Used sword to kill mosquito: Bombay HC raps FDA over Cadila drug stop-sale orders
The Bombay High Court on Tuesday granted relief to Cadila Pharmaceuticals Ltd and sharply rebuked the Maharashtra Food and Drug Administration (FDA) over its stop-sale
The Bombay High Court on Tuesday granted relief to Cadila Pharmaceuticals Ltd and sharply rebuked the Maharashtra Food and Drug Administration (FDA) over its stop-sale orders against medicines manufactured by the drugmaker, saying the food regulator had used its powers like a "sword to kill a mosquito". A bench of Acting Chief Justice RV Ghuge and Justice Gautam Ankhad was hearing a petition filed by Cadila challenging the FDA's recent directives to seize stocks and halt the sale and distribution of several of its medicines. The court said it had no doubt about the FDA's powers but questioned the manner in which they were exercised. Read Full Story "We have no doubts about your powers. You only display your powers, but the problem is you have the power to use the sword, but you use it to kill a mosquito," Ghuge told FDA's lawyer Neha Bhide.
The bench stressed that the issue was not whether the regulator had the authority to act, but how it exercised that power with adequate propriety. The FDA, headed by Commissioner Tukaram Mundhe, had seized stocks and stopped the sale and distribution of several Cadila medicines. Cadila's lawyer, senior advocate Birendra Saraf, sought the cancellation of the orders, arguing that they had caused substantial financial losses to the pharmaceutical company. The court, however, said its primary concern was not the company's financial losses but the impact of the stop-sale orders on patients. "The drug was not sold for 20 days. We are not concerned with the loss of Senior Advocate Saraf's client," ACJ Ghuge observed. "We are concerned that the drug was not available to the patients for 20 days, effectively 32 days till today," he added.
The bench also criticised what it viewed as the FDA's trigger-happy approach to regulatory action. "Shooting first and asking questions later is a rule of the Wild West which does not apply in the arena of law," the court observed. It also said such an approach could not be followed in the legal and regulatory system. "Even when it comes to hotels, you shoot first, then ask questions. The same is happening in this case," it said. The FDA defended its action by alleging that some Cadila products had similar branding despite containing different active pharmaceutical ingredients (APIs). According to the regulator, the similarity in branding could create a serious risk of medication errors if consumers or healthcare providers confused one medicine with another. While acknowledging the FDA's statutory mandate to regulate medicines and protect public health, the court questioned whether the manner in which the powers were exercised was proportionate.
The BriefWire