Observing that the Maharashtra FDA is using a sword to kill a mosquito and “shoots first” before asking questions, the Bombay High Court on Tuesday asked the regulator to use its power judiciously, warning of imposing heavy costs as cases of its drastic actions have come to its notice.
Hearing a petition filed by Cadila Pharmaceuticals challenging the FDA’s action on select drugs, the high court directed the agency to grant the company a hearing before taking any drastic action.
Following the remarks made by a bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, the FDA submitted that the regulator will revoke its orders against the petitioner, issue show-cause notices, and grant it a hearing before passing a reasoned order.
Cadila Pharmaceuticals Ltd has challenged the FDA’s decision to bar the sale and distribution of some of its medicines and seizure of stock worth ₹2.45 crore across the state over branding similarities.
Government pleader Neha Bhide told the court that there was confusion between the said medicines and hence the decision was taken.
“It was a preventive measure and not high-handed action,” she said.
Referring to the FDA’s order on Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus, the company claimed it was not granted a hearing before the injunction orders were passed.
The bench noted that the department ought to have granted the company an opportunity to present its case before taking any drastic action.
“We are not worried about the loss faced by the company in the past two weeks since the order was passed. We are worried about those people who have not had access to these medicines,” the high court said.
The court, while warning to impose heavy costs on the FDA, said it is coming across several such cases of drastic actions by the regulator.
“You (FDA) have the power to use a sword, but the problem is you are using it to kill a mosquito. The power has to be judiciously exercised. It has to be used properly. Even in the cases of hotels and restaurants, you shoot first and then ask questions,” the bench said.
After Bhide submitted to the court that the FDA would revoke its orders against the petitioner company and grant it a hearing before passing a reasoned order, the High Court accepted the statement and disposed of the petition.
The High Court used the “mosquito and sword” phrase against the FDA during a hearing on Friday, chiding the agency for a drastic action against a warehouse of Amazon Retail India.
The same bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad had lauded the FDA’s crackdown against violations of rules, but asked whether shutting down all commercial establishments was the way to deal with the situation.
It advised the agency, which is in the news for a slew of raids on food establishments including some famous eateries since IAS officer Tukaram Mundhe was appointed at its helm in May, to act systematically.
