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Of vitamin E

Vitamin E medicaments in measured doses for retail sale

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 37 (Of vitamin E) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence and drug-registration requirements under the Food Safety and Standards Act, 2006, and applicable drug-licensing obligations. The Ministry of Environment, Forest and Climate Change (MEFCC) conditions apply where the consignment constitutes used or refurbished medical equipment, and the Directorate General of Foreign Trade (DGFT) policy and Central Board of Indirect Taxes and Customs (CBIC) overlay govern entry-point and labelling compliance.

What this is
HSN code
3004 50 37
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 from CBIC
  • Batch release certificate from manufacturer
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
    Ensure all mandatory documents are uploaded 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 proper officer will verify these uploads before granting out-of-charge.
    CBIC e-Sanchit mandatory document codes 0010dc, 0030dc, 0110dc, 0110FS, 101dc1, 911001, 9111dc
  2. 2
    Route the consignment only through one of the designated food and drug import entry points notified under General Note 4(D) of Schedule I of the ITC (HS) 2022. Confirm labelling compliance with the Food Safety and Standards (Labelling and Display) Regulations, 2020; rectifiable labelling deficiencies may be corrected at customs bonded warehouses by affixing a single non-detachable sticker before inspection, per the dispensation under CBIC Instruction 10/2022-Customs.
    General Note 4(D) of Schedule I of 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
    Where the consignment contains used or refurbished medical equipment classified under this tariff line, obtain clearance under the conditions specified in the Office Memorandum issued by the Ministry of Environment, Forest and Climate Change dated 15-12-2023, which restricts import of high-value used and refurbished medical equipment other than critical care equipment.
    O.M. issued by Ministry of Environment, Forest and Climate Change dated 15-12-2023
A word of counsel

The most common error on this tariff line is overlooking the dual document requirement: both the FSSAI Import Licence (911001) and the drug-specific Import Licence for Drugs (9111dc) with the Registration Certificate (101dc1) must be independently uploaded in e-Sanchit — the FSSAI clearance does not substitute for the drug-registration overlay, and a bill of entry presenting only one set of credentials will be detained pending upload of the missing documents, triggering demurrage and ground rent at the designated port.

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Frequently asked
Does HSN 3004 50 37 require BIS certification?
No, vitamin E medicaments in retail-sale packaging 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, alongside drug-licensing requirements, with MEFCC conditions applying to any used or refurbished equipment component.
Which document codes must be uploaded in e-Sanchit for this tariff line?
Seven documents are mandatory: 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), all to be uploaded before the bill of entry is assessed for out-of-charge.
Is import of oxytocin-containing products under this chapter affected by the prohibition on oxytocin?
Yes. Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022; however, import of oxytocin reference standards is permitted exclusively for test and analysis, subject to submission of a test licence issued by DGCI/CDSCO.
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: