For malaria

Malaria diagnostic reagents and rapid test kits

MEFCC CLEARANCE

HSN 3822 11 00 (malaria diagnostic or laboratory reagents) is subject to Ministry of Environment, Forest and Climate Change (MEFCC) conditions for import, including restrictions on used and refurbished medical equipment per the O.M. dated 15 December 2023. Certificate of analysis, batch release certificate, and consignment label must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3822 11 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 drug authority
Batch release certificate from manufacturer
Label of consignment from importer

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Compliance steps

1
Upload the mandatory e-Sanchit documents — certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc) — prior to filing the bill of entry. The proper officer will verify these uploads before granting out-of-charge.
CBIC customs e-Sanchit verification requirement · document codes 0010dc, 0030dc, 0110dc
2
Where the malaria diagnostic equipment being imported is used or refurbished and falls within the high-end, high-value category as defined by the Directorate General of Health Services, comply with the conditions specified in the Ministry of Environment, Forest and Climate Change O.M. dated 15 December 2023. Such imports are Restricted and subject to multiple conditions.
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 assuming that new malaria diagnostic reagents and equipment face the same unrestricted pathway as generic laboratory reagents, while overlooking that used or refurbished high-end medical equipment under this CTI is Restricted and governed by the MEFCC O.M. dated 15 December 2023. Consignments of refurbished diagnostic equipment arriving without evidence of compliance with those conditions face detention and potential re-export, with no post-facto regularisation pathway available at the bill of entry stage.

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Frequently asked

Does HSN 3822 11 00 require BIS certification?

No, malaria diagnostic reagents under this tariff line are not within the BIS Quality Control Order regime. Import is governed by the Ministry of Environment, Forest and Climate Change under conditions set out in the O.M. dated 15 December 2023, with mandatory e-Sanchit document verification at the bill of entry.

Which document codes are mandatory in e-Sanchit for this HSN?

Three documents must be uploaded before out-of-charge: certificate of analysis (0010dc), batch release certificate (0030dc), and label of consignment (0110dc); the proper officer verifies all three before granting clearance.

Does the used or refurbished equipment restriction apply to all malaria diagnostic reagents under this HSN?

No, the Restricted-import conditions under the MEFCC O.M. dated 15 December 2023 apply specifically to high-end, high-value used or refurbished medical equipment as categorised by the Directorate General of Health Services, not to new reagents or test kits.

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