31/08/2026
FDA Cancels Cipla’s Licence then Withdraws it after HC Order
• Maharashtra FDA cancelled the drug sale licence of Cipla Pharma & Life Sciences Pune facility (Wadki) with effect from August 27, 2026
• The action followed alleged irregularities in the packaging, storage & recall of “Reactin Plus” tablets.. including promotional wording on a Schedule H drug & mismatched stock records
• Cipla challenged the order in the Bombay High Court
• Cipla’s lawyers pointed out the FDA had scheduled the hearing on August 26, a public holiday & cancelled the licence the same day despite Cipla seeking an adjournment
• The Bombay HC called the FDA’s action “high-handed” & against the principles of natural justice
• Following the court’s rap, the FDA agreed to withdraw the cancellation order & will now issue a fresh show-cause notice before taking any final decision
Cipla has clarified the case doesn’t raise concerns about drug safety, quality or efficacy of its products.
[Cipla, FDA, FSSAI, Tukaram Mundhe, Viral, Brahmi Kapasi, Pharma]
