The Central Board of Indirect Taxes and Customs has directed customs officers to manually verify regulatory documents for imported drugs, cosmetics, medical devices and associated manufacturing inputs while relevant Central Drugs Standard Control Organisation records remain incompletely integrated with SWIFT 2.0.
The requirement applies even to participating-government-agency-facilitated Bills of Entry that have otherwise cleared the customs risk-management system. Officers must complete the document review before granting “out-of-charge,” the final customs approval that permits importers to remove goods from customs custody. The implementation directive was reported on September 7.
SWIFT 2.0 is intended to give importers a common electronic interface for submitting information and securing approvals from multiple government agencies. In this case, licences, permissions and registration certificates required by CDSCO are still being incorporated into the platform. The temporary manual process is designed to prevent facilitated consignments from receiving final clearance without verification of mandatory healthcare-product documentation.
CBIC formalised the procedure through Circular No. 40/2026-Customs, dated September 3. CDSCO has supplied seven category-specific checklists: cosmetics; active pharmaceutical ingredients and finished drug formulations; drugs brought in for personal use or in small quantities by eligible government hospitals and autonomous medical institutions; drugs imported for examination, testing or analysis; medical devices including in-vitro diagnostic kits; specified medical-device imports for investigation, evaluation, demonstration, training or personal use; and raw materials or components used in medical-device manufacturing.
The final category extends beyond physical parts to substances, software, firmware, labelling and assemblies intended for incorporation into a finished, packaged and labelled device. The framework therefore reaches technology suppliers and manufacturers whose imported inputs may combine hardware, embedded software and regulated medical functionality. The circular’s category structure and filing directions confirm the seven-part scope.
Importers have been asked to upload the applicable material through e-SANCHIT so officers can complete verification without requesting the same documents separately. Customs formations must also inform industry participants of the requirement through public notices and report implementation difficulties to the board.
The direction does not reverse the government’s trade-facilitation programme or suspend SWIFT 2.0. It introduces a controlled manual step while the electronic integration is unfinished. The immediate operational effect will depend on how consistently importers upload complete records and how quickly individual customs formations incorporate the checklists into their clearance workflows.
For pharmaceutical, diagnostics and medical-technology companies, the affected documentation now needs to be available at the point of final customs clearance even when a consignment receives risk-based facilitation. The arrangement will remain relevant until the underlying CDSCO documents become fully available within the single-window system.
