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Page 1: Annual Report Modifed by Client 06 MARCH
Page 2: Annual Report Modifed by Client 06 MARCH

Annual Report2019-20

Government of India MInistry of Chemicals & Fertilizers

Department of Pharmaceuticals

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Annual Report 2019-20

CONTENTS

1. AN OVERVIEW

2. FUNCTIONS AND ORGANISATIONAL SET-UP

3. ABOUT MEDICAL DEVICE INDUSTRY

4. PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP)

5. NATIONAL INSTITUTES OF PHARMACEUTICAL EDUCATION & RESEARCH (NIPERs)

6. PUBLIC SECTOR UNDERTAKINGS (PSUs)

7. NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA)

8. IMPLEMENTATION OF RAJBHASHA

9. CITIZEN CENTRIC GOVERNANCE

10. INFORMATION AND COMMUNICATION TECHNOLOGY

11. ANNEXURES

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BRIEF CONTENT

1. AN OVERVIEW 1

1.1 Pharmaceutical Industry 1.2 National Pharmaceutical Pricing Policy 1.3 Foreign Direct Investment in Pharmaceutical Sector 1.4 Umbrella Scheme for Development of Pharmaceutical Industry. 1.5 International cooperation/Export Promotion of Pharmaceuticals 1.6 India Pharma 2020 and India Medical Device 2020 1.7 National Pharmaceutical Pricing Authority (NPPA) 1.8 National Institute of Pharmaceutical Education & Research (NIPER) 1.9 Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP)

2. FUNCTIONS AND ORGANISATIONAL SET-UP 15 2.1. Mandate of Department of Pharmaceuticals 2.2. Vision 2.3. Mission 2.4. Organizational set-up. 2.5. Attached Office 2.6. Registered Society 2.7. Autonomous Institutes 2.8. Public Sector Undertakings

3. MEDICAL DEVICE INDUSTRY 23

3.1. Indian Medical Device Sector 3.2 Import and Export Trends 3.3 Investment Scenario in Medical Device Sector in India 3.4 Existing & Proposed Medical Device Clusters in India 3.5 Initiatives for Promotion of Medical Device Industry

4. PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP) 31 4.1 Background of the Scheme 4.2 Progress achieved during 2019-20 4.3 Achievements of the first 100 days of incumbent government

4.4 Technology oriented initiatives 4.5 Progress likely to be made by 31st March 2024 as envisaged in Vision Plan

5. NATIONAL INSTITUTES OF PHARMACEUTICAL EDUCATION & RESEARCH (NIPERs) 39

5.1 Background 5.2 NIPER Mohali 5.3 NIPER Hyderabad

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5.4 NIPER Guwahati 5.5 NIPER Kolkata 5.6 NIPER Raebareli 5.7 NIPER Ahmedabad 5.8 NIPER Hajipur

6. PUBLIC SECTOR UNDERTAKINGS (PSUs) 81 6.1 Central Public Sector Undertakings 6.2 Indian Drugs & Pharmaceuticals Ltd. (IDPL) 6.3 Hindustan Antibiotics Ltd. (HAL) 6.4 Karnataka Antibiotics & Pharmaceuticals Ltd. (KAPL) 6.5 Bengal Chemicals & Pharmaceuticals Ltd. (BCPL) 6.6 Rajasthan Drugs & Pharmaceuticals Ltd. (RDPL)

7. NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA) 101 7.1 National Pharmaceutical Pricing Authority (NPPA) 7.2 Pricing Division 7.3 Monitoring and Enforcement Division 7.4 E-initiatives 7.5 Plastic Waste Management 7.6 Recovery of Overcharged Amount 7.7 Ease of Doing Business

8. IMPLEMENTATION OF RAJBHASHA 133

9. CITIZEN CENTRIC GOVERNANCE 137 9.1 Our Vision 9.2 Our Mission 9.3 Our Clients 9.4 Our Commitment 9.5 Our Services 9.6 Our Activities 9.7 RTI Act-2005 9.8 CPGRAMS

10. INFORMATION AND COMMUNICATION TECHNOLOGY 141

11. ANNEXURES 147

Annexure – I [A] List of PSUs and Other Organizations Annexure – I [B] Address and Name of various Organizations& PSUs Annexure – I [C] List of Responsibility Centers and Subordinate Organiza- tions Annexure – II Organizational Chart of NPPA

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CHAPTER 1 AN OVERVIEW

1.1PharmaceuticalIndustry

1.2NationalPharmaceuticalPricingPolicy

1.3ForeignDirectInvestmentinPharmaceuticalSector

1.4UmbrellaScheme-DevelopmentofPharmaceuticalIndustry

1.5Internationalcooperation/ExportPromotionofPharmaceuticals

1.6IndiaPharma2020andIndiaMedicalDevice2020

1.7 NationalPharmaceuticalPricingAuthority(NPPA)

1.8NationalInstituteofPharmaceuticalEducation&Research(NIPER)

1.9PradhanMantriBharatiyaJanaushadhiPariyojana(PMBJP)

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CHAPTER 1AN OVERVIEW

1.1 PharmaceuticalIndustry:

TheIndianpharmaceuticalindustryisthethirdlargestintheWorldintermsofvolumeandtenthlargestintermsofvalue.Thetotalsizeoftheindustry(includingdrugs&medicaldevices)isaroundUS$43billion(Rs.3,01,000crore)andiscurrentlyhavingagrowthrateof7-8%indrugsectorand15-16%inmedicaldevicesector.Totalexports(drugsandmedicaldevices)aretothetuneofUS$20billion(Rs.1,47,420crore)ofwhichdrugsformaround90%ofthetotalexports.TheimportsamounttoaroundRs.72,800croreofwhichmedicaldevicesformaround52%.

Indiaisthelargestproviderofgenericdrugsglobally.AccesstoaffordableHIVtreatmentfromIndiaisoneofthegreatestsuccessstoriesinmedicine.Indiaisoneofthebiggestsuppliersoflow-costvaccinesintheworld.Becauseoflowpriceandhighquality,Indianmedicinesarepreferredworldwide,therebyrightlynamingthecountry“the pharmacy of the world”.ThePharmaceuticalsectorcurrentlycontributesaround1.72%tothecountry’sGDP.

1.1.1 TradeinPharmaceuticals

Indianpharmaexportsaredestinedtomorethan200countriesincludinghighlyregulatedmar-ketsofUS,WestEurope,JapanandAustralia.IndiaexportedpharmaceuticalstothetuneofRs.1,33,910crorewitharecordedgrowthof10.72%in2018-19.Drugformulations&Biologicalswasthethirdlarg-estamongtheprincipalcommoditiesexportedbyIndiaduring2018-19.IndiaexportslargelytoUSA,UK,SouthAfricaandRussia.Importsofdrugsduring2018-19wasofRs.35,000crorewithbulkdrugsandintermediatescomprising63%ofthetotalpharmaceuticalimportsfollowedbyDrugFormulationsandBiologicals(36%).IndiaimportslargelyfromChina,USA,ItalyandGermany.Thecountryhashadsurplusesinpharmaceuticaltradeasshowninthetablebelow.

Table-1A(Exportandimportinpharmaceuticalsectorsince2010-11)

(Source:DGCISKolkata)

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The Annual Turnover of the Indian Pharmaceutical Industry was estimated to be about Rs.2,58,5341Croreduringtheyear2018-19.TheshareofexportofBulkDrugs,DrugIntermediatesandDrugFormulations,BiologicalswasRs.1,28,0282Crorefortheyear2018-19.Indianpharmaceuticalin-dustrysuppliesasignificantpercentageofglobalsupplyofmedicinesincludingvaccines,APIsandfin-ishedproducts.Indiaaccountsfor20%ofglobalexportsingenerics.

India’sPharmaexportsmainlyconsistofDrugFormulationsandBiologicalsupto77%followedbyBulkdrugsandintermediatesupto21%.

1.2 NationalPharmaceuticalPricingPolicy2012

TheDepartmentofPharmaceuticalsnotifiedtheNationalPharmaceuticalPricingPolicy-2012(NPPP-2012)on07.12.2012with theobjective toput inplacea regulatory framework forpricingofdrugstoensureavailabilityofrequiredmedicines–“essentialmedicines”–atreasonableprices,whileproviding sufficient opportunity for innovation and competition to support the growth of industry,therebymeetingthegoalsofemploymentandsharedeconomicwell-beingforall.TheGovernmentisnowcontemplatingtointroduceanewNational Pharmaceutical Policywiththefollowingobjectives:

– Makingessentialdrugsaccessibleataffordablepricestothecommonmasses;

– Providingalonger-termstablepolicyenvironmentforthepharmaceuticalsector;

– MakingIndiasufficientlyself-reliantinend-to-endindigenousdrugmanufacturing;

– Ensuringworldclassqualityofdrugsfordomesticconsumption&exports;

– CreatinganenvironmentforR&Dtoproduceinnovatordrugs;

– EnsuringgrowthanddevelopmentoftheIndianPharmaIndustry.

1.3 ForeignDirectInvestment(FDI)inPharmaceuticalSector:

FDIupto100%inpharmaceuticalsectorispermissiblethroughautomaticrouteforgreenfieldinvestmentandupto74% forbrownfield investment.Beyond74%,FDI inpharmaceutical sector forBrownfieldinvestmentispermissiblethroughGovernmentapprovalroute.UnionCabinetinitsmeet-ingheldon24.05.2017approvedtheabolitionoftheForeignInvestmentPromotionBoard(FIPB).TheadministrativeMinistries/DepartmentsaretoprocessapplicationsforFDIrequiringGovernmentap-proval.TheproposalsrelatingtoPharmaceuticalSectorarebeinghandledbythisDepartment,basedontheStandardOperatingProcedure(SOP)issuedbyDepartmentforPromotionofIndustryandInter-nalTrade(DPIIT)andinconsultationwithrelatedGovernmentAgencies.AfterabolitionofFIPB,underapprovalroute,DepartmentofPharmaceuticalshasapproved25FDIproposalsworthRs.2,496croresapproximatelytillnow.Pharmaceutical isamongthetopeightsectorsof IndiaattractingFDI. FDI inmedicaldevicesisunderautomaticrouteforbothbrownfieldandgreenfieldsectors.

1Source (PHARMATRAC/NPPA/DGCIS) 2Source (DGCIS)

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Table-1B(FDIinflowinPharmaceuticalsectorsince2014-15)

Source:DPIIT/RBI(Figurefor2019-20isuptoDecember2019)

1.4 UmbrellaScheme-DevelopmentofPharmaceuticalIndustry:

TheDepartmenthasanumbrellaschemenamely‘SchemeforDevelopmentofPharmaceuticalIndustry’.Itsobjectiveistoincreasetheefficiencyandcompetitivenessofdomesticpharmaceuticalin-dustrysoastoenablethemtoplayaleadroleintheglobalmarketandtoensureaccessibility,availabil-ityandaffordabilityofqualitypharmaceuticalsformassconsumption.ThisschemeisaCentralSectorScheme(CS)withatotalfinancialoutlayofRs.480croreforathree-yearperiodstartingfrom2017-18to2019-20andcomprisesthefollowingfivesub-schemes:

a) AssistancetoBulkDrugIndustryforCommonFacilityCentre;

b) AssistancetoMedicalDeviceIndustryforCommonFacilityCentre;

c) AssistanceforClusterDevelopment;

d) PharmaceuticalPromotionandDevelopmentScheme(PPDS);and

e) PharmaceuticalTechnologyUpgradationAssistanceScheme(PTUAS)

TheGuidelinesforimplementationofthesub-schemesareavailableontheDepartment’sweb-siteathttps://pharmaceuticals.gov.in/guidelines-implementation-schemes

a) AssistancetoBulkDrugIndustryforCommonFacilityCentre:

Thissub-schemeproposesfinancialassistanceforsettingupofCommonFacilityCentres(CFCs)inBulkDrugParksinthecountryatatotalcostofRs.200croresfor2018-2020.

FinancialassistancemaybeprovidedforcreationofcommonfacilitiesunderanyupcomingBulkDrugParkpromotedbyStateGovernments/StateCorporations.

TheSchemewouldbeimplementedthroughaone-timegrant-in-aidtobereleasedtoa S tateImplementingAgency(SIA)setupforthepurpose.

SomeoftheindicativeactivitiesundertheCommonfacilitiesare:-

• EffluentTreatmentPlants

• CaptivePowerPlants

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• SteamandCoolingSystems

• IncubationFacilities

• CommonLogisticsFacilities

• AdvanceCommonTestingCentre

• RegulatoryawarenessfacilitationCentre

• EmergencyResponseCentre

Themaximumlimitforthegrant-in-aidunderthiscategorywouldbeRs.100CroresperBulkDrugParkCFCor70%oftheprojectcostofCFC,whicheverisless.

TheDepartmenthasgiven‘in-principle’approvaltotheproposalsreceivedfromStateGovern-mentsofAndhraPradesh,Telangana,AssamandHimachalPradesh.StateGovernmentsofGujaratandTamilNaduhavealsoshowntheirinterestinestablishingbulkdrugmanufacturingparks.

Onceoperationalized, theseparksareexpectedto leadthecountrytowardsmakingamajormanufacturinghubofbulkdrugs.

b) AssistancetoMedicalDeviceIndustryforCommonFacilityCentre:

Thissub-schemeproposesfinancialassistanceforsettingupofCommonFacilityCentres(CFCs)inMedicalDeviceParksinthecountryatatotalcostofRs.100crorefor2018-2020.

Financial assistancemaybeprovided for creationof common facilitiesunder anyupcomingMedicalDeviceParkpromotedbyStateGovernments/StateCorporations.TheSchemewouldbeimple-mentedthroughaone-timegrant-in-aidtobereleasedtoaStateImplementingAgency(SIA)setupforthepurpose.

SomeoftheindicativeactivitiesundertheCommonfacilitiesare:-

• ComponentTestingCentre

• Electro-magneticinterferencelaboratory

• Biomaterial/Biocompatibilitytestingcentre

• Medicalgradelowvacuummoulding

• Cabinetmoulding

• Injectionmouldingcenters

• 2Ddesigningandprintingformedicalgradeproducts

• SterilizationandToxicitytestingcentre

• Radiationtestingcentre,etc.

Themaximumlimitforthegrant-in-aidunderthiscategorywouldbeRs.25CroreperMedical

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DeviceParkCFCor70%oftheprojectcostofCFCwhicheverisless.

TheDepartmenthasgiven‘in-principle’approvaltotheproposalsreceivedfromStateGovern-mentsofAndhraPradesh,Telangana,KeralaandTamilNadu.StateGovernmentsofGujaratandUttara-khandhavealsoshowntheirinteresttoestablishmedicaldevicemanufacturingparks.

Onceoperationalized, theseparksareexpectedto leadthecountry towardsmakingamajormanufacturinghubofmedicaldevices.

c) AssistanceforClusterDevelopment;

ThisisanexistingschemeoftheDepartment,earlierknownasClusterDevelopmentProgrammeforPharmaSector (CDP-PS),nowbeingsubsumedunder theumbrella scheme. Under thescheme,financialassistancewouldbeprovidedforcreationofcommonfacilitiesinanypharmaclustersinclud-ingBulkDrug,MedicalDevice,Ayurvedic,UnaniandCosmeticsUnits.SomeoftheindicativeactivitiesundertheCommonfacilitiesincludeCommonTestingFacilities,TrainingCentre,R&DCenters,EffluentTreatmentPlantandCommonLogisticsCentre.TheSchemewouldbeimplementedonaPublicPrivatePartnership(PPP)formatthroughonetimegrant-in-aidtobereleasedtoaSpecialPurposeVehicles(SPVs)setupforthepurpose.AtotalofRs.30crorehasbeenearmarkedforthescheme.Thepropos-alofM/sChennaiPharma Industrial InfrastructureUpgradationCompany(CPIIUC)wasapprovedbySchemeSteeringCommitteeinits7thmeetingdated05/10/2016forinstallationofCommonEffluentTreatmentPlant(CETP)atAlathur,Tamilnadu,which istobecompletedbytheendoffinancialyear2019-20.

d) PharmaceuticalPromotion&DevelopmentScheme(PPDS):

TheObjectiveofPharmaceuticalPromotion&DevelopmentScheme(PPDS)ispromotion,devel-opmentandexportpromotioninPharmaceuticalsectorbyextendingfinancialsupportforconductingseminars,conferences,exhibitions,mountingdelegationstoandfromIndiaforpromotionofexportsaswellasinvestments,conductingstudies/consultancies,forfacilitatinggrowth,exportsaswellascriticalissuesaffectingPharmasector. UnderPPDS,theDepartmentofPharmaceuticalsmayon itsownorthroughfinancialsupportbywayofGrant-in-aidtotheinstitutions,organizations,voluntaryorganiza-tionsorNon-GovernmentOrganizationsasmentionedinRule228ofGFR2017:-

i. Conduct Training/knowledge improvement programs/activities on issues/sub-jectsrelevanttogrowthofpharmaceuticalindustry.

ii. OrganizeSummits,Convention,Exhibitions,Pharmacyweek,meetingsetc.inIn-diaandabroadandproducepromotionalmaterialslikefilms,displaysetc.

iii. Conductresearchstudies,sectorreportsetc.

iv. Purchasebooks,qualitystandards,pharmacopoeias,magazines,directories,soft-warefordevelopinginformationdatabanks,developinge-learningmodulesetc.

v. Giveawardstoachieversinpharmaceuticalindustry.

ForanyotheractivitynotcoveredunderabovecategoriesmaybedecidedbytheDepartmentofPharmaceuticalsfromtimetotime.

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e) PharmaceuticalTechnologyUpgradationAssistanceScheme(PTUAS):

ThemainobjectiveoftheschemeistofacilitateSmallandMediumPharmaEnterprises(SMEs)toupgradetheirplantandmachinerytoWorldHealthOrganization(WHO)-GoodManufacturingPrac-tices(GMP)standardssoastoenablethemtoparticipateandcompeteinglobalmarkets.Assistanceintheformofinterestsubventionagainstsanctionedloanbyanyscheduledcommercialbank/financialin-stitution,bothinPublicandPrivatesectorwillbeprovidedto250pharmaSMEsofproventrackrecord.

PTUASisimplementedthroughaPublicSectorFinancialInstitution(PSFI)tobeidentifiedbytheGovernment.TheFinancialInstitutionwillbeselectedthroughaprocessofopenCompetitiveBiddingamongsttheeligiblePublicSectorFinancialInstitutions(PSFIs).Theframeworkforselectionoftheop-eratingPSFIwillbebaseduponcompetitivebiddinginlinewithExpressionofInterest(EoI)tobeinvitedthroughadequatepublicityasmandatedforsuchactivities.Theupperlimitofinterestsubventiononloansfortechnology/ infrastructureupgradationshallberestrictedto6%perannumforaperiodofthreeyearsonreducingbalancebasis.ThemaximumloaneligibleforthispurposewillbeRs.4crore,availedbytheconcernedSMEforpurposeofupgradationtoWHO-GMPnorms.Theschemeisyettobeimplemented.

1.5 Internationalcooperation/exportpromotionofpharmaceuticals:

1.5.1 JointWorkingGroup(JWG)/HighTechnologyCooperationGroup(HTCG)

DepartmentofPharmaceuticalshasthefollowingJointWorkingGroups/HighTechnologyCoop-erationGroup:-

1. EU-IndiaJointWorkingGrouponPharmaceuticals,Biotechnologyand MedicalDevices

2. India-TunisiaJointWorkingGrouponDrugsandPharmaceuticals

3. India-UkraineJointWorkingGrouponPharmaceuticalsandHealthcare

4. India-BelarusJointWorkingGrouponPharmaceuticals

5. India-PhilippinesTechnicalWorkingGroup(TWG)forconsidering“Pharm azone”and“RegistrationandotherIssuesrelatedtoPharmaceuticals”

6. India-AlgeriaJointWorkingGroup(JWG)onPharmaceuticals

7. India-EgyptJointStudyGroup(JSG)onPharmaceuticalsandHealth

8. India-UzbekistanJointWorkingGrouponPharmaceuticals

9. India-RussiaJointWorkingGrouponPharmaceuticalstoreaddressthe issuesonIndiaPharmaIndustries

10. India-ChinaJointWorkingGrouponPharmaceuticals

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InternationalParticipations

1. 1st Meeting of India-Russia Joint Working Group on Pharmaceuticals was held on18thNovember,2019atMoscow,RussiaundertheCo-ChairmanshipofShriNavdeepRinwa,JointSec-retary,DepartmentofPharmaceuticals.

2. 1stMeetingofIndia-ChinaJointWorkingGrouponPharmaceuticalswasheldon7thMay,2019inBeijingundertheCo-ChairmanshipofShriNavdeepRinwa,JointSecretary,DepartmentofPhar-maceuticals.

1.6 IndiaPharma2020andIndiaMedicalDevice2020:–

India Pharma2020 and IndiaMedicalDevice 2020- 5th Edition of International Exhibitions&ConferencesonPharmaceuticalsandMedicalDevicesectorsisscheduledtobeheldattheMahatmaMandir,Gandhinagar,Gujaratfrom5thto7thMarch,2020.ThisyeartheeventisbeingorganizedforthefirsttimeinthestateofGujarat.Theeventincludesthreedaysofdeliberationsbetweenpolicymakersandindustryleadersontheroadmap,issues,challengesandopportunitiesinboththesesectors.Boththe eventswouldbe comprisedof International Exhibitions andConferences alongwith a series ofconcurrentevents,suchasCEOs’Forum,InternationalDrugRegulators’Meet,CEOs’RoundtablewiththeHon’bleMinister,5thIndiaPharma&IndiaMedicalDeviceAwards,InternationalBuyerSellerMeet,ThematicConferenceSessionsetc.

Objective:- ThemainobjectiveoftheeventistoprovideaplatformtoglobalinvestmentcommunitytoconnectwithstakeholdersinPharmaceuticalandMedicalDeviceSectorsinIndia,CentralandStateGovernments, leadingbusinessleadersandtopexecutivesfromtheindustry,academicsandexpertsfromtheworld.TheeventisaninitiativetoincreaseoverallgrowthofPharmasectorincludingexportsandfocusonincreaseofdomesticproductioninthesector,withactiveparticipationfromallthestake-holders.

SummaryofEvent:-Theeventwillcoverall thesectorsofthepharmaceutical industrystartingfromfinishedformulations,APIs,Bio-pharmaceuticals,FineChemicalsandintermediates,Naturalextracts,Excipientsandmanymore.TherewouldbedisplayoflatestPharmaceuticalMachinery,Plants,Labora-toryEquipments,AnalyticalInstrumentandCleanroomEquipmentswithlivedemonstration.TheeventwouldprovideNetworkingopportunitiestomorethan5000globalpharmaceuticalandbiotechnologyprofessionals.

CurtainRaiserCeremonyofIndiaPharma2020andIndiaMedicalDevice2020heldon19thDecember,2019atAhmedabad,Gujarat

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5th IndiaPharmaandMedicalDeviceAwards-5th IndiaPharmaandMedicalDeviceAwardswillbeconferredon5thMarch,2020byShriD.V.SadanandaGowda,Hon’bleMinister(Chemicals&Fertilizers)tocelebrateinnovationandexcellenceinthePharmaandMedTechsectorsinfollowingcategories:-

Table-1C

(Categoriesofawards)

S.No. Category1 IndiaPharmaLeaderAward2 IndiaPharmaBulkDrugCompanyoftheYearAward3 IndiaPharmaInnovationofYearAward4 IndiaPharmaCorporateSocialResponsibility(CSR)ProgrammeoftheYearAward5 IndiaMedicalDeviceCompanyofYearAward6 IndiaPharmaSwachhtaChampionAward

TheCurtainRaiserCeremonyof IndiaPharma2020and IndiaMedicalDevice2020washeldon19thDecember,2019atAhmedabad,Gujarat.TheeventwasattendedbyShriD.V.SadandaGow-da,Hon’bleMinister(Chemicals&Fertilizers)andShriMansukhMandaviya,Hon’bleMinisterofState(Chemicals&Fertilizers).

Hon’bleMinister(C&F)attheCurtainRaiserCeremonyofIndiaPharma2020andIndiaMedicalDevice2020heldon19thDecember,

2019atAhmedabad,Gujarat

OutcomeofIndiaPharma2019&IndiaMedicalDevice2019:-

Theeventwitnessedparticipationofinternationaldrugregulatorsfrom7countriesviz.Russia,Kenya,UK,Malaysia,Guyana,SaudiArabia&Uzbekistan,alongwithparticipationofIndiandrugreg-ulatorsfrom13States.Over500IndianandInternationaldelegates,100+CEOsandMDsofPharma-ceuticalsandMedicalDeviceSectorand250+academiciansandstudentsattendedthetwo-daycon-ference.TheConferencewasinauguratedbyShriDVSadanandaGowda,UnionMinisterofChemicals&Fertilizers,GovernmentofIndia,inthepresenceofShriMansukhL.Mandaviya,MinisterofStateforChemicals&Fertilizers,GovernmentofIndia,ShriKLGeorge,MinisterforLarge&MediumScaleIn-dustries–Commerce&IndustriesDepartment,GovernmentofKarnatakaandotherseniorofficialsofGovernment ofIndiaalongwithIndustrystalwarts.Theinauguralwasfollowedbyplenarysessionsheldparallellyforboththesectors.TheconferencealsosawtheinteractionofIndustryCEOswiththeUnionMinisterofChemicals&FertilisersalongwiththeotherGovernmentofficialsfromDepartmentofPhar-

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maceuticals,MinistryofHealth&FamilyWelfare,NPPA,CDSCO,BIS,DPIITetc.inaseriesofroundtablesorganizedseparatelyforPharmaceuticalandMedicalsDevicesector. Duringthetwodays,BureauofIndianStandards(BIS)andWorldHealthOrganization(WHO)alsoconductedtechnicalworkshopsfortheconferencedelegates.TheBISsessionwasonthetheme-‘sensitizingthemedicaldeviceindustryonBISstandardization’andWHOsessionwason-regulatorysystemsstrengtheningandprequalificationprogrammeofmedicalproducts-recentupdates’.

Hon’bleMoS(C&F)attheCurtainRaiserCeremonyofIndiaPharma2020andIndiaMedicalDevice2020heldon19thDecember,2019atAhmedabad,Gujarat.LightingthelampattheCeremony.

4thIndiaPharmaandMedicalDeviceAwards-TocelebrateinnovationandexcellenceinthePharmaandMedTechsector,4thIndiaPharmaandMedicalDeviceAwardswereconferredbyShriD.V.Sadanan-daGowda,Hon’bleMinister(Chemicals&Fertilizers)atBengaluru. Thelistofwinnersismentionedbelow–

Table-1D(Winner-awardeesof2019)

Category AwardeesIndiaPharmaLeaderAward AkumsDrugs&PharmaceuticalsLtdIndiaPharmaInnovationofYearAward LupinLimitedIndiaPharmaCorporateSocialResponsibility(CSR)ProgrammeoftheYearAward

Dr.Reddy’sLaboratoriesLtd.

IndiaMedicalDeviceCompanyofYearAward PolyMedicureLtd.IndiaPharmaSwachhtaChampionAward Indian Drug Manufacturers’ Associa-

tion(IDMA)

1.7 NationalPharmaceuticalPricingAuthority(NPPA):

National Pharmaceutical PricingAuthority (NPPA)was established through aGovernment ofIndiaResolutiondated29thAugust,1997asanindependentbodyofexpertsforpricecontrolofes-sentialandlifesavingmedicines.NPPAisanattachedofficeoftheDepartmentofPharmaceuticalsandimplementstheNationalPharmaceuticalPricingPolicy2012andtheDrugs(PricesControl)Orderas

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amendedfromtimetotimewhichwereissuedbytheDepartment.

NPPAfixesceilingpricetoallDrugsnotifiedunderSchedule-IoftheDPCO,2013andmonitorsannualpriceincreaseforthesemedicines.Ithas,sofar,fixedceilingpricesof860scheduledformula-tionsandretailpricesfor1189newdrugs.ByinvokingpowersunderPara19ofDPCO,2013,ithasreg-ulatedpricesof106anti-diabeticandcardiovasculardrugs,stentsandkneeimplantsinpublicinterest.

InFebruary2019,NPPAlaunchedaPilotforpriceregulationof42anti-cancerdrugsasproofofconceptforTradeMarginrationalizationofnon-scheduleddrugs.Sofar,526brandshavereportedsav-ingupto90%,amountingtoRs.984croreperannum.ItisestimatedthatNPPAhasaffectedasavingofalmostRs.12,447croretotheconsumerssinceitsconstitution.

ForeffectivemonitoringofDPCOinthecountry,suchasmonitoringofnotifiedpricesofmedi-cines,detectionofviolationoftheprovisionsofDPCO,pricingcomplianceandensuringavailabilityofmedicines,cooperationandinvolvementofStateDrugControllers(SDCs)isimportant.Inviewofthat,NPPAhasdecidedtosetupPriceMonitoringandResourceUnits(PMRUs),asregisteredsocietiesundertheSocietiesRegistrationActinallthe37states/UTstosupportNPPAandrespectiveStateDrugControl-lers.Asofnow,10PMRUshavebeensetupinthestatesofKerala,Odisha,Gujarat,Rajasthan,Punjab,Haryana,Nagaland,Tripura,UttarPradeshandAndhraPradesh.

1.8 NationalInstituteofPharmaceuticalEducation&Research(NIPER):

IndianPharmaIndustryhasbeenagloballeaderinGenericdrugs.Inordertoacquireleadershippositionindrugdiscoveryanddevelopmentandtocontinuetoexcelintheformulations,Governmentrecognizedthathumanresources/talentpoolisverycritical.NationalInstituteofPharmaceuticalEdu-cation&Research(NIPER)atSASNagar(Mohali)wassetupasaregisteredsocietyundertheSocietiesRegistrationAct1860.SubsequentlytheInstitutewasgivenstatutoryrecognitionbyanactofParlia-ment,NIPERAct,1998andwasdeclaredasanInstituteofNationalImportance.

During2007-08,sixnewNIPERswerestartedatAhmedabad,Guwahati,Hajipur,Hyderabad,Kol-kataandRaebareliwiththehelpofMentorInstitutes.Subsequently,NIPERatMaduraiwasapprovedintheyear2012.During2015-16,FinanceMinisterinhisBudgetSpeechannounced3newNIPERsforthestatesofChhattisgarh,MaharashtraandRajasthan.

Objectivesare(a)toactasnucleusforinteractionbetweenacademicandindustrybyencour-agingexchangeofscientistandothertechnicalstaffbetweentheInstituteandtheindustryandbyundertakingsponsoredandfundedresearchaswellasconsultancyprojectsbytheInsti-tute,(b)tonurtureandpromotequalityandexcellenceinpharmaceuticaleducationandresearch,and(c) toconcentrateoncoursesleadingtomaster’sdegree,doctoralandpost-doctoralcoursesandresearchinpharmaceuticaleducation.

NIPER-Mohalihasregularfacultypostsandnon-facultyposts.DepartmentofExpenditurehascreated156facultyand150non-facultypostsinsixNIPERsviz.Ahmedabad,Guwahati,Hajipur,Hyder-abad,KolkataandRaebareliinJanuary2019.

NIPERsimpartPh.DandPGleveleducationandgrantdegreeundertheNIPERAct1998.Thestudentsareselectedthroughacommonentranceexamination.Eachmasterstudentisgivenstipend

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ofRs.12,400/[email protected],000/-toRs.33,000/-permonth.AspernationalNIRFranking,thethreeNIPERs,namely,NIPER,Mohali,NIPER,HyderabadandNIPER,Ahmedabadarerankedwithinfirstten.

Sinceinception,totalnumberof5901students(MPharma/MBA-5582;PhD-319)havepassedout,141MOUssignedwithIndustries,223patentsfiled/87granted,about4016researchpaperspub-lishedinvariousreputedjournalstill31stDecember2019bythesevenexistingNIPERs.

1.9PradhanMantriBharatiyaJanaushadhiPariyojana(PMBJP):

Withanobjectiveofmakingqualitygenericmedicinesavailableataffordablepricestoall,Prad-hanMantriBhartiya JanAushadhiPariyojana (PMBJP)was launched inNovember,2008.Under thisscheme,dedicatedoutletsknownasPradhanMantriBhartiyaJanaushadhiKendra(PMBJK)areopenedtoprovidegenericmedicines.UnderJanAushadhischemeatleastoneJanAushadhiStorewillbesetupineachDistrictofthecountry.

ObjectivesofthePariyojana-

•Ensureaccesstoqualitymedicinesforallthesectionofthepopulationespeciallyforthepoorandthedeprivedones.

•Createawarenessaboutgenericmedicinesthrougheducationandpublicitytocountert h e -perceptionthatqualityissynonymouswithhighpriceonly.

•GenerateemploymentbyengagingindividualentrepreneursinopeningofPMBJPkendra.

Savingstothecommonman

AmedicineunderPMBJPispricedontheprincipleofamaximumof50%oftheaveragepriceoftopthreebrandedmedicines.Therefore,thepriceofJanAushadhiMedicinesischeaperatleastby50%andinsomecases,by80%to90%ofthemarketpriceofbrandedmedicines.Inthecurrentfinancialyear(2019-20),PMBJPhasachievedsalesofRs.258crores(atMRP),upto30-11-2019.ThishasledtosavingsofapproximatelyRs.1800croresofthecommoncitizensofthecountry.

ProgressAchievedDuring2019ason20thDecember,2019

CoverageofthePariyojana- Ason20.12.2019,5891PMBJPKendrasarefunctionalacrossthecountry.UnderthePMBJP,693districtsoutof725,arealreadycovered.BPPIhasfixedatargettocoverall725districtsofthecountryby31stMarch,2020.

Basketofmedicines&Stockposition–ProductbasketofBPPIcomprisesofmorethan800drugsand154surgicalinstruments.Tendersforrequiredmedicinesarefloatedonregularbasisasitisanongoingprocess.Thus,regulareffortsaremadeforaugmentingtheproductbasketofPMBJPsothatessentialmedicinesarereadilyavailable.

SupplyofMedicinestoPMBJPKendras–InformationTechnology(IT)enabledEnd-to-EndsupplychainsystemwithPoint-of-Sale(POS)applicationforvalueaddedserviceshasbeenimplementedinPMBJP.BureauofPharmaPSUsofIndia(BPPI),theimplementingagencyofPMBJPhasfourmodernwarehous-esatGurugram,Bengaluru,GuwahatiandChennai for storageanddistributionofdrugs. Drugsaremadeavailabletoallkendrasacrossthecountryfromthesewarehouses.

