**Summary:**
This notice, reference number F.No. 120119DCPT1 95, is issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Office of Drugs Controller General India, New Drugs Division, FDA Bhawan, Kotla Road, New Delhi-110002, on 242 inne. The subject pertains to the stability data requirements for Bioavailability and Bioequivalence (BABE) studies conducted in humans for export registration. CDSCO receives and processes applications for permission to conduct BABE studies and requires the submission of one month stability data on product development batches within such applications.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India, involved in health services.
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Drugs Controller General India: Head of the Central Drugs Standard Control Organization (CDSCO) in India.
New Drugs Division: A division within the Central Drugs Standard Control Organization (CDSCO) responsible for new drugs.
FDA Bhawan, Kotla Road, New Delhi: Location of the New Drugs Division office
BABE study: Bioavailability and Bioequivalence study in humans.
CDSCO: Central Drugs Standard Control Organization, responsible for processing applications related to BABE studies.
F
F.No. 12-01/19-DC(PT-1
95)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
*—
Office of Drugs Controller General (India) HSou08
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Date: 24/2 inne
NOTICE
Subject: Stability data for BA/BE study in human for export- reg.
CDSCO receives and process application for permission to conduct BA/BE
, in ‘submission of such application.
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+ Aah yduct development one month stability data
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