Drug Updates Pharma News Scrub Typhus World Pharmacists …hpspc.in/pdf/Drug_Therapy_September_2019.pdf · Mr. Bihari Lal Gupta, Mr, Hemant Sharma, Mr. Rakesh Chandel, Mr. Praveen

Toll Free: 18001210443

HIMACHAL PRADESH STATE PHARMACY COUNCIL

DRUG INFORMATION CENTER

LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101

Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]

Issue 23 Volume 3 SEP 2019 | |

Drug Updates Scrub TyphusPharma News World Pharmacists Day 2019

Drug Therapy Bulletin


LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]

DRUG INFORMATION CENTER1 2

DrugUpdatesNourianzforParkinsondisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

TaltznowforAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Xenleta™forCABP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Rinvoq™forRheumatoidArthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

TreatmentforRareBoneMarrowDisorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

WakixforNarcolepsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

RozlytrekforNSCLCandSolidTumors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

NewTreatment-ResistantTBDrug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

TuralioforRareJointTumor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

NewKeytrudaIndication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

NubeqaforProstatecancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

FerricMaltolnowapprovedinUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6® ®Xeljanz /Xeljanz XRSafetyCommunication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

stBaqsimi™:1 GlucagonwithoutInjection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6nd ®Ruxience™:2 Rituxan Biosimilar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

®Otezla :OralUlcersduetoBehcetDisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6®FirstLyrica GenericsApproved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

RecarbrioforCutiandcIAI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Editorial

AdvisoryBoard

Dr.NavneetMarwah,Mr.SanjeevPandit,Dr.ManojKumar,Dr.RanjitSingh,

Prof.CPSVerma,Dr.PoonamSandhu,Dr.RajenderGuleria,Mr.ArvindKumar,

Mr.BihariLalGupta,Mr,HemantSharma,Mr.RakeshChandel,Mr.Praveen

Upadhya,Mr. Kamashwar Chauhan,Mr. Lokesh Kumar,Mr. Vishal Kumar,

Mr.Y.S.Chandel,Mr.BirbalSharma,Mr.ManojKumar,Mr.YogeshVerma,Mr.

SurenderNadda,Dr.Parshuram

Patron

Mr.GopalKrishanSharmaandDr.RanSingh

Editor-in-Chief

Dr.KamleshNaikandDr.M.S.Ashawat

Co-Editors

Dr.VinayPanditandMr.AnkushSharma

Content

XembifyforPrimaryImmunodeficiencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

XpovioforRRMM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

NewTioproninDoseForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Zirabev:SecondBiosimilartoAvastin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

DopteletNowforChronicITP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Darzalex:NewMultipleMyelomaComboRegimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8stSoliris:1 NMOSDAprroval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

HealthNewsMobileapplaunchedforlocatingoutletsandsearchingGenericmedicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Acontrolled-releaseoraltabletforkalaazarandfungalinfections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival . . . . . . . . . . . . . . . . . . . 10

AdditionalFAQonNewDrugsandClinicalTrialRules,2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection . . . . . . . 12

HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals . . . . . . . . . . . . . . . . . . . . . 13

FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections . . . . 13

ZydusCadilalaunchesinsomniadruginUSmarket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Doctorsshouldprovideonlygenericmedicines:DCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list . . . . . . . . . . 14

Allstategovernmentsaresupposedtodrawdrugsamplesandtestthem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Sugarinfruitjuicemayraiseriskofcancer,studyfinds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Antiparasiticdrugmayhelpfightskincancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskofleg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

NOTIFICATION(DepartmentofHealthandFamilyWelfare) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

ScrubTyphusIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

SymptomsandSign. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

WorldPharmacistsDay2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22






DRUG INFORMATION CENTER1 2

DrugUpdatesNourianzforParkinsondisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

TaltznowforAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Xenleta™forCABP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Rinvoq™forRheumatoidArthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

TreatmentforRareBoneMarrowDisorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

WakixforNarcolepsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

RozlytrekforNSCLCandSolidTumors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

NewTreatment-ResistantTBDrug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

TuralioforRareJointTumor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

NewKeytrudaIndication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

NubeqaforProstatecancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

FerricMaltolnowapprovedinUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6® ®Xeljanz /Xeljanz XRSafetyCommunication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

stBaqsimi™:1 GlucagonwithoutInjection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6nd ®Ruxience™:2 Rituxan Biosimilar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

®Otezla :OralUlcersduetoBehcetDisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6®FirstLyrica GenericsApproved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

RecarbrioforCutiandcIAI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Editorial

AdvisoryBoard

Dr.NavneetMarwah,Mr.SanjeevPandit,Dr.ManojKumar,Dr.RanjitSingh,

Prof.CPSVerma,Dr.PoonamSandhu,Dr.RajenderGuleria,Mr.ArvindKumar,

Mr.BihariLalGupta,Mr,HemantSharma,Mr.RakeshChandel,Mr.Praveen

Upadhya,Mr. Kamashwar Chauhan,Mr. Lokesh Kumar,Mr. Vishal Kumar,

Mr.Y.S.Chandel,Mr.BirbalSharma,Mr.ManojKumar,Mr.YogeshVerma,Mr.

SurenderNadda,Dr.Parshuram

Patron

Mr.GopalKrishanSharmaandDr.RanSingh

Editor-in-Chief

Dr.KamleshNaikandDr.M.S.Ashawat

Co-Editors

Dr.VinayPanditandMr.AnkushSharma

Content

XembifyforPrimaryImmunodeficiencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

XpovioforRRMM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

NewTioproninDoseForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Zirabev:SecondBiosimilartoAvastin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

DopteletNowforChronicITP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Darzalex:NewMultipleMyelomaComboRegimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8stSoliris:1 NMOSDAprroval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

HealthNewsMobileapplaunchedforlocatingoutletsandsearchingGenericmedicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Acontrolled-releaseoraltabletforkalaazarandfungalinfections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival . . . . . . . . . . . . . . . . . . . 10

AdditionalFAQonNewDrugsandClinicalTrialRules,2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection . . . . . . . 12

HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals . . . . . . . . . . . . . . . . . . . . . 13

FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections . . . . 13

ZydusCadilalaunchesinsomniadruginUSmarket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Doctorsshouldprovideonlygenericmedicines:DCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list . . . . . . . . . . 14

Allstategovernmentsaresupposedtodrawdrugsamplesandtestthem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Sugarinfruitjuicemayraiseriskofcancer,studyfinds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Antiparasiticdrugmayhelpfightskincancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskofleg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

NOTIFICATION(DepartmentofHealthandFamilyWelfare) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

ScrubTyphusIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

SymptomsandSign. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

WorldPharmacistsDay2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Drugs Update

NourianzforParkinsondiseaseOnAugust27,2019,theUSFDAapprovedNourianz™

(istradefylline) oral tablets indicated as adjunctive

treatment to levodopa/carbidopa in adult patients

with Parkinson disease (PD) experiencing "off"

episodes. Patients treated with Nourianz

experiencedasignificantdecreasefrombaselinein

daily "off" time comparedwith those treatedwith

placeboin4clinicaltrials.

Theprescribinginformationprescribinginformationcanbefound

atthislink.

TaltznowforASOn August 26, 2019, the US FDA approved a new

®indicationforTaltz (ixekizumab)subQinjectionfor

the treatment of adult patients with active

ankylosing spondylitis (AS), also known as

radiographicaxialspondyloarthritis(r-axSpA).Taltz,

whichisalreadyapprovedforplaquepsoriasisand

psoriaticarthritis,wasapprovedforASbasedonthe

COAST-V and COAST-W clinical trials in which a

greater proportion of patients treated with

ixekizumabachievedresponsecomparedwiththose

treatedwithplacebo.

T h e p r e s c r i b i n g i n f o rm a t i o n c a n b e f o u n d a t :

http://uspl.lilly.com/taltz/taltz.html?s=pi.

Xenleta™forCABPOnAugust19,2019,theUSFDAapprovedXenleta™

(lefamulin)IVinjectionandoraltabletsindicatedfor

the treatment of adults with community-acquired

bacterialpneumonia(CABP)causedbysusceptible

microorganisms. Xenleta, which was granted the

FDA's Qualified Infectious Disease Product

designation, was shown to have similar rates of

clinical success as moxifloxacin with or without

linezolidin2clinicaltrials.


https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21

1672s000,211673s000lbl.pdf.

Rinvoq™forRheumatoidArthritisOn August 16, 2019 the US FDA approved Rinvoq™

(upadacitinib)oralextended-release tablets indicated to

treat adult patients with moderately to severely active

rheumatoidarthritiswhohavehadinadequateresponseor

intolerance tomethotrexate.Approvalwasgrantedafter

data from clinical trials demonstrated patients

administered Rinvoq achieved clinical remission more

often than patients who received placebo plus

methotrexate. Additionally, Rinvoq met all primary and

rankedsecondaryendpointsacross theSELECTPhase3

trials.

Prescribinginformationcanbefoundat:https://www.accessdata.fda.gov/

drugsatfda_docs/label/2019/211675s000lbl.pdf.

Treatment for Rare Bone Marrow

DisorderOn August 16, 2019 the US FDA approved Inrebic(R)

(fedratinib) oral capsules for the treatment of adult

patients with intermediate-2 or high-risk primary or

secondary (post-polycythemia vera or post-essential

thrombocythemia) myelofibrosis. Inrebic is the second

FDA-approvedtreatmentoptionforthisrarebonemarrow

disease.Approvalwasbasedonresultsfromaclinicaltrial

where patients administered fedratinib experienced

greater reduction in myelofibrosis-related symptoms

comparedwith placebo at the end of 24weeks. Inrebic

carriesaboxedwarningregardingtheriskofseriousand

fatalencephalopathy,includingWernicke's.

The prescribing information can be found at: https://www.accessdata.

fda.gov/drugsatfda_docs/label/2019/212327s000lbl.pdf.

WakixforNarcolepsy®On August 15, 2019, the US FDA approved Wakix

(pitolisant) oral tablets indicated for the treatment of

excessivedaytimesleepiness(EDS)inadultpatientswith

narcolepsy.WakixisthefirstnarcolepsydrugtogainFDA

approval that is not a schedule controlled substance.

ApprovalwasbasedonasignificantimprovementinEDS


3 4 HIMACHAL PRADESH STATE PHARMACY COUNCIL





This page has been intentionally kept blank!

It isamatterof immensepleasure toknow thatall the studentsand facultyof HimachalPradesh

TechnicalUniversity affiliated pharmacyColleges areenthusiastically gatheringunderthesame

umbrellatomarkthecelebrationofWorldsPharmacistdayon25thSeptember2019.

IndiaisthelargestsupplierofgenericdrugsintheWorldMarket.Thestatisticaldatashowsthatover80

percentof theantiretroviraldrugsusedglobally tocombatAcquired ImmunodeficiencySyndrome

(AIDs) are supplied by Indianpharmaceutical firms.India's biotechnology andbio-pharmaceuticals

industryisexpectedtogrowatanaveragegrowthrateofaround30percentayearandreachUS$100

billion by 2025. The profession of Pharmacy has great contribution towards total Gross Domestic

Product(GDP).

TheacademicteachinglearningplayspivotalroleinseedingstheprofessionofPharmacy.AsaVice

chancellor, I assure that I extendall thehelp topharmacy colleges for theupliftmentof thisnoble

profession.

Pharmacy is the backbone of health care system.We are committed to this year theme "Safe and

effective medicines for all”. The organized events will motivate all the undergraduate and

postgraduatestudentstounderstandtheirsocial,moralandprofessionalresponsibilitiestowardsthe

society.Weadvocatethatpatientsshouldonlyreceivethemedicinefromthepharmacistshandandwe

believethatpharmacistsarebestcounselorofmedicine.

Drugabuseandaddiction isanothersocial issuesandpharmacist canplay important role through

awarenessprogramandpatientcounselling.Pharmacistscanusetheirbroadexperienceandexpertise

toensurethatpeoplegetthedesiredresultfromthemedicines.We,believethateverycitizenmustget

accesstotreatmentforanyailmentsandprescribedmedicinemustbeprovidedinaffordableprice.Drug

misuseanddiseasemongeringisoneofthealarmingsituationinourcountry.Onthisday,Irequestall

thepharmaciststotakeoathregardingthepracticeofpharmacyinsuchanethicalapproachthatrational

useofmedicineinsocietyisachievedincomingyears.

I,highlyappreciatethecontributionofpharmacisttohealthcaresystemandIonthebehalfofHimachal

Pradesh Technical University (HPTU) congratulate all the young and aspiring pharmacists in this

auspiciousday.

(ProfessorS.P.Bansal)

Message Drugs Update

NourianzforParkinsondiseaseOnAugust27,2019,theUSFDAapprovedNourianz™

(istradefylline) oral tablets indicated as adjunctive

treatment to levodopa/carbidopa in adult patients

with Parkinson disease (PD) experiencing "off"

episodes. Patients treated with Nourianz

experiencedasignificantdecreasefrombaselinein

daily "off" time comparedwith those treatedwith

placeboin4clinicaltrials.

Theprescribinginformationprescribinginformationcanbefound

atthislink.

TaltznowforAS

On August 26, 2019, the US FDA approved a new®indicationforTaltz (ixekizumab)subQinjectionfor

the treatment of adult patients with active

ankylosing spondylitis (AS), also known as

radiographicaxialspondyloarthritis(r-axSpA).Taltz,

whichisalreadyapprovedforplaquepsoriasisand

psoriaticarthritis,wasapprovedforASbasedonthe

COAST-V and COAST-W clinical trials in which a

greater proportion of patients treated with

ixekizumabachievedresponsecomparedwiththose

treatedwithplacebo.


http://uspl.lilly.com/taltz/taltz.html?s=pi.

Xenleta™forCABPOnAugust19,2019,theUSFDAapprovedXenleta™

(lefamulin)IVinjectionandoraltabletsindicatedfor

the treatment of adults with community-acquired

bacterialpneumonia(CABP)causedbysusceptible

microorganisms. Xenleta, which was granted the

FDA's Qualified Infectious Disease Product

designation, was shown to have similar rates of

clinical success as moxifloxacin with or without

linezolidin2clinicaltrials.



1672s000,211673s000lbl.pdf.

Rinvoq™forRheumatoidArthritis

On August 16, 2019 the US FDA approved Rinvoq™

(upadacitinib)oralextended-release tablets indicated to

treat adult patients with moderately to severely active

rheumatoidarthritiswhohavehadinadequateresponseor

intolerance tomethotrexate.Approvalwasgrantedafter

data from clinical trials demonstrated patients

administered Rinvoq achieved clinical remission more

often than patients who received placebo plus

methotrexate. Additionally, Rinvoq met all primary and

rankedsecondaryendpointsacross theSELECTPhase3

trials.

