Anemia affects 27% of the world’s population, about 1.93 billion people. Developing countries bear a disproportionate burden of 89% of all anemia-related disability, iron deficiency being a major reason (>60%).1 Women and children (about 800 million), especially from developing countries, bear the major burden.2 Iron deficiency not only results in negative health outcomes such as increased mortality and morbidity related to maternal and child health, but also has broader societal implications like decreased cognition in children from infancy through adolescence, and reduced work productivity in adults.3 About 42% of anemia in children and 50% in women is attributed to iron deficiency and could be eliminated or reduced by iron supplementation.4 However, challenges such as poor ante-natal care-seeking, insufficient doses, or behavioral challenges to regular use have limited the effectiveness of supplementation programs. Food fortification interventions are an effective mechanism to scale-up the coverage of micronutrients and contribute to addressing gender and income-related inequities in health status. They can cost-effectively reach larger populations and are generally more socially acceptable than pharmacological supplementation, or require less effort in changing nutrition-related behaviors.5,6 India has successfully reduced the burden of iodine-deficiency disorders by legislating fortification of salt with iodine and has built an extensive infrastructure for the production and distribution of iodized salt. With minimal additions to this infrastructure, salt fortification has the potential to act as a vehicle for the inclusion of other micronutrients (such as iron) and make a similar impact on deficiencies in these micronutrients, however, only if adequately scaled-up. There is empirical evidence to support the efficacy of double fortified salt (DFS) in improving iron status and reducing the prevalence of anemia. In one such study among school children in rural southern India, the prevalence of anemia decreased from 15.1% to 5% (a drop of more than 50%).7 Another Randomized Controlled Trial among women tea pickers in West Bengal found that the intervention group using DFS had greater increase in hemoglobin (+2.4 gm/L) and body iron (+1.43 mg/kg), in comparison to the control group.8

In recent years, India has witnessed a surge in the use of fortified foods both in the public and private markets, with an intention to increase intake of essential micronutrients by large populations, which are mostly deficient as a result of poor diets. Government of India policies are reinforcing the use of fortified foods in food security programs such as the mid-day meal (MDM), Integrated Child Development Services (ICDS), and the public distribution system (PDS).9–11 The PDS is a pan-India government programme for distributing foodgrains and other essential commodities at highly subsidized prices to families pre-identified as poor and vulnerable. It operates a network of more than 500,000 fair price shops (FPS) spread across India, enabling access to more than two-thirds of the country’s population.12 These shops are owned by small local entrepreneurs who facilitate the retail distribution of subsidized food and kerosene (cooking fuel) to pre-identified beneficiaries, in exchange for a small commission. In 2015, the University of Toronto (UofT), International Development Research Centre (IDRC), Global Affairs Canada (GAC), the Tata Trusts – an Indian philanthropic organization, and the State Government of Uttar Pradesh (GoUP), collaborated to launch the rollout of encapsulated ferrous fumarate DFS through the PDS. Launched as a pilot project in ten districts of Uttar Pradesh, the project also tested the scalability of the model of distributing DFS through the Public Distribution System and its effectiveness. The specific objectives of this case study are to describe the scale-up model utilizing the PDS, assess its scalability, critically analyze the process of scaling-up, and provide evidence to shape a national DFS scale-up agenda.

The state of Uttar Pradesh is home to a population of more than 200 million, i.e, 16% of India’s population.13 Uttar Pradesh has a high maternal mortality ratio,14 high infant mortality rate,15 a high percentage of stunted children,16 inadequate dietary diversity among children,16 and relatively high rates of poverty.17 Current efforts to address IDA are inadequate, for instance, only 12% of the pregnant women had consumed the recommended doses of 100 Iron and Folic Acid (IFA) tablets as per national guidelines,16 made freely available to the pregnant women through the facility and community-based health services of the government. The coverage of other essential micronutrient supplementation programs (except iodine through salt fortification) is also less than satisfactory (Figure 1). The introduction of DFS in an accessible and affordable manner in these settings, therefore, has a great potential to enhance iron intake on a consistent basis and reduce the high prevalence of iron deficiency anemia—a burden shared by most Indian states.

