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Medical
Product
Security
nonClonableIDTM
LABEL WITH BARCODE
Bilcare Technologies is a
division of Bilcare Ltd. focused
on creating next-generation
anti-counterfeiting, security,
and brand protection solutions
for a broad range of
industry sectors.
With breakthrough research in
nanotechnology, Bilcare
has developed a unique
technology-nonClonableID™-
that enables products to be
authenticated as they move
through the supply chain to
the end consumer.
elephantdesign.com
© 2010, Bilcare Ltd. All Rights Reserved. All product names, and logos mentioned herein are the trademarks or reg-
istered trademarks of Bilcare. No part of this document should be circulated, quoted, or reproduced for distribution
without prior written approval from Bilcare Ltd.
www.bilcaretech.com
tech@bilcare.com
Americas
USA
Bilcare Inc.
300 Kimberton Road Phoenixville, PA 19460
+1 610 422 3305
Europe
UK
Bilcare Technologies
Malvern Hills Science Park, Geraldine Road,
Malvern, WR14 3SZ, United Kingdom
+44 (0) 1684 585 257
Italy
Bilcare Technologies Italia Srl
Presso Veneto Nanotech,
Via San Crispino 106,
35129 Padua, Italy
+39 (049) 7705514
Asia
India
Bilcare Ltd.
601, ICC Tower, B Wing,
Pune 411 016
+91 (20) 30257700
Singapore
Bilcare Technologies Singapore Pte. Ltd.
52 Changi South Street
1, Singapore 486161
+65 63954130
Counterfeit drugs
in legitimate drug supply
Extent
of the problem
With the help of technology, counterfeiters are becoming more sophisticated and
capable thus making their fake goods hard to detect.
• $12M in Counterfeit Drugs
Seized in Southeast Asia;
January 28, 2010
• Counterfeit Drug Ring Busted in
Montreal; August 6, 2009
• Counterfeit Drugs Seized in
Kenya: July 30, 2009
• Medical Sales Representative
Caught Selling Fake Flu
Vaccines; July 28, 2009
• Counterfeit Anti-malarial Drugs
Found in Ghana; July 22, 2009
• 2 Million Counterfeit Needles
Found in Europe: July 9, 2009
The World Health Organization
(WHO) estimates that up to
15% of the $500bn world
pharmaceutical market is
counterfeit (up to 25% in some
countries).
PROBLEMPROBLEM
These are just some of the key
incidents of counterfeit drugs
in the legitimate drug supply
documented by the Counterfeit
Drug Incident Encyclopedia.
According to the Pharmaceutical
Security Institute (PSI) ,
counterfeiters sold more than
600 different types of branded,
generic and over-the-counter
drugs in 2007 (up more than 14
percent from 2006), including
expensive lifestyle drugs,
inexpensive pain relievers, and
essential medicines.
0 2 0 3
Are these issues impacting your brand reputation and revenues?
Impacting
brand reputation
and revenues
Current ecosystem
proliferates counterfeiting
Pharmaceutical counterfeiting is a serious global problem. The pharmaceutical industry
is facing significant challenges in its ability to combat counterfeiting amidst the
complexity of globally integrated supply chains.
•	 Counterfeits affecting
your brand
•	 Look-alikes riding on
your brand
•	 Revenue leakages from:
•	Imitation/spurious drugs
•	Product overruns
•	Drugs diverted from
institutions and doctors
•	Drugs diverted within
distributed channels
•	Expired recycled products
•	 Inadequate supply chain
visibility and security
Problems driving the growth of
counterfeiting
•	 Limited end-user ability to
recognize counterfeit
from original
•	 More outsourcing resulting in
less controls
•	 Easy availability of bulk supplies
to manufacturers
•	 Fragmented and parallel
distribution channels
•	 High distribution margin
offered by counterfeiters
•	 Vulnerable institutional
sales with easy access to
regular channels
PROBLEMPROBLEM
•	 Inability to authenticate
products through the
supply chain
•	 Inadequate control mechanism
in contract manufacturing
•	 Loosely controlled reverse
supply chain
To protect against the increasing
threat of counterfeiting,
companies need to adopt a
holistic approach and build a
secure ecosystem to prevent
breaches right from the
point-of-origin to the
point-of-use.
