Dr Santosh is at the forefront of a campaign to clarify the differences between the original ORS and a similarly named product, ORSL.
Published Feb 10, 2024 | 8:00 AM ⚊ Updated Feb 10, 2024 | 8:00 AM
Dr Sivaranjani Santosh. (Supplied)
Meet Dr M Sivaranjani Santosh, an ardent paediatrician hailing from Hyderabad, who has emerged as a pivotal force in the battle against the misleading ORSL.
ORSL, available in various flavours and packaged in Tetra Paks, can be found in numerous pharmacies. Dr Sivaranjani reveals that these, unfortunately, are being erroneously marketed as electrolyte-enriched rehydration solutions.
The product’s name and composition bear a striking resemblance to the World Health Organization (WHO)-recommended Oral Rehydration Salts (ORS), which Dr Sivaranjani finds disconcerting.
“It has been a four-year struggle against ORSL. The government has turned a deaf ear. I am pursuing legal action as well, having already reached out to everyone from the Prime Minister’s Office to the Health Minister,” laments Dr Sivaranjani, while speaking to South First.
Distinguishing between ORS and ORSL, Dr Sivaranjani emphasises that ORS, widely recognised as Oral Rehydration Solution or Oral Rehydration Salts, is a vital remedy for dehydration caused by diarrhoea.
Its familiarity in India stems from its role in assisting millions during emergencies. Its application ranges from economically challenged individuals creating makeshift ORS at home to the middle class opting for a convenient ₹12 packet from the market, available in orange and lemon flavours for easy preparation.
Contrastingly, ORSL, labeled as an electrolyte drink, asserts its ability to restore fluids, electrolytes, and energy. This fruit juice-based beverage, enriched with Vitamin C and essential electrolytes like sodium, potassium, and chloride, is ready to serve but explicitly not recommended during diarrhoea.
All ORSL variants are classified as “food”, falling under the “Electrolyte Drink” category, complying with the regulations of the Food Safety and Standards Authority of India (FSSAI). Importantly, they are not intended for the prevention, alleviation, treatment, or cure of any disease or disorder.
The confusion surrounding ORS and ORSL arises from their similar naming and packaging, potentially leading consumers to mistakenly purchase ORSL when seeking an ORS solution for diarrhoea treatment.
ORS and ORSL are distinct products meant for different purposes. ORS, recommended by the WHO, is specifically formulated to treat dehydration caused by diarrhoea, with a balanced mixture of electrolytes and glucose designed to replenish body fluids and electrolytes lost during dehydration. It has a specific osmolarity (measure of solute) of 245 mmol/L to ensure it’s effective for rehydration without worsening the condition.
Conversely, ORSL, despite its nomenclature, stands as a brand of rehydration drinks not formulated according to the WHO-recommended proportions for ORS. It’s more akin to a fruit-flavoured beverage with electrolytes and is not intended for treating dehydration due to diarrhoea. The osmolarity of ORSL is significantly higher (585 mmol/L) than the WHO-recommended ORS, making it unsuitable for treating dehydration caused by diarrhea.
“This higher concentration can potentially harm patients with diarrhoea by not effectively addressing their dehydration needs,” Dr Sivaranjani explains.
“It’s crucial to distinguish between these products to ensure the appropriate treatment for dehydration, especially in children, diabetics, older people who are more susceptible to the adverse effects of dehydration and diarrhoea,” she adds.
Insufficient replenishment of essential salts and the exacerbation of diarrhoea due to excessive sugar content in these beverages are the primary concerns that expose children to the perils of dehydration, potentially leading to fatal outcomes. The persistence of diarrhoea, exacerbated by the surplus sugar in these formulations, also contributes to the unwarranted use of antibiotics.
Dr Sivaranjani’s relentless fight against the misrepresentation of these products as ORS spans four years, with her proactive engagement reaching legal avenues. In 2022, she filed a Public Interest Litigation (PIL) with the Telangana High Court, challenging the deceptive marketing of these products.
In her pursuit to raise awareness and combat misleading practices, Dr Sivaranjani demanded regulatory action in 2022, specifically targeting companies falsely advertising “fruit juices” as ORS, failing to meet WHO standards. This initiative involved correspondence with Rajesh Bhushan, the then Secretary of the Ministry of Health and Family Welfare, prompting significant judicial scrutiny.
The Chief Justice of the Telangana High Court sought responses from the FSSAI and the Drug Controller General of India, emphasising the potential health risks posed by these products to both children and adults with diabetes.
Subsequently, on 8 April, 2022, FSSAI issued a directive restricting the use of terms like “ORS” on food labels or in advertisements. However, on 14 July, FSSAI informed Dr Sivaranjani that, following a writ petition by companies, “it has been decided to allow these companies with valid trademarks to manufacture such products under their respective trademarked names till the decision of the Controller General of Patents, Designs and Trademarks is received,”
Dr Sivaranjani tells South First that despite her persistent efforts, the only discernible change was the inclusion of a disclaimer on ORSL Tetra Paks. However, she asks, “Who reads the disclaimer? Imagine those poor, illiterate people. Even if they manage to get some money to buy the ORS, pharmacies are likely to hand them these ORSL Tetra Paks only.”
Dr Sivaranjani underscores the gravity of the situation, stating that diarrhoea stands as the third leading cause of death among children in India, constituting 13 percent of deaths in the under-5 age group. ORS, a life-saving remedy for millions of children, continues to play a crucial role in preventing fatalities.
Undeterred, she maintains an unwavering commitment to the cause, persistently corresponding with the Prime Minister and the Ministry of Health and Family Welfare. She says, “WHO-recommended formula ORS, as you know, has been formulated such that it replaces the water and salts lost from the body during episodes of diarrhoea and vomiting, in the correct proportions, and thus protects the child from the dangers of dehydration, including seizures, kidney failure, and death.”
She vows to not give up. “My efforts to reach out to FSSAI and CDSCO (Central Drugs Standard Control Organisation), Health Ministry, and Prime Minister’s Office has not yielded any results. But I will continue to fight against this, until these products either change their labels or are out of the market.”
Dr Sivaranjani pins her hope on the judiciary to address the matter seriously, calling upon organisations like HRDA and various paediatric and doctors’ associations in India to join the cause.
“We doctors have the biggest role to play. Imagine hundreds and thousands of diabetic patients drinking these ORSL Tetra Paks assuming that it’s ORS. Several will end up dead. Since the effect is not immediate, people don’t take this seriously. Poor people will succumb and the rich might get admitted for a IV drip for severe dehydration,” she argues.
Dr Sivaranjani has taken proactive steps to raise awareness about the distinctions between ORS and ORSL products, as well as the associated dangers of the latter. She actively imparts a set of guidelines and disease-related awareness, covering scenarios such as ‘what to do if a child chokes on something’.
“My children rarely get admitted for these conditions. They know what they should take and what they should not when suffering from diarrhoea. They also don’t take antibiotics unnecessarily. I am continuing my awareness in my own way and request all my fellow colleagues and the medical community to do this,” Dr Sivaranjani adds.
Dr Madap Karuna, a paediatrician from Hyderabad, aligns with Dr Sivaranjani’s perspective. She tells South First, “I always tells parents to avoid ORSL-type products resembling popular beverages like Frooti due to their contents. Instead, I educate them on the correct usage of ORS sachets by ensuring proper mixing with water.”
