FSSAI Restricts Use of ‘ORS’ Label After Hyderabad Doctor’s Long Campaign

Hyderabad paediatrician Dr. Sivaranjani Santosh’s eight-year advocacy leads FSSAI to restrict ORS labelling to WHO-approved formulations, protecting children from unsafe beverages.
FSSAI has issued a directive asking companies to stop using the term “ORS” on beverages that do not meet the exact standards set by the World Health Organization.
FSSAI has issued a directive asking companies to stop using the term “ORS” on beverages that do not meet the exact standards set by the World Health Organization.Shubjt/Freepik
Published on
Updated on

The Food Safety and Standards Authority of India (FSSAI) has issued a directive asking companies to stop using the term “ORS” (Oral Rehydration Solution or Salts) on beverages that do not meet the exact standards set by the World Health Organization (WHO).¹

The order, released on October 14, 2025, marks the end of an eight-year public health campaign led by Dr. Sivaranjani Santosh, a Hyderabad-based paediatrician who had been raising concerns about misleading product labelling.²

What the Directive Means

Under the new rule, companies can no longer use “ORS” in their brand name, prefix, or suffix unless their formulation is identical to the WHO-recommended oral rehydration formula.³ Earlier, a few drinks were allowed to use the term with disclaimers saying they were not the WHO formula, but that exception has now been withdrawn.

The FSSAI clarified that misuse of “ORS” will now be treated as misbranding under the Food Safety and Standards Act, 2006.¹ State and Union Territory food departments have been told to take action and remove such misleading products from the market.

Understanding the Science of ORS

An Oral Rehydration Solution is a precisely balanced mixture of salts and glucose designed to restore fluid and electrolyte balance during dehydration caused by diarrhoea or vomiting. According to WHO guidelines, the standard formula contains sodium chloride, potassium chloride, trisodium citrate (or bicarbonate), and 13.5 grams of glucose per litre of water.⁶

The presence of glucose is essential—it helps sodium and water get absorbed in the intestines through a natural transport process. If the sugar level is too high or sodium is too low, the solution may not work effectively and can even worsen dehydration.⁶

Many beverages previously marketed as “ORS drinks” were found to have high sugar content and low electrolytes, making them unsuitable for rehydration.⁴ Such formulations can delay recovery or lead to osmotic diarrhoea, particularly in children.

The Doctor Behind the Change

Dr. Sivaranjani Santosh, a practising paediatrician from Hyderabad, first noticed the issue in her clinical practice. She found that children brought to hospitals after consuming drinks labelled as “ORS” were often not improving, and in some cases, their dehydration worsened.²

Her investigation showed that several of these beverages were essentially sugary drinks presented as medical products. Concerned by the risks, she filed a Public Interest Litigation (PIL) in the Telangana High Court in 2022, urging authorities to regulate the misuse of “ORS” in product names.³ She also approached the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health for intervention.

Despite slow progress and industry resistance, Dr. Santosh continued her campaign through social media, news platforms, and educational outreach.² The Telangana High Court later sought responses from FSSAI, which led to a review and ultimately to the 2025 directive.³

Public Health Implications

The new regulation ensures that only WHO-standard formulations can be sold under the “ORS” label.¹ For consumers, especially parents and caregivers, it’s a reminder to check the label carefully and use only authentic ORS sachets available through pharmacies or healthcare providers.

Healthcare professionals have welcomed the directive, calling it a necessary step to prevent confusion and protect patients from unsafe substitutes. It also highlights the importance of health literacy—understanding that not all electrolyte beverages are medically effective ORS.⁶

References

  1. Food Safety and Standards Authority of India (FSSAI). FSSAI Directive on Use of “ORS” in Product Labels and Brand Names. New Delhi: FSSAI, October 14, 2025.

  2. Hindustan Times. “Emotional Doctor Cries on Camera, Declares Victory after FSSAI’s Latest ORS Directive: Here’s What She Is Celebrating.” Hindustan Times, October 15, 2025.

  3. Telangana Today. “FSSAI Bans Misleading ORS Labels on Beverages after Hyderabad Doctor’s 8-Year Campaign.” Telangana Today, October 15, 2025.

  4. The News Minute. “Hyderabad Paediatrician’s Legal Battle Forces FSSAI to Act against Misuse of ORS Label.” The News Minute, October 15, 2025.

  5. Deccan Chronicle. “FSSAI Bans Misuse of ORS Label after 8-Year-Long Battle; Paediatrician in Tears.” Deccan Chronicle, October 15, 2025.

  6. World Health Organization. Oral Rehydration Salts: Production of the New ORS (Revised WHO Formula). Geneva: WHO Press, 2006.

(Rh/Eth/SS/MSM)

Related Stories

No stories found.
logo
Medbound Times
www.medboundtimes.com