Heamatinics and erythropoietin preparations

Haematinics and erythropoietin medicaments (vitamin-containing preparations)

MEFCC CLEARANCE

HSN 3004 50 10 (Haematinics and erythropoietin preparations) is subject to drug import controls administered by 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 with an oxytocin-specific prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, and an Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023 imposes additional conditions on high-value used or refurbished medical equipment imports.

What this is

HSN code

3004 50 10

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940; DGFT ITC (HS) policy condition, Chapter 30

Customs documentation

Registration certificate (drugs) from CDSCO
Import licence for drugs from CDSCO
Batch release certificate 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 registration certificate for drugs (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO before filing the bill of entry. Both documents must be uploaded in e-Sanchit; a bill of entry presented without these credentials will be detained pending regularisation.
Drugs and Cosmetics Act, 1940 · CDSCO import licensing regime · document codes 101dc1, 9111dc
2
Upload all five mandatory documents in e-Sanchit before customs out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer must verify upload before granting out-of-charge on PGA-facilitated bills.
CBIC e-Sanchit document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Confirm the consignment does not contain oxytocin: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Import of oxytocin reference standards is permitted exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The single most common error on this tariff line is conflating the oxytocin prohibition with the broader haematinics and erythropoietin category: the prohibition is compound-specific, not a category-wide ban, but any consignment that includes oxytocin — even as an incidental ingredient or as a reference standard without the DGCI/CDSCO test licence — is subject to outright confiscation and DGFT enforcement. Separately, importers of used or refurbished equipment classified here should verify the conditions of the Ministry of Environment, Forest and Climate Change O.M. dated 15-12-2023 before shipment, as non-compliance triggers restricted-import enforcement independent of the drug-registration regime.

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Frequently asked

Does HSN 3004 50 10 require BIS certification?

No, haematinics and erythropoietin preparations are not covered by any BIS Quality Control Order. Import is governed by the drug registration and licensing regime administered by CDSCO under the Drugs and Cosmetics Act, 1940, with DGFT policy conditions 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 — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc), all to be uploaded before customs out-of-charge.

Can oxytocin reference standards be imported under this HSN?

Yes, but only for test and analysis purposes, and exclusively upon submission of a test licence issued by DGCI/CDSCO; commercial import of oxytocin remains prohibited under 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.