Bombay HC pulls up Maharashtra FDA over enforcement actions: What businesses need to know

The Bombay High Court has been closely examining the actions taken by the Maharashtra FDA (Food and Drug Administration) regarding enforcement against various businesses. Recently, the court scrutinized Cipla Pharma & Life Sciences, a pharmaceutical company, as well as restaurants, hotels, sweet shops, milk businesses, and other pharmaceutical companies. The focus has been on whether the FDA's actions were proportionate and followed due process, rather than questioning the regulator's authority to enforce safety standards.

In the case of Cipla, the FDA cancelled its wholesale drug-sale license after inspections found issues such as packaging problems, discrepancies in stock records, and concerns about the recall of tablets. Cipla challenged the cancellation, arguing it did not receive a fair opportunity to respond. The court questioned the procedural fairness and the FDA subsequently agreed to withdraw the cancellation order, giving Cipla a chance to respond before making a new decision.

The court also advised the FDA to avoid scheduling hearings on public holidays unless there is a genuine emergency.

Another case involved five restaurants operating on the Mumbai Cricket Association's premises, which faced suspension due to hygiene violations and third-party operation. The court set aside the FDA's suspension orders, criticizing their pedantic approach and warning of potential contempt proceedings. The court emphasized the need for a pragmatic approach when dealing with such issues.

The Bombay High Court has also intervened in other cases involving the Maharashtra FDA, such as the suspension of a dairy and sweets establishment following a food-poisoning incident, and the suspension of a hotel's license due to hygiene concerns. The court has quashed suspensions and directed the FDA to compensate businesses when appropriate. In the case of Aurangabad, the high court stayed FDA action against milk vendors and suppliers, questioning whether the statutory procedure was followed before the suspension.

While the court's interventions have not indicated a blanket opposition to FDA action, the outcomes have varied based on each case's circumstances. Businesses challenging FDA decisions can question factors such as adequate response opportunities, the justification for immediate suspension or cancellation, consideration of corrective action, and the reasons provided by the regulator. These developments come as the Maharashtra FDA has intensified inspections and enforcement since Tukaram Mundhe became FDA Commissioner.