Paclitaxel and docetaxel
Paclitaxel and docetaxel medicaments for therapeutic use
HSN 3004 90 44 (Paclitaxel and docetaxel) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies the tariff line under the Restricted-import policy, requiring a valid import licence for drugs alongside mandatory e-Sanchit documentation at the bill of entry.
- Registration certificate from CDSCO
- Import licence for drugs from CDSCO
- Batch release certificate from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.
- 1Obtain a valid drug registration certificate and import licence for the specific paclitaxel or docetaxel product from CDSCO before filing the bill of entry. Upload the registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) in e-Sanchit prior to out-of-charge.Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
- 2Upload all mandatory drug-import documents in e-Sanchit at the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). The customs proper officer will verify these uploads before granting out-of-charge.CDSCO mandatory document codes 0010dc, 0030dc, 0110dc · e-Sanchit OOC verification requirement
The most common error on this tariff line is uploading a registration certificate valid for one formulation strength or presentation while the consignment contains a different strength or pack size — CDSCO registration is product-specific, and a mismatch between the registered formulation and the bill of entry description results in consignment detention pending re-presentation or re-export. Confirm that the registered product description, including dosage form and strength, matches the invoice and label exactly before dispatch.