Bombay High Court Forces FDA to Restore Cipla License

The Maharashtra Food and Drug Administration (FDA) withdrew an order to cancel the drug sale licenses of a Cipla Pharma & Life Sciences Ltd Carry and Forwarding (C&F) unit in Wadki, Pune, on August 30, 2026. The regulator had originally cancelled the licenses effective August 27, citing irregularities including the use of unauthorized promotional text for Reactin Plus tablets, inadequate storage practices, and failure to comply with drug recall orders. The FDA seized stock worth ₹11.19 lakh during its inspections.

Cipla Pharma & Life Sciences contested the order in court, stating that the regulatory action did not involve concerns regarding the safety, quality, or efficacy of its products. The Bombay High Court subsequently ordered the restoration of the license, criticizing the FDA for acting in a high-handed manner. The court found that the FDA violated the principles of natural justice by scheduling a hearing on August 26—a public holiday—and passing the cancellation order that same day without granting the company a hearing.

The court noted that the abrupt closure of the Wadki facility threatened the distribution of critical life-saving medicines, as the warehouse handles over 400,000 products monthly. While FDA Commissioner Tukaram Mundhe previously stated the department would not show leniency regarding public health, the regulator must now issue a fresh show-cause notice and provide the company a reasonable opportunity to be heard before passing any further reasoned orders.