In this part of the document, the author discusses the currently available active technologies in the global marketplace for dealing with counterfeit and spurious drugs. This segment of the document is a continuation of Part I published earlier in Pharmabiz which described the general features to look when considering the adoption of an anti-counterfeiting technology.
The second general category of anti-counterfeiting solutions is referred to as the active technologies because they all require an active process during the act of verification. The application of the various technologies in this category begins with the insertion or placement of a special marker or device, which is known as a taggant, into or upon the branded product. In some instances, the taggant can be placed on the package whereas in others, it can be incorporated directly into the product itself. In all cases, the subsequent act of authenticating the product requires a specialized device, reader, or scanner. Each type of taggant described in this section can only be detected by its own specific reader.
Electromagnetic taggants (RFID)
The most commonly used and widely known of the active technologies is radio frequency identification, or RFID. These taggants rely on radio signals, which are emitted by an integrated chip or tag. The RFID tag itself can be placed anywhere within a package and in fact can be hidden because the emitted radio signals are able to penetrate through most materials. An RFID reader, which is a specialized instrument that detects the radio signals, can then be used to capture the information emitted by the tag.
The information in turn is then transmitted to a software system that coordinates all aspects of the RFID operation.
The major use of RFID to date has been in terms of supply chain management. Although the technology has been around since the 1960s, recent advancements in chip technology and miniaturization have made RFID a viable choice in a number of such settings. The American retail giant Wal-Mart adopted RFID as a supply chain management tool, which in turn required the many suppliers who covet their relationship with Wal-Mart to implement RFID in their supply chain operations as well. There are a number of other RFID applications that have been adopted, including its use as a discrete information reservoir in passports, electronic toll collection on some European highways, aviation maintenance and overhaul, and asset management in health care settings.
The RFID technology, however, has not broken through in terms of its use as a pure anti-counterfeiting tool in the pharmaceutical industry. To date, there is only one major example of RFID tags being applied at the product level, that being a pilot project on an expensive drug that has been a severe target of counterfeiting. Nevertheless, the RFID industry has undertaken major efforts to promote this technology as a valid anti-counterfeiting solution.
The major advantages of RFID relate to its wireless nature. The tags do not require line-of-sight or any direct human intervention in order to capture the digital information. As a result, RFID tags can be hidden in packages so as to provide a greater level of security. Furthermore, the tags can be read from a considerable distance, usually many metres, making it much easier to undertake roaming data capture. The tags can also be read rapidly in bulk, which is ideal for high-throughout supply chain tracking. And finally, RFID tags can contain significant amounts of information related to the product itself. In some cases, the reader can even write information directly to the tags, thereby making the RFID technology bi-directional in nature.
There are, however, a number of major disadvantages to the use of RFID as an anti-counterfeiting tool, which have been collectively responsible for its poor uptake in global markets. The principal factors are cost, reliability, and privacy. The greatest burden to adopting RFID is a financial one. The cost of the tags can vary depending on volume but are generally quite high, which eliminates its use at the product level except for truly expensive brands . In addition to the tag cost, companies intending to adopt RFID must allocate very large sums for infrastructure development and implementation, making the capital investment requirement extremely burdensome. The second factor inhibiting RFID use is reliability, primarily due to reading errors. The problem with error rates comes down to physics. Radio waves are easily deflected or impeded by metals and liquids. It is therefore difficult to predict how radio signals will be bounced around inside a pallet or carton of goods. Estimates on error rates vary from study to study, but values in the range of 2.5% to 25% failure rate have been reported. And finally, major concerns have been expressed by privacy advocates who believe that RFID has the potential to capture personal information and thereby represents a larger problem for society. For example, if RFID should become widely adopted, then it is conceivable that a retailer can gather all sorts of information from any RFID tags that the consumer may have on them in addition to the products about to be purchased. This issue has raised considerable alarm among privacy advocates and in some cases has led to public protests against the deployment of RFID. The concern is not just with the tags themselves but that the mere use of an
RFID reader can allow someone to gather considerable personal information due to the wireless nature of the technology.
Forensic taggants
The second group of active technologies encompasses a variety of different solutions, some of which are truly cutting-edge in nature. There is a large range of technologies that fall into this category, all of them requiring either laboratory testing or use of dedicated field test kits or specialized readers to prove authenticity. It is for this reason that this group of technologies belongs in the category of active taggants. Forensic taggants have the common property of imparting a unique fingerprint to each product and for this reason, they provide an extremely strong forensic platform. The difference between the various technologies lies in the scientific methodology required for authentication.
Optical taggants
The simplest form of optical taggants use inks or dyes that are invisible under ordinary conditions but become visible with the use of a special filter or light source. An example is ultra-violet ink, which becomes visible when the product is illuminated by a UV source, causing the ink to radiate in the visible spectrum. The more robust optical taggants employ specific formulations of rare light-emitting chemicals that produce a complex spectral signature when illuminated by light of a specific colour and intensity. The spectral signature can be custom developed for each branded product and therefore the emitted light signal can be used for authentication purposes.
The light signature itself is detected by a scanner-decoder that is customized for detecting the spectral signature in field or laboratory applications.
Chemical taggants
These technologies use a chemical marker that is applied either to a label or directly into the product itself. In terms of the latter, there exist a variety of inert compounds that can be added in trace quantities to medicines. In some cases, the detection process is more sophisticated because it involves spectrographic or chromatographic analysis in a laboratory setting.
It is, however, possible to embed certain kinds of chemical taggants whose presence can be identified with a portable detector in the field. A variety of chemical products can be used as taggants, including inert resins, mild isotopes, and DNA fragments. The use of DNA fragments is a particularly intriguing method because it brings to bear cutting-edge molecular technology into the forensics arena. Either the product package itself or the ink used in the printing of a label can be laced with a unique DNA code that is virtually impossible to replicate. The absence of the DNA fingerprint provides significant forensic evidence to identify the product as being a counterfeit, whereas the presence of the DNA fragment provides confirmation of product authenticity.
Micro-particle taggants (nanotaggants)
Nanotaggants are microscopic particles containing coded information that can uniquely identify each branded product. The nanoscale markers are incorporated into the product or its packaging, which then exhibit distinctive properties that can be captured by way of a specialized reader. These unique properties provide forensic evidence for product authenticity and can also be used in terms of supply chain operations because each product is microscopically encoded.
Review of forensic taggants
The advantage that the various types of forensic taggants offer is that they serve as extremely robust platforms for identifying fake products. These are generally high-technology offerings and therefore extremely secure against duplication. The disadvantages relate to the fact that each of the different types of solutions are licensed technologies, and therefore limited to one source. As a result, the forensic technologies described here come at significant cost. And finally, the major restriction to these technologies is that they all require either laboratory analysis or specialized readers. Consequently, none of these technologies provide consumer empowerment because an ordinary customer will not have one of these readers, which are also generally quite expensive.
Note
This document is continued in another part which discusses the third general category of anti-counterfeiting solutions which encompass technologies that encode individual branded products in an overt digital manner.