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
Malegaon Call Girls Service ☎ ️82500–77686 ☎️ Enjoy 24/7 Escort Service
Prevention of counterfeit medicine
1.
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
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
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
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
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
Lipitor and Viagra, probably the world's most counterfeited drug BY U.S. NEWS
A counterfeit drug is an imitation/substitute/illegal drug that is madewith an intent to deceptively represent its content or origins
Drug that do not contain any ingreadient:In 2001, in South-East Asia, a Wellcome Trust study revealed that 38% of 104 anti-malarial drugs on sale in pharmacies did not contain any active ingredients.
INDIAN SCENE;;;;;;;;;;;;;;;;;; Organization for Economic Co-operation and Development India is the leader in pharma production The Indian pharmaceutical industry is worth $ 6 billion and is growing at the rate of 10 percent, higher than the 7 % global industry growth rate . USA includes India under watch list special 301Total supply of fake drugs can be traced to India is 35%The World Health Organization (WHO) *According to figures released by the Organisation for Economic Co-operation and Development (OECD), India emerges as the biggest culprit in the fake drug manufacture i.e.. 75 percent of fake drugs supplied world wide have their roots from India, followed by seven percent from Egypt and six percent from China. Counterfeit market estimated to be 15 –20 % of India’s total pharmaceutical marketAssociated Chambers of Commerce and Industry of India (ASSOCHAM) has estimated that the annual rate of growth of the fake drugs market in India is 25% and worth US$34.9 billion *.India strives to become a major sourcing hub globally –counterfeit can be a major deterrent *: Asia times online June 7 ,2008;; PHARMA EXPRESS 16-31 JULY 2008
GLOBAL SECNEWorld Health Organization estimates that counterfeits could account for more than 10 per cent of the global medicines market.*According to the Centre for Medicines in the Public Interest in the United States, counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.* as 70% in developing countriesarecounterfeit:FIND SOURCE16% of counterfeit drugs contain the wrong ingredients17%contain incorrect amounts of theproper ingredients 60% have no active ingredients at all.Sales of counterfeit Rx products are estimated to be US$32B.Developing countries of the Western Pacific (China, Philippines and Vietnam) comprised the region with the most cases reported (48.7%) – WHOSOURCE : WHO OFFICILE SITE & PPT NO 5; (GLOBAL SENARIO TAKEN FROM THIS PPT )*:INTERNATIONAL NARCOTICS CONTROL BOARD(INCB);30-31 JAN 20072007; US $ 50 BILLION ; 2008 US $ 73.5 BN ;2010 75 US $ BNBY CENTRE FOR MEDICINES IN PUBLIC INTEREST, USA
GLOBAL SECNE ((The Organization for Economic Cooperation and Development (OECD) ))Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range is between 10% and 30% (WHO) 2, *In 2006, counterfeit drugs accounted for more than 10% of the global pharmaceutical market, i.e. about 45 billion euros1. The OECD reckons that the annual value of international trade in counterfeited consumer goods, including medicines, is US$200 billion, an amount equivalent to 2% of world trade*1WHO : http://www.who.int/en/2 International Medical Products Anti-Counterfeiting Taskforce (IMPACT), 2006, “Counterfeit medicines:an update on estimates”* Asia times .June 7 ,2008;; & WHO 2006 FIGUREThe Organization for Economic Cooperation and Development (OECD) reckons that 75% of the world's total supply of fake drugs can be traced to India. The World Health Organization (WHO) pegs the figure at 35%.
Cialis is a LillyICOS JV productSource:Combating PharmaceuticalCounterfeitingSecond Global Congress for CombatingCounterfeiting, Lyon, FranceNovember 14-15, 2005Presented by:Christopher James Shaw
Lipitor (United States):20 mgThe counterfeit Lipitor tablets on the left are nearly identical from the authentic tablets on the right. 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
By merkserono ,head quarter in geniva .Use in hivwesting . To increase lean body mass 7 physical in durance
Three Batches of Counterfeit Procrit® (epoetinalfa) by Ortho Biotech, found March, 2003. Product contained no active ingredient and may contain bacterial contamination (Acinetobacter and Pseudomonas). Source: Dr. Marvin ShepherdSource:www.orthobiotec.com
An anemia product used to treat renal insufficiency was purchased in Mexico and illegally imported to the U.S. Packaging is very similar to original, but in testing the counterfeit product, it only contained sesame seed oilSource: www.phrma.org/) & Counterfeit Pharmaceuticals in Developing Nations by Dr. Kristina M. LybeckerDecember 6, 2003
Manufactured in Taiwan, discovered in United Kingdom. Excellent packaging of counterfeit, even includes counterfeit package insert. (Source: www.phrma.org/)
Ponstan is an anti-inflammatory product. This counterfeit was found in Columbia. First is the yellow powder; it consist of boric acid, floor wax, yellow highway paint. Pressed into tablets and placed in foil packs with labeling. (Source: www.phrma.org/)
SOURC:6. DRUG THAT ARE FREQUENTLY COUNTERFEITAccording to the WHO, the categories of medicines most frequently counterfeited are antibiotics, antihistamines, hormones and steroids. Fast detection and identification of counterfeit antimalarial ... drugs, are frequently counterfeited. 4. Among the most well-. known counterfeit drugs in wealthier countries are Viagra. and Cialis, which are used against ...doi.wiley.com/10.1002/jrs.1621 - Similar pagesby M de Veij - 2007 - Cited by 9 - Related articlesIn developing countries, the most frequently counterfeited drugs are those used to treat life-threatening conditions, such as malaria, tuberculosis and HIV/AIDS, while in wealthier countries, drugs that are counterfeited are often the new, expensive 'lifestyle' drugs.
counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005)
Extent of Counterfeit Problem:Not just a commercial problemShould be tackled with priorityIndicative of technology advancement and lack of knowledge at the same timePharmaceutical counterfeit can be fatalNon cognizable and bail able crimeunder section 27 and section 27 (a) of the Drugs & Cosmetics Act if a counterfeit medicine would amount to grievous hurt within the meaning of section 320 of the Indian penal Code (IPC), then such person shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life with fine not less than Rs 10, 000 . Pharmaceutical counterfeit can be fatal:89 children died in Haiti in 1995 and 30 infants died in India in 1998 due to the consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze).
Consumer Awareness program along with promotional programsStrengthening of Trade marksBetter co-ordination between Trade Mark and Drug Regulatory AgenciesEffective dissemination of Trade Mark information eg: Publication of the information on a WebsiteChecks at exporting ports by Agencies involved in exports of medicines (Customs, ADC(I), State & Federal FDAs, Manufacturer and Merchant Exporters)NOC by manufacturer in name of traderCoA from Original ManufacturerInvoice from Original ManufacturerExcise Gate-pass from Original Manufacturer