CDSCO Mandates Import of Drugs and Medical Devices Only Through Notified Ports

The Central Drugs Standard Control Organization (CDSCO) has issued a directive to the National Customs Targeting Centre (Cargo) to ensure that all imports of Drugs, Medical Devices, and Cosmetics are routed exclusively through the ports of entry officially designated under the Drugs Rules, 1945. The directive, dated October 7, 2025, emphasizes strict compliance with Rule 43-A of the Drugs Rules, 1945, which specifies the legal entry points for drugs into India.

Key Regulatory Requirements

Rule 43-A states that “no drug shall be imported into India except through one of the following places.” This rule is the foundational provision governing import control.

CDSCO has successfully mapped its CDSCO Port Offices with the notified ports of entry on ICEGATE of customs. This integration standardizes the processing of import consignments.

The CDSCO has requested the Additional Director of the National Customs Targeting Centre to permit the entry of consignments only through the listed notified ports and to refer the Bills of Entry (BOE) on ICEGATE to the concerned CDSCO port offices for regulatory processing.

Notified Ports of Entry

The notification includes an annexure listing the authorized points of entry for import, categorized by mode of transport. The CDSCO Port Offices are mapped to the nearest designated entry points.