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Low quality malaria drugs found

20th May 2008

More than a third of drugs used to treat malaria in African cities have failed basic quality tests in a recent study carried out in Ghana, Kenya, Nigeria Rwanda, Tanzania and Uganda.

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The study, published in the peer-reviewed open-access journal PLoS One, found that some 35% of antimalarial drugs sold in six major African cities were below standard.

It also found that single-drug remedies, or monotherapies, containing artemisinin were still being used for the treatment of malaria, in spite of an explicit rejection of such practices by the World Health Organisation (WHO).

Researchers estimate that 200,000 avoidable deaths are caused annually by substandard medication.

Lead author Roger Bate, Resident Fellow at the American Enterprise Institute, said that efforts to increase access to quality antimalarial drugs in Africa were increasingly important.

Future malaria treatment strategies were being jeopardised by substandard drug regimes, which contributed to resistance among malaria parasites, he added.

The WHO recommends artemisinin combination therapies because they lower the chances that parasites will develop resistance, thereby reducing treatment efficacy.

But Bate's team found that a third of the drugs collected in the study were artemisinin monotherapies. 42% of them failed quality tets, and 78% were manufactured after the World Health Organisation proscribed them in January 2006.

WHO has asked Chinese pharmaceutical companies to stop making monotherapies of artemisinin, which is derived from a traditional Chinese herbal treatment for malaria in use in the country for centuries.

It has asked Shanghai-listed Kunming Pharmaceutical, located in the southwestern Chinese city of Kunming, to stop making them. But Chinese officials say WHO is being unfair to China, which developed artemisin-based drugs and brought them to production. The company also makes combination therapies, which are available in sub-Saharan Africa.

Malaria surged through Africa in the 1990s, fuelled by resistance to chloroquine and other historically effective drugs.

Post-market surveillance and pharmacovigilance are severely limited in Africa, yet crucial to detecting bad drugs and the inevitable development of parasite resistance for an at-risk population of 700 million.

Richard Tren, Director of Africa Fighting Malaria, a non-profit advocacy group, said artemisinin combination therapies now risked the same fate, because regulation and post-market surveillance of drugs is so poor in most malarial countries.

Tren's group recently published a report on malaria treatment policy in Africa, examining the challenges of pharmaceutical regulation and production on the continent.

WHO says that only 40 of 74 global manufacturers have agreed in principle to stop production, and 42 countries – 18 of them in sub-Saharan Africa – still allow companies to market these drugs.

Tren added that poor countries may now use taxpayers' money to buy untested drugs of uncertain quality under the Global Fund’s ‘Option C’.

While the scheme was originally intended to increase incentives for producers of combination therapies to enter the market and foster competition, it had not provided any incentives for these companies to go the extra step and submit to bioequivalence testing by a stringent regulatory authority, he said.

The PLoS One study said a fraction of the current global budget for malaria control could support a decentralized network for basic drug quality testing in Africa using Minilabs, portable chemistry sets, or equivalent technologies.

 

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