Roxithromycin

Roxithromycin antibiotic medicaments in measured doses

MEFCC CLEARANCE

HSN 3004 20 62 (Roxithromycin) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. Mandatory e-Sanchit document uploads — including a registration certificate, import licence, batch release certificate, and certificate of analysis — are verified at the bill of entry before out-of-charge.

What this is

HSN code

3004 20 62

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 an import licence for drugs (document code 9111dc) from CDSCO covering Roxithromycin before the consignment is dispatched. Both documents must be uploaded in e-Sanchit prior to filing the bill of entry.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc per CCR
2
Upload all mandatory drug documents in e-Sanchit before out-of-charge: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc). The proper officer will verify each document code before granting out-of-charge.
CBIC PGA-facilitated bill verification requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc per CCR

A word of counsel

The most common error on this tariff line is uploading the registration certificate and import licence while omitting the batch release certificate or certificate of analysis — these are treated as distinct mandatory document codes by the proper officer and a missing code, even when the primary licence is current, results in consignment detention pending e-Sanchit verification. Ensure all five document codes (0010dc, 0030dc, 0110dc, 101dc1, 9111dc) are uploaded and the IRNs are quoted on the bill of entry before arrival at the port of import.

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Frequently asked

Does HSN 3004 20 62 require BIS certification?

No, Roxithromycin 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 mandatory batch documentation verified through e-Sanchit.

Which document codes must be uploaded in e-Sanchit for Roxithromycin imports?

Five codes are mandatory: Certificate of Analysis (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 the proper officer grants out-of-charge.

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

No. The prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 is specific to oxytocin and does not extend to Roxithromycin; however, importers should confirm the consignment description is unambiguous on the bill of entry to avoid erroneous routing under the prohibited-goods flag.

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