In order to effectively combat the problems related to counterfeit medicines, several companies have come up with innovative technologies to provide the necessary tools to manufacturers, healthcare professionals and patients to authenticate pharmaceutical products. These technologies can be broadly classified under two categories, namely Authentication Technologies and Track & Trace Technologies.
Authentication technologies are further sub-categorized into technologies that provide Overt security features and those that offer Covert features. Each category has its own set of advantages and disadvantages. Overt security features are basically security checkpoints that are meant for end users. Most of them are visible to the naked eye. Examples of technologies used in providing overt security features include holograms, colour shift inks / films, security graphics (special graphics included on the packing that are visible to the naked eye) and on-product markings (markings of logos or other designs done on tablets and capsules). Although these technologies provide an easy way to verify the authenticity of the product, counterfeiters are much more advanced and are capable of faking these features as well. There are a number of past instances where imitation products bearing proper overt security features have been seized.
Such disadvantages of overt security technologies can be overcome using certain covert security features. Examples of such technologies include DNA Taggants (a unique DNA tag used in the product / packaging that can be scanned using a designated instrument / equipment), invisible printing technologies, digital watermark technologies and hidden markers / print technologies. Such technologies have been shown to have highly secured features. However, the use of these technologies significantly add to the overall cost of the product, which patients are liable to pay. In addition, most of such technologies require special equipment for verification, which further adds to the expenses.
Track & Trace technologies constitute a separate segment in the anti-counterfeiting technologies market. Such technologies are designed to assign a unique identity to each stock unit during the manufacturing process. This unique identification (ID) then remains with the product throughout the supply chain, until it is consumed. The ID includes the details of the product (strength and dose), lot number, expiry date, name of the manufacturer, location of manufacture and other essential details. The information is stored in a database that can be accessed when required for verification by distributors, retailers and end users (in some cases), as well as manufacturers.
The Concept of Serialization
Serialization refers to a process where unique codes are assigned and incorporated onto the primary product packaging. The examples of unique codes used for such purposes include linear or 2-dimensional barcodes, human- readable combinations of letters / numbers or unique serialized codes that can be written onto an RFID tag or label. These unique codes are assigned and placed on each package using special printers, such as variable data printers, which are equipped with software that generates a unique code for each package and then prints it. These codes are then uploaded onto a database, where all information related to the product along with its corresponding unique identifier are stored. The database can be accessed by multiple parties, including distributors, pharmacies, government authorities, dispensers and even consumers, after the product has been sold. It is also worth mentioning that there are various kinds of serialization solutions; some of which facilitate consumer access to database whereas others do not.
As an industry, the focus seems to be divided between the use of authentication and serialization technologies; stakeholders view both as a challenge, as well as an opportunity to foster further innovation. Some stakeholders are of the opinion that authentication technologies are much more effective as anti-counterfeiting measures rather than just providing a unique number to each product, as is the case with serialization. On the other hand, serialization is being viewed as a one stop anti-counterfeiting solutions by many countries in the world. Various legislations have been enacted by the governments, making item level serialization a mandatory procedure with deadlines in the near future. Some of the countries include the US, the EU, China, India, Japan, Korea, Brazil, Turkey and Argentina.
Some examples of active players in the anti-counterfeiting technologies market include (in no specific order) AlpVision, Infratrac, Sproxil, Amcor, LinkSmart Technologies, mPedigree, SecureRF, Thermo Scientific, TruTag Technologies, Zebra Technologies, Avery Dennison, Ingenia Technology and Alien Technology. Though the focus on emerging markets has been relatively weak so far, manufacturing companies are expected to increase their attention to deploy anti-counterfeiting technologies for products being manufactured or intended to be launched in regions such as India, China, Mexico and Brazil. However, still there is a long way to go and collective efforts by the companies and government authorities are necessary.
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