FDA Crackdown on Cipla Pharma's Pune Unit, License Cancelled over 'Unauthorised Promotional Text'
The regulator seized stock worth ₹11.19 lakh after finding misbranded packaging, storage lapses and recall failures at the company’s Pune unit.
- On August 27, the Maharashtra Food and Drug Administration cancelled the drug sale licenses of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding unit in Pune following inspection of its main warehouse at Wadki.
- An inspection in June revealed Reactin Plus Tablets packaging carried an unauthorized "analgesic and antipyretic" claim, violating the Drugs and Cosmetics Act and Drugs Rules; the FDA ordered a recall that the company failed to execute adequately.
- Further audits of the Wadki warehouse uncovered medicines stored directly on the floor and discrepancies between physical stock and computerized records. Officials seized misbranded Reactin Plus inventory valued at Rs 11.19 lakh.
- Maharashtra FDA Commissioner Tukaram Mundhe warned that the department would maintain a strict approach toward violations affecting drug safety. "Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," he said.
- Intensified enforcement measures now aim to ensure lawful storage and effective recall mechanisms across the pharmaceutical supply chain. Joint Commissioner Ganesh Rokade noted the department is continuing audits to guarantee medicine quality and safety statewide.
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11 Articles
Maharashtra FDA cancels Cipla unit's drug licences in Pune over Reactin Plus recall, storage lapses
Maharashtra FDA has cancelled the drug sale licences of Cipla Pharma & Life Sciences' Pune C&F unit following multiple violations. The regulator cited misbranding of Reactin Plus Tablets, incomplete recall compliance, stock discrepancies, improper storage and lapses in handling expired medicines.
The Maharashtra FDA has revoked the drug sales license of Cipla's Pune C&F Center. The administration took this action after an investigation into the Reactin Plus tablets revealed irregularities and violations. The company has also been directed to withdraw the drugs from the market.
FDA cancels Cipla Pune unit's licence over Reactin Plus storage, record lapses
The action was taken after an inspection of the company's Wadki facility found discrepancies between physical stock and computerised records, lapses in stock management and inadequate storage arrangements.
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