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Of vitamin B9

Vitamin B9 medicaments in measured doses for retail sale

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 33 (Of vitamin B9) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence requirements under the Food Safety and Standards Act, 2006, with concurrent drug-registration documentation required under the Drugs and Cosmetics Act, 1940 framework. The ITC (HS) policy administered by the Directorate General of Foreign Trade (DGFT) further requires compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022 for designated food-import entry points. Import of high-value used or refurbished medical equipment under this heading is separately restricted subject to conditions notified by the Ministry of Environment, Forest and Climate Change (MEFCC).

What this is
HSN code
3004 50 33
Chapter
30 · Pharmaceutical products
Primary regulator
FSSAI · Food Safety and Standards Act, 2006 (import licence and labelling regime)
Customs documentation
  • Import Licence from FSSAI
  • Registration certificate from DGFT
  • Certificate of Analysis from drug authority
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. 1
    Upload the FSSAI Import Licence (document code 911001) and the Import Licence for Drugs (document code 9111dc) in e-Sanchit before filing the bill of entry. The Registration Certificate for Drugs (document code 101dc1), Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) must also be uploaded before customs out-of-charge.
    CCR mandatory document list · e-Sanchit document codes 911001, 9111dc, 101dc1, 0010dc, 0030dc, 0110dc, 0110fs
  2. 2
    Route the consignment through a designated food-import entry point in compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022. Confirm that labelling meets FSS (Labelling and Display) Regulations, 2020 requirements; rectifiable labelling deficiencies may be corrected at customs-bonded warehouses by affixing a single non-detachable sticker before inspection by the authorised officer.
    General Note 4(D), Schedule I, ITC (HS) 2022 · CBIC Instruction 10/2022-Customs dated 28-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023 · FSSAI order dated 18-11-2022
  3. 3
    Note that import of oxytocin under heading 3004 is prohibited; import of oxytocin reference standards is allowed exclusively for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO. For used or refurbished high-value medical equipment classified under this heading, comply with the conditions in the Office Memorandum issued by MEFCC dated 15-12-2023.
    S.O. 2357(E) · DGFT Notification 09/2015-2020 dated 23-05-2022 · MEFCC O.M. dated 15-12-2023
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 drug-registration suite — Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Registration Certificate for Drugs (101dc1), and the drug-specific Import Licence (9111dc) — all of which must be independently uploaded in e-Sanchit. A bill of entry where any one of these document codes is missing will not receive out-of-charge, resulting in detention, demurrage, and ground rent at the designated port while the gap is remedied.

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Frequently asked
Does HSN 3004 50 33 require BIS certification?
No. No BIS Quality Control Order covers vitamin B9 medicaments in retail-sale packs. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, alongside drug-registration documentation requirements and DGFT ITC (HS) policy controls.
Which document codes must be uploaded in e-Sanchit for this tariff line?
Seven documents are mandated: 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.
Is the oxytocin prohibition relevant to vitamin B9 medicament importers?
Only tangentially — the oxytocin prohibition under S.O. 2357(E) and DGFT Notification 09/2015-2020 applies specifically to oxytocin, not to vitamin B9 products, but customs officers verify compliance with this restriction at the bill-of-entry stage for all heading 3004 consignments, so importers should confirm their product description is unambiguous.
Last verified against gazette notifications: 2026-05-16. Source: FSSAI / MEFCC / DGFT / CBIC / Indian Customs CUSDATA.
Related
ChapterChapter 30 · Pharmaceutical productsHSNMEDICAMENTS (EXCLUDING GOODS OF HEADING 3002, 3005 OR 3006) CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (IINCLUDING THOSE IN THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS OR PACKINGS FOR RETAIL SALEHSNOther, containing vitamins or other products of heading 2936: