In this part of the document, the author discusses the third general category of anti-counterfeiting solutions which encompass technologies that encode individual branded products in an overt digital manner. This segment of the document is a continuation of the currently available active technologies in the global marketplace for dealing with counterfeit and spurious drugs published in an earlier article.
The third general category of anti-counterfeiting solutions encompass those technologies that encode individual branded products in an overt digital manner. The digital information can appear on a product as a human-readable code (i.e., alphanumeric script) and in terms of a barcode, such as the traditional linear format or the new generation of 2D barcodes (DataMatrix). The barcode technology is discussed first, followed by two methods for generating and processing the digital information. The core foundation of all of these technologies is that individually coded items can help combat counterfeiting because only genuine products will have a valid code. Furthermore, encoded products can be supported by enterprise software solutions that permit product tracking through the various nodes in the supply chain operation and therefore provide an electronic trace of the product’s movement, which is becoming increasingly mandated by regulatory authorities.
Barcode application
A barcode is an optical machine-readable representation of data whose technological origins can be traced back to the 1930s but adopted in mass retail settings only by the 1970s. Since then, this technology has developed into and maintained an overwhelming presence with regard to digital coding of consumer products. Virtually every purchasable item now contains a barcode. The most commonly used barcodes are the linear or 1D (one-dimensional) pattern of lines. The coding system that is widely used, the so-called Universal Product Code (UPC), maps the data contained in the barcode to a standardized system of information representation. The data in a linear barcode can be captured by a wide variety of scanners, from high-throughput laser scanners used by many retail outfits to simple and cheap hand-held scanners. The digitized information is supported by back-end software for product identification purposes, supply chain management, asset tracking, inventory management, and various other functions that can be tailored to the needs of an individual client.
A new generation of barcodes has been recently developed that provide a 2-dimensional (2D) way of representing information. The biggest advantage to the 2D barcode technology is that much greater information can be encoded within a single barcode. Furthermore, linear barcodes depend on links to a larger database whereas 2D barcodes can contain a mini-database themselves, and therefore encode much greater information on the product.
The many benefits that 2D barcodes offer have led them to now become the default standard in many countries. The 2D barcode technology has now surpassed RFID as the most prominent track & trace technology for pharmaceutical applications. Although the US FDA has thus far not offered a preference, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has clearly come down on the side of 2D barcode. The results of a comprehensive study led them to announce their support in 2007 for a pan-European and industry-wide solution in which every medicinal product will contain a 2D barcode, ”instead of the less reliable and more expensive RFID”.
The advantages to using barcode application relate to the fact that this is a well-proven technology that has been in use for many decades and therefore enjoys substantial confidence in the retail marketplace. Furthermore, the cost is astonishingly low compared to all other technologies discussed thus far. For example, 2D barcodes offer similar functionalities to RFID at only a fraction of the cost. However, the real excitement in this field is being generated by the recent emergence of mobile decoders that allow consumers to actually use their mobile phones as a scanner for 2D barcodes. Some phone makers are already bundling their mobile phones with scanning software that decodes the 2D barcode image captured by the phone’s built-in camera. This new development allows consumers to directly interact with the codes and obtain immediate validation, which is just one example of a host of other exciting possibilities [20]. For example, all products sold in Japan are now tagged with 2D barcodes that allow consumers to validate their purchase and obtain important product information, such as the freshness of vegetables, the expiry date of medicines, and even to download memorable photos of a deceased person from the 2D barcode on a tombstone. The fast pace of mobile technology development makes it highly likely that such consumer convenience and empowerment will soon be available in all markets.
The one drawback to all barcode technologies is that they were not originally developed for anti-counterfeiting applications, but rather as an inventory and supply chain management tool. As a result, a robust system of encoding products for authentication and brand protection via a universal standard was never put in place. This was not an oversight but reflected the fact that linear barcodes were simply limited in terms of their information capacity. The development of 2D barcodes, however, has now paved the way for their use as an anti-counterfeiting tool. In this regard, two new technologies have emerged that take advantage of the power of 2D barcodes and the rapid growth and sophistication of mobile telephony. These new technologies, which are referred to as mass serialization and mass encryption, are discussed in the next two subsections, respectively.
Digital mass serialization (DMS)
Digital mass serialization (henceforth referred to as DMS) is the process by which a unique number or code is assigned to each product sold in the retail marketplace. The code itself is similar in nature to serial numbers found on many products. It can be generated in a random, pseudo-random, or sequential manner. Once a batch of codes is generated, it is transferred to the pharmaceutical company so that they can be printed directly on the packages during the production process. Alternatively, the code itself can be pre-printed on a label and then affixed to the product in a manner similar to a hologram or security seal. DMS technologies can therefore be bundled with any of the other passive technologies to offer additional levels of security as well as ease of visual confirmation by the consumer.
The process by which DMS works is the following. Once the technology provider generates a code, it is entered into a database that can be used later at the verification stage. The database itself is managed and maintained either by the technology provider or the brand owner. The code is printed in human-readable form as well as a 2D barcode directly on the product or on a label. The codes themselves can be numeric, alphabetical, or alpha-numeric in nature. The consumer can visually read the printed script code whereas a barcode scanner can capture the 2D barcode. The emergence of mobile phones with barcode scanners now allows consumers to even use their mobile phones to directly read the 2D barcode.
The authentication process involves matching the unique code on a product to those stored in the database. If the code is present in the database, then it is deemed to be authentic and so is the product. Several DMS providers have bundled this technology with their own SMS short-code number. Thus, all the consumer has to do to authenticate a product is to enter the code in the SMS field, send it to the short-code number, and then wait for the verification message, which usually arrives in a matter of seconds. The message will either provide confirmation of the product’s authenticity or raise a flag if the code is not found in the database. The cumbersome act of manually entering the code in an SMS field can be bypassed with those phones containing barcode readers. In this case, the consumer simply takes a picture of the 2D barcode, which then automatically sends the code either as an SMS or through mobile internet to the DMS technology provider for verification. In some instances, brand owners may wish to incorporate toll-free SMS or call-in numbers to allow verification, thereby preventing customers from having to bear any mobile charges for the authentication process.
The major advancement that DMS technology brings to anti-counterfeiting efforts is that it directly empowers consumers to verify a medical product. As a result, a very large independent field force is automatically recruited by brand owners to supplement their own direct vigilance of the marketplace. In terms of the latter, security officers can roam around with hand-held professional-grade barcode readers for rapid capture and verification of coded products. The twin aspects of consumer and professional vigilance provide immense deterrence because retailers who are involved in the sale of counterfeit goods will know that interdiction probability has suddenly become very high. Brand owners can implement a toll-free number, which consumers would use to tip off any failed verifications that can then be followed up by the company’s own sales force, security officers, or a private agency. A well-designed DMS system, however, will itself flag any failed authentication efforts and communicate this information to the brand owner, along with the date, time, place, and mobile number of the consumer who had made the verification attempt.
DMS offers a number of other important advantages that have led to acclaim by independent reviewers as well as regulatory agencies. Although these advantages are equally applicable to both the FMCG and pharmaceutical sectors, it is the latter where the urgency to implement DMS solutions has been especially vocal, leading a number of European countries to ensure that it is soon applied to their drug supply chain. A recent Frost & Sullivan report for the European pharmaceutical industry outlines the many advantages to using 2D barcodes and DMS as a supply chain management and anti-counterfeiting tool. The European move follows on the heels of an earlier opinion by the US FDA to implement DMS, either by way of RFID or 2D barcoding. The 2004 FDA report on anti-counterfeiting was especially prescient in remarking that ‘use of mass serialization to uniquely identify all drug products intended for use in the United States is the single most powerful tool available to secure the US drug supply.
