Diphtheria, pertussis and tetanus(DPT)

DPT vaccine for human medicine (diphtheria, pertussis, tetanus)

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 21 (Diphtheria, pertussis and tetanus vaccine) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. Five mandatory documents — including a batch release certificate, certificate of analysis, and import licence for drugs — must be uploaded in e-Sanchit before customs out-of-charge at the bill-of-entry stage.

What this is

HSN code

3002 41 21

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 CDSCO

Compliance steps

1
Obtain a valid CDSCO registration certificate for drugs (document code 101dc1) and an import licence for drugs (document code 9111dc) covering the DPT vaccine before shipment. Both documents must be current at the date the bill of entry is filed.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload all five mandatory documents in e-Sanchit prior to out-of-charge: 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). The proper officer will verify each upload 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 the registration certificate and import licence while omitting either the batch release certificate (0030dc) or the certificate of analysis (0010dc), which are batch-specific documents that must correspond to the exact consignment presented. A mismatch between the batch number on the certificate of analysis and the physical consignment labelling is treated as a documentation deficiency warranting detention, demurrage, and potential seizure under the Drugs and Cosmetics Act, 1940.

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Frequently asked

Does HSN 3002 41 21 require BIS certification?

No. No BIS Quality Control Order covers vaccines for human medicine. Import of the DPT vaccine is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring a valid registration certificate and import licence for drugs.

Are all five e-Sanchit document codes mandatory for every DPT vaccine consignment?

Yes. Document codes 0010dc, 0030dc, 0110dc, 101dc1, and 9111dc must all be uploaded in e-Sanchit before the customs proper officer grants out-of-charge; a bill of entry with any missing document will not receive out-of-charge clearance.

What happens if the import licence for drugs has expired at the time of filing the bill of entry?

An expired import licence (9111dc) renders the consignment non-compliant at the bill-of-entry stage, exposing it to detention and potential confiscation under the Drugs and Cosmetics Act, 1940; a fresh licence must be obtained before re-filing.

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