Maharashtra FDA Withdraws Cipla Drug Licence Cancellation After Bombay HC Rebuke

The Maharashtra Food and Drug Administration (FDA) has reversed its decision to cancel the drug sale licence of Cipla Pharma & Life Sciences Ltd's Pune carrying and forwarding facility. The Bombay High Court had previously rebuked the regulator for its handling of the matter, citing potential violations of natural justice principles.

Following the court's intervention, the FDA has agreed to withdraw its cancellation order and issue a new show-cause notice to Cipla before making a final decision. Initially, the FDA had cancelled the licences of Cipla's Wadki facility on August 27, based on concerns over irregularities in the packaging, storage, and recall of Reactin Plus Tablets.

Cipla argued against the decision, contending that the FDA's actions did not raise safety, quality, or efficacy issues with its products, nor did they involve any patient safety concerns. During a hearing on Saturday, Cipla's counsel pointed out that the FDA had scheduled the company's appearance for a public holiday, August 26, a day when no representatives were available.

Despite Cipla's request for an adjournment, the FDA proceeded to issue the cancellation order on the same day. The court expressed concern over the fairness of the situation, noting the lack of consideration for adjournment requests. The FDA maintained that the law did not guarantee Cipla the right to a hearing, but the court criticised the department for its "high-handed" approach and improper procedure.

The FDA has since agreed to withdraw the licence cancellation immediately and conduct fresh proceedings via a new show-cause notice. The original inspection had flagged several alleged compliance issues, such as promotional language on Reactin Plus packaging for a Schedule H prescription medication, discrepancies in stock records, gaps in documentation, and alleged non-compliance with recall instructions.