The role of pre-shipment batch testing in ensuring good medicine quality.

Background: Most donor agencies only procure drugs approved by a Stringent Regulatory Authority or the World Health Organization (WHO) Prequalification Programme in an effort to ensure high quality. However, the US President's Malaria Initiative has occasionally had to return approved drugs with quality issues to the manufacturer. This study compares the quality of artemisinin-based combination therapies (ACTs) produced by WHO-approved manufacturers with non-approved manufacturers and suggests policy changes to improve quality of donor-procured drugs.

Materials And Methods: Over the past five years, covert shoppers procured 1203 samples of ACTs from private pharmacies and drug stores in 16 cities across 14 developing countries. Samples were assessed using the Global Pharma Health Fund e.V. Minilab®protocol to identify substandard, degraded or counterfeit products, and a large number of suspect products were further analysed using high-performance liquid chromatography.

Results: Out of 1203 ACTs, 684 were produced by WHO-approved manufacturers and 519 were produced by non-WHO approved manufacturers. 2.6% (18/684) of ACTs of WHO-approved manufacturers had insufficient active pharmaceutical ingredient (less than 75%), while 12.5% (65/519) of ACTs of non-approved manufacturers had too little active pharmaceutical ingredient, and were considered substandard.

Conclusions: The results of this study suggest that ACTs produced by WHO-approved manufacturers perform nearly five times better than those of non-approved manufacturers, but some approved ACTs have too little active pharmaceutical ingredient. The US President's Malaria Initiative tests every batch of every drug it procures before distribution to recipient countries. Other donors should follow suit to ensure that drugs purchased with taxpayer dollars are of the highest quality.