Abstract
Oral Rehydration Salts (ORS) remain one of the simplest and most effective life-saving therapies ever developed. The World Health Organization (WHO) and UNICEF emphasise that ORS must be produced and distributed as an essential medicine — simple, affordable, and accessible. Yet, in many markets, cost inflation arises not from the ingredients but from packaging, flavoring, and branding. The WHO’s guidance document “Production of the New ORS” (WHO/FCH/CAH/06.1) offers a practical framework to ensure affordability through local manufacture, minimal formulation complexity, and rational packaging. India’s recent Food Safety and Standards Authority of India (FSSAI) directive banning the misuse of the term “ORS” in non-compliant beverages underscores the urgency of aligning with this global vision. The pharmaceutical industry must now act responsibly — to reduce unnecessary costs, avoid cosmetic modifications, and keep ORS truly affordable for all.
Introduction
Acute diarrhoeal diseases remain a major cause of mortality among infants and young children in developing nations, primarily due to dehydration. The WHO and UNICEF jointly advocate Oral Rehydration Therapy (ORT) — the simple oral administration of a glucose–electrolyte solution — as the cornerstone of diarrhoeal disease control. Since its adoption, ORT has saved millions of lives and stands as one of the most cost-effective health interventions in history.
To make this therapy universally available, the WHO’s “Production of the New ORS (WHO/FCH/CAH/06.1)” outlines a detailed framework enabling local manufacture of pharmaceutical-quality ORS using affordable, regionally available materials. The document emphasises that the new low-osmolarity ORS (endorsed since 2003) must be manufactured following Good Manufacturing Practices (GMP), yet adaptable to local climatic and economic conditions.
Key WHO recommendations include using country-specific packaging materials suited to the local environment and available resources; accepting both anhydrous and monohydrate glucose (the latter often being more cost-efficient); and permitting food-grade excipients that meet Codex Alimentarius standards where pharmacopoeial grades are not feasible. Proper drying and mixing control under tropical humidity is critical for ensuring uniformity and stability.
Ultimately, WHO’s vision is unambiguous: ORS is an essential medicine, not a premium product. Its production must prioritise accessibility, affordability, and simplicity — principles that are too often undermined by modern commercial practices such as elaborate packaging, colored printing, and flavored variants.
Formulation integrity: Keep it simple, keep it effective
WHO and UNICEF’s technical guidance mandates that ORS should contain only four essential ingredients: glucose, sodium chloride, potassium chloride, and trisodium citrate dihydrate. Excipients like colloidal silicon dioxide (Aerosil) are permitted only when necessary to aid automated filling and flow properties, as they may cause turbidity in solution and add unnecessary cost.
The addition of other minerals, vitamins, or nutrients has not been proven to enhance efficacy. WHO and UNICEF therefore do not approve ORS with additives, and any manufacturer choosing to modify composition must demonstrate clinical value, safety, and chemical stability. Each additional component must be reflected in the total solute concentration and clearly disclosed on the label.
Flavored and colored ORS products — sometimes marketed as more palatable — have shown no clinical advantage over the standard formulation in WHO-sponsored multicountry trials (Egypt and Philippines). Moreover, these additives introduce risks: sweeteners such as cyclamates or dulcin are banned for toxicity, and aspartame becomes unstable above 40 °C. Consumption variability among children makes dose control for such additives impossible.
Most critically, flavoring increases cost by 10–20 per cent, particularly when imported ingredients are used. WHO thus advises that ORS for public-health programs remain unflavored and uncolored, while flavored variants, if sold commercially, must be distinctly labeled as non-medical electrolyte beverages. Yet, the trend of marketing “flavored ORS” for competitive branding often forces other manufacturers to follow suit — diverting ORS from its essential-medicine purpose.