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CHAPTER 2 FUNCTIONSANDORGANISATIONALSET-UP

2.1 MandateofDepartmentofPharmaceuticals

2.2 Vision

2.3 Mission

2.4 Organizationalset-up.

2.5 AttachedOffice

2.6 RegisteredSociety

2.7 AutonomousInstitutes

2.8 PublicSectorUndertakings

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CHAPTER2

FUNCTIONSANDORGANISATIONALSET-UP

2.1 MandateofDepartmentofPharmaceuticals

TheDepartmentof Pharmaceuticalswas createdon the1st July, 2008under theMinistryofChemicals&Fertilizerswiththeobjectivetogivegreaterfocusandthrustonthedevelopmentofphar-maceuticalsectorinthecountryandtoregulatevariouscomplexissuesrelatedtopricingandavailabil-ityofmedicinesataffordableprices,research&development,protectionofintellectualpropertyrightsandinternationalcommitmentsrelatedtopharmaceuticalsectorwhichrequiredintegrationofworkwithotherministries.

ThefollowingworkshavebeenallocatedtotheDepartmentofPharmaceuticals:

1. DrugsandPharmaceuticals,excludingthosespecificallyallottedtootherdepartments.

2. MedicalDevices-Industryissuesrelatingtopromotion,productionandmanufacture;ex-cludingthosespecificallyallottedtootherDepartments.

3. Promotionandco-ordinationofbasic,appliedandotherresearchinareasrelatedtothepharmaceuticalsector.

4. Developmentofinfrastructure,manpowerandskillsforthepharmaceuticalsectorandmanagementofrelatedinformation.

5. Educationandtrainingincludinghigh-endresearchandgrantoffellowshipsinIndiaandabroad,exchangeofinformationandtechnicalguidanceonallmattersrelatingtophar-maceuticalsector.

6. Promotionofpublic-private-partnershipinpharmaceuticalrelatedareas.

7. InternationalCo-operationinpharmaceuticalresearch,includingworkrelatedtointerna-tionalconferencesinrelatedareasinIndiaandabroad.

8. Inter-sectorialcoordinationincludingcoordinationbetweenorganizationsandinstitutesundertheCentralandStateGovernmentsinareasrelatedtothesubjectsentrustedtotheDepartment.

9. Technicalsupportfordealingwithnationalhazardsinpharmaceuticalsector.

10. AllmattersrelatingtoNationalPharmaceuticalPricingAuthorityincludingrelatedfunc-tionsofpricecontrol/monitoring.

11. AllmattersrelatingtoNationalInstitutesofPharmaceuticalEducationandResearch.

12. Planning,developmentandcontrolof,andassistanceto,allindustriesdealtwithbytheDepartment.

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13. BengalChemicalsandPharmaceuticalsLimited.

14. HindustanAntibioticLimited.

15. IndianDrugsandPharmaceuticalsLimited.

16. KarnatakaAntibioticsandPharmaceuticalsLimited.

17. RajasthanDrugsandPharmaceuticsLimited.

TheworkoftheDepartmenthasbeenmainlydividedintoPricing,Policy,Scheme,NIPER,PSU&MedicalDeviceDivisions.NationalPharmaceuticalPricingAuthority(NPPA)isanattachedofficeoftheDepartment.

2.2 Vision:

TopromoteIndianpharmaasthegloballeaderforqualitymedicinesandtoensureavailability,accessibilityandaffordabilityofdrugsandmedicaldevicesinthecountry.

2.3 Mission:

• investmentforMakeinIndiainpharmasector

• MakeinIndiaincriticalAPIsandmedicaldevices

• industryexpansion,skilling,R&Dandinnovation

• stableandeffectivepriceregulationand

• genericmedicinesbyexpandingJanaushadhischeme

2.4 OrganizationalSet-up:

TheDepartmentisheadedbySecretarytotheGovernmentofIndiawhoisassistedbytwoJointSecretariesandoneEconomicAdviser.

TheDepartmenthasasmanyas13Divisionstocarryoutthevariousmandatedfunctionsandresponsibilities.ThesummaryofthevariousDivisionsisgivenbelow:

(a) IntegratedFinanceDivision (IFD)- exercisingexpenditurecontrolandmanagement,ensuringrationalizationofexpenditureandcomplianceofeconomymeasuresinaccordancewiththeinstruc-tionsoftheDepartmentofExpenditureincludingregularmonitoringofexpenditurethroughmonthly/Quarterly reviewsandsubmissionof reports to theconcerned. IFDalsoprepares thebudgetof theDepartmentinconsultationwithvariousDivisionsandDepartmentofExpenditure.

(b) PricingDivision-allmattersrelatingtoNationalPharmaceuticalPricingAuthority(NPPA)includ-ingadministrative/Establishmentbudgetarymatters/Fundreleaseetc.;ReviewcasesagainstNPPA’sor-ders;AdministrationofDPEAfunds;AdministrationofDPCOandallissuesrelatingtoPharmaceuticalPricingPolicy&Pricingofdrugs.

(c) PolicyDivision-allpolicymattersotherthanPricingPolicy;processingofForeignDirectInvest-ment(FDI)proposals;InternationalCooperationandanyothermattersrelatedtoWTO/TRIPS/Patents,

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etc.andtradeagreements;Jointworkinggroupsofvariouscountries,regionalgroupsetc.;Mattersre-latedtoMinistryofCommerce;issuesrelatedtoinvestmentinthepharmaceuticalandMedicalDevicesectors.

(d) PublicSectorUndertakings(PSUs)-allmattersrelatingtofiveCentralPublicSectorEnterprises(CPSEs)undertheadministrativecontroloftheDepartmentofPharmaceuticals.

(e) NIPERDivision -allmatters related toNational InstitutesofPharmaceuticalEducation&Re-search(NIPERs)undertheadministrativecontroloftheDepartmentofPharmaceuticals.

(f) SchemeDivision- implementationofthescheme“PMBJP”;Implementationof“Pharmaceuti-calsPromotionandDevelopmentScheme(PPDS)”;Coordination&PolicymattersrelatedtotheUm-brellascheme-“DevelopmentofPharmaceuticalIndustry”;R&DMatters-Promotion&coordinationofbasic,appliedandotherresearchrelatedtoPharmaceuticalsector.

(g) MedicaldeviceDivision-allmattersrelatedtoMedicalDevices&MedicalDeviceIndustryin-cludingpromotion,production&manufacture;implementationofthescheme“AssistancetoMedicalDeviceIndustryforCommonFacilityCentres”;Implementationofthescheme“AssistancetoBulkDrugIndustryforcommonfacilitycentres”.

(h) Rajbhasha-implementationofthevariousprovisionsoftheOfficialLanguagePolicyoftheUnionofIndiaincludingthoseofOfficialLanguagesAct,1963aswellasOfficialLanguages(UseforOfficialPur-posesoftheUnion)Rules,1976andordersissuedthereunder.

(i) Establishment & Administration Division- all matters related to Establishment, InformationTechnology (IT), Cash and Administration, dealing with provision of day to day articles needed forsmoothrunningofoffice,housekeepingservices,maintenanceofofficeequipmentincludingaircondi-tioners,photocopiersetc.,printingofannualreport,hospitalityservices.Establishmentdealswithallservice-relatedmattersofofficers/officialsofDepartmentofPharmaceuticals.

(j) ParliamentDivision- allmattersrelatedtotheMeetingsofconsultativecommittee,StandingCommittee,ParliamentaryAssurancesetcandalsocentralizedhandlingofparliamentquestions likemarkingofquestions,handlingofquestionsoncequestionsgetapprovedbyJointSecretary/Secretary,takingapprovalofMinisterandsubmissionofnecessarycopiestoLokSabha/RajyaSabha/PIBetc.

(h) CoordinationDivision- allmatters of coordination related to intra and inter-Dpartment, RTI,preparationofDepartmentAnnualreport.

(i) VigilanceDivision-allmattersrelatedtovigilance,transparencyandaccountability.

EmploymentofScheduledCastes/ScheduledTribes/PhysicallyHandicapped:-

ThestatusofemploymentofScheduledCastes/ScheduledTribes/OtherBackwardClasses/PhysicallyhandicappedintheDepartmentofPharmaceuticals,ason17/12/2019isasunder:-

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Table-2A(EmploymentpositionofSC/STintheDepartment)

Group TotalNo.ofPosts

Inposition ScheduledCastes

S c h e d u l e dTribes

Other Back-wardClasses

Physically Handi-capped

A 29 21 6 1 1 -B 46 23 3 3 6 -C 25 16 5 - 4 -

Total 100 60 14 4 11 -

OfficersinGroupAincludeofficersbelongingtoCentralSecretariatServicebesidesofficersondeputation fromAll IndiaServices,CentralServicesandotherDepartments/Undertakings.Appoint-menttopostsinGroupBandCismostlydonebasedonnominationsmadebytheDepartmentofPer-sonnel&Training.

(theorganisationalchartoftheDepartmentisgivenatAnnexure2A)2.5 AttachedOffice:-

NationalPharmaceuticalPricingAuthority– anattachedofficeoftheDepartmentandthefunctions,inter-alia,includefixationandrevisionofpricesofscheduledformulationsundertheDrugs(PricesCon-trol)Order(DPCO),aswellasmonitoringandenforcementofvariousprovisionsofDPCO.NPPAalsoprovidesinputstoGovernmentonPharmaceuticalpolicyandissuesrelatedtoaffordability,availabilityandaccessibilityofmedicines.2.6 RegisteredSociety:-

BureauofPharmaPSUsofINDIA(BPPI)–setupon1stDecember,2008bytheDepartmentofPharma-ceuticals,MinistryofChemicals&Fertilizers,GovernmentofIndia,withtheobjectivetohavefocusedandempoweredstructuretoimplementtheJanAushadhiSchemelaunchedbyDepartmentofPhar-maceuticals

2.7 AutonomousInstitutes:-

NationalInstituteofPharmaceuticalEducation&Research(NIPER)-NIPERatSASNagar(Mohali)wassetupasaregisteredsocietyundertheSocietiesRegistrationAct1860,SubsequentlytheInstitutewasgivenstatutoryrecognitionbyanactofParliament,NIPERAct,1998andwasdeclaredasanInstituteofNationalImportance.SixmorenewNIPERswerestartedatAhmedabad,Guwahati,Hajipur,Hyderabad,KolkataandRaebareliwiththehelpofMentorInstitutesduring2007-08.

2.8 PublicSectorUndertakings:-

CentralPublicSectionundertakings- theDepartmenthas5CentralPublicSectionundertakingsunderitsAdministrativecontrol,theyare(a)IndianDrugs&PharmaceuticalsLtd.(IDPL),DundaheraIndustrialComplex,Dundahera,Gurgaon,Haryana,(b)HindustanAntibioticsLtd,Pimpri,Pune,Maharahstra,(c)KarnatakaAntibiotics&PharmaceuticalsLimited,Bangalore-560010,(d)BengalChemicals&Pharma-ceuticalsLtd,Kolkata,WestBengaland(e)RajasthanDrugsandPharmaceuticalsLimited.RoadNO.12,V.K.I.Area,Jaipur-302013.

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ORGANIZATION CHART – DEPARTMENT OF PHARM

ACEUTICALSShri D. V. Sadananda Gow

da Hon'ble M

inister

Shri Mansukh L. M

andaviya Hon'ble M

inister of State

Dr. P. D. Vaghela, Secretary

Shri Navdeep Rinwa, JS

(Policy, Pricing, Scheme

including PMBJP, IC,

Scheme, M

edical Device)

Shri M. K.

Bhardwaj, DS

(Policy, Pricing)

Ms. Aprana,

US (Pricing)

Ms. Rem

ya Prabha, DD

(Policy)

Shri Jitendra Trivedi, Dir.

(Scheme, M

edical Device)

Shri Navin Kishor Joshi, US (Schem

e)

Shri Sandeep Kum

ar, US (M

edical Device)

Shri Rajneesh Tingal, JS (PSU, NIPER)

Shri A. V. Lakra, DS

(PSU)

Ms. Um

a M

agesh, US (PSU)

Shri Devendra Kum

ar, Dir (NIPER)

Shri Satish Kum

ar, US (NIPER)

Shri H. K. Hajong, EA (Parliam

ent, Coordination, Vigilance, Adm

in, Establishment,

Cash, Rajbhasha)

Shri Parveen Kum

ar, DS (Adm

in, Estt., IT & M

edia, Cash)

Shri Arvind Kum

ar, US (Adm

in, Estt & IT, Cash)

Shri Jitendra Trivedi, Director

(Parliament &

Coordination)

Shri S. U. Ansari, US

(Parliament &

Coordination)

Shri S. U. Ansari, US (Vigilance)

Shri Jitendra Trivedi, Director

(Rajbhasha)

Ms. Kiran

Chauhan DD (OL)

Ms. Anshu

Gupta, AD (OL) Ms. Ritu Dhillon,

JS & MS

(FDI) Shri M. K.

Bhardwaj, DS

(FDI)

Ms. Rem

ya Prabha, DD (FDI)

Ms. Alka

Tiwari, AS &

FA

Ms. Barnali

Khastgir, US (IFD)

Annexure-2A

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CHAPTER 3 ABOUTMEDICALDEVICEINDUSTRY 3.1 IndianMedicalDeviceSector

3.2 ImportandExportTrends

3.3 InvestmentScenarioinMedicalDeviceSectorinIndia

3.4 Existing&ProposedMedicalDeviceClustersinIndia

3.5 InitiativesforPromotionofMedicalDeviceIndustry:

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CHAPTER 3

ABOUTMEDICALDEVICEINDUSTRY

Medicaldeviceindustryisagrowingfieldandthepotentialforgrowthisthehighestamongallinthehealthcaresector.Thevariouscategoriesofdevicesstartingfromconsumablestoimplantablemedicaldeviceslikecardiacstentsandorthopedicimplantsetc.arebeingmanufacturedinIndia.Themajormanufacturingofmedicaldevicesinthecountryiscurrentlyhappeningwithrespecttodispos-ablessuchascatheter,perfusionsets,extensionlines,cannula,feedingtubes,needles,syringes,andimplantssuchascardiacstents,drugelutingstents,intraocularlensesandorthopedicimplants.

High-endmedicaldevices

MedicalDevices are verydifferent fromDrugs. TheMedicalDevice Industry is highly capitalintensivewithalonggestationperiodandrequiresdevelopment/inductionofnewtechnologies.TheMedicalDeviceSectoralsorequirescontinuoustrainingofhealthproviderstoadapttonewtechnolo-gies.Sincemosthi-techinnovativeproductsandtechnologyoriginatefromawell-developedeco-sys-temandinnovationcycle,whichisyettobefullydevelopedinIndia,IndianMedicalDeviceindustrydependsonimportsuptotheextentofalmost80%.DepartmentofPharmaceuticalshasamandatetoboostthemedicaldevicemanufacturingsectorinIndia.

Basicmedicaldevices

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3.1 IndianMedicalDeviceSector:-

InIndia,thereisskilledmanpowerhavingcapacitytomakedevicesundertheMakeinIndiaini-tiativeoftheGovernment.Therearegrowingresearchandmanufacturingopportunitiesinthecountry.However,thereisstillnon-availabilityofIndianplayersinmanufactureofhigh-endmedicaldevices. Themedicaldevicemarketencompassesawide rangeofproducts from relatively lowvalueitemssuchasSyringesandNeedlestothehighvalueequipmentsuchasCTScansandCathLabsetc.Themedicaldevicesindustrycanbebroadlyclassifiedasconsistingof(a)medicaldisposablesandconsum-ables;(b)medicalelectronics,hospitalequipment,surgicalinstruments;(c)Implants;and(d)DiagnosticReagents.AstatisticalviewoftheSectorisasunder:

• India’sshareinglobalmedicaldevicesmarketis1.5%.ItwasvaluedclosetoINR49842 crorein2018-19. • Currently,Indiaiscountedamongthetop30globalmedicaldevicemarketsandisthe 4thlargestmedicaldevicemarketinAsiaafterJapan,ChinaandSouthKorea. • In2018-19,CardiovascularDevicesformthelargestsegment(18%oftheIndianmedi caldeviceindustry),constitutingaboutINR8,772Crore,whiletheestimatedmarket sizeoftheconsumablessegmentisINR6,220Crore.

Graph-3(i)

Source:KalamInstituteofHealthTechnology(KIHT)

3.2 ImportandExportTrends:- India’s exports and imports ofmedical devices are growing significantly. In 2018-19, exportswerevaluedatINR14,867crorewhereasimportswereINR38948crorewithanannualgrowthrateof25.29%and24.2%respectively.ThefigureshowsthatIndiaimportsalargeshareofitsmedicaldeviceneeds.

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Table3A

(Exportsover100Croresanditscorrelativeimports)

(InRs.Crore)

Sr.No HSCode ProductDescription Exports2018-19

Imports2018-19

1 901890 OtherInstrumentsandappliancesofMedicalScience 1530 5189

2 901839 CathetersandTheLike;OtherNeedles 2100 20263 902230 X-RayTubes 885 2494 901819 Other Electro-Diagnostic Apparatus Including These

ForFunctionalExploratoryExaminationOrForCheck-ingPhysiologicalParameters

770 433

5 902290 Other,IncludingPartsandAccessories: 682 20056 902214 Other,ForMedical,SurgicalorVeterinaryUses 427 13137 382200 CompstDiagnostic/LaboratoryReagentsExclGoodsof

Heading.No.3002/3006385 3334

8 902139 Other 341 9369 902110 OrthopeaedicOrFractureAppliances 269 13810 901832 TubularMetalNeedlesandNeedlesforSuture 249 36311 902780 OtherInstrumentsandApparatusofHeading9027 238 2602

12 901831 Syringes,W/NwithNeedles 225 42413 901813 MagneticResonanceImagingApparatus 223 102114 300610 SterileSurgicaletcForSurgicalWoundClosuresterile

LaminariaetcSterileAbsorbleSurgicalorDentalHae-mostatics

219 96

15 901811 Electro-Cardiographs 211 4616 902790 Microtome;PartsandAccessoriesofHeading9027 206 2237

17 901812 UltrasonicScanningApparatus 199 116318 901850 OtherOphthalmicInstrumentsandAppliances: 159 115919 902131 ArtificialJoints 133 82520 902710 GasorSmokeAnalysisApparatus 128 73821 902750 OtherInstrumentsandApparatusUsingOpticalRadia-

tions(UV,Visible,IR): 125 991

22 940290 Medical,Surgical,VeterinaryFurnitureandParts 113 290

23 902190 OtherAppliancesofHeading9021 102 974

Source:EngineeringExportPromotionCouncil(EEPC)

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3.3 InvestmentScenarioinMedicalDeviceSectorinIndia:-

ThemedicaldevicesectorhasbeenseeingconsiderableForeignDirectInvestment(FDI),Ven-tureCapital(VC)andAngelfundingactivityaswell.

InJanuary2015,GovernmentofIndiamodifiedtheFDIregulationsallowing100percentFDIunderautomaticrouteinGreenfieldandbrownfieldprojectsinmedicaldevicesector.USA,EuropeandJapanarethekeysourcecountriesforFDIinmedicaldevices.Theequipmentandinstruments,consum-ablesandimplantssegmentshaveattractedthemostFDI.

3.4 Existing&ProposedMedicalDeviceClustersinIndia:-

Overtheyears,variousmedicaldeviceclustershaveemergedacrossthecountry.SomeofthekeystateshousingIndianandmultinationalmedicaldeviceplayersareasunder.

Graph-3(ii)

MedicalDeviceClustersinIndia

3.5 InitiativesforPromotionofMedicalDeviceIndustry:-

ThevisionoftheDepartmentistocatalyseandencouragequality,productivityandinnovationinMedicalDeviceSectorandtoenabletheIndianMedicalDeviceIndustrytoreducethedependenceonimportofMedicalDevices.Forthis,worldclassqualitymanufacturingfacilitieswithhighlevelofpro-ductivitywithinnovativecapabilitiesarerequired.However,theseareverycapitalintensiveandcannotbeestablishedandopenedbyMedicalDeviceManufacturingUnitsontheirownduetofinancialcon-straints.DepartmentofPharmaceuticalshascontemplatedthefollowingsub-schemeforthispurpose:

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Thesub-scheme-“promotionofMedicalDeviceparks”aimstosupport‘MakeinIndia’,reduceimportdependence,easyaccesstostandardtestingfacilities,reducethecostofproductionforafford-abilityandvalueadditioninthedomesticmedicaldeviceindustry.Thesub-schemewouldbeimple-mented through a one-timegrant-in-aid to be released for creationof identified infrastructure andcommonfacilitiestoaStateImplementingAgencysetupforthepurpose.ThetotalsizeoftheSchemeisproposedasRs.600croreforfiveyears(2020-2025).Underthesub-scheme,financialassistancetothetuneofRs.100croreor70%oftheprojectcostmaybeprovidedforcreationofcommonfacilitiesinanyupcomingMedicalDeviceParkspromotedbyStateGovernments/StateCorporations.IncaseofSC&STcommunitiesandNorthEastRegion,thegrant-in-aidwouldbeRs.100croreperMedicalDeviceParkor90%oftheprojectcostofCommonFacilities,whicheverisless.TheSchemeSteeringCommitteeundertheChairmanshipofSecretaryPharmaisempoweredtoapproveprojectsunderthesub-scheme.

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CHAPTER 4 PRADHANMANTRIBHARTIYAJANAUSHADHIPARIYOJANA(PMBJP)

4.1 BackgroundoftheScheme

4.2 Progressachievedduring2019-20

4.3 Achievementsofthefirst100daysofincumbentgovernment 4.4 Technologyorientedinitiatives

4.5 Progresslikelytobemadeby31stMarch2024asenvisaged invisionplan

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Chapter4

PRADHANMANTRIBHARTIYAJANAUSHADHIPARIYOJANA(PMBJP)

4.1 BackgroundoftheScheme:

Withanobjectiveofmakingqualitygenericmedicinesavailableataffordablepricestoall,Prad-hanMantriBhartiyaJanaushadhiPariyojana(PMBJP)waslaunchedbytheDepartmentofPharmaceu-ticals,MinistryofChemicals&Fertilizers,GovernmentofIndia.Underthisscheme,dedicatedoutletsknownasPradhanMantriBhartiyaJanaushadhiKendras(PMBJK)areopenedtoprovidegenericmedi-cines.

ObjectivesofthePariyojana:-

• Ensureaccesstoqualitymedicinesforallthesectionofthepopulationespeciallyforthepoorandthedeprivedones.

• Createawarenessaboutgenericmedicinesthrougheducationandpublicitytocountertheperceptionthatqualityissynonymouswithhighprice.

• GenerateemploymentbyengagingindividualentrepreneursinopeningofPMBJPkend-ras.

BureauofPharmaPublicSectorUndertakingsofIndia(BPPI):

BureauofPharmaPublicSectorUndertakingsofIndia(BPPI)wassetupbytheDepartmentofPharmaceuticals,MinistryofChemicals&Fertilizers,GovernmentofIndia,withmajorobjectivetohavefocusedandempoweredstructuretoimplementtheJanAushadhiCampaigninitiatedbytheDepart-mentofPharmaceuticals.

TheNeed:

Despitebeingoneoftheleadingexportersofgenericmedicinestotheworld,majorityofIndianshavenoaccesstoaffordablemedicines.Asperarecentlypublishedresearchpaperbasedoncross-sec-tionalanalysisofNationalSampleSurveyOrganization(NSSO)data,55millionIndianswerepushedintopovertyinasingleyearbecauseofhavingtofundtheirownhealthcare,andoutofthis,38millionfellbelowthepovertylineduetospendingonmedicinesalone.

Itistruethatthetotalexpenditureonout-patientcareissignificantlyhigherthanthein-patientcare.Further,asperthe71stRound(January-June2014)reportoftheNationalSampleSurveyOrganiza-tion(NSSO)onHealthinIndia,purchaseofmedicineaccountedforaround72%inruralsector,and68%inurbansector,ofthetotalexpenditureonnon-hospitalizedtreatmentofailments.

SalientfeaturesoftheScheme

Inordertoincreasethereachtogeneralpublicandtocreateemploymentopportunities,PMBJPKendrasareallowedtobeopenedbyindividualentrepreneurs,NGOs,societies,Institutions,pharma-cists,governmentbodiesatanysuitableplace.Thishasprovideddirectsourceofsustainableemploy-

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mentforabout11600educatedunemployedyouthofthecountrybyengagingtheminthescheme.

• PMBJKopenedbytheanyindividualentrepreneursisextendedanincentiveof15%ofmonthlypurchasessubjecttoaceilingofRs.10,000/-permonthuptoatotallimitofRs.2.5lakh.

• Forthenortheasternstates,Naxalaffectedareaandtribalareas,therateofincentiveis15%ofmonthlypurchasessubjecttoaceilingofRs.15,000/-permonthuptoatotallimitofRs.2.5lakh.IndividualSC/STanddifferentlyabledentrepreneursarealsoprovidedmedicinesworthofRs.50,000/-inadvance.

Graph-4(i)

SavingstothecommonmanAmedicineunderPMBJPispricedontheprincipleofamaximumof50%oftheaveragepriceof

topthreebrandedmedicines.Therefore,thepriceofJanAushadhiMedicinesischeaperatleastby50%andinsomecases,by80%to90%ofthemarketpriceofbrandedmedicines.Inthecurrentfinancialyear(2019-20),PMBJPhasachievedsalesofRs.258crores(atMRP),upto30-11-2019.ThishasledtosavingsofapproximatelyRs.1800croresofthecommoncitizensofthecountry.

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4.2 ProgressAchievedDuring2019-20

CoverageofthePariyojana– Presently,6068PMBJPKendrasarefunctionalacrossthecountry.UnderthePMBJP,696districtsoutof725,arealreadycovered.BPPIhasfixedatargettocoverall725districtsofthecountryby31stMarch,2020.

Basketofmedicines&Stockposition–Productbasketcomprisesofmore than800drugsand154surgical instruments.Tenders for requiredmedicinesarefloatedonregularbasisas it isanongoingprocess.Thus,regulareffortsaremadeforaugmentingtheproductbasketofPMBJPsothatessentialmedicinesarereadilyavailable.

SupplyofMedicinestoPMBJPKendras– InformationTechnology(IT)enabledEnd-to-EndsupplychainsystemwithPoint-of-Sale(POS)applicationforvalueaddedserviceshasbeenimplementedinPMBJP.BureauofPharmaPSUsof India (BPPI), the implementingagencyofPMBJPhas fourmodernware-housesatGurugram,Bengaluru,GuwahatiandChennaiforstorageanddistributionofdrugs.Drugsaremadeavailabletoallkendrasacrossthecountryfromthesewarehouses.

QualityofMedicinesunderPMBJP–

BPPIprocuresmedicinesonlyfromWorldHealthOrganization–GoodManufacturingPractices(WHO-GMP)certifiedsuppliersforensuringthequalityoftheproducts.Apartfromthis,eachbatchofdrugsistestedatlaboratoriesaccreditedby‘NationalAccreditationBoardforTestingandCalibrationLaboratories’(NABL).Onlyafterpassingthequalitytests,themedicinesaredispatchedtoPMBJPKen-dras.

Awareness&Publicity–

BureauofPharmaPSUsofIndia(BPPI),theimplementingagencyofPMBJPisspreadingaware-ness about the salient featuresof PradhanMantri Bhartiya Janaushadhi Pariyojana through varioustypesofadvertisementsuchPrintMedia,Radioadvertisement,TVadvertisement,CinemaAdvertise-mentandOutdoorpublicitylikeHoardings,BusQueueShelterbranding,Busbranding,Autowrappingetc.Inadditiontothis,BPPIalsoeducatesthepublicabouttheusagesofJanAushadhigenericmedi-cinesthroughsocialmediaplatformslikeFacebook,twitter,Instagram,YouTube,etc.onregularbasis.

4.3 Achievementoffirst100Daysofincumbentgovernment-

1) [email protected]/-perpad

ToensureeasyavailabilityofthemenstrualhealthservicestoallwomenacrossIndia,“Janau-shadhiSuvidha”sanitarypadshavebeenmadeavailableforsale@Rs1.00perpadsince27thAugust,2019inmorethan5800“PradhanMantriBhartiyaJanaushadhiKendras”acrossthecountry.Morethan60.25lakhpadshavebeensold@Rs.1.00perpadsince27thAugust,2019.

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Rs.1/-sanitarynapkinlaunchedbytheHon’bleMinister(C&F)andHon’bleMoS(C&F)on27thAugust,2019inNewDelhi

2) Openingof300newkendrasacrossthenation

313newkendraswereopenedacrossthenation.

3) InaugurationofregionalwarehouseinChennai

ModernwarehousewasinauguratedinChennaiforbetterlogisticsinSouthernIndia.

Modern warehouse for Jan Aushadhi medicines inaugurated by Hon’ble Minister (C&F) in Bengaluru on20.02.2019.

ModernwarehouseforJanAushadhimedicinesinauguratedbyHon’bleMoS(C&F)inGurugramon16.10.2018

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4.4 Technologyorientedinitiatives

(a) LaunchofmobileapplicationforeaseofaccesstoJanaushadhistoresandpricecomparison: Inordertomakeuseofdigitaltechnologyforeasingthe lifeofconsumers,amobileapplica-tionforPradhanMantriBhartiyaJanaushadhiPariyojana(PMBJP)i.e.“JanaushadhiSugam”waslaunchedforfacilitatingthegeneralpublicbyprovidingadigitalplatformatthetipoftheirfin-gers,byvirtueofwhichtheycanavailahostofuser-friendlyoptionslikelocatingnearbyJanau-shadhiKendra,directionguidedthroughGoogleMapfor locationoftheJanaushadhikendra,searchingJanaushadhigenericmedicines,analyzingproductcomparisonofGenericvsBrandedmedicineinformofMRP&overallSavings,etc.ThemobileapplicationisavailableonbothAn-droid&iOSplatforms.ItcanbedownloadedfreebytheuserfromGooglePlayStoreandAppleStore.

‘JanAushadhiSugam’mobileapplaunchedbytheHon’bleMinister(C&F)andMoS(C&F)on27thAu-gust,2019inNewDelhi

Thus,thisapplicationwillbeinstrumentalincreatingbetteraccessibilitytoaffordablemedi-cinesandcreationofawarenessaboutgenericmedicines.

(b) Digitalpaymentoptions:PradhanMantriBhartiyaJanaushadhiPariyojana(PMBJP)hasenteredintoanMoUwithPaytm(One97)inthemonthofMay2019forprovidingthePMBJKtheoptiontore-ceivepaymentsfromitsretailers/customersthroughPaytmplatformamongstotherpaymentoptionsforvariousproducts/servicesdistributed/soldbythem.OnboardingoptionisbeingrolledoutbyPaytminaphasedmannerandthePMBJKisatlibertytoavailtheoptionoutofchoice

4.5 Progresslikelytobemadeby31stMarch2024asenvisagedinvisionplan-

1. Coverage:TargetistocoveralldistrictsofthecountrybyopeningatleastonePMBJKineverydistrict,sothatatotalof10000kendrasbecomefunctionalbytheendof31stMarch2024.

2. Basketofmedicines:Thepresentproductbasketconsistsofmorethan800medicinesand154 surgicalinstruments.Targetissettoenhanceitupto2000medicinesand300surgicalproducts,

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sothatallessentialmedicinescoveringtherapeuticgroups,like-AntiDiabetics,Cardiovascular Drugs,Anti-Cancer,Analgesics&Antipyretics,AntiAllergic,GastroIntestinalAgents,Vitamins, Minerals&Foodsupplements,TropicalMedicines,etc.getincluded.

3. Storage&Logistics: Establishmentofaneffective IT-enabled logisticsandsupply-chainsyste-forensuringrealtimedistributionofmedicinesatalloutletstoavoidstockoutsituation.BPPIhasfourwarehousesatpresentatGurugram,Chennai,Bengaluru&Guwahati.Further,ithasplannedtoopentwomorewarehousesinWesternandCentralIndia,respectively.

JanAushadhiDiwascelebration–

FortheannouncementofJanAushadhiDiwas,aPressconferencewasheldon6thMarch,2019atPIBHall,ShastriBhawan,NewDelhi. ItwasannouncedduringtheconferencethatHon’blePrimeMinisterShriNarendraModiwouldinteractwithbeneficiariesoftheschemeaswellaspersonsrunningtheoutletsthroughvideoconferencingandthiswouldbetelecastedlivethrough‘Door-Darshan’.

AllKendraOwnersofPMBJPcelebratedthe“JanaushadhiDiwason7thMarch,2019”attheiroutletsoranyconvenientplacewheretheycouldtelecastthemessageofHon’blePrimeMinisterwithTVsets.Eventsatthestorescommencedat12noon.TheHon’blePrimeMinisterstartedinteractingwithbeneficiariesat1pm.Theeventwasattendedby8MinisterofStatesofdifferentCentralGov-ernmentDepartments.MinisterofStateforChemicals&Fertilizers,ShriMunsukhMadaviyaattendedtheeventatLucknow.OtherMinistersattendedthefunctionsorganizedatdifferentplaces.Further,doctors,pharmacists,representativesfromNGO,mediaandothereminentpersonalitiesparticipatedinevents.BikeRallies,padayatras,nukkadnataks,healthcampsandothereventswereorganisedforcreatingawarenessaboutqualityandaffordabilityof‘janaushadhi’.Itarousedinterestofcommonmanaboutthescheme.Itgotactivecoveragefromallcornersofmediaandtheypublishednews&discussedtheeventindetail.Further,JointSecretary(Pharma)ShriNavdeepRinwa&CEOBPPI,ShriSachinSinghappearedin2differenttalkshowsatDoordarshanandtalkedaboutvariousfeaturesofthescheme.AtalkshowwasalsoorganisedbyAllIndiaRadiowhichwasairedat9.45pmonthesameday.Eventend-edwithmessageofHon’blePrimeMinister.

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CHAPTER 5 NATIONALINSTITUTESOFPHARMACEUTICALEDUCATION&RE-

SEARCH(NIPERs)

5.1 Background

5.2 NIPERMohali

5.3 NIPERHyderabad

5.4 NIPERGuwahati

5.5 NIPERKolkata

5.6 NIPERRaebareli

5.7 NIPERAhmedabad

5.8 NIPERHajipur

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CHAPTER5

NationalInstitutesofPharmaceuticalEducation&Research(NIPERs)

5.1 Background

1. IndianPharmaIndustryhasbeenagloballeaderinGenericdrugs.Inordertoacquireleadershippositionindrugdiscoveryanddevelopmentandtocontinuetoexcelintheformulations,Governmentrecognizedthathumanresources/talentpoolisverycritical.NationalInstituteofPharmaceuticalEdu-cation&Research(NIPER)atSASNagar(Mohali)wassetupasaregisteredsocietyundertheSocietiesRegistrationAct1860.SubsequentlytheInstitutewasgivenstatutoryrecognitionbyanactofParlia-ment,NIPERAct,1998andwasdeclaredasanInstituteofNationalImportance.

