Dapsone (DDS), acedapsone (DADDS), solopsone and clofazimine

Dapsone, acedapsone, solopsone and clofazimine medicaments

MEFCC CLEARANCE

HSN 3004 90 55 (Dapsone, acedapsone (DADDS), solopsone and clofazimine) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under the Restricted-import policy, and five mandatory documents must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3004 90 55

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence for drugs 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
Obtain a valid drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before shipment. Both documents must be current and cover the specific active pharmaceutical ingredient — dapsone, acedapsone, solopsone or clofazimine — named on the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CBIC e-Sanchit mandate
2
Upload 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 — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer is required to verify each document code before granting out-of-charge.
CCR e-Sanchit mandate — document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The single most common error on this tariff line is uploading the registration certificate and import licence without simultaneously uploading the Certificate of Analysis and Batch Release Certificate — all five document codes are treated as a mandatory bundle, and a missing batch-level document (0030dc or 0010dc) is grounds for detention even when the product-level registration is in order. Because the CCR also contains an oxytocin prohibition note applicable to adjacent CTIs, importers must ensure their bill of entry and e-Sanchit uploads reflect only the dapsone/clofazimine product family and do not inadvertently trigger that prohibition flag.

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Frequently asked

Does HSN 3004 90 55 require BIS certification?

No, pharmaceutical medicaments of this kind 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 a DGFT Restricted-import policy overlay requiring a valid registration certificate and import licence.

Are all five e-Sanchit document codes mandatory even for small or sample consignments?

Yes. The e-Sanchit mandate for this tariff line requires the Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate (101dc1) and Import Licence (9111dc) to be uploaded before out-of-charge; the proper officer verifies each code regardless of consignment size.

Does the oxytocin prohibition noted in the customs compliance record affect dapsone or clofazimine imports?

No. The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies to oxytocin and is recorded on the same tariff chapter record as an adjacent restriction; it does not restrict import of dapsone, acedapsone, solopsone or clofazimine, which require only the standard drug registration and import licence from CDSCO.

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