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05/05/2016

AplantderiveddrugfordenguesoonNATIONALTheHindu

TODAY'SPAPERNATIONAL

NEWDELHI,May5,2016

Aplantderiveddrugfordenguesoon
SpecialCorrespondent
SunPharma,Indiaslargestpharmaceuticalcompany,signedanagreementwiththeInternationalCentreforGeneticEngineeringand
Biotechnology(ICGEB)onWednesdaytoturnaplantextractintoapotentialdrugfordenguefever,adiseasethatannuallyafflictsatleast
100,000andkillsatleast200inIndia.
ThedrugcompanymayalsobethefirsttotakeadvantageofanewregulatoryregimeinIndiatoencourageplantderiveddrugs.
IthaspartneredwithICGEB,whichhasbeenworkingondenguedrugsandvaccinefornearlytwodecades.Theyrecentlyreportedthe
potencyofaplantextractCissampelospariera,knownasabutaorlaghupathaintreatingthedisease.
Expensiveprocess
InNovember2015,theDrugControllerGeneralofIndia(DCGI),whichvetsapplicationsbydrugdeveloperstotestnewdrugs,clarifiedthe
proceduretotestpotentialnewdrugsthatderivefromplantbasedsources.
Anewdrug,evenbeforeitbeginsthesocalledclinicaltrialstotestitssafetyandefficacy,musteitherregisterasanewchemicalmoleculeor
showthatitsuseiswellestablishedintraditionalsystemssuchasAyurveda.
TheformerisalongdrawnandexpensiveprocessalmostnodrughasbeentestedthiswayinIndiaandtheAyurvedicroutemeansthat
herbaldrugscantpassregulatorymusterinseveralothercountries.
Therefore,manufacturersofbotanicalformulationsdidntknowwhethertoapproachtheDCGIortheMinistryofAyurveda,Unani,Siddhi
andHomeopathy(AYUSH)forapproval.
Thirdroute
ThereisnowathirdroutesinceNovember,saidMohammedAslam,aseniorofficialintheDepartmentofBiotechnology,whichhas
partlyfundedtheICGEBsdenguedrugresearch,andthatmakesiteasierforplantbasedextractstoberecognisedasvaliddrugsthatcanbe
clinicallytested.
ThethirdrouteisessentiallyaclarificationbytheDCGIthatbotanicalrawmaterial,claimingtobeadrug,besubjecttoastandardised
processandsatisfyregulatorsthatitcanbeconsistentlymanufactured.
Itshouldalsohaveprovedtobesafeandeffectiveforotherailmentsintraditionalliterature.
AseniorofficialatSunPharmadidntconfirmwhatroutethecompanywouldadoptfortestingthenewdrug.
Weareguided
bytheextremelypromising
preclinicaldata,
saysSunPharma

http://www.thehindu.com/todayspaper/tpnational/aplantderiveddrugfordenguesoon/article8557950.ece

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