This document discusses anti-counterfeiting packaging. It begins by defining counterfeit drugs and products and providing statistics on the counterfeit drug industry. It then discusses the health and economic risks of counterfeit drugs. The document outlines various anti-counterfeiting technologies including overt features like holograms, covert features like microprinting, and track and trace technologies like serialization. It provides examples of different anti-counterfeiting packaging technologies and discusses their purpose in verifying authenticity and preventing counterfeiting.

1. ANTI COUNTERFEIT
PACKAGING
Presented by: Samiksha
Sawant
M.Pharm IP, 2nd Sem
Guided by: Dr. A. A.
Joshi
CAN YOU TELL WHICH MEDICINE
IS FAKE?

2. • 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

3. • 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

4. 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

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

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

7. 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

8. 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

9. • 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.

10. Anti-counterfeit technologies can broadly be
classified as:
• Overt or visible features
• Covert or hidden markers
• Forensic techniques
• serialisation/ track and trace

11. 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

12. 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.

13. 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.

14. 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.

15. 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

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

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

18. 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

19. 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.

20. 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.

21. 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.

22. 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”

23. 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

24. 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.

25. 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

26. 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

27. 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.

28. 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

29. • 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.

31. 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

32. 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

33. 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

34. 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.

35. 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.

36. References
• Counterfeiting(http://en.wikipedia.org/wiki/Counterfeit),
• Counterfeiting-definition and meaning
(http://www.businessdictionary.com/definition/counterfeiti
ng.html)
• Anticounterfeit packaging technologies
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC325539
8/)
• Anticounterfeit technologies: A Pharmaceutical industry
Perspective by * Swathi Malla, Kapil Gudala, and Pramil
Tiwari
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC361766
6/)
• Counterfeit Drugs (http://www.phrma.org/counterfeit-
drugs)

37. • 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/phar
maceutical/)
• How can technology help to fight counterfeit
• (http://www.wipo.int/wipo_magazine/en/2009/05/arti
cle_0011.html)

38. • 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)

39. Thankyou!!