Cipla Licence Cancellation Withdrawn After Bombay HC Calls FDA Action ‘High-Handed’

The Maharashtra Food and Drug Administration has withdrawn its order cancelling the drug-sale licences of Cipla's carrying-and-forwarding unit at Wadki, Pune, but that withdrawal is not a clean bill of health for the company. It simply means the fight has shifted from what happened to how it was handled.

Inspectors had flagged real problems: unauthorised promotional claims on packaging for Reactin Plus Tablets, a Schedule H medicine, along with mismatched stock records, gaps in purchase-and-sale documentation, storage lapses, and alleged non-compliance with a recall order. Stock worth ₹11.19 lakh was seized. Cipla says none of this touched the safety or efficacy of its products, but on paper, the violations were serious enough to justify scrutiny.

What went wrong was the process. The FDA issued a show-cause notice on August 13; Cipla replied on August 25; it was then summoned for a personal hearing on August 26, a public holiday, and when it asked for more time, the licence was cancelled that same day. The Bombay High Court called this "high-handed" and a breach of natural justice, ordering the FDA to withdraw the order and start over with a fair hearing.

This sits inside a much bigger story: FDA Commissioner Tukaram Mundhe's sweeping enforcement drive, which has already touched Ayurvedic manufacturers, food chains like Domino's and McDonald's, and, separately, five outlets at the Mumbai Cricket Association, where the High Court again intervened. Some companies, like Inducare Pharma, got a full hearing before losing their licence. Cipla says it didn't.

That's the real question hanging over this crackdown: not whether Mundhe is right to enforce the law strictly, but whether every company, regardless of size, gets the same fair shot at responding before the axe falls. Strict enforcement and due process aren't opposites. But when one slips, even a legitimate case can start to look like overreach.