Bombay HC pulls up Maharashtra FDA, forces withdrawal of two orders

The Bombay High Court forced the Maharashtra FDA to withdraw two enforcement orders after criticising the regulator for acting hastily and taking a “pedantic” approach. The FDA withdrew Cipla’s licence cancellation and suspended restaurant operations at MCA premises, allowing the eateries to reopen

Mumbai: The Bombay High Court on Saturday dealt a double blow to the Maharashtra FDA, forcing the regulator to backtrack on two major enforcement actions after being admonished for acting against the “principles of natural justice” and taking a “pedantic instead of pragmatic view.”

Pulling up the FDA for showing “undue haste” in passing orders without analysing the law in connection with eateries on the Mumbai Cricket Association premises, the high court asked: “Do you feel you are a Lord and you can do anything?” In the first instance, the FDA withdrew its order cancelling the drug sale licence of Cipla Pharma and Life Sciences Limited’s unit in Pune after a bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad scolded the regulator for going “overboard” and behaving in a “high-handed” manner.

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In a separate setback for the agency, the FDA informed the court that it would also withdraw its order suspending the operations of five restaurants at the MCA premises in Bandra-Kurla Complex after the court warned of stinging orders against officials, noting that a fresh inspection showed the eateries were 88 per cent compliant with food safety rules.

However, the licences of eateries remained suspended as they were being operated by another entity, M/s Shirke Infrastructure, despite the licences being issued in MCA’s name. The court said there is no provision under the law prohibiting the same, noting that on the last hearing the court had specifically asked the FDA officials to apply their mind and take a pragmatic view of the situation.

“However, despite clearly saying this, the FDA has disobeyed our order and taken a pedantic view instead of a pragmatic view. We are tired of scolding the department and officers all the time. It is now time to pass stinging orders. We will issue contempt action against the concerned officers. Let them convince us or go to jail,” the HC said.

When warned of contempt action, the FDA said it would issue a fresh notice to MCA and grant them a hearing on the issue of the contract between the association and Shirke Infrastructure and then pass a reasoned order. The court accepted this and said since the eateries are now compliant with the rules, the order suspending their licenses stands vacated, and they can reopen their services.

The bench questioned why the FDA was always in “undue haste” and passed orders without properly analysing the law. “How many times should we try to convince and balance equities so that the department does not feel discouraged? Why do we say don’t kill a mosquito with a sword? Do you feel you are a lord and you can do anything?” the HC questioned. In the Cipla case, the High Court questioned the FDA’s email to the company calling their representative for a hearing on a state government declared public holiday.

“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 bench said. The court observed that the FDA has behaved in a “high-handed” manner and has followed a wrong procedure and cancelled the license.

“The order is against the principles of natural justice,” the high court said. The FDA had cancelled the drug sale licenses of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility at Wadki in Pune after alleged violations were detected during a follow-up investigation into the packaging and recall of Reactin Plus tablets. The licenses were cancelled with effect from August 27.