'Going Overboard': Maharashtra FDA Withdraws Order Cancelling Cipla Licence After HC Rap

Mumbai: The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order cancelling the drug sale licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) facility in Pune, after the Bombay High Court criticised the regulator for going “overboard” and acting in a “high-handed” manner.

The FDA told the court that it would withdraw the cancellation order forthwith and issue a fresh show-cause notice to Cipla. A reasoned order will be passed after the company is given an opportunity to respond.

The development came after a bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad questioned the manner in which the FDA had proceeded against the pharmaceutical company. The court observed that the regulator had acted against the “principles of natural justice”.

The FDA had cancelled the drug sale licences of Cipla’s C&F facility at Wadki in Pune with effect from August 27. The action was linked to alleged irregularities involving the packaging, storage and recall of Reactin Plus Tablets, a Schedule H prescription medicine.

Why Did FDA Cancel Cipla's Licence?

According to the FDA, an inspection conducted in June found unauthorised promotional text on the packaging of Reactin Plus Tablets. The packaging carried the words “analgesic and antipyretic”, which the regulator said amounted to an issue concerning the promotion of a prescription medicine.

The FDA had also flagged discrepancies between physical and computerised stock records, gaps in purchase and sale records, and alleged non-compliance with recall directions. The regulator had previously seized stock worth around Rs 11.19 lakh and directed its withdrawal from the market.

The FDA's action followed a show-cause process, but Cipla challenged the cancellation before the Bombay High Court.

What Happened in Bombay HC?

Senior counsel Aabad Ponda, appearing for Cipla, told the court that the FDA had emailed the company asking it to appear for a hearing on August 26, which was a public holiday.

According to Ponda, Cipla had no representative available that day and sought an adjournment. However, the FDA proceeded to pass the cancellation order on the same day without granting the company a hearing.

Additional Government Pleader P P Kakade, representing the FDA, argued that the law did not provide Cipla with a right to a hearing.

The court questioned why the FDA had asked the company to appear for a hearing on a state-declared holiday and then proceeded with the cancellation after Cipla sought more time.

“You are doing a laudable and appreciative job, but now you are going overboard,” the bench observed, adding that the FDA had “wronged” the company and would have to resolve the issue.

The court also questioned whether the procedure followed by the FDA was “fair and transparent”, noting that government departments themselves seek adjournments when hearings or proceedings fall on holidays.

Following the court's observations, the FDA agreed to withdraw the cancellation order and initiate the process afresh through a new show-cause notice. The regulator will subsequently pass a reasoned order after considering Cipla's response.

Cipla's Response

Cipla Pharma & Life Sciences had earlier said that the FDA order concerned the operations of a C&F warehouse operated on its behalf and that the matter was under judicial consideration.

The company also clarified that the FDA's order did not allege any concerns relating to the safety, quality or efficacy of its products and did not involve or indicate any patient-safety issue.

With the cancellation order now withdrawn, the matter will return to the regulatory process, with the Maharashtra FDA set to issue a fresh show-cause notice to Cipla and take a fresh decision after hearing the company.

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