Regulatory agency

REGULATORY AGENCIES

05/01/2305/01/23 Sagar SavaleSagar Savale 11

ContentsContents

IntroductionIntroduction United State Food And Drug United State Food And Drug

Administration Administration (USFDA)(USFDA) Medicines And HealthCare Products Medicines And HealthCare Products

Regulatory Agency Regulatory Agency (MHRA)(MHRA) Central Drug Standard Control Central Drug Standard Control

Organization Organization (CDSCO)(CDSCO) ReferencesReferences


INTRODUCTIONINTRODUCTION

WHAT IS REGULATION?WHAT IS REGULATION?

WHY REGULATION?WHY REGULATION?

WHAT IS REGULATORY AGENCY?WHAT IS REGULATORY AGENCY?05/01/2305/01/23 Sagar SavaleSagar Savale 33

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


History:-:- Firstly it was a division of Chemistry, Firstly it was a division of Chemistry,

then named as then named as The Bureau Of The Bureau Of Chemistry. Chemistry.

In Jully1930,the name was shortened In Jully1930,the name was shortened to to Food And Drug Administration.Food And Drug Administration.

Up to 1940,FDA was under Up to 1940,FDA was under Department Of Agriculture.Department Of Agriculture.

In 1968,it become part of In 1968,it become part of PublicPublic Health ServiceHealth Service within Health within Health Education And Welfare (HEW)Education And Welfare (HEW)..


FDA’s Mission:-:- According to FDA Modernisation According to FDA Modernisation

Act,1997-Act,1997-

To promot Public Health.To promot Public Health.

To communicate with To communicate with representatives of other countries.representatives of other countries.


FDA’s Organisational Units Are-FDA’s Organisational Units Are-

Center For Food Safety And Applied Center For Food Safety And Applied Nutrition Nutrition (CFSAN)(CFSAN)

Center For Drug Evaluation And Center For Drug Evaluation And Research Research (CDER)(CDER)

Center For Veterinary Medicine Center For Veterinary Medicine (CVM)(CVM) Center For Biologics Center For Biologics (CBER)(CBER) Center For Devices And Radiological Center For Devices And Radiological

Health Health (CDRH) (CDRH) 05/01/2305/01/23 Sagar SavaleSagar Savale 77

Food safetyFood safety Approval and safety Approval and safety

of food additivesof food additives Cosmetic safety Cosmetic safety Labeling-food, Labeling-food,

cosmetics and cosmetics and dietary supplementsdietary supplements

Center For Food Center For Food Safety And AppliedSafety And Applied NutritionNutrition (CFSAN(CFSAN))


Restaurants and grocery storesRestaurants and grocery stores Meat,poultry,eggs Meat,poultry,eggs (USDA)(USDA) Advertising for dietary supplements, Advertising for dietary supplements,

food,cosmetics food,cosmetics (FTC)(FTC) Alcohol Alcohol (Alcohol and Tobacco Tax and (Alcohol and Tobacco Tax and

Trade Bureau) Trade Bureau) Water Water (Environmental Protection (Environmental Protection

Agencies)Agencies) 05/01/2305/01/23 Sagar SavaleSagar Savale 99

Center For Drug Center For Drug Evaluation And Evaluation And Research Research (CDER)(CDER)

Rx,Generic,OTC DrugsRx,Generic,OTC Drugs -NDAs and ANDAs-NDAs and ANDAs Good Manufacturing Good Manufacturing

PracticePractice Adverce event Adverce event

reportingreporting Rx Drugs advertising.Rx Drugs advertising. LabelingLabeling


Drug Abuse Drug Abuse (Drug Enforcement (Drug Enforcement Administration)Administration)

OTC Drugs advertising OTC Drugs advertising (Federal Trade (Federal Trade Commision)Commision)

Methadone treatmentMethadone treatment05/01/2305/01/23 Sagar SavaleSagar Savale 1111

Center For Veterinary Medicines Center For Veterinary Medicines (CVM)(CVM)

Pet Food StandardsPet Food Standards Safe And Effective Safe And Effective

Animal DrugsAnimal Drugs

WHAT CVM WHAT CVM NOTNOT REGULATE:-REGULATE:-

Animal VaccinesAnimal Vaccines (USDA)(USDA) Meat ProductsMeat Products (USDA)(USDA)05/01/2305/01/23 Sagar SavaleSagar Savale 1212

Center For Biologics Center For Biologics (CBER)(CBER) Blood SupplyBlood Supply Vaccines for human useVaccines for human use Allergenic material and Allergenic material and

AntitoxinsAntitoxins

WHAT CBER DOES WHAT CBER DOES NOTNOT REGULATE REGULATE

Organs Organs (HRSA)(HRSA) DrgsDrgs


Electronic Electronic Radiation Radiation Emitting Emitting Products Products (Medical And (Medical And Non-medical)Non-medical)

Non-medical Non-medical products such as products such as TVs,Microwaves, TVs,Microwaves, ovens,Tannins ovens,Tannins beds, Laser beds, Laser products,X-ray products,X-ray productsproducts


Plastic glovesPlastic gloves

Toaster ovensToaster ovens

Nuclear materials in hospitalsNuclear materials in hospitals


Summary:-Summary:- To avoid confusion consumer should always To 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 consumer radiation emitting remaining consumer device productsdevice products Drugs:-Drugs:- advertising of OTC advertising of OTC drugsdrugs

In this way FDA protects all consumers In this way FDA protects all consumers in US with broad umbrella of safeguard.in US with broad umbrella of safeguard.


