Verification and Application of Pharmacopeial Methods in the Detection of Falsified Medicines at the National Quality Control Laboratory of the Democratic Republic of Congo

Introduction: World Health Organization (WHO) through its current Global Benchmarking Tools (cGBT) used in the self-assessment of regulatory authorities, found that regulatory functions in general and laboratory testing in particular in countries with low regulation are not compliant with ISO/IEC 17025:2017 and WHO Trs No. 957, 2010. It was noted that, to date, in sub-Saharan Africa, fewer than 10 countries have authorities that have reached at least Maturity Level 3. Objective: This study aimed to verify pharmacopeial methods in the detection of falsified medicines in accordance with ICH Q2(R1) requirements at in the D.R. Congo through a laboratory compliant with the ISO standard, estimated at maturity level 3. Methodology: Five concentration levels were prepared: 110%, 100%, 90%, and 80%, from the stock solution corresponding to 120% for the APIs (6 antimalarials and 1 antibiotic) allowed to identify non-compliant samples during the period from 2021 to 2024. Results: The methods, verified in compliance with ICH and WHO normative requirements, were deemed compliant and applicable under the applied conditions. And the non-compliant products were detected: 7/41 (17.1%) for Artemether & Lumefantrine, 3/11 (27.3%) for Sulfadoxine & Pyrimethamine, 1/46 (2.2%) for injectable Artesunate and 5/41 (12.2%) for Artemether & Lumefantrine (without any active ingredient). Conclusion: This research aimed to verify the relevance of pharmacopeial methods currently used in DR Congo for quality control to the ICH and WHO requirements with perspective of tackling medicines falsification. The obtained results showed the compliance of studied methods and allowed to identify substandard products for Artemether-Lumefantrine and Sulfadoxine and Pyrimethamine combinations. Also, they allowed the detection of lower concentration of Artesunate within injectable formulations. Which confirmed the real existence of the announced issue related to the falsified drugs circulation in developing countries.