In a number of publications since July 2012 Roger Bate of the American Public Enterprise Institute has made claims that some malaria medicines procured through the Global Fund-managed AMFm facility and prequalified by WHO were sub-standard, following random tests run by him and his co-workers.
The WHO Prequalification Programme immediately activated its networks to reassess the medicines quality. Namely, it asked four of the five manufacturers in question to investigate the batches and provide detailed reports of their investigations, it checked retained samples of the alleged defective batches and is testing medicines already arrived in three countries.
To date, all of the results obtained indicate that samples of the allegedly defective batches fully meet their approved regulatory shelf-life specifications. In every case, the retention samples of the batches that were alleged to contain less than 75% of the artemisinin component actually contained more than 90%.
WHO Prequalification is awaiting the results of further tests currently being carried out in three countries and will make these publicly available on its web site.
Briefing Note: