CDSCO on rejection of long-pending SUGAM Portal applications
CDSCO on Rejection of Long-pending SUGAM Portal Applications due to Non-Submission of Regulatory Responses

 

Dated: 16th January 2026

The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, Ministry of Health & Family Welfare, has issued a Public Notice regarding the disposal and rejection of long-pending applications on the SUGAM Portal due to non-submission of responses to regulatory queries.

This notice is a critical development for applicants across pharmaceuticals, medical devices, cosmetics, biologics, and related regulatory domains.

Background: Why This Notice Was Issued

CDSCO has observed that a significant number of applications across various divisions remain pending because applicants failed to respond to queries raised by the regulators. These unresolved applications have contributed to a growing backlog within the system.

To address this issue, CDSCO has initiated a structured reminder and disposal mechanism for applications that have been pending due to unanswered queries.

Structured Reminder Mechanism by CDSCO

CDSCO has implemented a four-stage reminder and disposal process for applicants who have not responded to queries:

Reminder Timeline (As per Annexure)

  • 1st Reminder: Customized reminder issued for old pending applications
  • 2nd Reminder: 1st reminder + 30 days
  • 3rd Reminder: 2nd reminder + 30 days
  • Final Disposal Notice: 3rd reminder + 30 days

Applicants are required to submit complete responses to pending queries within the stipulated timelines at each stage.

Regulatory Consequences

  • Applications that fail to receive a response even after three reminders are issued a final disposal communication via email.
  • Such applications will be rejected, and fees paid will be forfeited in accordance with applicable provisions.
  • Applications pending for more than two years have already being notified through three-reminder process and shall now be rejected within 30 days of this public notice.

Key Advisory for Applicants

CDSCO has strongly advised all stakeholders to:

  • Regularly monitor the SUGAM Portal
  • Respond promptly and comprehensively to all regulatory queries
  • Ensure submissions are made within prescribed timelines to avoid rejection

Failure to act may result in permanent loss of the application and associated fees.

How Vaayath Consulting Services Can Help:

At Vaayath Consulting Services, we support applicants by:

  • Reviewing pending SUGAM applications to identify unresolved regulatory queries
  • Preparing and validating query responses in line with CDSCO expectations
  • Tracking reminder timelines to ensure submissions are made within stipulated periods
  • Providing strategic regulatory guidance for legacy and complex applications
  • Preparing, Reviewing, and Validating application documents to ensure accurate and timely submission.

With increasing regulatory scrutiny, timely and accurate responses are essential. Vaayath Consulting Services helps companies remain compliant, responsive, and approval-ready in an evolving regulatory environment.

For More Details and support: Contact us at info@vaayath.com