2. During2007-08,sixnewNIPERswerestartedatAhmedabad,Guwahati,Hajipur,Hyderabad,Kol-kataandRaebareliwiththehelpofMentorInstitutes.Subsequently,NIPERatMaduraiwasapprovedintheyear2012.During2015-16,FinanceMinisterinhisBudgetSpeechannounced3newNIPERsforthestatesofChhattisgarh,MaharashtraandRajasthan.ThepresentstatusofNIPERsisasunder:

Table-5A(PresentstatusofNIPERs)

NIPER Academ-icsessionstartedin

Statusofland/construction

Mohali 1998 NIPER,Mohalihasitsowncampusin129.25Acresofland.

Ahmedabad 2007 60acreslandinGandhinagar,GujarathasbeenallocatedandHin-dustanSteelworksCorporationLimited(HSCL)hasbeenselectedas ProjectManagement Consultant (PMC). The tender for con-structionofcampushasbeenfinalized.

Guwahati 2008 51.42acreslandatVillageSila,ChangsariDist,KamruphasbeenallocatedandEngineeringProjectsIndiaLimited(EPIL)hasbeenselectedasProjectManagementConsultant(PMC).Constructionwasstarted in June2015.More than80%constructionworkofthecampushasbeencompleted.

Hajipur 2007 12.5 acresof land at EPIPCampus, IndustrialArea,HajipurhasbeenallocatedbyGovt.ofBihar.

Hyderabad 2007 GovernmentofTelanganahasallocated50acresoflandforcon-structionofNIPER-Hyderabadcampus.TheDepartmenthaspro-posedtoallot50acresofIDPLlandtoNIPER-Hyderabadforcon-structionofpermanentcampus.

Kolkata 2007 10acresof landatMouza-Gopalpur,P.S.Kalyani,DistNadiahasbeenallocatedbyGovt.ofWestBengal.Departmenthasproposedtoallot25acresoflandofBCPLtoNIPER-Kolkataforconstructionofpermanentcampus.

Raebareli 2008 49 acres land at Village Vinayakpur, Pargana Bachrawan, TehsilMaharajganj,Raebarelihasbeenallocated.

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TheaimsandobjectivesofNIPERare:

(i) tonurtureandpromotequalityandexcellenceinpharmaceuticaleducationandre-search:

(ii) to concentrate on courses leading to master’s degree, doctoral and post-doctoralcoursesandresearchinpharmaceuticaleducation;

(iii) toconferhonoraryawardsorotherdistinctions:

(iv) tocooperatewitheducationalorotherinstitutionshavingobjectiveswhollyorpart-lysimilar tothoseof the Institutebyexchangeof facultymembersandscholarsandgenerallyinsuchmannerasmaybeconductivetotheircommonobjective

(v) toconductcoursesforteachers,pharmaceuticaltechnologies,communityandhos-pitalpharmacistsandotherprofessionals:

(vi) to collect andmaintainworld literature on pharmaceutical and related sciencesandtechnologysoastodevelopaninformationcentreofitsownkindforotherinsti-tutionswithinthecountryandinthedevelopingworld:

(vii) tocreateacentralfacultyofpharmaceuticalinstrumentationandanalysisforusebytheresearcheswithinandoutsidetheInstitute:

(viii) tohaveacentretoexperimentandinnovateandtotrainteachersandotherwork-ersintheartorscienceorpharmaceuticalteaching:

(ix) todevelopaworldlevelcentreforcreationofnewknowledgeandtransmissionofexisting information in pharmaceutical areaswith focus on national, educa-tionalprofessionalandindustrialcommitments:

(x) todevelopamulti-disciplinaryapproachincarryingoutresearchandtrainingofphar-maceuticalmanpowersothatthelargerinterestsoftheprofessionacademiaandpharmaceuticalindustryarebetterservedandapharmaceuticalworkcultureisevolvedwhichisintunewiththechangingworldtrendsandpatternsofpharma-ceuticaleducationandresearch:

(xi) to organise national or international symposia, seminars and conferences in se-lectedareasofpharmaceuticaleducation,fromtimetotime:

(xii) toarrangecoursescateringtothespecialneedsofthedevelopingcountries:

(xiii) toactasnucleusfor interactionbetweenacademicandindustrybyencouragingex-changeofscientistandothertechnicalstaffbetweentheInstituteandtheindus-tryandbyundertakingsponsoredandfundedresearchaswellasconsultancyprojectsbytheInstitute:and

(xiv) topaydueattentiontostudiesonthedistributionandusageofdrugsbytheruralmasses,takingintoaccountthesocio-economicspectruminthecountry.

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AdministrativestructureofNIPERs

NIPERActwasnotified intheyear1998(Amended in2007),NIPERStatuteswerenotified in2003(Amendedin2014),NIPEROrdinancesnotifiedin2005(Amendedin2014).

BoardofGovernorsandotherCommittees

BoardofGovernors(BoG)oftherespectiveInstituteisresponsibleforgeneralsuperintendence,directionandcontrolofitsaffairs.Chairman,BoGisappointedbytheVisitor.DirectoroftheInstituteisappointedbytheBoGwithpriorapprovalofVisitor.BoGofNIPERMohaliwasconstitutedon03.10.2016foratermofthreeyears,whichhasexpiredon02.10.2019.FirstBoGofothersixNIPERsconstitutedon09.03.2019.

Table-5B

(BoardofGovernorsofNIPERs)

NIPER Chairman:BoGNIPER

NIPER-Ahmedabad Dr.KetanR.Patel

Chairman-cumManagingDirector,TroikaaPharmaceuticalsLtd.,GujaratNIPER-Guwahati Dr.SChandraShekhar

Director,CSIR-IICT,Tarnaka,HyderabadNIPER-Hajipur Dr.SanjaySingh

ViceChancellor,BabasahebBhimraoAmbedkarUniversity,Lucknow

NIPER-Hyderabad Dr.SatishReddy

Chairman,Dr.Reddy’sLaboratoryLtd.Hyderabad

NIPER-Kolkata Prof.(Dr.)BhabatoshBiswasFormerViceChancellorBengalUniversityofHealthSciencesKolkata

NIPER-Raebareli Prof.RakeshKapoorDirector,SanjayGandhiP.G.I.M.S.Lucknow

AnApexCouncilforpolicyissuesandcoordinationamongstvariousNIPERswasconstitutedwithapprovalofMinister(C&F)on07.05.2019.

OtherStatutoryCommitteesoftheInstitutesinclude:

• Senate

• AcademicPlanningandDevelopmentCommittee

• FinanceCommittee

• LaboratoryServices,BuildingandWorksCommittee

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AdmissionProcedureinNIPERs:

AtpresenttheseNIPERsimpartPh.D.andPGleveleducationandgrantdegreeundertheNIPERAct,1998.Thestudentsareselectedthroughacommonentranceexamination.EachMasterstudentisgivenstipendofRs.12,400/-andPh.DstudentsaregivenastipendofRs.31,000–Rs.33,000/-permonth.

NationalInstitutionalRankingFramework(NIRF):

AsperNationalInstitutionalRankingFrameworkoftheMinistryofHumanResourceDevelop-ment,underthepharmacycategory,threeNIPERsareamongstthetoptenpharmacyInstituteinthecountryasunder:-

Table-5C(NIPERsinNIRFranking)

NIPERs 2017 2018 2019Mohali 2nd 1st 3rd

Hyderabad 5th 6th 6th

Ahmedabad - 14th 9th

ApprovalofExpenditureFinanceCommittee(EFC)

TheEFCinitsmeetingheldon26.3.2018forconstructionandequippingoftenNIPERsincludingnewannouncedNIPERs,approvedRs959.53crorefortheperiod2017-18to2019-20.ConstructionofregularcampuswasapprovedforNIPERAhmedabadandGuwahationly@Rs103.88croreeach.Fur-ther,Rs100.00croreeachwereapprovedforequipmenttoNIPERAhmedabad,Guwahati&HyderabadwhileRs55.00croreeachapprovedforNIPERHajipur,Kolkata&Raebareli.TheEFC,however,deferredsettingupoftheproposedfournewNIPERsatMaduraiandintheStatesofMaharashtra,RajasthanandChhattisgarhtillMarch2020.

Creationofregularfacultyandnon-facultyposts

NIPER-Mohalihasregularfacultypostsandnon-facultyposts.DepartmentofExpenditurehascreated156facultyand150non-facultypostsinsixNIPERsviz.Ahmedabad,Guwahati,Hajipur,Hyder-abad,KolkataandRaebareliinJanuary2019.ThedetailsofthepostsfilledbyNIPERsinphaseIareasunder:-

Table-5D(DetailsofpostsfilledbyNIPERsinPhase-I)

NIPER No.ofPostsSanctioned No.ofPostsfilled.Faculty Non-faculty Faculty Non-faulty

NIPER-Ahmedabad 33 25 21 25postshasbeenad-vertised and likely tobefilledshortly.

NIPER-Guwahati 33 25 8 6

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NIPER-Hajipur 19 25 UnderprocessNIPER-Hyderabad 33 25 14 7NIPER-Kolkata 19 25 7 7NIPER-Mohali 62 223 26 127NIPER-Raebareli 19 25 11facultyand10nonfacultypostshas

beenadvertisedandlikelytobefilledby31stJanuary2020.

TheremainingpostswillbefilledbysixNIPERsinPhaseIIandPhaseIII.

Studentspassedout,Researchpaperspublished,PatentfiledandMoUsigned

Sinceinception,totalnumberof5901students(MPharma/MBA-5582;PhD-319)havepassedout,141MOUssignedwithIndustries,223patentsfiled/87granted,about4016researchpaperspub-lishedinvariousreputedjournalstill31stDecember2019bythesevenexistingNIPERs.

5.2NIPERMohali

NIPERMohalihasbeenconceptualized,plannedandsetuptoprovideleadershipinpharma-ceuticalsciencesandrelatedareasnotonlywithinthecountry,butalsotothecountriesinSouthEastAsia,SouthAsiaandAfrica.Itisonlyoneofitskindinitsdomainandishighlyvaluedforitsoutcomes–namelywelltrainedandfocusedhumanresources(students/researchers);publicationsofhighimpactandnovelprocesses/outputsofindustrialrelevanceinitschosenareasofworking.NIPERMohalihasacampusthatcatersforresearchfacilitiesfortendifferentfields,threeboyshostelsandagirlshostel,onemarriedhostelunit,133quartersfortheNIPERstaff.BoardofGovernorshasbeenconstitutedtooverseeitsfunctioning.NIPERoffersMasters’andPh.D.degreesin15streamsandcaterstothevariousneedsofpharmaceuticalindustry:

1. Achievements–

Academicexcellence: In2019-20,theInstitutehaspublished81articlesinjournalsofrepute(till31stDecember,2019).Institutehasfiled190patentsandoutofwhich87aregrantedtilldate.Sincetheinceptionofacademicprogramme(till31stDecember,2019),3496 studentshavepassedout(Mas-ters2579,MBA597&Ph.D.320).

2. Research–

A. Neglecteddiseases- Researchiscarriedoutintheareasoftuberculosis,leishmaniasis andmalaria.Newmoleculesarebeingsynthesizedandtheirmechanismsofactionarebeing workedout.

B. Otherdiseases-Metabolicpathwaysindiseaseslikeinflammation,infection,cancer, diabetes,obesity,Parkinson’sdisease,neurodegenerationarebeingworkedout.

C. Drugdevelopmentandformulation

i. Improvementoforalbioavailability,synergisticanticancerefficacyandreducedtoxicityofdrugshasbeenattempted.

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ii. Newformulationsarebeingdeveloped.’

iii. StandardizationofHerbaldrugsandformulations

iv. Toxicologicalstudies

D. Otherareas

i. Biopharmaceuticals

ii. Epigenetics

iii. Chemo-enzymaticsynthesisofdrugs

iv. Monographonherbalsisbeingdeveloped.

v. StudyoftheeffectofRNAaptamersonstabilizationofmisfoldedproteins

vi. Assessmentofanappropriateandreliablemethodtodiagnoseneuropathicpain

vii. Artificialintelligence,MachineLearning,BigdataAnalytics.

viii. UtilityofPhysiologyBasedPharmacokinetic(PBPK)ModelinginpredictionofPKofdrugsinspecialpopulationsandinstudyoffoodeffectsondrugPK

3. AcademicandNon–academicStaff

Table-5E

(Academicandnon-academicstaffposition)

Man-Power Sanctioned In-Position VacancyAcademic 62 26 36

Non-Academic 223 127 96

4. TotalfundallocatedbytheGovernmentduringthelast4years

Table-5F

(AllocationoffundbytheGovernmentduringlast4years)

(Rs.Incr.)

Year AllocationBE AllocationRE TotalRelease

2016-17 27.49 27.48 27.482017-18 27.74 42.32 42.31

2018-19 32.00 29.00 29.002019-20* 30.60 30.60 26.20

*FundreleasedtillDecember2019

5. Students

Degrees/programmesofferedandsubjectsoffered(withyear)withadmissionstatus

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Table-5G

(Degrees/programmes/subjectsofferedyear-wisewithadmissionstatus)

Level

Masters/Doctoral

Degree

MS/MBA/M.Tech/Ph.D

Discipline No.of studentsadmit-ted

Years 2018-19 2019-20Masters’ M.S.(Pharm.)

MedicinalChemistry26 28

Doctoral PhD 2 2

Masters’ M.S.(Pharm.)Pharmacoinformatics

20 17

Doctoral PhD 2 0

Masters’ M.S.(Pharm.)NaturalProducts

12 13Doctoral PhD 0 4Masters’ M.S.(Pharm.) TraditionalMedicine 3 5Masters’ M.S.(Pharm.)

PharmaceuticalAnalysis8 9

Doctoral PhD 0 0Masters’ M.S.(Pharm.)

Pharmacology&Toxicology18 18

Doctoral PhD 3 4

Masters’ M.S.(Pharm.) RegulatoryToxicology 8 9Masters’ M.Tech.(Pharm.) PharmaceuticalTechnology

(Formulations)

6 7

Doctoral PhD 0 0

Masters’ M.Tech.(Pharm.) PharmaceuticalTechnology(ProcessChemistry)

16 17

Doctoral PhD 4 1

Masters’ M.Tech.(Pharm.) PharmaceuticalTechnology(Biotechnology)

8 11

Doctoral PhD 2 0

Masters’ M.S.(Pharm.)Pharmaceutics

18 20Doctoral PhD 1 3Masters’ M.S.(Pharm.)

Biotechnology32 35

Doctoral PhD 5 0Masters’ M.Pharm.

PharmacyPractice8 9

Doctoral PhD 1 1

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6. Teacher-Studentratio:-

Table-5H(Teacher-studentratio)

Course Ratio2019-2020

Ph.D. 26:100Masters’(Science) 23:392MBA(Pharma) 3:82

7. Placement:-

Placementsstatus:incampus/offcampus

Table-5I(Placementsstatus:incampus/offcampus)

AcademicYear

TotalStu-dents

No.ofstudentsInterested

No.ofstudentsplaced

Average salary of placed stu-dents per annum (Amount inRs.)

2016-18 247 240 136 Rs4.67Lacs2017-19 242 232 155 Rs4.73Lacs

2018-20 224 203 90*(till31Dec2019) Rs6.31Lacs(till31Dec2019)

8. Innovation/knowledgetransfer

i. PatentsandCommercialization:190(filed)/87(granted)/08(licensed)sinceinception

ii. Researchincomeearnedfromindustry:Rs.27lakhs(receiptsin2019-20tilldate)

iii. Citationperfaculty:2482(till22-11-2019-ScopusandNo.ofFacultyConsidered-29(FY-2019-20))

iv. HIndex-NIPERSASNagar-Hindex-110(till22-11-2019-Scopus)

9. MoUssignedrecently:Table-5J

(MoUssignedduringthecurrentyear)

Sr.No PartytotheMOU DateofExecution 1 Johnson&JohnsonEducationGrantAgreement 25-09-20192 Johnson&JohnsonMasterServiceAgreement 25-09-20193 ZoetisPostDoctoralResearchFellowAgreement 23-08-2019

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4 AndijanStateMedicalInstitute(ASMI)Uzbekistan 23-07-20195 NationalResearchDevelopmentCorporation(NRDC) 24-04-2019

10. Institutionleadership

i. Ranked#3inthecategory‘Pharmacy’inNIRFMHRD2019Rankings.

ii. NIPERSASNagarRankedNo.1GovernmentPharmacyCollege in India (2019)byCa-reer360magazine(Outlookgroup)

iii. GreenMapleFoundationPrestigiousShiningGloryAward–2019foroutstandingcontri-butioninthefieldofeconomicandsocialdevelopmentofIndiaandconductingaware-ness programs on issues related to the protection of environmental, plantation andgreenbeltdevelopment,safety,childeducation,womenempowermentandeducationandothersocialactivities.

iv. Member,WHOExpertadvisorypanelontheInternationalPharmacopoeiaandPharma-ceuticalPreparations;Advisor,WHOexpertcommitteeonspecificationsforpharmaceu-ticalpreparations;MemberScientificBody,IPC.

v. Institutehas initiated skilldevelopment trainingsprograms forpharmacyand sciencestudentsfordifferentroleinpharmaceuticalindustry.

vi. InstitutehasestablishedanofficeforNIPERSASNagarAlumniassociationtomobilisenationalandinternationalalumnusfortheircontributiontowardsthedevelopmentoftheinstitute.

11. ImpactofNIPER

ThesuccessofNIPER,S.A.S.NagarhasencouragedtheGoItosetupmoreNIPERsacrossthecountrytomeetthegrowingdemandsofthepharmaceuticalsector.Inaddition,NIPERhascarriedouttrainingprogrammes forpersonnel from Indiaandabroadunder ITEC-SCAAP, capacitybuildingpro-grammes(WorldBank-sponsored)andSMPIC.ParticipationinrebuildingofpublicsectorenterpriseslikeIDPL,BCPL,HAL,etc.SkilldevelopmenttrainingsunderskillVigyanprogramweresanctionedbyPSCST&DBTprogramfordifferentroleinpharmaceuticalindustry.

• Institutehastrainedpharmacyandsciencestudentsunderskilldevelopmenttrainings.82student’s/IndustryemployeesweretrainedatSMPIC,14at IPRcelland69atTDC-Dosageformand28atTDC-APIpilotplant.

• 87foreignParticipantsfrom34countriesweretrainedin4differentITECprogramsspon-soredbyDPA-II,MEA,GoI.

• Trainingandanalyticalservicesprovidedtosmallandmedium-scaleenterprises(SMEs):SettingupofacentreforSMEs

• Memberofcommitteeevaluating‘InvestigationalNewDrugs’(IND)applications

• MemberofcommitteerevisingIndianpharmacopeia

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• ContributionofmonographstoAyurvedicpharmacopeiaofIndia

• Carriedoutstudyon“ImpactofTRIPSonpharmaceuticalpriceswithspecial focusongenericsinIndia”,undertheworkplanofWHObienniumandMHFW(GOI).

12. Variousevents/workshopscarriedoutbytheInstitute:

Table-5K(Events/workshopsorganizedbytheInstitute)

11May,2019 NationaltechnologyDay21May,2019 Dr.ParvinderSinghMemorialAwardlecture19-21June,2019 YogaCamponInternationalYogaDay20June,2019 InaugurationofAlumniOffice31July,2019 AstrazenecaAward19-29August,2019 TwoweeksIntensiveITECTrainingProgrammeonRecentTrends&

ChallengesinBiopharmaceuticals1-15September,2019 SwachhataPakhwada1-15September,2019 HindiPakhwada9-19September,2019 TwoweeksIntensiveITECTrainingProgrammeonAdvancedAnalytical

TechniquesBasicPrinciplesandapplicationforQualityAssessmentofDrugsandPharmaceuticals

14-24October,2019 TwoweeksIntensiveITECTrainingProgrammeonRecentTrendsandchallengesinRegulationandStandardizationofHerbalDrugsandFor-mulations

1November,2019 NationalUnityDay1November,2019 SMPICSeminaronRiskanalysisonPharmaceuticals26November,2019 ConstitutionDay18-28November,2019 TwoWeeksIntensiveITECTrainingProgrammeonPharmaceutical

QualitybyDesign:ARiskBasedApproach–ITECprogramme

NIPERNSSactivityduringSwachhataPakhwada

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5.2 NIPER-Hyderabad

NIPER-HyderabadstartedfunctioningasoneofthesixnewNIPERsinSeptember2007,inthepremisesofIDPL,R&Dcentre,Balanagar,Hyderabad.TheInstitutehasbeenfunctioningwiththemis-sionofdevelopinghumanresourcewithexcellencethroughconductingPostGraduateandPhDcours-es.NIPER-HyderabadhasM.S.(Pharm),M.Tech.andMBAcoursesindifferentdisciplinesi.e.,MedicinalChemistry, Pharmaceutical Analysis, Pharmacology& Toxicology, Pharmaceutics, Process Chemistry,RegulatoryToxicologyandPharmaceuticalManagement.

1. Achievements:

Table-5L(AchievementsofNIPERHyderabad)

1 MasterStudentsPassedOut 8422 StudentspursuingPh.Dcourse 743 Doctoraldegreeawarded 314 Patents(filed) 155 ResearchPublications 5846 Sanctionedextramuralresearchprojects 32

2. DetailsofFaculty&Staff:

i. RegularFaculty : 01,Director

ii. ContractualFaculty : 18

iii. ContractualAdministrativeandTechnicalStaff : 41

3. TotalAllocationbytheGovernmentduringthelast4years(Rs.incrores)

Table-5M(AllocationoffundbytheGovernmentduringthelast4years)

Year AllocationBE AllocationRE TotalRelease

2016-17 35.00 35.00 35.002017-18 20.00 30.00 30.002018-19 24.00 24.00 24.002019-20* 25.00 25.00 25.00

*FundreleasedtillDecember2019.

4. Teacher-Studentratio:

Presently1:8

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5. Employability/PlacementsStatus:-

A. YearwiseCompaniesparticipatedincampusselection/placement

Everyyearstudentswereplacedinreputedcompanies’like-Novartis,Biocon,DrRed-dy’s,GVK,Mylan,AstraZeneca,Shasun,Lupin,Aurobindo,BiologicalE,Eli lily,Aizant,Cipla,CognizantHealthcare,CoreDiagnostics,Johnson&Johnson,MacleodsPharma-ceuticals,Rocheetc.

B. Lastfewyearsplacementsstatus:incampus/offcampus

Table-5N

(Placementsstatus:incampus/offcampus)

Year 2012 2013 2014 2015 2016 2017 2018IncampusPlace-

ments(%) 88 85 82 82 80 83 100

6. Teachers

NIPERhassomeofthetalentedanddedicatedfacultywhocamefromthebestinstitutionsandhavinggoodtrainingabroadaspost-doctoralfellowsintheirspecializations.

7. RecognitiontoFaculty

Dr.ShashiBalaSingh,Director,NIPERHyderabadreceivedtheprestigious‘FICCIAwardofExcel-lenceWomeninR&D’fromHon’bleNkanduLuo,MinisterofHigherEducation,GovernmentofZambia,onFebruary21,2019atDSTFICCIGLOBALR&DSUMMIT2019,Hyderabad.

8. Peerreviewsystem:

Theperformanceofthefacultyisassessedperiodically.Theassessmentisbasedonthestudentfeedback,outputfromtheresearchactivitiesandcontributionstoinstitutionalgrowthassessedbysub-jectexperts.

9. CoreResearchareas:

• IntegratedDrugDiscovery&ProductDevelopmentProgrammes

Cancer,Inflammationandrelatedproliferativediseases

Diabetesandothermetabolicdisorders

Infectiousdiseases

Psoriasis

• In-vitroandin-vivoscreening

• DevelopmentofnovelProcessforNCEs,BulkDrugsandIntermediates

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• DevelopmentofAnalyticalMethods,ImpurityProfilingandStabilitystudies

• Solidstatecharacterization

10. Awards:

A. Mr.HarshBaruafromdepartmentofPharmaceuticshasbeenawardedtheLUPINMERITSCHOLARSHIPofrupeesfifty-onethousand.Hewasawardedthescholarshipforhisscho-lasticachievementsduringtheacademicyear2017-2019atNIPERHyderabad.

B. Mr. Srinivas Angapally, research scholar-Department of Medicinal Chemistry was re-ceivedbestposterpresentationawardinSPER7thAnnual InternationalConference&Exhibition[SPER2018],whichwasheldatB.S.AbdurRahmanCrescentInstituteofSci-enceandTechnology,Chennai[TamilNadu],during23rd-24thFebruary,2018.

11. Innovation/knowledgetransfer

A. Patentsandcommercialization-15patentsfiledinareasofCancerDrugDiscovery,For-mulationDevelopmentandAnalyticalMethodDevelopment

B. RevenueGeneration:3.39Crores

12. ImpactofNIPER:

Creatinghumanresourcesbyimpartinghighqualityeducationandtraininginpharmaceuticalscienceswhichwouldhelpthepharmaceuticalindustry.Servingasanresearchinstituteandfocusingonthrustareasofnationalandinternationalrelevance.FosteringacademicandindustrialcollaborationstoaddresssomeofthekeyissuesinthepharmasectorandtheneedsofPharmaceuticalindustryinthecountry.

13. Collaborations/MoUs

NIPER-Hyderabadsigned18MoUswithnationalandinternationalbodiestoenhancedresearchareasandmultidimensionalresearch.Theprincipalcollaboratorsare:

• DrReddy’sLaboratory• DaewoongPharma• Extrovis,NATCO• ISSARpharmaceuticalslimited• INST,HebrewUniversity• DST-UKIERI(UnivofManchester)• DSTIndo-Poland(UnivofBialystok)• DSTIndoBrazil(UnivofSaoPaulo)• DSTDAAD:RWTHAachenUniversity

14. Variousevents/Workshopscarriedoutbytheinstitute:-

NIPERHyderabadconductedvariousscientificevents,workshopstrainingforstudents.Follow-

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ingaresomephotographofthevariouseventsinNIPER-Hyderabad.

GoodLaboratoryPracticeWorkshop

Synergy-2018-NIPER-PharmaIndustryMeet:RoleofAcademiainStrengtheningoftheIndianPharma

5.3 NIPERGuwahati

NIPERGuwahatistartedfunctioningfrom2008undertheMentorInstitute,GuwahatiMedicalCollege,Guwahati(upto31July2017).Dr.USNMurtytookoverthechargeoftheDirectoroftheIn-

ShriMansukhL.Mandaviya,HonorableMinisterAddressingtheNIPERHydereabdFaculty

InteractionofschoolchildrenwithDean, facultyandstudentsofNIPERHyderabad

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stitute from3rdNovember2016.NIPER-Guwahati is functioning from theNITS-MirzaCampus sinceAugust2017.

1. Achievements:-i. Ph.D.-44(enrolled),Degreesawarded–09(sinceinception),ii. TotalM.S.(Pharm.)(sinceinception),

Studentsenrolled–460 Graduated-324(135studentsarecurrentlypursuingtheirP.G.courses)

iii. Tilldate6studentsgotplacedinNovartisthroughon-campusplacements.

iv. Publications:Intotal,130researcharticleshavebeenpublishedoutofwhich24articleshavebeenpublishedin2019-20invariousNationalandInternationalJournals.

v. Institutehastotal5patentsand1copyrightofwhich3patentsarefiledintheyearof2019.

2. Detailsoffaculty&staff:-

AdministrativeStaff : 09

AcademicStaff: AssociateProfessors : 04 AssistantProfessors : 07 ResearchAssociate : 03

Staff:Technical : 05 Multi-TaskStaff : 12

3. TotalAllocationbytheGovernmentduringthelast4years.Table-5O

(AllocationoffundbytheGovernmentduringlast4years) (Rs.incrores)

Year AllocationBE AllocationRE TotalRelease

2016-17 19.50 26.27 26.272017-18 31.50 52.00 52.002018-19 33.50 33.50 33.502019-20* 36.90 36.90 36.90

*FundreleasedtillDecember2019

4. Students:-

Degrees/programmesofferedandSubjectsoffered(withyear)

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Table-5P

(Degrees/programmesandsubjectsofferedyear-wise)

Level

Masters/Doctoral

Degree

MS/MBA/M.Tech/Ph.D

Discipline Year

2017-18 2018-19 2019-20

Masters MS(Pharm) PharmacologyandToxicology

20 15 15

Masters MS(Pharm) Biotechnology 9 10 10

Masters M.Pharm. PharmacyPractice 10 10 9

Masters M.Pharm. Pharmaceutics Notstart-ed

15 18

Masters M.Pharm. PharmaceuticalAnalysis

Notstart-ed

15 18

Doctoral Ph.D. PharmacologyandToxicology

2 2 1+2*

Doctoral Ph.D. Biotechnology 1 1 0

Doctoral Ph.D. PharmacyPractice 1 1 1

Doctoral Ph.D. Pharmaceutics Notstart-ed

2 1+2*

Doctoral Ph.D. PharmaceuticalAnalysis

Notstart-ed

1 1+1*

5. Teacher-Studentratio:

Biotechnology: 1:5

PharmacologyandToxicology: 1:8

PharmacyPractice: 1:5

Pharmaceutics: 1:8

PharmaceuticalAnalysis: 1:8

6. Employability/PlacementsStatus

Intheacademicsession,2019-20,6studentshavebeenplacedinNovartis,Hyderabad.Manyothercompaniesareinpipelineforplacements.

7. Research

BIOTECHNOLOGY:

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Development of Biopharmaceuticals using Biomolecular Engineering/Synthetic Biology ap-proaches-

OncogenicmRNAcleavingDeoxyribozymes

DevelopmentofnewapproachesofImmunereroutingfortargetingcancercells

Riboswitchmediatedgeneregulationofoncogenes

GenerationofrandomProteincodingsequences&Aptamerbasedtherapeuticsanddiagnostictools

InvestigationonGenomicsandProteomicstostudyvariousdiseases likeMultipleMyeloma,AcuteMyeloid leukemia,ChronicMyeloid leukemia,Myodisplasticsyndrome, Ischemia-Strokedisor-der,NeuropathicPain,etc.

PHARMACOLOGYANDTOXICOLOGY:

MolecularPharmacology

DevelopmentofCancertargeteddrugdeliverysystems

ScreeningIndianbiodiversityandIndianSystemsofMedicineinsearchofnewercompoundsintheareaofinflammation,arthritis,diabetes,cancerandhepatoprotectiveactivities

TargetingRANKLforthetreatmentofinflammationandcancerinducedbonedisorders

ScreeningofNCE’s&North-Eastplantproductsforanti-Parkinson’sandantidepressanteffects

Studies on themitigation of drug induced toxicities through natural products derived fromNortheastIndia

PHARMACYPRACTICE:

Studyofdrugutilizationpatternforantiepilepticandantipsychoticdrugs

ImpactofLipodystrophyonQualityofLife,SocialandPsychologicalAspectsinPLHIVonFirstlineandSecondlineAntiRetroviralregimen

Haemovigilance:Animportanttoolforimprovingsafebloodtransfusionpractices

PHARMACEUTICS:

Lipidnanoarchitectonicsagainstdreadfuldiseases

Pharmacooengineering&MolecularPharmaceutics

Ligandanchoredtargeteddrugdeliverysystems

Drugsin-adhesive(DIA)matrixpatchdesign

Pathogenmimeticdeliverydevices

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Nanomedicines&Nanobiotechnology

Translationalcuttingedgepharmaceutical&biomedicalresearch

Preformulationstudiesofactivepharmaceuticalingredients

Dosageformdevelopmentandoptimizationforpoorlywater-solubledrugmolecules

Drugtargetingusinglipid-andpolymer-basednanoparticulatesystems

Micro-andnano-theragnosisconceptsfortheearlydetectionandtreatmentofmalignantdis-easesandotherlife-threateningdiseases

Eradication of biofilm-producingmicroorganisms from the surfaces of implanted or insertedmedicaldevicesintohumanbody

PHARMACEUTICALANALYSIS:

Bioavailability,IVIVCandIVIVEanalysis

Analytical(ICHGuidelines)&Bio-analytical(FDA-IndustryGuidance)methoddevelopment&validationusingHPLC,UPLC,LC-MS/MS

Short-term/accelerated,mid-termandlong-termstabilitytestingofformulationsanddegra-dationstudies.

Pharmacokinetic,Toxicokinetic,MetabolicandImpurityprofiling

8. Studentsenrolment:

CurrentstrengthofPh.D.students:31

(Pharmacology&Toxicology-13;Biotechnology-06;PharmacyPractice-04;Pharmaceu t i c s -06andPharmaceuticalAnalysis-03)

CurrentstrengthofMastersStudents:135

(Pharmacology & Toxicology-30; Biotechnology-20; Pharmacy Practice-19; Pharmaceutics-33andPharmaceuticalAnalysis-33)

9. PatentsandCommercialization:

Institutehastotal5patentsand1copyright,ofwhich3patentsarefiledintheyearof 2019.

10.Collaboration

Duringtheyear,NIPER-GuwahatihasexchangedMoUswiththefollowingInstitutes:

1. InstituteofLiverandBiliarySciences(ILBS),Dated-4thJanuary2019

2. InnotechInterventionsPvt.Ltd,Dated-15thMarch2019

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3. RoyalGlobalUniversity,Dated-6thJuly2019

4. BVGLifeSciencesLtd.(BVGGroup),Dated-6thJuly2019

11.ImpactofNIPER:

TheestablishmentofNIPER-GuwahatihasgivenastrongboosttothepromotionofPharmaceu-ticalEducation&ResearchintheNorthEastregionofIndia.ResearcheffortsofNIPERGuwahatihaverevivedthestudiesonmedicinalvalueoflocalherbsofNorthEastRegionagainstvariousdiseases.

NIPER-GuwahatihasorganizedaNationalconferenceentitled“Ethno-medicineandTraditionalHealthPracticesinNortheastregionofIndia”incollaborationwiththeSocietyforEthnopharmacolo-gy(SFE),India,on25thAugust2018.Thisconferencefocussedonseveralcontemporaryissuesofdrugdiscovery&developmentfrommedicinalandaromaticplantstogetherwiththeirqualityevaluation,validationandsafetyrelatedaspects.

NIPER-Guwahatiplayedapivotalroleinagrandassemblyofplant-derivedmedicinepractitioners(TraditionalHealers living in theNorth-East statesof India) on26thAugust 2018atNIPER-Guwahatipremises.Around76traditionalhealersfromAssam,Mizoram,Meghalaya,SikkimandTripuraattendedthismeetandshowcasedtheirplant-derivedmedicinalproductsinindividualstalls.

ThefacultymembersofNIPER-Guwahatihavebeenawarded06Extramuralprojectsintheyear2018fromdifferentfundingagencieslikeDBT,DST,DRDO,MinistryofEnvironment,ForestandClimateChange,etc.

