MUMBAI: The Bombay High Court on Tuesday directed the Maharashtra Food and Drug Administration (FDA) to act “judiciously” after Cadila Pharmaceuticals Ltd challenged orders stopping the sale of some of its medicines.
A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad observed that the FDA appeared to be “displaying its powers” and questioned the regulator’s approach of taking drastic action before conducting proper inquiries.
The FDA subsequently offered to revoke its orders against Cadila, issue show-cause notices and give the pharmaceutical company an opportunity to be heard before passing fresh, reasoned orders. Government pleader Neha Bhide made the submission, which was accepted by the court. The bench then disposed of Cadila’s petition.
Bhide said the FDA’s action was a preventive measure and not “high-handed”, adding that it stemmed from confusion over the medicines in question.
Senior counsel Birendra Saraf, appearing for Cadila, argued that the FDA’s orders, issued between July 9 and July 15, were arbitrary and high-handed as they were passed without giving the company a prior hearing.
He sought quashing of the orders and an interim stay.
Cadila told the court that it had already suffered substantial losses after the sale ban remained in force for about 20 days. The company also said the FDA had seized stocks worth Rs 2.4 crore across Maharashtra over alleged branding violations.
The bench, however, said its concern was not the company’s losses but the impact of the ban on patients. The acting chief justice noted that a crucial medicine had remained unavailable for patients for 32 days.
The court reiterated its criticism of what it described as the FDA’s tendency to “shoot first” and conduct inquiries later. The bench also warned that costs could be imposed if more instances of such “drastic action” came before it.
“You have the power to use a sword, but the problem is you are using it to kill a mosquito. The power has to be judiciously exercised. It has to be used properly. Even in the cases of hotels and restaurants, you shoot first and then ask questions,” the bench observed.
The court’s remarks came amid scrutiny of the FDA’s recent enforcement drive under commissioner Tukaram Mundhe to tackle non-compliance with food and drug safety standards.
