Bombay High Court Orders FDA to Withdraw Enforcement Actions Against MCA Eateries and Cipla Facility

Bomaby High Court

MUMBAI: The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew two enforcement orders after the Bombay high court pulled up the regulator over its handling of separate cases involving five MCA eateries and a Cipla facility in Pune. The court's observations came while hearing two matters — one concerning five restaurants at the Mumbai Cricket Association (MCA) premises in Bandra-Kurla Complex and the other involving Cipla Pharma & Life Sciences Ltd's facility in Pune.

FDA withdraws action against MCA eateries

In the MCA matter, the FDA told the court that it would withdraw its order suspending the operations of five restaurants after the bench warned of contempt action against the officials concerned. A fresh inspection found that the restaurants were 88 per cent compliant with food safety rules, the bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad noted. The eateries, however, faced a separate licensing issue as they were being operated by M/s Shirke Infrastructure, while the licences were issued in the name of the MCA. The court said there was no provision under the law prohibiting such an arrangement. It also reminded the FDA that, at the previous hearing, it had specifically directed officials to apply their mind to the issue and take a pragmatic view. "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. Following the court's warning, the FDA agreed to issue a fresh notice to the MCA, hear its response on the contract with Shirke Infrastructure and pass a reasoned order. The court accepted the undertaking and said that since the restaurants were now compliant with food safety rules, the suspension order stood vacated. The eateries could therefore reopen. The bench also questioned the FDA's repeated "undue haste" in passing orders without properly examining 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.

FDA withdraws Cipla licence cancellation

In the second matter, the court questioned the FDA's decision to cancel the drug sale licences of Cipla Pharma & Life Sciences Ltd's facility in Pune. The regulator subsequently withdrew the cancellation order after the bench criticised the procedure it had followed. The court particularly questioned an FDA email asking a company representative to appear for a hearing on a public 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 bench said. The court said the FDA had acted in a "high-handed" manner and followed an improper procedure while cancelling the licence. "The order is against the principles of natural justice," the high court said. The FDA had cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding facility at Wadki in Pune after alleged violations were found during a follow-up investigation into the packaging and recall of Reactin Plus tablets. The cancellation order had come into effect from August 27 before the High Court's intervention led the regulator to withdraw it.

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