Bombay HC Warns Maharashtra FDA Over Its Sudden-Sale Ban On Cadila Pharmaceuticals’ Identically-Branded Aciloc Medicine Range

The Bombay High Court on Tuesday came down heavily on the Maharashtra Food and Drug Administration (FDA) for halting the sale and distribution of several medicines manufactured by Cadila Pharmaceuticals Ltd and seizing its stock, observing that the regulator was merely "displaying its powers" instead of exercising them with restraint.

A division bench of Acting Chief Justice Ravindra V. Ghuge and Justice Gautam A. Ankhad was hearing a plea filed by Cadila Pharmaceuticals, represented by senior advocate Birendra Saraf, challenging the FDA's decision to stop the sale and distribution of its products, including Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus. The company told the court that the regulator had seized stock worth ₹2.45 crore without issuing a prior show-cause notice, and that the action had severely disrupted its operations across the state.

The FDA, headed by Tukaram Mundhe, had taken the action on the ground that the branding of these medicines was similar to other products in the market, even though the active pharmaceutical ingredients were different, raising the risk of medication errors among patients. Cadila, on its part, argued that no opportunity was given to it to explain or rectify the alleged discrepancy before the drastic step of a blanket stop-sale order and stock seizure was imposed, leaving patients without access to widely used, commonly prescribed antacid medication for weeks.

Appearing for the FDA, government pleader Neha Bhide told the court that the step was "a preventive measure, not a high-handed action." She said the regulator would revoke the stop-sale notice and follow due procedure going forward, including issuing show-cause notices and granting a hearing before passing any final order.

The bench was unimpressed with the manner in which the FDA had proceeded, and made clear that patients had borne the brunt of the regulator's haste. "We are concerned that the drug was not available to the patients for 20 days, effectively 32 days till today," Acting Chief Justice Ghuge said, adding that the company's commercial loss was not the court's primary concern.

The bench was particularly critical of the FDA acting without first affording Cadila an opportunity to respond. "Shooting first and asking questions later is a rule of the Wild West, which does not apply in the arena of law," the court remarked, drawing a comparison to how even hotels facing an insect infestation would not fire indiscriminately before identifying the problem.

The court went on to caution the FDA against a heavy-handed approach to enforcement, telling the regulator's counsel that its authority was not in question, only the manner of its use. "We have no doubts about your powers. You only display your powers, but the problem is, as I said last week, you have the power to use the sword, but you use it to kill a mosquito. Power has to be judiciously exercised. How to use the powers with adequate propriety is the question," the bench observed.

The court also noted that the FDA did not appear to grasp the seriousness of repeatedly acting first and correcting course only after judicial intervention, remarking that at best it could keep hearing such petitions each time the regulator overstepped. The bench indicated this was not an isolated instance, referring to an earlier observation made the previous week, where the regulator had similarly been pulled up for disproportionate enforcement action.

Reiterating that its concern lay with the patients who were denied access to essential medication, the bench said, "We are not worried about the loss faced by the company in the past two weeks. We are worried about those people who have not had access to these medicines."

With the FDA agreeing to revoke the stop-sale order and follow proper procedure, including a show-cause notice and a hearing before any fresh action, the High Court disposed of the petition, closing the matter while putting the regulator on notice about proportionality in enforcement.

Inputs from HT