Of vitamin D

Vitamin D medicaments in measured doses for retail sale

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 36 (Of vitamin D) 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 the Drugs and Cosmetics Act, 1940. The Ministry of Environment, Forest and Climate Change (MEFCC) overlay applies to imports of used or refurbished medical equipment falling within this tariff line, and the Directorate General of Foreign Trade (DGFT) administers the ITC (HS) Restricted-import policy condition including the prohibition on oxytocin imports.

What this is

HSN code

3004 50 36

Chapter

30 · Pharmaceutical products

Primary regulator

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

Customs documentation

Import Licence for drugs from CBIC
Registration certificate from DGFT
Certificate of Analysis from exporter

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
Upload all mandatory documents in e-Sanchit before filing the bill of entry: Certificate of Analysis for drugs (document code 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). The proper officer will verify each document code before granting out-of-charge.
CBIC Instruction 09/2023-Cus dated 07-03-2023 · CBIC Instruction 10/2022-Cus dated 28-06-2022
2
Ensure import entry complies with General Note 4(D) of Schedule I of the ITC (HS) 2022 for designated food import entry points. Any labelling deficiencies must be rectified at a customs bonded warehouse before visual inspection by the authorised officer, by affixing a single non-detachable sticker without altering the original label.
CBIC Instruction 10/2022-Cus dated 28-06-2022 · FSSAI order dated 18-11-2022 under F.No.Import/TFM/Apex/2022-FSSAI · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022
3
Note that import of oxytocin under this chapter is prohibited; import of oxytocin reference standards is permitted exclusively for testing and analysis, subject to submission of a test licence issued by the DGCI/CDSCO. Separately, import of used or refurbished high-value medical equipment under this tariff line is Restricted and subject to MEFCC conditions per the Office Memorandum 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 uploading only the FSSAI Import Licence while neglecting the full suite of drug-specific document codes — particularly the Batch Release Certificate (0030dc) and the Registration Certificate for Drugs (101dc1). PGA-facilitated bills that bypass the NOC routing are subject to heightened scrutiny by the proper officer at out-of-charge, and a single missing document code results in consignment detention and accruing demurrage until the gap is rectified in e-Sanchit.

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Frequently asked

Does HSN 3004 50 36 require BIS certification?

No, vitamin D medicaments in measured doses are not within the BIS Quality Control Order regime. Import is governed primarily by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with concurrent drug-registration requirements and the DGFT ITC (HS) policy condition.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Seven document codes are mandatory: 0010dc (Certificate of Analysis), 0030dc (Batch Release Certificate), 0110dc (Label of Consignment), 0110fs (Specimen Copy of Label), 101dc1 (Registration Certificate for Drugs), 911001 (FSSAI Import Licence), and 9111dc (Import Licence for Drugs), all per CBIC Instruction 09/2023-Cus.

Is the import of used or refurbished medical equipment under this HSN permitted?

Import of high-value used or refurbished medical equipment — other than critical care medical equipment — is Restricted and subject to conditions notified by MEFCC in its Office Memorandum dated 15 December 2023; importers must verify compliance with those conditions before shipment.

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