Quality Performance of Drugs Analyzed in the Drug Analysis and Research Unit (DARU) during the Period 2006-2010

K.O. ABUGA*, B.K. AMUGUNE NDWIGAHKAMAUTHOITHIOGETOOKARUNGUYOKING’ONDUMUGOSNFN. "Quality Performance of Drugs Analyzed in the Drug Analysis and Research Unit (DARU) during the Period 2006-2010." East Cent. Afr. J. Pharm. Sci. . 2013;Vol. 16(33).


The quality of a drug product is determined by product design, manufacturing process as well as storage and distribution practices [1]. Effective quality control testing entails use of compendial or validated in-house methods [2]. The Frost and Sullivan report of 2008 revealed that 72% of the drug products in the Kenyan market were imported and majority (58.7%) of the drugs in circulation were generics [3]. The limited investment in the local pharmaceutical manufacturing industry is mainly attributable to the high cost of production which undermines competitiveness in the market [4].
Market authorization for pharmaceuticals in Kenya is granted by the national drug regulatory authority, the Pharmacy and Poisons Board after requisite evaluation of drug registration applications. The applicants are required to submit a certificate of analysis from a recognized independent laboratory operating within Kenya or the East African Community. The three Kenyan laboratories accredited to carry out pre-registration analysis for this purpose are the National Quality Control Laboratory (NQCL), Drug Analysis and Research Unit (DARU) and Mission for Essential Drugs and Supplies (MEDS) laboratory [5].
Drug quality control in DARU has been conducted since 1980 [6]. The laboratory has published periodic reports on the quality performance of drug samples analyzed therein. Previous reports have shown a continued improvement in the quality of products analyzed in DARU. In the 1980s the overall failure rate ranged from 21.6% to 31.4%, dropping to 17.6-21.1% in the 1990s and 6.1% in the years 2001-2005 [6-16]. The number of samples submitted to the DARU laboratory has gradually increased over the years due to enhanced consumption by the growing Kenyan population and drive for enhanced exports [17,18]. This paper reports on the quality performance of samples analyzed in DARU during the period 2006-2010.


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