Fake ORS labels are a health hazard; can't allow them to be in the market: Delhi High Court

The Delhi High Court on Friday observed that it will not interfere with the Food Safety and Standards Authority of India (FSSAI) directive banning the sale of beverages with misleading 'ORS' labels [Dr Reddys Laboratories Limited v. Union of India & Anr]. 

The FSSAI had issued a notification stating that using ORS, even with prefixes or suffixes in trademarked names, is misleading and constitutes a violation of the Food Safety and Standards Act, 2006, unless the product complies with the World Health Organisation (WHO) formulation.

ORS is the term used for oral rehydration solution formulations recommended by the WHO and is given to people suffering from dehydration.

Justice Sachin Datta today said that the public health hazard cannot be allowed to continue and that the embargo imposed on the manufacture and sale of such products will continue. 

“It is a health hazard…This embargo will continue. I am not doing away with the embargo, considering the public health concerns,” the Bench remarked. 

The Court made the comments while hearing a plea filed by Dr Reddy's Laboratories challenging the FSSAI orders of October 14 and 15, withdrawing earlier approvals that had allowed the use of the term 'ORS' with prefixes or suffixes in registered trademarks for electrolyte and beverage products. 

Dr Reddy's Laboratories manufactures a product called Rebalanz VITORS. Counsel appearing for the pharma company stated that it has already stopped manufacturing fresh batches and was ready to change the name. However, the counsel asked that the product, which is already on the market, may be allowed to be sold with the Rebalanz VITORS mark. 

Additional Solicitor General (ASG) Chetan Sharma and Central Government Standing Counsel (CGSC) Ashish Dixit appeared for the FSSAI and opposed the request. 

They also informed the Court about a detailed order passed by the FSSAI dealing with the representation made by JNTL Consumer Health India, the Indian subsidiary of the American company Kenvue.

On October 17, the Court had protected JNTL against the FSSAI decision. The order was portrayed on social media as the Court having allowed food business operators (FBOs) to continue manufacturing beverages and styling them as ORS. The firm was allowed to approach the FSSAI with its reasons and the food safety body was asked to pass a detailed reasoned order.

However, on October 28, while hearing Dr Reddy's Laboratories' case, the Court had clarified that its order was not meant for other companies to continue manufacturing and selling such products.

Ultimately, the Court today said that Dr Reddy's Laboratories can make a representation before the FSSAI regarding its proposal to rename the product and the selling of its existing product in the market. Justice Datta added that he will fix timelines for the FSSAI to consider and decide Dr Reddy’s plea. 

However, the Court reiterated that it is not passing any order allowing the sale or manufacture of the products. 

“Public health considerations are paramount. We can't pass any orders against it,” the Court said.