Other

Insulin-containing medicaments, other than insulin analogues

HSN 3004 31 90 (insulin-containing medicaments, other) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies the tariff line under import-policy controls, and mandatory e-Sanchit documentation — including a Registration Certificate, Import Licence, Certificate of Analysis, Batch Release Certificate, and label — must be uploaded before out-of-charge.

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

1. 1
   Obtain a valid drug Registration Certificate from CDSCO and an Import Licence for drugs before shipment. Both documents must be uploaded in e-Sanchit under document codes 101dc1 (Registration Certificate — drugs) and 9111dc (Import Licence for drugs) at the bill of entry stage before out-of-charge.
   Drugs and Cosmetics Act, 1940 · document codes 101dc1, 9111dc
2. 2
   Upload the Certificate of Analysis — drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and the label of consignment (document code 0110dc) in e-Sanchit. The proper officer must verify all five mandatory documents before granting out-of-charge on any PGA-facilitated bill of entry.
   Document codes 0010dc, 0030dc, 0110dc — e-Sanchit mandatory upload requirement
3. 3
   Note the absolute prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Import of oxytocin reference standards is permitted exclusively for test and analysis purposes, subject to submission of a test licence issued by DGCI/CDSCO.
   S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022