Bombay HC pulls up FDA over Cipla licence cancellation, cites natural justice

Maharashtra FDA withdrew its order cancelling Cipla Pharma & Life Sciences’ Pune drug sale licence after the Bombay High Court criticised the regulator for acting “high-handedly” and violating natural justice. FDA will issue a fresh show-cause notice and pass a reasoned order

Mumbai: The Maharashtra FDA on Saturday withdrew its order to cancel the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding unit in Pune after the Bombay High Court pulled up the regulator for going “overboard” and behaving in a “high-handed” manner.

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad said the FDA has acted against the “principles of natural justice”. The FDA said it would withdraw the license cancellation order forthwith and issue a fresh show cause notice to the company, pursuant to which a reasoned order would be passed.

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The Food and Drug Administration (FDA) had cancelled the drug sale licenses of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility at Wadki in Pune for serious irregularities related to the packaging, storage and recall of Reactin Plus Tablets, with effect from August 27.

On Friday evening, Cipla Pharma & Life Sciences said it had challenged the action while clarifying that the FDA order didn’t allege any concerns about the safety, quality or efficacy of its products, nor does it involve or indicate any patient safety issue.

Senior counsel Aabad Ponda, appearing for the company, on Saturday told the bench that the FDA had sent an email to the company directing them to appear before the department for a hearing on August 26, which was a public holiday.

“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,” Ponda said.

Additional government pleader P P Kakade, appearing for the FDA, said the law does not provide the company the right to a hearing. The bench questioned why the department sent an email to the drug company, asking it to send a representative for a hearing, especially on a holiday declared by the state government.

“You (FDA) 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 high court said. The bench observed that the FDA has behaved in a “high-handed” manner, followed a wrong procedure and cancelled the license. “The order is against the principles of natural justice,” it said.

The high court also questioned whether it was “fair and transparent” on the part of the FDA to send an email to the company and direct them to send a representative for a hearing on the same day. “If the court does the same thing, will it be fair? The government refuses or seeks adjournments claiming they cannot work on holidays; then how has the state’s department passed an order like this on a public holiday,” the bench questioned.

In the first round of inspection carried out in June, the FDA officials found unauthorised promotional text on the packaging of the tablets, a Schedule H prescription medicine. The words “analgesic and antipyretic” were found on the packaging, the FDA had said.

As per the FDA, promotion of such prescription medicine could encourage people to take the drug without medical advice and also increase the risk of self-medication. The FDA said its inspection also detected discrepancies between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with recall directions.