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.