Medicated toilet soaps

Medicated toilet soaps, liquid or cream skin-wash preparations

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3401 30 11 (Medicated toilet soaps) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Drugs and Cosmetics Act, 1940, as a medicated cosmetic product requiring a Registration Certificate before import. Mandatory documentation including a Certificate of Analysis, Batch Release Certificate, label declaration, and Registration Certificate must be uploaded in e-Sanchit prior to customs out-of-charge.

What this is

HSN code

3401 30 11

Chapter

34 · Soaps, organic surface-active agents, washing preparations, lubricating preparations, waxes

Primary regulator

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

Customs documentation

Registration Certificate from CDSCO
Certificate of Analysis from CDSCO
Batch Release Certificate from manufacturer

Compliance steps

1
Obtain a valid Registration Certificate for cosmetics (document code 101DC2) from the Central Drugs Standard Control Organisation covering the medicated toilet soap formulation to be imported. Upload this certificate in e-Sanchit before filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document code 101DC2 (Registration Certificate — Cosmetics)
2
Upload the Certificate of Analysis — Drug (document code 0010DC), Batch Release Certificate (document code 0030DC), and Label of Consignment (document code 0110DC) in e-Sanchit. The proper officer must verify all four documents are present before granting out-of-charge.
Document codes 0010DC, 0030DC, 0110DC · e-Sanchit mandatory upload requirement per CCR

A word of counsel

The most common error on this tariff line is submitting only the Registration Certificate and overlooking the batch-specific documents — the Certificate of Analysis (0010DC) and Batch Release Certificate (0030DC) — which must match the specific consignment batch numbers. A mismatch between the registered formulation and the batch documentation on record results in consignment detention at the port of import, with demurrage and ground rent accruing until the discrepancy is resolved or the goods are re-exported.

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Frequently asked

Does HSN 3401 30 11 require BIS certification?

No, medicated toilet soaps under this tariff line are not covered by any BIS Quality Control Order. Import is governed by the Drugs and Cosmetics Act, 1940, with CDSCO registration and batch-level documentation as the operative clearance requirements.

Which document codes must be uploaded in e-Sanchit for this HSN?

Four documents are mandatory: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), and Registration Certificate for Cosmetics (101DC2), all of which must be uploaded before customs out-of-charge.

Does the CDSCO Registration Certificate cover all formulations of a brand, or is it formulation-specific?

The registration under the Drugs and Cosmetics Act, 1940 is product- and formulation-specific; each distinct medicated formulation requires its own Registration Certificate, and importing a variant not covered by the registered formulation constitutes an unlicensed import.

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