CDSCO to Reject Long-Pending SUGAM Applications After 30 Days for Non-Response to Queries
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has announced that it will dispose of and reject long-pending applications submitted through the SUGAM portal where applicants have failed to respond to queries raised during the evaluation process, even after repeated reminders.
The decision has been conveyed through a public notice dated 16 January 2026, issued by the national drug regulator under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare.
The public notice applies to applications pending across multiple regulatory divisions due to the non-submission of responses by applicants.
According to the CDSCO, a review of applications on the SUGAM portal revealed that several submissions have remained pending at the applicant’s end, as responses to regulatory queries were not provided. These pending applications span various divisions, including:
- Subsequent New Drugs
- Investigational New Drugs
- New Drugs
- Fixed Dose Combinations
- Import of Cosmetics
- Biologics (applications pending since 2016)
- Medical Devices and In Vitro Diagnostics (applications pending since 2018)
The regulator stated that the prolonged pendency has contributed significantly to the backlog across divisions.
In order to reduce the backlog of long-pending applications awaiting query responses across various divisions, namely Subsequent New Drugs, Investigational New Drugs, New Drugs, Fixed Dose Combinations, Import Cosmetics, Biologics (applications pending since 2016), and Medical Devices and In Vitro Diagnostics (applications pending since 2018), the Central Drugs Standard Control Organization (CDSCO) has initiated a structured reminder mechanism for applicants who have submitted applications through 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 is 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.
Applicants who fail to respond to the pending 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
Importantly, the regulator has now set a final timeline for the disposal of such applications. The CDSCO informed all stakeholders that applications that have remained pending for more than two years and have already undergone the three-reminder process shall be rejected after a period of 30 days from the date of issuance of the public notice.
A final rejection communication will be issued to the concerned applicants once this 30-day period lapses.
In its concluding advisory, the CDSCO urged all stakeholders to ensure that all pending queries are addressed within the stipulated time period, cautioning that failure to do so would result in rejection of applications and forfeiture of fees.
To view the official notice, click the link below:
