Reactin Plus Violations: Maharashtra FDA Cancels Cipla Warehouse Licences
New Delhi: Following the fresh regulatory proceedings over Reactin Plus Tablets and deficiencies identified during inspections of the premises, Maharashtra's Food and Drug Administration (FDA) has revoked the drug sale and distribution licences of Warehouse No. A operated by Cipla Pharma & Life Sciences Ltd at Vadki in Pune.
According to a recent report by ET, the FDA’s Pune office completed the prescribed legal procedure in line with directions from the Bombay High Court before taking the action. The warehouse is operated by Cipla Pharma & Life Sciences Ltd, a subsidiary of Cipla Ltd. The regulator announced the decision in a statement issued on Friday.
The proceedings concerned Reactin Plus Tablets, a Schedule H prescription medicine, whose packaging carried advertisements and therapeutic claims that the FDA said were impermissible under the applicable provisions.
Further inspections revealed shortcomings in medicine storage, record maintenance, stock management and the handling of expired products.
The FDA stated that it had withdrawn its previous proceedings against the warehouse following the Bombay High Court’s directions in Writ Petition No. 11376/2026. It subsequently initiated fresh proceedings by issuing a revised show-cause notice to the company on September 4.
Cipla filed its written response on September 11 and was provided an opportunity for a personal hearing on September 21. After examining the reply, submissions made at the hearing, inspection findings, relevant records, and statutory provisions, the licensing authority passed a fresh, reasoned order on October 1 cancelling the licenses.
During the warehouse inspection, officials found that the Reactin Plus packaging described the product as an analgesic and promoted it for headache, muscular pain, backache, joint pain, sprain, body ache, and toothache.
The packaging also featured a human figure and imagery suggesting relief from muscular pain. According to the FDA, these claims and illustrations failed to meet statutory requirements and amounted to misbranding under the Drugs and Cosmetics Act, 1940.
Inspectors also observed medicines placed directly on the floor because sufficient pallets or racks were unavailable. Dust on stocks and inadequate cleanliness were among the other deficiencies recorded.
Expired medicines had not been segregated in a designated area marked “Expiry-Not for Sale”. The regulator also found that disposal records and standard operating procedures for handling these medicines were unavailable.
The FDA further identified shortcomings in purchase invoices and sales records. It reported mismatches between physical inventory and computerised or SAP stock records, including discrepancies involving antibiotics.
The October 1 order followed an earlier regulatory action taken on August 27 concerning Reactin Plus packaging, storage conditions, documentation and recall. Those proceedings were later withdrawn pursuant to the court’s directions, after which the FDA conducted the process afresh.
FDA Commissioner Tukaram Mundhe said the department’s aim was to safeguard medicine quality and safety, ensure appropriate storage and secure compliance with statutory requirements throughout the drug supply chain, ET reported.
