New Delhi: In a significant move to streamline the regulatory submission procedure, the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Veterinary Division, has announced that all applications for new veterinary drug and vaccine permissions will now be processed exclusively through the online SUGAM Portal.
The notice states,
"In order to streamline the regulatory submission procedure, the submission of application for issuance of New Drug permission of Vaccines/ Drugs for Bulk (API) in Form-45A/46A and finished formulation in Form-45/46 and Field Trial Permission is now functiohial on online system ofSUGAM Portal (www.cdscoonline.gov.in)."
SUGAM is an online e-governance portal introduced by the government of India to build an in-depth regulatory framework for the registration processes of the CDSCO. This site, which has already been used by pharmaceutical companies for human drugs, will now be the primary platform for handling veterinary-related drug and vaccine permissions.
According to the circular, applicants seeking permission for new bulk (API) drugs, vaccines, finished formulations in Forms 45A/46A and 45/46, and field trial permissions must submit their applications via the online system. The previous method of submitting applications in Form-44 via hard copy or through the e-office system will no longer be accepted after August 16, 2024.
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