Pune, October 2 (Daily Kiran) : The Maharashtra Food and Drug Administration (FDA) has revoked the license of Cipla Pharma and Life Sciences Limited’s warehouse located in Wadki, Pune. This decision, announced on October 1, followed a review prompted by the Bombay High Court, which highlighted several alleged deficiencies in the warehouse’s operations related to drug packaging, storage, inventory management, and documentation.
The FDA’s action comes after an initial investigation began on August 27. However, this was later paused to reassess the situation under revised procedures. Concerns were raised regarding the packaging and promotion of the prescription drug ‘Reactin Plus Tablets,’ which fell under Schedule H.
Regulatory officials claimed that the packaging made unauthorized health claims. They also identified shortcomings in how the warehouse handled drug storage, record-keeping, and the management of expired medications.
Following the High Court’s guidance, the FDA issued a revised show-cause notice to Cipla on September 4. The company responded in writing on September 11 and presented its case during a personal hearing on September 21. After reviewing the company’s response and relevant legal provisions, the licensing authority determined that revoking the license was warranted.
The FDA stated that this decision was based on the findings from the comprehensive review process and should not be seen as a mere repetition of previous actions. The packaging of ‘Reactin Plus’ was a major focus, as it was labeled as a pain reliever and claimed to provide relief from headaches, muscle pain, backaches, joint pain, sprains, body aches, and toothaches. The FDA also raised objections to the use of images depicting a human figure and illustrations suggesting relief from muscle pain on the packaging.
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