Prevention of counterfeit medicine


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  • 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 marketAssociated 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 : 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
  • 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: & 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:
  • 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:
  • 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 - 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
  • Prevention of counterfeit medicine

    2. 2. DEFINITIONWorld Health Organization(WHO)A counterfeit medicine is one which is deliberately and fraudulentlymislabeled with respect to identity and / or source.Counterfeiting can apply to both branded and generic products andcounterfeit medicines may includeproducts• With correct ingredients but fake packaging• With the wrong ingredients• Without active ingredients• With insufficient active ingredients3
    3. 3. SPURIOUS DRUGDrugs & Cosmetics Act 1940 –Definition:A drug shall be deemed to be spurious• If it is manufactured under a name which belongs to another drugor• If it is an imitation of, or is substitute for, another drug orresembles another drug in a manner likely to deceive or bearsupon its label or container the name of another drug unless it isplainly and conspicuously marked so as to reveal its true characterand its lack of identity with such other drug or• If the label or container bears the name of an individual orcompany purporting to be the manufacturer of the drug, whichindividual or company is fictitious or does not exist or• If it has been substituted wholly or in part by another drug orsubstance or• If it purports to be the product of a manufacturer of whom it isnot truly a product.4
    4. 4. NEW DEFINITION BY IMPACTWhen 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 ofactive ingredient /component or with fake packing.SOURCE:THE ECONOMIC TIMES , 17 OCT, 2008.
    5. 5. 6• The Indian pharmaceutical industry is 3rd largest in the worldin terms of volume accounting for 10 percent of world’sproduction 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 worthUS$8.34 billion and total APIs market was worth US$3.92billion. Total Export market was worth US$8.47 billion.• The domestic Indian Pharmaceutical market is expected toreach US$ 55 billion in 2020 at a Compound Annual GrowthRate (CAGR) of around 15 %.• India: 1in 5 medicines was fake, up to 14% annual loss.1 the Department of Pharmaceuticals, Ministry ofChemicals and FertilizersINDIAN SCENE
    6. 6. • As per Havoscope Global Black Market Index, the Indian sharein the industry is a $16.84 billion.• fake products with ‘Made in India’ label and manufactured inChina have been floating in the global market at an alarmingrate, bringing disrepute to the Indian domestic industry andcausing 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 marketare fake, according to the World Health Organisation.
    7. 7. GLOBAL SCENE• The impact of counterfeit medications on the legitimateglobal pharmaceutical market has been estimated to reach$75 billion 1• Estimates indicate that less than 1% of prescriptionmedications 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 ingredients1:International Narcotics Control Board(INCB);30-31 JAN 20072: 8
    8. 8. • Most cases of Counterfeit reported in developing countries ofthe Western Pacific (48.7%) – WHO• Africa, Asia and Latin America have > 30% of counterfeitmedicines1• Other developing markets have < 10%; overall range is 10% to30% (WHO)1• OECD: annual value of counterfeited consumer goods isUS$200 billion equivalent to 2% of world trade2 Medical Products Anti-Counterfeiting Taskforce (IMPACT), 2006, “Counterfeit medicines: an update on estimates”2:Asia times .June 7 ,2008 9GLOBAL SCENE
    10. 10. SELECTED EXAMPLECounterfeiter’s Manufacturing FacilitiesExamples of Counterfeit11
    11. 11. Counterfeit Cialis®12
    12. 12. Can You Tell the Difference?13
    13. 13. Counterfeit ProductCounterfeit Viagra found in two California pharmacies, June 2004:CounterfeittabletsGenuineViagratabletCounterfeittabletcontaining bluespecklesGenuine whitecore ViagratabletSource: FDA: Counterfeit Drug Photographs ; & Pfizer Global Security 14
    14. 14. Counterfeit LIPITORThe counterfeit Lipitor tablets on the right are nearly identical fromthe authentic tablets on the left. Only distinguishable to theconsumer by their bitter taste. More than 18 million counterfeitLipitor tablets were removed from the U.S. supply chain in 2003Source:FDA: Counterfeit Drug Photographs 15
    15. 15. Serostim®Comparison of an authentic Serostim and a counterfeited one,Source:FDA: Counterfeit Drug Photographs16
    16. 16. Procrit®17Three Batches of Counterfeit Procrit® (epoetin alfa) by Ortho Biotech, found March,2003. Product contained no active ingredient.Source: www.orthobiotec.comCounterfeit productAluminum wrapunder red cap is notsmooth & mayappear to dented Authentic PROCRITAluminum wrapunder red cap issmooth withoutdented
    17. 17. 18Counterfeit GenuineA product use by athletes to build
    18. 18. This is a Viagra counterfeiting site in Egypt. Counterfeit tablets werebeing given their blue coloring using an old cement mixer. Clearly,the manufacturing conditions were far from sterile,19Source:US Congress RogersFDA: Counterfeit Drug Photographs & Pfizer Global Security
    19. 19. ZantacManufactured in Taiwan, discovered in United Kingdom. Excellentpackaging of counterfeit.20Source:
    20. 20. Ponstan is an anti-inflammatory product. This counterfeit was found inColumbia contain yellow powder; it consist of boric acid, floor wax, yellowhighway paint.PonstanSource: 21
    21. 21. Would you trust Pharmaceuticals Manufactured at This factory?Counterfeit Ponstan, Colombia
    22. 22. Possible Inflow of Counterfeits to theLegitimate Distribution Channel23
