Drug Updates Pharma News Public Noticehpspc.in/pdf/drug_therapy_24_Jan_2020.pdf · hotline dic:...
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Hotline DIC: 9218428042 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 24 Volume 3 JAN 2020 | | Drug Updates Public Notice Pharma News
Transcript of Drug Updates Pharma News Public Noticehpspc.in/pdf/drug_therapy_24_Jan_2020.pdf · hotline dic:...
Hotline DIC: 9218428042
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 24 Volume 3 JAN 2020 | |
Drug Updates Public NoticePharma News
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER1 2
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
ContentDrugUpdatesGivlaariforRareGeneticDisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Fetroja:NewUTIAntibiotic. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
BrukinsaforMCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
TaliciaforH.PyloriInfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
VumerityforMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
LilettaNowSix-YearIUD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
BaxdelaNowforCABP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
ZejulaforAdvancedOvarianCancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
StelaraApprovedforUC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
FarxigaforCVRiskwithDiabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
BreakthroughCFTherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NplateAdultITPUseExpanded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
XofluzaNowforHigh-RiskPatients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Secuado:1stAsenapineTransdermalPatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Xarelto:VTEPreventioninAcutelyIll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
NewMigraineTreatmentApproved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Scenesse®forPain-FreeLightExposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
NewApprovalforWetAMD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
TrifaroteneCreamforAcne. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
InvokanaNowforDiabeticNephropathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ExpandedCrysvitaLabel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
RituxanforPediatricGPA/MPA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Mavyret:First8-WeekHCVTreatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Darzalex+VTdforMultipleMyeloma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
JynneosforSmallpox,MonkeypoxPrevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Pifeltro,DelstrigoforVirallySuppressedHIV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1stGLP-1AnaloginTabletForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Erleada®NowforMCSPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
FDA:NDMAinRanitidineSamples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
FDA:CDK4/6InhibitorsandILD/Pneumonitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
NucalaNowforYoungerChildren . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
IbsrelaforIBS-C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
NewGlucagonReady-To-UseInjection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
OfevNowforSSC-ILD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
PharmaNewsBharatBiotechlaunchesnewvariantofrotavirusvaccine,Rotavac5D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
"Delayinnotificationofrulesaffectinge-pharmaindustry''. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
TrialsfoundayurvedicdrugBGR-34hastherapeuticefficacyonnewlydiagnosed
type-2diabetes:Govt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
TakeactionagainstthosesellingprescriptiondrugsOTC:HCtoCentre,Delhigovt. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Drug-coatedboneimplantsmayhelptacklepost-surgeryinfections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
AntibioticdrugtargetidentifiedbyIndianresearchers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
NewWHOreport:Ignoringthehealthofpeopleinprisonsnowcomesatahighcost
forsocietylater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
IPAopposedamendmentinScheduleKofD&CRulesbyhealthministry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Rapamycinpreventsage-relatedbrainvasculardeterioration:Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
CabinetapprovesMoUbetweenIndiaandBrazilonCooperationinthefieldof
Health&Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
WhyIndianeedsasuperdrugregulatorlikeUSFDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Researchersdevelopingayurvedicalternativesfortreatingbacterial,fungalinfections . . . . . . . . . . . . . . . . . . . . . . . 15
J&Jrecalls33,000bottlesofbabypowderasFDAfindsasbestosinsample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
DCGItookmeasuresonRanitidinecontaminationtoensurepatientsafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
High-fructoseandhigh-fatdietdamageslivermitochondria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Healthministerlaunchestrans-fatfreelogo. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
PvPIurgesallstakeholderstoreportadverseeventsassociatedwithnutraceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Anaemicpeoplemorelikelytotransmitdengue:Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
StrictactionagainstonlinesellingofmedicinesinGujarat:2pharmacistssuspended . . . . . . . . . . . . . . . . . . . . . . . . 18
SowhydoesIndianeedasuperregulator?Commonobjective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Reducingworkload? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER1 2
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
ContentDrugUpdatesGivlaariforRareGeneticDisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Fetroja:NewUTIAntibiotic. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
BrukinsaforMCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
TaliciaforH.PyloriInfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
VumerityforMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
LilettaNowSix-YearIUD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
BaxdelaNowforCABP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
ZejulaforAdvancedOvarianCancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
StelaraApprovedforUC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
FarxigaforCVRiskwithDiabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
BreakthroughCFTherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NplateAdultITPUseExpanded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
XofluzaNowforHigh-RiskPatients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Secuado:1stAsenapineTransdermalPatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Xarelto:VTEPreventioninAcutelyIll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
NewMigraineTreatmentApproved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Scenesse®forPain-FreeLightExposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
NewApprovalforWetAMD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
TrifaroteneCreamforAcne. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
InvokanaNowforDiabeticNephropathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ExpandedCrysvitaLabel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
RituxanforPediatricGPA/MPA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Mavyret:First8-WeekHCVTreatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Darzalex+VTdforMultipleMyeloma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
JynneosforSmallpox,MonkeypoxPrevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Pifeltro,DelstrigoforVirallySuppressedHIV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1stGLP-1AnaloginTabletForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Erleada®NowforMCSPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
FDA:NDMAinRanitidineSamples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
FDA:CDK4/6InhibitorsandILD/Pneumonitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
NucalaNowforYoungerChildren . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
IbsrelaforIBS-C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
NewGlucagonReady-To-UseInjection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
OfevNowforSSC-ILD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
PharmaNewsBharatBiotechlaunchesnewvariantofrotavirusvaccine,Rotavac5D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
"Delayinnotificationofrulesaffectinge-pharmaindustry''. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
TrialsfoundayurvedicdrugBGR-34hastherapeuticefficacyonnewlydiagnosed
type-2diabetes:Govt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
TakeactionagainstthosesellingprescriptiondrugsOTC:HCtoCentre,Delhigovt. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Drug-coatedboneimplantsmayhelptacklepost-surgeryinfections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
AntibioticdrugtargetidentifiedbyIndianresearchers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
NewWHOreport:Ignoringthehealthofpeopleinprisonsnowcomesatahighcost
forsocietylater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
IPAopposedamendmentinScheduleKofD&CRulesbyhealthministry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Rapamycinpreventsage-relatedbrainvasculardeterioration:Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
CabinetapprovesMoUbetweenIndiaandBrazilonCooperationinthefieldof
Health&Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
WhyIndianeedsasuperdrugregulatorlikeUSFDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Researchersdevelopingayurvedicalternativesfortreatingbacterial,fungalinfections . . . . . . . . . . . . . . . . . . . . . . . 15
J&Jrecalls33,000bottlesofbabypowderasFDAfindsasbestosinsample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
DCGItookmeasuresonRanitidinecontaminationtoensurepatientsafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
High-fructoseandhigh-fatdietdamageslivermitochondria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Healthministerlaunchestrans-fatfreelogo. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
PvPIurgesallstakeholderstoreportadverseeventsassociatedwithnutraceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Anaemicpeoplemorelikelytotransmitdengue:Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
StrictactionagainstonlinesellingofmedicinesinGujarat:2pharmacistssuspended . . . . . . . . . . . . . . . . . . . . . . . . 18
SowhydoesIndianeedasuperregulator?Commonobjective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Reducingworkload? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Drugs Update
GivlaariforRareGeneticDiseaseOnNovember20,2019,theUSFDAapprovedGivlaari
(givosiran) subQ injection indicated to treat adult
patientswithacutehepaticporphyria(AHP).arare
genetic disorder resulting in the buildup of toxic
porphyrinmoleculeswhich are formed during the
production of heme. Givlaari, which was granted
breakthrough therapy, priority review, and orphan
drugdesignations,wasapprovedbasedonaclinical
trial in which patients treated with givosiran
experienced fewerporphyria attacks that required
hospitalization,urgentcarevisits,orat-homehemin
IV infusion compared with those treated with
placebo.
Theprescribinginformationcanbefoundat:https://www.access
data.fda.gov/drugsatfda_docs/label/2019/0212194s000lbl.pdf.
Fetroja:NewUTIAntibioticOnNovember14,2019,theUSFDAapprovedFetroja
(cefiderocol) IV injection indicated to treat
complicated urinary tract infections (cUTI),
including pyelonephritis caused by susceptible
Gram-negativemicroorganisms,inpatients18years
of ageorolderwhohave limitedorno alternative
treatmentoptions.Fetroja,whichreceivedtheFDA's
QualifiedInfectiousDiseaseProductdesignationand
wasgrantedpriorityreview,wasapprovedaspartof
anongoingeffortbytheFDAtoaddressantimicrobial
resistance.
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 :
https://www.shionogi.com/wp-content/themes/pdfs/fetroja.pdf.
BrukinsaforMCL
On November 14, 2019, the US FDA approved
Brukinsa™(zanubrutinib)oralcapsulesindicatedto
treat adult patients with mantle cell lymphoma
(MCL)who have received at least 1 prior therapy.
Brukinsa,whichwasgrantedbreakthroughtherapy
andorphandrugdesignations,showedefficacyina
single-armclinicaltrialinwhichasignificantnumber
of patients experienced complete or partial tumor
shrinkagefollowingtreatmentwithzanubrutinib.
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 :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s0
00lbl.pdf.
TaliciaforH.PyloriInfection
On November 4, 2019, the US FDA approved Talicia
(omeprazole magnesium/amoxicillin/rifabutin) oral
delayed-release capsules indicated for the treatment of
Helicobacterpylori(H.Pylori)infectioninadultpatients.
Talicia is the first rifabutin-basedH.pylori treatment to
gain FDA approval. Efficacy is based on 2 trials that
demonstrated significantly greater percentages of
infection eradication and response rate with Talicia
comparedwithactivecomparators.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/213004lbl.pdf.
VumerityforMS
On October 30, 2019, the US FDA approved Vumerity
(diroximel fumarate) oral delayed-release capsules
indicatedforthetreatmentofrelapsingformsofmultiple
sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressivedisease,inadultpatients.Approvalwasbased
on pharmacokinetic studies comparing Vumerity with
Tecfidera(R) (dimethyl fumarate) to establish
bioequivalenceaswellasinterimsafetyandefficacydata
fromtheongoingEVOLVE-MS-1clinicaltrial.
Prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/211855s000lbl.pdf.
LilettaNowSix-YearIUD
OnOctober28,2019,theUSFDAapprovedanextended
duration of use for Liletta (levonorgestrel) intrauterine
device(IUD)topreventpregnancyforupto6years.Liletta
gainedapprovalforanadditionalyearofusebasedonthe
ongoing ACCESS IUS clinical trial which demonstrated
greaterthan99%efficacyinpreventingpregnancyforup
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER3 4
Globalrespect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
PublicNoticeManufacturingandmarketingofFDCofAceclofenac100mg+
DrotaverineHydrochloride80mgTablet-Regarding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
PharmacovigilancereportingforveterinaryproductsinIndia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
The2019MedicineLaureates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Drugs Update
GivlaariforRareGeneticDiseaseOnNovember20,2019,theUSFDAapprovedGivlaari
(givosiran) subQ injection indicated to treat adult
patientswithacutehepaticporphyria(AHP).arare
genetic disorder resulting in the buildup of toxic
porphyrinmoleculeswhich are formed during the
production of heme. Givlaari, which was granted
breakthrough therapy, priority review, and orphan
drugdesignations,wasapprovedbasedonaclinical
trial in which patients treated with givosiran
experienced fewerporphyria attacks that required
hospitalization,urgentcarevisits,orat-homehemin
IV infusion compared with those treated with
placebo.
Theprescribinginformationcanbefoundat:https://www.access
data.fda.gov/drugsatfda_docs/label/2019/0212194s000lbl.pdf.
Fetroja:NewUTIAntibioticOnNovember14,2019,theUSFDAapprovedFetroja
(cefiderocol) IV injection indicated to treat
complicated urinary tract infections (cUTI),
including pyelonephritis caused by susceptible
Gram-negativemicroorganisms,inpatients18years
of ageorolderwhohave limitedorno alternative
treatmentoptions.Fetroja,whichreceivedtheFDA's
QualifiedInfectiousDiseaseProductdesignationand
wasgrantedpriorityreview,wasapprovedaspartof
anongoingeffortbytheFDAtoaddressantimicrobial
resistance.
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 :
https://www.shionogi.com/wp-content/themes/pdfs/fetroja.pdf.
BrukinsaforMCL
On November 14, 2019, the US FDA approved
Brukinsa™(zanubrutinib)oralcapsulesindicatedto
treat adult patients with mantle cell lymphoma
(MCL)who have received at least 1 prior therapy.
Brukinsa,whichwasgrantedbreakthroughtherapy
andorphandrugdesignations,showedefficacyina
single-armclinicaltrialinwhichasignificantnumber
of patients experienced complete or partial tumor
shrinkagefollowingtreatmentwithzanubrutinib.
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 :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s0
00lbl.pdf.
TaliciaforH.PyloriInfection
On November 4, 2019, the US FDA approved Talicia
(omeprazole magnesium/amoxicillin/rifabutin) oral
delayed-release capsules indicated for the treatment of
Helicobacterpylori(H.Pylori)infectioninadultpatients.
Talicia is the first rifabutin-basedH.pylori treatment to
gain FDA approval. Efficacy is based on 2 trials that
demonstrated significantly greater percentages of
infection eradication and response rate with Talicia
comparedwithactivecomparators.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/213004lbl.pdf.
VumerityforMS
On October 30, 2019, the US FDA approved Vumerity
(diroximel fumarate) oral delayed-release capsules
indicatedforthetreatmentofrelapsingformsofmultiple
sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressivedisease,inadultpatients.Approvalwasbased
on pharmacokinetic studies comparing Vumerity with
Tecfidera(R) (dimethyl fumarate) to establish
bioequivalenceaswellasinterimsafetyandefficacydata
fromtheongoingEVOLVE-MS-1clinicaltrial.
Prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/211855s000lbl.pdf.
LilettaNowSix-YearIUD
OnOctober28,2019,theUSFDAapprovedanextended
duration of use for Liletta (levonorgestrel) intrauterine
device(IUD)topreventpregnancyforupto6years.Liletta
gainedapprovalforanadditionalyearofusebasedonthe
ongoing ACCESS IUS clinical trial which demonstrated
greaterthan99%efficacyinpreventingpregnancyforup
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER3 4
Globalrespect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
PublicNoticeManufacturingandmarketingofFDCofAceclofenac100mg+
DrotaverineHydrochloride80mgTablet-Regarding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
PharmacovigilancereportingforveterinaryproductsinIndia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
The2019MedicineLaureates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER5 6
to6yearsinadiversegroupofwomen.Lilettanowhas
thelongestdurationofuseofanyIUDintheUS.
Prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/206229s008lbl.pdf.
