In a remarkable victory for medical ethics and child safety, the FSSAI ORS ban announced in October 2025 marks the end of a long-standing public health concern in India. After an eight-year crusade led by Hyderabad-based paediatrician Dr Sivaranjani Santosh, the Food Safety and Standards Authority of India (FSSAI) prohibited the use of the term “ORS” (Oral Rehydration Salts/Solution) on food and beverage products that do not meet the World Health Organization’s (WHO) scientifically approved formulation.
This decision comes as a result of Dr Santosh’s tireless campaign against fake ORS drinks that were misleading consumers, especially parents of young children. The new ORS labeling rule prevents manufacturers from using the “ORS” tag on sugar-based beverages that fail to meet medical safety standards — a move hailed as one of the most important health regulatory actions in recent years.
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Table of Contents
Who Is Dr Sivaranjani Santosh?
Dr Sivaranjani Santosh is a practising paediatrician in Hyderabad known for her uncompromising approach to medical ethics and child welfare. For nearly a decade, she noticed a troubling pattern in her clinic — dehydrated children whose parents claimed they had given “ORS” drinks that were supposed to rehydrate them.
However, instead of recovery, many children worsened. When Dr Santosh examined the packaging of those drinks, she discovered that these products contained dangerously high levels of sugar and negligible electrolytes. Despite being labelled as “ORS,” they were essentially sweetened soft drinks, not medical rehydration solutions.
This observation led her into an eight-year-long battle with food authorities, pharmaceutical companies, and bureaucratic systems — a fight that ultimately resulted in the FSSAI ORS ban.
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The Scientific Foundation Behind the FSSAI ORS Ban
To understand why Dr Sivaranjani Santosh fought so fiercely, it’s essential to grasp what makes an ORS a medical formulation, not a beverage.
The WHO-recommended oral rehydration solution contains a precise balance of electrolytes and glucose:
- Sodium chloride: 2.6 g/L
- Potassium chloride: 1.5 g/L
- Trisodium citrate: 2.9 g/L
- Glucose (anhydrous): 13.5 g/L
Total osmolarity: about 245 mOsm/L (See PDF).
This specific ratio is critical. The sodium-glucose co-transport mechanism in the small intestine allows water absorption only when the concentration of glucose and salt is balanced. Too much sugar increases osmolarity, drawing water out of the bloodstream and into the gut — effectively worsening dehydration.
The so-called fake ORS drinks on the Indian market had sugar levels up to ten times higher than the recommended formula, while sodium and potassium levels were alarmingly low. Instead of saving lives, these products could aggravate fluid loss in children suffering from diarrhoea or vomiting. In short, a true ORS heals; a fake one can harm.
“Even if a drink says ‘not an ORS’ in small print,” said Dr Sivaranjani Santosh, “parents trust it because of the big bold ‘ORS’ label. That false trust can cost a child’s life.”
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Why sugar-rich drinks don’t qualify as ORS
Dr Sivaranjani Santosh’s campaign highlighted that numerous beverages marketed as “ORS” or “Rehydrate with ORS” carried sugar levels far beyond what such electrolyte solutions require. These “pseudo-ORS” products lacked the proper ratio of electrolytes and often had excessive sugar, which increased osmolarity.
- According to sources, some mislabeled drinks contained over 120 g sugar per litre, while the proper ORS has ~13.5 g of glucose per litre.
- Sports drinks, sodas, or sweetened “rehydration” beverages generally do not meet ORS criteria: as the Merck Manual explains, “sports drinks, sodas, juices, and similar drinks do not meet these criteria … they generally have too little sodium and too much carbohydrate … The osmotic effect of the excess carbohydrate may result in additional fluid loss.”
Thus, the ORS label ban for sugar drinks in India is rooted in reinstating the distinction between lifesaving medical ORS and marketing-oriented beverages.
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The Eight-Year Journey of Dr Sivaranjani Santosh
The journey of Dr Sivaranjani Santosh from clinic-based observations to national reform was anything but easy.