Prescribinginformationcanbefoundat:https://www.accessdata.fda.gov/

drugsatfda_docs/label/2019/211675s000lbl.pdf.

Treatment for Rare Bone Marrow

Disorder

On August 16, 2019 the US FDA approved Inrebic(R)

(fedratinib) oral capsules for the treatment of adult

patients with intermediate-2 or high-risk primary or

secondary (post-polycythemia vera or post-essential

thrombocythemia) myelofibrosis. Inrebic is the second

FDA-approvedtreatmentoptionforthisrarebonemarrow

disease.Approvalwasbasedonresultsfromaclinicaltrial

where patients administered fedratinib experienced

greater reduction in myelofibrosis-related symptoms

comparedwith placebo at the end of 24weeks. Inrebic

carriesaboxedwarningregardingtheriskofseriousand

fatalencephalopathy,includingWernicke's.

The prescribing information can be found at: https://www.accessdata.


WakixforNarcolepsy®On August 15, 2019, the US FDA approved Wakix

(pitolisant) oral tablets indicated for the treatment of

excessivedaytimesleepiness(EDS)inadultpatientswith

narcolepsy.WakixisthefirstnarcolepsydrugtogainFDA

approval that is not a schedule controlled substance.

ApprovalwasbasedonasignificantimprovementinEDS

ProfessorS.P.BansalHon’bleViceChancellor

HimachalPradeshTechnicalUniversity

Hamirpur-HP








compared with placebo in the HARMONY1 and

HARMONY1bisclinicaltrials.

Theprescribinginformationcanbefoundat:https://www.accessdata.


Rozlytrek for NSCLC and Solid

TumorsOnAugust15,2019,theUSFDAapprovedRozlytrek™

(entrectinib) oral capsules indicated to treat adult

patients with metastatic non-small cell lung cancer

(NSCLC)whosetumorsareROS1-positiveandtotreat

adult andpediatric patients12 years of ageor older

withNTRKgenefusion-positivesolidtumors.Rozlytrek

isthethirdoncologydrugapprovedbytheFDAbased

on a common biomarker across different types of

tumorsratherthanthelocationinthebodywherethe

tumor originated. The FDA granted Rozlytrek

accelerated approval as well as priority review,

breakthroughtherapy,andorphandrugdesignations.

T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :


5s000lbl.pdf.

NewTreatment-ResistantTBDrugOnAugust14,2019,theUSFDAapprovedpretomanid

oraltabletsindicatedaspartofacombinationregimen

with bedaquiline and linezolid for the treatment of

adults with pulmonary extensively drug resistant

(XDR), treatment-intolerant or nonresponsive

multidrug-resistant (MDR) tuberculosis (TB). Of the

patientstreatedwithpretomanidincombinationwith

bedaquilineandlinezolidinaclinicaltrial,89%were

successesat6monthsaftertheendoftherapywhich

significantly exceeded thehistorical success rates for

treatmentofextensivelydrugresistantTB.Pretomanid

istheseconddrugapprovedundertheFDA'sLimited

Population Pathway for Antibacterial and Antifungal

Drugs.



2s000lbl.pdf.

TuralioforRareJointTumorOn August 2, 2019, the US FDA approved Turalio™

(pexidartinib) oral capsules indicated to treat adult

patients with symptomatic tenosynovial giant cell

tumor (TGCT) associated with severe morbidity or

functional limitations and not amenable to

improvementwithsurgery.Turalio,whichwasgranted

breakthroughtherapy,priorityreview,andorphandrug

designation by the FDA, demonstrated a significant

improvementinoverallresponseratecomparedwith

placebo in a clinical trial. Turalio carries a boxed

warningregarding theriskof seriousandpotentially

fatal liver injury and is only available through the

TuralioRiskEvaluationandMitigationStrategy(REMS)

program.



0s000lbl.pdf.

NewKeytrudaIndicationOnJuly31,2019,theUSFDAapprovedanewindication

®for Keytruda (pembrolizumab) IV injection to treat

patientswithrecurrentlocallyadvancedormetastatic

squamous cell carcinoma of the esophagus whose

tumorsexpressPD-L1(combinedpositivescore(CPS)

of10orgreater)asdeterminedbyanFDA-approved

test,withdiseaseprogressionafter1ormorepriorlines

of systemic therapy.Keytruda,which isnow the first

anti-PD-1 therapy approved for this indication,

demonstrated significant improvement in overall

response rate and duration of response in the

KEYNOTE-180andKEYNOTE-181clinicaltrials.

Prescribing information can be found at: http://www.merck.com/

product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf.

NubeqaforProstatecancer®On July 30, 2019, the US FDA approved Nubeqa

(darolutamide)oraltabletsindicatedforthetreatment

of patients with non-metastatic castration resistant

prostatecancer(nmCRPC).Nubeqa,whichwasgranted

FDA'sPriorityReviewdesignation,wasapprovedbased

on the ARAMIS trial, in which patients treated with

darolutamideplusandrogendeprivationtherapy(ADT)

demonstratedasignificantimprovementinmetastasis-

freesurvivalcomparedwithplaceboplusADT.


http://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI .p

df.

FerricMaltolnowapprovedinUS®OnJuly26,2019,theUSFDAapprovedAccrufer (ferric

maltol)oralcapsulesindicatedforthetreatmentofiron

deficiencyinadultpatients.Accrufer,whichisalready®marketedinEuropeasFeraccru ,wasapprovedbased

on studies showing a greater mean difference in Hb

from baseline in patients treated with ferric maltol

comparedwiththosetreatedwithplacebo.



0Orig1s000lbl.pdf.

® ®Xel janz /Xe l janz XR Sa fe ty

Communication

On July 26, 2019, the US FDA issued a drug safety® ®communication for Xeljanz /Xeljanz XR (tofacitinib)

oraltabletsandextended-releasetabletsregardingan

increasedriskofbloodclotsandofdeathwiththe10-

mg twice daily dose used to treat patients with

ulcerative colitis. Also, the use of tofacitinib for

ulcerativecolitiswillbe limited topatientswhohave

severe side effects orwho are not effectively treated

with certain other medications. Healthcare

professionalsshoulddiscontinuetofacitinibinpatients

withsymptomsofthrombosisandadvisetheirpatients

when to seek medical attention. Additionally,

healthcare professionals and patients should report

adverseeventsorsideeffectsrelatedtotheseproducts.

The prescribing information has been updated,

includingtheBlackBoxWarning,toincludetheserisks.



4s024,208246s010lbl.pdf.

stBaqsimi™: 1 Glucagon without

InjectionOn July 24, 2019, the US FDA approved Baqsimi™

(glucagon) nasal powder indicated to treat severe

hypoglycemiainpatientswithdiabetes4yearsofageor

older.Baqsimi,thefirstglucagonproductnotrequiring

injectiontogainFDAapproval,wasapprovedbasedon2

studies showing adequately increased blood sugar

levels in adult and pediatric patients comparedwith

thosetreatedwithglucagoninjection.

P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :


4s000lbl.pdf.

nd ®Ruxience™:2 Rituxan Biosimilar

On July 23, 2019, the US FDA approved Ruxience™

(rituximab-pvvr) IV injection indicated to treat adult

patients with: non-Hodgkin lymphoma, chronic

lymphocytic leukemia, and granulomatosis with

polyangiitis and microscopic polyangiitis. Ruxience,®whichisthesecondbiosimilartoRituxan (rituximab)

to gain FDA approval, was approved based on

pharmacokinetic, clinical immunogenicity, and other

clinical data demonstrating that rituximab-pvvr is

biosimilartorituximab.



3s000lbl.pdf

®Otezla : Oral Ulcers due to Behcet

Disease

OnJuly19,2019,theUSFDAapprovedanewindication®for Otezla (apremilast) oral tablets to treat adult

patients with oral ulcers associated with Behcet

Disease. Approval for this indication was based on

resultsfromtheRELIEFtrialinwhichpatientstreated

withapremilasthadagreaterreductionfrombaseline

inthepainandnumberoforalulcerscomparedwith

thosetreatedwithplacebo.Otezlaisthefirsttreatment

togainFDAapproval for the treatmentoforalulcers







compared with placebo in the HARMONY1 and

HARMONY1bisclinicaltrials.

Theprescribinginformationcanbefoundat:https://www.accessdata.


Rozlytrek for NSCLC and Solid

TumorsOnAugust15,2019,theUSFDAapprovedRozlytrek™

(entrectinib) oral capsules indicated to treat adult

patients with metastatic non-small cell lung cancer

(NSCLC)whosetumorsareROS1-positiveandtotreat

adult andpediatric patients12 years of ageor older

withNTRKgenefusion-positivesolidtumors.Rozlytrek

isthethirdoncologydrugapprovedbytheFDAbased

on a common biomarker across different types of

tumorsratherthanthelocationinthebodywherethe

tumor originated. The FDA granted Rozlytrek

accelerated approval as well as priority review,

breakthroughtherapy,andorphandrugdesignations.



5s000lbl.pdf.

NewTreatment-ResistantTBDrugOnAugust14,2019,theUSFDAapprovedpretomanid

oraltabletsindicatedaspartofacombinationregimen

with bedaquiline and linezolid for the treatment of

adults with pulmonary extensively drug resistant

(XDR), treatment-intolerant or nonresponsive

multidrug-resistant (MDR) tuberculosis (TB). Of the

patientstreatedwithpretomanidincombinationwith

bedaquilineandlinezolidinaclinicaltrial,89%were

successesat6monthsaftertheendoftherapywhich

significantly exceeded thehistorical success rates for

treatmentofextensivelydrugresistantTB.Pretomanid

istheseconddrugapprovedundertheFDA'sLimited

Population Pathway for Antibacterial and Antifungal

Drugs.



2s000lbl.pdf.

TuralioforRareJointTumorOn August 2, 2019, the US FDA approved Turalio™

(pexidartinib) oral capsules indicated to treat adult

patients with symptomatic tenosynovial giant cell

tumor (TGCT) associated with severe morbidity or

functional limitations and not amenable to

improvementwithsurgery.Turalio,whichwasgranted

breakthroughtherapy,priorityreview,andorphandrug

designation by the FDA, demonstrated a significant

improvementinoverallresponseratecomparedwith

placebo in a clinical trial. Turalio carries a boxed

warningregarding theriskof seriousandpotentially

fatal liver injury and is only available through the

TuralioRiskEvaluationandMitigationStrategy(REMS)

program.



0s000lbl.pdf.

NewKeytrudaIndicationOnJuly31,2019,theUSFDAapprovedanewindication

®for Keytruda (pembrolizumab) IV injection to treat

patientswithrecurrentlocallyadvancedormetastatic

squamous cell carcinoma of the esophagus whose

tumorsexpressPD-L1(combinedpositivescore(CPS)

of10orgreater)asdeterminedbyanFDA-approved

test,withdiseaseprogressionafter1ormorepriorlines

of systemic therapy.Keytruda,which isnow the first

anti-PD-1 therapy approved for this indication,

demonstrated significant improvement in overall

response rate and duration of response in the

KEYNOTE-180andKEYNOTE-181clinicaltrials.

Prescribing information can be found at: http://www.merck.com/

product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf.

NubeqaforProstatecancer®On July 30, 2019, the US FDA approved Nubeqa

(darolutamide)oraltabletsindicatedforthetreatment

of patients with non-metastatic castration resistant

prostatecancer(nmCRPC).Nubeqa,whichwasgranted

FDA'sPriorityReviewdesignation,wasapprovedbased

on the ARAMIS trial, in which patients treated with

darolutamideplusandrogendeprivationtherapy(ADT)

demonstratedasignificantimprovementinmetastasis-

freesurvivalcomparedwithplaceboplusADT.


http://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI .p

df.

FerricMaltolnowapprovedinUS®OnJuly26,2019,theUSFDAapprovedAccrufer (ferric

maltol)oralcapsulesindicatedforthetreatmentofiron

deficiencyinadultpatients.Accrufer,whichisalready®marketedinEuropeasFeraccru ,wasapprovedbased

on studies showing a greater mean difference in Hb

from baseline in patients treated with ferric maltol

comparedwiththosetreatedwithplacebo.



0Orig1s000lbl.pdf.

® ®Xel janz /Xe l janz XR Sa fe ty

Communication

On July 26, 2019, the US FDA issued a drug safety® ®communication for Xeljanz /Xeljanz XR (tofacitinib)

oraltabletsandextended-releasetabletsregardingan

increasedriskofbloodclotsandofdeathwiththe10-

mg twice daily dose used to treat patients with

ulcerative colitis. Also, the use of tofacitinib for

ulcerativecolitiswillbe limited topatientswhohave

severe side effects orwho are not effectively treated

with certain other medications. Healthcare

professionalsshoulddiscontinuetofacitinibinpatients

withsymptomsofthrombosisandadvisetheirpatients

when to seek medical attention. Additionally,

healthcare professionals and patients should report

adverseeventsorsideeffectsrelatedtotheseproducts.

The prescribing information has been updated,

includingtheBlackBoxWarning,toincludetheserisks.



4s024,208246s010lbl.pdf.

stBaqsimi™: 1 Glucagon without

InjectionOn July 24, 2019, the US FDA approved Baqsimi™

(glucagon) nasal powder indicated to treat severe

hypoglycemiainpatientswithdiabetes4yearsofageor

older.Baqsimi,thefirstglucagonproductnotrequiring

injectiontogainFDAapproval,wasapprovedbasedon2

studies showing adequately increased blood sugar

levels in adult and pediatric patients comparedwith

thosetreatedwithglucagoninjection.



4s000lbl.pdf.

nd ®Ruxience™:2 Rituxan Biosimilar

On July 23, 2019, the US FDA approved Ruxience™

(rituximab-pvvr) IV injection indicated to treat adult

patients with: non-Hodgkin lymphoma, chronic

lymphocytic leukemia, and granulomatosis with

polyangiitis and microscopic polyangiitis. Ruxience,®whichisthesecondbiosimilartoRituxan (rituximab)

to gain FDA approval, was approved based on

pharmacokinetic, clinical immunogenicity, and other

clinical data demonstrating that rituximab-pvvr is

biosimilartorituximab.



3s000lbl.pdf

®Otezla : Oral Ulcers due to Behcet

Disease

OnJuly19,2019,theUSFDAapprovedanewindication®for Otezla (apremilast) oral tablets to treat adult

patients with oral ulcers associated with Behcet

Disease. Approval for this indication was based on

resultsfromtheRELIEFtrialinwhichpatientstreated

withapremilasthadagreaterreductionfrombaseline

inthepainandnumberoforalulcerscomparedwith

thosetreatedwithplacebo.Otezlaisthefirsttreatment

togainFDAapproval for the treatmentoforalulcers







7 8

associatedwithBehcetDisease.


http://www.celgene.com/content/uploads/otezla-pi.pdf.

