The Maharashtra Food and Drugs Administration (FDA) on Saturday withdrew its order cancelling the drug sale licence of Cipla Pharma and Life Sciences Ltd’s carrying and forwarding (C&F) facility at Wadki in Pune. The decision was taken after the Bombay High Court criticised the regulator’s handling of the matter, describing its action as “high-handed” and observing that it had gone “overboard”. A division bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad observed that the procedure followed by the FDA while cancelling the licence was incorrect and contrary to the principles of natural justice. The regulator subsequently informed the court that the cancellation order would be withdrawn with immediate effect.
The FDA said a fresh show-cause notice would be issued to Cipla. The company’s response would then be considered before a reasoned order was passed. The licence had earlier been cancelled with effect from August 26 over alleged irregularities concerning the packaging, storage and recall of Reactin Plus tablets. The action was challenged by Cipla before the High Court.
Senior counsel Aabad Ponda, representing Cipla, told the bench that the company had been asked by the FDA to attend a hearing on August 27, which had been declared a public holiday by the Maharashtra government. As a company representative was unavailable on the holiday, an adjournment was sought. However, the FDA proceeded to cancel the licence on the same day without granting Cipla a hearing, Ponda submitted. Additional government pleader P P Kakade, appearing for the FDA, argued that the law did not provide the company with a right to a hearing. The bench questioned why the hearing had been fixed on a public holiday and why the licence had subsequently been cancelled after Cipla sought additional time.
The court also questioned whether requiring the company to send a representative on a public holiday could be considered fair and transparent. It noted that government departments themselves often seek adjournments when they are unable to function on holidays. The bench observed that although the FDA was carrying out a “laudable and appreciative job”, it had gone “overboard” in this instance and needed to address the issue. The FDA’s action had followed an inspection of the Wadki facility in June. During the inspection, officials found what the regulator described as unauthorised promotional wording on the packaging of Reactin Plus, a Schedule H prescription medicine. According to the FDA, the words “analgesic and antipyretic” had been printed on the packaging.
The regulator said such promotion of a prescription medicine could encourage its consumption without medical advice and increase the possibility of self-medication. The inspection also reportedly identified differences between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with directions concerning the recall of the tablets.
Cipla, while announcing that it had challenged the FDA’s decision, clarified that the cancellation order did not raise concerns regarding the safety, quality or efficacy of its products. The company also stated that the order did not involve or indicate any patient-safety issue.
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