Regulation of Infant Milk Substitutes and Foods: IMS Act, 1992

Breast milk is universally recognized as the optimal source of nutrition for infants, yet aggressive marketing by infant formula companies has historically threatened breastfeeding practices worldwide. To address this concern, India enacted the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992-commonly known as the IMS Act. This landmark legislation, along with its accompanying Rules of 1993, represents one of the world’s most comprehensive legal frameworks for protecting breastfeeding and regulating infant food products.

Why the IMS Act was necessary 🔗

During the 1980s, declining breastfeeding rates became a global public health concern. The World Health Organization recognized that poor infant feeding practices were negatively affecting the growth, health, and development of children and were a major cause of infant mortality. In response, the World Health Assembly adopted the International Code of Marketing of Breast-milk Substitutes in 1981, providing a framework for member states to regulate the marketing of these products.

India was among the early adopters, implementing its own national code in 1983 before enacting the IMS Act in 1992. The Act came into force on August 1, 1993, and was further strengthened through amendments in 2003 to close loopholes that formula companies had exploited.

Objectives and scope of the IMS Act 🔗

The IMS Act applies throughout India and covers three main categories of products: infant milk substitutes, feeding bottles (including teats and valves), and infant foods intended for children up to two years of age. The Act’s primary objectives are to protect and promote breastfeeding, regulate the marketing activities of infant formula companies, and ensure the safe and appropriate use of breast milk substitutes when genuinely needed.

Products covered under the Act 🔗

The legislation defines an infant milk substitute as any food marketed as a partial or total replacement for mother’s milk during the first two years of life. This includes popular commercial products such as infant formula marketed under various brand names. Feeding bottles include any bottle designed for feeding infants, along with teats and valves. Infant foods encompass any food marketed for infant consumption during the complementary feeding period.

Prohibition on advertising and promotion 🔗

One of the Act’s most significant provisions is its comprehensive ban on all forms of promotion of infant milk substitutes, feeding bottles, and infant foods for children up to two years of age. Under the IMS Act, no person shall advertise for the distribution, sale, or supply of these products through any medium.

What constitutes prohibited promotion? 🔗

The Act defines “promotion” broadly to include any method of encouraging purchases or use of covered products. Specifically prohibited activities include distributing free samples to pregnant women or mothers, providing gifts or incentives to healthcare workers, offering discounts or special displays at retail outlets, and creating any impression that infant formula is equivalent to or better than breast milk.

Companies cannot directly or indirectly contact pregnant women or mothers of infants to offer inducements. This prohibition extends to educational materials, which must not refer to brand names or contain promotional content for specific products.

Restrictions in healthcare settings 🔗

The IMS Act places special restrictions on activities within healthcare systems. No healthcare facility can be used for promoting infant formula or other products covered by the Act. This means hospitals, clinics, and health centers cannot display posters, pamphlets, or any promotional materials from formula manufacturers.

Healthcare worker obligations 🔗

Healthcare professionals have a critical role under this legislation. Formula producers, suppliers, and distributors are prohibited from providing any financial inducements to health workers. This includes funding for seminars, conferences, educational courses, research work, or sponsorships. The 2003 amendment specifically strengthened these provisions after evidence emerged that formula companies were using professional development funding to influence healthcare workers’ recommendations to mothers.

Mandatory labeling requirements 🔗

The IMS Act establishes strict labeling standards for all covered products. Every container of infant milk substitute or infant food must display specific information in a clear, conspicuous, and easily readable manner.

Required label declarations 🔗

Labels must prominently display the words “IMPORTANT NOTICE” in capital letters, followed by the statement “Mother’s milk is best for your baby.” Additional mandatory information includes a warning that the product should be used only on advice of a health worker, a clear statement that the product is not the sole source of nourishment for an infant, proper instructions for preparation and use, and the complete nutritional composition of the product.

The Rules of 1993 specify that these particulars must appear in both English and Hindi (in Devnagari script), with provision for additional local languages. Importantly, containers and labels cannot display pictures of women or infants, as such imagery could be perceived as promotional.

Safety standards and quality requirements 🔗

The IMS Act works in conjunction with food safety legislation to ensure product quality. Originally linked to the Prevention of Food Adulteration Act, 1954, the standards now fall under the Food Safety and Standards Act, 2006. Products not meeting these prescribed standards are liable for confiscation.

