Current National Quality Infrastructure Service Provision in Enhancing the Pharmaceutical Manufacturers' Productivity in Ethiopia: Challenges and Proposed Solutions

Abstract

Background: The National Quality Infrastructure (NQI), as a critical infrastructure supporting quality improvement, plays a pivotal role in ensuring products meet safety, efficacy, and quality standards. As Ethiopia strives to expand domestic pharmaceutical production, effective National QI services become crucial for ensuring product quality, regulatory compliance, and international market access. This study evaluates the current status of NQI service provision for Ethiopia’s pharmaceutical manufacturers, identifies challenges, and proposes solutions. Methods: A qualitative study design was employed, utilizing in-depth interviews guided by semi structured interview questions, along with flexible probing techniques for data collection. Participants were purposefully selected from key stakeholders, including managers from local pharmaceutical companies, officials from national quality infrastructure elements, and the Ethiopian Food and Drug Authority. All transcriptions of the interviews underwent thematic analysis and the NVivo® 14 coding software was used for data analysis. Results: A total of 22 participants were involved in this study, from which four themes emerged: manufacturers' current demands, their capacity, challenges in delivering NQI services, and proposed solutions. This study reveals critical gaps in Ethiopia’s National Quality Infrastructure (NQI) for the pharmaceutical manufacturing sector, including inadequate metrology services, weak policy enforcement, and poor institutional coordination. Limited industry awareness, resource constraints (funding, skilled staff), and insufficient private sector involvement further strain NQI providers like EMI, delaying services. To overcome these obstacles, participants emphasized the need to expand private-sector engagement in testing and calibration service provision, improve cooperation between NQI institutions and regulatory bodies in creating awareness, and integrate quality infrastructure priorities into the education and policy systems. Conclusion: This study highlights strategic interventions, including private sector engagement, stronger collaboration between regulators, and policy integration, as critical to addressing the challenges in Ethiopia’s NQI service provision for the pharmaceutical industry. Implementing these measures would strengthen local pharmaceutical production capabilities, which align with Ethiopia’s broader ambition for the sector.