Preparations of enzymes

Medicaments consisting of enzyme preparations for therapeutic use

MEFCC CLEARANCE

HSN 3004 90 84 (Preparations of enzymes) is subject to drug import controls under the Drugs and Cosmetics Act, 1940, with mandatory Central Drugs Standard Control Organisation (CDSCO) registration and import licence as the operative clearance requirements at the bill of entry. The Directorate General of Foreign Trade (DGFT) classifies this tariff line with a specific prohibition on oxytocin, permitting import of oxytocin reference standards exclusively for testing and analysis against a DCGI-issued test licence under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 90 84

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO import licensing regime)

Customs documentation

Registration certificate from CDSCO
Import licence for drugs 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 the consignment is dispatched. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · CDSCO import licensing regime · 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 before the bill of entry is filed. The proper officer will verify these documents before granting out-of-charge.
CBIC e-Sanchit requirement · document codes 0010dc, 0030dc, 0110dc
3
If the enzyme preparation contains oxytocin, note that import is prohibited; import of oxytocin reference standards is permitted solely for test and analysis purposes and requires a test licence issued by DCGI/CDSCO. Ensure the ITC (HS) policy prohibition is confirmed before purchase order placement.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is conflating the drug registration certificate with the import licence — both are distinct CDSCO instruments with independent validity windows, and absence of either at bill-of-entry stage results in consignment detention. Importers relying on the oxytocin-reference-standard carve-out must ensure the DCGI-issued test licence specifically authorises import for test and analysis; a general drug import licence does not satisfy the S.O. 2357(E) condition and will not secure out-of-charge.

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 90 84 require BIS certification?

No, enzyme medicament preparations are not subject to any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with the ITC (HS) policy overlay administered by the Directorate General of Foreign Trade, including the specific oxytocin prohibition under S.O. 2357(E).

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

Five documents must be uploaded in e-Sanchit: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc), all verified by the proper officer before out-of-charge.

Is any import of oxytocin permitted under this tariff line?

Import of oxytocin as a finished medicament is prohibited; however, oxytocin reference standards may be imported exclusively for test and analysis, subject to submission of a test licence issued by DCGI/CDSCO, per 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.