Carcino-chemotherapeutic drugs not elsewhere specified or included

MEFCC CLEARANCE

HSN 3004 90 95 (Carcino-chemotherapeutic drugs not elsewhere specified or included) is subject to drug import licensing and registration administered by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, with an ITC (HS) Restricted-import policy overlay administered by the Directorate General of Foreign Trade (DGFT). A categorical prohibition on the import of oxytocin applies under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, with a narrow exception for oxytocin reference standards imported exclusively for test and analysis. The Ministry of Environment, Forest and Climate Change additionally restricts import of used or refurbished medical equipment under this heading.

What this is

HSN code

3004 90 95

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug import licence and registration regime)

Customs documentation

Import licence for drugs from CDSCO
Registration certificate from CDSCO
Certificate of Analysis 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 import licence for drugs (document code 9111dc) and a registration certificate for the specific drug (document code 101dc1) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both documents must be uploaded in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 9111dc and 101dc1 per CCR
2
Upload in e-Sanchit the Certificate of Analysis for drugs (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc). The proper officer will verify these documents before granting out-of-charge on PGA-facilitated bills.
CCR e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc
3
Confirm the specific substance is not subject to the oxytocin import prohibition. Import of oxytocin is prohibited outright; import of oxytocin reference standards is permitted only for test and analysis purposes and requires a test licence issued by the DGCI/CDSCO. Used or refurbished medical equipment under this tariff line is restricted per the O.M. issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022 · 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 importing oxytocin or oxytocin-containing formulations without recognising that the prohibition under S.O. 2357(E) is absolute — the narrow exception applies only to reference standards for test and analysis backed by a DGCI/CDSCO-issued test licence, not to therapeutic or commercial consignments. A consignment arriving without the test licence, or where the declared end-use cannot be substantiated, is liable to seizure and confiscation under the Drugs and Cosmetics Act, 1940, with no rectification pathway at the port of entry.

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Frequently asked

Does HSN 3004 90 95 require BIS certification?

No, carcino-chemotherapeutic drugs fall outside the BIS Quality Control Order regime; no BIS QCO covers this product family. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with an ITC (HS) Restricted-import policy overlay administered by DGFT and a categorical prohibition on oxytocin imports under S.O. 2357(E).

Is the import of oxytocin reference standards permitted under this tariff line?

Yes, but only for test and analysis purposes, and only on submission of a test licence issued by the DGCI/CDSCO — import of oxytocin for therapeutic or commercial purposes remains prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

Are used or refurbished medical equipment imports under HSN 3004 90 95 freely permitted?

No. Import of high-end and high-value used or refurbished medical equipment other than critical care medical equipment is restricted and subject to conditions specified in the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023.

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