NIPER-GuwahatiistheonlyNIPERtohaveaSyntheticBiologyLaboratory,whichhasbeenaward-ed‘GenomeEditingTaskForce’projectbyDBT,Govt.ofIndia.100%MS(Pharm)andM.Pharm.admis-sionsduringthisacademicyear(2018-19)reflectsthegrowingreputationandthestatureofNIPER-Gu-wahatiamongtheStudentsandtheIndustrialcounterparts.TheInstitutehasenteredintoseveralMoUswithleadingResearchinstitutes,HospitalsandPharmaceuticalIndustriestogivestudentsandfacultythebestoftheacademicandresearchsupporttoeventuallycomeupwithtechnologiesandproductsforthebenefitofthesociety.

12.NumberofstudentsreceivedM.S./M.Pharm.degreeduringthe3rdConvocationheldon7th July,2019.

Table-5Q(StudentswhoreceivedM.S./M.Pharm.degreeduringthe3rdConvocationheldon7thJuly,2019)

Sl.No.

Batch Numberofstudentsenrolled

Numberofstudentsre-ceiveddegree

1 2015-17 26 262 2016-18 35 353 2017-19 39 39

Total 100 100

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FelicitationofChiefGuest,Prof.AnilD.Sahasrabudhe,Chairman,AICTE (FromLtoR:Prof.AnilD.Sahasrabudhe,Dr.USNMurty,Dr.,SChandrasekhar.Degree

recipientof3rdConvocationatNIPER-G)

GroupphotoatGlobalBioIndia-2019,NIPER-GPerformingyogaduringInternational YogaDayatNIPER-5.4 NIPERKOLKATA

TheNationalInstituteofPharmaceuticalEducation&ResearchKolkata(NIPER-Kolkata)wases-tablishedasanInstituteofNationalImportancebytheGovernmentofIndiathroughActofParliament(NIPERAct1998&NIPERamendmentAct2007).TheInstitutefunctionsfromitscampusat“ChunilalBhawan”,168,ManiktalaMainRoad,Kolkata–700054.NIPERKolkataisstrivingtoachieveacademicexcellencethroughteaching,researchandscholarship.Atthemomentteachingremainscentralfunc-tionandoverridinggoal.NIPER-KistryingtostretchinthefieldofresearchbysettingambitiousgoaltowardsdevelopingnewertherapeuticsagainsttuberculosisandLeishmaniasis.Studentsarethrivingbothnationallyandinternationally inthedifferentresearchlaboratories/ industriesandinstitutesasresearchers.

1. Achievements

In2019-20(tillDecember2019)17researchpaperspublished,7MoUsigned.Sinceinception,452studentshavebeengraduated.Master-450studentsandPhD-2students).

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2. AcademicandNon-Academicstaff:

Total19postsoffacultyand25postsofNon-facultyhavebeenapprovedbyDepartmentofExpenditureinJanuary2019.

3. TotalallocationbytheGovernmentduringthelast4years:-

Table-5R(AllocationoffundbytheGovernmentduringthelast4years)

(RupeesinCrore)

Year BE RE TotalRelease2016-17 08.00 08.00 08.002017-18 09.00 11.50 11.502018-19 12.00 12.00 12.002019-20*16.00 16.00 16.00

*FundreleasedtillDecember2019-20.

4. Students

Degrees/programsofferedandSubjectsoffered(withyear)withadmissionstatus:

Table-5S(Degrees/programsandSubjectsofferedyear-wisewithadmissionstatus)

Level Degree Discipline No.ofstudentsadmitted2015-

162016-17 2017-

182018-

192019-21

Masters M.S.(Pharm.)

MedicinalChemistry 17 14 16 08 08NaturalProducts 13 14 14 08 06Pharmacoinformatics 09 14 14 03 04Pharmacology&Toxicology

- - - 08 13

Raredisease - - - - -

Doctoral Ph.D. MedicinalChemistry - 04 04 - -NaturalProducts - 04 04 01 -Pharmacoinformatics - 02 04 -

Pharmacology&Toxicology

- - - - 01

5. Teacher-Studentratio:1:11

ClassesaremanagedbyNIPERfacultyandvisitingfaculty/guestfaculty.

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6. Employability/PlacementsStatus

Sinceinception,largenumberofPharmaCompaniescametoNIPER-Kolkatatorecruitstudents.Mostofthestudentshavebeenabsorbedintheindustries,collegesandresearchinstitutes.Anumberofstudentsarepursuinghigherstudieswithinthecountryaswellasabroad.PlacementwasachievedforthesestudentsaccordingtotheiroptionsforemploymentincompaniesaswellasinInstituteforteachingandhigherstudies.

Table-5T(Employability/PlacementsStatus)

Masters:M.S.(Pharm.)Year(Batch) TotalNo.ofstudents No.ofstudentsplaced

(*asperavailablerecordswithus)2007-2009 29 242008-2010 32 262009-2011 40 292010-2012 49 332011-2013 47 302012-2014 37 292013-2015 49 202014-2016 42 292015-2017 39 322016-2018 42 362017-2019 44 32

Total 450 320Doctorate:Ph.D.

2016-2020 10 09Pursuing2017-2021 12 10Pursuing2018-2022 01 01Pursuing2019-2023 01 01Pursuing

Total 22 21Pursuing

7. RecognitiontoFaculty:

FacultyofNIPER-KolkataofitsownincludesDSTawarded/fundedfacultyandotherguestfacultyarealsoinvolvedfromtheMentorInstituteandotherInstitutesofKolkata,suchasCalcuttaUniversity,JadavpurUniversity, IndianAssociation for theCultivationofScienceKolkata,Bose InstituteKolkata,SahaInstituteofNuclearScience,CSIR-CGCRI,NICED,AIIH&PHandSSKMHospital,TCGLifeSciencesandtheyarewellrecognizedintheirownareas.Forrarediseases16guestfacultyfromAIIHPH,KolkataMedicalCollege,KolkataApolloHospital,Medicalsuperspecialtyhospital,TataMedicalcentreallfromKolkata,DrugscontrollerKolkata,CSIR-IICBetc.Fiveadjunctfaculties(2fromSanofiIndiaLtd.,1fromBiologicalEand2fromCSIR-CGCRI)arealsopartofourfaculty.

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8. Research

• Structuralbioinformatics;Newdrugdiscovery/repurposingforInfectiousDiseasesandMetabolicdisorders.

• Structuralbioinformatics;Newdrugdiscovery/repurposingforInfectiousDiseasesandMetabolicdisorders.

• Metabolicbio-engineeringforproductionofsmallmolecules

• Immunology,Leishmaniabiology,Vaccines.

• DiabetesmediatedNon-alcoholicsteatohepatitisandHepatocellularcarcinoma:Phar-macologicalandbiochemicalcharacterization.

• Phytochemistry;Chemicalstransformation;Herbalproductsanalysis

• NetworkPharmacologyofherbalmedicinesinRespiratorydiseases

• Biopharmaceuticals

9.Innovation/Knowledgetransfer/MoUssigned

Memorandum of Understandingwas signed between Chittaranjan National Cancer Institute(CNCI), KolkataandNIPERKolkata topromoteacademicand research co-operation for fostering re-searchwork.

10.ImpactofNIPER:

a. Atotalof450highlyskilledstudentshavebeengraduated.

b. 2scholarshavebeenawardedwiththePh.D.degree.

c. 320studentsareengagedtoworkincompanies/institutions.

d. 89Researchpapershavebeenpublished.

e. M.S.(Pharm.)studentsofNIPER-Kolkatastood1stand2ndpositionintheNationalEli- gibilityTestforPh.D.courseadmissionconductedbyNIPER-Hyderabad,Mohaliand Ahmedabadcontinuouslythreeyears2016-17,2017-18and2018-19respectively.

11. InstitutionLeadershipImpactofNIPER Institutionsareimportantforthedevelopmentandsuccessofasociety.Institutionsserveasaplacefortheevolutionofideas.Aninstitutemustlabortomeettherequirementofsocialcircumstanc-es.NIPER-Khastakenamajorresearchdrivetowardsdevelopingnewerstrategiestotackletwoimport-antinfectiousdiseasesliketuberculosisandLeishmaniasis.

Dr.P.D.Vaghela,I.A.S.,SecretaryPharma,addressingthestudentsanddignitariesduringtheevent.

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Dr.P.D.Vaghela,IAS;SecretaryPharmainauguratedNMRfacilitiesatNIPERKolkatacampusinpresenceofProf.Bhaba-toshBiswas,Chairman,BoG,NIPERKolkataandProf.V.Ravichandiran,Director,NIPERKolkataon30thOctober2019.

Prof.V.Ravichandiran,Director,NIPERKolkataadministeredthePledgetotheStudents,FacultyandStaffmembersontheoccasionofRashtriyaEktaDiwason31stOctober,2019.

5.5 NIPER-RAIBARELI

NationalInstituteofPharmaceuticalEducationandResearch(NIPER),Raebareliwasestablishedin2008afterthe1998NIPERActwasamendedbytheParliamentin2007.ItisanautonomousInstitutewith itsownBoardofGovernorsand functionswithin theDepartmentofPharmaceuticals,MinistryofChemicals&Fertilizers (MoCF),Governmentof Indiawiththeaimtomeetthegrowingdemandsofskilledpharmaceuticalprofessionals,newpharmaceuticaltechnologiesandfundamentalresearch.NIPER,RaebareliofferscoursesforM.S.(Pharm.)inMedicinalChemistry,Pharmaceutics,Pharmacolo-gy&Toxicology,andRegulatoryToxicologywith142enrolledstudentsandPh.D.programmes(startedw.e.f.2017)infirstthreedisciplinesinordertoboostR&Dactivitiesinpharmaceuticalresearch.

1. Achievements:-.

• TheDivisionofPharmaceuticsatNIPER-Raebarelidevelopednewtechnologiesfornano-baseddrug-deliverysystemsforbetterdeliveryofanti-psychoticandanti-tuberculardrugs.

• TheInstitutehasfiled5patentsandonecopyrightin2019.

• DepartmentofMedicinalChemistrywasawardedDST-SERBCoreResearchGrant(41Lakhs)todoresearchintheareaofTuberculosis.

• Nearly100publications in last3years(42publications inthecurrentyear) inthe journalsofInternationalrepute.

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• Onebookentitled“HandbookonthePreparednessonChemicalWarfareAgents”publishedbyElsevier/AcademicPress(USA).

• CentralInstrumentationFacilitywascreatedhousingsophisticatedinstrumentssuchasNuclearMagneticResonance(NMR),LC-MS(QTOF-HRMS),HPLC,FT-IRetc.

• Dr.Munindra Ruwali in the department of Pharmacology and Toxicology received DST-TAREgrant.

• Dr.RevatiRamanUjwal in thedepartmentofPharmaceutics receivedNationalPost-DoctoralFellowshipfromDST-SERB.

2. Academic/Non-Academicstaff:-

Academic = 01 Director (Regular)10 AssistantProfessor/Assistant

Professor(Contract)(Contractual)

Non-Aca-demic

= 25 Administrative/TechnicalStaff (Contractual)

TheInstituterecruitsteachers/staffonyearlycontractualbasis.

Total19postsofregularfacultyand25postsofregularNon-facultyhavebeenapprovedbyDepartmentofExpenditureinJanuary2019whicharelikelytobefilledshortly.

3. TotalfundallocationbytheGovernmentduringthelast4years:-

Table-5U(AllocationoffundbytheGovernmentduringthelast4years)

(Rs.inCrore)Year AllocationBE AllocationRE TotalRelease

2016-17 7.00 6.25 6.252017-18 8.50 9.50 9.45 2018-19 12.00 15.00 15.002019-20* 16.00 16.00 16.00

*FundreleasedtillDecember2019.

4. Students:-

Degrees/programmesofferedandsubjectsoffered(withyear)withadmissionstatus:Table-5V

(Degrees/programmesandsubjectsofferedyear-wisewithadmissionstatus)

Subject Degree Sanctionedseats AdmissionStatus

MedicinalChemistry M.S.(Pharm) 22 20Pharmaceutics M.S.(Pharm) 17 15

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PharmacologyandToxicology

M.S.(Pharm) 16 15

RegulatoryToxicology M.S.(Pharm) 11 11MedicinalChemistry Ph.D 02 02

Pharmaceutics Ph.D 02 02Pharmacologyand

ToxicologyPh.D 02 02

5. Teacher:StudentRatio-

(1:14)

6. Employability/PlacementsStatus:-

Agraphshowingtheyear-wiseplacementstatusofNIPER-Raebareli.

Graph5(i)(Year-wiseplacementstatusofNIPER-Raebareli)

7. Awards/Teachers:-

- DrS.J.S.FlorahasbeennominatedasCouncilorforAsiabytheInternationalSocietyforTraceElementResearchinHumans(ISTERH)

- DrS.J.S.FlorawasnominatedasEditorialBoardMemberofthreeinternationalresearchjournalsCurrentMedicinalChemistry(USA),CellularandMolecularBiology(France)(AssociateEditorforAsia)andJournalofHeavyMetalandChelationTherapy(USA).

- Dr.S.J.SFloragaveCSIRPlatinumJubileeFoundationDayorationlectureatCSIR-IITR,LucknowonSeptember28,2017.

- Dr.S.J.S.FlorawasfelicitatedbyAcademyofEnvironmentalBiology(AEB)w i t h A E BHONORforhislifetimeachievementsinthefieldEnvironmentalBiology&ToxicologyonOcto-

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ber3,2018.

- Dr.S.J.S.Florawasconferredwith“LIFETIMEACHIEVEMENTAWARD”byIndianSocietyforLeadAwareness&Research(InSLAR)forhisoutstandingcontributionsinthefieldofChem-icalToxicologyinGeneralandMetalToxicologyonOctober4,2018.

8. Research

a) ActiveResearchAreas:

Neurodegenerativediseases

HeavyMetalToxicitystudy

Tuberculosis

DevelopmentandevaluationofdrugsusingNanoformulations.

Developmentofgreenandeco-friendlysyntheticmethods

b) Projects:Ongoing:02

c) Publications: 50Totalsofar,

9. ImpactofNIPER

NIPER-RaebarelihasemergedasanInstitutionofsignificancebothinacademicsandresearchparticularly in Central India with modern laboratories, highly sophisticated instrument. We haveachievednumberofmilestonesandPharmaindustrieshaveshowninterestincollaboratingwithusbe-sidestrainingourstudentsforshorttermandlongtermbasis.Wehaveinitiatedcollaborativeprojects/workwithnationaland internationalacademicandresearch institutes intheareaofour immediateimportancelikesuchasJapanese Encephalitis,TuberculosisandNeurodegenerativediseases.Anonlineportalhasbeencreatedtofacilitateseamlesssampleanalysisfordrugdiscovery.WearealsoprovidinghighlyskilledhumanresourcesfortheIndianPharmaceuticalIndustry.

10. Variousevents/workshopscarriedoutbytheinstitute:-

(i) DistinguishedLectureSeries

NIPER-Raebarelihasstartedthe“DistinguishedLectureSeries”duringthisacademicseasontobringthesubjectexpertsinthefieldofPharmaceuticalSciencesonaregularbasis.Thepurposeofthislectureserieswastobringeminentresearcherstoourcampustotalkabouttheirresearchandalsotoacquaintyoungstudentswiththeemergingtrendsinthisfield.Tostartthisseries.Variouseminentacademic&Industryexpertswereinvitedwho,visitedNIPER-Rcampus&interactedwithfaculty&stu-dentsofNIPER-Rforpossibleresearchcollaboration.

(ii) Conferences/Workshops/Seminars/TrainingPrograms

ThefacultymemberparticipatedintheonedayNationalSeminaronIntellectualProp e r t yRightsorganizedbyCCRUM,MinistryofAYUSHatCRIUM,Lucknowon10thJuly2019.“TraintheTrain-

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er”courseondevelopingandsustainingIndia’scapacityforPre-clinicalDrugDiscoveriesattheNationalInstituteofNutritioninHyderabad,TelanganafromJuly8th-12th2019andQualityImprovementPro-gram(QIP)forTeacherson“NANOMATERIALS”hostedBySchoolofMaterialsScience&Technology,IndianInstituteofTechnology(BHU),Varanasi.ThestudentsofdepartmentofMedicinalChemistryandPharmaceuticsattendedPharmaRIA,theIndianPharmaceuticalAssociationconventionheldatVigyanBhawaninNewDelhionSeptember11thand12th2019.

(iii) RajbhashaWorkshop

Hindiworkshopwasorganizedon14thJunetopromoteprogressiveuseofHindiasanofficiallanguageandinaccordancewithOfficialLanguageAct,rulesandorders.(iv) Workshopon“ImpactofPlasticonEnvironmentandHumanHealth”

TospreadtheawarenessaboutplasticwastewithinourinstitutionweorganizedOneDayWorkshopon“ImpactofPlasticonEnvironmentandHumanHealth”onSeptember24,2019,inwhichallthefaculty,staffandstudentsparticipated.(v) WorkshoponGEM

NIPER-Rishighlycommittedtoenhancingtransparency,efficiency,andaccounabilityinthepur-chaseofscientificequipmentsandgoodsofcommonlaboratoryuse.

DrP.D.Vaghela,SecretaryDepartmentofPharmaceuticalswastheChiefGuestof5thConvocationofNIPER-Raebareli

NIPER-RaebareliSymposium.

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5.6 NIPER-AHMEDABAD

NIPER-Ahmedabadwasestablishedwithanaimtotrainindividualsdisplayingcompetencyinthepharmaceuticalsectortomeettherequirementsoftheever-growinghealthcaresector.NIPER-Ahmed-abadiscurrentlyofferingMSandPh.DprograminPharmaceutics,PharmaceuticalAnalysis,Pharma-cology&Toxicology,Biotechnology,NaturalProducts,MedicinalChemistryandisthepremierInstituteconductingMSandPhDprogrammesinMedicalDevicesinthecountry.Itiscurrentlyfunctioningfromtransienttemporarybuildingon60-acrelandsiteatGandhinagarsinceAugust2016.ItplanstoestablishCentreforMedicalDevices(CMD)tocateraswellasnurturetheneedofboomingmedicaldeviceindus-trieswithinandoutsideIndia.TheinterdisciplinarycoursesandculturaldiversityatNIPER-Ahmedabadsparksthespiritofinnovativeresearchandall-rounddevelopmentofitsstudents.ThelocationoftheInstituteensuresasymbioticassociationwithpharmaceuticalindustries,medicalcentresandtechno-logicaluniversities.NIPER-AhmedabadaspirestobeaNationallyandInternationallyrecognizedpremierCentreofExcellenceinTeaching,ResearchandEntrepreneurialTraininginPharmaceuticalSciencesandBiomedicalTechnologies.

1. Achievements:

Publications-TheInstitutehaspublished146articlesinpeerreviewedjournalsofrepute(Nov.2018toDec.2019).

StudentsinMSProgramme

i. 511M.SPharm.studentshavealreadygraduatedfromNIPER-AhmedabadandarewellplacedinvariousPharmaindustriesinIndiaandabroad.

ii. Presently,204studentsarepursuingtheirM.S.(Pharm)coursein7disciplines.

StudentsinPhDProgrammei. 06studentshavebeenawardedPh.D.Degreetilldate.ii. 45studentsarecontinuingwiththeirPhDstudies.

Patents- Institutehasfileduptillnow8patentswhereinfacultyorstudentsofNIPER-Ahmedabadareinventors.PlacementofStudents-100%placementofwillingstudentshasbeenachieved

2. DetailsofFaculty&Staff:

Director–PermanentPost.

Faculty CountAssociateProfessor(Regular) 7*AssistantProfessor(Regular) 13**

AssistantProfessor(Contractual) 4****1AssociateProfessortobejoininFebruary2020**7AssistantProfessortobejoininMarch2020***1-RamalingaswamiFellow

ContractualTechnicalStaff – 05ContractualAdminStaff – 09

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Post-DocFellow – 01

3. TotalAllocationbytheGovernmentduringthelast4years

Table-5W(AllocationoffundbytheGovernmentduringthelast4years)

(Rs.incrores)

Year AllocationBE AllocationRE TotalRelease2016-17 21.96 21.96 19.48

2017-18 22.96 27.96 27.96

2018-19 12.00 12.00 12.00

2019-20* 15.00 15.00 15.00 *FundreleasedtillDecember2019

4. Students

Degrees/programmesofferedandSubjectsoffered(withyear)withadmissionstatus

Table-5X (Degrees/programmesandSubjectsofferedyear-wisewithadmissionstatus)

Level-Masters/Doctoral

DegreeMS/PhD

Discipline No.ofstudentsadmit-ted

2018-19 2019-20Masters M.S.(Pharm.)

Biotechnology10 11

Doctoral PhD 01 1Masters M.S.(Pharm.)

MedicinalChemistry16 17

Doctoral PhD 02 3Masters M.S.(Pharm.)

MedicalDevices10 11

Doctoral PhD 01 0Masters M.S.(Pharm.)

NaturalProducts10 11

Doctoral PhD 01 1Masters M.S.(Pharm.)

PharmaceuticalAnalysis19 22

Doctoral PhD 01 2Masters M.S.(Pharm.)

Pharmacology&Toxicology16 18

Doctoral PhD 02 3Masters M.S.(Pharm.)

Pharmaceutics18 22

Doctoral PhD 01 2108 124

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Degree/MS/MBA/M.Tech/Ph.D Discipline

No.ofstudentsadmitted2017-19 2018-20 2019-20

MS 7Disciplines 72 96 108Ph.D 7Disciplines 11 8 12

5. Teacher-Studentratio:

Presently1:13(18Faculty:249students)

Table-5Y(Teacher-studentratio)

Course RatioPh.D. (S-45:F18)2.5:1

Masters’(Science) (S-204:F18)11.3:1*Guestfacultymembersarealsotakingclasses

6. Employability/PlacementsStatus:Last2yearsplacementsstatus:in

Campus/offcampusTable-5Z

(Employability/PlacementsStatus)

Batch Totalnoofstudent Notplaced Totalnoofstudent

placedGoingforhigher

studies

2016-18 69 6 54 92017-19 72 1 46 25

Listofsomeofthecompaniesparticipatedintheyear2019

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7. Teachers: InternationalResearchCollaboration

NIPER-AhmedabadhasestablishedanInternationalResearchCollaborationwithfacultiesfromHarvardMedicalSchool,Boston,USA, JohnsHopkinsUniversitySchoolofMedicine,Baltimore,MD,USA,MassachusettsInstituteofTechnology,USA;MillerSchoolofMedicine,USA,UniversityofWash-ington,Seattle,USA;UniversityofNewcastle,SchoolofBiomedicalSciencesandPharmacy,Australia;UniversityofMississippiSchoolofPharmacy,USA;WayneStateUniversityUse-inspiredBiomaterials&IntegratedNanoDeliverySystemsLaboratory,USA;andNationalUniversityofIreland,Galway,Ire-land. Under this initiative research, faculties from these foreign Universities/Institutes have agreedtoestablishfutureresearchcollaborationsandacademicpartnershipwiththefacultymembersfromNIPER-Ahmedabad.

8. MoUssignedrecently:

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Table-5AA(MoUssignedrecentlybyNIPERAhmedabad)

12-11-2018 SanatProductsLimited,Delhi-11009203-12-2018 GujaratUniversity,Navrangpura,Ahmedabad-380009

21/3/2019 UniversityofPrinceEdwardIsland,550,UniversityAvenue,Charlottetown,PECIA4P3,CanadaAK

01-04-2019 UPEC,UniversitéParis-EstCréteilValdeMarne 61,avenueduGénéraldeGaulle94010CréteilCedexFrance

03-09-2019 Ophthalmicmarketing&ServicesPvt.Ltd.PlotNo.87/3/B,IndustriesRoad,PhaseI,GIDCVatwa,Ahmedabad,Gujarat382445

9. Research:ActiveResearchAreas:

• DepartmentofBiotechnology:-

Geneticprofileandbiomarker identificationofOSCCpatients throughtranscriptomeanalysisWearecurrentlyworking inanextensiveareaof transcriptomeanalysisof tobacco-addictedpatientsoforalsquamouscellcarcinomaontumoursamplestakenfromGujaratpopulation.Theresultsobtainedcanpavethewayforidentifyingbettertargetingapproachesandtheideaofpersonalizedmedicinewhichispresentlyintheboom.

EpigeneticmodulationindiabeticnephropathythroughmiRNA–TheInstitutecurrentlyworkingonDiabeticnephropathyanditsnewtherapeutictargetsforitstreatment

Targetingbreastcancerstemcellsusingcollaterallethalityapproach.

Bioengineeredthree-dimensionalstemcellnicheforintervertebraldiscrepairandregeneration.

• DepartmentofMedicinalChemistry:-

MultitargetdirectedPeptidesandpeptidomemeticsinAlzheimer’sproteopathy

Mis-foldedproteins(bothintracellularaswellasextracellular)isahallmarkfeatureinnumeroushumandisordersincludingsicklecellanemia,neurodegenerativediseasessuchasAlzheimer’sdisease(AD),Parkinson’sdisease(PD)andmetabolicdiseasessuchastypeIIdiabetes.

Alzheimer’sdisease:

ConstructionofpharmaceuticallyimportantmoleculesthroughC–Hbondactivation

Sustainablefunctionalizationofheterocyclesusingwaterasreactionmedium.

DepartmentofMedicalDevices:-

• BiomaterialPlatforms:Newconceptsinmaterialfabricationmethodshavebeenutilizedinde-veloping advanced formsofhydrogel andparticles for specificmedical andbiotechnologicalapplications.

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• Lab-on-a-chip:Bioengineeredthree-dimensional inflammatorydiseasemodelofdegeneratedtissues

• Smart3Dscaffoldsfortissueregenerationandrepairbynanotechnologyintervention

• Advancedstrategiesforcancertheranostics

• Papermicrofluidicsfordiagnosticapplications

• Micro/nanodevicesforlife-sciencesandbiomedicalapplications

DepartmentofNaturalProduct:-

• LC-MSbaseddereplicationstrategyforisolationofnovelbioactivenaturalproductsfromplantsources:-Naturalproductsplayaveryimportantroleinthediscoveryofnewdrugs.Dereplica-tiontechniquehasreinvigoratedthenaturalproductbaseddrugdiscoveryprocessbyimprovis-ingthetimerequiredforisolationofnovelmolecules.

• FingerprintingherbalextractsbyLC-UV-MSforchemicalmarkeridentification

• Bio-prospectingofendolichenicfungitodiscovernovelbioactivescaffolds

• IdentificationofaNaturalProductspossessingGLP-1Ragonistactivityfromtheplantsrecog-nizedtohaveanti-diabeticpotential; insilicoapproachfollowedbythetestingofshortlistedmoleculesbyspecificinvitroassay.

DepartmentofPharmaceuticalAnalysis:-

• MetaboliteprofilingofdrugsbyusingHPLCandLC-MS/MS

Drugsaremetabolized in thebodyandconverted tomorepolar compoundsandeliminatedeasily.Thesearemetabolizedbyphase1andphase2reactions.Enzymesinvolvedinthephase1reactionsareCytochromeP450s,flavincontainingmonooxygenasesandepoxidehydrolases.In thephase I reactions,oxidation, reductionandhydrolytic reactionswereobserved. In thephaseIIreactions,enzymesinvolvedaresulfotransferases(SULT),UDP-glucuronosyltransferas-es(UGT),glutathione-S-transferases(GST),N-acetyltransferases(NAT),andmethyltransferases.

• ForceddegradationandimpurityprofilingofdrugsbyHPLCandLC-MS-MS

• Drug-excipientcompatibilitystudiesusingisothermalstresstesting

DepartmentofPharmacologyandToxicology:-

• Mitochondrialprotectioninischemicstrokeusingintra-arterialmesenchymalstemcelltreat-ment.Inlastdecade,laboratorystudiessuggeststemcelltherapyasaprospectivetreatmentforstroke.Studiesdemonstratethatthepost-ischemicdeliveryofmesenchymalstemcells(MSCs)significantlyreducesischemicbraindamageinanimalmodelsofischemicstroke.

• StemCellTherapytoCounteractEndoplasmicReticulumStressinIschemicstroke.

• ExploringneuroprotectiveeffectofPhyllanthusemblicainanimalmodelofischemicstroke.

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• ExploringDAP-kinasepathwayinIschemicstrokebyIntra-ArterialMesenchymalStemCells(MSCs)intervention.

DepartmentofPharmaceutics:-

• Developmentofnovelpolymericnanomaterialforeffectivecytosolicdeliveryofanticancerbioactives:Thefocusofthisresearchistowardsthesuccessfuldeliveryoftherapeuticagentsinacontrolledandtargetedmannerandthedevelopmentofadvanceddeliverysystemsforavarietyofapplications.ProjectsrangingfromfundamentalsciencetoindustriallyrelevantapplicationsareundertakenbyPostdoc,Ph.Dandpostgraduatestudentswithinthecluster.

• FormulationDevelopmentofInjectableRNAinterferingnanoparticlefortargetedtherapyofdiabeticnephropathy

• Tripartiteapproachfortreatmentoftriplenegativebreastcancer(TNBC)usinggrapheneoxidewrappedpolymericnanoparticles

• NIRlaseractivatableNanoplatesforthetreatmentofresistanttumours

10. Institutionleadership:-

NIPERAhmedabad,aspirestobeaninternationallyrecognizedpremiercentreofexcellenceinteaching,research,andentrepreneurialtraining.TheinterdisciplinarycoursesandculturaldiversityatNIPER-Ahmedabadsparksthespiritofinnovativeresearchandall-rounddevelopmentofitsstu-dents.NIPER-Ahmedabadhasservedasagoodlaunchingplatformtorevampthepharmaeducationandresearch,toinitiatetheneweraofpharmaceuticalandbiomedicalsciences.NationalInstitutionalRankingFramework(NIRF)byMinistryofHumanResourceDevelopment,Govt.ofIndia,hasrankedNIPER–Ahmedabad1stRankinTLRandoverall9thbestPharmaInstituteinIndiaasperTheNationalInstitutionalRankingFramework-2019(NIRF)releasedbyMinistryforHumanResourceDevelopment,GovernmentofIndia..

11. ImpactofNIPER:

NIPER-Ahmedabadservesasagoodlaunchingplatformtorevampthepharmaeducationandresearch,initiatingtheneweraofpharmaceuticalandbiomedicalsciences.NIPER-Ahmedabadiscom-mittedtobuildinghumanresourceforpromotingresearchanddevelopmentinthecountryandcontrib-utetowards‘’MakeinIndia’’initiativeasapartofitsnationalresponsibility.

TheInstitutehasoutreachedtofetchscholarswithexcellentpostdoctoralandteachingexperi-encesfromallovertheworldtoenrichtheeducationandresearchqualityoftheinstitute.Withtheseexceptionalfaculties,theInstitutemotivatesitsstudentstoachievethehigheststandardsofexcellenceintheircourses.

NIPER-Ahmedabad has established itself as one of the top technological pharmacy researchinstitutes in the country with research collaboration as an integral part of the growth strategy.NIPER-Ahmedabadhasexpandeditsoutreachtotheindustryaswellascollaboratedwiththebestac-ademicinstitutionofUSA,UK,Australia,IrelandandMalaysiaforcollaboratingresearch,facultyvisit,syllabusup-gradationandregulatoryreformswithseveralindustriesandleadinginstitutes.

NIPER-Ahmedabadhasactivelycommittedtopromoteresearchandstimulatescientificcross

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talkacrossvariousdisciplines.Ithasconductedvariousconferences,symposiums,discussionsonchem-istry,biology,medicineandmaterialsattendedbymasters’students,Ph.D,postdocsandresearchersfromacademiaandindustry.Thediscussionsarescientificallystimulatingandhaveledtohealthycrosstalksandcollaborations.

12. Awards - Poster Presentation 39 Students participated in different Poster Presentation andamongthem9studentswereawardedfirst&secondprizeinrespectivepostercompetition.

13. PatentsandCommercialization:

1. PatentTitle: ProcessofisolationandpurificationofSwertiamarinfromEnicostemmelittorale,IndianPatentNo.201621008411(Date:10/03/2016)NameofInventor:VinodJairaj,SatyendraKumar,KiranKalia.

2. Patent Title: Cartilage Regeneration Using Piezoelectric Based Scaffold” Indian Patent No.201621008797 (Date: 14/03/2016).Nameof Inventor:Govinda Kapusetti, Jaicy Jacob, KiranKaliaandPiyushGondaliya

3. Patent Title: Minicircle DNA vector for inducing pluripotency in nucleated blood cells andothercell typesand its re-differentiation foruse in regenerativemedicine, IndianPatentNo.201621031592 (Date: 16/09/2016).Name of Inventor:Neelam Chauhan, Shaishavi Jansari,KiranKalia.

4. Patent Title: Graphene Oxide/Polypyrrole/Polyaniline / Zinc Oxide Nanocomposite BasedElectrode for Effective Detection of Cholesterol and Bilirubin, Indian Patent ApplicationNo.201821040222 (Date: 25/10/2018). Name of Inventor: Anup Kumar, Namdev More, KiranKalia,andGovindaKapusetti.

5. PatentTitle :Mix-and-Deliver-Type’ InVivoapplicablePolymericGeneTransfectingReagentfor Cancer Therapy, Indian Patent No. 201821043610 (Date: 20/11/2018).Name of Inven-tor:RakeshK.Tekade,KaushikKuche,PiyushGondaliya,VishakhaTambe,KiranKalia.

6. Patent Title : Supermacroporus, drug-loaded collagen punctum plug, Indian PatentNo.201821045485 (Date:02/12/2018).Nameof Inventor:AkshaySrivastava,GopalAgarwal,SilvyMarySebastian.

7. PatentTitle:TargetingPeripheralNeuronsusingTramadolhydrochlorideopioid-encapsulatedPEGylatedalbuminnanoparticlesforsafeandeffectiveantinociceptiveactivity,IndianPatentNo.201921010920 (Date: 20/03/2019).Name of Inventor : Rakesh K. Tekade, Vinod Tiwari,PankajBidve,DilipSharma,NamrataPrajapati,NidhiRaval,KiranKalia.

8. PatentTitle:Process and Composition for loading, stabilization, and delivery of RNAiTherapeutics inAnionic polymer, Indian PatentApplicationNo. 201921019898(Date: 21/05/2019).NameofInventor:NidhiRaval,HardiJogi,PiyushGondaliya,KiranKalia,RakeshKumarTekade.

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6thConvocationofNIPER-A

ShriRajneeshTingal,J.SVisitedNIPER-AandInauguratedTheFe-SemInstrumentFacilityOfTheInstitute

Dr.P.DVaghela,SecretaryPharma,visitedNIPER-Ahmedabad

FirstBoGMeetingHeldAtNIPER-A

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5.7 NIPER-Hajipur

NIPER-Hajipurstartedfunctioningin2007underthementorshipofInstituteRajendraMemorialResearchInstituteofMedicalSciences(RMRIMS),Patna.Thereare3(courses)viz.,(i)M.S.inBiotech-nology,(ii)M.Pharm.inPharmacyPracticeand(iii)M.S.Pharmacoinformaticswithanintakeof15ineachcourse.

