CDSCO directs SLAs & cos for e-submission of applications for Form 41 & Form 10 for veterinary vaccines
In order to streamline the regulatory submission procedure, the Central Drugs Standard Control Organisation (CDSCO) has directed all State Licensing Authorities (SLAs) and manufacturers for online submission of applications for issuance of Form 41 (Registration Certificate) and Form 10 (Import License) for veterinary vaccines through Sugam portal.
The applicants seeking for such certificates/license may now apply through online Sugam portal as per the checklist in the developed modules. The facility of offline submission of applications in hard copy may not be available after March 25, 2021 for processing, according to a CDSCO notice.
Sugam is an e-Governance system to discharge various functions performed by CDSCO under Drugs and Cosmetics (D&C) Act, 1940. The software system developed is an online web portal where applicants can apply for NOCs, licenses, registration certificates, permissions and approvals.
It provides an online interface for applicants to track their applications, respond to queries and download the permissions issued by CDSCO. It also enables CDSCO officials to process the applications online and generate the permissions online and generate MIS reports.
It contains step-by-step guidance to the applicants of the Sugam portal with screenshots of the workflow for various application submissions.
Following sections which are detailed in Sugam are user registration and login, applicant dashboard, managing sub login accounts, form submission for various processes and post approval changes.
Applications were made in hard copy dossier format to various divisions in CDSCO before the Sugam portal was introduced. The timelines for granting permissions or approvals for applications were almost three times more than what is there in the current scenario.
Earlier the fees for applications were made in the respective bank and then the copy of challan/receipt was submitted to CDSCO office. But now in Sugam portal, fee is calculated according to the applications and can be paid online on the same portal in bharatkosh.gov.in. The receipt for payment is available on the portal which can be downloaded and submitted in the application.
Due to the introduction of the Sugam portal, India is now in the state to compete with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions.
Source : 1