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IndianJPharmacol.2011Apr43(2):131136.

PMCID:PMC3081449

doi:10.4103/02537613.77344

Acomparativeevaluationofpriceandqualityofsomebrandedversusbranded
genericmedicinesofthesamemanufacturerinIndia
G.L.Singal,ArunNanda,andAnitaKotwani1
DepartmentofPharmaceuticalSciences,M.D.University,Rohtak,Haryana,India
1
DepartmentofPharmacology,V.P.ChestInstitute,UniversityofDelhi,Delhi,India
Correspondenceto:Dr.AnitaKotwani,Email:anitakotwani@gmail.com
Received2010Jun16Revised2010Sep6Accepted2011Jan16.
Copyright:IndianJournalofPharmacology
ThisisanopenaccessarticledistributedunderthetermsoftheCreativeCommonsAttributionNoncommercialShareAlike3.0Unported,whichpermits
unrestricteduse,distribution,andreproductioninanymedium,providedtheoriginalworkisproperlycited.

ThisarticlehasbeencitedbyotherarticlesinPMC.

Abstract

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Objective:

Tocompareandevaluatethepriceandqualityofbrandedandbrandedgenericequivalentsofsomecommonly
usedmedicinesmanufacturedbythesamepharmaceuticalcompanyinIndia.
MaterialsandMethods:

Fivecommonlyusedmedicines:alprazolam,cetirizine,ciprofloxacin,fluoxetine,andlansoprazolemanufacturedin
brandedandbrandedgenericversionsbythesamecompanywereselected.Pricetopatientandpricetoretailers
werefoundforfivepairofmedicines.Bothquantitativeandqualitativeanalysiswereperformedfollowingthe
methodsprescribedintheIndianPharmacopoeia2007onfivepairofmedicines.Thetestsperformedwere
identificationtest,chemicalcompositionestimationtest,uniformityofcontentstest,uniformityofweight,and
dissolutionstudies.
MainOutcomeMeasures:

Pricetopatient,retailermarkupandqualitativeanalysisofbrandedandbrandedgenericmedicines.
Results:

Retailermarginforfivebrandedmedicineswereintherangeof2530%butfortheirbrandedgenericsversion
manufacturedbythesamecompanyitwasintherangeof2011016%.Pricetopatientforthebrandedversionof
cetirizine,fluoxetine,ciprofloxacin,lansoprazole,andalprozolamwashigherby41%,33%,0%,14%,and31%
thanbrandedgeneric.Bothversionsoffivemedicineswerewithintheirpermissiblerangeforallthequantitative
andqualitativeparametersasprescribedinIndianPharmacopoeia.
Conclusion:

Differenceinpricetopatientwasnotashugeasitisexpectedforgenericsbutmarginsforretailerwereveryhigh

forbrandedgenerics.Qualityofbrandedgenericsissameasfortheirbrandedversion.Thestudyhighlightsthe
needtomodifythedrugpricepolicy,regulatethemarkupsingenericsupplychain,conductandwidelypublicize
thequalitytestingofgenericsforawarenessofallstakeholders.
Keywords:Brandedmedicines,brandedgeneric,generics,markups,medicineprice,India,qualitytesting
Introduction

