Nalidixic acid

Nalidixic acid antibiotic medicaments in retail packs

HSN 3004 20 32 (Nalidixic acid) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, as a finished antibiotic medicament in measured doses or retail packing. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay, and the Ministry of Environment, Forest and Climate Change applies a conditions-based restriction on used or refurbished medical equipment imports per its O.M. dated 15 December 2023.

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

1. 1
   Obtain a current CDSCO import licence for drugs (document code 9111dc) and confirm the drug registration certificate (document code 101dc1) is valid for the specific formulation before filing the bill of entry. Both documents must be uploaded in e-Sanchit prior to out-of-charge.
   Drugs and Cosmetics Act, 1940 · document codes 9111dc and 101dc1
2. 2
   Upload all mandatory drug-clearance documents in e-Sanchit at the bill of entry: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer verifies each document before granting out-of-charge.
   CBIC PGA-facilitated bills procedure · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3. 3
   Note that import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022; only oxytocin reference standards for test and analysis are permitted, subject to a test licence from DGCI/CDSCO. This prohibition does not apply to nalidixic acid but must be confirmed where a consignment contains multiple active pharmaceutical ingredients.
   S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022