Packaging: The silent cost driver
According to the World Health Organization’s Oral Rehydration Salts: Production of the New ORS (WHO/FCH/CAH/06.1), packaging should ensure adequate stability and affordability rather than serve as a marketing tool. The report notes that packaging can contribute up to 40 per cent of the total ORS cost when multilayer aluminum foil laminates are used unnecessarily. While three-layer structures such as polyethylene/aluminum/polyester provide very low water vapor transmission (WVTR < 0.02 g/m²/day), WHO specifies that such high barriers are not essential in most climatic conditions.
WHO recommends adapting packaging to local climate and cost realities.
Practical, affordable alternatives include:
- Polyethylene films in dry climates, which permit slight moisture exchange and can even help remove residual crystallisation water from the raw materials.
- Two-layer laminates (polyethylene + polyester) instead of costly three-layer metallic foils, while still ensuring sufficient protection from humidity and mechanical stress.
- Minimal two-color printing, as elaborate or multicolor designs raise ink, setup, and printing-plate costs without contributing to public-health benefit.
- Bulk or institutional sachets (e.g., 5–10 L packs) for hospitals and community programs, reducing the per-dose material footprint.
The WHO guidance stresses that packaging should be functional, not decorative, and must primarily provide accurate information—composition, reconstitution volume, dosage, and pictorial preparation instructions for low-literacy users. Excessive metallic finishes, embossing, or high-gloss designs only inflate costs without improving product quality, stability, or accessibility.
Regulatory wake-up call: India’s FSSAI ban on misuse of “ORS”
In October 2025, the Food Safety and Standards Authority of India (FSSAI) issued a directive banning the use of the term “ORS” on any beverage that does not comply with WHO’s composition criteria. This move came after several fruit-based or sugary drinks were marketed as “ORS beverages,” misleading consumers and posing potential health risks.
In November 2025, the Delhi High Court upheld the FSSAI directive, affirming that such misuse represents a public-health hazard. The ruling effectively distinguishes therapeutic ORS — a pharmaceutical preparation — from electrolyte or sports drinks.
This action reasserts the WHO’s long-standing position that products designed for exercise rehydration must not be marketed for medical dehydration due to diarrhoea. The Indian regulatory stance therefore aligns with WHO’s ethical and clinical framework, serving as a timely reminder for manufacturers to maintain scientific integrity in labeling and promotion.
Reclaiming WHO’s vision: The way forward
To realign with WHO and regulatory expectations, ORS manufacturers should:
- Reassess all cost components, prioritising formulation integrity over branding.
- Prefer locally sourced, WHO-compliant barrier films over imported multilayer laminates.
- Avoid flavors and colors in public-health or medical-grade ORS.
- Adopt minimal ink printing and focus on user instructions with pictorial clarity.
- Promote larger pack sizes for institutional and emergency use.
- Establish internal review mechanisms to ensure compliance with WHO composition and labeling.
By returning to the fundamentals — scientifically validated composition, rational packaging, and ethical marketing — the pharmaceutical industry can uphold the true purpose of ORS: an affordable, universally accessible medicine that saves lives.
Conclusion
The story of ORS is one of public-health success, achieved through simplicity and scientific integrity. Every deviation from that simplicity — be it through unnecessary additives, complex laminates, or aesthetic marketing — distances us from WHO’s vision. The FSSAI’s decisive action reinforces that alignment with WHO standards is both a moral and regulatory obligation.
It is time the industry recommits to the founding principle of ORS: life-saving therapy should never be a luxury product.
References
- World Health Organization. Oral Rehydration Salts: Production of the new ORS. WHO/FCH/CAH/06.1, 2006.
https://www.who.int/publications/i/item/WHO-FCH-CAH-06.1
- Food Safety and Standards Authority of India (FSSAI). “Withdrawal of Orders regarding ‘Usage of the term “ORS” along with brand names’ dt 14.10.2025.” PDF, 14 Oct 2025. https://www.fssai.gov.in/upload/advisories/2025/10/68ee3ba06bb7eWithdrawal%20of%20Orders%20regarding%20Usage%20of%20the%20term%20ORS%20along%20with%20brand%20names%20dt%2014.10.2025.pdf