After months of confusion over “ORS” beverages, the Delhi High Court has upheld FSSAI’s ban on using the term “ORS” for beverages that do not meet WHO regulatory standards. Vikram Raj Nanda traces the twists and turns leading to this decision and examines how trademark law and public interest interact in this case. Vikram Raj Nanda is a third year student at National Law School of India University, Bengaluru with a keen interest in IP law, Competition Law, and Arbitration. His previous posts can be accessed here.
ORS Under Pressure: What The FSSAI Order Means from A Trademark Law Perspective
By Vikram Raj Nanda
Recently, several debates have stirred up online and in news reports (see here and here) regarding the harmful consequences of beverages being sold as an ‘Oral Rehydration Solution’ (ORS). These discussions have largely been centred on the fact that many consumers are misled into believing that such beverages possess the same therapeutic properties as a medical ORS formulation, which can have harmful consequences for health, particularly for vulnerable patients.
This entire debate garnered significant attention when the Delhi HC stayed the operation of an FSSAI order that had banned the use of the phrase ‘ORS’ in beverages that did not qualify as a medical ORS in line with WHO regulatory standards, without providing any reasons in the order for doing so (see here). This post was originally written to critique this order. However, as of today, a final clarification has at last been issued by the DHC, with the Court deferring to FSSAI’s regulatory authority and upholding FSSAI’s ban on beverages being labelled as an ORS. This post now unpacks the several orders that have been issued by the DHC and the FSSAI in this regard and the key implications that emerge, particularly from a trademark law perspective.
A Brief Timeline
Fruit-flavoured electrolyte beverages have long been (mis)labelled as an ORS or similar substitutes and have been sold in Indian markets. One of the first companies to introduce such drinks was Jagdale Industries back in 2003, selling electrolyte drinks under the label ‘ORS-L’. In 2014, Johnson and Johnson acquired this electrolyte drink from Jagdale Industries, marketing the drug under the label ‘ORSL’ and similar formative marks, for which it had acquired the relevant trademarks. In fact, several other companies also began marketing drinks labelled with ‘ORS or ORS-type branding.
However, a persisting concern with such beverages was that they did not comply with the WHO standards of a medical ORS solution. Instead, many effectively amounted to high-sugar fruit or electrolyte drinks, containing significantly higher amounts of sugar than the prescribed regulatory amount (see here and here). As a result, often patients would suffer harmful consequences in case such beverages were utilised for the treatment of diseases like diarrhoea, gastroenteritis etc. for which a medical ORS is supposed to be used. These harmful effects are exacerbated for children for whom diarrhoea remains a leading cause of death in India
Such concerns had long been highlighted by medical professionals. Most notable among these is paediatrician Dr Sivaranjini Santosh’s 8-year long and arduous campaign against such beverages (see here and here). After a long struggle, these beverages started to catch the ire of the FSSAI. In this regard, the FSSAI issued its first order on April 8, 2022, noting that the utilisation of the mark ‘ORS’ by J&J and other companies selling products such as “ORSL’, ‘ElectroORS’ etc. could be an instance of misleading branding and the use of such trademarks consisting of the term ‘ORS’ could constitute a violation of the Food and Safety Standards Act, 2006.
However, on 14th July 2022, as an interim measure, FSSAI allowed the usage TMs containing ORS until the Controller General of Patents, Designs and Trademarks (CGPDTM) issued an appropriate clarification on the matter. While I have not been able to locate the CGPDTM’s order, the subsequent FSSAI order issued on February 2, 2024 explicitly references it. In this order, citing the CGPDTM’s decision, FSSAI allowed the usage of ORS as a trademark upon the fulfilment of two conditions: first, the mark ‘ORS’ could only be used a prefix or a suffix in conjunction with a brand name (in consonance with Section 17 of the Trademarks Act, 1999) and second, an explicit disclosure had to be made that the beverage in question was not compliant with the WHO standards for an ORS formula.
While this order stayed in force for some time, it appears that FSSAI was unconvinced that such conditional use still could allay health concerns and consequently, the final order dated 15th October, 2025 was issued, completely prohibiting the use of the mark ‘ORS’ in beverages.
How Have the Courts Treated These Orders?
