Containing insulin
Bulk insulin-containing medicaments, not retail-packed
HSN 3003 31 00 (Containing insulin) covers multi-constituent medicaments containing insulin, not put up in measured doses or retail packing, and is governed by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940. An Import Licence for drugs and a Registration Certificate for the product must be in place before the bill of entry is filed, with all mandatory documents uploaded in e-Sanchit prior to customs out-of-charge.
- Import Licence for drugs from CDSCO
- Registration Certificate from CDSCO
- Batch Release Certificate from manufacturer
- 1Obtain a valid Import Licence for drugs (document code 9111dc) and a Registration Certificate for the insulin-containing medicament (document code 101dc1) from CDSCO before the shipment is dispatched. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted until both are verified.Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
- 2Upload the Certificate of Analysis for the drug (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the consignment label (document code 0110dc) in e-Sanchit at the time of bill of entry filing. The proper officer is required to verify all five mandatory documents before issuing out-of-charge.e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO import documentation requirements
The most common error on this tariff line is uploading the Import Licence (9111dc) and Registration Certificate (101dc1) while omitting one or more of the three product-level documents — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), or consignment label (0110dc). All five document codes must be present in e-Sanchit simultaneously; a bill of entry with even one missing upload will be held at the out-of-charge stage, attracting demurrage and ground rent until the deficiency is rectified.