Vitamin H (Biotin)

Vitamin H (Biotin) and its derivatives

FSSAI CLEARANCE · NDPS CLEARANCE

HSN 2936 29 50 (Vitamin H / Biotin) 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) controls under Chapter VII-A of the NDPS Rules, 1985 where applicable. Directorate General of Foreign Trade (DGFT) ITC (HS) policy condition 2 of Chapter 29 and Central Board of Indirect Taxes and Customs (CBIC) mandatory Chapter 29 qualifier declarations apply as additional clearance requirements.

What this is

HSN code

2936 29 50

Chapter

29 · Organic chemicals

Primary regulator

FSSAI · Food Safety and Standards Act, 2006

Customs documentation

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

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
Upload the FSSAI Import Licence (document code 911001), the Registration Certificate for Drugs (document code 101dc1), the Import Licence for Drugs (document code 9111dc), the Certificate of Analysis for Drugs (document code 0010dc), the Batch Release Certificate (document code 0030dc), and Label and Specimen Label documents (document codes 0110dc and 0110fs) in e-Sanchit before filing the bill of entry. Out-of-charge will not be granted until all mandatory documents are verified.
CCR mandatory document list · CBIC e-Sanchit OOC verification requirement
2
Where Biotin is imported for medical or scientific purposes under the NDPS provisions, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 prior to shipment. Imports outside the medical and scientific category are governed by Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 of Chapter 29.
Chapter VII-A of the NDPS Rules, 1985 · Rule 53 of the NDPS Rules, 1985 · ITC (HS) policy condition 2 of Chapter 29
3
Include the 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. Confirm compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022 for food-import entry points and ensure labels meet the FSSAI rectifiable-labelling standards per CBIC Instruction 09/2023-Cus dated 07-03-2023.
CBIC Circular 23/2023-Cus dated 30-09-2023 · CBIC Instruction 09/2023-Cus dated 07-03-2023 · CBIC Instruction 10/2022-Cus dated 28-06-2022

A word of counsel

The most common error on this tariff line is treating the FSSAI Import Licence as the sole clearance requirement and overlooking the NDPS import-certificate obligation under Rule 53 of the NDPS Rules, 1985. Even a trace-quantity Biotin consignment for nutritional or food-supplement use may engage the NDPS overlay if the substance is listed in the applicable Appendix; a missing NDPS import certificate at the bill-of-entry stage results in consignment detention and potential seizure independent of the FSSAI clearance status.

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Frequently asked

Does HSN 2936 29 50 require BIS certification?

No, Vitamin H (Biotin) falls outside the BIS Quality Control Order regime; no BIS QCO covers this product family. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with an NDPS Rules, 1985 overlay for medical and scientific imports and DGFT ITC (HS) policy condition 2 of Chapter 29.

Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?

Seven documents are mandated: Certificate of Analysis for Drugs (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); all must be uploaded before out-of-charge is granted.

When does the NDPS import certificate requirement under Rule 53 of the NDPS Rules, 1985 apply to Biotin imports?

The Rule 53 import certificate is required when Biotin is imported for medical or scientific purposes under Chapter VII-A of the NDPS Rules, 1985; imports outside those categories are instead subject to the Appendix-I ITC (HS) Schedule controls under policy condition 2 of Chapter 29.

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