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Theuseofgenericdrugsissteadilyincreasinginternationallyasaresultofeconomicpressureondrugbudgets.
Genericdrugsprovidetheopportunityformajorsavingsinhealthcareexpendituresincetheyareusually
substantiallylowerinpricethantheinnovatorbrands.[1]However,physiciansareapprehensiveregardingthe
qualityofgenericdrugs[2,3]andhaveconcernsabouttheirreliabilityaswellasinterchangeofcertaindrug
categories.[4]Althoughthegenericmedicinesarebioequivalentsoftheirinnovatorcounterpartsandareproduced
insimilarfacilitiesaccordingtogoodmanufacturingpractices,[5]thesearewidelybelievedasinferiorintheir
therapeuticefficacyandqualitytobrandedproducts.[6,7]Marketingpracticesadoptedbymanufacturersof
importedbrandedmedicinesalsopropagatethebeliefthatgenericsareofinferiorqualityasreportedfromcountries
inCentralandEasternEuropeandindependentcountriesemergedfromformerSovietUnion.[8]Thepresentstudy
wasconductedtocomparethequalityandpriceofgeneric(brandedgeneric)drugproductstotheirexpensive
popularbrand(branded)productsmanufacturedbythesamepharmaceuticalcompanyinIndia.
Currently,almostallmedicinesinIndiaaresoldunderabrand(trade)nameandmedicinesarecalledasbranded
medicinesorbrandedgeneric.Inrealsense,Indianmarketdoesnothavebrandedmedicines(anamecommonly
giventoaninnovatorproduct)becausetillJanuary2005productpatentwasnotapplicableinIndia.InIndia,many
pharmaceuticalcompaniesmanufacturetwotypesofproductsforthesamemolecule,i.e.thebrandedproduct
whichtheyadvertiseandpushthroughdoctorsandbrandedgenericwhichtheyexpectretailerstopushinthe
market.ThesocalledbrandedmedicinesinIndiaaremanufacturedandpromotedbymultinationalsorbyreputed
Indianmanufacturers.brandedgenerics,ontheotherhand,arenotpromotedoradvertizedbythemanufacturer.
Thiscategorycloselyresemblesformulationsreferredtoasgenericsworldwide.Patientsanddoctorsperception
forallbrandedgenericsirrespectiveofcompanyisthesame.
InIndia,genericsubstitutionislegallynotallowedsopatientsawarenessaboutgenericsislimitedanddoctorsand
patientsdonotwantpharmacisttochangethetradenamewrittenbydoctor.Hence,consumerawarenessforthe
generics,varietyoftradenamesavailableinthemarket,andpricevariationisverylimited.Hence,thereisneedto
conductastudythatcandocumentthepricestructureandqualityofthebrandedproductandtheirbrandedgeneric
versionsmanufacturedinIndia.
Apairofproductfromthesamecompanywaschosentoappreciatethepricestructureandmarkupsforthetwo
versions.
Methods

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Qualityandpriceofmedicineswerestudiedtoevaluatethetwoversionsofthesametherapeuticmolecule.Data
werecollectedduringSeptembertoNovember2008.
Selectionofmedicines

Fivecommonlyusedmedicinesfromdifferentclasseswereselectedwhosebranded(popularbrand)andbranded
genericversionsweremanufacturedbythesamepharmaceuticalcompany.Thefivemedicineschosenwere
alprazolam,(0.25mg),cetirizine(10mg),ciprofloxacin(500mg),fluoxetine(20mg),andlansoprazole(30mg).
Medicineprice

Pricetopatientandpricetoretailer(PTR)wereanalyzed.Maximumretailprice(MRP)isthepricetopatientand

isalwaysprintedonthepackageinIndia.MedicinesareavailabletopatientattheMRPmentionedonthepackage
ofmedicine.Detailsofthefive"paired"drugproductssoldunderdifferenttradenameswiththeirMRPwere
checkedphysicallywiththeprivateretailpharmacies(chemistshop).
PTRisthepriceatwhichwholesaler(distributor)sellstheproducttotheretailerandthebill(voucher)givento
retailerbywholesalermentionsthePTR.PTRforallmedicineswasfoundbylookingatthevouchers.Thisprice
wascheckedandconfirmedfromFormV(underDPCO,1995)availableatthedistributorsofthecompany.Itis
mandatoryforallthecompaniestogiveFormVthatgivesdetailsoftheproductwithMRP,PTR,taxespaid,etcto
theirdistributors.
Qualitytesting

