The Central Board of Indirect Taxes and Customs (CBIC) has issued a standardised checklist which a Customs officers will have to follow before clearing import consignments of cosmetics, drugs and medical devices.
These products require certain mandatory compliance in terms of licenses, permissions, and registration certificates, as per the provisions of the Drugs and Cosmetics Act, 1940.
The checklist follows the Central Drugs Standard Control Organisation (CDSCO)’s measures to facilitate and enhance ease of doing business in these products, the CBIC circular said.
These products have been grouped into seven categories — cosmetics; Drugs in the form of API, finished formulation, import for personal use/import of small quantities of new drug by a medical institution, import for test/analysis.
The checklist for medical devices import has been grouped into in vitro diagnostics kits/devices, import of medical devices and import of raw material for manufacture of such devices.
“… The field formations may be sensitised to check the documents at the time of out of charge,” the CBIC said, while adding that businesses will have to upload the required documents on e-SANCHIT to facilitate expedited clearance.
An tax expert said the circular marks a monumental shift from discretionary manual vetting to an objective, checklist-driven compliance framework for medical device imports.
“By mandating a standardised, electronic verification protocol across all ports, this directive eliminates arbitrary bureaucratic hurdles and brings transparency to the clearance process,” he said.
This would drastically reduce port dwell times, safeguard companies from punitive demurrage charges, and inject much-needed velocity into the medical supply chain.
“Instead of a manual discretionary method, it’s moving towards a checklist-based clearance which will give more certainty during import of medical devices,” he said.
Another tax expert said through the circular, the CBIC has consolidated and standardised the existing CDSCO compliance framework into the Customs clearance process.
“Its success will depend on whether these checklists lead to predictable, uniform verification rather than another layer of discretionary scrutiny,” he added.
Source from: https://www.thehindubusinessline.com/economy/cbic-issues-checklist-for-clearance-of-cosmetics-drugs-medical-devices-imports/article71437783.ece