BaxdelaNowforCABP
On October 24, 2019, the US FDA approved a new
indicationforBaxdela(delafloxacin)oraltabletsandIV
injection to treat adult patients with community-
acquired bacterial pneumonia (CABP) caused by
designatedsusceptiblebacteria.Baxdelademonstrated
non-inferiority to moxifloxacin for the Early Clinical
responseandassessmentofsuccessatthetestofcure
visit. The label carries a boxedwarning for possible
tendinitisandtendonrupture,peripheralneuropathy,
adverse CNS effects, and exacerbation ofmyasthenia
gravis.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006l
bl.pdf.
ZejulaforAdvancedOvarianCancer
On October 23, 2019, the US FDA approved a new
indicationforZejula(niraparib)oralcapsulestotreat
adultpatientswithadvancedovarian,fallopiantube,or
primaryperitonealcancerwhohavebeentreatedwith
3 or more prior chemotherapy regimens and whose
cancer is associatedwithhomologous recombination
deficiency (HRD) positive status defined by either a
deleteriousorsuspecteddeleteriousBRCAmutationor
agenomic instabilityandwhohaveprogressedmore
than6monthsafterresponsetothelastplatinum-based
chemotherapy. In the QUADRA trial, Zejula, the only
once-daily poly ADP-ribose polymerase inhibitor
approved for this indication, improved the objective
responserateinasignificantproportionofpatients.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf.
StelaraApprovedforUCOn October 21, 2019, the US FDA approved a new
indication for Stelara (ustekinumab) subQ or IV
injection for the treatment of adult patients with
moderatelytoseverelyactiveulcerativecolitis(UC).in
theUNIFIclinicaltrial,Stelarainducedandmaintained
clinical remission in a greaterpercentage of patients
comparedwithplacebo.Stelaraisalsoapprovedtotreat
psoriasis,psoriaticarthritis,andCrohndisease.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/761044s003lbl.pdf.
FarxigaforCVRiskwithDiabetesOn October 21, 2019, the US FDA approved a new
indicationforFarxiga(dapagliflozinpropanediol)oral
tablets to reduce the riskofhospitalization forheart
failureinadultpatientswithtype2diabetesmellitus
andestablishedcardiovascular(CV)diseaseormultiple
CV risk factors. Approval is based on data from the
DECLARE-TIMI58,which is the largestCVoutcomes
trial conducted fora sodium-glucose cotransporter2
(SGLT2)inhibitor.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf.
BreakthroughCFTherapyOnOctober21,2019,theUSFDAapprovedTrikafta™
(elexacaftor/tezacaftor/ivacaftorandivacaftor)oralkit
totreatcysticfibrosis(CF)inpatients12yearsofageor
olderwhohaveat leastoneF508delmutation in the
cystic fibrosis transmembrane conductance regulator
(CFTR)gene,whichisestimatedtorepresent90%of
theCFpopulation.Approvedbasedonprovenefficacy
in2clinicaltrials,Trikaftawasgrantedpriorityreview
aswellasfasttrack,breakthroughtherapy,andorphan
drugdesignations.
The prescribing information can be found at: https://www.fda.gov/
news-events/press-announcements/fda-approves-new-breakthrough-
therapy-cystic-fibrosis
NplateAdultITPUseExpanded
OnOctober18,2019,theUSFDAexpandedtheadult
indication for Nplate (romiplostim) subQ injection
include those with newly diagnosed and persistent
immune thrombocytopenia (ITP) who have had an
i n su f f i c i en t re sponse to c o r t i c o s te ro id s ,
immunoglobulins, or splenectomy.Nplate,whichwas
previouslyapprovedforadultpatientswithchronicITP,
demonstratedefficacywithasignificantpercentageof
patientsachievingtreatment-freeremissionforatleast
6monthsandachieving1ormoreplateletresponses
duringthe12-monthtreatmentperiod.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/125268s164lbl.pdf.
XofluzaNowforHigh-RiskPatientsOn October 17, 2019, the US FDA expanded the
indication for Xofluza™ (baloxavir marboxil) oral
tablets for the treatment of acute, uncomplicated
influenzaorfluinpatients12yearsofageorolderwho
havebeensymptomaticfornotmorethan48hoursand
who are at high risk of developing flu-related
complications.Previouslyitapprovedonlyforhealthy
patients,Xofluzaisnowthefirstandonlyantiviraldrug
indicatedspecificallyforthoseathighriskofdeveloping
flucomplications.Efficacyforthisexpanded,indication
wasdemonstratedintheCAPSTONE-2clinicaltrial.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf.
stSecuado:1 AsenapineTransdermal
Patch
OnOctober 15, 2019, the US FDA approved Secuado
(asenapine) extended-release transdermal patches
indicated for the treatment of schizophrenia in adult
patients.Secuado,whichisthefirstandonlyasenapine
transdermalpatchformulation,wasapprovedbasedon
aclinicaltrialwhichshowedsignificantimprovement
from baseline compared with placebo. Like other
asenapineproducts,Secuadocarriesaboxedwarning
regardingincreasedmortalityinelderlypatientswith
dementia-relatedpsychosis(anunapproveduse).
Theprescribinginformationcanbefoundat:http://www.noven.com/
SECUADO_USPI.pdf.
Xarelto:VTEPreventioninAcutelyIll
On October 14, 2019, the US FDA approved a new
indicationforXarelto(R)(rivaroxaban)oraltabletsfor
theprophylaxisofVTEandVTE-relateddeathduring
hospitalization and post-hospital discharge in adult
patientsadmittedforanacutemedicalillnesswhoareat
risk for thromboembolic complications due to
moderateorsevererestrictedmobilityandotherrisk
factors for VTE and not at high risk of bleeding.
Rivaroxaban demonstrated non-inferiority to
enoxaparinfollowedbyplaceboinshort-termuseand
superiority in long-term use in the MAGELLAN and
MARINER trials. Xarelto carries a boxedwarning for
increased risk of thrombotic events following
premature discontinuation and for risk of
spinal/epiduralhematoma.
Theprescribinginformationcanbefoundat:https://www.accessdata.
fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf
.
NewMigraineTreatmentApprovedOnOctober11,2019,theUSFDAapprovedReyvow™
(lasmiditan) oral tablets indicated for the acute
treatment of migraine with or without aura in adult
patients. In clinical trials, the percentage of patients
whosepainandmostmigrainesymptom(nausea,light
orsoundsensitivity)resolvedin2hoursaftertreatment
were significantly greater among patients who
receiving Reyvow compared with those receiving
placebo. Reyvow is not indicated for the preventive
treatmentofmigraines.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/211280s000lbl.pdf.
® Scenesse for Pain-Free Light
Exposure®OnOctober 8, 2019, theUS FDA approved Scenesse
(afamelanotide) subQ implant indicated to increase
painfreelightexposureinadultpatientswithahistory
of phototoxic reactions from erythropoietic
protoporphyria (EPP). Patients treated with
afamelanotideexperiencedagreaternumberofhours
over 180 days spent in direct sunlight with no pain
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER5 6
to6yearsinadiversegroupofwomen.Lilettanowhas
thelongestdurationofuseofanyIUDintheUS.
Prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/206229s008lbl.pdf.
BaxdelaNowforCABP
On October 24, 2019, the US FDA approved a new
indicationforBaxdela(delafloxacin)oraltabletsandIV
injection to treat adult patients with community-
acquired bacterial pneumonia (CABP) caused by
designatedsusceptiblebacteria.Baxdelademonstrated
non-inferiority to moxifloxacin for the Early Clinical
responseandassessmentofsuccessatthetestofcure
visit. The label carries a boxedwarning for possible
tendinitisandtendonrupture,peripheralneuropathy,
adverse CNS effects, and exacerbation ofmyasthenia
gravis.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006l
bl.pdf.
ZejulaforAdvancedOvarianCancer
On October 23, 2019, the US FDA approved a new
indicationforZejula(niraparib)oralcapsulestotreat
adultpatientswithadvancedovarian,fallopiantube,or
primaryperitonealcancerwhohavebeentreatedwith
3 or more prior chemotherapy regimens and whose
cancer is associatedwithhomologous recombination
deficiency (HRD) positive status defined by either a
deleteriousorsuspecteddeleteriousBRCAmutationor
agenomic instabilityandwhohaveprogressedmore
than6monthsafterresponsetothelastplatinum-based
chemotherapy. In the QUADRA trial, Zejula, the only
once-daily poly ADP-ribose polymerase inhibitor
approved for this indication, improved the objective
responserateinasignificantproportionofpatients.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf.
StelaraApprovedforUCOn October 21, 2019, the US FDA approved a new
indication for Stelara (ustekinumab) subQ or IV
injection for the treatment of adult patients with
moderatelytoseverelyactiveulcerativecolitis(UC).in
theUNIFIclinicaltrial,Stelarainducedandmaintained
clinical remission in a greaterpercentage of patients
comparedwithplacebo.Stelaraisalsoapprovedtotreat
psoriasis,psoriaticarthritis,andCrohndisease.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/761044s003lbl.pdf.
FarxigaforCVRiskwithDiabetesOn October 21, 2019, the US FDA approved a new
indicationforFarxiga(dapagliflozinpropanediol)oral
tablets to reduce the riskofhospitalization forheart
failureinadultpatientswithtype2diabetesmellitus
andestablishedcardiovascular(CV)diseaseormultiple
CV risk factors. Approval is based on data from the
DECLARE-TIMI58,which is the largestCVoutcomes
trial conducted fora sodium-glucose cotransporter2
(SGLT2)inhibitor.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf.
BreakthroughCFTherapyOnOctober21,2019,theUSFDAapprovedTrikafta™
(elexacaftor/tezacaftor/ivacaftorandivacaftor)oralkit
totreatcysticfibrosis(CF)inpatients12yearsofageor
olderwhohaveat leastoneF508delmutation in the
cystic fibrosis transmembrane conductance regulator
(CFTR)gene,whichisestimatedtorepresent90%of
theCFpopulation.Approvedbasedonprovenefficacy
in2clinicaltrials,Trikaftawasgrantedpriorityreview
aswellasfasttrack,breakthroughtherapy,andorphan
drugdesignations.
The prescribing information can be found at: https://www.fda.gov/
news-events/press-announcements/fda-approves-new-breakthrough-
therapy-cystic-fibrosis
NplateAdultITPUseExpanded
OnOctober18,2019,theUSFDAexpandedtheadult
indication for Nplate (romiplostim) subQ injection
include those with newly diagnosed and persistent
immune thrombocytopenia (ITP) who have had an
i n su f f i c i en t re sponse to c o r t i c o s te ro id s ,
immunoglobulins, or splenectomy.Nplate,whichwas
previouslyapprovedforadultpatientswithchronicITP,
demonstratedefficacywithasignificantpercentageof
patientsachievingtreatment-freeremissionforatleast
6monthsandachieving1ormoreplateletresponses
duringthe12-monthtreatmentperiod.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/125268s164lbl.pdf.
XofluzaNowforHigh-RiskPatientsOn October 17, 2019, the US FDA expanded the
indication for Xofluza™ (baloxavir marboxil) oral
tablets for the treatment of acute, uncomplicated
influenzaorfluinpatients12yearsofageorolderwho
havebeensymptomaticfornotmorethan48hoursand
who are at high risk of developing flu-related
complications.Previouslyitapprovedonlyforhealthy
patients,Xofluzaisnowthefirstandonlyantiviraldrug
indicatedspecificallyforthoseathighriskofdeveloping
flucomplications.Efficacyforthisexpanded,indication
wasdemonstratedintheCAPSTONE-2clinicaltrial.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf.
stSecuado:1 AsenapineTransdermal
Patch
OnOctober 15, 2019, the US FDA approved Secuado
(asenapine) extended-release transdermal patches
indicated for the treatment of schizophrenia in adult
patients.Secuado,whichisthefirstandonlyasenapine
transdermalpatchformulation,wasapprovedbasedon
aclinicaltrialwhichshowedsignificantimprovement
from baseline compared with placebo. Like other
asenapineproducts,Secuadocarriesaboxedwarning
regardingincreasedmortalityinelderlypatientswith
dementia-relatedpsychosis(anunapproveduse).
Theprescribinginformationcanbefoundat:http://www.noven.com/
SECUADO_USPI.pdf.
Xarelto:VTEPreventioninAcutelyIll
On October 14, 2019, the US FDA approved a new
indicationforXarelto(R)(rivaroxaban)oraltabletsfor
theprophylaxisofVTEandVTE-relateddeathduring
hospitalization and post-hospital discharge in adult
patientsadmittedforanacutemedicalillnesswhoareat
risk for thromboembolic complications due to
moderateorsevererestrictedmobilityandotherrisk
factors for VTE and not at high risk of bleeding.
Rivaroxaban demonstrated non-inferiority to
enoxaparinfollowedbyplaceboinshort-termuseand
superiority in long-term use in the MAGELLAN and
MARINER trials. Xarelto carries a boxedwarning for
increased risk of thrombotic events following
premature discontinuation and for risk of
spinal/epiduralhematoma.
Theprescribinginformationcanbefoundat:https://www.accessdata.
fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf
.
NewMigraineTreatmentApprovedOnOctober11,2019,theUSFDAapprovedReyvow™
(lasmiditan) oral tablets indicated for the acute
treatment of migraine with or without aura in adult
patients. In clinical trials, the percentage of patients
whosepainandmostmigrainesymptom(nausea,light
orsoundsensitivity)resolvedin2hoursaftertreatment
were significantly greater among patients who
receiving Reyvow compared with those receiving
placebo. Reyvow is not indicated for the preventive
treatmentofmigraines.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/211280s000lbl.pdf.
® Scenesse for Pain-Free Light
Exposure®OnOctober 8, 2019, theUS FDA approved Scenesse
(afamelanotide) subQ implant indicated to increase
painfreelightexposureinadultpatientswithahistory
of phototoxic reactions from erythropoietic
protoporphyria (EPP). Patients treated with
afamelanotideexperiencedagreaternumberofhours
over 180 days spent in direct sunlight with no pain
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER7 8
comparedwith those treatedwithplacebo in clinical
trials.Scenesseisthefirsttreatmenttoincreasepain-
free light exposure in patientswith EPP to gain FDA
approvalandwasgrantedpriorityreviewandorphan
drugdesignationsbytheFDA.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf.
NewApprovalforWetAMD®On October 8, 2019, the US FDA approved Beovu
(brolucizumab-dbll) intravitreal injection for the
treatment of neovascular (wet) age-related macular
degeneration (AMD) inadults.Beovu is the firstFDA
approved anti-vascular endothelial growth factor
(VEGF) to provide greater fluid resolution when
comparedwithaflibercept.Eligiblepatientswithwet
AMDcanbemaintainedona3-monthdosinginterval
immediately after a 3-month loading phase without
compromisingefficacy,alsoafirstofitskind.Approval
was granted after thePhase IIIHAWKandHARRIER
clinical trials demonstrated non-inferiority versus
aflibercept in mean change in best-corrected visual
acuityatyear1(week48).
