Global Implementation of Anti-counterfeit Technologies

Multiple anti-counterfeit technologies with distinct advantages and drawbacks exist today. Primarily, these can be used in three different ways:

Tamper-evident/tamper-resistant packing

Packaging having an indicator or barrier to entry which, if breached or missing, should provide visible or audible evidence to consumers that tampering has occurred. Eg. film wrappers, shrinkable seals and bands, breakable caps, tape seals, blister packs, etc.

Product authentication

Authentication features can be embedded either on the dose or on packaging of the medicines.

Comparison of Authentication Characteristics

Holograms for Anti-counterfeiting

Holograms can combine three layered security features and become a most powerful weapon against counterfeiting. In such solutions, holograms can provide overt first line authentication while covert features such as scrambled images, microtext, UV-sensitive or other specialised inks provide second line authentication for trained examiners and appropriate decoding equipment. Serialization of holograms is another trend that combines authentication with traceability. Some of these developed technologies are binary encrypted holograms, light diffraction hologram elements in a product label, or a combination of a hologram, 2D datamatrix, and thermal monitoring.

Track and trace technology

This is the process of assigning a unique identity to each stock unit during manufacture which then remains with it through the supply chain until its consumption, and is called the track and trace system. Information is attached in the form of a unique pack coding, enabling access to the same information on a secure database.

Pedigree

This is a type of track and trace system of the drugs in a location. In the US, the final pedigree regulations were drafted in 1999 for PDMA. A drug pedigree is a paper document or electronic file that records the details of distribution of a prescription drug from its manufacture through wholesale transactions, until it is received by the dispenser, which is usually a pharmacy or physician. The person who receives a pedigree along with the drug shipment must verify that each recorded distribution took place and that the drug-specific information (such as lot number and manufacture date) is correct. This system of pedigree passage and authentication is intended to ensure that prescription drugs cannot easily be diverted or replaced with counterfeit products. The electronic system has largely replaced the paper system because of disadvantages like incompatibility with the bulk of pharmaceuticals, record keeping failures and fraud, and higher probability of counterfeit with paper pedigree.

Several other advantages are offered by the track and trace system like a reduction in the number of medication errors, automated pharmacy billing, effective inventory control, facilitation of product recalls, and identification of theft and product diversion.

Mass Serialization

Serialization includes the processes of generating, encoding, and verifying the unique identity of individual physical items. Without mass serialization, the authenticity and validity of the pedigree relates only to the lot number consisting of thousands of bottles. However, a specific bottle of a particular drug cannot be authenticated. When combined with track and trace technology, serialization facilitates the tracking of a product through the supply chain and allows for targeted identification of products for recall. Global Standards one (GS1) is a not-for-profit organization that develops global standards for the identification of goods and services. GS1 standards are used for the identification of pharmaceutical products in 60 countries around the world. The GS1 identifiers related to the pharmacy supply chain are:

Global Trade Item Number (GTIN)

A 14/13/12/8 digitally unique identification number is assigned by the manufacturer in accordance with GS1 allocation rules for trade items or products and services. It is constructed from a company prefix assigned by GS1, an item reference number designated by the company, and a check digit. Prior to market requirements for item-level serialization and verification, Astrazeneca made it as an internal initiative.

Serialized Global Trade Item Number (sGTIN)

A unique number that identifies a particular trade item, created by appending a serial number to the GTIN of the product. In their draft guidance for serialized identifier prescription drugs, the FDA proposed the use of the NDC (which forms part of the GTIN in the US realm) combined with an eight-digit serial number. In March 2010, the FDA issued guidance addressing the package level SNI (Serialized Numerical Identifier) to be “applied to a prescription drug at the manufacture and repackaging of the product to facilitate its track and trace”.

The main challenges of implementing serialization are the complexity of data that is to be tracked, and the need for potentially huge, multi-access databases.

Data Carriers

Data carriers are graphical systems used to convey the product identifiers and associated information in computer and/or human readable format. A mark, tag, or label applied at the source represents them. Computer readable formats include linear and two dimensional (2D) bar codes and radio frequency identifier (RFID) tags.

