The Real Thing - Copies, fakes and imitations pose a problem for nearly every segment of industry. Counterfeiting is booming. Imitations are not just a problem for consumers. Wholesalers and retailers as well are often victimized by sophisticated organized crime networks that produce and distribute counterfeit products.

A few industries have already set up organizations to combat product counterfeiting. The pharmaceutical industry is one of them. Few counterfeit products can have such serious consequences for consumers as imitation pharmaceuticals. Quite apart from the financial losses incurred by the companies involved, counterfeit drugs represent a danger to consumer health. The list of risks includes inefficacy, harmful substances and over or under dosage of the active ingredients.

The World Health Organization (WHO) has created the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which is attempting to bring nations together in an effort to stop the production, trade and sales of imitation pharmaceuticals. One task force working group is looking specifically at international standardization of product marking. Until uniform worldwide standards are in place, marking technology suppliers are being asked to come up with anti-counterfeiting strategies.

Existing Identification Techniques

As is the case with any other commercial item, identification features on pharmaceuticals are used for product authentication and to deter counterfeiters. Identification methods that are difficult to reproduce create enormous difficulties for imitators, and the costs involved in making copies are considerable.

There is a wide variety of identification techniques, from very simple to high-tech. Identification features can be added in different places including various parts of the packaging or on the product itself. Anti-counterfeit identification technology is divided into three main categories:

• Overt (open/visible) technologies
• Covert (hidden) technologies
• Forensic techniques

Overt marking provides basic product identification information for consumers, knowledgeable professionals and customs agents. It is generally highly visible on the product. In the case of pharmaceuticals, the marking is applied to the vial or folding carton, and imitating it is difficult and costly. Examples include holograms, which may contain customer-specific designs. Optional hidden features that are admissible as evidence in court provide added counterfeit protection.

Color shift ink as well as security ink and foil that change color depending on the viewing angle belong in this category. The ink and pigments are available only from certain manufacturers, which is an additional security aspect.

Marking on the product itself, for example a tablet, is an overt technique. It provides a certain level of security, because imitating tablet dies is costly and time consuming. In addition, color shift ink can be applied directly to products such as coated tablets to produce changing colors. This provides protection against product substitution later on. Slanted corners or similar features can be added to the packaging to differentiate it from standard versions.

Security graphics created by printing fine lines, micro text or images similar to what you see on banknotes combine overt and covert design features such as guilloches, grids and line embossing. Printed using standard offset lithography, they may be used as a background or placed in a less conspicuous location. Overt features provide protection, however, only if dealers or consumers are aware of their significance.

Partially hidden markings straddle the boundary between overt and covert technologies. Examples include thermo-reactive printing that changes color as a function of temperature. Pressing a finger on the color field is sufficient for immediate authentication.

Hidden Product Validation Identification

Hidden markers are used among other things to enable brand owners to identify counterfeit products and remove them from circulation. Only the manufacturer should know the exact details of the markings. Consumers either do not notice them or are unable to verify their authenticity.
This marking category includes such things as printing with invisible ink, which can be applied to virtually any product or packaging.

The printing is visible under UV or infrared light and may fluoresce at different wavelengths and in different colors. Invisible images, which appear only when a special filter is used, can also be produced. Other options include the use of special fluorescent fibers, watermarks, metal threads, scents or chemical reagents in the product packaging. The printing can also be designed in such a way that it cannot be copied.

Application of digital watermarks is one of the more complex methods. To verify authenticity, readers and special software are used to recover data that is digitally encoded in the watermarks. Laser coding is also complex and cost intensive, but that is precisely what makes it a very secure type of anti-counterfeit identification.

High-Tech Methods Provide Almost Total Security

Strictly speaking, forensic identification belongs to the covert category. Special equipment is needed to detect the markers, which are not visible to the naked eye and cannot be found using simple analysis techniques.

This category includes various types of taggants. Chemical taggants and marking with isotopes in defined ratios, which can only be detected with highly specialized reaction and analysis techniques, are one example. Biological and DNA taggants are another possibility. Minute amounts added to the product formulation or packaging are sufficient for identification. Highly sophisticated analysis equipment is needed to detect these substances. Forensic markers such as micro taggants made of microscopic particles or threads that contain encoded information require an equal amount of effort to detect.

These markers are very effective, but they are also very expensive; and consumers are not aware of them. They are primarily intended for extremely expensive pharmaceuticals and high-end products that counterfeiters often target. When imitators are at work, an effective method is needed to remove imitations from circulation.

Rather than relying on just one type of identification, a combination of different overt and covert technologies is often used. To make life as difficult as possible for counterfeiters, manufacturers do not reveal which methods they are using.

Traceability at Any Point in the Supply Chain

Track and trace techniques have been used for years to mark or serialize products to ensure authenticity and provide traceability of batches and packages as they pass through the distribution channel.

Despite, or perhaps because of, the fact that these methods have been in use for so long, there is as yet no standardized worldwide approach to documentation. One simple solution is autonomous recording of product movements at each point in the supply chain. Electronic pedigree systems are another option.

Serial numbers are passed along the supply chain, creating a distributed database containing electronic proof of origin. When complete end-to-end verification is implemented, each segment of the supply chain has an obligation to forward the product codes to a central server. The location of every product can then be determined no matter where it is, and the movement of goods can be traced after the fact using information available at a central location.

