Quality Control Report of Drugs Analyzed in the Drug Analysis and Research Unit during the Period 2011-2015

Kennedy O Abuga; Stanley N Ndwigah; Beatrice K Amugune; Dennis SB Ongarora; Peter M Njogu; Alex O Okaru; Isaac O Kibwage

Kennedy O Abuga Department of Pharmaceutical Chemistry, University of Nairobi
Stanley N Ndwigah Department of Pharmaceutical Chemistry, University of Nairobi
Beatrice K Amugune Department of Pharmaceutical Chemistry, University of Nairobi
Dennis SB Ongarora Department of Pharmaceutical Chemistry, University of Nairobi
Peter M Njogu Department of Pharmaceutical Chemistry, University of Nairobi
Alex O Okaru Department of Pharmaceutical Chemistry, University of Nairobi
Isaac O Kibwage Department of Pharmaceutical Chemistry, University of Nairobi

Keywords: 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.