This document provides an overview of CDSCO and FDA guidelines for drug approval. It begins with an introduction to CDSCO as India's national regulatory body equivalent to agencies like the EMA and FDA. It describes CDSCO's organization, functions in approving drugs and devices, and guidelines. It then explains the Common Technical Document format used for drug submissions and its modules. Guidelines for areas like cosmetics, clinical trials, and bioavailability and bioequivalence are summarized. The document concludes with references to CDSCO and FDA websites for further information.

1. CDSCO & FDA Guidelines
Presented To :
Dr. Mayur Patel
Dept. Of Pharmaceutics
Nirma University.
Presented By:
Dishant Shah
15MPH104 ,Pharmaceutics
Nirma University.

2. Content
› Introduction
› Organization
› Functions
› Guideline
› CTD
› Cosmetics
› Clinical Trials
› FDA
› Introduction
› Procedure
› References

3. Introduction
› The Central Drugs Standard Control Organization is the national
regulatory body for Indian pharmaceuticals and medical devices, and
serves parallel function to the European Medicines Agency of the
European Union, the PMDA of Japan and the Food and Drug
Administration of the United States.
› CDSCO is the national regulatory body for Indian Pharmaceuticals and
medical devices.
› Its Head quarter is located at FDA Bhawan , Kotla Road, New Delhi and
functions under the Directorate General of Health Services.
› Within the CDSCO, the Drug Controller General of India (DCGI)
regulates pharmaceuticals and medical devices.
› The DCGI is advised by the Drug Technical Advisory Board (DTAB) and
the Drug Consultative Committee (DCC).

4. › It is divided into zonal offices which do pre-licensing and post-licensing
inspections, post-market surveillance, and recalls when needed.

5. Organization Of CDSCO

6. Six laboratories
– Central Drugs Laboratory (CDL) Kolkata
– Central Drugs Testing Laboratory (CDTL) Chennai
– Central Drugs Testing Laboratory (CDTL) Mumbai
– Regional Drug Testing Laboratory (RDTL) Guwahati
– Regional Drug Testing Laboratory (RDTL) Chandigarh
– Central Drugs Laboratory (CDL) Kasuali
Laboratories Of CDSCO

7. Functions Of CDSCO
Functions of CDSCO
Approval of new drugs and clinical trials
Import Registration and Licensing
License approving of Blood Banks, LVPs, Vaccines, r-DNA
products & some Medical Devices (CLAA Scheme)
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

8. Functions State Licencing Authority
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

9. Guidelines
 Various guidelines are included :
 Guidelines for new drug
 Guidelines for medical devices and diagnostics
 Guidelines for cosmetics
 Guidelines for biological
 Guidelines for clinical trials
 Guidelines for BA BE studies
 Guidelines for post approval changes.
 Guidelines for import , manufacturing, sale and distribution
of drugs, cosmetics , medical devices, biologicals etc.
 Guidelines for blood banks.

10. Common Technical Guideline (CTD)
 Demonstration of safety and efficacy of the drug product for
use in humans is essential before the drug product can be
approved for import or manufacturing of new drug by the
applicant by CDSCO. The regulations under Drugs and
Cosmetics Rules 122A, 122B and 122D and further Appendix
I, IA and VI of Schedule Y, describe the information required
for approval of an application to import or manufacture of new
drug for marketing.
 Substantial documentation for such types of submissions are
required, creating number of hurdles and resulting in
unnecessary delay in approval. So the common format for
submission was developed through ICH for Japan, EU, and
U.S called CTD (common technical document).

