In the latest cleanup drive by the Maharashtra Food and Drug Administration, drug sale licences of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) unit in Pune have been cancelled.
The move comes after officials found serious irregularities related to the packaging, storage and recall of Reactin Plus tablets. The cancellation came into effect on August 27, following an inspection of its main warehouse at Wadki in Pune district.
"Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," FDA Commissioner Tukaram Mundhe said.
What did the officials find at the warehouse?
During an inspection around June, officials found that the packaging of Reactin Plus tablets, a Schedule H prescription medicine, carried an unauthorised claim describing it as an "analgesic and antipyretic", the statement said.
Officials also seized stock worth Rs 11.19 lakh, saying such advertising was contrary to the provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. Subsequently, the company was directed to recall the misbranded Reactin Plus Tablets from the market.
However, the company didn't fully comply with the directions and required measures, the regulator stated.
An inspection of the unit's drug sale and distribution system found deficiencies in storage arrangements, discrepancies between purchase and sale records and actual computerised stock, and non-compliance with recall directions as well. Medicines were found to be stored directly on the floor.
(With agency inputs)
