Other
Other medicaments for therapeutic or prophylactic use, retail pack
HSN 3004 90 39 covers residual medicaments for therapeutic or prophylactic use put up in measured doses for retail sale, and import is primarily governed by the Central Drugs Standard Control Organisation (CDSCO) drug-registration and import-licence regime under the Drugs and Cosmetics Act, 1940. Narcotic Drugs and Psychotropic Substances (NDPS) controls apply as a concurrent overlay where the consignment contains a scheduled psychotropic substance such as tramadol. The Ministry of Environment, Forest and Climate Change (MEFCC) imposes additional conditions on used or refurbished medical equipment, and the Directorate General of Foreign Trade (DGFT) administers the underlying ITC (HS) import policy.
- Registration certificate from CDSCO
- Import licence for drugs from CDSCO
- Import certificate from NDPS
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Obtain a valid drug registration certificate and import licence from CDSCO before filing the bill of entry. Upload the Registration Certificate (document code 101dc1) and the Import Licence for Drugs (document code 9111dc), along with the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit prior to out-of-charge.Drugs and Cosmetics Act, 1940 · document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc (e-Sanchit mandatory upload)
- 2Where the consignment contains tramadol or another scheduled psychotropic substance, produce an import certificate issued by the Narcotics Commissioner before clearance. Import of tramadol without this certificate is prohibited under Rule 53 of the NDPS Rules.Rule 53 of the NDPS Rules · S.O. 1761(E) dated 26-04-2018, Department of Revenue
- 3Note that import of oxytocin is prohibited; only oxytocin reference standards for test and analysis are permissible, subject to submission of a test licence issued by DGCI/CDSCO. Where the consignment comprises used or refurbished medical equipment, comply with the conditions issued by MEFCC in the O.M. dated 15-12-2023.S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022 · MEFCC O.M. dated 15-12-2023
The most frequent error on this residual tariff line is treating it as a standard CDSCO-only clearance when the consignment contains a substance subject to NDPS prohibition or restriction — tramadol in particular. An importer who holds a current CDSCO import licence but has not separately obtained the Narcotics Commissioner's import certificate will face detention and potential seizure of the entire consignment at the bill-of-entry stage; the NDPS certificate must be in hand before the vessel departs the load port.