Erythromycin

Erythromycin antibiotic medicaments in measured doses

MEFCC CLEARANCE

HSN 3004 20 61 (Erythromycin) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. Directorate General of Foreign Trade (DGFT) policy controls apply as an overlay, and mandatory documents — including the registration certificate, import licence, batch release certificate, and certificate of analysis — must be uploaded in e-Sanchit before out-of-charge.

What this is

HSN code

3004 20 61

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 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 registration certificate for the drug (document code 101dc1) and an import licence for drugs (document code 9111dc) from CDSCO prior to shipment. Both documents must be current and uploaded in e-Sanchit before the bill of entry is filed.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc (CBIC e-Sanchit mandate)
2
Upload all five mandatory documents in e-Sanchit at the bill of entry stage: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). Out-of-charge will not be granted until the proper officer verifies all five documents are present.
CBIC e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is treating the registration certificate (101dc1) and the import licence (9111dc) as interchangeable — they are separate instruments, each independently mandatory, and absence of either is sufficient to trigger consignment detention. Additionally, note that import of oxytocin (a separate antibiotic-related product under Chapter 30) is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; ensure correct product identification before filing to avoid a misclassification-triggered seizure.

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Frequently asked

Does HSN 3004 20 61 require BIS certification?

No, erythromycin medicaments are not within the BIS Quality Control Order regime; no BIS QCO covers antibiotic drug formulations. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT policy controls as an overlay.

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

Five documents are mandatory: certificate of analysis — drug (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 customs out-of-charge is granted.

Does the prohibition on oxytocin imports affect erythromycin consignments under this HSN?

No, the oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 applies specifically to oxytocin; erythromycin is a distinct antibiotic not subject to that prohibition, provided the consignment is correctly identified and the CDSCO registration and import licence documents are in order.

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