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IndianJPharmacol.2011Apr43(2):131136.doi:10.4103/02537613.77344
PMCID:PMC3081449
AcomparativeevaluationofpriceandqualityofsomebrandedversusbrandedgenericmedicinesofthesamemanufacturerinIndiaG.L.Singal,ArunNanda,andAnitaKotwani
DepartmentofPharmaceuticalSciences,M.D.University,Rohtak,Haryana,IndiaDepartmentofPharmacology,V.P.ChestInstitute,UniversityofDelhi,Delhi,India
Correspondenceto:Dr.AnitaKotwani,Email:[email protected]
Received2010Jun16Revised2010Sep6Accepted2011Jan16.
Copyright:IndianJournalofPharmacology
ThisisanopenaccessarticledistributedunderthetermsoftheCreativeCommonsAttributionNoncommercialShareAlike3.0Unported,whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.
ThisarticlehasbeencitedbyotherarticlesinPMC.
Abstract
Objective:
TocompareandevaluatethepriceandqualityofbrandedandbrandedgenericequivalentsofsomecommonlyusedmedicinesmanufacturedbythesamepharmaceuticalcompanyinIndia.
MaterialsandMethods:
Fivecommonlyusedmedicines:alprazolam,cetirizine,ciprofloxacin,fluoxetine,andlansoprazolemanufacturedinbrandedandbrandedgenericversionsbythesamecompanywereselected.Pricetopatientandpricetoretailerswerefoundforfivepairofmedicines.BothquantitativeandqualitativeanalysiswereperformedfollowingthemethodsprescribedintheIndianPharmacopoeia2007onfivepairofmedicines.Thetestsperformedwereidentificationtest,chemicalcompositionestimationtest,uniformityofcontentstest,uniformityofweight,anddissolutionstudies.
MainOutcomeMeasures:
Pricetopatient,retailermarkupandqualitativeanalysisofbrandedandbrandedgenericmedicines.
Results:
Retailermarginforfivebrandedmedicineswereintherangeof2530%butfortheirbrandedgenericsversionmanufacturedbythesamecompanyitwasintherangeof2011016%.Pricetopatientforthebrandedversionofcetirizine,fluoxetine,ciprofloxacin,lansoprazole,andalprozolamwashigherby41%,33%,0%,14%,and31%thanbrandedgeneric.BothversionsoffivemedicineswerewithintheirpermissiblerangeforallthequantitativeandqualitativeparametersasprescribedinIndianPharmacopoeia.
Conclusion:
Differenceinpricetopatientwasnotashugeasitisexpectedforgenericsbutmarginsforretailerwereveryhigh
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forbrandedgenerics.Qualityofbrandedgenericsissameasfortheirbrandedversion.Thestudyhighlightstheneedtomodifythedrugpricepolicy,regulatethemarkupsingenericsupplychain,conductandwidelypublicizethequalitytestingofgenericsforawarenessofallstakeholders.
Keywords:Brandedmedicines,brandedgeneric,generics,markups,medicineprice,India,qualitytesting
Introduction
Theuseofgenericdrugsissteadilyincreasinginternationallyasaresultofeconomicpressureondrugbudgets.Genericdrugsprovidetheopportunityformajorsavingsinhealthcareexpendituresincetheyareusuallysubstantiallylowerinpricethantheinnovatorbrands.[1]However,physiciansareapprehensiveregardingthequalityofgenericdrugs[2,3]andhaveconcernsabouttheirreliabilityaswellasinterchangeofcertaindrugcategories.[4]Althoughthegenericmedicinesarebioequivalentsoftheirinnovatorcounterpartsandareproducedinsimilarfacilitiesaccordingtogoodmanufacturingpractices,[5]thesearewidelybelievedasinferiorintheirtherapeuticefficacyandqualitytobrandedproducts.[6,7]MarketingpracticesadoptedbymanufacturersofimportedbrandedmedicinesalsopropagatethebeliefthatgenericsareofinferiorqualityasreportedfromcountriesinCentralandEasternEuropeandindependentcountriesemergedfromformerSovietUnion.[8]Thepresentstudywasconductedtocomparethequalityandpriceofgeneric(brandedgeneric)drugproductstotheirexpensivepopularbrand(branded)productsmanufacturedbythesamepharmaceuticalcompanyinIndia.
