Oral rehydration salts: PIL seeks action against pharma companies

They are selling products without conforming to World Health Organisation formula, it says

The Delhi High Court on Thursday asked the government to consider as representation a petition seeking action against pharma companies for selling products as ORS (Oral Rehydration Salts) without conforming to World Health Organisation (WHO) formula.

A bench of Chief Justice D.N. Patel and Justice Jyoti Singh directed the Food Safety and Standards Authority of India (FSSAI) and the Delhi government to decide the representation by Rupa Singh, an Assistant Professor at the Jawaharlal Nehru University, in accordance with the law.

Ms. Singh, who has an 8-year-old daughter, said she was sold ‘ORSL’ as an “ORS Liquid” solution by a local pharmacy in Delhi. Misled by the label, Ms. Singh administered the liquid to her daughter under the belief that she was administering her ‘ORS’.

“When the child’s health deteriorated, she consulted a paediatrician and was shocked when she was told that ‘ORSL’ is not ‘ORS’ and does not even have the composition as prescribed by WHO,” her petition said.

“There is grave misconception and misinformation amongst pharmacies, both in-store and online who are selling these drinks (i.e. ORSL, ORSL Plus, ORSL Rehydrate and Fruitnik Electro+ ORS) as ORS Solutions and/or claiming them to be WHO approved formula,” the petition said.

What is ORS?

‘ORS’ is a drug under Class 27 of Schedule K of Drugs and Cosmetics Rules 1945 and it is being widely manufactured, distributed and sold in the Indian market by leading pharmaceutical brands, the plea said.

All such ORS solutions use the composition of the new ORS formulation as prescribed by WHO with reduced osmolarity of 245 and clearly indicate on their label that the ORS is as per the WHO recommended formula, it said.

The petition said ‘ORSL’ is a brand of pharma giant Johnson and Johnson. It said none of the beverages being sold under the name ORSL uses the composition of the new ORS formulation as prescribed by WHO.

The plea claimed that Fruitnik Electro+ ORS, a brand owned by Amrutanjan Health Care Ltd., was also being sold using the word ‘ORS’ when it is not an ORS solution.

The petition has sought direction to take appropriate steps to inform the general public of the nature of the risk to health which the products such as ‘ORSL’ and ‘Fruitnik Electro+ ORS’ present.

It also sought direction to launch prosecution against the pharma companies for “intentionally and deliberately cheating the public at large by fraudulently making them believe their products to be ‘ORS’ and thereby causing health and monetary loss to the public”.

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