The discovery of fake vials of cancer drug Avastin in the US has prompted a call by The Lancet for stronger international laws against counterfeiting.
The counterfeit vials of the Roche drug, distributed in the US medical system, contained various laboratory chemicals but no pharmaceuticals.
The case has revealed a complex supply chain involving wholesalers in the UK, Denmark and Switzerland, with a possible source in Egypt or Turkey.
According to the International Journal of Clinical Practice, such global supply chains have resulted in worldwide sales of counterfeit medications doubling between 2005 and 2010 to $75bn.
The Lancet has called for “a binding, international standard for criminalising the manufacture and distribution” of counterfeit drugs to be launched by the WHO and backed up with stronger regulatory oversight and control.
The MHRA, which is participating in the investigation, commented that the counterfeit vials had “incorrect expiry dates and fake batch numbers”.
The manufacture of the fake Avastin was not sophisticated: several organic chemicals were included, but no active pharmaceutical ingredients.
The opportunity for concealment lay in the existing global supply chain. MHRA has stated that the vials were supplied to the US market via a UK wholesaler, buying from a Danish wholesaler, buying from a Swiss wholesaler.
Beyond that, it has been claimed, there may have been an Egyptian supplier and possibly a Turkish source of the vials.
The case reflects the growing risk of counterfeiting to high-cost injectable drugs as well as to oral medications.
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