Other
Other medicaments for therapeutic or prophylactic use, retail-packed
HSN 3004 90 79 covers residual medicaments put up in measured doses or retail-sale packaging, and import is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Two product-specific prohibitions overlay the general regime: import of oxytocin is prohibited except for reference standards authorised by DGCI/CDSCO for test and analysis, and import of the psychotropic substance tramadol is prohibited except on production of an import certificate from the Narcotics Commissioner under Rule 53 of the NDPS Rules. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy conditions governing these carve-outs.
- Registration certificate from CDSCO
- Import licence for drugs from CDSCO
- Import certificate from Narcotics Commissioner
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Upload the drug registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) in e-Sanchit before filing the bill of entry. The customs proper officer must verify both documents — along with the Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc) — are present before granting out-of-charge.CDSCO · e-Sanchit document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc
- 2If the consignment contains tramadol, produce the import certificate issued by the Narcotics Commissioner before clearance; import without this certificate is prohibited under Rule 53 of the NDPS Rules. If the consignment contains oxytocin, it must be exclusively for test and analysis and must be accompanied by a test licence issued by DGCI/CDSCO.Rule 53 of the NDPS Rules · S.O. 1761(E) dated 26-04-2018 (Dept of Revenue) · S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022
- 3For any used or refurbished medical equipment falling within this tariff line, comply with the conditions imposed by the Ministry of Environment, Forest and Climate Change (MEFCC); such imports are restricted and subject to the conditions set out in the MEFCC Office Memorandum dated 15-12-2023.O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
The single most frequent error on this residual medicaments line is filing a bill of entry without confirming which product-specific prohibition or carve-out applies to the active pharmaceutical ingredient in the consignment. A registration certificate and import licence valid for the general drug category do not override the tramadol import prohibition or the oxytocin prohibition; shipments that arrive without the Narcotics Commissioner's import certificate for tramadol, or without a DGCI/CDSCO test licence for oxytocin reference standards, are liable to detention, confiscation, and prosecution under the NDPS Act and the Drugs and Cosmetics Act, 1940 respectively.