Maharashtra FDA Withdraws Cancellation of Cipla Pune Warehouse Licence
The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale warehouse licence of Cipla Pharma & Life Sciences at Wadki in Pune after the Bombay High Court criticised the regulator for acting in a high-handed manner and violating the principles of natural justice.
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad was hearing a petition filed by the pharmaceutical major against the FDA's action. The regulator had cancelled the licence of the Wadki facility with effect from August 27 over alleged irregularities concerning the packaging, storage, and recall of Reactin Plus Tablets. The cancellation order had been passed on August 26, which was a public holiday.
During the hearing, the High Court observed that the FDA had behaved in a high-handed manner, followed an improper procedure, and issued an order contrary to natural justice. Following the court's reprimand, the FDA withdrew the cancellation. The regulator has been allowed to issue a fresh show-cause notice and pass a reasoned order after providing the company a reasonable opportunity to be heard.
Senior counsel Aabad Ponda, appearing alongside advocate Ranjeet Sangle for Cipla, argued that the regulator had converted a suspension into a cancellation in a hasty manner without giving the company a fair hearing. Cipla received an initial notice on August 13, replied to it, and sought time for a hearing scheduled for August 26.
According to the plea, the FDA sent an email directing the company to deliver the adjournment request by hand on August 26. Since it was a public holiday, the company sent the letter through an unauthorised staff member rather than an executive. The FDA treated this staff member as a representative, claimed to have conducted a hearing, and passed the cancellation order that very day without granting an adjournment.
Ponda informed the court that more than 4 lakh pharmaceutical products are dispatched every month from the Wadki warehouse, adding that the cancellation prevented critical life-saving medicines from reaching patients. The company maintained that the FDA's action raised no concerns regarding product safety, quality, or efficacy.
Additional Government Pleader P P Kakade, representing the FDA, contended that the law did not grant the company the right to a hearing. The court questioned whether it was fair and transparent for the regulator to demand an in-person adjournment request on a public holiday and immediately pass an order.
