Strengthening Nepal's Medicines Regulatory Capacity through an Indicator Based Tool

The World Health Organization (WHO) Global Benchmarking Tool (GBT) is the first globally accepted indicator-based tool for assessing the maturity of national regulatory systems, responsible for ensuring the quality, safety, and efficacy of medical products. According to the WHO GBT framework, a regulatory authority scoring 3 on a scale of 1–4 for maturity level is a stable, well-functioning and integrated regulatory system. The regulatory maturity of Nepal’s Department of Drug Administration (DDA) is rated very low as per the WHO GBT self-assessments carried out in 2019, 2020, and 2021. The GBT uses 268 sub-indicators across 8 regulatory functions. To strengthen the DDA’s regulatory capacity, Nepal targeted its institutional development indicators to reach maturity level 2 by the end of 2022 and level 3 by 2023. In order to realize this goal, a DDA maturity level action plan was developed which is regularly reviewed and updated through collaboration among the DDA, WHO, and USAID-funded MTaPS and PQM+ projects. Improvements in several regulatory functions have been observed after one year of continued activity by tracking each GBT indicator.

However, many improvements are linked to cross cutting issues such a law and regulation, reorganization and staffing norms and system change that all depend on political commitment to materialize.

USAID MTaPS is a five-year (2018-2023) global program implemented in 18 low- and middle-income countries to strengthen their pharmaceutical systems. MTaPS is implemented by a consortium of partners led by Management Sciences for Health and was implemented in Nepal from end of 2019.