Etoposide

Etoposide medicament, antineoplastic drug formulation

HSN 3004 90 45 (Etoposide) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory pre-clearance documents uploaded in e-Sanchit before out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay, and the Ministry of Environment, Forest and Climate Change applies conditions on used or refurbished medical equipment per the O.M. dated 15 December 2023.

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

1. 1
   Obtain a valid drug registration certificate and import licence for Etoposide from the Central Drugs Standard Control Organisation 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 the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The customs proper officer will verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
   e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc
3. 3
   Note that import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020, both dated 23 May 2022; only oxytocin reference standards for test and analysis are permitted, subject to a test licence from DGCI/CDSCO. Etoposide is a distinct active pharmaceutical ingredient and is not subject to that prohibition, but the bill of entry must clearly identify the product.
   S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022