When customers ask for ORS, pharmacies often offer the sweetened ORSL drink instead of the WHO-recommended rehydration solution
Hyderabad-based paediatrician Dr. Sivaranjani Santosh hailed the Delhi High Court’s decision upholding the Food Safety and Standards Authority of India’s (FSSAI) ban on the use of the term ‘ORS’ (Oral Rehydration Salts) in food and beverage labels, calling it a major victory for public health and consumer safety.
Dr. Sivaranjani, who led the legal campaign that prompted the regulatory action, said the verdict is a victory for India and that not a single child’s life should be endangered because of misleading labels falsely using the term ORS. She urged the FSSAI to act decisively to ensure full compliance and prevent such violations in future.
The judgment, delivered by Justice Sachin Datta on October 31, 2025, in Dr Reddy’s Laboratories Ltd. & Ors. vs Union of India & Anrupheld the FSSAI’s orders dated October 14 and 15, and a subsequent enforcement communication issued on October 23, 2025. The court ruled that the regulator’s decision was justified on serious public health grounds and fell squarely within its statutory powers.
In its October orders, the FSSAI withdrew earlier approvals that had permitted the use of ‘ORS’ with prefixes or suffixes in product trademarksclarifying that only formulations strictly adhering to World Health Organisation (WHO) standards may be labelled as Oral Rehydration Salts or ‘ORS’. The ruling follows an eight-year campaign by Dr. Sivaranjani, who had in 2022 filed a Public Interest Litigation (PIL) before the Telangana High Court challenging the sale of beverages misleadingly marketed as ORS.
Petitioner’s challenge
Hyderabad-based Dr. Reddy’s, which manufactures ‘Rebalanz Vitors’, contended that FSSAI’s decision was arbitrary, taken without notice, hearing, or consultation with stakeholders. The company claimed that the orders had a significant impact on its operations and proprietary trademark rights and infringed its fundamental rights.
The petition pointed out that large quantities of its beverage, sold in 200 ml packs under apple, orange, and mango flavours, were already manufactured and distributed before the FSSAI’s order, and were now lying unsold. According to the petition, Dr. Reddy’s Laboratories had a total of 8,47,181 units of its “Rebalanz Vitors” beverage lying unsold in its finished goods inventory, with a combined value of approximately ₹1.39 crore as of October 15.
The company argued that without relief, it would suffer heavy monetary losses since the products could not be sold with existing packaging.
FSSAI’s findings
During the final hearing on October 31, the FSSAI, represented by Additional Solicitor General Chetan Sharma, noted that earlier approvals (granted in July 2022 and February 2024) were conditional and subject to review, and could be withdrawn in public interest. It found that disclaimers on product labels were ineffective when brand names prominently featured ‘ORS’, using similar fonts and colour schemes as medical ORS formulations.
Court’s analysis
Justice Sachin Datta observed that the FSSAI’s actions were impelled by serious public health considerations and intended to safeguard consumers, particularly vulnerable groups. The court declined to interfere with the expert body’s technical and regulatory decisions, holding that it was not appropriate for judicial review to second-guess such policy determinations.
“The approach of utmost caution as adopted by the respondents on an issue which could endanger public health gravely cannot be faulted with,” the court said, adding that statutory obligations under the FSS Act could not be subordinated to private commercial losses.
Relief sought and final direction
The court recorded that Dr. Reddy’s had stopped production of new stocks and expressed willingness to relabel or rebrand existing inventory. The company also sought permission to sell products already in the supply chain to avoid financial loss.
The court declined to pass any direct relief, instead directing the FSSAI to consider the petitioner’s representation on this issue and pass a reasoned order within one week, after affording an opportunity of hearing. The writ petition was accordingly dismissed, while granting liberty to the petitioner to approach the FSSAI regarding the unsold stock.
Published – November 02, 2025 11:37 am IST
