Luteinising hormone

Luteinising hormone medicaments for therapeutic use

MEFCC CLEARANCE

HSN 3004 39 22 (Luteinising hormone) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies import of oxytocin under this heading as Prohibited per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with a narrow carve-out permitting oxytocin reference standards exclusively for test and analysis against a DGCI/CDSCO test licence.

What this is

HSN code

3004 39 22

Chapter

30 · Pharmaceutical products

Primary regulator

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

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 import licence for drugs (document code 9111dc) from CDSCO before filing the bill of entry. Both documents must be uploaded in e-Sanchit; consignments lacking either are liable to detention and denial of out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry before customs out-of-charge. The proper officer is required to verify all five mandatory documents before granting OOC.
CDSCO e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc
3
If the consignment involves oxytocin, verify that import falls within the sole permitted carve-out: reference standards for test and analysis only. A test licence issued by DGCI/CDSCO must accompany the shipment; all other oxytocin imports are Prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The oxytocin prohibition under S.O. 2357(E) is an absolute Prohibited-import classification — not a Restricted-import that can be licensed through routine DGFT channels. Importers who attempt to clear oxytocin under the standard CDSCO drug-import pathway without a DGCI/CDSCO test licence face confiscation and prosecution under the Drugs and Cosmetics Act; the test-and-analysis carve-out is narrow and the test licence must be current and specific to the consignment quantity at the time of filing.

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Frequently asked

Does HSN 3004 39 22 require BIS certification?

No, luteinising hormone medicaments fall outside the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with an ITC (HS) Prohibited-import overlay for oxytocin administered by DGFT under S.O. 2357(E) dated 23-05-2022.

Which e-Sanchit documents are mandatory at the bill of entry for this HSN?

Five documents are mandatory: Certificate of Analysis (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 the proper officer grants out-of-charge.

Can oxytocin under this heading ever be legally imported?

Yes, but only as reference standards for test and analysis, subject to a test licence issued by DGCI/CDSCO; all other forms and purposes are Prohibited under DGFT Notification 09/2015-2020 and S.O. 2357(E) both dated 23-05-2022.

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