FSSAI Implements Strict Rule: Only WHO-Approved Formulations Can Be Labelled as 'ORS'

Taking an important and conclusive step towards public health, the Food Safety and Standards Authority of India (FSSAI) issued a stringent order banning firms from using the name "Oral Rehydration Salts" or its acronym "ORS" on any product label unless it adheres to the exact formulation certified by the World Health Organization (WHO). This new order, which was made on Tuesday, October 14, essentially revokes earlier, more lenient rules and represents an important step towards avoiding deceptive marketing and getting consumers access to life-saving, medically effective products.

The essence of this regulatory change is the precise and science-based definition of ORS. Defined by UNICEF, ORS is a plain yet accurate solution of salt and sugar mixed in purified water, used to correct dehydration caused by severe illness such as diarrhoea and heatstroke. Its effectiveness, especially in childhood diarrhoea, is well documented. But its life-saving capacity lies in its specific formula, which contains glucose. Dr. Sivaranjani Santosh, a paediatrician who has been actively fighting against misbranded ORS brands, says glucose is the key ingredient that helps the body absorb sodium and water from the guts. Any change to this composition, like substituting glucose with other sweeteners or substances, makes the solution useless for its medical use.

The previous regulatory system, as provided by orders dated July 14, 2022, and February 2, 2024, had developed a loophole that was exploited by most beverage companies. These regulations permitted the use of "ORS" as a prefix or suffix in brand names for such products as fruit juices, non-carbonated drinks, and ready-to-drink teas, provided that they bore a disclaimer that read, "The product is not an ORS formula as recommended by the WHO." This had the effect, in practice, of causing mass consumer confusion, with people purchasing flavored beverages or electrolyte drinks thinking they were buying a medically sanctioned dehydration treatment. Not only did this deceive consumers, but it was also dangerous to health, for misuse of such products would cause salt poisoning, and their failure would mean a setback in receiving the right treatment for dehydration.

The new FSSAI directive cuts out this confusion completely. By insisting that only formulations approved by WHO can use the "ORS" name, the authority has made a very clear and non-negotiable cut. This move is the culmination of steps that started with an initial FSSAI directive in April 2022 to check false advertisements for "ORS substitutes." The recent ruling has received widespread acclaim from healthcare experts. A jubilant Dr. Santosh welcomed the decision on Instagram, saying, "No one can use ORS on their brand unless it's a WHO-recommended formula, and no one can retail it starting from today. We have won the battle."

This regulatory shift is a significant win for consumer protection and public health advocacy in India. It puts in place a guarantee that when a consumer purchases a product bearing the label "ORS," they can be certain it holds the precise, glucose-based formulation tested to save lives, thus protecting millions, particularly children, from the risks associated with ineffective treatments and deceptive commercial practices.