Bombay HC Slams Maharashtra FDA Over Cipla Licence Cancellation, Regulator Withdraws Order Against Pune Facility

The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) facility in Pune, after the Bombay High Court criticised the regulator for acting in a “high-handed” manner and “going overboard”.

Court Says FDA Failed To Follow Due Process

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad said the FDA had not followed due process and its action was contrary to the “principles of natural justice”.

Appearing for the FDA, Additional Government Pleader P P Kakade told the court that the department would withdraw the cancellation order forthwith. He said a fresh show-cause notice would be issued to the company, followed by a reasoned order after considering its response.

Cipla Facility Licence Cancelled Over Alleged Irregularities

The FDA had cancelled the drug sale licences of Cipla’s C&F unit at Wadki in Pune with effect from August 27, citing several irregularities concerning the packaging, storage, records and recall of Reactin Plus Tablets.

Senior counsel Aabad Ponda, representing Cipla, told the court that the company had challenged the FDA’s action. He said the regulator had emailed the company on August 26 noon, asking to appear for a hearing the same day, which was a public holiday.

Company Claims It Was Denied Opportunity Of Hearing

The company had no authorised representative available that day and sought an adjournment through a letter sent through a peon.

“However, the FDA treated that as adjournment request and passed the order the same day without granting a hearing,” Ponda said.

Kakade, however, submitted that the law does not specifically provide for a right to a hearing.

HC Questions Hearing Process Followed By FDA

The bench questioned the FDA’s decision to call the company for a hearing on a government-declared holiday and then proceed to pass the cancellation order on the same day.

“You are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue,” the bench observed.

Court Calls FDA Action Against Natural Justice Principles

The judges also questioned whether the process followed by the department was “fair and transparent”. The bench asked how the FDA could expect a company representative to appear on a public holiday and then reject the request for an adjournment.

The court further observed that the FDA had adopted an incorrect procedure and acted in a “high-handed” manner. “The order is against the principles of natural justice,” it said.

The FDA’s action followed a June inspection of Cipla’s Pune facility, where officials found unauthorised promotional wording on the packaging of Reactin Plus Tablets, a Schedule H prescription medicine. The packaging described the drug as an “analgesic and antipyretic”, which the FDA said could encourage self-medication without medical supervision.

Inspectors also found discrepancies in physical and computerised stock records, gaps in purchase and sale documentation, and alleged non-compliance with product recall directions.

Cipla clarified that the action did not concern the safety, quality or efficacy of its products or patient safety.

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