Bombay HC raps FDA for natural justice breach in Cipla licence revocation

The Bombay High Court on Saturday took exception to the procedure followed by the Food and Drug Administration (FDA) in revoking the drug sale licence of a Pune-based company, observing that the authority had acted against the principles of natural justice. Following the court's remarks, the FDA informed the Bench that it would withdraw the revocation order and issue a fresh show-cause notice to the company.

The division bench, comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, was hearing a petition filed by Cipla Pharma and Life Sciences Limited challenging the FDA's order dated August 27, which cancelled the licences for its carry and forwarding unit at Vadki, Pune.

The FDA had initiated action against the company for publishing unauthorised text on the packaging of its drug 'Rectin Plus' and for deficiencies in purchase-sale records and storage of drugs.

Senior counsel Abad Ponda, representing the company, submitted that the FDA's order did not raise any question regarding the safety, quality, or efficacy of the products, nor did it involve any patient safety issue. The company further informed the court that the FDA had sent an email on August 26, a public holiday, directing the company to appear for a hearing on the same day. The company requested an adjournment as no representative was available, but the FDA proceeded to pass the order without holding a hearing.

Additional Government Pleader Priyabhushan Kakade, appearing for the FDA, argued that the company did not have a legal right to a hearing under the law.

The court questioned the FDA's decision to send an email on a public holiday, asking why the authority expected the company to send a representative when the government itself often seeks adjournments citing holidays. The court also noted that this was not the first instance of such conduct from the FDA, observing that the authority had followed an incorrect procedure and passed an order that went against the principles of natural justice.

Following the court's observations, the FDA informed the bench that it would withdraw the revocation order and issue a fresh show-cause notice to the company. The authority stated that a final order would be passed after considering the company's response.

The court recorded the FDA's statement and disposed of the petition. The bench observed, “You are doing commendable work, but now you are acting beyond your limits.” The court further stated that the authority had made a mistake and would have to address the issue.