Maharashtra FDA Cancels Cipla Pune Unit’s Drug Licence Over Reactin Plus Lapses

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) unit in Pune over multiple regulatory violations linked to Reactin Plus Tablets, including alleged misbranding, improper storage, stock-record discrepancies and failure to fully comply with a recall order.

The cancellation came into effect on August 27 after the regulator inspected the company’s main warehouse at Wadki in Pune district.

The action followed an earlier inspection in June, when FDA officials found that the packaging of Reactin Plus, a Schedule H prescription medicine, carried an unauthorised claim describing it as an "analgesic and antipyretic". The regulator said the claim violated provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

The FDA subsequently seized Reactin Plus stock valued at around Rs 11.19 lakh and directed the company to recall the misbranded medicine from the market. However, according to the regulator, the company did not fully comply with the recall directions and other measures prescribed by the department.

Storage & Stock-Record Lapses Found

A subsequent inspection of the Pune C&F unit's drug sale and distribution system uncovered further deficiencies.

The FDA found discrepancies between physical stock and computerised inventory records, as well as inconsistencies involving purchase and sale records. Inspectors also found medicines being stored directly on the warehouse floor and flagged inadequate pallet and rack arrangements.

The regulator further identified deficiencies in the records and procedures followed for handling expired medicines. These findings added to the concerns surrounding the unit's compliance with drug storage and distribution requirements.

Following the findings, the FDA issued a show-cause notice to the licence holder. After examining the company's response, the department concluded that the deficiencies had not been adequately addressed and that the directions concerning the Reactin Plus recall had not been fully complied with.

Tukaram Mundhe Warns of Strict Action

Maharashtra FDA Commissioner Tukaram Mundhe said the department would maintain a strict approach towards violations involving drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H 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.

The FDA's action comes amid increased scrutiny of compliance in the pharmaceutical supply chain, with the regulator stressing that prescription medicines must meet prescribed standards not only at the manufacturing stage but also during storage, sale and distribution.

Cipla’s Statement

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 said 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 organisation for nine decades and continues to uphold the highest standards of quality, regulatory compliance and patient safety,” the company said.
 

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