The prescribing information for brolucizumab-dbll can be found at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76112
5s000lbl.pdf
TrifaroteneCreamforAcne®On October 4, 2019, the US FDA approved Aklief
(trifarotene) topical cream for the treatment of acne
vulgarisinpatients9yearsofageorolder.Aklieftargets
themost common retinoic acid receptor (RAR), RAR
gammafoundontheskin.Trifaroteneisthefirstnew
retinoidtreatmentapprovedforthetreatmentofacne
inmorethan2decadesandhasbeenproveneffectivein
bothfacialandtruncalacne.Approvalwasgrantedafter
clinical trialsdemonstrateda significant reduction in
inflammatory lesions within 2 weeks on face and 4
weeksontheback,shouldersandchestwhencompared
withvehicle.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/211527s000lbl.pdf.
I nvokana Now f o r D i abe t i c
NephropathyOn September 30, 2019, the US FDA approved
®Invokana (canagliflozin)oraltabletstoreducetherisk
ofend-stagekidneydisease(ESKD),doublingofserum
creat inine , cardiovascular (CV) death and
hospitalization forheart failure inadultswith type2
diabetes and diabetic nephropathywith albuminuria
greaterthan300mg/day.Invokana,whichisnowthe
onlytype2diabetesdrugapprovedforthisindication
andgainedapprovalbasedondatafromtheCREDENCE
trial showing a significantly reduced risk of primary
endpoint (ESKD, doubling of serum creatinine, and
renalorCVdeath)inpatientstreatedwithcanagliflozin
comparedwiththosetreatedwithplacebo.
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 :
ht tp ://www. janssenlabels . com/package- insert/product -
monograph/prescribing-information/INVOKANA-pi.pdf.
ExpandedCrysvitaLabelOnSeptember30,2019,theUSFDAexpandedthelabel
®for Crysvita (burosumab-twza) subQ injection to
include new clinical data in which burosumab-twza
demonstrated greater efficacy in pediatric patients
with X-linked hypophosphatemia (XLH) and
improvementinstiffnessandmaintenanceofefficacyin
adultpatientsbeingtreatedlong-termcomparedwith
oral phosphate and active vitamin D (conventional
therapy). Additionally, the pediatric XLH indication,
whichwaspreviously forpediatricpatientsof1year
ageorolderwasexpandedtoincludeinfants6months
ofageorolder.
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 :
http://www.ultragenyx.com/file.cfm/29/docs/Crysvita_Full_Prescribi
ng_Information.pdf.
RituxanforPediatricGPA/MPA®OnSeptember27,2019,theUSFDAapprovedRituxan
(rituximab) IV injection to treat granulomatosiswith
polyangiitis (GPA; formerly known as Wegener
granulomatosis)andmicroscopicpolyangiitis(MPA)in
pediatricpatients2yearsofageorolderincombination
with glucocorticoids. Rituxan, which was granted
priority review and orphan drug designation for this
expanded indication, is the first FDA-approved
treatment for pediatric patients with GPA and MPA.
Efficacywasdemonstratedinaclinicaltrialinwhichall
25 pediatric patients in the trial were complete
remissionafter18monthsofrituximabtreatment.
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 :
https://www.gene.com/download/pdf/rituxan_prescribing.pdf.
Mavyre t : F i r s t 8 -Week HCV
Treatment
On September 26, 2019, the US FDA expanded the
approval of Mavyret™ (glecaprevir/pibrentasvir) oral
tabletsfor8-weekdurationforthetreatmentofadults
and pediatric patients 12 years of age or older or
weighingatleast99poundswhohavechronichepatitis
Cvirus(HCV)genotype1,2,3,4,5or6infectionand
compensated cirrhosis and have not been previously
treatedforHCV.Mavyretisthefirst8-weektreatment
approved for this indication. Standard treatment
duration forpatientswithcompensatedcirrhosiswas
previously12weeksormore.
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 :
https://www.rxabbvie.com/pdf/mavyret_pi.pdf.
Darzalex+VTdforMultipleMyeloma
OnSeptember26, 2019, theUSFDAapproved anew®indication Darzalex (daratumumab) IV injection to
treat multiple myeloma in combination with
bortezomib,thalidomideanddexamethasone(VTd)in
newly diagnosed adult patients who are eligible for
autologousstemcelltransplant(ASCT).Darzalexisthe
firstbiologictogainFDAapprovalfornewlydiagnosed
patients who are eligible for a stem cell transplant.
Efficacywasdemonstrated in theCASSIOPEIAclinical
trial in which daratumumab plus VTd significantly
reduces disease progression risk or death compared
withVTdalone.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf.
Jynneos for Smallpox, Monkeypox
PreventionOnSeptember24,2019,theUSFDAapprovedJynneos™
(smallpox monkeypox vaccine, live non-replicating)subQ injection indicated to prevent smallpox andmonkeypoxdisease inadults18yearsofageorolder
determinedtobeathighriskforsmallpoxormonkeypox
infection. Jynneos, which is the only FDA-approved
vaccineforthepreventionofmonkeypoxdisease,ispartof the Strategic National Stockpile (SNS) for use in apublichealthemergencythatissevereenoughtocause
local supplies to be depleted. The availability of this
vaccineintheSNSwillhelpensurethatthevaccineisaccessibleintheUSifneeded.The prescribing information can be found at: http://www.bavarian-nordic.com/media/282996/jynneos-pi.pdf.
Pifeltro, Delstrigo for VirallySuppressedHIVOn September 20, 2019, the US FDA expanded the
indications of Pifeltro™ (doravirine) oral tablets andDelstrigo™ (doravirine/lamivudine/tenofovirdisoproxil fumarate) oral tablets to include adult
patients with HIV-1 infection who are virologically
suppressed(HIV-1RNAlessthan50copiespermL)ona
stable antiretroviral regimen with no history oftreatmentfailureandunknownsubstitutionsassociatedwith resistance to Pifeltro or to the individual
components of Delstrigo. Originally approved for the
treatment-naiveHIV-1infection,PifeltroandDelstrigo
gainedapprovalforthisnewindicationbasedondatafromtheDRIVE-SHIFTtrial.TheprescribinginformationforPifeltroandDelstrigocanbefoundat:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21080
6s002lbl.pdf and https://www.accessdata.fda.gov/drugsatfda_docs/
label/2019/210807s002lbl.pdf.
st1 GLP-1AnaloginTabletFormOn September 20, 2019, the US FDA approved
®Rybelsus (semaglutide) oral tablets indicated as an
adjuncttodietandexercisetoimproveglycemiccontrolinadultswithtype2diabetesmellitus.Rybelsus,whichis the firstglucagon-likepeptide-1(GLP-1) ina tablet
dose form was approved based on PIONEER clinical
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER7 8
comparedwith those treatedwithplacebo in clinical
trials.Scenesseisthefirsttreatmenttoincreasepain-
free light exposure in patientswith EPP to gain FDA
approvalandwasgrantedpriorityreviewandorphan
drugdesignationsbytheFDA.
The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf.
NewApprovalforWetAMD®On October 8, 2019, the US FDA approved Beovu
(brolucizumab-dbll) intravitreal injection for the
treatment of neovascular (wet) age-related macular
degeneration (AMD) inadults.Beovu is the firstFDA
approved anti-vascular endothelial growth factor
(VEGF) to provide greater fluid resolution when
comparedwithaflibercept.Eligiblepatientswithwet
AMDcanbemaintainedona3-monthdosinginterval
immediately after a 3-month loading phase without
compromisingefficacy,alsoafirstofitskind.Approval
was granted after thePhase IIIHAWKandHARRIER
clinical trials demonstrated non-inferiority versus
aflibercept in mean change in best-corrected visual
acuityatyear1(week48).
The prescribing information for brolucizumab-dbll can be found at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76112
5s000lbl.pdf
TrifaroteneCreamforAcne®On October 4, 2019, the US FDA approved Aklief
(trifarotene) topical cream for the treatment of acne
vulgarisinpatients9yearsofageorolder.Aklieftargets
themost common retinoic acid receptor (RAR), RAR
gammafoundontheskin.Trifaroteneisthefirstnew
retinoidtreatmentapprovedforthetreatmentofacne
inmorethan2decadesandhasbeenproveneffectivein
bothfacialandtruncalacne.Approvalwasgrantedafter
clinical trialsdemonstrateda significant reduction in
inflammatory lesions within 2 weeks on face and 4
weeksontheback,shouldersandchestwhencompared
withvehicle.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/211527s000lbl.pdf.
I nvokana Now f o r D i abe t i c
NephropathyOn September 30, 2019, the US FDA approved
®Invokana (canagliflozin)oraltabletstoreducetherisk
ofend-stagekidneydisease(ESKD),doublingofserum
creat inine , cardiovascular (CV) death and
hospitalization forheart failure inadultswith type2
diabetes and diabetic nephropathywith albuminuria
greaterthan300mg/day.Invokana,whichisnowthe
onlytype2diabetesdrugapprovedforthisindication
andgainedapprovalbasedondatafromtheCREDENCE
trial showing a significantly reduced risk of primary
endpoint (ESKD, doubling of serum creatinine, and
renalorCVdeath)inpatientstreatedwithcanagliflozin
comparedwiththosetreatedwithplacebo.
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 :
ht tp ://www. janssenlabels . com/package- insert/product -
monograph/prescribing-information/INVOKANA-pi.pdf.
ExpandedCrysvitaLabelOnSeptember30,2019,theUSFDAexpandedthelabel
®for Crysvita (burosumab-twza) subQ injection to
include new clinical data in which burosumab-twza
demonstrated greater efficacy in pediatric patients
with X-linked hypophosphatemia (XLH) and
improvementinstiffnessandmaintenanceofefficacyin
adultpatientsbeingtreatedlong-termcomparedwith
oral phosphate and active vitamin D (conventional
therapy). Additionally, the pediatric XLH indication,
whichwaspreviously forpediatricpatientsof1year
ageorolderwasexpandedtoincludeinfants6months
ofageorolder.
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 :
http://www.ultragenyx.com/file.cfm/29/docs/Crysvita_Full_Prescribi
ng_Information.pdf.
RituxanforPediatricGPA/MPA®OnSeptember27,2019,theUSFDAapprovedRituxan
(rituximab) IV injection to treat granulomatosiswith
polyangiitis (GPA; formerly known as Wegener
granulomatosis)andmicroscopicpolyangiitis(MPA)in
pediatricpatients2yearsofageorolderincombination
with glucocorticoids. Rituxan, which was granted
priority review and orphan drug designation for this
expanded indication, is the first FDA-approved
treatment for pediatric patients with GPA and MPA.
Efficacywasdemonstratedinaclinicaltrialinwhichall
25 pediatric patients in the trial were complete
remissionafter18monthsofrituximabtreatment.
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 :
https://www.gene.com/download/pdf/rituxan_prescribing.pdf.
Mavyre t : F i r s t 8 -Week HCV
Treatment
On September 26, 2019, the US FDA expanded the
approval of Mavyret™ (glecaprevir/pibrentasvir) oral
tabletsfor8-weekdurationforthetreatmentofadults
and pediatric patients 12 years of age or older or
weighingatleast99poundswhohavechronichepatitis
Cvirus(HCV)genotype1,2,3,4,5or6infectionand
compensated cirrhosis and have not been previously
treatedforHCV.Mavyretisthefirst8-weektreatment
approved for this indication. Standard treatment
duration forpatientswithcompensatedcirrhosiswas
previously12weeksormore.
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 :
https://www.rxabbvie.com/pdf/mavyret_pi.pdf.
Darzalex+VTdforMultipleMyeloma
OnSeptember26, 2019, theUSFDAapproved anew®indication Darzalex (daratumumab) IV injection to
treat multiple myeloma in combination with
bortezomib,thalidomideanddexamethasone(VTd)in
newly diagnosed adult patients who are eligible for
autologousstemcelltransplant(ASCT).Darzalexisthe
firstbiologictogainFDAapprovalfornewlydiagnosed
patients who are eligible for a stem cell transplant.
Efficacywasdemonstrated in theCASSIOPEIAclinical
trial in which daratumumab plus VTd significantly
reduces disease progression risk or death compared
withVTdalone.
Prescribing information can be found at https://www.access
data.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf.
Jynneos for Smallpox, Monkeypox
PreventionOnSeptember24,2019,theUSFDAapprovedJynneos™
(smallpox monkeypox vaccine, live non-replicating)subQ injection indicated to prevent smallpox andmonkeypoxdisease inadults18yearsofageorolder
determinedtobeathighriskforsmallpoxormonkeypox
infection. Jynneos, which is the only FDA-approved
vaccineforthepreventionofmonkeypoxdisease,ispartof the Strategic National Stockpile (SNS) for use in apublichealthemergencythatissevereenoughtocause
local supplies to be depleted. The availability of this
vaccineintheSNSwillhelpensurethatthevaccineisaccessibleintheUSifneeded.The prescribing information can be found at: http://www.bavarian-nordic.com/media/282996/jynneos-pi.pdf.
Pifeltro, Delstrigo for VirallySuppressedHIVOn September 20, 2019, the US FDA expanded the
indications of Pifeltro™ (doravirine) oral tablets andDelstrigo™ (doravirine/lamivudine/tenofovirdisoproxil fumarate) oral tablets to include adult
patients with HIV-1 infection who are virologically
suppressed(HIV-1RNAlessthan50copiespermL)ona
stable antiretroviral regimen with no history oftreatmentfailureandunknownsubstitutionsassociatedwith resistance to Pifeltro or to the individual
components of Delstrigo. Originally approved for the
treatment-naiveHIV-1infection,PifeltroandDelstrigo
gainedapprovalforthisnewindicationbasedondatafromtheDRIVE-SHIFTtrial.TheprescribinginformationforPifeltroandDelstrigocanbefoundat:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21080
6s002lbl.pdf and https://www.accessdata.fda.gov/drugsatfda_docs/
label/2019/210807s002lbl.pdf.
st1 GLP-1AnaloginTabletFormOn September 20, 2019, the US FDA approved
®Rybelsus (semaglutide) oral tablets indicated as an
adjuncttodietandexercisetoimproveglycemiccontrolinadultswithtype2diabetesmellitus.Rybelsus,whichis the firstglucagon-likepeptide-1(GLP-1) ina tablet
dose form was approved based on PIONEER clinical
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER9 10
trialsinwhichsemaglutideshowedasignificantgreater
reduction in A1C compared with sitagliptin,
empagliflozinandliraglutide.The prescribing information can be found at: https://www.novo-
pi.com/rybelsus.pdf.
