Of vitamin B1 and B2 and salts thereof

Vitamin B1 and B2 medicaments in retail or measured-dose packs

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 32 (Of vitamin B1 and B2 and salts thereof) is subject to Food Safety and Standards Authority of India (FSSAI) import licensing under the Food Safety and Standards Act, 2006, alongside drug-registration clearance requirements under the Drugs and Cosmetics Act, 1940 administered through CDSCO. Directorate General of Foreign Trade (DGFT) policy controls apply, and consignments must be routed through designated food-import entry points per General Note 4(D) of Schedule I of the ITC (HS) 2022.

What this is

HSN code

3004 50 32

Chapter

30 · Pharmaceutical products

Primary regulator

FSSAI · Food Safety and Standards Act, 2006 (high-risk food/drug import regime)

Customs documentation

Import Licence from FSSAI
Registration certificate (drugs) 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
Obtain a valid FSSAI Import Licence (document code 911001) and ensure the drug Registration Certificate (document code 101dc1) and Import Licence for Drugs (document code 9111dc) are current before filing the bill of entry. All three documents must be uploaded in e-Sanchit prior to out-of-charge.
FSSAI Import Licence (911001) · Registration Certificate Drugs (101dc1) · Import Licence for Drugs (9111dc) · CBIC e-Sanchit mandate
2
Upload in e-Sanchit the Certificate of Analysis – Drug (document code 0010dc), Batch Release Certificate (document code 0030dc), Label of Consignment (document code 0110dc), and Specimen Copy of Label (document code 0110FS) before the customs proper officer issues out-of-charge. Label deficiencies permissible for port-level rectification under CBIC Instruction 10/2022-Customs must be corrected by affixing a single non-detachable sticker at a customs bonded warehouse prior to visual inspection.
CBIC Instruction 10/2022-Customs dated 28-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023 · FSSAI order dated 18-11-2022 under F.No.Import/TFM/APEX/2022-FSSAI
3
Note the oxytocin prohibition: import of oxytocin is prohibited outright; import of oxytocin reference standards is permitted exclusively for test and analysis purposes, subject to submission of a test licence issued by DGCI/CDSCO. This carve-out does not apply to vitamin B1/B2 formulations but must be confirmed where a multi-ingredient product contains oxytocin-related compounds.
S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is treating the FSSAI Import Licence as the sole clearance document and overlooking the parallel drug-registration stack — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), and Registration Certificate (101dc1) — each of which must be independently uploaded in e-Sanchit. A consignment presented with an FSSAI licence but missing any one of the drug-document codes will be detained at the designated port pending e-Sanchit remediation, accruing demurrage and ground rent that the rectifiable-labelling dispensation does not cure.

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Frequently asked

Does HSN 3004 50 32 require BIS certification?

No. No BIS Quality Control Order covers vitamin B1 and B2 medicaments under heading 3004. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with concurrent drug-registration requirements administered by CDSCO and DGFT policy controls under the ITC (HS) 2022.

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

Seven document codes apply: Certificate of Analysis – Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Specimen Copy of Label (0110FS), Registration Certificate for Drugs (101dc1), FSSAI Import Licence (911001), and Import Licence for Drugs (9111dc) — all must be uploaded before out-of-charge.

Are there any prohibited substances relevant to this tariff line that importers should screen for?

Yes. Import of oxytocin under this chapter is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; only oxytocin reference standards for test and analysis are permitted, subject to a DGCI/CDSCO test licence — this must be verified when importing any multi-ingredient vitamin formulation.

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