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

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. Despite a few fragmented reports on trends and profiles of the sector, in-depth investigations into underlying challenges remain limited. This study explores the perspectives and insights of upfront executives and technical personnel in the Ethiopian pharmaceutical industry on its current state, challenges and opportunities for enhancing local production capacity. The findings are triangulated with literature reports and provide valuable insights for developing intervention strategies and policy updates.

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: Over half of the professionals (55.1%) rated the current production technology as advanced while 68% described it as semi-automated. Close to one-third (31.6%) reported that the companies are operating at acceptable level of performance, and 51.5% reported low-capacity utilization in their companies. Most professionals (67.8%) 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 highstaff 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. Enhancing economies of scale and capacity utilization, addressing policy and infrastructure bottlenecks, providing merit-based support for R&D and quality management, and implementing staff attraction and retention strategies are key steps towards developing competent local pharmaceutical manufacturing sector.