Foreign Food Manufacturer Registration in India

What Global Brands Must Know About the ReFoM Portal in 2026

By Dr. Ashwini Kumar

Founder & CEO, CE Group of Companies  |  Forbes Business Council Member

Regulatory Affairs Expert | Clinical Trials Advisor | Medtech & Food Regulatory Consultant

India Has Changed the Rules for Foreign Manufacturers — Has Your Team Noticed?

Few years ago, a foreign food manufacturer could export products to India through a local importer with relative ease — as long as the importer held an FSSAI Central License. The manufacturer’s own regulatory standing in India was essentially invisible. The importer bore the compliance burden.

That model has fundamentally changed.

FSSAI’s mandatory Foreign Food Manufacturing Facility (FFMF) registration programme — implemented through the ReFoM (Registration of Foreign Food Manufacturers) — now places the foreign manufacturer directly within FSSAI’s regulatory perimeter. For certain product categories, failure to register on ReFoM means your products cannot legally enter India, regardless of your importer’s compliance status.

If you are a global food OEM and you have not yet reviewed your ReFoM registration status for your Indian business, this article is for you.

What is ReFoM and Why Was It Created?

ReFoM — the Registration of Foreign Food Manufacturers — is FSSAI’s mechanism to extend regulatory oversight upstream, to the point of manufacture in the country of origin. It was created to address a fundamental gap in India’s import food safety framework: the fact that FSSAI had no visibility into the manufacturing standards of the overseas facilities producing food for the Indian market.

The rationale is straightforward. If India’s food safety standards are to be meaningful, they cannot stop at the port of entry. FSSAI must be able to verify that the facility producing the imported food operates under credible Food Production License from competent authority and food safety systems of the manufacturer’s country.

ReFoM gives FSSAI that visibility. Registered facilities are required to provide their Food production license, product specification, product lists, Form-16 and few undertaking from manufacturer as well as importer or Authorised Indian representative. FSSAI may conduct facility inspections — in person or remotely — and can suspend or cancel registration if standards are not maintained.

Which Categories Require Mandatory Registration?

Product Category	Mandatory Since	Registration Portal
Nutraceuticals & Health Supplements	September 1, 2024	ReFoM (Registration of Foreign Food Manufacturers)
Milk & Milk Products	September 1, 2024	ReFoM
Meat & Meat Products	September 1, 2024	ReFoM
Infant Food & Baby Food	September 1, 2024	ReFoM
Other food categories (phased)	Notifications pending	ReFoM  — monitor FSSAI gazette

Table1

FSSAI has signalled its intention to expand mandatory FFMF registration to additional food categories over time. Foreign manufacturers in categories not yet covered should monitor FSSAI gazette notifications closely — the expansion of this requirement is a stated regulatory priority.

What the Registration Process Looks Like

Step 1: Eligibility Check

Before applying, confirm that your product categories require FFMF registration, and that your facility’s Food production license is valid. Expired licenses are one of the most common reasons for registration delays.

Step 2: Designate Your India-Based Importer or Authorised Agent

Foreign food facility either directly or through importer or Authorised agent can apply for the registration. Importer or Authorised agent entity will be the regulatory point of contact in India and will be jointly accountable for compliance. Selecting your importer or agent is therefore not merely a commercial decision — it is a regulatory decision.

Step 3: Prepare Your Documentation Package

 

Document Required	Notes
Business Registration Certificate	Company incorporation / registration in country of origin
List of existing manufacturers	Those who are intended to export food products in India
Food Production License	As per the Competent Authority
Product List	All products to be exported to India with HS codes
Product description	For all products to be exported
Detailed composition/Specification of product	For all products to be exported
Authorised Signatory Details	Director / Senior Management declaration
India Importer / Authorised Agent Details	Mandatory — foreign manufacturer must designate an India-based importer or agent

Table2

Step 4: Apply on the ReFoM Portal

Application with all the required documents needs to share via email from the manufacturer’s competent authority to the FSSAI. All documents must be submitted in the prescribed format. FSSAI will conduct a technical review of the application and may raise queries or request additional information. Response timelines are important — delayed responses can push the application into lower priority queues.

Step 5: Approval and Ongoing Compliance

Once approved, the registration is valid for 2 years and must be renewed. Any significant change to the manufacturing facility, product range, or key personnel must be notified to FSSAI. Registration is facility-specific — if a manufacturer operates multiple plants, each plant supplying the Indian market may need separate registration.

 

The Three Mistakes Foreign Brands Most Commonly Make

Mistake 1: Assuming the importer’s license covers everything.

It does not. The FSSAI Central License held by your Indian importer covers the import and distribution activity in India. It does not substitute for FFMF registration of your overseas manufacturing facility. Both are required.

Mistake 2: Waiting until the first shipment is held at port.

Port holds for unregistered facilities in mandatory categories result in consignment detention, demurrage costs, and potential rejection. The registration process takes time — it should begin at least 4–6 months before your first planned shipment.

Mistake 3: Selecting the India importer or agent based only on commercial terms.

Your India importer becomes your regulatory face in India. Their FSSAI compliance track record, their ability to manage port clearance, their relationships with FSSAI-designated laboratories — all of these matter. Choose a partner with demonstrated FSSAI import compliance capability, not just a broad distribution network.

 

Figure1

How This Connects to Your Broader India Entry Strategy

FFMF registration is one component of a multi-layer India import compliance framework. The full picture for a foreign food manufacturer entering India in 2026 includes:

• ReFoM / FFMF registration (for mandatory categories)
• FSSAI Central Import License (held by your India importer)
• Product classification — Proprietary Food vs Non-Specified Food determination
• NSFP approval (if applicable — separate application, ₹5 lakh fee, 12–24-month timeline)
• India-compliant label development under FSS (Labelling & Display) Regulations 2020
• FICS (FSSAI Import Clearance System) prior intimation before each consignment
• Analytical testing compliance with FSSAI-approved or validated international methods (new requirement, effective May 2026)

 

Each element is necessary. None is optional. And the sequence matters — beginning with product classification and registration before moving to labelling and operational import setup is the framework that consistently produces the fastest market entry timelines.

How CliniExperts Can Help

CliniExperts provide full-service India market entry support for foreign food and nutraceutical OEMs, including:

• ReFoM / FFMF registration management — end to end, from documentation to portal filing
• India authorised agent services — IBH can act as your India-based regulatory representative
• Import compliance audit — gap assessment against current FSSAI import requirements
• Product classification and NSFP dossier preparation where required
• India label development and FSSAI labelling compliance review
• Port clearance and FICS management for ongoing import operations