REGULATORY AGENCIES GUIDE

REGULATORY AGENCIES
07/09/1607/09/16 Sagar SavaleSagar Savale 11

ContentsContents
 IntroductionIntroduction
 United State Food And DrugUnited State Food And Drug
AdministrationAdministration (USFDA)(USFDA)
 Medicines And HealthCare ProductsMedicines And HealthCare Products
Regulatory AgencyRegulatory Agency (MHRA)(MHRA)
 Central Drug Standard ControlCentral Drug Standard Control
OrganizationOrganization (CDSCO)(CDSCO)
 ReferencesReferences

INTRODUCTIONINTRODUCTION
 WHAT IS REGULATION?WHAT IS REGULATION?
 WHY REGULATION?WHY REGULATION?
 WHAT IS REGULATORY AGENCY?WHAT IS REGULATORY AGENCY?

United State Food And DrugUnited State Food And Drug
AdministrationAdministration (USFDA)(USFDA)

History:-:-
 Firstly it was a division of Chemistry,Firstly it was a division of Chemistry,
then named asthen named as The Bureau OfThe Bureau Of
Chemistry.Chemistry.
 In Jully1930,the name wasIn Jully1930,the name was
shortened toshortened to Food And DrugFood And Drug
Administration.Administration.
 Up to 1940,FDA was underUp to 1940,FDA was under
Department Of Agriculture.Department Of Agriculture.
 In 1968,it become part ofIn 1968,it become part of PublicPublic
Health ServiceHealth Service within Healthwithin Health
Education And Welfare (HEW)Education And Welfare (HEW)..07/09/1607/09/16 Sagar SavaleSagar Savale 55

FDA’s Mission:-:-
According to FDA ModernisationAccording to FDA Modernisation
Act,1997-Act,1997-
 To promot Public Health.To promot Public Health.
 To communicate with representativesTo communicate with representatives
of other countries.of other countries.

FDA’s Organisational Units Are-FDA’s Organisational Units Are-
 Center For Food Safety And AppliedCenter For Food Safety And Applied
NutritionNutrition (CFSAN)(CFSAN)
 Center For Drug Evaluation AndCenter For Drug Evaluation And
ResearchResearch (CDER)(CDER)
 Center For Veterinary MedicineCenter For Veterinary Medicine (CVM)(CVM)
 Center For BiologicsCenter For Biologics (CBER)(CBER)
 Center For Devices And RadiologicalCenter For Devices And Radiological
HealthHealth (CDRH)(CDRH)

 Food safetyFood safety
 Approval and safetyApproval and safety
of food additivesof food additives
 Cosmetic safetyCosmetic safety
 Labeling-food,Labeling-food,
cosmetics andcosmetics and
dietary supplementsdietary supplements
Center For FoodCenter For Food
Safety And AppliedSafety And Applied
NutritionNutrition (CFSAN(CFSAN))

 Restaurants and grocery storesRestaurants and grocery stores
 Meat,poultry,eggsMeat,poultry,eggs (USDA)(USDA)
 Advertising for dietary supplements,Advertising for dietary supplements,
food,cosmeticsfood,cosmetics (FTC)(FTC)
 AlcoholAlcohol (Alcohol and Tobacco Tax and(Alcohol and Tobacco Tax and
Trade Bureau)Trade Bureau)
 WaterWater (Environmental Protection(Environmental Protection
Agencies)Agencies)

Center For DrugCenter For Drug
Evaluation AndEvaluation And
ResearchResearch (CDER)(CDER)
 Rx,Generic,OTC DrugsRx,Generic,OTC Drugs
-NDAs and ANDAs-NDAs and ANDAs
 Good ManufacturingGood Manufacturing
PracticePractice
 Adverce eventAdverce event
reportingreporting
 Rx Drugs advertising.Rx Drugs advertising.
 LabelingLabeling

 Drug AbuseDrug Abuse (Drug Enforcement(Drug Enforcement
Administration)Administration)
 OTC Drugs advertisingOTC Drugs advertising (Federal Trade(Federal Trade
Commision)Commision)
 Methadone treatmentMethadone treatment

Center For Veterinary MedicinesCenter For Veterinary Medicines
(CVM)(CVM)
 Pet Food StandardsPet Food Standards
 Safe And EffectiveSafe And Effective
Animal DrugsAnimal Drugs
WHAT CVMWHAT CVM NOTNOT
REGULATE:-REGULATE:-
 Animal VaccinesAnimal Vaccines
(USDA)(USDA)
 Meat ProductsMeat Products
(USDA)(USDA)07/09/1607/09/16 Sagar SavaleSagar Savale 1212

