Other
Other medicaments for therapeutic or prophylactic use, retail packed
HSN 3004 90 29 covers residual medicaments for therapeutic or prophylactic use put up for retail sale and is primarily governed by the Narcotic Drugs and Psychotropic Substances (NDPS) regime — 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. Import of oxytocin is separately prohibited, with a narrow carve-out for reference standards for test and analysis subject to a test licence from DCGI/CDSCO under S.O. 2357(E) and DGFT Notification 09/2015-2020. All consignments require mandatory registration certificates and drug import licences uploaded in e-Sanchit before customs out-of-charge.
- Registration certificate from CDSCO
- Import licence from CDSCO
- Import certificate from Narcotics Commissioner
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Upload the mandatory drug-import documents in e-Sanchit before filing the bill of entry: Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), Registration Certificate for Drugs (document code 101dc1), and Import Licence for Drugs (document code 9111dc). The proper officer will verify all five documents prior to granting out-of-charge.e-Sanchit mandatory document list · CBIC PGA-facilitated-bill verification procedure
- 2If the consignment contains tramadol, secure a prior import certificate from the Narcotics Commissioner before shipment; import is prohibited without this certificate under Rule 53 of the NDPS Rules. If the consignment contains oxytocin, import is prohibited outright unless it is an oxytocin reference standard for test and analysis accompanied by a test licence issued by DCGI/CDSCO.Rule 53 of the NDPS Rules · S.O. 1761(E) dated 26-04-2018 · S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
- 3For used or refurbished medical equipment falling under this residual tariff line, comply with all conditions notified by the Ministry of Environment, Forest and Climate Change; such imports are classified as Restricted and are subject to the conditions in the O.M. dated 15 December 2023.O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023 · ITC (HS) Restricted-import policy
The most common error on this residual medicament line is treating the five-document e-Sanchit checklist as exhaustive and overlooking the substance-specific prohibitions: a consignment containing tramadol without a Narcotics Commissioner import certificate, or oxytocin outside the narrow reference-standard carve-out, is liable to outright seizure under the NDPS Rules and Drugs and Cosmetics Act irrespective of whether the registration certificate and import licence are current. Importers should confirm the product's INN against both the NDPS scheduled-substance list and the DGFT oxytocin prohibition before placing the purchase order.