Cimetidine, rantidine, nizatidine and roxatidine
H2-receptor antagonist medicaments (cimetidine, ranitidine, nizatidine, roxatidine)
HSN 3004 90 33 (cimetidine, ranitidine, nizatidine and roxatidine medicaments) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document upload before customs out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay, and an oxytocin-prohibition carve-out under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to the broader tariff line.
- Registration certificate from CDSCO
- Import licence from CDSCO
- Batch release certificate from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Secure a valid drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before the consignment is dispatched. Both documents must cover the specific active ingredient and dosage form being imported.Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR
- 2Upload all five mandatory documents in e-Sanchit before filing 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). Customs out-of-charge will not be granted until the proper officer verifies each upload.CCR e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
- 3Confirm the consignment contains none of the prohibited substances on the broader tariff line: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Import of oxytocin reference standards remains permissible exclusively for test and analysis purposes, subject to a test licence issued by DGCI/CDSCO.S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
The most common error on this tariff line is conflating the drug registration certificate with the import licence — they are two distinct CDSCO instruments (document codes 101dc1 and 9111dc respectively), both mandatory at the bill of entry. A consignment carrying only one of the two instruments will be detained pending the missing upload, attracting demurrage and ground rent; the rectification cannot be completed after the vessel has berthed without a formal amendment and PGA re-verification cycle.