Regulation of ORS in India

Why in News?

The DELHI High Court made it clear that it was not going to interfere with the FSSAI’s October 30 order, upholding its ban of ORS-labelled beverages, noting that such products have been flagged as a “health hazard” by the regulator and reiterated “public health considerations is of paramount”.

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Prelims, Health and Diseases

WHO Oral Rehydration Salts (ORS) Formulation

The World Health Organization (WHO) and UNICEF currently recommend a Low-Osmolarity ORS formulation for the prevention and treatment of dehydration due to diarrhea. This precise composition is essential for effective fluid and electrolyte absorption in the intestine.

The composition per 1 Litre of clean drinking water is as follows:

Key Role of Formulation: The $1:1$ molar ratio of glucose to sodium is crucial for activating the sodium-glucose co-transport mechanism in the small intestine, which facilitates the absorption of water into the body. High-sugar, non-compliant drinks can worsen diarrhea by drawing water into the intestines.

Component	Chemical Name	Concentration (g/L)	Concentration (mmol/L)
Glucose, Anhydrous (Sugar)	C6H12O6	13.5g/L	75 mmol/L
Sodium Chloride (Salt)	NaCl	2.6g/L	75 mmol/L
Potassium Chloride	KCl	1.5g/L	20 mmol/L
Trisodium Citrate, Dihydrate	C6H5Na3O.2H2O	2.9 g/L	10 mmol/L (Citrate)
Total Osmolarity			245 mOsm/L

Delhi High Court’s Stand on ORS-Labelled Beverages

• Upholding the FSSAI Ban: The Delhi High Court made it clear that it would not interfere with the FSSAI’s order (dated October 30) banning the sale of beverages labelled with the term ‘ORS’.
• Public Health is Paramount: The court firmly stated that “Public health considerations are paramount” and must take precedence over commercial interests.
• Product Flagged as Health Hazard: Justice Sachin Datta noted that the FSSAI had flagged such non-compliant ORS-labelled products as a “health hazard” and “hazardous,” making an interim arrangement impossible.
• Refusal to Exhaust Existing Stock: The court refused the plea by Dr. Reddy’s Laboratory (DRL) to permit the sale and exhaustion of its existing stock of the ‘Rebalanz VITORS’ product.
• Pathway for Rebranding: The court orally proposed that DRL could approach the FSSAI for guidance on its existing stock and indicated it will allow DRL to rebrand its product (e.g., to ‘Rebalanz Vitenergy’) before continuing to sell it.
• No Possibility of Interim Relief: The court clearly indicated that it would pass orders that would allow the FSSAI’s embargo to continue, stating, “I’m not disturbing it given the public health concerns.”

FSSAI Order:

• Violation and Misleading Practice: The FSSAI orders (October 14 and 15) reasoned that using the term ‘ORS’ in trademarks or names for food products (like fruit-based, ready-to-drink beverages)—even with prefixes or suffixes—violates the Food Safety and Standards Act, 2006, by being “false, deceptive, ambiguous, and erroneous.”
  • ORS (WHO formula) is classified as a drug and is regulated under the Drugs and Cosmetics Act, 1940. Most high-sugar electrolyte drinks are classified as food and are regulated by FSSAI.
  • Food Business Operators (FBOs) were directed to immediately remove the word ‘ORS’ from all product packaging, advertisements, and brand names.
  • Non-compliance is punishable as misbranding and misleading consumers under the Food Safety and Standards Act, 2006.
• Risk of High-Sugar Drinks: The FSSAI’s October 30 order specifically highlighted that the ingestion of high-sugar electrolyte drinks marketed as ORS can “worsen dehydration” by drawing water out of body cells, posing a “direct and immediate risk to human health.”

Note: This FSSAI directive withdrew previous FSSAI orders (from 2022 and 2024) that had temporarily permitted the use of ‘ORS’ in brand names provided they carried a mandatory disclaimer stating: “The product is NOT an ORS formula as recommended by WHO.”The new rule enforces a complete ban on the non-compliant use of the term.