Good Manufacturing Practices in the Kenyan Pharmaceutical Industry and Impact of Facility Upgrading on Domestic and International Sales

Sarah Vugigi; Grace Thoithi; Joshua Ogaji; Susan Onuonga

Sarah Vugigi Department of Pharmacy and Complementary/Alternative Medicine, Kenyatta University, P.O. Box 43844-00100, Nairobi, Kenya
Grace Thoithi Department of Pharmaceutical Chemistry, University of Nairobi
Joshua Ogaji Department of Pharmaceutics and Pharmaceutical Technology, University of Jos, PMB 2084- 930001, Jos, Plateau State, Nigeria
Susan Onuonga Department of Econometrics and Statistics, Kenyatta University, P.O. Box 43844-00100, Nairobi, Kenya

Keywords: Compliance, manufacturing, pharmaceutical, sales, upgrading

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.