The Cipla Pune warehouse has lost its drug sale and distribution licences after Maharashtra’s Food and Drug Administration flagged alleged violations involving medicine packaging, storage conditions, documentation and handling of expired products. The action concerns Cipla Pharma & Life Sciences’ carrying and forwarding facility at Wadki in Pune.
The final cancellation order was issued on October 1 following regulatory proceedings. The case partly relates to Reactin Plus, a Schedule H prescription medicine. During an inspection, officials reportedly found packaging carrying descriptions and promotional claims that the regulator considered inappropriate for a prescription-only product. Stock valued at around Rs 11.2 lakh was previously seized and recalled.
Storage and record-keeping issues flagged
The inspection also identified several concerns at the warehouse. Medicine boxes were reportedly found placed directly on the floor, with dust accumulation, while expired medicines were allegedly not kept separately in a designated “Not for Sale” area.
Officials also flagged discrepancies between physical inventory and computerised records involving medicines, including antibiotics. The regulator maintained that digital records could not replace required physical verification, hygiene practices and statutory documentation.
The FDA said Cipla’s response was considered during the proceedings and that the final action followed a detailed hearing process. The regulatory move highlights the importance of maintaining compliance throughout the pharmaceutical storage and distribution chain, where apparently small lapses can become a very expensive headache.
Cipla contests the decision
Cipla has disputed the regulatory action and said it remains committed to quality, patient safety and uninterrupted medicine availability. The company maintained that its Pune facility follows applicable distribution, storage and digital record-keeping protocols.
The company is reviewing the cancellation order and considering further options.
The action specifically concerns the licences of the Pune facility and the violations identified during the regulatory process. It does not amount to a finding that all Cipla medicines are affected. The company continues to contest the order and is evaluating its next steps.
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