The Bureau of Indian Standards (BIS) plays a crucial role in establishing quality parameters for infant foods and milk substitutes. Only products meeting BIS standards are permitted for sale in India. This ensures that when breast milk substitutes are genuinely necessary, parents can be confident about the safety and nutritional adequacy of available products.

Enforcement and penalties 🔗

Unlike many regulatory frameworks, the IMS Act treats violations as criminal offenses. Contravention of advertising and promotion provisions can result in imprisonment for up to three years, fines up to five thousand rupees, or both. For repeat offenders, minimum sentences of six months imprisonment and fines of at least two thousand rupees apply.

Monitoring mechanism 🔗

Section 21 of the Act authorizes specific entities to monitor compliance and file complaints. The Breastfeeding Promotion Network of India (BPNI) has been officially notified as a child welfare NGO authorized to initiate legal action under the Act since 1995. Food safety officials under FSSAI and state-level Commissioners of Food Safety are also empowered to monitor compliance and take enforcement action.

Impact on breastfeeding rates 🔗

The effectiveness of India’s regulatory approach is evident in breastfeeding statistics. Exclusive breastfeeding rates have risen significantly-from 36.8% in 2000 to over 64% in recent years. This improvement coincides with consistent enforcement of the IMS Act alongside promotional and educational activities on infant feeding.

Equally telling is the market data. While infant formula sales in countries like China increased dramatically from USD $1 billion in 2002 to USD $3.5 billion by 2008, India’s formula market remained under USD $500 million. This stability reflects both the legislation’s effectiveness and the cultural reinforcement of breastfeeding as the preferred feeding method.

Why breastfeeding protection matters 🔗

WHO and UNICEF recommend exclusive breastfeeding for the first six months of life, with continued breastfeeding alongside complementary foods until two years or beyond. Breast milk provides complete nutrition for infants and contains antibodies that protect against infections like pneumonia, diarrhea, and ear infections.

Research indicates that if all children were breastfed within an hour of birth, exclusively fed breast milk for six months, and continued breastfeeding until age two, approximately 800,000 child lives could be saved annually. The long-term benefits extend beyond infancy, potentially reducing risks of obesity, diabetes, cardiovascular disease, and certain cancers later in life.

Challenges and ongoing concerns 🔗

Despite its comprehensive framework, the IMS Act faces implementation challenges. Monitoring requires significant resources, and violations can be difficult to detect, particularly with digital marketing and social media platforms creating new promotional channels. FSSAI has issued advisories specifically directing e-commerce platforms and food business operators to comply with the Act’s provisions.

Some experts note that relatively light penalties may not sufficiently deter large multinational corporations. Additionally, enforcement capacity varies across states, leading to inconsistent implementation. However, vigilant monitoring by organizations like BPNI has resulted in successful legal actions, including product recalls and fines against major formula manufacturers.

Global significance 🔗

India’s IMS Act is recognized internationally as one of the most stringent national implementations of the WHO Code. The International Code itself is not legally binding-it provides recommendations that governments can adopt through legislation or other measures. India’s experience demonstrates that when political will aligns with robust monitoring, national legislation can effectively protect breastfeeding from commercial pressures.

For other countries seeking to implement similar protections, India offers valuable lessons about the importance of comprehensive prohibition on promotion, strong labeling requirements, authorized monitoring bodies, criminal penalties for violations, and regular amendments to address emerging loopholes.

What do you think? How can food safety professionals and healthcare workers better support the implementation of infant food regulations in their communities? What additional measures might help address the challenges posed by digital marketing of infant formula products?

References

1. https://www.who.int/tools/elena/interventions/regulation-breast-milk-substitutes
2. https://www.who.int/publications/i/item/9241541601
3. https://ysph.yale.edu/news-article/indias-infant-milk-substitutes-act-monitoring-and-enforcement/
4. https://www.bpni.org/national-policy-programme-4/
5. https://en.wikipedia.org/wiki/International_Code_of_Marketing_of_Breast-milk_Substitutes
6. https://www.foodsafetymantra.com/regulatory-update/food-supplements/infant-food/compliance-of-infant-milk-substitutes-feeding-bottles-and-infant-food-as-per-the-ims-act/
7. https://www.who.int/tools/elena/interventions/exclusive-breastfeeding
8. https://pmc.ncbi.nlm.nih.gov/articles/PMC11597163/
9. https://www.emro.who.int/nutrition/breastfeeding/exclusively-breastfeed-for-6-months.html
10. https://www.unicef.org.uk/babyfriendly/baby-friendly-resources/international-code-marketing-breastmilk-substitutes-resources/the-code/