Thetestsampleswereprocuredfromthelicensedauthorizedchemistdealersthroughvalidpurchaseinvoice.The
samplesizecomprised1010tablets/capsulesofbothbrandedandbrandedgenericversionsofeachdrugproduct.
Effortsweremadetoprocurethesetestsamples(pairs)withidenticaldateofmanufacturetoruleoutthepossibility
ofdifferenceinassaybecauseofdifferentdatesofmanufacturing.Thequalitativeaswellasquantitativeanalysis
wascarriedoutinaGovernmentapprovedlaboratoryfollowingthemethodsprescribedintheIndian
Pharmacopoeia,(2007)asperthestandardslaiddownintheDrugsandCosmeticsAct1940andRules1945.[9]
Followingtestswereperformed.
1. Identificationtest:Identityofthedrugmoleculewasestablishedbyperformingtheidentificationtest
throughinstrumentalanalysisusingHPLC(highpressureliquidchromatography)orIR(infrared
spectroscopy)aspermethodprescribedforeachmedicine.
2. Chemicalcompositiontest\:ThesamplesweresubjectedtoquantitativeanalysisusingHPLCinstrumental
analyticalmethodsasprovidedinIndianPharmacopoeia2007.
3. Uniformityofcontenttest:Toconfirmtheuniformityofcontentsinthebatch,thesampleddosageunits
weresubjectedtouniformityofcontentstestwhereinassayon10unitsofdosageformwereperformed
individuallyusinginstrumentalanalyticalmethods.Thetestforuniformityofcontentisnotapplicableto
tablets/capsulescontainingmorethan10mgitwasconductedonlyforalprazolam(0.25mg)and
cetirizine(10mg).
4. Uniformityofweight:All10unitsofsampleweretestedforuniformityofweightasprescribed.
5. TestsforDissolution:Thesamplesweresubjectedtodissolutionstudiestoevaluatetheirdrugrelease
pattern.Thesestudieswereperformedinthedissolutionmediaspecifiedintheindividualmonographof
theIndianPharmacopoeia2007onsixdosageunitsandwereindicativeoftheinvivoavailabilityofactive
drugmoietyfromthedosageform,i.e.tabletorcapsule.
Results

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ComparativePriceandMarkUpforBrandedandBrandedGenericPairofMedicines

DetailsoffivepairsofmedicinesincludingtheirtradenameassoldintheIndianmarket,strength,dosageform,
andthepharmaceuticalcompanythatmanufacturestheseproductsaregiveninTable1.Pricetopatient(MRP)and
pricetoretailer(PTR)foundforallthefivepairofmedicinesistabulatedinTable1.PTRforthebranded
productofcetirizinewas11timesthepriceforbrandedgenericbythesamecompany.RetailerisearningINR
22.76for10tabletsofbrandedgenericcetirizineversusRs8.16forthebrandedversionfromthesamecompany.
Forciprofloxacin,theMRPofboththebrandedandbrandedgenericproductwassamebutthebrandedgeneric
wasavailabletoretailerat3.6timeslesspricethanbrandedmedicinefromthesamecompany.
Table1
ComparativepricestructureofBrandedandBrandedgenericmedicines

Thepricetopatient(MRP)ofthebrandedproductforthefivemedicinesevaluatedwas41%,33%,0%,14%,and
31%higherthantheMRPofthebrandedgenericversionofthesamecompany.Ontheotherhand,PTRfor
brandedgenericwas1112%,397%,266%,170%,and439%lessthanthebrandedversionofcetirizine,
fluoxetine,ciprofloxacin,lansoprazole,andalprazolam,respectively.Retailermarkupsforfivepairofmedicines
forbrandedversusbrandedgeneric:cetirizine,fluoxetine,ciprofloxacin,lansoprazole,andalprazolamwere30%
versus1016%,25%versus367%,25%versus357%,27%versus201%,and25%versus415%,respectively[
Table1].
QualityofBrandedandBrandedGenericPairofMedicines

1. Identificationtest:Allthefivepairedmedicinesofbrandedandbrandedgenericsgavepositive
identificationtestswhentestedonHPLCorIRestablishingtheirchemicalidentity[Tables26].
Table2
Comparativeanalyticalevaluationofbrandedandbrandedgeneric
drugproductAlprazolamtablets(0.25mg)
Table6
Comparativeanalyticalevaluationofbranded/brandedgenericdrug
productLansoprazolecapsules(30mg)
2. Chemicalcompositiontest:ThequantitativeanalysisconductedusingtheHPLCmethodshowedeach
unitofthetestedsamplestobewellwithintheprescribedrange[Tables26].
3. Uniformityofcontent:Thistestwasdoneforalprazolamandcetirizineandresultsforboththeversionsof
medicineswerewithintheprescribedrange[Tables2and3].
Table3
Comparativeanalyticalevaluationofbrandedandbrandedgeneric
drugproductCetirizinetablets(10mg)
4. Uniformityofweight:Eachunitofthesamplewaswithintheprescribedrangeforallthefivepairof
medicines[Tables26]
5. Dissolutiontest:Thedissolutiontestforallthefivepairedmedicineswerewithinthepermissiblelimits
ofthestatutorystandards[Tables26].
Table4
Comparativeanalyticalevaluationofbrandedandbrandedgenericdrug
productCiprofloxacintablets(500mg)
Table5
Comparativeanalyticalevaluationofbrandedandbrandedgenericdrug
productFluoxetinecapsules(20mg)
Discussion

