ANTI COUNTERFEIT PACKAGING

Presented by: Samiksha Sawant

M.Pharm IP, 2nd SemGuided by: Dr. A. A.

Joshi

CAN YOU TELL WHICH MEDICINE IS FAKE?

• To counterfeit means to imitate something.• Counterfeit products

are fake replicas of the real product

• Counterfeit products are produced with the intent to take advantage of the superior value of the imitated product

• Counterfeit drugs are deliberately and fraudulently mislabelled with respect to identity and/or source

• They may be contaminated and contain the wrong active ingredient

• Counterfeits are unauthorized reproductions of a trademarked brand, which are closely similar or identical to genuine articles

Statistics for counterfeiting• The counterfeit drug industry is estimated to be worth $200

billion a year. • The United States Food and Drug Administration estimates that

counterfeits make up more than 10% of the global medicines market

• An estimated 10%–30% of medicines sold in developing countries are counterfeit.

• Industrialized world (countries such as the United States, Australia, Japan, Canada, New Zealand)estimates suggest that less than 1% of medicines sold are counterfeit.

• 12 to 25 percent of all drugs sold within India are thought to be counterfeit.

• Most cases of fake and spurious drugs in the local market were found in Bihar, West Bengal, Uttar Pradesh and Gujarat

Counterfeit drug manufacturing site Counterfeit cough syrup being dispensed from water cooler

These used vials, seized during a raid in Colombia, were being washed for reuse to hold counterfeit medications.

Counterfeiting can lead to:• Antibiotic resistance• Therapeutic failure• Toxicity• Economic losses• It could cost you• It's illegal• It supports child labour• It supports organized crime• It hurts legitimate companies

Anti-counterfeiting• The measure to prevent

imitation and reproduction without permission of ownership holder for the purpose of cheating.

• Anti counterfeit packaging is defined as the process of assigning secure packaging to the product in order to minimize counterfeiting or infringement.

• Anti-counterfeiting packaging is the process of secure packaging that prevents imitation and confirms safety of the goods

• Global anti-counterfeit packaging market was accounted for $57.4 billion in 2013

• It is forecasted to generate revenue of worth $128.6 Billion by 2019

• And to generate revenue of $142.7 billion by 2020 at 13.9% CAGR from 2013-2020.

Anti-counterfeit technologies can broadly be classified as:

• Overt or visible features• Covert or hidden markers• Forensic techniques• serialisation/ track and trace

Overt or visible features

• These are intended to enable the end users to verify authenticity of the pack

• These features are prominently visible and difficult or expensive to reproduce

• It should be applied in such a way that they cannot be reused or removed without damaging the product

• An overt device may be incorporated within a tamper evident feature for added security

Holograms • It normally incorporates an

image with some illusion of 3D construction, or of apparent depth and special separation

• Holography offers certain advantages as a security device:

1) Expensive and time consuming,

2) The equipment has been fairly difficult to obtain in the past.

3) It looks distinctively different from printed labels.

Disadvantages of holograms

• Because most holograms are embossed, mechanical copies are relatively easy to make. A skilled holographer can make optical copies of holograms that are very difficult to distinguish from the originals.

• once a good master copy has been made, high quality replicas are very easy to make.

Optical variable devices• OVDs are similar to holograms but without any

3D component• The Image or Word printed with this feature will

change its color when viewed in various angles.

Colour shifting security inks and films

• They show positive changes in colour according to the viewing angle

• Colour shifting pigments are finely ground metallic laminates which need to be laid down in a thick opaque film to get optical effect

• Their security value lies in the specificity and dynamics of the colour change(eg: blue to gold)

• Films have been used to build up a structure with unique diffractive properties and vibrant colour transitions

• Light sense is a invisible feature where printed image or phrase can be seen only under flashlight or sunlight

• Light sensitive colour change: seculite is a new light sensitive feature that shows one colour under sunlight and different colour under fluorescent light.

Sequential product numbering• Includes use of unique

sequential numbering of each label in a batch

• If printed visibly, it provides semi-overt means of authentication by reference to a secure database

• Disadvantage is that sequence can be predicted and easily replicated and user requires some means to access to the database.

• The more secure option is serialization

On product marking• This allows for special images or

codes to be placed on conventional oral dosage forms

• The new thermal inkjet ink cartridge – which is compatible with comprehensive HP Product

• Benefits include self -contained cartridges for cleaner maintenance and replacement , printing speeds, uniform printing of variable data, barcodes and logos on a variety of dosage-form shapes, and ready-to-use formulation with no solvents to mix or handle.

Triazole Feature • Triazole feature produces a dramatic colour change

from one colour to another when exposed to heat and on further heat which gives third color and Color will return to its original color upon cooling.

TILT-View

• Tilt - View is the most secure, cost effective security process.

• It is invisible in a glance but is visible under a specific angle with respect to the direction of the light.

