Cultures of micro-organisms(excluding yeast)

Cultures of micro-organisms for pharmaceutical or diagnostic use

FSSAI CLEARANCE · AQCS CLEARANCE

HSN 3002 49 10 (Cultures of micro-organisms, excluding yeast) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence under the Food Safety and Standards Act, 2006, and to Animal Quarantine and Certification Services (AQCS) health and veterinary clearance as a concurrent overlay. The Central Board of Indirect Taxes and Customs (CBIC) requires pre-out-of-charge e-Sanchit upload of all mandatory PGA documents, including a Registration Certificate for drugs, a Certificate of Analysis, and a Batch Release Certificate, before customs out-of-charge is granted.

What this is

HSN code

3002 49 10

Chapter

30 · Pharmaceutical products

Primary regulator

FSSAI · Food Safety and Standards Act, 2006

Customs documentation

Import Licence from FSSAI
Health Certificate from AQCS
Registration Certificate from CDSCO

Applicable Partner Government Agencies

FSSAIFSSAI·Food Safety and Standards Authority of India

AQCSAQCS·Animal Quarantine and Certification Services

Procedural directions for customs clearance are issued by: Central Board of Indirect Taxes and Customs.

Compliance steps

1
Obtain the FSSAI Import Licence (document code 911001) and the Import Licence for Drugs (document code 9111dc), and ensure the Registration Certificate for Drugs (document code 101dc1) is current. Upload all three in e-Sanchit before filing the bill of entry; the proper officer is directed to verify these uploads before granting out-of-charge.
CBIC Instruction 10/2022-Customs dated 28-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023
2
Upload the AQCS Health Certificate (document code 6360AQ), the Veterinary Health Certificate issued by the exporting country (document code 853AQ1), and the Laboratory Report or Certificate of Analysis (document code 001AQ1) in e-Sanchit. The AQCS Veterinary Health Certificate and COA are required per the CTI listing in Annexure A of CBIC Circular 24/2022-Cus.
CBIC Circular 24/2022-Cus dated 28-11-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023 · FSSAI order dated 18-11-2022 under F.No.Import/TFM/Apex/2022-FSSAI
3
Ensure the Certificate of Analysis for drugs (document code 0010dc), Batch Release Certificate (document code 0030dc), and the Label of Consignment (document code 0110dc) and Specimen Copy of Label (document code 0110FS) are uploaded in e-Sanchit. Label deficiencies permissible for rectification at the port must be corrected at the 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-Customs dated 28-06-2022 · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022 · FSS (Labelling and Display) Regulations, 2020

A word of counsel

The most common error on this tariff line is treating the FSSAI Import Licence as the sole pre-clearance document and overlooking the distinct AQCS veterinary and laboratory certificate requirements, which are separately mapped to Annexure A of CBIC Circular 24/2022-Cus. A consignment arriving without the Veterinary Health Certificate (853AQ1) or the COA (001AQ1) uploaded in e-Sanchit will be detained pending AQCS NOC, with demurrage and ground rent accruing independently of any valid FSSAI clearance already on record.

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Frequently asked

Does HSN 3002 49 10 require BIS certification?

No, cultures of micro-organisms (excluding yeast) are 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, with a concurrent Animal Quarantine and Certification Services veterinary overlay and drug-registration requirements.

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

The mandatory document codes are: 0010dc (Certificate of Analysis — drug), 0030dc (Batch Release Certificate), 0110dc (Label of Consignment), 0110FS (Specimen Copy of Label), 101dc1 (Registration Certificate — drugs), 6360AQ (Health Certificate), 911001 (FSSAI Import Licence), 9111dc (Import Licence for Drugs), 853AQ1 (Veterinary Health Certificate), and 001AQ1 (Laboratory Report/COA); all must be uploaded before out-of-charge.

Can labelling deficiencies be rectified at the port for this HSN?

Yes, but only for the specific deficiencies permitted under FSS (Labelling and Display) Regulations, 2020 and CBIC Instruction 10/2022-Customs; rectification must be carried out at the customs-bonded warehouse before visual inspection by affixing a single non-detachable sticker, and does not cure a missing PGA clearance.

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