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

Authors

  • Kinga Jamphel
  • Pelden Chejor Drug Regulatory Authority

DOI:

https://doi.org/10.21423/JRS-V06N02P035

Keywords:

medicines, regulation, evolution, Act, Bhutan

Abstract

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)

References

Ahonkhai, V., Martins, S., Portet, A., Lumpkin, M., & Hartman, D. (2016). Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization. PLoS ONE, 11(11). https://doi.org/10.1371/journal.pone.0166515

Chejor, P. (2018). Pharmacovigilance and Adverse Drug Reactions Reporting in Bhutan: A Review of Current Status. Indian Journal of Pharmacy Practice, 11(2), 67-60.

Dorji, C., Tragulpiankit, P., Riewpaiboon, A., & Al, E. (2016). Knowledge of Adverse Drug Reaction Reporting Among Healthcare Professionals in Bhutan: A Cross-Sectional Survey. Drug Safety, 39, 1239. https://doi.org/doi.org/10.1007/s40264-016-0465-2

Drug Regulatory Authority. (2012). Chapter IV Registration of medicinal products. In Bhutan Medicines Rules and Regulation 2012 (12-17). Retrieved from http://dra.gov.bt/wp-content/uploads/2015/07/Bhutan-Medicines-Rules-and-Regulation-2012.pdf

Drug Regulatory Authority. (2013). Guideline for Registration of Medicinal Products (2nd Edition). Retrieved from http://dra.gov.bt/wp-content/uploads/2015/07/Guideline-for-Application-for-Registration-of-medical-product-2013.pdf

Ministry of Economic Affairs. (1995). Rules and Regulations for Establishment and Operation of Industrial and Commercial Ventures in Bhutan, 1997. Retrieved November 18, 2017 from http://www.moea.gov.bt/wp-content/uploads/2017/07/Commercial-Rules-and-Regulations-1997.pdf

Ministry of Health. (2017). Annual Health Bulletin 2017. Retrieved January 12, 2018 from http://www.health.gov.bt/wp-content/uploads/ftps/annual-health-bulletins/Annual%20Health%20Bulletin-2017.pdf

Moran, M., Strub-Wourgaft, N., Guzman, J., Boulet, P., Wu, L., & Pecoul, B. (2011). Registering New Drugs for Low- Income Countries: The African Challenge. PLoS Med, 8 (2). https://doi.org/10.1371/journal.pmed.1000411

National Council of Bhutan. (2008). The Constitution of The Kingdom of Bhutan, pp. 20. Retrieved April 18, 2018 from http://www.nationalcouncil.bt/assets/uploads/files/Constitution%20%20of%20Bhutan%20English

National Statistics Bureau. (2017). Chapter 2- Economic Highlights. In National Accounts Statistics 2017 (3-7). Retrieved from http://www.nsb.gov.bt/publication/files/pub4pe1310cn.pdf

National Statistics Bureau. (2017). Key Facts of Bhutan. In Statistical Yearbook of Bhutan 2017 (v). Retrieved from http://www.nsb.gov.bt/publication/files/yearbook2017.pdf

National Statistics Bureau. (2018). 2017 Population & Housing Census of Bhutan. Retrieved June 24, 2018 from http://www.nsb.gov.bt/publication/files/PHCB2017_national.pdf

Poudel B. K., & Ishii, I. (2016). Assessment of physical premises of selected pharmacies of Nepal. SAGE Open Med, 4, 1-5. http://journals.sagepub.com/doi/10.1177/2050312116654590

Poudel, B. K., Ishii, I., & Khakurel, B. (2016). Assessment of regulatory compliance in selected pharmacy outlets of Nepal.Journal of Pharmaceutical Health Services Research, 7, 31-36. https://doi.org/10.1111/jphs.12127

Ratanawijitrasin, S., & Wondemagegnehu, E. (2002). Effective drug regulation: A multicountry study. Geneva, Switzerland: World Health Organization.

Silver, M., Lydecker, M., & Lee, P. (1990). The Drug swindlers. Internal Journal of Health Services, 20, 561. https://doi.org/10.2190/P32D-0141-M86B-F7AT

Stapleton, M. (2000). Bhutan Essential Drugs Program: A Case History. Geneva, Switzerland: World Health Organization. Retrieved December 20, 2017 from http://apps.who.int/medicinedocs/documents/s19041en/s19041en.pdf

Tobgay, T., Dophu, U., & Na-Banhchang, K. (2011). Health and Gross National Happiness: review of current status in Bhutan. Journal of Multidisciplinary Healthcare, 4, 293–298. https://doi.org/10.2147/JMDH.S21095.

World Health Organization. (2004). WTO's Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. Essential Drugs in Brief. Retrieved December 6, 2017 from http://www.who.int/medicines/publications/brief/en/edb13.pdf?ua=1

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Published

2018-11-05

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Section

Policy Commentaries