New Delhi: In 2021, the Modi government mandated that the poor in India should get only iron-fortified rice under all government schemes. Its public health experts warned about the dangers the rice would pose to people with certain genetic diseases such as thalassemia and sickle cell anaemia. The order was particularly dire for India’s tribespeople, with the last available official estimates suggesting that up to 34% of them are affected by these diseases. But, since the Prime Minister’s Office had endorsed fortified rice, there was no stopping. So, the government went ahead with just a weak cautionary notice on the rice sacks that told people with such diseases to avoid the rice.

A civil society organisation challenged the government’s decision to supply fortified rice in the Supreme Court on the grounds that crores of poor people are not being adequately and properly warned about its impact. 

As the legal pressure built on the government to step up the awareness about the health impact and screen people with the diseases to stop them from having the rice, it found an easy way out. The government has now entirely done away the rule that asked for such health warnings.

By scrapping the basic health warning, the government has copped out of its duty to warn about the dangers of fortified rice and come up with alternatives for those who shouldn’t have the rice. In effect, it concluded that citizens should not be warned at all about the harms of consuming fortified rice.

The Reporters’ Collective found that the Union government has done so on the basis of a hastily generated expert opinion of a scientific committee. A significant part of this evidence presented by the experts is an unrecorded conversation with an unidentified officer of the US Food and Drug Administration in the US Embassy in Delhi.

Fortified rice is regular rice that is ground into powder, mixed with iron, vitamin B12 and folic acid, and then shaped back into rice grains using a machine. One such grain, called a fortified rice kernel, is blended with a hundred grains of normal rice.

People suffering from severe forms of these genetic diseases are generally advised not to consume iron since they are at risk of ‘iron overload’ in their body. This in turn can lead to impaired immunity and even organ failure. But a large number of beneficiaries are not aware of what fortified rice contains.

The Collective while previously reporting in Jharkhand’s East Singhbhum district on fortified rice met a 20-year-old woman suffering from sickle cell anaemia. She was eating iron-fortified rice despite having undergone multiple blood transfusions in her lifetime. In the same area, we found evidence of patchy adherence to warning labels on gunny sacks of fortified rice. 

Even if citizens wanted to avoid fortified rice, the majority of beneficiaries of the public distribution system, like the woman, have little to eat other than what the government provides and are likely to overlook the warning on the wholesale rice sacks asking them to avoid it. In the remote tribal-dominated villages of central India, fortified rice has sparked panic and even protests as people found the artificially produced rice alien, earning it the name “plastic rice”.

The government’s insistence on this modified rice has been fortified last week with a Rs 17,082 crore fiscal allocation for the scheme over next four years. The move comes despite the PM’s Economic Advisory Council member publicly writing to warn about the failure of fortified rice to provide health benefits even to those not affected by the specific diseases. 

The Collective sent detailed queries to the Department of Food and Public Distribution, Ministry of Health and Family Welfare and to Food Safety and Standards Authority of India. None of them responded despite repeated reminders. 

Raw deal

Prime Minister Narendra Modi announced the government’s decision to supply fortified rice to more than half of India’s population during the Independence Day speech of 2021. But the public health policy to serve the rice, which now reaches over 80 crore people or 66% of the population, was made in haste, ignoring warnings and red flags.

In our previous investigation, The Reporters’ Collective had revealed that the Modi government ignored the fact that the majority of pilot projects launched by his government to test the rice’s nutritional impact were fundamentally flawed and had failed. It overruled the finance ministry’s red flag against “premature” implementation of the scheme before understanding its impact on human health. Sacks of fortified rice were trucked out despite the head of the country’s leading medical research body ICMR calling for wider consultations following “serious concerns” on the “adverse effects” of fortified rice on children.

Our investigation had also revealed that a network of global NGOs linked to the Dutch company that manufactures and supplies the micronutrient powder used for fortifying rice were part of a government resource centre that chalked up the government’s rice fortification policy. The Modi government’s decision forcing more than half of India to eat fortified rice created an assured market for the Dutch firm Royal DSM. 

