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FDA crackdown on Cipla Pharma's Pune unit, license cancelled over 'unauthorised promotional text'
The FDA seized Reactin Plus stock worth ₹11.19 lakh and ordered the firm to recall the drug from the market.
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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, citing serious irregularities found during inspections linked to Reactin Plus tablets.
The licences were cancelled with effect from August 27, the FDA officials said on Friday.
The action was taken following an inspection of the company’s main warehouse in June. During the inspection FDA officials found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. The words “analgesic and antipyretic” were found on the packaging, according to the FDA.
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Medicines worth ₹11.19 lakh seized
The regulator seized Reactin Plus stock worth ₹11.19 lakh and ordered the firm to recall the drug from the market, citing packaging violations as per the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945.
The FDA said such promotion of a prescription medicine could encourage people to take the drug without medical advice, increasing the risk of self-medication.
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Irregularities in storage, distribution
The subsequent inspection of the company’s C&F operations also found several irregularities in the storage and distribution of medicines. These included discrepancies between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with recall directions.
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Furthermore, inspectors also found medicines stored directly on the floor and inadequate pallet and rack facilities. The FDA further flagged shortcomings in the records and procedures for handling expired medicines.
Show-cause notice issued
The FDA had issued a show-cause notice to the company over the alleged violations. Its response was examined by the FDA before the licences were cancelled under the relevant provisions of the Drugs and Cosmetics Act and Drugs Rules.
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. Any violation by any part of the drug manufacturing or distribution system will invite strict action under the law,” Mundhe said.
