Of vitamin A

Vitamin A medicaments in measured doses for retail sale

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 50 31 (Of vitamin A) 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, with Central Drugs Standard Control Organisation registration documents mandated at the bill of entry. The Ministry of Environment, Forest and Climate Change (MEFCC) overlay applies to used or refurbished medical equipment imports, and the Directorate General of Foreign Trade (DGFT) administers the applicable ITC (HS) policy conditions including a prohibition on oxytocin imports.

What this is

HSN code

3004 50 31

Chapter

30 · Pharmaceutical products

Primary regulator

FSSAI · Food Safety and Standards Act, 2006

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
Upload the mandatory drug-clearance documents 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 for Drugs (101dc1), FSSAI Import Licence (911001), and Import Licence for Drugs (9111dc). The proper officer will verify all seven documents before granting out-of-charge.
CBIC Instruction 09/2023-Cus dated 07-03-2023 · e-Sanchit document codes 0010dc, 0030dc, 0110dc, 0110FS, 101dc1, 911001, 9111dc
2
Route the consignment only through one of the designated food-import entry points and confirm compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022. Ensure labelling meets FSS (Labelling and Display) Regulations, 2020; permitted labelling deficiencies may be rectified at customs bonded warehouses by affixing a single non-detachable sticker before authorised-officer inspection.
General Note 4(D) of Schedule I of ITC (HS) 2022 · CBIC Instruction 10/2022-Cus dated 28-06-2022 · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022
3
Note the absolute prohibition on oxytocin imports 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 on submission of a test licence issued by DGCI/CDSCO. If importing used or refurbished medical equipment under this tariff line, comply with the MEFCC Office Memorandum dated 15-12-2023 governing high-value used equipment.
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 filing the bill of entry with only the FSSAI Import Licence and overlooking the parallel drug-document stack — particularly the Registration Certificate for Drugs (101dc1) and the Import Licence for Drugs (9111dc), which are separately required and independently verified in e-Sanchit. A consignment cleared on FSSAI grounds alone but missing any of the seven mandatory document codes will be detained at port; demurrage and ground rent accrue from the moment the proper officer identifies the deficiency, not from the date of a formal notice.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 3004 50 31 require BIS certification?

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

Are all seven e-Sanchit document codes mandatory for every consignment under this HSN?

Yes. The proper officer is required to verify all seven codes — 0010dc, 0030dc, 0110dc, 0110FS, 101dc1, 911001, and 9111dc — in e-Sanchit before granting out-of-charge; absence of any single code is grounds for detention.

Is there any exemption allowing oxytocin to be imported under this tariff line?

Oxytocin as a finished medicament is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the only permitted import is oxytocin reference standards for test and analysis, and only on production of a test licence from DGCI/CDSCO.

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