11. Guideline For Preparation Of CTD
 Five Modules
– Module 1: General Information
– Module 2: CTD Summaries
– Module 3: Quality
– Module 4: Non-clinical Study reports
– Module 5: Clinical study reports

12. Module 1:General Information
 Contains
• Covering letter & comprehensive table of contents
• Administrative information(contains intro. about applicant
company, filled form 44, challan, information of co-
ordinates etc.)
• General information on drug product
• Summary of testing protocols
• Regulatory status in other country

13. Module 2:CTD Summaries
 Contains
• Table of contents
• Introduction
• Quality overall summery(QOS)
• Non clinical overview
• Clinical overview
• Nonclinical written and tabulated summaries
• Clinical summery

14. Module 3:Quality
 Contains
• Table of contents
• Body of data- Contains detailed information pertaining
to quality of
» Drug substance(s)
» Drug product
» Excipients
» Facility& equipment

15. Module 3:Quality Cont..
 Drug substance(s) (contains information about)
 General information
 Manufacturing of drug substance
 Characteristic of drug substance
 Quality control of drug substance
 Reference standard materials
 Container closure system
 Stability of drug substance

16. Module 3:Quality Conti..
 Drug product
 Composition of drug product
 Pharmaceutical development of drug product
 Manu. Of drug product
 Control of excipients
 Control of drug product
 Reference standard material
 Container closure system
 Stability of drug product

17. Module 4:Non-Clinical Study Report
 Table of contents
 Study reports
– Pharmacology
• Primary Pharmacodynamics
• Secondary Pharmacodynamics
• Safety Pharmacology
• Pharmacodynamic Drug Interactions

18. Module 4:Non-Clinical Study Conti..
– Pharmacokinetics
– Toxicology
• Single-Dose Toxicity
• Repeat-Dose Toxicity
• Carcinogenicity
• Reproductive and Developmental Toxicity
• Other Toxicity Studies (if available), for
example
• Antigenicity
• Immunotoxicity

19. Module 5:Clinical Study Report
 Contains
• Table of contents
• Tabular listing of all clinical studies
• Clinical study reports
 Reports of BA BE , IVIVC studies
 Reports of PK-PD studies
 Reports of efficacy & safety
 Reports of post marketing experience

20. Diagrammatic Representation Of CTD

21. Cosmetics
Import
 Statement to accompany imported cosmetics: All
consignments of cosmetics sought to be imported shall be
accompanied by an invoice or statement showing the name and
quantities of each article of cosmetic included in the
consignment and the name and address of the manufacturer.
 Documents to be supplied to the Collector of Customs:
Before any cosmetics are imported, a declaration signed by or
on behalf of the manufacturer or by or on behalf of the
importer that the cosmetics comply with the provisions of
Chapter III of the Act, and the rules made there under, shall be
supplied to the Collector of Customs.

22. Cosmetics
 Procedure for the import of cosmetics : If the officer appointed at the post of
entry by the Central Government has reason to believe that any cosmetic
contravenes any of the provisions of the Act or the rules made there under he
may take sample of the cosmetic from the consignment for inspection. If on
examination of the sample defects are noticed the officer shall advice the
Commissioner of Customs for further action to be taken.
 If there is suspected contravention of the provisions of the Act the officer shall
send the sample to the laboratory established for the purpose for performing
tests. The consignment of the said cosmetic shall be detained till such time that
the test report on such sample is received from the Director of the said
laboratory or any other officer of the laboratory empowered by him in this
behalf with the approval of the Central Government.

23. Cosmetics
 Exemption of cosmetics : Cosmetics as may be specified in Schedule D shall be
exempted from the provisions of Chapter III of the Act and the rules made there
under to the extent and subject to the conditions specified in that Schedule.
 Import through points of entry : No cosmetic shall be imported into India except
through the points of entry specified in Rule 43-A.
 Cosmetic containing Dyes, Colours and Pigments
 No Cosmetic shall contain Dyes, Colours and Pigment other than those specified
by the Bureau of Indian Standards (IS: 4707 Part I as amended) and Schedule Q.
 The permitted Synthetic Organic Colours and Natural Organic colours used in the
Cosmetics shall not contain more than
 i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.
 ii) 20 parts per million of Lead calculated as Lead.
 iii) 100 parts per million of Heavy Metals other than Lead calculated as the total of
the respective metals.]

