Mumbai: The Maharashtra Food and Drug Administration (FDA) withdrew its order to cancel the drug sale licence of Cipla Pharma & Life Sciences Limited’s Pune unit on Saturday after the Bombay High Court rapped it for going “overboard” and behaving in a “high-handed” manner.
The drug sale licenses of Cipla’s carrying and forwarding facility at Wadki in Pune were cancelled with effect from August 27, for serious irregularities related to the packaging, storage and recall of Reactin Plus Tablets.
The bench of acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad said the FDA has acted against the “principles of natural justice”. The observation came after Cipla said on Friday that it had challenged the action, while clarifying that the FDA order didn’t allege any concerns about the safety, quality, or efficacy of its products, nor did it involve or indicate any patient safety issue.
It would withdraw the licence cancellation order forthwith and issue a fresh show cause notice to the company, pursuant to which a reasoned order would be passed, the FDA said.
On Saturday, senior advocate Aabad Ponda, appearing for Cipla, told the bench that the FDA had sent an email to the company directing them to appear before the department for a hearing on August 26, which was a public holiday.
“The company had no representative available that day and had sought an adjournment. However, the FDA passed the order the same day without granting a hearing,” PTI quoted Ponda as saying.
The FDA was represented by additional government pleader P P Kakade, who countered that the law does not provide the company the right to a hearing.
The bench, however, did not agree and questioned why the department had emailed the drug company, asking it to send a representative to a hearing, especially on a holiday declared by the state government.
“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,” the Court said.
The FDA has behaved in a “high-handed” manner, followed a wrong procedure and cancelled the license, the bench observed. “The order is against the principles of natural justice,” it said.
The Court also questioned whether it was “fair and transparent” for the FDA to email the company and direct them to send a representative to a hearing on the same day.
“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,” the bench questioned.
In June, during the first round of inspection, the FDA found unauthorised promotional text on the packaging of the tablets, a Schedule H prescription medicine.
The words “analgesic and antipyretic” were found on the packaging, the agency had then said.
The promotion of such prescription medicine could encourage people to take the drug without medical advice and also increase the risk of self-medication, the FDA said.
Its inspection also detected discrepancies between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with recall directions, the FDA had claimed.