Multi-level approach

Anti-counterfeiting technological approaches are interdependent for their effectiveness, and integrating them yields a more robust system. In this respect, a combination of overt and covert measures may provide optimal security because they help prevent counterfeiting and reassure end-users. For example, using drug product serialization in combination with electronic pedigree greatly increased the level of security by the ability to verify both the product and the transaction integrity. For example, the serialization of holographic labels. Some organizations such as Authentix and Nosco have made initiatives to combine the respective limitations and the potential of both Data Matrix and RFID, such that cases and pallets can be tracked with RFID tags, while medicines can be tracked with Data Matrix. However, a multi-level approach may also result in additional costs as the technologies become more sophisticated and should be implemented based on the risk analysis of the drug to be counterfeited.

Key Benefits & Key Market Segments of Anti Counterfeiting

KEY BENEFITS

• Key market drivers and restraints of the anti-counterfeit packaging market segments are highlighted
• SWOT analysis enables to study the internal environment of the leading companies for strategy formulation
• Porters Five Forces analysis examines the competitive structure of the global anti-counterfeit technologies market and would help market strategists in making informed decisions
• The report highlights the market intellect along with the current trends and revenue for the period 2014- 2020
• This report highlights the key development strategies adopted by top companies in the market
• Trends in packaging technology are explained along with key market intelligence on packaging trends

KEY MARKET SEGMENTS
Global anti-counterfeit technology market is categorized into:

1. MARKET BY TECHNOLOGIES

• Authentication technology
• Ink and Dyes
• Holograms
• Watermarks
• Taggants
• Track and trace technology
• Barcode technology
• RFID technology

2. MARKET BY APPLICATIONS

• Pharmaceuticals
• Over the counter drugs
• Prescription based drugs
• Cosmetics and personal care
• MARKET BY GEOGRAPHY
• North America
• Europe
• Asia-Pacific
• LAMEA

Market Opportunities and Forecasts of World's Anti-counterfeit Pharmaceuticals and Cosmetics Packaging

Pharmaceutical, cosmetics and personal care products are the first line of target for counterfeiters. The fact behind the rigorous counterfeiting activities is the presence of high volume low value manufacturing nature of the market. Presently, the trends in cosmetics and personal care industry are shifting from premium beauty products to routine skin care products that are sold across local market. This would increase the threats from counterfeiting across cosmetics and personal care industry. Furthermore, the decentralization of pharmaceutical industry in terms of manufacturing and emergence of small scale personal care industry reduces the manufacturers control on the supply chain. Thus, increases the probabilities of counterfeiting. However, the advancement in track and trace technologies, increasing practices of multi-layered authentication technologies have bring revolutionary changes in securing original products. Companies with premium range of products are opting for RFID and ePedigree authentication technologies. However, economic product categories are majorly secured with the conventional authentication technologies such as holograms, inks and dyes. The unaffordable cost structure of track and trace technologies, complex operations involved in tracking the products are the major challenges for the growth of market.

The report covers geographical analysis of North America, Europe, Asia Pacific, and LAMEA. North America would continue to lead the market throughout the forecast period. Europe anti-counterfeit technology market would rank second in terms of revenue. Pharmaceutical and medical cosmetic companies would be the prominent consumer base for anti-counterfeit industry across Europe. The Asia-pacific, would be the fastest growing region, supplemented by a growing level of awareness for authenticated pharmaceutical drugs, and continuous support from the pharmaceutical companies in the form of awareness campaigns. Competitive landscape of anti-counterfeit packaging market highlights product launch, acquisition, and collaboration as key strategies. Key players profiled in this report are Alien Technology Corp., Alpvision, Zebra Technologies, Inksure Technologies, Avery Dennison, Flint Group, Impinj Incorporation, Honeywell (Datamax-O'Neil), Authentix Inc. and Sicapa.

How to handle anti counterfeiting at Bilcare

The material matrix encoding unique to each tag makes it prohibitively difficult for counterfeiters to duplicate. It is estimated that 5-7% of all world trade is in counterfeit goods, a problem affecting almost every sector from consumer and luxury goods through to pharma, automotive and defence.

Total Accountability through the secure supply chain.

Globally, counterfeiting has become a serious threat. Counterfeit products damage the reputation of brand owners, pose a real danger to the health and safety of consumers, and reduce the profits of legitimate players in the industry. Bilcare offers a foolproof end-to-end solution to combat this growing problem through the implementation of its nonClonableID technology.

Bilcare implements brand security through nonClonableID tags that use a material matrix encoding unique to each tag. This makes it prohibitively difficult for counterfeiters to replicate the tags.

