Blitz Bureau
NEW DELHI: The battle over the humble, life-saving sachet of Oral Rehydration Solution (ORS) is not being fought in hospital wards, but in the corridors of the Delhi High Court. It is a conflict that pits public health against corporate commerce, regulatory authority against trade stability, and the integrity of a medical term against the lure of a massive, profitable market.
For years, pediatricians and child health advocates in India have fought for a decisive line to be drawn: A ban on using the term ‘ORS’ for any food or beverage product that did not strictly adhere to the World Health Organisation (WHO) formulation. They won that fight — but only for a glorious moment.
On October 14, the Food Safety and Standards Authority of India (FSSAI) delivered a verdict long-awaited by the medical community. The regulator declared that any product — from a ready-to-drink beverage to a sachet — using the term “ORS,” even with branding prefixes like “Smart ORS” or “Hydra ORS,” would henceforth be deemed misbranded.
This directive effectively rescinded earlier, more lenient relaxations that had allowed companies to use the term under certain disclaimers. It was heralded as a “long-overdue win,” a monumental step to protect children from deceptively marketed, high-sugar drinks that often do more harm than good.
Yet, less than a week later, the entire victory was placed on hold.
In a dramatic legal twist, the Delhi High Court granted an interim stay on FSSAI’s key orders. The petition came from JNTL Consumer Health, a subsidiary of global giant Johnson & Johnson, a major player in the disputed beverage segment.
The stay allows the company to continue marketing its ORS-branded products and address an estimated inventory valued at a staggering Rs 155-180 crore. The court’s intervention was not a judgment on the health merits of the drinks, but a procedural pause, emphasising that FSSAI could not implement its directive until the company was “given adequate opportunity of hearing.”
The judiciary’s scrutiny of the regulator’s “rapid policy shift” has thrown the business of hydration into a complex legal and ethical quagmire, creating a high-stakes standoff where the bottom line clashes directly with the frontline treatment for childhood dehydration.
Misbranding a lifesaver
The core of the controversy lies in the vast, life-or-death difference between genuine ORS and its commercial impersonators.
Diarrhea remains a cruel statistic in India, responsible for around 13 per cent of deaths in children under five. The genuine ORS formula — a simple, calibrated mix of salts and sugar — is considered a frontline intervention that can reduce fatalities by over 90 per cent when used correctly.
The WHO-approved formula is an exacting standard, featuring a total osmolarity of 245 mOsm/L and a precise amount of sugar (dextrose anhydrous), specifically 13.5 grams per liter. This balance is critical: the sugar is necessary to co-transport sodium and water across the small intestine, but too much sugar is disastrous.
This is where the high-sugar commercial beverages enter the picture. Marketed with the ORS tag and often placed right next to the genuine sachets on pharmacy shelves, these drinks can contain anywhere from 110 to 120 grams of sugar per liter — nearly ten times the safe limit.
The FSSAI’s core contention was clear: Such products mislead consumers into believing they are purchasing the scientifically proven, life-saving therapy, when in fact, the dangerously high sugar content in these commercial versions can worsen diarrhea and dehydration by increasing the osmotic load in a child’s gut.
For eight years, pediatricians like Dr. Sivaranjani Santosh of Hyderabad spearheaded the fight against this misbranding. They argue that diluting the term ORS undermines a critical public health tool. The FSSAI’s October order was their moment of triumph, a powerful statement that the regulator was prioritising public safety over corporate convenience.
Corporate counter-punch
The market for these oral hydration and electrolyte drinks is colossal, and the stakes for the industry are immense.
JNTL Consumer Health’s petition was a direct challenge to the regulatory suddenness. The company argues that the October orders were “arbitrary and unreasonable,” citing that it had been permitted to use the ORS branding under previous FSSAI orders (including relaxations granted in July 2022 and February 2024).
In reliance on these earlier clearances, JNTL had manufactured large quantities of stock, accounting for the massive Rs 155-180 crore inventory now trapped in regulatory limbo.
Justice Sachin Datta’s stay, therefore, signals that the judiciary is examining not the quality of the product, but the process of the policy shift. The court’s initial decision to hold the ban until the company is granted an “adequate opportunity of hearing” means the immediate fate of the ban hinges on bureaucratic procedure and due process, not immediate medical necessity.
The stay has, predictably, created confusion and alarm.
Child health advocates are gravely concerned. Dr. Santosh reportedly criticised the interim relief, calling it a “national shame.” She warned that the stay could be an erosion of public health gains, suggesting that FSSAI has been forced to permit the “disposal of high-sugar ORS-type stock without fully protecting children.”
The message is clear: the delay allows potentially harmful products to remain in circulation and profit from a confusing brand identity, potentially leading to continued misuse by unsuspecting parents and caregivers.
The controversy in India underscores the global significance and delicate composition of Oral Rehydration Solution (ORS). Hailed by medical historians as one of the most significant medical advancements of the 20th century, ORS — and the Oral Rehydration Therapy (ORT) it anchors — is credited with saving an estimated 70 million lives globally.
