Supplementary info DARU, drug analysis, drug class, pharmacovigilance, post-market surveillance

Abstract

During the period 2011-2015, the Drug Analysis and Research Unit (DARU) analyzed 1972 drug samples. The samples consisted of 21.5% locally manufactured and 78.2% imported products while the origin of 0.3% of products was indeterminate. Samples were subjected to compendial and/or in-house analytical specifications. The overall non-compliance rate was 4.5% comprising 2.5% local products and 2.0% imports. High failure rates were recorded for uterotonics (37.5%), hemostatics (33%), anthelmintics (17%) and anticancers (10.5%) while ophthalmic, immunomodulatory, musculoskeletal and endocrine drugs all complied with the quality acceptance criteria. Erectile dysfunction drugs, received by the laboratory for the first time, all complied with specifications. The results obtained demonstrate an improvement in the quality of samples submitted to DARU when compared to previous performance.