The Central Drugs Standard Control Organization (CDSCO) has made the submission of applications for Post Approval Changes (PAC) related to Marketing Authorization (MA) for r-DNA products fully functional through the SUGAM online portal (www.cdscoonline.gov.in). Applicants must follow the checklist provided in the module for submission. Offline submission in hard copy will not be accepted from 5 March 2026. This initiative streamlines regulatory processes and ensures timely processing of applications.
Services, has enabled online submission of Post Approval Changes (PAC) for Marketing Authorization (MA) of r-DNA products through the SUGAM portal (www.cdscoonline.gov.in). This online facility aims to streamline the regulatory submission process, improve efficiency, and ensure timely processing of applications.
Offline submission of applications in hard copy will no longer be accepted from 5 March 2026.
Key provisions of the online PAC submission process include:
- Applicants: Must submit all Post Approval Changes for Marketing Authorization of r-DNA products through the SUGAM portal following the provided checklist.
- Hard Copy Submissions: Offline applications will not be processed after 5 March 2026.
- Guidance: The portal provides a structured module to ensure correct submission and documentation.
- Stakeholders: Zonal/sub-zonal offices, CRU sections, and all relevant stakeholders should comply with online submission procedures.
- Objective: Streamline regulatory processing, reduce paperwork, ensure transparency, and enable timely review of r-DNA product applications.