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www.aspaglobal.com
6
The Authentication Times
Issue 26
There has been a wave in the
global pharmaceutical industry
over the past several years,
driven by the need for battling the
scourge of spurious medicines,
which take thousands of lives
each year. This wave has led
to the evolution of technology
to help regulators ensure that
only genuine medicines are
distributed within or imported
into any market, and to empower
patients to verify that the
medicines they are taking are
indeed what they claim to be.
Serialization is one of the most
widely adopted technologies in
this new wave, and in this article
we present an overview of this
technology and its applications.
What does “Serialization”
mean?
The concept of Serialization is
very simple – allocate a unique
identifier (UID) to each package
of medicine at the primary
(blister pack, aluminium
foil, bottle, etc.), secondary
(monocarton, multicarton) or
tertiary (shipper pack) levels.
Often, relationships are created
across levels, creating a parent-
child hierarchy which is stored
in a database and accessible at
any time. This facilitates tracking
and tracing of these medicines
as they move through domestic
or global supply chains, with
authentication/verification/
registration at each point in the
supply chain.
Why is it needed?
Allocation of a UID to each
package prevents a counterfeiter
from infiltrating the supply chain
withspuriousdrugs,whichwould
of course either not have the
identifier or have a fake identifier
that would not pass verification.
This not only gives regulators the
assurance that every medicine
being sold to consumers within
their jurisdictions is safe and
from a verified source, but also
Serialization for the
Pharmaceutical
industry:
An overview
Nakul Pasricha
CEO, PharmaSecure &
Vice-President (ASPA)
npasricha@pharmasecure.com
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The Authentication Times
Issue 26
Cover Story
Figure: Serialization regulations across the world
empowers consumers to check
for themselves using multiple
channels like SMS, web interface,
mobile application or a call
centre.
Are there any standards
or regulations around it?
Countries around the world have
passed regulations requiring
serialization on all drugs being
distributed within their markets:
• In India, the Directorate
General of Foreign Trade
passed a regulation in 2011
requiring all drug exporters
to implement serialization
and track-and-trace on
primary, secondary and
tertiary levels of packaging.
This regulation has already
been implemented on the
tertiary level in 2011, the
secondary level in 2013, and
is slated to be in effect on the
primary level in 2015. Track-
and-trace and government
reporting requirements are
expected to follow in the
coming years.
• In the United States, the
Drug Supply Chain Security
Act (DSCSA) was signed into
law by President Obama in
November 2013, setting in
motion a process that within
ten years will see product
identification, tracing and
verification as well as
detection and response
processes for prescription
drugs in the U.S. supply chain
(Source: fda.gov)
• The European Union passed
the Falsified Medicines
Directive in 2011 requiring,
among other things,
authenticity features on outer
packaging of medicines. This
directive is in the process of
beingtransposedintonational
law by EU member states, and
will be implemented in the
coming years
• Other countries with similar
regulations in or about to be
in effect include Brazil, China,
South Korea, Turkey and
Saudi Arabia.
While many of these regulations
require GS1standards of
Barcoding to be used for
serialization, some have adopted
proprietary standards. This can
have the effect of requiring a drug
exporter to comply with different
standards with potential for
implementation complexity on

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The Authentication Times
Issue 26
manufacturing lines. Simplicity
and reliabilityof the technology
used for compliance is therefore
essential.
How is it implemented?
Serialization implementation
has a few components:
Format of the UID
The UID is a number or
alphanumeric string of
varying length (for example,
GS1 standards call for it to be
upto 21 characters long). It
can be sequential (e.g. 0001,
0002, 0003, etc.), but for extra
security, we recommend random
alphanumeric strings with no
pattern that can be used by a
counterfeiter to replicate the
system.
Representation of the UID
The UID can be represented
as human readable text that is
printed directly on the package
or on a scratch-off label that is
affixed to the package. It can
also be encoded into a 1-D or 2-D
barcode that is printed on the
package and read by a scanner
or a mobile phone app. Other
representations such as RFID are
also possible depending on the
particular implementation for
which serialisation is required.
Printing of the UID
The UID is printed directly
on the package (as human
readable text or as a barcode)
using a commercial printer,
usually a continuous inkjet,
thermal inkjet or laser printer.
The particular printer of
choice depends on resolution
requirements, printing speeds,
cost, space available and other
factors. There needs to be a
secure system for generation
of the UID, transmission to the
printer, printing on the package
and feedback in order to create
parent-child hierarchies and
record rejections.
Verification of the UID
The UID can be verified using
an SMS gateway, a mobile
app, a website, a call center,
social media or other methods
depending on availability and
cost. In developing countries,
PharmaSecure recommends
SMS as the most widespreadand
inexpensive mode available.
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Tracing of the UID through the
supply chain
Each time the coded package
passes a point in the supply
chain, such as a wholesaler, a
distributor, a shipping port,
a retailer, etc., the code on
the particular package can be
registered using one of the
above-mentioned means. These
events, taken together, constitute
a complete record (Tracking)
of the movement of the drug
package, which can be stored
and provided to regulators
or other stakeholders, and
investigated(Tracing) in cases of
any reported issues.
What is the future of
serialization?
The next few years will be quite
exciting for drug manufacturers
and exporters needing to comply
with the regulations of various
countries. There will be a need
for a comprehensive solution
that can be easily implemented,
meet quality requirements (e.g.
GMP, 21 CFR Part 11), and have
the flexibility to be modified as
global regulations evolve. Since
there are many components
of these implementations, it is
difficult for any one provider
to try to go it alone, and
complementary alliances will be
beneficial for the entire industry.
One example of that is for a
serialization software provider
to partner with a hardware
provider to offer a one-stop
shop kind of solution, or with
a physical security solution
provider (e.g. holograms) to
offer a strong solution with
aspects of digital and physical
security. ASPA provides a great
platform for such engagement
and we at PharmaSecure look
forward to working closely with
other members in order to tackle
the global drug counterfeiting
problem together.