Pharmaceutical News 2.0

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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BEIJING, Dec. 9 (Xinhua) — China’s State Administration of Traditional Chinese Medicine (SATCM) on Tuesday blacklisted 74 websites for selling fake Chinese herbal medicine.

Names of those sites have been made public on SATCM’s website at www.satcm.gov.cn.

Consumers are warned of buying any type of medicine from organizations such as the International Diabetes Institute of Genetic Engineering (www.010gbw.com), the China Research Center for Chinese Medicine (www.gxykf8.cn) and the China Cardiovascular Research Institute at (www.gxy007.cn).

Drugs sold on those websites claimed to be able to cure high blood pressure, skin diseases, diabetes and tumors.

SATCM has reported the 74 websites to the Ministry of Industry and Information Technology for further investigation. Those sites could be shut down.

As of now, they are still open.

Only one man, from the Diabetes Research Center of the Chinese Academy of Traditional Medicine website called Xinhua back. However, he hung up when he was asked about medicines for sale.

Yan Jiangying, spokeswoman with the State Food and Drug Administration (SFDA), said only those sites with the SFDA license of Internet medicine business can sell over-the-counter (OTC) drugs to individuals.

“So far, only ten websites across China have been issued with the license,” she said.

Read the rest of this article on fake medicine in China.

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New research released today (12 November) highlights the risk men are taking by purchasing counterfeit medicines. The ‘Cracking Counterfeit’ report commissioned by Pfizer reveals one in ten men interviewed - which would equate to more than 335,931 men living in major cities alone - admit to purchasing prescription only medicines without a prescription.1* ,2

Half (50%) of the men who have purchased medicine without a prescription have done so via the internet - a worrying statistic when you factor in that 90% of all medicines sold on the internet are thought to be fake.1** ,3

The reality is that counterfeit medicine can damage one’s health, and in some cases cause death. 4 Counterfeit medicine can contain high levels of toxic solvents5 for example, rat poison has been found in a counterfeit blood pressure lowering treatment, while boric acid and lead based road paint have both been found in a counterfeit medicine used to ease severe pain.5

The study also highlights the ignorance amongst men about which medicines actually require a prescription - only 40% of the men interviewed knew that erectile dysfunction medicine was in fact legally available only with a prescription.1**

The report also illustrates just how big the counterfeit medicine market is - with men potentially pouring more than £10 million into the counterfeit medicine market annually.1*, 2

The ‘Cracking Counterfeit’ report reveals:

– 68% of male respondents suspect ingredients found in counterfeit medicine to be very different from authentic medicines.1**

– 37% of men cited convenience and speed as the key reasons why they purchase medicine without prescription.1**

– The majority (60%) of the men who have bought medicine without prescription admit that if there was a possibility their medicine was counterfeit, it would have a great impact on their likelihood to purchase.1**

– Almost half (45%) of men purchasing without a prescription agreed that it was easy to get hold of.1**

Dr David Gillen, Pfizer’s Medical Director said: “Men bypassing the health system to purchase medicines is a growing problem in the UK, particularly relating to the increased availability of counterfeit medicines. These new findings show that men are not only often ignorant about what medicine actually requires a prescription but worryingly they know buying medicine from illicit sources might be harmful but convenience and anonymity often outweigh their fear levels.”

“Today, 12% of UK men like to gamble online.6 Almost the same proportion, 11%, may be literally gambling on life through purchasing potentially counterfeit medicine.1* The findings paint an interesting picture and help us to further educate the public around the risks of purchasing medicine through unregulated sources, ultimately reducing exposure to counterfeit medicine.”

Read more about the dangers men face when purchasing fake medicine.

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