FDA Cancels Cipla Pune Unit Licence Over Reactin Plus Violations

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd's carrying and forwarding (C&F) unit in Pune over regulatory violations involving Reactin Plus Tablets.

The licence cancellation took effect on August 27 after an inspection of the company's main warehouse at Wadki in Pune district. The FDA cited irregularities involving drug packaging, storage, record-keeping and compliance with recall directions.

Cipla has contested the order, stating that the matter is currently sub judice. The pharmaceutical company also clarified that the FDA's action does not allege any issue concerning the safety, quality or efficacy of its products.

"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 said.

FDA FLAGS REACTIN PLUS PACKAGING CLAIM

The action followed an inspection conducted around June, during which FDA officials found that packaging for Reactin Plus Tablets, a Schedule H prescription medicine, carried an unauthorised description identifying the drug as an "analgesic and antipyretic".

According to the regulator, the claim had not received the required approval and 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 11.91 lakh.

RECALL AND STORAGE IRREGULARITIES

The regulator also directed the company to recall the affected Reactin Plus Tablets from the market.

However, the FDA said the company did not fully comply with the recall directions and related requirements.

A follow-up inspection of the Pune C&F facility found discrepancies between purchase and sales records and the computerised stock records. Officials also reported non-compliance with directions issued regarding the recall of the affected medicines.

The FDA further found medicines stored directly on the floor, along with inadequate pallet and rack arrangements. Deficiencies were also identified in records and procedures for handling expired medicines.

LICENCE CANCELLED AFTER SHOW-CAUSE NOTICE

Following the inspections, the FDA issued a show-cause notice to the licence holder and reviewed the company's response.

The regulator concluded that the deficiencies identified during the inspections and the directions relating to the Reactin Plus recall had not been adequately addressed.

The drug sale licence of Cipla Pharma & Life Sciences Ltd's C&F unit at Wadki was subsequently cancelled with effect from August 27.

FDA Commissioner Tukaram Mundhe said the department would take strict action over violations involving the advertising, sale, storage and distribution of Schedule H prescription medicines.

He said violations of drug regulations by entities involved in the manufacture and distribution of medicines would attract action under the law.

Cipla has maintained that the proceedings are under judicial consideration and that the FDA order does not involve or indicate any patient safety issue. The company has reiterated its commitment to quality, regulatory compliance and patient safety.