For Zika and other diseases transmitted by mosquitoes of the genus Aedes

Diagnostic reagents for Aedes-transmitted diseases including Zika

MEFCC CLEARANCE

HSN 3822 12 00 (diagnostic reagents for Zika and other Aedes-transmitted diseases) is subject to oversight by the Ministry of Environment, Forest and Climate Change (MEFCC) under the conditions set out in the O.M. dated 15 December 2023, which imposes restrictions on import of high-end and high-value used or refurbished medical equipment. Mandatory documents — Certificate of Analysis, Batch Release Certificate, and consignment label — must be uploaded in e-Sanchit before out-of-charge is granted at the bill of entry.

What this is

HSN code

3822 12 00

Chapter

38 · Miscellaneous chemical products

Primary regulator

MEFCC · O.M. dated 15-12-2023 (Ministry of Environment, Forest and Climate Change)

Customs documentation

Certificate of Analysis from issuing authority
Batch Release Certificate from manufacturer
Label of consignment from CBIC

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit before filing the bill of entry. The proper officer will verify these documents are present before granting out-of-charge.
CCR mandatory document requirements · document codes 0010dc, 0030dc, 0110dc
2
Where the consignment comprises used or refurbished high-end, high-value medical equipment, confirm compliance with the conditions imposed by the Ministry of Environment, Forest and Climate Change O.M. dated 15 December 2023 before shipment. Import of such equipment is Restricted and subject to the conditions specified in that O.M.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most common error on this tariff line is conflating new diagnostic reagent kits with used or refurbished medical equipment: the MEFCC restriction and the O.M. dated 15 December 2023 apply specifically to high-end, high-value used or refurbished equipment, not to fresh consignments of in-vitro diagnostic reagents. Importers of new reagent kits must still upload all three mandatory e-Sanchit documents (0010dc, 0030dc, 0110dc) before out-of-charge; failure to upload any one of them results in consignment detention regardless of the equipment category.

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Frequently asked

Does HSN 3822 12 00 require BIS certification?

No, diagnostic reagents for Aedes-transmitted diseases fall outside the BIS Quality Control Order regime. Import is governed by the Ministry of Environment, Forest and Climate Change under the O.M. dated 15 December 2023, with mandatory e-Sanchit document uploads required at the bill of entry.

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

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

Does the MEFCC O.M. restriction on used or refurbished medical equipment apply to new diagnostic reagent kits under this HSN?

No — the O.M. dated 15 December 2023 targets high-end, high-value used or refurbished medical equipment; new diagnostic reagent kits are not within that restriction, though the mandatory e-Sanchit document requirements apply to all consignments under this tariff line.

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