A brief introduction to Drug Regulatory Affairs and Its Regulatory Authority.

1. PRESENTATION
ON
DRUG
REGULATORY
AFFAIRS
By :– Siddharth Kumar Sahu
M.Pharmacy

2. CONTENTS –
 Introduction to Drug Regulatory Affairs.
 Why & What Issue DRA Provide Assistant.?
 Role of Regulatory Affairs Expert.
 Regulatory Bodies.
 Implementing Authorities.
 Central Drug Standard Control Organization.
 Drug and Cosmetic Act. and other acts.
2

3. DRUG REGULATORY AFFAIRS –
 It is the new profession which developed from the
desire of the government to protect public health by
controlling the safety and efficacy of the product in
the area including:-
 Pharmaceuticals, Veterinary Medicines,
 Medical Devices, Pesticides,
 Agrochemical, Cosmetics,
 Complementary Medicines.
3

4. DRUG REGULATORY AFFAIRS –
 It is a dynamic and challenging field in the pharmaceutical
industry. It is an affair between the competent and an applicant
(company) to manage life cycle of the products.
 In present regulatory scenario, company requires expert in
regulatory activities to manage the product life cycle.
 RA experts are qualified professional to provide the right solution
to the technical problems under the light of laws and regulations.
4

5. DRUG REGULATORY AFFAIRS
5
Judge
(The Competent Authority)
Applicant
(The Company)
Advocate (RA Expert)

6. DRUG REGULATORY AFFAIRS
Judge (The Competent Authority)
Communication Gap
Applicant (The Company) 6

7. WHY DRUG REGULATORY AFFAIRS??
 Drug development and in order to develop the most
efficient and safe pharmaceutical products.
 The path of drug registration is laid down with good
intended but can be complicated.
 Somebody who gather all relevant information in
one umbrella to bring product in the market for sell.
 Helps to reduce number of development failures.
7

8. ON WHAT ISSUE DRA DEPARTMENT
PROVIDE ASSISTANCE???
8
 Licensing
 Registration
 Development
 Manufacturing
 Quality guidance
 Pricing
 Marketing
…..& many more
 GMP
 GLP
 GCP
 Patent
 Copyright
 Trademark
 Pharma-covigilance

9. WHAT ARE THE DOCUMENTS PREPARED AND/
MAINTAINED BY DRA DEPARTMENTS??
 Licence And Certificates Obtained By Drug Regulatory
Authorities. e.g. Mfg. Licence, GMP, ISO Etc.
 Common Technical Documents (CTD/eCTD)
 Drug Master File,
 Clinical Trials Reports, BA/BE Report.
 Quality Audits And Reports.
 Application for obtaining patent, copyrights and
trademark registration.
......& Many More 9

10. ROLES OF REGULATORY AFFAIRS EXPERTS
 Regulatory affairs plays a crucial role in the
pharmaceutical industry and is involved in all stages
of drug development and also after drug approval
and marketing.
 Pharmaceutical companies use all the data
accumulated during discovery and development
stages in order to register the drug and market the
drug.
 Throughout the development stages, the
pharmaceutical company have to abide by an array of
strict rules and guidelines in order to ensure the
safety and efficacy of the drug in humans.
10

11. ROLES OF R.A. EXPERT(CONT.)
 It plays a critical role as the leading department to
provide strategic advice on extremely difficult decision
through the life of a drug.
 To keep working order to meet regulatory commitments
within the health authorities.
 The Regulatory expert also ensures the maintenance
of the marketing license and leads life cycle such as
broadening and indication of the drug, change of
formulation, changes in dosage etc.
11

12. REGULATORY BODIES –
 India – CDSCO (Central Drug Standard Control Organization)
 US – USFDA (United State Food And Drug Administration)
http://www.fda.gov/
 Europe – EMA (European Medicine Agency)
http://www.ema.europa.eu
 Australia – TGA(Therapeutic Goods Administration)
http://www.tga.gov.au/
 United kingdom – MHRA (Medicine And Healthcare Regulatory
Agency)
http://www.mhra.gov.uk 12

13. REGULATORY BODIES –
 Ireland – IMB (Irish Medicine Board)
http://www.imb.ie/
 ICH – International Conference On Harmonization
http://www.ich.org/
 Japan – MHLW-PMDA (Medicines And Pharmaceutical
Device Agency)
http://www.pmda.go.jp
13

14. IMPLEMENTING AUTHORITIES
 Central Government:
 Central Drugs Standard Control
Organization(CDSCO)
 State Governments:
 State Drug Licensing Authorities
14

15. 15
(CENTRAL DRUG STANDARD
CONTROL ORGANIZATION)
(CDSCO)

16. CENTRAL DRUG STANDARD CONTROL
ORGANIZATION
16
VISION
TO PROTECT AND
PROMOTE PUBLIC
HEALTH IN INDIA
MISSION
TO SAFEGUARD AND
ENHENCE THE
PUBLIC HEALTH BY
ASSURING THE
SAFETY EFFICASY
AND QUALITY..

