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COMBATING COUNTERFEIT DRUGS COMBATING COUNTERFEIT DRUGS WITH PACKAGING TECHNOLOGY WITH PACKAGING TECHNOLOGY WITH PACKAGING TECHNOLOGY WITH PACKAGING TECHNOLOGY T R T apan Ray Director General Organisation of Pharmaceutical Producers of India ALCAN PACKAGING UNIVERSITY OCT 8, 2009 -LONAVALA
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COMBATING COUNTERFEIT DRUGS COMBATING COUNTERFEIT DRUGS WITH PACKAGING TECHNOLOGYWITH PACKAGING TECHNOLOGYWITH PACKAGING TECHNOLOGYWITH PACKAGING TECHNOLOGY

T RTapan RayDirector General

Organisation of Pharmaceutical Producers of India

ALCAN PACKAGING UNIVERSITYOCT 8, 2009 -LONAVALA

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ContentContentContentContent

Counterfeit Medicines: Counterfeit Medicines: DefinitionP iPerspectiveCConcerns

Emerging trends: anti-counterfeit packagingThe Way Forwardy“Do”

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DefinitionDefinition

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Counterfeit Medicines Counterfeit Medicines WHO DefinitionWHO Definition

“A medicine, which is deliberately & fraudulently mislabeled with respect to identity and / or source source.

Can apply to both branded & generic products Can apply to both branded & generic products

Include products with correct / wrong ingredients; without active ingredients / with insufficient active ingredients / fake packaging”.

Source: WHO

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PerspectivePerspective

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Counterfeit MedicinesCounterfeit MedicinesVarious TypesVarious Types

Growing threat to Global Public

Health

Various TypesVarious Types

5050

60

3240

50

21.4 20.215.620

30

8.5

0

10

With t AI W I di t I tQ titi Ri ht titi f AI Hi h L l f M di i h dWithout AIs Wrong Ingredients Incorrect Quantities of AIs

Right quantities of AIs but in Fake Packaging

High Level of Impurities and Contaminants  *

Medicines purchased from internet thru' 

illegal sites

AIs – Active Ingredients *(Substituted ingredients could be from paracetamol t b i id t l d t i d i t)to boric acid, talcum powder, rat poison or road paint)

Source: WHO

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Counterfeit Medicines Counterfeit Medicines f f

Growing threat to Global Public Health

Magnitude of the ProblemMagnitude of the Problem

Developed CountriesDeveloped Countries

New Products Hormones, Steroids, anti-asthma or anti-allergy medicinesanti-asthma, or anti-allergy medicines

WorldWorld

Developing CountriesDeveloping Countries

Malaria, Tuberculosis and HIV/AIDS

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Magnitude of the ProblemMagnitude of the ProblemMagnitude of the ProblemMagnitude of the Problem

Hi h i id i t i h t Higher incidence in countries where access to medicines is poor.Less than 1% in developed countries like USA Less than 1% in developed countries like USA, EU, Japan, Australia, Canada and New Zealand.

M h 30% d l l k More than 30% in developing nations like parts of Asia, Latin American and Africa.

33-53% of artesunate for malaria are counterfeit in S.E. Asia.

Source: WHO IMPACT 2006

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Growing threat to Global Public

HealthCounterfeit Medicines

15001600

- Incidence of Detection

12501200

1400

600

800

1000

150200

400

600

0

200

2000 2006 2007

Source: WHO Report

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Counterfeit Medicines Counterfeit Medicines Seizures World overSeizures World over

Growing threat to Global Public

Health

Seizures World overSeizures World over

In 2005 and 2006, 2.7 million articles of counterfeit drug seizures took place which originated from the following seizures took place, which originated from the following countries:

India31%

China

Others18%

UAE31%

20%

Source: WHO IMPACT

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Counterfeit Medicines Counterfeit Medicines Global ForecastGlobal Forecast