Currently,almostallmedicinesinIndiaaresoldunderabrand(trade)nameandmedicinesarecalledasbrandedmedicinesorbrandedgeneric.Inrealsense,Indianmarketdoesnothavebrandedmedicines(anamecommonlygiventoaninnovatorproduct)becausetillJanuary2005productpatentwasnotapplicableinIndia.InIndia,manypharmaceuticalcompaniesmanufacturetwotypesofproductsforthesamemolecule,i.e.thebrandedproductwhichtheyadvertiseandpushthroughdoctorsandbrandedgenericwhichtheyexpectretailerstopushinthemarket.ThesocalledbrandedmedicinesinIndiaaremanufacturedandpromotedbymultinationalsorbyreputedIndianmanufacturers.brandedgenerics,ontheotherhand,arenotpromotedoradvertizedbythemanufacturer.Thiscategorycloselyresemblesformulationsreferredtoasgenericsworldwide.Patientsanddoctorsperceptionforallbrandedgenericsirrespectiveofcompanyisthesame.
InIndia,genericsubstitutionislegallynotallowedsopatientsawarenessaboutgenericsislimitedanddoctorsandpatientsdonotwantpharmacisttochangethetradenamewrittenbydoctor.Hence,consumerawarenessforthegenerics,varietyoftradenamesavailableinthemarket,andpricevariationisverylimited.Hence,thereisneedtoconductastudythatcandocumentthepricestructureandqualityofthebrandedproductandtheirbrandedgenericversionsmanufacturedinIndia.
Apairofproductfromthesamecompanywaschosentoappreciatethepricestructureandmarkupsforthetwoversions.
Methods
Qualityandpriceofmedicineswerestudiedtoevaluatethetwoversionsofthesametherapeuticmolecule.DatawerecollectedduringSeptembertoNovember2008.
Selectionofmedicines
Fivecommonlyusedmedicinesfromdifferentclasseswereselectedwhosebranded(popularbrand)andbrandedgenericversionsweremanufacturedbythesamepharmaceuticalcompany.Thefivemedicineschosenwerealprazolam,(0.25mg),cetirizine(10mg),ciprofloxacin(500mg),fluoxetine(20mg),andlansoprazole(30mg).
Medicineprice
Pricetopatientandpricetoretailer(PTR)wereanalyzed.Maximumretailprice(MRP)isthepricetopatientand
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isalwaysprintedonthepackageinIndia.MedicinesareavailabletopatientattheMRPmentionedonthepackageofmedicine.Detailsofthefive"paired"drugproductssoldunderdifferenttradenameswiththeirMRPwerecheckedphysicallywiththeprivateretailpharmacies(chemistshop).
PTRisthepriceatwhichwholesaler(distributor)sellstheproducttotheretailerandthebill(voucher)giventoretailerbywholesalermentionsthePTR.PTRforallmedicineswasfoundbylookingatthevouchers.ThispricewascheckedandconfirmedfromFormV(underDPCO,1995)availableatthedistributorsofthecompany.ItismandatoryforallthecompaniestogiveFormVthatgivesdetailsoftheproductwithMRP,PTR,taxespaid,etctotheirdistributors.
Qualitytesting
Thetestsampleswereprocuredfromthelicensedauthorizedchemistdealersthroughvalidpurchaseinvoice.Thesamplesizecomprised1010tablets/capsulesofbothbrandedandbrandedgenericversionsofeachdrugproduct.Effortsweremadetoprocurethesetestsamples(pairs)withidenticaldateofmanufacturetoruleoutthepossibilityofdifferenceinassaybecauseofdifferentdatesofmanufacturing.ThequalitativeaswellasquantitativeanalysiswascarriedoutinaGovernmentapprovedlaboratoryfollowingthemethodsprescribedintheIndianPharmacopoeia,(2007)asperthestandardslaiddownintheDrugsandCosmeticsAct1940andRules1945.[9]
Followingtestswereperformed.
1.
Identificationtest:IdentityofthedrugmoleculewasestablishedbyperformingtheidentificationtestthroughinstrumentalanalysisusingHPLC(highpressureliquidchromatography)orIR(infraredspectroscopy)aspermethodprescribedforeachmedicine.
