The document discusses the process for submitting an Investigational New Drug (IND) application to regulatory agencies like the FDA in the US and DCGI in India to obtain approval to test new drugs in human clinical trials. It explains that an IND application includes preclinical data from animal and lab studies to show safety for testing in humans. It also outlines the types of IND applications and details on protocols, manufacturing, and other information required to be submitted. The application process and timeline for review within 30 days by the FDA is also summarized.

1. GLOBAL SUBMISSION OF IND

2. PRECLINICAL INVESTIGATION
The testing of new drugs in humans cannot begin until there is
solid evidence that the drug product can be used with
reasonable safety in humans. This phase is called “preclinical
investigation.”
Goal of preclinical investigation is to assess potential
therapeutic effects of the substance on living organisms and to
gather sufficient data to determine reasonable safety of the
substance in humans through laboratory experimentation and
animal investigation
A preclinical investigation usually takes one to three years to
complete.

3. INTRODUCTION
• The IND is the formal process by which a sponsor
requests approval for testing of a drug in humans.
• It includes information developed during preclinical
testing regarding safety and effectiveness.
• A pre - IND meeting can be arranged with the FDA to
discuss a number of issues
The design of animal research, which is required to
lend support to the clinical studies.
The intended protocol for conducting the clinical Trial.
The chemistry, manufacturing, and control of the
investigational drug.

4. INTRODUCTION
• Includes an investigational brochure that ensures that
clinicians conducting the trial and their institutional review
board(IRB) are adequately informed about possible effect of
the drug.
• If the FDA accepts the IND request within 30 days of
submission, clinical testing of new molecule on human may
begin by the investigator.
• If at any time during clinical testing, the data furnished to FDA
indicate the IP to be toxic under the criterion of FDA’s
Benefit/Risk ratio, FDA can terminate clinical trial and its
actions are not subject to any judicial review.

5. TYPES OF IND
Investigator IND-submitted by a physician who both
initiates and conducts an investigation, and under whose
immediate direction the investigational drug is administered
or dispensed.
Emergency Use IND-allows the FDA to authorize use of an
experimental drug in an emergency situation that does not
allow time for submission of an IND in accordance
with 21CFR , Sec. 312.23 or Sec. 312.20.
Treatment IND-is submitted for experimental drugs showing
promise in clinical testing for serious or immediately life-
threatening conditions while the final clinical work is
conducted and the FDA review takes place.

6. THE IND APPLICATION MUST CONTAIN
INFORMATION IN THREE BROAD
AREAS
Animal
Pharmacology
and Toxicology
Studies
Manufacturing
Information
Clinical
Protocols and
Investigator
Information

7. CRITERIA FOR IND
APPLICATION
A new
indication.
Change in
approval
route of
administratio
n or dosage
level.
Change in the
approved
patient
population.
Significant
change in the
promotion of
an approved
drug.

8. REGULATORY AND
ADMINISTRATIVE COMPONENTS
The content and format of IND application is laid out in
21CFR part 312.
 Cover sheet -312.23(a)(1)(FORM FDA 1571)
 Table of contents-313.23(a)(2)
 Introductory statement and a general investigational plan
-312.23(a)(3)
 Investigators brochure-312.23(a)(5)
 Clinical Protocols-312.23(a)(6)

9. REGULATORY AND
ADMINISTRATIVE COMPONENTS
 Chemistry , manufacturing and control information-
312.23(a)(7)
 Pharmacology and Toxicology information-312.23(a)(18)
 Previous human experience with the investigational drug-
312.23(a)(9)
 Other relevant information like no of IND submissions-
312.23(a)(10)
Number of copies to be submitted (1 + 2)
 Protocol amendments, any changes in the protocol.-
312.(a)(11)

10. IND APPLICATION PROCESS
Compile the components of the
IND Application.
Items with original signatures
should be scanned as PDF files.
Refer to FDA website for
submission addresses.

11. IND APPLICATION SUBMISSION
 FDA will send an acknowledgement via email and in a letter with the
following information:
Date of IND receipt
IND number
contact name
phone at FDA for questions
address and instructions for future submissions of the IND
 FDA has up to 30 days in which to respond to the sponsor-
investigator regarding the IND if there are clinical, regulatory, or
other concerns

12. IND SUBMISSION: THE FIRST
30 DAYS
• IND arrives to the Central Document Room
 If electronic: loaded in the Electronic Document Room (EDR)
 If paper: Sent to the White Oak Document Room
 Data entered into DARRTS (Document Archiving, Reporting,
and Regulatory Tracking System
• IND forwarded to CPMS (Chief, Project Management Staff)
• PM (Project Manager) assigned
• Review Team assigned

13. IND SUBMISSION: THE FIRST
30 DAYS
The Review team will determine within 30
days of receipt of your IND whether your
study is “safe to proceed” or will be placed in
clinical hold

14. FDA ADMINISTRATIVE
ACTIONS
Comments Or Requests
For Modifications
FDA communications to the
sponsor-investigator within the
30-day window following FDA
receipt of the IND must be
answered promptly
Updated materials submitted to
the FDA in response to a
request for
changes/information should be
submitted in the same manner
as the original IND.
Approval Of IND
. Research may commence 30
days following of receipt of the
IND if the FDA has not made
any request for additional
information or changes to the
IND Application as submitted
FDAApproval of the IND will be
sent electronically and in a letter
to the sponsor investigator

15. IND PROCESS IN INDIA
No clinical trial for new drug for any purpose be
conducted without permission, in writing, of the
Licensing Authority(DCGI).
Application for conducting clinical trials in India
require submission by the sponsor on Form 44
along with fee(Rs 50K) and documents as provided
under Schedule Y to Drugs and Cosmetic Act 1940.

16. Data to be submitted along with the application on Form44 to
conduct clinical trails (2 hard copies and 2 soft copies)
1.Application on Form44
2.Introduction of the drug
3.Fee Rs 50K through challan form
4.Chemical and pharmaceutical information as per Appendix I of
Schedule Y.
5.Animal pharmacology as per Appendix IV
6.Animal toxicology as per Appendix III.
7.Human/clinical pharmacology data as per Appendix I.
8.Regulatory status in other countries as per Appendix i.

17. DCGI along with its recommendations.If the report by
committee is favorable, DCGI approves the INDA.
The New Drug division where it is reviewed by IND committee.
The committee submits its report to
After receiving the application, the Central Drug Standard
Control Organisation (CDSCO) Headquarter in New Delhi refer
it to

19. REFERENCES
• https://www.fda.gov/drugs/investigational-
new-drug-ind-application/information-
sponsor-investigators-submitting-
investigational-new-drug-applications-inds
• https://www.fda.gov/drugs/types-
applications/investigational-new-drug-ind-
application#Introduction