Court calls FDA action hasty, restores Cipla licence and clears five MCA eateries to reopen
The Bombay High Court has pulled up the Maharashtra Food and Drug Administration (FDA), headed by Commissioner Tukaram Mundhe, over two separate enforcement actions involving Cipla Pharma & Life Sciences and eateries at the Mumbai Cricket Association (MCA) premises.
The court criticised the FDA for what it described as “undue haste”, saying the regulator had adopted a pedantic rather than pragmatic approach and, in the Cipla case, had followed a procedure that violated the principles of natural justice. Following the court’s intervention, the FDA agreed to withdraw both orders.
Bombay HC questions FDA’s action against Cipla
In the Cipla case, the FDA had cancelled the drug sale licence of the company’s carrying and forwarding facility at Wadki in Pune from August 27. The action followed inspections that flagged alleged irregularities related to the packaging and recall of Reactin Plus tablets, along with issues concerning storage and stock records.
The court questioned the FDA’s procedure, particularly after it emerged that the regulator had called a Cipla representative for a hearing on a day declared a public holiday by the state government.
The bench said the FDA had “gone overboard” and described its conduct as “high-handed”, observing that the cancellation order was contrary to the principles of natural justice.
Following the court’s criticism, the FDA withdrew the cancellation order, effectively restoring Cipla’s licence.
Five MCA eateries also get relief
In a separate matter involving five restaurants operating on MCA premises in Bandra-Kurla Complex, the FDA had suspended their operations over food safety and hygiene concerns.
However, a subsequent inspection found the eateries to be 88 per cent compliant with food safety regulations. The FDA nevertheless continued to question the establishments because their licences were in MCA’s name while the eateries were being operated by another entity, M/s Shirke Infrastructure.
The High Court questioned the legal basis for this approach and reminded the FDA that it had earlier directed officials to take a pragmatic view.
The court warned of possible contempt action against officials if its directions were not followed. The FDA subsequently agreed to issue a fresh notice to MCA, hear the association on the contractual arrangement and then pass a reasoned order.
Since the eateries were found compliant following the fresh inspection, the court vacated the suspension, allowing them to reopen.
Court questions FDA’s approach
The bench also questioned why the FDA was repeatedly acting in haste without adequately analysing the law and facts of individual cases.
The development comes after a series of high-profile enforcement drives led by Mundhe, who has overseen thousands of inspections and actions against food and drug businesses across Maharashtra. His aggressive regulatory approach has won public attention but has also faced criticism over whether some enforcement measures were proportionate.
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