Pancretin pure (excluding medicament)

Pancreatin pure enzyme preparation, non-medicament grade

FSSAI CLEARANCE

HSN 3507 90 20 (Pancretin pure, excluding medicament) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence requirements under the Food Safety and Standards Act, 2006, and must comply with food-import entry-point restrictions under General Note 4(D) of Schedule I of the ITC (HS) 2022. The tariff line also carries a drug-documentation overlay — Certificate of Analysis, Batch Release Certificate, and Drug Registration Certificate — verified at the bill of entry by the Central Board of Indirect Taxes and Customs (CBIC). Directorate General of Foreign Trade (DGFT) policy controls apply as an additional ITC (HS) compliance layer.

What this is

HSN code

3507 90 20

Chapter

35 · Albuminoidal substances; modified starches; glues; enzymes

Primary regulator

FSSAI · Food Safety and Standards Act, 2006

Customs documentation

Import Licence from FSSAI
Registration Certificate (Drugs) from CBIC
Certificate of Analysis from drug supplier

Applicable Partner Government Agencies

FSSAIFSSAI·Food Safety and Standards Authority of India

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

Compliance steps

1
Secure the FSSAI Import Licence (document code 911001) and upload it in e-Sanchit before filing the bill of entry. Also upload the Import Licence for Drugs (document code 9111DC) and the Registration Certificate for Drugs (document code 101DC1); the proper officer will verify all three before granting out-of-charge.
CCR mandatory-document list · FSSAI Import Licence 911001 · Import Licence for Drugs 9111DC · Registration Certificate (Drugs) 101DC1
2
Upload the Certificate of Analysis — Drug (document code 0010DC), Batch Release Certificate (document code 0030DC), Label of Consignment (document code 0110DC), and Specimen Copy of Label (document code 0110FS) in e-Sanchit. Ensure labelling complies with FSS (Labelling and Display) Regulations, 2020; permissible labelling deficiencies may be rectified at the port under the rectification scheme confirmed by CBIC Instruction 10/2022-Customs dated 28-06-2022.
CBIC Instruction 10/2022-Customs dated 28-06-2022 · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023
3
Route the consignment only through a designated food-import entry point in compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022. Non-designated port arrival will result in consignment detention pending reassignment or re-export.
General Note 4(D) of Schedule I of the ITC (HS) 2022 · CBIC Instruction 05/2023-Cus dated 08-02-2023

A word of counsel

The most common error on this tariff line is treating pancreatin pure as either a pure food ingredient or a pure drug, and thereby uploading only the FSSAI licence set or only the drug-documentation set. This HSN explicitly excludes medicaments, yet the e-Sanchit mandatory-document list requires both the FSSAI Import Licence and the full drug-documentation tranche — Certificate of Analysis, Batch Release Certificate, and Drug Registration Certificate — simultaneously. A consignment arriving with one track complete and the other absent will be detained at the designated food-import port until all seven document codes are uploaded and verified.

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Frequently asked

Does HSN 3507 90 20 require BIS certification?

No, pancreatin pure (excluding medicament) is not within the BIS Quality Control Order regime; no BIS QCO covers this enzyme preparation. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with a concurrent drug-documentation overlay verified by CBIC at the bill of entry.

Which document codes must be uploaded in e-Sanchit for this tariff line?

Seven document codes are mandated: 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). All must be uploaded before out-of-charge is granted.

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

Yes, but only for the categories of labelling information specified under FSS (Labelling and Display) Regulations, 2020 and the rectification scheme confirmed by CBIC Instruction 10/2022-Customs dated 28-06-2022 and CBIC Instruction 09/2023-Cus dated 07-03-2023; rectification must be done at a Customs bonded warehouse before visual inspection, using a non-detachable sticker that does not alter the original label.

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