2.
Chemicalcompositiontest\:ThesamplesweresubjectedtoquantitativeanalysisusingHPLCinstrumentalanalyticalmethodsasprovidedinIndianPharmacopoeia2007.
3.
Uniformityofcontenttest:Toconfirmtheuniformityofcontentsinthebatch,thesampleddosageunitsweresubjectedtouniformityofcontentstestwhereinassayon10unitsofdosageformwereperformedindividuallyusinginstrumentalanalyticalmethods.Thetestforuniformityofcontentisnotapplicabletotablets/capsulescontainingmorethan10mgitwasconductedonlyforalprazolam(0.25mg)andcetirizine(10mg).
4.
Uniformityofweight:All10unitsofsampleweretestedforuniformityofweightasprescribed.5.
TestsforDissolution:Thesamplesweresubjectedtodissolutionstudiestoevaluatetheirdrugrelease
pattern.ThesestudieswereperformedinthedissolutionmediaspecifiedintheindividualmonographoftheIndianPharmacopoeia2007onsixdosageunitsandwereindicativeoftheinvivoavailabilityofactivedrugmoietyfromthedosageform,i.e.tabletorcapsule.
Results
ComparativePriceandMarkUpforBrandedandBrandedGenericPairofMedicines
DetailsoffivepairsofmedicinesincludingtheirtradenameassoldintheIndianmarket,strength,dosageform,andthepharmaceuticalcompanythatmanufacturestheseproductsaregiveninTable1.Pricetopatient(MRP)andpricetoretailer(PTR)foundforallthefivepairofmedicinesistabulatedinTable1.PTRforthebrandedproductofcetirizinewas11timesthepriceforbrandedgenericbythesamecompany.RetailerisearningINR22.76for10tabletsofbrandedgenericcetirizineversusRs8.16forthebrandedversionfromthesamecompany.Forciprofloxacin,theMRPofboththebrandedandbrandedgenericproductwassamebutthebrandedgenericwasavailabletoretailerat3.6timeslesspricethanbrandedmedicinefromthesamecompany.
Table1ComparativepricestructureofBrandedandBrandedgenericmedicines
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Thepricetopatient(MRP)ofthebrandedproductforthefivemedicinesevaluatedwas41%,33%,0%,14%,and31%higherthantheMRPofthebrandedgenericversionofthesamecompany.Ontheotherhand,PTRforbrandedgenericwas1112%,397%,266%,170%,and439%lessthanthebrandedversionofcetirizine,fluoxetine,ciprofloxacin,lansoprazole,andalprazolam,respectively.Retailermarkupsforfivepairofmedicinesforbrandedversusbrandedgeneric:cetirizine,fluoxetine,ciprofloxacin,lansoprazole,andalprazolamwere30%versus1016%,25%versus367%,25%versus357%,27%versus201%,and25%versus415%,respectively[Table1].
QualityofBrandedandBrandedGenericPairofMedicines
1.
Identificationtest:AllthefivepairedmedicinesofbrandedandbrandedgenericsgavepositiveidentificationtestswhentestedonHPLCorIRestablishingtheirchemicalidentity[Tables26].
Table2ComparativeanalyticalevaluationofbrandedandbrandedgenericdrugproductAlprazolamtablets(0.25mg)
Table6Comparativeanalyticalevaluationofbranded/brandedgenericdrugproductLansoprazolecapsules(30mg)
2.
Chemicalcompositiontest:ThequantitativeanalysisconductedusingtheHPLCmethodshowedeachunitofthetestedsamplestobewellwithintheprescribedrange[Tables26].
3.
Uniformityofcontent:Thistestwasdoneforalprazolamandcetirizineandresultsforboththeversionsofmedicineswerewithintheprescribedrange[Tables2and3].
Table3ComparativeanalyticalevaluationofbrandedandbrandedgenericdrugproductCetirizinetablets(10mg)
4.
Uniformityofweight:Eachunitofthesamplewaswithintheprescribedrangeforallthefivepairofmedicines[Tables26]
5.
Dissolutiontest:Thedissolutiontestforallthefivepairedmedicineswerewithinthepermissiblelimitsofthestatutorystandards[Tables26].
