Ibuprofen with or without paracetamol or other compounds

Ibuprofen medicaments, with or without paracetamol

HSN 3004 90 63 (Ibuprofen with or without paracetamol or other compounds) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licence requirements under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line with policy overlays including a prohibition on oxytocin imports and ITC (HS) restricted-import conditions. All mandatory documents must be uploaded in e-Sanchit before customs out-of-charge is granted.

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

1. 1
   Obtain a valid drug registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before shipment. Both documents must be uploaded in e-Sanchit at the bill of entry stage prior to out-of-charge.
   Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc (e-Sanchit mandatory upload)
2. 2
   Upload the Certificate of Analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the consignment label (document code 0110dc) in e-Sanchit before the bill of entry is processed. The proper officer is required to verify all five mandatory documents before granting out-of-charge.
   CBIC e-Sanchit mandatory document upload 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 23-05-2022; 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