The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding unit at Wadki in Pune district over multiple regulatory violations.
The action took effect on August 27 following inspections that found serious deficiencies in the storage, record-keeping and distribution of medicines, including Reactin Plus Tablets.
According to the FDA, Reactin Plus, a Schedule H prescription medicine, was packaged with an unauthorised claim describing it as an “analgesic and antipyretic”. The regulator seized stock valued at around ₹11.91 lakh and directed the company to recall the affected medicines.
The FDA later found that the recall instructions had not been fully followed. Inspectors also reported discrepancies between physical stock and computerised records, medicines kept directly on the floor and inadequate pallet and rack arrangements.
Lapses were also detected in the handling and documentation of expired medicines.
After issuing a show-cause notice and reviewing the company’s response, the regulator concluded that the violations and recall directions had not been adequately addressed.
FDA Commissioner Tukaram Mundhe said strict action would be taken against violations involving the manufacture, storage, sale and distribution of medicines, particularly prescription drugs.