®FirstLyrica GenericsApprovedOn July 19, 2019, the US FDA granted approval to

®multiple applications for the first generics of Lyrica

(pregabalin)oralcapsulesandoralsolutionindicated

tomanageneuropathicpain associatedwithdiabetic

peripheral neuropathy, to manage postherpetic

neuralgia,asanadjunctivetherapytotreatpartialonset

seizuresinpatients17yearsofageorolder,tomanage

fibromyalgia, and to manage neuropathic pain

associatedwithspinalcordinjury.TheFDAapproved9

pregabalin generics as part of the Drug Competition

ActionPlanbywhichtheFDAisaddressingchallenges

related to developing generics and promoting more

genericcompetitionaswellashelpingadvancepatient

accesstomoreaffordablemedicines.

RecarbrioforCutiandcIAIOn July 17, 2019, the US FDA approved Recarbrio™

(imipenem/cilastatin/relebactam)IVinjectiontotreat

complicated urinary tract infections (cUTI) and

complicated intra-abdominal infections (cIAI) caused

by susceptible gram-negative bacteria in patients 18

yearsofageorolderwhohavelimitedornoalternative

treatment options. Recarbrio,whichwas granted the

FDA's Qualified Infection Disease designation, was

determinedtobeefficaciousinpartbythefindingsof

imipenem/cilastatinefficacyandsafetyintreatingcUTI

andcIAIaswellasin2clinicaltrials.

Theprescribinginformationcanbefoundat:https://www.merck.com/

product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf.

Xembify for Primary Immuno-

deficiencies®On July 3, 2019, the US FDA approved Xembify

(immune globulin-klhw) subQ injection indicated for

treatmentofprimaryhumoralimmunodeficiency(PI)

inpatients2yearsofageorolder.Xembify,a20%subQ

immunoglobul in , demonstrated safety and

pharmacokinetics in a clinical trial of adult and

pediatricpatients.There is alsoanongoing trial that

appears consistent with safety results of the first

clinicaltrial.


https://www.fda.gov/media/128601/download.

XpovioforRRMM

On July 3, 2019, the US FDA approved Xpovio™

(selinexor)oraltabletsindicatedincombinationwith

dexamethasoneforthetreatmentofadultpatientswith

relapsedorrefractorymultiplemyeloma(RRMM)who

have received at least 4 prior therapies and whose

diseaseisrefractorytoatleast2proteasomeinhibitors,

atleast2immunomodulatoryagents,andananti-CD38

monoclonalantibody.Xpovio,whichwasgranted fast

track and orphan drug designations, demonstrated

efficacyintheSTORMclinicaltrial.Continuedapproval

willbebasedondatafromtheongoingBostonclinical

trial.



6s000lbl.pdf.

NewTioproninDoseForm®On June 28, 2019, the US FDA approved Thiola EC

(tiopronin), a new enteric coated, delayed-release®tablet dose form of Thiola (tiopronin) oral tablets.

ThiolaECis indicated, incombinationwithhighfluid

intake,alkali,anddietmodification,fortheprevention

of cystine stone formation in adults and pediatric

patients 20 kg or greater with severe homozygous

cystinuria,whoarenotresponsivetothesemeasures

alone. This new formulation may be taken with or

withoutfoodandtherequirednumberoftabletsmaybe

reducedofferingflexibledosingoptionscomparedwith

Thiola which has limiting food restrictions and may

requiremoretabletstobetaken.



3s000lbl.pdf.

Zirabev:SecondBiosimilartoAvastin

On June 28 , 2019 , the US FDA approved

Zirabev™(bevacizumab-bvzr) IV injection to treat

metastatic colorectal cancer; unresectable, locally

advanced,recurrentormetastaticnon-squamousnon-

small cell lung cancer; recurrent glioblastoma;

metastatic renal cell carcinoma; and persistent,

recurrentormetastaticcervicalcancer.Zirabev,whichis®thesecondbiosimilartoAvastin (bevacizumab)togain

FDA approval, was approved based on comparative

analytical, pharmacokinetic, and clinical data which

showedclinicalequivalencetoAvastin.



9s000lbl.pdf.

DopteletNowforChronicITPOnJune27,2019,theUSFDAapprovedanewindication

®for Doptelet (avatrombopag) oral tablets to treat

thrombocytopenia in adult patients with chronic

immune thrombocytopenia (ITP) who have had an

insufficientresponsetoaprevioustreatment.Doptelet,

which is also approved to treat thrombocytopenia in

adultpatientswithchronicliverdisease,demonstrated

efficacycomparedwithplaceboinaclinicaltrial.

P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t


8s001lbl.pdf.

Darzalex: New Multiple Myeloma

ComboRegimenOnJune27,2019,theUSFDAapprovedanewindication

®forDarzalex (daratumumab)IVinjectiontotreatadultpatients withmultiplemyeloma in combination withlenalidomide anddexamethasone innewlydiagnosed

patients who are ineligible for autologous stem cell

transplantand inpatientswithrelapsedorrefractory

multiplemyelomawho have received at least 1 priortherapy. Darzalex demonstrated efficacy in the MAIAclinicaltrialinwhichdaratumumabincombinationwith

lenalidomideanddexamethasonesignificantlyreduced

disease progression risk or death compared withlenalidomideanddexamethasonealone.P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76103

6s020lbl.pdf.

stSoliris:1 NMOSDAprrovalOnJune27,2019,theUSFDAapprovedanewindication

®forSoliris (eculizumab)IVinjectionforthetreatment

ofneuromyelitisopticaspectrumdisorder(NMOSD)inadult patients who are anti-aquaporin-4 (AQP4)antibody positive. Soliris, the first drug to gain FDA

approvalforNMOSD,wasshowntobesafeandeffective

andmettheprimaryendpointofprolongingtimetofirst

adjudicatedrelapseandreducingtherelapseriskinthePREVENTtrial.Prescribing information can be found at http://alexion.com/

Documents/Soliris_USPI.aspx.







7 8

associatedwithBehcetDisease.


http://www.celgene.com/content/uploads/otezla-pi.pdf.

®FirstLyrica GenericsApprovedOn July 19, 2019, the US FDA granted approval to

®multiple applications for the first generics of Lyrica

(pregabalin)oralcapsulesandoralsolutionindicated

tomanageneuropathicpain associatedwithdiabetic

peripheral neuropathy, to manage postherpetic

neuralgia,asanadjunctivetherapytotreatpartialonset

seizuresinpatients17yearsofageorolder,tomanage

fibromyalgia, and to manage neuropathic pain

associatedwithspinalcordinjury.TheFDAapproved9

pregabalin generics as part of the Drug Competition

ActionPlanbywhichtheFDAisaddressingchallenges

related to developing generics and promoting more

genericcompetitionaswellashelpingadvancepatient

accesstomoreaffordablemedicines.

RecarbrioforCutiandcIAIOn July 17, 2019, the US FDA approved Recarbrio™

(imipenem/cilastatin/relebactam)IVinjectiontotreat

complicated urinary tract infections (cUTI) and

complicated intra-abdominal infections (cIAI) caused

by susceptible gram-negative bacteria in patients 18

yearsofageorolderwhohavelimitedornoalternative

treatment options. Recarbrio,whichwas granted the

FDA's Qualified Infection Disease designation, was

determinedtobeefficaciousinpartbythefindingsof

imipenem/cilastatinefficacyandsafetyintreatingcUTI

andcIAIaswellasin2clinicaltrials.

Theprescribinginformationcanbefoundat:https://www.merck.com/

product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf.

Xembify for Primary Immuno-

deficiencies®On July 3, 2019, the US FDA approved Xembify

(immune globulin-klhw) subQ injection indicated for

treatmentofprimaryhumoralimmunodeficiency(PI)

inpatients2yearsofageorolder.Xembify,a20%subQ

immunoglobul in , demonstrated safety and

pharmacokinetics in a clinical trial of adult and

pediatricpatients.There is alsoanongoing trial that

appears consistent with safety results of the first

clinicaltrial.


https://www.fda.gov/media/128601/download.

XpovioforRRMM

On July 3, 2019, the US FDA approved Xpovio™

(selinexor)oraltabletsindicatedincombinationwith

dexamethasoneforthetreatmentofadultpatientswith

relapsedorrefractorymultiplemyeloma(RRMM)who

have received at least 4 prior therapies and whose

diseaseisrefractorytoatleast2proteasomeinhibitors,

atleast2immunomodulatoryagents,andananti-CD38

monoclonalantibody.Xpovio,whichwasgranted fast

track and orphan drug designations, demonstrated

efficacyintheSTORMclinicaltrial.Continuedapproval

willbebasedondatafromtheongoingBostonclinical

trial.



6s000lbl.pdf.

NewTioproninDoseForm®On June 28, 2019, the US FDA approved Thiola EC

(tiopronin), a new enteric coated, delayed-release®tablet dose form of Thiola (tiopronin) oral tablets.

ThiolaECis indicated, incombinationwithhighfluid

intake,alkali,anddietmodification,fortheprevention

of cystine stone formation in adults and pediatric

patients 20 kg or greater with severe homozygous

cystinuria,whoarenotresponsivetothesemeasures

alone. This new formulation may be taken with or

withoutfoodandtherequirednumberoftabletsmaybe

reducedofferingflexibledosingoptionscomparedwith

Thiola which has limiting food restrictions and may

requiremoretabletstobetaken.



3s000lbl.pdf.

Zirabev:SecondBiosimilartoAvastin

On June 28 , 2019 , the US FDA approved

Zirabev™(bevacizumab-bvzr) IV injection to treat

metastatic colorectal cancer; unresectable, locally

advanced,recurrentormetastaticnon-squamousnon-

small cell lung cancer; recurrent glioblastoma;

metastatic renal cell carcinoma; and persistent,

recurrentormetastaticcervicalcancer.Zirabev,whichis®thesecondbiosimilartoAvastin (bevacizumab)togain

FDA approval, was approved based on comparative

analytical, pharmacokinetic, and clinical data which

showedclinicalequivalencetoAvastin.



9s000lbl.pdf.

DopteletNowforChronicITPOnJune27,2019,theUSFDAapprovedanewindication

®for Doptelet (avatrombopag) oral tablets to treat

thrombocytopenia in adult patients with chronic

immune thrombocytopenia (ITP) who have had an

insufficientresponsetoaprevioustreatment.Doptelet,

which is also approved to treat thrombocytopenia in

adultpatientswithchronicliverdisease,demonstrated

efficacycomparedwithplaceboinaclinicaltrial.

P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t


8s001lbl.pdf.

Darzalex: New Multiple Myeloma

ComboRegimenOnJune27,2019,theUSFDAapprovedanewindication

®forDarzalex (daratumumab)IVinjectiontotreatadultpatients withmultiplemyeloma in combination withlenalidomide anddexamethasone innewlydiagnosed

patients who are ineligible for autologous stem cell

transplantand inpatientswithrelapsedorrefractory

multiplemyelomawho have received at least 1 priortherapy. Darzalex demonstrated efficacy in the MAIAclinicaltrialinwhichdaratumumabincombinationwith

lenalidomideanddexamethasonesignificantlyreduced

disease progression risk or death compared withlenalidomideanddexamethasonealone.P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76103

6s020lbl.pdf.

stSoliris:1 NMOSDAprrovalOnJune27,2019,theUSFDAapprovedanewindication

®forSoliris (eculizumab)IVinjectionforthetreatment

ofneuromyelitisopticaspectrumdisorder(NMOSD)inadult patients who are anti-aquaporin-4 (AQP4)antibody positive. Soliris, the first drug to gain FDA

approvalforNMOSD,wasshowntobesafeandeffective

andmettheprimaryendpointofprolongingtimetofirst

adjudicatedrelapseandreducingtherelapseriskinthePREVENTtrial.Prescribing information can be found at http://alexion.com/

Documents/Soliris_USPI.aspx.






Pharma News


9 10

UnionMinisterforChemicalsandFertilizers,ShriD.V.Sadananda Gowda launched a mobile application“Janaushadhi Sugam” which will enable people to

searchJanaushadhigenericmedicinesandthestoresatthetipoftheirfingers.

“Janaushadhi Sugam” mobile application would haveuser-friendlyoptionslike-tolocatenearbyJanaushadhikendra, direction guidance for location of theJanaushadhikendra through Google Map, searchJanaushadhi generic medicines, analyse productcomparisonofGenericvsBrandedmedicineinformofMRP&overallSavings,etc.

ThemobileapplicationisavailableonbothAndroid&iOSplatforms.ItcanbedownloadedfreeofcostbytheuserfromGooglePlayStoreandAppleStore.Ref:www.pharmatutor.org

MobileapplaunchedforlocatingoutletsandsearchingGenericmedicines

Researchers at Indian Institute of Technology-

Hyderabad have developed a method to produce

controlled-release oral tablets for treating fungal

infections and kala azar. The tablets were found to

release the drug Amphotericin B in a sustained and

controlled manner over a period of 10 days.

Amphotericin B is the drug of choice for fungal

infections of the abdomen and heart valves, fungal

pneumonia,andkalaazar.However,itiscostly,causes

toxicity and its bioavailability is poor. The drug is

administered through injection, which results in

uncontrolledreleaseintothebloodstream.

The researchers have developed the oral tablet byloadingthedrugontogelatinnano-fabric.Theychosegelatinesinceitisnontoxicandbiocompatible,besidesbeing biodegradable. It is used in food and medicalindustries.Thedrugwasloadedontogelatinandwas

thendrawnoutintheformofnanofibresthroughtheprocess of electrospinning. It involves use of electricforce to draw out charged threads of polymers intofibres with diameters in the order of some hundrednanometres.Inordertoimprovestructuralconsistencyinaqueousconditions,saturatedvapoursofachemicalcalled glutaraldehydewere used. The team has alsofoundthatthenano-fibrousoraltabletwasstableoverawide range of pH,whichmeans that itwould not bedestroyed in the gastrointestinal track before drugabsorptionintothebloodstream.

