Anti-counterfeit Packaging for Medical Products

Dr. Ashish A. Kadam

Assistant Professor
Department of Paper Technology
IIT-Roorkee
©2019 by West Pharmaceutical Services, Inc.
All rights reserved. This material is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any
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Contents

o Definition of counterfeiting
o Threats of counterfeit medical products
o Factors behind the onset of counterfeiting
o Global state of counterfeit medical products
o Efforts to curb use of counterfeit medical products
o Conclusion
What is a counterfeiting?

 Deliberate and fraudulent mislabeling with respect to

identity and/or source (WHO, 2012).
 Counterfeit medicine is fake medicine. It may be
contaminated or contain the wrong or no active ingredient.
They could have the right active ingredient but at the wrong
dose. Counterfeit drugs are illegal and may be harmful to
your health (https://www.fda.gov/drugs/buying-using-
medicine-safely/counterfeit-medicine, Accessed on
29/10/2019).
What is a counterfeiting?

 First identified as an emerging problem by the WHO in

1985.
 Traditionally, more of a concern in developing regions
(mostly Africa and Asia), where regulatory and enforcement
systems for medicines are weak (The Lancet, 2012)
Threats of counterfeit medical
products

 Harm to patients
 Fail to treat the diseases for which they were intended
 Loss of confidence in medicines, healthcare providers and
health systems
 Financial loss defamation to the brand owners
 Contribute to antimicrobial resistance and drug-resistant
infections
Threats of counterfeit medical
products

Why brand owners should take it seriously?

Factors behind the onset of
counterfeiting

 Free trade agreements

 Growth and capitalization of emerging markets; Asia
becoming the ‘world’s factory’
 Internet
 Lack of regulations and knowledge
 Illicit traders who are well-funded and technologically
advanced, and who have a high reward-to-risk ratio
 Under-resourced regulatory and enforcement agencies
 Lack of protection for intellectual property (IP) in some
countries
Factors behind the onset of
counterfeiting

 Liberal legislation governing cross-border trade

 Lack of control and visibility of supply chain activities
 Ignorance and short-sightedness of brand owners (since
they didn’t create the counterfeits they are not responsible
for correcting the problem)
 Consumer demand for drugs that are not affordable
Global state of counterfeit medical
products
In 2012, the WHO estimated the Counterfeit and falsified medicines industry
to be worth USD 431 billion a year
Global state of counterfeit medical
products

 Ranges from playing with batch details to manufacturing

the fake product. Cottage industries, full-scale
manufacturing facilities, online pharmacies. Several times
more profitable than trafficking heroin.
 Globally, 700,000 annual deaths can be attributed to
counterfeit drugs to treat or prevent malaria and
tuberculosis.
 Estimated revenues of the US pharmaceutical industry was
USD 346.7 billion in 2015. Counterfeiting is a concern to
44% of industry professionals.
Global state of counterfeit medical
products

 Indian pharmaceutical sector was worth USD 33 billion in

2017, with exports of USD 17.27 billion in 2017-2018.
Nearly 30% of drugs in India are spurious, substandard,
counterfeit.
 India among top 3 sources of counterfeit medical products
seized in the US (CBP Office of International Trade).
Global state of counterfeit medical
products
Examples of counterfeit pharmaceuticals (WHO, 2012)
Global state of counterfeit medical
products
Supply chain of counterfeit
pharmaceuticals
Categories of counterfeit drugs
recognized by WHO
Type & prevalence:
1. No active ingredients (32.1%)
2. Incorrect amounts of active
ingredients (20.2%)
3. Incorrect ingredients (21.4%)
4. Correct quantities of active
ingredients but fake
packaging (15.6%)
5. An original product that has been
copied (1%)
6. High levels of impurities and
contaminants (8.5%)
Efforts to curb use of counterfeit
medical products

Agencies formed to conduct operations against

counterfeit medical products
 An international organization, IMPACT (International
Medical Products Anti Counterfeiting Task Force) created
by WHO in 2008
 INTERPOL
 Interpol’s Medical Products Counterfeiting and
Pharmaceutical Crime (MPCPC)
 National Agency for Food, Drug Administration and control
(NAFDAC)
Efforts to curb use of counterfeit
medical products

Agencies formed to conduct operations against

counterfeit medical products
 The Institute of Research Against Counterfeit Medicines
(IRACM)
 World Customs Organization (WCO)
 World Intellectual Property Organization (WIPO)
 FDA - US
 Intellectual Property Enforcement Coordinator (IPEC) - US
 Customs and Border Protection (CBP) – US
 Immigration and Customs Enforcement (ICE) - US
 Departments of Justice, State, and Commerce
Efforts to curb use of counterfeit
medical products

Operations conducted by agencies against counterfeit

medical products
 Operation MAMBA in 2008: NAFDAC, IMPACT, &
INTERPOL (Nigeria). Arrest of several manufacturers,
wholesalers and retail pharmacists, seizure and destruction
of counterfeit drugs valued at several billion of dollars
(http://www.inpharmatechnologist.com,
http://www.interpol.int/public/news/2008/mamba20081029.a
sp).
 Operation Pangea in 2008: INTERPOL (All around the
world). Targeted online pharmacies. Currently active in over
100 countries.
Efforts to curb use of counterfeit
medical products