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ThisisoneofthefirststudiesinIndiaconductedtosystematicevaluatethepricetopatientandretailermarkupfor
thebrandedandbrandedgenericversionsofthesametherapeuticmoleculemanufacturedbythesamecompany.
Thisstudyhasalsoevaluatedthequalityofthetwoversions.Findingsofthestudyrevealedthattherearehuge
markupsforretaileronbrandedgenericmedicines.Theretailermarginforfivebrandedmedicinesstudiedwasin

therangeof2530%,butfortheirbrandedgenericsversionmanufacturedbythesamecompanyitwasintherange
of2011016%.Bothversionsofallfivemedicinesclearedallthequantitativeandqualitativeparametersas
prescribedinIndianPharmacopoeia,2007.Thereexistsawidespreadbeliefamongpeopleanddispensingchemists
thatabrandedproductisbetterintermsofqualityandsafetythanthegeneric.[1012]Asystematicreviewhas
shownthatgenericandbrandnamecardiovasculardrugsweresimilarfornearlyallclinicaloutcomes.Thisstudy
concludedthatthereisnoevidenceofsuperiorityofbrandpreparationstogenericdrugs.[13]Suchstudiesmaybe
helpfulinpromotinggenericdrugusethatreducesunnecessaryspendingwithoutimprovingclinicaloutcome.In
mostdevelopedcountries,genericmedicinesarepromotedbycompetitionenhancingpoliciesoperatingthrough
healthcarereimbursementstocontainexpenditureandencourageefficientuseofresources.[14]
Resultsofourstudyrevealedthatpricetopatientforthebrandedgenericversionwasnotmuchlessthantoits
brandedcounterpartbrandedgenericwasavailableat70100%costofthebrandedproduct.InIndia,medicine
pricesaresetinoneofthetwoways.MedicinepricesareunderthepurviewofDepartmentofPharmaceuticals
whichitselfisunderministryofchemicalsandfertilizers.TheDrugPriceControlOrder(DPCO)identifiesactive
pharmaceuticalingredients(APIs)forwhichapricingformulaisusedtosettheMRP.Thereareonly74bulkdrugs
whichareunderpricecontrol[15]andarecalledscheduledmedicines.Forallothermedicinescallednon
scheduledmedicinesthemanufacturersetsthepriceandregistersthatpricewiththeNationalPharmaceutical
PricingAuthority(NPPA)underDepartmentofPharmaceuticals.[16]ThemedicinesaresoldattheprintedMRPon
theirlabelanddispensingpharmacistcannotchargeapriceexceedingMRPprintedonthepack,asperthe
provisionsunderparagraph16oftheDPCO,1995.Forscheduledmedicines,theNPPApricingformulasetsthe
8%markupforwholesalersand16%forretailers.Fornonscheduledmedicines,thesemarkupsarenotset,butitis
agreedbythepartnersofthetradethatforbrandedmedicinesaveragemarkupwouldbearound10%and20%for
wholesalersandretailers,respectively.
Inoursampleofmedicines,onlyciprofloxacinisunderpricecontrolandotherfourbelongtononschedule
medicine.Thestudyrevealedthatevenforthebrandedversionofbothscheduleandnonscheduledmedicines,the
retailermarginwasmorethantheestablishedmargin,itwasintherangeof2530%.Forthebrandedgeneric
version,theretailermarginswereverylarge,2011016%.Pharmaceuticalcompaniesdecidenotonlythefinalprice
(MRP)tothepatientbutalsothemarkupfortheretailer.Ifthemarketingisdonebythecompanyasforthe
"branded"versionthenthemajormarkupsareforthecompanyifthemarketingandpromotionaredonebythe
retailerasinthecaseofbrandedgenericthenthePTRisless,butMRPisnotmuchdifferent.Therefore,the
brandedgenericsarepromotedbytheretailersformonetaryconsiderationsintotaldisregardtothepatient's
interests.Theultimateconsumer,i.e.patientisnotbenefitedmuchbypreferringbrandedgenericversionstoits
brandedversion.Anewspaperreportsthehugeprofitmarginsforretailersrangingfrom500%to1000%ongeneric
medicinesinIndia.[17]Thehighmarkupsongenericsaretotallynegatingtheveryconceptofaffordablegeneric
medicinesforpatients.
Unlikedevelopedcountries,peopleindevelopingcountriespaythecostofmedicinesoutofpocket.InIndia,more
than80%healthfinancingisbornebypatients.[18]Indiaisknowntoexportmedicinestovariouscountriesatlow
cost,butfacesthechallengeofaccesstoaffordableandqualitymedicinesforitsownpopulation.[19]Hence,the
governmentshouldhaveapolicywherebythepricesofbrandedgenericdrugscanbemaderealisticandaffordable
tocommonman.Weneedtohavelegislationtothateffect.Theprofitmarginspresentlybeingsharedbytraders
mustbepassedtoconsumer.
InIndia,adispensingpharmacistisnotauthorizedtosubstituteabrandedmedicinewithabrandedgeneric(or
generic)aspertheprovisionsunderRule65oftheDrugsandCosmeticsAct,1940andRules,1945,whichalso
addtothepatient'sburden.IntheUSAsubstitutionisallowedandpatientsacceptgenericsubstitutionifphysician
approvesofthesame.Genericsubstitutionrateshaveincreasedremarkablythere,probablyduetogreater
acceptancebyphysiciansandpharmacistsaswellasencouragementfromthethirdpartypayers.[20]Cheaper
genericsareoneoftheimportantfactorstoreducehealthcarecost.Thepracticeofgenericsubstitutionisstrongly

