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Drug quality control work in Daru: observations during 1983-1986
I O Kibwage1, J O Ogeto, C K Maitai
1Department of Pharmacy, University of Nairobi.
East African Medical Journal
|October 1, 1992
Summary
Drug quality analysis revealed significant non-compliance issues in both locally manufactured and imported pharmaceutical products. Over 45% of local drugs and 31% of imported drugs failed to meet official quality standards.
Area of Science:
- Pharmaceutical Sciences
- Drug Quality Control
- Pharmacovigilance
Background:
- The Drug Analysis and Research Unit at the University of Nairobi received 418 drug analysis requests between 1983 and 1986.
- Requests originated from various entities including the Medical Supplies Coordination Unit, government hospitals, research institutions, and local manufacturers.
Purpose of the Study:
- To assess the quality compliance of pharmaceutical products analyzed by the Drug Analysis and Research Unit.
- To identify the prevalence of non-compliance in locally manufactured versus imported drugs.
Main Methods:
- Analysis of 418 drug samples submitted to the University of Nairobi's Drug Analysis and Research Unit over a 4-year period.
- Evaluation of drug samples against quality standards specified in official compendia such as the British Pharmacopoeia (B.P.), European Pharmacopoeia (Eur. Ph.), and Indian Pharmacopoeia (I.P.).
Main Results:
- 70.8% of analyzed samples were locally manufactured, 26.1% were imported, and 3.1% were from undeclared sources.
- A significant proportion of drugs failed to meet quality standards: 45.8% for locally manufactured drugs and 31.4% for imported drug products.
Conclusions:
- Substantial quality control failures were identified in pharmaceutical products available in Kenya during the study period.
- There is a critical need for enhanced regulatory oversight and quality assurance for both local and imported pharmaceuticals to ensure patient safety.