Page 9 - Guidance document for import of Drugs & Pharmaceuticals from India

Inspection by Agencies appointed by importing countries

Some FDAs of importing countries have appointed their own agencies in India

to inspect/test all the consignments destined to their countries. An

Inspection/Analysis Certificate (Certificate of Analysis) from such approved

laboratories has to be submitted by the exporter for export consignments.

Clearance by Customs at Indian Ports

When the consignment is ready for export, the exporter submits all Export

Formalities as required by Customs. In India, Drugs & Pharmaceuticals can be

Imported/Exported only from some notified ports (sea/air) where an Officer

from CDSCO is stationed/assigned. Any export consignment of Drugs &

Pharmaceuticals will be cleared by Customs only after producing Clearance

Certificate from the officer of CDSCO.

The CDSCO officer will

- Verify the Certificate of Analysis issued by manufacturer or a

laboratory approved by importing country or a laboratory approved

by CDSCO

- Draw samples of all consignments wherever required for test attest

and analysis for quality (particularly pharmaceutical formulations)

- Verify self-certification by the exporter that they have complied with

all barcoding procedures

- Verify all related authorizations/license copies.