On 10th November 2023, CDSCO issued a notification on the launch of the online system for Post-Approval Changes (PAC) with respect to Marketing Authorizations (MA) for human vaccines and anti-sera. With the introduction of the Online System of the SUGAM Portal, the main goal is to streamline the regulatory submission procedure.
The Directorate General of Health Services (DGHS), Central Drugs Standard Control Organization (CDSCO) on 30th November 2023 vide File No. X-11026/138/2022-BD announced the launch of the online system SUGAM portal for Post-Approval Changes (PAC) for Marketing Authorizations (MA) for human vaccines and anti-sera. Earlier, the CDSCO had launched the online system of applications for PAC for certain submissions and this facility is now extended to include Marketing Authorizations for human vaccines and anti-sera. The submission of applications through the online system of SUGAM Portal is easily accessible on the official website of CDSCO (www.cdscoonline.gov.in) under Post Approval Changes. All applicants seeking PAC applications must apply through the online portal as per the checklist provided in the module. The facility for offline submission of applications (hard copy of applications) will not be accepted from 1st December 2023.