The Poor-quality medical products in the Democratic Republic of Congo: A ten-year retrospective study in Kinshasa (2012–2021)

Introduction Substandard and falsified (SF) medical products continue to threaten public health worldwide, particularly in developing countries. Unfortunately, the available literature primarily focuses on anti-infective drugs. Purpose The aim of this study is to review data on the quality of medical products to contribute to the development of future field studies. Methods A ten-year retrospective study in Kinshasa, DRC, analyzed data on poor-quality medical products from 2012 to 2021. The study identified international non-proprietary names, pharmaceutical forms, countries of origin, causes of non-compliance, therapeutic classes, batch numbers, and labeling. Results Although the descriptive statistics derived from these data show a rate of non-compliance ranging from 0.45% to 1.34%, well below recent World Health Organization estimates, the current study reveals that quality problems with medical products also affect therapeutic classes other than antimalarials and antibiotics. Conclusion This study aimed to analyze data on the quality of medical products in Kinshasa to contribute to future studies. The study involved 59,961 samples analyzed over a decade, with 258 non-compliant samples in the first laboratory, 670 in the second laboratory, and 7,681 in the third laboratory. Factors such as the country and continent of manufacture, therapeutic classes, non-compliant drugs, and pharmacological forms were considered. These results highlight the need for regulatory authorities to implement effective surveillance and monitoring policies for all establishments involved in the quality control of medicines and health products. Such efforts are essential for ensuring consumer safety and reflecting the quality of regulatory activities, which must encompass all parameters that contribute to the development of an exemplary quality model.