Bombay High Court pulls up drug regulatory body over Cipla licence cancellation

On Saturday, the Bombay High Court criticized the Maharashtra Food and Drug Administration (FDA) for its excessive actions and questioned the transparency of its decisions, particularly in relation to a case involving Cipla Pharma. The FDA informed the court that the problematic order would be withdrawn immediately. During an inspection conducted on June 26 at Cipla Pharma's premises, FDA officers allegedly discovered irregularities involving packaging and advertising materials for certain tablets, leading to the cancellation of the company's licence.

Notice of the hearing was given on August 26, a state holiday, and the FDA's office was closed. Acting Chief Justice Ravindra V Ghuge expressed concern over the lack of fairness and transparency, stating that the court must not only do justice but also ensure it appears to be done. The bench questioned why the department issued a notice to the petitioner while supposedly considering a hearing under Section 66 of the Food Safety and Standards Act.

The court raised concerns about the violation of natural justice and the procedure followed. After the state lawyer confirmed that the impugned order would be withdrawn forthwith and fresh notices would be served on Cipla Pharma before September 4, the High Court ordered that a hearing would be arranged if the petitioners desired, based on previous communications between the petitioner company and the FDA, with the additional material and detailed reply to be given by September 11.

The court also advised the department not to hold personal hearings on holidays unless there is a dire urgency or emergency situation.