Bombay HC directs Maharashtra FDA to withdraw Cipla licence cancellation order
Court questions FDA’s handling of proceedings and directs regulator to issue fresh show-cause notice and conduct hearing on a regular working day
The Bombay High Court has directed the Maharashtra Food and Drug Administration (FDA) to withdraw its licence cancellation order against Cipla Pharma & Life Sciences and restart the proceedings by issuing a fresh show-cause notice and conducting a hearing on a regular working day.
The FDA had initiated action against Cipla following inspections at the company’s carrying and forwarding facility in Wadki, Pune. The regulator cited packaging issues with Reactin Plus tablets, gaps in purchase and sales documentation, discrepancies between physical and computerised stock records, unauthorised promotional text on artwork and non-compliance with standard product recall procedures.
The legal proceedings focused on the timeline followed by the FDA under Commissioner Tukaram Mundhe. The FDA issued a show-cause notice to Cipla on August 13, to which the company responded on August 25. The regulator then scheduled a personal hearing for August 26, which was a state public holiday.
Cipla requested an adjournment as its representatives were unavailable on the holiday. The FDA rejected the request and issued an order cancelling the company’s licence on August 26, with the cancellation taking effect from August 27.
A Bombay High Court division bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad questioned the manner in which the FDA had conducted the proceedings, stating what it considered an excessive and disproportionate approach by the regulator.
Senior Counsel Aabad Ponda, representing Cipla Pharma & Life Sciences, argued that the FDA had violated the principles of natural justice and acted with undue haste by scheduling the personal hearing on a public holiday declared by the Maharashtra state government.
Ponda argued that corporate offices were closed and Cipla’s representatives were unavailable on the holiday. The company therefore requested an adjournment to a regular business day.
Additional Government Pleader P. P. Kakade, representing the FDA, argued that the pharmaceutical company did not have a strict statutory right to a hearing. The bench rejected this position, stating that a “shoot first, ask questions later” approach has no place in law.
The court’s intervention does not clear Cipla of the packaging or record violations cited by the FDA. The regulator has been directed to restart the legal process by issuing a fresh show-cause notice and conducting a hearing on a regular business day.