Caffein and salts thereof

Caffeine and salts medicaments, measured-dose retail packs

FSSAI CLEARANCE · MEFCC CLEARANCE

HSN 3004 49 20 (Caffein and salts thereof) is subject to Food Safety and Standards Authority of India (FSSAI) Import Licence and drug-registration requirements under the Food Safety and Standards Act, 2006 and applicable Drugs regulations. A drug import licence, batch release certificate, and certificate of analysis must be uploaded in e-Sanchit before out-of-charge, and consignments are permitted only through designated food-import entry points under General Note 4(D) of Schedule I of the ITC (HS) 2022. The Directorate General of Foreign Trade (DGFT) and Central Board of Indirect Taxes and Customs (CBIC) apply policy overlays including rectifiable-labelling compliance under the FSS (Labelling and Display) Regulations, 2020.

What this is

HSN code

3004 49 20

Chapter

30 · Pharmaceutical products

Primary regulator

FSSAI · Food Safety and Standards Act, 2006 (high-risk food/drug import regime)

Customs documentation

Import Licence for drugs from DGFT
Registration certificate from CDSCO
FSSAI Import Licence from FSSAI

Applicable Partner Government Agencies

FSSAIFSSAI·Food Safety and Standards Authority of India

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

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

Compliance steps

1
Obtain a drug import licence (document code 9111dc) and ensure the registration certificate for drugs (document code 101dc1) is current before filing the bill of entry. Upload both documents in e-Sanchit alongside the certificate of analysis (document code 0010dc), batch release certificate (document code 0030dc), and consignment label (document code 0110dc) before customs out-of-charge.
CCR e-Sanchit document codes 9111dc, 101dc1, 0010dc, 0030dc, 0110dc · CBIC Instruction 09/2023-Cus dated 07-03-2023
2
Obtain the FSSAI Import Licence (document code 911001) and upload the specimen copy of label (document code 0110FS) in e-Sanchit. Confirm compliance with the rectifiable-labelling regime under FSS (Labelling and Display) Regulations, 2020 and the FSSAI clarification order dated 18-11-2022; label deficiencies must be corrected at customs bonded warehouses before visual inspection by the authorised officer.
FSSAI Letter 1828/Misc Matters/FSSAI/Imports-2021 dated 17-06-2022 · CBIC Instruction 10/2022-Customs dated 28-06-2022 · FSSAI clarification order dated 18-11-2022
3
Route the consignment only through a designated food-import entry point per General Note 4(D) of Schedule I of the ITC (HS) 2022. Note that import of oxytocin is prohibited; import of oxytocin reference standards is permitted exclusively for test and analysis subject to a test licence from DGCI/CDSCO, per S.O. 2357(E) and DGFT Notification 09/2015-2020 both dated 23-05-2022.
General Note 4(D) of Schedule I ITC (HS) 2022 · S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is uploading the FSSAI Import Licence without simultaneously uploading the drug-specific documents — registration certificate (101dc1), batch release certificate (0030dc), and certificate of analysis (0010dc) — treating the food-safety clearance as sufficient for a pharmaceutical medicament. Caffeine formulations in measured-dose retail packs are simultaneously regulated as drugs and as food-category products, triggering a dual-track documentation requirement; a consignment with an incomplete e-Sanchit set is detained at the designated entry port, attracting demurrage until all document codes are uploaded and verified.

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Frequently asked

Does HSN 3004 49 20 require BIS certification?

No, measured-dose medicaments containing caffeine and its salts are not within 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, alongside drug-import licensing and registration requirements, with DGFT and CBIC policy overlays.

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

Seven document codes apply: 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 customs out-of-charge.

Is there any prohibition on specific substances within this tariff line?

Yes. Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the narrow exception permitting import of oxytocin reference standards for test and analysis requires a test licence issued by DGCI/CDSCO.

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