Unit 3 Regulatory affairs.pdf

Role and Responsibility of Regulatory Affairs

1. Regulatory affairs
Dr. Kumara Swamy Samanthula
M. Pharm, Ph.D
Associate Professor
Faculty of Pharmaceutical Science
ASSAM DOWN TOWN UNIVERSITY

2. 1. INTRODUCTION
•WhatisRegulatoryAffairs?
•RegulatoryAffairsisaprofessionwhichhasdevelopedfromthedesireof
governmentstoprotectpublichealth,bycontrollingthesafetyandefficacyof
productsinareasincludingpharmaceuticals,veterinarymedicines,medical
devices,pesticides,agrochemicals,cosmeticsandcomplementarymedicines.
•Asmedicinesplayavitalroleinhuman’slifetheremustberegulationsfor
medicinesensuringQuality,SafetyandEfficacyofdrugs.
•Theregulatoryaffairsprofessionalistheonlyonewhoiscompletely
responsibleforholdingproductsincomplianceandmaintainingalltherecords.
•Evenasmallmistakeinanyoftheactivitiesrelatedtoregulatorycanmakethe
producttoberecallinadditiontolossofseveralmillionsofthemoney.

3. Introduction….
•Drugdevelopmenttocommercializationishighlyregulated.
•Everydrugbeforegettingmarketapprovalmustundergorigorousscrutiny
andclinicaltrialstoensureitssafety,efficacyandquality.
•Thesestandardsaresetbyregulatoryauthoritiesoftheirrespectivecountries
etc.
•Regulationaffectsallaspectsofthepharmaceuticalworld,fromindependent
innovatorsandpharmaceuticalcompaniestoregulatoryandadministrative
bodiesandpatientsalso.
•Regulatorydepartmentiscruciallinkbetweencompany,productsand
regulatoryauthoritieswhosepositiveornegativestandpointfosterthe
insightoftheregulatoryauthorityintotheindustry,forgoodorforbad.
•So,thebetterthescientificprecision,thegreaterwillbethechancesfora
producttocometothemarketwithintheexpectedtime.

4. Regulation and regulatory Affairs
•Regulationinvolvesextensiveevaluationofaparticulardrug
producttoensureprotectionofpublichealth,promotionofthe
product,Drugregistration,marketingauthorization,importand
distribution,pharmacovigilance.

5. 2. Historical overview of Regulatory
•Somenotablecasesinthehistoryresponsibleforrequirement
strictregulationformedicinewererequired
•1901-Diphtheriadisaster
•1937-Elixir-Sulphanilamide
•1955-CutterIncident
•1960-Thalidomidetragedy

6. What was the first modern medical disaster in St Louis
1901?
•In1901,13childreninSt.Louis,Missouri,diedfromdiphtheria
antitoxinthathadbeencontaminatedwithtetanusspores.
•ThistragedyledCongressin1902topassaBiologicsControlAct
thatrequiredcommercialmanufacturerstodemonstratethe
purity(andlaterpotency)oftheirproducts.

7. SulphanilamideElixir Tragedy
•In1937,S.E.MassengillCompany,apharmaceuticalmanufacturer,created
apreparationofsulfanilamideusingdiethyleneglycol(DEG)asasolvent,
andcalledthepreparation"ElixirSulfanilamide".
•WatkinswasunawarethatDEGwastoxictohumans,eventhoughthere
wereextantknowncasesoftoxicityandthatstudieswerepublished
severalyearspriorwhichconcludedthatDEGwasahighlynephrotoxic
agentandshouldbeavoidedinhumans.

8. Cutter Incident
•In1955,somebatchesofpoliovaccinegiventothepubliccontainedlive
poliovirus,eventhoughtheyhadpassedrequiredsafetytesting.
•InApril1955morethan200000childreninfiveWesternandmid-Western
USAstatesreceivedapoliovaccinesproducedbyonecompany:Cutter
Laboratories.
•Subsequentinvestigationsrevealedthatthevaccine,manufacturedbythe
California-basedfamilyfirmofCutterLaboratories,hadcaused40000
casesofpolio,leaving200childrenwithvaryingdegreesofparalysisand
killing10.

9. Thalidomide tragedy
•Thalidomidewasfirstmarketedtohealthprofessionalsasasedative.
•However,itsuserapidlyincreasedamongstpregnantwomenduetothe
drug'sabilitytoalleviatemorningsickness.(1950-1960)
•Soonafteritsriseinpopularity,medicalprofessionalsbegantonotea
seriesofcongenitalmutationsinchildrenbornfrommotherswhoused
thedrugduringpregnancy,resultinginthethalidomidetragedyknown
today

10. 3. Following acts and rules were passed
•DrugsandCosmeticsAct,1940:
•Thisactregulatesthemanufacturing,distribution,importandsaleof
allopathic,homeopathic,unaniandsidhadrugs.
•DrugsandCosmeticsRules,1945:
•ThisactregulatesmanufactureofAyurvedicdrugsforsaleonly,andnotfor
consumptionanduseorpossession
•PharmacyAct,1948:Controlsandregulatestheprofessionofpharmacyin
India
•DrugsandMagicRemedies(ObjectionableAdvertisements)Rule,1955:
•ThisruleregulatestheadvertisementofdrugsinIndia.
•DrugsPricesControlOrder,1955(DPCO)(undertheessentialcommodities
Act)

11. •IndianPatentAct1970(whichcameinforceon20April1972andreplacedIndian
PatentsandDesignsActof1911):
•ItservesasthebasisforpatentprotectioninIndia
•Drugpricescapped:DrugPricesControlOrder(DPCO)wasintroducedtocontrolthe
highpriceagainstconsumers
•1980-1990:
•TheIndianindustryhasstartedinvestinginprocessdevelopmentofAPIandcreated
productioninfrastructureforthesame
•1990-2000:
•Arapidexpansionindomesticmarkethasobservedinpharmaceuticalindustry.The
companieshavestartedenteringintoResearchandDevelopment.
•2000-2010:
•ThisperiodisconsideredtobetheInnovationandResearchera.Duringtheseyears,
innovativeresearchactivity,patentingofthedrugsformula,process,indicationaswell
asmergerofcompanieswasstarted.

