The Delhi High Court has granted a stay on the FSSAI order that banned usage of the term ‘Oral Rehydration Salt (ORS)’ on food and beverage product packs unless these meet the medical-grade norms. With ORS products classified as a drug, Ravi Udaya Bhaskar explains how deceptive branding can harm consumers
What exactly is ORS?
Oral Rehydration Solution or ORS is a scientifically formulated fluid replacement drink used to treat and prevent dehydration caused by diarrhea, vomiting, or excessive heat. It consists of a balanced mixture of water, salt, and sugar that helps replenish the body’s lost fluids and electrolytes.
ORS is considered safe for all age groups, including pregnant women and the elderly. However, individuals with kidney disorders or those on a low-sodium diet should consult a doctor before use. The World Health Organisation (WHO) recommends ORS as a simple, effective, and lifesaving measure to prevent dehydration.
This solution has saved millions of children worldwide from diarrhea-related deaths. Each sachet of 21.80 gram (gm) of ORS IP contains 2.6 gm Sodium Chloride IP, 1.5 gm Potassium Chloride IP, 2.9 gm Sodium Citrate IP and 13.5 gm Glucose Anhydrous IP. The contents are to be dissolved in 1 litre of water.
If commercial ORS is unavailable, a homemade solution can be prepared by adding six teaspoons of sugar and half a teaspoon of salt to 1 litre of clean potable water and mixing well. The dosage varies by age.
WHO-approved ORS vs branded beverages
The WHO approved formula of ORS is approved by the Drugs Control Department. Under the Drugs and Cosmetics Act, 1940, and Rules, 1945, ORS is classified as a drug. Manufacturers must obtain a license from the State Drugs Control Authority to produce and sell ORS.
They must also comply with good manufacturing practices (GMP) as prescribed under Schedule M of the Act. Retailers are required to have a valid sale licence to distribute ORS products legally. WHO-approved ORS packets licensed by the Drugs Control Department are available at medical stores and health centres.
In contrast, the products in the centre of the current controversy, branded as “ORS,” contain high levels of sugar and do not follow the WHO formula. According to pediatricians, such products can increase loose motions and worsen dehydration.
The ORS brand controversy
Some manufacturers have been branding their beverages as ‘ORS’, misleading consumers into believing that these drinks are genuine ORS. In reality, they do not follow the WHO-approved formula. The issue was first identified by Dr Sivaranjani Santhosh, a pediatrician from Hyderabad. In 2021, she requested the Central Drugs Standard Control Organisation (CDSCO) to order the firms to remove the term from such products.
The CDSCO clarified that these products were not licensed by it and told her to approach the Food Safety and Standards Authority of India (FSSAI), which had licensed them. An FSSAI order dated April 8, 2022, banned food and beverage brands from using the term ‘ORS’ unless their formulations met WHO standards. It stated that using ‘ORS’ for fruit juices, energy drinks, or electrolyte beverages was false and misleading.
A second FSSAI order on July 14, 2022 allowed such products to carry the label only with a disclaimer: “The product is not an ORS formula as recommended by WHO.” The disclaimer had to be prominently displayed on the pack.
FSSAI ban on misuse of the ORS label
WHILE THE PUBLIC Interest Litigation filed by Dr. Sivaranjani is pending before the High Court of Telangana, the FSSAI issued an order on October 14, 2025 withdrawing all its previous directives on this matter. It instructed food and beverage companies to stop using the term ‘Oral Rehydration Salt’ or ‘ORS’ unless their formulations strictly matched the WHO-recommended standards.
The FSSAI order also revoked earlier permissions that had allowed the use of ‘ORS’ with a disclaimer. It stated that non-compliant manufacturers will be punishable under the Food Safety and Standards Act, 2006. The directive aims to protect consumers from misleading labelling practices and follows a long-standing campaign led by Dr Sivaranjani, who has consistently advocated for stricter regulation of ORS labelling to prevent consumers being misled into believing that such drinks adhered to the WHO-approved formula for ORS.
Stay by Delhi HC on FSSAI ban
Unfortunately, the Delhi High Court has granted an interim stay on the FSSAI order, in response to a petition filed by JNTL Consumer Health, a Johnson & Johnson subsidiary which sells the energy drink ORSL. The stay allows the company to continue selling its existing stocks of ORS-branded products valued between Rs 155 crore and Rs 180 crore. The decision has disappointed public health activists, civil society groups, and doctors like Dr Sivaranjani, who continues to advocate for stricter enforcement of labelling standards to safeguard consumers, particularly children.
The writer is director general, All India Drugs Control Officers Confederation, and former director general, Pharmexcil
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