FDA Cracks Down on Cipla Pune: Drug Sales License Cancelled Over Major Irregularities

The Maharashtra Food and Drug Administration (FDA) has taken stringent action against Cipla Pharma & Life Sciences Ltd, revoking the drug sale licences for its Carry and Forwarding (C&F) facility in Wadki, Pune. This significant move, effective August 27, comes after inspectors uncovered a series of serious irregularities during their inspections, particularly concerning the widely used Reactin Plus tablets.

A primary reason for the cancellation was the discovery of unauthorised promotional text on the packaging of Reactin Plus.

Despite being a Schedule H prescription medicine, the packaging prominently featured the words “analgesic and antipyretic.” The FDA emphasized that such promotional language on a prescription drug could encourage self-medication, posing a risk to public health.

Following this discovery, the regulator seized Reactin Plus stock valued at ₹11.19 lakh and mandated the immediate recall of the drug from the market, citing violations of the Drugs and Cosmetics Act, 1940 and Rules, 1945. Further investigations into Cipla's C&F operations revealed a host of other critical issues in the storage and distribution of medicines.

Inspectors noted significant discrepancies between the physical stock and computerised records, along with gaps in purchase and sale records.

Additionally, the facility was found to be non-compliant with recall directions.

Physical storage conditions were also problematic, with medicines stored directly on the floor and a severe lack of adequate pallet and rack facilities.

These findings highlight a broader failure in maintaining proper inventory management and storage standards, which are crucial for ensuring the integrity and safety of pharmaceutical products. #Cipla #FDACrackdown #DrugSafety #PharmaNews