**Summary:**
The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, Government of India, announces the launch of an online module for processing applications for the registration of Bioavailability/Bioequivalence (BA/BE) study centers (CT08). This module, developed by CDAC in collaboration with CDSCO, aligns with the New Drugs and Clinical Trial Rules, 2019, and is accessible through the SUGAM portal at https://cdscoonline.gov.in. Stakeholders are requested to utilize this online facility, and feedback for improvement is welcomed. Effective October 15, 2021, BA/BE center registration applications will only be accepted online; physical applications will no longer be processed. This initiative, announced on October 1, 2071, by Drugs Controller General Dr. V. G. Somani, is part of the CDSCO's ongoing eGovernance implementation, which began on November 14, 2015. The notice has been disseminated to all stakeholders via the CDSCO website and copies sent to all Zonal and Sub-Zonal Offices of CDSCO and the CDAC Team.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India.
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
New Delhi, Delhi: Location of FDA Bhawan and CDSCO headquarters.
SUGAM: A portal for online services related to CDSCO.
CDAC: An organization that collaborated with CDSCO to develop a module for online processing of applications.
BA BE study centres CT08: Entities for Bioavailability and Bioequivalence studies
New Drugs and Clinical Trial Rules, 2019: The regulatory framework governing new drugs and clinical trials in India.
Dr. V. G. Somani: Drugs Controller General of India
7-5/2015/Misc/034 (e-Governance)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(International Cell Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Dated 01 OCT 2071
Notice
Subject: Module for online processing of applications for registration of BA BE study
centres (CT-08) — Regarding
CDSCO in pursuance to implementation of the e-Governance mechanism has
launched various online services through the "SUGAM" portal on 14.11.2015. In
continuation to same. CDAC in collaboration with CDSCO has developed a module for
online processing of applications for registration of BA BE study centres (CT-08) in
accordance with New Drugs and Clinical Trial Rules, 2019.
The module is finalized and has been made functional, which can be accessed
through https://cdscoonline gov.in. All concerned stakeholders are requested to avail
this facility and any comments/suggestions to help improve the module shall be
welcomed and addressed properly.
Thereafter, the BA BE centre registration applications processing will be
online and physical applications may not be accepted after 15.10.2021 in this regard.
\e
(Dr. V. G. Somani)
Drugs Controller General (India)
To
All Stakeholders through CDSCO Website
Copy to
4. All Zonal and Sub-Zonal Offices of CDSCO
2. CDAC Team