17. Indian Drug Regulatory System:
Government of India
Ministry of Health
& Family Welfare
DGHS
Central Drugs
Standard Control
Organization
(CDSCO)
Ministry of Science
& Technology
Indian Council
of Medical
Research
(ICMR)
Council of
Scientific &
Industrial
Research
(CSIR)
BARC
(Radioactive)
Ministry of
Chemicals &
Petrochemicals
National
Pharmaceutical
Pricing Authority
(NPPA)
Department of
Chemical &
Petrochemicals
(DCP)
Department of
Pharmaceuticals
Ministry of
Commerce &
Industry
Patent
Office
Dept. of
Commerce &
Pharmexil
Controller
General of
Patent
DGFT
Ministry of
Environment &
Forest
GEAC-
[Genetic
Engineering
Approval
Committee]
Department of
Biotechnology
r-DNA
Advisory
Committee
Review
Committee
Genetic
Manipulation
17

18. 18
Drug
controller
general (1)
Head Quarter
New drugs
Clinical trials
Imports
Biological
Medical
Devices
Export
QC
Pharmco.Vig
Legal etc
Zonal
Office(6)
GMPAudits
Enforcement
Draw drug
Samples
Sub-zonal (4)
GMPAudits
Coordination
with States
Port
Office(13)
Import
Export
Laboratory(7)
Testing of Drugs
Validation of
Test protocols
Central Drug Standard Control Organization

19. CDSCO OFFICES
 Zonal Offices:
 Ghaziabad, Mumbai, Chennai, Kolkata, Ahmedabad and
Hyderabad
 Sub Zonal Offices:
 Chandigarh, Bangalore, Goa and Jammu
 Port Offices: (13)
 Central Drugs Laboratories – 7
 Kolkata, Mumbai, Chennai, Hyderabad, Chandigarh,
Guwahati and Kasauli
 Other Labs: NIB, IVRI
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20. FUNCTIONS OF CDSCO
20
1 • Approval of New Drugs and Clinical Trials
2
• Import Registration and Licensing
3
• Licensing of Blood Banks, Vaccines, r-DNA products &
Notified Medical Devices
4
• Amendment to D &C Act and Rules
5
• Banning of drugs and cosmetics
6
• Grant of Test License,
• Personal License, NOCs for Export
7
• Testing of Drugs

21. FUNCTIONS OF STATE LICENSING AUTHORITIES
 Licensing of Manufacturing Site.
 Licensing of Establishment for sale or distribution of
Drugs.
 Approval of Drug Testing Laboratories.
 Monitoring of Quality of Drugs, Medical Devices
and Cosmetics marketed. 21

22. DRUG AND COSMETICS
ACT & RULE
1940 & 1945

23. DRUG AND COSMETICS ACT & RULE
Objective:
To Ensure Safety, Efficacy And Quality Of –
 Drugs
 Biological products
 Medical Devices
 Cosmetics
 Veterinary Drugs. 23

24. WHAT IS REGULATED UNDER THE ACT & RULE
24
Regulated Under The Act:-
 Manufacture
 Import
 Distribution
 Sale
 Regulated Under Rules
 New Drugs
 Exports
 Clinical Trials

25. ADMINISTRATION OF ACT
Advisory
* Drugs Technical Advisory Board
* Drugs Consultative Committee
Executive
*Licensing Authority
*Controlling Authority
*Drugs Inspector
Analytical
*Central Drugs Laboratories
*Drugs Control Laboratories in States
*Government Analyst
25

26. INTRODUCTION TO D & C ACT, 1940
• Part I:-
• Contains:
5 Chapters
38 Sections
2 Schedules
• Part II:-
• Contains:
19 Parts
169 Rules
Schedules A to Y
26

27. STANDARD OF THE DRUG AND COSMETICS
Schedule To The Act:-
 First Schedule:- Name Of Book Under Ayurvedic,
Unani and Siddha.
 Second Schedule:- Improved Drugs And By Drugs
Manufactured, Stocked For Sale.
Schedule To The Rules:- (Some Important)
27
schedule Rule for
C Biological And Other Special
Product By Special Provision
C1 List Of Other Special Product
F Operation Of The Blood Bank And
Component, Vaccines

28. 28
Schedules Rule for
H List Of Prescription Drug
M GMP Requirements
O Standard For Disinfectant Fluid
P Life Period Of Drug
R Standard For Mechanical
Contraceptives
T Requirements Of Factory Premises
And Hygienic Condition
Y Guidelines For Clinical Trials
W Marketed Under Generic Names

29. OTHER ACTS AND ORDERS
Drugs Price Control Order (DPCO):
 To ensure drugs are sold at the prescribed prices,
offenders are being monitored.
 Shortage and non-availability of drugs brought to
the notice of manufacturers.
Drugs and Magic Remedies Act:
 To monitor false/misleading advertisements.
Narcotic and Psychotropic Substances Act:
 To prevent Pharmaceutical abuse.
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30. THANKS FOR YOUR ATTENTION