Appliances identifiable for ostomy use

Ostomy appliances and related pharmaceutical goods

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3006 91 00 (Appliances identifiable for ostomy use) is classified under Chapter 30 pharmaceutical goods and is subject to Central Drugs Standard Control Organisation (CDSCO) regulatory oversight under the Drugs and Cosmetics Act, 1940. At the bill-of-entry stage, customs officers verify that a certificate of analysis, batch release certificate, and consignment label have been uploaded in e-Sanchit before out-of-charge is granted.

What this is

HSN code

3006 91 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Certificate of analysis from manufacturer
Batch release certificate from manufacturer
Label of consignment from importer

Compliance steps

1
Prepare and upload the certificate of analysis for the drug or device (document code 0010dc) and the batch release certificate (document code 0030dc) in e-Sanchit before filing the bill of entry. Both documents must be current and correspond to the specific consignment batch.
CCR mandatory document requirement · document codes 0010dc and 0030dc · e-Sanchit upload obligation
2
Upload the label of the consignment (document code 0110dc) in e-Sanchit. The customs proper officer will verify that all three mandatory documents are present before granting out-of-charge; consignments with missing uploads are detained pending compliance.
CCR mandatory document requirement · document code 0110dc · e-Sanchit out-of-charge verification

A word of counsel

The single most common error on this tariff line is uploading a certificate of analysis that does not correspond to the batch number on the commercial invoice and batch release certificate. A mismatch between the batch number on document code 0010dc and document code 0030dc is treated as a documentation deficiency, triggering detention at port and potential demurrage and ground rent liability until corrected documents are uploaded and verified by the proper officer.

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Frequently asked

Does HSN 3006 91 00 require BIS certification?

No. No BIS Quality Control Order covers ostomy appliances or Chapter 30 pharmaceutical goods. Import compliance is governed by the Drugs and Cosmetics Act, 1940, with CDSCO oversight, and mandates certificate of analysis, batch release certificate, and consignment label uploads in e-Sanchit.

Are all three e-Sanchit documents mandatory even when the bill is PGA-facilitated?

Yes. The customs proper officer is required to verify that document codes 0010dc, 0030dc, and 0110dc have all been uploaded in e-Sanchit before out-of-charge, regardless of whether the bill has been routed through the PGA for NOC.

What happens if the batch release certificate is missing at the time of bill of entry?

Absence of the batch release certificate (document code 0030dc) prevents the customs proper officer from granting out-of-charge, resulting in consignment detention, accruing demurrage and ground rent, until the document is uploaded and verified.

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