Assessment tool for establishing local pharmaceutical manufacturing in low- and middle-income countries

Abstract

Abstract Objective In many low- and middle-income countries (LMICs), limited availability, substandard quality and high prices of pharmaceutical products lead to lack of access to essential medicines and poor health outcomes. Manufacturing pharmaceuticals in LMICs may improve access for patients while increasing the market size for manufacturers. Methods We present a tool for assessment of local manufacturing feasibility of pharmaceuticals, intended for use among key stakeholders during the business development process. The tool consists of five domains: product selection and capacity, market sizing, market entry, funding and quality assurance. Key findings The tool is intended to identify barriers and facilitators for local manufacturing and provide a roadmap for decision-making across multiple stakeholders. A case study in Namibia identified key barriers and facilitators to successful manufacturing in that county. Conclusions Careful consideration of feasibility and potential for success may lead to improved health for the populations of LMIC as well as significant market potential for pharmaceutical manufacturers.