The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order to cancel the drug sale licence of Cipla Pharma & Life Sciences Limited's Pune unit after the Bombay high court rapped the state regulator for going "overboard" and behaving in a "high-handed" manner.
The FDA had cancelled the drug sale licenses of Cipla’s carrying and forwarding facility at Wadki in Pune for serious irregularities related to the packaging, storage and recall of Reactin Plus Tablets, with effect from August 27.
A 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.
Deep Dive
What irregularities led to the FDA canceling Cipla Pharma's sales license?
How did the Bombay High Court respond to the FDA's cancellation order against Cipla Pharma?
Why is unauthorized promotional text on prescription medicines a concern?
The FDA said 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.
What happened in the court?
{{/usCountry}}The FDA said 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.
What happened in the court?
{{/usCountry}}Senior counsel Aabad Ponda, appearing for Cipla, told the bench on Saturday 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," news agency 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.
However, the bench 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 high court said.
The bench observed that the FDA has behaved in a "high-handed" manner, followed a wrong procedure and cancelled the license. "The order is against the principles of natural justice," it said.
The high 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.
Why had the FDA cancelled the Cipla sales licence?
In the first round of inspection carried out in June, the FDA officials 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 said.
According to the FDA, 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.