delinking till 2010, DRA was headed by the Regulatory Officer (as officiating Drug Controller). It was only from March 2010 that DRA has Drug Controller with 19 other staff including both technical and non-technical staff. Currently we have 26 staff:
- 1 Drug Controller (Executive level)
- 10 Regulatory Officers (including 3 senior Regulatory Officers)
- 7 Drug Inspectors
- 1 HRO/ ADM officer
- 1 ICT Technical Associate
- 1 Accountant
- 1 PA to Drug Controller
- 2 Office Assistants
- 1 EPABX operator cum Dispatcher
- 1 Messenger
- 2 Drivers