Other

Penicillin and streptomycin medicaments, other formulations

MEFCC CLEARANCE

HSN 3004 10 90 (Other medicaments containing penicillins or streptomycins) requires a Registration Certificate for drugs and an Import Licence for drugs issued by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) classifies this tariff line under a Restricted import policy, and import of oxytocin within this CTI is prohibited except for reference standards admitted exclusively for test and analysis.

What this is

HSN code

3004 10 90

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug registration and import licence)

Customs documentation

Registration certificate from CDSCO
Import licence 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 Registration Certificate for the drug (document code 101dc1) and an Import Licence for drugs (document code 9111dc) from CDSCO before shipment. Both documents must be uploaded in e-Sanchit; customs out-of-charge will not be granted without verified uploads of both instruments.
Drugs and Cosmetics Act, 1940 · CDSCO drug registration and import-licence regime · e-Sanchit document codes 101dc1 and 9111dc
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer is required to verify all five mandatory documents before granting out-of-charge.
CBIC PGA-facilitated-bill verification requirement · e-Sanchit document codes 0010dc, 0030dc, 0110dc
3
If the consignment contains or is declared as oxytocin, import is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022, except for oxytocin reference standards admitted solely for test and analysis, which require a test licence from DGCI/CDSCO submitted at the time of clearance.
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 treating the drug registration certificate as the only document required and failing to separately upload the Import Licence (9111dc) and the Batch Release Certificate (0030dc) in e-Sanchit before the bill of entry is assessed. Customs verification checks for all five document codes as independent line items; absence of even one triggers detention and demurrage pending PGA re-routing. Importers of formulations containing oxytocin as an ancillary ingredient should confirm with CDSCO whether the prohibition under S.O. 2357(E) extends to their specific product category.

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Frequently asked

Does HSN 3004 10 90 require BIS certification?

No. No BIS Quality Control Order covers penicillin or streptomycin medicaments under this tariff line. Import is governed by CDSCO under the Drugs and Cosmetics Act, 1940, with a Restricted-import policy overlay administered by the Directorate General of Foreign Trade.

Which document codes are mandatory at e-Sanchit for this tariff line?

Five documents must be uploaded: Registration Certificate for drugs (101dc1), Import Licence for drugs (9111dc), Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Label of Consignment (0110dc). Out-of-charge is withheld until all five are verified.

Is import of oxytocin under this CTI entirely prohibited?

Import of oxytocin for commercial or therapeutic use is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the sole exception is oxytocin reference standards imported exclusively for test and analysis, which require a test licence from DGCI/CDSCO.

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