L-Asparaginase, cisplatin and carboplatin
Antineoplastic medicaments (L-Asparaginase, cisplatin, carboplatin)
HSN 3004 90 47 (L-Asparaginase, cisplatin and carboplatin) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import-licence requirements under the Drugs and Cosmetics Act, 1940, with a Directorate General of Foreign Trade (DGFT) Restricted-import policy overlay. A Certificate of Analysis, Batch Release Certificate, and valid Registration Certificate for drugs must be uploaded in e-Sanchit before customs out-of-charge.
- 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.
- 1Obtain 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 filing the bill of entry. Both documents must be current and uploaded in e-Sanchit at the bill-of-entry stage.Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
- 2Upload the Certificate of Analysis for drugs (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit prior to customs out-of-charge. Customs officers verifying PGA-facilitated bills must confirm all five mandatory documents are present before granting out-of-charge.e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO import documentation requirements
- 3Note that oxytocin import is prohibited under this product family except where it constitutes a reference standard for test and analysis, in which case a test licence from DGCI/CDSCO is required. L-Asparaginase, cisplatin and carboplatin remain subject to the standard drug-import controls above and are not affected by the oxytocin prohibition.S.O. 2357(E) · DGFT Notification 09/2015-2020, both dated 23-05-2022
The most common error on this tariff line is arriving at the port with a current Registration Certificate but without a co-valid Import Licence — the two are distinct CDSCO instruments and both must be present in e-Sanchit under their respective document codes (101dc1 and 9111dc) before out-of-charge is granted. A consignment carrying only one of the two documents will be detained pending submission of the missing instrument, and demurrage accrues from the date of arrival regardless of subsequent CDSCO processing time.