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It was in 2016-17 when Sivaranjani Santosh, a Hyderabad-based paediatrician, first noticed that children were not getting well despite her treatment. “As a doctor when you expect improvement upon administration of ORS [Oral Rehydration Solution] but instead the condition worsens and the child has to be hospitalised, you wonder what is happening. I asked the parents to show me the ORS they were administering to their children and realised what all is being sold in the market in the name of ORS. That is when I started investigating,” she says.
Nearly eight years later, her struggle has borne fruit. On October 31, 2025, the Delhi High Court ordered that no product in India can carry the label “ORS” unless it strictly follows the formula recommended by the World Health Organization (WHO).
The court was hearing a case filed by a pharmaceutical company against an order of Food Safety and Standards Authority of India (FSSAI) directing food business operators (FBOs) to remove the word “ORS” from their products that do not follow the WHO recommended formula—13.5 g of glucose (anhydrous), 2.6 g of sodium chloride, 1.5 g of potassium chloride and 2.9 g of trisodium citrate (dihydrate). The mixture should be dissolved in a litre of drinking water and consumed orally.
This simple, inexpensive mix of sugar and salts can prevent and treat dehydration from diarrhoea—a condition that claimed lives of over 14,000 children under five years of age in the country between 2017-18 and 2021-22, as per data submitted to the Parliament in 2022. If the composition of the ORS is incorrect, it can worsen dehydration instead of treating it. “If there is too much sugar, it will worsen the diarrhoea and dehydration, the blood pressure will fall, leading to even multi-organ failure and death. There are other inappropriately formulated liquids as well, such as zero sugar or low-sugar drinks. People take them believing they will rehydrate but that does not happen,” says Santosh.
Many variants sold across pharmacies often have a much higher percentage of glucose or sugar, or miss vital electrolytes sodium and potassium. Despite this, they are marketed and sold with reassuring labels and medical imagery, misleading consumers. This blurring of lines between a simple scientifically formulated rehydration solution and a sweetened beverage is what Santosh has been fighting against.
Her first move came in 2021, when she wrote to the Central Board of Secondary Education about the harmful effects of fruit-based non-carbonated or ready-to-drink beverages sold in tetra packs, following which the board asked her to approach FSSAI. She then wrote several letters to FSSAI and to the Union health ministry. On April 8, 2022, FSSAI passed an order on such misleading advertisement and marketing of ORS-substitute products and restricted the use of term “ORS” or products similar to it on food labels or through advertisement. It advised the state food safety commissioners and Central licensing authorities to issue improvement notices to FBOs for rectification of such food labels.
But a few months later, on July 14, 2022, FSSAI relaxed its order after several FBOs challenged it through a writ petition. The regulator said that few FBOs have valid trademarks similar to the term “ORS” for the name of their products and that it is temporarily allowing these companies to manufacture such products with a disclaimer on the front of their packs that the product is not the WHO-recommended ORS formula.
Furious at companies making “business against children’s lives”, Santosh filed a public interest petition in the Telangana High Court in 2022. The case is still going on.
Santosh has also been raising awareness about the issue in social media, along with writing to different authorities. The issue found fresh momentum after the news of deaths due to contaminated cough syrups in September and October raised questions about India’s drug quality and labelling oversight. Santosh believes it brought attention to her long-running campaign and that is when her social media posts and awareness videos began circulating widely, drawing the attention of both the public and regulators.
Just days later, on October 14, FSSAI withdrew its July 14 order. The next day, it said that no product can be marketed or sold as ORS unless it follows the WHO-prescribed formula. It also directed all FBOs to remove the word from their food products, irrespective of it being trademarked or not. “Social media did the job; without it, we would not have won this battle,” says Santosh.
However, two days later, on October 17, the Delhi High Court issued an interim stay on the FSSAI order while hearing a petition by the pharmaceutical company Dr Reddy’s Laboratories Ltd, challenging the FSSAI directive restricting use of ORS label for the company’s oral rehydration solution brand Rebalanz VITORS. The company had appealed that the stock which was already in the supply chain be allowed to be sold to prevent loss to the petitioner.
On October 31, Justice Sachin Dutta of the Delhi high court refused to interfere with FSSAI October 14 and 15 orders and dismissed the petition. For Santosh, it was a moment of vindication after years of solitary struggle. But looking back at her fight, she still finds it hard to come to terms with the delay. “It is difficult to believe that something that should have happened with one letter took so long,” she says.
This article was originally published in the November 16-30, 2025 print edition of Down To Earth