Bombay High Court Pulls Up Maharashtra FDA, Order Cancelling Cipla Unit License Withdrawn

The Maharashtra Food and Drug Administration (FDA) has withdrawn its order to cancel the drug sale licence of Cipla Pharma & Life Sciences Ltd's carrying and forwarding facility located at Wadki in Pune. The withdrawal came after the Bombay High Court strongly criticized the regulatory body for going "overboard" and acting in a "high-handed" manner.

A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad stated that the FDA had acted against the "principles of natural justice." Following the court's observations, the FDA informed the bench that it would withdraw the license cancellation order forthwith. The department stated it would issue a fresh show cause notice to the company and subsequently pass a reasoned order.

The regulatory body had earlier cancelled the drug sale licenses of the facility with effect from August 27, citing serious irregularities related to the packaging, storage, and recall of Reactin Plus Tablets. In response, Cipla Pharma & Life Sciences challenged the action. The company clarified that the initial FDA order did not allege any concerns regarding the safety, quality, or efficacy of its products, nor did it indicate any patient safety issues.

During the court proceedings, senior counsel Aabad Ponda, representing Cipla, pointed out that the FDA had sent an email directing the company to appear for a hearing on August 26, which was a declared public holiday. According to Ponda, no company representative was available on that day, and although an adjournment was sought, the FDA proceeded to pass the cancellation order on the same day without granting a proper hearing.

Additional government pleader P.P. Kakade, representing the FDA, argued that the law does not grant the company a right to a hearing. However, the bench questioned the rationale behind summoning a company representative on a state-declared public holiday.

"You are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue," the high court remarked. The bench further questioned the fairness and transparency of issuing a hearing notice via email on a holiday, noting the contradiction in government departments seeking adjournments on holidays while passing orders on similar days.

The dispute stems from an initial round of inspection conducted by FDA officials in June. During the inspection, authorities discovered unauthorized promotional text—specifically the words "analgesic and antipyretic"—on the packaging of Reactin Plus Tablets, which is a Schedule H prescription medicine. The FDA noted that the promotion of such prescription drugs could encourage self-medication and pose health risks without medical advice. Additionally, the inspection detected discrepancies between physical and computerized stock records, gaps in purchase and sale records, and non-compliance with recall directions.

With the withdrawal of the current order, the legal and regulatory process will resume through the issuance of a fresh show cause notice and subsequent proceedings by the state regulator.

"This case highlights the critical importance of procedural fairness and adherence to natural justice in regulatory enforcement. While regulatory bodies play an essential role in maintaining compliance and public safety, procedural lapses—such as scheduling hearings on public holidays without adequate opportunity for response—can undermine administrative actions. For businesses, robust compliance management and transparent record-keeping are vital, but this ruling also emphasizes that due process must be strictly maintained by authorities in all regulatory matters." — Dr. Shishir Gupta, Founder & CEO, StartupLanes