Table4ComparativeanalyticalevaluationofbrandedandbrandedgenericdrugproductCiprofloxacintablets(500mg)
Table5ComparativeanalyticalevaluationofbrandedandbrandedgenericdrugproductFluoxetinecapsules(20mg)
Discussion
ThisisoneofthefirststudiesinIndiaconductedtosystematicevaluatethepricetopatientandretailermarkupforthebrandedandbrandedgenericversionsofthesametherapeuticmoleculemanufacturedbythesamecompany.Thisstudyhasalsoevaluatedthequalityofthetwoversions.Findingsofthestudyrevealedthattherearehugemarkupsforretaileronbrandedgenericmedicines.Theretailermarginforfivebrandedmedicinesstudiedwasin
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therangeof2530%,butfortheirbrandedgenericsversionmanufacturedbythesamecompanyitwasintherangeof2011016%.BothversionsofallfivemedicinesclearedallthequantitativeandqualitativeparametersasprescribedinIndianPharmacopoeia,2007.Thereexistsawidespreadbeliefamongpeopleanddispensingchemiststhatabrandedproductisbetterintermsofqualityandsafetythanthegeneric.[1012]Asystematicreviewhasshownthatgenericandbrandnamecardiovasculardrugsweresimilarfornearlyallclinicaloutcomes.Thisstudyconcludedthatthereisnoevidenceofsuperiorityofbrandpreparationstogenericdrugs.[13]Suchstudiesmaybehelpfulinpromotinggenericdrugusethatreducesunnecessaryspendingwithoutimprovingclinicaloutcome.Inmostdevelopedcountries,genericmedicinesarepromotedbycompetitionenhancingpoliciesoperatingthroughhealthcarereimbursementstocontainexpenditureandencourageefficientuseofresources.[14]
Resultsofourstudyrevealedthatpricetopatientforthebrandedgenericversionwasnotmuchlessthantoitsbrandedcounterpartbrandedgenericwasavailableat70100%costofthebrandedproduct.InIndia,medicinepricesaresetinoneofthetwoways.MedicinepricesareunderthepurviewofDepartmentofPharmaceuticalswhichitselfisunderministryofchemicalsandfertilizers.TheDrugPriceControlOrder(DPCO)identifiesactivepharmaceuticalingredients(APIs)forwhichapricingformulaisusedtosettheMRP.Thereareonly74bulkdrugswhichareunderpricecontrol[15]andarecalledscheduledmedicines.ForallothermedicinescallednonscheduledmedicinesthemanufacturersetsthepriceandregistersthatpricewiththeNationalPharmaceuticalPricingAuthority(NPPA)underDepartmentofPharmaceuticals.[16]ThemedicinesaresoldattheprintedMRPontheirlabelanddispensingpharmacistcannotchargeapriceexceedingMRPprintedonthepack,aspertheprovisionsunderparagraph16oftheDPCO,1995.Forscheduledmedicines,theNPPApricingformulasetsthe8%markupforwholesalersand16%forretailers.Fornonscheduledmedicines,thesemarkupsarenotset,butitisagreedbythepartnersofthetradethatforbrandedmedicinesaveragemarkupwouldbearound10%and20%forwholesalersandretailers,respectively.
Inoursampleofmedicines,onlyciprofloxacinisunderpricecontrolandotherfourbelongtononschedulemedicine.Thestudyrevealedthatevenforthebrandedversionofbothscheduleandnonscheduledmedicines,theretailermarginwasmorethantheestablishedmargin,itwasintherangeof2530%.Forthebrandedgenericversion,theretailermarginswereverylarge,2011016%.Pharmaceuticalcompaniesdecidenotonlythefinalprice(MRP)tothepatientbutalsothemarkupfortheretailer.Ifthemarketingisdonebythecompanyasforthe"branded"versionthenthemajormarkupsareforthecompanyifthemarketingandpromotionaredonebytheretailerasinthecaseofbrandedgenericthenthePTRisless,butMRPisnotmuchdifferent.Therefore,thebrandedgenericsarepromotedbytheretailersformonetaryconsiderationsintotaldisregardtothepatient'sinterests.Theultimateconsumer,i.e.patientisnotbenefitedmuchbypreferringbrandedgenericversionstoitsbrandedversion.Anewspaperreportsthehugeprofitmarginsforretailersrangingfrom500%to1000%ongenericmedicinesinIndia.[17]Thehighmarkupsongenericsaretotallynegatingtheveryconceptofaffordablegenericmedicinesforpatients.
