Understanding India’s Infant Milk Substitutes, Feeding Bottles and Infant Foods Act: A Compliance Playbook for Legal Teams

1. Why this law exists

Aggressive marketing of infant formula in the 1970s and early-1980s was linked to declining breastfeeding rates and avoidable infant deaths worldwide. In response, the World Health Assembly adopted the International Code of Marketing of Breast-milk Substitutes in 1981 to curb promotional practices that undermine breastfeeding.

India embraced the Code’s spirit early. Public-interest litigation, investigative reports on formula promotions in maternity wards, and lobbying by paediatric associations created political consensus that self-regulation was inadequate. Parliament therefore enacted the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (“IMS Act”), later strengthened by a 2003 Amendment.

2. Scope and objectives

The IMS Act seeks to protect, promote and support breastfeeding by:

1. Eliminating marketing influence over parents, caregivers and health-care professionals.

2. Ensuring accurate, science-based labelling of substitutes and complementary foods.

3. Regulating quality and distribution to guarantee safe availability where medically necessary.

   
   

Its reach is broad: any food “marketed or otherwise represented” as a partial or total replacement for breast-milk for infants up to two years, plus feeding bottles and teats, falls within the Act.

3. Key compliance duties under the IMS Act

Compliance Pillar	Practical Requirements for Companies
Total advertising ban	No ads, discounts, displays, social media posts, paid influencer content or indirect promotions. Section 3 prohibits “any form of advertisement” whatsoever, including comparative claims such as “closer to breast-milk.”
No samples or inducements	Free tins, hospital discharge packs, coupons, gifts to doctors or sponsorship of medical events are barred.
Labelling	Front-of-pack statement: “Mother’s milk is best for your baby.” No pictures of infants, women or idealised imagery; mandatory preparation instructions in English and Hindi; batch & expiry; FSSAI licence number.
Information to health workers	Only scientific and factual data may be shared, and never by sales teams. Literature must carry the statutory breastfeeding statement and refrain from brand graphics.
Product standards	Composition must meet FSSAI’s 2022 Foods for Infant Nutrition regulations (protein, carbohydrate, DHA, etc.).
Record keeping & inspections	Manufacturers/distributors must maintain production and sale records and submit them to food-safety authorities on request. Authorised inspectors may seize non-compliant products.
Penalties	First offence: imprisonment up to three years and/or fine up to ₹5,000; repeat offences attract harsher terms and confiscation of stock. Directors and managers can be prosecuted personally.

4. Enforcement trends

Civil-society watchdogs such as the Breastfeeding Promotion Network of India (BPNI) routinely flag violations. Recent reports documented celebrity-endorsed discount campaigns that triggered notices from food-safety authorities. Courts have upheld the Act’s criminal nature, signalling low tolerance for “creative” surrogate advertising.

Enforcement spotlight

Year	Company / Event	Alleged violation & BPNI response	Regulatory follow-up
2025	Amul – launch of ready-to-feed “Amulspray” formula	Press release pitched the product as “ideal for working mothers,” used a teddy-bear graphic on pack. BPNI filed a detailed complaint with MoHFW, FSSAI and NCPCR citing Sections 3 & 6 and demanded an advertising ban plus label change.	Health and Women–Child ministries acknowledged receipt; FSSAI sought Amul’s explanation and asked state food-safety departments to monitor stocks.
2025	Abbott Nutrition – paediatric summit at Dehradun	BPNI alerted the Union Health Secretary that Abbott was underwriting doctors’ travel and five-star accommodation for a two-day meeting, contravening Section 9’s bar on sponsoring health-worker events.	MoHFW forwarded the complaint to all concerned state health secretaries; local police were asked to examine funding sources and, if needed, stop the event.
2023	“Indian Baby Food Law Offenders” report	BPNI’s annual monitoring dossier listed 15 separate IMS-Act violations such as discount coupons, influencer posts and in-hospital displays by Nestlé, Danone, Abbott, e-commerce sites and others.	On release of the report, FSSAI reiterated its 2020 advisory directing food-safety officers to inspect retail sites for infractions and submit action-taken reports.
2012 – present	Nestlé India criminal trial	A private complaint originally filed by BPNI’s Dr Arun Gupta in 1994 led a Delhi court to frame charges in 2012 over mis-labelling and advertising of Cerelac, establishing that IMS-Act offences remain cognisable long after the act.	Nestlé’s challenge to the proceedings was dismissed; the trial is ongoing and frequently cited in compliance workshops as a cautionary tale.

5. Building a robust compliance programme

• Governance: Appoint a “Breast-milk Substitutes Compliance Officer” reporting to legal.

• Policy: Issue a zero-promotion policy covering digital, POS and third-party platforms.

• Training: Mandatory annual sessions for marketing, sales and medical liaison teams.

• Packaging review: Implement a two-level legal and regulatory checklist before print.

• Third-party oversight: Audit distributors, e-commerce partners and healthcare-event agencies.

• Monitoring & remediation: Track social media chatter, run mystery-shopping audits and maintain a whistle-blower channel.

• Incident response: Pre-draft corrective action and regulator-notification templates to deploy within 48 hours of a breach.

  
  

7. Conclusion

The IMS Act is not simply an advertising ban; it is a comprehensive framework intertwining child-health policy with product safety and corporate accountability. Legal teams that treat compliance as a strategic function and not as a last-minute hurdle can still innovate within the law: think science-led content for paediatricians, corporate social-responsibility programmes on breastfeeding support, and transparent consumer-help lines. Aligning corporate goals with the Act’s public-health purpose is the surest path to both regulatory peace of mind and brand goodwill in India’s highly scrutinised infant-nutrition market.