03 October,2026 08:58 AM IST | Mumbai | Abhitash Singh
FDA inspection of drug facilities covers packaging, storage conditions, and purchase and sale records. Representation pic/iStock
In a significant regulatory crackdown, Maharashtra's Food and Drugs Administration (FDA) has cancelled the wholesale and distribution licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding warehouse located at Wadki in Pune.
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The action follows directions from the Bombay High Court in Writ Petition No. 11376/2026. Complying with the court's order, the department set aside its earlier proceedings and initiated a fresh legal process by serving a revised show-cause notice on September 4. Following Cipla's written explanation on September 11, and a personal hearing on September 21, the Licensing Authority & Assistant Commissioner (Drugs), FDA Pune Circle-3, issued a reasoned order on October 1 revoking the licences.
The regulatory clampdown was triggered by findings of misbranding on the packaging of Reactin Plus tablets, a Schedule H prescription formulation. Packaging at the warehouse displayed promotional claims promising quick relief from headaches, body ache, toothache, and muscular pain, alongside human illustrations showing pain relief.
The FDA held that such advertising directly violates provisions of the Drugs and Cosmetics Act, 1940. Dismissing Cipla's defence and holding the manufacturer accountable, the authority clarified that as a marketer introducing drugs into the supply chain, the company cannot bypass its statutory liabilities.
A physical inspection of the Wadki warehouse also unmasked extensive operational and storage lapses. Investigators discovered that drug cartons were stacked directly on the floor without pallets, accumulating dust under poor hygienic conditions. The facility lacked the mandatory Form 35 inspection book, had no designated signage or standard operating procedures for expired drugs, and showed multiple discrepancies in purchase and sale documentation. Crucially, FDA officers detected sharp mismatches between physical inventory and digital SAP records, which notably involved critical antibiotic stocks.
Tukaram Mundhe, FDA commissioner
âThe FDA's objective is not merely punitive action, but ensuring drug safety, quality, and statutory compliance across the supply chain. This action was executed adhering strictly to natural justice, transparency, and reasoned procedure. The administration will continue enforcing stringent measures to ensure compliance with drug safety laws.'
Issuing an official statement about the incident, Cipla said, "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."
"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," they added.
The pharmaceutical further added, "Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers."
