Chlortetracycline
Chlortetracycline antibiotic medicaments in measured doses
HSN 3004 20 41 (Chlortetracycline) is subject to drug registration and import licensing requirements for pharmaceutical medicaments containing antibiotics, with mandatory documents verified at the bill-of-entry stage under the oversight of the Ministry of Environment, Forest and Climate Change (MEFCC) and the Directorate General of Foreign Trade (DGFT). The tariff line carries an ITC (HS) policy overlay, and customs clearance requires upload of five specified e-Sanchit documents — including a Registration Certificate (Drugs) and an Import Licence for Drugs — before out-of-charge is granted.
- Registration certificate from DGFT/CDSCO
- Import licence for drugs from authority
- Batch release certificate from manufacturer
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Ensure the drug registration certificate (document code 101dc1) and the Import Licence for Drugs (document code 9111dc) are current and valid before shipment. Both documents must be uploaded in e-Sanchit at the bill of entry; customs out-of-charge will not be granted until both are verified.CCR e-Sanchit mandatory documents: 101dc1, 9111dc
- 2Upload all five mandatory documents in e-Sanchit before the bill of entry is filed: Certificate of Analysis – Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate (Drugs) (101dc1), and Import Licence for Drugs (9111dc). The proper officer is required to verify all five before granting out-of-charge on PGA-facilitated bills.CCR e-Sanchit mandatory document codes: 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
- 3Note the absolute prohibition on import of oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; import of oxytocin reference standards is permitted solely for test and analysis purposes on submission of a test licence issued by DGCI/CDSCO. Confirm the chlortetracycline consignment does not contain any scheduled prohibited substance.S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022
The most frequent error on this tariff line is treating the drug registration certificate and the import licence as interchangeable or assuming one suffices for the other — they are separate, independently mandatory documents with distinct issuing authorities, and the absence of either triggers consignment detention at the port of entry. Importers should also confirm that the batch release certificate (0030dc) is consignment-specific and issued by the manufacturing facility, not a generic product certificate, as a generic certificate will not satisfy the proper officer's pre-OOC verification requirement.