Center For BiologicsCenter For Biologics (CBER)(CBER)
 Blood SupplyBlood Supply
 Vaccines for human useVaccines for human use
 Allergenic material andAllergenic material and
AntitoxinsAntitoxins
WHAT CBER DOESWHAT CBER DOES
NOTNOT REGULATEREGULATE
 OrgansOrgans (HRSA)(HRSA)
 DrgsDrgs

 ElectronicElectronic
RadiationRadiation
EmittingEmitting
ProductsProducts
(Medical And(Medical And
Non-medical)Non-medical)
 Non-medicalNon-medical
products such asproducts such as
TVs,Microwaves,TVs,Microwaves,
ovens,Tanninsovens,Tannins
beds, Laserbeds, Laser
products,X-rayproducts,X-ray
productsproducts07/09/1607/09/16 Sagar SavaleSagar Savale 1414

 Plastic glovesPlastic gloves
 Toaster ovensToaster ovens
 Nuclear materials in hospitalsNuclear materials in hospitals

Summary:-Summary:-
To avoid confusion consumer should alwaysTo avoid confusion consumer should always
remember, what USFDAremember, what USFDA
CONTROLS NOT CONTROLSCONTROLS NOT CONTROLS
 Food:-Food:-
Bottled water meat, poultryBottled water meat, poultry
 Consumer product:-Consumer product:-
radiation emitting remaining consumerradiation emitting remaining consumer
device productsdevice products
 Drugs:-Drugs:-
advertising of OTCadvertising of OTC
drugsdrugs
In this way FDA protects all consumersIn this way FDA protects all consumers
in US with broad umbrella of safeguard.in US with broad umbrella of safeguard.07/09/1607/09/16 Sagar SavaleSagar Savale 1616

Medicines And Healthcare ProductsMedicines And Healthcare Products
Regulatory AgencyRegulatory Agency (MHRA)(MHRA)
 MHRA was setup in 1,April 2003 fromMHRA was setup in 1,April 2003 from
merger of Medicines Control Agency(MCA)merger of Medicines Control Agency(MCA)
and Medical Devices Agency(MDA).and Medical Devices Agency(MDA).
 The MHRA is executive agency of theThe MHRA is executive agency of the
Department Of Health, United Kingdom.Department Of Health, United Kingdom.
 MHRA is Government agency that isMHRA is Government agency that is
responsible for ensuring that medicinesresponsible for ensuring that medicines
and medical devices are safe andand medical devices are safe and
effective.effective.07/09/1607/09/16 Sagar SavaleSagar Savale 1717

Mission And Values:-Mission And Values:-
Mission:-Mission:-
To enhance and safeguard healthTo enhance and safeguard health
of public.of public.
Values:-Values:-
 IntegrityIntegrity
 ResponsivenessResponsiveness
 ProfessionalismProfessionalism
 ImpartialityImpartiality
 ConsistencyConsistency

Aims And Objectives:-Aims And Objectives:-
Aims:-Aims:-
 Protect public healthProtect public health
 Promoting public healthPromoting public health
 Improving public healthImproving public health
Objectives:-Objectives:-
 Minimize the cost of regulationMinimize the cost of regulation
 Support innovation and product developmentSupport innovation and product development
 Communicate with other Government bodiesCommunicate with other Government bodies
and regulatory agencies world wideand regulatory agencies world wide

Co-relation:-Co-relation:-
MHRA have to maintain contact with,MHRA have to maintain contact with,
 National Patient Safety AgencyNational Patient Safety Agency (NPSA)(NPSA)
 Health Protection AgencyHealth Protection Agency (HPA)(HPA)
 National Institute For Clinical ExcellenceNational Institute For Clinical Excellence
 Health development AgencyHealth development Agency (HAD)(HAD)
 European Medicine AgencyEuropean Medicine Agency (EMA)(EMA)

What MHRA regulate?What MHRA regulate?
 MHRA regulates wide range of materials,MHRA regulates wide range of materials,
i.e. from medicines or medical devices toi.e. from medicines or medical devices to
blood and therapeutic products which areblood and therapeutic products which are
derived from tissue engineeringderived from tissue engineering
 Quality, safety and effectiveness ofQuality, safety and effectiveness of
medicines and medical devicesmedicines and medical devices

