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During the five-year period January 2001 to December 2005, the Drug Analysis and Research Unit received and analyzed 394 drug samples. Samples were received from regulatory authorities, local industry, non-governmental organizations, hospitals and private practitioners. The samples analyzed constituted 37.8 % locally manufactured and 62.2 % imported products. In contrast to previous years when failure rates of over 20 % were recorded, the overall rate of failure to comply with compendial quality specifications was 6.1 %, comprising of 8.7 % locally manufactured and 4.5 % imported drugs.

Amoxycillin products were evaluated for quality by liquid chromatography at the Drug Analysis and Research Unit (DARU), University of Nairobi. Thirty three of these were capsule formulations and 24 were dry suspensions. Three capsule formulations failed the limits on content. The amoxycillin content in one suspension product was below the limit, while in two other products it dropped below 80% on storage at 25°C for 7 days.

The present paper reports on the findings of drug analyses carried out at Drug Analysis and Research Unit (DARU) between January 1996 and December 2000. (table I). The overall failure to meet one or more of the specifications was 2 1.1 % (55 samples). Local products had a higher failure (24.6 %, 38 samples) than imported ones (1 6.2 %, 17 samples). MATERIALS .AXD I E T H O D S SamplesThe major quality problem was the content of the active ingredients, which was often too low and occasionally too high. Some products did not meet dissolution, sterility and particulate matter specifications. None of the products analyzed was found to have the wrong or no active pharmaceutical ingredients (counterfeit).The anthelmintic drugs had the highest failure (37.5 %) and these failed in the content of active ingredient. Most of these products were for veterinary use and all came from the same local company. The manufacturer concerned eventually solved the problem following advice on product development.The failure of the antimalarial drugs was 27.7 %, with suJphadoxine/pyrimethamine and chloroquine (CQ) having a failure rate of 40.5 and 13.3 %; respectively. The quality of sulphadosine'p! rimethamine products in Kenya has k n discussed else~vhere [15]. As opposed to c. : " .=:!aswr of drugs. Lvhich had a problem with r?c content of the active ingredients, the sulphadoxine/pyrimethamine and CQ products mostly had a problem with dissolution and scmerimes lvith both dissolution and content.The Ministry of Health in Kenya changed the first line antimalarial drugs from CQ to SP products in 1998 [I 61. Many local pharmaceutical companies immediately started manufacturing these products and hence the .ptoblems of quality may be attributed to poor pharmaceutical product development. Samples of sulphamethoxypyrazine Ipyrimethamine, amodiaquine and quinine were too few for inferences to be made.Other groups of drugs that had quality problems, especially in the content of active ingredients, include skin preparations (25.0 %, both local and imported), electrolytes (23.1 %, all imported), antiprotozoal agents (14.3 %, all local), antibioticslantibacterial agents (10.3 %, local and imported) and analgesics (9.8 %, local and imported). The bronchodilators had a failure rate of 20.0 %, but the sample size was not big enough to make conclusions. CONCLUSIONThe failure rate (23.6 %) of. drugs analyzed in DARU over the period 1996-2000 is higher compared to those analyzed in the same laboratory in the period 1991-1995 (17.5 %) 191. This calls for strict market surveillance of drugs, especially antimalarial agents. Other drugs requiring close surveillance include antibioticslantibacterial agents, antiprotozoal agents, anthelmintic agents, skin preparations and electrolytes. ACKNOWLEDGEMENTS

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