Good manufacturing practices in the Kenyan pharmaceutical industry and impact of facility upgrading on domestic and international sales

Abstract

Good Manufacturing Practice is the main regulatory standard for ensuring pharmaceutical quality. Manufacturers are required to comply with this standard to warrant medicines which do not pose risk to consumers. The aim of this study was to assess compliance of Kenyan pharmaceutical industry with Good Manufacturing Practices and to determine the impact of facility upgrading on domestic and international sales. Information on key quality elements was collected from 16 manufacturers using a structured questionnaire. Data on domestic and export sales for two upgraded facilities was evaluated for the period, 2010 to 2014. Compliance with Good Manufacturing Practices varied amongst the facilities; all had local accreditation, 11 were accredited by Drug Authorities in East Africa region and 3 held international certification. Domestic sales for two facilities declined after upgradation and international sales increased fivefold for the facility accorded international accreditation. Upgrading of facilities improved international trade but negatively impacted domestic sales.

Keywords: Compliance, manufacturing, pharmaceutical, sales, upgrading