**Summary:**
This notice from the Central Drugs Standard Control Organization (CDSCO), dated February 24, 2095, announces the expansion of the SUGAM online portal (www.cdsconline.gov.in) to include the submission of applications for Clinical Trial Site Addition and change of Principal Investigator for clinical trials of Biological products, Vaccines, and rDNA products. This is a continuation of the notice F.No.10171DCGI102024eoffice dated 26.12.2024. All applicants seeking approval for these changes in clinical trials are now required to submit their applications through the SUGAM portal, including a checklist of required documents and Ethics Committee approval. The addition of clinical trial sites will be considered approved if no objection is received from the CDSCO within 30 days of application receipt. The change of Principal Investigator is deemed approved from the date of receipt of a complete application, as per the checklist. This directive is addressed to all stakeholders via the CDSCO website. The Drugs Controller General of India, ghRaghuvanshi, is the issuing authority. The file number for reference is DCGI102024eoffice, Computer No. 10171.
Key Entities Referenced
Directorate General of Health Service: A department under the Government of India.
Central Drugs Standard Control Organization: National Regulatory Authority responsible for regulating drugs and medical devices under the Ministry of Health and Family Welfare, Government of India.
FDA Bhawan, Kotla Road, New Delhi, Delhi: Location of the Central Drugs Standard Control Organization (CDSCO) headquarters.
SUGAM Portal: Online portal for submission of applications related to clinical trials, specifically for addition of Clinical Trial Site and change of Principal Investigator.
Clinical Trial Site: Location where clinical trials are conducted, requiring approval for addition.
Principal Investigator: The lead researcher responsible for a clinical trial, requiring approval for change.
CDSCO: An abbreviation for Central Drugs Standard Control Organization
Drugs Controller General India: Title of the signatory authority
F.No.10171/DCGI/10/2024-eoffice
Government of India
Directorate General of Health Service
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road,
New Delthi-110002
24 FEB 2095
Sub: Submission of Clinical Trial Site Addition and change of Principal Investigator
applications through SUGAM portal -Reg.
In continuation to notice vide F.No.1017/DCG(\)/10/2024-eoffice dated 26.12.2024
on the subject sited above, the submission of applications for addition of Clinical
Trial Site and change of Principal Investigator are now also functional on online
system of SUGAM Portal (www.cdsconline.gov.in) for clinical trials of Biological
products (Vaccine and rDNA). Applicants seeking for approval of Clinical Trial Site
Addition and change of Principal Investigator applications for all the clinical trials
may apply through the online portal.
The applicant should submit application through SUGAM along with the checklist
of documents along with the approval of the ethics committee. The proposed
addition of clinical trial sites is deemed to be approved if no objection is received
from the CDSCO within 30days of the receipt of the application and the proposed
change of Principal Investigator is deemed to be approved by the CDSCO from
date of receipt of application subject to the condition that application is complete as
per the checklist
gh\Raghuvanshi)
Drugs Controller General(India)
To,
1.All stakeholders through CDSCO website
2.CDAC team
sile No. DCGI/10/2024-eoffice (Computer No. 10171)