New Enforcement on Query Responses and Export Simplifications Aim to Reduce Backlogs and Boost Ease of Doing Business
NEW DELHI — The Central Drugs Standard Control Organization (CDSCO) continues to strengthen the SUGAM Portal as the primary digital gateway for medical device, drug, and clinical trial approvals in India. Several key updates rolled out in early 2026 are now in full effect, directly impacting manufacturers, importers, and exporters.
Here are the most important SUGAM Portal developments as of May 8, 2026.
1. Strict Rules for Long-Pending Applications (May 4, 2026 Notice)
CDSCO issued a public notice on May 4, 2026, announcing it will dispose of or reject long-pending applications on the SUGAM Portal that remain unanswered after multiple reminders.
- Applicants now have a clear 30-day window (in some cases up to 90 days total) to respond to regulatory queries.
- After three reminders with no response, applications risk automatic rejection or disposal.
- The move aims to clear backlogs and improve processing efficiency across medical devices, drugs, and biologics.
Recommendation: Manufacturers should enable portal notifications and assign dedicated team members to monitor query responses daily.
2. Prior Intimation System for Form CT-05 (Effective April 21, 2026)
A major simplification for exporters: CDSCO introduced the Prior Intimation System for Form CT-05 applications related to bioavailability and bioequivalence studies for export purposes.
- Eligible applicants can now submit directly through the SUGAM Portal.
- The system-generated acknowledgement itself serves as valid prior intimation — eliminating the need for separate prior approval in many cases.
- This change, notified under G.S.R. 50(E), significantly reduces timelines for export-related studies.
3. Enhanced Integration with National Single Window System (NSWS)
SUGAM continues to work alongside the NSWS portal for specific medical device activities (such as Notified Body registration, test licenses, and import licenses for clinical investigations). This dual-portal approach provides more streamlined options for certain workflows.
4. Ongoing Digital Improvements
- Better real-time tracking and automated notifications.
- Support for eCTD pilot features (expanding in 2026).
- Improved modules for adding formulations, license details from State FDAs, and vaccine batch release certificates.
- Stronger emphasis on digital compliance — almost all applications must now be filed online.
Medical Device Manufacturers & Importers
For U.S. and global companies entering the Indian market, these updates mean faster potential approvals but higher accountability on response times. Delays in answering queries can now result in outright rejection, making proactive portal management essential.
The changes align with India’s broader “Ease of Doing Business” initiatives while maintaining strict quality and safety standards.
Looking Ahead
CDSCO is expected to release the final version of the Medical Devices (Amendment) Rules, 2026 after the May 9, 2026 comment deadline. Further SUGAM enhancements, including possible full transition toward a new open-architecture platform in the future, are also under discussion.
Practical Tips for Users in 2026
- Log in regularly and set up email/SMS alerts.
- Respond to queries promptly (ideally within 7–15 days).
- Keep all supporting documents updated and properly indexed.
- Work with experienced regulatory consultants for complex Class C/D device applications.
FAQs
1. What is the new rule for pending applications on SUGAM Portal? CDSCO will dispose of or reject applications that remain unanswered after three reminders (typically after 30–90 days total).
2. When did the Prior Intimation System for Form CT-05 start? It became effective on April 21, 2026, simplifying export-related bioequivalence study applications.
3. Is the SUGAM Portal mandatory for medical device approvals? Yes. Almost all manufacturing, import, and related applications must be submitted through SUGAM in 2026.
4. How can I track my application status? Log in to cdscomdonline.gov.in and use the dashboard for real-time tracking and notifications.
5. Will SUGAM Portal be replaced soon? A new open-architecture platform is under planning, but SUGAM remains the primary system for most submissions in 2026.