Cipla Pharma & Life Sciences’ Pune C&F unit has lost its drug sale licences following multiple violations found by the Maharashtra FDAThe regulator flagged misbranding of Reactin Plus Tablets, incomplete recall compliance, stock mismatches, improper storage and poor handling of expired medicines.
Published: August 28, 2026, 8:44 PM IST
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the action came into effect on August 27 following an inspection of the company’s warehouse at WadkiRepresentational Image
Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) unit in Pune has had its drug sale licences cancelled by the Maharashtra FDA over alleged irregularities involving the packaging, storage and recall of Reactin Plus TabletsAccording to the regulator, the action came into effect on August 27 following an inspection of the company’s warehouse at Wadki.
The regulator had found that medicines were stored directly on the floor and flagged deficiencies in procedures for handling expired medicinesDuring an inspection around June this year, officials found that the packaging of Reactin Plus tablets, a Schedule H prescription medicine, carried an unauthorised claim describing it as an “analgesic and antipyretic”, the statement said.
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The FDA seized stock worth Rs 11.19 lakh, saying such advertising was contrary to provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945The FDA subsequently directed the company to recall the misbranded Reactin Plus Tablets from the marketHowever, the company didn’t fully comply with the directions and required measures, the regulator stated.
A subsequent inspection of the C&F unit’s drug sale and distribution system found deficiencies in storage arrangements, discrepancies between purchase and sale records and actual computerised stock, and non-compliance with recall directions, according to the statementThe FDA also found discrepancies between physical stock and computerised records, medicines stored directly on the floor, inadequate pallet and rack arrangements, and deficiencies in records and procedures for handling expired medicines.
The department issued a show-cause notice to the licence holderAfter examining the company’s explanation, the FDA found that the deficiencies and directions concerning the recall of Reactin Plus Tablets had not been adequately complied withFDA Commissioner Tukaram Mundhe said the department would not show any leniency on issues concerning drug safety and public health, particularly in 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,” he said.
