Ampicillin

Ampicillin medicaments, penicillin-class antibiotics for retail sale

MEFCC CLEARANCE

HSN 3004 10 20 (Ampicillin) is subject to Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing under the Drugs and Cosmetics Act, 1940. A Registration Certificate for Drugs (document code 101dc1) and an Import Licence for Drugs (document code 9111dc) must be uploaded in e-Sanchit before customs out-of-charge is granted. The Directorate General of Foreign Trade (DGFT) administers the import policy overlay for this tariff line.

What this is

HSN code

3004 10 20

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
ITC (HS) policy compliance from DGFT

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 Registration Certificate for Drugs from the Central Drugs Standard Control Organisation and an Import Licence for Drugs before filing the bill of entry. Both documents must be uploaded in e-Sanchit under document codes 101dc1 and 9111dc respectively, and the proper officer will verify their presence before granting out-of-charge.
CDSCO document codes 101dc1 and 9111dc · Drugs and Cosmetics Act, 1940
2
Note that import of oxytocin under this chapter is prohibited; import of oxytocin reference standards is permitted exclusively for test and analysis, subject to a test licence issued by DGCI/CDSCO. Ensure your consignment description and accompanying documents clearly establish that the product is ampicillin and not a prohibited substance.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is filing the bill of entry without pre-uploading both the Registration Certificate (101dc1) and the Import Licence for Drugs (9111dc) in e-Sanchit — an omission that triggers PGA-facilitated-bill scrutiny by the proper officer and results in consignment detention pending document verification. These are two distinct instruments issued separately by CDSCO; holding one without the other is treated as non-compliance regardless of the validity of the existing document.

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Frequently asked

Does HSN 3004 10 20 require BIS certification?

No. No BIS Quality Control Order covers penicillin-class medicaments. Import of ampicillin is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT administering the applicable ITC (HS) import policy overlay.

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

The Registration Certificate for Drugs (document code 101dc1) and the Import Licence for Drugs (document code 9111dc) are both mandatory and must be uploaded in e-Sanchit before the proper officer grants out-of-charge.

Is the prohibition on oxytocin import relevant to an ampicillin consignment?

Directly, no — ampicillin is a penicillin-class antibiotic and not oxytocin. However, the prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 applies at the chapter level, so any consignment description that could be misconstrued as containing oxytocin will attract additional scrutiny and potential detention pending clarification.

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