India

Clarify your brands not WHO recommended ORS: Patent body to ORS resembling products

Archana Jyoti

It’s official now. In line with the directives issued by the Food Safety and Standard Authority of India (FSSAI), the Controller General of Patents, Designs and Trademarks (CGPDTM) has made it clear to the manufacturers with trademarks resembling ‘ORS’ (oral rehydration salts) to clarify that their products are not WHO-recommended ORS.

The directives from the top patent body, says, the companies manufacturing energy drinks that have trademarks similar to the term ‘ORS’ (oral rehydration salts) will have to prominently display that their product is “not an ORS as recommended by the WHO.”

The move follows complaints regarding misleading marketing of products claiming to be ‘ORS’ substitutes, despite being medicinal formulations. Effective from April 1, 2024, all Food Business Operators (FBOs) in the manufacturing of products with such brand will have to adhere to these instructions to ensure compliance.

ORS, a drug under Drugs and Cosmetics Rules 1945, is specifically used for treating acute diarrhoea with a composition prescribed by the Drugs Controller General of India (DCGI). ORS, which comes in a small packet and dissolves in water, and can also be prepared at home is a sort of elixir  for kids suffering from life-threatening diarrhea. A whopping 500,000 children under five die from diarrhea globally. India accounts for the most global cases of child diarrhea.

Despite earlier directions from the FSSAI, some companies opposed declaring their products as non-ORS. However, the Delhi High Court’s August order and subsequent agreement from CGPDTM supported FSSAI’s stance.

 Following CGPDTM’s ruling, FBOs must cease production and recall such products, while also prominently stating on packaging that their product is not a WHO-recommended ORS.

Additionally, a disclaimer must clarify the product’s true nature.

The product ‘ORS’ is a drug under Drugs and Cosmetics Rules L945, which is used for treating acute diarrhoea and has a specific composition prescribed by the Drugs Controller General of India (DCGI).

As per the FSSAI,  “The marketing and labelling of the fruit-based beverages etc. in the name of ORS is not only misleading for the ordinary consumers but also harmful for the patients who may consume such products as ORS, especially in case of children suffering from diseases like diarrhoea, gastroenteritis, etc. may have serious health repercussions.”

With CGPDTM’s decision in the matter, the FBOs now will have to stop production of such products from the date of such decision and recall the products available in the market. In the meantime, FBOs will also provide a prominent declaration on their Front-of-Pack either through non-detachable stickers or printing that ‘The product is NOT a ORS formula as recommended by WHO’ or the FBOs may use similar meaning phrases without changing the intent.