**Summary:**
This notice from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, announces the mandatory online filing of applications for obtaining permissions to conduct Global Clinical Trials (GCT) through the SUGAM portal, effective October 2016. The online module for GCT applications has been developed and tested. Applicants who have not yet registered on the SUGAM portal are required to do so. While online filing is mandatory from October 2016, applicants must continue to submit hard copies until further notice. The notice is addressed to all Pharma Industry Associations and CROs. Further inquiries can be directed to the Drugs Controller General of India.
Key Entities Referenced
Central Drugs Standard Control Organization: A department of the Ministry of Health & Family Welfare, Government of India responsible for regulation of pharmaceuticals and medical devices.
CDSCO: Abbreviation for Central Drugs Standard Control Organization.
SUGAM: Portal for online services provided by CDSCO for filing applications.
Global Clinical Trials: Clinical trials that are conducted across multiple countries and sites around the world.
GCT: Abbreviation for Global Clinical Trials.
Dr. GN. Singh: Drugs Controller General of India at the time of the notice.
New Delhi: Capital of India, location of FDA Bhawan and CDSCO headquarters.
Ministry of Health Family Welfare: A ministry in the Government of India.
CDSCO/IT/2015 — (48)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, New Delhi
Dated: 05-[o- 7! t
Notice
You are aware that Central Drugs Standard Control Organization (CDSCO) in
pursuance of the implementation of e-Governance has launched various online services
through the portal “SUGAM"” .The development of software for filing online applications for
Global Clinical Trials(GCT) has been completed and its robustness was tested by the
industry users in several iterations. The module has already been live and applications can
be filed online henceforth. However, those applicants desiring to file applications for
obtaining permissions to conduct GCT are requested to register on the portal as per the
prescribed procedure, if they have not already registered.
Now, it is decided that the applications for obtaining permissions, to conduct GCT
have to be mandatorily filed online through SUGAM with effective from ...10.16. However,
the applicants shall continue to submit hardcopies even after..p.e .10.2016, till such time it is
indicated otherwise.
(Dr. G/N. Singh)
Drugs Controller Gereral (India)
To 1. All Pharma Industry Associations/CRO’s
2. JDC(I)'s/DDC(I)'s at CDSCO (HQ)
Copy to
=O PPS to DGHS
PPS to AS (KBA)
PS to JS (KLS)
Guard File
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