Inspection Division is responsible to inspect premises wherein any medicinal product is being manufactured, sold, distributed, stocked or offered for sale, or distributed. Medicines Act of the Kingdom of Bhutan 2003 and Bhutan Medicines Rules and Regulation 2012 empowers Drug Inspectors to conduct inspections.
There are basically three types of inspection normally conducted:
- Routine (Announced)
- Unannounced Inspection
- Investigational Inspection or Complaint type of inspection
Inspection Division is comprised of six staffs as follows:
- One Chief Regulatory Officer
- One Regulatory Officer
- Four Drug Inspectors
Inspection Division is functionally divided into two units or sections:
i. Sale and Distribution Unit:
This unit is responsible to inspect, verify compliances and enforce regulatory provisions for the government health facilities, private pharmacies and other premises wherein any medicinal products are sold or distributed or stored for sale and distribution. It is also responsible to operate investigational type of inspections as and when complaints related to the sale and distribution of medicinal products are being made to the Authority.
It is also responsible for conducting Authorization inspection or Pre-approval inspection to verify the adequacy and suitability of the proposed premise before the issuance of Technical Authorization or Technical Clearance by the Registration Division based on the inspection report.
Drug Inspectors must follow the Standard Operating Procedures (SOPs) for planning, conducting and reporting of inspection observations and follow up of the same.
ii. 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 conducted in phase wise and is planned and 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
GMP Audit is done in a coordinated manner as the team consists of officials from Ministry of Health and Ministry of Agriculture and Forest.