The Maharashtra Food and Drug Administration (FDA) on Saturday revoked its order cancelling the drug sale license of Cipla Pharma and Life Science Limited’s Pune facility, hours after the Bombay High Court (HC) accused the regulatory body of going ‘overboard’ and acting in a ‘high-handed’ manner.

Notably, the FDA had cancelled the drug sale licenses of Cipla’s carrying and forwarding facility at Wadki in Pune with effect from August 27, citing grave irregularities concerning the packaging, storage and recall of Reactin Plus Tablets.

However, the FDA informed the HC on Saturday that it would withdraw the cancellation order ‘forthwith’ and would also issue a fresh show-cause notice to the company. A reasoned order would be issued after and passed after considering Cipla’s response.

Court raises questions on FDA’s procedure

A bench of the HC, comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad noted that the FDA had acted against the principles of natural justice.

The bench made the remarks after Cipla challenged the regulatory action, clarifying on Friday that the FDA’s order did not mention about the safety, quality or efficacy of its products, nor did it involve or indicate any issue pertaining to patient safety.

During the hearing on Saturday, senior counsel Aabad Ponda, appearing on behalf of Cipla, told the bench that the FDA had sent an email to the company, directing it to appear before the department for a hearing on August 26. However, the date was a public holiday.

Ponda submitted before the court that Cipla had no representative available on the said date and had sought an adjournment. Despite this, the FDA passed the cancellation order on the same day without granting the company an opportunity to be heard, as per a report by news agency PTI.

“Now you are going overboard”: HC

The FDA, represented by Additional Government Pleader PP Kakade, contended that the law did not provide the company with a right to a hearing. However, the HC bench questioned the department’s decision to email Cipla and ask it to send representatives for a hearing, particularly when the date fell on a state-declared public holiday.

The HC remarked, “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.” Furthermore, it criticised the FDA for allegedly adopting a ‘high-handed’ approach and following an incorrect procedure before cancelling the license.

The court said, “The order is against the principles of natural justice.”

Court calls for transparency, fairness

The HC also questioned whether it was ‘fair and transparent’ for the FDA to direct Cipla through an email to send a representative for a hearing on the same day.

The bench questioned, “If the court does the same thing, will it be fair? The government refuses or seeks adjournments claiming they cannot work on holidays; then how has the state’s department passed an order like this on a public holiday.” Following the court’s observations, the FDA gave the nod to withdraw the license cancellation order and initiate fresh proceedings through a show-cause notice, paving the way for the matter to be reconsidered through due process.