7-5/2015/Misc/034 (e-Governance) Government of India Directorate General of Health Services Central Drugs Standard Control Organisation (International Cell Division)

Notice

FDA Bhawan, Kotla Road, New Delhi-110002 Dated ‘0 OCI 204

• 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.

(Dr. V. G. Somani) Drugs Controller General (India)

To

All Stakeholders through CDSCO Website

Copy to

1. All Zonal and Sub-Zonal Offices of CDSCO

2. CDAC Team