Cipla Pune Unit's Drug Sale Licence Cancelled Over 'Irregularities'
The Maharashtra FDA has cancelled the drug sale licence of a Cipla unit in Pune due to significant regulatory violations, including improper storage and misbranding of prescription drugs. Cipla has contested the order and stated the matter is currently under judicial consideration.
Why it matters
This highlights critical lapses in pharmaceutical supply chain compliance and the potential risks to public health regarding drug safety and storage standards.
The Maharashtra Food and Drug Administration (FDA) cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) unit in Pune over serious irregularities related to the Reactin Plus Tablets. The irregularities found during the inspection include unauthorised advertising, multiple storage, stock records, and recall-related violations. According to an FDA statement, the licence cancellation came into effect on Thursday. The FDA said that medicines were stored directly on the floor at the unit, and there were deficiencies in procedures for handling expired medicines. During an inspection in June, officials found that the packaging of Reactin Plus tablets, which is a prescription medicine, carried an unauthorised claim describing it as an "analgesic and antipyretic". It seized stock worth Rs 11.19 lakh and directed the company to recall the 'misbranded' tablets.
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