After repeated complaints to regulatory agencies, she realised that the confusion stemmed from jurisdictional overlap — these drinks were marketed not as “drugs” (governed by CDSCO) but as “food products” (under FSSAI). The food regulator had earlier permitted use of “ORS” branding as long as disclaimers were included — a loophole companies exploited.
Refusing to give up, Dr Santosh documented product compositions, consulted pharmacologists, and presented evidence to the Ministry of Health and the FSSAI. She also collaborated with professional bodies like the Women Paediatricians Forum and the Endocrine Society of India to raise awareness.
When official responses lagged, she took legal action. In 2022, she filed a Public Interest Litigation (PIL) in the Telangana High Court seeking a complete ban on such misleading beverages.
Her persistence finally paid off. On October 14, 2025, the FSSAI ORS ban was formally announced. The new directive stated that no product could use the term “ORS” or any derivative — such as “ORSL” or “Rebalance ORS” — unless it precisely matched the WHO formula.
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A Landmark in the ORS Controversy in India
The ruling reshaped the conversation around hydration products and ORS labeling rules in India. For years, many parents believed the colourful “ORS” tetra packs available in stores were safe alternatives to pharmacy-grade rehydration powders.
The FSSAI ORS ban dismantled that illusion, drawing a firm line between medical science and marketing strategy. It also underscored the responsibility of regulators to protect consumers from deceptive health claims.
“No high-sugar drink can have ORS on its label anymore,” Dr Sivaranjani Santosh told The New Indian Express. “This is not just my victory; it’s a win for every child and every parent in this country.”
Her triumph made national headlines in The Hindu, Hindustan Times, and Economic Times, with several outlets calling her “the woman who made India’s food regulator rethink hydration.”
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Why the FSSAI ORS Ban Matters
The FSSAI ORS ban goes far beyond product labels — it’s a public-health safeguard. India still records tens of thousands of child deaths annually from diarrhoea and dehydration. A correctly formulated ORS can reduce mortality by up to 93 percent, according to WHO data.
However, when parents unknowingly use fake ORS drinks, the results can be disastrous. By preventing companies from misusing medical terminology, the new ORS labeling rule ensures that only WHO-compliant formulations reach patients.
The directive also clarifies that using “ORS” in branding for non-compliant products will be treated as misleading advertising under Section 24 of the Food Safety and Standards Act, 2006 — a major precedent for truthful health labeling in India.
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The Human Side of a Scientific Revolution
For Dr Sivaranjani Santosh, this battle was never just legal or professional — it was deeply personal. She faced criticism, isolation, and pushback from powerful corporate lobbies. Some colleagues even advised her to drop the issue.
But she persisted, motivated by a simple truth: misleading health claims can kill. Her activism, rooted in scientific evidence and patient care, ultimately forced the FSSAI to confront a long-ignored regulatory gap.
Her story now stands as a model of evidence-based advocacy — a reminder that when science meets integrity, change follows.
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Lessons for Parents and Policymakers
Parents should now ensure that the ORS they purchase meets WHO standards and comes from reputable pharmacies or hospitals. True ORS is a medical product, not a flavoured drink. Sports beverages, sodas, and sweetened “energy” drinks should never be used to treat dehydration.
Policymakers, on the other hand, must continue strengthening food-label surveillance, ensuring that deceptive branding practices are penalised swiftly. The FSSAI ORS ban should serve as a blueprint for future regulation of misleading health products.
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Conclusion
The legacy of Dr Sivaranjani Santosh lies not only in the FSSAI ORS ban, but in her unwavering belief that truth in medicine must prevail over marketing. Her eight-year battle transformed India’s health-product landscape and reaffirmed the power of science-based advocacy.
Today, because of one determined doctor, millions of Indian parents can trust that when they reach for an ORS, it’s the real thing — not a sugary imitation.
“I only did what any doctor should do,” said Dr Sivaranjani Santosh. “Our first responsibility is to protect life — and sometimes, that means fighting labels.”