CDSCO to Dispose of Long-Pending SUGAM Portal Applications Awaiting Query Response: What It Means and How to Act | MedRegX
Regulatory Update

CDSCO to Dispose of Long-Pending SUGAM Portal Applications Awaiting Query Response: What It Means and How to Act

UrgencyCDSCO

Regulatory Notice

This update has significant impact on business operations. Our regulatory team recommends reviewing your existing licenses immediately to ensure compliance with the new directives.

CDSCO Update · SUGAM Portal · India
Action required: The Central Drugs Standard Control Organisation (CDSCO) has issued a public notice that long-pending applications on the SUGAM portal still awaiting the applicant's query response may be disposed of or rejected. If you have a pending CDSCO application with an open query, respond now — before your file is closed.

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.

Reject
Unanswered files disposed
SUGAM
Where your queries live
Now
Respond before disposal
2017
Medical Device Rules

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 typeFormAt risk if query unanswered
Medical device import licenceMD-14 → MD-15Yes
Device manufacturing licenceMD-3/MD-5, MD-7/MD-9Yes
Test licenceMD-16 → MD-17Yes
Drug & cosmetic import registrationRegistrationYes

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:

1
Audit every pending file. Log in to SUGAM and list every application with an open query — don't assume you only have one.
2
Read the exact query. Understand precisely what CDSCO asked — a document, a clarification, a correction — and against which clause.
3
Prepare a complete response. Assemble the exact documents requested, correctly formatted, so nothing is left open to interpretation.
4
Submit before the deadline. Upload the response on SUGAM within the timeline — late is treated the same as no response.
5
Track to approval. Monitor the file for any follow-up query and respond quickly to keep it moving.

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:

✓  Incomplete Device Master File or Plant Master File
✓  Labelling not aligned with Medical Device Rules requirements
✓  Missing or expired free sale certificate / ISO 13485 records
✓  Authorised Indian Agent documents incomplete (for imports)
✓  Test reports that don't match the declared specification

The risk of getting the response wrong

MistakeConsequenceSeverity
No response to the queryApplication disposed / rejectedHigh
Incomplete responseFresh query, clock restartsMedium
Late submissionTreated as no responseHigh

How MedRegX helps protect your application

Pending-file audit
We review every SUGAM application for open queries.
Query analysis
We interpret exactly what CDSCO is asking and why.
Complete responses
We prepare correct documentation the first time.
On-time filing
We submit on the portal within the deadline.
Dossier correction
We fix Master File and labelling gaps that trigger queries.
Authorised Indian Agent
We can act as your agent for import applications.
Follow-up tracking
We monitor the file to final approval.
Re-application, if needed
If a file is already lost, we re-file it correctly.
Ongoing compliance
We keep your licences current after approval.

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.

Have a pending CDSCO application?

Let MedRegX audit your SUGAM files, resolve open queries and protect your licence before it's disposed of.

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