National Quality Infrastructure and Local Pharmaceutical Manufacturing in Ethiopia: A Qualitative Analysis of System Gaps and Strategic Reforms

Abstract Background The National Quality Infrastructure (NQI) plays a critical role in ensuring medicine safety, quality, and regulatory compliance. This study assessed the current status of NQI service provision for Ethiopian pharmaceutical manufacturers, identified key institutional and operational challenges, and proposed strategic solutions. Methods A qualitative study design was employed using semi-structured in-depth interviews with flexible probing. Participants were purposively selected from key stakeholders, including pharmaceutical manufacturers, NQI institutions, and regulatory authorities. Data were analyzed thematically using NVivo® 14 software. Results Twenty-two participants were included in the study. Four major themes emerged: manufacturers’ demand for NQI services, institutional capacity of NQI providers, service delivery challenges, and proposed solutions. The findings show that Ethiopian pharmaceutical manufacturers primarily obtain basic calibration services from the Ethiopian Metrology Institute and ISO certification through conformity assessment, while their interaction with accreditation and standards institutions remains nonexistent. Critical gaps were observed in metrological calibration capacity, pharmaceutical testing services, accreditation coverage, and standards implementation training. Manufacturers also showed low adoption of international standards, with fewer than half implementing ISO standards and only one company obtaining NQI certification. In addition, approximately eighty percent of calibration and qualification services were outsourced to foreign providers due to limited local metrology capacity. Conclusion The study identifies critical structural and operational gaps in Ethiopia’s NQI system that hinder pharmaceutical manufacturing quality and competitiveness. Strengthening institutional coordination, expanding private sector participation in testing and calibration services, supporting regulatory quality requirements, and improving workforce training are essential strategic interventions.