Cholera and typhoid

Vaccines for human medicine, cholera and typhoid

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 11 (Cholera and typhoid vaccines) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. Mandatory documents including the drug 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 11

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

A word of counsel

The most frequent error on this tariff line is presenting the import licence without a concurrent batch-specific release certificate and certificate of analysis — three of the five mandatory documents are lot-specific and must correspond to the exact consignment batch declared on the bill of entry. A mismatch between the batch number on the release certificate and the physical consignment triggers detention at the port of entry and potential seizure under the Drugs and Cosmetics Act, 1940, with no rectification pathway short of re-export.

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Frequently asked

Does HSN 3002 41 11 require BIS certification?

No, human vaccines 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 drug registration, import licensing, and batch-level documentation at the bill of entry.

Which documents 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 present in e-Sanchit before the proper officer grants out-of-charge.

Does the import licence cover multiple batches or is it batch-specific?

The import licence is product-level, but the batch release certificate and certificate of analysis are lot-specific and must correspond to the exact batch being imported; a consignment arriving with documents referencing a different batch number will be detained pending CDSCO resolution.

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