Background
Background
A brief Background of BFDA
The Bhutan Food and Drug Authority (BFDA) ensures public health and safety by regulating food, medicines, and related products across the country.
The erstwhile Drug Regulatory Authority (DRA), Bhutan Agriculture and Food Regulatory Authority (BAFRA) and Bhutan Narcotics Control Authority (BNCA) is merged as Bhutan Food and Drug Authority (BFDA) in line with the provisions of the Civil Service Reform Act of Bhutan 2022. This restructuring exercise reflects the agency’s commitment to modernise their structure to advance the mission of protecting and advancing public health; and to meet the challenges of rapid innovation across the industries regulated by these three agencies. This restructuring realigns several entities, functions and policies across the agencies to promote strategic priorities.
Formerly, DRA and BNCA have been functioning as autonomous agencies and BAFRA as one of the non-department agencies under the then Ministry of Agriculture and Forests. The restructuring will foster optimal use of limited resources, enhance service delivery, reduce work duplication and usher in professionalism. DRA has been functioning as an autonomous agency and it is instituted as per the provisions of the Medicines Act of Kingdom of Bhutan 2003. It is primarily mandated to regulate medical products to ensure their quality, safety and effectiveness with the ultimate goal of protecting and advancing public health. The authority regulates human allopathic medicines, vaccines, veterinary medicines, blood and blood products, traditional medicines, health supplements and medical devices. Product registration and post marketing surveillance including testing of medical products and inspection of sale, storage and manufacturing premises form the core mandate of the authority and its primary objective is to increase patient’s access to quality assured medicinal products.
The Bhutan Narcotics Control Authority (BNCA) works towards ensuring a nation free of drugs and controlled substances and it is instituted as per the provision of the Narcotic Drugs, Psychotropic Substances and Substance Abuse (NDPSSA) Act of Bhutan 2005 (revised in 2015). It is a nodal regulatory authority that effectively coordinates, facilitates and combat the abuse and illicit trafficking of narcotic drugs and controlled substances to achieve a healthy and caring society. The authority also regulates and ensures the effective prevention, control and treatment measures for abuse of Narcotic Drugs Psychotropic Substances (NDPS) and Precursor Chemicals through two divisions namely Supply Reduction Division (SRD) and Demand Reduction Division (DRD). Effective prevention, control and treatment measures for abuse of NDPS, Precursor Chemicals, and Tobacco form the core mandate of the Authority and the primary objective is to ensure reduction in supply and demand of controlled substances.
The Bhutan Agriculture and Food Regulatory Authority (BAFRA) was established in 2000 and is the lead agency responsible to protect Bhutan from biosecurity and food safety threats related to plant, animal and their products with subsequent impact on human and environmental health. BAFRA as the competent authority for biosecurity and food safety in Bhutan, executes its functions under the provisions of the Food Act of Bhutan 2005, Livestock Act of Bhutan 2001,4 Plant Quarantine Act of Bhutan 1993 and Biosafety Act of Bhutan 2015 amongst others. The importance of biosecurity and food safety and its consequences on human and environmental health is gaining momentum and therefore there is an urgent need to upscale biosecurity and food safety interventions in near future. The key mandate of BAFRA includes protecting Bhutan’s rich biodiversity, environment and agricultural system from pests and diseases; invasive species; and genetically modified organisms; and ensuring safe and quality food. The National Food Testing Laboratory (NFTL) provides technical backstopping to the regulatory services (inspection, testing and certification) of BAFRA and facilitates trade by providing the analytical services.