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

Mixed immunological products, bulk, not retail-packed

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 14 00 (mixed immunological products, not put up in measured doses or retail packs) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and drug registration under the Drugs and Cosmetics Act, 1940. A Certificate of Analysis, Batch Release Certificate, and specimen label must be uploaded in e-Sanchit before customs out-of-charge at the bill-of-entry stage.

What this is

HSN code

3002 14 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

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

Compliance steps

1
Obtain a valid drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before the consignment is shipped. Both documents must be current and cover the specific immunological product category at the time of import.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and the consignment label (document code 0110dc) in e-Sanchit before filing the bill of entry. The proper officer will verify presence of all five mandatory documents — 0010dc, 0030dc, 0110dc, 101dc1, and 9111dc — before granting out-of-charge.
e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc · Drugs and Cosmetics Act, 1940

A word of counsel

The most common error on this tariff line is treating the drug import licence as a standalone clearance and overlooking the Batch Release Certificate and Certificate of Analysis as independent e-Sanchit uploads. Customs out-of-charge is withheld if any one of the five mandatory document codes is absent from e-Sanchit, regardless of whether the other four are present — a single missing code forces consignment detention and accumulating demurrage until the deficiency is remedied.

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Frequently asked

Does HSN 3002 14 00 require BIS certification?

No. No BIS Quality Control Order covers mixed immunological products. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring drug registration and an import licence alongside batch-level documentation at the bill of entry.

Which five documents must be uploaded in e-Sanchit before out-of-charge for this tariff line?

Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), consignment label (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all five must be present in e-Sanchit before the proper officer grants out-of-charge.

Do these CDSCO documentation requirements apply even when the consignment is not in retail packing?

Yes. The tariff line specifically covers immunological products in bulk or non-retail form; the drug registration and import licensing obligations under the Drugs and Cosmetics Act, 1940 apply irrespective of whether the goods are in measured doses or retail packs.

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