Bombay High Court censures FDA, forces withdrawal of Cipla license cancellation

The Maharashtra Food and Drug Administration (FDA) has withdrawn its order to cancel the drug sale license of Cipla Pharma & Life Sciences Limited's Pune unit, following strong criticism from the Bombay High Court.

The High Court had censured the state regulator, describing its actions as "overboard" and "high-handed." The FDA had initially cancelled the licenses for Cipla's carrying and forwarding facility in Wadki, Pune, citing serious irregularities in the packaging, storage, and recall of Reactin Plus Tablets, with the cancellation effective August 27.

A bench of acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad observed that the FDA had acted against the "principles of natural justice." Cipla had challenged the FDA's order, clarifying that it did not allege any issues with the safety, quality, or efficacy of its products, nor did it involve patient safety concerns.

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You (FDA) 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.

During the court proceedings, Cipla's counsel, Aabad Ponda, informed the bench that the FDA had sent an email directing the company to appear for a hearing on August 26, a public holiday. The company sought an adjournment, but the FDA proceeded to issue the cancellation order the same day without granting a hearing. The FDA's representative, Additional government pleader P P Kakade, argued that the law did not grant the company a right to a hearing.

However, the bench questioned the FDA's procedure, particularly its decision to schedule a hearing on a public holiday and issue an order without one. "You (FDA) 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 High Court stated. The court further noted that the FDA had behaved in a "high-handed" manner and followed an incorrect procedure. The FDA has now stated it will withdraw the cancellation order, issue a fresh show cause notice, and pass a reasoned order after a proper hearing.

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The order is against the principles of natural justice.