The research team, led by Santosh K. C. of Kathmandu University with Panna Thapa and Pramote Tragulpiankit of Mahidol University, set out to answer a question that health policy researchers in many low- and middle-income countries rarely ask with rigor: not whether a national medicines policy exists, but whether the individual actions written into it are actually operating. National Medicines Policies, as promoted by the World Health Organization, are meant to guarantee equitable access to medicines, assure their quality and safety, and promote their rational use. Yet systematic evidence on whether the specific actions embedded in such policies have moved beyond formal adoption into day-to-day operation has been strikingly limited. Nepal’s policy, guiding everything from domestic drug production to dispensing controls since the mid-1990s, had never been assessed at this granular level.

Methodologically, the study is a careful piece of policy forensics. The researchers extracted 44 discrete actions from the 1995 policy and its 2001 amendment, then mapped each one to the WHO’s canonical policy objectives: access, quality and safety, and rational use, plus a cross-cutting domain of enabling functions such as monitoring and coordination. Each action was coded against pre-specified, objectively defined criteria as fully operational, partially operational, or not operational, drawing on documentary and systems-level sources. The results were summarized through proportions and a descriptive operational status index, an unweighted summary of operational depth that the authors are careful to frame as a description rather than a performance score. In parallel, the team conducted 25 key informant interviews spanning policy makers, regulators, service delivery, industry, and civil society, analyzing them thematically with a hybrid deductive-inductive approach. The two strands were then integrated through a joint display and classified as convergence, complementarity, or divergence.

The headline numbers are sobering. Of the 44 policy actions, only 10, or 22.7 percent, were judged fully operational. Eighteen actions, 40.9 percent, were partially operational, and 16, or 36.4 percent, were not operational at all. In other words, more than a third of what Nepal’s medicines policy commits to has never functioned in any meaningful sense. The domain-level breakdown reveals a distinctive pattern: quality and safety, covering 16 actions, scored highest with an operational status index of 0.53, driven largely by product standards and import controls. Access, with 12 actions and an index of 0.50, showed moderate progress in production capacity and market availability. But rational use, covering 11 actions, collapsed to an index of 0.27, with not a single action fully operational, and enabling functions fared little better at 0.30 across five actions.

The quality and safety domain’s relative strength tells an important story about how Nepal’s policy has actually matured. Its gains rest on compliance-oriented instruments: product standards that manufacturers and importers must meet, and border controls that screen what enters the country. These are the kinds of discrete, enforceable measures that a resource-constrained regulator can implement without building elaborate institutions. Yet the interviews consistently qualified these documentary gains. Informants pointed to limited laboratory capacity, thin post-market surveillance, and incomplete regulatory maturity, suggesting that even the strongest domain of the policy operates with a shallow foundation. A country can demand quality standards on paper, the findings imply, but without laboratories to test products and surveillance systems to detect failures after products reach the market, the assurance is only as deep as the paperwork behind it.

Access presented a subtler picture, and one where the mixed-methods design proved its worth. The documentary strand recorded moderate progress in production capacity and market availability, and the interviews broadly converged with this. But the qualitative strand surfaced something the documents understated: persistent shortages of critical care medicines and weak pricing governance. This is complementarity in the methodological sense, where the interview data added dimensions that the formal record simply did not capture. Affordability governance emerged as an important complement that the paper trail missed entirely. For a policy whose first duty is equitable access, the gap between what documents show and what patients experience at the pharmacy counter is not a technical footnote; it is the difference between policy as text and policy as lived reality.

Rational use emerged as the study’s most alarming finding. Not one of the 11 actions in this domain was fully operational, and the interviews converged with the documentary evidence in describing prescription monitoring, antimicrobial stewardship, and dispensing controls as intermittent and non-institutionalized. The implications reach far beyond Nepal’s borders. Antimicrobial resistance is one of the defining global health threats of the coming decades, and stewardship systems, the mechanisms that keep antibiotics from being dispensed casually and prescribed without oversight, are its first line of defense. A medicines policy in which rational-use provisions exist only as aspiration means that the structural safeguards against resistance breeding in communities are effectively absent. The convergence between documents and informants here is particularly telling: this is not a case of paperwork overstating reality, but of both evidence streams independently confirming a systemic void.

The enabling functions domain, though small at five actions, may be the study’s most consequential diagnosis. Evidence converged on absent monitoring and evaluation systems, concentrated institutional ownership, and prolonged policy stasis. These are the machinery that keeps a policy alive between revisions: the feedback loops that tell a ministry whether its actions are working, the distributed ownership that prevents a policy from becoming the project of a single office, and the revision cycles that allow a policy to adapt to a pharmaceutical landscape transformed by globalization, new technologies, and emerging threats. A policy that has run for nearly thirty years without systematic monitoring and without revision is, in a precise sense, flying blind. The operational status index of 0.30 for this domain is low, but the qualitative finding of institutional concentration and stasis suggests the deeper problem is architectural rather than incremental.

What makes this study matter beyond Nepal is its template. The approach of decomposing a national medicines policy into discrete actions, coding each against objective operational criteria, and triangulating with frontline informants offers low- and middle-income countries a replicable method for auditing not just whether policies exist but whether they function. The study’s central conclusion is that Nepal’s policy 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 remain underdeveloped. As the country prepares to revise its policy for the first time in a generation, the authors argue that strengthening monitoring, accountability, workforce capacity, and rational-use systems is critical to translating policy intent into sustained public health impact. The lesson is universal: a medicines policy is not a document but a system, and systems fail quietly, action by unimplemented action, until someone finally counts.

Subject of Research: Operational status assessment of Nepal's national medicines policy using mixed methods

Article Title: Operational status of Nepal’s national medicines policy: a convergent mixed-methods assessment

Article References: Operational status of Nepal’s national medicines policy: a convergent mixed-methods assessment. (n.d.). https://doi.org/10.1186/s12913-026-15760-z

Image Credits: AI Generated

DOI: 10.1186/s12913-026-15760-z

Keywords: National Medicines Policy, Nepal, medicines regulation, mixed methods, rational use of medicines, essential medicines, access to medicines, drug quality, antimicrobial stewardship, health policy implementation, pharmaceutical governance, WHO