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Identifying counterfeit medicines with industry-suitable technologies


Author:GMP Platform


When looking at the product security market, there are over 200 security technologies (holograms, digital watermarks, DNA taggants, serialization, etc.) used to combat counterfeiting of primary or secondary packaging and of solid or flexible components, such as liquids, powders and tablets. For a branded pharmaceutical manufacturing company, it is however challenging to understand the scope and role of each of these technologies, especially when considering the cost of the technology feature itself and its nationwide or worldwide deployment. This paper hopes to shed light on the latest pharmaceutical anti-counterfeit technology developments and describe different criteria which will help readers select those that best safeguard public safety and the integrity of valuable pharmaceutical brands and products.


Identification and authentication: two problems that require adapted solutions

The original goal of batch or individual serialization was a means to identify and recall medicines with manufacturing or distribution problems. Although integral to patient safety, trying to change the primary purpose of serialization into an authentication process is problematic. Logistically speaking, this technology forces pharmaceutical companies to print a visible linear bar code on the packaging or label, which can sometimes be difficult given the variable size of the printable area and the code/substrate contrast. In addition, inspections and controls must be in place to ensure that a unique code is applied on each individual pack or label. Moreover, serialization requires adaptive hardware, software and skills.


In the case of authentication, there are many security features available to brand owners and manufacturers capable of detecting counterfeits, not only with primary and secondary packaging, but also with dosage forms. The most efficient features are covert, or invisible to the naked eye. According to the World Health Organization, "The purpose of a covert feature is to enable the brand owner to identify a counterfeited product. The general public will not be aware of its presence nor have the means to verify it" (2). These secret or covert procedures are widely available today and include invisible printing, embedded images, and digital watermarks, to name a few. These methods can help detect counterfeits by means of regular sample controls carried out at different points in the supply chain, even in the case of consumed or recovered packaging waste.


Some methods combine a human visual inspection with a device, such as the Raman Spectroscopy analyzer, which is capable of analyzing raw materials in medicinal and finished products, then comparing them with the analysis result of the correct chemical combination stored in the device. However, this device may cost dozens of thousands of Dollars and require some training to properly manipulate. In addition, only a few analyzers are generally available within a given company at a given time, forcing the manufacturer to send the suspected product to a dedicated lab.


Other more cost-effective, yet reliable technologies involve embedding an invisible marking on primary and secondary packaging using regular visible ink and standard printing processes, without having to change the packaging design or flow of production (3). Another option involves using the intrinsic micro-differences present in a cavity mold (4) commonly used to create vials or medicine containers, capturing an image of the random pattern, and then storing it in a database (5). In either case, the brand owner or manufacturer simply scans the item using a flatbed office scanner or an iPhone4 smartphone to receive a "genuine-or-fake" outcome.



Figure 1: Details of a molded closure of a medicine jar showing microscopic differences irregularities generated by the die cavity used to produce the part.


As a consequence, while serialization may be appropriate to identify basic fraudulent actions, such as extension of the expiration date or market diversion, it is not suitable to determine the authenticity of a medicine. As we can see, checking a batch of drugs not equipped with reliable authentication features could prove costly, sometimes requiring a chemical analysis of the substance in question. Using industry-suitable invisible authentication security technologies instead can therefore help increase the number of controls at a very low cost and prevent the introduction of falsified medicine into the legal supply chain.


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