Current Affairs
FSSAI Bans Misleading ORS Labels: Delhi High Court Stay Sparks Public Health Debate
Delhi High Court granted JNTL Consumer Health interim relief, allowing the company to sell its existing stock of ORSL despite the FSSAI ban on using the term “ORS” for products not meeting WHO standards.
After eight years of advocacy, Dr. Sivaranjani Santosh witnessed what she called a people’s victory on October 14, 2025. The Food Safety and Standards Authority of India (FSSAI) issued an order banning all beverages from using the term ORS in their trademarked names unless they adhered to World Health Organization (WHO) standards.
However, the Delhi High Court granted interim relief to JNTL Consumer Health (India), a Johnson & Johnson subsidiary, staying the FSSAI ban on 17th October, 2025. The stay allowed the company to continue selling existing stock valued between ₹155 crore and ₹180 crore.
ORS Formulation: Why It Cannot Be Compromised
The Oral Rehydration Solution (ORS) is a medical product developed by Dr. Dilip Mahalanabis during the Bangladesh Liberation War in 1971. It has saved millions of lives during the war by reducing mortality rates from 30% to 1% during a cholera epidemic in refugee camps.
The WHO approved formulation contains sodium chloride, glucose anhydrous, potassium chloride, and trisodium citrate dihydrate in 1 liter of water. This composition works through the sodium glucose co transport system.
The glucose to salt ratio is non-negotiable, facilitating sodium absorption and rehydrating the body during severe diarrhea. However, excess sugar content can alter the solution’s effectiveness, causing water to be drawn out of cells and worsening diarrhea instead of treating dehydration.
Fake ORS Products in Indian Markets
The regulatory crisis arose when commercial beverages with ORS brand names appeared on pharmacy shelves. These products contain sugar levels up to ten times higher than the WHO formula. While genuine oral rehydration solutions contain 13.5 grams of glucose per liter, some commercial variants contain 110 to 120 grams of sugar per liter.
In India, diarrhea accounts for 13% of deaths in children under five years and only 60% receive proper ORS treatment. Dr. Santosh documented cases over eight years, including a diabetic child from Chennai who was dehydrated despite being given an ORS drink from a tetra pack to highlight the health crisis caused by misleading labels.
FSSAI Ban: Decisive Regulatory Action
On October 14, 2025, FSSAI executed what medical professionals hailed as a much needed correction. The authority clarified that using ORS, even with prefixes or suffixes in trademarked names, constitutes a violation of the Food Safety and Standards Act, 2006, unless the product complies with WHO formulation. The order withdrew all earlier permissions from July 2022 and February 2024.
The FSSAI stated that the use of the term ORS in the trademarked name or in the naming of any food product, whether fruit based, non-carbonated, or ready-to-drink beverages, even when accompanied by a prefix or suffix, constitutes a violation. The regulator directed all food business operators to cease using the term and remove it from products.
The ban represented recognition that some medical standards are too critical to be diluted by commercial interests and that consumer protection cannot be managed through disclaimers alone. The order came into effect, prohibiting manufacture, sale, and distribution of non compliant products.
Judicial Intervention by High Court over FSSAI Bans
On October 17, 2025, Delhi High Court granted interim relief to JNTL Consumer Health. The court stayed the FSSAI orders against the company, directing the regulator to provide formal hearing and decide on the company’s representation before enforcing the ban. The court permitted JNTL to continue selling existing stock while mandating that production of new variants must remain halted.
The court observed that until FSSAI decides on the company’s representation after affording hearing opportunity, the orders would not be implemented. This stay suspended the ban for JNTL Consumer Health, though the regulator’s prohibition remained in force for other manufacturers.
The Delhi High Court’s order triggered criticism from medical professionals and public health advocates. Dr. Santosh urged consumers to boycott such products to safeguard their children’s lives.
Critics argued that allowing sale of ₹155 crore to ₹180 crore worth of non-compliant products prolonged consumer confusion and persisted health risks for children. The stay meant misleading ORS branded products would continue appearing on pharmacy shelves, the scenario the FSSAI ban sought to eliminate.
Public Health Concerns and Systemic Loopholes
On October 23, 2025, FSSAI issued clarification addressing social media confusion, stating that it is being wrongly claimed in some social media posts that FSSAI has permitted the disposal or sale of Oral Rehydration Solution with Lactate (ORSL). The authority reiterated no such permission was granted and the ban remained in effect, subject to judicial proceedings.
However, consumers and health activists reported ORSL and similar beverages continued being sold in retail pharmacies across cities.
The case highlighted the absence of large scale public awareness campaigns informing consumers about differences between genuine WHO compliant oral rehydration solutions and commercial high sugar beverages. Years of misleading marketing and labelling have created consumer confusion, requiring educational intervention.
Conclusion
The October 2025 legal proceedings, involving the FSSAI’s ban and the Delhi High Court’s interim stay, highlight the challenges and complexities inherent in healthcare product regulation. ORS stands as testament to how evidence based medicine can save millions of lives. Its WHO formulation cannot be diluted based on trademark law or marketing convenience without compromising therapeutic effectiveness and endangering lives.
For now, parents must remain vigilant, seeking only WHO compliant oral rehydration solution products. In a country where diarrhea remains the third leading cause of under five mortality, ensuring access to genuine oral rehydration therapy is not a regulatory technicality. It is about protecting children’s lives.
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FSSAI ORS Label Ban FAQs
1. What is the WHO-approved ORS formulation?
Ans. The WHO approved formulation contains sodium chloride, glucose anhydrous, potassium chloride, and trisodium citrate dihydrate in 1 liter of water.
2. Why are fake ORS products dangerous for children?
Ans. Excess sugar worsens dehydration instead of treating it.
3. Who invented the oral rehydration solution ORS?
Ans. Dr. Dilip Mahalanabis.
4. What percentage of under-five deaths in India are caused by diarrhea?
Ans. 13% of deaths.
5. How effective was ORS in treating cholera during the Bangladeshi Liberation War?
Ans. Reduces mortality rates from 30% to 1% among children.
