Other
Antibiotic medicaments in measured doses, retail packs
HSN 3004 20 69 (antibiotic medicaments, other) is subject to drug import registration and licensing under the Drugs and Cosmetics Act, 1940, administered through the Central Drugs Standard Control Organisation (CDSCO), with mandatory e-Sanchit document uploads at the bill of entry. The Directorate General of Foreign Trade (DGFT) imposes an ITC (HS) policy overlay, including a prohibition on oxytocin imports except for reference standards authorised by DGCI/CDSCO. The Ministry of Environment, Forest and Climate Change also applies conditions to used or refurbished medical equipment consignments under its Office Memorandum dated 15 December 2023.
- Registration certificate from CDSCO
- Import licence for drugs from CDSCO
- Batch release certificate from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Obtain a valid drug import licence (document code 9111dc) and a registration certificate for the drug (document code 101dc1) from the Central Drugs Standard Control Organisation before the consignment ships. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry to obtain out-of-charge.Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
- 2Upload 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. The proper officer is required to verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO drug import compliance requirements
- 3If the consignment contains oxytocin, import is prohibited unless the oxytocin is a reference standard exclusively for test and analysis purposes, supported by a test licence issued by DGCI/CDSCO. Any other oxytocin import is absolutely prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020, both dated 23 May 2022.S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
The most common error on this tariff line is uploading only the import licence and registration certificate while omitting the Certificate of Analysis and Batch Release Certificate — all five document codes (9111dc, 101dc1, 0010dc, 0030dc, 0110dc) are independently mandatory in e-Sanchit and a missing upload on any one will trigger detention at the port of entry. Additionally, importers handling any antibiotic formulation that includes oxytocin as an excipient or active ingredient must satisfy themselves that the strict prohibition under S.O. 2357(E) does not apply before shipment, since post-arrival discovery results in confiscation rather than rectification.