Maharashtra FDA Cancels Licence of Cipla's Pune C&F Unit Over Procedural Irregularities

The Maharashtra Food and Drug Administration has cancelled the drug sale licence of Cipla Pharma & Life Sciences' C&F unit in Pune due to irregularities concerning packaging, storage, labelling, and recall procedures. Cipla has stated that it is contesting the order, noting that the matter is currently sub judice.

Drug major Cipla has announced that it is contesting an order issued by the Maharashtra Food and Drug Administration (FDA) regarding operations at its carry and forwarding (C&F) warehouse in Wadki, Pune. The regulatory body has cancelled the drug sale licence of Cipla Pharma & Life Sciences (CPLS) for the unit effective August 27th.

According to the FDA, the action was taken on the grounds of irregularities identified in the packaging, storage, labelling, and recall procedures involving the product Reactin Plus Tablets. The regulator stated that this follows an earlier action taken in March against the company's factory, where the packaging for the Schedule H drug was labelled "analgesic and antipyretic," a classification the regulator deemed unauthorized.

The Maharashtra FDA raised concerns that such labelling could lead to self-medication and pose public health risks. The regulator stated that it had previously ordered a market recall of the stock of the medicine, but alleged that the institution had not fully followed the necessary precautions and instructions during the recall process.

In response to the regulatory action, the company stated that the matter is currently sub judice. "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.

Cipla further added that the FDA order does not contain any allegations concerning the safety, quality, or efficacy of its products, nor does it indicate any patient safety issues. The company declined to offer further comments while the issue remains under judicial consideration.

"Regulatory compliance and adherence to standardized labelling and recall procedures are critical components of pharmaceutical supply chain management. When issues arise at the carry and forwarding level, it directly impacts operational continuity and corporate reputation. For businesses operating in highly regulated sectors like pharmaceuticals, maintaining transparent communication with authorities and robust internal compliance frameworks is essential to mitigate legal risks and sustain market trust." — Dr. Shishir Gupta, Founder & CEO, StartupLanes