Covert features• The purpose of this is to enable the brand owner

to identify counterfeited product• The general public will not be aware of its

presence nor have means to verify it• It should not be easy to detect or copy without

specialist knowledge • Their details must be controlled on “need to know

basis”

Micro line/Anti copy/ anti scan design• A word or phrase so small that

appears to be a line or pattern to the naked eye and is digitally generated..

• When printed phrase or word is magnified the digitally encrypted word or message will be clearly visible in the magnifier.

• Or when scanned /copied reveal a latent image which was not previously visible laser coding

Polo Graphic• This feature is a multi-level security feature based on

simple authentication for different target groups.• This feature consists of color-shift that is simple for the

public to authenticate.• The second level, uses special decoder for the verification.

The decoder contains 2 layer when the same image is viewed under these two layer the appearance varies.

Invisible printing• Using special inks, invisible

markings can be printed on the substrate

• These markings appear only under certain conditions such as via UV or IR illumination

• They can be formulated to show different colours with illumination at different wavelengths

ODOUR• Micro-encapsulated distinct

odours can be applied as an additive to an ink or coating to provide a novel covert or semi-covert feature

Digital watermarks• Invisible data can be digitally

encoded within graphics elements and verified by means of a reader and a special software

• The data can be captured using webcam, mobile phone or other scanning equipment

• Eg: software technology Digimarc offer packaging with advanced functionality and product authentication

Hidden Ghost• An image or a word printed will be invisible to the naked

eye unless it is rubbed with the edge of a coin to reveal the hidden image or word in black color.

• The invisible image or word will also glows when exposed under Ultra Violet Black Light, which is an added security.

Forensic markers• Chemical taggants: trace chemicals which can only be

detected by highly specific reagent system, not by conventional analysis

• Micro taggants: they are microscopic particles containig coded information like alphanumerical data on small flakes or threads, fragments of multicoloured multilayered laminates

• Biological taggants: a biological marker may be incorporated in product/ applied to packaging components.

• DNA markers are usually printed in a defined area, a second testing liquid is used to prove the authenticity of the product. When the customised DNA pen applies the identifying liquid substance on the printed area either a colour change or luminescent reaction proves the authenticity.

TRACK and TRACE Technologies • 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.

Example: Pedigree system

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

Bar Codes• These are high-density linear

or 2 dimensional bar codes incorporating product identity down to unit pack level, which are scanned and referenced to the central database

• A 2D code can typically be 1cm square or smaller, and yet contains up to 1 Kb of data with some “redundancy” or error correction

Radio Frequency Identity (RFID) Tagging• An RFID tag comprises of an antenna with a microchip

at its centre. • This contains item-

specific and batch information which can be interrogated at a distance, and without requiring line of sight (unlike bar codes).

• The radio frequency used determines the range and sensitivity, but no one specification suits all applications.

• Some systems are able to capture multiple records for a mixture of different products, but there are some issues around orientation of the tags and absorbance of the radio signal by liquids and foils.

Conclusion • There is a huge range of possible solutions ranging

from the very simple to the highly complex, from zero cost to highly expensive and from fragile to highly secure against compromise.

• There is no single solution to every problem, and a secure strategy will almost certainly involve a mixture of technologies, often in combination.

• But as long as counterfeiters target medicines for illegal profit, a product with no form of anti-counterfeit marker represents a significant potential risk to public health and safety.

References • Counterfeiting(http://en.wikipedia.org/wiki/Counterfeit),• Counterfeiting-definition and meaning(http://www.businessdictionary.com/definition/

counterfeiting.html)• Anticounterfeit packaging technologies (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3255398/)• Anticounterfeit technologies: A Pharmaceutical industry

Perspective by * Swathi Malla, Kapil Gudala, and Pramil Tiwari (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3617666/)• Counterfeit Drugs (http://www.phrma.org/counterfeit-drugs)

• Pharmaceutical Capsules: Printed Capsules• (http://www.indiamart.com/healthcaps-india/

pharmaceuticals-capsules.html)• Hewlett-Packard: Pharma ink-jet print cartridge• (http://www.packworld.com/trends-and-issues/

traceability-authentication-serialization/hewlett-packard-pharma-ink-jet-print)

• Pharmaceutical packaging- Mattews marking system• (http://www.matthewsmarking.com/applications/

pharmaceutical/)• How can technology help to fight counterfeit• (http://www.wipo.int/wipo_magazine/en/2009/05/

article_0011.html)

• The Menance Of Fake Drugs:Consequences, Causes,Solution(http://www.medwelljournals.com/fulltext/?doi=rjmsci.2011.257.261)

• Recent trends and fire of pharmaceutical pacakaging Technology

• (http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2013;volume=5;issue=2;spage=98;epage=110;aulast=Zadbuke)

• Anticounterfeit technologies for protection of medicines

• (http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf)

Thankyou!!