Anti-counterfeiting Technology

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1 ARTICLE AUGUST 2014 Anti-counterfeiting Technology Author Sarabjeet Singh Sharad F Abstract: International free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Almost 10 % of medicines representing close to $75 billion globally are said to be illegal. Around 1% of products in the legal pharmaceutical supply chain in the developed world are estimated to be counterfeit, while this figure is 10-15% in emerging markets and 30% in developing countries. Drug counterfeiting is expected to increase in the future as pharma is. expanding to emerging and developing market where this demand for pharmaceuticals products will increase the supply of counterfeit drugs in future. Technological protection is seen to be the best way to avoid this problem, which will strengthen the security of pharmaceutical supply chain through innovative technologies like overt, covert, forensic and track and trace. This article will emphasize on the use of these technologies in pharma. Copyright Beroe Inc., 2014 All Rights Reserved

2 What is anti-counterfeiting? A counterfeit pharmaceuticals product is a product that is deliberately and fraudulently mislabeled with respect to identity and/or source, drugs are being sold under a product name without proper authorization which applies to both brand name and generic products. Counterfeit products may include products with incorrect ingredients, wrong ingredients, without active ingredients, with the incorrect quantity of active ingredient or with fake packaging. Drugs counterfeiting packaging are being counterfeited, putting millions of people s life in danger. In 2012, it was estimated that around 30% of the medicines sold in developing countries to be counterfeit, among which 50% are sold online. The market for counterfeit medicines was around USD 75 billion in 2010, and is expected to grow at a CAGR of 13% through 2015 Technological Advancements Aiding the Counterfeiters Feeble Criminal Sanctions Monetary Benefit Drivers of Counterfeiting Weak Supply Chain Well known Brands Lack of Consumer Awareness Key Highlights In 2012 US Food and Drug Administration (FDA) warned that 19 medical practices had bought counterfeit versions of Roche's cancer drug bevacizumab (Avastin) In 2009, the European Union seized 34 million fake tablets in just 2 months Number of Incidents of Conterfeiting %age Region-wise (2013) 12% 19% 16% Source: Beroe Survey Product Integrity Product integrity means the extend to which the manufacturers pack remains with its product through the supply chain. 18% 35% Effective Anti- Counterfeiting Strategy Asia Europe Latin America North America Others Authentication Authentication refers to authentication of the product by using various anticounterfeiting technologies like overt or covert or both. Identification Refers to identification of the product at its unit level or identification of its secondary packaging.e.g Serialization techniques Need for anti-counterfeit technologies? Counterfeit drugs lead to drug recalls, liability suit, brand loyalty is being compromised also consumers perceive additional risks when using a fake company product. The implementation of anti-counterfeit technologies is the preventive measure for identifying production of a counterfeit drug by employing these technologies, with implementation of these technologies companies can ensure that drugs in the supply chain are legitimate and safe for patients. Anti-counterfeiting techniques can broadly be classified into 4 types Overt Technologies (Visible features) Overt features are visible to human eyes. It is aimed to communicate and educate the end-user about the authenticity of the pack, with no requirement of high-tech devices or expert knowledge. Covert Technologies (Hidden markers) Purpose of having a covert feature on pharma carton helps brand owners to identify the counterfeit product. The general public is unaware of this, because it loses all of its security value if publicized. Forensic Techniques These technologies are purely a sub-set of covert technologies. However, the difference lies in the usage of scientific methodology like laboratory testing or dedicated field test kits for authentication. 12 percent of the prescription drugs distributed in Russia were counterfeit - (The Coalition for Intellectual Property Rights) 75 per cent of fake drugs supplied world over have some origins in India, followed by 7 per cent from Egypt and 6 per cent from China -(Organization for Economic Cooperation and Development) 123 countries where counterfeit drugs have been confirmed in 2012 Track and Trace Assigning of a unique identity to each unit of the product during it manufacture, which is later verified at each point in the supply chain to the data stored in the database. This technology is still in its nascent stage.

