Stories
Maharashtra FDA Cancels Cipla Pune Warehouse Licenses Over Violations; Company Disputes Claims
- •Maharashtra's FDA cancelled Cipla's Pune warehouse licenses due to alleged violations concerning Reactin Plus Tablets and inspection deficiencies.
- •Cipla expressed disappointment, asserting its Pune warehouse complies with distribution, storage, and digital record-keeping standards, and is reviewing the order.
- •The FDA cited Reactin Plus packaging for unpermitted claims and illustrations, constituting misbranding under the Drugs and Cosmetics Act, 1940.
- •Deficiencies at the Wadki facility included medicines stored on the floor, dust accumulation, improper handling of expired medicines, and record discrepancies.
- •FDA Commissioner Tukaram Mundhe emphasized the department's goal to ensure medicine safety, quality, proper storage, and compliance across the drug supply chain.
Key Questions Answered
The Maharashtra FDA cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences' warehouse in Wadki, Pune, due to alleged violations concerning Reactin Plus Tablets. The regulator cited issues regarding unpermitted claims and illustrations on the product packaging and deficiencies found during inspections.
According to the FDA, the packaging of Reactin Plus described the prescription medicine as an analgesic and promoted its use for conditions like headaches, backaches, and joint pain using unauthorized text and a human figure illustration. The regulator stated these claims violated statutory provisions, constituting misbranding under the Drugs and Cosmetics Act, 1940.
The FDA identified multiple operational shortcomings, including medicines stored directly on the floor due to insufficient pallets, dust accumulation, and expired goods not isolated in a designated area. Inspectors also noted inventory discrepancies between computerized SAP records and physical stock, along with a lack of proper documentation for expired drug disposal.
