India Mandates Manual Verification of Imported Drugs
The Indian government has ordered manual checks on all imported drugs and medical devices due to a gap in the SWIFT 2.0 digital single-window system, affecting even low-risk imports
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CBIC issues standardised checklist for clearance of cosmetics, drugs, and medical devices imports.
Story published. The Indian government has ordered manual checks on all imported drugs and medical devices due to a gap in the SWIFT 2.0 digital single-window system, affecting even low-risk imports
The Indian government has mandated manual verification of imported drugs and medical devices due to a gap in the SWIFT 2.0 system. This measure, announced on September 3, applies to all imports, including those that have been cleared through the customs risk-management system.
The Central Board of Indirect Taxes and Customs (CBIC) has sent a communication to importers and field formations regarding the manual verification process. The Central Drugs Standard Control Organisation (CDSCO) has provided customs with seven product-specific checklists for manual verification, covering a range of products including cosmetics, active pharmaceutical ingredients, finished medicines, and medical devices.
The manual verification is necessary because the CDSCO's regulatory documents are not yet fully integrated into the SWIFT 2.0 system. As a result, the drug regulator has requested the 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.
The product-specific checklists provided by CDSCO cover a range of products, including medicines imported for personal use, certain small-quantity imports of new drugs, in-vitro diagnostic kits, and raw materials and components used to manufacture medical devices. This means that all imports of these products will require manual verification, regardless of their risk profile.
## Why it matters The manual verification process is a significant development for importers of drugs and medical devices in India. The SWIFT 2.0 system was designed to streamline the import process and reduce clearance times. However, the gap in the system has necessitated the manual verification process, which may lead to delays and increased costs for importers. The move is likely to affect a wide range of stakeholders, including pharmaceutical companies, medical device manufacturers, and healthcare providers.
The manual verification process is a temporary measure until the CDSCO's regulatory documents are fully integrated into the SWIFT 2.0 system. The government's decision to mandate manual verification highlights the importance of ensuring the safety and efficacy of imported drugs and medical devices, and the need for effective regulatory oversight in the pharmaceutical and medical device sectors.