®Erleada NowforMCSPC®OnSeptember17,2019,theUSFDAapprovedErleada
(apalutamide) oral tablets to treat patients with
metastatic castration-sensitive prostate cancer
(mCSPC).OriginallyapprovedbytheFDAtotreatnon-
metastaticcastration-resistantprostatecancer,Erleadagainedapproval for thisnew indicationbasedon theTITANstudyinwhichoverallsurvivalandradiographic
progression-free survivalwere significantly extended
in patients treated with apalutamide compare with
thosetreatedwithplacebo.The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/210951s001lbl.pdf.
FDA:NDMAinRanitidineSamplesOnSeptember13,2019,theUSFDAissuedastatementr e g a r d i n g a n i t r o s am i n e i m p u r i t y , N -
nitrosodimethylamine (NDMA) being found in some®ranitidine products including Zantac products. The
FDA is working with international regulators andindustrypartnersinexaminingthesourceandlevelsofNDMA, which is classified as a probable human
carcinogenandevaluatingthepossiblerisktopatients.
Appropriatemeasureswillbetakenbasedonresultsoftheongoinginvestigation.FDAwillprovideinformationasitbecomesavailable.
The FDA is not calling for individuals to stop takingranitidine at this time; however, patients taking
prescriptionranitidinewhowishtodiscontinueshould
talk to their health care professional about othertreatmentoptions.
FDA: CDK 4/6 Inhibitors and
ILD/PneumonitisOn September 13, 2019, the US FDA issued a safety
communication regarding rare but severe cases of
interstitiallungdisease(ILD)and/orpneumonitiswiththeuseofcyclin-dependentkinase4/6inhibitors(CDK4/6). FDA-approved drugs in the CDK 4/6 inhibitor
®class include abemaciclib (Verzenio ), palbociclib® ®(Ibrance ),andribociclib(Kisqali ),aswellasribociclib
® ®and letrozole (Kisqali Femara Co-Pack). Healthcareprofessionalsareadvisedtomonitorpatientsregularlyfor pulmonary symptoms indicative of ILD/pneumonitis, interrupt CDK 4/6 inhibitor therapy in
patientswhohaveneworworseningsymptomsandto
permanently discontinue therapy in patients withsevereILD/pneumonitis.Patientsshouldbeinstructedto immediately report new orworsening respiratorysymptomstotheirhealthcareprovider.
NucalaNowforYoungerChildrenOn September 12, 2019, the US FDA approved an
expandedpediatricpopulationNucala(mepolizumab)subQinjectionasanadd-onmaintenancetreatmentofpatientswithsevereasthma6yearsofageorolderandwithaneosinophilicphenotype.Previouslyapprovedin
patients 12 years or older, Nucala was approved for
youngerpediatricpatientsbasedonpharmacokinetics,pharmacodynamicsandsafetydata.Nucalaisthefirstbiologicapprovedforsevereeosinophilicasthmainthisagegroup.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 :
https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-
COMBINED.PDF.
IbsrelaforIBS-C®OnSeptember12,2019theUSFDAapprovedIbsrela
(tenapanor) oral tablets indicated for treatment of
irritablebowelsyndromewithconstipation(IBS-C)inadults. Ibsrela,NHE3sodiumtransport inhibitor,wasapprovedbasedon2clinicaltrials inwhichagreater
proportion of patients treated with tenapanor
experiencedareductionofabdominalpaincomparedwiththosetreatedwithplacebo. Ibsrela,whichisnotindicatedforuseinpediatricpatients,carriesaboxedwarning for risk of serious dehydration in pediatric
patients.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 :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21180
1s000lbl.pdf.
New Glucagon Ready-To-Use Injection
OnSeptember10,2019,theUSFDAapprovedGvoke™
(glucagon) subQ injection indicated to treat severe
hypoglycemiainpediatric(2yearsofageorolder)andadultpatientswithdiabetes.Gvokeisthefirstready-to-use glucagon product to gain approval and can beadministered via a prefilled syringe or auto-injector.
Gvokewasshowntohaveanearly100%successratein
3clinicaltrials.The prescribing information can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212097s000lbl.pdf.
OfevNowforSSC-ILDOn September 6, 2019, the US FDA approved a new
®indicationOfev (nintedanib)oralcapsulestoslowthe
rateofdeclineinpulmonaryfunctioninpatientswith
systemic sclerosis-associated interstitial lung disease(SSc-ILD).Ofev,whichwasoriginallyapprovedtotreatidiopathicpulmonaryfibrosisisthefirstdrugtogainFDAapprovalforSSc-ILD.Efficacyisbasedonaclinical
trialinwhichpatientstreatedwithnintedanibhasless
lungfunctiondeclinecomparedwiththosetreatedwithplacebo.The prescribing information can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205832s012lbl.pdf.
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER9 10
trialsinwhichsemaglutideshowedasignificantgreater
reduction in A1C compared with sitagliptin,
empagliflozinandliraglutide.The prescribing information can be found at: https://www.novo-
pi.com/rybelsus.pdf.
®Erleada NowforMCSPC®OnSeptember17,2019,theUSFDAapprovedErleada
(apalutamide) oral tablets to treat patients with
metastatic castration-sensitive prostate cancer
(mCSPC).OriginallyapprovedbytheFDAtotreatnon-
metastaticcastration-resistantprostatecancer,Erleadagainedapproval for thisnew indicationbasedon theTITANstudyinwhichoverallsurvivalandradiographic
progression-free survivalwere significantly extended
in patients treated with apalutamide compare with
thosetreatedwithplacebo.The prescribing information can be found at: https://www.access
data.fda.gov/drugsatfda_docs/label/2019/210951s001lbl.pdf.
FDA:NDMAinRanitidineSamplesOnSeptember13,2019,theUSFDAissuedastatementr e g a r d i n g a n i t r o s am i n e i m p u r i t y , N -
nitrosodimethylamine (NDMA) being found in some®ranitidine products including Zantac products. The
FDA is working with international regulators andindustrypartnersinexaminingthesourceandlevelsofNDMA, which is classified as a probable human
carcinogenandevaluatingthepossiblerisktopatients.
Appropriatemeasureswillbetakenbasedonresultsoftheongoinginvestigation.FDAwillprovideinformationasitbecomesavailable.
The FDA is not calling for individuals to stop takingranitidine at this time; however, patients taking
prescriptionranitidinewhowishtodiscontinueshould
talk to their health care professional about othertreatmentoptions.
FDA: CDK 4/6 Inhibitors and
ILD/PneumonitisOn September 13, 2019, the US FDA issued a safety
communication regarding rare but severe cases of
interstitiallungdisease(ILD)and/orpneumonitiswiththeuseofcyclin-dependentkinase4/6inhibitors(CDK4/6). FDA-approved drugs in the CDK 4/6 inhibitor
®class include abemaciclib (Verzenio ), palbociclib® ®(Ibrance ),andribociclib(Kisqali ),aswellasribociclib
® ®and letrozole (Kisqali Femara Co-Pack). Healthcareprofessionalsareadvisedtomonitorpatientsregularlyfor pulmonary symptoms indicative of ILD/pneumonitis, interrupt CDK 4/6 inhibitor therapy in
patientswhohaveneworworseningsymptomsandto
permanently discontinue therapy in patients withsevereILD/pneumonitis.Patientsshouldbeinstructedto immediately report new orworsening respiratorysymptomstotheirhealthcareprovider.
NucalaNowforYoungerChildrenOn September 12, 2019, the US FDA approved an
expandedpediatricpopulationNucala(mepolizumab)subQinjectionasanadd-onmaintenancetreatmentofpatientswithsevereasthma6yearsofageorolderandwithaneosinophilicphenotype.Previouslyapprovedin
patients 12 years or older, Nucala was approved for
youngerpediatricpatientsbasedonpharmacokinetics,pharmacodynamicsandsafetydata.Nucalaisthefirstbiologicapprovedforsevereeosinophilicasthmainthisagegroup.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 :
https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-
COMBINED.PDF.
IbsrelaforIBS-C®OnSeptember12,2019theUSFDAapprovedIbsrela
(tenapanor) oral tablets indicated for treatment of
irritablebowelsyndromewithconstipation(IBS-C)inadults. Ibsrela,NHE3sodiumtransport inhibitor,wasapprovedbasedon2clinicaltrials inwhichagreater
proportion of patients treated with tenapanor
experiencedareductionofabdominalpaincomparedwiththosetreatedwithplacebo. Ibsrela,whichisnotindicatedforuseinpediatricpatients,carriesaboxedwarning for risk of serious dehydration in pediatric
patients.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 :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21180
1s000lbl.pdf.
New Glucagon Ready-To-Use Injection
OnSeptember10,2019,theUSFDAapprovedGvoke™
(glucagon) subQ injection indicated to treat severe
hypoglycemiainpediatric(2yearsofageorolder)andadultpatientswithdiabetes.Gvokeisthefirstready-to-use glucagon product to gain approval and can beadministered via a prefilled syringe or auto-injector.
Gvokewasshowntohaveanearly100%successratein
3clinicaltrials.The prescribing information can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212097s000lbl.pdf.
OfevNowforSSC-ILDOn September 6, 2019, the US FDA approved a new
®indicationOfev (nintedanib)oralcapsulestoslowthe
rateofdeclineinpulmonaryfunctioninpatientswith
systemic sclerosis-associated interstitial lung disease(SSc-ILD).Ofev,whichwasoriginallyapprovedtotreatidiopathicpulmonaryfibrosisisthefirstdrugtogainFDAapprovalforSSc-ILD.Efficacyisbasedonaclinical
trialinwhichpatientstreatedwithnintedanibhasless
lungfunctiondeclinecomparedwiththosetreatedwithplacebo.The prescribing information can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205832s012lbl.pdf.
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER11 12
BharatBiotechInternationallaunchedanewvariantofitsrotavirusvaccine,Rotavac5Dasmallerdosageformofitsearlieroralimmunisationshotthatcanbestoredatarelativelyhighertemperature.Available in0.5ml
dosage,Rotavac5Dcanbestoredat2-8degreeCelsius
for up to 24months and canbe administered in fivedrops.Rotavac5Disalsostableat37degreeCelsiusforsevendays.
Incontrast,theearlierversionofRotavacisavailablein
2.5mlvialperdoseandhastobestoredat-20degree
Celsius.In India, the company plans to target privatehospitalsforsupplyofthevaccines,aswellasexporttocountriesinAfricaandAsia.
Forvaccines,itisimportantthattheyarestoredatthe
righttemperatureasexposuretotemperaturesoutside
the specified range may result in reduced vaccinepotency or increased risk of vaccine-preventablediseases.
Ref:www.livemint.com
Thee-pharmacyindustryhasurgedthegovernmentfor
immediate release of new e-PharmacyRuleswithout
anyfurtherdelay.DigitalHealthPlatforms,whichisan
associationofentrepreneursoperatingindigitalhealth
industry,raisedtheirconcernontheimpactofthedelay
in the industry. The indecision of rules by the
governmentismakingittoughforinvestorstoinvestin
onlinepharmacies,makingithardtoretainemployees
andchallengingthetrustofconsumers.
Accordingtoindustryplayers,thee-Pharmacymodelis
wellcoveredundertheregulatorypurviewbytheITAct
2000 under the concept of intermediaries and the
pharmacy retail operations are covered under the
Drugs and Cosmetics Act. Currently the e-pharmacy
sectorisprovidingqualityandaffordablemedicinesto
around50lakhpatientspermonthacrossthecountry.
“We haveworked hard to build the online pharmacy
sectorfromsomethingthatdidn’texistfiveyearsback.
We have not only set global standards in creating
technology and Artificial Intelligence to digitize this
complexsectorbuthavealsogeneratedhugedatabases
of healthcare information and contributed analytics
with beneficial information about patients, chronic
diseasesufferers,andprovidedadeep-diveintohealth
problems faced by people from different cities and
states, ” said by Pradeep Dadha, Founder and CEO,
Netmeds”.
Ref:www.health.economictimes.indiatimes.com
“Delayinnotificationofrulesaffectinge-pharmaindustry''
Independent clinical trials conducted at the Banaras
Hindu University (BHU) revealed thatayurvedic drug
BGR-34 has therapeutic efficacy for treating newly
diagnosed type-2 diabetes, AYUSH Minister Shripad
Naik informed.The diabetic population in country is
close to hitting an alarmingmark of 69.9million by
2025,whichdenotesthatinstancesofthediseaseinthe
countryisexpectedtowitnessanincreaseof266per
cent,Naiksaidinawrittenreply.
TakeactionagainstthosesellingprescriptiondrugsOTC:HCtoCentre,Delhigovt.
TheDelhiHighCourtdirectedtheCentreandtheAAP
government to take action against those found to be
selling prescription drugs over-the-counter (OTC)
without a doctor's authorization. The Drugs and
CosmeticsAct,1940andRule65ofDrugsandCosmetic
Rules1945 list themanufactureandsaleofalldrugs
whichcannotbepurchasedwithouttheprescriptionof
aqualifieddoctor.
Thepetitionhadallegedthatchemistsdealinginretail
saleofmedicinesaresellingantibioticsandmedicines
mentioned in Schedule H and H1 of The Drugs and
Cosmetics Act, 1940, without the prescription and
supervisionofaregisteredpharmacist.
Ref:www.health.economictimes.indiatimes.com
About 10% of bone implants failures due to post-surgicalbacterial infections.Toovercomethishurdle,oftenheavydosageofmedicinesareinjectedorgiven
orally.AteamofresearchersfromIndiaandtheUShas
nowcomeupwithamethodtolocalisethedrugdeliverytosurgerysite.
This has been achieved by modifying the surface ofmetallicimplantsbyloadingthemwithanantibacterial
drugwhichgetsreleasedgraduallyoveraperiodofone
week at the implant site to prevent infections. “Oursurface-modifiedimplantaddresseslocalisedandlongterm drug release for areas that are prone to post-surgical infection that often arise during a joint
replacementprocedure.Themodifiedimplantsurface
servesforbothdrugdeliveryandboneintegration,”saidDr Debrupa Lahiri, lead researcher at the IndianInstitute of Technology, Roorkee”, while speaking to
IndiaScienceWire.
The medicine was embedded into a micro-layer ofhydroxyapatite which is a biocompatible porousmaterialwithabone-likemineral compositionand isused in ceramic implants. The pores anchored drugwhilethestructurefacilitatedthebridgingofboneandimplant.
