Cipla Warehouse Licences Cancelled
Maharashtra FDA Cancels Cipla Pune Warehouse Licences Over Regulatory and Misbranding Violations
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Key Points
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Before the licence cancellation, the FDA had seized Reactin Plus stock worth about Rs 11.2 lakh and ordered its recall.
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The latest cancellation followed an earlier FDA action against the warehouse on August 27 over alleged irregularities involving Reactin Plus packaging, storage, documentation and recall.
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FDA Commissioner Tukaram Mundhe said the department’s aim was not simply enforcement, but to ensure medicine safety and quality and statutory compliance throughout the drug supply chain.
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Mundhe said the proceedings respected the Bombay High Court’s directions and followed principles of natural justice, transparency and hearing before a reasoned decision.
Maharashtra's Food and Drug Administration cancelled the drug sale and distribution licences for a Cipla warehouse in Wadki, Pune, after finding widespread violations in medicine safety and handling. India Today reports the FDA cited misbranding of Reactin Plus, a prescription-only painkiller, along with defects in storage, hygiene, record-keeping, and disposal of expired drugs.
The action follows an earlier August 27 FDA crackdown that seized Rs 11.2 lakh worth of Reactin Plus stock and ordered a recall. Moneycontrol states FDA Commissioner Tukaram Mundhe emphasized the agency's focus on ensuring medicine safety and quality across the entire drug supply chain, not just enforcement for its own sake.
Reactin Plus Packaging Violated Drug Rules
The FDA found that Reactin Plus, which requires a doctor's prescription, was packaged and labelled to promote relief for multiple types of pain — a violation of drug regulations. NDTV notes the packaging crossed the line from legal medical claims into consumer advertising. This misbranding triggered the initial August seizure of stock worth Rs 11.2 lakh.
Warehouse Failed Hygiene and Storage Standards
Beyond the Reactin Plus issue, inspectors found serious gaps in how the warehouse operated. Rediff reports problems included poor storage conditions, hygiene failures, incomplete record-keeping, and improper handling of expired medications. These deficiencies raised questions about the safety and integrity of all drugs stored at the facility.
FDA Followed Legal Process, Court Directions
The cancellation came after fresh proceedings ordered by the Bombay High Court. Moneycontrol reports that Commissioner Mundhe said the FDA issued a revised notice, reviewed Cipla's written response and hearing submissions, and applied principles of natural justice and transparency before the final decision. The process respected the court's prior directions on how to handle the case.
Cipla Calls Decision Disappointing
Cipla described the licence cancellation as disappointing but did not immediately outline plans to appeal or challenge the order. India Today notes the company's warehouse now loses its ability to sell and distribute drugs in Maharashtra, a major setback for operations at the Pune facility.
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