PTC Web Desk: The Maharashtra Food and Drug Administration (FDA) has withdrawn its decision to cancel the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) unit in Pune.

The move came after the Bombay High Court criticised the regulator for acting in a “high-handed” manner and going “overboard” in the matter.

A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad said the FDA had not followed the proper procedure before cancelling the licence. The court also raised concerns over the violation of the principles of natural justice.

Following the court’s observations, the FDA informed the bench that it would withdraw the cancellation order with immediate effect.

The regulator will now issue a fresh show-cause notice to Cipla, consider the company’s response and then pass a fresh, reasoned order.

Why was Cipla's licence cancelled?

The FDA had cancelled the drug sale licences of Cipla Pharma & Life Sciences’ C&F facility at Wadki in Pune from August 27.

The action was linked to alleged irregularities involving the packaging, storage and recall of Reactin Plus Tablets. Cipla challenged the cancellation in the Bombay High Court.

During the hearing, senior advocate Aabad Ponda, appearing for Cipla, told the court that the FDA had asked the company to appear for a hearing on August 26. However, August 26 was a public holiday in Maharashtra.

Ponda said Cipla did not have a representative available on the holiday and requested more time. Despite the request, the FDA went ahead and cancelled the licence on the same day.

The FDA’s lawyer, Additional Government Pleader P P Kakade, argued that the company did not have a legal right to a hearing.

Court questions FDA's procedure

The bench questioned why the FDA had called the company for a hearing on a public holiday and then proceeded with the cancellation after Cipla asked for an adjournment.

The judges also questioned whether the regulator’s action was fair and transparent.

The court observed that the FDA had “wronged” the company and needed to resolve the issue. It also said the department appeared to have followed an improper procedure while taking the action.

Following the court’s remarks, the FDA agreed to withdraw the cancellation order and restart the process by issuing a fresh notice to Cipla.

What did FDA find during inspection?

The FDA’s action followed inspections at Cipla’s facility. During an inspection in June, officials reportedly found promotional wording on the packaging of Reactin Plus Tablets, a Schedule H prescription medicine. The packaging mentioned that the medicine was an “analgesic and antipyretic”.

According to the FDA, such wording amounted to promotion of a prescription drug. The regulator said this could encourage people to take the medicine without medical advice and increase the risk of self-medication.

The FDA also pointed to differences between the physical stock and computer records at the facility.

Officials reported gaps in purchase and sales records as well as alleged non-compliance with directions issued for recalling the medicine.

Cipla says no product safety issue was raised

Cipla had said on Friday that it was challenging the FDA’s decision. The company also clarified that the licence cancellation order did not raise concerns about the safety, quality or effectiveness of its products.

Cipla further said the FDA’s order did not involve or indicate any issue concerning patient safety.

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- With inputs from agencies

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