New Publication Raises Concerns that India's Food Fortification Standards Are Insufficient to Combat Widespread Micronutrient Deficiencies and Birth Defects

NEW DELHI, INDIA – August 4, 2025 – A new paper published in Birth Defects Research highlights a critical public health issue in India: the current national regulations for folic acid and vitamin B12 fortification in staple foods are significantly below what the World Health Organization (WHO) recommends for the Indian context, potentially rendering them ineffective in preventing widespread micronutrient deficiencies and severe, life-threatening birth defects. This regulatory decision yields unintended health consequences and presents a significant challenge to enhancing the health of some of the most vulnerable populations nationwide.

Micronutrient deficiencies, particularly of folate (vitamin B9) and vitamin B12, are highly prevalent in India. A recent meta-analysis (2015-2020) indicated that 37% of the Indian population is folate deficient and 53% is vitamin B12 deficient.

Folate deficiency in mothers at the time of pregnancy increases the risk of neural tube defects (NTDs) in babies. NTDs, like anencephaly and spina bifida, lead to stillbirths, early mortality, and lifelong disabilities. Vitamin B12 deficiency impacts a large segment of the population in India, resulting in anemia, neurological complications, and cognitive issues. Most of these deficiencies can be prevented through population-based nutrition interventions such as staple food fortification with adequate levels of micronutrients.

India allows food producers to voluntarily fortify wheat flour and rice sold on the open market, and the government requires rice distributed through safety-net programs to be fortified. However, the 2018 regulations by the Food Safety and Standards Authority of India (FSSAI) permit adding only 75-125 micrograms (mcg) of folic acid and 0.75-1.25 mcg of vitamin B12 per kilogram of wheat flour or rice. These levels are approximately 90% lower than the WHO's recommended levels, which are tailored to daily consumption levels of wheat flour and rice in India.

Prior to 2018, India's fortification standards aligned with WHO recommendations and specified that wheat flour should be fortified with 1300 mcg/kg of folic acid and 10 mcg/kg of vitamin B12. The decision to lower these standards in 2018 was reportedly driven by a sole focus on anemia prevention, without considering the high prevalence of NTDs and population-wide vitamin B12 levels. There was also a perception of harm associated with higher levels of folic acid, despite extensive evidence confirming the safety  of folic acid fortification, an intervention implemented in more than 65 countries.

"India is missing a remarkable opportunity to prevent at least 100,000 NTDs and many more nutritional anemias each year by lowering its fortification standards to levels that are not meeting prevention goals," says Dr. Vijaya Kancherla, lead author and Director of the Center for Spina Bifida Prevention at the Emory University Rollins School of Public Health.

"Many countries are benefitting from implementing fortification with right levels of micronutrients, tailored to their population-specific staple food consumption.  Reverting India’s fortification policy to its 2016 standards, which included adequate levels of folic acid and vitamin B12, will help achieve public health goals immediately. This move is feasible and time-sensitive, especially as rice fortification is scaling up nationally in India,” comments Dr. Kancherla.

Dr. Parveen Bhalla, India project lead for the Food Fortification Initiative, adds, "Our work with partners in Haryana has demonstrated the tangible benefits of adequate fortification. A population-based study in Haryana showed that when atta fortified according to WHO guidelines for folic acid was provided to Public Distribution System beneficiaries, their blood folate levels were raised above the threshold needed to prevent NTDs. This clearly illustrates that raising fortification standards to WHO-recommended levels and implementing large-scale food fortification significantly improves micronutrient levels in the population and prevents NTDs and other consequences of micronutrient deficiencies."

Fortification standards must be based on scientific recommendations to be effective and to benefit the population. This approach is followed in many countries worldwide. The paper raises an important issue in India: if fortification standards are based on scientific recommendations, fortification will have a significant public health benefit. 

The key message to policy-makers is to update the national fortification standards for folic acid and vitamin B12 to meet WHO-recommended guidance.  This simple revision in the fortification policy is a way for India to make a significant stride toward achieving the 2030 Sustainable Development Goals related to promoting healthier lives and preventing deaths.