Improvements to pharmaceutical manufacturing capacity, Ethiopia.

Abstract

Problem: Ethiopia's heavy dependence on imported pharmaceuticals created public health vulnerabilities, foreign exchange pressures and recurrent medicine stock-outs.

Approach: In 2015, Ethiopia launched a 10-year National Strategy and Plan of Action for Pharmaceutical Manufacturing Development to improve access to quality-assured medicines. The strategy, overseen by a Joint Steering Committee co-chaired by the Ministries of Health and Industry with technical assistance from the World Health Organization (WHO), combined industrial incentives, preferential centralized procurement and regulatory strengthening.

Local setting: Before strategy implementation, Ethiopia had limited manufacturing capacity. Local manufacturers supplied approximately 20% of national generic medicine demand, while supply chain fragmentation and foreign exchange constraints compromised access to imported medicines.

Relevant changes: By 2025, six facilities had achieved national good manufacturing practice compliance, 11 manufacturers were operational and the Ethiopian Food and Drug Authority reached WHO Maturity Level 3. Locally produced coverage of the National Essential Medicines List increased from 90 to 140 chemical entities, across 167 dosage forms, and a vaccine manufacturing initiative was launched. However, domestic supply only increased to 23% against a 60% public procurement target; active pharmaceutical ingredient production and WHO prequalification remained unachieved, and export and workforce targets were missed.

Lessons learnt: Combined, the strategy's cross-sectoral governance, regulatory strengthening, preferential centralized procurement and industrial incentives advanced local production. However, foreign exchange constraints, dependence on imported raw materials and financing and capacity gaps limited progress. Future efforts should prioritize WHO prequalification, upstream manufacturing, skilled workforce development, export competitiveness and sustainable financing while maintaining patient-centred objectives.