Bombay High Court Directs FDA to Be Judicious, Revoke Cadila Sale Ban
The Bombay High Court on Tuesday offered relief to Cadila Pharmaceuticals Ltd after the Food and Drug Administration offered to revoke its orders banning the sale of several of the company's medicines. A high court bench comprising acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad disposed of the pharmaceutical firm's petition in Mumbai after the state regulatory body agreed to issue show-cause notices and conduct a hearing before taking further action.
Addressing the widespread drive initiated by the state regulatory authority under its latest commissioner, Tukaram Mundhe, to root out non-compliance with safety standards, the high court bench suggested that the agency should "be judicious" in its approach. During the proceedings, the bench observed that the regulator was merely "displaying its powers" when it moved to halt the sale of the drug manufacturer's products without prior hearing.
Appearing on behalf of Cadila Pharmaceuticals, senior advocate Birendra Saraf explained to the court that the core issue involved the use of brand extension by pharmaceutical companies, describing it as an established industry-wide practice. Saraf highlighted that the Centre had called for a public consultation on 6 July 2026 regarding the subject. He argued that even while this central consultation process was ongoing, the state Food and Drug Administration initiated coercive steps against Cadila despite the company possessing a valid manufacturing licence.
Following suggestions from the high court bench that a hearing ought to be granted before any drastic enforcement action is taken, government pleader Neha Bhide made a submission on behalf of the FDA. Bhide stated that the state regulator would revoke its current restrictive orders against Cadila, issue show-cause notices to the firm, and allow the company a fair hearing prior to passing any reasoned order on the matter.
Submitting the regulator's position, Bhide maintained that the action taken by the authority was intended as a preventive measure rather than a high-handed action. She informed the bench that the regulatory intervention stemmed from confusion over the specific medicines involved. Accepting the government pleader's undertaking, the high court formally disposed of Cadila's plea while emphasizing the need for balanced enforcement.
