World Health Organization Statistics on Counterfeiting Worldwide

As reported in our last blog post, most experts agree (including the Chairman of Sanofi-Aventis) that the incidents of drug counterfeiting and adulterations are:

a) completely under reported
b) significantly on the rise

Just to put this into perspective, the following are the statistics from the World Health Organization on the Prevalence of Counterfeit Drugs in the West and the Developing World. These statistics represent WHO's 2006 estimates as to the percentage of counterfeit or adulterated drugs within that country or regions total drug supply chain.

• United States, less than 1%


• United Kingdom, less than 1%


• Europe, less than 1%, some estimate percentages as high as 10%


• Nigeria, 16%


• Kenya, 30%


• Lebanon, 35%


• Cambodia, 13%


• China, 8% on OTC medications


• India, 10-20%


• Indonesia, 25%


• Russia, 10%


• Former Soviet Republics, 20%


• Colombia, 5%


• Mexico, 10%


• Peru, 15-20%


• Venezuela, 25%

Realize that these numbers are all presumed to be very low and many of the percentages may have nearly doubled since 2006. Consider the tainted Heparin as a good example of the rise of counterfeit, adulterated or otherwise tainted drugs within the United States and other developed countries in 2008. Even the United States figure of less than 1% equals many billions of dollars in undetected counterfeit medications within our drug supply.

Most importantly realize that now, in the era of a Global Pharmaceutical Supply Chain that many drugs that are being imported into the United States and other developed countries now owe their source of raw materials, production and packaging to less developed countries like India, China and other countries whose pharmaceutical supply chain is riddled with counterfeit and adulterated medications.

Encourage your lawmakers and dispensers of medications to demand an authentication technology to double check the pharmaceuticals that your family consumes. Authentication of the pharmaceuticals is the only answer to properly knowing that the drugs you and your family are taking to maintain their health are not in fact harming them instead.

Current initiatives that are being debated in Washington and other regulatory agencies are almost exclusively centered on track and trace technologies that do not authenticate the drug. All the Heparin that has to date caused over 149 deaths in the United States all had a perfect pedigree and would have passed as authentic with track and trace technology.

Drug Safety Responsibility– For whom does the finger point?

The recent heparin recalls have left consumers fuming and pointing fingers at those who were supposedly protecting them from harm. With a difficult past year in both tainted food and medical products – this was the last straw.

But in reality, most in the industry knew the FDA was woefully understaffed and unequipped to cope with the expansion of global inspections required to guarantee the safety of our food and drug supply. Finally this week in answer to Pennsylvania Senator Arlen Spector’s request, FDA commission Andrew C. von Eschenbach asked congress for $275 million as an immediate budget submission. Increased funds will be use to increase inspections, modernize their science and staff, and upgrade their laboratory facilities.

Julie Zawisza, an F.D.A. spokeswoman said “These resources will accelerate the changes required for F.D.A. to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical product.”

One might asked, how could we let it get to this point? How indeed! The pharmaceutical industry has a history of relying of reactive testing, specific to the particular contaminant or variance they are guarding against. However, modern day protection requires a more proactive approach – a verification of the whole and an assurance against those criminal minds that can fool testing with traces of authentic material mixed in with the altered substance.

To further this point, we must have testing down the chain as well. As the saying goes, “Test Often, and Test Late!” The closer to consumer that authenticity testing is done, the more you are sure the consumer is receiving the “True Goods”. Too often each company points to the other on whose responsibility it is too safeguard the product.

Now it is the consumer who is doing the pointing and he or she is pointing at us all!