Bombay HC Warning Prompts FDA to Revoke Order Against Cadila Pharmaceuticals
MUMBAI — The Bombay High Court on Tuesday warned the Maharashtra Food and Drug Administration (FDA) against displaying its powers through drastic action without following due procedure, prompting the regulator to agree to revoke its orders halting the sale and seizure of medicines from Cadila Pharmaceuticals Ltd.
A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad made the observations while hearing a petition filed by Cadila Pharmaceuticals Ltd in Mumbai. The drug manufacturer had challenged FDA orders that stopped the sale and distribution of several medicines—including Aciloc 150, Aciloc 150 Plus, Aciloc 300, and Aciloc 300 Plus—and seized stock valued at approximately Rs 2.45 crore.
Senior advocate Birendra Saraf, appearing for Cadila, told the court that the company was not granted an opportunity to explain its position before the regulatory orders were issued. Government pleader Neha Bhide defended the FDA, arguing that the action was a preventive measure rather than high-handedness, citing potential confusion caused by branding similarities among the medicines despite differences in their active pharmaceutical ingredients.
The High Court bench questioned the procedural conduct of the regulator, noting that it was concerned about patients losing access to required medication. The court observed that while it was not focused on the financial loss suffered by the company over the preceding two weeks, it was worried about members of the public who were left without access to these medicines.
During the hearing, the bench remarked that the regulator had the power to use a sword but was using it "to kill a mosquito," emphasizing that authority must be exercised judiciously and with adequate propriety. The court criticized the FDA for taking action prior to hearing the affected party and warned that it might impose heavy costs on the regulator in future cases.
Following the court's remarks, Bhide assured the bench that the FDA would revoke its orders against Cadila. She stated that the regulator will instead issue show-cause notices to Cadila, allow the pharmaceutical firm to submit its response, and subsequently issue a reasoned order.
The High Court accepted the state's assurance and disposed of the petition. The same bench had expressed similar concerns the previous week regarding FDA action against an Amazon Retail India warehouse.
