Bhutan is a small Himalayan Kingdom situated between the two giants of the world, India and China. The road to modern healthcare system in Bhutan began in 1961 coinciding with the first Five Year Plan. Healthcare service in Bhutan is provided free by the government. The existing 27 blood banks in the country are located within the hospital setting under the laboratory sections. The Blood and Blood Products Regulation (BBP Regulation) of Bhutan was launched on 14 June 2016. Blood and Blood Products (BBPs) are regulated by the Drug Regulatory Authority (DRA).

Safe blood, safe donor and safe transfusion are the three elements of blood safety. BBPs are potential source of infections and other adverse events although millions of lives are saved each year through blood transfusions. The BBP Regulation of Bhutan, 2016 is the guiding regulatory tool to ensure the quality and safety of BBPs in the country. The regulatory provisions includes requirement for premise, personnel, equipment and quality assurance system for blood centers (BC) and blood storage centers (BSC) among others.

The DRA is faced with several challenges while implementing the BBP Regulation due to lack of expertise in regulating BBPs. Similarly, the existing blood banks in the country are not able to meet the requirements of BBP Regulation. Ministry of Health and relevant agencies should collaborate to comply with the BBP Regulation and ensure quality BBPs for safer transfusions. This article attempts to describe the key components of BBP Regulation, 2016 and highlights the progresses and challenges of the BBP Regulation in Bhutan.

Keywords: Drug Regulatory Authority, Regulation, Transfusions, Blood and Blood Products, Bhutan.

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Pelden Chejor

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