Maharashtra FDA on Saturday withdrew its cancellation of Cipla Pharma & Life Sciences’ Pune drug sale warehouse licence.
Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad were hearing a petition filed by the pharma major against the FDA action at a facility at Wadki in Pune for alleged serious irregularities related to the packaging, storage and recall of Reactin Plus Tablets, with effect from Aug 27. A notice was received on Aug 13 by Cipla, after which the company sent a reply to it and sought time for a hearing on Aug 26.
MUMBAI: Maharashtra FDA on Saturday withdrew its cancellation of Cipla Pharma & Life Sciences’ Pune drug sale warehouse licence after the Bombay High Court pulled up the regulator for acting “high-handed” and “going overboard” in violating principles of natural justice and wrongly passing an order on Aug 26, a public holiday. However, the FDA passed the order the same day without granting a hearing,” said Ponda. Additional govt pleader P P Kakade, appearing for the FDA, said the law does not provide the company the right to a hearing. But the ACJ observed that govt is often saying “give us time since there are public holidays…’’ and questioned whether it was “fair and transparent’’ on FDA’s part to email the company and ask it to send the request through a representative the same day — a public holiday?
Ponda pointed to the hasty manner in which a suspension was converted into cancellation by “hearing’’ an employee not authorised or tasked with such responsibilities. “The company had no representative available that day and had sought an adjournment.
