The document provides information on counterfeit drugs, including definitions, global and Indian statistics, examples of counterfeited drugs, and potential solutions. Some key points: - The WHO defines counterfeit drugs as deliberately mislabeled regarding identity and/or source, and they may contain incorrect ingredients, insufficient active ingredients, or no active ingredients. - India accounts for 10% of global drug production but also has high rates of counterfeiting, estimated at 20% of drugs. Globally, counterfeiting costs the legitimate pharmaceutical industry $75 billion annually. - Many popular drugs are frequently counterfeited, such as Viagra, Lipitor, and cancer treatments. Counterfeits are found to contain

2. FLOW OF PRESENTATION
• DEFINITION
• INDIAN & GLOBAL SCENE
• SELECTED EXAMPLES
• ENTRY OF COUNTERFEIT DRUGS IN
MARKET
• CANDIDATE FOR COUNTERFEIT
• EFFECT OF COUNTERFEIT
• EXTENT OF COUNTERFEIT
• HOW TO AVOID COUNTERFEIT
2

3. DEFINITION
World Health Organization(WHO)
A counterfeit medicine is one which is deliberately and fraudulently
mislabeled with respect to identity and / or source.
Counterfeiting can apply to both branded and generic products and
counterfeit medicines may include
products
• With correct ingredients but fake packaging
• With the wrong ingredients
• Without active ingredients
• With insufficient active ingredients
3

4. SPURIOUS DRUG
Drugs & Cosmetics Act 1940 –Definition:
A drug shall be deemed to be spurious
• If it is manufactured under a name which belongs to another drug
or
• If it is an imitation of, or is substitute for, another drug or
resembles another drug in a manner likely to deceive or bears
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
• 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
• If it has been substituted wholly or in part by another drug or
substance or
• If it purports to be the product of a manufacturer of whom it is
not truly a product.
4

5. NEW DEFINITION BY IMPACT
When there is false representation in relation to its identity,
history, or source. This applies to the product , its container,
packaging or other labeling information. Cover both branded &
generic may include with correct ingredient/component ,
without active ingredient /component, with incorrect amount of
active ingredient /component or with fake packing.
SOURCE:
THE ECONOMIC TIMES , 17 OCT, 2008.

6. 6
• The Indian pharmaceutical industry is 3rd largest in the world
in terms of volume accounting for 10 percent of world’s
production and stands 14th in terms of value. 1
• the total turnover of Indian Pharma Industry is US$21 billion.
Out of this total, domestic formulations market was worth
US$8.34 billion and total APIs market was worth US$3.92
billion. Total Export market was worth US$8.47 billion.
• The domestic Indian Pharmaceutical market is expected to
reach US$ 55 billion in 2020 at a Compound Annual Growth
Rate (CAGR) of around 15 %.
• India: 1in 5 medicines was fake, up to 14% annual loss.
1 the Department of Pharmaceuticals, Ministry of
Chemicals and Fertilizers
INDIAN SCENE

7. • As per Havoscope Global Black Market Index, the Indian share
in the industry is a $16.84 billion.
• fake products with ‘Made in India’ label and manufactured in
China have been floating in the global market at an alarming
rate, bringing disrepute to the Indian domestic industry and
causing losses to the tune of $5 billion.
• Counterfeit drugs affected people in 124 countries in 2011.
Among them was India, where 20% of the drugs on the market
are fake, according to the World Health Organisation.

8. GLOBAL SCENE
• The impact of counterfeit medications on the legitimate
global pharmaceutical market has been estimated to reach
$75 billion 1
• Estimates indicate that less than 1% of prescription
medications sold in the United States and Europe and 30%
sold in developing nations are counterfeit 1
• In 2005 market was US$32 billion
• In 2006 it was US$ 40 billion2
• 16% of counterfeit drugs contain the wrong ingredients
• 17% incorrect amounts of the proper ingredients
• 60% no active ingredients
1:International Narcotics Control Board(INCB);30-31 JAN 2007
2: http://www.who.int/en/ 8

9. • Most cases of Counterfeit reported in developing countries of
the Western Pacific (48.7%) – WHO
• Africa, Asia and Latin America have > 30% of counterfeit
medicines1
• Other developing markets have < 10%; overall range is 10% to
30% (WHO)1
• OECD: annual value of counterfeited consumer goods is
US$200 billion equivalent to 2% of world trade2
http://www.who.int/en/
1:International Medical Products Anti-Counterfeiting Taskforce (IMPACT), 2006, “Counterfeit medicines: an update on estimates”
2:Asia times .June 7 ,2008 9
GLOBAL SCENE

