The Bombay High Court has offered significant relief to Cadila Pharmaceuticals by reprimanding the Maharashtra Food and Drug Administration (FDA) for prematurely halting the distribution and sale of several of the company’s medications.
Cadila had approached the court challenging a series of orders by which the Maharashtra FDA had clamped injunctions across three of the company’s locations, restraining it from disposing of, distributing or selling its stock. The action extended to the seizure of stock valued at INR 2.45 crore across the State, on the basis of asserted similarities in branding. The matter was heard at length over two days, on 10 and 11 August 2026
While the court acknowledged the FDA’s statutory powers to regulate such matters, it heavily criticised the agency’s disproportionate and extreme execution of the same. Addressing FDA counsel, Acting Chief Justice Ravindra V. Ghuge noted that while the agency undoubtedly holds power, it was essentially using a “sword to kill a mosquito”. The Bench further stressed that regulatory bodies must act with propriety, observing that a “shoot first and ask questions later” mentality is a rule of the Wild West and has no place in the legal system.
Following the court’s severe reprimand, the state FDA, operating under Commissioner Tukaram Mundhe, withdrew its stop-sale orders. The agency assured the bench that it would strictly adhere to due process before initiating any future actions.
The division bench comprising ACJ Ravindra V. Ghuge and Gautam A. Ankhad, disposed of the writ petition by recalling and vacating the FDA’s impugned orders that restricted Cadila Pharmaceuticals from distributing and selling its “ACILOC 150”, “ACILOC 150+”, “ACILOC 300” and “ACILOC 300+” tablets, noting that the injunctions had lost their efficacy due to the lapse of the time line prescribed therein.
“The impugned notices would stand neutralized and would forthwith lose their efficacy. The Assistant Commissioner, Food & Drug Administration, Maharashtra State, would be issuing notices within seven working days,” the bench noted.
The Court directed the FDA to issue fresh show cause notices under Rule 85 of the Drugs Rules, 1945 within seven working days, granting the Petitioner a 21-day period to file written responses. Subsequently, the issuing authority is mandated to conduct a proper hearing, pass reasoned orders, and serve them to the Petitioners via email within 24 hours, while expressly preserving the Petitioner’s liberty to pursue legal remedies against any future adverse decisions.
“The Hon’ble Court’s observations underscore the fundamental obligation of regulators to observe the principles of natural justice, particularly the sacrosanct rule of audi alteram partem, ensuring that no adverse order is passed against a person without first affording them a fair opportunity of being heard,” said Ashutosh Kumar, senior partner, Singh & Singh.
Cadila Pharmaceuticals Ltd. was represented by senior advocate Dr. Birendra Saraf along with advocates Ashutosh Kumar, Kunal Vats, Anmol Saxena, and Ayush Sharma from Singh and Singh Law Firm LLP;
Bombay Counsels included Alankar Kirpekar and Shekhar Bhagat.
