Pharma companies invest vast sums of monies to develop wonderful drugs
to help cure maladies and diseases afflicting humanity. Great amount of
money is spent to bring the product to market by investing in new
testing and drug validation trials, production facilities, marketing and
promotion, etc. The medicinal product is accepted and is a great
success, but soon the brand gets unwanted publicity due to spurious
products in the market place. Companies spend crores of rupees on all
types of assets and promotion and yet the “Golden Goose” the brand, is
put out into the market without any protection.

Many studies have
been done in the past and now there is no doubt that there is presence
of counterfeit drugs and that they pose a real threat not only to the
health of the patients but also to the well being of the brand and the
company.

There are many ways to authenticate the packed medicine,
but before we discuss that; it is interesting to note that even with
the knowledge of the prevalence of counterfeiting there is still not
sufficient action being taken by the industry to counter what is seen to
be a growing problem. This lack of action to use devices to protect or
authenticate pharma brands may be due to misapprehension of the high
perceived cost of implementing a fool proof system to counter the
counterfeiters. Of course the goal must always be zero counterfeits if
an anti counterfeit system is employed, but as we all know life is not
perfect. To develop a fool proof anti counterfeit system would be very
prohibitive. Therefore, it would be expedient to develop a system or
methods that address most of the issues at an economical cost.

For
instance we have a police force to counter criminals, yet we still have
criminals. Clearly the police are not effective. Do we disband the
police force? Of course not! We reassess and improve policing by
developing special cells, new and better systems and methods to defeat
the criminals. Therefore, similarly not to take action until we find the
best system or method is flawed. As any action to protect one’s assets
is always right and action in the right direction will produce positive
results.

Imagine if the same argument was used for the police
force, then we would be over run by criminals. Similarly, one needs to
take appropriate action to minimise the possibilities of spurious
products in the market place.

The analogy can be further made to
that of locking of front door to one’s residence. When leaving the
building one locks the front door with a key lock to ensure that our
property is safe.

The key lock is not perfect, it can be easily
“picked” and opened within few minutes, yet we continue to use it even
when we know this fact. As not doing so, would pose even greater threat
of loss or problems. Any and every authentication device can be likened
to a perimeter protection to one’s property. The degree of protection
afforded by any particular method is dependent on the technique selected
or the combination of security methods chosen. The greater the number
of techniques and methods used effectively raises the odds against being
counterfeited. We all protect our assets in a number of ways and so
similarly a brand needs to be authenticated and protected by a multitude
of methods for best results.

Counterfeiting causes no cash loss
to the business. Losses due to counterfeiting do not appear in the
profit and loss or the balance statement of the company. As a result
most actions to curb counterfeiting are taken too late and often after
some damage has been caused to the brand. Even the smallest level of
counterfeiting is a serious threat to a business; it has the possibility
to greatly affect the reputation and future viability of a company.

The
counterfeit eats away at a brand’s good will and the confidence in the
product which has been built with care and great expense over many
years.

Counterfeiting can destroy brands in shorter time than it
takes to build the brand. Today not taking action in protecting the
brand is not an option.

Authentication techniques
A thorough brand authentication system has three levels :
? Deter – a highly visible device to deter counterfeiters and is known as overt security.
? Detect – a device that is not easily visible, often hidden and known to the manufacturer only, known as covert security.
?
Forensic – this device would also be hidden and would require special
equipment or test in a laboratory to verify its authenticity. This is
also a covert device.

To have a successful brand authentication
device, one does not necessarily require all the three elements to be
incorporated into a system. In many cases, it would not be practical and
probably for most applications uneconomical. In practice, just the fact
of applying a deterrent device is sufficient to stop most
counterfeiting activity. It is very much like protecting one’s house
just by locking the doors and windows with adequate locks. But if more
security is required then one adds grills, bars across doors, 24 hour
security guard, CCTV, etc. Similarly if your brand is likely to be at
great risk of being counterfeited then one must incorporate a range of
overt, covert and forensic features in the authentication system.