By using the plasma spray technique, a 200-micronthicklayerofhydroxyapatitewascoatedonatitaniummetalalloysheet.Acommonlyuseddrug,gentamicin,was mixed with a bio-degradable polymer called
Drug-coatedboneimplantsmayhelptacklepost-surgeryinfections
Pharma NewsBharatBiotechlaunchesnewvariantofrotavirusvaccine,Rotavac5D
TrialsfoundayurvedicdrugBGR-34hastherapeuticefficacyonnewlydiagnosedtype-2diabetes:Govt
TheCouncilofScientificandIndustrialResearch(CSIR),
through its constituent laboratories - CSIR-Central
Institute of Medicinal and Aromatic Plants (CSIR-
CIMAP)andCSIR-NationalBotanicalResearchInstitute
(CSIR-NBRI)bothinLucknow,developedscientifically
validatedherbalproductNBRMAP-DBasanti-diabetic
formulation,theministersaid.Theproductknow-how
waslicensedtoM/sAIMILPharmaLtd,Delhi,whoare
manufacturingandmarketingitasBGR-34,acrossthe
country,hesaid.
Ref:www.health.economictimes.indiatimes.com
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER11 12
BharatBiotechInternationallaunchedanewvariantofitsrotavirusvaccine,Rotavac5Dasmallerdosageformofitsearlieroralimmunisationshotthatcanbestoredatarelativelyhighertemperature.Available in0.5ml
dosage,Rotavac5Dcanbestoredat2-8degreeCelsius
for up to 24months and canbe administered in fivedrops.Rotavac5Disalsostableat37degreeCelsiusforsevendays.
Incontrast,theearlierversionofRotavacisavailablein
2.5mlvialperdoseandhastobestoredat-20degree
Celsius.In India, the company plans to target privatehospitalsforsupplyofthevaccines,aswellasexporttocountriesinAfricaandAsia.
Forvaccines,itisimportantthattheyarestoredatthe
righttemperatureasexposuretotemperaturesoutside
the specified range may result in reduced vaccinepotency or increased risk of vaccine-preventablediseases.
Ref:www.livemint.com
Thee-pharmacyindustryhasurgedthegovernmentfor
immediate release of new e-PharmacyRuleswithout
anyfurtherdelay.DigitalHealthPlatforms,whichisan
associationofentrepreneursoperatingindigitalhealth
industry,raisedtheirconcernontheimpactofthedelay
in the industry. The indecision of rules by the
governmentismakingittoughforinvestorstoinvestin
onlinepharmacies,makingithardtoretainemployees
andchallengingthetrustofconsumers.
Accordingtoindustryplayers,thee-Pharmacymodelis
wellcoveredundertheregulatorypurviewbytheITAct
2000 under the concept of intermediaries and the
pharmacy retail operations are covered under the
Drugs and Cosmetics Act. Currently the e-pharmacy
sectorisprovidingqualityandaffordablemedicinesto
around50lakhpatientspermonthacrossthecountry.
“We haveworked hard to build the online pharmacy
sectorfromsomethingthatdidn’texistfiveyearsback.
We have not only set global standards in creating
technology and Artificial Intelligence to digitize this
complexsectorbuthavealsogeneratedhugedatabases
of healthcare information and contributed analytics
with beneficial information about patients, chronic
diseasesufferers,andprovidedadeep-diveintohealth
problems faced by people from different cities and
states, ” said by Pradeep Dadha, Founder and CEO,
Netmeds”.
Ref:www.health.economictimes.indiatimes.com
“Delayinnotificationofrulesaffectinge-pharmaindustry''
Independent clinical trials conducted at the Banaras
Hindu University (BHU) revealed thatayurvedic drug
BGR-34 has therapeutic efficacy for treating newly
diagnosed type-2 diabetes, AYUSH Minister Shripad
Naik informed.The diabetic population in country is
close to hitting an alarmingmark of 69.9million by
2025,whichdenotesthatinstancesofthediseaseinthe
countryisexpectedtowitnessanincreaseof266per
cent,Naiksaidinawrittenreply.
TakeactionagainstthosesellingprescriptiondrugsOTC:HCtoCentre,Delhigovt.
TheDelhiHighCourtdirectedtheCentreandtheAAP
government to take action against those found to be
selling prescription drugs over-the-counter (OTC)
without a doctor's authorization. The Drugs and
CosmeticsAct,1940andRule65ofDrugsandCosmetic
Rules1945 list themanufactureandsaleofalldrugs
whichcannotbepurchasedwithouttheprescriptionof
aqualifieddoctor.
Thepetitionhadallegedthatchemistsdealinginretail
saleofmedicinesaresellingantibioticsandmedicines
mentioned in Schedule H and H1 of The Drugs and
Cosmetics Act, 1940, without the prescription and
supervisionofaregisteredpharmacist.
Ref:www.health.economictimes.indiatimes.com
About 10% of bone implants failures due to post-surgicalbacterial infections.Toovercomethishurdle,oftenheavydosageofmedicinesareinjectedorgiven
orally.AteamofresearchersfromIndiaandtheUShas
nowcomeupwithamethodtolocalisethedrugdeliverytosurgerysite.
This has been achieved by modifying the surface ofmetallicimplantsbyloadingthemwithanantibacterial
drugwhichgetsreleasedgraduallyoveraperiodofone
week at the implant site to prevent infections. “Oursurface-modifiedimplantaddresseslocalisedandlongterm drug release for areas that are prone to post-surgical infection that often arise during a joint
replacementprocedure.Themodifiedimplantsurface
servesforbothdrugdeliveryandboneintegration,”saidDr Debrupa Lahiri, lead researcher at the IndianInstitute of Technology, Roorkee”, while speaking to
IndiaScienceWire.
The medicine was embedded into a micro-layer ofhydroxyapatite which is a biocompatible porousmaterialwithabone-likemineral compositionand isused in ceramic implants. The pores anchored drugwhilethestructurefacilitatedthebridgingofboneandimplant.
By using the plasma spray technique, a 200-micronthicklayerofhydroxyapatitewascoatedonatitaniummetalalloysheet.Acommonlyuseddrug,gentamicin,was mixed with a bio-degradable polymer called
Drug-coatedboneimplantsmayhelptacklepost-surgeryinfections
Pharma NewsBharatBiotechlaunchesnewvariantofrotavirusvaccine,Rotavac5D
TrialsfoundayurvedicdrugBGR-34hastherapeuticefficacyonnewlydiagnosedtype-2diabetes:Govt
TheCouncilofScientificandIndustrialResearch(CSIR),
through its constituent laboratories - CSIR-Central
Institute of Medicinal and Aromatic Plants (CSIR-
CIMAP)andCSIR-NationalBotanicalResearchInstitute
(CSIR-NBRI)bothinLucknow,developedscientifically
validatedherbalproductNBRMAP-DBasanti-diabetic
formulation,theministersaid.Theproductknow-how
waslicensedtoM/sAIMILPharmaLtd,Delhi,whoare
manufacturingandmarketingitasBGR-34,acrossthe
country,hesaid.
Ref:www.health.economictimes.indiatimes.com
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER13 14
The“WHOstatusreportonprisonhealthintheWHO
EuropeanRegion”presentsananalysisofdatacollectedon the health status of people in prison and prisonhealthsystemsof39countriesintheRegion.TheWHOsurvey collected data from Member States between
2016and2017toenablemonitoringandsurveillanceof
healthinprisons.
Thereportrevealsthatthegeneralstateofmonitoringandsurveillancesystemsforhealthinprisonsispoor.An estimated 6million people are incarcerated each
year in theRegion.After release, ratesof reoffending
andreturningtoprisonarehigh.Thereportpointsoutthat this cycle between prison and community often
leadstodisjointedandineffectivehealthcareoutsideof
prison.Duringtheearlydaysofaperson’sreleasetherisk of suicide, self-harm and drug overdose isincreased.Thismeansthatcontinuityofcareduringthistransitioniscritical.Gapsincareduringthisperiodhave
significantnegativepublichealthimplicationsandcan
constrain a country’s ability to address inequalities.Prisons and other places of detention have anopportunity to deliver preventive and risk-reductioninterventions and treatments to a population that
previouslymay have lacked or had limited access to
healthcareandahealthylifestyle.
Ref:www.pharmatutor.org
NewWHOreport:Ignoringthehealthofpeopleinprisonsnowcomesatahighcostforsocietylater
Indian Pharmaceutical Association (IPA) stronglyopposed the proposed amendment in Schedule K ofDrugs&Cosmetics(D&C)Rulesbyhealthministry.IPAis the largest association of Pharmacists in India &workingnotonlyforupliftingthepharmacyprofessionbut also to ascertain that patients receives qualitypharmaceuticalcare.
Recently Health Ministry had made amendment inScheduleKofD&Crules1945 inwhichdrugscanbesuppliedbyHealthFunctionariesincludingCommunityHealthOfficers,Nurses,AuxiliaryNurseMidwivesandLady Health Visitors attached to Primary HealthCenters/ Sub-Centers/ Health &Wellness Centers inrural andurban areas, CommunityHealthVolunteerssuch as Accredited Social Health Activists (ASHAs)under the National Health Mission and AnganwadiWorkers.
Mr.BhupendraKumarSecretaryGeneral,IPAsaidinanotification,"AccordingtoSection42ofPharmacyAct,1948, “Nopersonother thana registeredpharmacistshallcompound,prepare,mixordispenseanymedicineontheprescriptionofamedicalpractitioner.Whoevercontravenes the provisions shall be punishable withimprisonmentforatermwhichmayextendtosixmonth
orwithfineorwithboth.
Rule 123 of Drugs and Cosmetic Act exempt ONLYDRUGSSPECIFIEDINSCHEDULEKfromtheprovisionsofChapterIVoftheActandtheRulesmadethereunder.NO EXEMPTION given to any person other than aRegistered Pharmacist. Therefore, serial number 23underthecolumn“ClassofDrugs”undertheDrugsandCosmeticRules,1945isILLEGALandUNETHICALandneedtobedeletedcompletely."
Asper IPA,ScheduleKexemptonly theprovisionsofChapter IV of the Act and Rules thereunder, whichrequiredthemtobecoveredbyasalelicense.ItmeansonlyrequirementofobtainingasalelicenseisexemptedandrequirementofaRegisteredPharmacistisnowhereexempted. These amendments will not only violateDrugsandCosmeticAct,PharmacyActbutalsoArticle16,Article21andArticle47ofIndianConstitution.
VariousPharmaceutical associationsandpharmacistsopposedthisdecisionbecauseitwillnotonlysupersedethequalificationbyunqualifiedbutatthesametimewillmakelakhsofQualifiedRegisteredPharmacistsjoblessandhomelessinourowncountry.Ref:www.pharmatutor.org
IPAopposedamendmentinScheduleKofD&CRulesbyhealthministry
A just-released study by UT Health San Antonio andcollaboratinginstitutionsshowsage-relateddecreasesin blood flow to the brain and memory loss can bemodified with the drug rapamycin. In the study,researchers began rats on a diet including low-doserapamycin at 19months old (past middle age in ratyears). Rapamycin treatment in daily food continueduntil the mice were of advanced age—34 monthsold—almost double the age they were when theystartedtreatment.“Essentiallythisisanoldastheseratscan get. These animalswere very old but still, blood
circulationinthebrainwasexactlythesameaswhenthey started treatment,” said study senior authorVeronica Galvan, Ph.D., professor of cellular andintegrativephysiologyatUTHealthSanAntonio.
Untreatedagedratsinthestudymirrored,ingeneral,whatisobservedinolderadultswithregardstolossofbloodflowtothebrainandlossofmemory.“Incontrast,theoldratstreatedwithrapamycinlookedlikemiddle-agedratsinourstudy,”Dr.VanSkikesaid.Ref:www.pharmatutor.org
Rapamycinpreventsage-relatedbrainvasculardeterioration:Study
Indianresearchershaveidentifiedaproteinpathwayinan antibiotic-resistant bacteria strain called
Staphylococcus aureus (S. aureus) and also a new
moleculethatcantargetthispathway.Thismayhelptodevelopnewantibacterialdrugsinfuture.
Thenewmolecule-indolebasedquinoneepoxide(IND-
QE) - has been developed by scientists at the CSIR-
CentralDrugResearchInstitute(CDRI),Lucknowand
Indian Institute of Science Education and Research(IISER),Pune.Thismoleculecancrossthebacterialcellbarriers and disrupt functioning of MarR proteins
which are essential for the growth and survival of S.
aureus bacteria. Development of new antibiotics is a
major challenge, given the increasing bacterialresistance.Newantibioticsareusuallybasedonnaturalproductssuchasfungalorplantextractsorfromlarge
chemical libraries, which are a series of stored
chemicals. The researchers have selected a relatively
less-exploredprocessofantibioticdiscovery.
"Newantibioticsareusuallybasedonnaturalproductssuchasfungalorplantextractsorfromlargechemicallibrarieswhichareaseriesofstoredchemicals."
“Anovelsetofproteins(MarR)hasbeenidentifiedinS.aureusthatcouldbetargetedbyantibacterialagentsinorder to tackle severe infections. This has led to theinhibitionofextremelydrug-resistantVRSAbacteria”,said Dr. Harinath Chakrapani, a researcher at IISER,Pune.
S. aureus is commonly found on human skin andmucosal membranes. if allowed to enter thebloodstream or internal tissues, it can cause seriousinfections such as endocarditis (heart valve infectionleadingtoheartfailureorstroke),osteomyelitis(boneinfection)orpneumoniaetc. It isaninfectioncausingbacteria which can readily become resistant toantibiotics. The MarR protein found in bacteria isessential for its growth and survival which can bedestroyedbyIND-QEmolecule.Ref:www.pharmatutor.org
AntibioticdrugtargetidentifiedbyIndianresearchers
chitosan.Thenthedrug-loadedpolymersolutionwasimpregnatedintotheporesofhydroxyapatitecoating,undervacuum.Attheimplantsite,chitosandegradesnaturally under the influence of body fluids, thereby
releasingtheloadeddrug.Thedrugformsaprotectivelayertoarrestbacterialgrowth.
Ref:www.pharmatutor.org
CabinetapprovesMoUbetweenIndiaandBrazilonCooperationinthefieldofHealth&MedicineTheUnionCabinetchairedbythePrimeMinisterShriNarendra Modi has approved the Memorandum of
Understanding(MoU)betweenIndiaandBrazilinthefieldofHealthandMedicine.TheMoU isexpected to
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER13 14
The“WHOstatusreportonprisonhealthintheWHO
EuropeanRegion”presentsananalysisofdatacollectedon the health status of people in prison and prisonhealthsystemsof39countriesintheRegion.TheWHOsurvey collected data from Member States between
2016and2017toenablemonitoringandsurveillanceof
healthinprisons.
Thereportrevealsthatthegeneralstateofmonitoringandsurveillancesystemsforhealthinprisonsispoor.An estimated 6million people are incarcerated each
year in theRegion.After release, ratesof reoffending
andreturningtoprisonarehigh.Thereportpointsoutthat this cycle between prison and community often
leadstodisjointedandineffectivehealthcareoutsideof
prison.Duringtheearlydaysofaperson’sreleasetherisk of suicide, self-harm and drug overdose isincreased.Thismeansthatcontinuityofcareduringthistransitioniscritical.Gapsincareduringthisperiodhave
significantnegativepublichealthimplicationsandcan
constrain a country’s ability to address inequalities.Prisons and other places of detention have anopportunity to deliver preventive and risk-reductioninterventions and treatments to a population that
previouslymay have lacked or had limited access to
healthcareandahealthylifestyle.
