Bhutan Agriculture and Food Regulatory Authority (BAFRA)

The Bhutan Agriculture and Food Regulatory Authority (BAFRA), Ministry of Agriculture and Forests, is the competent authority for biosecurity and food safety systems to promote the quality and safety of food and agricultural related products. The BAFRA was officially established as the Quality Control and Regulatory Services (QCRS) in August 2000.

The BAFRA is headed by a Director General and the agency has two divisions: the Quality Control and Quarantine Division (QCQD) and the Analytical and Certification Division (ACD). Apart from the head office, BAFRA has field offices in 20 Dzongkhags, Dungkhags, major entry points, minor entry points and other branch offices including the National Food Testing Laboratory (NFTL) at Yusipang, Thimphu.

 Mandate of BAFRA:

• Implement RNR (renewable natural resources) related legal instruments such as the Plant Quarantine Act, Seeds Act, Pesticide Act, Livestock Act, Food Act, National Biosafety Framework, Forest and Nature Conservation Act, Biodiversity Act and their secondary and tertiary legislations.
• Implement sanitary and phytosanitary (SPS) measures effectively to protect the health and life of humans, plants and animals including the environment from risks of entry, establishment and spread of exotic pests and diseases.
• Function as a National Food Inspectorate to ensure that food is of good quality and safe for human consumption.
• Regulate and promote the quality of agriculture inputs (seeds, agro-chemicals, livestock, veterinary biological, etc.).
• Facilitate development of agro based industries to promote trade and market access through standardization and implementation of quality assurance systems.
• Function as the Competent Authority (CA) for implementation of the Biosafety Act for safe transfer, handling and use of Living modified Organisms (LMOs), Genetically Modified Organisms (GMOs) and their products.
• Function as the Focal Points for International Organizations viz.,

• International Plant Protection Convention (IPPC),
• Codex Alimentarius Commission (CAC),
• National Enquiry Point for World Trade Organization-Sanitary and Phytosanitary Agreement (WTO-SPS agreement),
• International Food Safety Authorities Network (INFOSAN) for International Health Regulations (IHR)
• Cartagena Protocol on Biosafety (CPB) for Conventional Biodiversity (CBD)
  
  

Bhutan Standards Bureau (BSB)

The Bhutan Standards Bureau (BSB) was established as an autonomous organization in the year 2010 after the enactment of the Bhutan Standards Act 2010 on 7 July 2010, to foster and promote standards and standardization activities as a means of advancing the national economy, benefiting the health, safety and welfare of the public, assisting and protecting consumers, protecting natural environment, promoting industrial efficiency and development and facilitation of  domestic as well as international trade. BSB is now set to coordinate and oversee all standardization and conformity assessment activities in the country.

Mandate of the Bureau (as per Bhutan Standards Act 2010):

• Develop national standards and facilitate their implementation;
• Establish and operate metrological referral and calibration laboratories;
• Establish and operate product testing infrastructure;
• Carry out/operate product and management system certification schemes;
• Permit, coordinate and facilitate accreditation of laboratories and certification bodies;
• Promote quality and standardization;
• Oversee the implementation of Regional and International Trade Agreements related to standards and Technical Barriers to Trade; and
• Carry out such other mandate related to standardization and quality control including monitoring as may be assigned by the Royal Government

Bhutan Information Communications and Media Authority (BICMA)

The Bhutan Information Communications and Media Authority (BICMA) is an autonomous body that was formally de-linked from the Ministry of Information and Communication (MoIC) as of 1 January 2007 and it is the Communications and Media regulatory body in Bhutan.

Mandate of BICMA:

• Enabling a secure, efficient and reliable delivery of ICT and Media services at affordable prices;
• Managing access to the radiofrequency spectrum and monitoring their usage;
• Support continuous technological advancement to improve the standards of information, communications, media and entertainment;
• Improve and monitor the choice available in the content of the media and entertainment for news, current affairs, religious knowledge, art, culture, science, technology, social sector concerns, music, sports, drama and other subjects of public and national interest;
• Licensing of cable TV, broadcast media, printing presses, publications, entertainment licenses, ICT facility and service licenses.
• Maintain a dynamic and progressive regulatory system to promote market development, manage competitions while protecting consumers and other users;
• Facilitate the establishment of an integrated, efficient and high quality ICT infrastructure in the country;
• Issuance of filming permits, review and certification of films and accreditation of journalists;
• Develop rules, guidelines and appropriate standards for uniform ad consistent enforcement and efficient utilization of available resources.
• Set appropriate technical standards and rules to ensure interoperability, efficient use of radio spectrum and telephone numbers.

Department of Revenue and Customs (DRC)

The Department of Revenue and Customs (DRC) is the tax and customs regulatory body under the Ministry of Finance (MOF).  Its vision is to contribute to the nation building process through the development of an effective revenue system. The core mandate includes as follows;

• Implement and monitor the Sale Tax, Custom and Excise Act of Kingdom of Bhutan (2000) and ,Rules;
• Review and advise the Ministry of Finance on Custom and Excise policies;
• Coordinate with other law enforcement agencies in prevention of the smuggling of restricted and prohibited goods;
• Process Excise Duty Refund claims from Government of India;
• Liaise with WCO, Regional Custom Administration and other international agencies
  
  

Drug Regulatory Authority (DRA)

The DRA is an autonomous agency established in 2004 that controls and regulates medicinal products (both human and veterinary) in Bhutan.

Mandate of DRA:

• Authorizing for manufacture, import, export, sale, distribution and storage of 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 medicinal products;
• Inspection/monitoring of premises for manufacture sale, distribution and storage of medicinal products including blood and blood products;
• Monitoring 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.

For more information on regulatory departments and quality control laboratories’ contact details, please see the following links:

4.1 Bhutan Government Contact List

4.3 Bhutan Laboratory and Quality Testing Companies Contact List