Survey of the quality of selected antiretroviral medicines circulating in five African countries (Survey report)

The report presents results from a survey conducted by the WHO Prequalification Team on the quality of antiretroviral medicines (ARVs) in five Sub-Saharan African countries: Burkina Faso, DR Congo, Nigeria, Rwanda, and Zambia. The aim was to assess the quality of specific WHO prequalified ARVs sourced from authorized sectors, with a focus on fixed-dose combinations and pediatric formulations. Of the 126 samples tested, the majority met high-quality standards. A comparison with a 2007 survey showed an improvement in the quality of prequalified products, with the failure rate dropping from 1.8% to 0.8%. All ARVs were produced by eight Indian manufacturers, underscoring a lack of local production. The study also highlighted complexities in ARV distribution, with some manufacturers unaware of their products' final destinations. Storage conditions in the surveyed countries met good practice standards. Post-survey discussions emphasized the need for in-country testing and data-sharing platforms for results.