Papain, pure, of pharmaceutical grade

Pharmaceutical-grade pure papain enzyme

FSSAI CLEARANCE

HSN 3507 90 71 (Papain, pure, of pharmaceutical grade) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence requirements under the Food Safety and Standards Act, 2006, alongside a Drug Registration Certificate and Import Licence for Drugs administered through the e-Sanchit document regime. Compliance with General Note 4(D) of Schedule I of the ITC (HS) 2022 for designated food-import entry points and CBIC customs-overlay instructions also applies.

What this is

HSN code

3507 90 71

Chapter

35 · Albuminoidal substances; modified starches; glues; enzymes

Primary regulator

FSSAI · Food Safety and Standards Act, 2006

Customs documentation

Import Licence from FSSAI
Import licence for drugs from CBIC
Registration Certificate (Drugs) from CDSCO

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
Obtain the FSSAI Import Licence (document code 911001) and the Import Licence for Drugs (document code 9111DC) before filing the bill of entry. Both must be uploaded in e-Sanchit alongside the Registration Certificate for Drugs (document code 101DC1); out-of-charge will not be granted until all three are verified by the proper officer.
FSSAI Import Licence 911001 · Import Licence for Drugs 9111DC · Registration Certificate (Drugs) 101DC1 · General Note 4(D) of Schedule I of ITC (HS) 2022
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 before the bill of entry is assessed. The proper officer is required to verify all mandatory documents for PGA-facilitated bills before granting out-of-charge.
CBIC Instruction 10/2022-Customs dated 28-06-2022 · CBIC Instruction 09/2023-Cus dated 07-03-2023
3
Ensure labelling conforms to the FSS (Labelling and Display) Regulations, 2020. Rectifiable labelling deficiencies — including per-serve percentage contribution to recommended dietary allowance and date-of-expiry additions — may be corrected at customs-bound warehouses by affixing a single non-detachable sticker before inspection by the Authorised Officer, without altering original label information.
CBIC Instruction 10/2022-Customs dated 28-06-2022 · FSSAI Order dated 18-11-2022 under F.No. Import/TFM/Apex/2022-FSSAI · FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022

A word of counsel

The dual regulatory character of pharmaceutical-grade papain — simultaneously a food-related enzyme and a drug-classified substance — is the most common source of consignment detention on this tariff line. Importers who secure the FSSAI Import Licence but fail to upload both the Import Licence for Drugs (9111DC) and the Registration Certificate for Drugs (101DC1) face out-of-charge refusal even when the food-safety documents are in order. The Certificate of Analysis and Batch Release Certificate are independently mandatory and must reflect the specific pharmaceutical-grade specification of the consignment.

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Frequently asked

Does HSN 3507 90 71 require BIS certification?

No. No BIS Quality Control Order covers pharmaceutical-grade papain. Import is governed by the Food Safety and Standards Authority of India under the Food Safety and Standards Act, 2006, with a concurrent drug-registration overlay requiring an Import Licence for Drugs and a Registration Certificate for Drugs uploaded in e-Sanchit.

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

Seven mandatory documents apply: Certificate of Analysis — Drug (0010DC), Batch Release Certificate (0030DC), Label of Consignment (0110DC), Specimen Copy of Label (0110FS), Registration Certificate (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 corrected after the consignment arrives at port?

Yes, within the scope of the rectifiable-labelling regime under CBIC Instruction 09/2023-Cus — corrections must be made at a customs-bound warehouse before visual inspection by affixing a single non-detachable sticker without altering original label information; missing PGA clearances such as the FSSAI Import Licence or the drug registration are not rectifiable in this manner.

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