Alert of the Issue The Holography Times The Holography Times Alert of the Issue

Hologram: The first line of defence in the

Pharma Counterfeiting FIRST IN war on pharma counterfeiting
HOLOGRAPHY
C ounterfeit drugs are drugs that are sold as legitimate brand name medicines but
have been created without the authority of the brand owner. They have no active
ingredient or is an expired drug that been re-labelled and sold. Their active ingredients
Glaxo was the first company to
use a tamper evident hologram
Fighting the war on counterfeiting is a seemingly endless one for the pharmaceutical industry. The
World Health Organisation estimates that annual earnings from the global sales of counterfeit and
substandard medicines are over $32 billion. And the cost of counterfeiting doesn't finish there. The
are usually fraudulently diluted, adulterated or substituted. to seal packs of ZANTAC (the negative impact on a company's image can be immeasurable as high quality reproductions have made
trade name for the anti-ulcer
Ø Sales of counterfeit drugs are estimated at $ 50 billion a year World Health it virtually impossible for even the most trained eye to distinguish the genuine from the fake.
medication ranitidine) in 1989.
Organisation (WHO). However, the hologram has emerged over the last 25 years to become one of the most effective anti-
Ø 10-30% of all medicines in developing countries are feared to be counterfeits (WHO).
counterfeiting and security measures available. Here, Ian Lancaster, general secretary of the
International Hologram Manufacturers' Association (IHMA), examines the role of this versatile technology.
Ø In India it is 4 percent according to WHO and 5 percent according to health
ministry of India.
The ability of the hologram to provide
The counterfeit threat effective protection lies in the
Hologram initiatives
Ø India: Biggest culprit of fake drug manufacture.

Ø According to a report released by the Organisation for Economic Co-operation and

S ophisticated replication techniques
have made counterfeiting and fraud a
continuous innovation, invention and
evolution in holographic techniques
While the US Congress is currently
considering making the use of security
marking on some pharmaceutical
Development (OECD), 75 percent of fake drugs supplied world over have some that have succeeded in creating
serious threat to the pharmaceutical products mandatory, using ‘overt
origins in India, followed by 7 per cent from Egypt and 6 per cent from China. increasingly complex devices that are
i n d u s t r y. T h e Wo r l d H e a l t h optically variable counterfeit resistant
Zantac was the world's single easily recognised yet difficult to copy
Organization(WHO) estimates that technologies’ to protect consumers
Ø 50 percent of pharmaceutical drugs sold over the Internet without a prescription are largest-selling prescription annual earnings from the global sales of
accurately. The evolving role of the
hologram has also been accompanied from fakes, the hologram is already
believed to be counterfeit (Reuter). drug with sales exceeding $ 2.5 counterfeit and substandard medicines specified as the authentication feature
by the increased use of the security
billion in 1989. In 1994, are over $32 billion. on the world’s only statutory
Ø Most counterfeit drug includes Viagra, Lipitor, Tamiflu,Ambien and Diflucan. device in combination with other
Zantac generated $3.6 billion authentication technologies. In such pharmaceutical marking scheme – the
Both drugs and packaging are
Ø Viagra remains the world most counterfeit drug. Pfizer losses sales of $ 2 billion a in sales, $2.1 billion of that in
counterfeited, putting people’s lives at solutions holograms often provide Meditag programme in Malaysia.
year in Viagra alone. Source:bloomberg.com the USA. overt first line authentication, while
risk. The diversion of legitimate This initiative requires all registered
product outside authorised covert features such as scrambled
Ø Estimated death from counterfeit drugs vary from ten thousand to more than medicines, OTC pharmaceuticals
distribution channels is another images, micro text, UV-sensitive or
200,000 every year. and traditional medicines to carry a
problem. In response to this, many of other specialist inks provide second
uniquely numbered label which is
the world’s leading pharmaceutical line authentication for trained
Ø Lethal market for counterfeits is growing at the rate of 25 percent annually
(ASSOCHAM). FIRST companies have directed their efforts
towards authenticating their
examiners equipped with the
appropriate decoding equipment.
built around a hologram. The system
is supervised by a central authority
controlling the issue of tags and
Ø Main factors for the growth of the industry : Weak drug regulation, weaknesses in
enforcement of existing regulations and lenient punishment for counterfeiters.
IN packaging as part of the process of
protecting their products. As a result,
Another trend has seen the serialisation
of holograms as part of systems that
training inspectors to examine
holograms through the distribution

