CDSCO Implements Online System for Veterinary Drug Applications on SUGAM Portal

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-09-22T18:00:51+05:30 | Updated On 22 Sept 2024 6:00 PM IST

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.

In continuation with the above, the notice states, "The applicants seeking such certificate/approval/permission shall apply through 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 16th August 2024."

Also Read:CDSCO Panel Approves Sanofi's Protocol Amendment proposal for Fitusiran study

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/veterdate12sep-1-253762.pdf

cdscoveterinary drugDirectorate General Health ServicesSugam portal

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751