CDSCO to Reject Long-Pending Applications on SUGAM Portal After Final Reminder
The Central Drugs Standard Control Organization (CDSCO) has issued a new public notice regarding the disposal and rejection of long-pending applications on the SUGAM portal due to non-submission of query responses by applicants. The move is expected to streamline regulatory review processes and reduce backlog across multiple divisions.
According to the notice issued by the Ministry of Health and Family Welfare under the Directorate General of Health Services, applications pending with applicants for more than two years may now face rejection if responses to CDSCO queries are not submitted within the prescribed timelines.
Why CDSCO Issued This Public Notice
CDSCO observed that a significant number of applications across divisions remain pending because applicants failed to respond to regulatory queries raised during evaluation. To address this issue, CDSCO introduced a structured reminder mechanism for applications submitted through the SUGAM portal.
The initiative is an extension of the earlier office order dated 16 January 2026 and now includes additional divisions such as:
- GCT
- BABE
- Ethics Committee
- Veterinary applications pending since 2016
The authority stated that the objective is to reduce backlog, improve processing efficiency, and ensure timely regulatory compliance.
CDSCO Reminder Timeline for Pending Applications
As part of the updated compliance mechanism, CDSCO will issue reminders at fixed intervals for pending query responses.
Reminder Schedule
- 1st Reminder: Issued for old pending files
- 2nd Reminder: 30 days after the first reminder
- 3rd Reminder: 30 days after the second reminder
- 4th Disposal Notice: 30 days after the third reminder
Applicants who fail to respond even after three reminders will receive a final rejection communication, and the application fee may be forfeited as per applicable provisions.
Applications Older Than Two Years May Be Rejected
The public notice specifically highlights that applications pending with applicants for more than two years and already processed through the three-reminder mechanism will now be rejected after 30 days from the date of the notice.
CDSCO has advised all stakeholders, including pharmaceutical companies, medical device manufacturers, importers, exporters, and regulatory applicants, to review all pending queries carefully and submit responses within the stipulated timelines.
Impact on Medical Device and Pharma Companies
This development is important for companies involved in:
- Medical device registration in India
- CDSCO licensing
- Import license applications
- Clinical trial approvals
- Regulatory approvals through the SUGAM portal
Organizations with incomplete submissions or delayed query responses may face rejection, resulting in delays, additional regulatory burden, and financial losses due to forfeiture of application fees.
How Companies Can Avoid CDSCO Application Rejection
Businesses and regulatory applicants should:
- Regularly monitor the SUGAM portal
- Respond to CDSCO queries immediately
- Maintain complete technical documentation
- Ensure compliance with applicable Indian regulatory requirements
- Track reminder timelines carefully
- Work with experienced regulatory consultants for submission management
About Operon Strategist
Operon Strategist is a regulatory consulting and business advisory firm supporting medical device, pharmaceutical, IVD, and healthcare companies across India, the USA, the UK, Europe, and global markets.
The company provides end-to-end support for:
- Import License and Manufacturing License Support
Operon Strategist helps startups, manufacturers, importers, and exporters navigate complex regulatory pathways and accelerate market access while maintaining compliance with global standards.