Opacifying preprations for X-ray examinations; diagnostic reagents designed to be administered to the patient

Opacifying preparations for X-ray examinations and diagnostic reagents

PARTNER GOVERNMENT AGENCY CLEARANCE

HSN 3006 30 00 covers opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the patient, both of which are regulated as drugs under the Central Drugs Standard Control Organisation (CDSCO) regime by virtue of their classification under pharmaceutical Chapter 30. Import requires a valid import licence from CDSCO and mandatory pre-shipment documentation — Certificate of Analysis, batch release certificate, and consignment label — uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3006 30 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Certificate of Analysis from CDSCO
Batch release certificate from manufacturer
Label of consignment from importer

Compliance steps

1
Ensure a valid CDSCO import licence covers the specific opacifying preparation or diagnostic reagent being imported. The product must be registered with the Central Drugs Standard Control Organisation as a drug before the bill of entry is filed; unlicensed import attracts confiscation and prosecution under the Drugs and Cosmetics Act, 1940.
Drugs and Cosmetics Act, 1940 · Chapter 30 pharmaceutical goods regime
2
Upload three mandatory documents in e-Sanchit before the bill of entry is processed: Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc). Customs out-of-charge will not be granted until all three documents are verified by the proper officer.
CCR document codes 0010dc, 0030dc, 0110dc · e-Sanchit mandatory upload requirement

A word of counsel

The most common error on this tariff line is shipping without a batch release certificate that is product-specific and lot-matched to the consignment — a generic or mismatched batch release certificate fails PGA verification even when the Certificate of Analysis is current. Each shipment must carry its own batch release documentation; a single umbrella certificate covering multiple lots is not accepted at customs, and the consignment will be held until the correct lot-specific document is uploaded in e-Sanchit.

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Frequently asked

Does HSN 3006 30 00 require BIS certification?

No, opacifying preparations for X-ray examinations and diagnostic reagents administered to patients are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit upload of Certificate of Analysis, batch release certificate, and consignment label.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Three documents are mandatory: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc); all three must be uploaded and verified by the proper officer before out-of-charge is granted.

Are diagnostic reagents and X-ray opacifying preparations treated identically at the bill of entry?

Both sub-categories share the same 8-digit HSN and the same three mandatory e-Sanchit documents, but each product requires its own CDSCO import licence and registration; a licence covering one sub-category does not authorise import of the other.

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