Explainingtherationaleforusingnanofibrestoproducetheoral tablets,researcherssaid, “nanofibres– fibresthat are a hundred thousand times thinner than thehuman hair – are increasingly being considered as amedium for controlled release of drug moleculesbecauseoftheirlargesurfaceareaandporosity”.Ref:www.pharmatutor.org

Acontrolled-releaseoraltabletforkalaazarandfungalinfections

The U.S. Food and Drug Administration is warningconsumers not to purchase or drink a product soldonline as amedical treatmentdue to a recent rise inreportedhealthissues.Since2010,theFDAhaswarned

ExternalLinkDisclaimerconsumersaboutthedangersofMiracleorMasterMineralSolution,MiracleMineralSupplement, MMS, Chlorine Dioxide (CD) Protocol,Water Purification Solution (WPS) and other similar

FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution

products. Miracle Mineral Solution has not beenapproved by the FDA for any use, but these productscontinuetobepromotedonsocialmediaasaremedyfortreating autism, cancer, HIV/AIDS, hepatitis and flu,

among other conditions. However, the solution, whenmixed,developsintodangerousbleachwhichhascausedseriousandpotentiallylife-threateningsideeffects.Ref:www.pharmatutor.org

Serum Institute ofIndia (SII) and theNational Institute ofAllergyandInfectiousDiseases (NIAID), p a r t o f t h e U . S . National Institutes ofHealth (USA), joinedhands to create thefirst-ever heat-stableRotavirus vaccine inthe world. Albert Z.

Kapikian,M.D.,apioneeringvirologistatNIAIDdefinedthemodeof transmissionofRotavirus, identified theviral proteins critical for triggering an immuneresponse, and formulated a vaccine that targetedseveralimportantRotavirusstrains.In2005,NIAIDandSerumInstituteofIndiaPvt.Ltd.(SIIPL)joinedhandsforthedevelopmentofaRotavirusVaccine.

SII worked to develop a heat stable formulation toovercomethisproblemandRotasiil, is todaytheonly

Rotavirus vaccine to have the ability to withstandextremetemperatures.Itcanbestoredattemperaturesupto25°Cthroughoutitsshelflifeof30months,whichmakesRotasiilcompletelyuniquefromothervaccinesthat require refr igerat ion for storage andtransportation. The vaccine will revolutionizehealthcare for children across the globe due to itspotency,longevityandabilitytoendureseverechangesintemperature,therebyreducingwastageandstoragecosts.

IntroductionoftheRotasiilvaccine,withitslongshelflifeandlackofneedforrefrigeration,isatimelyboonformillions affected by Rotavirus. SII and NIAID’s jointendeavor in creating the heat-stable Rotasiil vaccineeffectively fills theneed, reducing costs and relievingbottlenecksinthevaccinesupply-chain.

Thisbreakthroughinventionhasalsobeenawardedapatent for being the first-of-its-kind thermostableRotavirus vaccine by United States Patent andTrademarkOffice(USPTO).Ref:www.health.economictimes.indiatimes.com

SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil

Pancreaticcancercellsareespeciallygoodatrepairingtheir DNA when it’s damaged by chemotherapy andradiation,whichisonereasonstandardtreatmentsforthediseaseareoftenineffective.Now,researchersfromthe University of Michigan Rogel Cancer Center arereportingpromisingresultsfromanearlytrialofadrugthatblocksanenzymecancercellsneedtorepairtheirownDNA.

The drug, AstraZeneca’s AZD1775, blocks an enzymecalledWee1andinsodoingpreventspancreaticcancercells fromshielding themselvesagainst radiationandchemo.InatrialcombiningAZD1775withradiationand

Gemzar (gemcitabine), 34 patients with pancreatictumors that were too advanced to be removed withsurgeryhadamedianoverallsurvivalrateof22months.ThatbestedaprevioustrialofGemzaralone,inwhichsurvivalwasjust12to14months.

The University of Michigan researchers are nowplanningaphase2studyofthecombinationtreatment.The results of the phase 1, which was primarilydesigned to determine the appropriate dose ofAZD1775, were published in the Journal of ClinicalOncology.Ref:www.fiercebiotech.com

AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival






Pharma News


9 10

UnionMinisterforChemicalsandFertilizers,ShriD.V.Sadananda Gowda launched a mobile application“Janaushadhi Sugam” which will enable people to

searchJanaushadhigenericmedicinesandthestoresatthetipoftheirfingers.

“Janaushadhi Sugam” mobile application would haveuser-friendlyoptionslike-tolocatenearbyJanaushadhikendra, direction guidance for location of theJanaushadhikendra through Google Map, searchJanaushadhi generic medicines, analyse productcomparisonofGenericvsBrandedmedicineinformofMRP&overallSavings,etc.

ThemobileapplicationisavailableonbothAndroid&iOSplatforms.ItcanbedownloadedfreeofcostbytheuserfromGooglePlayStoreandAppleStore.Ref:www.pharmatutor.org

MobileapplaunchedforlocatingoutletsandsearchingGenericmedicines

Researchers at Indian Institute of Technology-

Hyderabad have developed a method to produce

controlled-release oral tablets for treating fungal

infections and kala azar. The tablets were found to

release the drug Amphotericin B in a sustained and

controlled manner over a period of 10 days.

Amphotericin B is the drug of choice for fungal

infections of the abdomen and heart valves, fungal

pneumonia,andkalaazar.However,itiscostly,causes

toxicity and its bioavailability is poor. The drug is

administered through injection, which results in

uncontrolledreleaseintothebloodstream.

The researchers have developed the oral tablet byloadingthedrugontogelatinnano-fabric.Theychosegelatinesinceitisnontoxicandbiocompatible,besidesbeing biodegradable. It is used in food and medicalindustries.Thedrugwasloadedontogelatinandwas

thendrawnoutintheformofnanofibresthroughtheprocess of electrospinning. It involves use of electricforce to draw out charged threads of polymers intofibres with diameters in the order of some hundrednanometres.Inordertoimprovestructuralconsistencyinaqueousconditions,saturatedvapoursofachemicalcalled glutaraldehydewere used. The team has alsofoundthatthenano-fibrousoraltabletwasstableoverawide range of pH,whichmeans that itwould not bedestroyed in the gastrointestinal track before drugabsorptionintothebloodstream.

Explainingtherationaleforusingnanofibrestoproducetheoral tablets,researcherssaid, “nanofibres– fibresthat are a hundred thousand times thinner than thehuman hair – are increasingly being considered as amedium for controlled release of drug moleculesbecauseoftheirlargesurfaceareaandporosity”.Ref:www.pharmatutor.org

Acontrolled-releaseoraltabletforkalaazarandfungalinfections

The U.S. Food and Drug Administration is warningconsumers not to purchase or drink a product soldonline as amedical treatmentdue to a recent rise inreportedhealthissues.Since2010,theFDAhaswarned

ExternalLinkDisclaimerconsumersaboutthedangersofMiracleorMasterMineralSolution,MiracleMineralSupplement, MMS, Chlorine Dioxide (CD) Protocol,Water Purification Solution (WPS) and other similar

FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution

products. Miracle Mineral Solution has not beenapproved by the FDA for any use, but these productscontinuetobepromotedonsocialmediaasaremedyfortreating autism, cancer, HIV/AIDS, hepatitis and flu,

among other conditions. However, the solution, whenmixed,developsintodangerousbleachwhichhascausedseriousandpotentiallylife-threateningsideeffects.Ref:www.pharmatutor.org

Serum Institute ofIndia (SII) and theNational Institute ofAllergyandInfectiousDiseases (NIAID), p a r t o f t h e U . S . National Institutes ofHealth (USA), joinedhands to create thefirst-ever heat-stableRotavirus vaccine inthe world. Albert Z.

Kapikian,M.D.,apioneeringvirologistatNIAIDdefinedthemodeof transmissionofRotavirus, identified theviral proteins critical for triggering an immuneresponse, and formulated a vaccine that targetedseveralimportantRotavirusstrains.In2005,NIAIDandSerumInstituteofIndiaPvt.Ltd.(SIIPL)joinedhandsforthedevelopmentofaRotavirusVaccine.

SII worked to develop a heat stable formulation toovercomethisproblemandRotasiil, is todaytheonly

Rotavirus vaccine to have the ability to withstandextremetemperatures.Itcanbestoredattemperaturesupto25°Cthroughoutitsshelflifeof30months,whichmakesRotasiilcompletelyuniquefromothervaccinesthat require refr igerat ion for storage andtransportation. The vaccine will revolutionizehealthcare for children across the globe due to itspotency,longevityandabilitytoendureseverechangesintemperature,therebyreducingwastageandstoragecosts.

IntroductionoftheRotasiilvaccine,withitslongshelflifeandlackofneedforrefrigeration,isatimelyboonformillions affected by Rotavirus. SII and NIAID’s jointendeavor in creating the heat-stable Rotasiil vaccineeffectively fills theneed, reducing costs and relievingbottlenecksinthevaccinesupply-chain.

Thisbreakthroughinventionhasalsobeenawardedapatent for being the first-of-its-kind thermostableRotavirus vaccine by United States Patent andTrademarkOffice(USPTO).Ref:www.health.economictimes.indiatimes.com

SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil

Pancreaticcancercellsareespeciallygoodatrepairingtheir DNA when it’s damaged by chemotherapy andradiation,whichisonereasonstandardtreatmentsforthediseaseareoftenineffective.Now,researchersfromthe University of Michigan Rogel Cancer Center arereportingpromisingresultsfromanearlytrialofadrugthatblocksanenzymecancercellsneedtorepairtheirownDNA.

The drug, AstraZeneca’s AZD1775, blocks an enzymecalledWee1andinsodoingpreventspancreaticcancercells fromshielding themselvesagainst radiationandchemo.InatrialcombiningAZD1775withradiationand

Gemzar (gemcitabine), 34 patients with pancreatictumors that were too advanced to be removed withsurgeryhadamedianoverallsurvivalrateof22months.ThatbestedaprevioustrialofGemzaralone,inwhichsurvivalwasjust12to14months.

The University of Michigan researchers are nowplanningaphase2studyofthecombinationtreatment.The results of the phase 1, which was primarilydesigned to determine the appropriate dose ofAZD1775, were published in the Journal of ClinicalOncology.Ref:www.fiercebiotech.com

AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival







11 12

Incase,theEthicsCommitteehasgrantedapprovalforconductofacademic clinicaltrialofapermitteddrugformulation for a new indication or new route of

administrationornewdoseornewdosageformandthe

drug is to be imported for conducting the academic

clinical trial in accordance with Rule 28 of the said Rules,noimportlicenseisrequired,ifcopyoftheethics

committeeapprovalforthesaidclinicaltrialofthedrugtobeimportedisfurnishedtotheconcernedPortofficeat the time of import along with an undertaking

mentioning thequantityof thedrugbeing imported

willbeusedexclusivelyfortheacademicclinicaltrial.

Ref:www.cdsco.gov.in

AdditionalFAQonNewDrugsandClinicalTrialRules,2019

Combi kit ofMisoprostol andMifepristone tablets (1

uncoated mifepristone 200 mg tablet + 4 uncoated

misoprostol200mgtablets)forMTPwasapprovedon

24.12.2008byCDSCOwithfollowingwarning:

“Warning: product is to be used only under the

supervisionofaserviceproviderandinamedical

facility as specified under MTP Act 2002 & MTP

Rules2003”

The issue of labeling requirements for combi kit of

MisoprostolandMifepristonewasdeliberatedin56th

DrugsConsultativeCommittee(DCC)meetingheldon

01.06.2019.Inmeeting,theDCCsuggestedthataletter

shouldbeissuedbyCDSCOtoallStateDrugsControllers

aboutthelabelingrequirementsandalsotoensurethe

effective implementation of labeling requirements as

perMTPprovisions.

You are therefore, requested to ensure the effective

implementationoflabelingrequirementsforCombikit

of Misoprostol and Mifepristone tablets as per the

provisionsofDrugsandCosmeticsAct,1940&Rules,

1945andMTPAct,2002&MTPRules,2003.


AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP)

“The Health Ministry has drawn an ambitious plan

under the 100-days agenda of the newly elected

government, wherein it has been decided to provide

Rotavirusvaccinetoeverychildacrossall36statesand

UTsbySeptember,2019.”ThiswasstatedbyDrHarsh

Vardhan,UnionMinisterofHealthandFamilyWelfare

whilespeakingontheexpansionofRotavirusvaccineto

theentirecountry.TheUnionHealthMinister further

added that under the inspirational leadership of our

beloved Prime Minister Shri Narendra Modi ji, the

Government is committed to ending morbidity and

mortality in children due to diarrhoea by 2022.

Strengthening routine immunization is an essential

investmentinIndia’schildrenandwillensureahealthy

futureofthecountry,hestressed.

DrHarshVardhanfurthersaidthatDiarrhoeaisoneof

thebiggestkillersinchildrenandRotavirusisoneofthe

most commoncausesof severediarrhoea in children

lessthan2yearsofage.“Rotavirusvaccinealongwith

propersanitation,handwashingpractices,ORSandzinc

supplementation will go a long way in reducing the

mortalityandmorbidityduetodiarrhoeainchildren,”

hementioned.TheUnionHealthMinisterfurtheradded

thattheGovernmentisalsocommittedtoincreasingthe

full immunization coverage and ensuring that the

benefitofthelife-savingvaccinesisprovidedtoevery

child.

Ref:www.pharmatutor.org

EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan

IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugsResearchers at the Indian Institute of Technology-

Madrashavefoundawaytodevelopnon-animalmodels

totestnewcancerdrugs.

Humanbody containsdifferent typesof cells.Among

them are stem cells that help in regenerating and

repairing various organs and tissues. This

characteristics of stem cells and the discovery of the

originofleukemiahaveledscientisttohypothesizethat

cancermayalsobe initiated fromcells that resemble

stem cells. Cancer stem cells are now thought to be

responsible not only for cancer initiation but also its

progression, metastasis, recurrence and drug

resistance.

Scientistsgenerallyuseanimalsinresearchconsidering

that growing cancer cells on petri dish has its

limitations.Normallytheywouldplacesamplesofcells

inadishwithsomeappropriatemediumandwaitfor

them to grow. Since the dish has a flat surface, the

growthistwo-dimensional.Thisisunlikewhathappens

inthebodywherecellsarespherical.Anothermethodis

bioreactorswhicharesmallcapsulesinwhichcellscan

growintospheroids.However,manyphysicalcuesplay

avitalroleindeterminingthewaycancercellsworkand

thesearenotavailableinbioreactors.

Studies have shown that many internal and external

conditionsdeterminetheeffectofthesephysicalfactors

oncellfateandfunctions.Inparticular,experimentsin

outerspaceandongroundhaveshownthatgravityis

oneofthesignificantconditions.Theconditionofless

gravityormicrogravitywasfoundtohelpincreasethe

proportionofcancerstemcellsincanceroustumourin

comparisontoothercells.

