Children have their midday meal at a West Midnapore school. The fortified salt is used in school meals in some states
New Delhi, Dec. 9: An Indian government laboratory released a formulation of salt fortified with iodine and iron for mass consumption, calling it a tool to combat anaemia and iodine deficiency, without adequate and rigorous evidence to show that it increases blood haemoglobin levels, scientists have said.
The National Institute of Nutrition (NIN), Hyderabad, has shared the formulation and production technology for its double fortified salt (DFS) with seven salt-producing companies, some of whom are now supplying it for school midday meal programmes in several states and trying to break into the consumer market.
India’s ministry of women and child development and the Prime Minister’s Office, among other government arms, have supported the use of the DFS after presentations by the NIN.
But sections of nutrition experts have said the NIN and its parent body, the Indian Council of Medical Research (ICMR), have ignored the absence of large-scale efficacy data while promoting the DFS for mass consumption.
Like the child in Hans Christian Andersen’s tale who pointed out that the emperor wasn’t wearing any clothes, a senior Indian nutrition scientist has questioned the release of the DFS without what he says is the necessary scientific rigour to establish its efficacy.
Umesh Kapil, professor of nutrition at the All India Institute of Medical Sciences, New Delhi, has written to the ICMR questioning the decision.
“The core issue is: does India take public health decisions on hard scientific evidence or on what the heart or emotions tell us,” Kapil told The Telegraph.
Senior NIN scientists claim there is enough evidence to justify the launch of the DFS. “We have worked on the DFS for decades; it is not based on fragmentary research,” NIN director Kalpagam Polasa told this newspaper.
S. Ranganathan, a senior scientist involved in the DFS project, said the efficacy studies had been encouraging. He claimed the prevalence of anaemia in Chhattisgarh had declined after the state government introduced the DFS in school meals about five years ago.
The claims of efficacy are based on only two studies, in which NIN scientists gave the DFS to tribal populations and to children in four residential schools in Andhra Pradesh.
But, scientists familiar with the studies’ results say, a high incidence of malaria was blamed for the absence of any impact of the DFS on haemoglobin in the tribal population, while so many children dropped out from the school study that valid conclusions were difficult.
A senior paediatrician said the school study was of “moderate quality”.
“The results did show a benefit on haemoglobin, and the size of the effect (increase in haemoglobin) was comparable to the effect shown by iron fortification trials in other parts of the world,” said Harsh Pal Singh Sachdev, a member of an ICMR panel that examined the research dossier on the DFS in 2011.
The NIN had sought funding for a study on several hundred children in cities across India in the late 1990s.
“But for reasons known only to the higher-ups, the study was not cleared and the NIN could not do a thing,” Ranganathan told this newspaper.
Scientists from the NIN had themselves written in a paper in the British Journal of Nutrition in 2001 that while the DFS had effectively controlled iodine, “a clear impact on reducing anaemia was not demonstrated”.
Yet, in 2008, a fresh review paper by the NIN in another journal claimed the product would be an effective tool to fight anaemia — without any new study during the intervening seven years to justify this shift in position.
“I would call the evidence for the efficacy of the DFS shaky,” a nutrition scientist with an international agency said. “The product is under manufacture but we need more data to assess the efficacy of the DFS in real-life settings in India.”
The technology of the DFS is not easy. The double fortification leads to loss of iodine and oxidation of the iron. While NIN studies have established that the DFS is safe for long-term consumption, a panel of experts in 2003 had found the DFS unstable — in other words, the nutrients may not be available.
Yet, sometime between 2003 and 2006, the ICMR switched from a standard method of chemical estimation of iodine and iron in the DFS to another method, and declared the DFS as stable.
Kapil, the AIIMS professor of nutrition, says the chronology of actions indicates that the ICMR facilitated technology transfer for the production of the DFS even while questions about efficacy lingered.
Most of the DFS produced goes into state-supported school midday meal programmes or child development services.
“We’ve tried to get into the consumer market, but there is very little awareness about the need for iron-fortified salt,” said Ashok Parakh, managing director of India’s largest salt refinery in Kutch, which supplies about 15 million kilograms of the DFS every year to Chhattisgarh.
“We’ve also introduced it for retail sales through supermarket chains,” said Rajkumar Rautray, chairman of a Bhubaneswar-based company that supplies about 24 million kilograms of the DFS to several states and grocery chains across the country.
“We need strong government campaigns to get people to go out and buy it.”
The DFS costs a few rupees more than standard iodised salt.
In April 2011, the NIN presented its work on the DFS at a meeting in the Prime Minister’s Office. Weeks later, the women and child development ministry directed states to use the DFS for school midday meals and the integrated child development scheme.
When Kapil approached the ICMR with his concerns, the ICMR set up an expert panel, which met in November 2011 and conceded that the efficacy claims for the DFS had been based on limited studies.
The ICMR asked the NIN to provide data on the stability, shelf life and the bio-availability — the amount of the ingredients actually absorbed by the body — of its DFS. It is unclear how the NIN responded but in April 2012, the ICMR transferred the DFS technology to another company.
“It is sad to see short cuts after more than two decades of research,” Kapil said. “The DFS may indeed have the capacity to reduce anaemia, but it needs to be demonstrated before it is adopted for a public health programme.”