- On August 27, 2026, the FDA cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) unit in Pune due to serious irregularities in the handling of Reactin Plus Tablets.
- The FDA seized stock worth ₹11.19 lakh and directed the recall of misbranded Reactin Plus Tablets after finding that the packaging carried an unauthorized claim of being an 'analgesic and antipyretic'.
- A subsequent inspection revealed storage and record-keeping deficiencies, including medicines stored directly on the floor and discrepancies between physical stock and computerized records.
- After issuing a show-cause notice and examining the company's response, the FDA concluded that there was inadequate compliance with the required corrective measures.
- During an inspection in June 2026, FDA officials discovered that the packaging of Reactin Plus Tablets, a Schedule H prescription medicine, contained unauthorized advertising claims.
- The FDA emphasized that strict compliance with legal requirements is essential for the advertising, sale, storage, and distribution of prescription medicines.
The Maharashtra FDA has cancelled the drug sale licence of Cipla Pharma's Pune unit due to serious irregularities in the handling of Reactin Plus Tablets. The cancellation, effective August 27, followed an inspection revealing multiple violations, including improper storage and unauthorized advertising claims.128
During the June inspection, FDA officials found medicines stored directly on the floor and noted discrepancies between physical stock and computerized records. The packaging of Reactin Plus, a Schedule H prescription medicine, was flagged for carrying unauthorized claims of being an "analgesic and antipyretic," violating the Drugs and Cosmetics Act, 1940.
The FDA seized stock valued at ₹11.19 lakh and directed Cipla to recall the misbranded tablets. However, the company failed to comply fully with the recall directives, prompting the FDA to issue a show-cause notice. FDA Commissioner Tukaram Mundhe emphasized that the department would not tolerate violations affecting drug safety and public health, stating, "Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law."7
The FDA's findings included inadequate pallet and rack arrangements, deficiencies in handling expired medicines, and non-compliance with recall instructions. Joint Commissioner Ganesh Rokade noted that intensified inspection measures are in place to ensure the lawful distribution of medicines across Maharashtra.
“The FDA found medicines stored directly on the floor and discrepancies between physical and computerised stock, prompting Commissioner Tukaram Mundhe to warn that any violation will invite strict action. The company failed to fully comply with recall directions, leading to the cancellation effective August 27.”
The Indian Express
