The Food and Drug Administration (FDA) in Pune has revoked the wholesale drug sale license of Cipla Pharma and Life Sciences Ltd, located in Wadki, Pune. Tukaram Mundhe, the Commissioner of the Maharashtra FDA, indicated that this decision followed thorough legal and regulatory procedures.
Mundhe stated that significant irregularities were uncovered during the facility’s inspection. These included problems with the packaging and marketing of Reactin Plus Tablets, as well as shortcomings in the storage, record-keeping, and overall management of pharmaceuticals within the warehouse.
The FDA’s primary goal, Mundhe emphasized, is not solely to impose penalties but to ensure the safety and quality of medications, along with regulatory compliance throughout the pharmaceutical supply chain. He noted that the actions taken were in accordance with directives from the Bombay High Court, adhering to principles of natural justice, transparency, and due process.
During the inspection of the Wadki facility, authorities discovered stock of Reactin Plus, which is classified as a Schedule H drug. This product was marketed as an analgesic and anti-inflammatory, claiming to provide rapid relief from various types of pain, including headaches, muscle pain, backaches, and toothaches. The packaging featured illustrations suggesting that it alleviated muscular discomfort, according to official reports.
Girish Hukare, the Joint Commissioner (Drug) in Pune, pointed out that the inspection revealed that the claims and illustrations on the packaging did not meet the legal requirements. This raised issues of misbranding under the Drugs and Cosmetics Act of 1940, prompting the regulatory response.
Additionally, the inspection identified multiple deficiencies in the storage and management practices at the warehouse. An official statement highlighted the absence of a Form 35 inspection book mandated by regulations, as well as improper storage practices where medicine boxes were placed directly on the floor due to a lack of pallets or racks. There were also cleanliness issues, including dust accumulation on medicine stocks, and the absence of a designated area labeled “Expiry – Not for Sale” for expired medications.
In response to the FDA’s decision, Cipla stated, “Cipla is committed to maintaining high standards of quality and patient safety, and we find the Maharashtra FDA’s decision regarding our Wadki facility disappointing. We believe our Pune warehouse adheres to the required distribution and storage protocols, as well as digital record-keeping standards. We are currently reviewing the order and exploring further options. Cipla remains dedicated to providing uninterrupted access to safe, high-quality medicines for both patients and healthcare providers.”
Further deficiencies included issues with authorized signatures on duplicate sales invoices and inconsistencies between computer records and SAP data. Cipla previously contested the FDA’s cancellation of their carry and forwarding agent (CFA) license for the Pune warehouse, asserting that the FDA’s allegations did not pertain to the safety, quality, or efficacy of their products. FDA officials noted that earlier proceedings were withdrawn in compliance with High Court directives.
A revised show-cause notice was issued on September 4, to which Cipla responded in writing on September 11, and a personal hearing was held on September 21. FDA authorities remarked that the decision was made independently after completing the required procedures in line with the Bombay High Court’s guidance.
