Maharashtra FDA Cancels Drug Sale Licences of Cipla’s Pune C&F Unit Over Reactin Plus Lapses

Maharashtra FDA Commissioner Tukaram Mundhe, whose department cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding unit at Wadki in Pune district over alleged packaging, storage, stock-record and recall irregularities involving Reactin Plus Tablets. The cancellation took effect on Thursday, August 27, 2026.

Regulator cites alleged packaging, storage, stock-record and recall violations; Cipla contests order and says no product safety or patient-safety issue has been alleged

Key Factors

• Maharashtra FDA cancels drug sale licences of Cipla Pharma & Life Sciences’ C&F facility at Wadki in Pune district
• Action linked to alleged irregularities involving Schedule H prescription medicine Reactin Plus Tablets
• FDA says medicines were found stored directly on the floor and stock-record discrepancies were detected
• Reactin Plus stock worth about ₹11.19 lakh was seized following an earlier inspection
• Regulator alleges recall directions were not adequately complied with
• Cipla contests the order, says matter is sub judice and stresses that no concerns over product safety, quality or efficacy have been alleged

Mumbai : The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) facility at Wadki in Pune district, citing a series of alleged regulatory lapses involving the packaging, storage, stock records and recall of Reactin Plus Tablets.

The cancellation took effect on Thursday, August 27, 2026, following regulatory proceedings arising from inspections of the facility.

According to the Maharashtra FDA, an inspection conducted around June found that the packaging of Reactin Plus Tablets — a Schedule H prescription medicine — carried the description “analgesic and antipyretic”, which the regulator considered an unauthorised promotional claim.

The FDA said the claim was contrary to provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

Stock of Reactin Plus valued at approximately ₹11.19 lakh was subsequently seized and the company was directed to recall the affected tablets from the market.

The regulator alleged that the recall directions and required corrective measures were not fully complied with.

Storage and Stock Records Also Under FDA Scanner

A subsequent examination of the C&F unit’s drug sale and distribution system brought further alleged deficiencies to the regulator’s attention.

According to the FDA, discrepancies were detected between physical stock, purchase and sale records and computerised inventory. Inspectors also allegedly found medicines stored directly on the floor, inadequate pallet and rack arrangements, and shortcomings in records and procedures concerning expired medicines.

The FDA subsequently issued a show-cause notice to the licence holder. After considering the company’s explanation, the regulator concluded that the deficiencies identified during the inspections and its directions concerning the Reactin Plus recall had not been adequately addressed.

Maharashtra FDA Commissioner Tukaram Mundhe said the regulator would maintain a strict approach towards violations affecting drug safety and public health, particularly in relation to the advertising, sale, storage and distribution of Schedule H prescription medicines.

“Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law,” Mundhe said.

Cipla Pharma & Life Sciences, however, has contested the FDA order and said the matter is currently sub judice.

The company clarified that the regulatory action concerns operations of a C&F warehouse operated on its behalf and said it would not be appropriate to comment further while the matter is under judicial consideration.

Importantly, Cipla said the FDA order does not allege concerns relating to the safety, quality or efficacy of its products and does not indicate any patient-safety issue.

The company also reiterated its commitment to quality, regulatory compliance and patient safety.