Assessment of Local Pharmaceutical Manufacturing Sector in a Low-income Country: A Descriptive Study

Abstract Background In high-income countries and emerging economies, pharmaceutical manufacturing is a driver for socioeconomic development. In sub-Saharan Africa, local pharmaceutical production is still fledgling largely because of historical economic and technological asymmetry. In Ethiopia alike, this environment has changed little despite six decades long operations and several support initiatives; access to essential medicines remained a persistent challenge. This study attempted to explore the views and experiences of professionals working in Ethiopian pharmaceutical industry regarding the context, performance, challenges and potential opportunities towards local production. Methods A validated structured survey questionnaire was disseminated to professionals working in local pharmaceutical companies. Multiple regression analysis was conducted to study the effects of different factors on the performance of the local manufacturing sector. Results About half of the professionals rated the current production technology as advanced while 68% described it as semi-automated. Close to one-third reported that the companies are operating at acceptable level of performance, and about 50% reported low-capacity utilization in their companies. Most professionals viewed export market activities as poor and many identified weak research and development activities. Unplanned operations downtimes, limited physical infrastructure, inadequate access to foreign currency, shortage and high staff turnover of qualified experts, lack of commitment from top management, absence of merit-based support system and limitations in compliance with regulatory and quality requirements were reported as major challenges. Multiple linear regression analysis demonstrated that capacity utilization (α = 0.008), research and development capacity (α = 0.014) and export market activities (α = 0.027) have significant impact on the sector performance. Conclusion Despite commendable efforts by the industry and government, limitations in financing, infrastructure, qualified workforce, and quality system implementation are affecting capacity utilization and performance. Absence of reliable staff attraction and retention system, lack of effective leadership and non-favourable working environment were identified as missing elements.