Mumbai — The Maharashtra Food and Drug Administration has canceled the drug sale licenses of Cipla Pharma & Life Sciences Ltd.’s Carry and Forwarding facility in Wadki, Pune, after inspections uncovered multiple regulatory violations involving the company’s Reactin Plus tablets.
During an inspection in June, FDA officials found unauthorized promotional language on the packaging of Reactin Plus, a Schedule H prescription medicine. The packaging included the terms “analgesic and antipyretic,” which the regulator said violated provisions of the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945.
The FDA seized Reactin Plus stock valued at more than Rs 11 lakh and directed the company to recall the medicine from the market. According to the regulator, the company did not fully comply with those instructions.
The FDA said promotional claims on prescription drug packaging could encourage patients to use medicines without medical supervision, increasing the risk of self-medication.
A subsequent inspection of the company’s C&F operations identified additional problems involving medicine storage and distribution. Regulators reported discrepancies between physical and computerized inventory records, gaps in purchase and sales documentation and failures to comply with recall requirements.
Inspectors also found medicines stored directly on the floor, inadequate pallet and rack facilities and deficiencies in procedures and records related to expired drugs.
The FDA issued a show-cause notice to the company and reviewed its response before canceling the licenses under applicable provisions of the Drugs and Cosmetics Act and Drugs Rules.
FDA Commissioner Tukaram Mundhe said the department would take a strict approach to violations affecting drug safety and public health, particularly those involving the advertising, sale, storage and distribution of Schedule H prescription medicines.
“Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law,” Mundhe said. (Source: IANS)