1. Achievements

Sinceinceptiontotal294studentshavebeenpassedout(M.pharm-286andPh.D-8),93re-searchpapershavebeenpublishedand4MoUshavebeensigned.

2. Detailsoffaculty&staffareappendedbelow Academic: 08(oncontract)

Non-Academic: 08(oncontract)

3. FundallocationbytheGovernmentduringthelast4years:Table-5AB

(AllocationoffundbytheGovernmentduringthelast4years)

(Rs.incrores)

Year BudgetEstimated RevisedEstimated TotalRelease2016-17 6.00 5.00 5.002017-18 6.00 5.00 5.002018-19 9.50 9.50 9.502019-20* 10.50 10.50 3.00

*FundreleasedtillDecember2019.

4. Students

StudentsareadmittedthroughJointEntranceExamination(JEE)conductedbytheNIPER.ThePGsanctionedseatintakeineachofthe03(three)existingdepartmentsis16(sixteen)and02(two)forPh.D.ineachDepartment.

Table-5AC

(CapacityintakeforPGandPh.Ddegrees)

Students Male Female General OBC SC ST TotalPGPass-outs 18 14 13 14 05 00 32PG-II(Batch2018-20)

26 15 19 13 07 02 41

PG-I(AdmittedinJuly2019)

28 15 08 21 10 04 43

Ph.D.(onroll) 10 04 11 01 02 00 14

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5. Teacher-Studentratio1:9.9

6. Employability/PlacementsStatus

MostofthestudentspassedoutfromNIPERHajipurhavegottheirjobsatsuitableplacesandNationalimportanceInstitute.

7. Research

7.1. DepartmentalResearchActivities:Dept.ofBiotechnology

•Antibiotic sensitivityprofilesofStaphylococcus isolates fromskinofhumansubjectsand itsrelationtootherdermalinfections.

•ApplicationofNanotechnologyasabiosensorfordetectionanddiagnosisofdiseases.

•ApplicationoffunctionalizedandconjugatedgoldNanoparticlesforimprovedantimicrobialef-ficacy.

•UbiquitinconjugatingenzymesasdrugtargetsinLeishmania donovani.

•Effectofdifferentfruits,vegetablesandbeveragesonthegrowthofacommerciallyavailableprobioticundersimulatedgastricconditions.

•Effectofcommerciallyavailablenasalsprays,perfumes,floraloilsandvegetableextractsonstaphylococcalpopulationofsmokersandnon-smokers.

•Greensynthesizedgoldnanoparticlesasantifungalandantiparasiticagents.

7.2. DepartmentalResearchActivities:Dept.ofPharmacyPractice

• DietaryAssessmentofType-2DiabeticPatients:AsinglecenteredhospitalbasedProspectiveStudy.

• EvaluationofEfficacyandToxicityofConcurrentCapacitabinewithRadiation inLocallyAd-vancedRectalCancerPatientsofBihar.

• Knowledge,AttitudeandPracticesstudyregardingawarenessoncervicalcancerscreeningandHPVVaccinationinBihar,India.

• EvaluationofAdverseDrugReactionofImatinibwithreferencetoP110&p190fusionTran-scriptsinChronicMyloidLeukemiaPatientsanditsexplorationinIndianPopulations.

• Knowledge,Stigma,HealthSeekingBehavioranditsDeterminantsamongPatientswithPostKalaazarDermalLeishmaniasis,Bihar,India.

• AssessmentofRiskFactorsandManagementofPostKalaAzarDermalLeishmaniasis,Project.

• HPVanditsAssociatedClinicalOutcomesinCervicalCancer.(ProjectOngoing)

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7.3. DepartmentalResearchActivities:Dept.ofPharmacoinformatics

• Identificationofnovel inhibitors forcysteinesynthaseenzymefor Leishmania donovani,us-ingstructurebasedpharmacophoremodels,moleculardynamicsstudiesandvirtualscreeningmethods.

•DevelopmentofnovelinhibitorsforG-ProteinCoupledReceptor3(GPR3)forthetreatmentofAlzheimer’sdisease(AD)usingQMdockingstudies,homologymodelling,moleculardynamics(MD)studies,freeenergycalculationstudies.

•DevelopmentofnovelinhibitorsforG-ProteinCoupledReceptor3(GPR3)forthetreatmentofAlzheimer’sdisease(AD)usingQMdockingstudies,homologymodelling,moleculardynamics(MD)studies,freeenergycalculationstudies.

8. ImpactofNIPER

NIPERHajipurhassuccessfullyproduced314studentsinthreedisciplinesnamely,Biotechnolo-gy,PharmacoinformaticsandPharmacyPracticewhoareeitheremployedindifferentpharmaceuticalindustries or pursuing their higher education in different institutes or universities across the globe.ManyofNIPERHajipurex-studentsareengagedasfacultyatdifferentinstitutions.

InternationalYogadaycelebration

SwachhataPakhwada

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CHAPTER 6 PUBLICSECTORUNDERTAKINGS(PSUs)

6.1 CentralPublicSectorUndertakings

6.2 IndianDrugs&PharmaceuticalsLtd.(IDPL)

6.3 HindustanAntibioticsLtd.(HAL)

6.4 KarnatakaAntibiotics&PharmaceuticalsLtd.(KAPL)

6.5 BengalChemicals&PharmaceuticalsLtd.(BCPL)

6.6 RajasthanDrugs&PharmaceuticalsLtd.(RDPL)

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CHAPTER 6

PUBLICSECTORUNDERTAKINGS

6.1 CENTRALPUBLICSECTORUNDERAKINGS(CPSUs)

TherearefiveCentralPublicSectorUndertakings(CPSUs)undertheadministrativecontroloftheDepartmentofPharmaceuticals.TheGovernmenthasdecidedtoclosetwoPSUs,viz.IndianDrugs&PharmaceuticalsLimited(IDPL)andRajasthanDrugs&PharmaceuticalsLimited(RDPL)andstrategi-callyselltheremainingthreePSUs,viz.,HindustanAntibioticLimited(HAL),BengalChemicals&Phar-maceuticalsLimited(BCPL)andKarnatakaAntibiotic&PharmaceuticalsLimited(KAPL).ThegistofthesePSUsisasunder:

Table-6A

(SummaryofCPSUsoftheDepartment)

(AsonDecember2019)

HAL IDPL RDPL BCPL KAPLEstablishedin 1954 1961 1978 1981 1981

Classification Sick Sick Incipientsick

Sick(nowProfitMaking) ProfitMaking

Networth(incr.) -430.58 -7626.58 -76.88 -66.78 179.58

Turnover(incr.) 66.85 33.96 Nil 100.50 360.36

Operatingprofit/loss(incr.) -38.30 -13.25

Balancesheetnotfinalised

25.26 25.23

Liabilities(incr.) 806.82 7812 114Cr 208.92 168.81No.ofEmployees 918 15 128 195 658

Officerlevel 174 3 12 51 225Workerlevel 744 12 116 144 433

Totalland 263.57acres 1815.048acre 9.35 acre 72.89 acre40.34acres

Leasehold Nil 833.878 acre 9.35 acre 1.10acre Nil

Freehold 263.57acres 981.17 acre Nil 71.79 acre 40.34acres

GistofCabinetdecisionsonPharmaPSUs:

(A) Based on recommendations of a Committee of Ministers, the Cabinet in its meeting held on28.12.2016decidedthat:

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(i) OnlythatmuchofsurpluslandofHAL,IDPL,RDPLandBCPLaswouldberequiredtomeettheliabilitiesbesoldthroughopencompetitivebiddingtoGovernmentagenciesandtheoutstand-ingliabilitiesbeclearedfromthesaleproceeds.VoluntarySeparationScheme/VoluntaryRetire-mentSchemealsobeimplementedinthesePSUstopavewayfortheirclosure.RemainingpartofthelandshouldbemanagedinaccordancewithguidelinesofDepartmentofInvestmentandPublicAssetManagement(DIPAM)andDepartmentofPublicEnterprises(DPE) inthisregardandifneedbe,vestedinaSPVcreatedforthispurpose.

(ii) Afterliabilitieshavebeenmet,balancesheetcleansedandtheVoluntarySeparationScheme/VoluntaryRetirementSchemeeffected,theDepartmenttocloseIDPLandRDPLandHALandBCPLbeputupforstrategicsale.

(iii) WhiletakingadecisiontoclosethePSUs,theDepartmentmayalsoexplorethepossibilityofhivingoffthesubsidiarycompaniesofHALandIDPLforprivateparticipation,whereverfoundviable.

(B) Asnobids for surplus landwere received fromGovernmentagencies, theUnionCabineton17.07.2019modifieditsearlierdecisionandpermittedsaleofsurpluslandasperrevisedDPE’sguidelinesdated14.06.2018andtoprovidebudgetarysupportasloanofRs330.35cr.formeet-ingtheemployeesliabilities(Unpaidsalary–Rs.158.35cr.+VRSRs.172.00cr.)asunder:

a.IDPL–Rs.6.50cr.

b.RDPL–Rs.43.70cr.

c.HAL–Rs.280.15cr.

TheCabinetfurtherdecidedforconstitutionofaCommitteeofMinistersfortakingalldecisionspertainingtoclosure/strategicsaleincludingthesaleofassetsandclearanceofoutstandingliabilities.FurtheractionforimplementationoftheCabinet’sdecisionsisbeingtaken.

(C) Separately,theCabinetCommitteeofEconomicAffairs(CCEA)initsmeetingheldon01.11.2017accordedin-principleapprovalforstrategicdisinvestmentof100%GovernmentofIndiaequityinKAPL.Thedecision ispresentlykeptonholdasthematter ispendingbeforetheSupremeCourt.

(D) Further,theUnionCabineton20.11.2019hasapprovedextensionofPharmaceuticalPurchas Policy(PPP)tillfinalclosure/strategicsaleofthepharmaPSUs.

6.2 INDIANDRUGSANDPHARMACEUTICALSLTD.(IDPL)

Background:

IndianDrugs&PharmaceuticalsLimited(IDPL)wasincorporatedasapubliclimitedcompanyon5thApril,1961undertheCompaniesAct,1956.Themainobjectivesofthecompanyweretocreateself-sufficiencyinrespectofessential lifesavingmedicines,tofreethecountryfromdependenceonimportsandtoprovidemedicinestothemillionsataffordableprices.IDPLwasbasicallyconceivedandestablishedasapartofHealthcareInfrastructureandhasplayedapioneeringinfrastructuralroleinthegrowthofIndianDrugsIndustrybase.

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TheRegisteredOfficeof theCompany is locatedat IDPLComplex,Dundahera,Gurgaon.ThecompanyhasthreemainPlantsatRishikesh(Uttarakhand),Gurugram(Haryana),Hyderabad(Telanga-na)andtwo100%whollyownedsubsidiaries,namely,IDPL(TamilNadu)Limited,Chennai(TamilNadu)andBiharDrugs&OrganicChemicalsLimited(BDOCL)atMuzaffarpur(Bihar).Inaddition,IDPLhasoneJointVenture,promotedincollaborationwithIndustrialPromotion&InvestmentCorporationofOrissaLimited(IPICOL),GovernmentofOdisha,namelyOdishaDrugs&ChemicalsLtd.(ODCL)Bhubaneswarhavingshareof51%and49%respectively.

IDPLhasplayedamajorroleinthestrategicNationalHealthProgrammeslikeFamilyWelfareProgramme&PopulationsControl(Mala-D&Mala-N),anti-malarial(Chloroquine)andpreventionofdehydration (ORS)byprovidingqualitymedicines. IDPLhasencouraged indigenousproductionandsupportingGovernmentinmeetingemergentsituationsinCyclone,FloodandEarthquakeinOdisha,Ut-trakhandandJ&Kprovidinglifesavingmedicinesontime.Themainobjectivesofsetting-upIDPLwerenottoearnprofitsbuttoencourageindigenousproductionofpharmaceuticalsandtosupportvarioushealthprogrammesoftheCentralGovernment.

100%whollyownedsubsidiaries

a) IDPL(TamilNadu)Ltd,Chennai.

IDPL(TN)Ltd.ChennaiwasincorporatedinSeptember,1965.Initially itwasaSurgicalInstrumentsPlantandlaterdivertedforformulations.IntermsofrevivalpackageapprovedbyBIFRin1994,thePlantwasconvertedintoawhollyownedsubsidiaryinthenameandstyleofIDPL (Tamilnadu) Limited,Chennaiwitheffect from1.4.1994. ItwasaSchedule-McompliantplantengagedinmanufactureofpharmaceuticalsformulationsuptoSeptember’2018.ThereisnoproductionactivityintheUnitsinceOctober’2018.

b) BiharDrugs&OrganicChemicalsLtd.(BDOCL),Muzaffarpur

BiharDrugs&OrganicChemicalsLtd.,(BDOCL)Muzaffarpurwasincorporatedin1979,converted into awholly owned subsidiarywith effect from1.4.1994. SinceNovember 1996thereisnoproductionactivityinBDOCLPlant.

JointVenture

OrissaDrugsandChemicalsLtd(ODCL)

OrissaDrugs&ChemicalsLimited(ODCL)wasincorporatedin1979andcommissionedfullyforproductionfromSeptember,1983.ODCLisaJointVenturepromotedbyIndianDrugs&Pharmaceuti-calsLtd.(IDPL)andIndustrialPromotion&InvestmentCorporationofOrissa(IPICOL).IDPLholds51%oftheequitysharesand49%iswithIPICOL.BIFRpassedordersforwindingupinApril,2003undertheprovisionsofSICAAct,1985.HighCourtofOrissahadappointedaprovisionalLiquidator.ThishassincebeenstayedbyalargerBenchoftheOdishaHighCourt.

PresentlyCompanyisengagedinmanufactureofpharmaceuticalsformulationsintheformofTablets,Capsules,Powder,ORSandInjectablesetc.ODCLPlantisSchedule-Mcompliantandcompanyhasearnedoperatingprofitsince2011-12.

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Injectiblesection-ODCL

ModernizationofPlants(Governmentassistanceprojectsandstatus):

TomakeallIDPLPlantsWHO-GMPcompliantfundofRs740lacswasreleasedbytheGovern-ment.OutofRs.740lacs,afundofRs.65.67lacswasutilisedtowardsWHOGMPworkofRishikeshandODCL.Later,inviewofCabinetdecisiontocloseIDPLUnits,theun-utilisedfundofRs.674.33lacshasbeenreturnedbacktotheDepartmentinJuly,2019.RishikeshPlantisSchedule‘M’andWHO-GMPcompliant. COPPhasbeen received for9products.WhereasGurgaonPlant, Tablets Section is alsoSchedule-Mcompliant.

ProductprofileandRange:

Presently, IDPL ismanufacturingnearly86products (PPP)and25products (Non-PPP) in theformofCapsules,Tablets,DrySyrup,LiquidOralandInjection.ORS,basedonmainlyfollowingthera-peuticgroups:

Antibacterial/Anti-infective,Analgestic/Anti-inflammatory,Gastrointestinal,RespiratoryTract,Contraceptive/OCP,Vitamins/Mineral,Antiallergic,AntifungalAntimalarialAntidiabeticCardiovascular.

PopularBrands: Deacos,110ml,SukceeTab,Cebxin-Zarepopularbrands.

Manpower- PresentlyIDPLhas15regularemployeesand96oncontractualbasisintheCompanyincluding100%Subsidiaries.Companyappointedcontractualmanpoweronlyonneedbasisinstatutoryandcriticalpositiontoperformtheday-to-dayactivitiesandsafeguardoftheCompany’sproperty.AtpresentIDPLbearsallliabilitiesfromitsinternalresources.

Distributionnetworkifany; Companyisselling itsproductsthroughC&F/Distributorsto InstitutionslocatedalloverIndia.

Performance:In-houseproductionfiguresforthelastfiveyears(uptoDecember’2019)areasunder:Table-6B

(In-houseproductionfiguresforthelastfiveyears) (Rs.inCrore)

Subject 2015-16 2016-17 2017-18 2018-19 2019-20Production 87.94 78.34 34.58 33.96 7.08Sales 86.41 79.45 31.75 33.95 10.83

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Marketing:ShareofInstitutionsandretail:TheCompanyissupplyingitsproductstoGovt.InstitutionsonPPPasperNPPAcertifiedrates.MajorInstitutionsareESIC,MinistryofHealth,Defence,Railways,StateGovernments/CorporationsandPublicSectorEnterprisesHospitalswhoplaceordersunderdif-ferentcategoriesofTherapeuticMedicines.ApartfromabovethecompanyisfullysupportingPradhanMantriJanAushadhiPariyojna.

Presentstatus:

InviewofCabinetdecisiondated28.12.2016and17.07.2019,thecompanyisintheprocessofclosure.AnMoUbetween IDPLandLandManagement (LMA)NBCC(NationalBuildingConstructionCorporationhasbeensignedinOctober,2019fordisposalofitsland/immovableproperties.Also,anMoUbetween IDPL andAuctioningAgency (AA)Metal Scrap Trading Corporation (MSTC) has beensignedinOctober,2019forsalesofitsmoveableandimmovablepropertiesbye-auctioning.AvaluerhasalsobeenappointedtoassessthemoveableandimmoveablepropertiesofIDPL.

6.3 HindustanAntibioticsLimited(HAL)

1.0 Background:

HindustanAntibioticsLtd(HAL)iswhollyownedGovernmentCompanyengagedinthemanu-facturing&marketingoflifesavingdrugs.HALwasestablishedin1954withWHO/UNICFassistance.HALisfirsttoManufacturetheAntibioticslikeBulkdrugs,StreptomycinandGentamycin.HALhasraredistinctionofinventingtwonewmoleculesviz.HamycinandAuerofungin.

HAL,atpresent,isbouncingbacktoproductiveandefficientworkcultureandtakingallthestepstoachievetheenhancedturnoverandprofitabilityforthecompany.

PerformanceRatingUnderMOU:

HALhasentered intoMOUfortheyear2018-19withtheDepartment.BasedontheAuditedResultsoftheCompany,HALislikelytoreceive“VERYGOOD”MOURatingfortheyear2018-19.HALhasbeenrated“GOOD”intheMOU2017-18and2016-17byDepartmentofPublicEnterprises(DPE).

CorporateGovernance:

HAL is committed to followGoodCorporateGovernancePractices in conductingbusiness in

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legal,ethical&transparentmanner.DuringtheYear2018-19,HALgotthe“EXCELLENT”ratinginselfevaluationofcomplianceofGuidelinesonCorporateGovernanceissuedbyDPEforCPSEs.During2019-20also,HALisexpectedtoget“EXCELLENT”rating.

2.0BoardOfDirectors:

Ms.NirjaSaraf :ManagingDirector

Mr.ManojKumarBhardwaj :Govt.NomineeDirector

Mr.DineshKodarbhaiMakwana :IndependentDirector

3.0 SubsidiariesofHAL:Table-6C

(SubsidiariesofHAL)

Sr.No. Particulars Year

a. MaharashtraAntibioticsandPharmaceuticalsLimited(MAPL)

1979tilldate

b. ManipurStateDrugs&PharmaceuticalsLimited(MS-DPL)

1989tilldate

4.0 BriefofFacilitiesavailable:

HALmanufacturingfacilitiesincludethefollowing:

a) BulkPlant:

HALishavingfermentation-basedmanufacturingfacilitiesincluding19X92M3fermenteralongwithitsdownstreamprocessing,solventrecoveryandassociatedutilitieslikesteam,chilledwater,cool-ingtowerwater,compressedairetc.Thisfacilityearlierwasusedformanufacturingfermentation-basedbulkdrugslikePenicillin-G,StreptomycinSulphate.Thisfacilityisidleatpresentandisavailableforleas-ing

b) Formulationfacility:

HALisfocusingatpresentonmanufacturingPharmaformulationandpromisingAgro-formula-tiontocatertowiderangeofPharmaandAgromarket.HALPharmaproductsincludesvariousdosageformslikeInjectableproducts,Tablets,Capsules,Intra-Venousproducts,LiquidSyrupetc.Atpresent,manufacturingformulationcapacitiesincludingPharma&Agro-Chem,areasunder:

Table-6D(ManufacturingformulationcapacitiesincludingPharma&Agro-Chem)

Sr.No. Productionfacilities Capacities(Existing)LacNos./annum

A. PharmaPlants 1 PowderInjectable

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a. Cephalosporin 450b. Penicillin 4502 Tablets a. Penicillin 1200b. Non-Penicillin 24003 PenicillinCapsules 25004 I.V.Fluids 1205 LiquidSyrup&Externalpreparation 24

BAgro-ChemPlants 1 Agro-Chem(Streptocycline) 1802 Humaurformulation 210KL*3 AureofunginBulk 0.810tonnes4 Azotomeal 50KL*5 Phosphmeal 50KL*

CAlcoholicHandDisinfectant(AHD)*Capacityof theseproductscanbe increaseddependinguponrequirementsinceHAL ishaving idle

sizablefermentationfacilities

c) Duringtheyear2018-19,HALenteredintoMoUwithanotherCPSUM/sMishraDhatuNigamLtd.(MIDHANI),undertheadministrativecontrolofMinistryofDefence,formarketingofBio-Im-plantsmanufacturedbyMIDHANI.

d) Duringtheyear2018-19,HALre-startedmanufacturingoffollowingAgroProductswhichwerecloseddownforthelast8to10years:

i) Aureofunginii) Humauriii) Phosphomealiv) Azetomeal

12

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e) Duringtheyear2019-20,HALhasre-startedmarketingofoneofitspremiumproductwhichwascloseddownsince2010,namelyPen-Vtablet,whichisusedincuringRheumaticHeartDisease.HAListheonlyunitinthecountry,formanufacturingofPen-Vtablets.DiscussionsaregoingonwithMinistryofHealthandICMRfororders,whichareexpectedinJanuary2020.

f) ResearchandDevelopment:

HAL’sR&DDepartment isengaged inmanufacturingstandardsizeNarcoticDrugsDetectionKits,PrecursorChemicalsDetectionKitsandKetamineDetectionKitsasperrequirementsofNarcoticControlBureau,DepartmentofInternalSecurity,MinistryofHomeAffairs,Govt.ofIndia,NewDelhi.HAListheonlyexclusivemanufacturerofthisproductinthecountry.

5.0 PresentStatusoftheCompany

Companyishavingmanpowerstrengthof888employeesasagainsttherequirementof350em-ployees.TheCompanyhasinitiatedtheprocessofVRSfortheemployeesinthemonthofSeptember2019.Atotalof580employeeshavesubmittedapplicationforVRS.Theprocessofrelievingtheemploy-eesisinprogress.TheCompanyishaving263acresofland,outofwhichCabinethassanctionedsaleofsurplus87.70acresoflandtomeetupitsliabilities.TheCompanyhassignedanMOUwithNBCCon26.10.2019asLandManagementAgencyforsaleofland.TheCompanyhassubmitteddetailsofsurpluslandofHALandallpropertiesofits2SubsidiaryCompaniesnamely,MAPL,NagpurandMSDPL,Mani-purtoNBCC.

6.0 DetailsofProduction,Sales,TurnoverandNetProfit/Lossforthelastthreeyears:

Table-6E

(Production,TurnoverandNetProfitforthelastthreeyears) (RsinCrores)

Particulars 2015-16 2016-17 2017-18 2018-19 2019-20(uptoDec.’2019)

Production 14.45 11.36 37.44 54.51 26.25

SalesTurnover 15.12 10.73 35.21 66.85 36.40

NetProfit(Loss) (74.68) 78.24 208.32* (71.10) (42.70)

*NetProfitistheresultofanextraordinaryitemofincomeviz.waiverbyGovt.ofIndiaofitsPlanandNon-PlanloanofRs.186.96croresandtheinterestthereonofRs.89.94crores.

TheincreaseinsalesturnoverofRs.66.85CroresascomparedtoRs.35.21Croreduringthepreviousyearhasbeenpossibleduetorestartingofproductionactivitiesofvariousplants includingPilotPlant(formanufactureofAureofungin&Humaur)&IVFPlant(formanufactureoflargevolumeparenterals).

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Graph-6(i)

(SalesofHALsince2013-14)

Graph-6(ii)

(ValueofproductioninHALsince2013-14)

7.0 Projectsimplementedsofar:

HALhascompletedsetting-upofnewCephalosporinpowerinjectablefacilities.ThisfacilitywasaccreditedwithWHO-GMPcertificationinJuly2010.TheupgradationofBetalactam&QualityControlLabiscompleteandreadyforWHO-GMPinspection.Non-ParentalfacilityisalsobeingplannedtobeupgradedtoWHO-GMPcompliance,during2020-21.

8.0 PlannedProjects:

HAL isplanningupgradationoffollowingfacilitiestogeneratemorefundsforthecompany:

1.1 FacilityforbulkAmoxicillinTrihydrateIPwithinitialcapacityofaround50to60Tonnespermonth.

1.2 FacilityforbulkSulbactumSodiumIP.

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1.3 FacilityforAlcoholicHandrubDisinfectant,theonlyCPSUtohavesuchfacility.

1.4 MarketingofBio-medicalImplantsmanufacturedbyMishraDhatuNigamLtd.,aCPSUun-dertheMinistryofDefence,GOI,havingcertificationofISO9001:2015&AS9001:2016.

1.5 RooftopSolarPanelsforgenerationofpowerequivalentto1MW.

Thefundingfortheaboveprojectsshallbedonethroughinternalresources.ThemanufacturingofbulkAPIsshallalsocomplimenttheHon’blePrimeMinister’s‘MakeinIndia’initiativeforbulkdrugs/API’s.

9.0 StrategyforMarketing:

HAL’ssalesareatpresentlargelydependentoninstitutionalsalewithPPPmodel.ForreducingthedependenceonPPPbusinessfollowingstrategywouldbeadoptedbytheCompany:

EnhancingtheTradeSalethroughwellestablisheddistributionnetworkofdis tributors,C&Fagentsandbranchestosupportproductsupplychain.

Inductingnewproductshavinghighvalue&highmargin&phasingoutproducts whichareattheendoftheirlifecycle.

Increasingthesalesofexistinghighmarginproducts.

TobecompetitiveinInstitutionalbusinesswithcostreduction.

ToexpandAgro-vetbusinesshavinghighpotential&bettermargin.

Tocapturegrowingexportmarketssincethemanufacturingfacilitieswouldbe WHO-GMPcompliant.

10.0 RationalizationofManpower:

TheCompanyhas918employeeson31stMarch,2019.TheCompanyhas110womenemploy-ees.Ason1stDecember,2019,thetotalnumberofemployeesis885.VarioussocialsecurityschemeslikeProvidentFund,Gratuity&Medical schemesarealso inplace in theCompany.HALhasnot re-ceivedsalaryrevisionsince1997,whereasemployeesofotherCPSU’sarealreadyreceivingsalaryasper2007/2017revision.Itisnecessarytorevisepayscalessoastogetqualitypersonnelincoreareas.

11.0 ERPsystemforefficientfunctioning:

a. AllthesystemsincludingreceiptintheStores,issueforproduction,consumptionofraw materialaswellaspackagingmaterialfortheproduct,out-turnofproductiontomarketing& distribution,Personnelincludingtime-officeisbeingcomputerizedusingERPSystem.

b. Thissystemwillenabletohaveupdatedinformationinstantlyandtherebycanhaveeffi cientmonitoringofinventory,consumptionandreducemanpower.

12.0Costcuttingmeasures:

a. Systemofregularmonitoringof‘A’categoryrawmaterialandpackagingmaterialwith respecttothestandardconsumptionnormsisbeingintroduced.

b. Utilizationoffundstoreduceinterestburdenandcontrolsonfundmanagement.

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c. Costcuttingmeasuresinalltheareasofoperationisstrictlyenforced.

d. Optimumutilizationofavailablemanpowerisenforced.

13.0SocialCommitmentsofHAL:

a. SwachhaBharatAbhiyanwasheldinHALfrom16.08.2019to20.09.2019

b. “HindiPakhwada”programmewasorganizedbyHALfrom14/09/2019to14/10/2019.

c. VigilanceAwarenessWeekwascelebrated inHALwitheffectfrom28.10.2019.PledgewastakenandvariouscompetitionslikeDebate,EssayandSlogansorganized.

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6.4 KARNATAKAANTIBIOTICS&PHARMACEUTICALSLIMITED(KAPL)

BACKGROUNDKarnatakaAntibioticsandPharmaceuticalsLimited(KAPL)isaProfitmakingJointSectorCom-

panyincorporatedintheyear1981[with59%sharebyGovernmentofIndiaand41%sharebyGov-ernmentofKarnatakathroughKarnatakaStateIndustrialandInfrastructureDevelopmentCorporation(KSIIDC)].ThebasicobjectiveoftheCompanyistomakeavailablelifesavingdrugsofgoodqualitytoGovernmentHospitalsandotherInstitutionsalongwithPrivateMedicalPractitioners.TheCompanyhasWHO-GMPCertifiedmanufacturingfacilitiesforDryPowderInjectables,LiquidInjectables,Tablets,Capsules,DrySyrupsandSuspensions.Thepaid-upsharecapitaloftheCompanyasondateisRs.13.49crores.

ProductionandSalesPerformance:Table-6F

(ProductionandSalesPerformance) (Rs.inCrores)

Year Production Sales2014-2015 281.81 247.242015-2016 342.01 326.922016-2017 405.51 386.272017-2018 366.82 353.832018-2019 388.63 360.36

2019-20(Nov.2019) 298.98 280.67

PASTACHIEVEMENTS:- MiniRatnaCPSE- ISO9001(QMS)ANDISO14001(EMS)- PIC/SCertification

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POPULARBRANDS:

PHARMA–TRADE

Table-6G(Pharmatrade)

No. Products TherapySegments NLEM Monopoly MarketValue

1 Grenil Anti-Migraine No No Rs.794.65lakhs2 Oxytocin Hormone Yes No Rs.474.71lakhs3 Cyfolac Probiotics No No Rs.345.32lakhs

4 Remcc Cough&Cold No No Rs.176.07lakhs

5 Verclav Antibiotic Yes No Rs.160.71lakhs

6 POPE PlateletBooster No No Rs.155.39lakhs

7 Zinfe Haematinic No No Rs.138.86lakhs

8 Numol PainMedication No No Rs.111.37lakhs

AGROVET:Table-6H(Agrovet)

No Products TherapySegments Monopoly MarketValue1 Kalvimin AnimalFeedSupplement No Rs.3.0Cr2 K-live LiverTonic No Rs.2.5Cr3 CalK AnimalFeedSupplement No Rs.2.5Cr

DISTRIBUTIONNETWORK:

PHARMA

TheCompanyhasbeenexpandingitsoperationsinRetailTradeSectorwithaplannedeffortsoastocatertotheneedsofthePrivateMedicalPractitioners.InthisdirectiontheCompanyhasbeenperiodically launchingNewProducts inthevariousTherapeuticSegments. TheDomesticoperationsspansthroughthecountrymannedbyahighlydedicatedProfessionalFieldForceandbackedbyawellknitChannelofDistributionensuringKAPL’spresenceattheMetroaswellasMicroMarkets.

KAPLhasitsBrancheslocatedinalmostalltheStateHeadQuarters.TheCompanyalsohasanexcellentDistributionNetworkatalmost20branchesatMajorCitiescateringtotherespectiveStateareathroughChannelMarketing.ThesuppliesaremadeeffectivethroughapprovedStockiststoRe-tailers,NursingHomesandDispensingdoctorsintheTradeSegmentanddirectlytoInstitutionsinRateContract(RC)&Non-RateContract(NRC)Sectors.

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MARKETING:

PHARMA:TheCompanyhasbeenmainlyfocusingonPrescriptionMarketasMedicalProfessionalasour

Customers,wheremanyoftheMNCsandPrivatePharmaPlayershaveamajorshare.TheCompanyisalsodependantonPPPPolicyforInstitutionalBusiness,whereourconcentrationisonGovt.Hospitals,StateGovernmentHospitals,Corporates,PSUHospitals,DefenceandInsurance.IthaspotentialtoexpandinTradeSegmentandalsotoincreasevolumesbyfocusingonCPSEHospitalsandlargeCorpo-rateHospitals.

AGROVET:

TheCompany is focusingonAgroDealers, DepartmentofAgriculture/Horiculture forAgroProducts.ProductsarebeingfocusedonVeterinaryPractitioners,Farmers,AnimalHusbandaryDepart-mentofallStatesandMilkUnionsforVeterinaryProductsandFeedSupplements.

NEWPRODUCTS(PHARMA&AGROVET)FOR2019-20

Table-6I(Newproducts-pharma&agrovet-for2019-20)

Sl.No Products TherapeuticCategoryPHARMAa) Kapitra100 Antifungalb) Kapitra200 Antifungalc) Kaplicon AntifungalAGROVETd) VetCPMInjection AntiAlergice) PensbioticMD5gm Antibiotic

PresentlyCompany ismanufacturingandmarketingOxytocin InjectionasperthedecisionofGovernmentofIndia.FUTUREPLANS: WHOGMPCERTIFICATIONOFAYURVEDADHARWADPLANT

CombilinebothVialsandAmpoulesinaugurationatSmallVolumeParenterals(SVP)atFactory.

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InaugurationofNewFormulationDevelopmentDepartmentbyShriSunilKumarKaimal,ManagingDirectorduringOctober2019.

6.5 BengalChemicals&PharmaceuticalsLtd.(BCPL)

Background:

BengalChemicalsandPharmaceuticalsLimited(BCPL)wasformedin1901byAcharyaPrafullaChandraRoy,arenownedScientistandAcademician.GovernmentofIndiahadtakenoveritsManage-mentin1977,nationalisedin1980andRegistereditasBengalChemicals&PharmaceuticalsLimited(BCPL)undertheCompaniesActin1981.

BusinessOperations:

HeadquarteredinKolkata,BCPLisengagedinthebusinessofindustrialchemicals(Alum),brand-ed and unbranded generic pharmaceuticals, hair oil and disinfectants such as Phenol,Naphthaleneballs,Bleachingpowder,ToiletcleanersandFloorcleaners.

ManufacturingLocations:AtpresentBCPLhasfourfactories;atManiktalaandPanihatiinWestBengal,MumbaiandKanpur.

ManiktalaUnit: This unitwas set up in 1905 andprimarily produces Pharmaceuticals formulationswhichincludebrandedaswellasunbrandedgenericproducts.CommercialproductioninTablet,Cap-suleandOintmentsectionsisgoingonfull-fledged.

PanihatiUnit: Panihatiunitwassetupin1920andislocatedinNorth24Parganas,WestBengal.Pani-hatiunitprimarilyproducesIndustrialChemicalsandHomeProductswhichincludePheneol,Naphtha-leneBalls,andotherdisinfectants.Commercialproductioninmostoftherenovatedproduction-blockssuchasFerricAlum,Pheneol,NapthaleneandWhiteTigerhavecommenced.

