FDA Withdraws Cipla Pune Unit Licence Cancellation Following Bombay High Court Direction

The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carrying and Forwarding (C&F) unit in Wadki, Pune. The withdrawal came after the Bombay High Court sharply criticized the state regulator for acting in a "high-handed" manner and violating the principles of natural justice by issuing the cancellation order on a state-declared public holiday without granting a fair hearing. The regulatory body confirmed it will issue a fresh show-cause notice to the company to restart the administrative review process under proper legal procedure.

The initial regulatory action stemmed from a June inspection of the Wadki warehouse, where FDA inspectors flagged multiple alleged compliance violations involving Reactin Plus Tablets, a Schedule H prescription drug. Officials seized stock valued at ₹11.19 lakh, objecting to "analgesic and antipyretic" packaging claims that regulators characterized as unauthorized promotional text under the Drugs and Cosmetics Act, 1940, raising concerns over self-medication risks.

Subsequent warehouse audits further cited discrepancies between physical inventory and computerized stock records, improper storage of medicines directly on the floor, and incomplete compliance with market recall directives.

While FDA officials led by Commissioner Tukaram Mundhe maintained a zero-tolerance stance on Schedule H distribution standards, Cipla contested the order through judicial channels. The pharmaceutical major clarified that the administrative order pertained solely to third-party C&F warehouse operations and did not raise any concerns regarding the safety, quality, or efficacy of its products. Following the High Court's directives, the state regulator will re-examine the case through a transparent hearing process.