Researchers at IIT-Madras have comeupwith a new

strategytosimulatemicrogravityintheirlaboratoryby

usingequipmentcalledrotarycellculturesystem.With

its help, they have been able to increase the level of

cancerstemcellsinasampleofhumancolorectalcancer

cell.“Wehaveobserveddistinctfeaturesofcancerstem

cells including CD133/CD44 dual positive cells and

migration,” Prof. Rama Shanker Verma, group leader,

saidwhilespeakingtoIndiaScienceWire.

Dr. Verma said “the technique may be used for

development of organoids for drug testing, thus

avoidinganimalmodel. Inaddition, themodelcanbe

usedtounderstandthecelldeathpathwaysincancer,

for identification of target zones in and eventually

developthedrugs”.

The U.S. Food and Drug Administration approvedBaqsimi nasal powder, the first glucagon therapyapproved for the emergency treatment of severehypoglycemia that can be administered without aninjection.

Severe hypoglycemia occurs when a patient’s bloodsugar levels fall to a level where he or she becomesconfused or unconscious or suffers from othersymptomsthatrequireassistancefromanotherpersontotreat.Typically,severehypoglycemiaoccursinpeoplewithdiabeteswhoareusinginsulintreatment.Baqsimi

is approved to treat severe hypoglycemia in patientswithdiabetesagesfourandolder.

Baqsimi,whichisapowderadministeredintothenose,

willcomeinasingle-usedispenserthatcanbegivento

someonesufferingfromaseverehypoglycemicepisode.

Baqsimi increases blood sugar levels in the body by

stimulatingthelivertoreleasestoredglucoseintothe

bloodstream.Ithastheoppositeeffectofinsulin,which

lowersbloodsugarlevels.


FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection







11 12

Incase,theEthicsCommitteehasgrantedapprovalforconductofacademic clinicaltrialofapermitteddrugformulation for a new indication or new route of

administrationornewdoseornewdosageformandthe

drug is to be imported for conducting the academic

clinical trial in accordance with Rule 28 of the said Rules,noimportlicenseisrequired,ifcopyoftheethics

committeeapprovalforthesaidclinicaltrialofthedrugtobeimportedisfurnishedtotheconcernedPortofficeat the time of import along with an undertaking

mentioning thequantityof thedrugbeing imported

willbeusedexclusivelyfortheacademicclinicaltrial.


AdditionalFAQonNewDrugsandClinicalTrialRules,2019

Combi kit ofMisoprostol andMifepristone tablets (1

uncoated mifepristone 200 mg tablet + 4 uncoated

misoprostol200mgtablets)forMTPwasapprovedon

24.12.2008byCDSCOwithfollowingwarning:

“Warning: product is to be used only under the

supervisionofaserviceproviderandinamedical

facility as specified under MTP Act 2002 & MTP

Rules2003”

The issue of labeling requirements for combi kit of

MisoprostolandMifepristonewasdeliberatedin56th

DrugsConsultativeCommittee(DCC)meetingheldon

01.06.2019.Inmeeting,theDCCsuggestedthataletter

shouldbeissuedbyCDSCOtoallStateDrugsControllers

aboutthelabelingrequirementsandalsotoensurethe

effective implementation of labeling requirements as

perMTPprovisions.

You are therefore, requested to ensure the effective

implementationoflabelingrequirementsforCombikit

of Misoprostol and Mifepristone tablets as per the

provisionsofDrugsandCosmeticsAct,1940&Rules,

1945andMTPAct,2002&MTPRules,2003.


AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP)

“The Health Ministry has drawn an ambitious plan

under the 100-days agenda of the newly elected

government, wherein it has been decided to provide

Rotavirusvaccinetoeverychildacrossall36statesand

UTsbySeptember,2019.”ThiswasstatedbyDrHarsh

Vardhan,UnionMinisterofHealthandFamilyWelfare

whilespeakingontheexpansionofRotavirusvaccineto

theentirecountry.TheUnionHealthMinister further

added that under the inspirational leadership of our

beloved Prime Minister Shri Narendra Modi ji, the

Government is committed to ending morbidity and

mortality in children due to diarrhoea by 2022.

Strengthening routine immunization is an essential

investmentinIndia’schildrenandwillensureahealthy

futureofthecountry,hestressed.

DrHarshVardhanfurthersaidthatDiarrhoeaisoneof

thebiggestkillersinchildrenandRotavirusisoneofthe

most commoncausesof severediarrhoea in children

lessthan2yearsofage.“Rotavirusvaccinealongwith

propersanitation,handwashingpractices,ORSandzinc

supplementation will go a long way in reducing the

mortalityandmorbidityduetodiarrhoeainchildren,”

hementioned.TheUnionHealthMinisterfurtheradded

thattheGovernmentisalsocommittedtoincreasingthe

full immunization coverage and ensuring that the

benefitofthelife-savingvaccinesisprovidedtoevery

child.


EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan

IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugsResearchers at the Indian Institute of Technology-

Madrashavefoundawaytodevelopnon-animalmodels

totestnewcancerdrugs.

Humanbody containsdifferent typesof cells.Among

them are stem cells that help in regenerating and

repairing various organs and tissues. This

characteristics of stem cells and the discovery of the

originofleukemiahaveledscientisttohypothesizethat

cancermayalsobe initiated fromcells that resemble

stem cells. Cancer stem cells are now thought to be

responsible not only for cancer initiation but also its

progression, metastasis, recurrence and drug

resistance.

Scientistsgenerallyuseanimalsinresearchconsidering

that growing cancer cells on petri dish has its

limitations.Normallytheywouldplacesamplesofcells

inadishwithsomeappropriatemediumandwaitfor

them to grow. Since the dish has a flat surface, the

growthistwo-dimensional.Thisisunlikewhathappens

inthebodywherecellsarespherical.Anothermethodis

bioreactorswhicharesmallcapsulesinwhichcellscan

growintospheroids.However,manyphysicalcuesplay

avitalroleindeterminingthewaycancercellsworkand

thesearenotavailableinbioreactors.

Studies have shown that many internal and external

conditionsdeterminetheeffectofthesephysicalfactors

oncellfateandfunctions.Inparticular,experimentsin

outerspaceandongroundhaveshownthatgravityis

oneofthesignificantconditions.Theconditionofless

gravityormicrogravitywasfoundtohelpincreasethe

proportionofcancerstemcellsincanceroustumourin

comparisontoothercells.

Researchers at IIT-Madras have comeupwith a new

strategytosimulatemicrogravityintheirlaboratoryby

usingequipmentcalledrotarycellculturesystem.With

its help, they have been able to increase the level of

cancerstemcellsinasampleofhumancolorectalcancer

cell.“Wehaveobserveddistinctfeaturesofcancerstem

cells including CD133/CD44 dual positive cells and

migration,” Prof. Rama Shanker Verma, group leader,

saidwhilespeakingtoIndiaScienceWire.

Dr. Verma said “the technique may be used for

development of organoids for drug testing, thus

avoidinganimalmodel. Inaddition, themodelcanbe

usedtounderstandthecelldeathpathwaysincancer,

for identification of target zones in and eventually

developthedrugs”.

The U.S. Food and Drug Administration approvedBaqsimi nasal powder, the first glucagon therapyapproved for the emergency treatment of severehypoglycemia that can be administered without aninjection.

Severe hypoglycemia occurs when a patient’s bloodsugar levels fall to a level where he or she becomesconfused or unconscious or suffers from othersymptomsthatrequireassistancefromanotherpersontotreat.Typically,severehypoglycemiaoccursinpeoplewithdiabeteswhoareusinginsulintreatment.Baqsimi

is approved to treat severe hypoglycemia in patientswithdiabetesagesfourandolder.

Baqsimi,whichisapowderadministeredintothenose,

willcomeinasingle-usedispenserthatcanbegivento

someonesufferingfromaseverehypoglycemicepisode.

Baqsimi increases blood sugar levels in the body by

stimulatingthelivertoreleasestoredglucoseintothe

bloodstream.Ithastheoppositeeffectofinsulin,which

lowersbloodsugarlevels.


FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection







13 14

TheU.S.FoodandDrugAdministrationhasapprovedRecarbrio (imipenem, cilastatin and relebactam), anantibacterial drug product to treat adults withcomplicated urinary tract infections (cUTI) andcomplicated intra-abdominal infections (cIAI).Recarbrio is a three-drug combination injectioncontaining imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamaseinhibitor.

The determination of efficacy of Recarbrio wassupported in part by the findings of the efficacy andsafetyofimipenem-cilastatinforthetreatmentofcUTIandcIAI.ThecontributionofrelebactamtoRecarbriowasassessedbasedondatafrominvitrostudiesandanimal models of infection. The safety of Recarbrio,administeredviainjection,wasstudiedintwotrials,oneeachforcUTIandcIAI.ThecUTItrialincluded298adultpatients with 99 treated with the proposed dose ofRecarbrio.ThecIAItrialincluded347patientswith117

treatedwiththeproposeddoseofRecarbrio.

The most common adverse reactions observed in

patients treated with Recarbrio included nausea,

diarrhea,headache,feverandincreasedliverenzymes.

Recarbrio should not be used in patients taking

ganciclovir unless the benefits outweigh the risks asgeneralized seizures have been reported. PatientsshouldalsoavoidusingRecarbriowhentakingvalproic

acid or divalproex sodium, drugs used to manage

seizures,asareductioninvalproicacidlevelmayleadto

seizures.

Recarbrio receivedFDA’sQualified InfectiousDiseaseProduct (QIDP) designation. TheQIDP designation isgiven to antibacterial and antifungal drug productsintendedtotreatseriousorlife-threateninginfections

undertheGeneratingAntibioticIncentivesNow(GAIN)

titleoftheFDASafetyandInnovationAct.Ref:www.pharmatutor.org

FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections

Zydus Cadila announced the "launch of Ramelteontablets,8mguponreceivingthefinalapprovalfromtheUSFDA. Ramelteon is a sedative, also called ahypnotic".Ramelteon isused to treat insomnia that is

associated with having trouble falling asleep. Zydus

Cadilasaidthedrugwillbemanufacturedatthegroup'sformulations manufacturing facility at SEZ, Ahmedabad.

Ref:www.health.economictimes.indiatimes.com

ZydusCadilalaunchesinsomniadruginUSmarket

To promote usage of generic medicines, the Central

DrugsControl StandardOrganisation's (CDCSO)-Drug

ConsultantCommittee(DCC)hasproposedthatdoctors

should prescribe only generic instead of branded

medicinestopatients.Inthe56thmeetingoftheDCC,it

was proposed that Registered Medical Practitioners

(RMP)shallsupply'genericmedicines'only.However,it

hasalsobeenrecommendedthatRMPshallsupplythe

'physiciansample'freeofcost.

ItmaybenotedthatunderscheduleKoftheDrugsand

Cosmetics Rules, 1945 - RMP can supply different

categories of medicines including vaccines to theirpatients as per exemptions provided with certainconditions.

Thisisbeingdonetopromotegenericmedicinesinthe

country.Thegenericmedicinesareatleast90percent

cheaperthanthebrandedmedicines.Therearenearly

600typesofgenericmedicines.Thesemedicinescanbe

usedfortreatingdiabetes,viralfever,coughcold,kidney,

liver,cancerdiseasesetc.Ref:www.health.economictimes.indiatimes.com

Doctorsshouldprovideonlygenericmedicines:DCC

New medicines to treat cancer and cardiac diseasesalongwithantibioticsmaysoonbepartoftheNationalList of EssentialMedicines (NLEM),which forms thebasis for price regulation in India.WHOhas recentlyreviseditsguidanceonessentialmedicinesadding12ground-breakingmedicinesforfivecancertherapiestotreatmelanoma,lung,bloodandprostatecancer.Ithasalsoaddedneworalanticoagulantstopreventstroke.

Besides,theUNagencyhasstrengtheneditsadviceonantibioticusebyindicatingwhichantibioticstouseforthe most common and serious infections to achieve

better treatment outcomes and reduce the risk ofantimicrobial resistance. It has recommended threenew antibiotics for the treatment of multi-drugresistant infections be added as essential. The ideabehindthestakeholderconsultationistoevaluatetheWHO list in the Indian context by determining the“essentiality” and “affordability” factors of thesemedicines.

“ThecommitteewillhavetograpplewithseveralcriticalissuesincludinghowcloselyIndiachoosestofollowtheWHO list on addition of highly priced cancer drugs,expansionofthelisttoaddmoremedicaldevicesandcontextualizingWHOrecommendationsonclassifyingantibioticskeepinginmindlocalregulationsandaccessframeworks,”saidpublichealthexpertMaliniAisolaofAllIndiaDrugActionNetwork(AIDAN).

Over150countriesuseWHO’sEssentialMedicinesListtoguidedecisionsaboutwhichmedicinesrepresentthebest value for money, based on evidence and health

impact.EvenIndia’sNLEMisprimarilyguidedbytheUN

Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list

TheHealthMinistryhasbannedthemanufacture,saleand distribution of antibiotic, Colistin and itsformulationsforfoodproducinganimals,poultry,aquafarming and animal feed supplements in a bid topreservethedrug’sefficacyinhumans.

The ban has been imposed under provisions of theDrugsandCosmeticsAct,1940andanotificationinthisregardhasbeenissuedbytheCentre.Accordingtothenotification,itwasbroughttothenoticeoftheCentralgovernment that the use of the drug Colistin and its

formulationsforfoodproducinganimals,poultry,aquafarmingandanimalfeedsupplementsislikelytoinvolverisk to human beings.Following which the DrugTechnicalAdvisoryBoard(DTAB),thegovernment’stopadvisorybodyontechnicalmattersrelatedtodrugsinthecountryconsideredthematterandrecommendedprohibitingthesaiddrug,thenotificationstated.

“TheCentralGovernmentissatisfiedthatitisnecessaryand expedient in public interest to prohibitmanufacture,saleanddistributionofthedrugColistinand its formulations for food producing animals,poultry,aquafarmingandanimalfeedsupplements.

“Now, therefore, in exercise of powers conferred bysection26AoftheDrugsandCosmeticsAct,1940thegovernment hereby prohibits manufacture, sale anddistribution of the following drug with immediateeffect,Colistinanditsformulationsforfoodproducinganimals, poultry, aqua farming and animal feedsupplements,”thenotificationread.Ref:www.thehindubusinessline.com

HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals







13 14

TheU.S.FoodandDrugAdministrationhasapprovedRecarbrio (imipenem, cilastatin and relebactam), anantibacterial drug product to treat adults withcomplicated urinary tract infections (cUTI) andcomplicated intra-abdominal infections (cIAI).Recarbrio is a three-drug combination injectioncontaining imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamaseinhibitor.