HOW MHRA REGULATE?HOW MHRA REGULATE?
 Medicines approved by MHRA getMedicines approved by MHRA get
‘Marketing Authorization’ or License‘Marketing Authorization’ or License
 Manufacturers and distributors are alsoManufacturers and distributors are also
Licensed directly by MHRALicensed directly by MHRA
 Medical devices approved by privateMedical devices approved by private
sector organization called ‘Notifiedsector organization called ‘Notified
Bodies’Bodies’07/09/1607/09/16 Sagar SavaleSagar Savale 2222

Summary:-Summary:-
The MHRA is a responsibleThe MHRA is a responsible
Executive Agency of Department OfExecutive Agency of Department Of
Health, U.K. which works impartiallyHealth, U.K. which works impartially
to enhance and safeguard health ofto enhance and safeguard health of
public by ensuring that medicinespublic by ensuring that medicines
and medical devices are safe andand medical devices are safe and
effective.effective.

Central Drug Standard ControlCentral Drug Standard Control
OrganizationOrganization (CDSCO)(CDSCO)
 It is under control ofIt is under control of Ministry Of Health AndMinistry Of Health And
FamilyFamily Welfare,Welfare, Government of IndiaGovernment of India
(MOHFW)(MOHFW)
 It provides general information aboutIt provides general information about
regulatory requirements of drugs, cosmetics,regulatory requirements of drugs, cosmetics,
and devices in Indiaand devices in India
 It functions underIt functions under The Directorate General ofThe Directorate General of
Health ServicesHealth Services
 It is Located in Nirman Bhawan, New DelhiIt is Located in Nirman Bhawan, New Delhi07/09/1607/09/16 Sagar SavaleSagar Savale 2424

State Drug Standard ControlState Drug Standard Control
Organization (SDSCO)Organization (SDSCO)
Activity:-Activity:-
CDSCOCDSCO
 Approval of new drugApproval of new drug
 Control over clinical trialsControl over clinical trials
 Co-ordination withCo-ordination with
SDSCOSDSCO
SDSCOSDSCO

Regulation ofRegulation of
manufacturing, sale,manufacturing, sale,
distribution of drugsdistribution of drugs

Functions of CDSCO:-Functions of CDSCO:-
 Laying down standards of drugs,Laying down standards of drugs,
cosmetics, diagnostics and devicescosmetics, diagnostics and devices
 To regulate market authorization of newTo regulate market authorization of new
drugdrug
 To regulate standard of imported drugsTo regulate standard of imported drugs
 Testing of drugs by Central Drug LabsTesting of drugs by Central Drug Labs

Publication of Indian PharmacopoeiaPublication of Indian Pharmacopoeia07/09/1607/09/16 Sagar SavaleSagar Savale 2626

Offices:-Offices:-
Central Government haveCentral Government have
established four zonal offices ofestablished four zonal offices of
CDSCOCDSCO
East zone -East zone - KolkataKolkata
West zoneWest zone – Mumbai– Mumbai
North zoneNorth zone – Ghaziabad– Ghaziabad
South zoneSouth zone – Chennai– Chennai ..

Summary:-Summary:-
The Central Drug Standard ControlThe Central Drug Standard Control
Organization works under TheOrganization works under The
Ministry of Health and Family WelfareMinistry of Health and Family Welfare
to enforce The Drug and Cosmeticsto enforce The Drug and Cosmetics
Act 1940, with main object toAct 1940, with main object to
regulate import, manufacture, sale ofregulate import, manufacture, sale of
Drugs and Cosmetics.Drugs and Cosmetics.

References:-References:-
1.Kuchekar,B.S.;Khadatare,A.M.;1.Kuchekar,B.S.;Khadatare,A.M.;
Itkar,s.c.;Forensic Pharmacy;NiraliItkar,s.c.;Forensic Pharmacy;Nirali
Prakashan;Fifth edition;17.1-18.5 2.Prakashan;Fifth edition;17.1-18.5 2.
www.fda.govwww.fda.gov
3.http://3.http://mohfw.nic.inmohfw.nic.in
4.4.www.open.gov.ukwww.open.gov.uk
5.http://cdsco.nic.in5.http://cdsco.nic.in
6.http://pci.nic.in6.http://pci.nic.in07/09/1607/09/16 Sagar SavaleSagar Savale 2929

THANK YOUTHANK YOU

REGULATORY AGENCIES GUIDE

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