Maharashtra FDA Withdraws Cipla License

The Maharashtra Food and Drug Administration (FDA) withdrew its order to cancel the drug sale license of Cipla Pharma & Life Sciences Ltd's carrying and forwarding unit in Pune on Saturday. This action followed the Bombay High Court pulling up the regulator for going "overboard" and behaving in a "high-handed" manner.

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad stated the FDA had acted against the "principles of natural justice." The regulator said it would withdraw the license cancellation order immediately and issue a fresh show-cause notice to the company.

Court Criticizes FDA Procedure

The FDA had cancelled the drug sale licenses for the facility at Wadki in Pune, effective from August 27. The order cited serious irregularities related to the packaging, storage, and recall of Reactin Plus Tablets.

On Friday, Cipla Pharma & Life Sciences said it had challenged the action. The company clarified that the FDA order did not allege any concerns about product safety, quality, or efficacy. It also stated the order did not involve any patient safety issue.

Senior counsel Aabad Ponda, representing the company, told the court on Saturday that the FDA had emailed the company directing it to appear for a hearing on August 26. This date was a public holiday. "The company had no representative available that day and had sought an adjournment," Ponda said. "However, the FDA passed the order the same day without granting a hearing."

Additional government pleader P P Kakade, appearing for the FDA, argued that the law does not provide the company the right to a hearing.

The bench questioned why the department sent an email demanding a company representative appear on a state-declared holiday. "You (FDA) are doing a laudable and appreciative job, but now you are going overboard," the high court said. "This is not the first time this is happening. You have wronged, and now you have to resolve the issue."

Inspection Findings and Regulatory Concerns

The court observed that the FDA followed a wrong procedure. "The order is against the principles of natural justice," it said. The bench also questioned the fairness and transparency of sending an email and demanding a same-day hearing. "If the court does the same thing, will it be fair?" the bench questioned. "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?"

The initial inspection occurred in June. FDA officials found unauthorised promotional text on the packaging of Reactin Plus Tablets, a Schedule H prescription medicine. The packaging contained the words "analgesic and antipyretic."

According to the FDA, promoting such prescription medicine could encourage people to take the drug without medical advice. It also increases the risk of self-medication.

The FDA's inspection also detected discrepancies between physical and computerised stock records. Gaps in purchase and sale records were found, along with non-compliance with recall directions.

The regulator will now issue a fresh show-cause notice. A reasoned order will be passed following that process.