Having outlined the regulatory trajectory, it is useful to trace how the courts engaged with it. The first significant judicial intervention came through the Delhi HC’s interim stay dated 17 October 2025 granted on the representation made by J&J, which stayed the operation of FSSAI’s prohibition on the use of the ‘ORS’ label. This order was unreasoned, offering no explanation on why such an interim stay was granted. If we turn to news reports, one of the reasons for granting the stay was perhaps a large quantity of existing unsold stock with J&J, worth nearly 155 crore rupees. Even if true, such commercial considerations ought not to have outweighed clear public health concerns.
In a subsequent clarification to this (see here), the DHC indicated that the stay was to only allow the FSSAI to take appropriate steps and pass an order dealing with Johnson’s submissions (though the submissions aren’t available publicly – ostensibly one can assume J&J sought to assert its rights to continue selling its beverages with the ORS mark).
It appears that the FSSAI did decide on the matter and passed a comprehensive order dated 30th October 2025. Though this order is not yet publicly available, it seems to have formed the basis of the Delhi High Court’s final judgment (see here)in another case- Dr. Reddy’s Laboratories Ltd. v. Union of India (Oct, 31, 2025). In this case, Dr. Reddy’s sought permission to continue selling their own version of an ORS beverage with the label ‘Rebalanz VITORS’, relying on the earlier stay granted in favour of J&J. The Court, however, refused to extend the same relief and rejected their petition, clarifying that in such matters, the courts should defer to the regulatory expertise of bodies like FSSAI. Extensively citing FSSAI’s order and noting the presence of a clear public health concern, the Court refused to stay the operation of the ban on the usage of the ORS mark. However, the Court did not pass any directions on how the pending stocks of Dr Reddy’s Laboratories had to be dealt with and allowed the FSSAI to make an order in this regard.
Public Health and Trademark Law: Where the Two Intersect
This decision marks an important moment for trademark jurisprudence. It appears that the Court has sought to correct course from its earlier stay granted in favour of J&J and in doing so, has perhaps reaffirmed the central place that public health occupies in trademark law (see generally here). However, several aspects of the FSSAI order dated 31st October, 2025 as cited and approved by the DHC, merit closer examination.
Firstly, the FSSAI order explicitly cites Ram Nath vs State of UP (2024) wherein the Supreme Court has interpreted the non-obstante clause in Section 89 of the Food Safety and Standards Act, 2006 to hold that the Act has an overriding effect on any other law insofar as they apply to matters of food. On this basis, the FSSAI correctly observed that no provision of the TM Act can dilute or override the consumer protection mandate of the FSS Act, and that no person can rely on trademark rights to justify the use of deceptive or harmful marks. This raises an important point: since Ram Nath is a binding precedent, one could argue that the Delhi High Court, in granting its earlier stay, had unnecessarily complicated matters, as it ought to have deferred to the FSSAI’s authority exercised in accordance with the FSS Act.
Not only this, the Trade Marks Act, 1999 itself contains the safeguards that serve the same consumer protection purpose that seemingly evaded the court’s attention. For instance, Section 9(2)(a) of the TM Act bars the registration of marks likely to deceive or cause confusion. This provision is often interpreted by the courts through the lens of public health. For instance, in trademark infringement cases where the impugned marks relate to medicines, courts specifically cite the importance of prioritising public health and accordingly modify/relax trademark law standards. In Macleods Pharmaceuticals vs Union of India (2023, Bombay High Court), even the possibility of public confusion or deception in relation to medicinal products could have grave consequences for public health, requiring the courts to lessen the standard of proof for infringement. Interestingly, FSSAI’s order also mentions the bar on registration under Section 9(2), though the Court has not dealt with it extensively itself.
Additionally, the FSSAI order also notes that the mark ORS constitutes an International Non-Proprietary Name (INN). INNs are globally standardised names assigned by the WHO to identify pharmaceutical substances by their active ingredient rather than by brand, ensuring that such terms remain in the public domain and cannot be monopolised through trademark registration. Section 13(b) of the TM Act accordingly prohibits their registration, preventing any single entity from monopolising such names through trademark claims.
In conclusion, while the Court has cited key aspects of the FSSAI order, it has not independently analyzed them, particularly Section 9(2)(a). Perhaps it is hoped that the courts will endorse this reasoning in future cases and draw a clearer line, deferring to regulatory bodies in cases involving public health concerns and not simply deciding on the commercial interests of the trademark proprietor.