Other

Other vaccines for human medicine

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 41 19 (Other vaccines for human medicine) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017. Five mandatory documents — including the Registration Certificate for Drugs and the Import Licence for Drugs — must be uploaded in e-Sanchit before customs out-of-charge is granted.

What this is

HSN code

3002 41 19

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import Licence for Drugs from CDSCO
Registration Certificate for Drugs from CDSCO
Batch Release Certificate from CDSCO

Compliance steps

1
Obtain a valid Registration Certificate for Drugs (document code 101dc1) and an Import Licence for Drugs (document code 9111dc) from CDSCO before filing the bill of entry. Both documents must be current and uploaded in e-Sanchit prior to out-of-charge.
Drugs and Cosmetics Act, 1940 · CDSCO import licensing framework · document codes 101dc1, 9111dc
2
Upload all five mandatory documents in e-Sanchit at the bill of entry stage: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer must verify all five before granting out-of-charge.
CDSCO e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is uploading the Import Licence and Registration Certificate while overlooking the Batch Release Certificate (0030dc) and the Certificate of Analysis (0010dc), which are independently mandatory for each consignment. A bill of entry missing any one of the five required documents will be detained pending document completion, accruing demurrage and ground rent; the PGA-facilitated route does not dispense with the e-Sanchit upload obligation.

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Frequently asked

Does HSN 3002 41 19 require BIS certification?

No, human medicine vaccines are not within the BIS Quality Control Order regime; no BIS QCO covers this product family. 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.

Are all five e-Sanchit documents required for every consignment, or only on first import?

All five documents — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate (101dc1), and Import Licence (9111dc) — must be uploaded in e-Sanchit for each consignment before out-of-charge is granted.

What happens if the bill of entry is PGA-facilitated and has not been routed through CDSCO for NOC?

The proper officer is required to independently verify that all five mandatory documents are uploaded in e-Sanchit before granting out-of-charge; PGA facilitation does not substitute for document verification, and a deficient consignment is detained at the port.

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