Gonadotrophins

Gonadotrophin medicaments for therapeutic or prophylactic use

MEFCC CLEARANCE

HSN 3004 39 21 (Gonadotrophins) is subject to drug registration and import licensing under the Drugs and Cosmetics Act, 1940, administered by the Central Drugs Standard Control Organisation (CDSCO), with mandatory e-Sanchit document upload before customs out-of-charge. Import of oxytocin — a gonadotrophin-adjacent hormone under this chapter — is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, except for reference standards exclusively for test and analysis.

What this is

HSN code

3004 39 21

Chapter

30 · Pharmaceutical products

Primary regulator

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

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 and import licence for drugs from the Central Drugs Standard Control Organisation before the bill of entry is filed. Upload both documents in e-Sanchit under document codes 101dc1 (registration certificate — drugs) and 9111dc (import licence for drugs) before 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 stage. The proper officer must verify all five mandatory documents are present before granting out-of-charge on PGA-facilitated bills.
CBIC e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc
3
Confirm the consignment does not contain oxytocin: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. The sole exception is oxytocin reference standards imported exclusively for test and analysis, which requires a test licence issued by DGCI/CDSCO.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The oxytocin prohibition is the most consequential trap on this tariff line: importers who classify a product as a gonadotrophin formulation without confirming the absence of oxytocin — or without holding a DGCI/CDSCO test licence for reference-standard imports — face outright confiscation under the prohibition notification, not merely a documentation deficiency. The test-licence pathway is narrow and applies only to oxytocin reference standards for test and analysis; therapeutic oxytocin in any dose form or packing remains prohibited regardless of prior registration.

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Frequently asked

Does HSN 3004 39 21 require BIS certification?

No, gonadotrophin medicaments are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with drug registration, import licensing, and batch-release documentation as the operative requirements at the bill of entry.

Which e-Sanchit document codes are mandatory for gonadotrophin imports at the bill of entry?

Five documents must be uploaded: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); the proper officer will not grant out-of-charge until all five are verified.

Can oxytocin reference standards be imported under this HSN?

Yes, but exclusively for test and analysis, and only on production of a test licence issued by DGCI/CDSCO; all other forms of oxytocin remain prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

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