Situation of drug counterfeiting in Rajasthan and the ways to tackle this menace

©2017 ASPA www.aspaglobal.com
Situation of drug counterfeiting in
Rajasthan and
the ways to fight this menace.
ASPA Press Event,
Rajasthan
15th March 2017
Disclaimer: This presentation is a part of ASPA series of presentation against counterfeiting in various sectors. These
presentations are intended for educational purposes only and do not replace independent professional judgment.
Statements of fact and opinions expressed are those of the participants individually and, unless expressly stated to the
contrary, are not the opinion or position of the ASPA. ASPA does not endorse or approve, and assumes no responsibility
for, the content, accuracy or completeness of the information presented. The data used here are from various published
and electronically available primary and secondary sources. Despite due diligence the source data may contain occasional
errors. In such instances, ASPA would not be responsible for such errors.

AGENDA
1. Introduction about ASPA.
2. What is spurious medicines?
3. Pharma counterfeiting – Global problem
4. Scale of pharmaceutical Counterfeiting in India
5. Situation in Rajasthan.
6. Why it is important to fight counterfeiting?
7. Solution’s of Problem.
8. ASPA initiatives to fight counterfeiting
9. Conclusion.

1. ABOUT ASPA
• ASPA (Authentication Solution Providers’ Association) is a
non-profit organisation formed in 1998.
• Aim : To educate brand owners / authorities towards
importance of authentication solutions in order to fight the
problem of counterfeiting.
• ASPA has a strength of 50+ companies manufacturing
authentication solutions across the globe.
• Its member companies are protecting more than 11,000
brands across globe.
• Works very closely with industry association such as
International Hologram Manufacturers Association, UK,
Counterfeit Intelligence Bureau, UK, FICCI CASCADE, Indian
Beverage Association and others.

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.
2. SPURIOUS MEDICINES - DEFINITION
Drugs and Cosmetics Act, 1940

3. PHARMA COUNTERFEITING – GLOBAL PROBLEM

4. SCALE OF 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
2017
25% medicines in India are
fake, sub-standard or
counterfeit

5. SITUATION IN RAJASTHAN
प ांच स ल से चल रह धांध , नकली दव ओां की हो रही खरीद-
फरोख्त, ववभ ग है अनज न भनक तक नहीां
र जस्थ न में अब तक 9 करोड़ की नकली दव ओां क क रोब र, 3
हज र से ज्य द टेबलेट फ्रीज,
जोधपुर सवहत 10 शहरोां में छ प , नकली दव एां बर मद,
पेन-40, जालरा टेबलेट (ड यवबवटज), स्टेमेटटल (चक्कर उल्टी),
March 2017
चमम रोगोां की नकली दव विकी की सूचन पर प्रदेशभर में छ पेम री
Feb 2017
प्रदेश में नकली दव ओां के बेरोकटोक चलन को र ष्ट्र ीय
म नव वधक र आयोग ने गांभीरत से वलय है। आयोग ने प्रदेश के
स्व स्थ्य ववभ ग को नोवटस देकर जव ब म ांग है वक नकली दव ओां
के चलन को रोकने के वलए क्य उप य वकए गए ।.
Dec 2015
नकली दव फै क्ट्र ी पर छ पेम री, करोड़ोां के क रोब र क खुल सOct 2016

EXAMPLES
Sources: http://www.onlineap.com/featured/counterfeit-drugs-threaten-india

EXAMPLES
Medicines
Sources:
http://www.pharmacyreviewer.com/forum/erectile-dysfunction-and-other-sexual-aid-drugs/16604-how-spot-fake-cialis.html

6. WHY IT IS IMPORTANT TO FIGHT COUNTERFEITING?
EffecttoGovt.
• Reduction in
public health
crisis / illness /
life
• Loss of tax
revenue
• Increased
enforcement cost
• Funding of
criminal activity*
• Loss of
Government
image
Effecttomanufacturer
• Lost revenue
• Liability
crippling law
suit as incident
of
counterfeiting
increasing
health and
security
problems for
public
• Brand integrity
Effecttoconsumer
• Loss of life /
illness:
According to
WHO a fifth of
the one million
annual death
from malaria
could be
prevented if all
medicines for it
were genuine
and taken
properly.

