Vitamin B12 (Cyanocobalamin (INN))

Vitamin B12 cyanocobalamin and its derivatives

FSSAI CLEARANCE · NDPS CLEARANCE

HSN 2936 26 10 (Vitamin B12, Cyanocobalamin (INN)) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence requirements under the Food Safety and Standards Act, 2006, and to Narcotic Drugs and Psychotropic Substances (NDPS) import-certificate controls under Chapter VII-A of the NDPS Rules, 1985. The Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition No. 2 of Chapter 29 governs non-medical/non-scientific imports, and CBIC mandatory Chapter 29 qualifiers in the import declaration apply with effect from 15 October 2023.

What this is

HSN code

2936 26 10

Chapter

29 · Organic chemicals

Primary regulator

FSSAI · Food Safety and Standards Act, 2006; NDPS Rules, 1985 (Chapter VII-A)

Customs documentation

Import Licence from FSSAI
Import certificate from NDPS
Registration certificate from CDSCO

Applicable Partner Government Agencies

FSSAIFSSAI·Food Safety and Standards Authority of India

NDPSNDPS·Narcotics Control Bureau

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

Compliance steps

1
Obtain the FSSAI Import Licence (document code 911001) and ensure the foreign manufacturing facility is registered for the applicable food-additive or nutraceutical category. Upload the FSSAI Import Licence, Specimen Copy of Label (0110FS), and label of consignment (0110dc) in e-Sanchit before filing the bill of entry.
CBIC Instruction 10/2022-Cus dated 28-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023 · FSSAI order dated 18-11-2022 under F.No.Import/TFM/Apex/2022-FSSAI
2
Where the import is for medical or scientific purposes, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 (Central Bureau of Narcotics, cbn.nic.in) and upload the Certificate of Analysis – Drug (0010dc), Batch Release Certificate (0030dc), Registration Certificate (Drugs) (101dc1), and Import Licence for Drugs (9111dc) in e-Sanchit. Imports outside this category are governed by Appendix-I to the ITC (HS) Schedule under DGFT policy condition No. 2 of Chapter 29.
Chapter VII-A of the NDPS Rules, 1985 · Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition No. 2 to Chapter 29
3
Include mandatory additional qualifiers in the import declaration for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, effective 15 October 2023. Additionally, ensure compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022 for designated food-import entry points.
CBIC Circular 23/2023-Cus dated 30-09-2023 · General Note 4(D) of Schedule I of ITC (HS) 2022

A word of counsel

The most common error on this tariff line is treating the FSSAI Import Licence as the sole clearance and overlooking the parallel NDPS import-certificate requirement when the declared end-use is medical or scientific. An NDPS-applicable consignment arriving without a Rule 53 import certificate is liable to seizure and prosecution under the NDPS Act, 1985, regardless of FSSAI status. Additionally, omission of the Chapter 29 mandatory qualifiers in the bill of entry — operative since 15 October 2023 — independently triggers detention and query at customs.

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Frequently asked

Does HSN 2936 26 10 require BIS certification?

No, Vitamin B12 (Cyanocobalamin) is 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 NDPS Rules, 1985 import-certificate controls for medical and scientific end-uses.

Which e-Sanchit document codes are mandatory for a drug-category import of this HSN?

For drug-category imports, document codes 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) must all be uploaded in e-Sanchit before out-of-charge.

What governs imports of Vitamin B12 that are not for medical or scientific purposes?

Non-medical, non-scientific imports are governed by Appendix-I to the ITC (HS) Schedule under DGFT policy condition No. 2 of Chapter 29; FSSAI food-additive or nutraceutical licensing remains applicable depending on the declared end-use category.

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