Whopping cough (pertussis)

Whooping cough (pertussis) vaccine for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 18 (Whooping cough (pertussis) vaccine) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. A valid registration certificate for drugs and an import licence for drugs must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3002 41 18

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 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 current and cover the specific pertussis vaccine product being imported.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload all five mandatory documents in e-Sanchit prior to filing the bill of entry: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). The customs proper officer will verify these uploads before granting out-of-charge.
e-Sanchit mandatory document requirement · 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 the batch release certificate (0030dc) or the certificate of analysis (0010dc), treating them as supplementary rather than mandatory. All five document codes are independently verified by the customs proper officer before out-of-charge; a missing batch release certificate will detain the consignment regardless of the currency of the drug registration, and vaccine consignments subject to cold-chain storage accrue demurrage and ground rent at the port during the hold.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3002 41 18 require BIS certification?

No, pertussis vaccines for human medicine 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, requiring a drug registration certificate and import licence before customs out-of-charge.

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

Five documents are mandatory: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc); all must be present before the customs proper officer issues out-of-charge.

Does each imported batch require a separate batch release certificate?

Yes. The batch release certificate (document code 0030dc) is batch-specific and must correspond to the consignment being cleared; a certificate from a prior batch does not satisfy the e-Sanchit upload requirement for the current bill of entry.

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