Of vitamin B12

Vitamin B12 medicaments in measured doses for retail sale

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 34 (Of vitamin B12) 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 enforced at the bill-of-entry stage under the ITC (HS) policy administered by the Directorate General of Foreign Trade (DGFT). The Ministry of Environment, Forest and Climate Change (MEFCC) overlay applies where the consignment constitutes used or refurbished medical equipment, and all clearances are conditioned on the 79 designated food-import port restriction under General Note 4(D) of Schedule I of the ITC (HS) 2022.

What this is

HSN code

3004 50 34

Chapter

30 · Pharmaceutical products

Primary regulator

FSSAI · Food Safety and Standards Act, 2006

Customs documentation

Import Licence from FSSAI
Registration certificate from DGFT
Batch release certificate from CBIC

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 current FSSAI Import Licence (document code 911001) and ensure the Drug Registration Certificate (document code 101dc1) and Import Licence for Drugs (document code 9111dc) are in order before shipment. All seven mandatory documents — Certificate of Analysis for drugs (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) — must be uploaded in e-Sanchit before the bill of entry is filed.
CBIC Instruction 09/2023-Cus dated 07-03-2023 · CBIC Instruction 10/2022-Customs dated 28-06-2022; document codes 0010dc, 0030dc, 0110dc, 0110FS, 101dc1, 911001, 9111dc
2
Route the consignment only through one of the 79 designated food-import ports notified under General Note 4(D) of Schedule I of the ITC (HS) 2022. Confirm that labelling complies with the FSS (Labelling and Display) Regulations, 2020; permissible rectification of specified labelling deficiencies may be carried out at customs-bonded warehouses before FSSAI authorised-officer inspection, using a single non-detachable sticker without altering original label information.
FSSAI order dated 18-11-2022 under F.No.Import/TFM/Apex/2022-FSSAI · CBIC Instruction 10/2022-Customs dated 28-06-2022 · General Note 4(D) of Schedule I of ITC (HS) 2022
3
Where the consignment constitutes used or refurbished medical equipment (other than critical care equipment), comply with the conditions prescribed by the Ministry of Environment, Forest and Climate Change. Note that import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; oxytocin reference standards may only be imported for test and analysis purposes against a test licence from DGCI/CDSCO.
O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023 · 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 uploading the FSSAI Import Licence alone and treating the drug-specific documents as optional — the e-Sanchit verification requires all seven listed document codes (0010dc, 0030dc, 0110dc, 0110FS, 101dc1, 911001, and 9111dc) to be present before out-of-charge is granted, and absence of even one triggers consignment detention and accumulating demurrage at the designated port. Labelling rectification is available only for the specific deficiencies enumerated under the FSSAI order dated 18-11-2022 and CBIC Instruction 10/2022-Customs; a missing PGA clearance document is not a rectifiable deficiency and cannot be remedied post-arrival.

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Frequently asked

Does HSN 3004 50 34 require BIS certification?

No, no BIS Quality Control Order covers vitamin B12 medicaments in measured doses. 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 enforced via seven mandatory e-Sanchit document codes at the bill-of-entry stage.

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

Seven codes are mandatory: Certificate of Analysis for drugs (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.

Is oxytocin covered by this tariff line, and can it be imported?

Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; however, oxytocin reference standards may be imported exclusively for test and analysis purposes against a test licence issued by DGCI/CDSCO.

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