GThepharmaceuticalindustryisregulatedworldwideintermsofpatents,priceandproductquality.GInternationalpatentnormsrecogniseproductpatents,andthesenormswouldbebindingonallsignatoriestotheGeneralAgreementonTariffsandTrade(GATT),includingIndia,accordingtothestipulationundertheWorldTradeOrganisation(WTO—thesuccessortoGATT).GIndiarecognisesprocesspatents(asopposedtoproductpatents)undertheIndianPatentAct,1970.However,thecountrywillhavetoswitchovertotheproductpatentsregimebytheyear2005.Duringthetransitionphase,ExclusiveMarketingRights(EMRs)arebeingrecognised,subjecttotheconditionslaiddownunderthePatentsAmendmentAct,1999.EMRsareunlikelytohaveasignificantimpactontheIndianpharmaceuticalindustrysincetheywouldbegrantedonlytoproductsthathavebeenpatentedintheinternationalmarketsafterJanuary1,1995.GThePatentsSecondAmendmentBill,1999,introducedbytheIndianGovernmentandrecentlyclearedbyParliament,extendsthepatenttermto20yearsandincorporatesvariousprovisionsofTradeRelatedIntellectualPropertyRights(TRIPs).However,inrespectofpharmaceuticals,processpatentsandEMRscontinuetoberecognised.GDrugpricesareregulatedinalmostallcountriesintheworld.However,mostofthedevelopedcountrieshaveindirectpricecontrols.GTheDrugPriceControlOrder(DPCO)wasintroducedinIndiain1970toregulatethepricesofpharmaceuticalproducts.TheDPCO1995controlsthepricesof74bulkdrugsandallformulationsusingthesebulkdrugs.TheDPCOfixesthemaximumpriceallowableforthecontrolledproducts.GThePharmaceuticalPolicy2002announcedbytheGovernmentofIndiainFebruary2002seekstoreducethespanofpricecontrolbybringingdownthenumberofdrugsunderthepolicy.Detailsinthisregardarestillawaited.GEachcountryhasitsownnormsforcontrollingthequalityofpharmaceuticalproducts.TheInternationalCouncilforHarmonisationislikelytobringinuniformityintheproductqualitynormsofdifferentcountries.3ChapterHIGHLIGHTSREGULATIONTHEINDIANPHARMACEUTICALINDUSTRYPage27PRODUCTANDTECHNOLOGYPRODUCTANDTECHNOLOGYPRODUCTANDTECHNOLOGYPRODUCTANDTECHNOLOGYPRODUCTANDTECHNOLOGYREGULATIONBACKGROUNDDuringthelate1950s,adrugcalledThalidomidewasintroduced.Ineveryanimaltestconductedthroughoutthedrugindustry,itgotacleanbillofhealth.Thedrugwaschemicallyrelatedtootherdrugs,whichwereinuseforaverylongtimethen.Subsequently,ThalidomidewasmarketedthroughoutEuropeasa“safesedative”.However,thedrughadatragicimpactonwomenintheearlyweeksofpregnancy.Thebabiesthatsuchwomengavebirthtohadseveredeformitiesaneffect,whichcouldnothavebeenforetoldfromanyanimaltesttheninuse.Sincethennewdrugshavebeenstatutorilysubjectedtorigoroustestinginvariousanimalspeciestochecktheeffectonfoetaldevelopment.Thesetestsareinadditiontotheothersfortoxicity.TheThalidomidedisasterThalidomidedisasterThalidomidedisasterThalidomidedisasterThalidomidedisasteroftheearly1960sleddirectlytothesettingupofregulatorydrugagenciesinmostcountriesoftheworld.IntheUS,EuropeandJapan,differentsetsofregulationsweredrawnupbytherespectivehealthministriesinanattempttobuildafirewallagainstthepossibilityofanotherThalidomidedisaster.Nowitiswidelyacceptedthatanydrugthathasthepotentialtodosignificantgoodmayalsobecapableofdoingsignificantharm.Thedevelopmentandintroductionofnewdrugsisnowstrictlycontrolledinmostpartsoftheworld.Nonewdrugormodificationofanoldmoleculecanbesold,irrespectiveofwhetheronprescriptionornot,unlessithasbeengrantedaproductlicencebytherelevantregulatoryauthorityofthe...
