Presentation at

VINYL INDIA 2013

3rd International PVC & Chlor-Alkali ConferenceHotel Grand Hyatt, Mumbai, India

12th April 2013

Product & Process Innovations

Enhancing Value Proposition of Vinyl Substrates

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The Global issue of counterfeits

• Extent of the issue: an estimated 7% of global

trade being counterfeit, value exceeding US $

500 Billion*, and its increasing by 10% plus p.a

• This also includes over-runs and grey market

across a range of industries

• Counterfeiters have found a way to copy

barcodes, 2D Matrix and many other solutions.

One of the Detroit big three loses about $1 Billion

per year, because of the counterfeit issue

France’s anti counterfeit agency estimates

10% car parts sold in Europe are fake

*Source :- Anti-Counterfeiting , Brand Protection &

Security Packaging – iv report by Pira International Ltd. (UK)

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Counterfeit – A Global menace with increasing sophistication

Encompassing life saving medical products…

AMGEN COUNTERFEIT

Vial height is

approx 34 mmVial height is

approx 35 mm

The Famous Heparin Mimic case

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Motive has shifted from mere profiteering

To funding Terror outfits

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And now....

Counterfeit is increasingly becoming an effective tool

for International economic warfare

Wednesday, August 05, 2009 (10:14:36)

Nigeria more vigilant against fake drugs

New Delhi: Two months after Nigeria seized a

consignment of fake drugs made in China but carrying

the "Made in India"

label, an official delegation from the African country on

Tuesday met Indian industry here with the assurance that

they were

more vigilant against counterfeit medicines and open to

generic pharmaceuticals. In June, Nigeria's National

Agency for Food and Drug Administration and Control

(NAFDAC) announced it had detected a

large consignment of anti-malarial drugs from China, which

had been labelled "Made in India", being sold in that

country.

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Indian Industry reputation Multiple factors tarnishing International image

Global Concerns

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What we need to Address ? – A Multi pronged Threat

Authorised

factory

Authorised distribution

Grey market diversion

Product overruns

Copycat

factory

R&D $

Qualit

y

Testin

g

Brand owner

Counterfeit products

Impact on Brand Owner

Lower margins

Unforeseen liabilities

Distribution license issues

Lost revenues

Over supply

Increased warranty claims

Lower margins

Lost revenues

Increased warranty claims

Brand erosion

Product liabilities

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Complex supply chain makes it easier for fakes to go undetected

Typical Example of

Spurious Medicines

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Role of Vinyl derivatives

in medical Packaging

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PVC the most widely used polymer in

medical Applications

PVC is a versatile plastic that has been used for

medical applications for more than 50 years. It has

passed many critical tests and gained acceptance

by health regulators world-wide and is now the

most widely used polymer in pre-sterilised single

use medical applications.

Various medical applications are made from, or contain PVC, including:

1. Containers for blood, urine continence and ostomy products

2. Containers for intravenous solution giving sets

3. Heart and lung bypass sets

4. Catheters and cannulae

5. Tubing for dialysis, endotracheal, feeding and pressure monitoring

6. Surgical and examination gloves

7. Inflatable splints

8. Inhalation masks

9. Blister packs for pills and tablets.

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Medical Products

• Over 60% Medicines are in Solid Dosage form

• Packaged either in Unit dose pack or bottle

• Unit dose can be a blister pack, Alu strip pack or Alu-Alu pack

• PVC substrate is the most preferred Blister pack material

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+ve’s of PVC for Medical Application

• Clarity and transparency

• Flexibility, durability and dependability

• Excellent operational productivity

• Safety

• Biocompatibility

• Chemical stability

• Sterilizability

• Compatibility

• Resistance to chemical stress cracking

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-ve’s of PVC for Medical Application

• Low barrier to Moisture /gases

• Vinyl Monomer Content–Requirement has been lowered to 10 ppb

• Significant thinning on deep draw

• Requires plasticizer for making of flexible films

• Non- biodegradable

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Factors for packaging material use in medicines

• Functional Protection

– Physical & Chemical Stability

– Compatibility

– Shelf Life

• Mechanical Protection

– Transit Impact

• Identity

– Genuine Vs. Spurious

• Communication

– Right product

– Right Dose

• Convenience

– Ease of accessibility

• Compliance

– Adherence to prescribed

regimen

• Cos

t

Bilcare’s Innovation Approach

to enhance PVC usage

• 2 pronged approach

– Create solutions to understand the precise functional needs

– Bilcare Optima (Patents granted in USA & India)

– Create Products to address the functional and market needs

Bilcare PatinaTM

Bilcare ProtectTM & Protect LTM (Transparent)Bilcare Secure™Bilcare Ecomply™ – solution to biodegradable PVCBilcare Spectra ™Microtext & Specialty inksPVC/AclarPrinted Bilcare VenusTM

Bilcare Alpro™

(Most of the above have patent applications world-wide having granted & pending for grant status)

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Bilcare OptimaTM

(Pantented Method)

• Degradation pattern of formulation is evaluated under variousenvironmental conditions (T, RH, light)• Hygroscopic tendency• Degradation tendency (Physical and Chemical)• Effect on drug release properties• Effect on hardness• Photo sensitivity as a function of RH and temperature• Gas liberation tendency• Dimensional aspects• Material product interaction

• Recommend optimum material• Cost analysis of packaging costs

• Bilcare’s proprietary "Optima" process is a unique process which efficiently and quickly enables determination of the barrier and thinning profile for a particular packaging requirement

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Bilcare PatinaTM

• Novel metalized and coloured metalized PVC

• Excellent visual end-user recognizable anti-counterfeit feature

• Granted patents in India, USA and South Africa

• No fill product detection after forming is remained as feature

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Bilcare ProtectTM

• Novel embedded image metalized PVC

• Excellent visual end-user recognisable anti-counterfeit feature

• Granted patents in Switzerland, SA and Germany.

• No fill product detection after forming is remained as feature

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Bilcare Protect-L TM

• Novel embedded image transparent metalized PVC

• Granted patent in a few European countries and SA.

• Available in various colours

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Bilcare Secure™

• Novel embedded image transparent metalized PVC

coated with barrier polymer PVdC

• Suitable for packaging of mid sensitive to sensitive products

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Bio-degradable PVC

A cost effective Solution to Sustainability Challenges(Global patent applied)

Bilcare’s American Center of Excellence for Pharma

Packaging Research & Development. Calendering and

Stentering facilities

Bilcare ECOmply ™

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Bilcare ECOmply™

First Eco-Friendly Pharmaceutical grade PVC

• Bio degradable film - Degradation starts only under

Anaerobic condition

• Pharmaceutical grade film - No contamination by Microbial

growth

• Complies with Food and Drug regulation for direct contact

application

• Equivalent in all functional and machinability properties

• Available in Clear and Opaque colors

• Available in Paper-look alike Film

• Total eco-friendly package when use with barrier coated

paper lidding Bilcare NovaTM

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Bilcare Spectra™

• Unique Flexo Printed mono PVC / PVdC coated PVC films

• Complex graphics – Overt Features – Brand enhancement

• Brand recall and Visual appeal

• Provides excellent gloss and protection against abrasion

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PVC/Aclar Ultra High Barrier

• For pharmaceutical packing of highly sensitive drugs

• Very good barrier as compared to conventional Duplex and Triplex

• Economical alternative to Alu-Alu packing

• Convenience in handling and transport

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Printed Bilcare Venus™

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Bilcare Venus™ (Embedded Image)

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Mail: Avinash.mandale@bilcare.com

Cell: +919850041721