For tetanus

Antisera and blood fractions for tetanus

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 12 20 (For tetanus) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. A registration certificate for drugs (document code 101dc1) and an import licence for drugs (document code 9111dc) must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3002 12 20

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO

Compliance steps

1
Obtain a registration certificate for the drug product and an import licence from the Central Drugs Standard Control Organisation before shipment. Both documents must be current and uploaded in e-Sanchit under document codes 101dc1 and 9111dc respectively prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
At the bill-of-entry stage, verify that the mandatory PGA documents — registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) — have been uploaded in e-Sanchit. The customs proper officer will not grant out-of-charge until both uploads are confirmed.
e-Sanchit mandatory document verification · document codes 101dc1 and 9111dc

A word of counsel

The most frequent error on this tariff line is presenting a valid import licence while the drug registration certificate has lapsed or covers a different product formulation. Antisera for tetanus is a biological product with a manufacturer- and batch-specific registration scope; a registration certificate issued for a different blood fraction or a different foreign manufacturer does not satisfy the 101dc1 requirement, and the customs proper officer will detain the consignment pending a fresh CDSCO registration confirmation.

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Frequently asked

Does HSN 3002 12 20 require BIS certification?

No. No BIS Quality Control Order covers antisera or blood fractions; this tariff line is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, which mandates both a drug registration certificate and an import licence before clearance.

Which document codes must be uploaded in e-Sanchit for tetanus antisera?

The mandatory uploads are the registration certificate for drugs under document code 101dc1 and the import licence for drugs under document code 9111dc; out-of-charge will not be granted until both are verified in e-Sanchit.

Does each foreign manufacturing facility require a separate CDSCO registration for this product?

Yes. Drug registration under the Drugs and Cosmetics Act, 1940 is manufacturer- and product-specific; a registration certificate obtained for one facility or formulation does not cover antisera sourced from a different foreign manufacturer.

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