The Food and Drug Administration has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd. in Wadki, Pune, with effect from August 27, 2026.
The case relates to Reactin Plus Tablets, a Schedule H prescription medicine. FDA found the words “Analgesic and Antipyretic” printed on the packaging, which it said was unauthorised advertising and against the relevant drug laws.
During the action at Cipla’s main warehouse in Pune, FDA seized stock worth around Rs 11.19 lakh.
According to the department, such advertising on a prescription medicine could encourage people to take medicines without consulting a doctor, creating a public health risk.
FDA had further directed the company to recall the misbranded Reactin Plus Tablets from the market, but found that the required instructions were not fully complied with.
The inspection also found issues related to drug storage, differences between physical and computerised stock records, and non-compliance with recall instructions.
FDA also found medicines stored directly on the floor, inadequate pallet/rack arrangements and shortcomings in records and procedures for handling expired medicines.
After examining the company’s explanation and the inspection findings, Maharashtra FDA cancelled Cipla Pharma & Life Sciences Ltd.’s drug sale licences from August 27, 2026.
