Govt mandates manual verification of imported drugs and medical devices due to SWIFT 2.0 system gap

The Centre has asked customs officers to manually verify licences, permissions and registration certificates before clearing imported drugs, medical devices, cosmetics and a wide range of other healthcare products and manufacturing inputs.

The check will apply even to facilitated Bills of Entry, or imports that have otherwise been cleared through the customs risk-management system, according to a September 3 communication sent by the Central Board of Indirect Taxes and Customs (CBIC) to importers and field formations.

The reason is 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 instead of dealing separately with each agency. However, regulatory documents of the Central Drugs Standard Control Organisation (CDSCO) are not yet fully integrated into the system. Hence, the drug regulator 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.


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.

New Delhi: The Centre has asked customs officers to manually verify licences, permissions and registration certificates before clearing imported drugs, medical devices, cosmetics and a wide range of other healthcare products and manufacturing inputs.

The check will apply even to facilitated Bills of Entry, or imports that have otherwise been cleared through the customs risk-management system, according to a September 3 communication sent by the Central Board of Indirect Taxes and Customs (CBIC) to importers and field formations.

The reason is 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 instead of dealing separately with each agency. However, regulatory documents of the Central Drugs Standard Control Organisation (CDSCO) are not yet fully integrated into the system. Hence, the drug regulator 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.

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.