24. Cosmetics
› Prohibition of import of cosmetic containing
hexachlorophene
– No cosmetic containing hexachlorophene shall be
imported.
› Import of cosmetics containing mercury compounds
prohibited
– No cosmetic shall be imported which contains
mercury compounds.

25. Clinical Trials

26. Clinical Trials

27. USFDA Guidelines on Bioavailability &
Bioequivalence

29. Introduction
 PART 320 BIOAVAILABILITY& BIOEQUIVALANCE
 PARTS:-
◦ PART A—General Provision
◦ PART B—Procedure for Determining BA/BE

30. Introduction
 PART 320 BIOAVAILABILITY& BIOEQUIVALANCE
 PARTS:-
◦ PART A—General Provision
◦ PART B—Procedure for Determining BA/BE

31. Introduction
A. BIOAVAILABILITY :- The rate and extent to which the active ingredient
or active moiety is absorbed from a drug product and becomes
available at the site of action. For drug products that are not intended
to be absorbed into the bloodstream, bioavailability may be assessed
by measurements intended to reflect the rate and extent to which the
active ingredient or active moiety becomes available at the site of
action.
B. DRUG PRODUCT:- A finished dosage form, e.g., tablet, capsule, or
solution, that contains the active drug ingredient, generally, but not
necessarily, in association with inactive ingredients.

32. Introduction
C. BIOEQUIVALANCE:- The absence of a significant difference in the rate
and extent to which the active ingredient or active moiety in
pharmaceutical equivalents or pharmaceutical alternatives becomes
available at the site of drug action when administered at the same
molar dose under similar conditions in an appropriately designed
study.

33. Procedure
For Determining BA&BE of Drug Product
 320.21 - Requirements for submission of bioavailability and bioequivalence data.
 All the reports of the conducted BABE study to be attached
 320.22 - Criteria for waiver of evidence of in vivo bioavailability or
bioequivalence.
 Proof for the need of biowaiver in selected cases
 320.23 - Basis for measuring in vivo bioavailability or demonstrating
bioequivalence.
 Requirements on the basis for which BABE studies are carried out.
 320.24 - Types of evidence to measure bioavailability or establish
bioequivalence.
 320.25 - Guidelines for the conduct of an in vivo bioavailability study.
 Study conducted as per the guidelines provided

34. Procedure
 320.26 - Guidelines on the design of a single-dose in vivo
bioavailability or bioequivalence study.
 320.27 - Guidelines on the design of a multiple-dose in vivo
bioavailability study.
 320.28 - Correlation of bioavailability with an acute pharmacological
effect or clinical evidence.
 320.29 - Analytical methods for an in vivo bioavailability or
bioequivalence study.
 320.30 - Inquiries regarding bioavailability and bioequivalence
requirements and review of protocols by the FDA.

35. Procedure
 320.31 - Applicability of requirements regarding an "Investigational New
Drug Application.“
 320.32 - Procedures for establishing or amending a bioequivalence
requirement.
 320.33 - Criteria and evidence to assess actual or potential bioequivalence
problems.
 320.34 - Requirements for batch testing and certification by the Food and
Drug Administration.
 320.35 - Requirements for in vitro testing of each batch.

36. Procedure
 320.36 - Requirements for maintenance of records of
bioequivalence testing.
 320.38 - Retention of bioavailability samples.
 320.63 - Retention of bioequivalence samples.

37. Reference
 www.cdsco.nic.in
 http://www.cdsco.nic.in/forms/Default.aspx
 http://www.cdsco.nic.in/forms/list.aspx?lid=1586&Id=1
 http://www.cdsco.nic.in/forms/list.aspx?lid=1585&Id=1
 http://www.cdsco.nic.in/forms/SearchMore.aspx?Id=3
 http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1424
 http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1425
 http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1174
 http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=957
 http://www.fda.gov/
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformat
ion/default.htm
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformat
ion/Guidances/default.htm
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformat
ion/Guidances/ucm064964.htm