Every drug, cosmetic and medical device application in India passes through CDSCO's online SUGAM portal, and at some stage most applications receive a query — a request for clarification, a missing document, or a correction. When that query is raised, the file effectively pauses and waits for the applicant to respond. CDSCO has now made clear that files left waiting for too long will not sit in the queue indefinitely: long-pending applications awaiting a query response are being cleared out.
For any business, the risk is quiet but serious. An import licence, manufacturing licence, test licence or product registration you assumed was still "in process" could be rejected simply because a query was never answered — forcing you to start again and lose weeks or months of progress. This update explains exactly what the notice means, who it affects, the consequences, and precisely how to respond so your application reaches approval.
What the CDSCO notice says
In plain terms, CDSCO's notice states that applications pending on the SUGAM portal for a long time, where the applicant has not responded to a query raised by the department, are liable to be disposed of. "Disposed of" means the application is closed and treated as rejected. The onus is squarely on the applicant: once CDSCO raises a query, it is the business's responsibility to respond completely and on time, and files that remain silent are cleared from the pipeline.
Why CDSCO is clearing the backlog
The SUGAM portal handles a very large volume of applications across drugs, cosmetics and medical devices, and a significant share of them stall not because of any regulatory objection but because applicants never answer the query raised. These dormant files clog the queue and slow processing for everyone. Clearing long-pending, unanswered applications lets CDSCO focus on active files and keeps the system moving — which is good for compliant businesses, but costly for anyone who has lost track of an open query.
Who is affected
Anyone with a pending application on the CDSCO SUGAM portal that is awaiting a query response should treat this as urgent. That includes:
| Application type | Form | At risk if query unanswered |
|---|---|---|
| Medical device import licence | MD-14 → MD-15 | Yes |
| Device manufacturing licence | MD-3/MD-5, MD-7/MD-9 | Yes |
| Test licence | MD-16 → MD-17 | Yes |
| Drug & cosmetic import registration | Registration | Yes |
If CDSCO raised any clarification on your file that you have not yet answered, your application is exposed — regardless of how far along it was.
What happens if your application is disposed
Disposal is not a minor setback. When an application is closed, you typically cannot simply reopen it — you re-apply from the beginning. That means re-paying government fees, re-assembling and re-submitting the full dossier, and, most painfully, losing the queue position and the weeks or months already invested. For importers, it can also mean consignments held at customs while a fresh licence is processed. A single unanswered query can therefore erase a large amount of time, money and momentum.
How to respond to a CDSCO query correctly
Responding is not just about uploading something before the deadline — it is about resolving the query in one clean submission so the file moves forward instead of bouncing back. Follow this order:
Common reasons CDSCO raises queries
Most queries trace back to a handful of avoidable gaps. Fixing these at the response stage prevents a fresh round of queries:
The risk of getting the response wrong
| Mistake | Consequence | Severity |
|---|---|---|
| No response to the query | Application disposed / rejected | High |
| Incomplete response | Fresh query, clock restarts | Medium |
| Late submission | Treated as no response | High |
How MedRegX helps protect your application
If you hold — or think you might hold — a pending CDSCO application, do not wait for a rejection notice to find out a query went unanswered. Explore our CDSCO compliance services, medical device registration and medical device import support to keep your approvals on track.
The message from CDSCO is simple: an open query is a live deadline. Answer it completely and on time, and your application moves forward; ignore it, and the file is cleared. With the right review and a complete response, this notice is nothing to fear — it is a prompt to protect the progress you've already made.
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