The
method chosen must be “optimal”, not too much and not too little, but
just right. Just right can be achieved by reviewing and assessing the
risks likely to be faced by the brand. Establishing terms of reference,
then setting goals and key objectives that must be met. Then selecting
the right set of authentication and security devices, taking care to see
that the device is easy to validate, easy of incorporate, cost
effective, etc. In such a situation it is good to apply the Pareto
principle to achieve one’s goals. In order to approach the process of
arriving at a logical decision it may be beneficial to use a spider
chart to compare the various methods and combination of methods being
investigated. By comparing various options on the same chart one can see
where they overlap and where they compensate each other.

What is important is to set clear non negotiable objectives to meet goals set for the brand.
? Clear objectives
? Budget for buying and implementation (some devices are cheap to buy, but very expensive to implement).
? Select device economical devices that address most of your requirement – use the Pareto principle.
? Monitor incidences of counterfeiting and progressively improve the deterrence.
?
Companies looking to address counterfeiting situation should consider
establishing a multi disciplinary team, preferably headed by a
director, to work on the issue. Successful implementation is typically
the result of careful team work with all the stakeholders within the
company and the vendors also.

When deciding on the level and type
of brand authentication required, the company needs to make sure the
solution they choose is compatible with their existing set up. From the
above table, one can see that there are many different ways to protect
and the right selection will depend on your goals and objectives.

A review of the types of security devices suitable for use in India:
Substrates:
Watermark paper, incorporating special micro-tagants and fibres in the
paper can provide excellent security. Typically this special substrate
affords very high level of security. However, as the substrate has to
be custom made and has to be purchased in large quantities, this means
that there would be a large stock of special substrate that needs to be
held under tight security; this can be expensive.

Inks: wide
range of special inks are available at relatively economical rates,
needing special test by an expert, or equipment and cannot easily be
detected by the buying consumer. It is ideal for, “back to base’ testing
and forensic use. Excellent when multiple security techniques are used
in combination.

Chemical markers: This is basically a “back to
base”test and verification as it needs special chemicals to conduct the
required tests and this usually renders the package un-saleable, but
suitable when multiple security techniques are used.

Diffractive
optical variable devices: technical term that encompasses many optical
systems and particularly the hologram. Hologram is very versatile, it is
overt, with bright kinetic colours, very difficult to duplicate (that
is why over 88 currencies around the world have holograms on them to
combat the counterfeiters – the Pound Sterling, Euro, Swiss Franc, etc),
can have covert features within the image at several levels and is
machine readable.

For value for money and the security afforded, there is nothing to date to beat the hologram.

RFID:
excellent technology for tracking large shipments, but it has not yet
met the standard for item wise application in the pharmaceutical arena.
Also it requires tremendous electronic infrastructure and that makes it
very expensive for most medicines.

Track & Trace (T&T):
Ideal system to track and trace the medicine (using mass serialisation)
from the producing factory to the sales point. The application of the
mass serialisation, though very economical, but often it is not
practicable as it also requires costly electronic infrastructure to
ensure complete traceability.

From the above it can be seen that
the hologram appears to be the best and economical all rounder and has
proven itself, hence its use on currency notes around the world.

Why is the hologram successful?
? Hologram is based on optical technology.
? Cannot be scanned or electronically transmitted
? Hologram is viewed by refraction of light — impossible to photocopy.
? Cannot be simulated by any known printing technique.
? Involves the viewer — image is kinetic – image moves, colour changes, different images at different angles.
? Economical — unit value of a hologram is low compared to its effectiveness.
? Holograms combined with other technologies makes it a formidable combination for brand authentication.

It
is being agreed internationally, that counterfeiting is prevalent
(finding a solution to any problem is to first recognise that there is a
problem and then act to find an answer to solve it) and pharmaceutical
manufacturers must take protective action and prevent their product
brands from being counterfeited. The experience of companies that have
taken a lead in protecting their brands is very positive. International
companies use overt anti counterfeit systems like holograms because they
are able to make a return of 600% - 2000% or Rs.6 to Rs.20 for every
rupee invested in the hologram security to authenticate the brand. The
returns are real and tangible. Corporations the world over and in India
continue to use the hologram because they make returns, which far
outweigh the input costs. The computation below is a typical example.

The
key to successful brand authentication is to take preventive action and
if this is not possible to take immediate action by applying a brand
authentication device and then observing and improving and applying a
combination of devices where necessary. You can only win by protecting
your valuable brand.

The author is the Chairman ofHolographic Security Marking Systems Pvt Ltd