The Delhi High Court has dismissed a petition filed by Dr. Reddy’s Laboratories Ltd challenging the Food Safety and Standards Authority of India’s (FSSAI) directive prohibiting the use of “ORS” (Oral Rehydration Salts) labelling on fruit-based, non-carbonated, or ready-to-drink beverages. The court upheld the FSSAI’s move as a justified regulatory measure rooted in serious public health considerations.

Justice Sachin Datta, delivering the order on October 31, refused to interfere with the FSSAI’s circulars dated October 14 and 15, which withdrew prior permissions allowing food and beverage companies to use the term “ORS” on their products unless those products conformed to the standard medical formulation prescribed for oral rehydration solutions. The judge observed that the FSSAI’s actions were taken “in the larger interest of public health” and that the court would not sit in appeal over decisions made by an expert regulatory body acting within its mandate.

“In the circumstances, this court is not inclined to interdict with the impugned orders, in light of the aforesaid order dated October 30, 2025, passed by the FSSAI,” the court stated. “This is particularly in light of the deleterious effect and adverse health outcomes in the event of consumption of the offending products by those who are in medical need of an ORS formulation.”

FSSAI’s Crackdown on Misleading Branding

The FSSAI’s October 14 order marked a significant tightening of regulatory oversight in the food and beverage industry. The regulator withdrew all existing approvals for using “ORS” in product names, branding, or labelling unless the products strictly adhered to the medical composition standards for Oral Rehydration Solutions as defined under the Food Safety and Standards Act, 2006.

The decision came after concerns were raised that several companies were marketing sugary or fruit-based electrolyte beverages using the term “ORS,” misleading consumers into believing these drinks had the same therapeutic benefits as medically approved oral rehydration formulations. Health experts had warned that such products could pose risks to individuals — especially children, elderly people, and patients suffering from dehydration — who might consume them believing they were genuine medical solutions.

The FSSAI underscored that “ORS” is a globally recognized term associated with a precise medical formulation endorsed by the World Health Organization (WHO) for treating dehydration caused by diarrhea, heat, or illness. The regulator said that allowing its use on non-medical beverages not only violated labeling standards but also risked confusing consumers and undermining public trust in genuine ORS formulations.

Court Backs FSSAI’s Public Health Justification

Justice Datta emphasized that the court saw no reason to question the regulator’s judgment on matters of health and safety. “The measures taken by the FSSAI are impelled by serious public health considerations and are regulatory measures applicable across the food industry,” the court observed. It added that the FSSAI’s decision was within its statutory powers and consistent with its mandate to protect consumers from misleading food products.

The order noted that the FSSAI’s actions were aimed at preventing potential harm to vulnerable consumers who might depend on authentic oral rehydration solutions in medical emergencies. “The court does not find it apposite to sit in appeal over a measure taken by the FSSAI on public health considerations,” the bench said.

Dr. Reddy’s Plea and the Court’s Response

Dr. Reddy’s Laboratories had approached the High Court after the FSSAI restricted its use of the label “ORS” for its product line “Rebalanz VITORS,” which the company marketed as an oral rehydration solution. The pharmaceutical company argued that the ban would cause it significant commercial losses, particularly as stocks of the beverage were already in distribution.

During the proceedings, counsel for Dr. Reddy’s informed the court that the company had already ceased manufacturing fresh batches of the product and was willing to re-label or re-brand its existing inventory. The company also requested permission to sell the remaining stock already present in the supply chain to avoid financial loss.

The FSSAI’s counsel, however, opposed this request, stating that allowing such sales would defeat the purpose of the ban and continue to expose consumers to potentially misleading products. The regulator maintained that it was essential to ensure immediate compliance to protect public health.

The court, while dismissing the petition, declined to grant any relief allowing the sale of existing stock. It did, however, provide a limited window for the company to seek reconsideration directly from the FSSAI. “Accordingly, the present petition is dismissed, while granting liberty to make such a representation to the FSSAI, which shall be duly considered and disposed of by FSSAI by way of a reasoned order, after affording an opportunity of hearing to the petitioner, within a period of one week of receipt thereof,” the order stated.

Regulatory Context and Industry Implications

The FSSAI’s ban is part of a wider campaign to tighten regulation of food and beverage labeling in India, particularly in areas where marketing claims could mislead consumers regarding the nutritional or medical properties of products. The regulator’s stance aligns with its broader mission to ensure that products marketed for health or hydration benefits are scientifically substantiated and safe for consumption.

In this case, the FSSAI determined that fruit-based or electrolyte beverages marketed as “ORS” did not conform to the required balance of glucose and electrolytes prescribed under the WHO’s formulation for oral rehydration therapy. Instead, such drinks often contain excessive sugar or flavoring agents that can actually worsen dehydration in clinical situations.

Public health experts have backed the regulator’s position, warning that misbranding could have dangerous consequences, especially in rural or low-income areas where access to medical-grade ORS packets is limited. “When someone suffering from diarrhea or dehydration consumes a beverage believing it to be ORS, they may not get the required treatment, and this can be life-threatening,” a health official had earlier noted in discussions surrounding the ban.

Broader Legal and Commercial Impact

The court’s decision is likely to have far-reaching implications for India’s food and beverage industry, particularly for companies that have relied on medical terminology or therapeutic associations in their branding strategies. The ruling reinforces the FSSAI’s authority to act swiftly in the public interest and signals judicial support for robust regulatory interventions in the health and nutrition sectors.

For Dr. Reddy’s Laboratories, the decision marks a setback, though the court’s provision allowing a representation to the FSSAI offers a potential path for negotiation regarding existing inventory. More broadly, the judgment serves as a precedent affirming that consumer health takes precedence over commercial interests in cases involving potentially misleading food products.

In conclusion, the Delhi High Court’s dismissal of Dr. Reddy’s plea underscores the judiciary’s trust in regulatory expertise and its deference to FSSAI’s decisions made in the interest of public safety. The ruling reinforces a clear message: branding practices that blur the line between food products and medical formulations will not be tolerated — particularly when they risk endangering public health.