There are solutions to distinguish genuine pharmaceutical products from counterfeits on a worldwide basis using standard equipment.
Friday, August 01, 2008
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Protecting pharmaceutical products against counterfeiting or fraudulent importation of donated or discounted drugs is a concern of the supply chain. This remains as a permanent challenge in light of the increase in counterfeiting actions. This article describes new technologies based on digital imaging solutions using standard packaging printing processes (offset, rotogravure and flexography), which generate invisible marking on primary and secondary packaging, printed with regular visible ink.
The detection of the presence (genuine) or the absence (fake) of the invisible marking is remotely performed on a worldwide basis using consumer electronic products, such as low cost office scanners or personal digital assistant (PDA) phones equipped with digital cameras, combined with efficient and secured worldwide data communications facilities. These new solutions can be covertly and seamlessly integrated into packaging production without extra cost.
Almost every branded pharmaceutical product is a potential target for counterfeiters or fraudulent re-importation. The multiplication of supply sources in today’s global economy makes certification of every supply source a nightmare. This is a key factor for the rapid increase of counterfeiting attacks, including in countries where the supply chains are well established and trustworthy.
In 2006, the World Health Organization reported that many countries in Africa and parts of Asia and Latin America have areas where more than 30% of medicines on sale are counterfeit. About less than 10% are found in other developing markets. Generally, a reasonable range is between 10% and 30%. Custom seizures show an increase in criminal mixing of genuine drugs with fake ones reprocessed for delivery in the original genuine packaging, states Counterfeiting Intelligence Bureau of the International Chamber of Commerce, Anti-counterfeiting Directory 2007.
The real thing
It is commonly admitted among specialists that anti-counterfeiting processes can be divided into two main categories:
• the visible or overt processes;
• the processes which are invisible to the naked eye or covert.
Many pharmaceutical companies have added visible security features to their packaging. These include holograms, embossing, special ink and two-dimensional bar codes. However, these visible features provide minimal security and require staff training for effective authentication. Furthermore, companies are offering hologram duplication services via the Internet at very low prices.
Hopes were then placed on Radio Frequency Identification (RFID) technology, which consists of the inclusion of a passive antenna in the packaging. However, RFID technology was primarily developed for optimization of the supply chain to achieve just-in-time delivery and not for anti-counterfeiting purposes. It has been revealed that it is costly and incompatible with many substances, such as aluminum blisters, for use as an affordable and efficient anti-counterfeiting measure.
If fraudulent business is generated through sales of a mix of genuine and fake medicines in a reprocessed genuine secondary packaging, marking the secondary packaging with visible security features or visible coding may not provide sufficient protection.
Sophisticated techniques can therefore be found in covert security elements. They have features that are not visible to the naked eye and require dedicated detection means. With covert elements, counterfeiters must know that there is a security element before they can attack it. On the contrary, if the security feature is visible, the point of attack is evident.
The most popular covert security solution is invisible ink, such as ultra violet (UV) ink, which is visible under ultra violet light, or infrared (IR) ink, which is visible under infrared light. To authenticate these inks, a lamp emitting light in the required wavelength range is needed. However, these inks are easily available in the market. There are other chemical tracers or ink additives providing security against counterfeiting, such as DNA or magnetic tracers, which provide higher security as using rare and dedicated detection devices.
The problem with such special inks, ink additives or taggants resides in the related logistics and manufacturing procedures, such as press cleaning, temperature and pressure sensitivity, as well as interaction with other chemicals. Although they are very efficient and effective, it costs to implement and deploy. Onsite authentication, in the retail space for example, is also difficult.
These techniques based on a security additive can be qualified as analog or hardware based, as they require additional security elements or special substances that subsequently have to be managed by the branded product manufacturer in a secured environment, involving a third party security supplier in the packaging production chain.
As in other industries, the digital revolution opens exciting new possibilities. Digital technologies can now be used to fight counterfeiting and to track and trace pharmaceutical products. These digital or software technologies are breakthroughs compared to former analog or hardware solutions. Instead of being created by chemical or biology experts, they are developed by software engineers and digital imaging scientists. The most efficient solutions are based on the same digital imaging technologies and cryptography used to protect bank notes and to secure online banking services.
