Aluminium hydroxide gel

Aluminium hydroxide gel medicament, bulk therapeutic preparation

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3003 90 35 (Aluminium hydroxide gel) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. The product falls within heading 3003 as a multi-constituent medicament not put up for retail sale, and five mandatory documents must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3003 90 35

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Batch release certificate from manufacturer

Compliance steps

1
Obtain and maintain a current import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from the Central Drugs Standard Control Organisation before the bill of entry is filed. Both documents must be uploaded in e-Sanchit prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the label of the consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The customs proper officer is required to verify all five documents before granting out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is presenting the import licence and registration certificate while omitting one or more of the batch-level documents — Certificate of Analysis, batch release certificate, or consignment label. All five document codes (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) are independently verified in e-Sanchit before out-of-charge; a single missing upload detains the consignment and accrues demurrage and ground rent regardless of the validity of the other four documents.

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Frequently asked

Does HSN 3003 90 35 require BIS certification?

No, aluminium hydroxide gel 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 mandatory import licensing, drug registration, and batch-level documentation verified at the bill of entry.

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

Five documents are mandatory: Certificate of Analysis for drugs (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all must be present before the customs officer grants out-of-charge.

Does the bulk, non-retail-pack format of heading 3003 affect the CDSCO documentation requirement?

No. Heading 3003 covers multi-constituent medicaments not put up in measured doses or retail packings, but the full CDSCO import licensing and registration requirement — including batch release and Certificate of Analysis — applies in the same manner as for retail-packed pharmaceutical imports under heading 3004.

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