The determination of efficacy of Recarbrio wassupported in part by the findings of the efficacy andsafetyofimipenem-cilastatinforthetreatmentofcUTIandcIAI.ThecontributionofrelebactamtoRecarbriowasassessedbasedondatafrominvitrostudiesandanimal models of infection. The safety of Recarbrio,administeredviainjection,wasstudiedintwotrials,oneeachforcUTIandcIAI.ThecUTItrialincluded298adultpatients with 99 treated with the proposed dose ofRecarbrio.ThecIAItrialincluded347patientswith117

treatedwiththeproposeddoseofRecarbrio.

The most common adverse reactions observed in

patients treated with Recarbrio included nausea,

diarrhea,headache,feverandincreasedliverenzymes.

Recarbrio should not be used in patients taking

ganciclovir unless the benefits outweigh the risks asgeneralized seizures have been reported. PatientsshouldalsoavoidusingRecarbriowhentakingvalproic

acid or divalproex sodium, drugs used to manage

seizures,asareductioninvalproicacidlevelmayleadto

seizures.

Recarbrio receivedFDA’sQualified InfectiousDiseaseProduct (QIDP) designation. TheQIDP designation isgiven to antibacterial and antifungal drug productsintendedtotreatseriousorlife-threateninginfections

undertheGeneratingAntibioticIncentivesNow(GAIN)

titleoftheFDASafetyandInnovationAct.Ref:www.pharmatutor.org

FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections

Zydus Cadila announced the "launch of Ramelteontablets,8mguponreceivingthefinalapprovalfromtheUSFDA. Ramelteon is a sedative, also called ahypnotic".Ramelteon isused to treat insomnia that is

associated with having trouble falling asleep. Zydus

Cadilasaidthedrugwillbemanufacturedatthegroup'sformulations manufacturing facility at SEZ, Ahmedabad.


ZydusCadilalaunchesinsomniadruginUSmarket

To promote usage of generic medicines, the Central

DrugsControl StandardOrganisation's (CDCSO)-Drug

ConsultantCommittee(DCC)hasproposedthatdoctors

should prescribe only generic instead of branded

medicinestopatients.Inthe56thmeetingoftheDCC,it

was proposed that Registered Medical Practitioners

(RMP)shallsupply'genericmedicines'only.However,it

hasalsobeenrecommendedthatRMPshallsupplythe

'physiciansample'freeofcost.

ItmaybenotedthatunderscheduleKoftheDrugsand

Cosmetics Rules, 1945 - RMP can supply different

categories of medicines including vaccines to theirpatients as per exemptions provided with certainconditions.

Thisisbeingdonetopromotegenericmedicinesinthe

country.Thegenericmedicinesareatleast90percent

cheaperthanthebrandedmedicines.Therearenearly

600typesofgenericmedicines.Thesemedicinescanbe

usedfortreatingdiabetes,viralfever,coughcold,kidney,

liver,cancerdiseasesetc.Ref:www.health.economictimes.indiatimes.com

Doctorsshouldprovideonlygenericmedicines:DCC

New medicines to treat cancer and cardiac diseasesalongwithantibioticsmaysoonbepartoftheNationalList of EssentialMedicines (NLEM),which forms thebasis for price regulation in India.WHOhas recentlyreviseditsguidanceonessentialmedicinesadding12ground-breakingmedicinesforfivecancertherapiestotreatmelanoma,lung,bloodandprostatecancer.Ithasalsoaddedneworalanticoagulantstopreventstroke.

Besides,theUNagencyhasstrengtheneditsadviceonantibioticusebyindicatingwhichantibioticstouseforthe most common and serious infections to achieve

better treatment outcomes and reduce the risk ofantimicrobial resistance. It has recommended threenew antibiotics for the treatment of multi-drugresistant infections be added as essential. The ideabehindthestakeholderconsultationistoevaluatetheWHO list in the Indian context by determining the“essentiality” and “affordability” factors of thesemedicines.

“ThecommitteewillhavetograpplewithseveralcriticalissuesincludinghowcloselyIndiachoosestofollowtheWHO list on addition of highly priced cancer drugs,expansionofthelisttoaddmoremedicaldevicesandcontextualizingWHOrecommendationsonclassifyingantibioticskeepinginmindlocalregulationsandaccessframeworks,”saidpublichealthexpertMaliniAisolaofAllIndiaDrugActionNetwork(AIDAN).

Over150countriesuseWHO’sEssentialMedicinesListtoguidedecisionsaboutwhichmedicinesrepresentthebest value for money, based on evidence and health

impact.EvenIndia’sNLEMisprimarilyguidedbytheUN

Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list

TheHealthMinistryhasbannedthemanufacture,saleand distribution of antibiotic, Colistin and itsformulationsforfoodproducinganimals,poultry,aquafarming and animal feed supplements in a bid topreservethedrug’sefficacyinhumans.

The ban has been imposed under provisions of theDrugsandCosmeticsAct,1940andanotificationinthisregardhasbeenissuedbytheCentre.Accordingtothenotification,itwasbroughttothenoticeoftheCentralgovernment that the use of the drug Colistin and its

formulationsforfoodproducinganimals,poultry,aquafarmingandanimalfeedsupplementsislikelytoinvolverisk to human beings.Following which the DrugTechnicalAdvisoryBoard(DTAB),thegovernment’stopadvisorybodyontechnicalmattersrelatedtodrugsinthecountryconsideredthematterandrecommendedprohibitingthesaiddrug,thenotificationstated.

“TheCentralGovernmentissatisfiedthatitisnecessaryand expedient in public interest to prohibitmanufacture,saleanddistributionofthedrugColistinand its formulations for food producing animals,poultry,aquafarmingandanimalfeedsupplements.

“Now, therefore, in exercise of powers conferred bysection26AoftheDrugsandCosmeticsAct,1940thegovernment hereby prohibits manufacture, sale anddistribution of the following drug with immediateeffect,Colistinanditsformulationsforfoodproducinganimals, poultry, aqua farming and animal feedsupplements,”thenotificationread.Ref:www.thehindubusinessline.com

HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals







15 16

Shahid Akhter, editor, ETHealthworld spoke to Bejon

Misra, Founder Director of Patient Safety & Access

InitiativeofIndiaFoundation,NewDelhitoknowabout

the Nation Drug Survey that looked at the issue of

spuriousdrugs.

NationDrugSurvey2014-16:Keyissuesyoulookedat

There is a lot of data floating around in the public

domain which talks about India being the hub of

spuriousmedicineornotofqualitystandardmedicines.

Itwasaveryurgentrequirementthathowdowecreate

an authentic data in terms of India because India is

doing extremely well in terms of producing quality

medicinesatthemostaffordablepriceandgloballyitis

beingacknowledgedthatIndiaisthepharmacyofthe

world.

We inthehealthcaredeliverysystemonbehalfof the

patients wanted to know what it is exactly. So we

convincedthegovernmentthatweshoulddoascientific

studyintermsofthelevelofspuriousornotofquality

standardmedicinetodayfloatingaroundinthesupply

chaininourcountry.Sothatwasthewholemotivethat

howdowecomeoutwithcredibledata.

NationDrugSurvey2014-16:Outcomes

Themostimportantthingwasthatwheneveryoucreate

anydataithastobedoneinaveryscientificmanner.

That'swhywe created an extremely robust sampling

process and we engaged with the Indian Statistical

Institute to recommend the sample size and how to

createthatsample.

Thenextpointisalsomakingaverytransparentprocess

toensurethatthereisnobiasednessinthecollectionof

thesample.Sowemadesurethecitizenrepresentative

andrepresentativesfromthePharmacyCouncilofIndia

accompanied the inspectors who went to draw the

samplesfromthemarketplace.

Hence,wemadetheprocessverytransparent.Wealso

made sure that the labs are accredited labs or

governmentlabsthatarecompetenttodothesetests.

Thelabsweregiventhesamplesinamaskedmannerso

theywon'tknowwhosesamplestheyweretesting.

Soitwasallcodedanddonebytheuseoftechnologyi.e.,

wecreatedsoftwarewhichmadesurethatthereisno

biasednessoranykindofinterferenceintermsofthe

wholesamplingtestprocess.Soweensuredtodothat

very scientifically.Finally, the recommendation came

outwithaprocesswherewecreatedsoftware.Soasper

law, all state governments are supposed to draw

samplesandtest themregularly.Wesuggestedthat it

shouldalwaysbedoneinascientificmannerintermsof

collectionofthesamples.Itshouldnotbeleftwiththe

whimsand fancyof thedrug inspector towalk intoa

placeanddrawthesample.

Hence, it should be done in such a statistic and

significantmannerthatitisunbiasedandnobodycan

inter fere wi th the process . This was one

recommendationthatcameout.


Drinkinglargeamountsoffruitjuicemayraiseyourrisk

ofcancer,accordingtoabigstudywhichhasfoundalink

betweentheregularconsumptionofallkindsofsugary

drinksandthelikelihoodofdevelopingthedisease.The

study,carriedoutinFrance,isthefirstsubstantialpiece

ofresearchtofindaspecificassociationbetweensugar

andcancer.Sugarydrinkssuchascolas,lemonadeand

energydrinkshavebeen linked toobesity,which isa

cause of cancer, but the French researchers suggest

therecouldalsobeotherreasonssugarcouldtriggerit.

Thestudy finds theassociationwithcancer is justas

strongwith fruit juices as it iswith colas. “When the

groupofsugarydrinkswassplitinto100%fruitjuices

and other sugary drinks, the consumption of both

beverage types was associated with a higher risk of

overallcancer,”itsays.Cuttingdownontheamountof

sugarydrinksweallconsume,togetherwithsugartaxes

and restrictionsonmarketing,mighthelp reduce the

cancer burden, say the authors. That does notmean

nobody should ever drink them. “As usual with

nutrition,theideaisnottoavoidfoods,justtobalance

the intake,” said Dr Mathilde Touvier, who led the

research,frominterm,theFrenchnationalinstituteof

healthandmedicalresearch.Ref:www.theguardian.com

Sugarinfruitjuicemayraiseriskofcancer,studyfinds

Australianresearchershavediscoveredthatadrugused

foralmostfourdecadestocontrolparasiticinfectionscanhelpinhibitthegrowthandspreadofmelanomainmice.Melanoma,themostserioustypeofskincancer,develops in the cells (melanocytes) that produce

melanin—thepigmentthatgivesyourskinitscolour.

Thedrug,whichisavailableover-the-counterinEurope,is a so-called anthelmintic used to control parasiticinfections.

Researchers at the Sydney-based University of New

SouthWales(UNSW)foundthatthedrug,flubendazole,

inhibited growth and metastasis of human tumoursgrowninmice.Thefindingwasaresultofathree-yearcollaborationbetweenUNSWandtheUSscientists.“We

were surprised to discover that flubendazole’s anti-

tumour effects involve its inhibition of a cell surface

proteincalledprogrammedcelldeathprotein-1orPD-1,” lead author of the study Levon Khachigian said.“WhenPD-1isboundtoanotherproteincalledPD-L1,it

helpsstoptheimmunesystemfromkillingcancercells.

PD-1suppressionreleasesthebrakesonthe immune

system and allows immune cells to find and destroytumours,” Khachigian said. “These studies associateflubendazolewithPD-1inanexperimentalsystem,”hesaid.

Theresearchhasfoundthatinmice,flubendazoleisa

novel small molecule inhibitor of PD-1. “Patients on

small molecule PD-1 inhibitors could potentially be

dosed as outpatients. This would mean greater

convenience,avoidanceof intravenousadministration

andcostsavings forchemotherapyunits,”Khachigian

said. “Whilst flubendazole is anolddrug, itsuseasa

treatment for melanoma has not yet been tested in

humantrials.

“Thereisnoregulatoryapprovalforuseofflubendazole

forcancerpatients,andthusitisnotavailableforthis

indication.Patientsshouldcontinueseekingtheadviceoftheirhealthprofessional,”hesaid.

Ref:www.indianexpress.com

Antiparasiticdrugmayhelpfightskincancer

agency’s listwhichprioritizescriticalhealthproducts

that should be widely available and affordable

throughout hea l th sys tems . However, the

pharmaceutical industry is concerned that thegovernmentmustnotlookatadoptingtheWHOlistatitwithoutevaluatingitstrategically.

“We hope the government will look at it from

essentialityandaccessibilitypointofviewandnotbring

thesedrugsunderpricecontrol.Iftheydoso,thenall

strengthsmustnotbeaddedforformulationsaddedtothelist,”anindustryexecutivesaid.


Allstategovernmentsaresupposedtodrawdrugsamplesandtestthemregularly:BejonMisra







15 16

Shahid Akhter, editor, ETHealthworld spoke to Bejon

Misra, Founder Director of Patient Safety & Access

InitiativeofIndiaFoundation,NewDelhitoknowabout

the Nation Drug Survey that looked at the issue of

spuriousdrugs.

NationDrugSurvey2014-16:Keyissuesyoulookedat

There is a lot of data floating around in the public

domain which talks about India being the hub of

spuriousmedicineornotofqualitystandardmedicines.

Itwasaveryurgentrequirementthathowdowecreate

an authentic data in terms of India because India is

doing extremely well in terms of producing quality

medicinesatthemostaffordablepriceandgloballyitis

beingacknowledgedthatIndiaisthepharmacyofthe

world.

We inthehealthcaredeliverysystemonbehalfof the

patients wanted to know what it is exactly. So we

convincedthegovernmentthatweshoulddoascientific

studyintermsofthelevelofspuriousornotofquality

standardmedicinetodayfloatingaroundinthesupply

chaininourcountry.Sothatwasthewholemotivethat

howdowecomeoutwithcredibledata.

NationDrugSurvey2014-16:Outcomes

Themostimportantthingwasthatwheneveryoucreate

anydataithastobedoneinaveryscientificmanner.

That'swhywe created an extremely robust sampling

process and we engaged with the Indian Statistical

Institute to recommend the sample size and how to

createthatsample.

Thenextpointisalsomakingaverytransparentprocess

toensurethatthereisnobiasednessinthecollectionof

thesample.Sowemadesurethecitizenrepresentative

andrepresentativesfromthePharmacyCouncilofIndia

accompanied the inspectors who went to draw the

samplesfromthemarketplace.

Hence,wemadetheprocessverytransparent.Wealso

made sure that the labs are accredited labs or

governmentlabsthatarecompetenttodothesetests.

Thelabsweregiventhesamplesinamaskedmannerso

theywon'tknowwhosesamplestheyweretesting.

