New Delhi, August 28: 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 in Wadki, Pune, following serious irregularities linked to Reactin Plus tablets, Hindustan Times reported. The licences were cancelled with effect from August 27, FDA officials said on Friday.
The action followed an inspection of the company’s main warehouse in June, during which FDA officials found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. The packaging carried the words “analgesic and antipyretic”, according to the FDA.
The regulator seized Reactin Plus stock worth ₹11.19 lakh and directed the company to recall the medicine from the market, citing violations of packaging rules under the Drugs and Cosmetics Act, 1940 and Rules, 1945. The FDA said such promotion of a prescription drug could encourage people to take it without medical advice, increasing the risk of self-medication.
A subsequent inspection of the C&F facility found several other irregularities in the storage and distribution of medicines. These included differences between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with recall directions. Inspectors also found medicines stored directly on the floor, along with inadequate pallet and rack facilities. Shortcomings were also flagged in the records and procedures for handling expired medicines.
FDA Commissioner Tukaram Mundhe said the department would not compromise on drug safety and public health. “Strict compliance with legal provisions is essential, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines,” Mundhe said, adding that violations anywhere in the drug manufacturing or distribution system would invite strict action under the law.
The FDA had earlier issued a show-cause notice to the company over the alleged violations. After examining its response, the regulator cancelled the licences under the relevant provisions of the Drugs and Cosmetics Act and Drugs Rules.
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