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Basic solution
conguration set-up
that lacks exibility and
adaptation.
Conguration is
repeatable, but needs
detailed study and
design modication to
the code base.
Data and packaging
line congurations
are well-dened and
designed with elements
that can be assembled
and realigned to
quickly accommodate
changing demands.
Data management
and line-specic
congurations are
captured at the
planning stage and
global templates are
in place.
Adaptable, exible
congurable serialization
solution enabling support
of wide variety of packaging
line functions.
R
a
p
i
d
D
e
p
l
o
y
m
e
n
t
Solution deployment
is planned for only
the pilot line with no
replicable code base.
Solution can be
modied and installed
in similar packaging
lines, but not readily
repeatable and the
timelines are not
predictable.
Deployment plan is
well-dened with all
common site and
packaging-line-specic
serialization variations
with actionable
timelines.
Deployment plans
support multiple
serialization and
coding requirements
with manageable
timelines.
Global development
playbook is in place and
the solution is readily
installable, replicable and
easily upgradable across
packaging lines and
locations.
cognizant 20-20 insights 6
parts of the world, somewhere between 30%
and 50% of drugs to treat serious diseases are
actually counterfeit, said Food and Drug Admin-
istration commissioner Margaret Hamburg,
who added that the problem is growing every
day.
3
Meanwhile, Joe Ringwood, chief operating
ofcer of Systech International, noted: Phar-
maceutical counterfeiting is a global problem
that is growing rapidly.
4
As a result, serialization
has the potential to be a very efcient tool for
pharmaceuticals leaders in the ght against
counterfeiting.
Managing the transformation is a crucial and
essential part of the overall serialization imple-
mentation strategy. By choosing a reliable partner
and developing a diligent implementation plan,
manufacturers can realize even greater benets
such as total supply chain visibility and reduced
product recalls, over and above what is required
by regulatory compliance.
Making the right investments in the right
technology with the right business partner can
only help the pharmaceuticals ecosystem
manufacturers, wholesalers, distributors and
pharmacies alleviate and eventually eliminate
the threat of counterfeited drugs to patient safety
and wellness. Successful serialization will be a key
differentiator and a clear competitive advantage
for pharmaceuticals companies in the near term
and over the long haul as drug counterfeiting is
reduced to a distant memory.
Quick Take
We helped in implementing serialization for a
leading global pharmaceutical major.
Scenario
Client wanted to implement e-code serialization
which uses common capabilities (PIE, PIMMS,
EPCIS) and is designed to meet global standards
and service all markets.
A complete solution was required to address
data management and packaging functions.
Our Role
Ensuring client standards are met through
engaging appropriate architecture, EIS and
quality resources at the right time.
Engaging with other teams to deliver project
requirements.
Managing and monitoring the change
management plan.
Managing IT risks and issues.
Providing regular status reports to IT
management.
Benets Attained
Track-and-trace products deployed from the
point of packaging to the pharmacy.
Reduced the risk of counterfeit products being
dispensed.
Expired products now detected automatically.
Performs product recalls more effectively and
efciently.
Delivers the right product to the right patient.
E-code Serialization for a Pharma Major
cognizant 20-20 insights 7
Footnotes
1
GS1 is the international standards group whose healthcare component is working on pharmaceuticals
product tagging standards. The GS1 system of standards is the most widely used supply-chain standards
system in the world. It is composed of four key standards: barcodes (used to automatically identify items),
eCom electronic business messaging standards allowing automatic electronic transmission of data,
global data synchronization standards (GDSN), which allow business partners to have consistent item data
in their systems at the same time and EPCglobal which uses RFID technology for real-time item tracking.
For more information: http://www.gs1.org/about/overview.
2
Mass Serialization in the European Pharmaceuticals Market, Frost & Sullivan, page 23.
www.frost.com/prod/servlet/cio/140658996
3
http://drugstorenews.com/article/counterfeit-threat-intensies
4
http://www.contractpharma.com/issues/2012-03/view_features/packaging-serialization-update/
References
World Health Organization, Medicines: Counterfeit Medicines, Fact sheet No. 275 (January 2010),
available at www.who.int/mediacentre/factsheets/fs275/en.
Pharmaceuticals and Packaging News (PMP News), Combating Counterfeits, Sept. 9, 2011, available
at http://www.pmpnews.com/article/combating-counterfeits.
Center of Medicines in the Public Interest, Counterfeit Drugs and China NEW, available at
http://www.cmpi.org/in-the-news/testimony/counterfeit-drugs-and-china-new.
Pharmaceuticals and Packaging News (PMP News), Best Practices in Serialization, June 18, 2009,
available at http://www.pmpnews.com/article/best-practices-serialization.
GS1 Healthcare Reference book 2011/2012: http://www.gs1.org/docs/healthcare/GS1_Healthcare_
Reference_Book_2011-2012.pdf.
Life Science leader The Long Road to Serialization and Track and Trace, March 27, 2012, http://www.
lifescienceleader.com/magazine/current-issue-3/item/4083-long-road-to-usserialization-Track-and-trace.
Life Science Leader Planning Serialization for Pharmaceuticals Manufacturer:
http://www.lifescienceleader.com/magazine/current-issue-3/item/4124-planning-serializationfor-
Pharmaceuticals-manufacturers.
EFPIA Coding and Identication of Products: Towards Safer Medicines Supply:
http://www.efpia.eu/Content/Default.asp?PageID=566
Other Useful Links
http://www.bluespherehealth.com/wordpress/?p=236
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2888553
http://www.healthcarepackaging.com/archives/2012/02/fda_changes_to_drug_bar_code_r.php
http://www.bluespherehealth.com/wordpress/?tag=serialization
http://www.bluespherehealth.com/wordpress/?p=845
About Cognizant
Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process out-
sourcing services, dedicated to helping the worlds leading companies build stronger businesses. Headquartered in
Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry
and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 50
delivery centers worldwide and approximately 150,400 employees as of September 30, 2012, Cognizant is a member of
the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing
and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.
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About the Authors
Aravindhan Ramakrishnan is a Senior Consultant within Cognizant Business Consulting. He has extensive
experience across life sciences, energy and consumer goods industries. As an operations and technology
expert Aravindhan has been working with clients to help them transform their businesses. He focuses
on strategy development and implementation, technology strategy, organization design, operational
excellence and innovation management. Prior to Cognizant, Aravindhan was employed by IBMs Strategy
& Transformation Practice and by Honeywell. He holds a bachelors degree in engineering and an M.B.A.
Aravindhan can be reached at Aravindhan.Ramakrishnan@cognizant.com.
Ghazala Yasmin is a Consultant within Cognizant Business Consulting. She has over one year of experience
in management consulting and business development, and has supported projects across various
industries: life sciences, chemicals and consumer goods. She holds a bachelors degree in chemical engi-
neering and an M.B.A. from NITIE, Mumbai. Ghazala can be reached at Ghazala.Yasmin@cognizant.com.