Dr Reddy’s Laboratories Ltd has filed a petition in the Delhi High Court challenging the Food Safety and Standards Authority of India’s (FSSAI) directive restricting use of the label “ORS” for its oral rehydration solution brand Rebalanz VITORS, saying the abrupt regulatory move will inflict “huge monetary loss”, according to a petition filed by the pharma company, seen by Moneycontrol.
The company said large volumes of the product have already been manufactured, distributed, or are in production. Unless the finished goods are permitted for sale and existing packaging materials are allowed to be used, the petition stated, “the entire inventory will be a complete loss.”
Launched in 2018, Rebalanz VITORS is a ready-to-serve fruit beverage with essential electrolytes and minerals to help replenish essential salts in the body. Dr Reddy's did not immediately respond to request for a comment.
"The Impugned Orders have exposed the Petitioners to immediate enforcement actions nationwide, including prohibition on sales, product seizures, license suspensions and criminal penalties," the company said in its petition.
On October 14, FSSAI issued a sweeping order withdrawing all prior permissions for food-and-beverage companies to use the term “ORS” in product names or branding unless they met the standard medical formulation. The regulator deemed use of “ORS” branding by sugary or electrolyte drinks as misleading to consumers, particularly children, and in violation of the Food Safety and Standards Act, 2006.
Soon after which, JNTL Consumer Health, which manufactures and markets the popular hydration drink ORSL, filed a petition challenging the order and sought relief to sell its existing stock worth Rs 180 crore. The court later allowed the company to sell its stock after hearing the plea, but the company was asked to give a representation to the food regulator within seven days from the order dated October 17.
In the latest petition, Dr Reddy’s points out that its stock, packaging materials and supply chain were aligned to prior permissions and then suddenly caught in this regulatory change. The company is therefore seeking relief to sell existing inventory and use existing packaging, while contesting the regulatory order’s impact.
According to the petition, Dr Reddy’s has around 8.47 lakh units of unsold Rebalanz VITORS across its apple, orange, and mango variants, with a total realizable value of Rs 1.39 crore, as of October 15. The matter is now listed for October 31 and the court has directed FSSAI to take a decision based on the representation submitted by JNTL.
The petition was argued by senior advocate Neelam Tripathi along with Sanam Tripathi, Anjali Kaushik, Kriti, and Harjeet Singh on behalf of Dr Reddy’s, while Aamir Zafar Khan, Tanvi Kakar, and Aparna Banerjee appeared for the Food Safety and Standards Authority of India (FSSAI)
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