Metronidazole

Metronidazole medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 90 22 (Metronidazole) is governed by the Central Drugs Standard Control Organisation (CDSCO) drug-import registration and import-licence regime under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies the tariff line under its policy overlay, and mandatory e-Sanchit documentation — including a registration certificate, import licence, batch release certificate, and certificate of analysis — must be uploaded before customs out-of-charge.

What this is

HSN code

3004 90 22

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Batch release certificate from CDSCO

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid drug registration certificate and import licence for Metronidazole from the Central Drugs Standard Control Organisation before shipment. Both documents — registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) — must be uploaded in e-Sanchit before the bill of entry is filed.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc (e-Sanchit)
2
Upload the Certificate of Analysis — Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit. The customs proper officer must verify all five mandatory documents are present before granting out-of-charge on any PGA-facilitated bill.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc · CCR mandatory-document instruction

A word of counsel

The most common error on this tariff line is conflating Metronidazole with oxytocin-related prohibitions noted in the same Chapter 30 CCR context. Oxytocin import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; Metronidazole faces no such prohibition but is subject to the full five-document CDSCO regime. Presenting incomplete e-Sanchit uploads — most frequently an absent batch release certificate or unlabelled consignment declaration — results in detention at the port of entry and accrual of demurrage.

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Frequently asked

Does HSN 3004 90 22 require BIS certification?

No. Metronidazole medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers this product family. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT policy oversight and a mandatory five-document e-Sanchit upload at the bill of entry.

Which five documents must be uploaded in e-Sanchit for a Metronidazole consignment?

The mandatory documents are the Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be uploaded before customs out-of-charge.

Does the oxytocin import prohibition affect Metronidazole consignments?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 is specific to oxytocin; Metronidazole is a distinct active pharmaceutical ingredient and is not subject to that prohibition, though the full CDSCO import-licence and registration regime applies.

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