06th May,2026
The Central Drugs Standard Control Organisation (CDSCO) has announced a new step to clear old and pending applications on the SUGAM portal.
Many applications are stuck because applicants did not reply to the queries raised by CDSCO officials. To reduce this backlog, CDSCO has started a reminder system for applicants.
Why CDSCO Issued This Notice
Over the years, a significant number of applications submitted on the SUGAM portal have remained pending because applicants did not submit responses to clarification requests or queries raised by CDSCO officials. These delays have impacted timely processing and created an administrative burden across various divisions.
In continuation of the office order issued on 16 January 2026, CDSCO has now expanded the scope of this initiative to include additional divisions such as:
- GCT
- BA/BE
- Ethics Committee
- Veterinary Division (applications pending since 2016)
The authority has introduced a structured reminder and rejection framework to streamline pending applications and encourage timely compliance from applicants.
Structured Reminder Mechanism Introduced
To ensure transparency and provide sufficient opportunity for applicants to respond, CDSCO has implemented a communication process through email and the SUGAM portal.
- Three Reminder Notifications
Applicants with pending query responses receive three separate reminders at fixed intervals. These reminders request submission of the required information or clarification within the prescribed timeline mentioned in the Annexure attached to the public notice.
The reminders serve as an opportunity for applicants to regularize their applications before any regulatory action is taken.
- Final Rejection Communication
If the applicant fails to respond even after receiving all three reminders, CDSCO issues a fourth and final communication stating that:
- The application stands rejected
- The application fee is forfeited
- The rejection is in accordance with applicable regulatory provisions
This step marks the closure of the application process.
Applications Pending for More Than Two Years
CDSCO has specifically highlighted that applications pending with applicants for more than two years have already undergone the three-reminder process.
Such applications will now be rejected within 30 days from the date of issuance of the public notice if no response is received from the applicant.
A final rejection communication will then be issued to the concerned stakeholders.
Important Advisory for Stakeholders
CDSCO has advised all applicants and stakeholders to:
- Regularly monitor their SUGAM portal dashboard
- Check registered email communications frequently
- Respond to all pending queries within the stipulated timelines
- Carefully review the Annexure attached to the public notice for form-specific deadlines
Failure to comply may result in permanent rejection of applications and forfeiture of fees.
Impact on Industry and Applicants
This initiative reflects CDSCO’s increasing focus on:
- Digital governance
- Faster regulatory processing
- Reduction of administrative backlog
- Improved accountability among applicants
Organizations handling multiple regulatory submissions should consider implementing stronger internal tracking systems to ensure that no CDSCO communication goes unanswered.
Conclusion
CDSCO has clearly stated that long-pending applications without query responses will not remain active forever. Applicants should immediately review their pending applications and submit all required responses within the given timelines to avoid rejection.
🔍 Know Your Drug Approval Status
Before you act, ensure complete clarity on whether your product is approved, unapproved, or falls under the “new drug” category.
👉 Access real-time insights through Pharminho — your smart companion for tracking CDSCO approvals, upcoming drugs, and regulatory pathways.
👉 Partner with Vaayath Consulting Services Pvt Ltd, a trusted name in regulatory strategy and compliance solutions which will help you to understand and comprehend CDSCO queries to so that the same can be resolved in timely manner meeting the regulatory expectations.
🔗 For the official notice, click here.
