Other

Vitamin-containing medicaments, other than penicillin or streptomycin

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 90 covers vitamin-containing medicaments in retail or measured-dose form and is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence under the Food Safety and Standards Act, 2006, and the FSS (Import) Regulations, 2017. The Ministry of Environment, Forest and Climate Change (MEFCC) overlay applies where the consignment involves used or refurbished medical equipment. The Directorate General of Foreign Trade (DGFT) administers an ITC (HS) Restricted-import prohibition on oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

What this is

HSN code

3004 50 90

Chapter

30 · Pharmaceutical products

Primary regulator

FSSAI · Food Safety and Standards Act, 2006; FSS (Import) Regulations, 2017

Customs documentation

Import Licence from FSSAI
Certificate of Analysis from drug authority
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 and upload in e-Sanchit the FSSAI Import Licence (document code 911001), the Certificate of Analysis — Drug (document code 0010dc), the Batch Release Certificate (document code 0030dc), the Label of Consignment (document code 0110dc), and the Specimen Copy of Label (document code 0110fs) before filing the bill of entry. Customs out-of-charge will not be granted until all five documents are verified in e-Sanchit.
CBIC CCR e-Sanchit mandatory document requirement · FSSAI Import Licence 911001 · document codes 0010dc, 0030dc, 0110dc, 0110fs
2
Route the consignment through one of the 79 designated food-import ports in compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022. Rectifiable labelling deficiencies — including per-serve RDA contribution and expiry/best-before date — may be rectified at the customs bonded warehouse by affixing a single non-detachable sticker before inspection by the authorised FSSAI officer, per the CBIC Instruction 10/2022-Customs dated 28-06-2022 and FSSAI clarification order dated 18-11-2022.
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
Verify that the consignment does not contain oxytocin in any form: import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. The sole exception is oxytocin reference standards imported exclusively for test and analysis, which requires a test licence issued by DGCI/CDSCO submitted at the bill of entry.
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 treating the FSSAI Import Licence as the only clearance needed and neglecting to upload all five e-Sanchit documents — in particular the Batch Release Certificate (0030dc) and the Label of Consignment (0110dc) — before the bill of entry is filed. A PGA-facilitated bill that bypasses the NOC route receives no automatic dispensation: the customs proper officer will independently verify all five document codes, and a missing upload results in consignment detention and ground rent accrual until the deficiency is rectified.

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Frequently asked

Does HSN 3004 50 90 require BIS certification?

No. No BIS Quality Control Order covers vitamin-containing medicaments under heading 3004. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with a concurrent DGFT prohibition on oxytocin under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022.

Is any form of oxytocin under this tariff line permitted for import?

Only oxytocin reference standards imported exclusively for test and analysis are permitted, subject to submission of a test licence issued by DGCI/CDSCO at the bill of entry; all other oxytocin imports are prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020.

What labelling deficiencies can be rectified at the port and how?

Per CBIC Instruction 10/2022-Customs and the FSSAI clarification order dated 18-11-2022, per-serve RDA contribution percentages and expiry/best-before date information may be rectified at the customs bonded warehouse by affixing a single non-detachable sticker next to the principal display panel, without altering the original label, before the authorised officer's inspection.

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