Bincristine and vinblastine

Vincristine and vinblastine medicaments for therapeutic use

HSN 3004 90 43 (Vincristine and vinblastine) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document verification at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay, and the Ministry of Environment, Forest and Climate Change applies additional conditions relevant to high-value used or refurbished medical equipment under its O.M. dated 15 December 2023.

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

1. 1
   Obtain a valid import licence for drugs and confirm that the foreign manufacturer holds a current CDSCO registration certificate before filing the bill of entry. Both the registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) must be uploaded in e-Sanchit prior to out-of-charge.
   Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2. 2
   Upload in e-Sanchit the Certificate of Analysis – Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) at the bill of entry. The proper officer is required to verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
   CBIC CCR mandatory-document requirement · document codes 0010dc, 0030dc, 0110dc
3. 3
   Note that oxytocin import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23 May 2022; oxytocin reference standards may be imported exclusively for test and analysis subject to a test licence issued by DGCI/CDSCO. Ensure this HSN is not used to mis-declare any oxytocin formulation.
   S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022