MumbaiUnit:Mumbaiunitwassetupin1938andfurtherthecommercialspacedevelopedhasbeenleasedouttothirdpartiesforgenerationofadditionalsourcesofincome.

KanpurUnit: KanpurUnitwassetupin1949,primarilyproduceslow-valuetablets.

PastAchievements:TheCompanyhasretaineditsbrandpositioninhomeproductsevenduringthecrisisperiodandwellsettocapitalizeonthesebrandsnow.

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Productprofileandrange:

Theproductsmanufacturedundereachofthesebusinesssegmentsarementionedbelow:

ProductProfileTable-6J

(ProductProfile)

Division-I Division–II Division–IIII n d u s t r i a lChemicals

Pharma Ge-nerics

P h a r m a Branded

Disinfectants HairOil OtherProducts

Alum

B l e a c h i n gPowder

Tablets, Cap-sules, Inject-ables

Ointments

Liquids

External-Liq-uids

ASVS

Aqua Pty-chotis

Kalmegh

Eutheria

Benflam

Pheneol

WhiteTiger

KlinToilet

Lysol

CantharidineHairOil

Naphthal-eneBalls

LiquidSoap

AguruEssence

Popularbrands:Pheneol–Lampbrand,WhiteTiger,Naphthalene,CantharidineHairOil.

Manpower:

Table-6K(Manpower)

Particulars Manpower(Ason30.11.2019)Executives 51Supervisors 22Workers 102

GrandTotal 175

Distributionnetworkifany:

ThecompanyhasastrongdistributionnetworkpanIndiawith6Depotsand6C&FAgencies.BCPLhasopened5RetailStoresinKolkata.

Performance:

DetailsofProduction,TurnoverandFinancialPerformanceofBCPLforlastfiveyearsisunder:

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Table-6L(FinancialPerformanceofBCPLforlastfiveyears)

(Rs.inCrores)

Particulars 2018-19 2017-18 2016-17 2015-16 2014-15Production 123.45 98.18 102.69 106.70 64.10Income 119.67 94.80 110.25 112.76 65.53GrossMargin(Loss) 32.83 24.23 24.05 11.24 1.65Interest Expenses(Financecost)

2.45 9.05 15.07 16.42 15.36

Depreciation 5.12 5.12 4.47 3.95 3.61NetProfit(Loss) 25.26 10.06 4.51 (9.13) (17.32)

DPErating:Table-6M

(DPErating)

Year MOUAssessment CorporateGovernance2014-15 “Good” “Fair”2015-16 “Excellent” “Excellent”2016-17 “VeryGood” “Excellent”2017-18 “Notapplicable” “Excellent”2018-19 “Notapplicable” “Excellent”

Futureplans: Cabinethasdecidedon28thDecember2016forstrategicdisinvestmentofthecompanyaftermeetingall its liabilities fromsaleofsurplus landthroughopencompetitivebiddingtoGovernmentAgencies.BengalChemicalsSramikKarmachariUnionfiledaWritPetitionbeforetheHon’bleHighCourtofCalcuttaon20/06/2017againstthedecisionoftheUnionCabinetofStrategicSaleofBCPL.VideitsdatedFebruary13,2018,theHighCourtofCalcuttahassetasidethedecisionoftheUnionCabinetregardingstrategicsaleofBCPL.AnappealhasbeenfiledattheDivisionBench.

38thAGMofBCPLHeldon22ndMay2019

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VisitofSecretary,DepartmentofPharmaceuticals,GovernmentofIndia,toManiktalafactory

6.6. RajasthanDrugs&PharmaceuticalsLtd.(RDPL) RajasthanDrugs&PharmaceuticalsLimited(RDPL)isaCentralPublicSectorUnitinJointSectorwithatotalpaid-upequitycapitalofRs.4.98crorewhereGovernmentofIndia(GoI)andRajasthanStateIndustrialDevelopment&InvestmentCorporationLimited(RIICO,Govt.ofRajasthan)hold51%and49%sharesrespectively.Itwasincorporatedin1978andcommercialproductionstartedin1981.TheCompanyhas itsmanufacturingfacilities&registeredofficeatRoadno.12,VKI IndustrialArea,Jaipur(Rajasthan).

Thecompanyhasawell-equippedlaboratorywithmodernequipmentlikeHPLC,FTIR,etc.,forensuringhighqualityparameters.TheCompanywasengagedinmanufactureandsellingofmedicinesofhighqualityatreasonableratestotheGovt.ofRajasthan,CentralGovernmentInstitutions,vizESIC,Defence,Railways,otherPSUsandalsotootherStateGovt.Institutions.RDPLhadsuppliedmedicinesforimplementationof‘JANAUSHADHI’programmewherequalitygenericmedicinesaremadeavailabletothepublicatlargeinthecountryataffordableprices.TheproductionoftheCompanyhasstoppedsinceOctober2016duetofireatitsplant.

Performance:Table-6N

(PerformanceofRDPL) (Rs.inCrore)

Particulars 2016-17 2017-18 2018-19NetWorth (-)39.53 (-)54.78 (-)69.88Turnover 7.66 0.40 0.14Earnings(BeforeTax) (-)14.88 (-)15.25 (-)15.10Earnings(AfterTax) (-)14.88 (-)15.25 (-)15.10NetProfit/Loss (-)14.88 (-)15.25 (-)15.10

UnionCabinetdecidedon28.12.2016forclosureofRDPLaftermeetingitsliabilitiesfromsaleof itssurplus landtogovernmentagencies. M/sMSTCLtd.wasappointedasauctioningagencyfore-auctionofRDPLon19.04.2017.CentralGovernment/StateGovernment/leadingPSUs/Financial In-stitutionswereinvitedtobidfortheland,butnoresponsewasreceived.TheUnionCabinethason17.07.2019modifieditsearlierdecisionandpermittedsaleofsurpluslandtoanyentity.Further,ithassanctionedRs.43.70cr.formeetingemployees’liabilities.

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CHAPTER 7 NATIONALPHARMACEUTICALPRICINGAUTHORITY(NPPA)

7.1 NationalPharmaceuticalPricingAuthority(NPPA)

7.2 PricingDivision

7.3 MonitoringandEnforcementDivision

7.4 E-initiatives

7.5 PlasticWasteManagement

7.6 RecoveryofOverchargedAmount

7.7 EaseofDoingBusiness

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CHAPTER 7

7.1 NATIONALPHARMACEUTICALPRICINGAUTHORITY(NPPA)

i. TheNationalPharmaceuticalPricingAuthority(NPPA),anindependentbodyofexpertsintheMinistryofChemicalsandFertilizerswasconstitutedbytheGovt.ofIndiavideResolutionpublishedintheGazetteofIndiaNo.159dated29.08.97.ThefunctionsofNPPA,inter-alia,includefixationandrevisionofpricesofscheduledformulationsundertheDrugs(PricesControl)Order(DPCO),aswellasmonitoringandenforcementofvariousprovisionsofDPCO.NPPAalsoprovidesinputstoGovernmentonpharmaceuticalpolicyandissuesrelatedtoaffordability,availabilityandaccessibilityofmedicines.

ii. TheGovernmentnotifiedDPCO,2013on15thMay2013insupersessionofDPCO,1995.

iii. SalientfeaturesofDPCO,2013areasfollows.

• TheNational ListofEssentialMedicines (NLEM),notifiedby theMinistryofHealth&FamilyWelfareisadoptedastheprimarybasisfordeterminingessentialityandisincorporatedintheFirstScheduleofDPCO,2013whichconstitutesthelistofscheduledmedicinesforthepurposeofpricecontrol.

• Ceilingpricesofscheduledformulationsarefixedbasedon‘market-baseddata’.

• Pricecontrol isappliedtospecificformulationswithreferencetothemedicine(activepharmaceuticalingredient),routeofadministration,dosageform/strengthasspecifiedintheFirstSchedule.

• TheNationalListofEssentialMedicines2015(NLEM2015)wasnotifiedbytheMinistryofHealthandFamilyWelfareinDecember2015.NLEM2015wasthereafternotifiedastheFirstScheduleofDPCO2013,inMarch2016,bytheDepartmentofPharmaceuticals.

iv. ThefunctionsoftheNationalPharmaceuticalPricingAuthority(NPPA)are:

• ToimplementandenforcetheprovisionsoftheDPCO,1995/2013inaccordancewithpowersdelegatedtoit.

• Toundertakeand/orsponsorrelevantstudiesinrespectofpricingofdrugs/formulations.

• Tomonitortheavailabilityofmedicines,identifyshortages,ifany,andtotakeremedialsteps.

• Tocollect/maintaindataonproduction,exportsandimports,marketshareofindividualcompanies,profitabilityofcompaniesetc.forbulkdrugsandformulations.

• TodealwithalllegalmattersarisingoutofthedecisionsoftheAuthority.

• TorenderadvicetotheCentralGovernmentonchanges/revisionsinPharmaceuticalpol-icy.

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• To render assistance to the Central Government in parliamentarymatters relating toPharmaceuticalpricing.

7.2 PRICINGDIVISION

A. PriceFixation

i. CeilingPrice

NPPAfixestheceilingpriceofformulationlistedinScheduleIofDPCO,2013.Underthemar-ket-basedapproachadoptedinDPCO,2013,theceilingpriceofascheduledformulationisdeterminedbyfirstworkingoutthesimpleaverageofpricetoretailer(PTR)inrespectofallbranded-genericandgenericversionsofthatparticularformulationhavingamarketshareofonepercentandabove,andthenaddinganotionalretailermarginof16percenttoit.Themaximumretailprice(MRP)forthatdrugformulationmustnotexceedthenotifiedceilingpriceplusapplicabletaxes.

NLEM2015 contains 954 scheduled drug formulations spread across 31 therapeutic groups.NPPAalsofixestheceilingpricesof formulations listedunderExplanation-I toSchedule– IofDPCO2013.NPPAhasfixedtheceilingpricesof860formulationsunderDPCO,2013tillDecember2019.

Statementshowingrangeofreductioninceilingpriceofscheduledformulationwithrespecttothehighestpriceonthebasisofdatafurnishedbypharmatrac/pharmaceuticalcompanies.

Table-7A(Statementshowing%rangeofreductioninceilingprice)

%reductionwithrespecttoMaximumPrice No.offormulations0<=5%* 2365<=10% 13810<=15% 9815<=20% 10020<=25% 9225<=30% 6530<=35% 4635<=40% 26Above40% 59

TotalformulationsinNLEM2015 860

ThepricesarenotifiedthroughGazetteNotificationswhicharealsouploadedonNPPA’swebsiteatwww.nppaindia.nic.in.TheceilingpricesbecomeoperativeandlegallyenforceablefromthedateonwhichthepriceisnotifiedintheGazette.

NPPAalsocappedthemaximumretailpriceof106formulations(anti-diabeticandcardiovascu-larunderpara19ofDPCO2013inJuly2014.

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ii. RetailPrice

NPPAfixestheretailpriceofmedicinebasedontheForm-Iapplicationreceivedfromtheman-ufacturing/marketingcompanies.Thenotifiedretailpricesareapplicableonlytotheapplicantmanu-facturing/marketingcompanies.Theretailpricesofthemedicinearealsofixedonthesamemethodasapplicableforfixationofceilingprice.NPPA is actively taking up the New drugs applications of Pharma companies and has fixed the retail price of 329 retail prices during 2018-19, 195 New drugs applica-tions in 2019-20 till December 2019 and pendency has been brought to concurrent level.NPPAnotifiedretailpricesoftotal1189‘newdrugs’[thosequalifyingas‘newdrugs’asperpara2(u)ofDPCO,2013]tillDecember,2019underDPCO,2013.

Moreover,NPPAhasimplemented47Reviewcasespertainingto68formulationsduring2018-19and6in2019-20(tilldate).Thependencyhasbeenbroughttoconcurrentlevel.

B. ReviewOrder

AnycompanyaggrievedbytheordersofNPPAfilesreviewapplicationtoDepartmentofPhar-maceuticalsunderpara31ofDPCO,2013.DepartmentofPharmaceuticalsafterphysicalhearinggivesnecessaryreviewdirections.NPPAimplementsthereviewdirectionsofDepartmentofPharmaceuticalsonmerit.

NPPA has taken special efforts for implementation of review orders in time and implemented 47 review orders comprising 68 formulations during 2018-19 and 5 review orders in 2019-20(Till18th December2019)andason18.12.2019noreviewordersarependingforimplementation.

C. PriceFixationofMedicalDevices:

i. CoronaryStents:

GovernmenthadincludedCoronaryStentsinSchedule-IofDPCO,2013inDecember2016.Af-terward,Governmenthadnotifiedtheceilingprices forCoronaryStentsvidenotificationdated13th February2017fortheperiodofoneyear.Sincetheceilingpricefixedon13thFebruary2017wasvalidforoneyear,NPPAre-fixedtheceilingpricesforCoronaryStentsvideOrderdated13thFebruary2018.ThesamehasbeenrevisedseveraltimesconsideringincreaseinWholesalePriceIndexes.AsummaryofpricerevisionforCoronaryStentsisasunder:

Table-7B(PricerevisionofCoronaryStents)

Particulars DrugElutingStents(Rs.)

BareMetalStents(Rs.) Remarks

Ceilingpricesfixedon13-02-2017un-derPara19oftheDPCO,2013 29,600 7,260 Initialfixationofceilingprices

Ceilingpricesw.e.f.01-4-2017 30,180 7,400 [email protected]%Ceilingpricesre-fixedon13-02-2018underPara19oftheDPCO,2013 27,890 7,660 Ceiling prices revisited in

Feb’18Ceilingpricesw.e.f.01-4-2018 28,849 7,923 [email protected]%Ceilingpricesw.e.f.01-4-2019 30,080 8,261 [email protected]%.

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Theaforesaidprice reduction for Coronary Stents worked out up to 85% for Bare Metal Stents and 74% for Drug Eluting Stents.TheceilingpricefixationofCoronaryStentsresultedinnotionalsavingofRs.4,547croresannuallytotheconsumers/patients.

ii. OrthopedicKneeImplantsforKneeReplacementSystem:

NPPAhasalsofixedtheceilingpriceoftheNon-scheduledOrthopedicKneeImplantsforthefirsttimeon16thAugust2017underPara19oftheDPCO,2013intheextraordinarycircumstances.Theaboveceilingpricewastobemaintainedforoneyeari.e.upto15thAugust2018.Subsequently,NPPAvideOrderdated13thAugust2018,extendedtheapplicabilityofaboveceilingpricesforanotheroneyear(i.e.upto15thAugust2019).Afterrevisitingtheceilingpricesoftheorthopedickneeimplants,NPPAvideOrderdated13thAugust2019hasallowedthemanufacturers/importersofkneeimplantstotakeincreaseinMaximumRetailPrices(MRPs)oforthopedicKneeImplantsupto10%ofthepreviousMRP.ThepreviousMRPmaybeconsideredaspriceincompliancetotheNotificationsNo.S.O.2668(E)dated16thAugust2017andS.O.3987(E)dated13thAugust2018plusapplicableTaxes.AsummaryofpricerevisionfororthopedicKneeImplantsisasunder:

Table-7C(PricerevisionoforthopedicKneeImplants)

TypeofKneeImplantCeilingPricew.e.f.16/08/2017to15/08/2019(Rs.)

Ceiling

Pricew.e.f.16/08/2019

PrimaryKneeImplants NPPAvideOrderdated13thAugust2019hasallowedthemanufactur-ers/importersofkneeimplantstotakeincreaseinMaximumRetailPrices(MRPs)oforthopaedicKneeImplantsupto10%oftheprevious

MRP.

CobaltChromium(widelyused) 54,720

SpecialMetallikeTitanium&OxidizedZirconium

76,600

HighFlexImplant 56,490RevisionKneeImplantsRevisionImplants 1,13,950

Theaforesaidprice reduction for orthopedic Knee Implants worked out up to be 69%.Theceil-ingpricefixationoforthopedicKneeImplantsresultedinnotionalsavingofRs.1,500croresannuallytotheconsumers/patients.

D. PricerevisionofAnti-cancerdrugsbasedonTradeMarginRationalization

NationalPharmaceuticalPricingAuthoritycappedtheTradeMarginofallthenon-scheduledfor-mulationsofselect42Anti-Cancerdrugs(Annexure-I),recommendedbyExpertCommitteeofMinistryofHealth&FamilyWelfare,underthe‘TrademarginRationalizationApproach’videorderSO1041(E)dated27thFebruary2019.ThedecisionhasbeentakenupasPilotforProofofConcept,underthelaiddownprovisionofparagraph19ofDPCO,2013,underextra-ordinarycircumstancesinpublicinterest.Asperthedatareceived,total526brands(Annexure–II)ofthesemedicineshaveshownreductioninMRP.ThelistsofrevisedMRPshavebeenuploadedonNPPA’swebsiteshowingthereductioninMRPupto90%ofoldMRP.Basedondatasubmittedbymanufacturers,ithasbeenanalyzedthattherewould

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be annual saving of approx. Rs. 984 crores to the patients.NPPAhasissuednecessarydirectionstoStateDrugControllersandSuperintendentsofHospitals/MedicalInstitutionstoensurecomplianceoftheorderissuedsothatthebenefitsunderthismeasurebeavailabletothepatients.

E. Savingstotheconsumers

The fixationof ceiling prices of scheduled formulations listed inNLEM2015 (revised Sched-ule-I)hasenabledsavingsofRs.2643.00croretotheconsumersinadditiontothesavingofRs.4,547crorestoconsumersonaccountofpricefixationcoronarystents.FixationofceilingpricesofscheduledformulationsunderSchedule-IofNLEM2011enabledsavingsof2422.24croretotheconsumers.Thepara19pricenotificationsresultedinsavingsofapproximatelyRs.350croretotheconsumers.NPPAhasalsofixedtheceilingpriceoftheNon-ScheduledOrthopedicKneeImplantshasenabledsavingsofRs.1500croretotheconsumersAsavingsofRs.984crorestotheconsumersisestimatedthroughthetrademarginrationalizationofanti-cancerdrugs.Thus,regulationofpricesofmedicinesunderDPCO2013byNPPAhasresultedinnetsavingsofapproximatelyRs.12447crorestotheconsumers(ason17th December2019).

F. Upwardrevisionofceilingpriceunderpara19ofDPCO,2013

Para19ofDPCO,2013empowerstheGovernmenttorevisetheceiling/retailpriceofmedicinesunderextraordinarycircumstancesasitdeemsfit.Presently,thepowersunderpara19ofDPCO2013isentrustedwithNPPA.NPPAhasreceivedapplicationsforupwardpricerevisionunderpara19ofDPCO,2013citingvariousreasonslikeincreaseinAPIcost,increaseincostofproductionexchangeratesetc.resultinginunviabilityinsustainableproductionandmarketingofthedrugs.Basedontherecommen-dationofSCAMHP,ceilingpriceofshortlisted21scheduledformulationsof12medicines(http://www.nppaindia.nic.in/wp-content/uploads/2019/12/Notification_English_with-SO.pdf )were revisedbyallowingone-timepriceincreaseof50%fromthepresentceilingpriceinpublicinterestasanexcep-tionalmeasurebyinvokingpara19ofDPCO,2013.

Graph-7(i)

*TotalSavingsperannum=Rs.12,447crore

Anticancer

UnderNLEM,2011fromMay2013toFeb2016

UnderNLEM,2015fromMarch2016totillJanuary2020

984

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7.3 MONITORING&ENFORCEMENTDIVISION

i. MonitoringAvailabilityofMedicines

TheGovernmentiseffectivelymonitoringthepricesofscheduledaswellasnon-scheduledmed-icinesunderDPCO,2013andtakesactionagainstcompaniesfoundoverchargingtheconsumersbasedonthereferencesreceivedfromtheStateDrugsControllers/individuals,samplespurchasedfromtheopenmarketandreportsfrommarketbaseddataandcomplaintsreportedthroughthegrievancere-dressalwebsites, ‘PharmaJanSamadhan’and ‘CentralizedPublicGrievanceRedressandMonitoringSystem(CPGRAMS)’.Themonitoringof increase inthepriceofformulationsbeyondthepermissiblelimitisalsodoneonthebasisofdatasubmittedbyAIOCD(PharmatracData)andindividualcomplaintsreceived.

WhenevercompaniesarefoundsellingscheduledformulationsatpriceshigherthanthepricenotifiedbyNPPA,actionistakenagainstsuchcompaniesundertherelevantprovisionsofDPCO2013andtheoverchargedamount,alongwithinterestisleviedonthecompany.Similaractionistakenwhen-evercompaniesarefoundsellingnon-scheduledformulationatapricewhichis10%higherthantheMRPoftheprecedingtwelvemonthsandWholesalePriceIndex(WPI)violationforscheduledformula-tions.

Non-compliancewiththenotifiedceilingprices incaseofscheduleddrugformulationsor, inotherwords,theMRPbreachingceilingpriceplusapplicablelocaltaxestantamounttooverchargingtheconsumer.Suchoverchargedamountsarerecoveredfromthepharmaceuticalcompanyalongwithinterestthereonfromthedateofovercharging.Casesofcompaniesnotcomplyingwiththedemandno-ticesarereferredtotheDistrictCollectorsforrecoveryofoverchargedamountsasarrearsoflandrev-enueandcouldalsoattractprosecutionundertheprovisionsoftheEssentialCommoditiesAct(ECAct),1955.

NPPAmonitorstheavailabilityofdrugs, identifyshortages, ifany,andtakeremedialstepstomakethedrugsavailabletoconsumers.NPPAiscarryingoutthisresponsibilitymainlythroughtheStateDrugsControllers,NGOsandindividuals.Asandwhenthereportsforshortagesofparticulardrug(s),inanypartofthecountryarereceived,theconcernedcompanyisaskedtorushthestocktotheaffectedareasandtomakethedrugsavailable.Powerregardingmonitoringofavailabilityofnon-scheduledfor-mulationvestwithDepartmentofPharmaceuticals.

ii. MonitoringofpricemovementofMedicalDevices: Para20oftheDPCO,2013empowerstheGovernmenttomonitortheMaximumRetailPrices(MRP)ofallthedrugsincludingthenon-scheduledformulations&notifiedmedicaldevicesasdrugsandensurethatnomanufacturerincreasesthemaximumretailpriceofadrugmorethantenpercentofmaximumretailpriceduringprecedingtwelvemonthsandwheretheincreaseisbeyondtenpercentofmaximumretailprice,itshallreducethesametotheleveloftenpercentofmaximumretailpricefornexttwelvemonths.Themanufacturershallbeliabletodeposittheoverchargedamountalongwithinterestthereonfromthedateofincreaseinpriceinadditiontothepenalty.

There are twenty-four (24)medical deviceswhich havebeennotified/regulated asDrugs byMinistryofHealth&FamilyWelfare,GovernmentofIndia.Outoftheabove,four(4)medicaldevicesnamely(i)CardiacStents(ii)DrugElutingStents(iii)IntraUterineDevices(Cu-T)and(iv)CondomsarescheduledmedicaldeviceswhichhavebeenincludedintheSchedule-IoftheDPCO,2013.Hence,these

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fourmedicaldevicesareunderpricecontrol.

NPPAbyexercisingthepowerunderPara20oftheDPCO,2013,collectedMRPdatafromcom-paniesconcernedfortheremainingnineteen(19)non-scheduledmedicaldevices,whicharenotified/regulatedasdrugs,formonitoringpriceincreasesfortheperiodfromyear2014to2017intheyear2017.TheMRPdatareceivedfortheyears2014to2017formonitoringofpricemovementsofaforesaid19medicaldevices(drugs)havebeenanalyzedandatotal75no.ofShowCauseNotices(SCN)have beenissuedforviolationofPara20oftheDPCO,2013.Sofar,NPPAhasinitiated26no.ofoverchargingcasestillDecember2019underPara20oftheDPCO,2013wheredemandnoticeshavebeenissuedtoMedicalDevicescompaniesamountingtoRs.185.32crore.AnamountofRs.35.66 crorehasbeenrecoveredfromtheerrantcompaniestillDecember2019.

iii. PriceMonitoringandResourceUnits(PMRUs)

UndertheCentralSectorSchemeofNPPA,viz.,‘ConsumerAwareness,PublicityandPriceMon-itoring’(CAPPM),PriceMonitoringandResourceUnits(PMRUs)arethesocietiesregisteredundertheSocietiesRegistrationActhavingitsownMemorandumofAssociation/Byelaws.TheprimaryfunctionofPMRUsistoassistNPPAinpricemonitoring,detectionofviolationoftheprovisionsofDPCO,pricingcompliance, ensuring availability ofmedicines and consumerawareness. Theyare also responsibleforcollection,compilationandanalysisofmarket-baseddataofscheduledaswellasnon-scheduledformulations.TillnowPMRUshavebeensetuptenStates(Kerala,Gujarat,Odisha,Rajasthan,Punjab,Haryana,Tripura,Nagaland,UttarPradeshandAndhraPradesh).

Followingactivitieshavebeenundertakenduringtheyear2019-20:

a. SeminarinLucknow,UttarPradeshwasorganizedon08.04.2019onthecompli-anceoftheprovisionsofDPCO,2013andreductioninpricesofAnti-cancerdrugs.TheSeminarwasattendedbyseniorofficersfromtheGovernmentofUttarPradesh,repre-sentativesfromgovernmentandprivatehospitalsandfieldofficersofStateHealth/DrugDepartment.b. AWorkshopwasorganisedinDelhion22.07.2019whichwasattendedbyStateDrugControllers.TheissuesrelatingtosettingupofPMRUsandotheroperationalissueswereelaboratelydiscussed.c. AmeetingwiththeseniorofficersofGovernmentofRajasthanwastakenbytheChairmanonthefunctioningofPMRURajasthanwastakeninJaipur,Rajasthand. ARegionalSeminarwasorganizedinKeralaon13.12.2019on‘Availability,Acces-sibilityandAffordabilityofMedicinesforall’.Smt.K.K.ShailajaTeacher,Hon’bleMin-ister,Health&FamilyWelfareDepartment,GovernmentofKeralawastheChiefGuest.TheSeminarwasattendedbytheseniorofficersfromGovernmentofKerala,represen-tativesfromKeralaStatePlanningBoard,KMSCL,KSDP,KeralaStateIndustrialDevelop-mentCorporationLtd.,Food&DrugsControlAdministration,Govt.ofGujarat,industry,consumergroups,fieldstaffofStateDrug/HealthDepartments.Twoofthebeneficiariesofthegovernmentpoliciesalsosharedtheirexperiences.

TheseminarwaswidelycoveredbylocalnewspaperswhichincludeTimesofIn- dia,Pharmabiz,MalayalaManoramaandMathrubhumi.

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InaugurationofRegionalSeminaron‘Availability,AccessibilityandAffordabilityofMedicinesforall’on13.12.2019.

e. ThecontractualstaffhasbeenrecruitedinPMRUsoffiveStateswhiletheprocessisoninotherPMRUs.

iv. Information,EducationandCommunication(IEC) AnIECcampaignhasbeenlaunchedfordisseminationof informationregardingvariousstepstakenbyNPPAformakingmedicinesandmedicaldevicesaffordableintheinterestofpublic.

a. Displayofhoardings/BusQueueSheltersconveyingtothemassesthereductioninthepricesofAnti-Cancermedicinesandsavingsinrespectofothermedicinesingen-eral.ThemessagewasalsoconveyedthroughLEDScreensinPostOfficesandRailwayStationsinDelhi

b. Ahalf-pageNewspaperadvertisement innewspapersconveyingtothemassesthereductioninthepricesofAnti-Cancermedicines.

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Newspaperadvertisementc. TwoRadiojingleson‘Reductioninpricesofanti-cancermedicines’wereairedin20statesfor5days.

v. Enforcementactivities Toensure thatmedicinesareavailable topatientsat thenotifiedprices,NPPAworkscloselywithStateDrugsControllersforenforcementactivities.Samplesofmedicinesarepickedupfromopenmarketregularlyandanalyzedtomonitorthepriceatwhichthemedicinesaresoldtopatients.Enforce-mentactivitiesfrom2010-11to2019-20(tillNovember,2019)aregivenasunder:

Table-7D [Enforcementactivitiesfrom2010-11to2019-20(tillNovember,2019)]

Year No.ofSamplesCollected PrimaFacieViolationsdetected2010-2011 553 2252011-2012 559 1562012-2013 626 1652013-2014 993 3892014-2015 3898# 10202015-2016 2534# 6132016-2017 1817# 9302017-2018 2418# 10322018-2019 1391# 3242019-2020

(upto30.11.2019) 774# 161

#CasesofOverchargingreferredfromStateDrugControllersareincludedunderthe‘SamplesCollected’.

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7. E-INITIATIVES

NPPAhasalsoundertakenfollowinge-initiativesforbetterdisposalofgrievancesofgeneralpub-lic:

i. PharmaJanSamadhan(PJS)

ThePJSwaslaunchedon12thMarch,2015.PJSisawebenabledsystemdevelopedbytheNPPAwiththeassistanceofNationalInformaticsCentre(NIC).PJSservesasarobuste-governancetoolforprotectionofconsumerinterestthrougheffectiveimplementationoftheDrugs(PricesControl)Order,2013.TheprimaryobjectiveofPJSistoputinplaceaspeedyandeffectivecomplaintredressalsystemwithrespecttoavailabilityofmedicines,overpricingofmedicines,saleof ‘newdrugs’withoutpriorpriceapproval(WPA)andrefusaltosupplyorsellmedicines.ComplaintscanberegisteredunderPJSlinkavailableattheNPPAswebsitei.e.www.nppaindia.nic.inandalsoatthetollfreenumber1800111255.

Anyindividualorconsumerorganizationorstockiest/distributor/dealer/retailerorStateDrugControllercanlodgecomplaintsonlinetoNPPAthroughPJS.ActiononthecomplaintreceivedthroughPJSwithcompleteinformationisinitiatedwithin48hoursbytheNPPA.

ii. PharmaDataBank(PDB)-IntegratedPharmaceuticalDatabaseManagementSystem(IPDMS)

IPDMSwaslaunchedon25thJune,2015.IPDMSwasdevelopedbytheNPPAincollaborationwiththeNational InformaticsCentre (NIC).This comprehensiveonlinesystemprovidesaplatformto thepharmaceuticalmanufacturer/marketing/importer/distributorcompaniestofilemandatoryreturnsprescribedinFormII,FormIIIandFormVofDPCO,2013.Applicationforpriceapprovalof‘newdrug’inForm-Icanalsobefiledthroughthisportal.

IPDMSisexpectedtobenefitindustry,consumerandtheregulator.Itprovidesindustrywithauserfriendlymechanismtocomplywiththemandatoryrequirementoffilingreturns;itwillalsohelpNPPAtomonitorpricecompliance.943pharmacompanieshaveregisteredthemselvesunder IPDMSand76764Productregisteredtill30.11.2019.ThegrowthinnumberofcompaniesregisteredinIPDMSsince31.03.2019till30.11.2019isasfollows.

Graph-7(ii)

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iii. MobileApplication‘PharmaSahiDaam’and‘SearchMedicinePrice’utility

NPPAlauncheditsmobileappon29.08.2016namedas“PharmaSAHIDAM”forthebenefitofthecommonpeopleofIndiathroughwhichanybodycaneasilysearchthebrandname,composition,ceilingpriceandMRPoftheformulation.ThisappcanbedownloadedfromGoogleplaystorefreeofcostforAndroidbasedmobilephonesandfromAppstoreforIOSbasedmobilePhone(iphone).CeilingPriceofscheduledformulationsmayalsobeobtainedbyusingthetool‘SearchMedicinePrice’avail-ableinthewebsiteofNPPA.Theapporsearchmedicinefacilitytoolwillfacilitateconsumerstoverifywhethermedicinesarebeingsoldwithintheapprovedpricerangeandalsotodetectanycaseofover-pricingbypharmaceuticalcompany/chemist.Ifthereisanyceilingpriceviolation,thebuyerwillbeabletolodgeacomplaintagainstcompany/chemistthroughPharmaJanSamadhan(http://www.nppaindia.nic.in/redressal.html).

7.5 PlasticWasteManagement

InpursuanttotheHon’blePM’scallon15thAugust,2019toacttowardsfocusedPlasticWasteManage-mentandeffectivebanofsingleuseplastic,NPPAundertookthefollowingactivities:-

i) Shramdaanforabouthalfanhourwasgivenby60personson17.10.2019atPatelChowkforthiscause.

Shramdaanby60personson17.10.2019atPatelChowk.

ii) Jute/clothbags,havebeendistributedtoemployeesasalternativestosingleuseplastics.

iii) T-shirts&Capsweredistributedtoemployeesasaawarenesscampaignagainstsingleuseplastic.

iv) SeparateDustbinshavebeeninstalledtocollectplasticwastesothatitcanbecollected-properlyorfurthercarryingtorecyclelocation/disposalcenters.

7.6 Recoveryofoverchargedamount:

NPPAhas initiatedabout2083casesofoverchargingason31stDecember,2019.AmountofRs. 960.38 Crore (Rs. 557.53 Crore underDPCO1995 and Rs. 402.85 Crore underDPCO2013) has

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beenrecoveredason31stDecember,2019,frompharmaceuticalcompanies.Actionforrecoveryoftheoverchargedamountalongwithinterestthereonisacontinuousprocess.NPPAtakesactionaspertheprovisionsofDPCO’1995/DPCO’2013readwithEssentialCommoditiesAct,1955.ThestatusofOver-chargingcasessinceinceptionofNPPA,till31.12.2019underDPCO1995&DPCO2013areasunder:-

Table-7E

(StatusofOverchargingcasessinceinceptionofNPPA,till31.12.2019underDPCO1995&DPCO2013)

S.No. Particulars DPCO,1995

DPCO,2013

Total

1 No.ofcases 1327 756 20832 Overchargedamountdemandedincludinginter-

est(Rs.InCrore)4999.27 1407.06 6406.33

3 Totalamountrealized(Rs.InCrore) 557.53 402.85 960.38

4 Amountoutstanding(Rs.InCrore) 4441.74 1004.21 5445.955 Amountunderlitigation(Rs.InCrore) 3365.94 666.97 4032.91

6 Casesreferredtocollector&amountstilltoberecovered(Rs.InCrore)

339.80 115.81 455.61

7.7 EaseofDoingBusiness:

ThefollowingactivitieshavebeenundertakentowardspromotingEaseofDoingBusiness:

1. NPPApresentlyholds theAuthoritymeetingand themeetingof theMultidisciplinaryCommitteeofExpertsonaregularbasistobringdownpendency.Accordingly,thepenndencyofthenewdrugsapplicationsandimplementationofthereviewordershascometoaconcurrentlevel.

2. Tobring improvedefficiency,qualityand fasterdisposal, twopharmacoeconomicsex-pertshavebeeninductedintheMultidisciplinaryCommitteeofExperts.

3. NPPAhasencouragedR&DandinnovationandimplementedtherecommendationoftheMultidisciplinaryCommitteeofexpertsregardingincrementalinnovationwherebyupto15%/20%increaseinthepriceisallowabletotheinnovativeproductbasedoncertaincriteria.

