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

The Indian government has mandated customs officers to manually verify licences, permissions and registration certificates for imported drugs, medical devices, cosmetics and other healthcare products. This new requirement comes into effect even for facilitated Bills of Entry, which are typically cleared through the customs risk-management system. The directive was issued by the Central Board of Indirect Taxes and Customs (CBIC) in a September 3 communication to importers and relevant authorities.

The decision to implement manual verification stems from a gap in the government's digital single-window system for imports, known as SWIFT 2.0. This system, designed to streamline the clearance process by allowing importers to submit information and obtain clearances from various government agencies electronically, is currently lacking in the integration of regulatory documents from the Central Drugs Standard Control Organisation (CDSCO).

Consequently, the drug regulator has tasked CBIC with conducting the necessary document checks before granting the final approval, known as "out-of-charge," which permits the importers to take the goods out of customs custody.

To address this issue, CDSCO has provided customs with seven product-specific checklists. These checklists cover a wide range of healthcare products and manufacturing inputs, including cosmetics, active pharmaceutical ingredients, finished medicines, medicines for personal use, certain small-quantity imports of new drugs, medical devices, in-vitro diagnostic kits, and raw materials and components used to manufacture medical devices.