Quality of antimalarials in Kinshasa peri-urban areas with regard to local pharmaceutical legislation and regulation

Abstract

BACKGROUND: In the context of old pharmaceutical legislation and regulations not adapted to current realities, the aim of the present study was to evaluate the existing pharmaceutical system in peri-urban areas of Kinshasa. METHODS: A prospective study was carried out during the period 2016–2018. The most used antimalarial medicines were identified through household and pharmaceutical establishment surveys. The samples of the obtained medicines were assayed with generic separation methods using the high-performance liquid chromatography technique coupled to a diode array detector. The registration status was checked for 126 antimalarial brand names. A characterization was carried out in 196 pharmaceutical establishments on the basis of standards set out by the Ministry of Health. RESULTS: Of the 75 samples assayed, 19% (14/75) were non-compliant. Of the 124 brand names, 46.0% (57/124) were unlicensed and 14.5% (18/124) had an expired licence. Of the 196 pharmaceutical establishments, only 2 (1.0%) had an authorization to practice, none met all the Ministry of Health minimum standards and 24.5% (48/196) met the World Health Organization Guidelines for the Storage of Essential Medicines and Other Health Commodities. CONCLUSIONS: More resources should be mobilized to apply regulator sanctions.