Operations conducted by agencies against counterfeit

medical products
 Operation Pangea IV in 2011: INTERPOL (81 countries). 55
people arrested / investigated, 13500 illegal online
pharmacies shut down, unlicensed drugs worth > £5 million
were found, > 45000 packages investigated, 2.5 million
illicit doses seized
(https://www.manufacturingchemist.com/news/article_page/
Operation_Pangea_IV_seizes_illegal_medicines_worth_5m
/64704. Accessed on 03112019).
Efforts to curb use of counterfeit
medical products

Operations conducted by agencies against counterfeit

medical products
 Falsified medical product strategy in 2012: Enhancing
communication, collaboration and regulatory activities
between MHRA and stakeholders to improve existing anti-
counterfeiting strategy (https://www.raps.org/regulatory-
focus%E2%84%A2/news-articles/2012/5/mhra-launching-
new-anti-counterfeiting-strategy. Accessed on 03112019).
Efforts to curb use of counterfeit
medical products

Device to identify counterfeit medical products

USFDA, 2012
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures

 Categorized according to their mode of operation:

communication related, management related, distribution
related, product related, process related, and social value
related
 Two elements of traceability:
 Logistics: Tracking, tracing, and logging
 Qualitative: Manufacturing techniques, storage, and
distribution conditions
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures

 Communication from brand owners to consumers through

government media campaigns: Promoting ethical purchase
and usage standards
 Regulatory controls to reduce illicit sales of counterfeit
medical products, strengthen penalties for sellers and
buyers from deviating
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures

 Anti-counterfeiting hurdles
 Formal system components that reduce opportunity for
counterfeiting by either as a deterrent or by assisting in
detection of activity
 Physical in terms of protecting structural assets
(barriers, enclosed production systems)
 Procedures and protocols or cyber-protection via
firewalls and anti-virus software
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Product-related)

 Differentiate authentic products as much as possible and

stress genuineness e.g. using distinct labelling, serial
numbers, codes and packaging features
 Differentiate between tangible product quality benefits
(labour, taste, durability) and intangible product quality
benefits (prestige, image, social acceptance)
 Authentication certificates and technologies that are difficult
to replicate
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Product-related)

 Ensure authentic product purchase allows access to

additional consumer benefits e.g. lower prices
 Provide functional benefits that are not easily reproduced
and drive product innovation to limit the ability of others to
produce Shanzhai products
 Protect products by protecting core technology and not
outsource the entire manufacturing process
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Control over used packaging

 Track-and-trace technologies
 Barcode: an optical machine-readable symbol consisting of
a pattern of bars and spaces to represent the product and
the manufacturer via an identification number. Ease of
integration, readability and direct marketing opportunities
are high. Batch identification and security is low. Combined
with other technologies.
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Radio frequency identification (RFID) microchips: More

advanced data carrier, have higher data storage capacity.
Used for product identification and traceability, information
can be gathered automatically without visual scanning.
RFID tag can be incorporated into the packaging and
allows reading through multiple materials, is non-invasive
and allows traceability over the whole distribution chain.
Can be utilized in combination with GPS and TTIs to
monitor vehicles' location, temperature and unauthorized
opening of vehicles' doors. Embedding RFID tags in every
product is expensive and impacts recyclability of packaging
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Technologies:
 Differentiate fraudulent products from authentic ones
 Need to be difficult to duplicate, hard to re-use, and yet
easily applied and to identify visually, and easily
noticeable when tampered with
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Overt: End user must be aware of the features

 Enables end users to visually verify the originality of
the packaging
 Holograms, watermarks, barcodes, RFID, and
tamper-evident seals
 Near-field communication (NFC) tags: Integrated
with label. Allow access to product and brand
information through smartphone. Is torn if container
seal broken.
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Holograms: Generate rainbow-like radiance by

diffracting white light into the spectrum of visible light
and allow end users to view the holographic images
directly
 Watermarks: Images or patterns that are embedded
into packaging design and are visible when
packaging is held up to light.
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Covert: Requires a certain level of expertise and

dedicated equipment
 Special inks, UV threads, and fluorescence fibers,
digital watermarks, microtext, intaglio printing,
 Special inks: Thermochromic inks, change color with
thermal stimuli. Strong visual cue to consumer. Need
to be combined with other such technologies.
 Security threads: Plastic or metal ribbon embedded
into paper, visible only in transmitted light.
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Fluorescence fibers: Can only be viewed in UV light.

 Digital watermarks: Informs consumer package
authenticity through smartphone
 Microtext: Extremely small texts or codes inserted
into larger overt text / image, not visible to the naked
eye.
Efforts to curb use of counterfeit
medical products

Anti-counterfeit measures (Packaging-related)

 Intaglio printing: Uses exceptionally fine lines and

dots. Most difficult to counterfeit.
 Taggants: Biological or chemical markers, trace
chemicals that are usually detected by highly specific
reagent system.
Conclusion

 Counterfeiting vs. anti-counterfeiting … never ending battle

 Developing novel ways a key to keep counterfeiting at bay
 Packaging can play a vital role
 Strong and holistic international collaborations required
Thank You!!