Sulfonamides and cotrimoxazole

Sulfonamide and cotrimoxazole antibiotic medicaments

MEFCC CLEARANCE

HSN 3004 20 20 (Sulfonamides and cotrimoxazole) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit documentation at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers an ITC (HS) policy overlay that includes a specific prohibition on oxytocin imports, with a narrow carve-out for oxytocin reference standards used exclusively for test and analysis.

What this is

HSN code

3004 20 20

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug registration and import licensing)

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Batch release certificate from CDSCO

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
Ensure the drug product holds a valid CDSCO registration certificate (document code 101dc1) and a current import licence for drugs (document code 9111dc) before filing the bill of entry. Both documents must be uploaded in e-Sanchit; consignments where either document is absent at the bill-of-entry stage will be held without out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR
2
Upload all mandatory e-Sanchit documents — Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), Registration Certificate for drugs (document code 101dc1), and Import Licence for drugs (document code 9111dc) — before customs out-of-charge is granted.
CDSCO e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc per CCR
3
Note that import of oxytocin is prohibited under this tariff line. Import of oxytocin reference standards is permitted solely for test and analysis, subject to submission of a test licence issued by the DGCI/CDSCO. Verify that the consignment does not contain prohibited formulations before shipment.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most frequent error on this tariff line is uploading an import licence that covers one drug formulation or strength while the consignment contains a variant not expressly named on the registration certificate — a mismatch that triggers detention and mandatory re-verification by CDSCO. The five mandatory e-Sanchit documents (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) must each reflect the exact product, batch, and manufacturer on the bill of entry; a single misaligned document is treated as a missing document for out-of-charge purposes.

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Frequently asked

Does HSN 3004 20 20 require BIS certification?

No, sulfonamide and cotrimoxazole medicaments are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT policy controls including a specific prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020.

Which documents must be uploaded in e-Sanchit before customs out-of-charge 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 out-of-charge is granted.

Can oxytocin be imported under HSN 3004 20 20 for laboratory use?

Import of oxytocin is prohibited, but oxytocin reference standards may be imported exclusively for test and analysis upon submission of a test licence issued by the DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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