CDSCO Introduces 90-Day Rule for Application Rejection on SUGAM Portal
India’s Central Drugs Standard Control Organisation (CDSCO) has announced that product applications will be rejected if applicants fail to respond to official regulatory queries within 90 days of receiving the first reminder. The CDSCO aims to clear long-pending applications across drugs, medical devices, and IVDs.
On January 16, 2026, the CDSCO cited a significant backlog of applications, some of which have been pending for 8–10 years, largely due to unanswered inquiries on the SUGAM Portal (the official online application portal).
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As a one-time measure, the CDSCO issued a final warning to applications pending for more than two years that have already received three reminders. If they do not receive responses by February 14, 2026, these applications will be rejected.
Moving forward, the CDSCO will follow a structured reminder mechanism — a first reminder for unanswered inquiries, followed by a second and third reminder at 30-day intervals. If no response is received within 30 days of the third reminder, the application will be discarded.
In addition, the CDSCO has introduced a voluntary pre-filing consultation facility that enables medical device manufacturers and importers to obtain official confirmation of device risk classification before submitting a license application. The initiative aims to address inconsistencies in risk classification, especially for Class A and B devices, which can affect regulatory requirements, fees, and approval timelines. The facility is available for medical devices (excluding IVDs), free of charge, and requires submission of basic product and global regulatory information.
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How Operon Strategist Can Help:
Medical device manufacturers and importers can avoid application rejection risks by ensuring timely query responses, accurate documentation, and correct risk classification. Operon Strategist supports end-to-end CDSCO registration, SUGAM portal handling, and pre-filing consultation services to streamline approvals.
Learn more: CDSCO Registration for Medical Devices
FAQs
What is the new CDSCO rule for application rejection?
CDSCO will reject applications if applicants fail to respond to regulatory queries within 90 days from the first reminder.
What is the deadline for old pending applications?
Applications pending for more than two years with three reminders must be responded to by February 14, 2026, or they will be rejected.
What is the SUGAM portal?
It is the official CDSCO online platform used for submitting and tracking drug, medical device, and IVD applications.
What is the new pre-filing consultation facility?
It allows manufacturers and importers to get confirmation on medical device risk classification before applying for a license.
Is the pre-filing consultation facility free?
Yes, it is available free of charge for medical devices (excluding IVDs).
