Rabies

Rabies vaccine for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 16 (Rabies vaccine for human medicine) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. Five mandatory documents — including the Import Licence for Drugs, Registration Certificate, Batch Release Certificate, Certificate of Analysis, and consignment label — must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3002 41 16

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 manufacturer

Compliance steps

1
Obtain a valid Import Licence for Drugs (document code 9111dc) and a Registration Certificate for Drugs (document code 101dc1) from CDSCO before the consignment is dispatched. Both documents must be current at the time of filing the bill of entry.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload all five mandatory documents in e-Sanchit prior to out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify each document 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 an incomplete document set — typically missing the Batch Release Certificate (0030dc) or the Certificate of Analysis (0010dc) while the Import Licence and Registration Certificate are in order. Customs will not grant out-of-charge if any one of the five mandated document codes is absent from e-Sanchit, and vaccine consignments detained at port face cold-chain deterioration that cannot be remedied by subsequent document submission.

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Frequently asked

Does HSN 3002 41 16 require BIS certification?

No, no BIS Quality Control Order covers human vaccines. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with five mandatory documents verified in e-Sanchit before customs out-of-charge.

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

Five document codes are mandatory: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc).

What happens if the bill of entry is PGA-facilitated and not routed through the PGA for NOC?

The proper officer is required to independently verify that all five mandatory documents have been uploaded in e-Sanchit before granting out-of-charge; the absence of any single document code is grounds for detention of the consignment.

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