Counterfeit drugs: why on-dose authentication offers the most viable solution (part I)
Leading excipient and film coating manufacturer Colorcon has developed a solution to help in the fight against fake drugs through the inclusion of taggants embedded onto individual pills … and the use of smart readers to track and verify branded/authentic products
By Kevin Robinson 14-Dec-2020
The issue of counterfeit drugs is moving higher up the pharmaceutical agenda owing to COVID-19; the ongoing pandemic is massively increasing the rate of online drug sales through illegal websites.
In the UK, for example, the problem will only get worse when we leave the EU and the Falsified Medicines Directive ceases to apply. Manufacturing Chemist’s Dr Kevin Robinson caught up with Colorcon’s Chief Scientific Officer, Dr Ali Rajabi-Siahboomi, and Global Product Authentication Lead, Gary Pond, to discuss the latest developments.
KSR: Wasn’t the serialisation and widespread implementation of track and trace legislation, which is now in place around the globe, intended to combat the problem of counterfeit drugs?
ARS: Manufacturing companies have put huge resources into meeting the legal requirements for serialisation and have seen benefits in terms of track and trace, but the supply of counterfeit drugs continues to rise.
KSR: In the case of DNA, how stable is it, for how long and in what conditions?
ARS: DNA molecules are proteins and their sensitivity to environmental conditions is well understood. There’s a large amount of data that demonstrates the stability of DNA for very long periods, and DNA technology has been used for many years in courts of law for legal cases.
We’ve tested coated tablets to demonstrate that the detectability and integrity of the DNA remain consistent throughout the shelf-life of the product and we have supporting data to confirm that standard manufacturing procedures don’t damage the DNA.
Also, we have developed know-how around the application process and cleaning procedures to ensure that no residues of DNA taggants are left, which could contaminate the next product in manufacturing lines. The same goes for the silica taggants, which are equally stable throughout a typical manufacturing process.
