Drug Quality Control in Kenya: Observation in Drug Analysis and Research Unit during the Period 1996-2000

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 practitioners. The samples analyzed constituted 59.8 % locally manufactured and 40.2 % imported products. The overall 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.


Key Words: Quality control, active pharmaceutical ingredient content, dissolution.


East and Central African Journal of Pharmaceutical Sciences Vol.5(2) 2002: 28-32