Ref:www.pharmatutor.org
NewWHOreport:Ignoringthehealthofpeopleinprisonsnowcomesatahighcostforsocietylater
Indian Pharmaceutical Association (IPA) stronglyopposed the proposed amendment in Schedule K ofDrugs&Cosmetics(D&C)Rulesbyhealthministry.IPAis the largest association of Pharmacists in India &workingnotonlyforupliftingthepharmacyprofessionbut also to ascertain that patients receives qualitypharmaceuticalcare.
Recently Health Ministry had made amendment inScheduleKofD&Crules1945 inwhichdrugscanbesuppliedbyHealthFunctionariesincludingCommunityHealthOfficers,Nurses,AuxiliaryNurseMidwivesandLady Health Visitors attached to Primary HealthCenters/ Sub-Centers/ Health &Wellness Centers inrural andurban areas, CommunityHealthVolunteerssuch as Accredited Social Health Activists (ASHAs)under the National Health Mission and AnganwadiWorkers.
Mr.BhupendraKumarSecretaryGeneral,IPAsaidinanotification,"AccordingtoSection42ofPharmacyAct,1948, “Nopersonother thana registeredpharmacistshallcompound,prepare,mixordispenseanymedicineontheprescriptionofamedicalpractitioner.Whoevercontravenes the provisions shall be punishable withimprisonmentforatermwhichmayextendtosixmonth
orwithfineorwithboth.
Rule 123 of Drugs and Cosmetic Act exempt ONLYDRUGSSPECIFIEDINSCHEDULEKfromtheprovisionsofChapterIVoftheActandtheRulesmadethereunder.NO EXEMPTION given to any person other than aRegistered Pharmacist. Therefore, serial number 23underthecolumn“ClassofDrugs”undertheDrugsandCosmeticRules,1945isILLEGALandUNETHICALandneedtobedeletedcompletely."
Asper IPA,ScheduleKexemptonly theprovisionsofChapter IV of the Act and Rules thereunder, whichrequiredthemtobecoveredbyasalelicense.ItmeansonlyrequirementofobtainingasalelicenseisexemptedandrequirementofaRegisteredPharmacistisnowhereexempted. These amendments will not only violateDrugsandCosmeticAct,PharmacyActbutalsoArticle16,Article21andArticle47ofIndianConstitution.
VariousPharmaceutical associationsandpharmacistsopposedthisdecisionbecauseitwillnotonlysupersedethequalificationbyunqualifiedbutatthesametimewillmakelakhsofQualifiedRegisteredPharmacistsjoblessandhomelessinourowncountry.Ref:www.pharmatutor.org
IPAopposedamendmentinScheduleKofD&CRulesbyhealthministry
A just-released study by UT Health San Antonio andcollaboratinginstitutionsshowsage-relateddecreasesin blood flow to the brain and memory loss can bemodified with the drug rapamycin. In the study,researchers began rats on a diet including low-doserapamycin at 19months old (past middle age in ratyears). Rapamycin treatment in daily food continueduntil the mice were of advanced age—34 monthsold—almost double the age they were when theystartedtreatment.“Essentiallythisisanoldastheseratscan get. These animalswere very old but still, blood
circulationinthebrainwasexactlythesameaswhenthey started treatment,” said study senior authorVeronica Galvan, Ph.D., professor of cellular andintegrativephysiologyatUTHealthSanAntonio.
Untreatedagedratsinthestudymirrored,ingeneral,whatisobservedinolderadultswithregardstolossofbloodflowtothebrainandlossofmemory.“Incontrast,theoldratstreatedwithrapamycinlookedlikemiddle-agedratsinourstudy,”Dr.VanSkikesaid.Ref:www.pharmatutor.org
Rapamycinpreventsage-relatedbrainvasculardeterioration:Study
Indianresearchershaveidentifiedaproteinpathwayinan antibiotic-resistant bacteria strain called
Staphylococcus aureus (S. aureus) and also a new
moleculethatcantargetthispathway.Thismayhelptodevelopnewantibacterialdrugsinfuture.
Thenewmolecule-indolebasedquinoneepoxide(IND-
QE) - has been developed by scientists at the CSIR-
CentralDrugResearchInstitute(CDRI),Lucknowand
Indian Institute of Science Education and Research(IISER),Pune.Thismoleculecancrossthebacterialcellbarriers and disrupt functioning of MarR proteins
which are essential for the growth and survival of S.
aureus bacteria. Development of new antibiotics is a
major challenge, given the increasing bacterialresistance.Newantibioticsareusuallybasedonnaturalproductssuchasfungalorplantextractsorfromlarge
chemical libraries, which are a series of stored
chemicals. The researchers have selected a relatively
less-exploredprocessofantibioticdiscovery.
"Newantibioticsareusuallybasedonnaturalproductssuchasfungalorplantextractsorfromlargechemicallibrarieswhichareaseriesofstoredchemicals."
“Anovelsetofproteins(MarR)hasbeenidentifiedinS.aureusthatcouldbetargetedbyantibacterialagentsinorder to tackle severe infections. This has led to theinhibitionofextremelydrug-resistantVRSAbacteria”,said Dr. Harinath Chakrapani, a researcher at IISER,Pune.
S. aureus is commonly found on human skin andmucosal membranes. if allowed to enter thebloodstream or internal tissues, it can cause seriousinfections such as endocarditis (heart valve infectionleadingtoheartfailureorstroke),osteomyelitis(boneinfection)orpneumoniaetc. It isaninfectioncausingbacteria which can readily become resistant toantibiotics. The MarR protein found in bacteria isessential for its growth and survival which can bedestroyedbyIND-QEmolecule.Ref:www.pharmatutor.org
AntibioticdrugtargetidentifiedbyIndianresearchers
chitosan.Thenthedrug-loadedpolymersolutionwasimpregnatedintotheporesofhydroxyapatitecoating,undervacuum.Attheimplantsite,chitosandegradesnaturally under the influence of body fluids, thereby
releasingtheloadeddrug.Thedrugformsaprotectivelayertoarrestbacterialgrowth.
Ref:www.pharmatutor.org
CabinetapprovesMoUbetweenIndiaandBrazilonCooperationinthefieldofHealth&MedicineTheUnionCabinetchairedbythePrimeMinisterShriNarendra Modi has approved the Memorandum of
Understanding(MoU)betweenIndiaandBrazilinthefieldofHealthandMedicine.TheMoU isexpected to
Drug Therapy Bulletin
15 16
Researchers at AIIMS, Bhopal, are working ondevelopingayurvedic alternatives for antibioticsusedfor treating bacterial and fungal infections with theglobal medical fraternity pitching for rational use ofdrugs amid rising cases of antimicrobial resistance(AMR).Preliminaryresultsoftheongoingresearchhaveindicated that herbal drug Fifatrol can be a suitablealternativetoallopathicantibioticswithoutcausinganysideeffects,aseniordoctorattheinstitutesaid.
Theayurvedicdrug,enrichedwithimmune-enhancingherbs, hasbeen found tobe effective in curingmajorbacterialinfectionssuchasstaphylococcusspeciesthatcauses fever,cough,andcoldandskindiseasesamongothers.Ifnottreatedintimeitcanbefatalforpeople
withweakimmunesystem,hesaid.
TheresearchalsoindicatesthatthedrugissuitableincontrollingspreadofinfectiousdiseasescausedduetoE. coli bacteria and others. Giving details about theresearch, the doctor said, "Ayurvedic medicinesgenerally increase immunity, but Fifatrol so far hasshown very promising results against combatingbacteriatoo.
"Detailedresearchtoarriveatthefinalresultison,"headded. Manufactured by AIMIL Pharmaceuticals,Fifatrolisananti-microbialsolutionpreparedfrom13key herbs including sudarshan vati, sanjeevani vati,godantibhasma,tribhuvankirtirasandmrityunjayras,tulsi,kutki,chirayata,mothaandgiloy.
Commentingonthedevelopment,anayurvedicexpertsaid medicinal plants have been widely used inmanagementofinfectiousdiseasesandbynowmanyoftheancientremedieshaveproventheirvaluethroughscientificmethodologies.
"This research is on itsway toprove that there is analternative to antibiotics in Ayurveda. Therefore, thegovernmentshouldexplorethisdirectiontoo,"hesaid.
Ref:www.health.economictimes.indiatimes.com
DCGI asked manufacturers of Ranitidine API &formulations to verify their products and takeappropriate measures to ensure patient safety afternewsofranitidinecontaminationcameinpicture.
InthebeginningofSeptembermonth,USFDAreportedthat some ranitidine medicines including someproducts commonly known as the brand-name drugZantac, contain a nitrosamine impurity called N-nitrosodimethylamine(NDMA)atlowlevels.NDMAisclassifiedasaprobablehumancarcinogen(asubstancethat could cause cancer) based on results fromlaboratory tests. NDMA is a known environmentalcontaminantand found inwaterand foods, includingmeats,dairyproductsandvegetables.
Ranitidine is an over-the-counter (OTC) andprescription drug. Ranitidine is an H2 (histamine-2)
blocker,whichdecreasestheamountofacidcreatedbythestomach.
Dr.V.G.SomaniDrugsControllerGeneral(India)saidinanotificationtoallzonal/subzonalofficesofCDSCOthat, "It has been reported that some ranitidinemedicines contain a nitrosamine impurity called N-nitrosodimethylamine(NDMA)atlowlevels.TheNDMAhas been classified by International Agency forResearchonCancer(IARC)asprobablycarcinogenictohumans."
Hefurthersaid,"inviewofabove,theywererequestedtocommunicatetothemanufacturersofRanitidineAPI&formulationsundertheirjurisdictiontoverifytheirproducts and take appropriate measures to ensurepatientsafety."Ref:www.pharmatutor.org
DCGItookmeasuresonRanitidinecontaminationtoensurepatientsafety
Researchershavefoundthathighlevelsoffructoseinthe diet which inhibits the liver's ability to properlymetabolizefat.Thiseffectisspecifictofructose.Indeed,equally high levels of glucose in the diet actuallyimprove the fat-burning function of the liver. Thisexplainswhyhighdietaryfructosehasmorenegativehealth impacts than glucose does, even though theyhavethesamecaloriccontent.
Fructosemakestheliveraccumulatefat.Itactsalmostlikeaddingmorefattothediet.Thiscontraststheeffectofaddingmoreglucosetothediet,whichpromotestheliver'sabilitytoburnfatandthereforeactuallymakesfor a healthier metabolism. "The most important
takeawayofthisstudyisthathighfructoseinthedietisbad," says Dr. Kahn. "It's not bad because it's morecalories,butbecauseithaseffectsonlivermetabolismto make it worse at burning fat. As a result, addingfructosetothedietmakestheliverstorefatter,andthisisbadfortheliverandbadforwholebodymetabolism.""Surprisingly,whenyouswitchthesugar indiet fromfructose to glucose, even though they'reboth equallycaloric,theglucosedoesn'thavethateffect.
Researchers also monitored the activity of a criticalenzymeforfat-burningknownasCPT1a.InthecaseofCPT1a, higher the levels better they indicate thatmitochondria are performing their fat-burning jobs
High-fructoseandhigh-fatdietdamageslivermitochondria
WhyIndianeedsasuperdrugregulatorlikeUSFDA
sign in November, 2019. The bilateral MoU betweenIndiaandBrazilwill encouragecooperationbetweenthetwocountriesthroughjointinitiatives,technologydevelopmentinthehealthsectoranddevelopmentofresearch in the health sector. It will facilitate in
improvingthepublichealthstatusofpeopleofboththecountries.ItwillstrengthenbilateraltiesbetweenIndiaandBrazil.Ref:www.pharmatutor.org
Thegovernment’sthinktank,NitiAayog,hasproposed
setting up a clone of the US FDA in India to be the
umbrellabodyofallotherregulatorsinIndia,suchastheCentral Drugs Standard Control Organization
(CDSCO), theFoodSafetyandStandardsAuthorityof
India (FSSAI) and the proposed Medical Device
Authority(MDA).
Researchersdevelopingayurvedicalternativesfortreatingbacterial,fungalinfections
J&Jrecalls33,000bottlesofbabypowderasFDAfindsasbestosinsampleJohnson& Johnsonsaid it is recallingaround33,000bottlesofbabypowderintheUnitedStatesafterU.S.health regulators found traceamountsofasbestos in
samplestakenfromabottlepurchasedonline.
Themovemarksthefirsttimethecompanyhasrecalledits iconic baby powder for possible asbestos
contaminationandthe first timeU.S.regulatorshaveannounced a finding of asbestos in the product.Asbestosisaknowncarcinogenthathasbeenlinkedtodeadlymesothelioma.
J&JsaidontheconferencecallthatitreceivedareportfromtheFDAonOct.17alertingthecompanyabouttheasbestosfinding.Itsaidithasstartedaninvestigationandisreviewingmanufacturingrecordsandcollectingdataonthedistributionofthelottodeterminewheretheproductwasshipped.Ref:www.health.economictimes.indiatimes.com
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
15 16
Researchers at AIIMS, Bhopal, are working ondevelopingayurvedic alternatives for antibioticsusedfor treating bacterial and fungal infections with theglobal medical fraternity pitching for rational use ofdrugs amid rising cases of antimicrobial resistance(AMR).Preliminaryresultsoftheongoingresearchhaveindicated that herbal drug Fifatrol can be a suitablealternativetoallopathicantibioticswithoutcausinganysideeffects,aseniordoctorattheinstitutesaid.
Theayurvedicdrug,enrichedwithimmune-enhancingherbs, hasbeen found tobe effective in curingmajorbacterialinfectionssuchasstaphylococcusspeciesthatcauses fever,cough,andcoldandskindiseasesamongothers.Ifnottreatedintimeitcanbefatalforpeople
withweakimmunesystem,hesaid.
TheresearchalsoindicatesthatthedrugissuitableincontrollingspreadofinfectiousdiseasescausedduetoE. coli bacteria and others. Giving details about theresearch, the doctor said, "Ayurvedic medicinesgenerally increase immunity, but Fifatrol so far hasshown very promising results against combatingbacteriatoo.
"Detailedresearchtoarriveatthefinalresultison,"headded. Manufactured by AIMIL Pharmaceuticals,Fifatrolisananti-microbialsolutionpreparedfrom13key herbs including sudarshan vati, sanjeevani vati,godantibhasma,tribhuvankirtirasandmrityunjayras,tulsi,kutki,chirayata,mothaandgiloy.
Commentingonthedevelopment,anayurvedicexpertsaid medicinal plants have been widely used inmanagementofinfectiousdiseasesandbynowmanyoftheancientremedieshaveproventheirvaluethroughscientificmethodologies.