In 2005, an article in the Washington Post said some manufacturers of home and office printers delivered printing equipment in such a way that it added invisible marks on each printed page. This was introduced without informing the users. The purpose of this hidden marking is to identify the printer used in cases of fraudulent printing. Aside from the political or legal implications, this incident shows that with today’s technologies and equipment, it is possible to print invisible information with normal ink and standard printing machines.
Translated into the packaging industry and security printing domain, the incident described above has two important implications. First, an industrial packaging printer could produce secured packaging for manufacturers using standard printing machines and standard visible ink. Secondly, a branded product manufacturer can secure its products without informing the printer that the packaging contains an invisible security feature. This reduces the number of parties involved in a product security process and creates a distinct advantage, because secrecy and privacy are the two pillars of an efficient security policy.
Depending on the printing process and the color of the carton and the ink, dots can vary in size from about 10Î¼m to 80Î¼m. It is important to note that the security level is also a function of the dot color and the dot size. The security level increases as lower contrasts are used and as the dots get smaller. Any printed surface can be protected this way, such as carton for folding boxes or aluminum or polymer for blister foils.
Cryptoglyph invisible marking using regular visible ink
A technology, now mature and already protecting over a billion items worldwide, is marketed by AlpVision SA, a Swiss supplier of digital security printing solutions, under the name of Cryptoglyph. It creates a pattern made by apparently random microdots invisible to the naked eye.
The Cryptoglyph patented solution combines two elements:
1. Printing of the invisible microdot pattern over the entire surface of the primary or secondary packaging, such as the blister foil. As these dots are invisible and spread over the whole surface of the packaging, it is impossible to replicate or erase them.
2. These invisible microdots contain encrypted information, which can only be deciphered with a 128-bit encryption key. If the detection process is performed in a unique and secured place, the key is not endangered. Deciphering the information by a fraudulent party is impossible.
These microdots are integrated in the packaging design before printing and are invisible to the naked eye. They are very difficult to distinguish, even with a magnifying glass, as the dots’ color and size are chosen to be camouflaged within the imperfections found in all printed material structures.
The detection of the presence (genuine) or the absence (fake) of these microdots on a packaging is performed by software based on advanced signal detection capabilities that have very low signal-to-noise ratios and built-in conceptual redundancies.
The Cryptoglyph file is embedded in the packaging’s digital image file at the pre-press level, without modification of the packaging design. The introduction of a security element into the existing product’s packaging is best achieved when packaging modification or partial redesign is performed by the brand manufacturer. The color of the microdots is selected according to the level of security required and other packaging printing constraints.
Cryptoglyph provides invisible marking with nothing more than regular visible ink and standard printing processes (offset, rotogravure, flexography, laser, inkjet, etc). It can be easily integrated into any existing packaging production line, without alteration of the printing speed and without modification of the production workflow, namely without extra production cost.
Detection of Cryptoglyph
Although covert security markings usually need specific scanners, the detection of the Cryptoglyph covert security marking is software-based. It requires standard electronic devices such as office scanners or a PDA that is equipped with a camera. The presence of the invisible marking indicates a genuine product, while its absence uncovers a fake one. Deciphering the information contained in the pattern uncovers market diversion through comparison of the data stored in the invisible pattern with the actual localization of the item. The authentication process is machine-readable and it can be performed remotely using a centralized and secured server.
Developing an anti-counterfeiting program worldwide
A technology solution alone cannot provide totally adequate industry-compatible brand protection. It must take into account the realities of large volume production of pharmaceutical goods, which can be in billions spread over hundreds of production centers. A global and customized solution is necessary, integrated into existing product production management systems at any pharmaceutical products manufacturer.
Have solutions with a secured server that stores a database containing the anti-counterfeiting and other identification marks of every product. Have turnkey secured server that is Internet/Intranet based that is accessible through an Internet browser with severe access security control processes. It is best for the system to meet the regulatory requirements such as the FDA 21 CFR Part 11 ERES and FDA Revitalization Act S.1082 for medicines delivered in the USA.