In a major development, the Bombay High Court sharply criticized the Maharashtra Food and Drug Administration (FDA) for taking harsh and quick actions without following fair rules. Rapping the state safety regulator, the court remarked that the agency was "going overboard" and behaving in a "high-handed" manner. Following the stern warnings, the FDA immediately withdrew its cancellation order and restored the drug sale license for Cipla Pharma's facility in Wadki, Pune.
The controversy began when the FDA cancelled the license of Cipla major warehouse over packaging and storage issues regarding Reactin Plus tablets. Cipla quickly challenged the decision in court, pointing out that the cancellation was ordered on a public holiday without giving the company a fair chance to present its case. Furthermore, the company highlighted that stopping operations at the warehouse blocked life saving medicines from reaching thousands of patients.
A division bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad noted that while enforcing safety standards is appreciated, the authority cannot ignore natural justice or act unfairly. The court questioned how the regulator could force a hearing on a public holiday when government departments themselves regularly ask for extensions. After the High Court strong rebuke, the FDA took back its decision. The regulator will now issue a proper show cause notice and give the pharma company a fair hearing before taking any further action under the law.
