Tuberculosis

Tuberculosis vaccine for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 15 (Tuberculosis vaccine for human medicine) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. A valid import licence for drugs and a registration certificate for the drug product must be uploaded in e-Sanchit before customs out-of-charge at the bill-of-entry stage.

What this is

HSN code

3002 41 15

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Batch release certificate from CDSCO

Compliance steps

1
Obtain a valid import licence for drugs (document code 9111dc) and a registration certificate for the tuberculosis vaccine (document code 101dc1) from the Central Drugs Standard Control Organisation before shipment. Both documents must be uploaded in e-Sanchit at the bill of entry prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload the Certificate of Analysis (document code 0010dc), the batch release certificate (document code 0030dc), and the consignment label (document code 0110dc) in e-Sanchit before customs clearance. The proper officer will verify all five mandatory documents before granting out-of-charge.
e-Sanchit document codes 0010dc, 0030dc, 0110dc · Drugs and Cosmetics Act, 1940

A word of counsel

The most common error on this tariff line is presenting the import licence and registration certificate while neglecting to upload the batch release certificate and Certificate of Analysis as separate e-Sanchit entries. Customs officers treat the absence of any one of the five mandatory document codes — 0010dc, 0030dc, 0110dc, 101dc1, or 9111dc — as grounds for withholding out-of-charge, resulting in consignment detention, demurrage, and cold-chain compromise for a temperature-sensitive biological product.

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Frequently asked

Does HSN 3002 41 15 require BIS certification?

No; no BIS Quality Control Order covers vaccines for human medicine. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with mandatory import licensing, drug registration, and batch-level documentation at the bill-of-entry stage.

Which five documents must be uploaded in e-Sanchit for this tuberculosis vaccine?

The Certificate of Analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) must all be uploaded before customs out-of-charge.

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

An expired import licence (9111dc) renders the consignment non-compliant under the Drugs and Cosmetics Act, 1940; the proper officer will withhold out-of-charge, and the consignment faces detention or re-export until a current licence is produced.

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