For rabies

Antisera and blood fractions for rabies prophylaxis

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 12 30 (Antisera for rabies) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration 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 both be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3002 12 30

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO

Compliance steps

1
Obtain a Registration Certificate for the drug product (document code 101dc1) from the Central Drugs Standard Control Organisation before shipment. This registration must cover the specific antisera or blood fraction formulation for rabies prophylaxis.
Drugs and Cosmetics Act, 1940 · document code 101dc1
2
Secure an Import Licence for drugs (document code 9111dc) from CDSCO and upload both the Registration Certificate and Import Licence in e-Sanchit prior to filing the bill of entry. Customs out-of-charge will not be granted until both documents are verified in the e-Sanchit system.
Drugs and Cosmetics Act, 1940 · document code 9111dc

A word of counsel

The most common error on this tariff line is uploading only one of the two mandatory CDSCO instruments — importers frequently upload the Import Licence and omit the Registration Certificate (101dc1), or vice versa. Both documents are independently verified by the proper officer before out-of-charge is granted, and a missing instrument results in consignment detention and accruing demurrage regardless of how current the other document is.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3002 12 30 require BIS certification?

No. No BIS Quality Control Order covers antisera or blood fractions; this product family is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, which requires both a Registration Certificate and an Import Licence at the bill-of-entry stage.

Are both the Registration Certificate and the Import Licence required at the time of the bill of entry?

Yes. Both document code 101dc1 (Registration Certificate for drugs) and document code 9111dc (Import Licence for drugs) must be uploaded in e-Sanchit before customs out-of-charge is granted.

Does the CDSCO Import Licence cover all formulations and pack sizes of rabies antisera?

The Import Licence is product-specific and must correspond to the exact formulation, strength, and manufacturer covered by the Registration Certificate; a licence issued for one formulation does not authorise import of a variant or a product from a different manufacturing facility.

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