3 Cost to Low Implement High What are the different kinds of anti-counterfeiting techniques? Anti-Counterfeiting Technologies Overt (Visible Features) Covert (Hidden Markers) Forensic Techniques Track and Trace Holograms Variable Devices (OVD) Optically Color Shifting Security Inks/Films Invisible Printing Embedded Image Digital Watermarks Chemical Taggants Biological Taggants DNA Taggants Serialization Bar Codes RFID Tagging The global sales of anti-counterfeiting packaging technologies were worth USD 64 billion in 2010, and the value is projected to be USD 74.2 billion in Security Graphics Sequential Product Numbering Printed and Embossed Anti-Copy Key Anti-Copy/Anti-Scan Design Laser Coding Security Labels Micro-Taggants Topography Source: International Medical Products Anti-Counterfeiting Taskforce (IMPACT) Track and trace technologies and authentication technologies made up for sales of USD 31.7 billion and is projected to be USD 36.5 billion in Low Bar codes Cost - Security Matrix of Different Anti-Counterfeiting Techniques RFID Serialization Holograms Digital Watermarks Topography Biological Taggants PEAK Laser Coding DNA Taggants Color Shifting Inks Tamper Evident Seals High Security Source: World Health Organization Pharmaceutical companies like Pfizer (Viagra), Purdue Pharma (Oxycontin) and GSK (Trizivir) have implemented RFID technology for specific brands of their product. Holograms, being an overt feature can be used as a primary method for product authentication, followed by Nano-text and hidden images (that is so minute and almost invisible to naked eyes) as second and third level technique respectively. Bar codes are used as a track and trace mechanism by incorporating it to unit level packs on pharma cartons, which is authenticated by scanning and referring it to a central database. Pharmaceutical manufacturers use a combination of overt and covert features to safeguard their product against counterfeiting. For e.g. Holograms, being an overt feature can be used as a primary method for product authentication, followed by Nano-text and hidden images (that is so minute and almost invisible to naked eyes) as second and third level technique respectively.

4 Technologies Advantages Disadvantages Overt Technologies Covert Technologies Forensic Techniques Track and Trace Source: World Health Organization Visible to user and hence the consumer can verify it Increases the packaging appeal and serves as a deterrent to the counterfeiters It is simple and low cost (E.g. Anti-Scan design) to implement Can be incorporated in-house, regulatory approval not required, Facilitates easy addition and modification High-tech and provides better security against copying Used for product/packaging authentication High-tech and provides better security against copying, Can also be authorized by investigators without compromise Helps to eliminate dispensing errors and Speedy recall of defective products Remote authentication is possible via phone or internet Requires to be backed by additional anticounterfeiting techniques like covert technologies for enhanced security which may add significant cost to the manufacturer. It can be easily copied therefore requires strict secrecy. If technology is applied by the component supplier, then there are chances that security value might be compromised Licensed (Patent protected) technology and hence suppliers of this particular technology is limited. Wider use of the technology results in increased risk of counterfeit Involves significant cost to implement Difficult to implement and access control to different markets e.g Labels, when damaged during transit causes readability issues It is required for optimum result standards needs be harmonized Clinical trial Supply Chain Perspective: There has been increase in number of counterfeiting cases for comparator over the last few years, mostly due to inefficient clinical supply chain security. In 2010, 80 patients taking part in a clinical trial developed acute inflammation of the eye after using counterfeit version of Avastin drug in China In 2013, a leading Indian drug maker was fined USD 500 million in the US for, misrepresenting clinical generic drug data and selling adulterated drugs to the US Clinical trial supply players are now investing in anti-counterfeiting technologies for tracking of comparator drugs used in different phases of clinical trials. For example, nonclonableid technology by Bilcare is used in verifying the drug origin in the clinical supply chain.

5 Conclusion The implementation of anti-counterfeit technologies is an important strategy taken up by several drug manufacturers and regulatory authorities. The track and trace system and serialization are given importance and are widely used among all anti-counterfeit technologies in different countries. Counterfeit medicines have been found in every disease category, and in every region of the world therefore business personnel must be educated about the implementation of good anti-counterfeit technology and make consumers aware of such strategies used. Regulatory authorities must conduct checking plans and devise necessary measures to ensure the absence of counterfeits, increasing the penalty of the pharmaceutical counterfeiting based on the risk imposed on public health. Manufacturers and health care providers need to take into consideration the individual profile of each product specific to a particular country also they should be encouraged to implement anti-counterfeiting platforms for harmonization of pharmaceutical supply chain. Secondary Sources: Bansal,D. (2013). Anti-Counterfeit Technologies: A Pharmaceutical Industry Perspective. March, pg Power, G. Anti counterfeit Technologies for the Protection of Medicines, pg ACTechnologiesv3LIS.pdf Deming, W. (2010). Drug Safety: An Update from the FDA. April. Primary Source: Beroe Survey Disclaimer: Strictly no photocopying or redistribution is allowed without prior written consent from Beroe Inc. The information contained in this publication was derived from carefully selected sources. Any opinions expressed reflect the current judgment of the author and are subject to change without notice. Beroe Inc accepts no responsibility for any liability arising from use of this document or its contents. For more information, please contact:

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