The Central Drugs Standard Control Organization (CDSCO) has made online submission mandatory for applications seeking New Drug permission of Vaccines/ Drugs for Bulk (API) in Form-45A/46A and finished formulation in Form-45/46 and Field Trial Permission for Veterinary purpose only. The facility of offline submission will be discontinued from August 16, 2024. Applicants can submit applications through the online system of the SUGAM Portal (www.cdscoonline.gov.in).
The Central Drugs Standard Control Organization (CDSCO) has issued a directive requiring online submission of applications for New Drug approvals for veterinary use. This applies to Vaccines/ Drugs for Bulk (API) in Form-45A/46A and finished formulations in Form-45/46, as well as Field Trial Permissions. > Key points:
- Online submission through SUGAM Portal: Applicants must submit applications online using the SUGAM Portal (www.cdscoonline.gov.in).
- Deadline for offline submissions: The facility for offline submission will be discontinued from August 16, 2024.
- Affected applications: The mandate applies to applications for New Drug permission of Vaccines/ Drugs for Bulk (API) in Form-45A/46A and finished formulation in Form-45/46 and Field Trial Permission for Veterinary purpose only.