The Central Drugs Standard Control Organisation (CDSCO) has announced that it will dispose of and reject long-pending applications submitted through the SUGAM portal if applicants fail to respond to regulatory queries within 30 days.
This decision was communicated through a public notice dated 16 January 2026, issued under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare.
Looking For a Medical Device Regulatory Consultant?
Why CDSCO Is Rejecting Pending Applications
According to the regulator, several applications have remained pending at the applicant’s end because responses to regulatory queries were not submitted, even after repeated reminders.
To improve regulatory efficiency and clear backlog cases, CDSCO has now implemented a strict 30-day response window. If applicants do not provide satisfactory responses within this timeline, their applications will be rejected.
This move is aimed at:
- Reducing long-standing backlog
- Improving transparency and accountability
- Ensuring faster processing for active applicants
- Strengthening India’s regulatory framework
Applications Affected by the Notice
The pending applications span multiple regulatory divisions, including:
- Subsequent New Drugs
- Investigational New Drugs
- New Drugs
- Fixed Dose Combinations (FDCs)
- Import of Cosmetics
- Biologics (applications pending since 2016)
- Medical Devices and In Vitro Diagnostics (applications pending since 2018)
Pharmaceutical companies, cosmetic importers, biologics manufacturers, and medical device companies with pending SUGAM submissions are advised to review their application status immediately.
What This Means for Manufacturers and Importers
Failure to respond within 30 days may result in:
- Automatic rejection of the application
- Requirement for fresh submission
- Additional government fees
- Significant delay in product approval and market entry
Companies should proactively monitor SUGAM portal updates and ensure timely compliance with CDSCO queries to avoid regulatory setbacks.
Unsure how to respond to CDSCO queries?
How Operon Strategist Can Help
Navigating CDSCO queries and regulatory responses requires technical expertise and documentation precision. Operon Strategist supports pharmaceutical, biologics, cosmetic, and medical device companies with:
- End-to-end SUGAM application filing
- Regulatory query response drafting
- Gap analysis and documentation review
- CDSCO compliance strategy
- Fast-track resubmission support after rejection
With strong expertise in Indian regulatory pathways, Operon Strategist ensures timely, compliant, and structured responses that reduce approval delays and prevent application rejection.
If your SUGAM application is pending or has received a query notice, immediate expert intervention can safeguard your approval timeline.
We also assist manufacturers with ISO 13485 compliance, CE Marking strategy, US FDA regulatory consulting, and global market entry planning.