7. SOLUTION’S OF PROBLEM: AUTHENTICATION SOLUTIONS
Authentication
Physical
Authentication
Anti-
Counterfeiting
OVD’s
Security
Printing
Security Inks &
Coatings
Substrates –
Security Papers
Chemical &
molecular
taggants
Anti-Tamper
Tamper Evident
Labels /
Closures
Digital
Serialization
Track and
Trace

EXAMPLE : AUTHENTICATION SOLUTIONS - MEDICINES
Security
Hologram as
Excise Seal
Holographic
Component for
Visual verification
Code for
Digital
verification
2D Barcode
For scanning
convenience
These kind of high security label incorporating hologram with 2D code can be onto
each individual blister packs, bottle or injectable vial.
Regulatory labelling
Code printing on medicine
blister

EXAMPLE : HOW AUTHENTICATION SOLUTIONS WORK

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
_________.

ISO Recommendation for fighting counterfeiting
Authentication solutions recommended by ISO 12931 “Performance
criteria for authentication solutions used to combat counterfeiting of
material and goods”
Human
Senses
Authentication Tool Forensic
Analysis
Off the shelf Purpose
built
General audience
(Public)
OVERT COVERT - -
Restricted audience
(Enforcement
agencies)
OVERT COVERT COVERT COVERT
Characteristics of categories for authentication solutions
Track and trace technology when used alone is not considered to be an
authentication solution and as such is not covered by this international standard.
15

AUTHENTICATION SOLUTIONS LEVEL
Conforms to the level of security features recommended by INTERPOL
Level 3
(Forensic
features)
Level 2
(Covert features,
hidden information)
Level 1
(Overt features,
visual authentication)

SECURITY FEATURES IN AUTHENTICATION SOLUTIONS
Overt features
(visible with naked eyes)
Optical features Printing features Non-Optical features
▪Pure 3D effect
▪Four channel effect
▪Animated images
▪True color photo
▪ Fresnel effect
▪Slip effect
•Color changing inks
•Watermark etc.
▪Bar-code
▪Sequential
numbering
▪Mirror effect

Covert features
(visible with hand held readers)
•Concealed text
•Pearl with CLR
•Nano text/images
•Raster image
•UV invisible
•Magnetic
•Thermochromic
•Anti-photocopying
mark etc.
•Text tampering
•Taggant (readable
with readers)

Forensic features
(Can be seen at forensic laboratory)
•Nano text /
images
•Shape of
pixels/dots
•Raster image
•Reading of
line/dots
•Taggant

INTEGRATED SOLUTIONS TO MEET THE CHALLENGES
Security
solutions
OVD with
other non
optical and
special
security
features
Customised IT
solutions e.g.
track and
trace via SMS,
Web, Android
APP and
handheld
reader
High security
authentication
solutions
Authentication
Device
Authentication
Digital
verification
Complete
authentication
solutions
20

AN IDEAL SOLUTION / STRATEGY
An ideal solutions should provides basic characteristics
such as;
- Tamper Evident and difficult to copy
- Provide layers of security recommended by ISO &
Interpol (use-at least one level of overt authentication)
- Easy identification by users, facilitate product level
authentication
- Combination of physical and digital
- 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

8. ASPA INITIATIVES AGAINST COUNTERFEITING
 Working very closely with Industry bodies such as FICCI
CASCADE (Committee Against Smuggling and
Counterfeiting Activities Destroying the Economy),
Automotive Component Manufacturers Association (ACMA),
Confederation of Indian Industries (CII) and looking
forward for work with others such as IBA, OPPI and others
prominent industry association.
 Start a Nation wide campaign “MAKE SURE INDIA” with
an aim to create awareness amongst industry, government
and brand owners on importance of authentication
solutions against counterfeiting.

8. ASPA INITIATIVES AGAINST COUNTERFEITING
 Organised first of its kind International Authentication Conference in New
Delhi, scheduled on 8-9 February 2017. The event provides an
opportunity to brand owners to review all the available authentication
technologies across the globe.

9. 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 Rajasthan, and within all
of India.

THANK YOU…..
For more information, please contact
Secretary
Authentication Solution Providers’
Association
21-Ground Floor, Devika Tower 6,
Nehru Place, New Delhi 110019, India
Email: info@aspaglobal.com
Website: www.aspaglobal.com

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