Maharashtra FDA Cancels Drug Sale Licences Of Cipla Pharma & Life Sciences’ Pune C&F Unit Over Reactin Plus Irregularities

The Maharashtra FDA has cancelled the drug sale licences of Cipla Pharma & Life Sciences’ Wadki facility in Pune with immediate effect from August 27, citing unauthorised claims on Reactin Plus, incomplete recall compliance, stock discrepancies and deficiencies in drug storage and records. Cipla’s response was awaited.

Maharashtra FDA cancels the drug sale licences of Cipla’s Wadki facility after citing multiple regulatory violations involving Reactin Plus | AI Generated Representational Image

Mumbai, August 28, 2026: The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd.’s Carry & Forwarding (C&F) establishment at Wadki in Pune, citing violations related to the packaging of a Schedule H drug, failure to comply with recall directions and serious deficiencies in drug storage and record-keeping.

The licences were cancelled with immediate effect from August 27, according to the FDA order issued on Thursday.

Reactin Plus Packaging Violation

The FDA had inspected the company’s main warehouse at Wadki around June and found Reactin Plus Tablets, a Schedule H medicine, carrying the unauthorised claim “analgesic and antipyretic” on its packaging. The department seized stock worth Rs 11.19 lakh, terming the drug misbranded under provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945.

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“Analgesic” refers to a pain-relieving medicine, while “antipyretic” means a medicine that reduces fever. The FDA objected to the unauthorised therapeutic claim on the packaging of a prescription medicine, saying such labelling could make consumers perceive it as suitable for treating pain or fever and potentially encourage self-medication without medical advice.

The FDA said such promotion of a prescription drug could increase the risk of inappropriate use and pose a public health concern. The company was subsequently directed to recall the affected stock from the market.

Maharashtra FDA has cancelled the C&F drug sale licence of Cipla Pharma & Life Sciences’ Pune unit over serious irregularities in the Reactin Plus Tablets case. An unauthorised advertisement and multiple storage, stock-record and recall-related violations were found during… pic.twitter.com/bTzr5MJxCI

— IANS (@ians_india) August 28, 2026

Recall And Storage Deficiencies

However, during a subsequent inspection of the C&F establishment, officials found that the company had not fully complied with the recall directions. The inspection also revealed discrepancies between physical and computerised stock records, deficiencies in purchase and sale records, and shortcomings in the storage of medicines.

Officials found medicines kept directly on the floor and inadequate availability of pallets and racks required for proper storage. There were also deficiencies in the maintenance of records and procedures related to expired medicines.

FDA Cancels Drug Sale Licences

The FDA issued a show-cause notice to the licence holder. After examining the company’s explanation and inspection findings, the department concluded that the violations warranted cancellation of the drug sale licences.

An email was sent to Cipla’s corporate communications team seeking the company’s response to the FDA’s findings and cancellation of the licences. However, no response was received until the time of going to press.

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Cipla Pharma & Life Sciences (CPLS) has contested the Pune FDA’s order and said the matter is currently sub judice. The company also clarified that the order does not allege concerns relating to the safety, quality or efficacy of its products, and does not involve or indicate any patient safety issue.

In a statement, Cipla Pharma & Life Sciences said:

“Cipla Pharma & Life Sciences (CPLS) has contested the Pune FDA's order pertaining to the operations of a C&F warehouse operated on behalf of CPLS and the matter is currently sub judice. As the issue is under judicial consideration, it would not be appropriate to comment further on the proceedings at this stage.We would, however, like to clarify that the order does not allege any concerns relating to the safety, quality, or efficacy of our products, nor does it involve or indicate any patient safety issue.Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance, and patient safety.”

The statement comes after the FDA cancelled the licences with immediate effect from August 27. Cipla said that since the matter is under judicial consideration, it would not be appropriate to comment further on the proceedings at this stage.

FDA Commissioner On Drug Safety

FDA Commissioner Tukaram Mundhe said the department would not compromise on drug safety and public health, particularly in the case of prescription medicines such as Schedule H drugs.

“Strict compliance with legal provisions governing the advertising, sale, storage and distribution of medicines is essential. Any violation by entities involved in the drug supply chain will invite strict action as per law,” Mundhe said.

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