Figure 1.Coverage of micronutrients among eligible beneficiaries through supplementation, in comparison to iodine coverage through fortified salt.

Graph prepared by author using data from state fact sheets-National Family Health Survey-4, India (2015-16).16,18

# METHODS

## The intervention

The UP-DFS project resulted from a unique partnership between international donors, universities, Indian private salt and premix manufacturers, a leading national philanthropic organization, and the Government of Uttar Pradesh.19 Involving the private sector was essential to provide the infrastructure to produce iron premix and DFS, and because salt production is mostly limited to the private sector. Previous efforts at introducing DFS had faced acceptability challenges primarily relating to organoleptic issues. The encapsulated ferrous fumarate formulation overcame this barrier by protecting the iron premix molecules with an inert coating agent followed by a waterproofing agent. The encapsulant would break either when the salt was used in cooking foods at high temperatures or in low pH in the gastrointestinal tract. This provides stability to the iron premix and prevents unwarranted reactions with the iodine or other contaminants present on the surface of the salt particles.20 The technology for the encapsulated ferrous fumarate iron premix was developed at UofT and transferred free of cost to JVS Foods, a private premix manufacturer in India, enabling local production of encapsulated DFS in India. The construction of a full-scale commercial premix plant at JVS Foods was supported with funding from the IDRC, Global Affairs Canada (through the Canadian International Food Security Research Fund - CIFSRF), and Tata Trusts. The Tata Trusts through a subsidiary trust—The India Nutrition Initiative—provided program implementation, promotion, and monitoring support to the government of Uttar Pradesh in ten project districts. On a parallel track, the Global Alliance for Improved Nutrition (GAIN) with funding support from the Bill and Melinda Gates Foundation agreed to conduct an effectiveness trial in the ten pilot districts to assess the impact on health and nutrition status following 12 months of a continuous intervention (Table 1).

# DISCUSSION

Scale-up models must be adaptive to accommodate the diverse socio-economic and political environment in which the scaling-up occurs. Also, scaling-up can assume different meanings in the context of different programs.22 For the UP-DFS intervention model, scaling-up means replication of the intervention to distribute/sell subsidized DFS through the public distribution system in other Indian states, i.e. horizontal scale-up. The PDS being a pan-India infrastructure offers the opportunity for national scale-up of the intervention. Another dimension to scaling-up would be the coverage of more districts within the states that have begun small by launching the intervention in pilot districts. Thus, we look at horizontal scaling-up of DFS as both replication and expansion of the UP-DFS model. Simultaneously, the intervention also attempts at vertical scale-up by influencing policy and regulations on fortification, institutional strengthening, and innovative financing mechanisms. Since the UP-DFS scale-up project was shaped by the existing policies, financing, regulation, and systems, it also influenced the vertical scaling-up of DFS by informing food fortification policies and providing ways of innovative financing for DFS scale-up through public-private and civil sector partnerships. The UP-DFS project is unique in two ways. First, it is a unique health-focused program that is implemented and managed ministry of Food and Civil Supplies that is not directly responsible for generating health outcomes. Secondly, DFS along with fortification of other food items included in the food safety-net scheme of the PDS has expanded the scope of food security programs to serve as a potential mechanism to address both macro and micro-nutrient deficiencies. The UP-DFS model builds on the ‘successful yet long’ journey of near-universal coverage of iodized salt in India. In the case of iodine, this has been mainly achieved through mandatory legislation of iodization of all salt in the market.30 The case for mandatory legislation of iron fortification, though ideal, will require more work in building evidence for impact at scale; private sector collaboration; and most importantly consumer acceptability and other ethical clearances. Meanwhile, the government food and nutrition security programs such as the Public Distribution System, Integrated Child Development Scheme, and Mid-Day-Meal in schools provide a readily available platform to reach vulnerable population especially women, children, and the low-income groups, at scale. The ICDS and MDM schemes together reach a total of over 100 million beneficiaries (pregnant and lactating women, children up to the age of 13). However, poor utilization rate of the services of both these programs,31 along with a one-time food supplementation to most beneficiaries, can considerably reduce the impact potential of DFS interventions in these programs. In contrast, the PDS delivery platform is a sustainable social-business model involving a distribution network of local shops. The delivery platform reaches 67% of the country’s population (nearly 75% of the rural population and 50% of the urban population) reaching more than 800 million individuals. The PDS system caters to households from the lower-income groups, that are most vulnerable to iron-deficient diets and anemia. The public distribution delivery mechanisms allow for subsidization of the product removing financial barriers to access. The availability of DFS at the local shops of the PDS that are frequently visited by people to collect other rations also helps to create demand by providing a nudge factor. The PDS has been criticized for leakage and pilferage of commodities, however, new monitoring systems using electronic point of sales machines, wider promotion of entitlements, a telephonic grievance reporting mechanism and such other initiatives (mostly community empowerment measures and awareness on entitlements) have considerably overcome this constraint.32

