Stories
Maharashtra FDA Cancels Cipla Warehouse Licenses Over Violations
- •The Maharashtra FDA cancelled Cipla Pharma & Life Sciences Ltd's C&F warehouse licenses at Wadki, Pune, due to alleged violations.
- •The action followed fresh proceedings in compliance with Bombay High Court directions, ensuring safety and quality in the drug supply chain.
- •Key issues included misbranding of Reactin Plus Tablets, with unauthorized claims and illustrations on packaging, violating the Drugs and Cosmetics Act, 1940.
- •Deficiencies in storage and warehouse management were cited, including lack of inspection books, improper storage, dust accumulation, and inadequate handling of expired medicines.
- •Cipla expressed disappointment, stating its Pune C&FA warehouse operates in compliance, and is reviewing the order while evaluating further options.
Key Questions Answered
The Maharashtra FDA cancelled the licences of Cipla's C&F warehouse at Wadki in Pune following alleged violations, including misbranding and unauthorised promotional claims on the packaging of Reactin Plus Tablets under the Drugs and Cosmetics Act, 1940, along with several storage and record-keeping deficiencies.
The FDA found that the packaging of the Schedule H prescription medicine carried unauthorised claims describing it as an analgesic, along with illustrations and wording promoting its use for various pains, constituting misbranding.
Inspectors found the absence of the prescribed Form 35 inspection book, boxes stored directly on the floor due to inadequate pallets or racks, dust accumulation, and shortcomings in cleanliness. Additionally, expired medicines lacked a designated marked area, and required standard operating procedures for their disposal were unavailable.
