Bombay HC Pulls Up FDA, Cipla Licence Cancellation Order Withdrawn
What Happened
The Maharashtra FDA withdrew its order cancelling the drug sale licence of Cipla Pharma & Life Sciences' Pune carrying and forwarding facility after the Bombay High Court criticized the regulator for acting "overboard" and violating principles of natural justice. The FDA has agreed to issue a fresh show-cause notice and follow due process before taking any further action.
Key Takeaways
The court's objection was primarily about procedure, not product safety. Cipla argued it was denied a proper hearing after being asked to appear on a public holiday, while the FDA's original action related to alleged irregularities in the packaging, storage and recall of Reactin Plus tablets. The regulator will now restart proceedings and pass a fresh reasoned order.