Maharashtra FDA cancels licence of Cipla's Pune unit

The Maharashtra Food and Drug Administration (FDA) has terminated the license for drug distribution of Cipla Pharma & Life Sciences Ltd’s Pune facility following serious infractions discovered during inspections concerning Reactin Plus tablets.The cancellation took effect on August 27, according to FDA officials. The decision stemmed from a June inspection of the company’s primary warehouse, where officials spotted unauthorized promotional language on Reactin Plus packaging.

This text included the terms "analgesic and antipyretic," which are prohibited for Schedule H prescription medications.The FDA seized Reactin Plus inventory valued at ₹11.19 lakh and instructed the firm to recall the drug from circulation, in accordance with the Drugs and Cosmetics Act, 1940, and Rules, 1945. The agency warned that promoting prescription medicines without proper authorization could lead consumers to self-medicate, heightening the risk of adverse effects.The FDA subsequently inspected Cipla Pharma’s commission and forwarding operations, uncovering multiple irregularities.

These issues included inconsistencies between physical and digital stock records, missing purchase and sale records, and failure to adhere to recall instructions.Additionally, inspectors observed medicines stored directly on the floor and inadequate pallet and rack systems. They also noted gaps in expired medications' handling procedures.

FDA Commissioner Tukaram Mundhe emphasized the department's commitment to drug safety and public health, stating that strict adherence to legal requirements is non-negotiable, especially in the areas of advertising, sale, storage, and distribution of Schedule H prescription drugs.