Plasma expanders

Plasma expanders for therapeutic or prophylactic use

MEFCC CLEARANCE

HSN 3004 90 92 (Plasma expanders) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940, with mandatory document verification at the bill-of-entry stage. The Directorate General of Foreign Trade (DGFT) administers an ITC (HS) policy overlay that includes a categorical prohibition on oxytocin import under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Ministry of Environment, Forest and Climate Change conditions apply to used or refurbished medical equipment within this tariff line.

What this is

HSN code

3004 90 92

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Drugs and Cosmetics Act, 1940 (CDSCO drug import regime); DGFT ITC (HS) policy overlay

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Certificate of analysis from exporter

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 current Import Licence for drugs (document code 9111dc) and a Registration Certificate for drugs (document code 101dc1) from CDSCO before shipment. Both documents must be uploaded in e-Sanchit, along with a Certificate of Analysis (document code 0010dc), a Batch Release Certificate (document code 0030dc), and the Label of consignment (document code 0110dc), before customs out-of-charge is granted.
Drugs and Cosmetics Act, 1940 · CDSCO drug import regime · document codes 9111dc, 101dc1, 0010dc, 0030dc, 0110dc
2
Verify that the consignment does not contain oxytocin. Import of oxytocin is prohibited; the sole exemption covers oxytocin reference standards imported exclusively for test and analysis purposes, subject to a test licence issued by DGCI/CDSCO. The prohibition is operative 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
3
If the goods comprise used or refurbished medical equipment, comply with the conditions stipulated in the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023, under which import of high-end and high-value used or refurbished medical equipment other than critical-care medical equipment is Restricted.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most common error on this tariff line is conflating the oxytocin prohibition with a general exclusion rather than a product-specific categorical ban: importers occasionally ship formulations containing oxytocin as a secondary constituent believing the prohibition applies only to standalone oxytocin preparations. Any oxytocin content in the consignment — other than reference standards accompanied by a DGCI/CDSCO test licence — triggers confiscation and prosecution under both the Drugs and Cosmetics Act, 1940 and the DGFT policy condition in S.O. 2357(E).

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Frequently asked

Does HSN 3004 90 92 require BIS certification?

No. Plasma expanders are pharmaceutical medicaments and no BIS Quality Control Order covers this product family. Import is governed by CDSCO drug licensing under the Drugs and Cosmetics Act, 1940, with an ITC (HS) policy overlay administered by the Directorate General of Foreign Trade.

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

Five documents must be uploaded in e-Sanchit before out-of-charge: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc).

Is the oxytocin prohibition absolute, or are there any permitted imports?

The prohibition is near-absolute. The sole carve-out permits import of oxytocin reference standards exclusively for test and analysis purposes, conditional on production of a test licence issued by DGCI/CDSCO, as notified 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.