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.The Food and Drug Administration (FDA) can issue a fresh show cause and pass a reasoned order after giving the company a reasonable opportunity at being heard.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.
The U-turn after rap and what happened
The HC said FDA behaved in a “high-handed” manner, followed a wrong procedure and cancelled the licence. “The (cancellation) order is against the principles of natural justice.”Senior counsel Aabad Ponda with advocate Ranjeet Sangle for Cipla said the FDA actions smacked of high handedness and “disregard’’ for natural justice. The FDA action raised no concerns about the safety, quality, efficacy or patient safety issued over its products, said the company’s plea. Ponda said over 4 lakh pharma products are sent out every month from the warehouse and the cancellation prohibited “critical life saving medicines from reaching patients.”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. 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.The FDA emailed, asking the company to send the adjournment request by hand, which being a holiday, was sent through a staff, not an executive, but FDA said it heard him and passed its order, said Ponda, showing HC a letter it had written to the sent email.“The company had no representative available that day and had sought an adjournment. 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?
