Penicillins

Penicillin medicaments containing penicillanic acid or streptomycin derivatives

CDSCO CLEARANCE · MEFCC CLEARANCE

HSN 3004 10 10 (Penicillins) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act administered by the Drug Controller General of India (DCGI). The ITC (HS) import policy administered by the Directorate General of Foreign Trade (DGFT) treats imports under this tariff line as permitted subject to CDSCO registration and associated requirements. A Ministry of Environment, Forest and Climate Change (MoEFCC) overlay applies to high-value used or refurbished medical equipment consignments.

What this is

HSN code

3004 10 10

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act (DCGI registration and import licence regime)

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Test licence from DCGI/CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

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 the Central Drugs Standard Control Organisation before filing the bill of entry. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted until this upload is verified.
ITC (HS) import policy · Drugs and Cosmetics Act · CDSCO registration requirement · document codes 101dc1 and 9111dc
2
Note that import of oxytocin under this tariff line is prohibited; only oxytocin reference standards intended exclusively for test and analysis may be imported, and solely against a test licence issued by DCGI/CDSCO. Ensure the shipment contains no oxytocin formulations beyond this narrow exemption.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
3
If the consignment includes high-value used or refurbished medical equipment, confirm compliance with the conditions set out in the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023, under which such imports are restricted and subject to additional scrutiny.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023

A word of counsel

The most frequent error on this tariff line is conflating the CDSCO drug registration certificate with the import licence — these are two distinct documents carrying two separate document codes (101dc1 and 9111dc respectively), and the absence of either triggers consignment detention. Additionally, importers sometimes ship penicillin batches alongside other formulations containing oxytocin, overlooking that the prohibition on oxytocin under S.O. 2357(E) applies to this CTI and will result in seizure of the prohibited portion of the consignment regardless of the validity of the drug registration.

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Frequently asked

Does HSN 3004 10 10 require BIS certification?

No. No BIS Quality Control Order covers penicillin medicaments under this tariff line. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, with registration and import licensing administered by the Drug Controller General of India as the operative requirements.

Are both the registration certificate and the import licence required at the bill of entry, and how are they uploaded?

Yes — the drug registration certificate (document code 101dc1) and the import licence for drugs (document code 9111dc) are separate mandatory uploads in e-Sanchit; customs out-of-charge is withheld until the proper officer confirms both are present on PGA-facilitated bills.

Can oxytocin reference standards be imported under this HSN, and what does the prohibition cover?

Import of oxytocin formulations is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the only exception is oxytocin reference standards imported exclusively for test and analysis against a test licence issued by DCGI/CDSCO.

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