The Central Drugs Standard Control Organisation (CDSCO) has introduced a structured reminder system on its SUGAM portal to address application backlogs and accelerate the processing of long-pending cases.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India, said a large number of applications across multiple divisions are stalled because applicants have not responded to queries raised during the evaluation process. These pending cases span categories such as Subsequent New Drugs, Investigational New Drugs, New Drugs, Fixed Dose Combinations, Imports, Cosmetics, Biologics (pending since 2016), as well as Medical Devices and In Vitro Diagnostics (pending since 2018).
As part of the new process, CDSCO will send periodic reminders to applicants. After three reminders, a fourth and final notice will be issued, informing applicants that their application will be treated as rejected and the applicable fees forfeited, in line with existing regulations.
The regulator has also clarified that applications pending for over two years have already completed the three-reminder cycle and will be rejected if no response is received within 30 days from the date of the public notice. Formal rejection letters will subsequently be issued to the respective applicants.
CDSCO has advised stakeholders to promptly address outstanding queries to prevent automatic rejection of their submissions.