How a Hyderabad paediatrician waged 8-year battle to have ORS tags removed from energy drinks

A paediatrician’s nearly decade-long battle to have the Oral Rehydration Salts (ORS) tag removed from energy drinks and beverages has finally resulted in victory.

The Food Safety and Standards Authority of India (FSSAI) has now passed an order banning food and beverage firms from using the label on products that do not meet the standards of the World Health Organization (WHO).

This came as a result of efforts from Dr Sivaranjani Santosh from Hyderabad.

But what happened? What do we know about Dr Sivaranjani’s long court battle to get the tag removed?

Let’s take a closer look.

First, let’s take a brief look at Oral Rehydration Salts.

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What are ORS?

ORS are a glucose-electrolyte formula first used in 1969 and approved by the WHO and UNICEF.

They are used to treat dehydration from diarrhoea among infants and children. This is no small matter given that acute diarrhoeal diseases are among the leading causes of mortality in infants and young children in many developing nations.

In the majority of cases, death occurs due to dehydration. This can be solved effectively and cheaply by giving children extra fluids at home. However, in more extreme cases, they also can be administered ORS orally. According to the WHO, ORS have had a dramatic effect on reducing mortality from diarrhoeal disease around the world since their introduction.

The WHO and UNICEF have laid out a precise formula for ORS – 2.6 grams of sodium chloride, 1.5 grams of potassium chloride, 2.9 grams of sodium citrate, and 13.5 grams of dextrose anhydrous (sugar) per litre.

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This is the latest formula adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its meeting in October 2005. The combination replenishes electrolytes, restores lost fluids and is safe for both children and adults.

What happened?

The FSSAI, in an order dated October 14, w ithdrew all permission allowing food and business operators to use the term ‘ORS’ as part of their brand names or as a trademark.

“All food business operators are directed to remove the word ‘ORS’ from their products and ensure strict compliance with labelling and advertising requirements prescribed under the Food Safety and Standards Act, 2006,” the FSSAI said in its order.

“No food product shall use the term ‘ORS’ as part of its name, trademark, or brand unless it conforms to WHO-recommended formulation standards,” the regulator ordered.

It added that the use of ‘ORS’ in any food product’s name, whether fruit-based, non-carbonated, or ready-to-drink, violates the Food Safety and Standards Act, 2006, and related regulations. The FSSAI said such labelling ‘misleads consumers by way of false, deceptive, ambiguous, and erroneous names or label declarations,’ and therefore contravenes multiple provisions under the Act.

The food safety governing body also revoked two previous orders dated July 14, 2022, and February 2, 2024, which had allowed companies to use ‘ORS’ with disclaimers that said “the product is not an ORS formula as recommended by WHO.”

The long battle

Dr Sivaranjani had for years campaigned for this WHO standard to be upheld by the FSSAI. She had claimed that beverages were falsely being marketed and sold as ORS despite having dangerously high sugar levels and improper electrolyte balances. Dr Sivaranjani told India Today she found that many such products had over 120 grams of sugar per litre combined with dangerously low electrolyte levels. She said that they would be detrimental to the health of dehydrated children.

“If your child is sick and you go to a pharmacy asking for ORS, the very solution meant to save lives, and you’re handed a sugary drink that worsens the illness, how would you feel as a parent?” Dr Sivaranjani enquired. “As a paediatrician, watching children suffer from something so preventable made me furious. How can anyone label a drink this way and market it so deceptively?” she wondered.

Dr Sivaranjani initially began reaching out to parents about the dangers of such products via Instagram and other social media. However, the regulators remained unmoved. Dr Sivaranjani approached the Central Drugs Standard Control Organisation (CDSCO) but was told it wasn’t within their purview. The body instead told her to reach out to the FSSAI.

Dr Sivaranjani did so, and also contacted the health ministry. In 2022, she also filed a Public Interest Litigation (PIL) before the Telangana High Court challenging the sale of such products to the public. After a ruling from the court, the regulator initially sided in her favour.

In April 2022, the FSSAI restrained companies selling non-medical beverages from using the “ORS” tag. However, in July 2022, the FSSAI did a U-turn. It allowed companies to use the label albeit with a small disclaimer that read: “This product is not an ORS formula as recommended by WHO.”

Dr Sivaranjani had had enough. She filed yet another PIL before the Telangana High Court, this time with Central Health Ministry, FSSAI, and several companies, including Dr Reddy’s Laboratories and Kenvue as respondents. Now, after years of battle, the FSSAI has finally ruled in her favour on October 14.

“It has been eight years since I persisted, and I have won it,” an emotional Dr Sivaranjani said on Instagram after the verdict. “No high sugar drinks can have ORS on its label anymore, and they cannot sell a single drink from here on.”

Dr Sivaranjani had doubled down on her campaign after the death of several children in Maharashtra and Rajasthan who had drunk contaminated cough syrups.
All it took for change was the persistence of one doctor.

With inputs from agencies