**Summary:**
This notice from the Directorate General of Health Services, Central Drugs Standard Control Organisation (CDSCO), BABE Division, announces the mandatory online submission of Post Approval Changes applications via the SUGAM portal (www.cdscoonline.gov.in) for BABE Study Permission and Import Licence for Export purposes. Effective October 8, 2021, the CDSCO will no longer accept offline submissions (hard copy or email) for these applications. All stakeholders are directed to utilize the online portal for submitting Post Approval Changes applications. This notice is addressed to all stakeholders via the CDSCO website, State/UT Licensing Authorities for information and necessary action, and the CDAC Team. The Drugs Controller General of India, Dr. V. G. Somani, issued this notice on September 24, 2021. The reference number for this notice is F. No. 12092021BABEMisc16DC Pt. File.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
BABE Division: A division within the Central Drugs Standard Control Organisation (CDSCO) likely dealing with Bioavailability and Bioequivalence studies.
SUGAM Portal: An online portal (www.cdscoonline.gov.in) used for regulatory submissions to the Central Drugs Standard Control Organisation (CDSCO).
Post Approval Changes: Refers to changes made to a drug product or process after its initial approval by a regulatory authority.
BABE Study Permission: Permission required to conduct Bioavailability and Bioequivalence studies.
Import Licence for Export purpose: A license required to import drugs for the purpose of exporting them.
Dr. V. G. Somani: The Drugs Controller General of India at the time of the notice.
CDSCO Website: The official website of the Central Drugs Standard Control Organisation (CDSCO), used for disseminating information to stakeholders.
F. No. 12-09/2021/BA-BE/Misc-16/DC (Pt. File)
Government of India
Directorate General of Health Service
Central Drugs Standard Control Organisation
(BABE Division For Export)
FDA Bhawan, Kotla Road,
New Delhi,
Dated: 24 |4) >}
NOTICE
Sub: Submission of Post Approval Changes Applications through SUGAM
Portal - Reg.
In order to streamline the regulatory submission procedure, the submission of
applications on Post Approval Changes in BA/BE Study Permission and Import
Licence for Export purpose is functional on online system of SUGAM Portal
(www.cdscoonline.gov.in). Applicants seeking for approval of such Post Approval
Changes may now apply through the online portal.
The facility of offline submission of applications in hard copy or through e-mail
may not be available after 8" October 2021 for processing.
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\—
(Dr. V. G. Somani)
Drugs Controller General (India)
To,
1. All stakeholders through CDSCO Website
2. State/ UT Licensing Authorities (For information and necessary action)
3. CDAC Team