FDA cancels drug sale licence of Cipla in Pune

Mumbai: The Maharashtra Food and Drug Administration (FDA) on Friday said it has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding (C&F) warehouse at Wadki in Pune following detection of alleged violations.

The FDA said in a statement that the action followed the completion of fresh proceedings in compliance with the Bombay High Court's directions.

It follows an earlier FDA action taken against the facility on August 27 this year over alleged irregularities involving the packaging, storage, documentation and recall of Reactin Plus Tablets. The FDA had then cited unauthorised claims on the packaging of the Schedule H prescription drug and several deficiencies at the warehouse.

The latest order was passed on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune, after the department withdrew its earlier proceedings in compliance with the directions of the Bombay high court, the FDA said.

According to the statement, the department issued a revised show-cause notice to the company on September 4.

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