Diphtheria and tetanus (DT)

Diphtheria and tetanus (DT) vaccine for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 22 (Diphtheria and tetanus vaccine) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration requirements under the Drugs and Cosmetics Act, 1940. Five mandatory documents — including a registration certificate, import licence, batch release certificate, certificate of analysis, and label copy — must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3002 41 22

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

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

Compliance steps

1
Obtain a valid drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO prior to shipment. Both documents must be current and must cover the specific DT vaccine formulation being imported.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1, 9111dc
2
Upload all five mandatory documents in e-Sanchit before the bill of entry is assessed: certificate of analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). The proper officer will verify each code before granting out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is uploading only the registration certificate and import licence while omitting the batch release certificate and certificate of analysis, treating them as optional secondary documents. For DT vaccines, all five document codes are independently mandatory; a single missing code causes the bill of entry to remain in PGA-facilitated status and the proper officer is required to withhold out-of-charge — resulting in consignment detention, port demurrage, and cold-chain risk for a temperature-sensitive biological product.

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Frequently asked

Does HSN 3002 41 22 require BIS certification?

No. No BIS Quality Control Order covers human vaccines or biological pharmaceutical products. Import of this DT vaccine is governed by the Drugs and Cosmetics Act, 1940 under CDSCO oversight, requiring drug registration, import licensing, and batch-level documentation at each consignment.

Are all five e-Sanchit document codes required for every shipment of DT vaccine?

Yes. Document codes 0010dc (certificate of analysis), 0030dc (batch release certificate), 0110dc (label of consignment), 101dc1 (registration certificate), and 9111dc (import licence) must each be uploaded in e-Sanchit for every bill of entry; none is waivable at the bill-of-entry stage.

What happens if the import licence has expired at the time the bill of entry is filed?

An expired import licence (document code 9111dc) renders the consignment non-compliant under the Drugs and Cosmetics Act, 1940; the proper officer must withhold out-of-charge, and the consignment faces detention and potential re-export or confiscation until a valid licence is produced.

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