Maharashtra FDA cancels Cipla's Pune C&F unit drug sale licenses over storage and recall violations

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) unit in Pune, citing serious irregularities regarding the storage, packaging, and recall procedures for Reactin Plus Tablets, the regulatory body announced.

The licence cancellation took effect on August 27 following an inspection at the company's primary warehouse located in Wadki, Pune district, according to a statement released by the regulator on Friday.

During an initial inspection around June this year, FDA officials discovered that the packaging for Reactin Plus tablets, a Schedule H prescription drug, carried an unauthorised claim describing the medication as an "analgesic and antipyretic." Acting on these findings, the FDA seized stock valued at Rs 11.19 lakh, noting that such promotional statements violate provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

Following the initial inspection, the regulator ordered the company to pull the misbranded Reactin Plus Tablets from the market. However, the FDA stated that the firm failed to fully comply with the recall directions and necessary measures.

A subsequent review of the unit's distribution and sales system uncovered further non-compliance. Inspectors identified discrepancies between actual computerised stock and physical purchase-and-sale records, inadequate pallet and rack setups, improper storage of medicines directly on the floor, and deficient procedures for handling expired drugs.

The FDA issued a show-cause notice to the licence holder following the findings. After evaluating the company's response, the regulatory authority determined that the cited deficiencies and recall directives had not been adequately addressed.

FDA Commissioner Tukaram Mundhe emphasized that the department maintains a zero-tolerance policy regarding public health and drug safety, particularly concerning Schedule H prescription drugs and their storage, sale, advertising, and distribution.

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

Responding to the action, Cipla Pharma & Life Sciences (CPLS) stated that it has contested the Pune FDA's order regarding the operations of the C&F warehouse, noting that "the matter is currently sub judice" and refraining from further comments on the ongoing judicial proceedings. The company clarified that the regulatory order does not allege any concerns regarding the safety, quality, or efficacy of its products, nor does it indicate any patient safety issues.