Cipla Pune Unit Loses Drug Sale Licences: What Triggered FDA Action?

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences’ Pune C&F unit over what the regulator described as serious irregularities in the packaging, storage and recall of Reactin Plus tablets.

According to a PTI report citing a statement from the Maharashtra FDA, the cancellation took effect on August 27 after inspections of the unit’s main warehouse at Wadki in Pune district.

The regulator had found deficiencies in the unit’s drug storage and distribution practices, including medicines being kept directly on the floor and gaps in procedures for handling expired medicines.

Reactin Plus Packaging Triggered Regulatory Action

During an inspection around June, FDA officials found that the packaging of Reactin Plus, a Schedule H prescription medicine, carried an unauthorised claim describing the tablets as an “analgesic and antipyretic”, according to the regulator.

The FDA seized Reactin Plus stock worth ₹11.19 lakh, stating that the packaging claim was contrary to provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.

The regulator subsequently directed the company to recall the misbranded tablets from the market. However, the FDA said the company did not fully comply with the recall directions and the required measures.

FDA Flags Storage, Stock Record Lapses

A later inspection of the C&F unit’s drug sale and distribution system found further deficiencies, according to the FDA statement. These included discrepancies between physical stock, purchase and sale records, and computerised inventory.

The regulator also found medicines stored directly on the floor, along with inadequate pallet and rack arrangements. It flagged shortcomings in records and procedures related to expired medicines.

The FDA issued a show-cause notice to the licence holder and examined the company’s response. After reviewing the explanation, the regulator concluded that the deficiencies and directions related to the Reactin Plus recall had not been adequately addressed, PTI reported.

Maharashtra FDA Commissioner Tukaram Mundhe said the department would not show leniency on matters involving drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H medicines.

He said violations of rules by entities involved in the manufacture and distribution of medicines would invite action under the law.

Cipla Says Matter Is Sub Judice

Cipla Pharma & Life Sciences, in a statement, said it has contested the Pune FDA’s order concerning the C&F warehouse operated on its behalf. The company said “the matter is currently sub judice” and that it would not comment further while the issue is under judicial consideration.

Cipla also clarified that the order “does not allege any concerns relating to the safety, quality, or efficacy” of its products and does not involve or indicate any patient safety issue.

The company said it has been a trusted healthcare organisation for nine decades and continues to uphold high standards of quality, regulatory compliance and patient safety.