Bombay HC Directs Maharashtra FDA to Grant Hearing Before Banning Medicines

The Bombay High Court on Tuesday directed the Maharashtra Food and Drug Administration (FDA) to grant pharmaceutical companies a hearing before taking regulatory action against their products. A Division Bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad made the observation while criticizing the regulator for using "a sword to kill a mosquito" in its enforcement actions across Maharashtra.

The court was hearing a plea filed by Cadila Pharmaceuticals Limited, which had challenged the state FDA’s decision to ban the sale and distribution of some of its medicines. The regulator had also seized stock worth ₹2.45 crore across Maharashtra over alleged branding similarities.

During the hearing, the High Court warned that it might start imposing costs on the FDA, noting that it was repeatedly coming across similar cases involving the regulator in the state. The bench expressed strong disapproval over how the agency exercised its authority, remarking that power must be used with restraint and proper procedure.

"You have the power to use a sword, but the problem is you are using it to kill a mosquito. Power has to be exercised with restraint. It has to be used properly," the bench said. The judges added that even in cases involving hotels and restaurants, the regulatory practice appeared to be to "shoot first and then ask questions."

In response, government pleader Neha Bhide defended the agency's actions, stating that there was confusion between the medicines in question. She argued that the decision was taken purely as a preventive measure rather than high-handed action by the authority.

However, Bhide submitted to the court that the FDA would revoke its orders against Cadila Pharmaceuticals Limited. She assured the bench that the regulator would issue show-cause notices and grant a hearing to the company before passing any reasoned order on the matter.

Following the government pleader's assurance, the High Court accepted the statement and officially disposed of Cadila Pharmaceuticals' petition.