The project baseline assessment revealed that 80% of the households in the project areas utilized PDS to regularly purchase their requirements of rice, wheat, sugar, and kerosene (cooking fuel) from the government fair price shops. Moreover, 90% of the women with iron deficiency had access to and utilized the PDS services (GAIN baseline report, 2016, unpublished). The introduction of DFS in the PDS would, therefore, ensure iron intake of at least 30-40% of Dietary Reference Intakes (DRI), in more than 80% of the most vulnerable population. Considering acceptability based on sensory trials, DFS would be consumed by most of this population. However, the effective coverage of DFS through PDS depends on consumer uptake and utilization of DFS, which may vary across settings. Since DFS is a new product and most of the population is unaware of its health potential, there is no existing demand for the product. DFS interventions would have to create a demand for DFS in order to be scaled-up and this means changing the behavior of consumers who prefer to buy other salts easily available in the open market at relatively affordable prices. Hence, the key to ensuring the acceptability of DFS and use at-scale in the community lies in the health awareness levels, and demand creation for fortified products in the community. DFS by nature is organoleptically slightly different from the regular salt and perceived notions of high-quality salt is a critical barrier. Thus, in some situations, consumer illiteracy and consumer preferences may offset the expected increase in demand by providing subsidies. Increase in awareness of DFS and entry of DFS in the private sector may create a demand for the product, eventually transforming into a pull system. In certain geographies, knowledge and awareness levels are low to begin with and slow to show improvement. In such situations, mandatory fortification for public health reasons may be justified; especially when no adverse effects are reported, the purchasing price is unaffected, and the incremental industry cost of fortification is meager. Until then, consumers having alternative choices to purchase their salt in the open market need to be informed and convinced about the health benefits of the sustained use of DFS.

A favorable policy environment, partnership with the salt industry, and consumer demand for DFS are the foundations of the scale-up of DFS. Policies such as mandatory inclusion of DFS in food and nutrition programs can be a starting point to create demand beginning with institutional markets such as the PDS and ICDS. Salt production in India is purely in the private domain, and therefore, the cost of fortification would be influenced by the market. Market policies such as tax rebates for pre-mix and DFS manufacturers could support the development of the market for DFS and help to keep prices low. Also, the potentially high coverage of the intervention due to the integration of DFS with the public distribution system and choice of a universally consumed food vehicle (salt) – resulting in enhanced nutritional outcomes – is expected to increase the cost-effectiveness of the intervention in the long run. Partnership with the salt industry as well as infrastructure and equipment for iron premix production are essential organizational elements for a full scale-up. The investments and alliances with the industry could be sustainable only if the demand for DFS catches up the supply potential. Thus, consumer awareness and demand would be the most critical driver deciding the scaling-up potential of this promising intervention. An essential consideration for scaling-up is the cost-effectiveness of an intervention. DFS has a high benefit:cost ratio of 6:1 that rises to 36:1 when discounted future benefits due to cognitive improvements are included33 The unit costs for the intervention is slightly higher than other studies, yet much less than supplementation programs.34 However, considering the high benefit:cost ratio, economies of scale and efficient methods of DFS distribution are expected to further reduce the costs.

