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APPLICATION

INDA filed before conducting clinical trials. It is a submission to the regulatory

authority requesting permission to initiate a clinical study on the new drug product

by sponsor (Fig. 9.1).

IND is Required

At the time of the clinical trial of an unapproved drug.

IND is not Required

i. In case the drug is not intended for human subjects.

ii. In case the drug is intended for in vivo testing.

iii. When the drug is already approved and study is conducted within the approved

indication for use.

Types of INDs

There are four types of INDs

Investigator's INDs: It is submitted by a physician. A physician is a person who

conducts and initiates the investigation. The investigational drug is only administered

or dispensed by the direction of physician.

Commercial INDs: This IND is submitted primarily by companies whose main

goal is to obtain the approval for new drug marketing.

Emergency Use INDs: It is for the speed approval for drugs in an emergency.

Treatment INDs: It is for the experimental drugs which show promising results in

clinical testing of life-threatening conditions.

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INDA and NDA

9

Fig. 9.1: Essential steps for getting market approval of the drug

INDA and NDA 131

Format and Content of IND

a. Cover sheet

i. Name, address, telephone no. of sponsor

ii. Identification of phases

iii. Commitment not to begin clinical trials until IND approval

iv. Commitment by Investigational Review Board (IRB)

v. Commitment for conducting clinical trials

vi. Name and title: Monitor

vii. Name and title: Persons for reviewing

viii. Name, address of contract research organisation, if any