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Technology in The Pharma Supply Chain A Focus On Anti Counterfeiting in India PDF
Technology in The Pharma Supply Chain A Focus On Anti Counterfeiting in India PDF
A White Paper by
Frost & Sullivan
TABLE OF CONTENTS
Business Case: Technologies and Their Application for the Pharma Supply Chain
........................................................................................................................ 15
Annexure ......................................................................................................... 18
FROST & S U L L I VA N Technology in the Pharma Supply Chain A Focus on Anti-Counterfeiting in India
The Indian pharmaceutical industry is 3rd largest in the world in terms of volume
accounting for 10 percent of worlds production and stands 14th in terms of value.
According to data published by the Department of Pharmaceuticals, Ministry of
Chemicals and Fertilizers, the total turnover of Indian Pharma Industry is US$21
billion. Out of this total, domestic formulations market was worth US$8.34 billion
and total APIs market was worth US$3.92 billion. Total Export market was worth
US$8.47 billion. Indian exports go to more than 200 countries around the globe
including the highly regulated markets of US, Europe, Japan and Australia. The
domestic Indian Pharmaceutical market is expected to reach US$ 55 billion in 2020
at a Compound Annual Growth Rate (CAGR) of around 15 percent.
3.92
8.74
8.34
Indian Pharma industry with more than 20,000 registered units is highly fragmented
with severe price competition and government price control. There are
approximately 250 large units and more than 8,000 small scale units, which form the
core of the Pharmaceutical industry in India.
Indian pharmaceutical companies today are known for their global reach with high
quality generic formulations and world class APIs.
The Pharma Supply Chain is highly sensitive where anything less than 100 percent
customer service level is unacceptable as it directly impacts patient health and
safety. The solution that many Pharmaceutical industries adopt is to maintain a large
inventory in the supply chain to ensure close to 100 percent fill rate. However, it is
a challenge to ensure 100 percent product availability at an optimal cost across
multiple locations, unless supply chain processes are streamlined towards customer
needs and demands. In this environment, it is no surprise that companies
throughout the industry are hungry for opportunities to improve the efficiency of
their operations, better understand their customers demands, and devise more
creative responses to the marketplaces challenges.
Until recently, supply chain was used to track and trace the product up to the
retailer. Product dispensation at retailer and replenishment of the stocks at retailer
levels was part of the sales and marketing function.
Patients /
Consumer
Source: Frost & Sullivan
With growing importance of supply chains, technology today has an integral role to
play in the system. Companies today are willing to invest in technology to ensure
seamless order to delivery.
Analytical tools and data-based decision tools such as Enterprise Resource Planning
(ERP) have been implemented by many Pharma companies to fine tune traditional
forecasting and replenishment strategies This analytically driven nimbleness has
allowed leading manufacturers to increase their speed-to-market while improving
their management of working capital critical capabilities in a world where
product lifespans are shrinking year after year. The utility of such an approach for
pharma companies facing tougher generic competition and lengthening R&D
timeframes is obvious.
ERP systems are theoretically based on industry best practices and are intended to
be deployed "as is". ERP vendors do offer customers configuration options that
allow organizations to incorporate their own business rules but often functionality
gaps remain even after the configuration is complete.
ERP's scope usually implies significant changes to staff work processes and
practices. Generally, three types of services are available to help implement such
changes: consulting, customization, and support. Implementation time depends on
business size, number of modules, customization, the scope of process changes, and
the readiness of the customer to take ownership for the project. Modular ERP
systems can be implemented in stages. The typical project for a large enterprise
consumes about 14 months and requires around 150 consultants. Small projects can
require months; multinational and other large implementations can take years.
Customization can substantially increase implementation times.
Advantages
The fundamental advantage of ERP is that integrating the myriad processes by which
businesses operate saves time and expense. Decisions can be made more quickly
and with fewer errors. Data becomes visible across the organization. Tasks that
benefit from this integration include:
billion worth of counterfeit drugs will be sold annually. Fake drug sales are expected
to grow at 13 percent yearly until 2010, a rate significantly higher than the
estimated 7.5 percent annual growth for genuine pharmaceutical commerce. The
Indian Government recently passed a law mandating the use of track-and-trace
barcodes on all drugs meant for export, effective July 2011, following reports that
Chinese counterfeiters were selling fake medicines labelled Made in India in
several African countries.
Developing nations are technologically well behind, primarily due to the fact that
new anti-counterfeit technologies are oft beyond their means. History has shown
that by the time such technologies are affordable, resourceful counterfeiters could
have copied the technology, turning it into a great risk consumers can have a false
sense of security in "protected" counterfeit products. This trend is evidenced in
events that have led to the compromising of microprint, advanced product
packaging, security inks, tableting molds, unique blister packs and even holograms as
fool-proof product security technologies.
