This document outlines the requirements for registering a new drug in India. It discusses that new drugs must be registered with the Central Drugs Standard Control Organization (CDSCO) for safety, quality, and efficacy reasons. The registration process involves filing an Investigational New Drug (IND) application with preclinical data, then conducting clinical trials in three phases before filing a New Drug Application with full clinical data. The NDA requires documentation of manufacturing methods, non-clinical and clinical studies, and evidence that the drug is safe and effective for its intended use. Approval of the NDA by the Drugs Controller General of India allows the drug to be legally marketed.

2. Requirements for
Registration of a
New Drug
Presented by –
Nadim Dinani
MSc-I Bioanalytical Sciences
Ramnarain Ruia College
Seat no: - XYZABC

3. Overview

4. What is a New Drug ?
 New substance meant for medical use in
humans
 except during local clinical trials has not been
used & recognized in the country to any
significant extent
 composition is not generally recognized, as safe
and effective under the conditions
recommended in its labeling by qualified
experts

5.  fixed dose combination of 2 or more drugs ,
individually approved earlier for certain claims
which are now proposed to be combined for
the first time in fixed ratio
 marketed with modified or new claims but is
already approved by the licensing authority for
certain claims.

6. Why is Registration required ?
Primary Goal
 Safety
 Quality
 Efficacy
Secondary Goal

9. Who provides registration
Guidelines?
FDA
CDER CBER CDRH CFSAN CVM NCTR

10. Who is the regulatory agency
in India?
Central Drugs Standard Control Organization
(CDSCO),
and the office of its leader,
the Drugs Controller General (India) [DCGI]

14. HOW
is a New Drug
Registered ?

15. Applicant
Application to Ethical IND application filing
Committee to CDSCO
Headquarters
Report of ethical
committee

16. IND application filing to CDSCO Headquarters
Examination by New Drug Division
Detailed Review by IND Committee
Recommendation to DCGI
IND Application Approved
Positive response from Clinical Trials
Ethical committee Starts

17. Completion of Clinical Trial Phase 3
Application for New Drug Registration to CDSCO
Reviewed by DCGI
License is granted
Refused to Grant License

18. Preclinical Studies
Investigational New Drug
Phase I
Phase II
Phase III
New Drug Application
FDA approval
Phase IV

19. IND
Investigational New Drug
• synthesized and prepared for human administration?
• identity and purity controlled?
• protocol to be followed in proposed trial?
• drug ?
• qualifications (trial conductors and result evaluators)?
• information sponsor provides clinicians?
• convinced about safety of drug (enough to be tested on
humans)?

20. Requirements for IND
1. Cover Sheet (FDA Form-1571) [21 CFR 312.23(a)(1)]
2. Table of Contents [21 CFR 312.23(a)(2)]
3. Introductory Statement and General Investigational Plan
[21 CFR 312.23(a)(3)]
4. Investigator's Brochure [21 CFR 312.23(a)(5)]
5. Protocols [21 CFR 312.23(a)(6)]

21. 6. Chemistry, Manufacturing, and Control Information [21
CFR 312.23(a)(7)]
a) Chemistry and Manufacturing Introduction
b) Drug Substance [21 CFR 312.23 (a)(7)(iv)(a)]
c) Drug Product [21 CFR 312.23 (a)(7)(iv)(b)]
d) A brief general description of the composition, manufacture, and
control of any placebo to be used in the proposed clinical trial(s)
[21 CFR 312.23(a)(7)(iv)(c)]
e) A copy of all labels and labeling to be provided to each investigator
[21 CFR 312.23(a)(7)(iv)(d)]
f) A claim for categorical exclusion from or submission of an
environmental assessment [21 CFR 312.23(a)(7)(iv)(e)]

22. 7. Pharmacology and Toxicology Information [21 CFR 312.23(a)(8)]
a) Pharmacology and Drug Distribution [21 CFR 312.23(a)(8)(i)]
b) Toxicology: Integrated Summary [21 CFR 312.23(a)(8)(ii)(a)]
i. A brief description of the design of the trials
ii. A systematic presentation of the findings from the animal
toxicology and toxico-kinetic studies.
iii. Identification and qualifications of the individual(s) who
evaluated the animal safety data and concluded
iv. A statement of where the animal studies were conducted and
where the records of the studies are available for inspection
v. A declaration that each study subject to good laboratory
practices (GLP) regulations was performed in full compliance

23. c) Toxicology - Full Data Tabulation [21 CFR312.23(a)(8)(ii)(b)]
d) Toxicology - GLP Certification [21 CFR 312.23(a)(8)(iii)]
e) Monitoring of Effects of these Clarifications
8. Previous Human Experience with the Investigational
Drug [21 CFR 312.23(a)(9)]
9. 21 CFR 312.23(a)(10), (11) and (b), (c), (d), and (e)

24. Form FDA 1571

26. NDA
New Drug Application
• drug safe and effective?
• Do benefits outweigh risks?
• labeling (package insert) appropriate?
• manufacturing and drug quality control methods adequate?

27. Requirements for NDA
NDA
Scientific
Documentation
Requirements

28. Scientific Requirements
 Manufacturing Methodology
 Authentication
 Testing of Drug for
- safety
- Efficacy

29. Scientific Requirements
 Bioavailability and Bioequivalence Studies Data
 Container Closure Systems for Packaging Human Drugs and
Biologics
 Microbiological analysis Data
 Clinical Research Data
 Statistical Data
 Human Pharmacokinetics and Bioavailability test Data
 Non-clinical pharmacology and toxicology studies Data
 Clinical evidence of effectiveness
 Summary of New Drug
 Samples and Analytical Data – for Method Validation
 Manufacture process of Drug
 Impurities in the Drug

30. Documentation for NDA
FIRST: Documents
• Organization & administrative information
• Certificates, information & administrative documents about
the product
• Technical file documents
• Clinical studies documents
SECOND: Attachments to the registration file
• 15 copies of internal information
• 15 copies of “The approved information form of the drug”
duly completed
• 2 samples of finished product
THIRD : separate copy of technical file for analysis
purpose to Drug Control Laboratory

31. Form FDA 356h

34. Bibliography
 GUIDANCE FOR INDUSTRY ON PREPARATION OF COMMON TECHNICAL
DOCUMENT FOR IMPORT / MANUFACTURE AND MARKETING APPROVAL OF NEW
DRUGS FOR HUMAN USE (NEW DRUG APPLICATION – NDA), CENTRAL DRUGS STANDARD
CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH &
FAMILY WELFARE GOVT. OF INDIA, NOVEMBER 2010
 Richard A. Guarino ,M.D., New drug approval process, 5th edition, vol 190, 93-
155
 Dr. Harish Dureja, New Drug Approval Process: Regulatory
View, Pharmainfo.net online article – (link)
 http://www.fda.gov/RegulatoryInformation/Guidances/ucm129703.htm
 http://www.fda.gov/aboutfda/reportsmanualsforms/forms/default.htm
 http://cdsco.nic.in/
 http://cdsco.nic.in/new_drugs_division.htm


35. THANK YOU

FOR YOUR KIND ATTENTION