The Central Drugs Standard Control Organization has announced the rejection of long-pending applications on the SUGAM portal due to non-response to queries. Applications across divisions such as new drugs, biologics, cosmetics, and medical devices pending since 2016–2018 will be disposed of. CDSCO issues three reminders at 30-day intervals, followed by a final rejection notice if no response is received. Applications pending over two years will now be rejected within 30 days, with fees forfeited, urging stakeholders to act promptly.
CDSCO, under the Ministry of Health & Family Welfare, has issued a public notice regarding the disposal of long-pending applications submitted through the SUGAM portal. Many applications across divisions such as Subsequent New Drugs, Investigational New Drugs, Fixed Dose Combinations, Imports, Cosmetics, Biologics, Medical Devices, and In Vitro Diagnostics have remained unresolved since 2016–2018 due to applicants failing to respond to queries raised during evaluation. To address this backlog, CDSCO introduced a structured reminder mechanism, sending three reminders at 30-day intervals to applicants urging them to submit responses.
If no action is taken, a fourth and final communication is issued, declaring the application rejected and the fee forfeited. As per this notice, applications pending for more than two years and already notified through reminders will be rejected within 30 days of the notice’s issue. Stakeholders are strongly advised to respond promptly to avoid rejection and ensure compliance with regulatory timelines. This measure aims to streamline processes and reduce administrative delays.