Wednesday, February 28, 2024

Delhi High Court tells petitioner to approach FSSAI over sale of misleading ORS sachets

The Delhi High Court on Thursday disposed of a plea highlighting the sale of misleading Oral Rehydration Salts (ORS) solutions, which is administered to prevent dehydration caused more particularly due to diarrhoea, by leading pharmaceutical brands in the Indian market, asking to the competent authority to treat the petition as a representation. 

The Division Bench comprising Chief Justice D. N. Patel and Justice Jyoti Singh was hearing a plea by a JNU Professor, alleging that Johnson and Johnson Private Limited’s ORSL, ORSL Plus, ORSL Rehydrate; and Amrutanjan Health Care Limited’s Fruitnik Electro+ ORS does not conform to the ORS formulation prescribed by the World Health Organisation. 

The Bench asked the Food Safety and Standards Authority of India (FSSAI) or any other competent authority to treat the petition as a representation and to decide the same as expeditiously as possible, in accordance with law, rules, regulations and government policies applicable to the facts of the case, after giving an adequate opportunity of being heard to the concerned parties in case any adverse order is to be passed against any of the respondents.

Filed though Advocate Gurinder Pal Singh by one Rupa Singh, a mother of an eight-year-old girl, who administered ‘ORSL’ to her daughter under the belief of giving ‘ORS’, which resulted in deterioration of her child’s health. A paediatrician, subsequently, informed her that ‘ORSL’ is not ‘ORS’ and does not even have the composition as prescribed by WHO, claimed the plea.

The petition pointed out that the Drug Controller General of India, in June 2004, issued a notification to all ORS manufacturing companies to introduce ORS with reduced osmolarity of 245 mOsmol/l, in conformity with the WHO standards. 

It further pointed out that manufacture and sale of ORS other than those conforming to the parameters prescribed by the WHO is prohibited by the Centre under Section 26A of Drugs and Cosmetics Act, 1940

Relying on various articles written by several paediatricians, the plea stated that consumption of ‘ORSL’ or ‘Fruitnik Electro+ ORS’ drinks is harmful during diarrhoea, as these contain fruit juices or are high in sugar, which could adversely affect the health of the consumer of such drinks.

The plea alleged that sale of such fruit juice-based drinks, which are not meant to be manufactured, distributed or marketed as an ‘ORS’ drink using names like ‘ORSL’, create deception and confusion amongst consumers, as also amongst in-store or online pharmacies selling these drinks.

The petitioner inter alia prays for the following: a) A direction to take appropriate steps to inform the general public of the nature of risk to health involved in administration of such misleading drinks;  as also to reduce or eliminate such risk.

b) Publicizing and making school authorities aware that ‘ORSL’, ‘ORSL Plus’, ‘ORSL Rehydrate’ and ‘Fruitnik Electro+ ORS’ are not to be administered to children as an ORS option.

c) Ensuring compliance with Rule 5 (1) of the Food Safety and Standards (Labelling and Display) Regulations, 2020, and prohibiting advertisement, marketing or sale of such drinks, including free sale in school campus or to school children, in an area within 50 meters from the school gate.

d) Ensuring strict compliance of Section 30 and 34 of the Food Safety and Standards Act, 2006, and prohibiting the manufacturing, storage, marketing, distribution and/or sale of ‘ORSL’, ‘ORSL Plus’, ‘ORSL Rehydrate’ and ‘Fruitnik Electro+ ORS’ in the manner shown and description projected as at present and in their present labelling format.

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e) A direction to the FSSAI and manufacturers of such drinks to make modifications in their packaging labels so as to remove any doubt or misgiving about the products; and further, to add ‘disclaimers’ in bold clearly mentioning that “it is not an ORS”, “it is not a WHO recommended formula” and “its use in diarrhoea would be injurious to health.f) Initiating prosecution against the manufacturers of the aforementioned drinks 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.

g) Ensuring strict enforcement and implementation of Advertising and Labelling Regulations in relation to online pharmacies to enable average customers to check and verify all product related information.


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