Polio

Polio vaccines for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 14 (Polio vaccines 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 Registration Certificate for drugs and an Import Licence for drugs must both be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3002 41 14

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import Licence for drugs from CDSCO
Registration certificate from CDSCO
Certificate of analysis from manufacturer

Compliance steps

1
Obtain a valid Import Licence for drugs (document code 9111dc) and a Registration Certificate for drugs (document code 101dc1) from the Central Drugs Standard Control Organisation before the consignment is shipped. Both documents must be current and cover the specific polio vaccine product being imported.
Drugs and Cosmetics Act, 1940 · document codes 9111dc and 101dc1
2
Upload all five mandatory documents in e-Sanchit at the bill-of-entry stage before customs out-of-charge: Certificate of Analysis (drug) (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate (drugs) (101dc1), and Import Licence for drugs (9111dc). The proper officer will verify these documents for PGA-facilitated bills not routed through the PGA for NOC.
CDSCO e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most frequent error on this tariff line is uploading a Registration Certificate that covers a different formulation or manufacturer than the specific batch being imported. A batch release certificate or certificate of analysis that does not precisely match the product registration on file triggers detention at the port of entry; the consignment cannot obtain out-of-charge until a conforming certificate is produced, attracting demurrage and ground rent.

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Frequently asked

Does HSN 3002 41 14 require BIS certification?

No, polio vaccines are not within the BIS Quality Control Order regime; no BIS QCO covers vaccines for human medicine. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring an Import Licence, Registration Certificate, and batch-level documentation.

Which five documents must be uploaded in e-Sanchit before customs out-of-charge for this HSN?

The mandatory documents are: Certificate of Analysis (drug) (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate (drugs) (101dc1), and Import Licence for drugs (9111dc); all must be uploaded in e-Sanchit before the proper officer grants out-of-charge.

Is a separate batch release certificate required for each import consignment of polio vaccines?

Yes, the Batch Release Certificate (document code 0030dc) is a mandatory per-consignment document and must correspond to the specific batch being imported; a generic or expired certificate will not satisfy the e-Sanchit verification requirement.

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