In a major regulatory move aimed at protecting consumers, the Food Safety and Standards Authority of India (FSSAI) has prohibited the use of the term “ORS” (Oral Rehydration Solution) on all food and beverage labels, including within brand names or trademarks. The decision comes amid rising concerns over the misleading marketing of products that falsely imply medical or therapeutic properties associated with WHO-recommended ORS formulations.
In its latest directive, FSSAI stated that the use of “ORS” on labels or packaging of drinks and beverages—whether standalone or combined with prefixes, suffixes, or trademarks—violates provisions of the Food Safety and Standards Act, 2006, as such usage can deceive consumers. The regulator termed these practices “false, deceptive, ambiguous, and misleading,” and directed all food business operators to remove the term from their products with immediate effect.
The order withdraws two previous relaxations issued in July 2022 and February 2024, which had allowed companies to use “ORS” in their brand names provided they displayed a clear declaration stating, “NOT an ORS formula as recommended by WHO.” These concessions have now been revoked entirely, signaling a stricter stance against misleading health-related branding.
FSSAI further clarified that the use of “ORS” will not be permitted under any circumstances in the naming or labelling of fruit-based beverages, non-carbonated drinks, or ready-to-drink products. The authority instructed companies to ensure strict compliance with all labelling and advertising norms under the Food Safety and Standards Act.
Background of the Decision
The regulatory tightening follows a Public Interest Litigation (PIL) filed in the Telangana High Court in 2022 by Hyderabad-based pediatrician Dr. Sivaranjani Santosh, who challenged the sale of drinks marketed as “ORS” that failed to meet World Health Organization (WHO) standards. Dr. Santosh has been advocating this cause for nearly eight years, writing to health authorities, including then Health Minister J.P. Nadda and the Prime Minister, to draw attention to the misuse of the term.
According to the WHO, an Oral Rehydration Solution must contain precise concentrations of sodium, potassium, chloride, citrate, and glucose to effectively treat dehydration caused by diarrhoea. However, several tetra-pack and bottled beverages marketed as ORS or electrolyte drinks were found lacking these prescribed compositions, misleading consumers into believing they were medically equivalent.
Industry Reaction
Following the announcement, Cipla Health, manufacturer of Prolyte ORS, welcomed FSSAI’s move. A company spokesperson told CNBC-TV18 that its Prolyte ORS strictly adheres to the WHO’s recommended formulation.
“At Cipla Health, we are championing everyday wellness solutions by bringing exactly what our consumers need. Our leading brand, Prolyte ORS, is a WHO-recommended Oral Rehydration Solution that provides rehydration without compromising on taste through 10 unique flavours,” the spokesperson said.
The company added that as the second-largest player in the ORS category, it supports the regulator’s guidelines, which would bring greater transparency and ensure safe and effective rehydration formulations in the market.
Strengthening Earlier Measures
FSSAI had earlier, in April 2022, issued warnings against misleading advertisements and marketing of so-called “ORS substitutes.” The latest directive now strengthens those measures, completely banning the use of “ORS” on any food or beverage product that does not comply with WHO-recommended formulations.
The move is expected to eliminate consumer confusion, ensure scientific accuracy in product labelling, and reinforce public trust in health-related beverages sold across India.