"This research is on itsway toprove that there is analternative to antibiotics in Ayurveda. Therefore, thegovernmentshouldexplorethisdirectiontoo,"hesaid.
Ref:www.health.economictimes.indiatimes.com
DCGI asked manufacturers of Ranitidine API &formulations to verify their products and takeappropriate measures to ensure patient safety afternewsofranitidinecontaminationcameinpicture.
InthebeginningofSeptembermonth,USFDAreportedthat some ranitidine medicines including someproducts commonly known as the brand-name drugZantac, contain a nitrosamine impurity called N-nitrosodimethylamine(NDMA)atlowlevels.NDMAisclassifiedasaprobablehumancarcinogen(asubstancethat could cause cancer) based on results fromlaboratory tests. NDMA is a known environmentalcontaminantand found inwaterand foods, includingmeats,dairyproductsandvegetables.
Ranitidine is an over-the-counter (OTC) andprescription drug. Ranitidine is an H2 (histamine-2)
blocker,whichdecreasestheamountofacidcreatedbythestomach.
Dr.V.G.SomaniDrugsControllerGeneral(India)saidinanotificationtoallzonal/subzonalofficesofCDSCOthat, "It has been reported that some ranitidinemedicines contain a nitrosamine impurity called N-nitrosodimethylamine(NDMA)atlowlevels.TheNDMAhas been classified by International Agency forResearchonCancer(IARC)asprobablycarcinogenictohumans."
Hefurthersaid,"inviewofabove,theywererequestedtocommunicatetothemanufacturersofRanitidineAPI&formulationsundertheirjurisdictiontoverifytheirproducts and take appropriate measures to ensurepatientsafety."Ref:www.pharmatutor.org
DCGItookmeasuresonRanitidinecontaminationtoensurepatientsafety
Researchershavefoundthathighlevelsoffructoseinthe diet which inhibits the liver's ability to properlymetabolizefat.Thiseffectisspecifictofructose.Indeed,equally high levels of glucose in the diet actuallyimprove the fat-burning function of the liver. Thisexplainswhyhighdietaryfructosehasmorenegativehealth impacts than glucose does, even though theyhavethesamecaloriccontent.
Fructosemakestheliveraccumulatefat.Itactsalmostlikeaddingmorefattothediet.Thiscontraststheeffectofaddingmoreglucosetothediet,whichpromotestheliver'sabilitytoburnfatandthereforeactuallymakesfor a healthier metabolism. "The most important
takeawayofthisstudyisthathighfructoseinthedietisbad," says Dr. Kahn. "It's not bad because it's morecalories,butbecauseithaseffectsonlivermetabolismto make it worse at burning fat. As a result, addingfructosetothedietmakestheliverstorefatter,andthisisbadfortheliverandbadforwholebodymetabolism.""Surprisingly,whenyouswitchthesugar indiet fromfructose to glucose, even though they'reboth equallycaloric,theglucosedoesn'thavethateffect.
Researchers also monitored the activity of a criticalenzymeforfat-burningknownasCPT1a.InthecaseofCPT1a, higher the levels better they indicate thatmitochondria are performing their fat-burning jobs
High-fructoseandhigh-fatdietdamageslivermitochondria
WhyIndianeedsasuperdrugregulatorlikeUSFDA
sign in November, 2019. The bilateral MoU betweenIndiaandBrazilwill encouragecooperationbetweenthetwocountriesthroughjointinitiatives,technologydevelopmentinthehealthsectoranddevelopmentofresearch in the health sector. It will facilitate in
improvingthepublichealthstatusofpeopleofboththecountries.ItwillstrengthenbilateraltiesbetweenIndiaandBrazil.Ref:www.pharmatutor.org
Thegovernment’sthinktank,NitiAayog,hasproposed
setting up a clone of the US FDA in India to be the
umbrellabodyofallotherregulatorsinIndia,suchastheCentral Drugs Standard Control Organization
(CDSCO), theFoodSafetyandStandardsAuthorityof
India (FSSAI) and the proposed Medical Device
Authority(MDA).
Researchersdevelopingayurvedicalternativesfortreatingbacterial,fungalinfections
J&Jrecalls33,000bottlesofbabypowderasFDAfindsasbestosinsampleJohnson& Johnsonsaid it is recallingaround33,000bottlesofbabypowderintheUnitedStatesafterU.S.health regulators found traceamountsofasbestos in
samplestakenfromabottlepurchasedonline.
Themovemarksthefirsttimethecompanyhasrecalledits iconic baby powder for possible asbestos
contaminationandthe first timeU.S.regulatorshaveannounced a finding of asbestos in the product.Asbestosisaknowncarcinogenthathasbeenlinkedtodeadlymesothelioma.
J&JsaidontheconferencecallthatitreceivedareportfromtheFDAonOct.17alertingthecompanyabouttheasbestosfinding.Itsaidithasstartedaninvestigationandisreviewingmanufacturingrecordsandcollectingdataonthedistributionofthelottodeterminewheretheproductwasshipped.Ref:www.health.economictimes.indiatimes.com
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
17 18
PharmacovigilanceProgrammeofIndia(PvPI)urgesallstakeholderstoreportalltheadverseeventsassociatedwith nutraceuticals/ health supplements and foodsupplements.
Nutraceuticals arede f ined as any substance that arefoodorpartsoffooda n d p r o v i d e s medical or healthbenefits, including
the prevention and treatment of disease. The use ofnutraceuticals/healthsupplements/ foods forspecialdietarypurposesisnowwidespreadamongtheurbanaswellasruralpopulaceinIndia.IncidenceofADRsdueto use of nutraceuticals in the past have raised the
concerns for regularlymonitoring the safety of theseproducts.
IndianCouncilofMedicalResearch-NationalInstituteofNutrition (ICMR-NIN), Hyderabad is one of the PvPIcollaborating centers for monitoring the safety ofnutraceuticalsbuttheyarenotreceivingenoughADRsdue to lack of awareness amongst differentstakeholders.
PvPI reported in an email to PharmaTutor that,“Currently, PvPI receives a very limited number ofadverse drugs reactions (ADRs) related to the use ofnutraceuticals/health supplements and foodsupplements;henceitisimperativetoposteracultureofreportingadverseeventsassociatedwiththeuseofsuchproductstoensurepatientsafety.”
PvPIurgesallstakeholderstoreportadverseeventsassociatedwithnutraceuticals
Peoplewithlowironlevelsinthebloodaremorelikelytospreadthedeadlydenguevirus,accordingtoastudywhichsuggests thatpatients taking ironsupplementsduring the illness may limit the transmission of thediseasebymosquitoes.Denguefever,adiseasespread
mainlybytheAedesegymosquitocausesfever,rashesandterribleachesandcanalsoleadtoshockanddeath.
Accordingtothestudy,publishedinthejournalNatureMicrobiology,denguepatientswithhigherlevelsofiron
intheblood,hadlesserchancesofinfectingmosquitoesthatdrawtheirbloodwiththevirus.TheresearchersledbyPenghuaWangofUniversityofConnecticutintheUS,wantedtoseeifthequalityofadenguepatient'sbloodhad an impact on the spread of dengue virus. Theycollected blood from healthy human volunteers andaddeddenguevirustoeachsample.Whentheyfedtheblood to mosquitoes, and checked how many of themosquitoeswereinfectedfromeachbatch,theyfoundlotsofvariations.Wangandhiscolleaguesfoundthatthevariationwaslinkedcloselywiththelevelofironinthe blood. "The more iron in the blood, the fewermosquitoeswereinfected,"saidWang.
Theresearchersalsofoundsimilarresultswhenusingamousemodel.Theyfoundthatanaemicmiceweremorelikely to transmit thevirus tomosquitoes that fedontheirblood.Theresearchersfoundthatthegutcellsofmosquitoestakeupironfromtheirbloodfeed,anduseitto produce reactive oxygen, which kills the denguevirus.
Anaemicpeoplemorelikelytotransmitdengue:Study
HealthMinisterHarshVardhanlaunchedthe'transfatfree' logo, which can be voluntarily used by foodbusiness operators in their outlets and also on foodproducts.Thelogowaslaunchedatthe8thInternationalChefsConferenceorganizedinAeroCity,NewDelhi.
"India is committed to eliminating it from the foodsupplyandisprogressingtowardsitsobjectiveoftransfateliminationby2022;ayearaheadoftheglobaltargetbyWHO,"theministersaid.TheFSSAIiscommittedtoreducingtheindustriallyproducedtransfattyacidstolessthan2percentbytheyear2022inaphasedmannerandgeareduptogetfreedomfromtransfats.
Vardhanalsoreleasedaslogan'Chefs4TransFatFree',underwhichmorethan1,000chefsfromdifferentparts
ofthecountrytookapledgetousetransfatfreeoils/fatsintheirrecipesandworktowardsitseliminationfromdietsofIndianpopulaceatlarge.
Industrial trans fatsaremadebyaddinghydrogen to
liquidvegetableoils tomake themmore solidand to
increase the shelf life of foods. Trans fats are largely
present in partially hydrogenated vegetable fats/oils,
vanaspati,margarineandbakeryshortenings,andcan
befoundinbakedandfriedfoods.
Globally,industrialtransfatintakeleadstomorethan
5400,000 deaths fromcardiovascular disease every
yearandinIndia,thefigurereachesto60,000number.
Ref:www.health.economictimes.indiatimes.com
Healthministerlaunchestrans-fatfreelogo
correctly.However,inthehigh-fatplusfructosediettheresearchersfoundthatlevelsofCPT1aarelowandtheiractivity was very low, meaning mitochondria can'tfunction properly. This led the researchers toinvestigate the mitochondria themselves. "Whenmitochondria are healthy, they have this nice ovoidshapeandcrosshatching,"saysDr.Kahn."Inthehigh-fatplusfructosegroup,thesemitochondriaarefragmentedandthey'renotabletoburnfataswellasthehealthy
mitochondria.
Dr.Kahnandcolleaguesplanbelievethatdevelopinga
drugwhichblocksfructosemetabolismcouldprevent
thenegativeactionsoffructoseandhelppreventfatty
liverdiseaseanditsadversemetabolicconsequences,
including impaired glucose tolerance and type 1
diabetes.Ref:www.sciencedaily.com
Therefore, PvPI urges all stakeholders includingClinicians,NursesandPharmacistsotheralliedhealthworkersandalsothecommonpublictoreportallthe
adverse events associatedwith nutraceuticals/healthsupplementsandfoodsupplements.Ref:www.pharmatutor.org
Atatimewhenthereisnorulesorregulationsforonlinesellingofmedicineshavebeenframedandseveralcasesarependinginvariouscourts,e-pharmacieshavestartedworkingillegally.GujaratStatePharmacyCouncil(GSPC)hassuspendedtheregistrationsoftwopharmacistsforfiveyearsandimposedfine.FortheFirsttimeinIndiasuch strong action has been initiated againste-pharmacies for violating rule 8 & 9 of PharmacyPracticeRegulationAct. The action has been initiatedundertheprovisionsofrule36ofpharmacyact1948.
Mr. Montukumar Patel, president of GSPC said, "Wereceivedcomplaintsfromalertcitizens.WeforwardedthecomplaintstoFDCAandrequestedtotakeinstantactionagainstsuchillegalactivities.Wehavesuspendedregistration of two pharmacists -Meet Kapadiya andVasimPathanassociatedwithsuchillegale-pharmacies.
Council believes that such e-pharmacies will promptself-medications.ThiswillendangertheexistenceofJanaushadhi store for affordable medicines started byGovernment.TheCouncilhastakenseriousnoteofthecomplaintsandsentthemtoFDCAtotakeagainstactiononillegalpractisingepharmacycompaniesandsupplychannelpartners.Inanotherstrongaction,wehavealsoidentified several other pharmacists involved in dualjobs & other illegal activities." Council is alsoconsidering to organize special hearings forpharmacistsinvolvedinsuchillegalactivities.Sincelast3months,registrationsofmorethan138pharmacistshavebeensuspended.ForthefirsttimeinIndiaandinthehistoryofthecouncil,suchabiglevelactionshavebeeninitiated.Ref:www.health.economictimes.indiatimes.com
StrictactionagainstonlinesellingofmedicinesinGujarat:2pharmacistssuspended
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
17 18
PharmacovigilanceProgrammeofIndia(PvPI)urgesallstakeholderstoreportalltheadverseeventsassociatedwith nutraceuticals/ health supplements and foodsupplements.
Nutraceuticals arede f ined as any substance that arefoodorpartsoffooda n d p r o v i d e s medical or healthbenefits, including
the prevention and treatment of disease. The use ofnutraceuticals/healthsupplements/ foods forspecialdietarypurposesisnowwidespreadamongtheurbanaswellasruralpopulaceinIndia.IncidenceofADRsdueto use of nutraceuticals in the past have raised the
concerns for regularlymonitoring the safety of theseproducts.
IndianCouncilofMedicalResearch-NationalInstituteofNutrition (ICMR-NIN), Hyderabad is one of the PvPIcollaborating centers for monitoring the safety ofnutraceuticalsbuttheyarenotreceivingenoughADRsdue to lack of awareness amongst differentstakeholders.
PvPI reported in an email to PharmaTutor that,“Currently, PvPI receives a very limited number ofadverse drugs reactions (ADRs) related to the use ofnutraceuticals/health supplements and foodsupplements;henceitisimperativetoposteracultureofreportingadverseeventsassociatedwiththeuseofsuchproductstoensurepatientsafety.”
PvPIurgesallstakeholderstoreportadverseeventsassociatedwithnutraceuticals
Peoplewithlowironlevelsinthebloodaremorelikelytospreadthedeadlydenguevirus,accordingtoastudywhichsuggests thatpatients taking ironsupplementsduring the illness may limit the transmission of thediseasebymosquitoes.Denguefever,adiseasespread
mainlybytheAedesegymosquitocausesfever,rashesandterribleachesandcanalsoleadtoshockanddeath.
Accordingtothestudy,publishedinthejournalNatureMicrobiology,denguepatientswithhigherlevelsofiron
intheblood,hadlesserchancesofinfectingmosquitoesthatdrawtheirbloodwiththevirus.TheresearchersledbyPenghuaWangofUniversityofConnecticutintheUS,wantedtoseeifthequalityofadenguepatient'sbloodhad an impact on the spread of dengue virus. Theycollected blood from healthy human volunteers andaddeddenguevirustoeachsample.Whentheyfedtheblood to mosquitoes, and checked how many of themosquitoeswereinfectedfromeachbatch,theyfoundlotsofvariations.Wangandhiscolleaguesfoundthatthevariationwaslinkedcloselywiththelevelofironinthe blood. "The more iron in the blood, the fewermosquitoeswereinfected,"saidWang.
