Hydralazine, minoxidil and diazoxide

Medicaments containing hydralazine, minoxidil or diazoxide

MEFCC CLEARANCE

HSN 3004 90 77 (Hydralazine, minoxidil and diazoxide) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document verification at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay for this tariff line, and the Ministry of Environment, Forest and Climate Change is listed as an additional regulatory touchpoint.

What this is

HSN code

3004 90 77

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO drug import regime)

Customs documentation

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

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 drugs from the Central Drugs Standard Control Organisation before shipment. Both documents must be uploaded in e-Sanchit under document codes 101dc1 (registration certificate — drugs) and 9111dc (import licence for drugs) prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR
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 before customs out-of-charge. The proper officer must verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CCR e-Sanchit mandatory document list · document codes 0010dc, 0030dc, 0110dc
3
Note that import of oxytocin is prohibited under this chapter; however, import of oxytocin reference standards is permitted exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO. This carve-out is separate from the hydralazine/minoxidil/diazoxide regime but applies to related bills filed under adjacent CTIs in Chapter 30.
S.O. 2357(E) · DGFT Notification 09/2015-2020 both dated 23-05-2022

A word of counsel

The most common error on this tariff line is presenting only the import licence (9111dc) at the bill of entry without uploading all five mandatory e-Sanchit documents — Certificate of Analysis, Batch Release Certificate, Label of Consignment, Registration Certificate, and Import Licence. Customs out-of-charge is withheld until every document code is present in e-Sanchit, and a single missing upload causes consignment detention, demurrage, and ground rent with no short-form remedy available at the port.

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Frequently asked

Does HSN 3004 90 77 require BIS certification?

No. No BIS Quality Control Order covers medicaments in this product family. Import is governed by the CDSCO drug import regime under the Drugs and Cosmetics Act, 1940, with DGFT administering the ITC (HS) policy overlay and five mandatory e-Sanchit documents required at the bill of entry.

Which five documents must be uploaded in e-Sanchit before out-of-charge for this tariff line?

The mandatory documents are: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc), all uploaded in e-Sanchit before the proper officer grants out-of-charge.

Does the oxytocin prohibition under S.O. 2357(E) affect imports of hydralazine, minoxidil or diazoxide?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin, not to hydralazine, minoxidil or diazoxide; however, importers filing mixed Chapter 30 bills must ensure the oxytocin line item is not included unless importing approved reference standards under a valid DGCI/CDSCO test licence.

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