For diptheria

Antisera and blood fractions for diphtheria

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 12 10 (Antisera for diphtheria) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. At the bill of entry, 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 10

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 valid registration certificate for the diphtheria antiserum from CDSCO and ensure it is uploaded in e-Sanchit under document code 101dc1 before filing the bill of entry. The registration must cover the specific product and manufacturer.
Drugs and Cosmetics Act, 1940 · document code 101dc1 (e-Sanchit)
2
Obtain and upload the import licence for drugs under document code 9111dc in e-Sanchit prior to out-of-charge. The customs proper officer will verify both the registration certificate and the import licence before granting out-of-charge on PGA-facilitated bills.
Drugs and Cosmetics Act, 1940 · document code 9111dc (e-Sanchit)

A word of counsel

The most common error on this tariff line is uploading only one of the two mandatory CDSCO documents — either the registration certificate or the import licence — and assuming the other will be waived. Both document codes (101dc1 and 9111dc) are independently verified by the customs proper officer before out-of-charge; a consignment with only one uploaded document will be detained pending the missing clearance, attracting demurrage and ground rent at the designated port.

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Frequently asked

Does HSN 3002 12 10 require BIS certification?

No, antisera and blood fractions are not within the BIS Quality Control Order regime. Import of diphtheria antisera is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring both a drug registration certificate and an import licence.

Are both the registration certificate and the import licence required to be uploaded in e-Sanchit for this HSN?

Yes. Document code 101dc1 (registration certificate for drugs) and document code 9111dc (import licence for drugs) must both be uploaded in e-Sanchit; the customs proper officer verifies both before granting out-of-charge.

Does the registration and import licence requirement apply even when the bill is PGA-facilitated?

Yes. Where a bill has not been routed through the PGA for NOC, the customs proper officer is required to independently verify that both mandatory documents are present in e-Sanchit before out-of-charge is granted.

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