**Summary:**
This notice, reference number F.No. 120119DCPT195, issued on 2220 by the Government of India, Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Office of Drugs Controller General India, New Drugs Division, located at FDA Bhawan, Kotla Road, New Delhi-110002, concerns subacute toxicity study reports for injectable products intended for Bioavailability and Bioequivalence (BABE) studies. The notice specifies the requirement of a subacute toxicity study report in at least two [details missing from text]
Key Entities Referenced
Directorate General of Health Services: An Indian government organization under the Ministry of Health and Family Welfare.
Central Drugs Standard Control Organization: National Regulatory Authority (NRA) of India.
Drugs Controller General India: Head of the Central Drugs Standard Control Organization.
New Drugs Division: A division within the Central Drugs Standard Control Organization, responsible for new drug approvals.
FDA Bhawan, Kotla Road, New Delhi, Delhi: Location of the Office of Drugs Controller General India.
Subacute toxicity study report: A type of preclinical study report assessing the toxicity of a substance over a relatively short period.
Injectable products: Pharmaceutical products that are administered via injection.
BABE: Likely refers to Bioavailability and Bioequivalence studies required for drug approval.
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 (India)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Dethi-110002
Date: 2)/2)20
NOTICE
bject: Sub-acute toxicity study report for injectable products for BA/BE
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ir ised that sub-acute toxicity study report in at least two