Pituitary hormones

Pituitary hormone medicaments in measured doses

MEFCC CLEARANCE

HSN 3004 39 11 (Pituitary 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 import of oxytocin as prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with a narrow carve-out for oxytocin reference standards imported exclusively for test and analysis against a DGCI/CDSCO test licence.

What this is

HSN code

3004 39 11

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 (document code 101dc1) and import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before shipment. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry; customs out-of-charge will not be granted without verified upload.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
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 at the bill of entry stage. The proper officer is required to verify all five mandatory documents before granting out-of-charge on PGA-facilitated bills.
CDSCO e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
If the specific pituitary hormone being imported is oxytocin, confirm the consignment is restricted to reference-standard quantities for test and analysis only, supported by a test licence issued by DGCI/CDSCO. General commercial import of oxytocin is 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 most common error on this tariff line is conflating the blanket oxytocin prohibition with the residual pituitary-hormone regime: importers shipping oxytocin under a standard CDSCO drug import licence — without a specific DGCI/CDSCO test licence and a reference-standard end-use justification — face confiscation and prosecution, not merely detention. The MEFCC O.M. dated 15-12-2023 also imposes separate conditions on high-value used or refurbished medical equipment; verify that this entry point does not inadvertently cover any such equipment falling under that O.M.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3004 39 11 require BIS certification?

No, pituitary hormone 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 the oxytocin prohibition overlay administered by DGFT under S.O. 2357(E).

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

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 uploaded before out-of-charge is granted.

Can oxytocin be imported under this tariff line for commercial therapeutic use?

No. Import of oxytocin for commercial use is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; only oxytocin reference standards for test and analysis are permitted, exclusively against a test licence issued by DGCI/CDSCO.

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