Other

Adhesive dressings and other adhesive-layer wound-care articles

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3005 10 90 (Other adhesive dressings and articles having an adhesive layer) is regulated as a medical device or drug under the Drugs and Cosmetics Act, 1940, with mandatory batch-level documentation required at the bill-of-entry stage. Importers must ensure the certificate of analysis, batch release certificate, and consignment label are uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3005 10 90

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

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

Compliance steps

1
Obtain and upload the Certificate of Analysis for the drug/device (document code 0010dc) in e-Sanchit prior to filing the bill of entry. This document must cover the specific batch being imported and confirm conformance to the applicable pharmacopoeial or product standard.
CCR mandatory-document requirement · document code 0010dc
2
Upload the Batch Release Certificate (document code 0030dc) and the Label of Consignment (document code 0110dc) in e-Sanchit before the bill of entry is presented for out-of-charge. The proper officer verifies all three documents for PGA-facilitated bills not routed through the PGA for NOC.
CCR mandatory-document requirement · document codes 0030dc, 0110dc

A word of counsel

The most frequent error on this tariff line is uploading the batch release certificate and certificate of analysis for a different batch than the one declared in the bill of entry. Customs officers conducting PGA-facilitated bill verification cross-reference batch numbers across all three documents — a mismatch between the certificate of analysis (0010dc), the batch release certificate (0030dc), and the label (0110dc) results in consignment detention pending rectification, with demurrage and ground rent accruing at the port.

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Frequently asked

Does HSN 3005 10 90 require BIS certification?

No, adhesive dressings and adhesive-layer articles under this tariff line are not covered by any BIS Quality Control Order. The operative compliance framework is the Drugs and Cosmetics Act, 1940, with batch-level documentation mandated at the bill-of-entry stage under customs out-of-charge procedures.

Are all three e-Sanchit documents mandatory even for a small commercial shipment?

Yes. The CCR specifies that the certificate of analysis (0010dc), batch release certificate (0030dc), and label of consignment (0110dc) must all be uploaded in e-Sanchit before out-of-charge is granted, with no de minimis exemption recorded in the regulatory record.

What happens if the consignment has not been routed through the PGA for an NOC?

The proper officer is required to independently verify that all three mandatory documents are present in e-Sanchit on PGA-facilitated bills; failure to upload any one of them will result in out-of-charge being withheld and the consignment detained at port.

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