Online Applications Now Mandatory for New Veterinary Drug Permissions and Field Trials

The Central Drugs Standard Control Organization (CDSCO) has announced a shift to online applications for all new drug permissions and field trials related to veterinary medicine. This circular was issued on September 12, 2024.

All new applications for new drug permissions and field trials concerning veterinary products must be submitted electronically through the SUGAM Portal.

The online system allows applicants to submit forms and documents through a user-friendly interface with built-in checklists, aiming to streamline the regulatory submission process.

The system will now accept the following submissions for veterinary products in addition to the already existing mechanisms:

1. Permission to import Finished Formulation of a New Drug – Form 45
2. Permission to import raw material (new bulk drug substance) – Form 45A
3. Permission / Approval for manufacture of new drug formulation – Form 46
4. Permission/ Approval for manufacture of raw material (new bulk drug substance) – Form 46A and
5. Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial – Form 44

It is also important to note that offline submissions of applications for veterinary products in Form 44 in hard copy or through e-office will no longer be accepted for processing after August 16, 2024.

This transition to an online system is expected to enhance efficiency and transparency in the regulatory review process for veterinary drugs and vaccines.