Medicated toilet soaps

Medicated toilet soaps for skin use

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3401 11 10 (Medicated toilet soaps) is subject to the Drugs and Cosmetics Act, 1940, which governs the registration and import of cosmetic and medicated preparations for skin use in India. Four mandatory documents — Certificate of Analysis, Batch Release Certificate, Label of Consignment, and Registration Certificate (Cosmetics) — must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3401 11 10

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 (Cosmetics) from CDSCO
Certificate of Analysis from manufacturer
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 before filing the bill of entry. Medicated toilet soaps fall within the cosmetics regulatory perimeter under the Drugs and Cosmetics Act, 1940, and import without a current registration certificate attracts consignment detention.
Drugs and Cosmetics Act, 1940 · e-Sanchit document code 101DC2
2
Upload all four mandatory documents in e-Sanchit at the bill of entry stage before out-of-charge: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), and Registration Certificate (Cosmetics) (101DC2). PGA-facilitated bills not routed through the PGA for NOC are subject to mandatory verification of these uploads by the proper officer.
e-Sanchit document codes 0010DC, 0030DC, 0110DC, 101DC2

A word of counsel

The most common error on this tariff line is treating medicated toilet soaps as a general cosmetic and uploading only the label declaration, while omitting the Certificate of Analysis — Drug (0010DC) and Batch Release Certificate (0030DC) on the grounds that the product is not a scheduled drug. The 'medicated' qualifier brings the product within the drug-documentation overlay of the Drugs and Cosmetics Act, 1940; a missing batch-release or analysis certificate triggers a hold at out-of-charge regardless of the cosmetics registration certificate being current.

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Frequently asked

Does HSN 3401 11 10 require BIS certification?

No, medicated toilet soaps are not covered by any BIS Quality Control Order. Import is governed by the Drugs and Cosmetics Act, 1940 through the Central Drugs Standard Control Organisation cosmetics registration regime, with four mandatory e-Sanchit documents required at the bill of entry.

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

Four codes are mandatory: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), and Registration Certificate (Cosmetics) (101DC2); all must be uploaded before the proper officer grants out-of-charge.

Does the drug-documentation requirement apply even when the product is primarily a soap rather than a pharmaceutical?

Yes. The 8-digit tariff descriptor 'Medicated toilet soaps' brings the product within the drug-documentation overlay, requiring the Certificate of Analysis and Batch Release Certificate in addition to the cosmetics registration certificate, irrespective of the concentration of the active ingredient.

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