Bombay High Court Overturns Maharashtra FDA Order Against Cipla Pune Unit

The Maharashtra Food and Drug Administration (FDA) has been forced to withdraw its cancellation of drug sale licences for Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) unit in Pune. The regulatory reversal followed a sharp rebuke from the Bombay High Court, which criticized the state agency for acting in a high-handed manner and failing to adhere to the principles of natural justice during its enforcement proceedings.

The dispute originated from inspections conducted by the Maharashtra FDA in June 2026 at the company’s Wadki facility. The regulator had initially moved to cancel the unit's licences, citing alleged irregularities in the storage, packaging, and recall procedures for Reactin Plus Tablets, a Schedule H prescription medication. The FDA had also seized stock valued at approximately ₹11.19 lakh, claiming the company failed to comply with its recall directives.

The Bombay High Court bench, comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, intervened after Cipla challenged the FDA’s summary cancellation order. During the proceedings, the court highlighted that the FDA had directed the company to appear for a hearing on August 26, which was a public holiday in Maharashtra. When the company could not produce a representative on that day, the regulator proceeded to cancel the licences without granting a further hearing.

The court described the FDA’s actions as going overboard, noting that while the regulator’s mandate to ensure public safety is laudable, its procedural execution in this instance was flawed. The bench emphasized that the department had acted in a high-handed manner, failing to provide a fair and transparent process. Consequently, the FDA agreed to withdraw the cancellation order immediately, issue a fresh show-cause notice, and conduct a new hearing to reach a reasoned decision.

The FDA’s initial case against the Pune facility centered on several specific operational deficiencies. According to the regulator, inspections revealed that medicines were being stored directly on the floor, which violates standard pharmaceutical storage protocols. Furthermore, the agency reported significant discrepancies between physical stock levels and computerized records, as well as gaps in the facility's purchase and sale documentation.

Beyond storage issues, the FDA took exception to the marketing of Reactin Plus Tablets. The regulator alleged that the packaging carried unauthorized promotional claims, specifically labeling the product as an “Analgesic & Antipyretic.” The FDA argued that such promotional language on a Schedule H prescription drug could encourage consumers to engage in self-medication without professional medical guidance, thereby posing a potential risk to public health.

Cipla has consistently contested the allegations, maintaining that the matter is sub judice. In its public statements, the company clarified that the FDA’s order did not raise any concerns regarding the safety, quality, or efficacy of the products themselves, nor did it indicate any immediate threat to patient safety. The company’s legal team, led by senior counsel Aabad Ponda, successfully argued that the FDA’s refusal to grant an adjournment on a public holiday denied the firm its right to be heard.

This regulatory challenge occurs as Cipla continues to pursue an aggressive expansion of its global oncology portfolio. In a separate development announced on September 4, 2026, the company confirmed a new partnership with China’s Qilu Pharmaceutical. Under this agreement, Cipla’s subsidiary, Invagen Pharmaceuticals, will handle the exclusive licensing and commercialization of QL2107, a biosimilar to the cancer drug Keytruda (pembrolizumab), in the United States. This strategic move underscores the company's focus on high-value biosimilar assets despite the ongoing regulatory scrutiny in its domestic operations.

With the cancellation order now withdrawn, the immediate future of the Pune C&F unit depends on the outcome of the fresh show-cause process. The FDA is expected to provide Cipla with a formal opportunity to address the specific findings regarding storage and record-keeping. The company will need to demonstrate that it has rectified the procedural gaps identified during the June inspections to avoid further regulatory action.

The case serves as a reminder of the delicate balance between regulatory enforcement and procedural fairness in India’s pharmaceutical sector. As the FDA prepares to issue a reasoned decision, the industry will be watching to see how the regulator reconciles its mandate for strict compliance with the court’s requirement for transparent, fair administrative practices. The resolution of this dispute will likely set a precedent for how the Maharashtra FDA handles future enforcement actions against major pharmaceutical distributors.