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Of vitamin C

Vitamin C medicaments in measured doses for retail sale

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 35 (Of vitamin C) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence requirements under the Food Safety and Standards Act, 2006, and to drug-registration controls administered by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940. The Ministry of Environment, Forest and Climate Change (MEFCC) conditions apply where used or refurbished medical equipment is imported, and the Directorate General of Foreign Trade (DGFT) administers overlapping ITC (HS) policy conditions including a designated food-import port requirement under General Note 4(D) of Schedule I.

What this is
HSN code
3004 50 35
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 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. 1
    Upload all mandatory e-Sanchit documents before filing the bill of entry: Certificate of Analysis – Drug (document code 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). Customs out-of-charge will not be granted until all seven documents are verified in e-Sanchit.
    CBIC Instruction 09/2023-Cus dated 07-03-2023 · CBIC Instruction 10/2022-Cus dated 28-06-2022
  2. 2
    Route the consignment through one of the designated food-import entry points and ensure compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022. Labelling deficiencies permissible under FSS (Import) Regulations, 2017 and the FSSAI orders dated 22-05-2018 and 14-01-2019 may be rectified at customs bonded warehouses by affixing a single non-detachable sticker before inspection, per the rectifiable-labelling dispensation.
    CBIC Instruction 10/2022-Cus dated 28-06-2022 · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022 · FSSAI clarification order dated 18-11-2022
  3. 3
    If the consignment contains oxytocin or oxytocin-based reference standards, note that commercial oxytocin import is prohibited; import of oxytocin reference standards is allowed exclusively for test and analysis upon submission of a test licence issued by the DGCI/CDSCO.
    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 conflating the FSSAI Import Licence (document code 911001) with the drug-specific Import Licence (9111dc) and the Registration Certificate for Drugs (101dc1), treating them as interchangeable or submitting only one. All three are independent mandatory uploads in e-Sanchit; absence of any single document triggers detention at the designated port, and the rectifiable-labelling dispensation does not extend to missing PGA clearances — only to defined labelling deficiencies.

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Frequently asked
Does HSN 3004 50 35 require BIS certification?
No, vitamin C medicaments in measured doses 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 drug-registration controls under the Drugs and Cosmetics Act, 1940, with seven mandatory e-Sanchit documents required at the bill of entry.
Which document codes must be uploaded in e-Sanchit for this tariff line?
Seven documents are mandatory: 0010dc (Certificate of Analysis – Drug), 0030dc (Batch Release Certificate), 0110dc (Label of Consignment), 0110fs (Specimen Copy of Label), 101dc1 (Registration Certificate – Drugs), 911001 (FSSAI Import Licence), and 9111dc (Import Licence for Drugs), per CBIC Instruction 09/2023-Cus.
Is the oxytocin prohibition relevant to vitamin C medicaments under this HSN?
Only where the specific product contains oxytocin — commercial import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020; import of oxytocin reference standards remains permitted exclusively for test and analysis upon submission of a DGCI/CDSCO test licence.
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: