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Selling infant formula and baby food in India

In India, infant milk substitutes and infant foods meet FSSAI's standards under the Food Safety and Standards Act, 2006, and the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992 adds its own rules. That Act bars advertising and promotion, and requires an "IMPORTANT NOTICE" on each container stating that mother's milk is best.

Updated · Each section links to the official source it comes from

Standards
FSSAI, under the Food Safety and Standards Act, 2006
Promotion and labels
Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992
Infant milk substitute
Replacement for mother's milk, up to two years
Infant food
Complement to mother's milk, six months to two years
Advertising
Not allowed
Feeding bottles
BIS Standard Mark (IS 14625 plastic, IS 5168 glass)

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it an infant milk substitute, an infant food or a feeding bottle under the IMS Act? Read more
  2. 2Does it meet FSSAI's standard for the product? Read more
  3. 3Does the container carry the IMPORTANT NOTICE and the other particulars? Read more
  4. 4Does any marketing, sample or gift fall foul of the promotion ban? Read more
  5. 5Who holds the licence, and how is an import cleared? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

What the IMS Act covers

The products the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992 applies to.

  • An infant milk substitute is any food marketed or represented as a partial or total replacement for mother's milk for an infant up to the age of two years.
  • An infant food is any food marketed or represented as a complement to mother's milk to meet the growing nutritional needs of an infant after six months and up to two years.
  • A feeding bottle is any bottle or receptacle used for feeding infant milk substitutes, including an attached teat or valve.
  • Food Safety Officers under the FSS Act have powers of entry and search under the IMS Act (section 12).

How we help: Compliant Always records which of these definitions your product falls under, with the section, so the rules that follow from it are listed together. Ask about this

Standards and the BIS mark

Composition standards, and where BIS certification now stands.

  • Section 11 of the IMS Act requires infant milk substitutes and infant foods to conform to the standards specified under the FSS Act.
  • Where FSSAI has specified no standard for a product, it may be sold only with the Central Government's permission for the product and its label.
  • Section 11 also refers to the BIS Standard Mark on the container; BIS now lists infant milk substitutes (IS 14433), processed cereal-based complementary foods (IS 11536) and milk-cereal-based complementary foods (IS 1656) as de-notified from compulsory BIS certification under FSSAI's 2022 and 2024 amendments.
  • Feeding bottles are sold only with the BIS Standard Mark; BIS lists plastic feeding bottles (IS 14625) and glass feeding bottles (IS 5168) under the IMS Act.
  • The FSS Act includes infant food in its definition of food (section 3(j)).

How we help: Compliant Always reads the specification and certificates of analysis against the standard, and keeps the BIS licence for feeding bottles with the product, dated. Ask about this

Label

What the container of an infant milk substitute or infant food shows.

  • The words "IMPORTANT NOTICE" in capital letters, followed by "MOTHER'S MILK IS BEST FOR YOUR BABY" in capital letters.
  • A statement that the product should be used only on the advice of a health worker, and a warning that it is not the sole source of nourishment of an infant.
  • Preparation instructions and a warning about the hazards of improper preparation.
  • The ingredients, the composition or analysis, storage conditions, the batch number, the date of manufacture and the date before which it is to be consumed.
  • The container may not show pictures of an infant or a woman, graphics or phrases designed to increase sales, or the words "humanised" or "maternalised".
  • Milk powders and similar products that can be reconstituted into liquid milk carry "NOT TO BE USED FOR INFANTS BELOW SIX MONTHS" under the Labelling and Display Regulations, 2020.

How we help: Compliant Always reads the container artwork against section 6 and shows which particulars are missing and which images or words are not allowed. Ask about this

Advertising and promotion

What the IMS Act bars in marketing.

  • No one may advertise infant milk substitutes, feeding bottles or infant foods, or take part in their promotion (section 3).
  • No one may suggest that they are equivalent to, or better than, mother's milk.
  • No one may supply samples, or gifts of utensils or other articles, to promote their use (section 4).
  • Financial inducements or gifts to health workers to promote them are barred (section 9).
  • Educational material on infant feeding explains the benefits of breastfeeding (section 7).

How we help: Compliant Always keeps your marketing material with the product record, so it can be read against these sections before use. Ask about this

Licensing and import

FSSAI licence and port clearance.

  • Makers and sellers hold an FSSAI licence or registration under section 31 of the FSS Act.
  • Importers hold a central FSSAI licence, and FSSAI clears each consignment at the port under the Import Regulations, 2017.
  • Net quantity, retail sale price and consumer care details follow the Legal Metrology (Packaged Commodities) Rules, 2011.

How we help: Compliant Always keeps licences and import papers with each lot and shows which are expiring. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Brand ownerThe container label and the ban on advertising and promotion.Label and marketing material read against the IMS Act.
ManufacturerA product that meets FSSAI's standard, under its licence.Specifications and certificates of analysis kept with each batch.
ImporterThe central import licence and port clearance.Supplier documents read and dated before shipment.
Feeding bottle maker or importerThe BIS Standard Mark on the container.The BIS licence and test reports kept with the product.

Central and state rules

Most product rules in India are central: FSSAI for food, CDSCO for imported cosmetics, BIS for standards and the Department of Consumer Affairs for packaged-goods declarations.

States license cosmetics manufacture, enforce food and legal metrology rules through their own officers, and run excise on alcohol.

Questions businesses ask

Can I advertise infant formula in India?
No. Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992 bars advertising and promotion of infant milk substitutes, feeding bottles and infant foods.
What must an infant formula label say in India?
"IMPORTANT NOTICE" and "MOTHER'S MILK IS BEST FOR YOUR BABY", that it should be used only on a health worker's advice, that it is not the sole source of nourishment, preparation instructions and warnings, ingredients, composition, storage, batch number and dates.
Can a baby formula tin show a picture of a baby?
No. Section 6(2) of the IMS Act bars pictures of an infant or a woman, graphics designed to increase sales, and words such as "humanised" or "maternalised".
What age does the IMS Act cover?
An infant milk substitute replaces mother's milk for infants up to two years; an infant food complements mother's milk from six months up to two years.
Does infant formula need the ISI mark in India?
Section 11 of the IMS Act refers to the BIS Standard Mark, but BIS lists infant milk substitutes (IS 14433) as de-notified from compulsory BIS certification under FSSAI's 2022 and 2024 amendments. Check FSSAI's current position for your product.
Do feeding bottles need BIS certification?
Yes. Section 11(2) of the IMS Act requires the BIS Standard Mark, and BIS lists plastic feeding bottles (IS 14625) and glass feeding bottles (IS 5168).
Can I give free samples of baby food in India?
No. Section 4 of the IMS Act bars supplying samples of infant milk substitutes, feeding bottles or infant foods, and gifts of utensils or other articles.
Which standards do infant foods have to meet?
Those specified under the Food Safety and Standards Act, 2006. Where FSSAI has specified none, the Central Government's permission is needed for the product and its label.
Who enforces the IMS Act?
Food Safety Officers appointed under the FSS Act, and officers authorised by the state government, have powers of entry and search under section 12.
Do I need an FSSAI licence to import infant food?
Yes. Importers of food hold a central FSSAI licence, and each consignment is cleared at the port under the Import Regulations, 2017.
How does Compliant Always help with selling in India?
Our team reads the rules for the markets you sell in, including India's central regulators and the state rules that sit beside them. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in India and what your paperwork needs to show.

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