Immunological products, put up in measured doses or in forms or packings for retail sale

Immunological products in measured doses or retail packings

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3002 15 00 (immunological products, put up in measured doses or in forms or packings for retail sale) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and product registration under the Drugs and Cosmetics Act, 1940. Five mandatory documents — including a Registration Certificate and Import Licence for drugs — must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3002 15 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

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

Compliance steps

1
Secure a valid Registration Certificate for the immunological product (document code 101dc1) and an Import Licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before the consignment departs the exporting country. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CBIC e-Sanchit CCR
2
Upload the remaining three mandatory documents in e-Sanchit before out-of-charge: Certificate of Analysis (drug) under document code 0010dc, Batch Release Certificate under document code 0030dc, and Label of Consignment under document code 0110dc. The proper officer must verify all five documents are present before granting out-of-charge on PGA-facilitated bills.
Document codes 0010dc, 0030dc, 0110dc per CBIC e-Sanchit CCR

A word of counsel

The most common error on this tariff line is uploading the Import Licence (9111dc) while omitting the Batch Release Certificate (0030dc) or the Certificate of Analysis (0010dc) — treating the licence as the sole gating document. All five e-Sanchit document codes are independently mandatory; a bill of entry presenting four of five triggers detention and demurrage at the port of import until the missing document is uploaded and verified by the proper officer.

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Frequently asked

Does HSN 3002 15 00 require BIS certification?

No, immunological products in measured doses or retail packings are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with a mandatory registration certificate and import licence required at the bill of entry.

Are all five e-Sanchit document codes mandatory for every consignment under this HSN?

Yes — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc) must all be uploaded in e-Sanchit; the proper officer is required to verify each before granting out-of-charge.

What happens if the Import Licence for drugs has expired at the time of filing the bill of entry?

An expired Import Licence (9111dc) constitutes a missing mandatory document; the consignment is liable to detention at the port of import, and continued storage attracts demurrage and ground rent until a valid licence is furnished and verified in e-Sanchit.

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