How a Hyderabad Paediatrician’s crusade made FSSAI crack down on ‘ORS’ drinks

THE Food Safety and Standards Authority of India (FSSAI) on October 14 issued an advisory prohibiting food and beverage companies from using the term ‘ORS’ (Oral Rehydration Solution) on any product name, label, or trademark, even as a prefix or suffix.The order comes in the wake of an eight-year hard and lonely battle fought by Dr Sivaranjani Santosh, a Hyderabad-based paediatrician. It all began when she noticed that many of her young patients were getting worse instead of improving after she prescribed ORS for diarrhoea. For decades, doctors have been prescribing the WHO-recommended ORS packets in severe cases of diarrhoea or dehydration, which is usually an after-effect, in children under 5.Hyderabad-based paediatrician Dr Sivaranjani Santosh's eight-year battle has forced the FSSAI to issue an order barring non-medical beverages from using 'ORS' on their labels.“Many of the children were getting hospitalised and had to be administered IV fluids, after initially being prescribed ORS treatment. I asked the parents to show me the ORS packet. Instead of the standard WHO-recommended white and green sachet that usually has ORS in a powder form (to be mixed with clean drinking water), it was a fruit-flavoured drink in a tetra pack called ORS-L. The label showed 120 gm sugar per litre, way higher than the WHO-recommended ORS formula which only has 13.5 gm per litre sugar,” says Dr Santosh.Based on an analysis of the National Family Health Survey-4 (2015-2016), many research articles report that childhood diarrhoea is the third most common disease responsible for under-5 mortality in India, causing 1,20,000 deaths annually (approximately 13 per 100 children), most of them preventable.ORS has been the standard low-cost and life-saving treatment for dehydration caused by diarrhoea as adopted and promoted by the WHO since 1978 after it was successfully used to treat cholera in the 1971 Bangladesh war refugee camps.The WHO-recommended ORS formula contains 2.6 gm of sodium chloride, 1.5 gm of potassium chloride, 2.9 gm of sodium citrate, and 13.5 gm of dextrose anhydrous (sugar) per litre. The extra sugar content as well as disproportion of other ingredients (as against the WHO recommended formula) in these drinks was causing acute diarrhoea instead of rehydrating the child. These were available freely in pharmacies, hospitals, schools, supermarkets and online under various names like ORSL, ORS Fit, Rebalance with ORS, etc. Unaware and misled by marketing, parents were buying these sugary drinks, which could be potentially fatal, adds Dr Santosh.Not sure whom to approach, she initially started posting on her Instagram and YouTube channel. “Finally, in 2021, I wrote to the Central Drugs Standard Control Organisation (CDSCO), under the Union Ministry of Health, along with the data and evidence. They wrote back that these were not being marketed as medicinal drinks but being sold under the ‘food and beverages’ category, and the licence was given by FSSAI,” adds the determined crusader, who then wrote to the FSSAI and finally to the Union Ministry of Health.Her efforts paid off and on April 8, 2022, FSSAI issued an order that barred these non-medical beverages from using ‘ORS’ on their labels. Her euphoria on this success barely lasted three months. On July 14, 2022, the FSSAI reversed its order, allowing companies to use ‘ORS’ with a disclaimer: ‘This product is NOT an ORS formula as recommended by WHO,’ printed on the pack in a hardly readable font, prompting many major fast-moving consumer goods (FMCG) companies, including Reliance Consumer and Hindustan Unilever, to enter the lucrative Indian ORS market, valued at approximately Rs 1,000 crore.Dismayed but undeterred, Dr Santosh filed a PIL in September last year before the Telangana High Court, including the Union Health Ministry, FSSAI and several companies like Dr Reddy’s Laboratories and Kenvue (a spin-off from Johnson & Johnson), as respondents.As her aggressive public campaign gained traction, she got some much-needed support from the Endocrine Society of India and Women Paediatricians Forum, as well as thousands of parents, journalists, health professionals and social media influencers. The massive public backing forced the FSSAI to issue its latest directive, reiterating the 2022 ban: “No drink, carbonated beverage, or food product shall carry ‘ORS’ on its label or trademark, with or without a prefix or suffix. Any such product is to be removed from sale immediately.”The war is far from over though because the Delhi High Court has put FSSAI’s latest ban on hold after a plea by Johnson & Johnson’s subsidiary, JNTL Consumer Health (an Indian subsidiary of Kenvue), to be allowed to present their case to FSSAI. This interim stay means that JNTL can continue to sell its stock of ORSL and Rebalance worth nearly Rs 200 crore until a final resolution by the court or the FSSAI.Dr Santosh, who calls it a people’s victory, has full faith in the government for a favourable outcome.Dr Arun Gupta, founder of infant care advocacy group Breastfeeding Promotion Network of India, however, is not so sure about an eventual or a timely outcome. The case can drag for years given the state of our judicial system, he says. But more than that, he lays the blame squarely on FSSAI’s lax regulatory practices. “Anyone can apply online, choose a sector and get the licence. There is no physical verification.”The problem is compounded by the lack of awareness even among doctors, says Dr Mahesh Hiranandani, a Chandigarh-based paediatrician. “I have been referred cases where the doctor had recommended a sports drink containing artificial sweeteners to a child with diarrhoea. Not only parents or common people but even doctors must read the labels before prescribing or buying any medicine or drink or food item,” he adds.All experts agree though that strict laws and their even stricter implementation can save people from commercial greed, unethical practices and apathy by the authorities.

How a Hyderabad Paediatrician’s crusade made FSSAI crack down on ‘ORS’ drinks

The recent FSSAI order says most fruit-flavoured ORS drinks have misleading labels, and do not conform to WHO standards

Renu Sud Sinha

How a Hyderabad Paediatrician’s crusade made FSSAI crack down on ‘ORS’ drinks

The recent FSSAI order says most fruit-flavoured ORS drinks have misleading labels, and do not conform to WHO standards

Renu Sud Sinha

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