0 4 0 5
Bilcare Technologies offers a comprehensive solution with multiple checkpoints within
the supply chain to identify counterfeits. It can also address unauthorized activities of
players within the legal pharmaceutical supply chain. Bilcare adopts three approaches
to effectively address unauthorized activities by channel partners and secure the
supply chain:
A comprehensive
approach
Capabilities for
the brand owner
Bilcare’s comprehensive approach leverages Secure Process Control, Secure Systemic
Lock, Authentication and Track-and-Trace to offer the following Solution Capability for
the brand owners:
•	 Secure Process Control and
Authentication
	 Product sample authentication
at targeted checkpoints in
the distribution chain results
in evidence-based “policing”
of the legal system from
counterfeit infiltration.
•	 Irreproducible and secure
product authentication online
from remote locations through
a handheld device.
•	 Four-dimensional product
track-and-trace – enables
building a log of all events in
the product lifecycle from the
point-of-manufacture to the
point-of-sale.
•	 Secure supply chain – product
authentication and track-and-
trace through an auditing
program provides the ability to
detect counterfeit products.
SOLUTIONSOLUTION
•	 Secure Systemic Lock
•		Our solution creates a
stakeholder ecosystem that
prevents the counterfeit in
scope with direct impact
on product overruns, drug
diversions and recycled drugs
•		A claims gateway tracks all
claims made by stockists or
other channel partners thus
acting like a system deterrent
to malpractice.
•		A compliance gateway
tracks the drug consumption
patterns of enrolled
patients driving higher
patient compliance.
•	 Effective claims
and promotional
products management.
•	 Ability to take corrective
and preventive action
through alerts and reporting
mechanisms that help in
plugging the loopholes in the
supply chain.
•	 Effective auditing programs.
•	 Business intelligence – reports
on performance of supply
chain partners and
anti-counterfeiting
program effectiveness.
•	 Secure Track-and-Trace	
A four-dimensional (What,
Why, When, Where) EPICS-
standard compliant object
event repository for identifying
the areas where counterfeit
products enter the supply
chain, Product Tracking 
Authentication (PTA) and
business intelligence (e.g.
diversion reporting, product
recall support, chargeback
claims reconciliation).
0 6 0 7
Brand Owner
Contract
Manufacturer
Drug Destruction
Agency
Captive
Manufacturer
StockistStockist
Distributor
Institutions
(Defense /
Govt. Hospitals)
• Retailer
• Chemist Retailer
• Chemist
Doctors
Patient
Re-Circulation
of Expired Drugs
Issuance of tags by Bilcare as
per scheduled contractual
agreements between BO and
contract manufacturer
Capture outbound supplies,
counterfeit check and drug
diversion control
Capture outbound supplies at
stockist through claims gateway
and counterfeit check
Sampling and audit at retailer
and counterfeit check.
Reporting and alerting services
Label authentication on the
production line
1
2
3 5
6
4
1
2 3
5
6
Counterfeit
Manufacturer
Brand Owner
Key Distribution Channel
4
The solution enables a systemic way of tracking activities in the supply chain
through multiple checkpoints and provides an indication to the brand
owner about the possible locations where counterfeits are getting in.
nonClonableID™ LABEL WITH BAR CODE
The solution enables a systemic way of tracking activities in the supply chain through
multiple checkpoints and provides an indication to the brand owner about the possible
locations where counterfeiters are getting in.
How it works Secure management of
the supply chain
Enhanced brand recognition in the marketplace, brand loyalty from patients and
an ecosystem that discourages counterfeiters.
