Cipla Pune warehouse licence cancelled over Reactin Plus packaging claims

Maharashtra's Food and Drug Administration cancelled the drug sale and distribution licences for Cipla Pharma & Life Sciences Ltd's Warehouse No. A at Wadki, Pune, on October 1. The action was taken over prohibited claims on Reactin Plus packaging and a series of storage and documentation violations found during inspections.

Inspectors found the Reactin Plus packaging carried claims describing the medicine as an analgesic and promoting its use for headache, muscular pain, backache, joint pain, sprain, body ache, and toothache. The packaging also featured a human figure depicting relief from muscular pain. The FDA stated these claims and illustrations did not comply with statutory provisions and constituted misbranding under the Drugs and Cosmetics Act, 1940.

Storage and Documentation Deficiencies

The inspection revealed widespread failures in basic warehouse operations. Medicines were stored directly on the floor due to inadequate pallets or racks. Dust had accumulated on drug stocks, and general cleanliness was lacking. Expired medicines were not kept in a separately marked 'Expiry-Not for Sale' area. The facility also lacked the required standard operating procedure and records for the disposal of these expired drugs.

Record-keeping was deficient. The FDA noted problems with purchase invoices and sale-invoice records, including issues with signatures on duplicate copies. Significant discrepancies were found between the computerised SAP records and the physical stock on hand, a finding that included antibiotics. The regulator concluded that maintaining digital records does not exempt a licensed establishment from its statutory responsibilities regarding physical stock, storage, and documentation.

Regulatory Process and Company Response

The October 1 order followed a fresh regulatory process initiated after the Bombay High Court directed the FDA to withdraw its earlier August 27 action against the same facility. The regulator issued a revised show-cause notice on September 4. Cipla submitted a written reply on September 11 and was given a personal hearing on September 21. The licensing authority said it considered the company's response, hearing submissions, inspection findings, and legal provisions before issuing the final cancellation order.

FDA Commissioner Tukaram Mundhe stated the action was taken after proceedings respected the Bombay High Court's directions. "The department's objective was to ensure the safety and quality of medicines, proper storage and statutory compliance across the drug supply chain," Mundhe said. Reactin Plus Tablets are a Schedule H prescription drug.

Cipla expressed disappointment with the decision. The company maintained that its Pune carrying and forwarding warehouse complies with distribution, storage, and digital record-keeping standards. It reiterated its commitment to quality and patient safety, adding that it remains focused on ensuring uninterrupted access to medicines. Cipla is reviewing the order and evaluating further options.