Hepatitis

Hepatitis vaccines for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 12 (Hepatitis vaccines for human medicine) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. Mandatory documentation — including a registration certificate, import licence, batch release certificate, and certificate of analysis — must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3002 41 12

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import licence from CDSCO
Registration certificate from CDSCO
Batch release certificate from CDSCO

Compliance steps

1
Obtain a valid import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both documents must be uploaded in e-Sanchit prior to out-of-charge.
CDSCO · document codes 9111dc and 101dc1 · e-Sanchit mandatory upload per CCR
2
Upload the certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and consignment label (document code 0110dc) in e-Sanchit at the bill-of-entry stage. The proper officer will verify all five mandatory documents before granting out-of-charge.
Document codes 0010dc, 0030dc, 0110dc · e-Sanchit mandatory upload per CCR

A word of counsel

The most common error on this tariff line is presenting only the import licence and overlooking the batch release certificate and certificate of analysis as independent, co-mandatory uploads. Customs officers verify all five document codes in e-Sanchit before granting out-of-charge; a single missing document triggers consignment detention and accruing demurrage, regardless of the validity of the remaining four.

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Frequently asked

Does HSN 3002 41 12 require BIS certification?

No. No BIS Quality Control Order covers hepatitis vaccines for human medicine. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with a mandatory five-document e-Sanchit upload at the bill-of-entry stage.

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

Five documents are mandatory: certificate of analysis (0010dc), batch release certificate (0030dc), consignment label (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all must be uploaded before out-of-charge is granted.

What happens if the import licence or registration certificate has expired at the time of filing?

An expired import licence (9111dc) or registration certificate (101dc1) renders the bill of entry non-compliant; the consignment will be detained pending production of a current document, attracting demurrage and ground rent until clearance is obtained.

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