BENEFITSSOLUTION
•	 Secure process control
prevents counterfeit products
from entering the supply
chain, plugs diversion in the
distribution channel and tracks
expired drugs.
•	 Secure systemic lock
prevents an unauthorized
manufacturing overrun and
prevents recycled, expired
drugs from entering the legal
distribution channel.
•	 Product authentication
capability on the ground
secures brand value.
Bilcare’s solution combats
counterfeiting through the
implementation of its unique
nonClonableID™ technology.
Integrated as unit-level labels on
blister packs, secondary packaging
or tamper-evident closure
labels, nonClonableID™ enables
identification, authentication and
brand protection. The system
enables real-time authentication
across the supply chain from
a central database through
handheld portable readers.
0 8 0 9
The nonClonableID™ label is a
unique, materials-based
fingerprint consisting of randomly
distributed particles and cannot
be reproduced even by Bilcare.
Bilcare’s system is designed to be
compatible with the upcoming
legislation in Europe and can
also integrate with national and
regional labeling legislations
where required.
Tracking of potential
sources of counterfeits in
the distribution chain
Paving the way for
a robust ecosystem
BENEFITSSOLUTION
Brand Owners
•	 Prevents counterfeits from
affecting the brand
•	 Sales increase / increased sales
volume at higher price
•	 Prevents counterfeit products
from entering the supply chain
•	 Increased profitability
•	 Enhanced brand image
•	 Better control over
material consumption
•	 Cleaned up distribution
channel
•	 Better market penetration due
to focused regional promotions
•	 Right price for consumers and
better visibility of product flow
•	 Stops misuse of
government funds
•	 Better tracking in government
audit programs
(Drug Inspectors)
•	 Increases legal sales
•	 Pushes back illegal channels
Consumer
•	 Assured genuine medicine
•	 Improved health outcome
•	 Ensures value for money
•	 Safeguard sales in
unintended markets
•	 Reduced product claims
•	 Reduction in claim
processing expenses
Government
•	 Enhanced country/
government image
•	 Protection of citizen health and
assures government credibility
•	 Increased exports
•	 Reduced economic offence in
the distribution channel	
•	 Enhanced regulatory control in
the distribution channel
Brand Owner
Patient
Counterfeit API
Counterfeit
Medicinal
Product
Counterfeit
Medicinal
Product
Counterfeit
Medicinal
Product
API Manufacturer
Medicinal
Products
Manufacturer Wholesaler 1 Wholesaler 2
Dispenser
(Pharmacy, Hospital)
Sub-contracted
Manufacturer
Sub-contracted
Manufacturer
1 0 1 1

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Pharma

  • 1. Medical Product Security nonClonableIDTM LABEL WITH BARCODE Bilcare Technologies is a division of Bilcare Ltd. focused on creating next-generation anti-counterfeiting, security, and brand protection solutions for a broad range of industry sectors. With breakthrough research in nanotechnology, Bilcare has developed a unique technology-nonClonableID™- that enables products to be authenticated as they move through the supply chain to the end consumer. elephantdesign.com © 2010, Bilcare Ltd. All Rights Reserved. All product names, and logos mentioned herein are the trademarks or reg- istered trademarks of Bilcare. No part of this document should be circulated, quoted, or reproduced for distribution without prior written approval from Bilcare Ltd. www.bilcaretech.com tech@bilcare.com Americas USA Bilcare Inc. 300 Kimberton Road Phoenixville, PA 19460 +1 610 422 3305 Europe UK Bilcare Technologies Malvern Hills Science Park, Geraldine Road, Malvern, WR14 3SZ, United Kingdom +44 (0) 1684 585 257 Italy Bilcare Technologies Italia Srl Presso Veneto Nanotech, Via San Crispino 106, 35129 Padua, Italy +39 (049) 7705514 Asia India Bilcare Ltd. 601, ICC Tower, B Wing, Pune 411 016 +91 (20) 30257700 Singapore Bilcare Technologies Singapore Pte. Ltd. 52 Changi South Street 1, Singapore 486161 +65 63954130
