Maharashtra’s Food and Drug Administration (FDA) withdraws its cancellation of Cipla Pharma & Life Sciences’ drug sale licence for its Pune carrying-and-forwarding (C&F) facility after the Bombay High Court criticized the regulator’s procedure. The earlier cancellation, effective from August 27, was linked to alleged irregularities involving Reactin Plus Tablets, a Schedule H prescription medicine.
The FDA had cited issues found during inspections, including allegedly unauthorized promotional wording on packaging, deficiencies in storage practices (such as medicines stored on the floor and handling of expired stock), discrepancies between physical and computerized stock records, gaps in purchase and sale documentation, and alleged non-compliance with recall directions. Cipla challenged the action in court, arguing that the licence was cancelled without a proper opportunity to be heard. Its counsel told the court the FDA asked for a hearing on August 26, a state-declared public holiday, and after Cipla sought an adjournment due to no authorized representative, the order was issued the same day.
In response to the court’s concerns about due process and “natural justice,” the FDA says it will withdraw the cancellation order and issue a fresh show-cause notice, followed by a new reasoned decision after considering Cipla’s response. Some outlets emphasize the specific storage and misbranding-related violations described by the FDA, while the court-focused reports highlight the procedural lapse that led to the withdrawal.
