Pune: In a major regulatory clampdown, the Maharashtra Food and Drug Administration (FDA) has cancelled the sales and distribution licence of a Pune-based warehouse belonging to Cipla Pharma and Life Sciences Ltd. The stringent action comes after authorities uncovered severe irregularities in the facility’s storage practices and drug packaging.
The order to revoke the licence of the company’s carrying and forwarding (C&F) warehouse, located in Wadki, was issued on October 1 by the FDA’s Pune Division-3 Assistant Commissioner (Drugs). This move followed a fresh legal review process initiated under the directions of the Bombay High Court.
According to FDA officials, an inspection of the premises revealed significant violations regarding Cipla’s ‘Reactin Plus’ tablets. The packaging falsely advertised the Schedule-H prescription drug with over-the-counter painkiller claims, suggesting it relieved headaches, muscle pain, backaches, and toothaches. Inspectors also noted unauthorised illustrations of human figures depicting muscle pain relief on the packets.
The FDA categorised these practices as misbranding under the Drugs and Cosmetics Act, 1940. Officials emphasised that a marketing company cannot escape its legal accountability by simply shifting the blame to the manufacturer.
Beyond packaging flaws, the inspection exposed glaring operational lapses in warehouse management. Essential regulatory documents, including the mandatory Form-35 inspection book, were missing. Inspectors found medicine boxes, including antibiotic stocks, resting directly on the dusty floor due to a shortage of storage racks and pallets.
Furthermore, the facility lacked a designated, clearly labelled area for expired drugs and failed to maintain standard operating procedures (SOP) or records for their safe disposal. The FDA also flagged discrepancies between the company’s computerised SAP inventory records and the actual physical stock. The department clarified that maintaining digital records does not waive a licence holder’s legal responsibility for physical cleanliness and accurate stock matching.
Addressing the regulatory action, FDA Commissioner Tukaram Mundhe stated that the department’s primary objective is not merely punitive. “Our aim is to ensure the safety and quality of medicines and enforce strict adherence to legal provisions within the drug supply chain,” he noted, adding that the proceedings were transparent and followed the principles of natural justice as directed by the Bombay High Court.
The FDA had previously taken action against the same warehouse on August 27. However, following the High Court’s intervention, the department withdrew its initial order, issued a revised show-cause notice on September 4, and granted Cipla a personal hearing before passing the final cancellation order.