Terming the Maharashtra FDA's decision regarding its Wadki C&FA in Pune disappointing, Cipla told NDTV Profit it was reviewing the order and evaluating the options available to it.
The company maintained that the facility follows prescribed protocols for drug storage and distribution, along with applicable standards for digital record-keeping.
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Cipla reiterated its commitment to quality and patient safety and said it would continue working to ensure uninterrupted access to safe, high-quality medicines for patients and healthcare providers.
“Cipla maintains an unwavering commitment to quality and patient safety, and we find the Maharashtra FDA's decision regarding our Wadki C&FA in Pune disappointing,” the company said in a statement.
"We believe, our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards. We are reviewing the order and evaluating further options."
"Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers," the statement concluded.
The statement came after the Maharashtra Food and Drug Administration said on Friday that it had cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding (C&F) warehouse at Wadki in Pune over alleged violations.
The FDA said the latest action followed fresh proceedings conducted in compliance with directions issued by the Bombay High Court.
The order was passed on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune, after the regulator withdrew its earlier proceedings and initiated the process afresh.
The Maharashtra FDA said it issued Cipla a revised show-cause notice on September 4, followed by the company's written response and a personal hearing.
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The regulator cited alleged violations involving Reactin Plus packaging, including unauthorised claims describing it as an analgesic for various ailments, which it termed misbranding under the Drugs and Cosmetics Act.
The FDA also flagged medicines being stored directly on floors, dust accumulation, inadequate segregation of expired stock, missing disposal records and discrepancies between SAP records and physical inventory.
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