*Challenges in Development and Implementation of Anti-counterfeit Features

* Definition: As per definition developed by WHO

A Counterfeit medicine is one which is deliberatelyand fraudulently mislabeled with respect to identity and or source.

*Counterfeit products may include:

Products with correct ingredients but with insufficient quantities

b) With wrong ingredients

c) Without active ingredients

d) With fake packagingCounterfeit Products:

*Extent of problem5-20% of drugs in world market as per IFPMA

Problem exists since 1989

Developing countries and developed countries Small and big manufacturers

Loss estimated to be 20 billion USD

*Impact Serious threat to public health

Sales loss

Brand image

Corporate image

*Key Considerations in selection of productsHigh value / High volume New to launch/existing

Product potential

Level of automation

*Level of Security High-Medium-Low

Overt or covert

Combination

Method of detection

*MethodologyComplexity in Mfg.

Complexity in printing

Limited resources

Exclusivity/tie-up

Patent

ClassificationAnti-counterfeit technologies can be broadly classified as follows: Overt, or visible features Covert, or hidden markers Forensic techniques Serialisation/Track and Trace*

ChallengesMarketing Requirements Preferably overt feature Economical Long term solution Ease in Field education

*

ChallengesTechnicalSelection Difficult to copyConspicuousCombination of overt and covertEffect of process parametersConsistency in applicationConfidentialityDevelop new features*

ChallengesVendor devp.Consistency in reproductionSingle sourceCostDevp. of alternate vendorSpecification *

*Special features (Overt) Both sides print registration

Cold form blister

Embossing and perforation

Child resistant closures

Peelable blister

Peel-push blister

Tropical blister

* Coin reactive printing Hologram Fluorescent inks Guilloche Laser printingInkjet codingOVD Seriallisation/Track and trace

Special features (Overt)

Overt features*

AdvantagesDisadvantagesUser verifiableRequire user education not alwayswidely understoodNewer technologies more secureMay be easily mimickedCan add decorative appealMay add significant costCan be a deterrent to counterfeitersMay rely on covert features for authenticationMay be re-used or refilledMay give false assurance

*Special features (Covert) Hidden text UV printing/coding Split line Magnetic inks Thermochromic inks Sandwich printing Micro textDeliberate errorsTaggants

Covert features

*

AdvantagesDisadvantagesCan be simple and low cost to implementNeed strict secrecy need to knowNeeds no regulatory approvalIf widely known or used, may be easy to copyCan be easily added to or modifiedMore secure options add supplycomplexity and costCan be applied in-house or viacomponent suppliersIf applied at component suppliers,greater risk of compromise

*Other developmentsBrand shield printingSpecial size capsulesSpecial films Preventis

Forensic technologies*

AdvantagesDisadvantagesHigh tech and secure against copyingLicensed technologies usually limitedto one sourceProvide positive authenticationSignificant costMay be disclosed for overt purposesWider use increases risk ofcompromiseUnlikely to be available to authoritiesor public

Seriallisation/Track and trace*

AdvantagesDisadvantagesHigh tech and secure against copyingSignificant cost to implement and monitorMay be capable of remoteauthentication, via phone or internetDifficult to implement across multiplemarketsMay be accessible to authorities andinvestigators without compromiseMay be vulnerable to hackersFacilitates recall of defective productDamaged labels may not readBenefits in supply efficienciesNeeds harmonisation of standards

*Advanced technologies 2D Barcode

Water marks

Security thread

RFID

Bio-molecular marker

*Implementation Provide hand outs

Training

Automation

Market feedback

Agreements with converters

Develop more features

Thanks*