FSSAI Bar on Dr Reddy's Nutraceutical Put on Hold: Delhi HC Awaits Regulatory Hearing Outcome

The case, heard by Justice Sachin Datta, pertains to a writ petition (W.P.(C) 16303/2025) filed by Dr. Reddy’s Laboratories Limited and others against the Union of India and the FSSAI.

The matter arises from FSSAI’s orders F. No. RCD-15001/6/2021-Regulatory-FSSAI [E-1475] dated October 14, 2025, and a subsequent clarification issued on October 15, 2025, along with a related communication dated October 23, 2025. These actions had the effect of restricting the manufacture, marketing, and sale of Dr. Reddy’s product Relalanz Vitors, a nutraceutical preparation.

Dr. Reddy’s sought the quashing of these orders, a direction restraining FSSAI from taking coercive steps against the company, and a mandate to hold a stakeholder consultation involving industry representatives, scientific experts, and consumer groups as envisaged under the Food Safety and Standards Act.

Earlier, the Medical Dialogues Team reported that the FSSAI directive clarified that, upon further review, the use of the term "ORS" in the trademarked name or in the naming of any food product otherwise—whether fruit-based, non-carbonated, or ready-to-drink beverages—even when accompanied by a prefix or suffix, constitutes a violation of the provisions of the Food Safety and Standards Act, 2006 and the regulations made thereunder.

Appearing for Dr. Reddy’s, Senior Advocate Neelam Tripathi argued that the impugned orders were issued without following due process and in violation of the principles of natural justice. She pointed out that in a similar matter decided by the Delhi High Court on October 17, 2025, the court had already directed that the FSSAI orders of October 14 and 15, 2025, would remain in abeyance until the concerned company’s representation was decided after hearing. It was therefore urged that Dr. Reddy be extended the same protection, as the issues were identical.

On behalf of FSSAI, counsel Aamir Zafar Khan informed the court that, in line with the earlier order of October 17, a hearing had been scheduled the same day (October 28) to consider the representation made by affected companies. He assured that the process would be completed by October 31, 2025, and that FSSAI was acting strictly in accordance with law. The counsel also clarified that no arbitrary enforcement action would be taken while the matter was being reviewed.

Justice Datta observed that the exercise contemplated in the earlier consent order was inherently urgent to ensure procedural fairness and legality in FSSAI’s actions. He noted that it would be prejudicial if the disputed product continued to be manufactured while the regulatory proceedings were ongoing.

Taking note of the assurance given by Dr. Reddy that it had already stopped manufacturing fresh stocks of Relalanz Vitors, the Court recorded the statement and indicated that the issue of disposing of the already manufactured stock would be considered at the next hearing.

In his order, Justice Datta stated:

“It is assured and undertaken that the said exercise shall be concluded before 31.10.2025. Let the outcome thereof be placed on record inasmuch as the same will also have a bearing on the present matter.”

The Court further recorded:

“Dr. Reddy’s Laboratories Limited has ceased manufacturing of fresh stocks of its product (Relalanz Vitors). The said statement is taken on record. However, it is sought that appropriate orders be passed to enable the company to dispose of the already manufactured stocks. The said aspect shall be considered on the next date of hearing.”

Accordingly, the High Court directed that the FSSAI’s orders dated October 14 and 15, 2025, shall not be given effect against Dr. Reddy’s until the representation is decided after due hearing. The matter has been listed for further consideration on October 31, 2025, under the “Supplementary Matters” category.