    23. 23. 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
    24. 24. Candidates for Counterfeit• Fast moving and well known brand.• Easily manufactured.• Available over the counter (OTC).• Supplies to Government institutions.• Products for Exports25
    25. 25. • ConsumerHealth HazardLoss of confidence in the healthcare systemEventually a costlier affairEffect of Counterfeit• IndustryLoss of ReputationLoss of Brand EquityMistrust of Authorities, Health Practitionersand ConsumersEventually a costlier affair• GovernmentLoss of ReputationMistrust of importersLoss of Revenue• EthicsIncreased corruption
    26. 26. Extent of Counterfeit Problem• Not just a commercial problem• Should be tackled with priority• Indicative of requirement of technology advancement and lackof initiative at the same time• Pharmaceutical counterfeit can be fatal• Punishment: minimum 5 years , fine 10,00011:PHARMA EXPRESS 16-31 JULY 2008 27
    27. 27. Avoid Counterfeit• Consumer Awareness• Strengthening of Trade marks• Checks at exporting ports by Agencies involved in exports ofmedicines28
    28. 28. Potential Solutions• Product based solutions– Holographic labels, embeded technology in the packagingor 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 documentedpedigree
    29. 29. Novel Approach• E-pedigree• RFID• EPCIS(Electronic Product Code InformationService)• M-pedigree
    30. 30. What is pedigree ?• Record of the sale and physical distribution of a prescriptiondrug prior to being dispensed or administered to the patient• According to FDA regulations related to the Prescription DrugMarketing Act of 1987, which requires drug distributors toprovide documentation of the chain of custody of drugproducts -- the so-called "pedigree" -- throughout thedistribution system• This record, or “custodial history,” can be in two formats:– Paper– Electronic
    31. 31. Disadvantages of paper pedigree• Paper process is:– Ineffective because it does not preventcounterfeit drugs entering the healthcaresystem, only assists in investigation andprosecution– Cost-prohibitive because it adds a manualprocess to the millions of transactions–It is time-sensitive
    32. 32. Electronic : most effective• Streamlines cumbersome paper process• Most efficient, secure and cost-effective method to trackauthentic 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 beforged
    33. 33. Electronic Solutions: Advanced BarCoding and RFID• Advanced bar coding and RFID technologies are potential technologiesto enable efficient electronic pedigree• There are two possible approaches– Adding lot number, expiration date and other information to the barcode or RF-ID tag– Mass serialization where each package has a unique id numberassigned by the manufacturer• RFID is emerging as the preferred solution for package level trackingPDF417High data densityRugged 2-DRSS StackedLimitedspace“1.5-D”Example RFIDLabels
    34. 34. Bar Code V/S RFID• Require line of sight• Scan one item at a time• Inexpensive• Modification ofinformation notpossible(unless reprinted)• Standards developed• Line of sight not needed• Scan multiple items• More expensive• Modification or updatingof information possible• Standards still developingBarcodes : these are symbols printed on labels that are read by a scanner and used toidentify the product. These are printed as group of light and dark linesBarcodes RFID
    35. 35. • The data elements in the EPCIS standard data model defineWHAT (product),WHERE (location), WHEN (time), and WHY(business step and status) for product movements in the supplychain.
    36. 36. The Authentication ProcessSource: “How to Eliminate Counterfeit Pharmaceuticals -Authenticate at the Point ofDispensing™”, Rob Whewell, PA Consulting, RFID Network Forum, June 2004
    37. 37. m-pedigree Mobile Product Authentication (MPA)• m-pedigree are using mobile technology toauthenticate drugs• The technology is deployed at four levels.
    38. 38. • Manufacturers sign up to the cloud-based serviceand then integrate their label sourcingmechanisms with mPedigrees intelligent labellogistics management process.• Consumers, upon receiving a pack of medicineprotected under the scheme, remove the tamper-evident panel from the serialization area of thepack, unveil the pack-unique ID and, via free textmessaging on even the most basic phone, querythe mPedigree cloud for the latest qualityassurance data within 5 to 10 seconds.
    39. 39. Tips for detecting counterfeitmedicines• If a product is being offered at an unusually cheap price,treat with extra caution.• Consider developing a list of key pharmaceuticalproducts that will not be purchased from sources otherthan the manufacturer, or authorised distributionchannel.• 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
    40. 40. 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 themFDA 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}
    41. 41. The World Health Organisation(WHO) has established an International MedicalProducts Anti-Counterfeiting Task Force (IMPACT) in order to bring together allstakeholders on the global level to fight counterfeit medical products. IMPACTrequested The World Health Professions Alliance (WHPA) to develop a toolkit forhealth professionals and patients.• 1. An overview of the situation and suggestions as to what healthprofessionals can do to help fight counterfeit medicines• 2. A reporting form that can be copied and used to report anysuspected counterfeit (This form serves as a model and does notreplace any existing ones in-country)• 3. A visual inspection check list that can be used if a counterfeitmedicine is suspected• 4. An information leaflet that you can share with healthprofessionals• 5. A patient information leaflet for distribution to patients or incommunity areas• 6. A poster that can be put in waiting rooms
    42. 42. International initiative