Authentication Solutions are a must to curb spurious medicines There are a variety of solutions available, as per requirement, through member companies of ASPA. The Government of India has already taken steps to protect medicines that are exported. Now it is time to protect medicines that are being distributed and consumed within India.

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Authentication
Solutions to stop the Scourge
of Spurious Medicines
ASPA Press Event
Lucknow
24th May, 2016

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Spurious drugs. –For the purposes of this chapter, a drug shall be deemed to be
spurious, –
(a) If it is manufactured under a name which belongs to another drug; or
(b) If it is an imitation of, or is a substitute for, another drug or resembles another drug
in a manner likely to deceive or bears upon it or upon its label or container the name
of another drug unless it is plainly and conspicuously marked so as to reveal its true
character and its lack of identity with such other drug; or
(c) If the label or container bears the name of an individual or company purporting to
be the manufacturer of the drug, which individual or company is fictitious or does not
exist; or
(d) If it has been substituted wholly or in part by another drug or substance; or
(e) If it purports to be the product of a manufacturer of whom it is not truly a product.
Spurious Medicines: Definition
Drugs and Cosmetics Act, 1940

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Scale of the Problem in India
2012 7% of anti-malarials are fake
2014 10.9% of antibiotics and TB
medicines failed basic quality tests
2016 1 in 7 painkillers (diclofenac
sodium) tested found to be
substandard

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How Authentication
Solutions can Help
Image courtesy: PharmaSecure

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Benefits
• Empower patients and increase consumer
confidence
• Give police and drug inspectors a valuable tool to
find counterfeiters
• Increase collection of tax
• Enhance reputation of country’s industry
• Be in line with international standards
• USA, European Union, Turkey, China, South
Korea, etc., all have authentication solution
mandates (“track-and-trace”)

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Security
Technologies
Authentication
Logical
Cryptographic
Structure
analysis
Physical
Printed
Inks/Taggants
OVD / Hologram
Serialization
Identification
Track & Trace
Types of Authentication Solutions
 *Use at-least one level of overt authentication
 *Focus on ethical vendor who provide multi layered security solution instead just one technology
 *To select technology take help of published standards such as ISO 12931 and NASPO

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Case Study: Serialization
Image courtesy: PharmaSecure

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By applying an identity to each unit of the
product, the following benefits can be attained:
• Anti-counterfeiting /product authentication
• Loyalty management
• Bundling services with products
• Warranty registration
• Fulfill regulatory serialization mandates
• and many more…
Label on bottle
Code on Rubber (Tyre)
Code printing on medicine
blister
Regulatory labelling Label on FMCG product
What is Serialization?

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Brand Protection solution to meet the anti-counterfeiting needs
• The solution starts from Coding/Serializing a product right at the
manufacturing line to verification of this coded product by the consumer at the
time of purchase of medicine.
• The above solution also provides a means of communication with the
consumers at a later point of time.
It’s time for
your next
injection of
_________.

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How to Serialize
Labels that are pre-printed, branded, with/without added security
features (e.g. scratch peel off) which can be applied on the
monocartons with available automated industrial grade label applicator
systems. Labels will be supplied to brand owners according to his need
to be affixed on your consumer packs at your manufacturing /
warehousing facility. Depending upon order size, it can be applied
manually or with use of industrial grade on-line label application
systems.

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Direct Printing:
Software can provide encrypted code
files directly on printing line which can
be decrypted and shared with any
printer capable of doing variable
printing. The selection of printer is
dependent on the parameters like
substrate, line speeds, space on the
line, any other preferences.
How to Serialize

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Regulatory Requirements (DGFT – India)
• A Parent-Child relationship between the Secondary and
Tertiary levels be maintained
• Tracking movement of the packages through the supply chain
• The data out of the parent-child relationship shall be
uploaded on the central portal of the Government of India by
the manufacturer or its designated agency before release of
the drugs for sale or distribution

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Summary
• Authentication Solutions are a must to curb
spurious medicines
• There are a variety of solutions available, as per
requirement, through member companies of
ASPA
• The Government of India has already taken steps
to protect medicines that are exported
• Now it is time to protect medicines that are being
distributed and consumed within Uttar Pradesh,
and within all of India

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Thank You
For more information visit
www.aspaglobal.com
Or email at
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