Cipla warehouse license revoked by Maharashtra FDA in Pune

The Maharashtra Food and Drug Administration (FDA) has revoked the drug sale and distribution licenses of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) warehouse in Wadki, Pune. The decision, issued on October 1, follows a renewed regulatory process prompted by directives from the Bombay High Court.

The revocation stems from several alleged irregularities. A primary concern involves the packaging of ‘Reactin Plus’ tablets, a Schedule H prescription drug. The FDA identified misleading claims on the packaging, which suggested relief for various types of pain—including headaches, muscle, joint, and toothaches—and utilized human figures to depict muscle pain relief, which the regulator deemed non-compliant with labeling laws.

Additionally, inspections of the warehouse revealed significant deficiencies in storage and inventory management. Findings included medicine boxes being stored directly on the floor rather than on pallets or racks, dust accumulation on stock, and the absence of a dedicated, clearly marked area for expired medications. The FDA also noted discrepancies between computer records and actual physical stock, including antibiotics, and a lack of required inspection documentation.