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). 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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.