High Court Intervenes: Maharashtra FDA Backtracks on Cipla Licence Cancellation

In a significant turn of events, the Maharashtra Food and Drug Administration (FDA) has officially withdrawn its prior order that sought to cancel the drug sale licence for Cipla Pharma & Life Sciences Ltd.'s vital Carry and Forwarding (C&F) facility located in Wadki, Pune. This reversal, made on Saturday, August 29, 2026, comes directly after the Bombay High Court sharply rebuked the FDA for what it deemed a "high-handed" and procedurally flawed approach.

Indeed, the Bombay High Court didn't mince words. It found that the FDA had acted against the very principles of natural justice, effectively going "overboard" and following an incorrect procedure when issuing its initial cancellation order, which was originally set to take effect on August 27. It’s a classic case of regulatory overreach meeting judicial scrutiny, one might say.

During the court proceedings, represented by senior counsel Aabad Ponda for Cipla and additional government pleader P P Kakade for the FDA, the regulatory body ultimately conceded. They agreed to pull back the contentious licence cancellation order and committed to issuing a fresh, proper show-cause notice to Cipla. This will then be followed by a carefully reasoned order, ensuring that due process is finally observed.

The original allegations from the FDA were quite varied. They concerned supposed irregularities related to the packaging, storage, and recall procedures for Reactin Plus Tablets. Furthermore, the FDA pointed to what it described as unauthorized promotional text appearing on the packaging of Schedule H prescription medicine. There were also claims of discrepancies between physical and computerized stock records, gaps in purchase and sale records, and a perceived non-compliance with recall directions.

However, it's crucial to note that Cipla swiftly clarified the nature of these allegations. The company explicitly stated that the FDA's order did not raise any concerns regarding the safety, quality, or efficacy of its products. More importantly, it did not involve or indicate any patient safety issues, a point that surely calmed many nerves within the pharmaceutical giant and among consumers alike.

The High Court bench, comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, evidently took issue with the FDA's conduct leading up to the cancellation. It came to light that the FDA had, rather incredibly, directed Cipla to appear for a hearing via email on August 26 – a public holiday! And without granting an adjournment or conducting a proper hearing, the cancellation order was summarily passed. Such a lapse in procedure left little doubt in the court's mind that the FDA's actions were, to put it mildly, out of line.

So, while the initial cancellation sent ripples through the pharmaceutical sector, this withdrawal signifies a strong affirmation of judicial oversight and the necessity for regulatory bodies to adhere strictly to established legal procedures and principles of natural justice. Cipla and the FDA will now restart the process, hopefully on a more level playing field.