This case study has sought to understand the critical contextual factors for fortification inventions such as enabling policy environment and political leadership; appropriate technology, institutional infrastructure, and market incentives for the private sector; and consumer awareness and acceptance of the product. To our knowledge, there are very few case studies that have evaluated the integrated role of these factors in successful scaling-up of fortification interventions. Most notably, there has been inadequate attention given to the role of the private sector as a source of innovative financing for global health nutrition. Integration with other public food and nutrition programs, multi-sectoral partnerships for financing and implementation, addressing contextual factors influencing scale-up, and consumer literacy on fortification are essential considerations for large-scale food fortification interventions. Our case study highlights the need for further research in understanding the approaches and pathways of scale-up models and contextual factors in scaling-up fortification programs. Our paper brings out the complexities of implementing a multi-partnership fortification program on a large-scale and provides learnings to inform future program and research designs in scaling-up fortification interventions; especially using the public sector channels. Our research has high local and national relevance, and also significant implications for global nutrition programming directed at the reduction of micronutrient deficiencies. Primarily, we propose and demonstrate the integration of DFS and food security interventions targeted to vulnerable populations, as an efficient way to address iron deficiency anemia, when scalability considerations are adequately met.

## Limitations of the study

While we understand that the scalability assessment of the project’s model can best be done externally, in our opinion the preparation of the case study to document the model, the processes, and implementation experiences and challenges is best done by an insider; someone closely and continuously involved in the scale-up process. Our findings are limited to our implementation experiences, and the same model may have different results in a different setting. Further follow-up on the sustainability of the intervention is also needed. The cost considerations for scaling-up DFS need further exploration involving a full costing analysis that was beyond the scope of this case study.

# CONCLUSION AND POLICY IMPLICATIONS

Introducing fortified food and food products in existing nutrition and food security schemes can accelerate the scaling-up of fortification interventions and reduction of micronutrient deficiencies. Several contextual factors critical to scaling-up, from both the supply and demand perspectives, should be considered before replication and expansion. Public policies and food regulations promoting fortification are key factors in ensuring the scale-up of fortified foods. However, the nature of the fortified product, health literacy of the population, operational efficiencies of the distribution mechanism, sustainable financing, and consumer choices, food behaviors, and taste influence the effectiveness of fortification interventions and should, therefore, be appropriately evaluated and addressed. Consumer behavior and acceptability of fortified foods could be altered by using the ‘nudge factor’ by making fortified foods easily and readily available at an affordable price. At the same time, consumer preferences and tastes should be considered while developing new fortified products. Demand creation through consumer awareness and promotion of fortified foods is urgently needed if food fortification were to be a global health success. Mass fortification should be encouraged through public-private partnerships with the food industry voluntarily fortifying their products until such a time that mandatory fortification is feasible. Partnership with the private sector (premix producers and salt industry), to mobilize private investments, along with creating sustained consumer demand, is essential to ensure sustainability.

## Acknowledgements

Tata Trusts - The India Nutrition Initiative, and International Development Research Centre and Global Affairs Canada through the Canadian International Food Security Research Fund, partially funded the field intervention with major funding provided by the Government of Uttar Pradesh, India.

None.

## Competing interests

The authors completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available upon request from the corresponding author) and declare no conflicts of interest.