4. NPPAregularlyconductsstakeholderconsultationforobtainingitsviewstowardseaseofdoingbusiness.ThestakeholdersincludingPharmaassociationacrossthesectorlikeindigenousmanufacturer,foreignmanufacturers,importers,MSMEgroupsandtheNGOsoperatinginthesector.

5. Fortransparency,NPPAuploadsthedecisionoftheminutesoftheAuthoritymeetingandtheMultidisciplinaryCommitteemeeting in itswebsite.Further,NPPAuploads thedraftworkingsheetofitsceiling/retailpricecalculationfor10daysbeforeapprovingandnotifyingthesame.

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6. AIOCDhasbeenassignedtheauthoritytocollectdataregardingmedicaldevices.Thisshallcreatedatabaseacrossthecountrytobecreatedformedicaldevicesandenablebatterregulation,monitoringandaccess.

Annexure-IListofMedicinesunderTradeMarginRationalisation

Sl.No. NameoftheDrug1 Azacitidine2 BendamustineHydrochloride3 Bortezomib4 Crizotinib5 Cytarabine6 Dasatinib7 Decitabine8 DoxorubicinHCIPegylatedLiposomalInjection9 Enzalutamide10 Epirubicin11 Eribulinmesylate12 ErlotinibHCI13 Estramustinephosphate14 Everolimus15 Exemestane16 Fulvestrant17 IrinotecanHCITrihydrate18 Lapatanib19 LeuprolideacetatedepotforInj.20 Lomustine21 Mitoxantrone22 Nilotinib23 Plerixafor24 Carfilzomib25 Cladribine26 Triptorelin27 Pomalidomide28 Osimertinib29 Pegasperagase30 Regorafenib

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31 Ribociclib32 Clofarabine33 Sunitinib34 Olaparib35 Olaratumab36 Paclitaxel(Protein-boundparticles)37 Cabazitaxel38 Bevacizumab39 Lenalidomide40 Pegfilgrastim41 Mitomycin42 Pemetrexed

Annexure-IIConsolidatedlistofRevisedMRPofNon-ScheduledAnti-CancerMedicinesw.e.f.08.03.2019

Sl. No

Drug Strength&DosageForm

BrandName Pack Size

OldMRP RevisedMRP

1 Azacitidine 100mgInjection MDSPlus Vial 8900.00 4,367.07

2 Azacitidine 100mgvial AZALIVE100MGperVial Vial 10044.08 5043.11

3 Azacitidine 100mgInjection AzakemInj Vial 8740.00 46654 Azacitidine 100mgInj.(Powder) Mylotex100mg 1Vial 5150 4748.15

5 Azacitidine 100mgInjection Azatend Vial 7600.00 2980.05

6 Azacitidine 100mginjection HEMAZIDEINJ 50mlVial 8900.00 3840

7 Azacitidine 100mgInjection Azacytin100mgInjection Vial 8995.00 5079.50

8 Azacitidine 100mgInjection ATSA 1X1 8,750.00 4514.009 Azacitidine 100mginj Azactiv 1,s 7800.00 222110 Azacitidine 100mgInjection AZASHINE Vial 9000.00 4068.0011 Azacitidine 100mgInjection Azadine 30ml 8900.00 3951.1012 Azacitidine 100mgInjection MYAZA Vial 4950.00 3201.0013 Azacitidine 100mginj Xpreza100 1Vial 7800 4283.1714 Azacitidine 100mg1Vial AzafabInj. SingledoseVial 4590 2978.5

15 Azacitidine 100mgInjection Azatirel Vial 8900.00 4,265.60

16 Azacitidine 100mgInjection AZAPLAST100MGInj Vial 8500.00 3373.00

17 Azacitidine 100mgInjection AZZUREINJECTION Vial 9000.00 7701.56

18 Azacitidine 100mgInjection AZAFECT Vial 7800 390019 BendamustinHcl 100mgInjection Kabimustin Vial 7,900 2244.05

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20 BendamustinHcl 100mgInjection Bendashil Vial 9,000 2727.2721 BendamustinHcl 100mgInjection CytoBendomaInj Vial 7,200 2014

22 BendamustinHCL

100mgInj. Adben-100 Singledosevial 8000 4001

23 BendamustinHcl 100mgPowder Ribomustin 1Vial 11000 550024 BendamustinHcl 100mginj Bendit100 1Vial 6950 3643.3525 BendamustinHcl 100mgInjection THERMUSTIN 10MG/VIAL 6400 1,700

26 BendamustinHcl+Mannitol

100+170mgVial Lymphtor100 1 8572.20 4051.8

27 Bendamustine 100mgInjection GENMUS Vial 7200.00 2214.5228 Bendamustine 100mgInjection Bizisa Vial 7000.00 2561.4929 Bendamustine 100mgSingleDose

VialBendamax Pervial 7542.00 2267

30 Bendamustine 100mgInjection LEUBEN Vial 8200.00 1811.0031 Bendamustine 100mgInjection Benzz Vial 7848.00 4007.3632 Bendamustine 180mgInjection Benzz Vial 5000.00 4776.8933 Bendamustine 45mgInjection Benzz Vial 1250.00 1194.5634 Bendamustine 100mgInjection MaxtorinInjection100mg

(Inj.)20ml*1 11144.70 9503.18

35 Bendamustine 100mgInjection BIMODE 1X1 7,683.00 1951.0036 Bendamustine 100mgInjection ZUMUSTIN Vial 8,121.75 2,028.0037 Bendamustine

Hydrochloride100mgInjection PurplzInjection1’s Vial 7830.00 3981.00

38 BendamustineHydrochloride

100mgInjection(1vial*1)

Bemustin SinleuseVial 6950 2684

39 BendamustineHydrochloride

100mgInjection NEOMUSTININJ Vial 7304.66 2666.00

40 Bevacizumab 100mg/4mlInjec-tion

Vegfxta Vial 28500 13026.09

41 Bevacizumab 100mgInjection Advamab100inj 4ml 28800 11802

42 Bevacizumab 400mgInjection Advamab400inj 16ml 40000 37998

43 Bevacizumab 100mgInj KRABEVA100MG 4MLVIAL 26376 12214.14

44 Bevacizumab 400mgInj KRABEVA400MG 16MLVAIAL 39990 35777.44

45 Bevacizumab 100mg/4mlInjection Bryxta Vial 27000.00 16059.00

46 Bevacizumab 100mg/4mlInjection Zybev Vial 27000.00 17470.43

47 Bevacizumab 400mg/16mlInjec-tion

Bryxta Vial 48999.00 43369.40

48 Bevacizumab 100mgInjection BEVAREST 1X1 28,500.00 13223.0049 Bevacizumab 100mgInjection CIZUMAB Vial 31200.00 11838.0050 Bevacizumab 400mgInjection CIZUMAB Vial 52000.00 43859.0051 Bevacizumab 100mgInjection Bevatas Vial 25990.00 9500.0052 Bevacizumab 400mgInjection Bevatas Vial 39995.00 36061.64

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53 Bevacizumab 100mgInjection BevazzaInj. 4MLVial 24181.00 1824754 Bevacizumab 400mgInjection BevazzaInj. 16MLVial 43,900 3891555 Bevacizumab 100mgInjection ABEVMY Vial 24000.00 13451.0056 Bevacizumab 400mgInjection ABEVMY Vial 39990.00 35120.0057 Bevacizumab 100mgInjection Bevacirel Vial 31196.55 12,356.89

58 Bevacizumab 400mgInjection Bevacirel Vial 49990.00 38,856.3459 Bortezomib 3.5mgInjection Bortiad Vial 17140.00 4,001.2060 Bortezomib 2.5mgInjection TEZOMIB Vial 12420.00 2346.7261 Bortezomib 3.5mgInjection TEZOMIB Vial 12600.00 4446.0762 Bortezomib 2.5mgInjection Proteoz Vial 18133.50 3415.1463 Bortezomib 2.5mginjection BORTECAD2.5MGINJ Vial 12,929 3180

64 Bortezomib 2.5mgInjection Brorviz Vial 12929.03 4522.2365 Bortezomib 3.5mgInjection Brorviz Vial 12499.00 6245.3966 Bortezomib 3.5mgPowder Velcad 1Vial 60360 5435067 Bortezomib 1mgPowder Velcad 1Vial 19850 1806068 Bortezomib 3.5mginj Bortenat3.5 1Vial 13900 4140.6869 Bortezomib 3.5mgInjection Brortezomib Vial 14000.00 3,678.93

70 Bortezomib 3.5mgInjection BORTETHER3.5 3.5MG/VIAL 15000 4215.91

71 Bortezomib 3.5mgInjection Zortemib Vial 13500.00 6057.8272 Cabazitaxel 60mgInjection Z-TEXEL Vial 54000.00 12689.9773 Cabazitaxel 60mgInj. Arbaz Singledosevial 48000 12552.474 Cabazitaxel 60mgInjection Cabaxan Vial 11999.00 11041.9275 Cabazitaxel 60mgInj. Procabazi 1,s 20000 1110076 Cabazitaxel 60mginj Kabanat60/1.5 1Vial 19990 12020.777 Cabazitaxel 60mgInjection CABAZITHER60 6ML/VIAL 54000 19272.29

78 Carfilzomib 60mgInjection Kyprolis60mg Vial 49500 47325.0079 Carfilzomib 60mginj Carfilnat60 1Vial 9990 999080 Cladribine 10mg/10mlInjec-

tionCladrim Vial 17721 11994.06

81 Clofarabine 20mgInjection BDCLOR Vial 16200.00 10227.4082 Clofarabine 20mgInjection Cfara Vial 15000.00 14503.9083 Clofarabine 20mgInjection Farabine Vial 15000.00 11119.5584 Cloforabine 20mginj Colymph 1,s 15,000 1380085 Crizotinib 250mgCapsules Crizalk250mg60’sCaps(-

capsule)6Capsule*10 106698.00 106270.25

86 Crizotinib 200mgCapsules Crizalk200mg60’sCaps(-capsule)

6Capsule*10 106698.00 100177.53

87 Cytarabine 100mg/1mlInjection Cytarine Vial 195.79 89.9488 Cytarabine 100mgInjection Biobin Vial 288.70 50.7489 Cytarabine 100mgSingleDose

VialCytramax Pervial 167.00 98

90 Cytarabine 100mgInjection Arasid ml 195.79 117.85

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91 Cytarabine 100MG/1MLInjec-tion

CYTANEON100MG./1ML. 100MG/1ML.VIAL

91.5 45.73

92 Cytarabine 100mg/5ml.Injec-tion

CYTANEON100MG./5ML. 100MG/5ML.VIAL

99 77.76

93 Decitabine 50mgInjection D-NIB Vial 7992.00 3563.1494 Decitabine 50mgInjection Xalibo(Injection) Vial 8100.00 5187.00

95 Decitabine 50mginj Deczuba 1,s 7800 340196 Decitabine 50mgInjection Decitas 50mg 8501.00 4250.5097 Decitabine 30mgInjection Decitas Vial 5900.00 3562.5298 Decitabine 50mgPowder DacogenIV 1Vial 80000 6143099 Decitabine 50mginj Natdecita50 1Vial 7800 5097.71100 Decitabine 50mgInjection DECITEX50MGINJECTION Vial 7973.05 6229.39101 Decitabine 30mgInjection DECITEX30MGINJECTION Vial 5980.00 5546.43102 DoxarubicinHcl 2mgPegLiposomal

Con.ForsolnCaelyx 1Vial 49427 48850

103 Doxorubicin 20mgInjection Nudoxa Vial 9650.00 4353.04104 Doxorubicin 50mgInjection Nudoxa Vial 20490.00 12000.00105 Doxorubicin 20mgInjection Tadro Vial 7290.00 2977.30106 Doxorubicin 50mgInjection Tadro Vial 14147.00 8435.64107 Doxorubicin 20mgInjection Pegadria 10ml 7848.00 2879.50108 Doxorubicin 50mgInjection Pegadria 25ml 20056.00 7827.52109 Doxorubicin

(Liposomal)20mgInjection LIPODOX20MGINJEC-

TION10ML10ml 8040.00 3893.95

110 Doxorubicin(Liposomal)

50mgInjection LIPODOX50MGINJEC-TION25ML

25ml 18400.00 11797.26

111 DoxorubicinHCL 2mgInjection ONCODEX Vial 9350 3166.97112 DoxorubicinHCL 50mgInjection DOXOREX50 Vial 943.60 262.10113 DoxorubicinHCL 10mgInjection DOXOREX10 Vial 188.71 128.86114 DoxorubicinHcl

Pegliposomal2mgInjection Liposolinj 10ml 7600 4635

115 DoxorubicinHclPegliposomal

20mginj NatdoxLP20/10 1Vial 7200 3282.65

116 DoxorubicinHCLPegylatedLipo-somalInjection

20mgInjection LIPOPEGINJJECTION Vial 7000.00 3395.00

117 Doxorubicinhydrochloride

2mginjection CADRIAlINJ. Vial 8500 6766

118 Enzalutamide 40mgCapsule Xtandi 112’s 335635 3,35,635.00119 Enzalutamide 40mgCapsule AzelCapsules 28 27500.00 18081.00120 Enzalutamide 40mgcapsule ENZUTA 28C 27,500.00 20059.00121 Enzalutamide 40mgcapsule Glenza 28 27500 18600122 Enzalutamide 40mgCapsule Enzamide 28’s 27500.00 20298.72123 Enzalutamide 40mgCapsule Encrpc 28’s 27500.00 20298.72

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124 Enzalutamide 40mgCapsule BDENZA 28’s 27501.75 17983.91125 Epirubicin 50mgInjection Appeos50 Vial 2850 1200126 Epirubicin 10mgInjection Appeos10 Vial 650 338127 Epirubicin 100mgInjection EPIFECT Vial 4800 2525128 Epirubicin 10mgInjection Shilepi Vial 700 372129 Epirubicin 50mgInjection EPIFECT Vial 2380 1530130 Epirubicin 10mgInjection EPIFECT Vial 480 330131 Epirubicin 50mgInjection Relirubicin50 Vial 2395 1817132 Epirubicin 10mgInjection Relirubicin10 Vial 565 429133 Epirubicin 50mginj Epribenz 1Vial 2500 1935.5134 Epirubicin 10mginj Epribenz 1Vial 600 540135 Epirubicin 10mgInjection Alrubicin10Inj Vial 573 320136 Epirubicin 50mgInjection Alrubicin50Inj Vial 2210 1182137 Epirubicin 100mgInjection Alrubicin100Inj Vial 4290 2314138 Epirubicin 150mgInjection Alrubicin150Inj Vial 6480 2903

139 Epirubicin 10mgInjection INNORUBICIN Vial 522.00 255.37140 Epirubicin 50mgInjection INNORUBICIN Vial 2290.00 931.83141 Epirubicin 50mgInj. Adricin50 Singledosevial 3200.00 1370.48142 Epirubicin 10mgInj. Adricin10 Singledosevial 950.00 339.64143 Epirubicin 50mgInjection Biorubin Vial 3551.30 900.85144 Epirubicin 50mgInjection Epixtra Vial 3079.90 1036.56145 Epirubicin 10mgInjection Biorubin Vial 723.40 264.15146 Epirubicin 10mgInjection Epixtra Vial 735.60 448.32147 Epirubicin 10mgSingleDose

VialEpiget 1Vial 2250.00 1530

148 Epirubicin 50mgSingleDoseVial

Epiget Pervial 495.00 412

149 Epirubicin 50mgInjection EPITERO Vial 2000.00 978.00150 Epirubicin 50mgInjection Epitaz 25ml 2235.00 1573.80151 Epirubicin 100mgInjection Epitaz 50ml 4360.00 2890.49152 Epirubicin 10mgInjection Epitaz 5ml 600.00 454.12153 Epirubicin 50MG/VIALInjec-

tionEPINEON-50 50MGVIAL 1080 637.63

154 Epirubicin 10MG/VIALInjec-tion

EPINEON-10 10mgVIAL 268 169.77

155 Epirubicin 50mgInjection FarmorubicinRTU50mg/25mlInjection(injection)

25ml*1 3813.70 3589.82

156 Epirubicin 50mgInjection FarmorubicinRD50mgInjection(injection)

25ml*1 3318.42 3250.95

157 Epirubicin 10mgInjection FarmorubicinRTU10mg/5mlInjection(in-jection)

5ml*1 805.20 799.34

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158 Epirubicin 50mgPowdertoInjection

EPIDOX-50 Vial 3954.33 1171.36

159 Epirubicin 10mgPowdertoInjection

EPIDOX-10 Vial 941.35 355.74

160 Epirubicin 100mgInjection EPITHER100 100MG/VIAL 4500 1212.31161 Epirubicin 50mgInjection Zepirubin Vial 2600.00 2025.60162 Epirubicin 100mgInjection Zepirubin Vial 4800.00 3526.06163 Epirubicin 10mgInjection Zepirubin Vial 640.00 577.67164 epirubicin 10mgInjection epichlor Vial 561 276.8165 epirubicin 50mgInjection epichlor Vial 2662 960166 Epirubicin 50mginjection CADRUBIN50MG Vial 3300 1568167 Epirubicin 10mginjection CADRUBIN10MG Vial 1030 569168 Epirubicin 50mgInjection EPICURE 1X1 2,390.00 1113.00169 Epirubicin 100mgInjection EPICURE 1X1 4,132.00 2229.00

170 Epirubicin 10mgInjection EPICURE 1X1 478.00 333.00171 Epirubicin 50mginj Epithra 1,s 2270 971172 Epirubicin 100mginj Epithra 1,s 4277 1916173 Epirubicin 10mginj Epithra 1,s 551 230174 Epirubicin 10mgInjection ERUBIN10MG(Injection) Vial 500.00 258.00

175 Epirubicin 50mgInjection ERUBIN50MG(Injection) Vial 2000.00 597.00

176 Epirubicin 50mgInjection ZUVICIN Vial 2,392.00 1,298.00177 Epirubicin 100mgInjection ZUVICIN Vial 4,130.00 2,335.00178 Epirubicin 10mgInjection ZUVICIN Vial 526.00 405.00179 EribulinMy-

sylate0.44mg/mlParen-tralPrepration

Halaven 1Vial 32860.00 31885

180 Erlotinib 100tablet Erlot 30 19800 7775181 Erlotinib 150tablet Erlot 30 25000 13190182 Erlotinib 100mgTablet BIRLOTIB 10’s 6666.00 800.00183 Erlotinib 150mgTablet BIRLOTIB 10’s 9999.00 891.79184 Erlotinib 150mgTablet Zycev 30’s 13078.10 3330.00185 Erlotinib 100mgTablet Zycev 30’s 10880.10 2860.30186 Erlotinib 150mgTablet Tyrokinin250mg 10 5580.00 2918.00

187 Erlotinib 150mgtablet Erlotiva bottleof10tabs

4143 2251

188 Erlotinib 100mgtablet Erlotiva bottleof10tabs

2250.00 1004

189 Erlotinib 150mgTablet ERLOTERO 30’s 9900.00 3990.00190 Erlotinib 150mgTablet ERLOMY 30Tabs 11900.00 6106.00191 Erlotinib 100mgTablet ERLOMY 30Tabs 9990.00 6490.00192 Erlotinib 100mgTablet Erlotaz 10 6600 1840193 Erlotinib 150mgTablet Erlotaz 10 8800 2400194 Erlotinib 100mgTablet Erlotad 10’s 7500.00 1,638.89

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195 Erlotinib 100mgtablet Erlotad100 1*10tab 7500.00 1164.27196 Erlotinib 150mgtablet Erlotad150 1*10tab 11000.00 2996.1197 Erlotinib 150mgTablet ERLOCIP 30Tabs 10989 7479198 Erlotinib 100mgTablet ERLOCIP 30Tabs 7326 4690.24199 Erlotinib 150mgTablet Erleva 30 9688.65 5280200 Erlotinib 100mgTablet Erleva 30 6392.51 3222201 Erlotinib 150mgTablet Erlotib 10’s 6666.00 2975.24202 Erlotinib 150mgTablet Esrlonat150 30 11900 9353.24203 Erlotinib 100mgTablet Esrlonat100 30 9990 4348.61204 Erlotinib 150MG/TABTablet ERLIB 1Tablet 270 112.67205 Erlotinib 150mgTablet ERTINIB 30T 16500.00 6,400.00206 Erlotinib 100mgTablet ERTINIB 30T 10500.00 4,679.11207 Erlotinib 100mgTablet LORTNIB100MG(Tablet) 10 7900.00 1026.00

208 Erlotinib 150mgTablet LORTNIB150MG(Tablet) 10 11159.85 1535.00209 Erlotinib 100mgTablet ERLOTED100 15000 2878.85210 Erlotinib 150mgTablet ERLOTED150 18000 3598.56211 Erlotinib 150mgTablet ERTINIB 10T 8,550.00 2,080.00212 Erlotinib 150mgTablet ERTINIB 30T 9,500.00 4,469.00213 Erlotinib 150mgTab Erlonon 10 6200.00 3721.12214 Erlotinib 100mgTab Erlonon 10 5000.00 2640.79215 ErlotinibHcl 150mgInjection Erloshil 10 10000 2848.93216 ErlotinibHcl 50mgInjection Shilepi Vial 2800 1425217 ErlotinibHcl 100mgtab Erlokinase100 30 16650 10827218 ErlotinibHcl 100mgInjection Erlotin100 Vial 2600 2440219 ErlotinibHcl 150mgTab Erlotin150 10 3900 3664220 Estramustin

Phosphate140mgCap xtrant140 100 14650 7773.15

221 EstramustinePhosphate

140mgCapsule ESTRAMIN 30Caps 4263.00 3573.96

222 Everolimus 10mgTablet EVERBLISS 10’s 29700.00 10178.77223 Everolimus 5mgTablet EVERBLISS 10’s 18999.00 5947.96224 Everolimus 0.5mgTab ADVACAN0.5 10 1595.7 825.59225 Everolimus 10mgTab EVERTOR10MG 10 32603.6 14690.87

226 Everolimus 5mgTab EVERTOR5MG 10 21735.6 9644.9227 Everolimus 0.25mgTab ADVACAN0.25 10 797.8 439.97228 Everolimus 10mgTablet ROLIMUS 10Tabs 12839.67 9,000.00229 Everolimus 5mgTablet ROLIMUS 10Tabs 7133.15 5,250.00230 Everolimus 10mgTablet Volantis10stablet10mg 10 20020.00 9837.50231 Everolimus 5mgTablet Volantis10stablet5mg 10 10010.00 6438.50232 Everolimus 10mgTablet Evermil 10 15000 6835233 Everolimus 5mgTablet Evermil 10 10000 5168234 Everolimus 10mgTablet Afinitor 10 53400 19882.43

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235 Everolimus 0.5mgTablet Certican 10 1840 1615236 Everolimus 0.25mgTablet Certican 10 920 789237 Everolimus 0.75mgTablet Certican 10 2760 2320238 Everolimus 0.50mgTablets EverGraf0.50 1*10tabs 1392.5 1298.35239 Everolimus 0.25mgTablets EverGraf0.25 1*10tabs 696.25 579240 Everolimus 0.25mgTablets Lanolimus0.25mg 10 726 406241 Everolimus 0.50mgTablets Lanolimus0.5mg 10 1452 739242 Everolimus 0.5Tablet Evercon0.5 10 1450 823243 Everolimus 0.25Tablet Evercon0.25 10 725 426244 Exemestane 25mg10tabs Exeget stripsof10tabs 850 511245 Exemestane 25mgTablet xtrant25 30 1290 1059.96246 Exemestane 25mgTablets Aromasin25mgTablet 15nos*1 5284.40 4867.77247 Fulvestrant 250PFS Fulvidax 2PFS 40000 28200248 Fulvestrant 250mgInjection FulvetrazInj 5mlPFS 25200 15798

249 Fulvestrant 250mgInjection FulvetrazInj(twinpack0 2x5mlPFS 41400 32303250 Fulvestrant 250mgPFS V-STRANT 2’s 41400.00 23500.47251 Fulvestrant 250mgInj FASNORM 1MLVIAL 24727.5 15054.45252 Fulvestrant 250mginjection FUVESTROLINJ 5mlPFS 22000 13511253 Fulvestrant 250mgSingleDose

VialFaslomax Pervial 18500 12521

254 Fulvestrant 250mgInjection Strantas 5ml 20000.00 13300.08255 Fulvestrant 250mginj Fulvent250 1Vial 18000 12229.66256 Fulvestrant 250mgInjection FULVESER 5ml 21000.00 7920.99257 Fulvestrant 250mgInjection FULVETHER250 5ML/VIAL 17500 15232.3

258 Fulvestrant 5mlInjection Fistent PFS 24500.00 16,516.95259 Fulvestrant 250mgInjection FULVIRA 2x5ml. 44,000.00 21342.00

260 Fulvestrant 250mgInjection FULVIRA 1x5ml. 22,000.00 11109.00261 Fulvestrant 250mginj Fulviglen 1,s 20700 11365262 Irinocetan 100mgInjection Campto100mg/5ml(injec-

tion)5ml*1 22651.20 18151.11

263 Irinocetan 40mgInjection Campto40mg/2ml(injec-tion)

2ml*1 9059.60 7628.31

264 Irinotecan 40mg/2mlInjec-tion

Irinotel Vial 2174.92 421.14

265 Irinotecan 100mg/1mlInjection Irinotel Vial 4658.68 948.29

266 Irinotecan 100mgInjection IRITERO Vial 4100.00 1000.00267 Irinotecan 40mgInjection IRITERO Vial 1800.00 617.00268 Irinotecan 40mgInjection Zinotecan Vial 1800.00 1576.48269 Irinotecan 100mgInjection Zinotecan Vial 2200.00 2160.65270 Irinotecan 20mgInjection Irnocam100Inj Vial 4084.00 1566.00271 Irinotecan 20mgInjection Irnocam40Inj Vial 1825.50 777.50272 Irinotecan 100mgInjection IMTUS 1X1 4,610.00 1267.00

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273 Irinotecan 40mgInjection IMTUS 1X1 1,969.00 322.00274 Irinotecan 100MG/5ML

InjectionINTENSIC 100MG/5ML.

VIAL850 517.82

275 Irinotecan 40MG/2mLInjec-tion

INTENSIC 40MG/2ML.VIAL

486 472.78

276 Lapatanib 250mgTablet AbnibTablet30mg 30 12990.00 8403.76

277 Lapatanib 250mgTablet LAPATEM 30T 11,000.00 6745.00278 Lapatanib 250mgTablet LAPATEM 120T 29,500.00 28384.00279 Lapatanib 250mgTablet LapaHope 30 10000 8750280 Lapatanib 250mgTablet HERTAB 150’s 32995.00 28160.00281 Lapatanib 250mgTablet HERTAB 30’s 6995.00 5950.00282 Lapatanib 250mgTablet LupidocTab 30Tabs 11952 10305283 Lapatanib 250mgTablet HERLAPSA 30Tabs 9750.00 8057.00284 Lapatanib 250mgTablet Herduo250 150 29900 29900285 Lapatanib 250mgTablet Herduo250 30 6000 6000286 Lenalidomide 10mgInjection Lindishil 10 3000 863.55287 Lenalidomide 5mgCapsule Kabilen 30’sbottel 6594 2838.75288 Lenalidomide 25mgCapsule Kabilen 30’sbottel 19782 8666.67289 Lenalidomide 10mgCapsule Kabilen 30’sbottel 9781 4593.2290 Lenalidomide 10mgCapsule Lenofect 10 2800 1320291 Lenalidomide 5mgCapsule Lenofect 10 1400 700292 Lenalidomide 25mgCapsule Lindishil 10 6000 3040293 Lenalidomide 25mgCapsule Lenofect 10 7000 3890294 Lenalidomide 10mgCaps Adlinod-10 1*10caps 2660 1852.76295 Lenalidomide 25mgCaps Adlinod-25 1*10caps 6650.00 3680296 Lenalidomide 10mgCapsule LENMID 10Caps 2051.79 998.61 297 Lenalidomide 25mgCapsule LENMID 10Caps 4409.02 2,796.72298 Lenalidomide 5mgCapsule LENMID 10Caps 1024.1 795.73 299 Lenalidomide 10mgCapsule Lenangio10 10 2821.70 1013.00300 Lenalidomide 25mgCapsule Lenangio25 10 7400.00 2759.00301 Lenalidomide 5mgCapsule Lenangio5 10 1410.80 632.00302 Lenalidomide 25mgCapsule LENDOMY 30Caps 18000.00 7700.00303 Lenalidomide 10mgCapsule LENDOMY 30Caps 9000.00 3408.00304 Lenalidomide 5mgCapsule LENDOMY 30Caps 4400.00 1887.00305 Lenalidomide 25mgCap Lenalid25mg 30 18360 9296.85306 Lenalidomide 15mgCap Lenalid15mg 30 12240 6294.85307 Lenalidomide 10mgCap Lenalid10mg 30 8976 4516.18308 Lenalidomide 5mgCap Lenalid5mg 30 4386 2196.8309 Lenalidomide 10mgCapsules Lenomust-10 1*30Capsule 8700 2454.25310 Lenalidomide 25mgCapsules Lenomust-25 1*30Capsule 18000 4601.95311 Lenalidomide 25mgCapsule Relidomide 28’s 16000.00 6,400.00

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312 Lenalidomide 10mgCapsule Relidomide 28’s 7500.00 4,080.00313 Lenalidomide 5mgCapsule Relidomide 28’s 4000.00 1,259.00314 Lenalidomide 25mgCapsule LENATED25 6000 3862.45315 Lenalidomine 25mgCapsule Laviat 10’s 4800.00 2447.32316 Lenalidomine 10mgCapsule Laviat 10’s 2400.00 1220.12317 Lenalidomine 5mgCapsule Laviat 10’s 1200.00 734.65318 Lenalidomine 10mgCapsule Lenome 10’s 3815.00 1691.13319 Lenalidomine 25mgCapsule Lenome 10’s 6540.00 3040.93320 Lenalidomine 5mgCapsule Lenome 10’s 2180.00 948.87321 Leuprolide 11.25mgInjection LeuprostaDepot11.25mg Depot 11250 8877

322 Leuprolide 22.5mgInjection LeuprostaDepot22.5mg Depot 19980 16812323 Leuprolide 11.25mgInjection BDSURE Vial 11250.00 7661.99324 Leuprolide 22.5mgInjection BDSURE Vial 21000.00 12698.43325 Leuprolide 3.75mgInjection BDSURE Vial 4500.00 2537.19326 Leuprolide 3.75mgInjection LuprorinDepot 1Vial+1Am-

poule4634.00 2351.12

327 Leuprolide 22.5mgInjection Leupo 22.5mg 21000.00 16893.51328 Leuprolide 4mgInjection Luprorin 4mg/4ml 560.00 478.58329 Leuprolide 22.5mgInjection Luprotas 22.5mg 21000.00 16893.51

330 Leuprolide 11.25mgInjection Leupo 11.25mg 11500.00 10167.27331 Leuprolide 11.25mgInjection Luprotas 11.25mg 11500.00 10167.27332 Leuprolide 3.75mgInjection Leuprorel Vial 4400.00 2,224.20333 Leuprolide 22.5mgInjection ELIGARDDEPOT 1X1 24,000.00 22650.00

334 Leuprolide 45mgInjection ELIGARDDEPOT 1X1 38,350.00 36357.00335 Leuprolide

Acetate22.50mgInjection Leprol Vial 18700 12620

336 LeuprolideAcetate

11.25mgInjection Leprol Vial 11500 9330

337 LeuprolideAcetate

3.75mgInj.(Powder) Luprodex3.75mgDepot 2ml-vial 4095 2257.07

338 LeuprolideAcetate

22.5mgInj.(Powder) Luprodex22.5mg 2ml-vial 20100 12552.85

339 LeuprolideAcetate

11.25mgInj.(Pow-der)

Luprodex3M(11.25mg) 2ml-vial 11,576 7500

340 LeuprolideAcetate

11.25mgInj.(Pow-der)

Luprodex11.25mgdepot 2ml-vial 11576.00 7339.71

341 LeuprolideAcetate

4mgMultidoseVial LuprodexMD4mg 4ml 510 439.17

342 Leuprolideacetate

3.75mgInjection MATERNA 1X1 4,395.00

2203.00

343 LeuprolideAcetate

22.5mgInj Glerelin 1’s 19990 12210

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344 LeuprolideAcetate

3.75mgInjection EUROLIDE-DEPOT Vial 5072.76 1772.10

345 LeuprolideAcetate

4mgInjection EUROLIDE 4ml 795.96 527.92

346 LeuprolideAcetate

1mgInjection EUROLIDE 0.5ml 304.37 196.45

347 LeuprolideAcetate

3.75mgInjection LeuprogonDepot Vial 3990 2650

348 LeuprolideAcetate

1mg/mlinj Luprofact 1x4mlVial 727 566.25

349 LeuprolideAcetate

1mg/0.5mlinj Luprofact 1x0.5mlV 233.5 155.5

350 LeuprolideAcetateDepotforInj.

11.25mgInjection LUPRIDE11.25MGINJEC-TION

Vial 11500.00 10137.88

351 LeuprolideAcetateDepotforInj.

22.50mgInjection LUPRIDE22.50MGINJEC-TION

Vial 18700.00 17466.04

352 LeuprolideAcetateDepotforInj.

3.75mgInjection LUPRIDE3.75MGINJEC-TION

Vial 4200.00 3917.36

353 LeuprolideAce-tateforInj.

3.75mgVial EndorelinInj. 1 4250 2778.22

354 Leuprolidede-potInj.

3.75mgSingleDoseVial

Prolimax Pervial 4646 2349

355 Linalidomide 10mg10caps Lenaget bottleof10caps

3293 1451

356 Linalidomide 5mg10caps Lenaget bottleof10caps

1476 805

357 Lomustin 40mgCapsule Es-Tine 10’s 1,150 870358 Lomustin 40mgCapsule LOMOOTHER40 900 599.76

359 Mitomycin 40mgInjection MitomycinC Vial 2879.40 2245.69360 Mitomycin 10mgInjection MitomycinC Vial 556.60 491.69361 Mitomycin 2mgInjection MitomycinC Vial 216.20 172.23362 Mitomycin 10mg/VialInjection MITO-10 10MG.LYOVIAL 529 472.34363 Mitomycin 40mg/VialInjection MITO-40 40MGLYO.

