Oxytetracycline

Oxytetracycline antibiotic medicaments for therapeutic use

MEFCC CLEARANCE

HSN 3004 20 42 (Oxytetracycline) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing requirements under the Drugs and Cosmetics Act, 1940, with mandatory e-Sanchit document uploads verified before customs out-of-charge. The Directorate General of Foreign Trade (DGFT) administers an ITC (HS) policy overlay that prohibits the import of oxytocin — a substantively distinct substance — while permitting oxytocin reference standards exclusively for test and analysis against a DGCI/CDSCO test licence.

What this is

HSN code

3004 20 42

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 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 the consignment is shipped. Both documents must be uploaded in e-Sanchit; customs will verify their presence before granting out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc · CCR e-Sanchit instruction
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer is instructed to verify all five mandatory documents before granting out-of-charge.
CCR e-Sanchit mandatory-document instruction · document codes 0010dc, 0030dc, 0110dc
3
Note the DGFT-notified prohibition: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022. If the consignment contains oxytocin reference standards intended for test and analysis only, a test licence from DGCI/CDSCO is required as a condition of the permitted exemption.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The single most common error on this tariff line is conflating oxytetracycline with oxytocin and either applying the prohibition incorrectly or, conversely, failing to notice that an oxytocin-containing product in the same shipment triggers an outright ban. Oxytetracycline itself is a tetracycline-class antibiotic and moves under the standard CDSCO drug-registration regime; the prohibition and the test-licence carve-out in S.O. 2357(E) apply to oxytocin only. Ensure the import licence and registration certificate remain current at the bill-of-entry date — expired documents result in detention pending CDSCO re-validation.

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Frequently asked

Does HSN 3004 20 42 require BIS certification?

No, no BIS Quality Control Order covers this antibiotic medicament. Import is governed by the drug registration and import-licensing regime administered by CDSCO under the Drugs and Cosmetics Act, 1940, with a DGFT ITC (HS) policy overlay applicable to oxytocin (a distinct substance) under S.O. 2357(E).

Which five documents must be uploaded in e-Sanchit before customs out-of-charge?

The mandatory documents are: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc). All five must be present in e-Sanchit before the proper officer can grant out-of-charge.

Is the import of oxytocin reference standards permitted under this HSN?

Yes, but exclusively for test and analysis purposes, and only on submission of a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; commercial import of oxytocin formulations is prohibited.

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