Prednisolone

Prednisolone medicaments in measured doses for retail sale

MEFCC CLEARANCE

HSN 3004 39 12 (Prednisolone) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit documentation including a Registration Certificate for Drugs (101dc1) and an Import Licence for Drugs (9111dc). The Directorate General of Foreign Trade (DGFT) classifies the tariff line under the pharmaceutical import policy, and the Ministry of Environment, Forest and Climate Change (MEFCC) overlay applies as an additional clearance requirement for specified product categories.

What this is

HSN code

3004 39 12

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Import Licence for Drugs from CDSCO
Registration certificate 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 Import Licence for Drugs (document code 9111dc) and Registration Certificate for Drugs (document code 101dc1) from CDSCO before the bill of entry is filed. Both documents must be uploaded in e-Sanchit; a consignment arriving without either triggers detention and denial of out-of-charge by the proper officer.
Drugs and Cosmetics Act, 1940 · CDSCO import licensing regime · document codes 9111dc and 101dc1
2
Upload all mandatory batch-level documents in e-Sanchit at the bill of entry stage: Certificate of Analysis for Drugs (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc). The proper officer is required to verify these uploads before granting out-of-charge on PGA-facilitated bills.
CDSCO e-Sanchit mandatory document regime · document codes 0010dc, 0030dc, 0110dc
3
Note the absolute prohibition on import of oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; however, oxytocin reference standards may be imported exclusively for test and analysis subject to a test licence issued by DGCI/CDSCO. Prednisolone medicaments are not subject to this prohibition but importers should confirm no mis-classification with oxytocin-containing formulations.
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 treating the CDSCO Registration Certificate and Import Licence as interchangeable or as a single instrument — they are separate documents with separate issuance pathways and separate document codes (101dc1 and 9111dc respectively), and customs will detain the consignment if either is absent from e-Sanchit. Additionally, importers of used or refurbished medical equipment falling within the MEFCC O.M. dated 15 December 2023 must satisfy that overlay independently of the CDSCO drug-licensing regime.

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Frequently asked

Does HSN 3004 39 12 require BIS certification?

No, prednisolone medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers pharmaceutical products under Chapter 30. Import is governed by CDSCO licensing under the Drugs and Cosmetics Act, 1940, with DGFT policy controls and an MEFCC overlay applicable to specified categories.

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

Five document codes 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 the proper officer grants out-of-charge.

Does the oxytocin import prohibition under S.O. 2357(E) affect prednisolone consignments?

The prohibition applies specifically to oxytocin, not prednisolone; however, any consignment containing or mis-declared as an oxytocin formulation is subject to the absolute prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with oxytocin reference standards permitted only under a DGCI/CDSCO test licence.

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