Dr Sumedha Nadkar, Pharma Consultant and Visiting Faculty, recommends a focused regulatory pathway with collaboration with industrial bodies to pave the way for an ethical, sustainable growth of the infant food industry
“A baby fills a place in your heart that you never knew was empty.” – Anonymous
This quote speaks volumes about the joy and warmth that a baby brings into our lives. However, this sentiment may not hold true for all parents at all times.
A recent conversation with a friend who was desperately searching for a “special” infant formula for her baby diagnosed with Chronic Kidney Disease (CKD), caught my attention. While this baby was fortunate to receive a one-year supply of Similac 60/40 from the US, not every infant is so lucky. Upon some preliminary research, I found that this formula has import restrictions and is not available for sale in India. Despite being a core pharma professional, I did not delve further at the time.
Yet, I now feel a deep sense of responsibility to highlight the gaps that exist in this space. These can potentially be addressed through collaboration between regulators and players in the infant food industry—without much delay or deliberation.
Let us look at some key considerations and needs within the infant nutrition sector, especially for infants with CKD:
a) Key risk factors
Infants with CKD are often at risk due to factors such as increasing maternal age, maternal nutritional deficiencies, and health conditions like diabetes.
Although breastfeeding is the recommended method for feeding infants with CKD, they often need supplementary formulae that have a low renal solute load, especially low phosphate and potassium content.
The consequences of inadequate nutrition for these infants are serious: stunted growth, impaired final height potential, abnormal body composition, cognitive delays, and even increased mortality.
b) Key statistics
India’s baby food and infant formula market reached $6.0 billion in 2024. It is expected to grow to $9.3 billion by 2033, at a CAGR of 4.73 per cent during 2025–2033 (Source: IMARC Group). This growth is driven by rising awareness about child nutrition and developmental needs among Indian parents.
c) Is infant food for “special” needs still in its infancy in India?
Despite the expanding infant nutrition market, awareness and access to specialised baby food, beyond relatively common needs like lactose intolerance—remains limited. The Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 govern the manufacturing, labelling, and sale of infant milk substitutes and foods for special medical purposes intended for infants.
These regulations are largely aligned with the Codex Alimentarius (WHO), a global standard for food safety. Yet, implementation and enforcement in the Indian context remain inconsistent and questionable.
d) Key innovations
Ready-to-feed products that are portable, nutrient-rich, and convenient are boosting market growth. Factors such as rising disposable incomes, increasing female workforce participation, and urbanisation are contributing significantly. Millennial and Gen Z parents are more aware and informed. Some of the notable innovations in this space are formulas with Omega-3 fatty acids, prebiotics like Galactooligosaccharides (GOS) and Fructo-oligosaccharides (FOS), and probiotics, such as lactose-free formulas, are also available to meet the needs of babies who suffer from lactose intolerance.
e) Notable actions by Indian regulators
Here’s the proofread version with minimal corrections for grammar, language, and clarity:
Certain steps by FSSAI are laudable, such as in 2018, when FSSAI permitted the import of highly specialised life-saving formulas. This was a boon for kids suffering from inborn errors of metabolism like Phenylketonuria, Galactosemia, Tyrosinemia, etc. as well as hypo-allergenic formulas for infants suffering from cow milk allergy.
Even though CKD and certain other insufficiencies is a highly niche segment and the volumes are quite low, many companies are still investing here despite poor margins as a moral gesture.
◆ In July 2021, the FSSAI made amendments to the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. (First Amendment Regulations, 2022) and these came into effect on 1st October 2022.
Some of the amendments are as follows:
◆ The labelling of the food for infant nutrition shall be in accordance with Food Safety and Standards (Labelling and Display) Regulations, 2020.
◆ Sub-regulation 3 has been added under regulation 7 for Infant Formula, which states that where an infant formula in powder format is manufactured without the use of any vegetable oil, linoleate, vitamin E, starch, specified food additive and optional ingredients, the product may be named as ‘Infant Milk Food’.
