Abstract

Aim
This study analyzes the evolution of Nepal’s medicines regulatory system, identifies key institutional and political drivers of reform, and examines the structural and operational gaps limiting regulatory effectiveness across quality, safety, and access domains.
Methods
A qualitative documentary and policy analysis was conducted between August 2024 and May 2025 using publicly available and officially endorsed documents, including national laws, regulations, policies, operational guidelines, institutional reports, and World Health Organization reference materials. Chronological mapping and thematic synthesis were used to identify phases of regulatory evolution, cross-cutting constraints, and functional performance patterns. The WHO Global Benchmarking Tool was used as a reference framework to organize evidence across regulatory function domains, without independent maturity scoring.
Results
Four phases of regulatory evolution were identified: the pre-regulatory era (pre-1978), the foundational legislative era (1978-1995), the modernization and integration era (1996-2010), and the capacity building and system evaluation era (2011-2025). Reforms demonstrate progressive institutionalization and increasing alignment with global regulatory norms, but persistent implementation gaps remain evident. A recurring pattern of capacity asymmetry was observed, where pre-market and administrative functions expanded more rapidly than post-market quality assurance and pharmacovigilance capacities, contributing to uneven functional consolidation.
Conclusion
Nepal’s medicines regulatory system shows sustained legislative and institutional progress, yet operational constraints continue to limit integrated performance. Strengthening post-market surveillance, laboratory capacity, regulatory competencies, digital systems integration, and intergovernmental coordination is essential to ensure resilient oversight and equitable access to quality-assured medicines.

Key words: Medicines regulation, Access to medicines, Department of Drug Administration, Nepal, WHO Global Benchmarking Tool