The Central Drugs Standard Control Organization (CDSCO) on September 12, 2024, issued a circular regarding the online application in Form-44 for issuance of New Drug permission of Bulk (API) drugs/vaccines in Form 45A/46A and finished formulation in Form-45/46 & Field Trial Permission for Veterinary purposes only.
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 functional on the online system of SUGAM Portal (www.cdscoonline.gov.in). The applicants seeking such certificate/approval/permission shall apply through the online portal as per the checklist in the developed modules.
The facility of offline submission of applications in Form-44 in hard copy/through e-office may not be available for processing from August 16, 2024.
[File No. VET-13014(19)/1/2024-eoffice]