Growing threat to Global Public

Health

Global ForecastGlobal Forecast

7580

50

60

70

n

39.5

20

30

40

US$

Bill

io

0

10

20

200 2010

U

2005 2010

Source: Centre for Medicines in Public Interest - 2007

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Counterfeit Medicines Counterfeit Medicines Growing threat

to Global Public Health

Factors Influencing Flourishing TradeFactors Influencing Flourishing Trade

Consumer push for cheaper drugs

High price Low probability EnablersLarge number

of smallParallel trading

DriversHigh price p y

of captureo s a

distributorstrading

Low penalties Internet pharmacies

Low risk/high returns on investment in counterfeit drugs

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A Recent ReportA Recent Report

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ConcernsConcerns

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Counterfeit Medicines Counterfeit Medicines Emerging ViewsEmerging Views

1. Innovator Companies : Generic Industry & Drug R l k l h iRegulators not very keen to resolve the issue.

2. Generic Companies & Drug Regulators : Problem not as acute as projected by Innovator Companies. Exploiting situation to fight against generics & parallel Exploiting situation to fight against generics & parallel imports.

3 Other Group / NGOs : 3. Other Group / NGOs : Global Pharmaceutical Companies trying to extend IPR to patients’ safety issues and have gone to ACTA & WHO IMPACT.

IMPACT- International Medical Products Anti-Counterfeiting Task ForceACTA - Anti Counterfeiting Trade Agreement

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Counterfeit Medicines Counterfeit Medicines Concerns

IPR being extended to the definition

Even in India “misbranded” drugs are considered gcounterfeit under - Section 17 of the Drugs & Cosmetics Act.

Estimated U.S.$ 30 billion - 6% of global turnover.*

* Albany Law Journal 2006 * Albany Law Journal 2006

turnover.

y Jy J

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Counterfeit Medicines

Apprehension of Generic Pharma Industry

Counterfeit Medicines Concerns

Attempt being made to bring generic drugs under t f it m di i

Apprehension of Generic Pharma Industry

counterfeit medicines.

- No threat to non-patent infringing generics anywhere in the world.

- Generic Industry is growing much faster than - Generic Industry is growing much faster than patented drugs in the developed markets.

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Counterfeit Medicines- Demands Immediate Action

Harmful effects on patients' health & can killHarmful effects on patients health & can killFrustrate efforts to deal with high burdens of diseaseUndermine health care systemsUndermine health care systems

Demands….I t ti l ll b tiInternational collaborationSimultaneous action on• legislation• regulations• enforcement• awarenessawareness• innovative packaging technology

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Legislature in IndiaLegislature in India

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The Way ForwardThe Way Forward

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Combating CounterfeitingCombating CounterfeitingCorporate are part of the solution

Requires an integrated approach

Every company needs to protect :

Corporate are part of the solution

Make it difficult for its products to be counterfeited.Enable authentication of products and its source.Enable authentication of products and its source.Train sales staff to spot counterfeit productsRegular testing of samples from marketQuick redressal of consumer complaints Storm signal ( mismatch sales figures Internal with ORG/IMS )

|

ORG/IMS )Close liaison with regulatory authorities

Only 21% of large pharma companies had a dedicated Only 21% of large pharma companies had a dedicated anti-counterfeiting project team

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Combating CounterfeitingCombating Counterfeiting Requires an integrated approach

Overt features: Covert features:

OPPI Recommendations:

Overt features:

embedded holograms,RFID….

FDA approved markers as excipients, invisible ink

Technical / Communications & PR /

LegalCommittees

Packaging Design Components controlOther considerations in design

Components control

Incident management

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Counterfeit Medicines S P i t t P d– Some Points to Ponder

One in 5 medicines sold in India is fake.

75% f d li d ld h th i i i i 75% of drugs supplied world over have their origin in India.

As per Lancet 10 to 30% of medicines are counterfeit As per Lancet 10 to 30% of medicines are counterfeit in India.

< 1% of the drugs manufactured in India are tested. g

26 Government labs. Test 2,500 drugs samples annually. Each has backlog of 6-9 months.

WHO estimates that 200,000 of 1 million malaria death annually are due to fake drugs.

Source: The Times of India - 15th May, 2008

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Combating CounterfeitingS Summing up

Counterfeit Medicines : Growing menace against Counterfeit Medicines : Growing menace against humanity.

All stakeholders to join hands to address this public health issue.

Packaging technology and creation of awareness play a major role to address this public health menace.

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