10. COUNTERFEIT DRUGS CASES OPENED BY
FDA PER YEAR
www.fda.gov/(OFFICIAL SITE OF USFDA) 10

11. SELECTED EXAMPLE
Counterfeiter’s Manufacturing Facilities
Examples of Counterfeit
11

12. Counterfeit Cialis®
12

13. Can You Tell the Difference?
13

14. Counterfeit Product
Counterfeit Viagra found in two California pharmacies, June 2004:
Counterfeit
tablets
Genuine
Viagra
tablet
Counterfeit
tablet
containing blue
speckles
Genuine white
core Viagra
tablet
Source: FDA: Counterfeit Drug Photographs ; & Pfizer Global Security 14

15. Counterfeit LIPITOR
The counterfeit Lipitor tablets on the right are nearly identical from
the authentic tablets on the left. Only distinguishable to the
consumer by their bitter taste. More than 18 million counterfeit
Lipitor tablets were removed from the U.S. supply chain in 2003
Source:
FDA: Counterfeit Drug Photographs 15

16. Serostim®
Comparison of an authentic Serostim and a counterfeited one,
Source:
FDA: Counterfeit Drug Photographs
16

17. Procrit®
17
Three Batches of Counterfeit Procrit® (epoetin alfa) by Ortho Biotech, found March,
2003. Product contained no active ingredient.
Source: www.orthobiotec.com
Counterfeit product
Aluminum wrap
under red cap is not
smooth & may
appear to dented Authentic PROCRIT
Aluminum wrap
under red cap is
smooth without
dented

18. 18
Counterfeit Genuine
A product use by athletes to build body
Deca-Durabolin
Source:
www.pharma.org

19. This is a Viagra counterfeiting site in Egypt. Counterfeit tablets were
being given their blue coloring using an old cement mixer. Clearly,
the manufacturing conditions were far from sterile,
19
Source:
US Congress Rogers
FDA: Counterfeit Drug Photographs & Pfizer Global Security

20. Zantac
Manufactured in Taiwan, discovered in United Kingdom. Excellent
packaging of counterfeit.
20Source: www.phrma.org/

21. Ponstan is an anti-inflammatory product. This counterfeit was found in
Columbia contain yellow powder; it consist of boric acid, floor wax, yellow
highway paint.
Ponstan
Source: www.phrma.org/ 21

22. Would you trust Pharmaceuticals Manufactured at This factory?
Counterfeit Ponstan, Colombia

23. Possible Inflow of Counterfeits to the
Legitimate Distribution Channel
23

24. Drugs Frequently Counterfeited
– Ambien® (sleep medication)
– Combivir® (AIDS)
– Diflucan® (fungal infections, AIDS)
– Epogen® (kidney failure, side effects of chemo-therapy)
– Lipitor® (high cholesterol)
– Neupogen® (side effects of chemo-therapy)
– Ortho Evra ® (birth control patch)
– Procrit® (kidney disease, cancer)
– Viagra® (erectile dysfunction)
– Serostim® (AIDS wasting)
– Zyprexa® (schizophrenia, acute bipolar syndrome)
24

25. Candidates for Counterfeit
• Fast moving and well known brand.
• Easily manufactured.
• Available over the counter (OTC).
• Supplies to Government institutions.
• Products for Exports
25

26. • Consumer
Health Hazard
Loss of confidence in the health
care system
Eventually a costlier affair
Effect of Counterfeit
• Industry
Loss of Reputation
Loss of Brand Equity
Mistrust of Authorities, Health Practitioners
and Consumers
Eventually a costlier affair
• Government
Loss of Reputation
Mistrust of importers
Loss of Revenue
• Ethics
Increased corruption

27. Extent of Counterfeit Problem
• Not just a commercial problem
• Should be tackled with priority
• Indicative of requirement of technology advancement and lack
of initiative at the same time
• Pharmaceutical counterfeit can be fatal
• Punishment: minimum 5 years , fine 10,0001
1:PHARMA EXPRESS 16-31 JULY 2008 27

28. Avoid Counterfeit
• Consumer Awareness
• Strengthening of Trade marks
• Checks at exporting ports by Agencies involved in exports of
medicines
28

29. Potential Solutions
• Product based solutions
– Holographic labels, embeded technology in the packaging
or product
– Use specific kind of ink in printing
• Supply chain level solutions
– Stop counterfeit product from entering the supply chain
– Tightly control the chain of custody with documented
pedigree

