Introduction
The Bombay High Court recently issued a strong rebuke to the Maharashtra Food and Drug Administration (FDA) for what it described as an overreach in the abrupt cancellation of wholesale drug sale licenses belonging to Cipla Pharma & Life Sciences Limited. This judicial intervention arose from the case of Cipla Pharma and Life Sciences v. State of Maharashtra & Ors.
Judicial Disapproval
The division bench, comprised of acting Chief Justice Ravindra V. Ghuge and Justice Gautam A. Ankhad, expressed disapproval of the FDA’s actions, labeling them as ‘high-handed.’ Cipla, a major pharmaceutical entity, sought the court’s intervention after its licenses governing operations at a significant distribution hub in Wadki, Pune, were abruptly nullified. The firm serves approximately 180 customers, distributing over 430,000 units of medications monthly throughout Maharashtra.
Court’s Remarks
During the proceedings, Chief Justice Ghuge criticized the FDA’s procedural missteps. “Notice of hearing was given on August 26, a state holiday, when your office was not open. How is this appropriate, fair, and transparent?” the Chief Justice questioned. He acknowledged the FDA’s commendable work but cautioned against overstepping boundaries, noting this wasn’t the first incident of such nature.
Government’s Response
Following the court’s stern observations, the State government pleader assured the bench that the cancellation order would be retracted immediately. The FDA committed to issuing a fresh notice to Cipla by September 4.
Background of the Dispute
The legal contention emerged from FDA inspections at Cipla’s Wadki facility conducted in June and August. FDA officials identified discrepancies in the packaging and artwork of the drug ‘Reactin Plus.’ Subsequently, a show-cause notice was issued on August 13, to which Cipla responded on August 25.
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Procedural Injustice
Compounding matters, the FDA summoned Cipla representatives for a hearing on August 26, a State holiday, only to issue a cancellation order when an administrative employee delivered a request for adjournment.
High Court’s Directive
Emphasizing procedural fairness, the court remarked, “Justice must not only be done but must appear to be done. Show us that sufficient time was given for a hearing. You’ve followed an incorrect procedure and set it aside. We’re giving you a chance; you’ve acted high-handedly.” Justice Ankhad further questioned the legality of the FDA’s decision, highlighting potential violations of natural justice principles.
Conclusion
The High Court instructed the FDA to refrain from scheduling hearings on public holidays unless absolutely necessary. With these directives, the petition was disposed of. Cipla was represented by Senior Advocate Aabad Ponda with Advocate Ranjeet Sangle, while Government Pleader P.P. Kakade appeared for the FDA.
