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Holograms have anti-counterfeiting function: Ian Lancaster of the IHMA (International Hologram Manufacturers' Association) describes how holograms continue to successfully overcome counterfeiting problems in the pharmaceutical industry.

Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry. The World Health Organization estimates that annual earnings from the global sales of counterfeit and substandard medicines are more than $32 billion.

Drugs and packaging are both counterfeited and people's lives have been put at risk, while diversion of legitimate product outside authorized distribution channels is another problem. In response, many of the world's leading pharmaceutical companies have directed their efforts at authenticating their packaging as part of the process of protecting their products. As a result, diffractive optically variable devices--referred to generically as holograms--have become one of the most widely used overt authentication features on pharmaceutical products around the world.

Since GSK first used a tamper evident hologram to seal packs of Zantac in 1989, holograms have been taken up in a big way by the industry. Many major drug companies use holograms on at least some of their medicines in selected markets and they are used in the form of labels, seals, hot stamped patches and blister-foils.

The ability of the hologram to provide effective protection lies in the continuous innovation, invention and evolution in holographic techniques that have succeeded in creating increasingly complex devices that are easily recognized yet difficult to copy accurately.

The evolving role of the hologram has also been accompanied by the increased use of the security device in combination with other authentication technologies. In such solutions, holograms often provide overt first line authentication while covert features, such as scrambled images, microtext, UV sensitive or other specialist inks, provide second line authentication for trained examiners equipped with appropriate decoding equipment.

Another trend has seen the serialization of holograms as part of systems that combine authentication with traceability. So called 'track and trace' systems link on-pack security devices with database management and field tracking services. In this way, the ability to know where a pharmaceuticals consignment has been, where it is now, and where it is heading, has become a fundamental part of many drugs companies' production and logistical operations. This is particularly important where the ability to identify the source and provenance of products is becoming a mandatory requirement, as it is in the US with the FDA's and some state requirements foar pedigree.


While the US Congress is currently considering making the use of security marking on some pharmaceutical products mandatory using 'overt optically variable counterfeit-resistant technologies' to protect consumers from fakes, the hologram is already specified as the authentication feature on the world's only statutory pharmaceutical marking scheme--the Meditag program in Malaysia. This initiative requires all registered medicines, OTC pharmaceuticals and traditional medicines to carry a uniquely numbered label, which is built around a hologram. The system is supervised by a central authority which controls the issue of tags and trains inspectors to examine holograms through the distribution chain.

Since its introduction this system has led to a significant increase in the identification and confiscation of illegal items from the market and prevented their entry into distribution channels. As a result, consumer confidence in the integrity of pharmaceuticals has increased and public health has been safeguarded.


More recently NAFDAC, the National Agency for Food & Drug Administration and Control, in Nigeria, has also announced that it is planning to introduce uniquely numbered holographic labels to be used on all licensed medicines distributed in the country. Perhaps unsurprisingly, the success and near ubiquitous use of holograms in anti-counterfeiting applications has inevitably led to attempts to copy or replicate them. However, the intrinsic features of holograms mean that the techniques and visual effects make it very difficult to copy a properly conceived and executed authentication hologram with 100% accuracy.

Historically holograms have succeeded in their job. They have proved to be extremely difficult to copy accurately and, invariably, while the product and packaging they protect may have been counterfeited, the lower quality copy of the hologram has, more often than not, been the feature that has demonstrated that it is a counterfeit. In this way, the hologram serves as an effective detection feature when sophisticated criminals have the resources to reproduce packaging that is barely distinguishable from the genuine--the same cannot be said of the fake holograms.

As an example, the situation involving Artesunate, an important anti-malarial treatment, is often quoted. It is reported that more than half the sales of this drug in SE Asia are fake, despite the blister pack incorporating a hologram.

What can be seen here is that, despite the fact that the hologram used is relatively simple and has been used unchanged for several years, the fake holograms are identifiable as such. The problem is that in a region of low rural literacy, very high poverty and very poor drug regulation, where medicines are sold in street markets and non-specialist shops, most buyers and users of Artesunate see a hologram and think this means the medicine is genuine.

The overall conclusion should be that the Artesunate case is a classic example of how not to manage a hologram authentication program on a brand of medicine. The hologram has not been redesigned since it was first introduced and insufficient attention was paid to the distribution, examination and purchasing patterns in the region.

In contrast, there are many examples of how holograms continue to provide a successful and vital detection function in pharmaceutical anti-counterfeiting strategies. In all these cases it is widely understood by those involved that formal inspection of the hologram provides the quickest way to identify a fake product, even if this then needs to be supported by forensic examination.

Importantly, as well as understanding the need to invest in the creation of a properly designed secure hologram, those pharmaceutical companies and organisations involved in successful anti-counterfeiting efforts also recognize that it should not be the sole responsibility of the consumer to examine a hologram to check that the product is genuine. Rather than rely on untrained members of the public to identify counterfeits, it must be the primary responsibility of manufacturers and the enforcement agencies to ensure that fake pharmaceuticals should not be able to enter the legitimate supply chain in the first place. This is why successful brand protection programs now involve formal examination and inspection systems at different stages in the distribution network.

The holographic industry is working hard to destroy the myth that sophisticated holograms cannot be counterfeited; anything can be counterfeited, the question is how well and this is where the real value of holograms should be appreciated. The evolving anti-counterfeiting role of holograms lies in their ability to combine authentication with detection, and this is why the more enlightened pharmaceutical companies and enforcement agencies continue to make them an integral part of modern anti-counterfeiting strategies.

The International Hologram Manufacturers Association (IHMA) is made up of more than 80 of the world's leading hologram companies. IHMA members are the leading producers and converters of holograms for banknote security, anti-counterfeiting, brand protection, packaging, graphics and other commercial applications around the world. IHMA member companies actively cooperate to maintain the highest professional, security and quality standards.
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Title Annotation:packaging
Author:Lancaster, Ian
Geographic Code:4EUUK
Date:May 1, 2008
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