CBIC releases import clearance checklist for cosmetics, drugs, and medical devices

The CBIC has introduced a new checklist for customs officers reviewing imports. This standardized process aims to streamline clearances for drugs and medical devices. Businesses must upload all required documentation onto the e-SANCHIT portal. Ind...

Agencies

Customs officers inspect imported pharmaceuticals and medical devices using a new standardized CBIC checklist designed to streamline clearances and align with CDSCO regulatory guidelines.

The Central Board of Indirect Taxes and Customs (CBIC) has released a standardized checklist for Customs officers to review prior to approving import consignments of cosmetics, drugs, and medical devices.

Under the provisions of the Drugs and Cosmetics Act, 1940, these goods must adhere to strict regulatory compliance, including mandatory licenses, permissions, and registration certificates. According to the CBIC circular, the newly introduced checklist aligns with measures established by the Central Drugs Standard Control Organisation (CDSCO) aimed at promoting ease of doing business for these sectors.

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The compliance guidelines organize the products into seven distinct categories:

  • Cosmetics
  • Drugs as Active Pharmaceutical Ingredients (APIs)
  • Finished Formulations
  • Imports for Personal Use
  • Import of Small Quantities of New Drugs by Medical Institutions
  • Imports for Testing and Analysis
  • Medical Devices (further divided into in vitro diagnostic kits/devices, general medical device imports, and raw materials used for manufacturing)
To enable expedited clearances, businesses are required to upload all necessary documentation onto the e-SANCHIT portal. "... The field formations may be sensitised to check the documents at the time of out of charge," the CBIC stated.

Industry experts have welcomed the shift toward a streamlined, digital process:
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  • Sivakumar Ramjee, Executive Director - Indirect Tax at Nangia Global: "By mandating a standardised, electronic verification protocol across all ports, this directive eliminates arbitrary bureaucratic hurdles and brings transparency to the clearance process." He noted that the circular marks a monumental shift from discretionary manual vetting to an objective, checklist-driven compliance framework for medical device imports. "Instead of a manual discretionary method, it's moving towards a checklist-based clearance which will give more certainty during import of medical devices," Ramjee said, emphasizing that it will reduce port dwell times, shield companies from punitive demurrage charges, and accelerate the medical supply chain.
  • Rajat Mohan, Managing Partner at AMRG & Associates: "Its success will depend on whether these checklists lead to predictable, uniform verification rather than another layer of discretionary scrutiny," Mohan added, noting that the CBIC has effectively consolidated and standardized the existing CDSCO compliance framework directly into the Customs clearance process.
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