supportedbyhealthauthoritiesinmanydevelopedcountries.[21]Useofgenericdrugs,whicharebioequivalentto
brandnamedrug,canhelpcontainprescriptiondrugspending.[22]GovernmentofIndiahasopenedfewgeneric
drugstoresinsomestatesthatsellgenericmedicinesmanufacturedbypublicsectorcompanies.[23]Thequalityof
genericmedicinesavailableonthesestoresatcheaperratesshouldbetestedandcomparedwithpopularbrandsand
resultsshouldbewidelypublished.Studiesinvolvingcomparativeevaluationonqualityofbrandedandtheir
genericcounterpartmaybemademandatoryforthegeneric(orbrandedgeneric)manufacturerandtheirreports
shouldbemadepublictopromotegenericuseandprescriptions.
Oneinherentlimitationofthisstudyisthatwehavetestedpairofbrandedandbrandedgenericmedicinesthat
weremanufacturedbythesamereputedcompany.Thoughitisexpectedthatboththeversionsshouldhavethe
samequalitybutperceptionforanybrandedgenericissameamongdoctorsandpatients.Sotostartwith,wehave
takenbothbrandedandbrandedgenericproductsofthesamecompanyandstudiednotonlythequalitybutalso
thepricestructure.
Conclusions

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Findingsofthepresentstudyindicatethatboththebrandedandbrandedgenericversionsofthefivepaired
medicineshadidenticalqualityandtheyfulfilledallthecriteriaprescribedbythestatutorystandards.Hence,the
generalnotionanddoubtregardingthequalityofthebrandedgenericversionofmedicinesneedstobeerased
conductingmoresuchstudiesandpublishingthemwidely.Suitablechangesinthedrugpricepolicymaybemade
tohavelowerpricesforbrandedgenericversions.TransparencyinfixingtheMRPbythemanufacturerandclear
guidelinesformarkupsatleastforbrandedgenericsisrequiredinpharmaceuticaltrade.Thegovernmentmust
takeupgenericpromotionalschemes,generalawarenessprogramsonqualityofgenericstobuildconfidence
amongprescribers,pharmacists,andconsumers.Availabilityofgenericsorbrandedgenericsinthemarketwith
lowerpricetagandassuredqualityisessentialtomakethemedicinesaffordable.
Acknowledgments

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Weappreciatethecooperationofretailpharmacistsanddistributorswhohelpedusincollectionofthedata.
Footnotes

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SourceofSupport:Nil.
ConflictofInterest:Nonedeclared.

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