1. Holograms
This category is preferred as a passive technology. The creation of a holographic
image, or hologram, requires some technical knowledge and expertise, though a
recent explosion of companies and low-cost machinery has made this technology
extremely accessible within many sectors of the consumer marketplace. A hologram
typically incorporates an image that appears as an illusory 3-dimensional object
with vivid depth characteristics.
Advantages
Holograms and security seals are generally low priced, easy to apply, and represent
a rapid way of providing a distinguishing feature to a branded product.
Disadvantage
The major disadvantage is this solution is easily replicable by a counterfeiter, and
indeed, there have been numerous instances where genuine security holograms
have been easily and expertly copied or simulated, leading to the contention that
holograms when used alone are less about security and more about sparkle. The
fact that fake holograms used by counterfeiters are not easily distinguishable by the
consumer because many products available in the marketplace have holograms; it is
extremely difficult for consumer to keep up with which products should contain a
particular type of hologram or seal.
!" #$
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2. Taggants
This category of anti-counterfeiting solutions is referred to as the active
technologies because they all require an active process during the act of
verification. The application of the various technologies in this category begins with
the insertion or placement of a special marker or device, which is known as a
taggant, into or upon the branded product. In some instances, the taggant can be
placed on the package whereas in others, it can be incorporated directly into the
product itself. In all cases, the subsequent act of authenticating the product requires
a specialized device, reader, or scanner. Each type of taggant can only be detected
by its own specific reader.
RFID technology, however, has not broken through in terms of its use as a pure anti-
counterfeiting tool in the pharmaceutical industry. RFID industry has undertaken
major efforts to promote this technology as a valid anti-counterfeiting solution.
Advantages
The major advantages of RFID relate to its wireless nature. The tags do not
require line-of-sight or any direct human intervention in order to capture the
digital information. As a result, RFID tags can be hidden in packages so as to
!" #$
1 2 3 4 5
3. Barcode Applications
This category of anti-counterfeiting solutions includes those technologies, which
encode individual branded products in an overt digital manner. The digital
information can appear on a product as a human-readable code (that is,
alphanumeric script) and in terms of a barcode, such as the traditional linear format
or the new generation of 2D barcodes.
Advantages
The 2D barcode technology has now surpassed RFID as the most prominent
track and trace technology for pharmaceutical applications. The European
Federation of Pharmaceutical Industries and Associations (EFPIA) have clearly
come down on the side of 2D barcode.
The cost of 2D barcodes is very low compared to all other technologies. 2D
barcodes offer similar functionalities to RFID at only a fraction of the cost.
Consumer convenience and empowerment will soon be possible because the
emergence of mobile decoders allows consumers to directly interact with the
codes and obtain immediate validation.
Disadvantage
All barcode technologies were originally developed as an inventory and supply chain
management tool and not as anti-counterfeiting applications. As a result, a robust
system of encoding products for authentication and brand protection via a universal
standard was never put in place. The development of 2D barcodes, however, has
now paved the way for their use as an anti-counterfeiting tool. In this regard, two
new technologies have emerged that take advantage of the power of 2D barcodes
and the rapid growth and sophistication of mobile telephony.
!" #$
1 2 3 4 5
3. Code labeling
7. Consumer authenticate
products through mobile
4. Shipping
6. Consumer purchase
The technology provider generates a code; it is entered into a database that can be
used later at the verification stage. The database itself is managed and maintained
either by the technology provider or the brand owner. The code is printed in
human-readable form as well as a 2D barcode directly on the product or on a label.
The codes themselves can be numeric, alphabetical, or alphanumeric in nature. The
consumer can visually read the printed script code whereas a barcode scanner can
capture the 2D barcode. The emergence of mobile phones with barcode scanners
now allow consumers to even use their mobile phones to directly read the 2D
barcode.
Advantage
DMS technology directly empowers consumers to verify a medical product. A well-
designed DMS system, however, will itself flag any failed authentication efforts and
communicate this information to the brand owner, along with the date, time, place,
and mobile number of the consumer who had made the verification attempt.
Disadvantage
The major disadvantage to the DMS technology concerns the operational
characteristics and security of the database containing the serial codes. It is well
known that the larger a database becomes, the greater the time needed to find an
individual item within it. Thus, a database containing hundreds of millions (or even
billions) of codes for a major brand owners annual drug production requirements
becomes problematic in terms of database management and speed optimization. The
brand owner will have to adopt extremely high-end database software systems well-
suited for the purpose, which adds significant cost of the solution.
!" #$
1 2 3 4 5
data security. DME can therefore be considered to be a more advanced and highly
secure version of DMS. The core technology used in DME solution through which
the codes are created and authenticated is fundamentally different from DMS
whereas serialized codes are generally created by random number generators,
encrypted codes are produced by a cryptographic algorithm. The DME algorithm is
also responsible for the decoding process involved in the authentication step.
