The Maharashtra Food and Drug Administration (FDA) has revoked the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carrying and Forwarding (C&F) unit in Pune following serious irregularities involving the packaging, storage, record-keeping and recall of Reactin Plus Tablets.
The cancellation took effect on August 27 after FDA officials inspected the company’s main warehouse in Wadki, Pune district.
The regulatory action came after the FDA identified several lapses in the company’s drug storage and distribution processes. Inspectors found medicines placed directly on the floor, insufficient pallet and rack facilities, mismatches between physical inventory and computerised records, and shortcomings in the procedures and documentation for managing expired medicines.
UNAUTHORISED CLAIM ON PRESCRIPTION DRUG PACKAGING
During an inspection conducted around June this year, FDA officials found that the packaging of Reactin Plus Tablets, a Schedule H prescription medicine, carried an unauthorised description of the drug as an “analgesic and antipyretic”, according to the regulator’s statement cited by PTI.
The FDA said the claim had been printed without the necessary approval and violated provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Following the violation, the regulator seized Reactin Plus stock valued at approximately Rs 11.91 lakh.
RECALL DIRECTIONS NOT FULLY FOLLOWED
The FDA ordered the company to recall the misbranded Reactin Plus Tablets from the market. However, the regulator said the company failed to completely follow the recall instructions and other measures issued in connection with the matter.
A later inspection of the C&F unit’s drug sale and distribution operations revealed additional shortcomings. These included differences between purchase and sales records and the actual computerised inventory, along with failure to comply fully with instructions regarding the recall of the affected medicines.
The FDA also highlighted problems with inventory management, including discrepancies between physical stock and computerised records. Inspectors found medicines stored directly on the floor and noted that the facility lacked adequate pallets and racks for proper storage.
The inspection further revealed shortcomings in maintaining records and adhering to prescribed procedures for handling expired medicines.
SHOW-CAUSE NOTICE ISSUED
Following the inspection findings, the FDA issued a show-cause notice to the licence holder and reviewed the company’s response.
After examining the explanation, the regulator concluded that the deficiencies identified during the inspections, along with the instructions issued for recalling Reactin Plus Tablets, had not been sufficiently addressed.
The FDA then cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s C&F unit in Wadki, Pune, effective August 27.
FDA Commissioner Tukaram Mundhe said the department would take a strict approach towards violations involving drug safety and public health, particularly in 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, according to PTI.
The Maharashtra FDA has reiterated that prescription medicines must be advertised, sold, stored and distributed in accordance with applicable laws and regulations. The regulator said violations occurring at any stage of the drug supply chain would attract legal action.
