Other

Antisera and other blood fractions, residual category

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 12 90 (antisera and other blood fractions, other) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. A current drug registration certificate and a valid import licence for drugs are mandatory at the bill-of-entry stage, along with a batch release certificate and certificate of analysis.

What this is

HSN code

3002 12 90

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
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 filing the bill of entry. Both documents must be 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), the batch release certificate (document code 0030dc), and the label of the consignment (document code 0110dc) in e-Sanchit at the bill of entry. The proper officer will verify all five mandatory documents before granting out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is presenting the registration certificate and import licence while omitting one or more of the product-level documents — certificate of analysis (0010dc), batch release certificate (0030dc), or consignment label (0110dc). All five document codes are individually verified by the proper officer; a missing batch release certificate alone is sufficient to withhold out-of-charge, triggering detention and demurrage regardless of the validity of the CDSCO licence.

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Frequently asked

Does HSN 3002 12 90 require BIS certification?

No, antisera and other blood fractions 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 drug registration, an import licence, batch release certificate, and certificate of analysis.

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

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 uploaded before out-of-charge is granted.

What happens if the import licence for drugs has expired at the time of filing the bill of entry?

An expired import licence (document code 9111dc) renders the consignment non-compliant at the bill-of-entry stage; the proper officer will withhold out-of-charge, and the consignment is liable to detention until a current licence is produced or, failing that, re-export or confiscation under the Drugs and Cosmetics Act, 1940.

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