Be judicious, says Bombay high court to FDA after pharma company challenges sale ban | Mumbai News


Be judicious, says Bombay high court to FDA after pharma company challenges sale ban

Mumbai: The Bombay high court on Tuesday offered quick relief to Cadila Pharmaceuticals Ltd, which challenged the FDA move to stop the sale of some of its medicines.The FDA was only “displaying its powers”, said the high court bench of acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad.For Cadila, senior advocate Birendra Saraf said the issue at hand was a larger one, of use of brand extension by pharmaceutical companies, which was an industry-wide practice. The Ccentre had called for a public consultation on 6 July 2026 and even while it was on, the state Food and Drug Administration took coercive steps despite a valid manufacturing licence.The FDA in court then offered to revoke its orders against Cadila, issue show-cause notices, and grant it a hearing before passing a reasoned order. The regulator made the submission through government pleader Neha Bhide after the high court suggested that a hearing be given before any drastic action is taken. The high court accepted her statement and disposed of Cadila’s plea.Bhide submitted that the FDA “action was a preventive measure, not-high-handed action’’. She said it stemmed from a confusion over the medicines.“Be judicious,” the high court suggested to the widespread drive initiated by the FDA under its latest commissioner, Tukaram Mundhe, to root out non-compliance of safety standards.“Once there is a valid licence, the prohibition of sale can be only by following the prescribed procedure of issuing show-cause and hearing the licence holder,’’ said Saraf, seeking a stay of the “arbitrary” stoppage order.Saraf said that without a hearing “prohibition of sale tantamounts to an illegal suspension or revocation of licence’’.The pharmaceutical major said it had already incurred large losses due to the sale ban in force for 20 days when the petition was filed. The company said its stocks worth Rs 2.4 crore was also seized statewide over alleged branding issues.The ACJ said the bench is not concerned with the company’s losses but with the lack of availability of a crucial drug to patients for effectively 32 days so far. The medicines are for stomach acid issues, including acid reflux, heartburn and stomach or intestinal ulcers.The ting chief justice orally reiterated its “using a sword to swat a mosquito” analogy and said the FDA appeared to “shoot first” before it makes enquiries. The high court warned of imposing costs as a number of cases of the department’s “drastic action” had come to its notice.“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.



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