Hyderabad paediatrician’s eight-year long battle leads to FSSAI prohibiting usage of ORS on food products

A Hyderabad-based paediatrician’s long-standing fight against sugar-rich beverages falsely marketed as oral rehydration solutions (ORS) has resulted in a significant regulatory change. The Meals Security and Requirements Authority of India (FSSAI) has issued an order stating that no meals model could use the time period ‘Oral Rehydration Salts’ or ‘ORS’ on its merchandise until the formulation adheres strictly to the requirements advisable by the World Well being Organisation (WHO).

The directive, issued on October 14, mandates the instant withdrawal of all earlier permissions granted to Meals Enterprise Operators (FBOs) for utilizing ‘ORS’ along with their model names. Particularly, it rescinds two earlier orders, dated July 14, 2022, and February 2, 2024, that had allowed using ‘ORS’ as a part of a trademark with a prefix or suffix, supplied the label included a disclaimer stating, “The product is Not an ORS components as advisable by WHO.”

Clarification issued on deceptive labelling

On October 15, day after the directive on October 14, FSSAI issued an in depth clarification reaffirming that using ‘ORS’ in any meals product’s title, whether or not fruit-based, non-carbonated, or ready-to-drink, violates the Meals Security and Requirements Act, 2006, and associated laws. The regulator acknowledged that such labelling ‘misleads customers by means of false, misleading, ambiguous, and inaccurate names or label declarations,’ and due to this fact contravenes a number of provisions underneath the Act.

A paediatrician’s struggle for shopper security

This regulatory intervention stems from a persistent legal campaign by Dr. Sivaranjani Santosh, who started questioning misleading advertising practices practically a decade in the past. In 2022, she filed a Public Curiosity Litigation (PIL) earlier than the Telangana Excessive Courtroom, difficult the sale of drinks falsely marketed as ORS regardless of not assembly WHO-recommended electrolyte and glucose requirements.

Her petition highlighted how a number of corporations marketed ‘fruit juices’ and different sweetened drinks underneath the guise of being oral rehydration options, posing potential dangers, notably to youngsters and diabetic sufferers. Dr. Sivaranjani’s complaints additionally reached Rajesh Bhushan, the then Secretary of the Ministry of Well being and Household Welfare, prompting judicial and regulatory scrutiny.

Courtroom intervention and preliminary FSSAI response

The Telangana Excessive Courtroom, led by the Chief Justice, sought responses from each the FSSAI and the Drug Controller Normal of India, recognising the potential public well being implications of deceptive ORS claims. Following this, on April 8, 2022, FSSAI issued its first directive limiting using ‘ORS’ in meals labels or ads. Nonetheless, on July 14 that very same yr, the FSSAI knowledgeable Dr. Sivaranjani that the restriction was quickly relaxed following a writ petition filed by a number of corporations. The regulator determined to permit producers holding legitimate emblems to proceed producing such merchandise underneath their registered names till the Controller Normal of Patents, Designs and Emblems issued a last resolution.

WHO-approved ORS vs. sugar-loaded imitations

The World Well being Organisation prescribes a regular oral rehydration answer with a complete osmolarity of 245 mOsm/L. This composition consists of 2.6 grams of sodium chloride, 1.5 grams of potassium chloride, 2.9 grams of sodium citrate, and 13.5 grams of dextrose anhydrous (sugar) per litre of water.

In distinction, a number of merchandise marketed as ORS by pharmaceutical corporations comprise considerably increased sugar ranges, round 120 grams of whole sugar per litre, with practically 110 grams being added sugar. Their electrolyte steadiness can be inconsistent with WHO norms, offering simply 1.17 grams of sodium, 0.79 grams of potassium, and 1.47 grams of chloride per litre.

Reflecting on the result, Dr. Sivaranjani described the FSSAI order because the fruits of years of persistence and public assist. “It was a battle. Eight years of battle, three years of submitting PILs, and 4 to 5 years of preventing indifference. This victory belongs to not one individual, however to folks’s energy, all of the medical doctors, advocates, mothers, and influencers who stood with me. I stood steadfast, and we received,” she mentioned.