The DME code itself can be used by anyone with a mobile phone to authenticate
the product at the point of sale, either through SMS or by way of mobile internet.
The reply message sent by the Pharma Company provides verification on the
authenticity of the product, as well as any other information that the brand owner
wishes to transmit to the consumer (for example, expiry date, MRP, usage cautions,
etc). The communication aspects of this technology can also be of significant
importance in the event of a recall since it allows highest degree of granularity, that
is, right now to the consumer level.
%
!
2. Code labeling
1. Code Generation
6. Consumers authenticate
products through mobile
3. Shipping
5. Consumers purchase
The code generated in a DME system is valid for only one authentication. Multiple
authentications attempts of the same code will raise an alert. Multiple failed
authentications of the same code will raise a flag and when confirmation is made
that a particular code has been replicated on duplicate products that code itself
serves as a tag by which the duplicate products can be identified. In such instances,
consumers are directly warned about the duplicate product and they should report
this case along with other pertinent information to the Pharma Company.
!" #$
1 2 3 4 5
Thus, all of the passive technologies when used alone do not sufficiently empower
consumers in terms of product authentication. The situation changes considerably,
when it comes to the actual ability of an ordinary consumer to use the technology
for authenticating a product. These active technologies are also poor in terms of
consumer empowerment for the simple reason that customers do not carry around
the special readers that are needed for verification. As a result, none of the positive
aspects associated with consumer empowerment are made available to the brand
owner when implementing an active technology. When used as a stand-alone
feature, DMS and DME codes can be verified via SMS on mobile phones, which are
expected to have a market in excess of 850 million subscribers in India alone by
2011. The only technologies that empower consumers in an anti-counterfeiting
requirement are DMS and DME solutions (mass encoding).
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Business Case: Technologies and Their Applications for the Pharma Supply Chain
The technology innovatively exploits the intrinsic nature of nano- and micro-
structured composites together with their magnetic and optical properties to
provide a foolproof security system. It can significantly enhance security levels with
an impregnable personal access control and identity management system.
Features of nonClonableID
Solution Offerings
Pharmaceutical
Bilcare offers a comprehensive brand security solution with multiple
checkpoints within the pharmaceutical supply chain to identify counterfeits. It
can also address unauthorized activities of players within the legal
pharmaceutical supply chain. Bilcares solution ensures enhanced brand
recognition in the marketplace, brand loyalty from patients and an eco-system
that discourages counterfeiters.
Medical Compliance
Patient Compliance
Bilcares solution ensures proper dispensation of medication and compliance
with the medication regimen. It also creates the capability to monitor
compliance on a real-time basis.
Clinicom Solution
nonClonableID enhances the positive outcome of clinical trials by verifying
the authenticity of origin and pedigree of a drug in the clinical trial phase
through its advanced Clinicom solution.
Agrochemicals
Bilcare offers a holistic solution to combat Agrochemical counterfeiting through
the implementation of its unique nonClonableID technology. Integrated as
unit-level tags, nonClonableID enables identification, authentication and
brand protection. With increased visibility across the supply chain,
consignments can be tracked down to individual Stock Keeping Units.
Sproxil Inc.s Mobile Product Authentication (MPA) technology
India ships drugs to over 150 countries and is a key supplier to emerging markets
where counterfeiting is often an issue. Brand and product pirates in Indian markets
pose a significant risk to legitimate Indian manufacturers, leading to brand
degradation, decrease in sales and consumer purchasing apprehension.
Sproxil Inc, a global brand protection company with its novel Mobile Product
Authentication (MPA) technology, would help to restrict proliferation of counterfeit
medicines in developing markets. The company has received a fund infusion of $1.8
million from Acumen to kick start the technology in India and East African countries
of Kenya, Tanzania and Uganda in East Africa.
MPA technology is the worlds only patented consumer SMS (Short Message
Service) verification service via cell phone. It enables consumers to verify the
authenticity of a pharmaceutical product by sending the unique code on the drug as
a free text. Sproxil has ensured smooth compliance of MPA with Indian pharma
companies adhering to the Indian regulatory requirements. The company has
already signed up two major pharma companies in India at Mumbai and Bangalore
who will use MPA to prevent drug counterfeiting.
The US-based company, set up in 2009, launched MPA in February 2010 with Merck
Serono as a pilot project for its anti diabetic product Glycophage. It has established
the first national mobile-based anti-counterfeit service in Africa and sold millions of
anti-counterfeit labels. The anti-counterfeiting strategy is now adopted by
GlaxoSmithKline for its drug Ampiclox and Johnson & Johnson Janssen for its derma
cream Cilag (Nizoral).
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