7 Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response 2026-May-04 779 KB

IT-11011(11)/16/2026 Ministry of Health and Family Welfare Directorate General of Health Services Central Drugs Standard Control Organization FDA Bhawan, Kotla Road, New Delhi — 110002

PUBLIC NOTICE

Date: 94 MAY 2006

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

It has been observed that applications across various divisions are pending at the applicant’s end due to non-submission of response to queries raised.

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In order to reduce this backlog of long-pending applications awaiting | query responses across various divisions, in continuation to the office order released on 16 January 2026 File No. IT-11011(11)/1/2026 more divisions including GCT, BABE, Ethics Committee and Veterinary (applications pending since 2016), the Central Drugs Standard Control Organisation (CDSCO) has initiated a structured reminder mechanism for applicants who have submitted applications on the SUGAM portal. As part of this mechanism, CDSCO issues reminders at fixed intervals to inform applicants to respond to the pending queries raised during the evaluation of their applications.

A series of three reminders are sent to the applicants, requesting them to submit responses to the pending queries within the prescribed timelines, as detailed in the Annexure attached to this notice.

The applicants who fail to respond to these queries through email and the SUGAM portal even after issuance of the three reminders are subsequently issued a fourth and final communication, informing them

that their application stands rejected, with the fee amount forfeited, in accordance with the applicable provisions.

In this regard, all stakeholders are hereby informed that applications pending with the applicants for more than two years have already been notified through the three-reminder process, shall now be rejected after a period of 30 days from the date of issue of this public notice. A final rejection communication shall be issued accordingly to the concerned applicants.

All stakeholders are advised to ensure that all pending queries are addressed within the stipulated time period to avoid rejection of their applications.

Carefully review the Annexure attached to this notice and take note of the prescribed timelines applicable to specific forms, and to respond to pending queries within the stipulated time to avoid rejection of their applications.

( feevSingh Raghuvanshi) ‘ Drugs Controller General (India)

TO,

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All stakeholders

Copy to:

I. All JDC(I)s, DDC(I)s in CDSCO(HQ)

li. Staff of DCGI

lii. Notice Board

iv. CDSCO Website

v. PRO Cell

vi. All Zones and Port Offices

Annexure

Days calculations for sending series of reminders

• ¢ Ist Reminder (Customised) on old files

• e 2nd Reminder = 1st reminder + 30 days

• ¢ 3rd Reminder = 2nd reminder + 30 days

• e 4th Disposal Notice = 3rd reminder + 30 days