Quality control of anti-infective medicines : case of ciprofloxacin and metronidazole formulations in Butembo

The circulation of substandard or falsified medicines has increased around the world and this is one of the biggest health crimes considering the potential harm. Democratic Republic of Congo (DRC) is not spared by this scourge with an almost non-existent quality assurance and quality control system. This work aimed to assess the quality of formulations based on Ciprofloxacin and Metronidazole marketed in Butembo, specifically, by checking some parameters based on the WHO checklist for visual inspection. The pre-survey and the collection of samples were limited to 12 pharmacies known as wholesalers. 51 samples of metronidazole and ciprofloxacin formulations (tablets, oral suspensions and solutions for injection) were randomly selected, in which we found 27 different brands manufactures. Concerning the packaging and labelling, all the products presented a satisfactory result. For physical characters of the product, only two samples of tablet showed an integrity defect. Overall, 40 samples (78.4%) were out of specifications of the WHO visual inspection, in which the majority was in tablet forms (100,0 % for metronidazole and 68.2 % for Ciprofloxacin). The majority of non-compliance was due to the not-registration of samples in DRC. This study showed a great pharmaceutical regulation problem in RDC. Limited to visual inspection, it constituted the first step of the analytical approach of quality control of ciprofloxacin and metronidazole formulations found on the Butembo market