Polymyxin B and colistin

Polymyxin B and colistin antibiotic medicaments

MEFCC CLEARANCE

HSN 3004 20 97 (Polymyxin B and colistin) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit documentation including a registration certificate and import licence for drugs. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay for this tariff line, and the Ministry of Environment, Forest and Climate Change imposes additional compliance conditions on restricted import categories.

What this is

HSN code

3004 20 97

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO drug import regime)

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Certificate of Analysis from manufacturer

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from CDSCO before filing the bill of entry. Both documents must be uploaded in e-Sanchit; consignments without these clearances are liable to detention at the port of import.
Drugs and Cosmetics Act, 1940 · document codes 9111dc and 101dc1 as per CCR e-Sanchit mandate
2
Upload 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 before out-of-charge is granted. The proper officer is required to verify all five mandatory documents on PGA-facilitated bills.
e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc · CCR PGA-facilitated bill verification requirement

A word of counsel

The most common error on this tariff line is conflating the polymyxin B and colistin antibiotics regime with the oxytocin prohibition applicable elsewhere under Chapter 30. Oxytocin import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, but that prohibition does not extend to polymyxin B and colistin; however, importers must confirm their specific drug is not subject to any product-specific restriction or prohibition before shipment, as a mistaken clearance attempt on a prohibited drug results in outright confiscation.

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Frequently asked

Does HSN 3004 20 97 require BIS certification?

No, antibiotic medicaments containing polymyxin B and colistin fall outside the BIS Quality Control Order regime. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, requiring an import licence, drug registration certificate, and batch-level documentation uploaded in e-Sanchit.

Which document codes are mandatory in e-Sanchit at the bill of entry for this tariff line?

Five documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); all must be uploaded before customs out-of-charge is granted.

Does the oxytocin import prohibition under S.O. 2357(E) apply to polymyxin B and colistin imports?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin; polymyxin B and colistin are distinct antibiotic substances subject to the standard CDSCO drug import licensing regime, not the oxytocin prohibition.

Last verified against gazette notifications: 2026-05-16. Source: MEFCC / DGFT / Indian Customs CUSDATA.