Sanchayita Lahkar

The High Court of Delhi, Single Bench of Justice Sachin Datta has dismissed a petition challenging the Food Safety and Standards Authority of India’s (FSSAI) decision to prohibit the use of “Oral Rehydration Salts (ORS)” in the labelling and branding of drink beverages. The Court declined to interfere with the FSSAI’s orders, observing that the regulatory measures were based on serious public health concerns and the potential “deleterious effect” and adverse health outcomes arising from the consumption of such products by individuals requiring genuine ORS formulations. The Court noted that the FSSAI’s actions were consistent with its statutory duty to prevent misleading representations and granted the petitioner liberty to approach the authority for permission to re-label or dispose of existing stocks.

The petition was filed by Dr. Reddy’s Laboratories Limited challenging the orders of the Food Safety and Standards Authority of India (FSSAI) dated 14.10.2025, 15.10.2025, and a subsequent communication dated 23.10.2025. These directives imposed an embargo on the use of the term “ORS,” whether alone or with any prefix/suffix, in naming any food product, including fruit-based or non-carbonated beverages.

Also Read: Delhi High Court Upholds Dismissal Of BSF Sub-Inspector For Illicit Relationship With Colleague’s Wife; Says Such Conduct Erodes Public Confidence And No Ground For Interference Under Article 226

The petitioner claimed these orders were issued without notice or consultation and that they infringed upon its proprietary rights and caused commercial losses due to unsold inventory. The petitioner referred to a prior decision in JNTL Consumer Health India Pvt. Ltd. v. Union of India (17.10.2025), seeking similar interim relief.

The respondents contended that the orders were based on scientific and public health grounds. FSSAI’s subsequent order of 30.10.2025 was placed before the Court, detailing that “ORS” denotes a WHO-recognized therapeutic formulation under the Drugs and Cosmetics Rules, 1945, and its misuse in food labels caused consumer confusion and health risks.

The FSSAI justified its regulatory action under Sections 16, 18, 23, and 24 of the Food Safety and Standards Act, 2006, and corresponding regulations concerning labelling, display, and advertising. The petitioner’s request for disposal of already manufactured stocks was deferred pending further representation to FSSAI.

The Court recorded that “the impugned orders and measures taken by the FSSAI are impelled by serious public health considerations. The same is in pursuance of, and to effectuate the statutory mandate of the FSSAI.” It observed that the orders were regulatory directions applicable industry-wide and not punitive in nature. Justice Sachin Datta stated that it would not be appropriate for the Court to “sit in appeal over a measure taken by the FSSAI on public health considerations.”

 The judgment noted that the FSSAI’s order dated 30.10.2025 identified “ORS” as a non-proprietary, therapeutic formulation and recorded evidence of consumer confusion and adverse health outcomes caused by beverages mislabeled with the term. The Court highlighted that the FSSAI’s decision was based on expert analysis, including complaints about products being mistaken for medical rehydration solutions, particularly endangering children and diabetic patients.

The Court cited precedents, including Vincent Panikurlangara v. Union of India (1987) and E. Merck (India) Ltd. v. Union of India (2001), to stress judicial restraint in matters involving scientific and technical expertise. It noted: “Having regard to the magnitude, complexity, and technical nature of the enquiry involved in the matter, a judicial proceeding of this nature is not an appropriate one for determination of such matters.” Further, the Court referred to Section 89 of the FSS Act, stating that the provisions of the Act override other laws, including the Trade Marks Act, wherever food safety is concerned. Accordingly, the Court found no infirmity in FSSAI’s action and stated that the regulator was justified in adopting a precautionary approach to protect public health.

Also Read: Supreme Court Upholds Woman’s Murder Conviction; First Dying Declaration Carries Evidentiary Value When Corroborated

The Court stated: “This Court is not inclined to interdict with the impugned orders, in light of the aforesaid order dated 30.10.2025 passed by the FSSAI. The petitioner has ceased manufacturing fresh stocks of its products” and allowed the company to make a representation before FSSAI regarding disposal or relabelling of existing stock. The regulatory body (FSSAI) shall consider this aspect of the matter on a representation being made by the petitioner in this regard… by way of a reasoned order, after affording an opportunity of hearing to the petitioner, within a period of one week of receipt thereof.”

Advocates Representing the Parties
For the Petitioners: Ms. Neelima Tripathi, Senior Advocate with Ms. Sanam Tripathi, Ms. Anjali Kaushik, Ms. Kriti Sharma, Mr. Harjeet Singh, Advocates, and Mr. Gopal K. Gangawali, Authorized Representative for Dr. Reddy’s Laboratories Limited.
For the Respondents: Mr. Chetan Sharma, Additional Solicitor General, with Mr. Ashish K. Dixit, CGSC, Mr. Aamir Zafar Khan, Mr. Umar Hashmi, Mr. Amit Gupta, Mr. Shubham Sharma, Mr. Abdullah Shahid, Mr. Vikram Aditya Singh, Mr. Yash Wardhan Sharma, Mr. Naman, Ms. Iqra Sheikh, Mr. Harshit Chitransh, Mr. Aditya Shandily, and Mr. Shivam Tiwari, Advocates.

Case Title: Dr. Reddy’s Laboratories Ltd. & Ors. v. Union of India & Anr.
Neutral Citation: 2025: DHC:9592
Case Number: W.P.(C) 16303/2025
Bench: Justice Sachin Datta