Rifampicin
Rifampicin antibiotic, pharmaceutical bulk substance
HSN 2941 90 11 (Rifampicin) 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 imports outside the medical and scientific category, and Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus mandates additional Chapter 29 qualifiers in the import declaration effective 15 October 2023.
- Import certificate from NDPS
- Import licence for drugs from CDSCO
- Registration certificate 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 from the Central Bureau of Narcotics (cbn.nic.in) before shipment. This certificate is mandatory for all imports of Rifampicin for medical and scientific purposes under Chapter VII-A of the NDPS Rules, 1985; imports without a current certificate are liable to seizure at the bill-of-entry stage.Rule 53, Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
- 2Upload all mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify these uploads before granting out-of-charge.CCR PGA facilitated-bills instruction · CBIC 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, applicable with effect from 15 October 2023. Non-compliant declarations are liable to be held for amendment before out-of-charge.CBIC Circular 23/2023-Cus dated 30-09-2023, paragraphs 4.1 and 4.2
The most common error on this tariff line is conflating the NDPS import certificate issued by the Central Bureau of Narcotics under Rule 53 with the drug import licence issued by CDSCO (document code 9111dc): these are two distinct instruments from two distinct authorities, both required before the bill of entry is filed. Presenting only the drug import licence while the NDPS import certificate is absent will result in consignment detention regardless of CDSCO clearance status, because the NDPS-channel obligation is independent of the Drugs and Cosmetics Act regime.