Since September 2024, Indian customs check the plant before they check the product. Most exporters find out at the port.
A container of capsules arrives at Nhava Sheva. The importer holds a valid FSSAI licence in the right category. Every active sits inside the permitted schedules at a compliant dose. The label carries the FSSAI logo at the correct numeral height, the allergen declaration, the MRP, the importer's address, the country of origin. Months of work went into getting all of that right.
The consignment is held anyway.
Not because of anything in the bottle. Because of the building it came from.
What actually changed
India has been moving steadily from product-level control to facility-level control, and the step that matters most for food and nutraceutical exporters took effect on 1 September 2024.
The mechanism is the Registration of Foreign Food Manufacturing Facilities, or ReFoM. Its legal basis sits in the FSS (Import) First Amendment Regulations, 2021, which introduced provisions for the registration and inspection of foreign food manufacturing facilities. FSSAI implemented it through an order dated 10 October 2022, naming the product categories in scope.
The requirement is straightforward to state. If your facility is not registered, and your product falls into one of the specified categories, the consignment does not clear. Customs verify facility registration on the ReFoM portal as part of import clearance, under a CBIC instruction issued in November 2024.
This is not a document that travels with the shipment. It is a status the factory either has or does not have, established long before anything is packed.
The confusion worth clearing up first
A great deal of exporter confusion on India comes from treating two different requirements as one. They are not the same instrument, and they have moved in opposite directions.
The first is the health certificate order of 2021, which required a certificate from the exporting country's competent authority to accompany each consignment of milk, pork and fish products. That order was deferred three times, and in February 2023 it was extended until further notice. It remains on the books and it remains dormant.
The second is ReFoM. It was deferred once, from February 2023 to September 2024, and then brought into force.
| Health certificate (2021 order) | ReFoM facility registration | |
|---|---|---|
| What it is | A certificate accompanying each consignment | A registration held by the manufacturing facility |
| Level | Product and shipment | Facility |
| Status | Deferred until further notice | In force since 1 September 2024 |
| Checked by customs | No | Yes, on the ReFoM portal at clearance |
An exporter who has been tracking the health certificate and concluded that India relaxed its position has drawn exactly the wrong inference. One requirement went dormant. A different, broader one came into force.
Who is covered
Five categories fall within ReFoM:
- Milk and milk products
- Meat and meat products, including poultry, fish and their products
- Egg powder
- Infant food
- Nutraceuticals
The last one is where most of the surprise sits. Dairy and meat exporters have long expected facility-level scrutiny; it is the norm in most markets. Nutraceutical manufacturers generally have not. A supplements company thinks in terms of ingredient schedules, dose limits and label claims, because that is what the category has historically demanded. ReFoM asks a different kind of question, and it asks it of the plant rather than the portfolio.
Three assumptions that hold up containers
1. “We are registered.”
Registration attaches to a premises, not to a corporate entity. A company operating three manufacturing sites needs three registrations. A registration granted for one address does not extend to product made at another, however similar the operation or common the ownership. Where a brand has added capacity, moved a line, or shifted production between plants since it first registered, the position needs rechecking.
2. “We did this already, for our dairy line.”
Registration is granted against categories. A facility registered for milk and milk products is not thereby registered for nutraceuticals. For a manufacturer running a protein powder line alongside a capsule and tablet operation, this is the single most common gap, and it is invisible until a nutraceutical consignment is the one being cleared.
3. “It is done.”
Registration runs for two years. Renewal is applied for ahead of the expiry date shown on the registration, not after it. Facilities that registered early in the cycle are now reaching their second or third renewal, and a lapse puts the exporter back at the port rather than at the portal.
The pattern in all three is the same. Product-level compliance is continuous and visible. Facility-level compliance is binary and easy to forget, right up to the moment it is the only thing that matters.
What registration involves
Application is made in Form 16, filed by the facility directly or through an authorised representative in India. It is supported by:
- The registration, licence or equivalent authorisation granted by the food authority of the country in which the facility operates
- The consent of the facility owner to verification by FSSAI officials
- Detailed compositions of the products intended for export to India
- Authorisation for the authorised representative, where one is appointed
An incomplete application triggers a notice to furnish the missing information within thirty days, failing which it is rejected. The facility may be inspected before or after registration. Where the food category falls under the mandatory BIS Certification Mark Scheme and the BIS inspection already covers the relevant requirements, a separate inspection is not required.
A compliant facility is registered for two years and the registration number is communicated in Form 17. That number is what customs look for.
Two of the supporting documents do not sit with the importer. The owner's consent to verification and the detailed product compositions have to come from the manufacturer. On a multi-brand or contract-manufacturing arrangement, that is a conversation to start well before anyone is planning a first shipment.
A sensible sequence
- Establish which of your manufacturing sites would ship to India, by address rather than by entity.
- Check the current status of each on the ReFoM portal, and record not just whether it appears but which categories it is registered against and when the registration expires.
- Map your India-bound catalogue to those categories. Any product falling in a category the site is not registered for is exposed, regardless of how compliant the product itself is.
- Where registration is needed, assemble the Form 16 document set, allowing time for the manufacturer-side items.
- Put registration expiry on the same compliance calendar as your import licence and other renewals, rather than treating it as a one-off task that closed when the certificate arrived.
The wider point
ReFoM is one instrument, but it reflects a direction of travel. India is increasingly interested in where food is made and under what conditions, not only in what the finished product contains. Facility registration, quarantine permits for animal-origin goods, foreign establishment listing, and inspection powers all point the same way.
For an exporter, the practical consequence is that a compliance file organised entirely around SKUs will have a hole in it.
The product file answers what is in the bottle. It does not answer whether the plant is allowed to send it.
That second question is now the one asked first.
We advise overseas food, nutraceutical and consumer health brands on entering the Indian market — covering facility registration, import licensing, product classification, labelling and claims, and customs. If you are unsure whether your sites are registered for the right categories, or when they expire, talk to us and we will map it. See also our India Certification and labelling services.
India Market Access, Launch Rocket. Launch Rocket advises overseas food, nutraceutical and consumer health brands on entering the Indian market, covering facility registration, import licensing, product classification, labelling, claims and customs.
This article is regulatory commentary for exporters considering the Indian market. It is not legal advice, and positions should be confirmed against the current text of the relevant instruments before a filing decision.