Ø Methods for success of Anti counterfeiting market: Full cooperation between drug
INDIA diffractive optically variable devices
– referred to generically as holograms
combine authentication with
traceability. So called ‘track-and-trace’
chain.

regulatory authorities, law enforcement agencies, manufacturers, association of
pharmacists and consumers.
Again in 2003, Glaxo
Smithkline Consumer
Healthcare Ltd (GSKCH) an
Indian associate of
GlaxoSmithKline (GSK) was
the first company to use a 3-D
hologram on its popular
medicine CROCIN. It is the
first and only analgesic /
antipyretic brand in India with
a sophisticated 3-D hologram.
Source: www.tribuneindia.com
– have become one of the most
widely-used overt authentication
features on pharmaceutical products
around the world.
Holograms as a solution
Since Glaxo first used a tamper-evident
hologram to seal packs of Zantac in
1989, holograms have been taken up in
a big way by the whole industry. Many
major drug companies use holograms
on at least some of their medicines in
selected markets and they are used in
the form of labels, seals, hot stamped
patches and blister-foils.
Since its introduction this system has
systems link on-pack security devices
led to a significant increase in the
with database management and field
identification and confiscation of
tracking services. In this way, the
illegal items from the market as well as
ability to know where a
pharmaceuticals consignment has
been, where it is now and where it is
heading has become a fundamental part
of many drugs companies’ production
and logistical operations. This is
particularly important where the ability
to identify the source and provenance
of products is becoming a mandatory
requirement, as it is in the US with the
FDA’s requirements for pedigree.

