Counterfeit Medicines

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    Introduction

    The problem of DrugCounterfeiting is as old ascivilization.

    17thcentury Cinchona bark wasbeing faked

    Drug counterfeiting has

    assumed such an alarming ratethat it is now being perceived tobe a Public ealth hazard thatmerits !lobal attention

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    Definition

    "ccording to#lack$s Dictionarythe term %counterfeit drug$ refersto a drug made by someone

    other than the genuinemanufacturer& by copying orimitating an original productwithout "uthority or 'ight& witha view to deceive or defraud andmarketing the product as theoriginal

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    (..). has come out with a

    definition to guide national drug

    regulatory authorities*

    " C)+, -'-/ 0-D/C/,- /1

    ),- (/C /1 D-2/#-'" -23

    ",D '"+D+2-, 23

    0/12"#-22-D with respect to

    identity and or source

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    Contd.

    Counterfeiting can apply to

    both #'",D-D and !-,-'/C

    products and these may

    include products with

    the C)''-C ingredients&

    or with the ('),! active

    ingredients

    without "C /4- ingredients&

    /,1+/C/-, "C /4- ingredients

    "5- P"C5"!/,!.

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    W.H.O. Figures

    ome figures presented by

    (..). indicate the e6tent of

    the problem:

    1992-1994 survey uncovered 51 of

    counterfeited drugs !it" no #ctive ingredient.

    25 of $edicines in deve%o&ing countries

    counterfeited or su'-st#nd#rdFD( re&orted 1 in 1) $edicines so%d

    !or%d!ide !#s f#*e !it" no $edic#% effect.

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    Contd.

    2++ c"i%dren died fro$ consu$&tion of

    ,#r#cet#$o% syru& cont#ining #nti-freee in

    #ng%#des" /19920

    25)) c"i%dren died #fter 'eing inocu%#ted

    !it" counterfeited C..3. v#ccine /19950

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    Factors Encouraging

    Counterfeiting of Drugs

    Medicines are high value items for bothcurative and preventive health care.

    Demand for medicine is innite.

    Ingredients for producing counterfeit drugscheaper.

    No infrastructure;No quality assurance;

    High margins of cost.

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    1.

    Lack of Political Will AndCommitment

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    2.

    Lack of Appropriate DrugLegislation

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    3.

    Absence of or Weak DrugRegulation

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    4.

    ! Weak Enforcement and PenalSanctions.

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    Illegal Trading in

    pharmaceuticals: b !eof"o#er$!la%o&mith'line

    Franchising

    Parallel trading

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    Diversion or illegal tradingCounterfeiting

    Counterfeiting

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    Corruption and conflict of interest

    demand exceeding supply

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    high prices of medicines

    inefficient co-operation betweenstakeholders

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    lack of regulation by exportingcountries and within free trade zones

    Trade through several intermediaries

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    substitution

    adulteration and re-use

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    /mpact on Public ealthre#t$ent f#i%ures

    oss of confidence in "e#%t" c#re &roviders

    W#ste of resources /'ot" tient 6govern$ent0

    o! &roductivity

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    Conclusion

    Cre#te &u'%ic #!#reness

    7duc#te &u'%ic on detection

    r#cing #nd tr#c*ing 'y #ut"orities /,O87 6 WH770

    everer s#nctions for counterfeiters

    3#nuf#cturers $ust 'e "e%d %i#'%e for t"ird rty inuriesresu%ting fro$ counterfeited drugs.

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    H(8 ;O