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In a decisive move aimed at safeguarding public health and consumer trust, the Food Safety and Standards Authority of India (FSSAI) has ordered all food business operators to stop using the term ‘ORS’ (Oral Rehydration Solution) on the labels and advertisements of energy drinks and other products. The directive, issued on October 14, comes after an eight-year relentless campaign led by Hyderabad-based paediatrician Sivaranjani Santosh, who raised alarm over the misleading use of the term ‘ORS’ by private companies. Her fight has forced a regulatory correction that is expected to reduce deceptive food labelling and protect millions from preventable health risks associated with consuming misleading products marketed as medical solutions.

FSSAI withdraws previous relaxations and tightens rules on ORS labelling

The FSSAI’s latest directive is a significant reversal of earlier decisions from July 2022 and February 2024, which had allowed companies to use the term ‘ORS’ on their labels as long as they included a disclaimer stating that the product was not an ORS formula recommended by World Health Organization. After a comprehensive review, the regulator concluded that such allowances had failed to protect consumers and continued to mislead them through “false, deceptive, ambiguous and erroneous names or label declarations.”

The new order explicitly bans the use of the term ‘ORS’ on any food product, whether it appears as a standalone word, combined with a prefix or suffix, or embedded within a trademark or brand name. It also clarifies that any such use will now be considered a violation of the Food Safety and Standards Act, 2006 and treated as misbranding, attracting legal action and penalties. The regulator emphasised that using the ORS tag for sugary drinks and energy products not only misleads consumers but poses serious health risks, particularly for children and vulnerable groups.

“All food business operators are directed to remove the word ‘ORS’ from their food products, whether used as a standalone term or in combination with any prefix or suffix or as part of the trademark with prefix or suffix in the product name, and to ensure strict compliance with the labelling and advertisement requirements prescribed under the Food Safety and Standards Act, 2006,” the FSSAI order stated.

The regulator has also instructed commissioners of food safety across states and Union Territories, along with central licensing authorities, to enforce this directive strictly. The earlier direction issued under Section 6(5) of the Act regarding misleading advertising and marketing of ORS substitute products, dated April 8, 2022, remains in force, giving the order additional legal strength. By issuing this directive, the regulator has closed a loophole that allowed companies to sell sugar-laden energy drinks using a medically trusted term that consumers associated with lifesaving treatment for dehydration.

This move is particularly important in a country where diarrhoeal diseases remain a leading cause of death among children under five. Real ORS solutions, developed with precise concentrations of glucose and electrolytes, have long been considered a medical breakthrough that saves lives during dehydration. Misusing the term to market high-sugar beverages not only exploits public trust but can worsen dehydration and diarrhoea, posing dangerous risks to vulnerable populations.

Dr Sivaranjani Santosh’s unwavering fight for consumer protection

Behind this landmark regulatory decision lies the story of one doctor’s sustained fight against powerful commercial interests. Dr Sivaranjani Santosh, a paediatrician from Hyderabad, first noticed how private companies were using the ORS label on sweetened beverages being sold in pharmacies, hospitals, and even schools. These products were not medically approved oral rehydration solutions but were being marketed with similar branding, creating confusion among consumers who believed they were purchasing therapeutic solutions.

Dr Santosh began raising awareness about the issue more than eight years ago. She warned that falsely branded energy drinks were being purchased by patients, including children suffering from diarrhoeal dehydration, leading to worsening symptoms. Real ORS, she explained, is one of the greatest medical interventions of the 20th century — a simple but effective formula that saves lives by restoring fluids and electrolytes. Using the same label on sugary drinks, she argued, was not just deceptive but dangerous.

Speaking with Asian News International (ANI), Dr Santosh described the FSSAI’s directive as a “huge relief” and a long-awaited victory. “This means now I know that no child will die, no adult will die because of worsening of diarrhoea because of these drinks. ORS is supposed to save lives. It’s supposed to rehydrate us. It is like Amrut for us. And here, people have labelled their high sugar drinks as ORS with a suffix or prefix. For the past 14 years, they have been cheating the public through deceptive labelling and unethical marketing,” she said.

She also pointed out that more than 13 children out of 100 in India’s under-five age group die due to diarrhoea. In this context, the misuse of ORS labelling is not a trivial marketing issue but a matter of life and death. “How can you give something which worsens diarrhoea and then say it’s the public’s responsibility to read disclaimers? How many literate people in India actually read disclaimers, let alone the illiterate population? This is cruel,” she said.

Her battle was not easy. Dr Santosh faced opposition not only from private companies but also from her own fraternity and even her family, who feared the consequences of her fight. Despite pressure, she filed litigation against companies and government authorities, refusing to back down. “I had to fight with my own fraternity, raise my voice against authorities, and file a public interest litigation where both the government and these companies were respondents. I didn’t back out. Even when I felt tense and pressured, I just deleted those thoughts from my mind because I knew I was meant to do this,” she said.

Her persistence finally paid off. The FSSAI acknowledged the validity of her concerns and moved to remove the ORS term from all non-medical beverage labels. Her campaign brought national attention to the deceptive marketing tactics that had gone unchecked for years, and it is expected to lead to stricter monitoring of similar misleading practices in the future.

For eight years, Santosh used every platform available to highlight how energy drink companies were undermining public health. She gave interviews, conducted awareness campaigns, reached out to regulatory authorities, and mobilised medical professionals to support her cause. She argued that the ORS label carries an emotional and medical weight in India, particularly for families dealing with diarrhoeal diseases, and its misuse was both unethical and dangerous.

Her relentless advocacy not only exposed a widespread problem but also helped shape a national regulatory response. The FSSAI’s directive now ensures that companies cannot exploit a medically trusted term to sell sugary drinks. The move is expected to reduce the risk of dehydration-related complications and reinforce consumer trust in genuine ORS solutions used in hospitals and households across India.

This case highlights the power of sustained civic action in bringing about regulatory change. What began as one doctor’s concern over children’s health has ended with a nationwide directive that will impact every food business operator in the country. It is also a reminder of the responsibility that companies hold when using medically associated terms in their marketing, and the power regulators have to act when public health is at stake.

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