Public Health vs Profit: Delhi High Court’s Stay on “ORS” Ban Sparks Debate

The Delhi High Court’s interim stay on the Food Safety and Standards Authority of India’s (FSSAI) recent ban on the use of the term “ORS” in beverage branding has reopened a debate at the intersection of public health, corporate power, and regulatory consistency. The order, issued on October 17, granted relief to JNTL Consumer Health (India), a subsidiary of Kenvue (a Johnson & Johnson spin-off), but has raised fresh alarm among doctors and public health experts.

Justice Sachin Datta, while granting the interim relief, allowed the company to continue selling its existing stock, valued between Rs.155 crore and Rs.180 crore, and directed the FSSAI to hear the company’s representation before enforcing its ban. The petition, filed on October 16, had challenged the FSSAI’s orders of October 14 and 15 as arbitrary and unreasonable, alleging that they were issued in haste and had abruptly withdrawn earlier permissions.

The court observed that until FSSAI decides on the company’s representation after affording an opportunity of hearing, the impugned orders would not be implemented. For now, the regulator’s prohibition on the use of “ORS” in product trademarks has been stayed. The stay has rekindled a concern: medical terminology can be co-opted and diluted in the marketplace.

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The FSSAI’s October 14 order had withdrawn all previous directions permitting companies to use “ORS” with prefixes or suffixes in beverage trademarks with immediate effect. A clarification issued the next day reiterated that any such usage—whether for fruit-based, non-carbonated, or ready-to-drink beverages—constitutes a violation of the Food Safety and Standards Act, 2006. The regulator called such practices misleading to consumers by way of false, deceptive, ambiguous, and erroneous names, and directed all food business operators to remove the term from their products.

This marked another turn in a regulatory tug-of-war that has persisted for over three years. In July 2022, FSSAI had allowed companies with registered trademarks containing “ORS” to continue manufacturing such products, provided a front-of-pack disclaimer was displayed. A February 2024 clarification went further, permitting the use of the term with prefixes or suffixes. The recent orders reversed that position—prompting JNTL to argue that the move ignored longstanding trademark rights and disrupted supply chains, causing significant commercial loss.

Misleading marketing

Among those who have cautioned against misleading marketing is Dr. Sivaranjani Santosh, a Hyderabad-based paediatrician whose persistent campaigning has been instrumental in drawing regulatory attention to the issue. Over the past eight years, she has documented cases of children arriving at her clinic severely dehydrated despite being administered what parents believed to be Oral Rehydration Solution (ORS). The fluids were, in fact, commercial beverages such as ORSL (by JNTL), Rebalanz, VitORS, ORSfit, and Glucon-D Active ORS, all marketed by pharmaceutical and consumer health companies.

In 2021, Dr. Santosh wrote to the Central Drugs Standard Control Organisation, the FSSAI, and the Union Ministry of Health. While the FSSAI initially prohibited the use of “ORS” labels in April 2022, it reversed the decision three months later, prompting her to file a public interest litigation in 2023.

ORS is a precise medical formulation used to prevent and treat dehydration caused by diarrhoea and other illnesses. The WHO specifies its composition as 2.6 grams of sodium chloride, 1.5 grams of potassium chloride, 2.9 grams of trisodium citrate dihydrate, and 13.5 grams of anhydrous glucose per litre of water. By contrast, some commercially sold “ORS-like” beverages contain up to 120 grams of sugar per litre—nearly ten times the recommended level—and dangerously low electrolyte concentrations. Such formulations can worsen dehydration, particularly in children.

The stakes are high in India. According to NFHS-5 data, only around 60 per cent of children suffering from diarrhoea receive proper ORS treatment. Diarrhoea remains the third leading cause of under-five mortality, accounting for roughly 13 per cent of deaths in that age group. Public health experts warn that the proliferation of misleadingly branded “ORS” drinks not only delays effective treatment but also undermines decades of public health messaging around Oral Rehydration Therapy, which has been shown to reduce mortality by up to 93 per cent.

The High Court’s interim order allows JNTL to sell its existing stock until the FSSAI decides on its representation, but the production of new variants remains suspended. In a video statement after the order, Dr. Santosh urged consumers to boycott such products, saying, “Don’t let them sell a single extra pack at the cost of children’s lives.”

Commercialisation of health

The FSSAI issued a statement on October 23 clarifying that “it is being wrongly claimed in some social media posts that FSSAI has permitted the disposal or sale of ORSL,” reiterating that no such permission had been granted. The case brings into focus the gap between regulatory orders and on-ground enforcement. Despite the FSSAI’s clarification, several users on social media reported that ORSL and other similar beverages continued to be sold in the market. The development also comes weeks after the deaths of at least 20 children in Madhya Pradesh linked to contaminated cough syrup, raising concerns about monitoring and compliance in food and drug safety.

Amulya Nidhi, national convenor of Jan Swasthya Abhiyan India (JSAI), told Frontline that the issue went beyond one product or company. “The misleading use of medical terms like ORS in sugary drinks is not an isolated case,” he said, pointing out that similar marketing practices exist in several dietary and nutritional products. “This is not about public health—it is about the commercialisation of health products. Patient welfare should come before profit.”

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He described the situation as a regulatory failure, questioning why such products were allowed in the market for years despite their formulations not matching WHO standards. “It’s an offence and a form of cheating the public,” he said. “Even now, there has been no large-scale awareness campaign to inform people that these are not medically approved ORS solutions.”

On the Delhi High Court stay order, he said it reflected how commercial interests often outweigh public health concerns. “If a company says it will lose Rs.180 crore, is that more important than the health of citizens?” he asked. “This shows the influence of the pharma lobby and the weakness of our regulatory systems.”