Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation.

1. Dr. Ashwani Dhingra
Associate Professor
GGSCOP, Yamunanagar

2. MEANING OF DRUG REGULATION
• Drug
“All medicines for internal or external use of human beings or animals and
all substances intended to be used for diagnosis, treatment, mitigation or
prevention of any disease or disorder in human beings or animals”
• Regulation
“To regulate means to control something so that it functions properly”
• Key functions of drug regulatory agency
o Product registration
o Regulation of drug manufacturing, importation, and distribution
o Regulation & Control of drug promotion and information
o Adverse drug reaction (ADR) monitoring
o Licensing of premises, persons and practices
o To guarantee the safety, efficacy and quality of drugs available to public

3. WHY REGULATE?
“All substances are poisons; there is none which is not a poison.
The right dose differentiates a poison and a remedy (medicine)”-
Anonymous
Need for Regulation:
• To ensure quality, safety and efficacy of drug products in order to assure the
continued protection of Public Health.
• No drug product is completely safe or efficacious in all circumstances, but there
is a moral, as well as legal, expectation that appropriate steps are taken to assure
optimal quality, safety and efficacy by the producers concerned.
“BENEFIT VERSUS RISK”

4. Role of Regulatory Affairs
What is this?
Registration
documents to
regulatory
agency.
To keep track
on every
change in
legislation.
To give strategic
& technical advice
to R&D,
Production & QC
Dept.

8. Major Regulatory Agencies of the world are:
INDIA: Central Drugs Standard Control Organization (CDSCO)
USA : Food and Drug Administration (FDA)
EUROPE: European Medicines Agency (EMA)
JAPAN: Pharmaceuticals and Medical Devices Agency (PMDA)
UK: Medicine and Healthcare Products Regulatory Agency (MHRA)
AUSTRALIA: Therapeutic Goods Administration (TGA)
CANADA: Health Canada
International Conference on Harmonization (ICH)
• A network of the authorities in EU, US, Japan and industry
organizations
• Provide guideline on Quality, Safety, Efficacy and CTD
• No authority – recommendations which will have to be regionally
implemented

9. Functions of Drug regulatory affairs
By whom? (the authority)
no (=does not belong to drug
regulatory affairs)
yes
Prior authorisation needed?
Based on which (objective and
subjective) criteria?
Subject to regular control
(quality, inspection)?
By whom? (the authority)
Based on which (objective and
subjective) criteria?

10. Product Life Cycle - Regulatory Affairs
Perspective
Development Phase
• Advice on development
• Scientific Advice
• Clinical Trial Applications
• Project management /
Strategy
• Product Information - Claims
Approval Phase
• Application Procedure
• Authority meetings/hearings
• Electronic submission
• Readability Testing / Labeling
Support
Post Approval Phase
• Life Cycle Management/
Compliance
• Post-approval Commitments
• Clinical Trial Applications
• New Indications

12. DRUGS REGULATORY SYSTEM IN
INDIA

13. DRUG REGULATION SYSTEM IN INDIA
• When a company wants to manufacture/import a new drug in India, it has to
apply to seek permission from the Drug Controller General of India (DCGI) by
filing, Form 44 along with the data mentioned in Schedule Y of Drugs and
Cosmetics Act 1940 and Rules 1945
DRUG APPROVAL IN INDIA
• Drug Regulatory Authority ensures that of medicinal products are of acceptable
Quality, Safety and Efficacy which are Approved, Manufactured and Imported
• Drug Controller General of India (DCGI) is the head of Central Drug Standard
Control Organization (CDSCO) which regulates Drugs & Device in India

14. Goa
New Delhi
Chennai
CDSCO North Zone (Ghaziabad)
Kolkata
.
CDSCO West Zone (Mumbai)
CDSCO South Zone (Chennai)
CDSCO East Zone (Kolkata)
CDSCO, HQ
• Hyderabad
Ahmedabad
*New Zonal Offices : 2
(Ahmedabad & Hyderabad)
*Sub- Zonal Office : 3
*Port Offices/Airports : 11
*Central Laboratories : 6
35 SLAs= 29 States+ 6 UTs
Bengaluru
Geographical Location of CDSCO
Chandigarh
J&K
HQ

15. Functions of CDSCO
Approval of new drugs and clinical trials
Import Registration and Licensing
License approving of Blood Banks, LVPs, Vaccines, r-DNA
Prdts. & Medical Devices (Central Licensing Approval Authority)
Amendment to D &C Act and Rules
Banning of drugs and cosmetics
Grant of Test License, Personal License, NOCs for
Export
Testing of New Drugs

16. Functions of State Licensing Authorities
Licensing of Manufacturing Site for Drugs including API and
Finished Formulation
Licensing of Establishment for sale or distribution of Drugs
Approval of Drug Testing Laboratories
Monitoring of Quality of Drugs and Cosmetics marketed in
the country
Investigation and prosecution in respect of contravention of
legal provision
Recall of sub-standard drugs

17. Functions of Drug Technical Advisory Board (DTAB)
 Is a group of technical experts and they advice the central and
state governments on all technical matters arising out of the
enforcement of drug control
 No rules can be made by the central government without
consulting DTAB

18. DRUG APPROVAL PROCESS

19. Drug Approval Process (Continued….)
 As per section 2.4(a), of Schedule Y of Drugs & Cosmetics Act, 1940 and
Rules 1945, drug substances that are discovered in India are required to
perform all phases of trials.
 As per section 2.4(b), of Schedule Y of Drugs & Cosmetics Act, 1940 and
Rules 1945, drug substances that are discovered in countries other than India,
the applicant is to produce data available from other countries and licensing
authority may require him to repeat the study or permit him to proceed to Phase
III clinical trials.
 As per section 2.8, of Schedule Y of Drugs & Cosmetics Act, 1940 and Rules
1945 says that the licensing authority may require pharmacokinetic studies
(Bioequivalence studies) first to show that the data generated in Indian
population is equal to data generated abroad and then require him to proceed
with Phase III trials.

20. Timeline and Fees for NDA
 It generally takes one year to scrutinize these documents by Data
Associates/Drug Inspectors of CDSCO and during this period
clarification if any, are required by them are answered and thereafter
the importer gets the approval.
 Treasury Challan of Rs 50,000 – For fresh application
 Treasury Challan of Rs 15,000 – For subsequent application

21. Expanded
Programme on
Immunization.

22. Thank you