Going overboard: HC raps FDA over Cipla Pune licence cancellation; order withdrawn

The Bombay High Court pulled up the Maharashtra FDA after Cipla challenged the cancellation of its Pune unit's drug sale licence. The regulator withdrew the order, promised a fresh show-cause notice and said it would pass a reasoned decision after hearing the company.FDA withdraws Cipla Pune unit's licence cancellationThe 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 criticised the regulator for going “overboard” and acting in a “high-handed” manner.A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad said the FDA had followed an improper procedure and acted against the “principles of natural justice”. The regulator told the court that it would withdraw the cancellation order with immediate effect, issue a fresh show-cause notice to Cipla and pass a reasoned order after considering the company's response.The FDA had cancelled the drug sale licences of Cipla Pharma & Life Sciences' C&F facility at Wadki in Pune, effective August 27, citing serious irregularities linked to the packaging, storage and recall of Reactin Plus Tablets.The company had challenged the FDA's action. 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, a public holiday in Maharashtra. Ponda said Cipla had no representative available on the holiday and had sought an adjournment. However, the FDA passed 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 give the company a right to a hearing. The bench questioned the FDA's decision to ask Cipla to appear for a hearing on a public holiday and then proceed with the cancellation after the company 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”, pointing out that the department had itself directed the company to appear on a day when government offices were closed.The court said the FDA had behaved in a “high-handed” manner, followed the wrong procedure and cancelled the licence without adhering to natural justice.The FDA's action stemmed from inspections of the Cipla facility. During its first inspection in June, officials found 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 promotion of a prescription drug.According to the FDA, such promotion could encourage consumers to use the medicine without medical advice and increase the risk of self-medication.The regulator also reported discrepancies between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with directions issued for the recall of the medicine.On Friday evening, Cipla Pharma & Life Sciences had said it was challenging the FDA's action while clarifying that the cancellation order did not raise any concerns about the safety, quality or efficacy of its products and did not involve or indicate any patient safety issue.- EndsPublished By: Akash ChatterjeePublished On: Aug 29, 2026 18:06 IST