**Summary:**
This notice, reference number F.No. 120119DCPT195, is issued 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. Dated 21xno, the notice addresses the subject of fixing limits for impurities in the specifications of Investigational New Drugs (INDs). This pertains to the CDSCO's role in receiving and processing applications for clinical trials of INDs.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India.
Central Drugs Standard Control Organization: National Regulatory Authority responsible for regulating drugs and cosmetics 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 Central Drugs Standard Control Organization (CDSCO) office in New Delhi, Delhi.
Investigational New Drugs: New pharmaceutical drug that is under investigation.
Clinical Trial: A research study to evaluate the safety and effectiveness of a new drug or treatment.
CDSCO: Central Drugs Standard Control Organization. An organization under the Government of India.
F.No. 12-01/19-DC(PT-195)
= Government of India
‘ rectorate General of Health Services
entral Drugs Standard Control Organization
of Drugs Controller General (India)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Date: 21)>)«xno
NOTICE
Subject: Fixing of limit of impurities in the specification of INDs — reg.
CDSCO receives and process applicatic for clinical trial of Investigational
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