Pharmacies still selling mislabelled ORS

Despite a ban on food brands for wrongly labelling their sugary drinks as ORS, some pharmacies in Bengaluru are tricking unsuspecting customers into buying them.

Doctors advise using only the WHO-recommended ORS (oral rehydration salts) formulation to replace fluids and electrolytes lost to dehydration. According to the WHO, diarrhoeal diseases are the third leading cause of death in young children and it considers ORS as a safe, cost-effective solution for its treatment.

Reality check

Metrolife visited 11 pharmacies between Sunday and Tuesday. When asked for ORS, five handed out tetra packs bearing the word ‘ORS’ in the product name but also carrying the disclaimer ‘Not an ORS’. In HSR Layout, a pharmacy belonging to a large chain said each of their branches had at least two boxes of non-compliant tetra packs to clear. At a private hospital pharmacy in Malleswaram, a staffer tried to sell a pseudo-ORS drink as “WHO formula with calories”. Several pharmacists believe the ban applied only to one brand — ORSL. In Dasarahalli, a store owner initially offered an ORSL pack with the said disclaimer but quickly fetched a WHO-recommended version from the same brand after we mentioned the recent court order (see box). A Richmond Town pharmacy tried to sell a fruit drink with ‘Electro’ in its branding. It cost Rs 4 more than genuine ORS packs in their stock.

Inside real ORS

Paediatricians say that while the problem of spurious ORS has come under public glare only recently, the medical community has long been aware of it. Many doctors write down the WHO-compliant ORS brands in their prescriptions, and where cost and access are limited, they teach patients how to make a safe ORS mix at home — with sugar (or rice ganji), salt, and a squeeze of lime.

They say giving a child non-WHO ORS can worsen diarrhoea rather than relieve it. Paediatrician Dr Kritika Agarwal says the reason lies in osmolarity, or the concentration of dissolved salts and sugars in the solution. She explains, “The osmolarity of the WHO-recommended ORS formula is 245 mOsm/L, and it provides 75 mg of glucose per litre. In contrast, many of these tetra pack drinks have up to 12 gm of sugar. The excess sugar draws water from the body into the intestines, further dehydrating the child.” Children under five are particularly vulnerable. “The surface area of their intestines is relatively larger compared to their body size, so they lose fluids more quickly,” she says.

Dr Yogesh Kumar Gupta, paediatrician and intensivist, says an imbalanced solution can lead to hypernatremia (excess sodium in the blood, causing thirst, nausea, and weakness) or hyperkalemia (excess potassium, leading to muscle weakness). Conversely, overly diluted ORS can cause hyponatremia or hypokalemia. While a one-off use of an ORS substitute may not cause immediate harm, he cautions against complacency. “In children, the elderly, or anyone with weaker kidney function, even mild imbalances can be risky,” he notes.

Paediatrician Dr Reena Philip Kovoor explains that electrolytes like sodium and potassium occur naturally in the body. “The role of ORS,” she says, “is to restore this internal chemical balance, which in turn regulates hydration mechanisms in the body”. This cannot be achieved by drinking water alone, she adds. Thus, giving an imbalanced ORS to a dehydrated child can lead to complications.

Experts says while buying ORS sachets or tetra packs, look for words ‘Based on WHO formula’ or ‘WHO recommended formula’ printed on them. He lists some brands that follow the right formulation: Electral from FDC, Prolyte ORS from Cipla, Walyte from Wallace, and Zelect from Bharat Biotech.

Action in Karnataka

A source close to the development said manufacturers of such drinks are primarily based in Andhra Pradesh, Punjab, and Assam. “One manufacturer in Karnataka has been issued a notice to direct its distributors to recall the existing stocks in 15 days,” he said. He added auditing the pharmacies doesn’t come under their purview, but that of the drug control department.

Food safety consultant Mamatha Mishra interprets the latest turn of developments: “The FSSAI ban emphasises that only the WHO-recommended formula (classified as the drug) is entitled to be lablleed as ‘ORS’. Other similar beverages are prohibited from using the term because they often fail to meet the therapeutic standard and can be harmful due to high sugar content. Therefore, while the concept of ORS fits within the definition of a food for special dietary use under Section 22, the actual, life-saving, WHO-compliant product is treated as a drug for regulatory purposes.”

She says the latest development is also a reminder to learn to read product labels carefully and contact brands for clarifications. “Adopting a science-based approach to our food choices is essential, as food offers much more than just taste,” she says.

‘Many battles yet to win’
Dr Reena notes that India faces major public health challenges from unqualified practitioners and dubious manufacturers, who are thriving because of grassroots corruption and official apathy. “There are many battles yet to be won,” she says.

Dr Kritika and Dr Gupta want tighter controls on the pharmacy level, especially with regards to the sale of antibiotics against dated prescriptions, milk powders loaded with sugar, and zero-calorie drinks. “Studies are increasingly linking these drinks to liver, kidney and metabolic diseases,” says Dr Gupta.

To report

According to Ramesh Agarwal, CEO of a food safety solutions company, citizens can visit the Office of the Food Safety Commissioner on Seshadri Road, or file a complaint through the Food Safety Connect app or on foscos.fssai.gov.in/consumergrievance.

According to advocate K M Sai Apabharana, non-compliance with such orders can attract a penalty of up to Rs 2 lakh under Section 55 of the Food Safety and Standards Act, 2006. If unsafe food causes harm, Section 65 allows consumers to seek compensation before the adjudicating officer or court, with compensation limits starting from Rs 3 lakh for grievous injuries and not less than Rs 5 lakh in case of death.

She adds that issuing misleading advertisements can also amount to unfair trade practices under the Consumer Protection Act, 2019. Section 21 empowers the Central Consumer Protection Authority to take action against manufacturers or endorsers for misleading ads, ordering their withdrawal or modification and imposing fines of up to Rs 10 lakh for a first offence. Under Section 82, consumers can approach the forum for compensation for harm caused by defective products. Section 89 provides for criminal liability against product sellers in cases of misleading advertisements, prescribing imprisonment of up to two years and fines of up to Rs 10 lakh, with stricter penalties for repeat offences.

Timeline of landmark regulation

2021-24: After years of campaigning, Hyderabad-based paediatrician Dr Sivaranjani Santosh starts writing to the Central Drugs Standard Control Organisation, FSSAI, and the health ministry about the dangers of misleading ORS-labelled drinks. In 2022, she files a PIL in the Telangana high court. FSSAI initially bars non-medical beverages from using the 'ORS' label, but shortly reverses the order, allowing the label with a disclaimer. Dr Sivaranjani continues her advocacy on social media, arguing such drinks were worsening dehydration among children.

Oct 2025: FSSAI issues directives asking food businesses to remove ‘ORS’ from products that don’t meet WHO standards, revoking two of its earlier orders. Following which, the Delhi high court grants interim relief to JNTL Consumer Health (maker of ORSL) on its petition to sell its existing stock worth Rs 180 crore, and directs FSSAI to hear the company’s representation. Later, when Dr Reddy’s Laboratories (Rebalanz Vitors) approaches the Delhi high court with a similar petition, it upholds FSSAI’s ban, citing public health concerns, but allows the company to approach FSSAI for disposal of existing stock.

Nov 2025: Metrolife finds some Bengaluru pharmacies still selling ORS-labelled sugary drinks to unsuspecting consumers.