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Pharmaceutical Manufacturing and Packing Sourcer

Counterfeit Crack-Down

Everyone involved in the pharmaceutical supply chain – manufacturers, distributors, consumers, government authorities and tax advisors – has learnt the value of security holograms and will be reassured by their presence on products and packaging, recognising the benefits they provide. However, as coding and serialisation becomes mandatory for medicines in a number of countries, the ability to incorporate quick response (QR), data matrix and other types of code into holograms further enhances the role they can play in supply chain control.

Pharma companies have to contend with challenges stemming from supply chain security lapses (which can result in theft, diversions and product recalls), counterfeiting and regulations. In addition, these factors can impair the health and reputation of companies by adversely impacting on profits, brand credibility and research initiatives. With industry, regulatory authorities, security agencies and governments around the world realising the significance of implementing product tracking and tracing systems which build on product serialisation, it becomes mandatory for those in the supply chain to comply with legislation pertaining to the locations in which they operate. Even where this is not mandated by law, track and trace systems fortify defences against counterfeiting and other infringements, as well as improving distribution and inventory control.

Typically, distribution systems run the gamut of manufacturers, wholesalers, distributors, stockists and retail outlets before products reach the end-user or customer. Ensuring product protection – including authentication capabilities – across various touch points throughout the supply chain via track and trace implementation, is important to address industry obstacles. Apart from providing visibility and full traceability from manufacturer to consumer, successful serialisation programs can prove to be key differentiators and provide a clear competitive advantage for companies.

QR Codes

Today, QR codes that use four standardised encoding modes (numeric, alphanumeric, byte/binary and kanji) to efficiently store data are being linked with holograms to provide integrated track and trace and authentication solutions. These, among other benefits, can minimise product counterfeit, contraband and illegal parallel trading by enabling tracking of each saleable item from its point of origin to the point of sale. Incorporating these codes into a hologram delivers authentication of the product and the code in one feature, making this an efficient and effective method of product protection.

Systems like Andrews & Wykeham’s THESEUS™ can also be applied as an anti-counterfeit solution for such market segments as pharma. Not only do systems like this assist in maximising tax collection and reducing counterfeits, they are also tools the government can use to leverage public confidence. THESEUS, for example, includes an open internet interface, which enables any member of the public to verify whether products are genuine and duty-paid, and uses high security labels with holographic and security print features, carrying two-dimensional (2D) QR-format barcodes with item-specifi c information. These codes are protected from unauthorised access and reproduction by state-of-the-art electronic digital signature technology.

Coding Foil

Another technology finding its way towards increased integration with holography is coding foil, which is used to stamp various markings onto product packaging by means of a coding device. These markings provide the consumer with important information such as a product’s expiration date, production date, weight or price, and are especially beneficial when it comes to marking a product’s quality or adding high-performance labelling.

In today’s health- and eco-conscious world, manufacturers ensure that these foils comply with all necessary regulations, including the strict limits in EN 71/Part 3, the EU packaging guidelines 94/62/EC, and the American CONEG specifi cation for heavy metals and lead chromate. The Kurz Group, for example, is a market leader whose ecofriendly coding foils are enabling product manufacturers and others in the supply chain to choose from a diverse product line that includes a wide range of grades and colours to meet the demanding requirements of modern product packaging, labelling and retailing.

Virtual Identification

Coding foils are just one product that can be integrated with holograms to boost the role played in supply chain control. Kurz’s TRUSTSEAL® range of difficult to copy holographic authenticity features visually enhance the brand, build consumer confidence, and provide a high level of counterfeit protection. These optical security features can be combined with the web-based TRUSTCODE® identification system. This system connects the real world to the virtual one: detailed product information can be accessed by buyers, retailers, customs officials and brand owners using different smartphone scanning processes.

The company has also developed diffractive 2D barcodes with an appealing aesthetic that enhances the value of the product. Rather than being printed, the barcode is applied as a silver-coloured stamping foil into which the actual code has been incorporated as a diffractive, holographic-like structure.

Honing the Technology

Elsewhere, holography solutions like Meditag III, introduced in Malaysia, are proving successful. The regulation of medicines in Malaysia dates back to the Sale of Drugs Act 1952, which required the registration of all medicines available in the country. This was amended in 2006 with new (albeit retrospective) regulations defining a label as “a display of information, safety marks or features” referring to “any kind of security tools/technology such as hologram, imprints or even microchips”, and put legal provisions in place to ensure effective implementation.

In 2005, the Ministry of Health (MOH) in Malaysia introduced the Meditag®, a holographic numbered label to be used on all registered medicines, cosmetics and other treatments on sale in the country, partly to confirm that a medicine is registered (as all are required to be) and also to serve as a counterfeit detection label. A second version of the label was introduced in 2008, with a hidden polarised feature.

Sadly, 2011 saw an increase in the adulteration of food supplements (and hence a rise in seizures), leading the MOH to seek a more sophisticated design for Meditag. Accordingly, Meditag III was introduced late in 2012, with a new design and improved security. It has new overt and covert features, such as diffusing switch Movigram® with high diffractive kinematic animation, as well as colours and embossing effects to keep ahead of counterfeiters and, at the same time, make it more user-friendly. It also has a polarisation effect, micro-photo, microelements, and nano-graphic text and symbols. The MOH backed the label with an educational campaign and a team of inspectors, with the result that it has succeeded in reducing the prevalence of unregistered medicines and counterfeit drugs on the market.

There is now a new Malaysian pharmacy bill being drafted which specifically addresses the problem of counterfeit, adulterated, unregistered and expired products, increasing the penalties to a minimum mandatory jail sentence and fines at ten times the current level.

Meditag III is supported by the Meditag Checker, a new smartphone app created by Hologram Industries, which shows the animations and changing images on the label simply by the viewer tilting the phone in exactly the same way as the Meditag would be tilted to show these changes. There is also a more advanced version for professional employer organisations which includes the covert features.

Successful Security

The success of the MOH’s comprehensive approach to drug security uses Meditag as a secure label at the centre of a committed and strategic program, which applies to all medicines, cosmetics and other self-medication treatments in the country. At the 2014 Global Forum on Pharmaceutical Anti-Counterfeiting and Diversion, Maslan Ismail – Deputy Director of the Pharmacy Enforcement Division – concluded that: “The Meditag hologram label is unique because it serves as one security label with unique serialised numbers for all medicinal products in Malaysia; thus, it can be easily monitored and verified by the enforcement officers, which would be more difficult if every manufacturer devised their own security marking on their products.”

Unquestionably, one of the reasons for the success of holograms – since being adopted for authentication purposes in the early 1980s – has been their ability to adapt and constantly find new roles. We will undoubtedly see more and more interesting developments for the technology that will offer farreaching benefits which develop and expand the role of track and trace. As a result, with the seemingly remorseless march of technology and the resolve of governments, anti-counterfeiting agencies and companies around the world are standing firm in the face of international organised crime, as well as the casual opportunist. There is no reason why the hologram will not keep evolving, becoming further entrenched in global supply chains and continuing to add real value.

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Ian Lancaster founded Reconnaissance International in 1994 and has many years’ experience in security and authentication. Previously, he was Director of the hologram manufacturer Third Dimension Ltd, and worked as Executive Director of the Museum of Holography, New York. Ian has served as the General Secretary to the International Hologram Manufacturers Association since its foundation in 1994 and is a member of the BSI Security products committee, as well as the ISO Fraud Countermeasures and Controls committee. He holds an honours degree and a postgraduate Business Studies diploma.

Ian Lancaster
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