Soitwasallcodedanddonebytheuseoftechnologyi.e.,

wecreatedsoftwarewhichmadesurethatthereisno

biasednessoranykindofinterferenceintermsofthe

wholesamplingtestprocess.Soweensuredtodothat

very scientifically.Finally, the recommendation came

outwithaprocesswherewecreatedsoftware.Soasper

law, all state governments are supposed to draw

samplesandtest themregularly.Wesuggestedthat it

shouldalwaysbedoneinascientificmannerintermsof

collectionofthesamples.Itshouldnotbeleftwiththe

whimsand fancyof thedrug inspector towalk intoa

placeanddrawthesample.

Hence, it should be done in such a statistic and

significantmannerthatitisunbiasedandnobodycan

inter fere wi th the process . This was one

recommendationthatcameout.


Drinkinglargeamountsoffruitjuicemayraiseyourrisk

ofcancer,accordingtoabigstudywhichhasfoundalink

betweentheregularconsumptionofallkindsofsugary

drinksandthelikelihoodofdevelopingthedisease.The

study,carriedoutinFrance,isthefirstsubstantialpiece

ofresearchtofindaspecificassociationbetweensugar

andcancer.Sugarydrinkssuchascolas,lemonadeand

energydrinkshavebeen linked toobesity,which isa

cause of cancer, but the French researchers suggest

therecouldalsobeotherreasonssugarcouldtriggerit.

Thestudy finds theassociationwithcancer is justas

strongwith fruit juices as it iswith colas. “When the

groupofsugarydrinkswassplitinto100%fruitjuices

and other sugary drinks, the consumption of both

beverage types was associated with a higher risk of

overallcancer,”itsays.Cuttingdownontheamountof

sugarydrinksweallconsume,togetherwithsugartaxes

and restrictionsonmarketing,mighthelp reduce the

cancer burden, say the authors. That does notmean

nobody should ever drink them. “As usual with

nutrition,theideaisnottoavoidfoods,justtobalance

the intake,” said Dr Mathilde Touvier, who led the

research,frominterm,theFrenchnationalinstituteof

healthandmedicalresearch.Ref:www.theguardian.com

Sugarinfruitjuicemayraiseriskofcancer,studyfinds

Australianresearchershavediscoveredthatadrugused

foralmostfourdecadestocontrolparasiticinfectionscanhelpinhibitthegrowthandspreadofmelanomainmice.Melanoma,themostserioustypeofskincancer,develops in the cells (melanocytes) that produce

melanin—thepigmentthatgivesyourskinitscolour.

Thedrug,whichisavailableover-the-counterinEurope,is a so-called anthelmintic used to control parasiticinfections.

Researchers at the Sydney-based University of New

SouthWales(UNSW)foundthatthedrug,flubendazole,

inhibited growth and metastasis of human tumoursgrowninmice.Thefindingwasaresultofathree-yearcollaborationbetweenUNSWandtheUSscientists.“We

were surprised to discover that flubendazole’s anti-

tumour effects involve its inhibition of a cell surface

proteincalledprogrammedcelldeathprotein-1orPD-1,” lead author of the study Levon Khachigian said.“WhenPD-1isboundtoanotherproteincalledPD-L1,it

helpsstoptheimmunesystemfromkillingcancercells.

PD-1suppressionreleasesthebrakesonthe immune

system and allows immune cells to find and destroytumours,” Khachigian said. “These studies associateflubendazolewithPD-1inanexperimentalsystem,”hesaid.

Theresearchhasfoundthatinmice,flubendazoleisa

novel small molecule inhibitor of PD-1. “Patients on

small molecule PD-1 inhibitors could potentially be

dosed as outpatients. This would mean greater

convenience,avoidanceof intravenousadministration

andcostsavings forchemotherapyunits,”Khachigian

said. “Whilst flubendazole is anolddrug, itsuseasa

treatment for melanoma has not yet been tested in

humantrials.

“Thereisnoregulatoryapprovalforuseofflubendazole

forcancerpatients,andthusitisnotavailableforthis

indication.Patientsshouldcontinueseekingtheadviceoftheirhealthprofessional,”hesaid.

Ref:www.indianexpress.com

Antiparasiticdrugmayhelpfightskincancer

agency’s listwhichprioritizescriticalhealthproducts

that should be widely available and affordable

throughout hea l th sys tems . However, the

pharmaceutical industry is concerned that thegovernmentmustnotlookatadoptingtheWHOlistatitwithoutevaluatingitstrategically.

“We hope the government will look at it from

essentialityandaccessibilitypointofviewandnotbring

thesedrugsunderpricecontrol.Iftheydoso,thenall

strengthsmustnotbeaddedforformulationsaddedtothelist,”anindustryexecutivesaid.


Allstategovernmentsaresupposedtodrawdrugsamplesandtestthemregularly:BejonMisra







17 18

Microvasculardiseaseisindependentlyassociatedwith

a higher risk of leg amputation compared to people

withoutthedisease,accordingtonewresearchintheAmericanHeartAssociation's journalCirculation.Thestudy, funded by the American Heart Association

Strategically Focused Research Network in Vascular

Disease and the U.S. Department of Veterans Affairs,

examined amputation risk among people withmicrovascular disease or peripheral artery disease(PAD)orthosewhohadbothmicrovasculardiseaseand

PAD.

ResearchersuseddatafromtheVeteransAgingCohort

Study,whichincludedmorethan125,000veteranswho

initially did not have amputations when the studybegan.Overanaverageofnineyears,participantswith:

Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskoflegamputations

ThefollowingdraftofcertainrulesfurthertoamendtheDrugsandCosmeticsRules,1945whichtheCentralGovernment proposes to make, in exercise of thepowersconferredby sub-section(1)ofsection12andsub-section(1)ofsection33oftheDrugsandCosmeticsAct,1940 (23of1940)and in consultationswith theDrugsTechnicalAdvisoryBoardisherebypublishedforinformationofallpersonslikelytobeaffectedtherebyandnoticeisherebygiventhatthesaiddraftrulesshallbetakenintoconsideration.

• a. These rules may be called the Drugs and Cosmetics(......Amendment)Rules,2019.

b. They shall come into force on the date of their finalpublicationintheOfficialGazette.

•IntheDrugsandCosmeticsRules,1945, inrule96,after sub-rule (4), following sub-rule shall beinserted,namely:-

“(5) Every active pharmaceutical ingredient (bulkdrug)manufacturedorimportedinIndiashallbear

Quick Response code on its label at each levelpackaging that store data or information readablewith software application to facilitate tracking andtracing.Thestoreddataorinformationshallincludethefollowingminimumparticulars,namely:-

a) Uniqueproductidentificationcode,

b) NameoftheAPI,

c) Brandname(ifany),

d) Nameandaddressofthemanufacturer,

e) Batchno.

f) Batchsize,

g) Dateofmanufacturing,

h) Dateofexpiryorretesting,

i) Serialshippingcontainercode,

j) Manufacturinglicenceno.orimportlicenceno.

k) Specialstorageconditionsrequired(ifany)”.Ref:www.cdsco.gov.in

NOTIFICATION(DepartmentofHealthandFamilyWelfare)

Astrainof thecommoncoldvirushasbeen found topotentially target, infect and destroy cancer cells inpatientswithbladdercancer,anewstudyinthemedicaljournalClinicalCancerResearchreports.Notraceofthecancerwas found in one patient following treatmentwiththevirus.

Researchers from theUniversity of Surrey and RoyalSurrey County Hospital investigated the safety andtolerability of exposure to the oncolytic ('cancer-killing') virus coxsackievirus (CVA21), a naturallyoccurringstrainofthecommoncold,infifteenpatients

with non-muscle invasive bladder cancer (NMIBC).NMIBCisfoundinthetissueoftheinnersurfaceofthebladderandisthetenthmostcommoncancerintheUKwithapproximately10,000peopleeachyeardiagnosedwiththeillness.

During this pioneering study fifteen NMIBC patients,oneweekpriortoprescheduledsurgerytoremovetheirtumours,receivedCVA21viaacatheterinthebladder.Examinationoftissuesamplespost-surgerydiscoveredthat the virus was highly selective, targeting onlycancerouscellsintheorganandleavingallothercellsintact.Theviruswasfoundtohaveinfectedcancerouscellsand replicated itself causing thecells to ruptureanddie.Urinesamplestakenfrompatientsonalternatedaysdetected'shedding'fromthevirusindicatingthatonce virally infected cancer cells haddied, thenewlyreplicated virus continued to attack more cancerouscellsintheorgan.

Following treatment with the virus cell death wasidentified in themajorityof thepatients' tumours. Inone patient no trace of the cancerwas found duringsurgery.Ref:www.medicalxpress.com

Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer • microvasculardiseasehada3.7-foldincreasedriskof

lowerlimbamputation,andexperienced18%ofall

amputationsduringthestudy;

• PAD had a 13.9-fold increased risk of lower limbamputation and suffered 22% of all amputations;

microvasculardiseaseandPADhada23-foldincrease

intheriskoflowerlimbamputationwhichaccounted

for45%ofallamputations.

PADisanarrowingofthearteriesawayfromtheheartandistypicallyfoundinthelegs.Itcausescramping,painorfatigueinthelegmuscleswhilewalkingorclimbing

stairs.Ifleftuntreated,PADcanleadtogangreneandthe

need for amputation."PAD (in the legs) has long been

consideredasignthatapatientlikelyalsohasnarrowedarteriesleadingtotheheartorbrain.IfapatienthasPAD,theyhaveahigherriskofothercardiovasculardiseases,

suchasheartattacksandstrokes,"Beckmansaid."Our

studysuggeststhatmicrovasculardiseaseinanypartof

thebody,suchastheeyes,kidneysorfeet(neuropathy)maybelinkedtodecreasedbloodvesselfunctioninotherpartsof thebody,puttingpatientsat risk forpotential

lower-limbamputations."Ref:www.medicalxpress.com







17 18

Microvasculardiseaseisindependentlyassociatedwith

a higher risk of leg amputation compared to people

withoutthedisease,accordingtonewresearchintheAmericanHeartAssociation's journalCirculation.Thestudy, funded by the American Heart Association

Strategically Focused Research Network in Vascular

Disease and the U.S. Department of Veterans Affairs,

examined amputation risk among people withmicrovascular disease or peripheral artery disease(PAD)orthosewhohadbothmicrovasculardiseaseand

PAD.

ResearchersuseddatafromtheVeteransAgingCohort

Study,whichincludedmorethan125,000veteranswho

initially did not have amputations when the studybegan.Overanaverageofnineyears,participantswith:

Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskoflegamputations

ThefollowingdraftofcertainrulesfurthertoamendtheDrugsandCosmeticsRules,1945whichtheCentralGovernment proposes to make, in exercise of thepowersconferredby sub-section(1)ofsection12andsub-section(1)ofsection33oftheDrugsandCosmeticsAct,1940 (23of1940)and in consultationswith theDrugsTechnicalAdvisoryBoardisherebypublishedforinformationofallpersonslikelytobeaffectedtherebyandnoticeisherebygiventhatthesaiddraftrulesshallbetakenintoconsideration.

• a. These rules may be called the Drugs and Cosmetics(......Amendment)Rules,2019.

b. They shall come into force on the date of their finalpublicationintheOfficialGazette.

•IntheDrugsandCosmeticsRules,1945, inrule96,after sub-rule (4), following sub-rule shall beinserted,namely:-

“(5) Every active pharmaceutical ingredient (bulkdrug)manufacturedorimportedinIndiashallbear

Quick Response code on its label at each levelpackaging that store data or information readablewith software application to facilitate tracking andtracing.Thestoreddataorinformationshallincludethefollowingminimumparticulars,namely:-

a) Uniqueproductidentificationcode,

b) NameoftheAPI,

c) Brandname(ifany),

d) Nameandaddressofthemanufacturer,

e) Batchno.

f) Batchsize,

g) Dateofmanufacturing,

h) Dateofexpiryorretesting,

i) Serialshippingcontainercode,

j) Manufacturinglicenceno.orimportlicenceno.

k) Specialstorageconditionsrequired(ifany)”.Ref:www.cdsco.gov.in

NOTIFICATION(DepartmentofHealthandFamilyWelfare)

Astrainof thecommoncoldvirushasbeen found topotentially target, infect and destroy cancer cells inpatientswithbladdercancer,anewstudyinthemedicaljournalClinicalCancerResearchreports.Notraceofthecancerwas found in one patient following treatmentwiththevirus.

Researchers from theUniversity of Surrey and RoyalSurrey County Hospital investigated the safety andtolerability of exposure to the oncolytic ('cancer-killing') virus coxsackievirus (CVA21), a naturallyoccurringstrainofthecommoncold,infifteenpatients

with non-muscle invasive bladder cancer (NMIBC).NMIBCisfoundinthetissueoftheinnersurfaceofthebladderandisthetenthmostcommoncancerintheUKwithapproximately10,000peopleeachyeardiagnosedwiththeillness.

During this pioneering study fifteen NMIBC patients,oneweekpriortoprescheduledsurgerytoremovetheirtumours,receivedCVA21viaacatheterinthebladder.Examinationoftissuesamplespost-surgerydiscoveredthat the virus was highly selective, targeting onlycancerouscellsintheorganandleavingallothercellsintact.Theviruswasfoundtohaveinfectedcancerouscellsand replicated itself causing thecells to ruptureanddie.Urinesamplestakenfrompatientsonalternatedaysdetected'shedding'fromthevirusindicatingthatonce virally infected cancer cells haddied, thenewlyreplicated virus continued to attack more cancerouscellsintheorgan.

Following treatment with the virus cell death wasidentified in themajorityof thepatients' tumours. Inone patient no trace of the cancerwas found duringsurgery.Ref:www.medicalxpress.com

Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer • microvasculardiseasehada3.7-foldincreasedriskof

lowerlimbamputation,andexperienced18%ofall

amputationsduringthestudy;

• PAD had a 13.9-fold increased risk of lower limbamputation and suffered 22% of all amputations;

microvasculardiseaseandPADhada23-foldincrease

intheriskoflowerlimbamputationwhichaccounted

for45%ofallamputations.