30. Novel Approach
• E-pedigree
• RFID
• EPCIS(Electronic Product Code Information
Service)
• M-pedigree

31. What is pedigree ?
• Record of the sale and physical distribution of a prescription
drug prior to being dispensed or administered to the patient
• According to FDA regulations related to the Prescription Drug
Marketing Act of 1987, which requires drug distributors to
provide documentation of the chain of custody of drug
products -- the so-called "pedigree" -- throughout the
distribution system
• This record, or “custodial history,” can be in two formats:
– Paper
– Electronic

32. Disadvantages of paper pedigree
• Paper process is:
– Ineffective because it does not prevent
counterfeit drugs entering the healthcare
system, only assists in investigation and
prosecution
– Cost-prohibitive because it adds a manual
process to the millions of transactions
–It is time-sensitive

33. Electronic : most effective
• Streamlines cumbersome paper process
• Most efficient, secure and cost-effective method to track
authentic drugs in the healthcare supply chain
• Efficient storage of electronic documents
• Retrieval is fast and accurate
• Tampering is easily detected
• Digital signatures and pedigree documents can not be
forged

34. Electronic Solutions: Advanced Bar
Coding and RFID
• Advanced bar coding and RFID technologies are potential technologies
to enable efficient electronic pedigree
• There are two possible approaches
– Adding lot number, expiration date and other information to the bar
code or RF-ID tag
– Mass serialization where each package has a unique id number
assigned by the manufacturer
• RFID is emerging as the preferred solution for package level tracking
PDF417
High data density
Rugged 2-D
RSS Stacked
Limited
space
“1.5-D”
Example RFID
Labels

35. Bar Code V/S RFID
• Require line of sight
• Scan one item at a time
• Inexpensive
• Modification of
information not
possible(unless reprinted)
• Standards developed
• Line of sight not needed
• Scan multiple items
• More expensive
• Modification or updating
of information possible
• Standards still developing
Barcodes : these are symbols printed on labels that are read by a scanner and used to
identify the product. These are printed as group of light and dark lines
Barcodes RFID

36. • The data elements in the EPCIS standard data model define
WHAT (product),WHERE (location), WHEN (time), and WHY
(business step and status) for product movements in the supply
chain.

37. The Authentication Process
Source: “How to Eliminate Counterfeit Pharmaceuticals -Authenticate at the Point of
Dispensing™”, Rob Whewell, PA Consulting, RFID Network Forum, June 2004

38. m-pedigree Mobile Product Authentication (MPA)
• m-pedigree are using mobile technology to
authenticate drugs
• The technology is deployed at four levels.

39. • Manufacturers sign up to the cloud-based service
and then integrate their label sourcing
mechanisms with mPedigree's intelligent label
logistics management process.
• Consumers, upon receiving a pack of medicine
protected under the scheme, remove the tamper-
evident panel from the serialization area of the
pack, unveil the pack-unique ID and, via free text
messaging on even the most basic phone, query
the mPedigree cloud for the latest quality
assurance data within 5 to 10 seconds.

40. Tips for detecting counterfeit
medicines
• If a product is being offered at an unusually cheap price,
treat with extra caution.
• Consider developing a list of key pharmaceutical
products that will not be purchased from sources other
than the manufacturer, or authorised distribution
channel.
• Look for an altered expiry date
• Look for subtle changes in the product’s package
(compare with previously purchased products),
• Look for variations in the size of the container
(compare with previously purchased products
• Compare the physical characteristics of the product

41. An 8-Step Medicine Safety
[S.A.F.E.D.R.U.G. Approach]
• Sample (Request a sample from your physician)
• Appearance (Compare the prescription medicine)
• Feel (taste and any associated feelings)
• Evaluate (are you benefiting from the medication?)
• Doctor (if anything wrong contact to the doctor)
• Report [contact the pharmacy where you purchased them
FDA can be contacted by calling toll-free no. or site
• Unavailable( make unavailable counterfeit drug)
• Gather (Gather all the information you can find on how)
{developed by Bryan A.Liang San Diego Center for Patient Safety}

42. The World Health Organisation(WHO) has established an International Medical
Products Anti-Counterfeiting Task Force (IMPACT) in order to bring together all
stakeholders on the global level to fight counterfeit medical products. IMPACT
requested The World Health Professions Alliance (WHPA) to develop a toolkit for
health professionals and patients.
• 1. An overview of the situation and suggestions as to what health
professionals can do to help fight counterfeit medicines
• 2. A reporting form that can be copied and used to report any
suspected counterfeit (This form serves as a model and does not
replace any existing ones in-country)
• 3. A visual inspection check list that can be used if a counterfeit
medicine is suspected
• 4. An information leaflet that you can share with health
professionals
• 5. A patient information leaflet for distribution to patients or in
community areas
• 6. A poster that can be put in waiting rooms

43. International initiative