**Summary:**
This notice, issued by the Central Drugs Standard Control Organization (CDSCO), BAIBE Division, Directorate General of Health Services, Government of India, outlines a streamlined process for applications related to Bioavailability and Bioequivalence (BABE) studies for export purposes. Specifically, it concerns applications for BABE permission in Form CT07 and Import Licenses in Form CT17, as per the New Drugs and Clinical Trial Rules, 2019. The notice states that the CDSCO will process such applications within 15 working days of receipt. The decision was made to further streamline the application process. The notice is addressed to all stakeholders. Dr. V.G. Somani, Drugs Controller General of India, is the issuing authority. The document reference number is File No.1209BABE2020Misc02DC, and the date of issue is January 21, 2020.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
BAIBE Division: A division within the Central Drugs Standard Control Organization (CDSCO), likely dealing with Bioavailability and Bioequivalence studies.
New Delhi: The location of FDA Bhawan, where the notice was issued.
Form CT07: A form prescribed under the New Drugs and Clinical Trial Rules, 2019, for granting permission to conduct Bioavailability and Bioequivalence (BABE) studies of New Drugs for export.
Form CT17: A form prescribed under the New Drugs and Clinical Trial Rules, 2019, for granting Import Licence.
New Drugs and Clinical Trial Rules, 2019: A set of rules governing the regulation of new drugs and clinical trials in India.
Central Licensing Authority: The authority responsible for granting permission to conduct BABE study of New Drugs for export purpose.
Dr. V.G. Somani: Drugs Controller General of India.
File No.-12-09/BA-BE/2020/Misc-02/DC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(BAI/BE Division for Export)
FDA Bhawan, New Delhi
Date: 21/1/2020
NOTICE
Subject: Processing of application for BA/BE permission issued in Form CT-07
and Import Licence issued in Form CT-17 for Export —regarding.
Permission to conduct BA/BE study of New Drugs for export purpose is granted by
Central Licensing Authority (CLA), as per the New Drugs and Clinical Trial Rules,
2019, in Form CT-07. Import Licence in Form CT-17 is also granted for import of
study drug for this purpose.
In order to further streamline the processing of such applications, it has been
decided that, such applications will be processed by CDSCO within 15 working days
of receipt of application.
Ye
ee
(Dr. V.G. Somani)
Drugs Controller General (India)
To,
All stakeholders /C>+co sia,
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