Introduction
Oral Rehydration Salts (ORS) are a globally recognised life-saving therapy for dehydration caused by diarrhoea, vomiting, and heat-related illnesses. Since its adoption by WHO and UNICEF in the late 20th century, ORS has been credited with dramatically reducing child mortality worldwide. However, in India, the regulatory framework governing the use of the term “ORS” has been contentious, straddling the boundaries between drug regulation and food safety law.
Recent developments, including FSSAI’s prohibition on non-WHO compliant products using “ORS” branding and a subsequent challenge before the Delhi High Court, have brought the debate into sharp focus.
WHO Standards for ORS
The WHO/UNICEF “new ORS” formulation (2003) is designed to improve safety and efficacy. The solution contains:
- Glucose (anhydrous): 13.5 g
- Sodium chloride: 2.6 g
- Potassium chloride: 1.5 g
- Trisodium citrate (dihydrate): 2.9 g
When dissolved in one litre of water, this yields:
- Sodium: 75 mmol/L
- Glucose: 75 mmol/L
- Potassium: 20 mmol/L
- Citrate: 10 mmol/L
- Total osmolarity: 245 mOsm/L
This precise balance is what distinguishes ORS as a medicine rather than just a hydration drink.
ORS under Indian Drug Law
The Drugs and Cosmetics Act, 1940 and rules made thereunder classify ORS as a drug. The landmark notification G.S.R. 57(E) dated 07.02.1995 prohibits the manufacture, sale, and distribution of “Patent and Proprietary Oral Rehydration Salts” unless they conform to specified parameters
Key requirements include:
- Sodium: 50–90 mmol/L
- Osmolarity: 240–290 mOsm/L
- Dextrose:Sodium ratio: 1:1 to 3:1
- Restrictions on use of saccharin or polysaccharides
This framework ensures that ORS formulations available in India align with WHO’s therapeutic justification.
FSSAI’s Regulatory Trajectory
- April 2022 – Misleading Advertisements Direction
FSSAI received complaints of misuse of “ORS” in products like ORSL Rehydrate and Electro Plus ORS. It clarified that since ORS is a drug under DCGI, such branding is misleading and may render products misbranded food under the FSS Act
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- July 2022 – Delhi High Court & the Rupa Singh Case
In W.P.(C) 9051/2021, Rupa Singh v. Union of India & Ors., the petitioner argued that FSSAI was permitting misleading use of “ORS” by food business operators (FBOs). Acting on the High Court’s directions, FSSAI heard representations from companies. Many claimed to hold valid trademarks incorporating “ORS”.
In response, FSSAI issued its order dated 14.07.2022 allowing those FBOs with registered trademarks to continue using such names temporarily, pending a decision from the Controller General of Patents, Designs and Trademarks (CGPDTM). However, disclaimers had to be added on packs: “This is NOT a WHO-recommended ORS formula”
The Rupa Singh case was significant because it forced the regulator to address the overlap between food law and intellectual property rights, while still acknowledging that consumer protection is paramount.
- February 2024 – Disclaimers Strengthened
FSSAI reiterated the position, mandating front-of-pack disclaimers with specified font sizes for products using “ORS” as part of a trademark, emphasising that they were not WHO-ORS - October 2025 – Prohibition and Withdrawal
FSSAI attempted a complete ban on the use of “ORS” in food branding. But within days, this order was withdrawn, likely due to industry challenges and pending litigation
Case Spotlight: Rupa Singh v. Union of India & Ors.
- Court: Delhi High Court
- Petition: W.P.(C) 9051/2021
- Issue: Misuse of “ORS” branding by food and beverage companies.
- Relief Sought: To prohibit FBOs from using “ORS” on non-WHO compliant products.
- Outcome: The Court directed FSSAI to review and hear affected parties. This led to the July 2022 order that temporarily allowed use of trademarked names with disclaimers.
The case set the stage for later FSSAI actions, highlighting the public health risk of consumer confusion and the regulatory gap between FSSAI and DCGI.
Case Spotlight: JNTL Consumer Health India Pvt Ltd v. Union of India & Anr.
- Court: Delhi High Court
- Petition: W.P.(C) 16217/2025
- Petitioner: JNTL Consumer Health India Pvt Ltd, subsidiary of Kenvue (Johnson & Johnson spin-off).
- Issue: Challenge to FSSAI’s October 2025 orders prohibiting use of “ORS”.
- Order: On 17.10.2025, the Court recorded that JNTL may file a representation before FSSAI. Until that is decided, the FSSAI orders of 14th and 15th October 2025 shall not apply to JNTL’s products
This interim relief means the prohibition remains unenforceable against JNTL, pending regulator review.
Analysis and Implications
- Consumer Protection: The core concern is preventing patients, especially children with diarrhoea, from consuming misleading “ORS-like” drinks that do not have therapeutic value.
- Regulatory Overlap: The conflict stems from dual jurisdiction — FSSAI over food, DCGI over drugs. Companies exploited this to sell beverages under food licences while riding on ORS’s medical credibility.
- Industry Impact: Beverage makers will face rebranding costs. Trademark rights are unlikely to outweigh public health priorities.
- Legal Fluidity: With FSSAI’s prohibition withdrawn and High Court relief to JNTL, the regulatory landscape remains uncertain, leaving companies and consumers in a state of flux.
Conclusion
The ORS saga reflects India’s broader regulatory challenges — balancing public health, consumer protection, and intellectual property rights.
- Rupa Singh v. UOI was the first significant push that forced FSSAI to act against misleading branding.
- JNTL (Kenvue) v. UOI shows the continuing pushback from industry and judicial insistence on procedural fairness.
Ultimately, the message is clear: ORS is a drug, not a marketing term. Indian regulators are moving towards stronger alignment with WHO standards, and companies must adapt.
Author’s View
The ORS saga illustrates a fundamental principle: public health must outweigh commercial branding interests. The confusion caused by ORS-labelled beverages is not trivial — it touches on life-or-death situations for vulnerable populations, especially children.
While intellectual property rights over trademarks deserve protection, they cannot override the clear classification of ORS as a drug with a globally prescribed formula. Allowing beverages to continue under ORS-like names risks eroding consumer trust and undermines India’s commitment to WHO standards.
The High Court’s interventions (Rupa Singh and JNTL) highlight two sides of judicial scrutiny: first, pushing the regulator to act; second, ensuring that affected businesses get a fair hearing. But the direction of travel is clear — the law and policy must converge towards eliminating misleading ORS branding in the food space.