&imwidth=800&imheight=600&format=webp&quality=medium "Maharashtra FDA cancels Cipla facility drug licences over Reactin Plus irregularities")
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) facility at Wadki in Pune, citing serious irregularities linked to Reactin Plus tablets. According to FDA officials, the licences were cancelled with effect from August 27 following inspections that revealed violations related to the storage, distribution and packaging of medicines.
Reactin Plus packaging violation
The action followed an inspection of the company’s main warehouse in June. During the inspection, FDA officials found unauthorised promotional wording on the packaging of Reactin Plus, which is classified as a Schedule H prescription medicine.
The words “analgesic and antipyretic” were printed on the packaging, according to the FDA. The regulator said such promotional information on a prescription medicine could encourage consumers to use the drug without consulting a doctor, potentially increasing the risk of self-medication.
Medicines worth ₹11.19 lakh seized
Following the inspection, the FDA seized Reactin Plus stock valued at ₹11.19 lakh and directed the company to recall the medicine from the market. The regulator cited provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, while taking action over the packaging violations.
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FDA flags storage and distribution lapses
A subsequent inspection of Cipla’s C&F operations revealed several additional irregularities involving the storage and distribution of medicines. The FDA found discrepancies between physical stock and computerised inventory records. Inspectors also identified gaps in purchase and sales records and alleged non-compliance with directions issued for the recall of medicines. The inspection further found medicines stored directly on the floor, along with inadequate pallet and rack facilities at the facility. The FDA also flagged shortcomings in the maintenance of records and procedures for dealing with expired medicines.
Show-cause notice issued to company
Before cancelling the licences, the FDA issued a show-cause notice to the company concerning the alleged violations. The regulator examined Cipla’s response before proceeding with the cancellation under the applicable provisions of the Drugs and Cosmetics Act and Drugs Rules. The licence cancellation came into effect on August 27, according to FDA officials.
