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ORS Trademark Ban: Delhi HC Says “No License to Deceive Consumers” – Dr Reddy’s Challenges FSSAI

Justice Sachin Datta of Delhi High Court issued critical clarifications on ORS trademark controversy, stating earlier order wasn't meant to allow continued manufacture of beverages with misleading ORS labels as companies misinterpreted on social media.
Delhi HC Delhi Government Hospital Audit
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New Delhi: The Delhi High Court on Tuesday issued crucial clarifications regarding its earlier order on the controversial issue of beverages carrying misleading ‘ORS’ (Oral Rehydration Solution) labels, setting the record straight after widespread social media misinterpretation.

Justice Sachin Datta made it explicitly clear that the court’s October 17, 2025 order was not intended as a blanket permission for food business operators to continue manufacturing and styling their beverages as ORS products with an aim to deceive consumers.

The clarification came while hearing a separate petition filed by pharmaceutical giant Dr Reddy’s Laboratories challenging the Food Safety and Standards Authority of India’s (FSSAI) orders dated October 14 and 15, 2025.

Background of the ORS Trademark Ban Controversy

The FSSAI had withdrawn earlier approvals that permitted the use of the term ‘ORS’ with prefixes or suffixes in registered trademarks for electrolyte and beverage products. This decision followed an eight-year crusade by Hyderabad-based paediatrician Dr Sivaranjani Santosh, who exposed how misleading ORS-branded drinks were endangering children’s lives.

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The regulatory authority clarified that using ORS, even with prefixes or suffixes in trademarked names, constitutes a violation of the Food Safety and Standards Act, 2006, unless the product strictly complies with the World Health Organisation (WHO) formulation for oral rehydration solution.

ORS Trademark Ban: Court’s Stern Warning to FSSAI Over Delayed Decision

Justice Datta expressed strong displeasure over FSSAI’s tardiness in deciding the matter, stating, “I would have restrained the manufacturers from manufacturing fresh batches had I known that the FSSAI would take two weeks to make a decision.”

The judge emphasized that the consent order passed on October 17 was specifically designed to enable FSSAI to take requisite steps after considering representations from affected companies. “It wasn’t to allow all these manufacturers to continue manufacturing these products. The idea was that the FSSAI would do the needful in two to three days,” Justice Datta remarked.

The court noted FSSAI counsel’s submission that the authority will decide the matter by Friday. However, Justice Datta warned, “If you [FSSAI] are unable to do it, you move an application. I contemplate passing orders to restrain the manufacturers from manufacturing.”

Social Media Misinterpretation and Clarification on ORS Trademark Ban

The October 17 order protecting JNTL Consumer Health India—the Indian subsidiary of American company Kenvue—was widely portrayed on social media platforms as the court having permitted food business operators (FBOs) to continue manufacturing beverages and styling them as ORS.

However, Justice Datta categorically rejected this interpretation, clarifying that the consent order’s objective was solely to enable FSSAI to make an informed decision after considering JNTL’s representation, not to provide manufacturers with continued license to produce potentially misleading products.

Dr Reddy’s Laboratories Enters the Legal Battle for ORS Trademark Ban

Dr Reddy’s Laboratories has challenged the FSSAI’s October 14 and 15 orders, arguing that their product ‘Rebalanz VITORS’ carries all the disclaimers required by WHO and other organisations.

The company’s counsel informed the court that proper labelling and disclaimers have been incorporated to ensure consumers are not misled. The matter has been scheduled for further hearing on October 31, 2025.

WHO Guidelines for ORS 

According to WHO standards, genuine oral rehydration solution must contain a precise formulation of sodium chloride, glucose anhydrous, potassium chloride, and trisodium citrate dihydrate in one litre of water.

Many commercial beverages using the ORS label contain 8 to 10 times more sugar than the WHO-recommended formula and often lack the critical electrolyte balance necessary for treating dehydration effectively.

Public Health Implications and Expert Concerns

Health experts have raised serious concerns about these misleading products. Dr Sivaranjani Santosh, who fought tirelessly for eight years on this issue, documented multiple cases where children suffered severe dehydration despite consuming products marketed as ORS.

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If a label says ‘not ORS’, the branding still confuses parents,” Dr Santosh explained. In India, diarrhoea accounts for 13% of deaths in children under five years, and only 60% receive proper ORS treatment according to NFHS-5 data.

The JNTL Consumer Health Case

JNTL Consumer Health manufactures and markets the popular hydration drink ORSL. The company argued that FSSAI’s withdrawal was effected without prior notice, consultation, or hearing, violating the Food Safety and Standards Act, 2006, and related rules.

JNTL submitted that products worth approximately ₹155-180 crore were currently in the supply chain, and the abrupt reversal would cause irreparable harm to its brand and goodwill built over two decades.

The company also referenced the Controller General of Patents, Designs and Trademarks’ view, which confirmed that “ORS” with prefixes or suffixes can form part of a composite mark under Section 17 of the Trade Marks Act, 1999.

FSSAI’s October 14 Directive and Its Implications

The FSSAI’s October 14, 2025 advisory explicitly states that any food or drink product using the term “ORS,” including with prefixes or suffixes like “Smart ORS” or “Hydra ORS,” would be considered misbranded under the Food Safety and Standards Act, 2006.

The directive withdrew two earlier FSSAI circulars issued on July 14, 2022, and February 2, 2024, which had allowed limited use of the term ‘ORS’ with disclaimers. The fresh order closed this loophole entirely.

The Road Ahead: Next Hearing Scheduled

The court has scheduled the next hearing for October 31, 2025, where it will examine Dr Reddy’s Laboratories’ petition in detail and monitor FSSAI’s compliance with the directive to expeditiously decide on pending representations.

The case represents a crucial intersection of trademark rights, food safety regulations, consumer protection, and public health concerns, with far-reaching implications for the food and beverage industry in India.

ORS Trademark Ban: Consumer Advisory and Vigilance

Until the regulatory matter is fully resolved, parents and caregivers are strongly advised to use only WHO-approved ORS sachets for treating childhood dehydration and diarrhoea.

Medical professionals emphasize that giving children sugary drinks during diarrhoea or vomiting can worsen dehydration, as excessive sugar alters the osmotic balance and draws more fluid into the bowel instead of helping absorb it.


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