Medicines And Healthcare Products Medicines And Healthcare Products Regulatory Agency Regulatory Agency (MHRA)(MHRA)

MHRA was setup in 1,April 2003 from MHRA 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 the The MHRA is executive agency of the Department Of Health, United Kingdom.Department Of Health, United Kingdom.

MHRA is Government agency that is MHRA is Government agency that is responsible for ensuring that medicines responsible for ensuring that medicines and medical devices are safe and and medical devices are safe and effective. effective. 05/01/2305/01/23 Sagar SavaleSagar Savale 1717

Mission And Values:-Mission And Values:-

Mission:-Mission:- To enhance and safeguard health To enhance and safeguard health

of public.of public.

Values:-Values:- IntegrityIntegrity ResponsivenessResponsiveness ProfessionalismProfessionalism ImpartialityImpartiality ConsistencyConsistency 05/01/2305/01/23 Sagar SavaleSagar Savale 1818

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 bodies Communicate with other Government bodies

and regulatory agencies world wideand regulatory agencies world wide 05/01/2305/01/23 Sagar SavaleSagar Savale 1919

Co-relation:-Co-relation:- MHRA have to maintain contact with,MHRA have to maintain contact with,

National Patient Safety Agency National Patient Safety Agency (NPSA)(NPSA)

Health Protection Agency Health Protection Agency (HPA)(HPA)

National Institute For Clinical ExcellenceNational Institute For Clinical Excellence

Health development Agency Health development Agency (HAD)(HAD)

European Medicine Agency European Medicine Agency (EMA) (EMA) 05/01/2305/01/23 Sagar SavaleSagar Savale 2020

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 to i.e. from medicines or medical devices to blood and therapeutic products which are blood and therapeutic products which are derived from tissue engineeringderived from tissue engineering

Quality, safety and effectiveness of Quality, safety and effectiveness of medicines and medical devicesmedicines and medical devices


HOW MHRA REGULATE?HOW MHRA REGULATE?

Medicines approved by MHRA get Medicines approved by MHRA get ‘Marketing Authorization’ or License‘Marketing Authorization’ or License

Manufacturers and distributors are also Manufacturers and distributors are also Licensed directly by MHRA Licensed directly by MHRA

Medical devices approved by private Medical devices approved by private sector organization called ‘Notified sector organization called ‘Notified Bodies’Bodies’


Summary:-Summary:-

The MHRA is a responsible The MHRA is a responsible Executive Agency of Department Of Executive Agency of Department Of Health, U.K. which works impartially Health, U.K. which works impartially to enhance and safeguard health of to enhance and safeguard health of public by ensuring that medicines public by ensuring that medicines and medical devices are safe and and medical devices are safe and effective.effective.


Central Drug Standard Control Central Drug Standard Control Organization Organization (CDSCO)(CDSCO)

It is under control of It is under control of Ministry Of Health And Ministry Of Health And FamilyFamily Welfare,Welfare, Government of India Government of India (MOHFW)(MOHFW)

It provides general information about It provides general information about regulatory requirements of drugs, cosmetics, regulatory requirements of drugs, cosmetics, and devices in Indiaand devices in India

It functions under It functions under The Directorate General of The Directorate General of Health ServicesHealth Services

It is Located in Nirman Bhawan, New DelhiIt is Located in Nirman Bhawan, New Delhi05/01/2305/01/23 Sagar SavaleSagar Savale 2424

State Drug Standard Control State 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 with Co-ordination with SDSCOSDSCO

SDSCOSDSCO

Regulation of Regulation 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 new To regulate market authorization of new drug drug

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 Pharmacopoeia 05/01/2305/01/23 Sagar SavaleSagar Savale 2626

Offices:-Offices:-

Central Government have Central Government have established four zonal offices of established four zonal offices of CDSCOCDSCO

East zone - East zone - Kolkata Kolkata West zoneWest zone – Mumbai – Mumbai North zoneNorth zone – Ghaziabad – Ghaziabad South zoneSouth zone – Chennai – Chennai . . 05/01/2305/01/23 Sagar SavaleSagar Savale 2727

Summary:-Summary:-

The Central Drug Standard Control The Central Drug Standard Control Organization works under The Organization works under The Ministry of Health and Family Welfare Ministry of Health and Family Welfare to enforce The Drug and Cosmetics to enforce The Drug and Cosmetics Act 1940, with main object to Act 1940, with main object to regulate import, manufacture, sale of regulate 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;Nirali Itkar,s.c.;Forensic Pharmacy;Nirali Prakashan;Fifth edition;17.1-18.5 2.Prakashan;Fifth edition;17.1-18.5 2.www.fda.gov

3.http://3.http://mohfw.nic.in 4.4.www.open.gov.uk 5.http://cdsco.nic.in5.http://cdsco.nic.in 6.http://pci.nic.in6.http://pci.nic.in


http://www.fda.gov/

http://www.mohfw.nic.in/

http://www.open.gov.uk/

THANK YOUTHANK YOU


Regulatory agency

Health & Medicine

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