Cloxacillin

Cloxacillin medicaments, penicillin-derivative formulations for retail sale

MEFCC CLEARANCE

HSN 3004 10 50 (Cloxacillin) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory documents including the Certificate of Analysis, Batch Release Certificate, and Registration Certificate must be uploaded in e-Sanchit before out-of-charge; the Directorate General of Foreign Trade (DGFT) policy overlay applies as an additional clearance requirement.

What this is

HSN code

3004 10 50

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
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 Import Licence for drugs (document code 9111dc) from CDSCO before filing the bill of entry. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted until the proper officer verifies their presence.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis for drugs (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. PGA-facilitated bills not routed through the PGA for NOC are subject to direct verification of all five mandatory documents by the proper officer before out-of-charge.
CDSCO e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc

A word of counsel

The most common error on this tariff line is uploading an incomplete document set — typically omitting either the Batch Release Certificate (0030dc) or the Label of Consignment (0110dc) while the Registration Certificate and Import Licence are in order. All five document codes (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) are individually mandatory; the proper officer is directed to verify each code before granting out-of-charge, and a single missing upload is sufficient to detain the consignment.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3004 10 50 require BIS certification?

No, Cloxacillin medicaments are not within the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, requiring drug registration, an import licence, and a full set of batch-level documents uploaded in e-Sanchit.

Which five documents must be uploaded in e-Sanchit for this tariff line?

The mandatory documents are: Certificate of Analysis for drugs (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); all must be present before out-of-charge is granted.

Does the oxytocin import prohibition under S.O. 2357(E) affect Cloxacillin consignments?

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin, not to Cloxacillin; however, importers should ensure the commercial invoice and label clearly identify the active substance to avoid misclassification detention at the bill-of-entry stage.

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