12. •PatentAmendmentAct2005:
•IndianGovernmentbroughtoutthePatents(Amendment)Ordinance,2004
toaddresstheissuesrelatingtothepatentinthecountrywhichwaslater
replacedbytheIndianPatent(Amendment)Act,2005.
•ThenewActbroughtsomecrucialchangesonthelegalregimeofpatent
protectionsoastoaddresspatentissuesintechnology,chemicalsand
pharmaceuticalssectors
•CompulsoryLicenses:
•Suchlicensescanbegrantedformanufactureandexportofthedrug
products“toanycountryhavinginsufficientornomanufacturingcapacity
forthesaidproducts,toaddresspublichealthproblems”.

13. 4. Role and Responsibility of Regulatory Affairs
Department
•Theregulatorybodiesplayavitalroleinbetweenthecompaniesandthe
governmentagencies.
•Regulatoryaffairsdepartmentplaysavitalroletoensurethesafetyand
efficacyofthedrugsavailabletothepublicinthemarket.
•RADepartmentatitsheartisallaboutCollecting,Analyzingand
CommunicatingtheRisksandBenefitsofhealthcareproductstoregulatory
agenciesandpublicallovertheworld.

14. •Theirrolebeginsrightfromdevelopmentofaproducttomaking,
marketingandpostmarketing.
•Theyadviceatallstagesbothintermsoflegalandtechnicalrequirements
andrestrainshelpcompaniessavealotoftimeandmoneyindeveloping
theproductandmarketingthesame.
•Theregulatoryaffairsdepartmentalsohandlesthedrugpricing,
prescribing,andalsothespecialcontrolifany(narcotics).

15. 4.1 ROLE OF REGULATORY AFFAIRS DEPARTMENT….
•1.Ensuringthattheircompaniescomplywithallofthesystempolicyand
lawspertainingtotheirbusiness.
•2.Workingwithfederal,state,andlocalregulatoryagenciesandworking
withagenciesastheFoodandDrugAdministrationorEuropeanMedicines
Agency(pharmaceuticalsandmedicaldevices).
•3.Advisingtheircompaniesontheregulatoryaspectsandclimatethat
wouldaffectproposedactions.i.e..describingthe"regulatoryclimate"in
theregionofissuessuchastheendorsementofprescriptiondrugs.

16. 5. Responsibility of Regulatory Affairs Professionals
•Primeresponsibilitiesinvolvespreparationandpresentationofregistration
documentstoregulatoryagencies
•Toobtainandmaintainmarketingauthorization(MA)fortheproductsconcerned.
•Tokeepintouchwithinternationallegislation,guidelinesandcustomerpractices.
•Topromotepublichealthandprotectthepublicfromharmfulanddubiousdrugs.
•TheirmainroleistocomplywithSafety&Efficacyoftheproductsasperregulation
laiddownbythegovernment.
•Keepuptothedatewithacompany’sproductrangeandcoordinate,prepareand
reviewallappropriatedocuments
•Monitortheprogressofallregistrationsubmission.
•Maintainapprovedapplicationsandtherecordofregistrationfeespaidagainst
submissionofDMF’sandotherdocuments.
•Managereviewauditreportsandcompliance,regulatoryandcustomerinspections.

17. 6. Regulatory Authorities
•Regulatoryauthorityandorganizationsareresponsibleforeffectivedrug
regulationrequiredtoensurethesafety,efficacyandqualityofdrugs,as
wellastheaccuracyandappropriatenessofthedruginformationavailable
tothepublic.
•TherulesandregulationsarebeingframedconsideringGlobal,Regional
andNationalpharmaceuticaltradeaswellasnecessityofthedrugsbased
onpopulationofpatient.
•Mostofthenationalguidelinesregardingthedevelopmentandmarket
authorizationapplicationofdrugsarebasedonGlobalandRegional
Harmonizedguidelines.

18. •GlobalNetworkregulatoryiscomposedoftherepresentativesofeach
countryintheworld
•(a)HealthAuthority(HA):
•TheHealthAuthoritytopreparedrugregulatorygidelinesandguidance
documentswhicharecompliantandconformitytoexistinglawsand
regulationsandalsocoordinatewithGlobalandorregionalregulatorybody
andinconsultationwithPharmaceuticalManufacturer'sAssociationissues
technicalrequirementsandprocessforMarketingAuthorizationApproval
•(b)PharmaceuticalIndustry:
•Manufacturerdevelopsdrugsaccordingtoregulatorynecessityofquality,
safetyandefficacyandappliesforMarketingAuthorization

19. CDSCO
MISSION
To safeguard and enhance
the public health
by assuring
the safety, efficacy and quality
of
drugs, cosmetics and medical devices
Central Drugs Laboratory (CDL) Kolkata