Our comprehensive anti-counterfeiting solution also enables secure Track-n-Trace and leads to e-Pedigree through the supply chain.

ANTI-COUNTERFEIT TECHNIQUES

1. OVERT (Visible) Features:

Overt features are intended to enable end users to verify the authenticity of a pack. Such features will normally be prominently visible, and difficult or expensive to reproduce. It should be noted that overt features can add significant cost, may restrict supply availability, and require education of end users to be effective. Where overt features are used, experience is often that counterfeiters will apply a simple copy which mimics the genuine device, sufficiently well to confuse the average user. They also require utmost security in supply, handling and disposal procedures to avoid unauthorized diversion. They should be applied in such a way that they cannot be reused or removed without being defaced or causing damage to the pack – otherwise genuine used components may be recycled with fake contents, giving a false impression of authenticity. For this reason an overt device might be incorporated within a Tamper Evident feature for added security.

2. COVERT (Hidden) Features:

The purpose of a covert feature is to enable the brand owner to identify counterfeited product. The general public will not be aware of its presence nor have the means to verify it. A covert feature should not be easy to detect or copy without specialist knowledge, and their details must be controlled on a “need to know” basis. If compromised or publicized, most covert features will lose some if not all of their security value. For this reason such techniques will not be disclosed in detail.

3. FORENSIC Markers:

There is a wide range of high-technology solutions which require laboratory testing or dedicated field test kits to scientifically prove authenticity. These are strictly a sub-set of covert technologies, but the difference lies in the scientific methodology required for authentication.

4. Serialisation/TRACK and TRACE Technologies:

A number of Track and Trace applications are under development for the pharmaceutical sector, although the principles have been established for many years in other contexts. These involve assigning a unique identity to each stock unit during manufacture, which then remains with it through the supply chain until its consumption. This identity will normally include details of the product name and strength, and the lot number and expiry date – although in principle it may simply take the form of a unique pack coding which enables access to the same information held on a secure database. (This latter solution overcomes some of the concerns about privacy where the encoded data can be read at a distance by radio equipment.)

Anti counterfeiting at Bilcare Technologies

Bilcare Technologies is a division of Bilcare Ltd., focused on creating next-generation solutions for anti-counterfeiting, security and brand protection across a wide array of industry sectors.

With breakthrough research in nanotechnology, Bilcare has developed a unique security technology called nonClonableID™. It enables products to be authenticated as they move through the supply chain to the end consumer, thus protecting brands and preventing misuse.

The technology comprises a nonClonableID™ fingerprint that can be seamlessly integrated into any Supply Chain system, providing totally secure and irrefutable real-time product identification and authentication. It also provides a reliable means for effective track-n-trace and e-pedigree of products across the supply chain - from manufacturer to consumer.

Bilcare has spearheaded the application of nonClonableID™ across various sectors in India. We have a relentless focus to expand our presence to cover brand authentication of market goods, E-Commerce initiatives with Information Portals, E-Governance and Public Services Solutions for the Govt. of India, trend analysis & business intelligence solutions.

Our technology has been tested in the private sector including FMCG, electronic part and product manufacturing companies, the auto industry and fashion accessories. We have also partnered with the State and Central Government Services in distribution of goods and services for access control in high security zones and police network systems for anti counterfeiting.

Anti Counterfeiting Technology

There are a great many anti-counterfeit technologies available to manufacturers and brand owners, ranging from the very simple but effective, through to the highly sophisticated and extremely secure. The majority can be implemented on one or more of the packaging components, but some features can even be applied at the product level, either by direct marking or by using physical or chemical markers within the formulation.

The purpose of an anti-counterfeit feature is primarily to enable the authentication of an item, by government, industry investigators, or ideally, by the wider public. The second function may be to act as a deterrent to anyone considering counterfeiting a product based on the difficulty or cost involved set against the likelihood of detection, and therefore prosecution. It must be stressed that security devices on packaging components provide no assurance as to the authenticity of the contents, which may have been substituted or adulterated. Security devices alone do not reduce counterfeits, but are designed to make them easier to detect.

Anti-counterfeit technologies can be broadly classified as follows:

•      Overt, or visible features

•      Covert, or hidden markers

•      Forensic techniques

•      Serialisation/Track and Trace