PADisanarrowingofthearteriesawayfromtheheartandistypicallyfoundinthelegs.Itcausescramping,painorfatigueinthelegmuscleswhilewalkingorclimbing

stairs.Ifleftuntreated,PADcanleadtogangreneandthe

need for amputation."PAD (in the legs) has long been

consideredasignthatapatientlikelyalsohasnarrowedarteriesleadingtotheheartorbrain.IfapatienthasPAD,theyhaveahigherriskofothercardiovasculardiseases,

suchasheartattacksandstrokes,"Beckmansaid."Our

studysuggeststhatmicrovasculardiseaseinanypartof

thebody,suchastheeyes,kidneysorfeet(neuropathy)maybelinkedtodecreasedbloodvesselfunctioninotherpartsof thebody,puttingpatientsat risk forpotential

lower-limbamputations."Ref:www.medicalxpress.com







19 20

Scrub Typhus

Scrub typhus or mite-borne typhus is an infectiousdisease caused by a specific type of bacteriacalledOrientia tsutsugamushi. It is spread andmaintained by the larvae of mites. These larvae arecalled “chiggers”. They bite human skin and leave acharacteristic mark called an "eschar" (scar). Thedisease presents nonspecifically, but may rapidlyprogress to dreaded complications such as lung andliver failure. "Typhus" means fever with stupor, orsmoke.Itwasadreadeddiseaseinthepre-antibioticera,causing the deaths of thousands of soldiers duringWorldWar II. The area of maximum occurrence is atrianglebetweenJapan,RussiaandAustralia,calledthe"Tsutsugamushi Triangle". In India, scrub typhus is

oftenseenintheSouthernstatesAndhraPradeshandTamilNadu.

Introduction

SymptomsandSignThediseasebeginstomanifestitselfapproximately10-12 days after the chigger bites. The first symptom isusuallyasmallraisedmarkatthesiteofthebite,whichlater becomes a dried out, blackish spot called an“eschar” (scar). It ismostoften foundnear thegroin,armpits,neckandintheexternalgenitalregions.Theremaybeanassociatedrasharoundtheeschar,andthelymph nodes near the affected area may becomeswollen.Fevermaystartabruptly,accompaniedalmostalways by severe headache, chills, muscle pain andcough. There may also be redness of the eyes,drowsiness,vomiting,andshinpain.

Diagnosis

Thediagnosisofscrubtyphusisaidedbythepresenceofthe characteristic “eschar” (scar). It is difficult todiagnose from the clinical findings alone, as they arenonspecific,andahighdegreeofsuspicionisrequired,particularlyinendemicareas.Manylaboratorytestscanaid indiagnosingscrubtyphus, includinggeneralandspecifictests.

Generaltests:

• Completebloodcountmayshowalargenumberof whitebloodcellsandalowlevelofplatelets.

• Liverandkidneyfunctiontestsmaybeabnormal.

• ChestXrayisoftennecessaryandmayrevealfeatures oflunginvolvement.

• Ultrasound of the abdomen may be required to

confirmenlargementoftheliverorspleen.

Specifictests:

• ELISAfordetectionofantibodiestothebacterium, whichiscommonlyusednowadays.

• IndirectImmunofluorescenceantibodytest,whichis

thegoldstandard.

• Weil-Felixtest,whichisnotusedsooftennow.

• Bloodculture

• PCR(polymerasechainreaction)

TreatmentTreatment of scrub typhus should be initiated early,based on clinical suspicion. The recommendedtreatmentisdoxycycline100mgtwicedailyorallyfor7to14daysbasedontheseverityoftheillness.Inchildrenandpregnantwomen,azithromycin500mgoncedailyisused.Inplaceswherethereisresistancetodoxycyclinealone,azithromycinmaybeusedincombinationwithrifampicin. Complications such as ARDSmay requireinvasive ventilation and supportive care in the ICUsetting.

TreatmentguidelinesassuggestedintheIndianMedicalGazetteincludedoxycyclineasthetreatmentofchoice

in adults, and azithromycin during pregnancy.Alternatives to doxycycline include chloramphenicol,telithromycin, roxithromycin, rifampicin andlevofloxacin. It is important to note that rifampicinshouldnotbeusedasasingleagent.

ComplicationsofScrubTyphus

• Pneumonitis

• AcuteLungInjury(ALI)

• AcuteRespiratoryDistressSyndrome(ARDS)

• AcuteKidneyInjury(AKI)

• Myocarditis

Thepresenceofanescharisavaluablediagnosticcluetothephysician,anditispresentinapproximately50%ofaffected individuals. There may be evidence of liverenlargement and congestion of the lungs on physicalexamination. Sometimes, in case of advanced disease,there may be features of lung involvement such asintractablecough,shortnessofbreathanddrowsiness.

SeverelunginvolvementmayleadtoAcuteRespiratoryDistress Syndrome (ARDS) which may require ICUadmissionandventilatorsupport.Othermanifestationsofseveredisease includeinvolvementofthe lungs, thekidneys, thebrainand inappropriate clottingofblood,called DIC (disseminated intravascular coagulation)whichisadreadedcomplication.

Causes







19 20

Scrub Typhus

Scrub typhus or mite-borne typhus is an infectiousdisease caused by a specific type of bacteriacalledOrientia tsutsugamushi. It is spread andmaintained by the larvae of mites. These larvae arecalled “chiggers”. They bite human skin and leave acharacteristic mark called an "eschar" (scar). Thedisease presents nonspecifically, but may rapidlyprogress to dreaded complications such as lung andliver failure. "Typhus" means fever with stupor, orsmoke.Itwasadreadeddiseaseinthepre-antibioticera,causing the deaths of thousands of soldiers duringWorldWar II. The area of maximum occurrence is atrianglebetweenJapan,RussiaandAustralia,calledthe"Tsutsugamushi Triangle". In India, scrub typhus is

oftenseenintheSouthernstatesAndhraPradeshandTamilNadu.

Introduction

SymptomsandSignThediseasebeginstomanifestitselfapproximately10-12 days after the chigger bites. The first symptom isusuallyasmallraisedmarkatthesiteofthebite,whichlater becomes a dried out, blackish spot called an“eschar” (scar). It ismostoften foundnear thegroin,armpits,neckandintheexternalgenitalregions.Theremaybeanassociatedrasharoundtheeschar,andthelymph nodes near the affected area may becomeswollen.Fevermaystartabruptly,accompaniedalmostalways by severe headache, chills, muscle pain andcough. There may also be redness of the eyes,drowsiness,vomiting,andshinpain.

Diagnosis

Thediagnosisofscrubtyphusisaidedbythepresenceofthe characteristic “eschar” (scar). It is difficult todiagnose from the clinical findings alone, as they arenonspecific,andahighdegreeofsuspicionisrequired,particularlyinendemicareas.Manylaboratorytestscanaid indiagnosingscrubtyphus, includinggeneralandspecifictests.

Generaltests:

• Completebloodcountmayshowalargenumberof whitebloodcellsandalowlevelofplatelets.

• Liverandkidneyfunctiontestsmaybeabnormal.

• ChestXrayisoftennecessaryandmayrevealfeatures oflunginvolvement.

• Ultrasound of the abdomen may be required to

confirmenlargementoftheliverorspleen.

Specifictests:

• ELISAfordetectionofantibodiestothebacterium, whichiscommonlyusednowadays.

• IndirectImmunofluorescenceantibodytest,whichis

thegoldstandard.

• Weil-Felixtest,whichisnotusedsooftennow.

• Bloodculture

• PCR(polymerasechainreaction)

TreatmentTreatment of scrub typhus should be initiated early,based on clinical suspicion. The recommendedtreatmentisdoxycycline100mgtwicedailyorallyfor7to14daysbasedontheseverityoftheillness.Inchildrenandpregnantwomen,azithromycin500mgoncedailyisused.Inplaceswherethereisresistancetodoxycyclinealone,azithromycinmaybeusedincombinationwithrifampicin. Complications such as ARDSmay requireinvasive ventilation and supportive care in the ICUsetting.

TreatmentguidelinesassuggestedintheIndianMedicalGazetteincludedoxycyclineasthetreatmentofchoice

in adults, and azithromycin during pregnancy.Alternatives to doxycycline include chloramphenicol,telithromycin, roxithromycin, rifampicin andlevofloxacin. It is important to note that rifampicinshouldnotbeusedasasingleagent.

ComplicationsofScrubTyphus

• Pneumonitis

• AcuteLungInjury(ALI)

• AcuteRespiratoryDistressSyndrome(ARDS)

• AcuteKidneyInjury(AKI)

• Myocarditis

Thepresenceofanescharisavaluablediagnosticcluetothephysician,anditispresentinapproximately50%ofaffected individuals. There may be evidence of liverenlargement and congestion of the lungs on physicalexamination. Sometimes, in case of advanced disease,there may be features of lung involvement such asintractablecough,shortnessofbreathanddrowsiness.

SeverelunginvolvementmayleadtoAcuteRespiratoryDistress Syndrome (ARDS) which may require ICUadmissionandventilatorsupport.Othermanifestationsofseveredisease includeinvolvementofthe lungs, thekidneys, thebrainand inappropriate clottingofblood,called DIC (disseminated intravascular coagulation)whichisadreadedcomplication.

Causes







21 22

• Septicshock

• DisseminatedIntravascularCoagulation(DIC)

• Scrub typhus in pregnancy - Itmay cause preterm labourandNeonatalRespiratoryDistressSyndrome.

RiskFactorsforScrubTyphus

• Farmandforestworkers

• Livingattheedgeofvillages

• Wearingshortsleeves

• Workingbarehands

• Immunedeficiency

Healthtips

• Avoidplaceswheremitesareknowntobepresentin alargenumber

• Wear protective clothing when travelling to an endemicarea.Longsleevedclotheshavebeenshown tobeapreventivefactorfromgettinginfected.

• Apply mite repellents to exposed skin e.g. diethyl toluamide.

• Peoplewhohaveriskfactorsandwhohavetowork inanendemicareacanbegivenonceweeklydoseof doxycycline.Ref:www.medindia.net

World Pharmacists Day 2019

World Pharmacists Day was adopted by the International Pharmaceutical Federation (FIP)

Council at the 2009World Congress of Pharmacy and Pharmaceutical Sciences in Istanbul,

Turkey.September25waschosenbecauseitisthedatethatFIPcameintoexistencein1912.The

purposeofWorldPharmacistsDayistoencourageactivitiesthatpromoteandadvocateforthe

roleofthepharmacistinimprovinghealthineverycorneroftheworld.

The International Pharmaceutical Federation (FIP) is the global federation of national

associationsofpharmacistsandpharmaceuticalscientists,andisinofficialrelationswiththe

World Health Organization. Through its 144member organizations, it represents over four

millionpractitionersandscientistsaroundtheworld.

Eachyearnewthemeisdevelopedtoshowcasethepharmacistintheirpositiveroleonhealth.

Thethemeofthisyear'sWorldPharmacistsDay,heldonSeptember25,is"Safeandeffective

medicinesforall",accordingtotheInternationalPharmaceuticalFederation(FIP).Thetheme

aimstohighlightthekeyrolethatpharmacistsplayinprotectingpatientsafetythroughimproved

medicineuseandreducedmedicationerrors.

Pharmacistsensurethattheyprovidetherightmedicinewiththerightdosetoeverypatientwho

walksintoapharmacy.Theyalsoguidethemwithsuitableinformationaboutthemedicines,

whatistherighttimetohavethem,dotheyneedtobeeateninanemptystomachorimmediately

afterameal,willtheycausedrowsinessorweakness,etc.

Traditionally,manypeopleconsiderpharmacistsashealthcareprofessionalswhosimplyweara

whitecoatanddispensepills.Buttheroleofapharmacistisfarmorethandispensingdrugsand

fillingprescriptions.Pharmacistsareanimportantpartofhealthcaresystem.WorldPharmacists

Dayismeanttohighlightroleofpharmacists.Today,morethanever,pharmacistsarecharged

withtheresponsibilitytoensurethatwhenapatientusesamedicine,itwillnotcauseharm.

ThisWorldPharmacistsDay,let'spayourpharmaciststheirdueregardsandsalutethemfor

helpingpatientsallacrosstheworld.AveryhappyWorldPharmacistsDaytoallofyou!







21 22

• Septicshock

• DisseminatedIntravascularCoagulation(DIC)

• Scrub typhus in pregnancy - Itmay cause preterm labourandNeonatalRespiratoryDistressSyndrome.

RiskFactorsforScrubTyphus

• Farmandforestworkers

• Livingattheedgeofvillages

• Wearingshortsleeves

• Workingbarehands

• Immunedeficiency

Healthtips

• Avoidplaceswheremitesareknowntobepresentin alargenumber

• Wear protective clothing when travelling to an endemicarea.Longsleevedclotheshavebeenshown tobeapreventivefactorfromgettinginfected.

• Apply mite repellents to exposed skin e.g. diethyl toluamide.

• Peoplewhohaveriskfactorsandwhohavetowork inanendemicareacanbegivenonceweeklydoseof doxycycline.Ref:www.medindia.net

World Pharmacists Day 2019

World Pharmacists Day was adopted by the International Pharmaceutical Federation (FIP)

Council at the 2009World Congress of Pharmacy and Pharmaceutical Sciences in Istanbul,

Turkey.September25waschosenbecauseitisthedatethatFIPcameintoexistencein1912.The

purposeofWorldPharmacistsDayistoencourageactivitiesthatpromoteandadvocateforthe

roleofthepharmacistinimprovinghealthineverycorneroftheworld.

The International Pharmaceutical Federation (FIP) is the global federation of national

associationsofpharmacistsandpharmaceuticalscientists,andisinofficialrelationswiththe

World Health Organization. Through its 144member organizations, it represents over four

millionpractitionersandscientistsaroundtheworld.

Eachyearnewthemeisdevelopedtoshowcasethepharmacistintheirpositiveroleonhealth.

Thethemeofthisyear'sWorldPharmacistsDay,heldonSeptember25,is"Safeandeffective

medicinesforall",accordingtotheInternationalPharmaceuticalFederation(FIP).Thetheme

aimstohighlightthekeyrolethatpharmacistsplayinprotectingpatientsafetythroughimproved

medicineuseandreducedmedicationerrors.

Pharmacistsensurethattheyprovidetherightmedicinewiththerightdosetoeverypatientwho

walksintoapharmacy.Theyalsoguidethemwithsuitableinformationaboutthemedicines,

whatistherighttimetohavethem,dotheyneedtobeeateninanemptystomachorimmediately

afterameal,willtheycausedrowsinessorweakness,etc.

Traditionally,manypeopleconsiderpharmacistsashealthcareprofessionalswhosimplyweara

whitecoatanddispensepills.Buttheroleofapharmacistisfarmorethandispensingdrugsand

fillingprescriptions.Pharmacistsareanimportantpartofhealthcaresystem.WorldPharmacists

Dayismeanttohighlightroleofpharmacists.Today,morethanever,pharmacistsarecharged

withtheresponsibilitytoensurethatwhenapatientusesamedicine,itwillnotcauseharm.

ThisWorldPharmacistsDay,let'spayourpharmaciststheirdueregardsandsalutethemfor

helpingpatientsallacrosstheworld.AveryhappyWorldPharmacistsDaytoallofyou!






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