  • 2. Counterfeit drugs in legitimate drug supply Extent of the problem With the help of technology, counterfeiters are becoming more sophisticated and capable thus making their fake goods hard to detect. • $12M in Counterfeit Drugs Seized in Southeast Asia; January 28, 2010 • Counterfeit Drug Ring Busted in Montreal; August 6, 2009 • Counterfeit Drugs Seized in Kenya: July 30, 2009 • Medical Sales Representative Caught Selling Fake Flu Vaccines; July 28, 2009 • Counterfeit Anti-malarial Drugs Found in Ghana; July 22, 2009 • 2 Million Counterfeit Needles Found in Europe: July 9, 2009 The World Health Organization (WHO) estimates that up to 15% of the $500bn world pharmaceutical market is counterfeit (up to 25% in some countries). PROBLEMPROBLEM These are just some of the key incidents of counterfeit drugs in the legitimate drug supply documented by the Counterfeit Drug Incident Encyclopedia. According to the Pharmaceutical Security Institute (PSI) , counterfeiters sold more than 600 different types of branded, generic and over-the-counter drugs in 2007 (up more than 14 percent from 2006), including expensive lifestyle drugs, inexpensive pain relievers, and essential medicines. 0 2 0 3
  • 3. Are these issues impacting your brand reputation and revenues? Impacting brand reputation and revenues Current ecosystem proliferates counterfeiting Pharmaceutical counterfeiting is a serious global problem. The pharmaceutical industry is facing significant challenges in its ability to combat counterfeiting amidst the complexity of globally integrated supply chains. • Counterfeits affecting your brand • Look-alikes riding on your brand • Revenue leakages from: • Imitation/spurious drugs • Product overruns • Drugs diverted from institutions and doctors • Drugs diverted within distributed channels • Expired recycled products • Inadequate supply chain visibility and security Problems driving the growth of counterfeiting • Limited end-user ability to recognize counterfeit from original • More outsourcing resulting in less controls • Easy availability of bulk supplies to manufacturers • Fragmented and parallel distribution channels • High distribution margin offered by counterfeiters • Vulnerable institutional sales with easy access to regular channels PROBLEMPROBLEM • Inability to authenticate products through the supply chain • Inadequate control mechanism in contract manufacturing • Loosely controlled reverse supply chain To protect against the increasing threat of counterfeiting, companies need to adopt a holistic approach and build a secure ecosystem to prevent breaches right from the point-of-origin to the point-of-use. 0 4 0 5
  • 4. Bilcare Technologies offers a comprehensive solution with multiple checkpoints within the supply chain to identify counterfeits. It can also address unauthorized activities of players within the legal pharmaceutical supply chain. Bilcare adopts three approaches to effectively address unauthorized activities by channel partners and secure the supply chain: A comprehensive approach Capabilities for the brand owner Bilcare’s comprehensive approach leverages Secure Process Control, Secure Systemic Lock, Authentication and Track-and-Trace to offer the following Solution Capability for the brand owners: • Secure Process Control and Authentication Product sample authentication at targeted checkpoints in the distribution chain results in evidence-based “policing” of the legal system from counterfeit infiltration. • Irreproducible and secure product authentication online from remote locations through a handheld device. • Four-dimensional product track-and-trace – enables building a log of all events in the product lifecycle from the point-of-manufacture to the point-of-sale. • Secure supply chain – product authentication and track-and- trace through an auditing program provides the ability to detect counterfeit products. SOLUTIONSOLUTION • Secure Systemic Lock • Our solution creates a stakeholder ecosystem that prevents the counterfeit in scope with direct impact on product overruns, drug diversions and recycled drugs • A claims gateway tracks all claims made by stockists or other channel partners thus acting like a system deterrent to malpractice. • A compliance gateway tracks the drug consumption patterns of enrolled patients driving higher patient compliance. • Effective claims and promotional products management. • Ability to take corrective and preventive action through alerts and reporting mechanisms that help in plugging the loopholes in the supply chain. • Effective auditing programs. • Business intelligence – reports on performance of supply chain partners and anti-counterfeiting program effectiveness. • Secure Track-and-Trace A four-dimensional (What, Why, When, Where) EPICS- standard compliant object event repository for identifying the areas where counterfeit products enter the supply chain, Product Tracking Authentication (PTA) and business intelligence (e.g. diversion reporting, product recall support, chargeback claims reconciliation). 0 6 0 7
