|Survey of the quality of antiretroviral medicines circulating in selected African countries
(2007; 58 pages)
Background: Provision of antiretroviral therapy has expanded in Sub-Saharan Africa and quality assurance of
antiretrovirals is of crucial importance for the success of treatment programmes. Therefore
WHO, in co-operation with national authorities, organized a quality survey of antiretrovirals in
selected African countries.
Methods: The survey was performed in Cameroon, the Democratic Republic of Congo, Kenya, Nigeria,
United Republic of Tanzania, Uganda and Zambia. Country teams made up of WHO country
officers and national authority representatives collected samples at public and private sector
antiretroviral procurement organizations and treatment centres around the capital cities. Samples
included monocomponent products of didanosine, efavirenz, lamivudine, nevirapine, stavudine
and zidovudine, and fixed-dose combinations of lamivudine/zidovudine, stavudine/lamivudine,
stavudine/lamivudine/nevirapine. All samples were tested by the Official Medicines Control
Laboratory of Switzerland, Swissmedic, for appearance, labelling, identity, related substances,
and content of each active ingredient. In addition, capsules and tablets were tested for
uniformity of mass and either dissolution or disintegration; oral solutions were tested for pH if
appropriate. Methods of the International Pharmacopoeia, United States Pharmacopoeia, Indian
Pharmacopoeia or manufacturers’ methods with method transfer were used as appropriate.
Sampling and testing were carried out over a period of six months from 13 June to 15 December
Findings: None of the antiretrovirals sampled had any critical quality deficiencies which would pose a
serious risk to patients.
In 394 samples collected, the overall failure rate was 1.8%. One sample contained a broken
tablet and tablets with chipped coating. Two samples were insufficiently labelled on the
immediate packaging. The content of active ingredient of one sample exceeded the upper limit.
One of 163 samples tested for disintegration failed to disintegrate completely within 30 minutes,
and two of 153 samples tested for dissolution showed lower results than required.
Fifty-three percent of sampled products were WHO-prequalified. Information on registration by
National Drug Regulatory Authorities was available for 285 products; of these, 84% were
registered. Products not registered at the time of sampling were found in three countries, mostly
at private sector facilities, and constituted 12% of the total of 394 sampled products.
Conclusions: The generally good quality and safety of products sampled indicate the positive effect of
common efforts of National Drug Regulatory Authorities, WHO and other organizations
involved in prequalification and purchase policies. Market control was still incomplete in at
least three countries.
Since the survey was limited to official distribution points and treatment centres around the
capital cities, these results cannot be generalized to the entire territories of the countries