Sulpha drugs not elsewhere specified or included

Sulpha drug medicaments, not elsewhere specified or included

MEFCC CLEARANCE

HSN 3004 90 83 (Sulpha drugs not elsewhere specified or included) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line as subject to policy restrictions, including a complete prohibition on oxytocin imports under DGFT Notification 09/2015-2020 dated 23-05-2022, with a narrow carve-out permitting oxytocin reference standards for test and analysis only.

What this is

HSN code

3004 90 83

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence for drugs 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 drug registration certificate from the Central Drugs Standard Control Organisation and an import licence for drugs before filing the bill of entry. Upload both documents in e-Sanchit under document codes 101dc1 (registration certificate) and 9111dc (import licence for drugs) prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · CCR e-Sanchit mandatory-document list
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry. The proper officer must verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CCR e-Sanchit mandatory-document list · document codes 0010dc, 0030dc, 0110dc
3
Confirm that the consignment does not contain oxytocin in any form other than reference standards for test and analysis. If importing oxytocin reference standards under the permitted carve-out, attach the test licence issued by DGCI/CDSCO; oxytocin in all other forms is prohibited.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is overlooking the oxytocin prohibition when sourcing multi-ingredient sulpha-drug formulations that contain oxytocin as an excipient or co-active. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 is absolute for commercial quantities; only reference-standard quantities backed by a DGCI/CDSCO test licence qualify for the carve-out, and an absence of that test licence results in confiscation and potential prosecution under the Drugs and Cosmetics Act, 1940.

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Frequently asked

Does HSN 3004 90 83 require BIS certification?

No, sulpha drug 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 restrictions including a prohibition on oxytocin imports.

Which five documents must be uploaded in e-Sanchit before customs out-of-charge?

The mandatory documents are: 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 in e-Sanchit before the proper officer grants out-of-charge.

Is any import of oxytocin permitted under this tariff line?

Only oxytocin reference standards for test and analysis are permitted, exclusively upon submission of a test licence issued by DGCI/CDSCO; all other oxytocin imports are prohibited under 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.