Prazosin, terazosin, phentolamine and phenoxybenzamine

Alpha-blocker medicaments (prazosin, terazosin, phentolamine, phenoxybenzamine)

MEFCC CLEARANCE

HSN 3004 90 75 (Prazosin, terazosin, phentolamine and phenoxybenzamine) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document upload before customs out-of-charge. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy overlay, and importers must note that oxytocin import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 — a restriction relevant where combination packs are miscoded to this line.

What this is

HSN code

3004 90 75

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence 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 (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO before the consignment is shipped. Both must cover the specific active substance — prazosin, terazosin, phentolamine, or phenoxybenzamine — as formulated and packed for retail sale.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CUSDATA CCR
2
Upload all five mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). The customs proper officer will verify e-Sanchit completion before granting out-of-charge.
CUSDATA CCR · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Verify that the consignment does not contain oxytocin in any form; import of oxytocin is prohibited except for reference standards exclusively for test and analysis (which requires a test licence from DCGI/CDSCO). Miscoding of oxytocin-containing products to this tariff line attracts confiscation and prosecution.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is uploading the registration certificate and import licence while omitting the Batch Release Certificate (0030dc) or the Certificate of Analysis (0010dc) — both are independently mandatory in e-Sanchit and their absence holds the consignment at port even when the registration and licence are current. Label compliance (0110dc) is verified at the same out-of-charge stage; a label defect that would otherwise be rectifiable becomes a detention trigger when the drug is a scheduled formulation.

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Frequently asked

Does HSN 3004 90 75 require BIS certification?

No. No BIS Quality Control Order covers alpha-blocker medicaments. Import is governed by CDSCO drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with an ITC (HS) policy overlay administered by DGFT.

Which document codes must be uploaded in e-Sanchit before customs out-of-charge?

Five documents are mandatory: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be present before the proper officer can grant out-of-charge.

Is the oxytocin prohibition relevant to this tariff line?

It becomes relevant when a consignment is miscoded to 3004 90 75 or where combination products contain oxytocin — import of oxytocin is prohibited per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with the sole exception of reference standards imported under a DCGI/CDSCO test licence.

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