  • 5. Brand Owner Contract Manufacturer Drug Destruction Agency Captive Manufacturer StockistStockist Distributor Institutions (Defense / Govt. Hospitals) • Retailer • Chemist Retailer • Chemist Doctors Patient Re-Circulation of Expired Drugs Issuance of tags by Bilcare as per scheduled contractual agreements between BO and contract manufacturer Capture outbound supplies, counterfeit check and drug diversion control Capture outbound supplies at stockist through claims gateway and counterfeit check Sampling and audit at retailer and counterfeit check. Reporting and alerting services Label authentication on the production line 1 2 3 5 6 4 1 2 3 5 6 Counterfeit Manufacturer Brand Owner Key Distribution Channel 4 The solution enables a systemic way of tracking activities in the supply chain through multiple checkpoints and provides an indication to the brand owner about the possible locations where counterfeits are getting in. nonClonableID™ LABEL WITH BAR CODE The solution enables a systemic way of tracking activities in the supply chain through multiple checkpoints and provides an indication to the brand owner about the possible locations where counterfeiters are getting in. How it works Secure management of the supply chain Enhanced brand recognition in the marketplace, brand loyalty from patients and an ecosystem that discourages counterfeiters. BENEFITSSOLUTION • Secure process control prevents counterfeit products from entering the supply chain, plugs diversion in the distribution channel and tracks expired drugs. • Secure systemic lock prevents an unauthorized manufacturing overrun and prevents recycled, expired drugs from entering the legal distribution channel. • Product authentication capability on the ground secures brand value. Bilcare’s solution combats counterfeiting through the implementation of its unique nonClonableID™ technology. Integrated as unit-level labels on blister packs, secondary packaging or tamper-evident closure labels, nonClonableID™ enables identification, authentication and brand protection. The system enables real-time authentication across the supply chain from a central database through handheld portable readers. 0 8 0 9 The nonClonableID™ label is a unique, materials-based fingerprint consisting of randomly distributed particles and cannot be reproduced even by Bilcare. Bilcare’s system is designed to be compatible with the upcoming legislation in Europe and can also integrate with national and regional labeling legislations where required.
  • 6. Tracking of potential sources of counterfeits in the distribution chain Paving the way for a robust ecosystem BENEFITSSOLUTION Brand Owners • Prevents counterfeits from affecting the brand • Sales increase / increased sales volume at higher price • Prevents counterfeit products from entering the supply chain • Increased profitability • Enhanced brand image • Better control over material consumption • Cleaned up distribution channel • Better market penetration due to focused regional promotions • Right price for consumers and better visibility of product flow • Stops misuse of government funds • Better tracking in government audit programs (Drug Inspectors) • Increases legal sales • Pushes back illegal channels Consumer • Assured genuine medicine • Improved health outcome • Ensures value for money • Safeguard sales in unintended markets • Reduced product claims • Reduction in claim processing expenses Government • Enhanced country/ government image • Protection of citizen health and assures government credibility • Increased exports • Reduced economic offence in the distribution channel • Enhanced regulatory control in the distribution channel Brand Owner Patient Counterfeit API Counterfeit Medicinal Product Counterfeit Medicinal Product Counterfeit Medicinal Product API Manufacturer Medicinal Products Manufacturer Wholesaler 1 Wholesaler 2 Dispenser (Pharmacy, Hospital) Sub-contracted Manufacturer Sub-contracted Manufacturer 1 0 1 1