Cephalexin

Cephalexin antibiotic medicaments in measured doses

MEFCC CLEARANCE

HSN 3004 20 12 (Cephalexin) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. Mandatory e-Sanchit document uploads — including the registration certificate, import licence, batch release certificate, certificate of analysis, and consignment label — are verified by the proper officer before out-of-charge.

What this is

HSN code

3004 20 12

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Batch release certificate 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 drug registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) from CDSCO before the consignment is dispatched. Both documents must be uploaded in e-Sanchit at the bill of entry stage; the proper officer will verify their presence before granting out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per regulatory record CCR
2
Upload in e-Sanchit the certificate of analysis for drugs (document code 0010dc), the batch release certificate (document code 0030dc), and the consignment label (document code 0110dc). All five mandatory documents must be present before out-of-charge; a single missing upload is grounds for detention.
Document codes 0010dc, 0030dc, 0110dc per regulatory record CCR · Drugs and Cosmetics Act, 1940

A word of counsel

The most common error on this tariff line is presenting a current registration certificate while uploading an expired or batch-mismatched batch release certificate. Customs officers cross-verify the batch number on the certificate of analysis (0010dc) against the batch release certificate (0030dc) and the consignment label (0110dc); a mismatch triggers detention pending re-submission, accruing demurrage and ground rent. Note also that oxytocin imports under Chapter 30 are prohibited except as reference standards under a DGCI/CDSCO test licence — verify the commodity scope before filing.

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Frequently asked

Does HSN 3004 20 12 require BIS certification?

No, cephalexin medicaments fall outside the BIS Quality Control Order regime; no BIS QCO covers this product family. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with mandatory registration certificate, import licence, and batch documentation uploaded in e-Sanchit before out-of-charge.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Five documents are mandatory: certificate of analysis for drugs (0010dc), batch release certificate (0030dc), consignment label (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) — all must be present before the proper officer grants out-of-charge.

Does the oxytocin import prohibition affect cephalexin consignments under this HSN?

No, the prohibition on oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin; cephalexin is a distinct antibiotic not subject to that prohibition, though the standard CDSCO registration and licensing regime applies in full.

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