Cipla Pharma Licence Cancellation Order Withdrawn; Maharashtra FDA To Issue Fresh Show-Cause Notice

The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding unit at Wadki in Pune, as per news reports.  

The decision followed the Bombay High Court’s observations on the way the order was issued. The FDA had cancelled the unit’s licence with effect from August 27 over alleged irregularities involving the packaging, storage and recall of Reactin Plus Tablets.  

The regulator will now issue a fresh show-cause notice and pass a new order after completing the process. 

What The Inspection Found 

The action followed an inspection in June, when FDA officials found unauthorised promotional wording on the packaging of Reactin Plus Tablets, a Schedule H prescription medicine. The packaging carried the words “analgesic and antipyretic”. 

According to the FDA, such wording could encourage people to use the medicine without medical advice and increase the risk of self-medication.  

The inspection also found differences between physical and computerised stock records, gaps in purchase and sale records, and issues with compliance with recall directions. 

High Court Questions Procedure 

The matter reached the Bombay High Court after Cipla Pharma & Life Sciences challenged the cancellation order. The company said it had received an email asking it to send a representative for a hearing on August 26, which was a public holiday. 

Senior counsel Aabad Ponda told the court that the company sought an adjournment as no representative was available. However, the FDA passed the cancellation order on the same day without granting the company a hearing, according to the submission. 

Regulator Pulled Up 

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad questioned the FDA over the procedure followed. The court asked why the department had called the company for a hearing on a state-declared holiday. 

The bench said the FDA had acted against the principles of natural justice and described its approach as high-handed. Counsel appearing for the FDA said the law did not provide the company with a right to a hearing. 

Matter To Be Taken Up Again 

Cipla had earlier said the FDA order did not raise concerns about the safety, quality or efficacy of its products and did not indicate any patient safety issue. With the earlier order withdrawn, the matter will now be taken up again following a fresh notice from the FDA. 

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Conclusion  

With the cancellation order withdrawn, the matter will be reconsidered by the Maharashtra FDA. The regulator has said it will issue a fresh show-cause notice before taking a further decision. 

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