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CDSCO

Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response


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Regulatory update
Importer & Manufacturer   |   Source: CDSCO
Published On: 04-05-2026

Enforcement Date: 04 May, 2026
Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response

The Central Drugs Standard Control Organisation has issued a public notice regarding disposal of long‑pending applications on the SUGAM portal. Applicants who fail to respond to queries after three reminders will receive a final disposal notice, leading to rejection of their applications and forfeiture of fees. Applications pending for more than two years will be rejected within 30 days of this notice, unless responses are submitted within the prescribed timelines.


CDSCO, under the Ministry of Health and Family Welfare, has issued a public notice regarding the disposal and rejection of long‑pending applications on the SUGAM portal. It has been observed that several applications remain pending due to non‑submission of responses to queries raised during evaluation. To address this backlog, CDSCO has introduced a structured reminder mechanism. Applicants receive three reminders at fixed intervals, urging them to respond to pending queries. If no response is submitted, a fourth and final communication is issued, confirming rejection of the application and forfeiture of the fee. Applications that have been pending for more than two years and already notified through the reminder process will now be rejected within 30 days of this notice. Stakeholders are advised to carefully review the annexed timelines, ensure compliance, and submit responses promptly to avoid rejection. This measure aims to streamline regulatory processes and improve efficiency.   The process begins with a customized first reminder for old applications. A second reminder is sent 30 days after the first, followed by a third reminder 30 days later. If applicants still fail to respond, a fourth and final disposal notice is issued 30 days after the third reminder. This staged mechanism ensures applicants are given multiple opportunities to address queries before their applications are formally rejected and fees forfeited.

Applicable For: Importer & Manufacturer
Reference Number: IT-11011(11)/16/2026 Notification Link

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