Clarithromycin

Clarithromycin antibiotic medicaments for therapeutic use

MEFCC CLEARANCE

HSN 3004 20 63 (Clarithromycin) is subject to Central Drugs Standard Control Organisation (CDSCO) import licensing and registration under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under the ITC (HS) policy, and mandatory e-Sanchit documentation — including a registration certificate, import licence, batch release certificate, and certificate of analysis — must be uploaded before customs out-of-charge.

What this is

HSN code

3004 20 63

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Import licence for drugs from CDSCO
Registration certificate 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 current import licence for drugs (document code 9111dc) and a registration certificate for drugs (document code 101dc1) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both must be uploaded in e-Sanchit prior to customs out-of-charge.
Drugs and Cosmetics Act, 1940 · e-Sanchit document codes 9111dc and 101dc1
2
Upload the batch release certificate (document code 0030dc), certificate of analysis for drugs (document code 0010dc), and label of the consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer will verify these documents before granting out-of-charge on PGA-facilitated bills.
e-Sanchit document codes 0010dc, 0030dc, 0110dc · CDSCO import clearance procedure

A word of counsel

The most frequent error on this tariff line is confusing the drug registration certificate (101dc1) with the import licence (9111dc) — both are distinct, independently mandatory documents, and the absence of either triggers detention at the port of entry with no rectification permitted post-arrival. Importers should also note that the oxytocin prohibition recorded in the CCR for Chapter 30 is product-specific and does not restrict Clarithromycin, but the e-Sanchit upload requirements apply equally to all antibiotic medicaments under this chapter.

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Frequently asked

Does HSN 3004 20 63 require BIS certification?

No, Clarithromycin medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers antibiotic pharmaceutical products. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with ITC (HS) policy oversight by DGFT.

Which document codes must be uploaded in e-Sanchit for Clarithromycin at the bill of entry?

Five documents are mandatory: 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 uploaded in e-Sanchit before customs out-of-charge.

Does the oxytocin import prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 affect imports of Clarithromycin?

No. The prohibition under S.O. 2357(E) dated 23-05-2022 is specific to oxytocin formulations; Clarithromycin is an unrelated macrolide antibiotic and is not subject to that prohibition, though all standard CDSCO licensing and e-Sanchit upload requirements continue to apply.

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