Amoxycillin

Amoxycillin medicaments containing penicillins or derivatives

MEFCC CLEARANCE

HSN 3004 10 30 (Amoxycillin) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under a restricted-import policy, and mandatory documents including the drug registration certificate and import licence must be uploaded in e-Sanchit before customs out-of-charge.

What this is

HSN code

3004 10 30

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
ITC (HS) restricted-import declaration to DGFT

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 and verified by the proper officer before out-of-charge is granted.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Note that import of oxytocin is prohibited under this chapter; however, import of oxytocin reference standards is permissible exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO. Ensure the consignment does not include prohibited substances without the prescribed licence.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most frequent error on this tariff line is conflating the drug registration certificate with the import licence: both are independent documents carrying separate CDSCO authorisation tracks, and the absence of either at the bill-of-entry stage causes customs detention regardless of the other being current. Confirm that document codes 101dc1 and 9111dc are individually uploaded in e-Sanchit — a single combined upload or mislabelled document code will not satisfy the proper officer's verification requirement.

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Frequently asked

Does HSN 3004 10 30 require BIS certification?

No, Amoxycillin medicaments fall outside the BIS Quality Control Order regime. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, requiring a drug registration certificate and import licence, with the ITC (HS) restricted-import policy administered by DGFT as an overlay.

Are both document codes 101dc1 and 9111dc mandatory at the bill of entry?

Yes. The registration certificate for drugs (101dc1) and the import licence for drugs (9111dc) must each be uploaded separately in e-Sanchit; the proper officer verifies both before granting out-of-charge on PGA-facilitated bills.

Is the prohibition on oxytocin import relevant to Amoxycillin consignments?

The oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 applies to a separate substance; however, importers must confirm the consignment contains no prohibited active pharmaceutical ingredients, as any co-shipment of prohibited drugs attracts seizure and confiscation under the Drugs and Cosmetics Act, 1940.

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