Ciprofloxacine and its salts
Ciprofloxacin and its salts, antibiotic substance
HSN 2941 90 30 (Ciprofloxacin and its salts) is subject to Narcotic Drugs and Psychotropic Substances (NDPS) import certificate requirements under Chapter VII-A of the NDPS Rules, 1985, specifically Rule 53, for imports intended for medical and scientific purposes. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 governs all other imports, and Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus dated 30-09-2023 mandates additional Chapter 29 qualifiers in the import declaration.
- Import certificate from NDPS
- Registration certificate from CDSCO
- Import licence for drugs from CDSCO
Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.
- 1Obtain an import certificate under Rule 53 of the NDPS Rules, 1985 for imports of ciprofloxacin and its salts intended for medical or scientific purposes. Details and the application process are available at http://cbn.nic.in. Imports falling outside the medical/scientific category are governed by Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 to Chapter 29.Chapter VII-A of the NDPS Rules, 1985 · Rule 53, NDPS Rules, 1985 · ITC (HS) policy condition 2 to Chapter 29
- 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 for Drugs (101dc1), and Import Licence for Drugs (9111dc). Customs out-of-charge will not be granted until all codes are present in e-Sanchit.CCR e-Sanchit document codes: 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
- 3Ensure the import declaration includes the mandatory additional qualifiers for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, operative with effect from 15 October 2023. Non-compliance with the qualifier requirement leads to detention at the bill-of-entry stage.CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2
The most common error on this tariff line is assuming the drug registration certificate and import licence alone satisfy customs clearance, while overlooking the NDPS import certificate under Rule 53 as a parallel and independent requirement. Where ciprofloxacin is being imported for medical or scientific purposes, both the NDPS certificate and the full suite of five e-Sanchit drug documents must be simultaneously present; a consignment cleared for drug purposes but without the Rule 53 certificate is detained as an NDPS violation, attracting potential criminal liability under the NDPS Act, 1985.