Whatever the method, every product must have a unique identifier, e.g. product name, batch number and possibly the expiration date. Additional product details, for example the distribution channel, can be included when the encoding is more complex. Making the coding or serialization more specific (e.g., pallets, cartons or individual packages) enhances the security of product authentication.

Identification Techniques

A number of identification techniques provides varying degrees of anti-counterfeiting protection: barcodes, 2D codes, RFID tags.

Linear barcodes have a proven track record, and they have been in use worldwide for many years. However, they can store only a limited amount of information, and they are hardly suitable for product individualization. As a general rule, they should have a certain minimum height.

A number of different printing techniques are available for applying them to the product or packaging. Manufacturers are free to define their own barcodes, but ISO/IEC 15420 defines commercial barcodes such as European Article Number (EAN) and Universal Product Code (UPC), which ensure unique product identification worldwide. There are other forms of barcoding besides commercial barcodes such as Code 39, which is commonly used in industry, and 2/5 Interleaved, which packs a large number of digits into a small space to increase information density.

The information density of 2D codes is even higher. Information is encoded in stacked barcodes, a rectangular matrix made up of individual pixels (e.g., QR codes), or circular barcodes (e.g., ShotCodes). Matrix codes in particular are used worldwide, and they can be scanned with CCD cameras. Nevertheless, matrix codes are not standardized either. Quick-response (QR) codes are very popular in Japan, whereas data matrix codes as defined in ISO/IEC 16022 are more widely used in Europe and the U.S. Other manufacturer-specific versions such as the UPS MaxiCode are also not uncommon. However, there are fewer matrix code versions compared with barcodes.

For that reason and also because of the higher information density, matrix codes are more suitable for international product identification that is standardized, unique and traceable. As an added security feature, any type of barcode or 2D code can be printed in invisible ink on the product or packaging.

RFID (radio-frequency identification) works with transponders. Special readers extract the information and may write data back depending on the version. Printing techniques that are now available for producing the transponders make them much less expensive than they were just a few years ago. Nevertheless, they are still relatively expensive compared with barcodes and 2D codes. The equipment needed to read out the information is also generally more expensive than barcode scanners, etc.

The tags consist of a microchip, an antenna and a substrate or enclosure. They may also require a power source depending on the design. State-of-the-art RFID tags can send encrypted data to the reader as an added security feature. In contrast to barcodes and 2D codes, visual contact is not necessary to read the data. The tags can be located inside sealed packaging for added product protection. However, RFID tags are not standardized worldwide, and operating frequencies may vary.

In addition to the traceability aspect, track and trace also helps to identify weaknesses in the logistics chain. Cost can be eliminated by increasing the efficiency of the distribution channel.

No Agreed Method for Identifying Pharmaceuticals

The FDA already recommends the use of RFID tags, at least for identification of pharmaceuticals. The experts at IMPACT also see considerable potential in RFID technology. However, until the technology has reached a sufficient stage of maturity, they currently favor 2D codes, which have a proven track record.

The European Union is working on standardized identification for pharmaceuticals. Directive 2011/62/EU of the European Parliament and the Council defines the information that must appear on the outer packaging of pharmaceuticals, which in the future will have to have certain security features that allow verification of the product's authenticity and prevent manipulation of the packaging. 2D codes are regarded as the most likely method of identification. Information such as a unique, randomized serial number, batch identifier, expiration date and Pharmacy Product Number (PPN) could be stored in the code.

After the test phase for technical implementation of product serialization, which has been under way since December 2010, mandatory security features will be introduced in 2015. Matrix codes and a central database will provide the foundation for end-to-end verification. The extent to which consumers will be involved in the verification process is not yet clear. In any case, state-of-the-art communication devices such as smart phones give consumers new ways of detecting counterfeit products.

Packaging as an Additional Security Factor

Apart from specific identification techniques, there are other ways of making secure packaging. Besides the methods discussed above, the list of options includes sealing labels and adhesive strips that prevent tampering or provide evidence that the packaging has been opened. These items can also be used as warranty seals, security labels or asset labels.
Labels can also help prevent counterfeiting. The adhesive, for example, can contain micro particles and fragrances that are detectable after the label is opened. This, however, requires special equipment, and as a result these techniques are not very widespread.

Void labels are much more common. They are made so that lettering such as the word "Void" appears on the label and also on the product when the safety label is removed, and the label will no longer adhere. The text can be customized to include the batch number or expiration date. It is readily apparent when packaging has already been opened. Polyester security film is based on the same principle. A pattern appears when the film is removed, and the film will no longer adhere. Any tampering becomes obvious when the film is removed.

"Destructible" foil can also be used to provide evidence that the packaging has been opened. The foil cannot be totally removed. Security perforation is based on a similar principle. The label tears along the perforation when any attempt is made to remove it.

Numbered labels provide enhanced trace and track functionality. Each label has an individual number that can be used for detailed traceability and also to verify authenticity. The overt, covert and forensic identification techniques discussed above can of course also be used for labels.

Summary

Intelligent brand protection systems can deter counterfeiters if imitation of the identification/marking is made impossible or very costly. These technologies can also help clarify what is happening in the distribution and logistics chain and contribute to supply chain optimization.
This article is based on a trend report compiled on behalf of Dechema Gesellschaft für Chemische Technik und Biotechnologie (Society for Chemical Engineering and Biotechnology), Frankfurt am Main, Germany.

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