Tukaram Mundhe-led Maharashtra FDA cancels Cipla unit's drug licence over Reactin Plus irregularities

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carrying and Forwarding (C&F) unit in Pune over serious irregularities related to the packaging, storage, record-keeping and recall of Reactin Plus Tablets. Cipla has contested the order, saying the matter is currently sub judice and clarifying that the FDA's action does not allege any concerns relating to the safety, quality or efficacy of its products.

The licence cancellation came into effect on August 27, following an inspection of the company's main warehouse at Wadki in Pune district, according to the FDA.

In a statement, Cipla said the FDA order pertains to the operations of a C&F warehouse operated on behalf of Cipla Pharma & Life Sciences and is currently under judicial consideration. The company said it would not be appropriate to comment further on the proceedings at this stage.