Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale

Immunological products, unmixed, not in measured doses

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 13 00 covers immunological products, unmixed and not put up in measured doses or retail packings, which are 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 for Drugs, an Import Licence for Drugs, a Certificate of Analysis, a Batch Release Certificate, and a consignment label — must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3002 13 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Certificate of Analysis from manufacturer

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 filing the bill of entry. Both documents must be current and uploaded in e-Sanchit prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for Drugs (document code 0010dc), Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer is directed to verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is uploading only the Import Licence and Registration Certificate while omitting the Batch Release Certificate or Certificate of Analysis — treating the product-level credentials as sufficient without the batch-specific documentation. All five documents (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) are independently mandatory; a missing batch-level document will trigger consignment detention and demurrage even when the import licence and registration certificate are current and valid.

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Frequently asked

Does HSN 3002 13 00 require BIS certification?

No, no BIS Quality Control Order covers immunological products under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with mandatory licensing, registration, and batch-level documentation required at the bill of entry.

Which e-Sanchit document codes are mandatory for this HSN at the bill of entry?

Five document codes are mandatory: 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) — all must be uploaded before out-of-charge is granted.

Do unmixed immunological products in bulk packaging face different requirements than retail-packed products?

HSN 3002 13 00 specifically covers immunological products unmixed and not put up in measured doses or retail packings; the same five mandatory CDSCO documents apply, but importers should confirm at the bill of entry stage that the product description and packaging format match this sub-classification and not an adjacent 8-digit tariff line.

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