08 www.homai.org www.homai.org 09
Alert of the Issue
preventing their entry into distribution
channels. As a result, consumer
confidence in the integrity of
pharmaceuticals has increased and
is barely distinguishable from the
genuine article – the same cannot be
said of the fake holograms.
public health has been safeguarded. The situation involving Artesunate, an
important antimalarial treatment, is
More recently, the National Agency for often quoted as an example. It is
Food & Drug Administration and reported that over half of the sales of
Control in Nigeria (NAFDAC) has also this drug in South East Asia are fake,
announced that it is planning to despite the blister pack incorporating a
introduce uniquely numbered hologram. What is evident is that,
holographic labels to be used on all despite the fact that the hologram used
licensed medicines distributed in the is relatively simple and has been used in
country. Perhaps unsurprisingly, the its unchanged form for several years,
success and near ubiquitous use of the fake holograms are identifiable as
holograms in anti-counterfeiting such. The problem is that in a region of
applications has inevitably led to low rural literacy, very high poverty
attempts to copy or replicate them. and very poor drug regulation, and
However, the intrinsic features of where medicines are sold in street
holograms mean that the techniques markets and non-specialist shops, most
and visual effects make it very difficult buyers and users of Artesunate see a
to copy a properly conceived and hologram and think this means that the
executed authentication hologram with medicine is genuine.
one hundred per cent accuracy.
The Artesunate case is a classic example
of how not to manage a hologram
The real thing? authentication programme on a brand of
H i s t o r i c a l l y, h o l o g r a m s h a v e medicine. The hologram has not been
succeeded in doing their job. They have redesigned since it was first introduced,
proved to be extremely difficult to copy and insufficient attention was paid to the
accurately and, invariably, while the distribution, examination and
product and packaging they protect purchasing patterns in the region.
may have been counterfeited, the lower
quality copy of the hologram has In contrast, there are many examples of
how holograms continue to provide a
successful and vital detection function
in pharmaceutical anti-counterfeiting
strategies. In all these cases, it is widely
understood by those involved that
formal inspection of the hologram
provides the quickest way to identify a
fake product, even if this then needs to
be supported by forensic examination.
Importantly, as well as understanding
typically been the feature that has
the need to invest in the creation of a
demonstrated that it is a counterfeit. In
properly designed secure hologram,
this way, the hologram serves as an
those pharmaceutical companies and
effective detection feature when
organisations involved in successful
sophisticated criminals have the
anti-counterfeiting efforts also
resources to reproduce packaging that
Historically, holograms have succeeded in doing their job. They have proved to be extremely
difficult to copy accurately and, invariably, while the product and packaging they protect may have
been counterfeited, the lower quality copy of the hologram has typically been the feature that has
demonstrated that it is a counterfeit. In this way, the hologram serves as an effective detection
feature when sophisticated criminals have the resources to reproduce packaging that is barely
distinguishable from the genuine article – the same cannot be said of the fake holograms.
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The Holography Times
recognise that it should not be the sole
responsibility of the consumer to
examine a hologram to check that the
product is genuine.
Rather than rely on untrained members
of the public to identify counterfeits, it
must be the primary responsibility of
manufacturers and the enforcement
agencies to ensure that fake
pharmaceuticals should not be able to
enter the legitimate supply chain in the
first place. This is why successful brand
protection programmes now involve
forma l examination and inspection
systems at different stages in the
distribution network.
Conclusion
The holographic industry is
working hard to destroy the myth
that sophisticated holograms cannot
be counterfeited; anything can be
counterfeited, the question is how
well, and this is where the real value
of holograms should be appreciated.
The evolving anti-counterfeiting
role of holograms lies in their
ability to combine authentication
with detection – and this is why the
more enlightened pharmaceuticals
companies and enforcement
agencies continue to make them an
integral part of modern anti-
counterfeiting strategies.
www.homai.org
The Holography Times
Holographic optical elements:
Printing technology enables HOE volume manufacturing
New master
replicating technology
that borrows
concepts from the
printing industry
enables volume
production of
holographic optical
elements for
applications in
general and backlit
illumination, displays,
and automotive LED-
based optics.
Evgeni Poliakov and Leo
Katsenelenson
Methods for storing and reproducing
optical information have greatly
boosted interest in holographic
products. Indeed, because they are
diffractive in nature (with feature size
approximately 0.1λ to 10λ, where λ
is the recording wavelength),
holographic optical elements (HOEs)
offer several types of optical
functionality. Instead of bending light
by curvature and shape, as in the case
of typical optical elements such as
lenses, HOEs diffract light waves by
using a corresponding material profile
to make new waves. These HOEs can
www.homai.org
function like standard lenses,
gratings, or mirrors, and they are
lightweight and do not require precise
surface machining.
Unfortunately, the development of
many obvious applications for HOEs,
such as three-dimensional (3-D)
visualization, 3-D cinema, or 3-D
displays has been hampered for many
years. There are two reasons that
holography and HOEs have found a
limited range of applications that are
generally restricted to medicine,
museum pictorials, or one-shot
visualization objects: cost and
complexity. But if you could make a
perfect master hologram, a mother of
all the others, the master HOE could be
replicated numerous times without
going through the same development
cycle, saving time and reducing costs.
Currently, Luminit (Torrance, CA) is
using this master hologram
methodology to develop custom
holographic products; in particular,
optical films and diffusers.
HOE science
Optical holography, invented by
Dennis Gabor in the 1940s, deals with
the recording of scattered optical fields
from objects. Derived from Greek for
"science of writing," holography and
the holographic recording process
produces holograms or HOEs. These
HOEs are typically made by the
interference of a reference beam
(usually a laser) and an illumination
beam (scattered by an object). The
resultant two-dimensional (2-D)
picture--the hologram--is stored on a
photographic film, photoresist
material, charge-coupled device
(CCD), or is generated numerically.
The hologram is essentially a collection
of interference fringes obtained during
exposure of the photosensitive medium
to a high-low intensity profile. During
playback, the laser light diffracts on the
fringes, and the object is reconstructed.
Technology
This unique and rather peculiar way of
reproducing objects that are no longer
there (that is, during playback the laser
beam illuminates the interference
fringes) is based on retrieval of phase
and amplitude information, which
uniquely represents the original object.
To preserve the phases of the scattered
fields, a photosensitive medium is
insensitive to the phase and reacts to
light intensity. That is what made
Dennis Gabor's invention unique: using
a second illumination beam along with
an object beam allows the beams to
interfere so that the interference pattern
can be recorded. As long as the
interference pattern is preserved, the
phase information is preserved and the
object can be reconstructed.
Overcoming Limitations
Holography has been perceived as an
interesting science but a rather complex
and nonapplicable technology,
especially in terms of high-volume
manufacturing. Considering the typical
drawbacks associated with using a
standard holographic lab such as high
material costs, operation in a dark,
vibration-free environment, chemical
development, materials storage, long
recording times, and demanding
requirements for uniformity, yield,
efficiency, and most importantly,
reproducibility, all of these factors can
add up to an expensive undertaking.
New technology from Luminit
borrows concepts from the printing
industry for manufacturing HOE
elements with surface microstructure
relief patterns applicable to general
and backlight illumination, display,
automotive, and light-emitting-diode
(LED)-based optics. Instead of
optimizing an optical recording in an
expensive and often futile attempt to
produce thousands of identical copies,
our HOE development plan is
different: make one good master and
replicate from it.
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