Going overboard: HC raps FDA over Cipla Pune licence cancellation; order withdrawn
The Bombay High Court reprimanded the Maharashtra Food and Drug Administration (FDA) for canceling Cipla's Pune unit's drug sale license in a manner deemed excessive and lacking due process. Following legal challenges by Cipla, the FDA withdrew the cancellation order and agreed to issue a new show-cause notice while promising a reasoned decision after reviewing the company's response. The court criticized the FDA for acting improperly and violating principles of natural justice, particularly noting that the agency requested Cipla to appear for a hearing on a public holiday and proceeded with the cancellation despite the company's request for an adjournment. The FDA's initial action was based on findings during inspections of Cipla's facility, including unauthorized promotional text on the packaging of Reactin Plus Tablets.
The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order to cancel the drug sale licence of Cipla Pharma & Life Sciences Limited's Pune unit following criticism from the Bombay high court. The court rebuked the state regulator for acting in a "high-handed" manner and going "overboard." The FDA had previously cancelled the drug sale licenses of Cipla’s carrying and forwarding facility at Wadki in Pune due to serious irregularities involving the packaging, storage, and recall of Reactin Plus Tablets, effective August 27. The court’s bench, comprising acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, stated that the FDA had violated the principles of natural justice. Cipla had challenged the FDA’s action, asserting that the cancellation order did not raise concerns about the safety, quality, or efficacy of its products and did not involve any patient safety issues. Senior counsel Aabad Ponda, representing Cipla, informed the court that the FDA had sent an email requesting the company to appear for a hearing on August 26, a public holiday in Maharashtra. Cipla claimed it had no representative available on that day and requested an adjournment. However, the FDA proceeded with the cancellation order without granting a hearing. The FDA was represented by Additional government pleader P P Kakade, who contended that the law did not grant Cipla the right to a hearing. The court, however, questioned the fairness and transparency of the FDA’s actions, noting that the department had directed Cipla to appear on a public holiday when government offices were closed. The court emphasized that the FDA had acted improperly and needed to resolve the issue. It noted that the FDA had previously faced similar criticisms and should ensure adherence to proper procedures moving forward. The bench ordered the FDA to withdraw the cancellation order immediately and issue a fresh show-cause notice to Cipla. A reasoned order would be passed after considering the company’s response. The FDA’s initial decision to cancel the licence stemmed from inspections conducted in June. Officials discovered unauthorized promotional text on the packaging of Reactin Plus Tablets, a Schedule H prescription medicine. The packaging included the words "analgesic and antipyretic," which the FDA deemed inappropriate for promoting a prescription drug. According to the FDA, such promotions could encourage individuals to use the medication without medical advice and increase the risk of self-medication. Further issues identified during the inspection included discrepancies between physical and computerized stock records, gaps in purchase and sale records, and non-compliance with recall instructions. These findings prompted the FDA to take action against Cipla’s operations. Following the court’s directive, the FDA confirmed it would withdraw the cancellation order and initiate a new process to address the alleged violations. The company is expected to respond to the fresh show-cause notice, leading to a formal decision by the regulatory body.
The Maharashtra Food and Drug Administration (FDA) revoked its decision to cancel the drug sale license of Cipla Pharma's Pune unit after the Bombay High Court criticized the regulatory body for acting 'overboard' and 'high-handed.' The FDA had initially canceled the license due to irregularities in the handling of Reactin Plus Tablets. Cipla challenged the order, arguing that the FDA's actions violated the principles of natural justice by conducting a hearing on a public holiday without allowing the company to present its case. The court ruled in favor of Cipla, ordering the FDA to issue a new show cause notice and reconsider its decision. The court emphasized the need for fairness and transparency in administrative procedures.
Bias read (Progressive): The article frames the FDA's actions as overly strict and lacking procedural fairness, aligning with a critique of bureaucratic overreach often associated with left-leaning perspectives. The court's emphasis on natural justice and transparency suggests a judicial approach that prioritizes individual
Why factuality (90): This article accurately describes the Bombay High Court's reprimand of the FDA regarding the cancellation of Cipla's license. It provides specific dates, the names of the judges, and the nature of the court's criticism. While slightly less detailed than some others, it aligns with the cross-source c
Why objectivity (85): The article uses phrases like 'going overboard' and 'high-handed' which may imply a slight negative tone towards the FDA. However, these terms are attributed to the court's statements rather than the author's personal opinion, maintaining a relatively balanced perspective.
India TodayIndependentCenterFactual 85Objective 808/29/2026
The Bombay High Court reprimanded the Maharashtra Food and Drug Administration (FDA) for canceling Cipla's Pune unit's drug sale license in a manner deemed excessive and lacking due process. Following legal challenges by Cipla, the FDA withdrew the cancellation order and agreed to issue a new show-cause notice while promising a reasoned decision after reviewing the company's response. The court criticized the FDA for acting improperly and violating principles of natural justice, particularly noting that the agency requested Cipla to appear for a hearing on a public holiday and proceeded with the cancellation despite the company's request for an adjournment. The FDA's initial action was based on findings during inspections of Cipla's facility, including unauthorized promotional text on the packaging of Reactin Plus Tablets.
Bias read (Center): The article presents a balanced account of the legal proceedings between Cipla and the FDA, highlighting both the court's criticism of the FDA's actions and the regulatory concerns raised by the FDA regarding the pharmaceutical company's practices. There is no evident bias toward either side, with a
Why factuality (85): The article reports on the Bombay High Court criticizing the Maharashtra FDA for improperly canceling Cipla's drug sale license and ordering them to withdraw the decision. It provides details from the court proceedings, including the reasons given by the FDA for the cancellation (irregularities in p
Why objectivity (80): The article presents the court's criticism of the FDA as a factual development and includes quotes from legal representatives on both sides. It maintains a neutral tone, focusing on the procedural issues raised by the court rather than taking a clear stance on the merits of the case. However, the us
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