Cipla Pune Warehouse Licence Cancelled Over Packaging and Storage Lapses
Maharashtra FDA has cancelled Cipla’s Pune warehouse licences after flagging packaging, storage, record-keeping and expired medicine handling violations.
Maharashtra’s Food and Drug Administration has cancelled the drug sale and distribution licences of a Cipla Pharma & Life Sciences warehouse in Pune after inspections found alleged violations involving medicine packaging, storage, record-keeping and expired drugs.
The action concerns Cipla’s Carrying and Forwarding warehouse at Wadki. The final cancellation order was issued on October 1 after regulatory proceedings that followed directions from the Bombay High Court.
A key issue involved Reactin Plus, a Schedule H prescription medicine. During an inspection, FDA officials flagged packaging that described the product as an “analgesic and antipyretic” and included promotional claims about relief from several types of pain. The regulator considered the claims inappropriate for the prescription medicine and had earlier seized stock worth around Rs 11.2 lakh and ordered its recall.
Inspectors also reportedly found medicine boxes stored directly on the floor, dust accumulation, missing mandatory inspection documentation and expired medicines allegedly not separated in a designated area. Differences between physical inventory and computerised records were also flagged.
FDA Commissioner Tukaram Mundhe said the action was intended to maintain safety, quality and compliance across the pharmaceutical supply chain.
Cipla has contested the decision, saying its warehouse follows applicable storage, distribution and digital record-keeping protocols. The company said it was reviewing the order and considering further options.
For a pharmaceutical warehouse, “check the storage conditions” is not exactly an optional item on the to-do list.
