- Bombay High Court reprimanded the Maharashtra FDA for its high-handed cancellation of Cipla's wholesale drug sale licences, stating it acted against the principles of natural justice.
- The FDA withdrew its cancellation order after the Court's remarks and agreed to issue a fresh notice to Cipla before September 4.
- Cipla's licences were cancelled on August 27 due to alleged packaging and artwork irregularities involving the drug Reactin Plus.
- Cipla challenged the FDA's action, clarifying that the order did not allege any concerns about the safety, quality, or efficacy of its products.
- The legal dispute arose from FDA inspections at Cipla's Wadki facility in June and August, which found irregularities in the packaging of Reactin Plus.
- Cipla submitted a detailed reply to the FDA's show-cause notice on August 25, following the notice issued on August 13.
- On August 26, the FDA summoned Cipla for a personal hearing on a state holiday, leading to the cancellation order being handed over without granting a hearing.
The Bombay High Court reprimanded the Maharashtra FDA for its 'high-handed' cancellation of Cipla Pharma's drug licenses, which affected its operations at a key distribution hub in Pune. The court's intervention came after Cipla challenged the FDA's actions, citing violations of natural justice.12
Cipla's licenses were revoked following inspections that revealed alleged irregularities in packaging and storage of Reactin Plus tablets. The FDA's cancellation order was issued on August 27, despite Cipla's request for an adjournment due to a hearing scheduled on a public holiday, August 26. Chief Justice Ravindra Ghuge criticized the FDA's approach, stating, *“How is it appropriate, fair and transparent?”* and emphasized the need for the FDA to adhere to principles of fairness in regulatory processes.5
The court highlighted that the FDA's actions were not only hasty but also lacked transparency, questioning the legality of conducting hearings on public holidays. The FDA's allegations included unauthorized promotional text on the drug's packaging, which could mislead consumers into self-medication. However, Cipla clarified that the FDA's order did not raise concerns regarding the safety or efficacy of its products.
Following the court's strong remarks, the FDA agreed to withdraw the cancellation order and issue a fresh notice to Cipla, ensuring that due process is followed in future hearings. The court's decision underscores the importance of natural justice in regulatory actions, particularly in the pharmaceutical sector.34
“The FDA's cancellation stemmed from inspections at Cipla's Wadki facility that found packaging irregularities for Reactin Plus, a Schedule H prescription drug. The court noted the FDA gave notice on a state holiday, and the regulator has now agreed to issue a fresh notice before September 4.”
