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hygiene
Federal/Central


The Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, ITO
New Delhi- 110002



Ministry of Health & Family Welfare
Nirman Bhavan, Maulana Azad Road
New Delhi - 110011

2

CDSCO
(Central Drugs Standard
Control Organization)

State Licensing Authority
(28 States)
- Monitor storage
- Monitor primary and secondary sale - Issue of State Licence (General)

Drug Controller General India

Govt. Testing Laboratories
(National Institute of Biologicals)

Head Office:
-Approval of new Medical devices
-Registration of medical devices
-Issue of import permit (licence)
-Issue of Clinical trial permission
-Submission of safety data
-Making of new rules and policies
-Re-registration and renewals

-Testing of Medical Devices

Central Drug Laboratory (Calcutta/ Kasauli)
Central drug Testing Laboratory
(Mumbai/Chennai/Chandigarh/Hyderabad)

Port Office:-Inspection on arrival of shipment
-Import/clearance of shipment
-Re-export
3

Drug Controller General India
Port Office
Head Office

Assistant Drug Controller

Joint Drug Controller

Technical Officer

Deputy Drug Controller

Senior Technical Assistant

Assistant Drug Controller

Technical Data Associate
Section Officer

Technical Officer/Drug Inspector
Senior Technical Assistant

Technical Data Associate
Section Officers
4

Review Process for Approval of Clinical Trial
Dossier submission in DCGI office
Drugs Controller General

7-10 working days

New Drug Division/Biological Section
Review Panel
 Technical Data Associate
 Senior Technical Assistant
 Technical Officer

Recommendation for Approval or rejection Presentation in NDAC

1st Review (Technical)

Assistant Drug Controller
2nd Review (Critical)

Refer to NDAC
Overview

Deputy Drug Controller
5

Drugs Controller General approves/reject/comments based on NDAC recommendation Assistant Drugs Controller
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