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Vitamin-containing medicaments in retail packs (other)

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 39 covers vitamin-containing medicaments in measured-dose or retail-pack form and is subject to Food Safety and Standards Authority of India (FSSAI) import licensing under the Food Safety and Standards Act, 2006, and to drug-registration requirements administered by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940. The Ministry of Environment, Forest and Climate Change (MEFCC) imposes additional conditions on used or refurbished medical equipment under its O.M. dated 15 December 2023, and the Directorate General of Foreign Trade (DGFT) administers the ITC (HS) policy overlay including the prohibition on oxytocin import.

What this is

HSN code

3004 50 39

Chapter

30 · Pharmaceutical products

Primary regulator

FSSAI · Food Safety and Standards Act, 2006 (food-drug interface, retail medicament imports)

Customs documentation

Import Licence from FSSAI
Registration certificate from CDSCO
Batch release certificate from CDSCO

Applicable Partner Government Agencies

FSSAIFSSAI·Food Safety and Standards Authority of India

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

Compliance steps

1
Upload all mandatory drug and food-interface documents in e-Sanchit before filing the bill of entry: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Specimen Copy of Label (0110FS), Registration Certificate — Drugs (101dc1), FSSAI Import Licence (911001), and Import Licence for Drugs (9111dc). The customs proper officer will verify each code before granting out-of-charge.
CCR e-Sanchit mandatory-document list · CBIC Instruction 09/2023-Cus dated 07-03-2023
2
Note the absolute prohibition on importing oxytocin: import is not permitted except for oxytocin reference standards destined exclusively for test and analysis, and only upon submission of a test licence issued by DGCI/CDSCO. Ensure the product description and intended use are clearly documented to avoid consignment seizure at the port.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022
3
Ensure compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022 for designated food-import entry points. Rectifiable labelling deficiencies — including per-serve RDA percentage and expiry-date information — may be corrected at customs bonded warehouses by affixing a single non-detachable sticker, subject to FSSAI authorised-officer verification.
CBIC Instruction 10/2022-Cus dated 28-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023 · FSSAI order dated 18-11-2022 · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022

A word of counsel

The most common error on this tariff line is conflating the FSSAI Import Licence with the CDSCO drug-registration certificate and assuming that one satisfies the other. Both are independently mandatory and carry separate document codes in e-Sanchit; a bill of entry missing either the 911001 or the 101dc1 upload will be routed for PGA verification and the consignment detained pending NOC, accruing demurrage. Separately, any oxytocin-content product — even trace formulations — will be treated as a prohibited import unless accompanied by a DGCI/CDSCO test licence.

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Frequently asked

Does HSN 3004 50 39 require BIS certification?

No, vitamin-containing medicaments in retail packs are not within the BIS Quality Control Order regime. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, and by CDSCO drug-registration requirements, with an ITC (HS) policy overlay administered by DGFT.

Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?

Seven documents must be uploaded: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Specimen Copy of Label (0110FS), Registration Certificate — Drugs (101dc1), FSSAI Import Licence (911001), and Import Licence for Drugs (9111dc), per the CCR mandatory-document list verified under CBIC Instruction 09/2023-Cus.

Is import of oxytocin-containing products under this HSN ever permitted?

Import of oxytocin is prohibited outright; the only exception is oxytocin reference standards imported exclusively for test and analysis, which require a test licence issued by DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022.

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