Unlikedevelopedcountries,peopleindevelopingcountriespaythecostofmedicinesoutofpocket.InIndia,morethan80%healthfinancingisbornebypatients.[18]Indiaisknowntoexportmedicinestovariouscountriesatlowcost,butfacesthechallengeofaccesstoaffordableandqualitymedicinesforitsownpopulation.[19]Hence,thegovernmentshouldhaveapolicywherebythepricesofbrandedgenericdrugscanbemaderealisticandaffordabletocommonman.Weneedtohavelegislationtothateffect.Theprofitmarginspresentlybeingsharedbytradersmustbepassedtoconsumer.
InIndia,adispensingpharmacistisnotauthorizedtosubstituteabrandedmedicinewithabrandedgeneric(orgeneric)aspertheprovisionsunderRule65oftheDrugsandCosmeticsAct,1940andRules,1945,whichalsoaddtothepatient'sburden.IntheUSAsubstitutionisallowedandpatientsacceptgenericsubstitutionifphysicianapprovesofthesame.Genericsubstitutionrateshaveincreasedremarkablythere,probablyduetogreateracceptancebyphysiciansandpharmacistsaswellasencouragementfromthethirdpartypayers.[20]Cheapergenericsareoneoftheimportantfactorstoreducehealthcarecost.Thepracticeofgenericsubstitutionisstrongly
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supportedbyhealthauthoritiesinmanydevelopedcountries.[21]Useofgenericdrugs,whicharebioequivalenttobrandnamedrug,canhelpcontainprescriptiondrugspending.[22]GovernmentofIndiahasopenedfewgenericdrugstoresinsomestatesthatsellgenericmedicinesmanufacturedbypublicsectorcompanies.[23]Thequalityofgenericmedicinesavailableonthesestoresatcheaperratesshouldbetestedandcomparedwithpopularbrandsandresultsshouldbewidelypublished.Studiesinvolvingcomparativeevaluationonqualityofbrandedandtheirgenericcounterpartmaybemademandatoryforthegeneric(orbrandedgeneric)manufacturerandtheirreportsshouldbemadepublictopromotegenericuseandprescriptions.
Oneinherentlimitationofthisstudyisthatwehavetestedpairofbrandedandbrandedgenericmedicinesthatweremanufacturedbythesamereputedcompany.Thoughitisexpectedthatboththeversionsshouldhavethesamequalitybutperceptionforanybrandedgenericissameamongdoctorsandpatients.Sotostartwith,wehavetakenbothbrandedandbrandedgenericproductsofthesamecompanyandstudiednotonlythequalitybutalsothepricestructure.
Conclusions
Findingsofthepresentstudyindicatethatboththebrandedandbrandedgenericversionsofthefivepairedmedicineshadidenticalqualityandtheyfulfilledallthecriteriaprescribedbythestatutorystandards.Hence,thegeneralnotionanddoubtregardingthequalityofthebrandedgenericversionofmedicinesneedstobeerasedconductingmoresuchstudiesandpublishingthemwidely.Suitablechangesinthedrugpricepolicymaybemadetohavelowerpricesforbrandedgenericversions.TransparencyinfixingtheMRPbythemanufacturerandclearguidelinesformarkupsatleastforbrandedgenericsisrequiredinpharmaceuticaltrade.Thegovernmentmusttakeupgenericpromotionalschemes,generalawarenessprogramsonqualityofgenericstobuildconfidenceamongprescribers,pharmacists,andconsumers.Availabilityofgenericsorbrandedgenericsinthemarketwithlowerpricetagandassuredqualityisessentialtomakethemedicinesaffordable.
Acknowledgments
Weappreciatethecooperationofretailpharmacistsanddistributorswhohelpedusincollectionofthedata.
FootnotesSourceofSupport:Nil.
ConflictofInterest:Nonedeclared.
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