**Disclaimer:** This article is for informational purposes only and does not constitute legal or regulatory advice. Import regulations change frequently and vary by product classification. Always consult CDSCO or a qualified regulatory advisor before filing.
Since early June 2026, the Central Drugs Standard Control Organisation (CDSCO) has deployed stricter backend validation rules within the SUGAM (System for Unified Guidance on Accelerated Marketing) portal. Import applications for new drugs, biologics and certain medical devices now face higher rejection rates at the Form 10A stage—the point at which CDSCO formally registers an importer or processes import applications. Importers and their regulatory consultants report a 40% first-submission rejection rate, driven by three specific documentation gaps that the portal now flags automatically. Understanding these gaps and pre-filing them reduces resubmission cycles, preserves your import calendar, and protects shelf-life windows on time-sensitive shipments.
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Form 10A (Application for Registration of a New Drug or Import of New Drug) now requires an explicit Batch-wise Certificate of Analysis (CoA) cross-referenced to your manufacturing site licence number and the batch number on the physical shipment. Previously, a generic notarised CoA from the manufacturer sufficed. The SUGAM portal now auto-rejects if the CoA file uploaded does not match the batch number in the accompanying shipping or customs documentation (Bill of Lading or AWB). Importers must now obtain a separate CoA per batch, verify batch number consistency across all documents before upload, and store them in a unified digital folder by importer code. This adds 7–10 days to the pre-filing timeline and increases document coordination costs with overseas suppliers.
Section 10A(1) of the Drugs and Cosmetics Rules, 1945 requires that Form 10A be signed by a Qualified Person (QP)—a pharmacist holding a current registration with the State Pharmacy Council. As of June 2026, SUGAM cross-references the QP's name and PAN against the All India Pharmacy Council registry in real-time. If the QP's registration has lapsed, been suspended, or the name/PAN does not match, the portal rejects the form immediately and locks the application status. Importers must now verify QP registration status directly on the State Pharmacy Council's public portal (accessible via the National Council for Pharmacy Education and Research portal) before drafting the Form 10A. A QP with a gap in renewal or a PAN transcription error triggers a 15–20 day correction cycle and potential loss of import priority dates.
SUGAM now validates that any stability data submitted with Form 10A conforms to ICH Q1A(R2) (International Council for Harmonisation Guideline on Stability Testing of Drug Substances and Products) and that the claimed shelf-life does not exceed the tested storage duration. If a manufacturer claims 36 months shelf-life but stability data covers only 24 months at 25°C/60% RH, the portal flags and rejects the application, forcing importers to request extended stability studies or negotiate a reduced shelf-life with the supplier. Many pharmaceutical importers discover this gap only after submission, delaying approvals by 3–4 weeks. Pre-filing requires an importer's quality team to independently audit all stability protocols against ICH Q1A(R2) and reconcile claimed shelf-
Frequently asked questions
The SUGAM portal's stricter backend validation now auto-rejects incomplete Form 10A submissions, particularly those missing batch-wise Certificate of Analysis (CoA) linkage to manufacturing site licence and shipment batch numbers. Three specific documentation gaps drive the 40% rejection rate.
Form 10A now requires an explicit batch-wise Certificate of Analysis cross-referenced to your manufacturing site licence number and the batch number on the physical shipment (Bill of Lading or AWB). A generic notarised CoA no longer suffices.
The new CoA linkage requirement adds 7–10 days to the process. Obtain a separate CoA per batch, verify batch number consistency across all documents, and pre-file before uploading to reduce resubmission cycles and protect shelf-life windows.