The pharmaceutical industry supply chain has always been a prime target for counterfeiters and suppliers of substandard and adulterated products. One of the most serious incidents in the past decade was the contamination of raw heparin stock, which is derived from pigs’ intestines, imported from China. This caused many deaths and led to a major recall of the injectable anticoagulant by the US Food and Drug Administration (FDA) and other authorities in Europe, Australia and New Zealand.
The heparin contaminant was identified as an ‘over-sulphated’ derivative of chondroitin sulfate, a closely related substance obtained from mammal or fish cartilage and often used as a treatment for arthritis. Since over-sulphated chondroitin is not a naturally occurring molecule, costs a fraction of true heparin starting material, and mimics the in vitro properties of heparin, the contamination was almost certainly intentional rather than an accidental lapse in manufacturing. The motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China. Further investigation led to the facility of Baxter’s Chinese heparin supplier, Changzhou SPL.
Concerns about pharmaceutical supply chain security have since given rise to a number of voluntary schemes, such as Rx-360 and Excipact, as well as national legislation and the European Union’s Falsified Medicines Directive, requiring serialisation of all drug products from point of manufacture to point of use.
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