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New tools to fight fake medicines

May 13th, 2009

New technologies can help African countries identify counterfeit or substandard drugs, says director of Africa Fighting Malaria Roger Bate.

Poor quality medicines are pervasive across Africa. The WHO reports that more than 30 per cent of medicines on sale in many African countries are counterfeit, with some pills containing nothing more than chalk or water.

In last month’s African Journal of Pharmacy and Pharmacology, my research colleagues and I report that 41–47 per cent of antimalarial, antibiotic and antimycobacterial drugs sampled from pharmacies in five African countries and in India failed at least one quality test. [1]

Some drugs fail quality tests because they have been stored and transported inappropriately. Vaccines, antibiotics and antimalarials degrade when exposed to long periods of humidity, temperature variations and sunlight, and anecdotal reports suggest that many developing-world distributors and pharmacies lack adequate storage facilities.

Other substandard drugs come from sloppy manufacturing or outright faking.

Naming and shaming fakers

The Organisation for Economic Co-operation and Development reports that between 39 and 81 per cent of all counterfeit drugs seized by European Union officials from 2005–2007 originated in China or India. But a wholesale ban on products from these countries would be counterproductivebecause China and India also produce many good-quality, low-cost generic drugs.

African countries must be able to assess which producers and distributors are to blame and impose selective embargoes on them. Nigeria provides a good model. Nearly a decade ago, Nigerian health authorities indicated that more than 50 per cent of drugs in the country were fake or adulterated. But a rigorous anticounterfeiting campaign — introducing stiffer penalties and banning several dozen Chinese and Indian companies — has reduced this number to 10–16 per cent.

If more African countries can name and shame producers of poor quality and counterfeit drugs, India’s federal government, which is itself trying to combat fake drugs, will have more political ammunition to crack down on bad firms and their state-level sponsors.

To do so, African countries must differentiate between acceptable and counterfeit, or substandard, products — no easy task, given the growing sophistication of counterfeiters. But new technologies can help.

Detection devices

The German Pharma Health Fund’s ‘Minilab’ uses thin layer chromatography, disintegration and simple dye tests to help weed out the worst-quality products. Generally, a product will ‘pass’ the Minilab test if it contains 80 per cent or more of the labelled active ingredient. The system is effective and relatively cheap, costing just under US$10,000 for basic equipment, training and materials. But it does require potable water, reliable electricity and an air-conditioned room for testing. The US government and other donors have helped deploy more than 300 Minilabs in over 70 countries in the past decade. Tanzania has set up over 20 donated Minilabs across the country and health officials say they’re working well in routing out fake drugs.

Read the rest of this article on identifying fake medicine in Africa.

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