Other progestogen and oestogen group hormones

Medicaments containing progestogen and oestrogen group hormones

MEFCC CLEARANCE

HSN 3004 39 19 (Other progestogen and oestrogen group hormones) 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 the tariff line as subject to policy conditions, and the import of oxytocin — a product within this residual category — is prohibited except for reference standards for test and analysis under a DGCI/CDSCO test licence, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 39 19

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Certificate of Analysis 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 CDSCO before filing the bill of entry. Upload the registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) in e-Sanchit; out-of-charge will not be granted without these documents.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the label of consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer is mandated to verify all five mandatory documents before granting out-of-charge.
CCR mandatory document list · e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
If the consignment contains oxytocin, import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, unless imported exclusively as a reference standard for test and analysis and accompanied by a test licence issued by DGCI/CDSCO. Any consignment that does not meet this carve-out is liable to confiscation.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The residual nature of this tariff line means it covers a wide spectrum of progestogen and oestrogen formulations, and importers routinely overlook the product-specific prohibition on oxytocin embedded within this 8-digit code. Filing under 3004 39 19 does not create a blanket entitlement to import all substances in the category — the oxytocin prohibition is product-level, not code-level, and a consignment containing oxytocin without a DGCI/CDSCO test licence will be confiscated even if all five standard e-Sanchit documents are otherwise in order.

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Frequently asked

Does HSN 3004 39 19 require BIS certification?

No, pharmaceutical medicaments under this tariff line are not within the BIS Quality Control Order regime. Import is governed by CDSCO drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with DGFT policy conditions including an oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Five documents are mandatory: Certificate of Analysis for drugs (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 out-of-charge is granted.

Under what circumstances is oxytocin import permitted under this HSN?

Import of oxytocin is permitted exclusively as a reference standard for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; commercial import of oxytocin is prohibited.

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