However, it was the Union government’s feckless safety regulations that became the focal point of criticism. The government had mandated warning labels cautioning people diagnosed with thalassemia and sickle cell anaemia to seek medical advice before consuming fortified rice because dietary iron can deteriorate their health and may even lead to organ failure. The government-recommended warning label was an official declaration that consuming the rice might put some people at serious risk. 

A visual representation of the size of a typical warning label on gunny sacks carrying fortified rice. The government has decided to do away with even the most minimalistic cautionary note possible.

The “premature” policy decision of the Union government wound up in the Supreme Court seeking course correction.
In January 2023, public health expert Dr Vandana Prasad filed a petition in the Supreme Court calling for compulsory adherence to the warning label regulation. The court dismissed the petition and asked the petitioner to “first make a proper presentation bringing the facts to the notice of the concerned authorities (sic)”.

The petitioner sent two letters to the Secretary of Health in February and June 2023 but didn’t receive any response.

In September 2023, activists from the Alliance for Sustainable and Holistic Agriculture filed a public interest litigation against the Union government. They pointed out that the government’s own regulations recognise the dangers this rice poses, particularly for individuals with conditions like thalassemia and sickle cell anaemia. The petition called for the government to inform all beneficiaries of these risks and to provide suitable alternatives for the most vulnerable.

Some may argue that it’s unrealistic to expect the Union government to screen crores of beneficiaries for these diseases. However, the government has separately launched a sickle cell anaemia elimination mission under which it’s planning to screen at least 7 crore people from 278 districts with tribal population.

The Defence

For the government, fortification’s safety has been an afterthought. It began looking into the risks of feeding fortified rice to Indians two years after Prime Minister Narendra Modi announced the scheme and a year after the cabinet approved it.

The result was a cacophony of reports from scientists commissioned by different ministries, each with a stake in assessing the safety and effectiveness of fortified rice.

In June 2023, a report on the safety and efficacy of fortified rice reached the Ministry of Health and Family Welfare. The scientists of the National Institute of Nutrition (NIN), a research institute affiliated with ICMR, noted that the scheme “requires to be dovetailed with regular monitoring of dietary intakes, impact evaluation, adverse effects in different segments of populations, risk of over consumption, development of bio-markers of excess intake and long-term health effects.” In simpler words, the researchers wanted the government to take on a more proactive role in ensuring people’s safety, like the petitioners in the Supreme Court later demanded.

ICMR-NIN paper made the case for regular monitoring of dietary intakes to rule out bad side effects – something the government failed to do.

The report clearly said that people with diseases such as thalassemia and sickle cell anaemia should be cautious of consuming  iron-fortified rice. This was particularly true for individuals who required blood transfusion because of the diseases. They concluded that the warning labels should stay on.

The scientists recommended supplying both fortified and unfortified rice under the public distribution system, something experts too have been asking for.

The report urging caution came a little too late—though it likely wouldn't have deterred the government, which had already ignored numerous such red flags. By then over 90 lakh tonnes of fortified rice had already been distributed to Indians across 27 states and union territories.

In its court submissions, the Union government mentioned receiving another research paper on the safety of iron-fortified rice. This one, commissioned by the Department of Food and Public Distribution under the Ministry of Consumer Affairs, Food and Public Distribution, had a view that contradicted that of the scientists from the National Institute of Nutrition. It said warning labels can be done away with. Its reasoning? No other country has  made warning labels mandatory for fortified foods.

However, neither is this paper publicly available nor any details about the authors and when it was published.

The government now had a problem of two conflicting conclusions. 

To solve this, it decided to bring in a third group of scientists to review the scientific literature and come up with a final answer.

