Tetanus

Tetanus vaccine for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 13 (Tetanus vaccine for human medicine) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. Every consignment requires a valid Registration Certificate for drugs and an Import Licence for drugs, both uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3002 41 13

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 Registration Certificate for drugs (document code 101dc1) and an Import Licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before shipment. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for drugs (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 five mandatory documents are present before granting out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc · Drugs and Cosmetics Act, 1940

A word of counsel

The most common error on this tariff line is arriving at the port with a current Import Licence but without a batch-specific Certificate of Analysis or Batch Release Certificate for the exact lot being imported. These batch-level documents are distinct from the registration and licence credentials; a missing or mismatched batch document will detain the consignment at the port of import and attract demurrage while the oversight is resolved.

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Frequently asked

Does HSN 3002 41 13 require BIS certification?

No, no BIS Quality Control Order covers vaccines for human medicine. Import of tetanus vaccines is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring a Registration Certificate and Import Licence for drugs.

Which documents must be uploaded in e-Sanchit for a tetanus vaccine consignment?

Five documents are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); all must be present in e-Sanchit before out-of-charge is granted.

Does each imported batch require its own Batch Release Certificate?

Yes. The Batch Release Certificate (document code 0030dc) is batch-specific and must correspond to the exact lot being imported; a certificate from a prior batch does not satisfy the requirement for a new consignment.

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