Drug quality control in Kenya: Observation in drug analysis and research unit during the period 1996-2002

Abstract

The Drug Analysis and Research unit received and analyzed 261 drug samples over a five-year period, 1996 to 2000. Samples were received from regulatory authorities, local industry, non-governmental organizations, hospitals and private practitoners. The samples analyzed constituted 59.8 % locally manufactured and 40.2 % imported products. The overal rate of failure to comply with quality specifications set out in the respective monographs was 21.1 %. This represents 24.6 % and 16.2 % of the locally manufactured and imported drugs, respectively.