Cipla Drug Licence: Maharashtra FDA Withdraws Cancellation Order After Bombay HC Rebuke

The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) facility in Pune after the Bombay High Court pulled up the regulator for acting in a high-handed manner and going overboard. The FDA told the court that it would withdraw the licence cancellation order forthwith and issue a fresh show-cause notice to the company, following which a reasoned order would be passed.

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad observed that the FDA had followed the wrong procedure and acted against principles of natural justice. The court was hearing a challenge filed by Cipla Pharma & Life Sciences against the FDA's action cancelling the drug sale licences of its C&F facility at Wadki in Pune with effect from August 27. Senior counsel Aabad Ponda -- appearing for the company -- told the bench that the FDA had directed Cipla through an email to appear before the department for a hearing on August 26, which was a public holiday declared by the state government.

Ponda said the company had sought an adjournment as it did not have a representative available on holiday but the FDA passed the cancellation order the same day without granting a hearing. Additional government pleader P P Kakade -- appearing for the FDA -- argued that the law did not provide the company a right to a hearing. The bench questioned the regulator on why it had asked the company to appear for a hearing on a public holiday and subsequently passed the order without granting an opportunity to be heard.

"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 court said. The FDA had cancelled the licences over alleged irregularities concerning the packaging, storage and recall of Reactin Plus Tablets. The regulator had earlier said its inspections found unauthorised promotional text on the packaging of the Schedule H prescription medicine, discrepancies between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with recall directions. However, Cipla had clarified that the FDA order did not allege any concerns regarding the safety, quality or efficacy of its products and did not involve or indicate any patient safety issue.

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