This new committee of scientists drawn from institutions such as AIIMS , ICMR, PGIMER set up on November 30, 2023 had three weeks to give its report and “to give clear recommendations on this issue” . Two months ago, food rights activists had dragged the government to the apex court over the fortified rice scheme and the government badly needed a new scientific report to back it up in the court. The regulation requiring warning labels was the focal point of the petitioners. Their prayers revolved around the government’s failure to ensure the safety of crores of Indians.

Days after the new committee was set up to review the need for warning labels, the ICMR-NIN white paper was uploaded online. Strangely, the ICMR-NIN report’s conclusion recommending warning labels is available only in the Union government’s counter affidavit in the Supreme Court case. In the white paper that the research centre uploaded on its website, this conclusion has been omitted.

 The ICMR-NIN white paper submitted to the government recommended allowing warning labels to stay on while the one uploaded online six months later did away with all references to warning labels.

The third group of scientists, too, agreed that some individuals with certain types of severe thalassemia and sickle cell anaemia could develop health complications after consuming iron-fortified rice.

It, however, downplayed the problem as one that affects a “very small proportion of the population” with certain types of thalassemia.

Yet, it went with the logic that proved convenient to the government: that warning labels that could scare aren’t necessary because they are rare diseases, affecting a “very small proportion of the population”. Furthermore, it observed that other countries that promote food fortification don’t have such a rule asking for a label.

The US is one such country that the scientists looked to for cues. The ICMR Director General spoke to the India office of the US Food and Drug Administration. The FDA India office, in response to a query why the US didn’t carry such a warning on fortified rice, said that people with such diseases would have been made aware of the health risks by their healthcare providers.

In India, the burden of these genetic diseases is high  among the poor, and are particularly prevalent among tribal communities who don’t have access to even basic medical advice. Yet, the committee’s report suggested that the FDA’s rationale could be applied to India, ignoring the stark socio-economic differences between the two countries.

The government-appointed committee spoke to the FDA India office to know why the US does not mandate warning labels for fortified foods.

With this communication as one of the key pieces of ‘evidence’, the committee recommended to the Union government that warning labels be done away with.

On July 19, 2024, the Union government issued an advisory to eliminate the basic requirement for warning labels on gunny bags carrying fortified rice, even while the Supreme Court is hearing the case on warning labels.

Admission of Failure

Even as the Modi government continues to defend the fortified rice scheme in court, the Prime Minister’s Economic Advisory Council, an elite committee that advises the Prime Minister, finally spoke up.

In its recent working paper, the council pointed out that fortification has had a “limited impact” on mitigating anaemia.

The paper – about changing food consumption patterns in India – said this about fortification: “While such a program has a natural appeal due to the simplicity of implementation, we must acknowledge the empirical finding that a significant impact on reducing anaemia might be achieved by pushing policies that promote dietary diversity at the household level.”

This is what public health experts have been saying all along.
But this wasn’t all. 

Sanjeev Sanyal, a member of the council, along with Srishti Chouhan, a young professional at the council, went a step ahead. In a column for The Economic Times, they pitched for a diversified diet to mitigate micronutrient deficiencies.

The authors pointed out facts that The Collective had reported first, over a year before the column was published, as part of its investigative series title “#ModifiedRice”: The Union government relied on patchy scientific evidence to justify the fortification push. Only four papers the government referred to were India-related. Other research papers, they said, had “ambiguous results”.

“The issue seems to be that the human body does not absorb micronutrients from fortified sources as easily as from natural food,” the authors suggested.

Why then did the government launch the scheme to begin with?

“An important driver of the fortification-heavy strategy is advocacy by international donors and NGOs,” they said. This is exactly what The Collective revealed last year with documented proof as part of its 3-part investigative series.

The Collective sent queries to Sanyal and Chauhan but neither responded despite reminders.

Three years after the Prime Minister launched the scheme with much aplomb from the ramparts of the Red Fort, one of his economic advisors decided to be blunt: “We need much stronger evidence supporting different kinds of fortification.”