The World Health Organization defines a counterfeit drug is one made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or right, with a view to deceive or defraud, and then marketing the copied or forged drug as the original.
Three decades ago this problem was largely restricted to low income developing countries. Drugs were poor copies sold in informal settings to poor sick people desperate to obtain medicines they could not otherwise afford. In the intervening years, manufacturing and sale of fake drugs has become big business. The manufacturing, carried out mainly in China and India, has become very sophisticated. Mass produced fakes are nearly identical in appearance to the original, but contain no active ingredients. The true extent of the problem has not been well known until two recent studies describing the true extent of the problem and how little is being done about it. (1) An estimated 10-30% of medicines sold in developing countries are counterfeit. In some areas the estimates run as high as 50-80%. Although the figures from industrialized countries are much lower, the increasing use of the internet for sales and the rapidly increasing cost of legitimate drugs are causing an escalation of sales of fakes, even in the US. The estimated worldwide annual value of the counterfeit drug trade is $200 billion,
The selling and manufacturing of fake drugs is in some ways the perfect crime, often attracting the interest of drug cartels and other organized crime. Laws are inadequate and enforcement is lax. Ridiculously low penalties are combined with immense profits.
The major fake drugs sold in developed countries are so-called life style drugs, such as Viagra. In contrast, the fake antimalarials, antibiotics, and anti-cancer drugs peddled in developing countries are a direct serious threat to health or even survival, and constitute a much more serious crime. An estimated 120,000 children in Sub-Saharan Africa died in 2013 because of ineffective fake antimalarial drugs. Sellers and manufacturers of these fakes should face serious penalties. Steps need to be taken to put in place technology to detect counterfeit drugs, including facilities for chemical analysis. Also needed are intelligence systems to detect the counterfeiters, and stricter laws and punishments to deter them.
In the meantime, let the buyer beware. It becomes critically important to avoid the temptation to purchase bargain drugs through the internet or through any other unreliable source, particularly if they are to be used to treat the sick.
Submitted by Roger Boe MD
1. Mackey, TKA et al. Counterfeit Drug Penetration into Global Legitimate medicine supply Chains. Am J. of Tropical medicine and Hygiene, 2015
2. Blackstone, E. A. et al: the health and Economic Effects of Counterfeit Drugs. Am health Drug Benefits, e014 June 7:216-224.