The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) facility at Wadki in Pune following serious irregularities linked to the company’s Reactin Plus tablets.
During an inspection in June, FDA officials found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. The words “analgesic and antipyretic” were printed on the packaging despite not being permitted.
The regulator seized Reactin Plus stock worth more than Rs 11 lakh and directed the company to recall the drug from the market, citing violations of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. However, the company did not fully comply with the recall order, the FDA said.
According to the regulator, promotional claims on the packaging of a prescription medicine could encourage consumers to take the drug without medical advice, increasing the risk of self-medication.
A subsequent inspection of the company’s C&F operations uncovered further irregularities in the storage and distribution of medicines. Officials found discrepancies between physical and computerised stock records, gaps in purchase and sale documentation, and non-compliance with the recall directions.
The inspection also found medicines stored directly on the floor, along with inadequate pallet and rack facilities. Shortcomings were also identified in the records and procedures for handling expired medicines.
The FDA had issued a show-cause notice to the company over the alleged violations. Its response was examined by the regulator before the licences were cancelled under the relevant provisions of the Drugs and Cosmetics Act and Rules, the FDA statement said.
FDA Commissioner Tukaram Mundhe said the department would take a strict approach to 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,” he said.
The action comes amid the regulator’s continued focus on ensuring that prescription medicines are marketed, stored and distributed in accordance with safety and legal requirements.
(With IANS inputs)