VIAL2140 1,924.00

364 Mitomycin 2mg/vialInjection MITO-2 2MG.LYOVIAL 168 164.56365 Mitoxantrone 20MG/10MLInjec-

tionNITROL 20MG/10ML

VIAL433 427.17

366 Nilotinib 200cap Tasigna 4 8768 8507.57367 Paclitaxel 100mgInjection AB-Pacli Vial 12160.00 6,563.58368 Paclitaxel 100mgInjection Taxonab Vial 14058.70 6739.83369 Paclitaxel 100mgInjection Petaxel Vial 13056.48 5946.24

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370 Paclitaxel 260mginjection PACLICAD260MGINJ 50mlVial 10182.03 2775

371 Paclitaxel 100mgInjection(100mg/vial)

PacliAll Singleusevial 12697.74 5242.9

372 Paclitaxel 6mgInjection43.4ml*1

PacliTrust260 SingledoseVial 9000 1781.6

373 Paclitaxel 100mgVial NabTortaxel 1 12737.40 7918.2374 Paclitaxel 260mgInjection DUTAXEL Vial 8800.00 1203.28375 Paclitaxel 100mgInjection DUTAXEL Vial 3917.90 508.72376 Paclitaxel 30mgInjection DUTAXEL30 Vial 1173.03 423.01377 Paclitaxel(albu-

minbased)100Injection Paclimin Vial 12440 6410

378 Paclitaxel(Proteinboundparticle)

100mgInjection NAB-Altaxel100Inj Vial 10530 5392

379 Paclitaxel(Proteinboundparticle)

100mgInjection NABPAC100MG(Injec-tion)

Vial 12333.00 4628.00

380 Paclitaxel(ProteinBoundparticles)

100mgvial NANOPACLI100MG Vial 11957.22 7256.63

381 Paclitaxel(Proteinboundparticle

100mgInjection NABPACLITERO Vial 10900.00 4622.00

382 Paclitaxel(Proteinboundparticle

100mgInjection NABTOXOL Vial 11543.00 6418.00

383 PaclitaxelIP100,HumenalbuminIP

100mginjection PACLICADNINJ 50mlVial 12169.5 5138

384 PaclitaxelNanoparticle

100mgInjection PACLITAX Vial 13172.5 6803.88

385 PegLAspergin-aseInj

750/IUinjection LAGIPEGINJECTION 5mlVial 43378.43 34560

386 PegL-Asparagi-nase

5mlInjection PEGL-ASPATERO Vial 43370.00 25536.00

387 Pegliposomaldoxorubicin

50mg/25mlInjec-tion

PegAdrim Vial 20883.9 8255.93

388 Pegliposomaldoxorubicin

20mg/10mlInjec-tion

PegAdrim Vial 8353.56 3632.7

389 Pegliposomaldoxorubicin

20mgInjection Adrisom Vial 7500 4780

390 Pegr-humenG-CSF

6mginj Glenstim 1,s 11997 3665

391 Peg-Asparagi-nase

750IUInj. Peg-Lasgen Singledosevial 59990 29448.83

392 Pegasperagase 3750IUInjection Asviia Vial 24990.00 20383.71

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393 Pegfilgrastim 0.06mgPFS ImupegInjection(Pref-filledSyringes)

PFS 12023.06 6984.45

394 Pegfilgrastim 6mgInjection Pegstim Vial 12078.00 3592.93395 Pegfilgrastim 6mgInjection Pegstim Vial 5500.00 3894.46396 Pegfilgrastim 6mgInjection Pegheal Vial 10990.00 3420.34397 Pegfilgrastim 6mgInjection CIPLASTIM Vial 12000 6,399.99398 Pegfilgrastim 6mgInjection Peg-grafeel6mg 1 10790.00 3010.00

399 Pegfilgrastim 6mgInjection PEGEX 1X1 9,340.00 3455.00400 Pegfilgrastim 6mgInjection PEGEX Vial 9,340.00 3,455.00401 Pegfilgrastim 6mgInjection PEGLAST Vial 10,870.00 6,400.00402 Pegfilgrastim 6mgInjection Pegasta 0.6ml 11227.00 2958.93403 Pegfilgrastim 6mgInjection Neupeg ml 18530.00 6849.99404 Pegfilgrastim 6mgInjection Pegasta 0.6ml 3900.00 2958.93405 Pegfilgrastim 6mgInjection LUPIFIl-P Vial 8930 4172406 Pegfilgrastim 6mg/0.6ml.PFS

InjectionPEGNEON 6MG/0.6ML.

PFS7200 2,882.30

407 Pegfilgrastim 6mgInjection Pegreligrast Vial 12000.00 2,919.14408 Pegfilgrastim 6mgInjection PEGFRASTIM(Injection) PFS 14500.00 4016.00

409 Pegfilgrastim 6mgprefilledsy-ringe

Fillif-peg 1 10352.60 7086.4

410 Pegfilgrastim 6mgInjection PEGLAST Vial 10,870.00 6,400.00411 PEG-FILGRASTIM 6mgInjection PEGXPHIL6MG(0.6ml)

INJECTION0.6ml 11000.00 6334.13

412 Pegfilgrastin 6mgInjection6mg/0.6ml

PegTrust Singleusevial 13233 4992.1

413 PegylatedDoxo-rubicin

20mgInjection PEGDOXRUB Vial 5400.00 3248.60

414 PegylatedLipo-somalDoxoru-bicin

2mgInjection RUBILONG Vial 9,898.00 3,918.00

415 PegylatedLipo-somalDoxoru-bicinHydrochlo-ride

10mlInjection PIGLIT 1X1 8,353.00 3158.00

416 Pemetrexed 500mginj Benzpee 1Vial 8100 4289417 Pemetrexed 100mginj Benzpee 1Vial 2100 1024418 Pemetrexed 100mgInjection PEMETREX Vial 3600.00 914.45419 Pemetrexed 500mgInjection PEMETREX Vial 19440.00 2543.83420 Pemetrexed 500mgInjection Pempro Vial 18000.00 3224.76421 Pemetrexed 100mgInjection Pempro Vial 5500.00 936.79422 Pemetrexed 500mginjection PEMECAD500MG Vial 19255.27 4349

423 Pemetrexed 100mginjection PEMECAD100MG Vial 6080.61 1909424 Pemetrexed 500mgInjection PEMETA Vial 21450 4071.7425 Pemetrexed 100mgInjection PEMETA Vial 4950 862.78

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426 Pemetrexed 500mgInjection Pemgem500mginj 500mg 21215.00 5123.50427 Pemetrexed 100mgInjection Pemgem100mginj 100mg 5373.00 1378.50428 Pemetrexed 500mgInjection PEMCURE 1X1 16,500.00 3431.00429 Pemetrexed 100mgInjection PEMCURE 1X1 3,800.00 1034.00430 Pemetrexed 500mgInj Pexotra 1’s 8000 4690431 Pemetrexed 100mgInj Pexotra 1’s 2000 1050432 Pemetrexed 500mgSingleDose

VialGiopem Pervial 13125 4074

433 Pemetrexed 100mgSingleDoseVial

Giopem Pervial 2990 1606

434 Pemetrexed 500mgInjection PEMETERO Vial 13200.00 2673.00435 Pemetrexed 100mgInjection PEMETERO Vial 2750.00 1014.00436 Pemetrexed 500mgInjection Pemmet Vial 19075.00 5467.60437 Pemetrexed 100mgInjection Pemmet Vial 5450.00 1344.18438 Pemetrexed 500mgInjection MYTREX Vial 12000.00 2691.00439 Pemetrexed 100mgInjection MYTREX Vial 4500.00 957.00440 Pemetrexed 500mg/vialInjec-

tionPEMEPLAST-500 500MG/5ML.

VIAL4299 2,506.02

441 Pemetrexed 100mg/vialInjec-tion

PEMEPLAST-100 100MG/VIAL 904 634.53

442 Pemetrexed 100mgInjection Pexetrust100 Singleusevial(100mg*1)

5150 740.75

443 Pemetrexed 500mgInjection Pexetrust500 Singleusevial(500mg*1)

20394 2745.2

444 Pemetrexed 500mgPowdertoInjection

PEMAXAM-500 Vial 13200.00 2259.95

445 Pemetrexed 100mgPowdertoInjection

PEMAXAM-100 Vial 3080.00 801.84

446 Pemetrexed 500mgInjection PEXITAZ500MGINJEC-TION

Vial 12785.05 7115.23

447 Pemetrexed 100mgInjection PEXITAZ100MGINJEC-TION

Vial 2516.75 1339.88

448 Pemetrexed 500mgVial Pemotide500 1 21403.00 5346.8449 Pemetrexed 100mgVial Pemotide100 1 5268.40 2140.9450 Pemetrexed 500mgInjection Antifol Vial 8500.00 3905.17451 Pemetrexed 100mgInjection Antifol Vial 2300.00 936.29452 Pemetrexed 100mgInjection pemxcel Vial 7700 800453 pemetrexed 500mgInjection pemxcel Vial 22000 2880454 Pemetrexed 500mgInjection Pemestar500 Vial 25400 2509455 Pemetrexed 100mgTab Pemestar100 10 5950 856456 Pemetrexed 500mgInjection Pemshil Vial 20000 3270.59457 Pemetrexed 100mg/10ml

InjectionKabipem Vial 5786 1049.15

458 Pemetrexed 100mgInjection Pemelive100 Vial 6350 1200

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459 Pemetrexed 500mg/50mlInjection

Kabipem Vial 23144.94 5054.46

460 Pemetrexed 100mgInjection Pemshil Vial 5000 1204461 Pemetrexed 500mgInjection Pemelive500 Vial 19750 4800462 Pemetrexed 500Injection Pamifect Vial 21000 6870463 Pemetrexed 100Injection Pamifect Vial 5500 2480464 Pemetrexed 500mgInjection Relitrexed Vial 20900.00 5,461.33465 Pemetrexed 100mgInjection Relitrexed Vial 5500.00 1,272.46466 Pemetrexed 500mgInjection ZUPEMED Vial 14,900.00 4,246.00467 Pemetrexed 100mgInjection ZUPEMED Vial 4,550.00 960.00468 Pemetrexed

100mg100mgInj. Adpem100 Singledosevial 5350 1014

469 Pemetrexed500mg

500mgInj. Adpem500 Singledosevial 19500 4416

470 PemetrexedDisodium

100mginj Es-Peme 1Vial 6500 860

471 PemetrexedDisodium

500mginj Es-Peme 1Vial 17000 3730

472 PemetrexedDisodium

100mgInjection Pemeetron100inj Vial 5400 1817

473 PemetrexedDisodium

500mgInjection Pemeetron500inj Vial 22200 5778

474 PemetrexedDisodium

100mgInjection Alimta100mg Vial 19451 6000

475 PemetrexedDisodium

500mgInjection Alimta500mg Vial 81026 30000

476 PemetrexedDisodium

500mginj Pemnat500 1Vial 14850 2442.46

477 PemetrexedDisodium

100mginj Pemnat100 1Vial 3675 916.8

478 PemetrexedDisodium

100mgInjection PEMETED100 100MG/VIAL 5500 956.42

479 PemetrexedDisodium

500mgInjection PEMETED500 500MG/VIAL 19780 3838.46

480 PemetrexedDisodium100mg+manni-tol106mg(PerVial)

100mgInjection PEMEXAR(Injection) 100Vial 5000.00 1141.00

481 PemetrexedDisodium500mg+manni-tol500mg(PerVial)

500mgInjection PEMEXAR(Injection) 500Vial 19000.00 4249.00

482 Plerixafor 24mgInj IRANSEZE 1VIAL 75000 45685.99483 Plerixafor 20mgInjection Stemfor 20mg 39950.00 33222.97484 Plerixafor 24mgInjection PLERIXA 1.2ML/VIAL 45000 28561.37

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485 Pomalidomide 4mgCapsule POMAHOPE4MG 21 21000.00 17955.74

486 Pomalidomide 2mgCapsule POMAHOPE2MG 21 10000.00 7916.21487 Pomalidomide 1mgCapsule POMAHOPE1MG 21 5500.00 3680.02488 Pomalidomide 3mgCapsule POMAHOPE3MG 21 16000.00 15199.99489 Pomalidomide 4mgCapsule Pomiat 21’s 20000.00 14868.00490 Pomalidomide 2mgCapsule Pomiat 21’s 10000.00 8800.00491 Pomalidomide 1mgCapsule Pomiat 21’s 5000.00 4640.00492 Pomalidomide 4mgCapsule POMALONG 21Caps 20000 12,000.00493 Pomalidomide 1mgCapsule POMALONG 21Caps 5000 3,000.00494 Pomalidomide 4mgCapsule Pomired4mgcapsule 21 21000.00 16021.00495 Pomalidomide 2mgCapsule Pomired2mgcapsule 21 10500.00 10371.50496 Pomalidomide 4mgcapsule Pomacel 21Cap 20000 14200497 Pomalidomide 2mgcapsule Pomacel 21Cap 10000 8100498 Pomalidomide 3mgcapsule Pomacel 21Cap 15000 11650499 Pomalidomide 1mgcapsule Pomacel 21Cap 5000 3600500 Pomalidomide 4mgCapsule IBIPOLID4 21CAP 20000 14400501 Pomalidomide 2mgCapsule IBIPOLID2 21CAP 10000 9219.28502 Pomalidomide 1mgCapsule IBIPOLID1 21CAP 5000 4176503 Pomalidomide 4mgCapsule Pomyelo 21’s 20000.00 15805.22504 Pomalidomide 2mgCapsule Pomyelo 21’s 10000.00 9047.77505 Pomalidomide 1mgCapsule Pomyelo 21’s 5000.00 4586.70506 Pomalidomide 2mgCapsules Pomavia 21Capsulesin

bottle9980 5748

507 Pomalidomide 4mgCapsules Pomavia 21Capsulesinbottle

21880 16432

508 Pomalidomide 4mgCapsule MYHB 21Caps 20000.00 14201.00509 Pomalidomide 2mgCapsule MYHB 21Caps 10000.00 7497.00510 Pomalidomide 1mgCapsule MYHB 21Caps 5000.00 3590.00511 Pomalidomide 4mgCap Pomalid4 21 20000 15946.24512 Pomalidomide 2mgCap Pomalid2 21 10000 8190.21513 Pomalidomide 1mgCap Pomalid1 21 5000 4219.68514 Pomalidomine 4mgCapsule POMIDE 21’s 19740.00 16567.00515 Pomalidomine 2mgCapsule POMIDE 21’s 9975.00 7572.00516 Pomalidomine 1mgCapsule POMIDE 21’s 5040.00 3084.00517 Regorafenib 40mgtab Nublexa 28tab 59294 36965518 Regorafenib 40mgTablet Resihance 28’s 42385.10 42194.57519 Sunitinib 25mgCapsules Sutent25mgCapsules

(Capsules)7Capsules*1 30501.71 29204.51

520 Sunitinib 12.5mgCapsules Sutent12.5mgCapsules(Capsules)

7Capsules*1 15250.52 14786.42

521 Triptorelin 11.25mgInjection PamorelinLA11.25 1 20055.00 17876.50522 Triptorelin 22.5mgInjection PamorelinLA22.5 Vial 38000.00 36409.00

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523 Triptorelin 3.75mgInjection PamorelinLA3.75 Vial 8137.50 7506.00

524 TriptorelinAcet-tateInjection

3.75mgInjectable DecapeptylDepot 1 7259.85 6231.17

525 TriptorelinAcet-tateInjection

0.1mg/mlInjectable Decapeptyl0.1mg 7 2454.76 2361.62

526 TriptorelinAcet-tateInjection

0.1mg/mlInjectable Gonapeptyl 10 10145.00 9581.10

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CHAPTER 8 IMPLEMENTATIONOFRAJBHASHA

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CHAPTER 8

IMPLEMENTATIONOFRAJBHASHA

UseofHindiinofficialwork

EverypossibleeffortwasmadeforimplementationofthevariousprovisionsoftheOfficialLan-guagePolicyof theUnionof India including thoseofOfficialLanguagesAct,1963aswellasOfficialLanguages(UseforOfficialPurposesoftheUnion)Rules,1976andordersissuedthereunder.AllthedocumentsmentionedinSubSection(3)ofSection3oftheOfficialLanguagesAct,1963wereissuedbilinguallyi.e.inHindiaswellasinEnglish.LettersreceivedinHindiandrepresentationsetc.signedinHindiwererepliedinHindiasperprovisionsoftheRule5andRule7(2)oftheOfficialLanguages(UseforOfficialPurposesoftheUnion)Rules,1976(asamendedin1987).

OfficialLanguageImplementationCommittee

Department ishavingOfficialLanguageImplementationCommitteeworkingundertheChair-manshipoftheJointSecretarytoperiodicallyreviewtheprogressiveuseofHindiintheofficialworkandsuggestthesuitablemeasurestoincreasetheuseofHindiintheofficialwork.ItsmeetingswereheldonregularintervalsandimplementationstatusofthevarioustargetssetintheAnnualProgrammefortransactionoftheofficialworkoftheUnioninHindifortheyear2019-20issuedbytheDepartmentofOfficialLanguage,MinistryofHomeAffairswasreviewed.

HindiPrayogProtsahanPakhwara,2019

HindiPrayogProtsahanPakhwarawasobservedintheDepartmentfrom16thto30thSeptem-ber,2019withtheobjectivetoencouragetheofficersandemployeesoftheDepartmenttoprogres-sivelyincreasetheuseofHindiintheirofficialworkandalsotohelptheDepartmenttocreateanatmo-sphereconducivetouseofHindi.

InadditiontothemessageissuedbytheSecretary(Pharma)requesting,inter-alia,alltheoffi-cers/employeestomakeacommitmenttouseofHindi,variousHindicompetitionswereheldduringthePakhwara inwhichofficers/officialsparticipated inunprecedentednumbersandmadethispro-grammesuccessful.Winnerswereawardedwithcashprizes.

ReviewofthestatusofuseofHindiintheofficesundertheDepartment

PeriodicalreviewoftheuseofHindiintheofficesundertheDepartmentwasmadethroughthequarterlyreportsonprogressiveuseofHindireceivedfromthemincompliancewiththetargetssetintheAnnualProgrammeforuseofHindifortheyear2018-19.Moreover,duringthisyear,toachievetheprescribedtarget(inspectionofatleast25%offices)intheAnnualOfficialLanguageProgramme2018-19,thesuccessfulinspectionofthreesubordinateofficesofDepartmentofPharmaceuticalswascarriedout.

ConductofHindiWorkshop

Tohelptheofficers/employeesof theDepartmentofPharmaceuticals towork inofficial lan-guagesinofficialworkandtoencouragetouseofficiallanguageHindi,aHindiworkshoponthesubject

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‘HindiTypingonComputer’wasorganisedon15.04.2019.TwomoreHindiWorkshopson“OfficialLan-guageRulesandHindiQuarterlyProgressReport”and“OfficialLanguageAct/RulesandHindiQuarterlyProgressReport”wereorganisedon29.07.2019and13.11.2019respectively.

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CHAPTER 9 CITIZENCENTRICGOVERNANCE

9.1 OurVision

9.2 OurMission

9.3 OurClients

9.4 OurCommitment

9.5 OurServices

9.6 OurActivities

9.7 RTIAct-2005

9.8 CPGRAMS

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CHAPTER9

CITIZENCENTRICGOVERNANCE

9.1 OurVision:

TopromoteIndianpharmaasthegloballeaderforqualitymedicinesandtoensureavailability,accessibilityandaffordabilityofdrugsandmedicaldevicesinthecountry.

9.2 OurMission:

• investmentforMakeinIndiainpharmasector• MakeinIndiaincriticalAPIsandmedicaldevices• industryexpansion,skilling,R&Dandinnovation• stableandeffectivepriceregulationand

• genericmedicinesbyexpandingJanaushadhischeme

9.3 OurClients

• CitizensofIndia

• PharmaceuticalIndustryincludingMicro,SmallandMediumEnterprises

• PharmaceuticalcompaniesseekingreliefunderDPCOs

• NPPA/CPSUs/NIPERs

9.4 OurCommitment

Wearecommittedtoprovideimpartial,sympatheticandpromptservicestothepublicinmat-tersrelatingtothepharmaceuticalindustry.

Ourcommitmentistotakepromptstepstoprovidequickredressalofthegrievancesofourper-sonnelandpublicatlarge.

Ourcommitment is to formulatepoliciesand initiateconsultationswithall IndustryAssocia-tions/stakeholdersandtoamendthemwheneversorequired.

9.5 OurServices

Weformulateandimplementpoliciesrelatingtodrugsandpharmaceuticals,dyestuffanddyeintermediates.

9.6 OurActivities

ThekeyactivitiesoftheDepartment:

1. Ensureavailabilityofdrugsat reasonablepricesasperprovisionsof theDrugs(PricesControl)Order,2013

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2. EnsureproperfunctioningoftheCentralPharmaUndertakingsincontroloftheDepartment.

3. ProjectBasedSupportandRevivalSchemesforCPSUs

4. EnsurepropermanagementofMPharmaandPh.D.programsinNIPERs

5. DevelopHumanResources,InfrastructureforPharmaR&DandIndustryincludingPublic-Private-Partnerships(PPP)

6. FormulateScheme/ProjectforpromotingPharmaBrandIndia

7. Formulate Scheme/ Project for promoting environmentally sustainabledevelopmentofPharmaceuticalIndustry

8. FormulationofAnnualPlan,BudgetandMonitoringofBudgetExpenditure

TheCitizenCharteroftheDepartmenthasbeenplacedonthewebsiteoftheDepartment.

9.7 RighttoInformationAct2005

AspertheprovisionsoftheRTIAct,2005,alltherelevantinformationrelatingtoDepartmentofPharmaceuticalshasbeenmadeavailableonthewebsiteinamanner,whichiseasilyaccessibleandcomprehensibletothepublic.

CentralPublicInformationOfficersandAppellateAuthoritieshavebeennominatedinthede-partmenttoprovideinformationtothepublic.

9.8 CPGRAMS(CentralizedPublicGrievancesRedressandMonitoringSystem)

PublicGrievancesreceivedofflineandthroughCPGRAMSaremonitoredanddisposedonregu-larbasis.

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CHAPTER 10 INFORMATIONANDCOMMUNICATIONTECHNOLOGY

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Chapter10InformationandCommunicationTechnology

UnderDigitalIndiaprogram,DepartmentofPharmaceuticalshastakeninitiativestowardsadop-tionofE-Governancetodeliver informationandservicesonline.Thishas ledtobenefits intermsoftransparency,easyaccessibilityofservices, improvementof internalprocessesanddecisionsupportsystem.

AnITbasedComputerCentre,setupbyNationalInformaticsCentre(NIC)isoperationalintheDepartmentandisequippedwithlatestClientmachinesforprovidingvariousITrelatedservicestotheDepartment.NICisdeliveringvaluablekeyserviceslikeTechnicalconsultancy,Networking,applicationdevelopmentandimplementation,Internet&E-Mail,databasemanagementandTraining.WithNIC’spresenceandexpertise,DepartmenthasbeenactiveinsteeringfollowingIT/E-governanceinitiatives.Inordertoenhancethedeliveryandsecurity,webapplicationsaremigratedtocloudenvironment.

LocalAreaNetwork(LAN):

AllworkplacesinthedepartmentareconnectedtoLocalAreaNetwork(LAN)whichisalreadyIPv6compliantandismanagedbytheNationalInformaticsCentre(NIC)toprovideroundtheclockfa-cilitiesforE-mail,intranet/internetanddatabaseaccessoperations.TheIPv6compliantICThardwareisavailabletoallofficers/divisions/sectionsforuseattheirdesktops.

WebsiteandSocialMedia

BilingualWebSiteofdepartmenthttp://pharmaceuticals.gov.inishostedonNICcloudtoensuresecurityandmaximumreachofinformationtothecitizens.ThewebsiteisdevelopedbyNICusingcon-tentmanagementframeworkandisGIGWcompliant.Itprovidesdetailsoforganizationalsetupofthedepartment,itsfunctions,subordinateoffices,policies,publicationsandstatisticaldata/informationonfunctionalparameters.StandardizationtestingandQualityCertificate(STQC)certificationiscompleted.

Socialmediahasenormouspotentialtoreachpeople.ToimprovethequalityofGovernmentdecision,policymakingandcreateawareness,DepartmenthascreatedFacebookandTwitteraccounts.InformationregardingtheconferencesandSeminarslaunchedbyMinister,MoS,SecretaryandotherofficersofDepartmentispostedonitpromptly.VariouspoststocreateawarenessregardingvariousactivitiesanddecisionstakenbytheDepartmentarepostedonFacebookandtwitterpagesoftheDe-partment.

VideoConferencing:

VideoConferencing(VC)facilityisoperativeforSecretaryandJointSecretariesoftheDepart-ment.PSUsandNIPERshavealsoinstalledtheVideoConferencingfacility.VCfacilityenablesDepart-menttointeractwithPSUsandNIPERsfrequentlytomonitortheirperformanceandcommunicatethedecisions.Pragatimeeting,MonitoringtoolofPMoffice, isconductedeverymonthandHon’blePMinteractswithallSecretariesandStateCStoaddressissueswhicharelongpendingthroughVideoCon-ferencing.VideoConferencingfacilityisalsoutilizedforinteractingwithforeigndelegates.

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WorkFlowAutomation

AnotherinitiativetakenbytheDepartmenttowardsDigital IndiaistoimplementautomationofworkflowinsidetheDepartment.E-officeisastandardproductpresentlyconsistsofe-File,e-Tour,KnowledgeManagementSystem(KMS),PersonnelInformationManagementSystem(PIMS),Collabora-tion&MessagingService(CAMS)andisaimedatincreasingtheusageofworkflowandrulebasedfilerouting,quicksearchandretrievaloffilesandofficeorders,digitalsignaturesforauthentication,formsandreportingcomponents.e-Officehasbeenimplementedtoreduceduplicityofworkandtoincreasetransparencyandefficiency.

e-Governance:

TakingadvantageoflatestICTenabledtools,DepartmentofPharmaceuticalswiththesupportofNIChastakeninitiativestowardsadoptionofbestpractices.Variousapplicationshavebeendevel-opedandimplementedbyNICtostrengthenmonitoringanddecisionmakingandhighavailabilityofrightinformationatrighttime.

• AadhaarenabledBiometricsAttendanceSystem(AEBAS)-BiometricsAttendanceSystemrecordsattendanceofallemployees(PermanentandCasual)oftheDepartment.Variousreportsaregeneratedformonitoringofattendance.

• SPARROW-SmartPerformanceAppraisalReportRecordingonlineWindow(SPAR-ROW)applicationwhichallowsonlinesubmissionofAPARofIASandCSScadreofficersisimplementedsuccessfully.

• VisitorManagementSystem–e-VisitorSystemisawebbasedsolutionforVisitorManagement.Thisfacilitatescitizensforonlineregistrationofrequestsfortheirvisitandapprovalisgiventoauthenticatedvisitorsandgatepassisissued.

• LegalInformationManagement&BriefingSystem(LIMBS)–LIMBSisawebbasedportaldevelopedbyDepartmentofLegalAffairs,MinistryofLaw&Justiceformonitor-ingandhandlingofvariouscourtcasesofGovernment.CasespertainingtoHighCourtandTribunalsarebeinguploadedbytheconcerneddepartments.Itfacilitatesofficialstogenerateusefulreports.

• OnlineRTI-MIS–TodisposeofandmonitorRTIapplicationsefficiently,Depart-menthastakeninitiativetouseOnlineRTI-MIS.Necessarytrainingwasimpartedtocon-cernedofficials/stafftoimplementRTI-MISsuccessfully.

• CentralizedPublicGrievanceRedressMonitoringSystem(CPGRAMS):CPGRAMSisimplementedintheDepartmentandalltheattachedofficestoaddressPublicgriev-ancesreceivedonlinewithminimumdelay.

• E-publishingofTenders–E-publishingoftenders is implementedbyuploadingtendersonCentralPublicProcurementPortal. Ithasimprovedtheaccessibilityoften-ders.

• Electronic-HumanResourceManagementSystem(e-HRMS)isawebbasedHu-

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manResourceManagement System. E-HRMS, thewebportal https://ehrms.gov.in/ isimplementedintheDepartmentofPharmaceuticals.Dataofalltheemployeesareup-loaded.ModulesofServiceBookDetail,LeaveandLTCareoperational.

• https://supremo.nic.in/ isweb portal beingmaintained by theDepartment ofPersonnelandTraining(DOPT),GovernmentofIndia.ThisissingleuserplatformrelatedtoemployeesofGovernmentofIndia.InformationofthepersonnelunderAppointmentCommitteeoftheCabinet(ACC)arebeinguploadedontothewebsite.

Toenhancee-Governancefurtherfollowinginitiativeshavebeentakenup.

• Developmentofsoftwareforgrant–in-aidunderPlanScheme“Pharmaceuti-calPromotionandDevelopmentScheme(PPDS)”.TheobjectiveofPPDS ispromotionanddevelopmentofPharmaceuticalsectorbyextendingfinancialsupportforconductofseminars,conferences,exhibitions,mountingdelegationsfromIndiatoothercountriesforpromotionofexportsaswellasinvestments,conductingstudies/consultancies,forfacilitatinggrowth,exportsaswellascriticalissuesaffectingPharmaSector.ThesoftwareisintegratedwithDarpanofNitiAayogandapplicationsforgettingassistanceundertheschemearebeingreceivedonline.

• NationalInstitutesofPharmaceuticalEducation&Research(NIPERs)aresituatedatAhmedabad,Guwahati,Hajipur,Hyderabad,Kolkata,Raebareli,andMohali.NIPERMIShttp://nipermis.pharmaceuticals.gov.in/hasbeendevelopedandhostedonNICcloudtomonitordifferentactivitiesoftheinstitutes.NextVersionoftheMISisdevelopedandisundertheprocessofimplementation.

• DBTMISportalhttp://dbt.pharmaceuticals.gov.inishostedontheNICcloudfortwo schemes of theDepartment of Pharmaceuticals – Scholarship to students underNIPERandPardhanMantriBhartiya JanAushadhiPariyojana (PMBJP).Thisportaldis-seminatestheinformationaboutbeneficiariesandtransactions.Thisportalvalidatesthebeneficiary’sdetailsfromAadharandtransactiondetailsaresharedwithDBTBharat.

• DashboardoftheDepartmentisdevelopedandunderimplementation.

• StationeryMIS(http://10.21.81.76/store)istheMISoftheStationeryitemsforthe Department of Pharmaceuticals. Here employees can request for the stationeryitems.DealinghandacceptstherequestandafterapprovaloftheAdministration,em-ployees can receive the items. Stock of the stationery items is beingmaintained andissuedthroughthisportaldynamically.NextVersionofthissoftwareisunderdevelop-ment.

• E-registryofallDak:TheDepartmenthasstartede-diarisingofalldak/receiptsintheDepartmentforthepurposeofdatabaseande-monitoring.AllpapersreceivedintheDepartmentincludingallofficiale-mailsarediarisedelectronicallyintheCentralRegistryoftheDepartment.Periodicalreportsofpendingpapersaregeneratedandmonitored.

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CHAPTER 11 ANNEXURES

Annexure–I[A] ListofPSUsandOtherOrganizations

Annexure–I[B] AddressandNameofvariousOrganizations&PSUs

Annexure–I[C] ListofResponsibilityCentersandSubordinateOrganiza- tions

Annexure–II OrganizationalChartofNPPA

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CHAPTER 11

ANNEXURES

ANNEXUREI[A]

ListofPublicSectorUndertakings

1 IndianDrugs&PharmaceuticalsLtd,DundaheraIndustrialComplex,Dundahera, Gurgaon,Haryana.

2 HindustanAntibioticsLtd,Pimpri,Pune,Maharahstra.

3 KarnatakaAntibiotics&PharmaceuticalsLimited,Bangalore-560010.

4 BengalChemicals&PharmaceuticalsLtd,Kolkata,WestBengal.

5 RajasthanDrugsandPharmaceuticalsLimited.RoadNO.12,V.K.I.Area,Jaipur- 302013.

OTHERORGANISATIONS

1. BengalImmunityLimited,Kolkata,WestBengal.

2. SmithStanistreetPharmaceuticalsLtd.Kolkata,WestBengal.

ANNEXUREI[B]

AddressandNamesofHeadofvariousOrganization&PSUsundertheDepartmentofPharma-ceuticals:-

Table-11A(Contactaddressof5PSUs)

Sl.No. AddressandOrganization Name Designation1. IndianDrugs&PharmaceuticalsLim-

ited(IDPL),GurgaonShriNavdeepRinwa Chairperson &Manag-

ingDirector2. HindustanAntibioticsLimited(HAL),

Pune-411010Ms.NirjaSaraf ManagingDirector

3. Karnataka Antibiotics & Pharma-ceuticals Limited (KALP), Banglo-re-700013

Mr.SunilKumarKaimal ManagingDirector

4. BengalChemicals&PharmaceuticalsLimited(BCPL),Kolkata-700013

ShriP.M.Chandraiah ManagingDirector

5. Rajasthan Drugs & PharmaceuticalsLimited (RDPL), Road No. 12 V.K.IAreaJaipur-302013

ShriNavdeepRinwa ManagingDirector(Ad-ditionalCharge)

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ANNEXU

REI[C]

ListofResponsibilityCentersandSubordinateO

rganizations

S.no.N

ame of D

irectorsO

fficial Num

berEm

ailM

obile N

umber

Address

1D

r. SJS

Flora (Director)

Additional C

harge0172-22146900172-2214697

[email protected]

9425482305S

AS

Nagar, N

IPE

R M

ohali,P

unjab - 160062

2D

r. Kiran K

alia, (Director)

079-66745555kirankalia@

gmail.com

9714618573P

alaj Opp. A

ir Force Station H

ead Q

uarter, G

andhinagar-382355, G

ujarat.3

Dr. S

hashi Bala S

ingh

(Director)

040-23073741director.niperhyd@

gov.indirector@

niperhyd.ac.in

9999297992N

IPE

R,

Hyderabad

IDP

L Tow

nship, B

alangar, H

yder-abad-500007

4D

r. Gayathri V. P

atil0612-2631565

patilgayathri@yahoo.

co.in8600376332

E.P.I.P. C

ampus, Industrial A

rea,

Hajipur-844102, B

ihar5

Dr.V.

Ravichandiran,

(Di-

rector)033-24995803

033-23200086

vishnuvardhr@gm

ail.com

director@niperkolk-

ata.edu.in

9443963481Indian Institute of C

hemical B

iol-ogy (IIC

B, under C

SIR

),

Mentor Institute for N

IPE

R-K

ol-kata

Chunilala B

hawan, 168, M

anik-tala m

ain road, Kolkata-700054,

West B

angal6

Dr. U

SN

Murty (D

irector)0361-2132751

murtyusn@

gmail.com

murty_usn@

yahoo.com

9127060998C

/o NITS

-Mirza

Santipur, P

arlli Part, N

H-37

Mirza, K

amrup, A

ssam - 781 125

7D

r. SJS

Flora (Director)

0535-2700851sjsflora@

hotmail.com

9425482305B

ijnor-Sisendi

Road,

Sarojini

Nagar, N

ear CR

PF B

ase Cam

p, Luknow

(UP

) - 226002

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ANNEX

URE

-II

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