**Policy Summary:**
This notice, reference number F.No. 120119DCPT195, issued by the Government of India, Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Office of Drugs Controller General of India, New Drugs Division, located at FDA Bhawan, Kotla Road, New Delhi-110002, concerns the permission to conduct Bioavailability and Bioequivalence (BABE) studies and clinical trials. The notice indicates that under the New Drugs and Clinical Trials Rules 2019, CDSCO has evaluated concerns and proposed changes for processing. The date of the notice is 2;;2".
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 of India: Head of the Central Drugs Standard Control Organization (CDSCO) responsible for drug regulation.
New Drugs Division: A division within the Central Drugs Standard Control Organization (CDSCO) responsible for new drug approvals.
FDA Bhawan, Kotla Road, New Delhi, Delhi: Location of the Office of Drugs Controller General of India.
New Drugs and Clinical Trials Rules 2019: A set of rules governing the approval and conduct of new drug and clinical trials in India.
BABE study: Likely refers to a Bioavailability and Bioequivalence study, used in pharmaceutical development.
clinical trial: A research study to evaluate the safety and efficacy of a new drug or treatment.
F.No. 12-01/19-DC(PT-195)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
Office of Drugs Controller General rat (india)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Dethi-110002
Date: 2;;2>"<
NOTICE
Subject: Permission to conduct BA/BE study and clinical trial — reg.
Under the provision of New Drugs and Clinical Trials Rules 2019, CDSCO
eval Concerns have been ised and changes have been proposed for processing
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