Evolution of Medicines Regulatory System in Bhutan: History, Status and Challenges

Bhutan is a small landlocked Kingdom in the eastern Himalayas, situated between China and India. Health care in Bhutan is provided free by the government, as guaranteed under the Constitution. No proper system for regulation of medicines existed before 2003. The Essential Drugs Program, instituted in 1986, played the role of regulatory authority and issued technical clearances for sale and distribution of medicines. Notable improvements were seen in the procurement, quantification and store management of medicines under the umbrella of the Essential Drugs Program. The path to medicines regulation in Bhutan started with the enactment of The Medicines Act of the Kingdom of Bhutan in 2003. The Drug Regulatory Authority, established under the Ministry of Health in 2004, began to register medicines before they were imported into Bhutan. Premises licensed for manufacture, sale, distribution, storage and dispensing medicines are monitored for regulatory compliance. Systems for pre-marketing and post-marketing control of medicines were initiated. Bhutan's medicines regulatory system has gradually evolved over the last decade. As a new regulatory system, it faces a number of challenges as the scope of regulatory activities continues to expand. However, there is a need to further strengthen the capacity of drug testing laboratories, and the availability and capacity of regulatory human resources should be enhanced and infrastructure improved for effective regulation of medicinal products in the country. As systems evolve and people change over time, institutional memory is lost. It is important to document the steps adopted by Bhutan, so that other small nations can learn from Bhutan's experiences. This article documents the path Bhutan has taken towards strengthening the regulatory system for medicines. The article also addresses the challenges invovled and recommends measures to address them.https://doi.org/10.21423/jrs-v06n02p035 (DOI assigned 3/11/2019)