Theresearchersalsofoundsimilarresultswhenusingamousemodel.Theyfoundthatanaemicmiceweremorelikely to transmit thevirus tomosquitoes that fedontheirblood.Theresearchersfoundthatthegutcellsofmosquitoestakeupironfromtheirbloodfeed,anduseitto produce reactive oxygen, which kills the denguevirus.
Anaemicpeoplemorelikelytotransmitdengue:Study
HealthMinisterHarshVardhanlaunchedthe'transfatfree' logo, which can be voluntarily used by foodbusiness operators in their outlets and also on foodproducts.Thelogowaslaunchedatthe8thInternationalChefsConferenceorganizedinAeroCity,NewDelhi.
"India is committed to eliminating it from the foodsupplyandisprogressingtowardsitsobjectiveoftransfateliminationby2022;ayearaheadoftheglobaltargetbyWHO,"theministersaid.TheFSSAIiscommittedtoreducingtheindustriallyproducedtransfattyacidstolessthan2percentbytheyear2022inaphasedmannerandgeareduptogetfreedomfromtransfats.
Vardhanalsoreleasedaslogan'Chefs4TransFatFree',underwhichmorethan1,000chefsfromdifferentparts
ofthecountrytookapledgetousetransfatfreeoils/fatsintheirrecipesandworktowardsitseliminationfromdietsofIndianpopulaceatlarge.
Industrial trans fatsaremadebyaddinghydrogen to
liquidvegetableoils tomake themmore solidand to
increase the shelf life of foods. Trans fats are largely
present in partially hydrogenated vegetable fats/oils,
vanaspati,margarineandbakeryshortenings,andcan
befoundinbakedandfriedfoods.
Globally,industrialtransfatintakeleadstomorethan
5400,000 deaths fromcardiovascular disease every
yearandinIndia,thefigurereachesto60,000number.
Ref:www.health.economictimes.indiatimes.com
Healthministerlaunchestrans-fatfreelogo
correctly.However,inthehigh-fatplusfructosediettheresearchersfoundthatlevelsofCPT1aarelowandtheiractivity was very low, meaning mitochondria can'tfunction properly. This led the researchers toinvestigate the mitochondria themselves. "Whenmitochondria are healthy, they have this nice ovoidshapeandcrosshatching,"saysDr.Kahn."Inthehigh-fatplusfructosegroup,thesemitochondriaarefragmentedandthey'renotabletoburnfataswellasthehealthy
mitochondria.
Dr.Kahnandcolleaguesplanbelievethatdevelopinga
drugwhichblocksfructosemetabolismcouldprevent
thenegativeactionsoffructoseandhelppreventfatty
liverdiseaseanditsadversemetabolicconsequences,
including impaired glucose tolerance and type 1
diabetes.Ref:www.sciencedaily.com
Therefore, PvPI urges all stakeholders includingClinicians,NursesandPharmacistsotheralliedhealthworkersandalsothecommonpublictoreportallthe
adverse events associatedwith nutraceuticals/healthsupplementsandfoodsupplements.Ref:www.pharmatutor.org
Atatimewhenthereisnorulesorregulationsforonlinesellingofmedicineshavebeenframedandseveralcasesarependinginvariouscourts,e-pharmacieshavestartedworkingillegally.GujaratStatePharmacyCouncil(GSPC)hassuspendedtheregistrationsoftwopharmacistsforfiveyearsandimposedfine.FortheFirsttimeinIndiasuch strong action has been initiated againste-pharmacies for violating rule 8 & 9 of PharmacyPracticeRegulationAct. The action has been initiatedundertheprovisionsofrule36ofpharmacyact1948.
Mr. Montukumar Patel, president of GSPC said, "Wereceivedcomplaintsfromalertcitizens.WeforwardedthecomplaintstoFDCAandrequestedtotakeinstantactionagainstsuchillegalactivities.Wehavesuspendedregistration of two pharmacists -Meet Kapadiya andVasimPathanassociatedwithsuchillegale-pharmacies.
Council believes that such e-pharmacies will promptself-medications.ThiswillendangertheexistenceofJanaushadhi store for affordable medicines started byGovernment.TheCouncilhastakenseriousnoteofthecomplaintsandsentthemtoFDCAtotakeagainstactiononillegalpractisingepharmacycompaniesandsupplychannelpartners.Inanotherstrongaction,wehavealsoidentified several other pharmacists involved in dualjobs & other illegal activities." Council is alsoconsidering to organize special hearings forpharmacistsinvolvedinsuchillegalactivities.Sincelast3months,registrationsofmorethan138pharmacistshavebeensuspended.ForthefirsttimeinIndiaandinthehistoryofthecouncil,suchabiglevelactionshavebeeninitiated.Ref:www.health.economictimes.indiatimes.com
StrictactionagainstonlinesellingofmedicinesinGujarat:2pharmacistssuspended
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
19 20
So why does India need a super regulator? Public Notice
Currently,eachoftheregulatorsconcernedwithproductscertifiedforhumanconsumption—medicines,cosmetics,
foodandmedicaldevices—operateindependentlyeventhoughtheheadsoftheCDSCOandtheFSSAIreporttoa
JointSecretaryintheMinistryofHealth.IntheUSFDAmodel,thereareeightsub-divisionstotackleregulatory
issuesintheirrespectivesectors—food,drugs.Cosmetics,medicaldevices,radiationemittingproducts,biologics
(whichincludesvaccinesandblood),veterinaryproductsandtobaccoproducts.IntheNitiAayogproposal,the
IndianFDAwillbeheadedbyanIASlevelofficeroftherankofadditionalsecretaryinthehealthministry.
Commonobjective
Indiaasyetdoesnothaveaseparateregulatorformedicaldevices—22ofwhicharecategorizedasdrugsandhave
DCGIoversightwhiletherestaresoldwithoutanystandardsgoverningthem.Infact,forimporteddevices,the
CDSCOreliesonUSFDAcertificationoranEUcertificationtoallowtheiruse in India.Similarly, forveterinary
products,theCDSCOonlylastyearapprovedthesettingupofaseparatecellwithintheorganizationtomonitorthe
“marketingauthorization,import,registration,licensingandfieldtrialsofveterinaryvaccinesanddrugs.”Inthis
case,itisn’tjusttheimpactofthemedicinesanddrugsontheanimalsthatneedstobereviewed—withmanyof
thembeingusedtoproducefoodforhumanconsumption,suchaspoultryandmeatproducts, their impacton
humansalsoneedstobeknown.
Globalrespect
manufacturingfacilitieswentup18%toanalltimehigh—withmorethan200drugqualitychecks.Oneofthe
reasonsIndiaisundertheUSFDAlensisthatit’stheworld’slargestexporterofgenericdrugs,making40%ofallnew
genericdrugsthatreceivedtheFDA’sapprovallastyear.QualityissuesaboutIndianmadegenericdrugsbecameso
frequentthattheUSFDAopenedtwoofficesinIndia,inDelhiandMumbai,in2009.WiththeUSFDA’snormsbeing
amongthemoststringent,IndiawillbehopingitsownFDA-lookalikewillearnthesamerespect.
Ref:www.health.economictimes.indiatimes.com
ManufacturingandmarketingofFDCofAceclofenac100mg+DrotaverineHydrochloride80mgTablet-Regarding
FDCofAceclofenac100mg+DrotaverineHydrochloride80mg tablet was initially approved by the office ofDirectorate General of health Services (CDSCO, FDCDivision)on15-09-2008.Basedonthe59threportofParliamentaryStandingCommittee(PSC)dated08-05-2012,itwasdecidedthatFDCofAceclofenac100mg+Drotaverine Hydrochloride 80mg tablet would bereferredtoasNewDrugAdvisoryCommittee(NDAC)/Subject Expert Committee (SEC) for examination andreviewrelatedtoitscontinuedmarketingandupdatingofproductmonographinthelightofrecentknowledgeandregulatorychangesinoverseas.
Accordingly the matter was discussed in a series ofmeetingsofNDAC/SEC.basedontherecommendationofSubjectExpertCommittee,itwasdecidedthatFDCof
Aceclofenac100mg+DrotaverineHydrochloride80mgtabletshallbeindicatedforthetreatmentofcolickypaindue to smooth muscle spasm for its continuedmarketing. However, manufacturers of this productshallconductclinicaltrial.
Recently,proposalwasagainre-deliberatedin60thSECdated on 29-08-2019 with current status. Thecommitteerevieweditsearlierdecisionforconductingthe Phase-IV clinical trial on FDC. After detaileddeliberationcommitteerecommendedthatfirmmaybedirectedtoconductActivePostMarketingSurveillanceinminimum200patientsfortreatmentofcolickypainduetosmoothmusclespasmasperdrugsandcosmeticsrules.Ref:www.cdsco.gov.in
PharmacovigilancereportingforveterinaryproductsinIndiaVarious stakeholders of the veterinary products have
raised concern regarding clarificationwith respect to
pharmacovigilancereportingforveterinaryproductsin
India.Inthisregarditisstatedthatasperconditionfor
grantofapproval/permissioninform45andform46of
Drugsandcosmeticsact1940andrulesthereunder,the
applicant shall submit periodic safety update reports
everysixmonthsforthefirsttwoyears.Forsubsequent
twoyears, theperiodicsafetyupdatereportsshallbe
submittedannually.
Ref:www.cdsco.gov.in
Reducingworkload?
The2019MedicineLaureates
The 2019 Nobel Prize in Physiology or Medicine is
awardedjointlyto
WilliamG.KaelinJr, SirPeterJ.Ratcliffe, Gregg L.
Semenza
fortheirdiscoveriesofhowcellssenseandadaptto
oxygen availability. They identified molecular
machinery that regulates the activity of genes in
responsetovaryinglevelsofoxygen.
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
19 20
So why does India need a super regulator? Public Notice
Currently,eachoftheregulatorsconcernedwithproductscertifiedforhumanconsumption—medicines,cosmetics,
foodandmedicaldevices—operateindependentlyeventhoughtheheadsoftheCDSCOandtheFSSAIreporttoa
JointSecretaryintheMinistryofHealth.IntheUSFDAmodel,thereareeightsub-divisionstotackleregulatory
issuesintheirrespectivesectors—food,drugs.Cosmetics,medicaldevices,radiationemittingproducts,biologics
(whichincludesvaccinesandblood),veterinaryproductsandtobaccoproducts.IntheNitiAayogproposal,the
IndianFDAwillbeheadedbyanIASlevelofficeroftherankofadditionalsecretaryinthehealthministry.
Commonobjective
Indiaasyetdoesnothaveaseparateregulatorformedicaldevices—22ofwhicharecategorizedasdrugsandhave
DCGIoversightwhiletherestaresoldwithoutanystandardsgoverningthem.Infact,forimporteddevices,the
CDSCOreliesonUSFDAcertificationoranEUcertificationtoallowtheiruse in India.Similarly, forveterinary
products,theCDSCOonlylastyearapprovedthesettingupofaseparatecellwithintheorganizationtomonitorthe
“marketingauthorization,import,registration,licensingandfieldtrialsofveterinaryvaccinesanddrugs.”Inthis
case,itisn’tjusttheimpactofthemedicinesanddrugsontheanimalsthatneedstobereviewed—withmanyof
thembeingusedtoproducefoodforhumanconsumption,suchaspoultryandmeatproducts, their impacton
humansalsoneedstobeknown.
Globalrespect
manufacturingfacilitieswentup18%toanalltimehigh—withmorethan200drugqualitychecks.Oneofthe
reasonsIndiaisundertheUSFDAlensisthatit’stheworld’slargestexporterofgenericdrugs,making40%ofallnew
genericdrugsthatreceivedtheFDA’sapprovallastyear.QualityissuesaboutIndianmadegenericdrugsbecameso
frequentthattheUSFDAopenedtwoofficesinIndia,inDelhiandMumbai,in2009.WiththeUSFDA’snormsbeing
amongthemoststringent,IndiawillbehopingitsownFDA-lookalikewillearnthesamerespect.
Ref:www.health.economictimes.indiatimes.com
ManufacturingandmarketingofFDCofAceclofenac100mg+DrotaverineHydrochloride80mgTablet-Regarding
FDCofAceclofenac100mg+DrotaverineHydrochloride80mg tablet was initially approved by the office ofDirectorate General of health Services (CDSCO, FDCDivision)on15-09-2008.Basedonthe59threportofParliamentaryStandingCommittee(PSC)dated08-05-2012,itwasdecidedthatFDCofAceclofenac100mg+Drotaverine Hydrochloride 80mg tablet would bereferredtoasNewDrugAdvisoryCommittee(NDAC)/Subject Expert Committee (SEC) for examination andreviewrelatedtoitscontinuedmarketingandupdatingofproductmonographinthelightofrecentknowledgeandregulatorychangesinoverseas.
Accordingly the matter was discussed in a series ofmeetingsofNDAC/SEC.basedontherecommendationofSubjectExpertCommittee,itwasdecidedthatFDCof
Aceclofenac100mg+DrotaverineHydrochloride80mgtabletshallbeindicatedforthetreatmentofcolickypaindue to smooth muscle spasm for its continuedmarketing. However, manufacturers of this productshallconductclinicaltrial.
Recently,proposalwasagainre-deliberatedin60thSECdated on 29-08-2019 with current status. Thecommitteerevieweditsearlierdecisionforconductingthe Phase-IV clinical trial on FDC. After detaileddeliberationcommitteerecommendedthatfirmmaybedirectedtoconductActivePostMarketingSurveillanceinminimum200patientsfortreatmentofcolickypainduetosmoothmusclespasmasperdrugsandcosmeticsrules.Ref:www.cdsco.gov.in
PharmacovigilancereportingforveterinaryproductsinIndiaVarious stakeholders of the veterinary products have
raised concern regarding clarificationwith respect to
pharmacovigilancereportingforveterinaryproductsin
India.Inthisregarditisstatedthatasperconditionfor
grantofapproval/permissioninform45andform46of
Drugsandcosmeticsact1940andrulesthereunder,the
applicant shall submit periodic safety update reports
everysixmonthsforthefirsttwoyears.Forsubsequent
twoyears, theperiodicsafetyupdatereportsshallbe
submittedannually.
Ref:www.cdsco.gov.in
Reducingworkload?
The2019MedicineLaureates
The 2019 Nobel Prize in Physiology or Medicine is
awardedjointlyto
WilliamG.KaelinJr, SirPeterJ.Ratcliffe, Gregg L.
Semenza
fortheirdiscoveriesofhowcellssenseandadaptto
oxygen availability. They identified molecular
machinery that regulates the activity of genes in
responsetovaryinglevelsofoxygen.
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER
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codetoknowmore
YoumaydownloadanyQRcodescannerfrom
PlayStore/iTunes
DIC Hotline: 9218428042 • Phone: 9218428042/9459220253
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]
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