Delhi HC Stays FSSAI’s ORS Ban; Dr Sivaranjani’s 8-Year Fight Sparks Debate on Misuse of Medical Labels
In a significant development, the Delhi High Court has issued an interim stay against the Food Safety and Standards Authority of India’s (FSSAI) notification on limiting misuse of the “ORS” label.
Aadrika Tayal 
New Delhi (India) October 24: On October 14, the FSSAI had ordered that any food or beverage product which is not in compliance with those prescribed by the World Health Organization cannot carry the label “ORS” (Oral Rehydration Salts). The order contradicted previous relaxations that had allowed companies to use the label with a disclaimer if products contained less sugar than they used to advertise.
But the Delhi High Court stayed that directive, and JNTL was given a week to make its representation. The company said in its petition that the extent of business impact was very high, with the value of unsolid stock estimated to be somewhere between ₹ 155 crore and ₹ 180 crore. Justice Sachin said the FSSAI cannot enforce a ban until the company was given an adequate opportunity of hearing.
Doctor’s Battle
Dr Sivaranjani Santosh fought for it single-handedly, against the corporate behemoths, for eight hopeless years. She said that Oral Rehydration Solution (ORS) packaging is reserved for medical grade rehydration mixes approved by the WHO, and not sweetened electrolyte drinks in medicine costumes.
Her persistence did pay off in the end. And finally on October 15, the FSSAI woke up and declared a belated ban on spurious ORS products.
She asked why Indian authorities permitted JNTL, the Indian arm of Kenvue (a spin-off company of Johnson & Johnson) to be permitted to sell its stocks of the sweetened drink ORSL after the October 14 advisory banning non-medical drinks from using “ORS" on their label.
Dr Santosh urged the government to ensure in future only WHO-recommended ORS formulation is made available in pharmacies, hospitals, schools and online.
Health First
Founded as an awareness drive, it was only in 2021 that Dr Sivaranjani wrote to the Central Drugs Standard Control Organisation (CDSCO), and subsequently FSSAI and Ministry of Health. The FSSAI banned the ORS label in April 2022, but was made to reverse the order in July 2023, permitting companies to use the label with a disclaimer. It was misleading, since most people don’t read disclaimers.
Public Concern
Last year, she filed a public interest litigation (PIL) and kept up the issue on social media, with support from the Women Paediatricians Forum.
After fighting for eight years to see that her patients had access to better healthcare, Dr Sivaranjani emerged victorious. The Food Safety and Standards Authority of India (FSSAI) has set a precedent today by banning the use of the term‘ORS’ on any drink that does not comply with what WHO dictates as its strict medical recipe, preventing misuse of an important healthcare label.
What is ORS?
ORS is the acronym for Oral Rehydration Solution, which is also known as Oral Rehydration Therapy (ORT). It is a form of fluid replacement with the addition of sugar and salts, sodium and potassium in it used for preventing dehydration caused by certain diseases (diarrhoea). The risk of death due to diarrhoea can be reduced by as much as 93% by the use of oral rehydration therapy. The WHO recommendations a particular amount of each ingredient, to help make sure that the highest-quality ORS gets to people.
