E-DRUG: BMJ on Africa medicines manufacturing
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The WHO Prequalification Team (WHO/PQT) battles with many of the issues raised by Mara Kardas-Nelson in, 'Can (and should) Africa makes its own medicines?' (BMJ, 2015(350):h2178). The team works to increase access to quality medicines by prequalifying a range of generic and innovator products, for procurement by donors, and by international and national procurement agencies.
It works with manufacturers - in all geographic regions - to help them reach international quality standards. And it works with regulators to develop the capacity and expertise needed for verifying that quality has been achieved and is maintained.
WHO/PQT's experience demonstrates that single remedies are not effective, but that multi-stakeholder co-operation can initiate positive change. Nigeria is a case in point. As a fast-growing economy and large provider of goods and services to West Africa, it is seeking to expand its pharmaceutical production, achieve self-sufficiency in essential medicines and compete on regional and global markets.
WHO Drug Information, Vol. 28(4), 2014:425 430,1 describes the combined efforts of Nigerian manufacturers, their manufacturers association,2 the National Agency for Food and Drug Administration and WHO/PQT which have so far resulted in four Nigerian manufacturers attaining international good manufacturing practice standards.
But as it points out, further challenges must be overcome before Nigeria's pharmaceutical sector will be able to achieve the level of quality production and autonomy to which it aspires. This includes making the right choice of products which respond to pressing public health needs and meet commercial objectives. International, regional and national procurers have a major role to play in this respect, and especially in terms of contributing to creation of a sustainable market for good-quality products.
1 http://www.who.int/entity/medicines/publications/druginformation/issues/DrugInformation2014_Vol28-4/en/index.html
2 Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria.
Lembit Rago MD, PhD
Head, Regulation of Medicines and other Health Technologies
Essential Medicines and Health Products
World Health Organization
Geneva
Switzerland
Tel. +41 22 791 4420
Assistant: Laura Oakes at oakesl@who.int
Web site: http://www.who.int/medicines/en/
"RAGO, Lembit" <ragol@who.int>