Abstract / Summary
National Medicines Policies (NMPs) aim to ensure equitable access, quality and rational use of medicines. However, systematic evidence on whether the actions set out in such policies are actually operating remains limited. In Nepal, the 1995 National Drug Policy has guided the medicines sector for nearly three decades and is now due for revision, but the operational status of its individual actions has never been systematically assessed. A convergent mixed-methods study described the NMP’s operational status, the extent to which policy actions have moved from formal adoption into functioning operation, a first-order dimension distinct from broader implementation outcomes. Forty-four discrete actions were extracted from the NMP 1995 (with its 2001 amendment) and mapped to WHO objectives (access; quality and safety; rational use) plus a cross-cutting enabling-functions domain. Each action was coded against pre-specified, objectively defined criteria as fully operational (FO), partially operational (PO), or not operational (NO) using documentary and systems-level sources, and summarized via proportions and a descriptive operational status index (OSI, 0–1). The OSI is a descriptive summary of operational depth (unweighted across actions), not a performance score. Concurrently, 25 key informant interviews across policy, regulation, service delivery, industry, and civil society were analysed thematically using a hybrid deductive-inductive approach. Strands were integrated through a joint display and classified as convergence, complementarity, or divergence. Of the 44 policy actions, 10 (22.7%) were FO, 18 (40.9%) PO, and 16 (36.4%) NO, with an overall OSI of 0.43. Access (12 actions; OSI 0.50) showed moderate progress in production capacity and market availability. Interviews complemented this by identifying persistent shortages of critical care medicines and weak pricing governance that the documentary record understated. Quality and safety (16 actions; OSI 0.53) had the highest operation status, driven by product standards and import controls. However, interviews consistently qualified these gains by pointing to limited laboratory capacity, post-market surveillance, and regulatory maturity. Rational use (11 actions; OSI 0.27) was the weakest domain, with no action fully operational. Interviews converged with documents in describing prescription monitoring, antimicrobial stewardship, and dispensing controls as intermittent and non-institutionalized. Enabling functions (5 actions; OSI 0.30) showed limited operation, with converging evidence of absent monitoring and evaluation systems, concentrated institutional ownership, and prolonged policy stasis. Integration showed that the documentary and interview strands mostly converged, with affordability governance being an important compliment surfaced in the interviews. Nepal’s NMP has become operational primarily through discrete instruments and compliance-oriented controls, while the institutional and governance functions essential for reliable access, regulatory maturity, and rational use are underdeveloped. With a policy revision forthcoming, strengthening monitoring, accountability, workforce capacity, and rational-use systems is critical to translate policy intent into sustained public health impact.