Maharashtra FDA Cancels Pune Warehouse Licence for Cipla
The Maharashtra Food and Drug Administration cancelled the wholesale drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding warehouse at Wadki in Pune. The action followed fresh regulatory proceedings completed in compliance with directions from the Bombay High Court.
Commissioner of Food and Drug Administration, Maharashtra Tukaram Mundhe stated that the action was taken after completing the legal and regulatory procedures. The penalty stems from regulatory inspections targeting packaging violations and storage deficiencies involving Schedule H prescription drugs.
Misbranding Findings Over Reactin Plus Tablets
Inspectors focused part of their investigation on Reactin Plus Tablets, a Schedule H medicine restricted from over-the-counter sales. The product’s packaging carried unauthorized promotional claims describing it as an analgesic and anti-inflammatory agent providing quick relief from headaches, muscular pain, backaches, joint pain, sprains, body aches, and toothaches.
The packaging also featured an illustration of a human figure indicating muscular pain relief. Girish Hukare, Joint Commissioner (Drug), Pune, confirmed these text and illustration choices violated statutory requirements under the Drugs and Cosmetics Act, 1940, constituting misbranding.
Storage Deficiencies and Digital Record Discrepancies
Beyond packaging issues, enforcement officers uncovered severe warehouse management lapses during their site visit. Medicine boxes were found dumped on the floor with visible dust accumulation, while expired medications failed to sit in a designated “Not for Sale” zone.
Officials also discovered significant discrepancies between physical stock—including antibiotics—and computer records, alongside missing signatures on duplicate sales invoices and the absence of a mandatory inspection book. The FDA rejected the company’s defense that maintaining digital SAP records exempts a facility from physical safety, hygiene, and statutory paperwork mandates.
Cipla reviews order after regulatory cancellation notice
The October 1 order followed a sequence of legal notices after an initial August 27 enforcement action against the same warehouse. The department issued a revised show-cause notice on September 4, received Cipla’s written reply on September 11, and conducted a personal hearing on September 21.
In an official statement, Cipla expressed disappointment with the penalty. The company maintained that its Pune warehouse operates in full compliance with distribution protocols, storage standards, and digital record-keeping rules, adding that it is currently reviewing the order and evaluating further options while remaining dedicated to ensuring uninterrupted medicine supplies for patients and healthcare providers.
Maharashtra FDA cancels license over misbranded drug packaging
What specific drug triggered the regulatory action against Cipla’s Pune warehouse?
The enforcement action centered primarily on Reactin Plus Tablets, a Schedule H prescription drug that regulators found to be misbranded due to unauthorized analgesic claims and promotional human figures on its packaging.
When was the final cancellation order issued by the Maharashtra FDA?
Assistant Commissioner (Drugs), Division 3, FDA Pune passed the final cancellation order on October 1 following a revised show-cause notice issued on September 4 and a personal hearing granted on September 21.
What physical storage violations did inspectors find at the Wadki facility?
Inspectors discovered medicine boxes dumped on the floor with dust accumulation, expired products missing from designated “Not for Sale” zones, a missing mandatory inspection book, and inventory discrepancies between physical stock and computer SAP records.
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