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) unit in Pune after the Bombay High Court pulled up the regulator for acting in a “high-handed” manner.
A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad observed that the FDA had followed an improper procedure and violated the principles of natural justice.
During the hearing, the FDA told the court that it would immediately withdraw the cancellation order, issue a fresh show-cause notice to Cipla and pass a fresh reasoned order after considering the company’s response.
The FDA had cancelled the drug sale licence of Cipla Pharma & Life Sciences’ C&F facility at Wadki in Pune with effect from August 27. The action was taken over alleged irregularities related to the packaging, storage and recall of Reactin Plus Tablets.
Cipla challenged the regulator’s decision before the Bombay High Court. Senior counsel Aabad Ponda, appearing for the company, told the court that the FDA had asked Cipla through an email to appear for a hearing on August 26, which was a public holiday in Maharashtra.
Ponda said the company had no representative available on the holiday and sought an adjournment. However, the FDA went ahead and passed the cancellation order on the same day without giving Cipla an opportunity to present its case.
Additional government pleader P P Kakade, appearing for the FDA, argued that the law did not give the company a right to a hearing.
The court, however, questioned the FDA’s decision to call the company for a hearing on a public holiday and then proceed with the cancellation after Cipla sought more time.
“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 observed.
The bench also questioned whether the FDA’s action was fair and transparent, noting that the department itself had directed the company to appear on a day when government offices were closed.
The court said the regulator had acted in a high-handed manner and followed the wrong procedure while cancelling the licence without adhering to the principles of natural justice.
The FDA’s action followed inspections at Cipla’s facility. During an inspection in June, officials found what they described as unauthorised promotional text on the packaging of Reactin Plus Tablets, a Schedule H prescription medicine.
The packaging carried the words “analgesic and antipyretic”, which the regulator said amounted to the promotion of a prescription drug. According to the FDA, such wording could encourage people to use the medicine without proper medical advice, increasing the risk of self-medication.
The regulator had also pointed to discrepancies between physical and computerised stock records, gaps in purchase and sale records, and alleged non-compliance with directions related to the recall of the medicine.
On Friday evening, Cipla Pharma & Life Sciences said it was challenging the FDA’s action. The company also clarified that the cancellation order did not raise any concerns about the safety, quality or efficacy of its products and did not indicate any patient safety issue.