Drugmaker Cipla said it was contesting the Maharashtra Food and Drug Administration’s order involving irregularities involving storage, packaging and recall procedures at its Pune unit.
“Cipla Pharma & Life Sciences (CPLS) has contested the Pune FDA’s order pertaining to the operations of a C&F warehouse operated on behalf of CPLS and the matter is currently sub judice,” the company said, without further comment as the issue was under “judicial considertation”. The drugmaker added that the FDA order did not allege concerns relating to the “safety, quality or efficacy of our products, nor does it involve or indicate any patient safety issue”.
Maharashtra FDA cancels Pune unit licence
The Maharashtra FDA had cancelled the drug sale licence of CPLS’ carry and forwarding (C&F) unit in (Wadki) Pune, from August 27th, on the grounds of irregularities in packaging, storage, labelling and recall procedures involving Reactin Plus Tablets, the FDA said. This was the second time the regulator was raising concerns, the first being in March 2026, when it acted against the company’s factory on the grounds that packaging for a Schedule H drug Reactin Plus Tablets, was labelled “analgesic and antipyretic”, which the regulator said, was “unauthorized”.
FDA flags recall and self-medication concerns
This could lead to a possibility of self-medication, posing a public health, the regulator said, adding that it had ordered the recall of the stock of “misbranded medicine” Reactin Plus Tablets from the market, but found that the institution had not fully followed the necessary precautions and instructions in this regard, the Maharashtra FDA alleged.