Inspection Division ensures safety, efficacy and quality of medicinal products by monitoring regulatory compliance and compliance to the standards (both national and international adopted standards). Drug Inspectors empowered by the Medicines Act of the Kingdom of Bhutan 2003, the Bhutan Medicines Rules and Regulation 2012 and the Blood and Blood Products Regulation 2016 inspects premises wherein any medicinal products are being manufactured, sold, distributed, stocked or offered for sale, or distributed.
Roles of Different Unit under Inspection Division:
Inspection Division has two units with distinct roles.
Sale and Distribution Unit
- This unit is responsible to inspect, verify compliances and enforce regulatory provisions for the government health facilities, Blood Storage Centers, private pharmacies and other premises wherein any medicinal products are sold or distributed or stored for sale and distribution.
- Before issuance of the Technical Authorization or Technical Clearance by the Registration Division, Drug Inspectors verify the adequacy and suitability of the proposed premise. Additionally, the unit also performs investigational type of inspections as and when complaints related to the sale and distribution of medicinal products are being made to the Authority
Good Manufacturing Practice (GMP) Unit
This unit is responsible for planning and coordination, conducting and reporting GMP Inspection of manufacturing firms both in the country and overseas. GMP Audit is generally targeted for:
- New Companies who have more number of products registered with DRA
- Companies whose product quality either failed or is suspected for its quality
- To verify the information provided at the time of registration