Other

Antibiotic medicaments in measured doses, retail packs

MEFCC CLEARANCE

HSN 3004 20 19 (Other antibiotic-containing medicaments) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies the tariff line under restricted-import policy, and a specific prohibition on oxytocin applies under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 20 19

Chapter

30 · Pharmaceutical products

Primary regulator

MEFCC · Ministry of Environment, Forest and Climate Change (legacy code); CDSCO drug registration under Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence 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 drug registration certificate (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO before shipment. Both must be uploaded in e-Sanchit at the bill of entry; consignments lacking either document are detained pending out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1, 9111dc (e-Sanchit CCR)
2
Upload the Certificate of Analysis for the drug (document code 0010dc), the Batch Release Certificate (document code 0030dc), and the consignment label (document code 0110dc) in e-Sanchit before filing the bill of entry. The proper officer must verify all five mandatory documents before granting out-of-charge.
CBIC e-Sanchit mandatory document list · document codes 0010dc, 0030dc, 0110dc
3
Verify that the consignment does not contain oxytocin in any finished formulation. Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the sole exception is oxytocin reference standards imported exclusively for test and analysis, subject to a test licence issued by DCGI/CDSCO.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The oxytocin prohibition is product-specific and sits within a broadly-coded antibiotic tariff line that importers routinely treat as a standard drug-registration exercise. A consignment of oxytocin-containing finished formulations will be confiscated and the importer exposed to criminal liability under the Drugs and Cosmetics Act even where all five e-Sanchit drug documents are current and validly uploaded. Confirm the active pharmaceutical ingredient at the API level before filing; a test licence covering oxytocin reference standards does not extend to finished therapeutic formulations.

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Frequently asked

Does HSN 3004 20 19 require BIS certification?

No, antibiotic medicaments in measured doses for retail sale are not within the BIS Quality Control Order regime. Import is governed by CDSCO drug registration and import licensing under the Drugs and Cosmetics Act, 1940, with DGFT restricted-import policy and a specific oxytocin prohibition under S.O. 2357(E).

Which e-Sanchit document codes are mandatory for this tariff line?

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

Is any import of oxytocin permitted under this HSN?

Only oxytocin reference standards imported exclusively for test and analysis are permitted, subject to a test licence issued by DCGI/CDSCO; all other oxytocin imports are 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.