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Pharmaceutical Standards in Africa: The Road to Improvement and Their Role in Technological Capability Upgrading

Banda, G   Mugwagwa, J   Ndomondo-Sigonda, M   Kale, D

January 2016

in ‘Making Medicines in Africa: The Political Economy of Industrializing for Local Health’

Mackintosh, M, Banda, G, Tibandebage, P and Wamae, W (eds)

Palgrave Macmillan

ISBN 978-1-137-54646-3 (hardback)

This chapter discusses standards, an elusive term and concept. For the African pharmaceutical sector especially, the term is used by the manufacturing sector, regulators, technical experts, procurement agencies, health system actors and policy makers to mean different things. There is a dearth of systematic studies that address what standards are, their classification and the logic behind their set-up and operation, and this has contributed to a huge asymmetry in understanding. The socioeconomic, technical and political issues and how they have an impact on local production and industry development, including their effects on access to markets, have also not been systematically explored. Our discussion of standards is informed by extensive literature searches, fieldwork in India, Kenya, Zimbabwe and South Africa where we interviewed technical experts in 2014, and interaction with regulatory and compliance experts in the UK.
A PDF version of this chapter is available on the OU publication page.