◆ The limits for Vitamin B12 under the requirement per 100 g and requirements per 100 kcal have been increased from 0.25 – 0.70 mcg and 0.05 – 0.15 mcg, respectively, to 0.25– 4.0 mcg and 0.05 – 0.90 mcg, respectively, for both Infant Formula and Follow-up Formula.
◆ Packaging gases, carbon dioxide and nitrogen have been added for use at GMP for follow-up formula. Even as the FSSAI expert panel reviews norms and prepares recommendations, a startling report brought to light an investigation by the Swiss investigative agency revealed that the international food giant Nestlé adds sugar to powdered baby food in low- and middle-income countries, including India, but not in rich countries.
Recent controversy and actions
Currently, a FSSAI expert panel has been assigned to assess the existing Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, meant for packaged food items for infants and toddlers aged 6-24 months.
The panel is reviewing norms that allow 20 per cent carbs in the form of sugar in baby foods and is working on making suitable recommendations.
Our action? It is expected that recommendations from the panel are likely in a few months and will lead to a revised draft regulation for infant nutrition. This will then be put in the public domain for feedback. What the exact timelines of this project are is not yet understood, at least not publicly.
g) The US scenario
In the US, it is the FDA which regulates the production of infant formulas to help ensure that these products are safe and support healthy growth in infants who consume them.
Moreover, the agency also takes steps to educate parents and caregivers with the latest information on care for both full-term as well as low birthweight infants. Infant Formula | FDA The formulas are broadly categorised as Routine formulas and Specialty formulas; we have a similar one in India as well.
Operation Stork Speed by USFDA
In March 2025, the USFDA announced ‘Operation Stork Speed’ to improve infant formula in an effort to guarantee “the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula.” The process involves issue of a ‘Request for Information’ to start the first comprehensive update and review of infant formula nutrients. This will be followed by intensive testing for heavy metals and other contaminants. Formula companies will be encouraged to proactively engage with the FDA to address questions, focusing on increased transparency. Communication with consumers and industry stakeholders on significant developments will be stepped up. Last but not least, the FDA will collaborate with the National Institutes of Health and other scientific organisations to address critical gaps in scientific research concerning the short- and long-term health outcomes linked to formula.
Swift actions by USFDA
One particular event recall in December 2023 highlights the swift action the FDA has taken. The Israeli Ministry of Health had notified the FDA on December 14 that Nutramigen Hypoallergenic Powdered Infant Formula, produced at the Mead Johnson Nutrition Zeeland, Michigan, facility, which was imported, was tested at the Israeli border during routine sampling. The FDA immediately commenced a for-cause inspection at Reckitt/Mead Johnson Nutrition’s Zeeland facility on December 18 that included collecting environmental samples as well as testing additional samples of finished product from the same batch of Nutramigen infant formula powder tested by Israel.
On December 29, Reckitt/Mead Johnson Nutrition agreed to initiate a voluntary recall of 675,030 cans of Nutramigen powdered infant formula distributed to the US. USFDA immediately alerted parents, caregivers, and health care providers about the possibility of Cronobacter sakazakii contamination. Even though no illnesses had been reported in connection with this recall, the agency took prompt action at every stage of the supply chain to complete the recall in order to protect the most vulnerable population.
The Indian scenario
Back home, albeit late, we have woken up to the fact that Nestlé adds sugar to powdered baby food in low- and middle-income countries, including India, but not in rich countries, after a report by an investigation by the Swiss investigative agency. The recent HADSA conference, the Vitafoods B2B exhibition certainly highlighted the exploding impact of the nutraceutical industry, and hopefully, the impact will be seen speedily. While we may not exactly act swiftly like “Operation Stork,” we should not act like a clucking hen either.
Conclusion
A focused regulatory pathway with collaboration with industrial bodies such as HADSA, etc., will pave the way for an ethical, sustainable growth of the infant food industry while nurturing our most important asset, our future Indian citizens.
References
https://www.imarcgroup.com/india-baby-food-infant-formula-market
https://theprint.in/health/nestles-double-stan-dard-baby-food-has-added-sugar-in-india-not-in-rich-countries/2046184/
https://medicalxpress.com/news/2025-03-fda-stork-infant-formula.html
https://medicalxpress.com/tags/scientific+re-search/
