MUMBAI — The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Limited’s Pune facility after the Bombay High Court sharply reprimanded the regulatory body for acting in a high-handed manner and violating the principles of natural justice.
The regulatory dispute stemmed from the FDA’s decision to revoke the drug sale licences of Cipla’s carrying and forwarding establishment located in Wadki, Pune, effective August 27. The state regulator had cited alleged irregularities related to the packaging, storage, inventory documentation, and recall procedures for Reactin Plus tablets. During an inspection in June, FDA officials flagged the terms “analgesic and antipyretic” on the packaging of the Schedule H prescription formulation, contending that promotional text could encourage self-medication without proper medical consultation.
Cipla approached the Bombay High Court challenging the administrative measure, maintaining that the order raised no concerns regarding product safety, quality, or therapeutic efficacy. During the court proceedings, senior counsel Aabad Ponda, appearing for Cipla, argued that the FDA directed the pharmaceutical company via email to attend a hearing on August 26, a declared public holiday. When the company requested an adjournment due to the unavailability of representatives on that day, the department proceeded to pass the cancellation order without granting an opportunity for a hearing.
A division bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad criticized the regulator’s procedure, questioning the fairness of scheduling mandatory hearings and issuing punitive orders on official state holidays. The bench observed that the department had bypassed due process and acted against basic legal fairness. Following the court’s stern remarks, government counsel confirmed that the FDA would immediately revoke the cancellation order and issue a fresh show-cause notice to facilitate a formal, reasoned administrative process.