The major disadvantage to the DMS technology concerns the operational characteristics and security of the database containing the serial codes. It is well known that the larger a database becomes, the greater the time needed to find an individual item within it. Thus, a database containing hundreds of millions (or even billions) of codes for a major brand owner’s annual drug production requirements becomes problematic in terms of database management and speed optimization. In such instances, the brand owner will have no choice but to adopt extremely high-end database software systems. Although these are extremely well-suited for the purpose, the annual licensing cost and employment of dedicated IT personnel with database systems experience can add significantly to the cost of the solution.
A related problem concerns database security. There are numerous examples in which even the most protected databases have been successfully hacked and information stolen. Although database files are usually maintained in an encrypted form, the fact that the databases of even major credit companies and defense agencies have been successfully intruded shows the limitations of file protection strategies . And finally, the security breach can be an internal one as well. Given the high level of mobility among IT employees in most regions, it is quite conceivable that a disgruntled database specialist can cause severe harm to a brand owner upon leaving the firm through malicious tampering or outright theft of the serial codes. The outcome of such a malicious act by a single person could be devastating to the brand owner due to the fact that all its coded products may no longer be verifiable in the marketplace, leading to a nightmare public relations scenario.
Digital mass encryption (DME)
Digital mass encryption (henceforth referred to as DME) is similar to DMS in all respects except for one major difference — the DME technology does not operate on a database system. As such, it offers all the advantages of DMS that were discussed in the last section but avoids its major drawbacks—requirement for database management, verification bottleneck at high volumes, and data security. DME can therefore be considered to be a more advanced and highly secure version of DMS. The DME solution is being separately described here because the core technology through which the codes are created and authenticated is fundamentally different from DMS.
Whereas serialized codes are generally created by random number generators, encrypted codes are produced by a cryptographic algorithm. The DME algorithm is also responsible for the decoding process involved in the authentication step.
Consequently, no database is ever created or required, either by the technology provider or the brand owner. The encrypted alphanumeric code is unique, unpredictable, and non-repetitive for eternity. The code can be used not only for authentication (anti-counterfeiting) purposes but also for hierarchical tracing in a complex supply chain operation. As such, DME is fully compliant with all regulatory standards, including the emerging e-pedigree requirements for pharmaceutical products in some countries .
The recent availability of DME in India, for example, has been met with significant interest by the pharmaceutical industry and mainstream media The DME code itself can be used by anyone with a mobile phone to authenticate the product at the point of sale, either through SMS or by way of mobile internet. The bounceback message provides verification on the authenticity of the product, as well as any other information that the brand owner wishes to transmit to the consumer (e.g., expiry date, MRP, usage cautions, etc). The additional benefits of this direct-to-consumer interaction includes notification of new product launch, a feature that may be especially valuable to pharmaceutical companies with OTC products, as well as obtaining market intelligence on sales by brand, region, or even retailer. The communication aspects of this technology can also be of significant importance in the event of a recall since it allows highest degree of granularity, i.e., right now to the consumer level.
The operational aspects of the DME technology are otherwise similar to those of DMS. The code itself is typically valid for only one authentication. Multiple authentications attempts of the same code will raise an alert. This allowance denies the ability of a counterfeiter to copy one valid code and apply it onto many fake products as a means of trying to bypass the DME system. Multiple failed authentications of the same code will raise a flag and when confirmation is made that a particular code has been duplicated on fake products, that code itself serves as a tag by which the fake products can be identified. In such instances, consumers are directly warned that the product is fake and that they should report this case along with other pertinent information to the brand owner (or its appointed security agency). The ability to actually identify fake products in the marketplace and directly warn consumers is a twist of fate that was likely unknown to the counterfeiter.
Note
This document is continued in another part, which contains a comparison of the different anti-counterfeiting technologies, including their strengths and weaknesses.