The Central Board of Indirect Taxes and Customs (CBIC) has issued a mandatory directive requiring manual verification of licenses, permissions, and registration certificates for imported drugs, medical devices, cosmetics, and other healthcare products. According to a September 3 communication sent to importers and field formations, this manual check applies even to facilitated Bills of Entry or imports that have otherwise been cleared through the customs risk-management system. The directive addresses a gap in the government's digital single-window system for imports, SWIFT 2.0, which allows importers to submit information and obtain clearances from different government agencies through a common electronic process.
The manual verification requirement stems from regulatory documents of the Central Drugs Standard Control Organisation (CDSCO) not being fully integrated into the SWIFT 2.0 digital system. As reported by Business Standard, CDSCO has requested CBIC to check the documents themselves before giving out-of-charge, the final approval that allows an importer to take the goods out of customs custody. This gap in the government's digital system necessitates the manual document check to ensure regulatory compliance across all healthcare product categories.
CDSCO has provided customs with seven product-specific checklists covering cosmetics, active pharmaceutical ingredients and finished medicines, medicines imported for personal use, certain small-quantity imports of new drugs as well as medical devices, in-vitro diagnostic kits, and raw materials and components used to manufacture medical devices. These products require mandatory compliance in terms of licenses, permissions, and registration certificates as per the provisions of the Drugs and Cosmetics Act, 1940. The categorised approach provides clearer compliance management and streamlined verification processes for customs officers.
Nangia Global's Executive Director Sivakumar Ramjee described the circular as marking a monumental shift from discretionary manual vetting to an objective, checklist-driven compliance framework for medical device imports. As reported by Business Standard, Ramjee noted that this directive eliminates arbitrary bureaucratic hurdles and brings transparency to the clearance process. He expects the new system to drastically reduce port dwell times, safeguard companies from punitive demurrage charges, and inject much-needed velocity into the medical supply chain.
AMRG Global Managing Partner Rajat Mohan highlighted that the CBIC has consolidated and standardised the existing CDSCO compliance framework into the Customs clearance process. According to Business Standard, Mohan emphasised that the success of this initiative will depend on whether these checklists lead to predictable, uniform verification rather than another layer of discretionary scrutiny. The new system represents a move towards checklist-based clearance which will give more certainty during import of medical devices compared to the previous manual discretionary method, though the manual verification requirement adds an additional layer of compliance verification.
