Mumbai – The Maharashtra Food and Drug Administration (FDA) has canceled the drug sale and distribution licenses of Cipla Pharma & Life Sciences Ltd.’s warehouse in Wadki, Pune, citing alleged violations involving drug packaging, storage, inventory management and recordkeeping.
The cancellation order was issued October 1 by the Assistant Commissioner (Drugs), Division 3, Pune, following a fresh review conducted under directions from the Bombay High Court.
The action follows earlier proceedings initiated against the facility on August 27, which were subsequently withdrawn and reconsidered. The FDA issued a revised show-cause notice on September 4, received Cipla’s written response on September 11 and held a hearing on September 21 before issuing its latest order.
A central concern was the packaging of Reactin Plus Tablets, a Schedule H prescription medication. According to the regulator, the packaging contained unauthorized claims promoting the drug for headaches, muscular pain, backaches, joint pain, sprains, body aches and toothaches.
The FDA also objected to illustrations on the packaging, including a human figure suggesting relief from muscular pain. It alleged that the claims and images violated the Drugs and Cosmetics Act, 1940, and constituted misbranding.
The regulator maintained that Cipla, as the product’s marketer, remained responsible for compliance even though the medication was manufactured by another company.
Inspections also identified alleged shortcomings in warehouse operations, including the absence of a mandatory Form 35 inspection book, inadequate storage infrastructure, medicines stored directly on the floor, dust accumulation on drug stocks and poor maintenance.
The FDA further alleged that expired medicines were not kept in a designated area clearly labeled “Expiry-Not for Sale.” It also cited missing standard operating procedures and inadequate records concerning the disposal of expired drugs.
After reviewing Cipla’s submissions, inspection findings and relevant legal provisions, the licensing authority determined that the violations warranted cancellation of the warehouse’s licenses.
The regulator emphasized that its latest decision was an independent determination based on renewed proceedings rather than a repetition of its earlier action. (Source: IANS)
