Drug manufacturing in Africa

Lembit Rägo, Jitka Sabartova & Jacqueline Sawyer | 18 Sep 2010
The Lancet
Tatum Anderson (May 8, p 1597)1 highlights important elements of the debate surrounding local pharmaceutical production in developing countries. But some of her points relating to the WHO Prequalification of Medicines Programme (WHO/PQP) lack nuance and detail.

WHO/PQP does indeed do a "stringent quality check" of any medicinal product submitted to it for assessment. However, the check is not "imposed" but part of a process that manufacturers undergo voluntarily and at no cost to themselves.

Analysis of sampling and testing results for antimalarials indicates that prequalification by WHO is a strong indicator of a medicine's quality. In a study funded by the European Union (as yet unpublished), 935 samples were collected in 2008 in Cameroon, Ethiopia, Ghana, Kenya, Nigeria, and Tanzania. Quality-control laboratories tested about 30% of the samples. Only three (3·6%) of the 83 samples of WHO-prequalified antimalarials deviated from prespecified quality criteria, compared with 73 (39·7%) of the 184 samples of non-WHO-prequalified antimalarials.

The study also compared the results of minilabs used to screen medicines in the field with those of quality-control laboratories. The quality-control laboratories identified a greater number of poor-quality antimalarials than did the minilabs. WHO/PQP has so far prequalified 14 quality-control laboratories, and a further 30 (16 in sub-Saharan Africa) are working towards prequalification.

Anderson mentions the efforts of Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) to help African manufacturers identify the improvements necessary to reach international standards, but not similar efforts undertaken by WHO/PQP. In fact, WHO/PQP works with many national regulatory authorities, quality-control laboratories, and manufacturers, in numerous developing countries, to help them acquire the skills needed for ensuring medicines quality.

Local manufacturing in Africa remains a difficult issue since compliance with international standards within Africa varies significantly. But WHO/PQP targets resources and efforts to boost both the quality of that production, and the capacity to ensure that it is monitored and maintained. We believe that our efforts, combined with those of many other parties, can contribute to better medicines for Africa. Our aspiration, however, is that any local pharmaceutical production, independent of its location, meets quality standards.