The Central Drugs Standard Control Organization (CDSCO) on March 09, 2026, issued circular regarding the Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products.
The regulatory authority has introduced an online system on the SUGAM Portal to streamline the submission process for Post Approval Changes (PAC) related to Marketing Authorization of r-DNA products. Applicants can now submit PAC applications through the “Post Approval Changes – MA” module available on the portal.
All applicants seeking such changes are required to submit their applications online and follow the checklist provided within the portal module to ensure proper documentation and compliance with regulatory requirements.
Further, the authority has discontinued the offline submission process. From March 05, 2026 onwards, applications in hard copy will no longer be accepted for processing, making online submission through the SUGAM Portal mandatory.
[Circular No. r-DNA-15011(11)/72/2025-eoffice (e-office no. 26991)]
