Delhi High Court Mandates WHO Formula for 'ORS' Labeling, Upholds Food Safety Standards

Doctor's Fight Secures Accurate 'ORS' Labeling: Delhi High Court Mandates WHO Standards

A paediatrician's nearly eight-year struggle against misleadingly labeled Oral Rehydration Solution (ORS) products has culminated in a significant ruling by the Delhi High Court. On October 31, 2025, the court upheld orders from the Food Safety and Standards Authority of India (FSSAI) mandating that only products strictly following the World Health Organization's (WHO) recommended formula can use the "ORS" label.

Background: The paediatrician, Sivaranjani Santosh, observed children worsening despite ORS treatment, leading her to investigate market products. She discovered many variants deviated from the WHO's precise formula of glucose, sodium chloride, potassium chloride, and trisodium citrate, often containing excessive sugar or missing vital electrolytes. Incorrect compositions can exacerbate dehydration, leading to severe health consequences, including death.

Regulatory Journey: Santosh's advocacy led to an FSSAI order in April 2022 restricting the use of "ORS" on non-compliant products. However, FSSAI temporarily relaxed this order in July 2022 after industry challenges, allowing products with disclaimers. This relaxation was revoked on October 14, 2022, following renewed regulatory focus, partly influenced by concerns over drug quality following the contaminated cough syrup incidents. FSSAI then reiterated that no product could be marketed as ORS unless it met the WHO formula.

Legal Challenge and Outcome: Dr. Reddy's Laboratories Ltd. challenged the FSSAI directive with a petition in the Delhi High Court, seeking to sell its product Rebalanz VITORS. On October 31, 2025, Justice Sachin Dutta dismissed the petition, refusing to interfere with the FSSAI orders. This decision validates the stance that "ORS" is a medical necessity defined by a specific scientific formula and not merely a brand name or generic term for a beverage.

Impact: This ruling reinforces stricter labeling regulations for pharmaceutical and food products, particularly those related to public health. Companies must ensure their products strictly adhere to WHO-recommended formulas to use specific health claims or designations like "ORS." It may lead to product reformulations, rebranding efforts, or market exits for non-compliant products. Consumer awareness about accurate rehydration solutions is expected to rise.

Impact Rating: 7/10

Difficult Terms:

• Oral Rehydration Solution (ORS): A simple, inexpensive mixture of sugar and salts that helps prevent and treat dehydration, especially from diarrhoea, by replenishing fluids and electrolytes lost from the body.
• World Health Organization (WHO): A specialized agency of the United Nations responsible for international public health.
• Food Safety and Standards Authority of India (FSSAI): A statutory body established under the Food Safety and Standards Act, 2006, responsible for protecting and promoting public health through the regulation and supervision of food safety.
• Food Business Operators (FBOs): Any undertaking involved in any stage of production, processing, packaging, storage, transportation, distribution, or sale of food.
• Dehydration: A condition caused by losing more body fluid than you take in, leading to a lack of sufficient fluid in the body.
• Electrolytes: Minerals in your body that have an electric charge, such as sodium, potassium, and chloride. They are essential for maintaining fluid balance, nerve function, and muscle contraction.
• Public Interest Petition: A legal petition filed in court in a representative capacity to protect public interest, often concerning issues of public importance, environmental protection, or human rights.