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HomeHSNChapter 30HSN 3002 41 17

Japanese encephalitis

Japanese encephalitis vaccine for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 17 (Japanese encephalitis vaccine) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. Five mandatory documents — Certificate of Analysis, Batch Release Certificate, consignment label, drug registration certificate, and import licence — must be uploaded in e-Sanchit before customs out-of-charge at the bill of entry.

What this is
HSN code
3002 41 17
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. 1
    Obtain a drug registration certificate (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 Japanese encephalitis vaccine formulation being imported.
    Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
  2. 2
    Upload all five mandatory documents in e-Sanchit prior to filing the bill of entry: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), consignment label (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). The proper officer will verify e-Sanchit uploads 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 the Batch Release Certificate (0030dc) or the Certificate of Analysis (0010dc), treating them as secondary. For vaccines, all five documents form a complete set; a customs proper officer reviewing a PGA-facilitated bill will withhold out-of-charge if even one document code is absent from e-Sanchit, resulting in consignment detention and accumulating demurrage.

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Frequently asked
Does HSN 3002 41 17 require BIS certification?
No, no BIS Quality Control Order covers vaccines for human medicine. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with registration and import-licence requirements applying at the bill of entry.
Which document codes must be uploaded in e-Sanchit for this vaccine?
Five document codes are mandatory: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), consignment label (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all must be present before out-of-charge is granted.
Does the import licence need to name the specific vaccine strain or formulation?
The import licence and registration certificate must correspond to the specific drug being imported; a licence issued for a different vaccine or formulation does not satisfy CDSCO requirements for this tariff line and will result in consignment detention.
Last verified against gazette notifications: 2026-05-16. Source: CDSCO / Indian Customs CUSDATA.
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