The success of ORS is entirely dependent on its precise, scientifically-validated formulation. The current World Health Organisation (WHO) and Unicef standard is the Reduced Osmolarity ORS, which features a total osmolarity of 245 mOsm/L.
This critical balance of glucose (sugar) and electrolytes (sodium, potassium, chloride, and citrate) ensures maximum absorption in the small intestine, effectively reversing the fatal effects of dehydration caused by diarrheal diseases. It is a simple, low-cost, and easily administered treatment, designed to be accessible in all settings.
The Indian ORS market, which includes both the true medical sachets and the broader category of oral electrolyte / hydration drinks, is a substantial and rapidly growing segment.
The core market for genuine ORS is estimated to be around ₹1,000 crore (approximately $120-$130 million) annually. However, the total market for all ‘dehydration drinks’ — which includes the commercial, high-sugar substitutes — is a much larger segment that has more than doubled its moving annual turnover in the last four years. This aggressive growth is driven by rising temperatures, increased health and wellness awareness, and a consumer demand for flavored, convenient hydration.
The high mortality rates from diarrhea in children under five make India a critical and intensely scrutinised public health region for ORS. The regulatory fight is fundamentally about protecting the integrity of the life-saving WHO standard against commercial pressure to commodify the ORS name for high-margin, high-sugar beverages.
The outcome of the Delhi High Court case will set a precedent for how public health integrity is balanced against the massive economic interests of the hydration drink industry in one of the world’s most vulnerable markets.
Business battlefield and the big players
The regulatory action by FSSAI affects not just JNTL Consumer Health, but the entire ecosystem of food business operators (FBOs) marketing products in the multi-billion dollar hydration space.
While the FSSAI ban applies universally to any brand failing to meet the WHO medical standard, the dispute highlights how large pharmaceutical and Fast-Moving Consumer Goods (FMCG) entities operate in the ‘grey area’ of electrolyte drinks.
The global ORS market is projected to be worth between $2.5 billion and $3.6 billion in 2024 and is expected to grow to over $5 billion by 2030, with a compound annual growth rate (CAGR) projected between 6.5 per cent and 8.5 per cent. This growth is a powerful incentive for companies to seek every branding advantage.
In India, the brands implicated in the broader debate for selling products often mistaken for true ORS — due to branding, placement, or similar packaging — include major names whose products fall under the food category, not the strict drug category:
• JNTL Consumer Health (Johnson & Johnson Subsidiary): Their ORSL brand has been at the center of the legal proceedings, holding a significant share in the ready-to-drink electrolyte segment.
• Other commercial / sports drinks: The controversy extends to other popular products found on pharmacy and grocery shelves such as Gatorade (owned by PepsiCo), Enerzal, Tata Gluco Plus, 100Plus, and others.
These products are marketed as energy or hydration drinks, but their placement and branding strategies have been criticised for capitalising on the consumers’ need for a medical rehydration solution.
By using suffixes or prefixes to ‘ORS’ or by being sold alongside WHO-compliant sachets, these companies benefit from public trust in the ORS brand while delivering a high-sugar beverage unsuitable for treating severe dehydration.
The current stay allows these commercial market forces to continue, underscoring the legal battle’s impact on the competitive landscape and consumer safety.
The Path Ahead: Legal Limbo and Consumer Confusion
The current scenario is a study in regulatory and commercial deadlock.
FSSAI has been quick to clarify that the stay is a “legal procedural outcome, not a policy reversal,” reaffirming its commitment to the spirit of the ban. It has indicated that it will act once JNTL’s representation is fully considered and the matter is up for “full adjudication.” The immediate future of the ban—and the products—rests on the outcome of this hearing process.
For consumers, the stay translates directly into confusion. A parent seeking a life-saving solution for a sick child is faced with a baffling array of choices: a sachet carrying the WHO logo, or a colorful, palatable bottle with an “ORS” suffix on the label. The immediate need is for a clear distinction: how does one distinguish a genuine, WHO-formulated ORS from a sugar-rich ‘hydration’ drink?
The regulatory limbo has also ensnared retailers and distributors. While some continue sales under the court’s permission, others are pulling stock, fearing future liability should the stay be lifted and the ban enforced.
Consumer-safety experts and pediatricians are united in their advice: Until the regulatory matter is resolved, parents and caregivers must rely only on WHO-approved ORS sachets. These products, which clearly state their electrolyte content and suitability for therapeutic use, are the only proven intervention. Consumers must deliberately avoid relying on beverages that simply carry the ORS name, regardless of where they are sold.
The Delhi High Court’s stay has merely paused the conflict. The business of ORS in India is now a courtroom drama where the final verdict will not just decide the fate of crores of rupees worth of inventory, but will ultimately determine whether a critical, life-saving medical term can be diluted and exploited for commercial gain—a question that has the deepest implications for public health and the lives of millions of vulnerable children. The Salt and Sugar War is far from over.