Pharmaceutical Packaging

How to Fight Pharmaceutical Counterfeiting

06/17/2013 | Author / Editor: Dr. Jérôme Freissmuth / Dominik Stephan

Each pharmaceutical pack must be equipped with a batch number and expiry date. In future, a machine readable code such as a data matrix code with a serial number must be additionally printed onto each pack. The serial number at the package level is one of the most important strategies laid down in recent guidance and legislations. (Picture: Bosch Packaging Technology)

Counterfeiters are increasingly targeting the pharmaceutical supply chain – a dangerous trend that can have fatal consequences. All supply chain players can contribute to increased safety, from producers of Active Pharmaceutical Ingredients (APIs) to packagers and equipment manufacturers, supported by numerous initiatives and legislative efforts.

Counterfeit pharmaceuticals are those that have arrived on the market as licensed drugs without having passed through the official channels. In such cases, the counterfeit drugs may contain wrong or any active ingredient or the correct active ingredient in an incorrect quantity.

The bestcase scenario may find a drug becoming ineffective and in the worst case, fatalities may occur if the illegitimately made drugs do not have the desired effect. Counterfeiters not only manufacture imitations of prescription-only drugs, but also over-thecounter (OTC) products, generics, originator products and traditional drugs.

New Distribution Channels

The World Health Organization (WHO) estimates that every second pharmaceutical product purchased via the Internet is counterfeit. Anabolic drugs and potency pills range among the most frequently ordered products. Apart from these so-called lifestyle medicines, more and more prescription drugs like antibiotics and medicines for cancer treatment are sold by online pharmacies. A study conducted by the European Alliance for Safe Medicines (EAASM) found that in 90.3 per cent of all cases, no prescription was required for the online purchase of prescription-only drugs.

More than 50 per cent of medicines purchased from illegal websites concealing their physical address have been found to be counterfeit. But the Internet is not the only channel by which counterfeits enter the market. The pharmaceutical wholesalers too are targeted by counterfeiters. By introducing large quantities of falsified medicines into the legal supply chain, lucrative transactions are made in a very short time. This depends strongly on the geographical area. For example, in most of Europe, the amount of falsified medicine is estimated at approximately one per cent, while the developing world sees figures up to 50 per cent of counterfeit pharmaceuticals.