Reply Within 30 Days or SUGAM Applications Will Be Rejected, CDSCO Warns Applicants

New Delhi: In a major regulatory move aimed at reducing backlog and improving efficiency, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has issued a public notice announcing the disposal and rejection of long-pending applications on the SUGAM portal that remain incomplete due to non-response from applicants.

The notice, issued from FDA Bhawan, New Delhi, highlights that numerous applications across various CDSCO divisions have been pending at the applicant’s end because applicants failed to respond to queries raised during the evaluation process.

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. Specifically, a series of three reminders are issued, each requesting the applicant to submit responses within prescribed timelines.

"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." the notice stated.

In this regard, it is stated:

"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," the notice added.

To view the official notice, click the link below

https://medicaldialogues.in/pdf_upload/2026/05/06/disposal-of-long-pending-application-345842.pdf