Preparations of minerals and their supplements

Mineral preparations and supplements in measured doses

MEFCC CLEARANCE

HSN 3004 50 20 (Preparations of minerals and their supplements) is subject to drug-import controls administered through the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, requiring a Registration Certificate and Import Licence for drugs before the bill of entry is filed. The Directorate General of Foreign Trade (DGFT) classifies this tariff line as Restricted, and the import of oxytocin within this CTI is prohibited except for reference standards authorised exclusively for test and analysis under DGFT Notification 09/2015-2020.

What this is

HSN code

3004 50 20

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug registration and import licence 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 Registration Certificate for the drug (document code 101dc1) and an Import Licence for drugs (document code 9111dc) from CDSCO before filing the bill of entry. Both must be uploaded in e-Sanchit; consignments routed through PGA-facilitated bills without NOC are verified by the proper officer against these mandatory uploads before out-of-charge is granted.
Drugs and Cosmetics Act, 1940 · document codes 101dc1, 9111dc · CDSCO import licence regime
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 will verify all five mandatory documents before issuing out-of-charge.
e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc per CDSCO import compliance requirements
3
If the consignment contains or is declared as oxytocin, import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020. The sole exception is oxytocin reference standards imported exclusively for test and analysis, which require a test licence issued by DGCI/CDSCO to be submitted at clearance.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The oxytocin prohibition under S.O. 2357(E) applies within this CTI even where the broader consignment is a legitimate mineral or vitamin-based medicament — misclassification of an oxytocin-containing preparation under HSN 3004 50 20 does not shield it from the prohibition. Separately, importers of used or refurbished medical equipment classified here must also satisfy the conditions in the Ministry of Environment, Forest and Climate Change O.M. dated 15 December 2023; that overlay is independent of the CDSCO drug-import licence requirement.

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Frequently asked

Does HSN 3004 50 20 require BIS certification?

No. No BIS Quality Control Order covers mineral preparations and supplements classified under this tariff line. Import is governed by CDSCO drug registration and import-licence controls under the Drugs and Cosmetics Act, 1940, with a Restricted ITC (HS) policy overlay administered by DGFT.

Which document codes must be uploaded in e-Sanchit before out-of-charge for this HSN?

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 present before the proper officer grants out-of-charge.

Can oxytocin reference standards be imported under this tariff line?

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

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