**Summary:**
Effective March 25, 2021, the Central Drugs Standard Control Organization (CDSCO), Veterinary Division, announces the mandatory adoption of the online SUGAM portal (www.cdscoonline.gov.in) for submitting applications for Form 41 Registration Certificates and Form 10 Import Licenses for Veterinary Vaccines. This initiative streamlines the regulatory submission process. Applicants are required to apply online, adhering to the checklist provided within the developed modules on the SUGAM portal. After March 25, 2021, offline (hard copy) submissions will no longer be accepted for processing. Stakeholders and State/UT Licensing Authorities are requested to take note of this change and implement the online application process accordingly. Inquiries may be directed through the CDSCO website. The notice was issued by Dr. V.G. Somani, Drugs Controller General.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Veterinary Division: A division within the Central Drugs Standard Control Organization focusing on veterinary products.
Form 41 Registration certificate: A certificate required for registration related to veterinary vaccines.
Form 10 Import License: A license required for importing veterinary vaccines.
Veterinary Vaccines: Vaccines specifically designed for use in animals.
SUGAM portal: An online portal (www.cdscoonline.gov.in) used for regulatory submissions to CDSCO.
Dr. V.G. Somani: The Drugs Controller General.
State/UT Licensing Authorities: Licensing authorities in various States and Union Territories of India, responsible for licensing and regulation.
File No: X-11026/03/CDAC/18-VC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Veterinary Division)
FDA Bhawan, Kotla Road,
New Delhi-110002, India,
Dated: S|3\202)
NOTICE
Sub: Online Application for the issuance of Form 41 (Registration certificate) and
Form 10 (Import License) for Veterinary Vaccines — reg.
In order to streamline the regulatory submission procedure, the submission of
applications for issuance of Form 41 (Registration certificate) and Form 10 (Import
License) for Veterinary Vaccines is now functional on Online System of SUGAM portal
(www.cdscoonline.gov.in) The applicants seeking for such certificates/license may now
apply through online portal as per the checklist in the developed modules.
The facility of offline submission of applications in hard copy may not be available
after 25'" March, 2021 for processing.
ys
Ve
Dr. V.G. Somani
Drugs Controller General (I) _
To,
1. All stakeholders through CDSCO Website
2. State/UT Licensing Authorities (For information and necessary action
3. CDAC Team